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Solea 100 User Manual

The Solea 100 User Manual provides comprehensive instructions for operating a fully automated coagulation analyzer designed for in vitro blood plasma analysis. It includes safety information, operational guidelines, maintenance procedures, and troubleshooting tips to ensure effective use and compliance with safety regulations. The analyzer features high throughput capabilities, continuous operation, and advanced measurement technologies for accurate coagulation testing.
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0% found this document useful (0 votes)
34 views181 pages

Solea 100 User Manual

The Solea 100 User Manual provides comprehensive instructions for operating a fully automated coagulation analyzer designed for in vitro blood plasma analysis. It includes safety information, operational guidelines, maintenance procedures, and troubleshooting tips to ensure effective use and compliance with safety regulations. The analyzer features high throughput capabilities, continuous operation, and advanced measurement technologies for accurate coagulation testing.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 181

SUP/MAN/0030 - Version 1 - 20/02/2024

Fully automated coagulation analyser

User manual

SOLEA-100_USER-MANUAL_EN 1 / 181
SUP/MAN/0030 - Version 1 - 20/02/2024

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Table of contents

SAFETY INFORMATION ................................................................................................................................. 5


GENERAL SAFETY INFORMATION..................................................................................................................................6
WARNINGS ..............................................................................................................................................................9
GRAPHIC SYMBOLS .................................................................................................................................................10
INTRODUCTION ........................................................................................................................................... 11
GENERAL ...............................................................................................................................................................12
THE ANALYZER PRINCIPLE .........................................................................................................................................13
ANALYZER OVERVIEW ..............................................................................................................................................15
ACCESSORIES..........................................................................................................................................................21
SPECIFICATIONS .......................................................................................................................................... 27
PC ...................................................................................................................................................................31
ANALYZER PREPARATION .......................................................................................................................... 33
GETTING STARTED ..................................................................................................................................................34
LOCATION..............................................................................................................................................................35
PREPARATIONS FOR OPERATION................................................................................................................................36
ACCESS RIGHTS ......................................................................................................................................................37
USER INTERFACE OVERVIEW .....................................................................................................................................38
HARDWARE PREPARATION........................................................................................................................................39
OPERATION .................................................................................................................................................. 43
MAIN MENU WINDOW ............................................................................................................................................45
SAMPLE PROCESSING ...............................................................................................................................................50
STAT ...................................................................................................................................................................53
RUN DISPLAY .........................................................................................................................................................54
REAGENT...............................................................................................................................................................55
CALIBRATION..........................................................................................................................................................59
QUALITY CONTROL..................................................................................................................................................68
QC ..................................................................................................................................................................69
HARDWARE ...........................................................................................................................................................73
RESULTS ................................................................................................................................................................79
BACKUP ................................................................................................................................................................85
TEST PARAMETERS ..................................................................................................................................................86
EXIT .....................................................................................................................................................................87
MAINTENANCE AND CARE ......................................................................................................................... 89
OVERVIEW.............................................................................................................................................................90
REGULAR MAINTENANCE ACTIONS ............................................................................................................................91
SPECIFIC MAINTENANCE ACTIONS..............................................................................................................................95
REPLACING HARDWARE COMPONENTS .......................................................................................................................99
TROUBLE SHOOTING ................................................................................................................................. 105
PC AND COMMUNICATION .................................................................................................................................... 107
SAMPLER............................................................................................................................................................ 109
NEEDLE LIQUID SENSOR ........................................................................................................................................ 110
DILUTOR ............................................................................................................................................................ 111
WASH STATION ................................................................................................................................................... 113
DISPENSING AND LIQUID SYSTEM ........................................................................................................................... 114
CUVETTE RACK TRANSPORT SYSTEM ....................................................................................................................... 115

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MEASURING RESULTS ........................................................................................................................................... 116


MESSAGES .................................................................................................................................................. 119
RESULT ERROR FLAGS........................................................................................................................................... 120
MESSAGES.......................................................................................................................................................... 124
TRANSPORT MOTOR ERROR CODES ......................................................................................................................... 169
ACCESSORIES ............................................................................................................................................. 172
INDEX .......................................................................................................................................................... 177
PERSONAL NOTES: .............................................................................................................................................. 179

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Safety information
This chapter includes all general safety information and explanations of the safety symbols and used
remark definitions, used in this document.

Table of contents
GENERAL SAFETY INFORMATION............................................................................................................. 6

WARNINGS ............................................................................................................................................ 9

GRAPHIC SYMBOLS .............................................................................................................................. 10

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General safety information


All biological substances should be regarded as a potential source of infection!

Wear gloves when handling blood, blood samples and objects contaminated by blood!
Follow good laboratory practices and regularly change lab gloves to minimize the
risk of infection and contamination (especially after contact with waste or sample
material).

CAUTION!
▪ Strictly follow the existing regulations pertaining to the handling and manipulation of reagents and
blood samples for laboratory use!

▪ To avoid serious or fatal injury, read this publication thoroughly before you use the analyzer.
▪ Pay particular attention to all safety precautions.
▪ Always follow the instructions in this publication.
▪ Do not use the analyzer in a way that is not described in this publication.

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ATTENTION!
▪ Keep this publication in a safe place to ensure that it is not damaged and remains available for
use. This publication must always be easily accessible.

▪ This analyzer shall only be operated by trained specialists, who have been instructed and
trained in In Vitro Diagnostic procedures. They must be familiar with the instructions and able
to work accordingly in order to fully utilize the analyzers functionality.

▪ This equipment generates, uses and can radiate radio frequency energy, and, if not installed
in accordance with measures stated in the instruction manual, may cause harmful interference
to radio communications. We recommend that you observe the different warnings inscribed on
the analyzer itself and indicated in the documentation supplied.

▪ This product is an In Vitro Diagnostic medical device. It complies with the requirements of the
regulation 2017/746 and the standards mentioned in the certificate supplied with it. These
limits are designed to provide reasonable protection against harmful interference when the
equipment is operated in a, commercial or ”light industrial” environment.

▪ Any use of the device beyond the purpose (Intended Use), leads to a repeal of the guarantee
by the manufacturer.
▪ If the equipment is used in a manor deviating from the specifications of the
manufacturer, the protection can be impaired or be without function.
▪ Intervention in and modification of the product, not explicitly approved by the
equipment manufacturer, may result in loss of functional capability. The costs for
necessary repairs are to be borne by the user.
▪ The equipment manufacturer is not liable for any damage resulting from disregard of
the specifications stated in these instructions, damage caused by handling of reagents
and biological fluids, or other action with the product not in conformity with these
instructions.

▪ This device has been designed and tested in accordance with CISPR 11 Class A. It may
cause radio interference in a domestic environment. In this case, it may be necessary to take
action to eliminate the interference.

▪ The system generates liquid and solid waste. Liquid waste contains concentrated reaction
solutions, solid
▪ waste is potentially biohazardous. Improper disposal may contaminate the environment.
▪ Treat solid waste as infectious waste.
▪ Dispose of waste in accordance with the local regulations.

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Infectious waste
Contact with solid waste may result in infection. All materials and mechanical components associated
with the solid waste systems are potentially biohazardous.
▪ Wear appropriate personal protective equipment. Take extra care when working with lab
gloves. They can easily be pierced or cut, leading to infection.
▪ If any biohazardous material is spilled, wipe it up immediately and apply a disinfectant.
▪ If waste comes into contact with your skin, wash the affected area immediately with soap and
water and apply a disinfectant.
▪ Use an appropriate solid waste container for the used cuvette racks.

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Warnings
ATTENTION!

It is strongly recommended that the user reads and understands these instructions in order to fully
utilize the analyzers capacity!

Meaning of the warnings used in this document

WARNING! Indicates a hazardous situation which, if not avoided, could result in death or serious
injury.

CAUTION! Indicates a hazardous situation that, if not avoided, could result in minor or moderate
injury.

ATTENTION! Indicates a hazardous situation that, if not avoided, may result in damage to the
system.

IMPORTANT! Indicates important information to verify correct execution of technical procedures.

NOTICE! Indicates additional information for correct use or useful tips.

Read and follow this information before using the analyzer.

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Graphic symbols
ON (Main switch)

OFF (Main switch)

CAUTION; observe documentation

Warning of dangerously high voltage

Warning of a hot surface

Warning of a biological hazard

Direct current (DC)

Protective isolation protection class II

Keep steel balls out of magnetic fields! (Speakers, CRT, monitors etc.)

Please refer to the user manual.

This symbol indicates that BIOLABO complies with WEEE EC Directive


(2012/19/UE) about recycling of electrical and electronic equipment waste.
This EC Directive forbids collecting no more used electrical and electronic
equipment waste with normal rubbish and entrust the producers the collection
and the recycling of such kind of waste.
When you have to dismiss a BIOLABO instrument, please don’t throw it with
normal rubbish, but contact BIOLABO or the authorized dealer.
Wasting should be performed in the country were the instrument has been sold.
BIOLABO also assures that no one of the materials listed by ROHS Directive
(2011/65/UE) is used to build and assemble its instruments.

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Introduction
This chapter describes the general concept, the ball function, functional modules and used accessories
of the analyzer.

Table of contents

GENERAL ..............................................................................................................................................................12
Intended use .............................................................................................................................................................. 12
General function description ..................................................................................................................................... 12
List of features ........................................................................................................................................................... 12
THE ANALYZER PRINCIPLE .........................................................................................................................................13
Measuring system ..................................................................................................................................................... 13
Ball function ............................................................................................................................................................... 14
ANALYZER OVERVIEW ..............................................................................................................................................15
Function groups overview ......................................................................................................................................... 15
Function group description ....................................................................................................................................... 16
ACCESSORIES..........................................................................................................................................................21
Overview .................................................................................................................................................................... 21

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General

Intended use
The Solea 100 coagulation analyzer is a fully automated blood plasma analysis system intended for in
vitro determination of coagulation. It performs optical clotting time detection, using chronometric,
chromoge- nic and immuno-turbidimetric measurement methods. It is designed for 24h/day operation.

General function description


The analyzer can achieve a throughput of more than 100 determinations per hour. The cuvette rack
reservoir for 240 tests allows a walkaway time of more than 1 hour.
Continuous loading of samples, reagent and cuvettes makes an uninterrupted workflow possible.
Emergency samples can always be immediately integrated into the running process.
A patented procedure allows for simultaneous incubation of both sample and reagent, in one cuvette.
Due to the micro method, a measuring volume of only 150 μl is required.
The software provides an intelligent measurement monitoring; questionable results are flagged or
repetition measurements are started. The LED booster technology provides the measurement option
to determine samples with high interferences.

List of features
▪ Throughput approx. 100 PT’s per hour
▪ Cuvette magazine for 240 tests
▪ 24 h operation mode
▪ Digital measuring system with dynamic sample adjustment
▪ 8 measuring channels
▪ Two wave lengths red 620nm / blue 405nm
▪ LED booster technology for samples with high interferences
▪ Chronometric, chromogenic and immunological tests
▪ Personal user login
▪ Bidirectional LIS interface
▪ Open system for nearly all reagents
▪ Automatic reagent change
▪ Sample tray for 32 primary tubes
▪ Continuous operation and emergency analyses
▪ Sample, reagent and cuvettes reloading during operation
▪ Automatic subsequent testing
▪ Automatic calibration curve calculation
▪ MNPT and ISI calculation within the INR calibration
▪ Graphic display of the measuring process
▪ Full result traceability (plasma and reagent)
▪ Error monitoring during the course of clotting reaction curve
▪ QC program including Levey Jennings Graph
▪ 8 positions for the quality control

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The analyzer principle

Measuring system
An cuvette rack is moved
from the cuvette register
to the pipetting position.
Plasma and reagent are
pipetted separately into
the cuvette, this
procedure allows a
simultaneous incubation
in one cuvette.

After the incubation time


has lapsed, the rack is
moved into the measuring
block. This illustration
demonstrates the tilting
technology.

When the tilting starts, the


ball is located in the upper reagent
part of the cuvette. When
the tilting
progresses, the ball runs
into the drops and
transports them to the
bottom of the cuvette. The
con- vergence of reagent
and plasma starts the tipping
measuring process.

The ball rotates during the


entire measuring time.
When clotting sets in, the
rotating ball causes the mixing
forming fibrin fibers to
bind. This effect enables
the detection of smallest
blood clots.
measuring
After measuring the
cuvette rack is ejected or,
if there are still unused
cuvettes in the rack,
returned back to the
pipetting station.

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Ball function
1. normal plasma
1. Excellent reproducibility
due to the gentle mixing
of the sample. In the
normal range the ball’s
rotation is stopped by the
strong blood clot. Here
the concentration of the
blood clot has only little
effect on the signal
dynamics due to the
rotation of the ball.
with ball
2. abnormal plasma
2. In case of abnormal
samples, the ball without ball
concentrates the blood
clot in the light path. The
dynamics of the clouding
difference between the
fluid and clotted sample
are very high. This leads
to positive detection of
the beginning of clotting.
3. abnormal plasma with low fibrinogen

3. In case of low fibrinogen


contents, the forming
fibrin bonds to the ball.
This bonding of the fibrin
to the ball causes quick
brightening of the sample
with a large dynamic
signal.

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Analyzer overview
ID Description

1. Cuvette racks
2. Cuvette rack register 10
2
3. Cuvette down holder
4. Predilution bar
5. Sample tray
6. Reagent block
8
7. Incubation cover
8. Protection cover
9. Needle 11
10. Signal light bar
11. Syringe 9
1 7
12. Mains switch 3 6
13. Function buttons 12 13
4
5

Function groups overview


The analyzer includes five function groups. These groups combine several function units. These
function units are described in the next chapter.

ID Description

1. Cuvette rack transport


2. Sampler area
3. Analyzer left side
4. Control button bar
4
2
3

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Function group description

Cuvette rack transport unit

ID Description
1. Cuvette rack register
1
2. Cuvette rack transport rail
3. Pipetting position 2 3 4
4. Measuring unit

Cuvette rack register


Stores the cuvette racks. (max. 58 cuvette racks / 2 stacks It can be easily reloaded or exchanged.

Cuvette rack transport rail


The cuvette racks are transported from the Cuvette rack register to the pipetting position, the
incubation positions and measuring unit. A cuvette rack reverse is possible in case not all cuvettes of
one rack was used.

Pipetting position
Position where the sampler pipetting needle aspirates samples and reagent into the cuvettes.

Measuring unit
The measuring unit takes care of all functions required to complete the measurement:
▪ Positioning of the cuvette rack
▪ Tipping the cuvette and mixing the samples
▪ Measuring
▪ Ejecting the cuvette rack

The measuring unit measures the reaction of pipetted liquids in cuvette rack. 8 cuvettes can be
measured simultaneously and independently of each other.

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Sampler area
The sampler moves the needle to the correct positions for pipetting, cleaning, and maintenance
actions.
At the sample area is the sample plasma block located . The sample rack is removeable to
load more comfortable the sample tube to the rack. The rack is traced by an sensor.

ID Description 7
1. Wash station
2. Test point
3. Sample tray
4. Predilution bar
5. Reagent block
6. Control positions 1 8 9
7. Pipetting position 2
8. Clean position
9. Buffer

6
3 4
5

Wash station
To avoid contamination, the needle is cleaned in the wash station, efficient on the inside and outside.
The washing cycle depends on which test is selected.

Test point
The test point is used to check the needle in their position and straightness.

Sample tray
To place the patient samples as primary cups or other cup types in the workspace of the
analyzer, 32 positions and 4 positions for Calibration and Control plasma are available.

Predilution bar
Predilution positions are available to made high plasma dilutions.

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Reagent block
The reagents are loaded into the reagent block according to the layout found in the main menu
of the Sample Prep.
By inserting the reagent drawer into the analyzer, the reagents are cooled to 16-22 °C (dependent
upon room temperature). Some pre-defined positions can be stirred by inserting magnetic stirrers.

Control position
The control positions are designed for 1,7 ml Sample cups (Hitachi cups). Fill the control plasma into
this cups and place to this position. The corresponding positions are displayed on the GUI.

Pipetting position
Area where the sampler pipetting needle aspirates samples in the cuvettes.

Clean position
The clean position is a specific fixed position at the reagent block used only for the analyzer clean
solution to clean the needle during the pipetting processes.

Sampler arm (X/Y axis)


The sampler arm moves the needle to the right position to aspirate or dispense the liquid. The axis are
moved by stepper motors and traced by encoder.

Pipette tube & needle


Liquid system, connected to the syringe of the diluter. The needle is equipped to work with active LLD.

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Analyzer, left side


On the left side of the analyzer all required external tube and cable connections are located.
Additional you will find the syringes of the dilutor.

ID Description

1. Syringe
2. Wash water connector 1
3. Waste water
connector
4. EXT connector
5. HOST connector
6. Main switch
7. Main fuses
8. Mains connector
9. PC interface 4
10. Water sensor
connector
5

2
6
9
7
8 10 3

Syringe
To aspirate and dispense fluids, the plunger of the syringe moves up and down. The highest position
is also the home position of the syringe, in which it stays when the analyzer is not pipetting. The lowest
position of the plunger is the replacement position, in which you can replace the plunger or the plunger
tip.

Wash water connector


Connects the analyzer with the tube for the wash water.

Waste water connector


Connects the analyzer with tube to the liquid waste container.

EXT.
Serial port, that connects to another analyzer. Both connected analyzers require only one connection
to the LIS.

HOST
Serial port, for LIS connection.

Mains switch
Switches the analyzer on and off.

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Main Fuses
Protects the analyzer from excessive electrical currents. (Fuse: T 3.14A)

Mains connector
The mains cable for the power supply is connected here. Connects the analyzer to the mains
electricity.

PC interface
USB connection to the PC all communication between PC, analyzer and host pass these port.

Wash water sensor


Sensor to detect the level of the washing solution.

Control button bar


Via the control button you can control direct some features at the analyzer .
F.e. stop the sampler movements (stop button) and quit messages (alarm off).

ID Description
1. Stop button
2. Alarm off button
1 2

Stop button
The stop button stops immediately the sampler movements on the X&Y axis. The Z-axis moves up.
The already pipetted cuvette rack will be still transported an measured. An already started measuring
process will as well continued.
By activating the integrated LED light will switch on.

Alarm off button


Confirms that the operator has noted the information in a status message or has dealt with an error
message.
The button must be pressed (or F4) to continue processing.

Protective signal bar


The signal bar is an optical status indicator.
The signal bar lightning white during the routine. If
an error occur the bar turns into a red blinking
status.
The protective signal bar protect as well the sampler area.

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Accessories

Overview

ID Description

1. Cuvette racks
2. Cuvette register 2
3. Cuvette downholder
4. Predilution bar
5. Sample tray
6. Reagent block
7. Incubation cover
8. Needle
9. Syringe 9
8
1
3 6

5 4 6

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Cuvette rack
A cuvette rack consists of eight cuvettes and a cuvette rack
frame. The cuvettes stay always in the cuvette rack frame and is
designed for single use. Inside each cuvette a ball for stirring is
placed.
The one side of the cuvette rack is serrated for the transportation
mechanism inside of the cuvette rack transport unit.
In the two holes on the upper side of the cuvettes, reagent and
plasma will be dispense from the sampler needle.
The cuvettes racks are delivered in stacks. 29 cuvette racks are
combined to one stack.

ATTENTION!
Use only original product to guarantee the functionality of the analyzer

Cuvette rack register LƯU Ý!


The cuvette register is able Không
to store sử
twodụng
stackslon có thể gây
of cuvette racks,raand vận chuyển giá đỡ cuvet.
lỗi is
placed at the analyzer to deliver the transport unit with cuvette racks.

Cuvette downholder
The cuvette downholder has to be placed always in the cuvette
rack register on top of the cuvette racks.
It protect the cuvette stirring balls against falling out.

ATTENTION!
Not using can causes cuvette rack transport failures.

Predilution bar
The predilution bar consists of 40 dilution cups, which are used
to perform high plasma dilutions. The predilution bar are used to
dilute the plasma before it is pipet to the cuvette. Each cup is
checked by the LLD before using.

ATTENTION!
Use only the original product to guarantee the functionality
of the analyzer.

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Sample tray
The sample tray hold up to 32 sample tubes and four positions
for controls or calibration dilutions.

Reagent block
The reagent block hold the different reagents which are used for the
performed test on the analyzer.
Up to 20 different reagents are possible. As well control plasma can be
stored here. The reagent block is cooled to 16-18°C by a Peltier element.

Maintenance adapter
The test cup adaptor is used during the daily maintenance check to
control the washing pump, needle and pipetting tube.

Incubation cover
The incubation cover stabilize the temperature condition in the
cuvette rack and keep the cuvette rack in the correct position.

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Needle
The needle transfer plasma and the reagents to the
cuvette at the pipetting position.

Clean stick
The clean stick is used at the weekly maintenance procedure to prevent pollution in the measuring
chamber.

Liquid container
The liquid container provide the fresh water for the analyzer needle
cleaning and system priming. The level of water is sensor traced.

Liquid waste container


The waste water container is an optional accessory.
This container is used to collect the waste water for proper disposal.

ATTENTION!
The waste water container fill level is not traced by a sensor. The
waste water container has to be evacuated each time the water
container is refilled.

NOTICE!
This liquid waste container is not a part of the delivery package
for the analyzer and need to order separately.

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Water sensor
The water sensor trace the fill level. Additional the sensor guide the
tubing for the fresh water input for the analyzer.
The sensor is placed in the liquid container and the sensor cable is
connect to the corresponding plug at the analyzer left side.

Cleaning solution
The cleaning solution is used at the daily routine to verify a proper needle
cleaning.

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Specifications

Table of contents

Physical dimensions ........................................................................................................................................................... 28


Power requirements .......................................................................................................................................................... 28
Ambient conditions ............................................................................................................................................................ 28
Temperature specifications ................................................................................................................................................ 29
Water specifications ........................................................................................................................................................... 29
Disposal specification ......................................................................................................................................................... 29
Technical data .................................................................................................................................................................... 30
PC ......................................................................................................................................................................31

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Physical dimensions
The following dimension are relating only to the analyzer. Parts which has to be installed after the
unpackaging are not considered.
L= length W= width H= height

With packing
▪ L x W x H: 120 cm x 80 cm x 81 cm
▪ Weight: 67 kg

Without packing
▪ L x W x H: 70.5 cm x 55 cm x 61.5 cm
▪ Weight: 36.0 kg

Space required
The required space describes the space which is needed to install the complete analyzer including the
accessories.
▪ L x W x H: 130 cm x 70 cm x 80 cm

Power requirements
▪ Protection class: I
▪ Working voltage: 100 to 240 VAC
▪ Supply frequency: 50 / 60 Hz
▪ Power Input: 100 VA
▪ Fuses: 5 x 20 mm, T 2.0A UL / IEC 127
▪ Over Voltage Category: II (EN61010-1:2001)

Ambient conditions
▪ Operating temperature: +17° C to +30° C
▪ Storage temperature: +10° C to +40° C
▪ Relative humidity: 50 % to 80 %
▪ Maximum heat output: 80 W
▪ Sound intensity: 65 dB (A)
▪ Overvoltage category: II according to EN 61010 -1:2001
▪ Pollution degree: 2
▪ Usage environment: Indoor use in residential areas, commercial dwellings and
light industrial environments.

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Temperature specifications
▪ Incubation: 40.5° C ±0.8° C*
▪ Measuring block: 38.0° C ±0.8° C*
▪ Reagent cooling: 16.0° C to 22.0° C **

* Corresponds to a temperature in the cuvette of 37.0° C ±0.8° C after 3 minute waiting period and a
filling
volume of 220 µl.
** Corresponds to a room temperature 17.0° C to 30.0° C

Water specifications
Wash water: max. 50 µS/cm

Disposal specification
Sample tubes
▪ Diameter: 12 mm
▪ Max. length: 105 mm
▪ Min. length: 40 mm
▪ Identification: Barcode or manual data input.

Reagent bottles
▪ Diameter: 12/14/16/18/21/22/24/26/30/32mm
▪ Identification: manual

Cuvette volume limits


▪ Maximal individual volume: upper position 200 µl / lower position150 µl
▪ Minimum total volume: 150 µl
▪ Maximum total volume: 260 µl

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Technical data
Dilutor
▪ Syringe 500 µl Hamilton
▪ Total path of the syringe: 60 mm
▪ Total steps of the motor: 4000 steps
▪ Steps for 1 µl: 8 steps
▪ Lifetime: 20 000 tests
▪ random error
▪ 500 µl +/- 1,0 µl
▪ 250 µl +/- 1,0 µl
▪ 50 µl +/- 0,2 µl
▪ systematic error:
▪ 500 µl +/- 4,0 µl
▪ 250 µl +/- 4,0 µl
▪ 50 µl +/- 0,9 µl

Sampler
▪ Steps for 1 mm path:
▪ X-axis: 8 steps
▪ Y-axis: 8 steps
▪ Z-axis: 16 steps
▪ Needle absorbency volume: approx. 180 µl
▪ Needle lifetime: 20 000 samples

Rinsing fluids:
▪ Water: Depends of the entered test parameter: approx. 6.5mL per test
▪ Clean: Depends by the series of samples (f.e. 100 PT 1.6 ml)

Photometer
▪ Light source: LED
▪ Wavelength: 405 nm / 620 nm
▪ Sensor: Photodiode
Interface
▪ 1 USB : For communication with the PC
▪ 2 Serial ports: HOST: RS232 (For HOST connection)
EXT: RS232 (For connection with another analyzer (Daisy
chain)
Communication protocols
▪ internal: serial
▪ LIS: Behnk protocol, ASTM

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PC
The computer is an independent unit which controls all processes through a multi-tasking operating
system. This system also receives and calculates the data from measurements.

System configuration
The computer hardware must be compatible with 64bit.
The following system configuration is the minimum system requirements for a computer to be used
with the analyzer.

RAM: 2 GB
HDD: 160 GB
USB: USB2.0 4x
Mouse: USB mouse 1x
Keyboard: USB keyboard 1x
Software
Operating System: Linux (Debian 8.xx, 64bit)

Mass storage
External: USB memory flash (installation medium, backup)
Internal: HDD

Interfaces
USB (for connection with the PC)
USB (for backing up or loading data on the system)

Monitor
Min.size 17 inch
Min resolution: 1280x1024

Printer (optional)
Requirements: Printer must support Post Script or PCL 5e or PCL6.
The OS Debian used for analyzer includes the drivers (Generic Post Script, PCL 5e, PCL6).

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Analyzer preparation

Table of contents

Getting started 34

Location 35

Preparations for operation 36


Turning on the device 36

Access rights 37
Standard user interface 37
Restricted user interface 37

User Interface overview 38

Hardware preparation 39
Reagents 39
Reagent area 39
Predilution 40
Cuvette register 40
Wash water container 40
Sample tray 41

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Getting started
Check the packaging for any signs of transport damage.

ATTENTION!
If the packaging or contents are damaged, make a complaint with the forwarding company and
notify the equipment manufacturer or your service representative.

Assembly and installation should only be conducted by trained specialists, your analyzer supplier or
service engineer.
The analyzer is delivered with a set of standard accessories, the necessary software and various
components required for initial operation (also see chapter Accessories). Hardware for the required
LIS-system is optionally available.
Keep the original packaging for the purpose of possible future transport.

Preparation for transport or storage:


Ask your service representative for assistance and instructions.

ATTENTION!
Direct or indirect damage to the analyzer, caused by shipment in improper packaging, is
excluded from liability or warranty.

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Location
Choose a location where the analyzer is not subjected to direct sunlight, excess heat, humidity, dust,
direct cooled air from air condition and vibrations. The room temperature should be between 17 °C
and 30 °C. Place the analyzer in a position which allows unhindered access to the mains outlet at all
times.

ATTENTION!
Avoid the immediate vicinity of water taps, baths, sinks, etc.
Avoid the immediate vicinity of centrifuges, washing machines or dishwashers, etc.
Avoid the immediate vicinity of radiators or devices which produce large amounts of heat, etc.
Avoid direct draughts.
Place the analyzer on a firm, level table which has a depth of at least 80 cm and is up to 140 cm
wide.

WARNING!
The mains voltage must coincide with the technical specifications of the analyzer.
The mains circuit must have adequate fuse protection. The analyzer must be connected to a
properly grounded outlet. If in doubt about mains voltage or the circuit in general, contact a
qualified electrician.

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Preparations for operation


Prior to initial operation of the system, the following requirements should be met:
▪ All electrical connections established

ATTENTION!
Make sure that an “electric ground” is also connected.

▪ All tubes and sensors connected


▪ Pipetting tube assembled
▪ Water tank is filled
▪ Waste water tank is emptied
▪ The cuvette register is filled
▪ Predilution bar is available
▪ Incubation station cover correctly inserted

Turning on the device


If all conditions are fulfilled, switch on
the analyzer first, then the monitor and
then the PC.
On the monitor, the login screen appear.
Enter the password for the user routine into the
appropriate fields and confirm with e.

Optional you can change the user in the upper


field.
User the yw buttons
or use the mouse to
change the user.

Possible user:
▪ routine
▪ labhead
▪ service
▪ user0 - user9
▪ others...

When user0 - user9 is used, the service technician need to set previous single passwords for the
different user. This feature is used when the lab staff request for single user access.

ATTENTION!
After the login of the routine program, the software will load and the analyzer sampler arm move.

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Access rights
The analyzer software has different levels of access, login service, login labhead and login routine
(user 0-9).

Login service the desktop appears with full access rights to the Adjusting, Maintenance and
Routine program (User interface). The desktop icons are available.

Login labhead or routine the user interface is opened with different access rights depending
on the setting in the Maintenance program, Menu System Parameters, (b7) System Type.
Selectable are Standard and Restricted user interface.
The setting is defined by your service technician with login service.

Standard user interface


The login service and labhead have full access to all options.

Login routine:
▪ TEST PARAMETERS, no access.
▪ REAGENT SETUP, CALIBRATION SETUP, access to column Lot No., Expiry date and Comment.
▪ QC SETUP, access to column Lot No., Expiry date, Control Target and Range.
▪ QC, precision measurements in column N are executable.
▪ REAGENT PREP., timer and level-bar reset available via F6 and Shift+F6. Reagent settings are not
changeable.
▪ CALIBRATION, changes for Reference, Normal and ISI value. The calibration Min. value / Max. value
and the dilution stages are not changeable.

Restricted user interface


The service has full access to all options.

The login labhead has no access to TEST PARAMETERS, but can change all entries in REAGENT-,
CALIBRATION-, QC SETUP
and CALIBRATION menu.

The login routine has no access to the menus TEST PARAMETERS, CALIBRATION and cannot change the
entries in
REAGENT-, CALIBRATION- and QC SETUP menu.

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User Interface overview


The standard Graphical User Interface is displayed after logging in. All full screenshots and cropped
screens- hots in this manual display information intended for easier understanding of the system and
navigation of the various menu items. Some minor deviations to the illustrated items may, however,
exist.
A detailed user interface description you will find in chapter Operations.

1 2

ID Description

1. Main menu 3
2. Sub menu
3. Working area
4. Message window
5. Information area

4
5

Main menu
Main menu for choosing the various analyzer functions for the routine.

Sub menu
The selection is determined by the cursor‘s position in the main menu. Depending on the selected
menu item, information is displayed or data can be edited.

Working area
The selection is determined by the cursor‘s position in the sub/main menu. Depending on the selected
menu item, information is displayed or data can be edited.

Message window
System status display area (system and error messages).

Information area
Information concerning the function keys, time, date and software version.

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Hardware preparation

Reagents
Prepare all to used reagents according to their package inserts and use them accordingly. When the
re- agents are ready to use place the reagent in the corresponding reagent block positions. See
chapter reagent area for further information.

ATTENTION!
Users are responsible to define adequate controlling procedures are which agree with the country
specific valid lab regulations.

Reagent area

Cooled reagent block


The reagent block is an massive cooled aluminum block, equipped with 12 positions for standard
reagent bottles, 4 positions for small plastic cups and further positions for control or reference plasma.
The reagent block is designed as a module insert, so it can be loaded outside the analyzer.
In order to load reagent blocks, select the REAGENT BLOCK in the main menu.
The reagent block screen inform about the reagent positions, where to place the corresponding
reagents. Each single position informs about the identification codes of the tests, the reagent
identification code and the name of the reagent. Additional the countdown timer for the onboard
stability and the filling level indica- tor will be displayed, when these options are enabled.
Some positions are marked with mix. In those positions a magnetic reagent mixer can be added to stir
the reagent. Load the reagent block according to the diagram on the screen.
The position CLEAN has a fixed position. The term CLEAN represents a decontamination liquid for the
needle.
The following reagent identification codes are used for the reagent block:

▪ RE = Reagent
▪ BU = Buffer
▪ DP = Deficiency plasma
▪ CC = Calcium chloride
▪ AC = Activator
▪ LA = Latex reagent
▪ BL = Bleach
▪ SU = Substrate
▪ NP = Normal plasma
▪ (blank) = not in use

Place the reagent block into the intended position. In order to cool down the reagent to approx. 18°C,
push the module insert until it stops. The positioning is sensor monitored.

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Predilution
For plasma predilution. 1 insert with 40 positions is available.
A required replacement of the predilution insert is indicated in the
message window: “Predilution rack is full ...“.

The sampler pipettes additional buffer in position 40.


▪ Place the insert in the designated position.
▪ With oor ALARM OFF the message will be
deleted and with mthe process continues.
The sampler checks the replacement by leveling position 40 after
oor ALARM OFF is pressed. If liquid is detected, the message will
be displayed again.

ATTENTION!
Use only original product to guarantee the functionality of the analyzer

WARNING!
Warning of a biological hazard.

Cuvette register
The cuvette register can accommodate up to 58 cuvette racks.
The cuvette register can be replaced or reloaded at any time,
even if only half-filled. When the analyzer is working, it must be
stopped with n before continuing. As soon as the sampler has
stopped, the register can be reloaded or replaced with a full one.
Please make sure the cuvette cover is returned to its original
position. Continue the process by pressing oor ALARM OFF.

Loading the cuvette register


In the package of cuvette racks is a leaflet included which
provides information, on how to load the register.

ATTENTION!
Use only original product to guarantee the functionality of the analyzer

Wash water container


The washing solution is stored in a receptacle which is situated
outside the analyzer. For the washing solution, deionized water
or distilled water could be used. When using distilled water, it is
recommended to add 15 ml Clean solution per 5 l water to the
washing tank. Empty the container before refill to avoid a rising
clean concentration.
The water level is monitored by a sensor. If the water level is
insufficient, an alarm is sounded and the following message is
displayed in the message window: “Distilled reservoir low level.
Refill”

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Refilling the wash water container

In standby
When the system is in standby, remove the sensor from the washing tank and refill the washing
solution.
Replace the sensor and delete the message in the message window by pressing o or ALARM OFF.

During processing
Press n and wait for end of pipetting the current cuvette rack. Remove the sensor from the washing
tank and refill. Replace the sensor and press o.
If the following message is displayed in the message window: “Distilled reservoir low level. Refill” the
analyzer stops the run after pipetting the current cuvette. Remove the sensor from the washing tank
and refill. Replace the sensor and press o. The analyzer continues the process.

Sample tray
Load the sample tray with samples you want to measure on the
analyzer.
The sample tray can be equipped outside the analyzer, e.g.
directly by the centrifuge. When you finished the sample loading
to the sample tray, scan the sample barcodes with the internal
or external scanner to insert the sample data to the menu
Sample prep.
Alternative type manually the data (patient name or code) into
the system. See section: Manual data entry

ATTENTION!
The cursor must be located at the corresponding line at the menu
Sample Prep.

When finish with the data entry place the sample tray into the intake of the analyzer.

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Operation

Table of contents

Main menu window 45


Function Keys 47

Sample processing 50
Sample loading 50
Data entry 50
Manual data entry 50
Adding samples during sample processing 51

Sample Prep. 52

STAT 53

Run Display 54

Reagent 55
Reagent Setup 55
Reagent preparation 56
Refilling Reagent 58

Calibration 59
About calibration / liquid validation 59
Calibration Setup 61
Calibration 62
Calibrator set calibration 64
Single calibrator calibration 65
Manual calibration 66

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Re-Calibration 66
Reactivate calibration 67

Quality control 68
QC Setup 68
QC 69
Precision measurement 71

Hardware 73
Sampler 74
Needle 74
Syringe 77
LEDs 78

Results 79
Patients 80
Patient Search 80
Transmit New 80
Controls 81
Control Search 82
Calibration 82
Protocol 83
Errors 83
Error Search 83
Status 84

Backup 85
Backup Parameter 85
Backup Database 85
Backup Log 85

Test Parameters 86

Exit 87

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Main menu window


In the Menu window, the various analyzer functions can be selected. Move the cursor with yw to
a menu item or enter the menu item’s first letter. When going to a different menu item, the display of
the window changes accordingly. Pressing e moves the cursor to the corresponding window
for editing. ^brings you back to the menu to access a different menu item.

Main menu

Sample Prep.
Here the patient ID´s and the desired tests can be entered.

Reagent Preparation
Display of the reagent positions in the reagent block. Replacement of the reagent block when several
blocks are available.

STAT
For inserting STAT‘s into the current routine. STAT‘s are given priority in processing.

Run Display
Status display of the cuvette racks in the incubation / measuring unit, as well as the results of the last
rack(s).

Calibration
Display and input of calibration curves and standard values.

QC
Selection and start of the QC. The statistics of all QC measurements of the individual QC plasma, test
and unit can be displayed as a graph.

QC Setup
Display and input of the QC threshold parameters for each test.

Reagent Setup
Display and input of the reagents and reagent conditions for each test.

Calibration Setup
Display and input of the calibration plasma / reagent for the to be calibrated tests.

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Hardware
Maintenance and control menu for needle, syringe, cuvette racks, optic, water level and temperatures.

Results
Database access for measuring results, quality controls, calibration curves and system messages for
viewing, printing and transmitting to the HOST. Further menus for backup functions and status
information.

Test Parameters
Menu to check the selected test parameters. Changes can only be made with the appropriate
access rights, see chapter Access rights.

Exit
You leave the main menu by selecting this menu item. The program switches to the login
window. This step is necessary in order to properly boot down your system (PC).

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Function Keys

Keypad Function Use

Cursor keys
w x y z Chooses the next/previous menu, table cell, row or field Menus Tables, Lists

^e Common standard functions

l Help window. Displays Signs, Function keys and the


result
Error flags.

m Starts the processing Main menu

n Pipetting process stop after the pipetting of a rack; wait


for the message “Arm ready“. The AutoStart is avoided
with an online LIS.

o Confirms that the operator has noted the information of


the status message or has dealt with an error message.
Needs to be pressed to continue working.

Pressing the key has the following effects:


▪ The message is not displayed anymore.
▪ If any processes on the analyzer were interrupted by
the message, they continue.
▪ If any functions in the software were blocked by
the message, they are accessible again.
▪ The system stores the message in the Results
Errors panel
(RESULTS > ERRORS).
▪ If the problem described in an error message is
not solved, the error message is displayed
again.

This keyboard command does the same as the inhibit


alarm button of the analyzer.

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Keypad Function Use

Cursor keys

p Initiate communication with the LIS. SAMPLE PREP


Retrieves order information for the selected ID from the RESULTS
LIS. Sends the test results of the selected ID to the LIS

jp Initiate communication with the LIS. SAMPLE PREP


Retrieves order information for all ID´s from the LIS. RESULTS
Sends the test results of all selected ID´s to the LIS.

bp Reactivates the HOST connection. Main Menu


q Deletes test orders of the selected ID with ≡ sign. Input of SAMPLE PREP
new/same test identification code possible. REAGENT BLOCK
Deletes the level bar of the selected reagent and the timer
starts new.
jq Delete test orders of all ID´s with ≡ sign. Input of new/ SAMPLE PREP
same REAGENT BLOCK
test identification codes possible.
Delete the level bar of all reagents and all timer starts
new.
bc Delete the selected ID. If held down all subsequent SAMPLE PREP
positions can be deleted.
k Toggle key. Displays predefined values for the selected REAGENTS
table cell, if any predefined. CALIBRATION

] square To register a Quality Control in the Id.-No. box of the SAMPLE PREP.
routine for manual QC entry. STAT
bh Inserting a test order to all ID´s. After pressing in main Main menu
menu/ Sample Prep. the cursor switches to the test panel.
Select a test and press e.

bc Deletes all test orders after entering with Main menu


bh.
br Deletes all ID´s and tests orders with ≡ sign. SAMPLE PREP.

t Activates manual order editing. SAMPLE PREP.


Activates comment editing. RESULTS SAMPLE/QC PANEL

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Keypad Function Use

u Graphic view. Displays the Levey Jennings graph. RESULTS QC PANEL


SHOW CURVE display the calibration curve. COPY reactivates the RESULTS CALIBRATION
calibration curve.
Show the result of the selected sample ID. After SAMPLE PREP.
ethe
reaction curve of the selected test is shown. If this test is
currently measured, the reaction curve is displayed as live
view.
}{ Moves the cursor through the table, one page up or down. SAMPLE PREP.
RESULTS
Moves the cursor within the column to the next or previous QC / QC-, REAGENT-, CALIBRATI-
row. ON SETUP

dg Moves within a table, beginning or end. SAMPLE PREP.


RESULTS
i ▪ Print working list. ▪ SAMPLE PREP.
▪ Print calibration data and graphics. ▪ CALIBRATION
▪ Print QC graphics. ▪ QC
▪ RESULTS
▪ Print results of selected sample(s).
▪ RESULTS
▪ Print clotting of chromo measuring graphics. ▪ RESULTS
▪ Print error messages ▪ TEST PARAMETER
▪ Print test parameters.

bi
Reactivates the printer. Main Menu

ji Print / captures a screenshot of your active window.

Letter key Chooses a menu command that starts with this letter. Menus

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Sample processing
An order represents one sample with all tests to be performed for this sample. It is defined by the
sample ID and the order date. During processing, the orders are displayed in the Sample prep. panel.
Each row represents an order. When processing is complete, the orders and the results are displayed
in the Results panel. When you load samples, the analyzer creates an order for each sample tube,
based on the barcode information.
When you start the processing of the samples, the analyzer performs pipetting, incubation, measuring,
and results storage.

ATTENTION!
Make sure that your calibrations and quality controls for the used reagent are valid, before you start the
sample measurement.

Sample loading
The sample tray can be equipped outside the analyzer, e.g. directly by the centrifuge. When you
finished the sample loading to the sample tray, scan the sample barcodes with the internal or external
scanner to insert the sample data to the menu Sample prep. Alternative type manually the data (patient
mane or code) into the system. See section: Manual data entry

ATTENTION!
The cursor must be located at the corresponding line at the menu Sample Prep.

When finish with the data entry place the sample tray into the intake of the analyzer.

Data entry
After all of the barcodes have been scanned, and if an LIS is connected, the corresponding tests for
each patient sample are received and entered into the SAMPLE PREP. area. If no LIS is connected, the tests
must be entered by the keyboard. Return to the menu with ^ and start with m .

Manual data entry


Should the barcode not be available or legible, the data can be entered manually. If the system is
linked to an LIS, the tests can be retrieved with p or jp from the LIS after entering the ID.
Manual entry is then marked with the sign and this specimen cannot be read by the scanner. In case
there is no LIS connection, the test must also be entered manually.

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Adding samples during sample processing


You can add specimens at any time during the running process by pressing n. Message “stopped
(arm is still working) wait for ‘ready’ – restart F4“ appears.
The analyzer finishes pipetting the current cuvette rack and interrupts its current run. Wait until the
message “stopped with F3 (arm ready: restart F4)“ appears.
▪ Type or scan the sample data in the correct line where you want to place the sample. If no LIS is
connected, you need to select as well the tests.
▪ Open the protection cover.
▪ Place the sample in the correct position. The desired position in the software menu sample prep
▪ Close the protection cover.
▪ Reactivate the interrupted process with o and press mfor an actuated start with the new
sample.

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Sample Prep.
Display all orders that are waiting to be started or are in progress.

▪ Status: Status symbols; meaning: See Signs and Symbols, or press l (Help screen).
▪ ID Number: Sample ID of the sample tube (barcode number).
▪ Prep.: Tray number and position of the sample tube on the sample tray
▪ Tests: Tests to be measured for the sample, listed with their abbreviations.

Signs and Symbols


These signs appear to the left of the ID-number, in the Status column in menu SAMPLE PREP. and RESULTS.

* Sample is being processed


≡ Sample has being processed
≡ (red) Sample status with errors
▷ STAT
◎ Sample ID manually entered
— No more plasma has been found
⇓ Cuvette bar return
≢ At least one test not done

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STAT
Analyses for emergency patient samples (STAT= short turnaround time) can be performed at any time.
STAT measurements, including result printing, are prioritized. The sequence is the same as in the menu
SAMPLE PREP.

Inserting STAT measurements


Place STAT specimens in any free place in the sample tray.
For data input enter the menu STAT, enter the order. End the data input with ^ and start with m.
These orders are marked with ▷.

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Run Display
Displays which sample is at which state of being processed: pipetting, incubation, measurement.
During processing, a cuvette rack with sample(s) moves through the panel, starting at the bottom, and
then moving upwards.

The menu item RUN DISPLAY shows the status of eight cuvette rack positions

▪ Fin. : The previous measured samples.


▪ MEASUR.: Current measured samples.
▪ PIPETT.: Current samples pipetting.
▪ WAITING: Samples in waiting position. This samples will be pipetted to the next cuvette rack.

Sample status information


▪ The patient ID.
▪ Position of the specimen in the cuvette rack.
▪ The accomplished test.
▪ Measured time in case of clotting determination.
▪ The optical density in case of chromogenic determination.
▪ Calculated measured value.
▪ A possible error flag.

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Reagent
Following are described all information relating the reagent and the data handling in the software.

ATTENTION!
Prepare all to used reagents according to their package inserts and use them accordingly. When the
reagents are ready to use place the reagent in the corresponding reagent block positions.

ATTENTION!
Users are responsible to define adequate controlling procedures are which agree with the country
specific valid lab regulations.

Reagent Setup
Displays data about the test reagents and diluents.
For traceability, the entries in the fields Reagent, Lot No and Date will be deposited with the result of the
following measurements.

Select REAGENT SETUP in the menu window by using yw. The screen with all active tests appears in
the working area. To move to a different column, press yw, e or {/ }.
The column Test is a fixed position, not changeable. The entries in column Lot No and Date are
changeable with login routine (user 0-9) access rights, the other entries are given during test
application by the system administrator with login service or labhead.

▪ Test: Tests for which the reagent can be used. The test parameters panel determines the
names and abbreviations of the tests.
▪ Liq.: Identification code of the reagent as defined in menu Test parameters.
▪ Reagent: Name of the reagent.
▪ Lot No: Lot number of the reagent.
▪ Date: Expiry date of the reagent.
▪ mix.: Indicates whether the reagent needs to be stirred and therefore placed on a mixing
position with magnetic stirrer.
▪ cool: Indicates whether the reagent needs to be cooled.
▪ Stb: Onboard stability of the reagent in hours, that is, the number of hours you can use the
reagent, once you have prepared it and loaded on the analyzer.
▪ Comment: Comment by the manufacturer of the reagent.

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For traceability it is recommended to enter the actual data of the reagent:


▪ Lot number
▪ Expiry date
▪ Comment (optional)
After actualization of this entries, the test must be calibrated; actively with calibration or passive by
liquid validation via menu calibration. Then, the reagent name, Lot number and the expiry date will be
deposited with all subsequent measurements using this reagent.
Upon calibration the lot number is automatically entered in the menu item calibration.
When the date of the reagent is expired, continuous working is possible, but all results are flagged with
EF80.

Reagent preparation
The menu Reagent Preparation displays the position of the reagents in the reagent block and, if
enabled, the corresponding filling level and stability on board timer.

Reagent positions
The area above the reagent block is uncooled.
CLEAN is exclusively reserved for Clean Solution.
PREDIL. BUF. is exclusively reserved for calibration dilution buffer.

ATTENTION!
The cleaning solution S100CS must be closed when the instrument is not running to avoid rusting.

The reagent block is the cooled reagent area.


Positions 1 to 12 are available for larger reagent bottles.
Positions 1 and 3 are stirred positions.
Positions 13 to 16 are available for small reagent container.
Positions Control 1-4 are available for calibration or control plasma.

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A reagent can be defined in several positions, so more than one bottle can be placed on the analyzer,
for residual amounts in position 13 to 16.

Reagent display
▪ Reagent short cut: Identification code, as defined in TEST PARAMETERS.
▪ RE: Reagent
▪ BU: Buffer
▪ DP: Deficiency plasma
▪ CC: Calcium chloride
▪ AC: Activator
▪ LA: Latex reagent
▪ BL: Bleach
▪ SU: Substrate
▪ NP: Normal plasma
▪ (blank): not occupied
▪ Letter: Test abbreviation as defined in menu TEST PARAMETERS.
▪ Level bar: Graphical indication of the filling level in the reagent bottle/container.
▪ Reagent name: Name of the reagent as defined in menu REAGENT SETUP.
▪ Timer: Indicates how long the loaded reagent can still be used. The onboard stability time is
defined in menu REAGENT SETUP. Starts at the first pipetting of this reagent and runs backwards. If
there is no timer displayed, no stability on board time is entered in the REAGENT SETUP.
▪ IDA*: Immersion depth automatic. The analyzer can calculate the immersion depth of the
needle individually for the reagent, based on the registration of the level reduction.

Preconditions for the SW to activate IDA


▪ The needle have to pipette the reagent three times.
▪ The minimum difference level has to be 1,2 mm lower.
▪ The pipetted volume is over 150 µl.

IMPORTANT!
Do not use IDA for small reagent container.

▪ mix.: Mixing Position. The reagent can be stirred by using a magnetic stirrer.

* only displayed with login labhead or service.

Reagent monitoring
Reagent amount
During the pipetting process, the analyzer monitors the reagent volume, shown as level bar in menu
REAGENT BLOCK. If there is insufficient reagent in the reagent block, this is reported in the message box
“not enough reagent ... for further testing”.
If no reagent is found, the needle remains positioned over the corresponding reagent position.
If the reagent is placed multiple times, the positions are used one after another. If all reagent positions
are empty, the message “Liquid XY not found” appears.

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Reagent onboard stability


If the on board stability time of the reagent is defined in menu REAGENT SETUP a timer is displayed. This
timer starts at the first pipetting of this reagent and runs backwards. When the time is expired a
message appears that the onboard stability is expired.

Refilling Reagent
In standby
Replace the reagents in the corresponding positions, as displayed in the menu of the reagent block. If
the timer should start immediately, press q in the according position in menu. The level bar is
diplayed in gray and will be updated while the first pipetting. When the timer should start for all
reagents, press jq.

NOTICE!
For rarely used reagents the level difference for automatically timer start could be not enough, so the
timer does not start after replacing this reagent. Please start the timer manually by pressing q.

During sample processing


When pressing n the message “stopped (arm is still working) wait for ‘ready’ – restart F4 (Sample
Prep.)” is displayed. The analyzer finishes pipetting of the current cuvette rack and interrupts the
running process. Wait until the message “stopped with F3 (arm ready: restart F4 Sample Prep.)“
appears. Replace the corresponding reagent and start the routine with o / ALARM OFF. After a
reagent has been changed or refilled, the liquid level is automatically checked while the first pipetting,
the new filling level will be displayed and the timer starts new.

In case of emergency, use STOP to immediately stop the movement of the arm. The software will allow
this procedure within 60 seconds. In case the reagent drawer is not re-inserted within the 60 second
time limit, the cuvette rack currently being pipetted is discarded.

Loading a reagent with a new Lot number


When loading a reagent with a new Lot number, please enter the new Lot No and the new Date in the
menu REAGENT SETUP. After calibration of the test, the new Lot number and expiry date will be traced for all
subsequent measurements using this reagent.
For PT reagent with a new Lot number, you need to enter the ISI / Normal reagent properties from the
package insert to the calibration panel, when using the calibration method Nor/ISI (result calculation
by factors).

ATTENTION!
Never place foreign objects, e.g. coins, under the reagent receptacles.

WARNING!
Warning of a biological hazard.

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Calibration

About calibration / liquid validation


A calibration / liquid validation is required whenever settings are changed. With calibration / liquid
validation, the changes are applied to the test parameters.
Changes in the reagent setup menu are also applied with calibration / liquid validation and will be
deposited with the following sample measurements.
The liquid validation is needed for tests that do not require a calibration curve.

You must perform a calibration or liquid validation in the following cases:


▪ When you enter a reagent of a new Lot number and expiry date in menu Reagent Setup.
▪ When test settings have been modified in menu Test Parameters.
▪ When a new test has been activated.
Certain maintenance actions for the measuring unit or pipetting system, performed by the service
representative also require subsequent calibration.

IMPORTANT!
When reactivating a calibration curve or liquid validation with previous settings from the result
database, the settings are reset to the settings of this activated calibration curve or liquid validation
(see, chapter Reactivate calibration).

INR calculation
The analyzer provides two calibration methods for INR result calculation. The calculation by factors
(Normal (MNPT) / ISI) and by calibration curve. The TEST PARAMETERS panel determines the calibration
method ( Calculation (g1) / (g4) First / Second value: type) and can only be altered by the system
administrator with access rights of login labhead or service.

When using the calibration method Curve, only the Calibrator Set calibration is possible. The Normal
and ISI value are automatically determined by the system during calibration . The calculated values
are displayed in the calibration chart.

When using the calibration method NorISI, the Normal and the ISI of the reagent has to be entered
from the package insert to the calibration panel. The entered values are displayed in the calibration
chart. In case of a new Lot number of PT reagent you need to enter the new values and calibrate.

IMPORTANT!
When using NorISI as second calculation and Cruve in first calculation, the analyzer uses the
Normal value of the calibration curve.
The analyzer uses the entered value of Normal when (g2) first calculation: unit is defined as .%
(entering of a dot, before percentage).

Reference values
The first time that you use a calibrator of a new Lot number, you need to enter the new reference
value(s)
(concentration) of the calibration plasma from the package insert to the calibration panel.

The first time that you use a PT reagent of a new Lot number, you need to enter the ISI value and the
Normal value of the reagent from the package insert to the calibration panel, if you use the calibration
method Nor- mal / ISI by factors for INR result calculation.

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Calibrator dilutions
The calibrator dilution stages for calibration type Single Calibrator can only be altered by the system
administrator with access rights of login labhead or service.
▪ In the Calibration panel, choose the SINGLE CALIBRATOR command; e.
▪ Choose EDIT VALUES; e. The column dilution of the calibrator table is selected.
▪ Press y to move to the field Dilution, position X1. With kyou can select the first dilution.
With y move down one position and do the same to select the next dilution. Continue to
proceed in this manner; yor euntil you have entered all the dilutions, which the analyzer
should execute and measure, then press ^.
▪ START is selected; e.

After successfully calibration, the dilution stages are stored for this test and cannot be changed by
login routine user(s).

Calibration range
The calibration range and the graphical display of the curve are defined in Min. value and Max. value and
can only be altered by the system administrator with access rights of login labhead or service.
All calibration points must be within the Min. value and Max. value. No values outside this range are
calculated.

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Calibration Setup
Displays information about the calibrators.

Select CALIBRATION SETUP in the menu window by using yw. The screen with all active tests
appears in the working area. To move to a different column, press yw, e or { /
}. The column Test is a fixed position, not changeable.

The entries in column Lot No, Date and Comment are changeable with login routine (user 0-9) access
rights, the other entries are given during test application by the system administrator with login service
or labhead.
In tests, without the need for calibration, the input fields remain free.

▪ Test: Tests for which the calibrator can be used. The test parameters panel
determines the names and abbreviations of the tests.
▪ Liq.: Identification code for the to be used calibration plasma and buffer.
▪ Plasma/Reagent: Name of the calibration plasma or buffer.
▪ Lot No: Lot number of the calibration plasma or buffer.
▪ Date: Expiry date of the calibration plasma or buffer.
▪ Comment: Comment by the manufacturer of the calibrator.

For traceability, it is recommended to enter the actual data of the calibration plasma or reagent:
▪ Lot number
▪ Expiry date
▪ Comment
For all results of calibration point measurements, the calibration plasma / reagent name(s), Lot
numbers and the expiry dates will be deposited.
Upon Calibration, the calibration plasma and buffer with the according lot numbers are automatically
entered in the menu item CALIBRATION.

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Calibration
In the Calibration menu values and times for the calibration are registered. There are three alternatives
of creating a calibration curve: CALIBRATOR SET, SINGLE CALIBRATOR and MANUAL ENTRY.

For tests that not need a calibration curve: VALIDATION.


▪ Test: The name of the test.
▪ Plasma: Name of the calibration plasma as defined in CALIBRATION SETUP.
▪ Reagent: Name of the reagent as defined in REAGENT SETUP.
▪ Calibration date: Date and time of calibration execution.
▪ Activation date: Date and time of activation, via RESULTS > CALIBRATION > u.
▪ Lot No: Lot number of the calibration plasma or reagent as defined in
CALIBRATION or REAGENT SETUP.
▪ Calibrator Set: The analyzer determines the values from calibration plasmas
with different concentrations.
▪ Single Calibrator: The analyzer calculates calibration curves using fully automatic
plasma predilution.
▪ Manual entry: Input of the calibration curve values by using the keyboard.
▪ Show Curve: Menu entry to view the calibration curve.
▪ Table: In the column Pos. the calibration plasma positions are shown. In
the example illustrated, the second column shows the percentages. The TEST PARAMETERS panel
determines the type of calculation and automatically included in the chart. In the third column the
corresponding times or values of the activity, concentration or optical density (for chromogenic
analyses) are shown.
▪ Min. / Max. Value: Min. and max. value specifies the limitation of the calibration
curve. All the results outside this range are not accepted and are marked with an error flag.
▪ Normal /ISI: Optional when calculating the INR value by calibration method
factors.

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Calibration Chart
The calibration chart shows the graphic, the calculations and the conditions of the calibration curve.
Use the following process in the menu CALIBRATION in order to view the graph.
▪ Choose CALIBRATION; e. The test menu is displayed.
▪ In the test menu, choose the test for which you want to see the calibration chart; e.

▪ The calibration panel for the selected test is displayed, the cursor switches to CALIBRATOR SET.
▪ Press yw to change to SHOW CURVE; e. The calibration chart is displayed in the working
area.
Information in the chart
▪ Test and date of the calibration.
▪ Conditions of the calculation and of the graphic; the used scaling and interpolation.
▪ Calculated min. and max. values.
▪ Display of the calculated Normal and ISI values in case of INR calibration method curve
calculation, or display of the used factors in case of INR calibration method Nomal / ISI factor
calculation.
▪ Table of calibration point concentrations and measurements.
▪ Calibration curve graphic.

Use yw to see individual calculated results within the curve, or use {/ } for
detailed values displayed below the table. The curve can be printed using i.

Values of the curve are given e.g. in %, mg/dl, g/l, IU/ml on the X-axis of the curve. The Y-axis shows
the corresponding times. All calibration points must be within the Min. value and Max. value. No values
outside this range are calculated.

NOTICE!
Parameters of the calibration curve display and calculation can only be altered by the system
administrator with access rights of login labhead or service. For details see Application Manual.

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Calibrator set calibration


The Calibrator Set calibration requires a multi calibrator set with several instances of calibration
plasmas, each having a different concentration.

Choose CALIBRATION and in the sub menu Test the test for which you want to run the calibration. The
Calibration panel for the selected test is displayed.
▪ In the Calibration panel, choose the CALIBRATOR SET command; e.
▪ A new table for editing calibrator set properties is displayed in the calibration panel.
▪ Choose EDIT VALUES; e. The column concentration (e. g. %) of the calibrator table is selected.
▪ Type the values as given in the package insert. Press e to choose the next
value to be entered or checked.
▪ When you have entered the correct values in descending order for all calibration plasmas and
reagent properties (Normal (MNPT) / ISI), press ^.
▪ START is selected.

Prepare the calibration plasmas as described in their package insert. Place the calibration plasmas in
the corresponding positions (X1...X8) in the analyzer and press eto start.
▪ Once the measured values are automatically entered in the chart, the analyzer shows the message
“Calibration finished (see curve)“.
▪ Press e to move the cursor to the field SHOW CURVE.
▪ Press e to view the curve.
▪ After leaving the curve chart with ^ the cursor is in the field Accept, which has changed from
No to Yes.
▪ To accept the curve press ^ or e.
▪ To not accept the curve, change the field Accept with k from No to Yes, press ^or
e.

If there are no changes of the calibrator concentration values (no new Lot number) or reagent
properties (no new PT reagent Lot number) of your calibration curve, go directly to Start in the Edit
values table and press e to start the calibration.

ATTENTION!
Do not remove the sample tray after start of calibration.

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Single calibrator calibration


The single calibrator calibration requires a calibration plasma, which will be diluted by the analyzer for
the different concentrations.
Choose CALIBRATION and in the sub menu Test the test for which you want to run the calibration.
The Calibration panel for the selected test is displayed.
▪ In the Calibration panel, choose the SINGLE CALIBRATOR command; e.

▪ A new table for editing calibrator properties is displayed in the Calibration panel.
▪ Choose EDIT VALUES; e. The column dilution of the calibrator table is selected.
▪ Press w to move the cursor up to the item Reference.
▪ Type the value as given in the package insert; e
▪ A message with the required positions for dilution buffer, reference plasma and empty receptacles
will be displayed. START is selected.

Prepare the calibration plasma as described in their package insert. Place the calibrator, empty
receptacles, buffer and all the reagents in the correct positions and press e to start.
▪ Once the calibration curve is successfully measured, the message “System has finished calibration
(see curve)“ appears.
▪ Press e to move the cursor to the field SHOW CURVE.
▪ Press e to view the curve.
▪ After leaving the chart with ^ the cursor is in the field Accept, which has changed from No to
Yes.
▪ To accept the curve press ^ or e.
▪ To not accept the curve, change the field Accept with k from No to Yes, press ^ or
e.
If there are no changes of the calibrator concentration values (no new Lot number) or reagent
properties (no new PT reagent Lot number) of your calibration curve, go directly to Start in the Edit values
table and press e to start the calibration.

ATTENTION!
Do not remove the sample tray after start of calibration.

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Manual calibration
The manual calibration requires measurement results of different calibration plasmas or dilutions that
you have performed manually.

Choose CALIBRATION and in the sub menu Test the test for which you want to run the calibration. The
Calibration panel for the selected test is displayed.
▪ In the Calibration panel, choose the MANUAL ENTRY; e.
▪ A new table for editing calibrator properties is displayed in the calibration panel.
▪ Choose VALUES and press e.
▪ Press w to move the cursor up to the item reference.
▪ Type the value as given in the package insert; e.
▪ Press y to move to the column concentration (e. g. %).
▪ Type the values. Press e to choose the next value to be entered or checked. If you want to
use less entries for calibration, overwrite the values of the previous entries with 0 (zero).
▪ When you have entered the correct values for all calibration plasmas and reagent properties,
press ^.
▪ SHOW CURVE is selected; e.
▪ After leaving the chart with ^ the cursor is in the field Accept, which has changed from No to
Yes.
▪ To accept the curve press ^ or e.
▪ To not accept the curve, change the field Accept with k from No to Yes, press ^ or
e.

Re-Calibration
The Re-Calibration is a blank calibration for chromogenic tests, that have been calibrated with two
calibration points, calibrator and buffer. The interpolation of the calibration curve must be linear
regression. Once the tests was calibrated by calibration type Single Calibrator, the system shift this
calibration within the Re-Calibration by the delta absorbance value of the buffer, which is measured
during the Re-Calibration.

Choose CALIBRATION and in the sub menu Test the test for which you want to run the Re-Calibration. The
Calib- ration panel for the selected test is displayed.
▪ In the Calibration panel, choose the RE-CALIBRATION command; e.
▪ START is selected.
Place the buffer and all the reagents in the correct positions and press eto start.

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▪ Once the buffer is successfully measured, the message “System has finished calibration (see
curve)“
appears.
▪ Press e to move the cursor to the field SHOW CURVE.
▪ Press e to view the curve.
▪ After leaving the chart with ^ the cursor is in the field Accept, which has changed from No to
Yes.
▪ To accept the new curve press ^ or e.
▪ To not accept the curve, change the field Accept with k from No to Yes, press ^ or
e.

ATTENTION!
Do not remove the sample tray after start of calibration.

Reactivate calibration
The menu option RESULTS > CALIBRATION displays a list with all calibrations, listed by test name. You can
view all calibrations including results with the according reaction curves, the calibration curve and the
reagent/calibration plasma information of the used reagents / calibration plasma.
There is an opportunity to reactivate a calibration curve.
Choose RESULTS in the main menu and CALIBRATION in the sub menu. The screen with the list of all tests is
displayed.
▪ From the list, choose the test for which you want to view or reactivate the calibration; e.
▪ The screen with the list of all calibrations of this test appears.
▪ From the list, choose the calibration which you want to view or reactivate. In the bottom of the
screen the Lot No of the used reagents / calibration plasma are displayed.
▪ With u you can reactivate or view the calibration curve. A new panel appears with the menu
items SHOW
CURVE or ACTIVATE CURVE. Choose the menu item SHOW CURVE to view the curve, or ACTIVATE CURVE to
reactivate the curve. Press ^ to return to the previous display.
▪ With t you have the opportunity to enter a comment for this calibration curve. Press
^ to return to the previous display.
▪ With e you can view the results of the calibration point measurements in detail.

IMPORTANT!
When reactivating a calibration curve or liquid validation with previous settings from the result
database, the settings in menu Test Parameters are taken over again from this calibration in the
current test.

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Quality control
Quality control is made by using special control plasmas or calibration plasmas. In their instructions of
the respective reagent the reagent manufacturers name the control or calibration plasmas required for
performing a quality control.
All information for preparation and use of the control or calibration plasmas is given by the
manufacturer in the instructions for the plasma used. Always follow this information, disregard may
result in incorrect results.

QC is a prerequisite for correct test results.


QC materials are usually test specific, but some can be used for several tests. A QC is therefore
defined by the combination of the QC material and the test. You can perform QCs with repetitions. Your
laboratory defines how often a QC must be performed.

The analyzer provides the following QC methods:


▪ Loading the QC material on the reagent area.
▪ Loading the QC material on the sample area.

You have to prepare the QC material as described in its value sheet. Once you have prepared the QC
material, it usually expires after a few hours. For detailed description refer to the value sheets of the
control plasma.

ATTENTION!
Users are responsible to define adequate controlling procedures are which agree with the country
specific valid lab regulations.

QC Setup
The QC SETUP window displays information about the control plasmas. You can specify the Lot number,
the expiry date to the control plasmas and the corresponding confidence values.

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Select QC SETUP in the menu window by using yw. The screen with all active tests appears in the
working area. To move to a different column press yw, e or { / }. The column
Test is a fixed position, not changeable.
The entries in column Lot No, Date, Target and Range are changeable with login routine (user 0-9) access
rights, the other entries are given during test application by the system administrator with login service
or labhead. For details see Application Manual.

▪ Test: Tests for which the control can be used. The test parameters panel determines the
names and abbreviations of the tests.
▪ Plasma: Name of the control plasma.
▪ Lot No: Lot number of the control plasma.
▪ Date: Expiry date of the control plasma.
▪ Stb: On board stability of the control in hours, that is, the number of hours you can use
the control, once you have prepared it and loaded on the analyzer.
▪ Valid: Displays the interval in hours, that is, how often a QC needs to be run for a test.
The value in this column is defined by the laboratory, according to the appropriate laboratory
regulations. Entry of zero indicates infinite.
▪ Target mean: Type the mean value for the control as given in the package insert.
▪ Range low: Type the value for the negative tolerance as given in the package insert.
▪ Range high: Type the value for the positive tolerance as given in the package insert.

QC
Displays the status of the controls. The measurements for the control plasma will started from this
window. There is a graphic for all control plasmas. This Levey Jennings chart represents the results of
the current control QC Lot as given in the QC SETUP menu.

Select QC in the menu window by using yw. The screen with all active tests appears in the
working area. To move to a different column press yw, { / }or e for graphic
view.
The column Test, Plasma, Posit., Result and Valid are fixed positions, not changeable.

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▪ Test: Tests for which the control can be used. The test parameters panel determines
the names and abbreviations of the tests.
▪ Plasma: Name of the control plasma as given in the QC Setup menu.
▪ Posit.: Position of the control plasma on the analyzer. Will be displayed after leaving the menu
with ^, if Start: Yes.
▪ Start: Start of the QC by setting the field from No to Yes with k.With {/ }you can
switch quickly to the next QC start field.
▪ N: Number of repetitions of the QC. The number is limited by the number of sample
plasma positions of the analyzer.
▪ Result: Displays „ok” or „not ok”, when the last result is in the range of the current QC. Lot as
given in the QC SETUP menu.
▪ Valid: Displays a timer for the remaining valid time of the QC. After this time, the patient
results of this test are marked. The valid time is entered in the QC Setup menu. If there‘s no entry in
this column, the valid time has not been entered in menu QC Setup.
▪ Graphic: Access to the Levey Jennings chart.

Start QC
Prepare the control plasma as described in their package insert.
▪ Choose QC and press e.
▪ In the QC panel, the cursor switches to the column Start. Press k(No/Yes) to start this
test/control plasma.
▪ Press {/ } to start several tests/control plasmas.
▪ After leaving the QC panel with ^, the position of the control plasma is displayed in the
column Posit.
▪ “Analyzer ready (Quality control)” is displayed in the message window.

Place the control plasma and all reagents in the correct positions. Press m to start the QC.
When the measurements are completed the established results are transmitted to the result
database and the corresponding chart. Depending on whether the result is within the
specified range, in the column Result ok or not ok will be displayed.

QC Graphic (Levey Jennings chart)


First the information of the QC plasma is displayed.
▪ Value Min and Max: Displays to lowest and the highest measuring value.
▪ Mean: Displays the average value calculated in the chart.
▪ SD: Displays the calculation of standard deviation.
▪ CV: Displays the calculated coefficient of variation.
▪ Press e or, if there are several units for this control, choose the unit with yw;
e.
▪ Use k to change Curve values from all to valid:
▪ Choose all to include all QC results.
▪ Choose Valid to exclude results that you have marked as invalid in the results control panel.
▪ Use the xz to see the individual results above the chart.
▪ Print out of the chart by pressing i.

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Precision measurement
The QC menu offers the option to make a determination of a within-run precision. The results are
calculated and displayed graphically in the Levey Jennings Graph.
In the column N of the QC menu the number of repetitions for the according control plasma and test
can be entered.
The number is limited by the number of sample plasma positions of the analyzer. That means, the total
of repetitions for one run may not exceed the number of plasma positions.

Example (sample plasma positions: 31)


Precision run of one control plasma:
▪ Control 1: up to 31 repetitions of Test A, Test B etc., depending on control plasma amount.

Precision of two control plasmas:


▪ Control 1: up to 15 repetitions of Test A, Test B etc., depending on control plasma amount.
▪ Control 2: up to 15 repetitions of Test A, Test B etc., depending on control plasma amount.

Start the within-run precision


Prepare the control plasma as described in their package insert.
▪ Choose QC and press e.
▪ In the QC panel, the cursor switches to the column Start. Press k (No/Yes) to start this
test/control plasma.
▪ Press e and type the number of repetitions in the column N.
▪ Press {/ } to start several tests/control plasmas; observe limitations, see above.
▪ After leaving the QC panel with ^, the position of the control plasma is displayed in the
column Posit.
▪ “Analyzer ready (Quality control)” is displayed in the message window.

Place the control plasma and all reagents in the correct positions. Press m to start the precision run.

Within-run precision evaluation


To see the within-run precision and to get the calculation with Mean, CV, SD, Min., Max. value and the
Levey Jennings Graph, you have to mark all results of this control, that are measured before or after
the precision run.

▪ In the RESULTS report panel, choose CONTROLS; e.


▪ The screen with the list of all controls appears.
▪ From the list, choose the control for which you want to view the precision; e.
The corresponding chart with all results that have been run for this control is displayed.
▪ Choose a result with wy and mark the results, that should not calculated and included in the
chart with k.
▪ Press u to enter the Levey Jennings chart.
▪ Press e or, if there are several units for this control, choose the unit with yw;
e.
▪ Use k to change Curve values from all to valid:
▪ Choose all to include all QC results.
▪ Choose Valid to exclude results that you have marked as invalid in the results control panel.
▪ Use the xz to see the individual results above the chart.
▪ Printout of the chart by pressing i.
▪ Press ^ to return to the previous display.

NOTICE!
If the Control is already used for a long time, you must mark many results to see the within-run precision.

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1. Workaround:
▪ Change the Lot number of the control, before start of the within-run precision, e.g.
the Lot No and CV1, CV2 etc. (123456CV1).
▪ The software creates from every Lot number a file in the QC result database.
▪ You have always the overview of the control day by day (123456) and the
within-run precisions (123456CV1 - 123456 CV2 etc.).
▪ When removing the addition (CV1) after the end of within-run precision, the daily QC will be
entered in
the database of the control Lot number without addition again.
▪ With this method, you also avoid the influencing of the day by day QC by the within-run precision
results.
2. Workaround:
▪ Perform a precision of a material / control plasma, that is not defined in the QC Setup menu.
▪ Define the material in the QC Setup menu. This could only be done by the system administrator
with login
labhead or login service access rights.

NOTICE!
The QC result database is depending on login.
The QC measurements that has been done with labhead access rights are only visible in Login Labhead. The
QC measurements that has been done with service access rights are only visible in Login Service.
The QC measurements that has been done with routine access rights are only visible in Login Routine and
Login User 0-9.

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Hardware
The menu item HARDWARE is a control and maintenance program (also see chapter maintenance and
care). In the status window the water level condition and temperature status are displayed.

Before you can start a maintenance action, the analyzer needs to be in the standby mode.
Select HARDWARE in the menu window by using yw. The screen with hardware areas appears in
the sub menu window. To move to the desired hardware area press yw. To select the area
press e. The cursor switches to the hardware action panel. To move to the desired hardware
action press yw. To select the action press e.

CAUTION!
After selecting a hardware action the needle moves to the according position. Please wait until the
needle is in the specified position.

Water Levels and Temperatures


Water reservoir status and the temperatures are displayed in a chart. If the water level is not shown to
be OK, refill the wash water container. If one of the temperatures is not OK, the analyzer stops. A + / -
shows the direction of the wrong temperature.

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Sampler
All menu items concerning the area SAMPLER refer to the pipetting arm to the of the analyzer.

Needle

Test Position
Checking the reference position of the needle ensures that the needle moves correctly into sample
tubes, cuvettes and containers for pipetting.
▪ In the hardware action panel, choose the TEST POSITION; e.
▪ The needle moves over the red dot of the wash position.
▪ Visually check if the tip of the needle is situated exactly over the red dot at the same level as the
wash station.

If the tip of the needle is not situated exactly over the red dot, but within an area of 5mm, carefully
bend the needle until the tip is located exactly over the red dot.
Replace the needle when you observe one of the following situations:
▪ The tip of the needle is more than 5 mm away from the red dot.
▪ The tip of the needle is at a higher level than the surface of the wash station.
▪ The tip of the needle is within the dot notch so you cannot bend it sideways.
Choose the next hardware action with yw. To exit the hardware action panel, choose WASH
POSITION. The needle moves to the wash position.

Needle Check
Checking the fluid system tests the pipetting volume and the dispensing quality.
▪ In the hardware action panel, choose NEEDLE CHECK; e.
▪ The needle moves to the Home position.
▪ The message “Please put test cup on the wash station and press enter“ appears.

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After placing the test cup, the needle moves to the wash station and dispenses
approximately 3 ml of water in the test cup. While the needle is dispensing water into the test
cup, check visual the appearance of the water jet.
▪ The water jet must be straight without bows.
▪ The water jet must be a single flow without disturbances.
▪ The water must appear milky at first (high dispensing velocity), then clear at the end (low dispensing
velocity).

After this has been done, check the tip of the needle for any development of water drops.
▪ The message “Please remove test cup from wash station and press Enter“ appears.
▪ Remove the test cup. Visually check, whether the surface of the water level is above the inner edge
of the test cup (2 ml marker).
If your visual check fails or the dosage is under the 2 ml marker, check the syringe, the tubing, and the
need- le for damages, proper connections, and blockages. Perform the needle clean. Water droplets
on the tip of the needle are an indication that the system might be leaky.
If you cannot solve the problem, contact the service department.

Choose the next hardware action with yw. To exit the hardware action panel, choose WASH
POSITION. The needle moves to the wash position.

Needle Clean
Cleaning the needle prevents any buildup of deposits that may affect results.
▪ In the hardware action panel, choose NEEDLE CLEAN; e.
▪ The needle moves to the Home position.
▪ The message “Add 1 ml 5% bleach in wash station and press enter for start“ appears.
▪ Pipette 1 mL of 5% bleach into the wash station. Press e to start the cleaning procedure.

The needle moves to the wash station and aspirates 300 µl bleach. After incubation of 20 minutes the
analyzer performs the cleaning procedure. The needle moves down into the wash station, aspirates
and dispenses the bleach several times and rinses the needle with water.
▪ While incubation the message “Press enter to end the needle clean“ displayed.
▪ You can interrupt the incubation and start the cleaning procedure at any time by pressing e.
Choose the next hardware action with yw. To exit the hardware action panel, choose WASH
POSITION. The needle moves to the wash position.

Needle Clean Manual


The needle should be cleaned manually if any droplets, on the shaft of the needle after pipetting, are
observed. To clean the needle remove the sample tray before you select NEEDLE CLEAN MANUAL.
▪ In the hardware action panel, choose NEEDLE CLEAN MANUAL; e.
▪ The needle moves to the change position.
▪ The message “Wipe needle only from top to bottom“ appears.
Cleaning the surface of the needle manually
To clean the surface of the needle manually wipe the needle from the top to the tip several times,
using a tissue moistened with 0.9% NaCl.

CAUTION!
The needle should only be cleaned from top to bottom. Please pay special attention to the instructions
displayed in the message box!

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Choose the next hardware action with yw. To exit the hardware action panel, choose WASH
POSITION. The needle moves to the wash position.

Change Position
This menu item is selected in order to change the needle. For details see chapter maintenance and
care, replacing the needle.

Reagent Position
Serves the position check of individual positions in the reagent block.
▪ In the hardware action panel, choose REAGENT POSITION; e.
▪ A toggle field is displayed to select the reagent position to be tested. Enter the position to be
approached by using k. Press e, the needle moves to the corresponding position.
▪ Press ^.

Choose the next hardware action with yw. To exit the hardware action panel, choose WASH
POSITION. The needle moves to the wash position.

Cuvette Rack Adjust


With this maintenance action, you can adjust the position to which the needle moves for pipetting in
the cuvettes. The analyzer moves the needle over the reference point of the cuvette rack. You can
check the x-coordinate, the y-coordinate, and the z-coordinate of the cuvette reference position. You
can adjust each of the coordinates separately. Changing the cuvette reference position of the needle
does not influence other essential positions of the needle, such as the positions for pipetting samples
and reagents.

▪ In the hardware action panel, choose CUVETTE RACK ADJUST; e.


▪ The cuvette rack moves to the pipetting station.
▪ The needle moves over the reference point of the cuvette rack. It moves down until it detects
the surface of the cuvette rack, and then stops.
▪ The Cuvette position REF window is displayed.
▪ Check the Z difference field in the Cuvette position REF window.
▪ If the Z difference field displays 0, the z coordinate of the needle cuvette position is correct.
▪ If the Z difference field does not display 0, press e to save the current z-coordinate as the
new needle cuvette position.
▪ Check and adjust the x- and the y-coordinate of the needle cuvette position. The needle should be
centered exactly over the reference point of the cuvette rack.
▪ If the tip of the needle is positioned exactly over the cuvette reference point, no further action is
necessary.
▪ If the tip of the needle is positioned left, right, before or behind of the cuvette reference
point, you need to adjust the x- or the y-coordinate of the needle.
▪ Press yw to move the needle until it is positioned exactly over the cuvette reference point.
▪ Each time you press an arrow key, the probe moves up, then sideways, and then down again.
▪ The Pos. field in the Cuvette position REF window changes.
▪ Press e to confirm the current x- and y-coordinate. The software saves the current x- and y-
coordinate as the new cuvette reference position.
▪ The Pos. field is empty.
▪ To quit without saving your adjustments, press ^.
▪ The needle moves to the home position. The cuvette rack returns to the waiting position.

Choose the next hardware action withyw. To exit the hardware action panel, choose WASH POSITION.
The needle moves to the wash position.

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Wash Position
The wash position must always be selected in order to be able to exit the hardware panel.
▪ In the hardware action panel, choose WASH POSITION; e .
▪ The needle moves to the wash position.
▪ Press ^.

Syringe
This menu item is selected in order to change the syringe, to remove air bubbles in the syringe or to
prime the system. For details see chapter maintenance and care.

Change Position
▪ In the hardware action panel, choose SYRINGE > CHANGE POSITION; e.
▪ The syringe plunger moves to the lowermost position.
▪ Press ^.

Home Position
▪ In the hardware action panel, choose SYRINGE > HOME POSITION; e .
▪ The syringe plunger moves to the uppermost position.
▪ Press ^.

Prime Pumps
▪ In the hardware action panel, choose PRIME PUMPS; e.

The analyzer performs the priming procedure. The needle moves down into the wash station, the
pumps rinse and fill the tubing system with water. The needle aspirates clean solution, dispenses the
cleaning solution and rinses the needle with water.
▪ Press ^.

NOTICE!
Prime Pumps is only necessary if the system was switched off for several hours. In standby mode, an automatic
short rinsing takes place every 30 minutes.

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LEDs
The menu items concerning the optic system. This hardware area is selected in order to clean the
measuring unit. (see chapter maintenance and care)

LED Test
The light intensity of the measuring system is checked.
▪ In the hardware action panel, choose LED TEST; e.
▪ The measuring unit moves to the measuring position and measure the light intensity of the LEDs.
▪ The message “LED ok (620nm)” appears. Press o.
▪ The message “LED ok (405nm)” appears. Press o

If the LEDs are not ok, please clean the measuring unit. To exit the hardware action panel, press
^.

A/D Values
Upon selecting this menu item, a chart opens which displays the A/D values of the measuring
channels. Please clean the measuring unit if one or more channels are outside the displayed range.
▪ In the hardware action panel, choose A/D VALUES 405 or A/D VALUES 620; e .
▪ The measuring unit moves to the measuring position and measure the A/D values.
▪ The A/D value chart for the selected test is displayed.
▪ Check, whether the values are inside the displayed range.
▪ Quit the test by pressing ^.

If the values are not ok, please clean the measuring unit. High values indicates that the LEDs have to
replace soon. Please contact your service department.

To exit the hardware action panel, press ^.

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Results
In the menu option RESULTS you can view all saved messages and measurement values. All results are
stored since the first database entry.

Select RESULTS in the menu window by using yw. The screen with report panel appears. To move to
the desired report, press yw. To select the report, press e. The cursor switches to a list of
results. To move to the desired result press yw or for several data sets j+ yw. To
select the result press e in the corresponding row.
Press i to send the data to the printer. Press p to send the data to the LIS.
▪ PATIENTS Test results for all patients incl. all reaction curves.
▪ CONTROLS Contains all data from QC measurements.
▪ CALIBRATION Contains all the executed calibration curves.
▪ PROTOCOL Contains the work log of the previous measurements.
▪ ERRORS List of generated error messages.
▪ STATUS Number of specimens, Q.C’s, tests
▪ BACKUP Create a backup on a USB stick.

No message or measurement value will be deleted, as long as no deletion of the database held by the
ser- vice technician or the PC is replaced.

Result display:
The report table displays a time based selection of results.
▪ Patients 90 days
▪ Calibration 750 days
▪ Error Messages 180 days
▪ Protocol 30 days
▪ Controls No limitation

If you want to see previous results, select the menu items PATIENT SEARCH, CONTROL SEARCH and ERROR SEARCH.

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Patients
The menu option PATIENTS displays a list with the patient data including all test results incl. reaction
curves and the reagent information of the used reagent. The patient measured last is displayed at the
bottom.
▪ In the report panel, choose PATIENTS; e.
▪ The screen with patient list appears.
▪ From the list, choose the patient sample for which you want to view the test results. Press e.
The corresponding index card with all tests that have been run for that patient is displayed. Choose a
test.
▪ Press e ; the result is displayed. In the bottom of the screen the name, Lot
number and expiry date of the used reagents are displayed.
▪ Press e; the result and the curve characteristics are displayed.
▪ Press e again to enlarge the curve.
▪ Press ^ to return to the previous display.

Patient Search
This menu item is selected in order to search patient data of a specific patient. The system will search
for an alpha-numeric combination, which may take place at any place in the Patient ID (observe upper
and lower base letters).
In this menu you can search patient data for a prolonged period. The system searches the entire
database.
▪ In the report panel, choose PATIENTS SEARCH; e .
▪ At the bottom of the report panel, the Search: field is displayed.
▪ As search item, type the ID of the patient sample. You can also type part of the ID only; e.
▪ The Results, Patient search panel lists the processed orders for all sample IDs that contain the search
item.
▪ From the list, choose the patient sample that you want to view; e.

The corresponding index card with all tests that have been run for that patient is displayed. Choose a
test.
▪ Press e ; the result is displayed. In the bottom of the screen the name, Lot number and
expiry date of the used reagents are displayed.
▪ Press e; the result and the curve characteristics are displayed.
▪ Press e again to enlarge the curve.
▪ Press ^ to return to the previous display.

Transmit New
This menu item displays all results, which are not sent to the LIS. In case of problems with the LIS you
can mark the results and send them by pressing p or j p for all displayed results.
▪ In the report panel, choose TRANSMIT NEW; e .
▪ The screen with patient list appears.
▪ From the list, choose the patient sample that you want send to the LIS and press p .
If your analyzer setup is defined to validate manual all test results before sending to the LIS, all results
will be displayed in this menu item. To change the setup for result validation you need service access
rights.
▪ In the report panel, choose TRANSMIT NEW. Press e .
▪ The screen with patient list appears.
▪ From the list, choose the patient sample, which you want to validate; e.

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The corresponding index card with all tests that have been run for that patient is displayed.
Choose a test.
▪ Press e ; the result is displayed. In the bottom of the screen the name, Lot number
and expiry date of the used reagents are displayed.
▪ Press e; the result and the curve characteristics are displayed.
▪ Press e again to enlarge the curve.
▪ Press ^ to return to the previous display.
▪ Press p to send the patient sample from the list to the LIS.
▪ Press ^ to return to the previous display.

Controls
The menu option CONTROLS displays a list with all controls including results incl. reaction curves and the
reagent information of the used reagent. There is an opportunity to enter a comment for a control
result or to mark a control result as not valid. This marked results will not be calculated in the Levey-
Jennings chart, when choosing Valid in the chart.
▪ In the report panel, choose CONTROLS; e .
▪ The screen with the list of all controls appears.
▪ From the list, choose the control for which you want to view the test results; e.
The corresponding chart with all results that have been run for this control is displayed.
▪ Choose a result.
▪ With t you have the opportunity to enter a comment for this control.
▪ With k you have the opportunity to mark this result as not valid.
▪ With u you enter the Levey-Jennings chart.
▪ Press e ; the result is displayed. In the bottom of the screen the Lot No of
the used reagents are displayed.
▪ Press e; the result and the curve characteristics are displayed.
▪ Press e again to enlarge the curve.
▪ Press ^ to return to the previous display.
NOTICE!
The QC result database is depending on login.
The QC measurements that has been done with labhead access rights are only visible in Login Labhead. The
QC measurements that has been done with service access rights are only visible in Login Service.
The QC measurements that has been done with routine access rights are only visible in Login Routine and
Login User 0-9.

The Levey Jennings chart


First the information of the QC plasma is displayed.
▪ Value Min and Max: Displays to lowest and the highest measuring value.
▪ Mean: Displays the average value calculated in the chart.
▪ SD: Displays the calculation of standard deviation.
▪ CV: Displays the calculated coefficient of variation.
▪ Press e or, if there are several units for this control, choose the unit with yw ; e.
▪ Use k to change Curve values from all to valid:
▪ Choose all to include all QC results.
▪ Choose Valid to exclude results that you have marked as invalid in the results control panel.
▪ Use the xz to see the individual results above the chart.
▪ Print out of the chart by pressing i.
▪ Leave the chart by pressing ^.

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Marking results in the Levey Jennings chart


▪ Choose a control.
▪ Press e ; the results are displayed. Press yw to choose a result.
▪ With t you have the opportunity to enter a comment for this control.
▪ With k you have the opportunity to mark this result as not valid.
▪ Press u to enter the Levey-Jennings Graph.
▪ Select Curve values: Valid with k.

Control Search
This menu item is selected in order to search results of a specific control. The system will search for an
alpha-numeric combination, which may take place at any place in the control name (observe upper
and lower base letters).
In this menu you can search control data for a prolonged period. The system searches the entire
database.
▪ In the report panel, choose CONTROL SEARCH; e .
▪ At the bottom of the report panel, a search field is displayed.
▪ As search item, type the name of the control plasma. You can also type part of the name only; e.
▪ The Results Control search panel lists controls that contain the search item.
▪ From the list, choose the control that you want to view; e.

The corresponding chart with all results that have been run for this control is displayed.
▪ Choose a result.
▪ With t you have the opportunity to enter a comment for this control.
▪ With k you have the opportunity to mark this result as not valid.
▪ With u you enter the Levey-Jennings chart.
▪ Press e ; the result is displayed. In the bottom of the screen the Lot No of the used
reagents are displayed.
▪ Press e; the result and the curve characteristics are displayed.
▪ Press e again to enlarge the curve.
▪ Press ^ to return to the previous display.

Calibration
The menu option CALIBRATION displays a list with all calibrations, listed by test name. You can view all
calibrations including results incl. reaction curves, the calibration curve and the reagent/calibration
plasma information of the used reagent/calibration plasma. There is an opportunity to enter a
comment for a calibration curve or to reactivate a calibration curve.
▪ In the report panel, choose CALIBRATION; e .
▪ The screen with the list of all tests appears.
▪ From the list, choose the tests for which you want to view or reactivate the calibration; e.
▪ The screen with the list of all calibrations of this test appears.
▪ From the list, choose the calibration for which you want to view the results. In the bottom of
the screen the Lot No of the used reagents and calibration plasma are displayed.
▪ With u you can reactivate or view the calibration curve. A new panel appears with the menu
items SHOW CURVE or ACTIVATE CURVE. Choose the menu item SHOW CURVE to view the curve, or ACTIVATE
CURVE to reactivate the curve. Press ^ to return to the previous display.

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▪ With t you have the opportunity to enter a comment for this calibration curve. Press ^ to
return to the previous display.
▪ Press e.The corresponding chart with results that have been run for this calibration is
displayed. Except the results of a manual calibration curve, you can view results incl. reaction
curves.
▪ Choose a result.
▪ Press e ; the result is displayed.
▪ Press e; the result and the curve characteristics are displayed.
▪ Press e again to enlarge the curve.
▪ Press ^to return to the previous display.

Protocol
The menu option PROTOCOL displays a list with all measurement results including results incl. reaction
curves in chronological order.
▪ In the report panel, choose PROTOCOL; e .
▪ The screen with chronological result list appears.
▪ From the list, choose the result which you want to view. Press e.
▪ The result and the curve characteristics are displayed.
▪ Press e again to enlarge the curve.
▪ Press ^to return to the previous display.

Errors
The menu option ERRORS displays a list with all error messages of the last 180 days.

Error Search
This menu item is selected in order to search a specific error message. The system will make a full
text search. The entered word/letters may take place at any place in the error message (observe
upper and lower base letters). In this menu you can search error messages for a prolonged period.
The system searches the entire database.
▪ In the report panel, choose ERROR SEARCH; e .
▪ At the bottom of the report panel, a search field is displayed.
▪ As search item, type the word/letters of the error message; e.
▪ The Results Error search panel lists the error messages that contain the search item.
▪ Press ^ to return to the previous display.

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Status
The menu option STATUS displays an overview of all entries in the database. A summary of all analyses
since the first database entry.
▪ In the report panel, choose STATUS; e.

The screen with a summary of all analyses since the first database entry appears.
▪ Patients: Number of processed patient samples.
▪ Controls: Number of processed controls.
▪ Error messages: Number of all error messages.
▪ Tests: Number of processed tests. This counter includes Patients, Controls and
In case of maintenance actions, e.g. Replacing the needle, this counter is the deciding.
▪ Press ^ to return to the previous display.

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Backup
This menu items are in order to create a backup of the system configuration or of the result database.
Every morning at 6:25 A.M., the analyzer automatically saves the results and the errors to the hard disk
in a compressed format, as a basis for backup actions. It does not perform this automatic backup
preparation when it is switched off. You need to ensure that the analyzer is running or in standby mode
in the morning.

Backup Parameter
The system parameters and the test parameters, including the active calibration curves.
▪ Connect an USB stick to the PC.
▪ In the report panel, choose BACKUP PARAM; e .
▪ The message “Success” appears.
▪ Remove the USB stick and store it at a secure location.

The analyzer creates a backup with all system and test parameters including the active calibration on
the USB Stick. Make sure to always have a current backup of your parameters!

Backup Database
The results of tests, QC`s and calibrations.
▪ Connect an USB stick to the PC.
▪ In the report panel, choose BACKUP DATABASE. Press e .
▪ The message “Success” appears.
▪ Remove the USB stick and store it at a secure location.

The analyzer creates a backup on the USB Stick with all error messages and all patient, control and
calibration results without reaction curves.

NOTICE!
The backup includes only the database till the automatic internal database backup at 6 am every day. That
means the results which are produced from 6 am until the Backup action will not been saved.

Backup Log
The log file is important in case of software troubleshooting actions of the service department.
▪ Connect an USB stick to the PC.
▪ In the report panel, choose BACKUP LOG; e .
▪ The message “Success” appears.
▪ Remove the USB stick and send the “Behnk” file to your service department.

The analyzer creates a backup with parameters located in the “Temp.dat” folder. That means all
analyzer software activities of the last 24h are saved here. The individual parameters for the selected
tests are dis- played in this working area.

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Test Parameters
The menu item TEST PARAMETERS shows all parameters of the active tests. All parameters can only be
changed if you have the appropriate access rights.

IMPORTANT!
A calibration / liquid validation is required whenever settings are changed.

With calibration / liquid validation, the changes are applied to the test parameters.
The liquid validation is needed for tests that do not require a calibration curve.

IMPORTANT!
When reactivating a calibration curve or liquid validation with previous settings from the result
database, the settings in menu Test Parameters are taken over again from this calibration in the
current test.

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Exit
The panel EXIT is used to shut down the software

▪ Choose EXIT and press e.


▪ The Exit panel is displayed. Press e.
▪ The analyzer finishes the last step.
▪ The analyzer cleans the needle.
▪ The sampler moves to the wash station.
▪ The software shuts down.
▪ The login window is displayed.
▪ To shut down the PC, press a+S.
▪ You will be ask if you want to shut down the PC.
Press e to shut down or change with zx to Cancel.
▪ The PC switches off automatically.
▪ Press the power switch of the monitor.
▪ To switch off the analyzer, press the power switch of the analyzer left side.

NOTICE!
If the STOP was activated, the EXIT to quit the software can not be completed. Please release STOP, or
restart the computer in this situation.

Unloading the reagents


▪ Unload all reagents, diluents, cleaners, calibrators, and control materials from the analyzer.
▪ Store the reagents in accordance with the storage conditions defined in their respective package
inserts.

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Maintenance and care


This section gives an overview of the user maintenance action and care.

Table of contents

Overview 90

Regular maintenance actions 91


Daily care 91
Weekly care 93

Specific maintenance actions 95


Filling the water container 95
Priming the fluid system 95
Removing air bubbles in the syringe 95
Cleaning the housing 96
Manually needle cleaning 96
Checking the cuvette reference position 97
Shutting down the analyzer 98

Replacing hardware components 99


Replacing the needle 100
Replacing the syringe 102

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Overview
The analyzer is designed and manufactured for low maintenance and a long life cycle. This section
gives an overview of the user maintenance actions and their intervals.
A technical preventive maintenance should be performed by your analyzer supplier or trained service
engineer!

Regular maintenance
The following maintenance actions should be performed regularly:

Maintenance action Interval


Checking the reference position of the needle Daily.
After you have replaced the needle.
Checking the fluid system Daily.
After you have replaced the needle.
When there are pipetting problems.
If you suspect the pipetting volume to be
incorrect.
Checking the tube system Daily.
After you have replaced the needle.
When there are pipetting problems.
Cleaning a needle automatically Weekly.
When the needle is blocked.
Cleaning the surface of a needle manually Weekly.
When the outside of the needle is
contaminated with foreign substances.
Cleaning the measuring block Weekly.

Specific maintenance
The following maintenance actions should be performed when required:

Filling the water container Before starting the analyzer.


When the software prompts you to do so.
Priming the fluid system When the analyzer was switched off more
than six hours.
After you have replaced the syringe.
When there is air in the fluid system, for
example, in the syringe or in the tubing.
Removing air bubbles in the syringe When there is air in the in the syringe.
Cleaning the inside of the needle manually When checking the fluid system shows
problems with the pipetting volume or the
dispensing quality.
Replacing the needle After 20 000 tests or as part of the
preventive maintenance visit by a service
technician.
When the needle is damaged.
Replacing the syringe After 20 000 tests or as part of the preventive
maintenance visit by a service technician.
Checking the cuvette reference position Possibility of checking/correcting the needle
position with the cuvette rack by the trained
operator
Shutting down the analyzer When you want to turn off the analyzer.

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Regular maintenance actions


This section describes the regular maintenance actions.
The daily and weekly maintenance actions.
The duration time for the daily checks are approx 3 min.
The duration time for the weekly care is 25 min. (20 min. residence time of the cleaner )

Daily care

Checking the reference position of the needle

Checking the reference position of the needle ensures that the


needle moves correctly into sample tubes, cuvettes and containers
for pipetting.
▪ In the hardware action panel, choose the TEST POSITION; e .
▪ The needle moves over the red dot of the wash position.
▪ Visually check if the tip of the needle is situated exactly centered
over the metal dot and barely touched. If the tip of the needle is
not situated exactly over the metal dot, but within an area of
5mm, carefully bend the needle until the tip is located exactly
over the red dot.

Replace the needle when you observe one of the following situations:
▪ The tip of the needle is more than 5 mm away from the dot.
▪ The tip of the needle is at a higher level than the surface of the wash station.
▪ The tip of the needle is within the dot notch so you cannot bend it sideways.
To Exit the hardware action panel, choose WASH POSITION. The needle moves to the wash position.

Checking the fluid system


Required material:
▪ Test cup

Checking the fluid system tests the pipetting volume and the dispensing quality.
▪ Place on top of the wash station.
▪ In the hardware action panel, choose NEEDLE CHECK; e .
▪ The needle moves to the Home position.
▪ The message “Please exchange Clean with maintenance adapter and press ENTER“ appears.
Follow this instruction.

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After placing the test cup and pressing e the needle moves to the test cup and dispenses
approximately 3 ml of water in the test cup. While the needle is dispensing water into the test cup,
check visual the appearance of the water jet.
▪ The water jet must be straight without bows.
▪ The water jet must be a single flow without disturbances.
▪ The water must appear milky at first (high dispensing velocity), then clear at the end (low dispensing
velocity).

OK Not OK Not OK

Check the tip of the needle for any occur water drops. A drop occurrence is an indicator of an leakage
pipetting system. If you cannot solve the problem, contact your Service representative.

▪ The message “Please remove test cup from wash station and press Enter“ appears.
▪ Remove the wash control cup. Visually check, whether the surface of the water level is above the
inner edge of the test cup (2 ml marker).By pressing F4 the message „ Please exchange
maintenance adapter with Clean and press <ENTER>“ appears and the needle move to the home
position.
▪ To quit the message press F4. The message “Please exchange maintenance adapter
with Clean and press <ENTER>

To exit the hardware action panel, choose WASH POSITION. The needle moves to the wash position.

Checking the tube system


Checking the tube system general sequence and visually check whether air bubbles are present in the
system.
▪ In the hardware action panel, choose PRIME PUMPS; e .

The analyzer performs the priming procedure.


▪ The needle moves down into the wash station, the pumps rinse and fill the tubing system with
water.
▪ The needle aspirates clean solution, dispenses the clean solution and rinses the needle with
water.
▪ Visually check the syringe and the tube system.
If you observe any air bubbles in the syringe glass tube or the tube system, check how firmly the
syringe is mounted: both top and bottom. Prime the system again. If the air bubbles in the syringe
persists, remove them manually (see chapter Removing air bubbles in the syringe).
To exit the hardware action panel, press ^.

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Weekly care

Cleaning the needle automatically

Required material:
▪ 1 ml bleach 5%

Cleaning the needle automatically


Cleaning the needle prevents any buildup of deposits that may affect results.
▪ In the hardware action panel, choose SAMPLER >NEEDLE CLEAN; e.
▪ The needle moves to the Home position.
▪ The message “Add 1 ml 5% bleach in wash station and press e for Start“ appears.
▪ Pipette 1 mL of 5% bleach into the wash station. Press e to start the cleaning procedure.

Process description:
The needle moves to the wash station and aspirates 300 µl bleach. After incubation of 20 minutes the
analyzer performs the cleaning procedure. The needle moves down into the wash station, aspirates
and dispenses the bleach several times and rinses the needle with water.
▪ While incubation the message “Press Enter to end the needle clean“ is displayed.
▪ You can interrupt the incubation and start the cleaning procedure at any time by pressing e.

To exit the hardware action panel, choose WASH POSITION. The needle moves to the wash position.

Cleaning the surface of the needle manually


The needle should be cleaned manually if any droplets, on the shaft of the needle after pipetting, are
observed. To clean the needle remove the rotor before you select NEEDLE CLEAN MANUAL.
▪ In the hardware action panel, choose SAMPLER > NEEDLE CLEAN MANUAL; e.
▪ The needle moves to the change position.
▪ The message “Wipe needle only from top to bottom“ appears.
To clean the surface of the needle manually wipe the needle from the top to the tip several times, using
a tissue moistened with 0.9% NaCl.

CAUTION!
The needle should only be cleaned from top to bottom. Please pay special attention to the instructions
dis- played in the message box!

To exit the hardware action panel, choose WASH POSITION. The needle moves to the wash position.

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Cleaning the measuring block

Preparing the clean stick: Moisten one side of the fabric of the clean
stick with 300µl NaCl 0.9% solution.

Process description:
▪ Choose HARDWARE>OPTICES>A/D VALUES 405 NM In the
hardware action panel and press e .
The measuring block moves to the measuring position.
▪ Lift the ejection flap and insert the clean stick into the measuring
block.
▪ Move the end with the fabric in and out several times.
▪ Press the moistened side to one side of the measuring chamber and clean this side of
the measuring chamber.
▪ Remove and turn the clean stick180 degree. Clean now the other side of the
measuring chamber with the moistened side.
▪ After the cleaning process, dry both sides of the measuring chamber with the dry fabric side.
▪ To move the measuring block in the incubation position, exit the hardware action panel by
pressing ^.

Store or dispose of the clean stick, depending on how often it has been used:
If the clean stick looks grey and dirty, dispose of it according to the appropriate local regulations. If the
clean stick looks white and clean, store it in a place where it can dry for later use.

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Specific maintenance actions


Filling the water container
The water container provides the water for pipetting and rinsing.
▪ If the analyzer is not in Standby mode, press n.
▪ Remove the liquid level sensor from the water container.
▪ Unscrew the cap of the water container.
▪ Empty the water container
▪ Fill the water container with deionized water.
▪ Screw the cap on the water container.
▪ Insert the liquid level sensor in the opening in the container
cap, push it down firmly, so that it covers the cap completely.
Delete the message in the message window by pressing o or
ALARM OFF. Prime the system.

NOTICE!
Check the container frequently regarding fungal attack or other
contaminations. Clean the container firmly or change the
container.

Priming the fluid system


Priming the fluid system completely exchanges the water in the tubing.
▪ In the hardware action panel, choose PRIME PUMPS; e .

The analyzer performs the priming procedure.


▪ The needle moves down into the wash station, the pumps rinse and fill the tubing system with
water.
▪ The needle aspirates clean solution, dispenses the clean solution and rinses the needle with
water.
To exit the hardware action panel, press ^.

Removing air bubbles in the syringe


Visually check the syringe during PRIME PUMPS. If you observe any air bubbles in the syringe glass tube or
above the surface of the Teflon plunger tip, prime the system again.
▪ In the hardware action panel choose SAMPLER LEFT or SAMPLE RIGHT for the corresponding syringe, choose
PRIME PUMPS; e .
The analyzer performs the priming procedure.
▪ The needle moves down into the wash station, the pumps rinse and fill the tubing system with
water.
▪ The needle aspirates clean solution, dispenses the clean solution and rinses the needle with
water.

If the air bubble is still exists remove the syringe out of the analyzer. See Chapter Replacing hardware
components> Replacing the syringe.

Prime the system again and check visually if the air bubble has disappeared.

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Cleaning the housing


You clean the analyzer or parts of it when you observe soiling and as part of certain maintenance
actions. A cleaning contribute to the proper functioning of the analyzer.

To clean / decontaminate the analyzer, use a paper towel moistened with an alcoholic solution (ethanol
70%) or wiping disinfectant with a pH value between 7.4 and 9.0.
Any other detergents having a higher pH value may cause damage to the casing.

Remove all loosen accessories like sample tray, reagent block, cuvette rack register etc. before you start
cleaning the analyzer and the accessories.

NOTICE!
▪ Any liquid spilled on the analyzer may result in malfunction or damage.
▪ When you clean the housing and covers, do not pour water, ethanol, or any other liquid on the
analyzer.
▪ If liquid does spill on the analyzer, wipe it up immediately and follow the applicable
decontamination procedure. Wear appropriate personal protective equipment.

Manually needle cleaning


Cleaning the inside of the needle manually
The necessary needle clean wire is delivered with each needle.

CAUTION!
Please be careful and avoid any injuries which could be caused by the tip of the needle. Always wear
protective gloves in order to protect yourself against contamination!

▪ In the hardware action panel, choose HARDWARE> SAMPLER > CHANGE POSITION; e
▪ The needle moves to the change position. The syringe plunger moves
down, in order to withdraw any liquid from the needle.
▪ Remove the protective tube out of the guide on the inner black casing.
▪ Push the protective tube back until the needle is exposed on the top.
▪ Remove the pipetting tube from the top of the needle.

ATTENTION!
When removing the tube, tightly hold on to the needle’s black guide.

▪ Insert the needle clean wire into the end of the needle until
you see the tip appearing at the needle tip.
▪ Move the needle clean wire in and out of the needle several times.
▪ Remove the needle clean wire from the needle by pulling it out of the needle end.
▪ After the cleaning process:
▪ Put the end of the pipetting tube over the upper end of the needle by holding the needle with one
hand and moving the tube with the other hand. The pipetting tube covers the upper end of the
needle.

ATTENTION!
When removing the tube, tightly hold on to the needle and the needle’s black guide.

NOTICE!
For a better grip you can use gloves

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▪ Slide the black protection tube, which is around the transparent pipetting tube, towards the needle
guide until it completely covers the pipetting tube and touches the upper needle holder.
▪ Fasten the pipetting tube in the tubing guides. The beginning of the black tube must be in
line with the tubing guide.

Checking the cuvette reference position


With this maintenance action, you can adjust the position to which the needle moves for pipetting in
the cuvettes. The analyzer moves the needle over the reference point of the cuvette rack. You can
check the x-coordinate, the y-coordinate, and the z-coordinate of the cuvette reference position. You
can adjust the x- and y -coordinates manually. The z-coordinate is auto adjusted. Changing the cuvette
reference position of the needle does not influence other essential positions of the needle, such as the
positions for pipetting samples and reagents.

▪ In the hardware action panel, choose SAMPLER for the corresponding


needle, choose CUVETTE RACK ADJUST; e .
▪ The cuvette rack moves to the pipetting position.
▪ The needle moves over the reference point of the cuvette
rack. It moves down until it detects the surface of the cuvette
rack, and then stops. There are two different reference points,
depending of the used analyzer model (and cuvettes).
▪ The Cuvette position REF window is displayed.
▪ Check the Z difference field in the Cuvette position REF window.
▪ If the Z difference field displays 0, the z coordinate of the
needle cuvette position is correct.
▪ If the Z difference field does not display 0, press e to save the current z-coordinate as
the new needle cuvette position.
▪ Check and adjust the x- and the y-coordinate of the needle cuvette
position. The needle should be centered exactly over the reference
point of the cuvette rack. See Picture.
▪ If the tip of the needle is positioned exactly over the cuvette
reference point, no further action is necessary.
▪ If the tip of the needle is positioned left, right, before or
behind of the cuvette reference point, you need to adjust the
x- or the y-coordinate of the needle.
▪ Press yw to move the needle until it is positioned exactly over the
cuvette reference point.
▪ Each time you press an arrow key, the probe
moves up, then sideways, and then down
again.
▪ The Pos. field in the Cuvette position REF window changes.
▪ Press e to confirm the current x- and y-coordinate. The software saves the current x- and y-
coordinate
as the new cuvette reference position.
▪ The Pos. field is empty.
▪ To quit without saving your adjustments, press ^.
▪ The needle moves to the Home position. The cuvette rack returns to the waiting position.

To exit the hardware action panel, choose WASH POSITION. The needle moves to the wash position.

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Shutting down the analyzer


This section describes the required actions for shutting down the analyzer and the control unit.
The analyzer is designed for 24h/day operation. You need to shut it down only in exceptional
situations, or if you do not use the analyzer for several days.

The panel EXIT is used to shut down the software


▪ Choose EXIT and press e.
▪ The Exit panel is displayed. Press e.
▪ The analyzer finishes the last step.
▪ The analyzer cleans the needle.
▪ The sampler moves to the wash station.
▪ The software shuts down.
▪ The login window is displayed.
▪ To shut down the PC, press a+S.
▪ You will be ask if you want to shut down the PC.
Press eto shut down or change with z x to Cancel.
▪ The PC switches off automatically.
▪ Press the power switch of the monitor.
▪ To switch off the analyzer, use the mains power switch at the analyzer left side.

NOTICE!
If the STOP was activated, the EXIT to quit the software can not be completed. Please release STOP, or
restart the computer in this situation.

Unloading the reagents


▪ Unload all reagents, diluents, cleaners, calibrators, and control materials from the analyzer.
▪ Store the reagents in accordance with the storage conditions defined in their respective package
inserts.

Preparation for transport or storage:


Ask your service representative for assistance and instructions.

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Replacing hardware components


ATTENTION
All following described action should be performed only by a trained user.

Replacing interval of hardware components


Some hardware components need to be replaced after a defined number of test runs.
This section describes how to find out how many tests have been run since the hardware component
was last replaced. The analyzer keeps track of the number of test runs that have been performed
since the analyzer was installed as long as the database was not deleted. The analyzer does not store
any information when a component was last replaced. It does not inform you when a designated
number of tests has been run.
To keep track of the replacements, you need to take the following actions:
▪ Keep a record of all relevant replacements.
▪ When an operator or a service technician replaces a hardware component, make a note of the
current test
number since installation.
▪ To determine how many tests have been run since the last replacement, compare the test number in
your
record with the current test number since installation.

To look up the test number since installation


▪ Choose RESULTS > STATUS; e .
▪ The status panel is displayed.
▪ Look up the number in the Tests: field.
We recommend changing the needle and syringe after 20000 tests. An alternative to this is a yearly
inspection by a service technician.

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Replacing the needle


ATTENTION
This action should be performed only by a trained user.

CAUTION
Please be careful and avoid any injuries which could be caused by the tip
of the needle. Always wear protective gloves in order to protect yourself
against contamination!

Preparations
▪ Remove the sample tray, the reagent block and the predilution rack out of the analyzer.
▪ In the hardware action panel, choose SAMPLER > CHANGE POSITION; e .
▪ The needle moves to the change position. The syringe plunger moves down, in order to withdraw
any
liquid from the needle.

Removing
▪ Remove the pipetting tube from the tubing guide which is located on top of the inner cover.

▪ Slide the protection tube, which is around the pipetting tube,


away from the upper needle holder of the needle until you
see the upper end of the needle and approximately 10 cm of
the transparent pipetting tube.
▪ Remove the end of the pipetting tube from the upper end
of the needle by holding the needle with one hand and
pulling the tube upwards with the other hand.

ATTENTION!
When removing the tube, tightly hold on to the needle’s black guide.

▪ Lift up the needle clip in that way the needle is unlocked


from the needle guide

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▪ Remove the upper end of the needle from its upper needle
holder by holding the socket with one hand and moving the
needle backwards away from the socket with the other
hand.

▪ While pressing the metal cap of the needle support upwards, pull the
needle upwards to remove it.

Assembly
Replace the (new)needle in reverse order of the removing procedure:
▪ Hold the needle with its tip facing down.
▪ While pressing the metal cap of the needle support upwards, move the needle vertically down
through the needle support until the installation cylinder of the needle is completely inside the
needle support. The upper edge of the installation cylinder must be on the same level as
the upper edge of the needle support. (See pictures)

ATTENTION!
When fitting the needle make sure it is inserted as far as it goes.
Not OK
▪ Hold the socket with one hand and move the upper end of the
needle towards the socket into the upper needle holder. You hear a
„click“.
▪ Move the needle clip to the top of the needle guide. The clip must
lock the needle and completely down to the needle guide.
▪ Look the needle in the upper support.
▪ Put the end of the pipetting tube over the upper end of the needle
by holding the needle with one hand and moving the tube with the OK
other hand. The pipetting tube covers the upper end of the needle.

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▪ Slide the black protection tube, which is around the transparent pipetting tube, towards the needle
guide until it completely covers the pipetting tube and touches the upper needle holder.
▪ Fasten the pipetting tube in the tubing guides on top of the sampler cover. The beginning of the
black tube must be in line with the tubing guide.
▪ Place the protection cover on the analyzer.

Checks after assembling:


▪ Check if the cover is correct placed.
▪ Check if the pipetting tube is not jammed below the cover.
▪ Perform hardware action TEST POSITION and PRIME PUMPS.
▪ To exit the hardware action panel, choose WASH POSITION. The needle moves to the wash position.

Replacing the syringe


ATTENTION!
This action should be performed only by a trained user. Actions to remove / assembly the syringe
needs no tools. The explained fastenings means by only by Hand power

Remove
▪ Select HARDAWRE>SAMPLER > SYRINGE >CHANGE POSITION and press e
The syringe plunger moves to its lower position for syringe
remove.

▪ Unscrew the lower syringe holder by turning it to the left.

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▪ Hold the syringe up at it’s upper end and unscrew the


syringe by turning it to the left.
▪ The syringe is released from the upper syringe holder.
NOTICE!
Prepare some tissue to collect the eventually off flowing water.

▪ Move the syringe glass cylinder down and remove the syringe.
remove

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Assembly
ATTENTION!
Check if the red O-ring is placed in the syringe connector.

▪ Place the syringe directly below the upper syringe holder

▪ Insert the syringe plunger into the syringe guide above the lower syringe
holder.

▪ Hold the syringe at its upper end and turn the syringe to the right to screw
it upwards into the upper syringe holder. While you move the syringe glass
tube upwards, the syringe guide holds down the syringe plunger.

▪ Screw the lower syringe holder to the right until it is fastened. The lower
syringe holder encloses the lower end of the syringe.
▪ In the hardware action panel, choose SYRINGE > HOME POSITION. Press e
▪ Perform hardware action PRIME PUMPS. To exit the hardware action panel,
press ^.

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Trouble shooting
This chapter contains a list of possible errors and the corresponded recommended solutions.

Table of contents

PC and communication 107


No communication please restart the system 107
Unexpected reset from X/Y/Z 107
No communication (X) please restart the software 107
Interface (X) not ok. Please exit 107
Software freeze 108

Sampler 109
Needle misses correct pipetting positions 109

Needle liquid sensor 110


The needle sensor is not detecting liquid. 110
The needle starts to continuously move up and down. 110
The needle position above the cuvette is too high. 110
The needle sensor is not detecting liquid or only very large volumes. 110

Dilutor 111
Dilutor stop moving. 111
Dilutor generate abnormal noise 111
Needle is dripping during the pipetting process. 111
Tube has worked loose at the dilutor’s compression fitting. 111
Tubes are not completely filled with fluid. 112
Syringe of the dilutor is leaky or not correctly fastened. 112

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Wash station 113


Wash station overflow 113

Dispensing and liquid system 114


Dispensing of liquid with “Needle test” is not correct. 114
Message “Wash station overflow” appears 114
“Defined switching” or “No start on channel 1” (EF 25 or EF26 appears). 114
“No water transport to the wash station” 114

Cuvette rack transport system 115


Error (er 273) transport of strip not OK. Please exit 115
Error (er 273) transport of strip backwards not Ok.(R_IN_ WAIT). 115

Measuring results 116


No clot 116
Bad reproducibility 116
Undefined / no clot / Start Not ok / Start not ok channel 1 116
No clear ascending /descending of calibration values 117
Quality control is out of range 117
Noisy 117

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PC and communication

No communication please restart the system


Description:
The communication between the system and pc is missing or defective.

Help:
▪ Check Power supply ,Fuses, cables
▪ Open the adjusting program
▪ Check firmware via Eproms

Unexpected reset from X/Y/Z


Description:
Communication with sub controller failed

Help:
▪ Open the adjusting program.
▪ Update firmware via. Eproms.
▪ Check Power supply ,Fuses, cables.
▪ Check the keypad via comterm.

No communication (X) please restart the software


Description:
Communication error between Pc and sub controller.

Help:
Check if the system is switched on.
Check if the connection between the system and PC is missing
or defect. Check connections inside the system (sub controller).

Interface (X) not ok. Please exit


Description:
PC interface not accessible.

Help:
▪ Check the interface and login again
▪ Restart the PC

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Software freeze
Description
Cursor moving is not possible. It is not possible to exit the Software via the menu EXIT

Help
Start a controlled shut down of the PC by a short pressure of the PC power button.

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Sampler

Needle misses correct pipetting positions


Description:
Needle bent during pipetting.

Cause:
▪ Needle inadvertently bent by operator interference during the routine, e.g. replacing a reagent
without using n or STOP, by the operators hand.
▪ A primary cup was not correctly positioned in the sample rotor; the needle made contact with the cup
when moving sideways.
▪ Test position not checked before the routine was started.
▪ Test position not check after needle replacement.
▪ Movement of the pipetting arm was prevented by force.
▪ The arm forward/back guide bars = “Y”-axis and up/down = “Z”-axis have run dry (very rare) or
become dirty, causing stiffness.
Help:
Press STOP, select EXIT wait 1 min., then turn off the PC and the analyzer.
While the analyzer is turned off, manually check left/right/forward/back shaft guides, with needle in
upper position, for smoothness of operation.
Check test position after restarting, adjust if necessary.

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Needle liquid sensor


The needle sensor is not detecting liquid.
Description:
The pipette needle is not secured correctly. The sensor cable is not connected correctly or the cable is
defective.

Help:
Check that needle is assembled correctly, check that the cable’s plug connections are secure and
check the cable for damage. The cable must be replaced if it is damaged in any way.

The needle starts to continuously move up and down.


Description:
The pipette needle is not secured correctly. The sensor cable is not connected correctly or the cable is
defective Sensor setting is incorrect.

Help:
Check that needle is assembled correctly, check that the cable’s plug connections are secure and
check the cable for damage. The cable must be replaced if it is damaged in any way. If the error is still
present, reset the sensor as described below

Sensor setting
▪ Press the Stop button.
▪ Press the adjustment button on the pipette arm.
▪ Press the Stop button.
▪ Restart the analyzer by using o / ALARM OFF.

The needle position above the cuvette is too high.


Description:
The pipette needle is not secured correctly.

Help:
Check that needle is assembled correctly.

The needle sensor is not detecting liquid or only very large


volumes.
Description:
Sensor setting is incorrect. Undertake sensor setting as described below.

Sensor setting
▪ Press the Stop button.
▪ Press the adjustment button on the pipette arm.
▪ Press the Stop button. Restart the analyzer by using o / ALARM OFF.

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Dilutor

Dilutor stop moving.


Description:
The dilutor stop moving the plunger and error messages appear in the message box.
277 ATTENTION: dilutor position not ok. Please Exit!

Help:
Check if the spindle nut is too tight.
Clean the dilutor spindle. Remove all dirt from the spindle.

ATTENTION!
Clean only with a lint-free fabric. Do not grease the spindle.

Dilutor generate abnormal noise


Description:
The dilutor generate squealing sounds during the plunger movement.

Help:
Check the panel sheet which covers the trench of the
plunger support. It may scratch to the dilutor base plate.

Different cause is may the spindle.


Slightly oil the spindle with pharmaceutical white oil. max 20µl to the spindle. Coat the oil with a cotton
bud.

Needle is dripping during the pipetting process.


Description:
The tube to the dilutor is kinked, resulting in a contraction and reduced fluid flow.

Help:
Replace tube.

Tube has worked loose at the dilutor’s compression fitting.


Help:
Pull tube from the guide to the compression fitting, then retighten the fitting and run it properly. (If only
the fitting is tightened, any possible tension on the tube could cause the fitting to loosen again.
Therefore dis- mounting and reinstallation are necessary after the fitting has been retightened!

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Tubes are not completely filled with fluid.


Help:
Perform PRIME PUMPS again.
Check if any internal tube is squeezed.

Syringe of the dilutor is leaky or not correctly fastened.


Help:
Check syringe and/or fastening (sealing washer at the seat’s top).

IMPORTANT!
Following any service to the dilutor/tubing/needle system the following checks must be performed on
the HARDWARE menu:

TEST POSITION, NEEDLE CHECK , PRIME PUMPS, and strongly recommended:


A within precision run, e.g. with Fibrinogen, using the same sample 16 times.

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Wash station
General:
The wash station’s rinse cycle is software controlled by the needle sensor.

Wash station overflow


Description
Waste water drain tube squeezed.

Help
Check tube path outside of the analyzer (possibly also a blocked drain port, e.g. after transport of the
analyzer).

Description:
Waste water tank without vent opening.

Help:
Provide vent opening.

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Dispensing and liquid system

Dispensing of liquid with “Needle test” is not correct.


Help:
▪ The needle’s tip is too narrow. Change the positioning.
▪ Remove the needle and rinse with 5% hypochlorite solution .Re-mount needle. Control with menu
item “Prime pumps (clean needle)”.
▪ Replace the needle in case this does not help.
▪ The needle was bent and then straightened.
▪ The tube is not correctly attached to the needle.
▪ The tube is not correctly attached to the solenoid valve.
▪ The syringe leaks.
▪ Tube is possibly torn.
▪ The connectors on the solenoid valve leak.
▪ The solenoid valve leaks.
▪ The needle has a crack and leaks.

Message “Wash station overflow” appears


Help:
▪ Needle sensor not OK
▪ Waste pump not working,
▪ Waste filter is blocked.
▪ The waste water container has no air exit.

“Defined switching” or “No start on channel 1” (EF 25 or EF26


appears).
Help:
▪ The dispensing of liquid is not correct, e.g. liquid is dispensed diagonally or spirally.

“No water transport to the wash station”


Help:
▪ The quality of Aqua Dest. is too good. The needle sensor cannot detect the liquid surface.
▪ The access water pump is defective.
▪ The solenoid valve in the access water tube does not switch correctly.

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Cuvette rack transport system

Error (er 273) transport of strip not OK. Please exit


Description:
Error in the cuvette rack transport system during forward transportation.

Help:
▪ Open the error database and check the previous error messages.
▪ Open the adjusting program; check the first mistake that you find in the database.
▪ Transport motor, sensors.
▪ Check measuring block parallels

Error (er 273) transport of strip backwards not Ok.(R_IN_ WAIT).


Description:
Error in the cuvette rack transport system during backward transportation.

Help:
▪ Open the error database and check the previous error messages.
▪ Open the adjusting program; check the first mistake that you find in the database.
▪ Transport motor, sensors.
▪ Check measuring block parallels

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Measuring results

No clot
Description:
No coagulation detected within the measuring time 1/ measuring time 2.

Help:
▪ Check the Stop button on the keyboard
▪ Check encoder via adjusting
▪ Check the maximum drive of the sampler positions via SAMPLER MANAGEMENT.
▪ Check the reagent.
▪ Check the dispensing and liquid system.
▪ Check the needle sensor
▪ Check the parameter settings of the test.

Bad reproducibility
Description:
Bad results at fibrinogen test results.

Help:
▪ Kaolin has not been shaken before use.
▪ Kaolin has not been stirred.
▪ Check the Reagent.
▪ Check the dispensing and liquid system.
▪ Check the needle sensor

Undefined / no clot / Start Not ok / Start not ok channel 1


Description:
An expected change in the first channel did not occur in the ilting process.
Measuring results are undefined.

Help:
▪ Check the Reagent.
▪ Check the parameter settings of the test.
▪ Check the dispensing and liquid system.
▪ Check the needle sensor.
▪ The complete rack is rejected.
▪ Check the cuvette rack transport (measuring block)

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No clear ascending /descending of calibration values


Description
During calibration the measuring results are not ascending /decending in a row.

Help
▪ Check the dispensing and liquid system.
▪ Check the reagent and plasma.
▪ Check positions of the calibration plasma. If using a calibrator set.

Quality control is out of range


Description:
The quality control results of one or more test are out of range.

Help:
▪ Check the dispensing and liquid system.
▪ Check the reagent and plasma.
▪ Check positions of the reagent in the reagent bock.

Noisy
Detection of an irregular (noisy) reaction cycle during a clotting test.
Causes for this could be:
▪ Micro-clot
▪ A piece of the rubber (or cap material) is in the cuvette (when working with “cap-piercing”).

EF 55 flags the measuring value without overwriting it.

With an LIS connection: the data is not automatically sent to the LIS. A warning message is displayed
in the message box.

It is recommended to recheck the result. If any doubts remain, repeat the measurement.

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Messages
This chapter describes all possible Messages of this analyzer.
The %1, %2, %3 are space holder for individual words, numbers, codes.
Possible entries are described below the message explanations of the particular message.

Table of contents

Result error flags 120

Messages 125

Transport motor error codes 170


Possible motor numbers 170
Error codes: 171

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Result error flags


The Result error flags, named ER, are always related to measurements and be shown in the result
panel, protocol panel as well on the results printouts as ER xx (xx =number of the error flag, see list
below).

NOTICE!
See also main screen in routine program F1 - help window. The result error flags you will find there as
well.

2 Test not proceed,


because of missing reagent(s), or test not calibrated.

4 Needle not OK. (cap piercing mode)


After delivery of the plasma from the closed primary tube into the intermediary chamber of the cuvette
rack, the pipetted amount could not be found. Check needle and cuvette position via Maintenance,
Cuvette rack adjust.
Check needle connection, cable and sensor. Clean the surface and the inside of the needle manually.

5 Pipetting timeout
A time out has occurred during the pipetting process using e.g. the D_Dimer
„AC“ reagent. The measurement will be repeated.

6 Cuvette rack pipetting timeout


A time out occurred during the pipetting process. The measurement will be repeated

7 Plasma not found secondary cup


After delivery of the plasma from the closed primary tube into the intermediary chamber of the cuvette
rack, the pipetted amount could not be found.
Check needle and cuvette position via Maintenance, Cuvette rack adjust.
Check needle connection, cable and sensor. Clean the surface and the inside of the needle manually.

8 Not enough plasma secondary cup


After delivery of the plasma from the closed primary tube into the intermediary chamber of the cuvette
rack, not enough amount could not be found.
Check needle and cuvette position via Maintenance, Cuvette rack adjust.
Check needle connection, cable and sensor.
Clean the surface and the inside of the needle manually.

9 Sample removed
During rescanning of the barcode before pipetting, a free position was found.

10 Plasma not found


Not enough plasma in the sample tube.

11 Reagent not found


Not enough reagent in the reagent container.

12 Pipetting stop timeout


The Stop button was pressed. The test(s) will be repeated.

13 Plasma timeout
The sample rotor was removed during processing.
The test(s) will be repeated.

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15 Reagent timeout
The reagent block was removed during processing.
The test(s) will be repeated

16 Predilution position not free


All vials within a predilution rack have been used.
Replace the predilution rack. The test(s) will be repeated.

17 Predilution plasma not found


After the device has completed a dilution, it could
not be found. Check whether the dilution rack has
been inserted.

18 Barcode not readable


The barcode on the primary tube is not
readable. Check the position and
quality of the barcode.

19 Barcode wrong
The barcode on the primary tube is not correct.
The primary tube has been exchanged during processing.

20 Ball missing
A ball is missing in at least one position within a cuvette rack. The test(s) will be repeated.

21 Mixing motor defective


The drive motor for the measuring unit magnetic stirrer is not working.

22 Reaction curve not OK


The chromogenic or immunologic reaction curve runs out of the allowed range, or has artefacts.

23 No clot
There was no coagulation detected.

24 Start not OK
An expected optical change in channel 2-4 did not occur in the tilting process.
The test(s) will be repeated.

25 Start not OK at channel 1


An expected optical change in the first channel did not occur in the tilting process. The test(s) will be
repeated.

26 Threshold signal out


At start time, the measuring signal is outside the measuring thresholds.

27 Ignored measuring signal


The reaction signal during clotting detection is not efficient. The test(s) will be repeated.

28 Signal at threshold slow


Test PT combined with derived Fibrinogen.
The progression of the clotting signal was too slow for the PT clot detection. Choose standard PT for
measurement.

29 Signal at threshold fast


Test PT combined with derived Fibrinogen.
The progression of the clotting signal was too fast for the PT clot detection. Choose standard PT for
measurement.

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30 LED balancing too weak


A measuring channel is not receiving enough light. Perform cleaning of the measuring block.

31 LED balancing too bright


The measuring channels are receiving too much light.

32 Measuring channel < defined range


A measuring channel is receiving not enough light. Perform cleaning of the measuring block.

33 Measuring channel > defined range


A measuring channel is receiving too much light.

41 Chromo curve not OK


Reaction curve cannot be calculated.
The curve is invalid, no result can be calculated.

42 Chromo linear < 0.94


The CV of the reaction curve, calculated by the 5 measuring points with linear regression is < 0.94.
The curve is invalid, no result can be calculated.

43 Chromo polynom < 0.95


The CV of the reaction curve, calculated by the 5 measuring points with polynom, is < 0.95. The curve
is invalid, no result can be calculated.

44 No signal (derived)
Too less reaction signal to calculate a derived Fibrinogen result. Choose the standard fibrinogen test.

45 Chromo result > 3.0


Reaction signal is above the limits.

48 Value < single min


The measured raw value was recorded below the programmed Single minimum in menu Test
Parameters. Test will be repeated.

49 Value > single max.


The measured raw value was recorded above the programmed Single maximum in menu Test
Parameters. Test will be repeated.

50 Duplication error
The two measured values of duplication are outside the programmed Tolerance in menu Test
Parameters.

51 Sample very dark


The sample is too cloudy.
The sample is too lipaemic, hemolytic or icteric.

52 Measuring point 1 not OK


Derived Fibrinogen:
The signal at the start of the reaction is not OK.
Choose the standard fibrinogen test.

53 Measuring point 2 not OK


Derived Fibrinogen:
The signal at the end of the reaction is not OK.
Choose the standard fibrinogen test.

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55 Noisy
Detection of an irregular (noisy) reaction path during a coagulation test due to a micro-clot or in cap
piercing mode, rubber or cap material in the cuvette. Test will be repeated.

59 Duplication error
The two measured values of duplication are different e.g. result and no result with Flag.

60 Result < calibration range


The measured value cannot be calculated, because it is below the calibration curve limit.

61 Result > calibration range


The measured value cannot be calculated, because it is above the calibration curve limit.

62 Result < 0.0


The measured value is in the negative area of the calibration curve.

63 Value < QC min.


The result of the quality control is below the programmed QC range.

64 Value > QC max.


The result of the quality control is above the programmed QC range.

65 Value < Normal min.


The measurement result is below the programmed Normal minimum in menu Test Parameters.

66 Value > Normal max.


The measurement result is above the programmed Normal maximum in menu Test Parameters.

67 Value cannot be displayed


The calculated result, due to the format overrun, cannot be displayed.

68 Same results
All results within one cuvette rack are identical.

71 Measuring block mixing motor slow


The speed of the mixing unit of the measuring block is too low.

72 Measuring block not in incubation position


The measuring block cannot reach or is not in the incubation position. Check the cuvette rack
transport system.

73 Measuring block not in measuring position


The measuring block cannot reach or is not in the measuring position. Check the cuvette rack
transport system.

74 Value < measuring range


The value exceeded the lower limit of the defined measuring range. No result is reported.

75 Value > measuring range


The value exceeded the upper limit of the defined measuring range. No result is reported.

80 Any reagent of this test expired


For one or more reagents required for this measurement, the expiry date is exceeded.
Please provide new reagent.

81 Any QC of this test is not OK


The QC is out of range or the valid time is exceeded.

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Messages
Following are all Messages described. The %1,%2,%3 are space holder for individual words,
numbers, codes.
Possible entries are described below the message explanation of the particular message.

1 %1 is not yet ready, ejecting strips


Normal status message once the routine software has been started. You must wait for the cuvette rack
to eject after the system has been restarted.
%1 - system name // defined in „System parameters“: „(a1) Name of system“

2 %1 is not yet ready


This message indicates that the system cannot be started yet. Details are also provided for the area in
which it is working. Please wait until the system has completed the process
%1 - system name, defined in „System parameters“: „(a1) Name of system“

3 %1 is working
The system is working. Details are also provided for the area in which it is working.
%1 - system name // defined in „System parameters“: „(a1) Name of system“

4 %1 ready
Normal status message the routine can be started. System finished with startup or a routine.
%1 - system name, defined in „System parameters“: „(a1) Name of system“

5 %1 ready (F3, for start press first F4)


Pipetting Stop is activated by pressing of F3. Press F4 to restart.
%1 - system name, defined in „System parameters“: „(a1) Name of system“

6 %1 stopped with error. Restart with F4


An error occurred, check the incident before pressing F4.
%1 - system name, defined in „System parameters“: „(a1) Name of system“

7 Stopped with F3 (arm ready: restart F4)


The system has been stopped using F3 and can be restarted using F4.

8 Stopped (arm is still working) wait for „ready“


Pipetting Stop is activated by pressing F3. The routine process will stop after pipetting the current
rack. Press F4 to restart.

9 Wait for scanning (arm is still working)


The scan button is pressed to undertake a scanning process after pipetting the current rack.
Scanning process is started automatically after pipetting the current rack.

10 Scanning in progress
Wait until the scanning process is complete.

11 (Sample prep.)
Additional information. This process is currently in operation.

12 (Calibration)
Additional information. This process is currently in operation.

13 (Quality control)
Additional information. This process is currently in operation.

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14 (Hardware)
Additional information. This process is currently in operation.

15 (Prime Pumps)
Additional information. This process is currently in operation.

16 (Needle clean)
Additional information. This process is currently in operation.

17 > %1 minutes
Additional information. Gives the prospective rest time in minutes for the currently started specimens.

18 Distilled reservoir level low - refill


There is not enough water in the wash tank. You can only start the machine once you have topped up
the water. If there is ready sufficient water, the sensor may be defective. Press F4 to restart.

19 Temperature out of range (Pipetting station)


The warm up phase can last up to one hour depending on the environmental temperature/conditions.

20 Temperature out of range (Incubation station)


The warm up phase can last up to one hour depending on the environmental temperature/conditions.

21 Temperature out of range (Measuring station)


The warm up phase can last up to one hour depending on the environmental temperature/conditions.

22 Temperature out of range (Reagent station)


Service message: in case reagent cooling fails. Check environmental temperature.

23 Plasma block%1 is not present


The plasma rack or rotor is not in the system during routine.
%1 - „“|“left“|“right“ , empty (for one plasma workstation);

24 Reagent block%1 is not present


The reagent rack is missing or is not completely inserted.
%1 - “left“|“right“ , empty (for one reagent work station)>

25 Plasma block%1 is not present (arm stopped)


The plasma block is missing or is not completely inserted.
%1 - „“|“left“|“right“,empty (for one plasma block)

26 Reagent block%1 is not present (arm stopped)


The reagent block is missing or is not completely inserted.
%1 - „“|“left“|“right“ , empty (for one reagent block)

27 Pipetting stop is active


The pipetting process has been stopped using the stop button on the system. Press the stop button
again to restart the process. Only press the stop button if the pipetting process is to be stopped
immediately. Caution: To prevent an influence on the measurement results, a time out may occur. The
tests repeated automatically.

28 Waste container not present


The container for the solid waste is not in the system. Please insert an empty waste container into the
device.

29 Waste container nearly full


The container for the solid waste is almost full and must be emptyied at the next opportunity.
Please insert an empty waste container into the device.

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30 Waste container full


The container for the solid waste is full and must be emptied. Please insert an empty waste container
into the device.

31 Place pre.buf. at pos.%1, plasma at %2, cups at %3


This message appears if the fully automatic calibration is to be started. Place the reference plasma in
the reagent block in the “control 1” position, corresponding empty containers (e.g. Hitachi cups) in the
specified positions X (e.g. X2..X4) in the rotor or plasma rack.
%1 - position for predilution buffer
%2 - position for reference plasma
%3 - positions for empty containers

32 Place plasma in %1, cups in %2


Place the reference plasma in the reagent block in the “X” position, corresponding empty container
(e.g. Hitachi cups) in the specified positions in the plasma rack.
%1 - position for reference plasma
%2 - positions for empty containers

33 Place predil buffer at pos.%1 and press <ENTER>


No predilution buffer at position X. Please place the predilution buffer at position X.
%1 - position for predilution buffer: XRC „7“; XRM „3 left“.

34 Calibration finished. Failed


The calibration curve produced is incorrect and must be repeated. Check the calibration process.

35 %1 has finished calibration. See curve


The system has completed the measurements for automatic calibration, for fully automatic calibration
or for recalibration. Enter the “calibration” menu item and look at the curve.
%1 - system name // defined in „System parameters“: „(a1) Name of system“

36 Host offline
Data transfer to the Host (EDV, LIS) is not possible at the moment. Reactivate with CTRL+F5.

37 Printer offline
Print outs not possible at the moment. Check printer and reactivate with CTRL+PrintScreen.

38 System parameter not ok


The system parameters are not in order. Please check, e.g. device for host

39 Barcode parameter not ok %1 %2


The bar code parameters are not in order. Please check.
%1 - „RC-Plasma“|“RC-Reagent“; Other: empty
%2 - empty

40 Reagent block parameter not ok


The reagent block parameters are not in order. Please check.

41 Some barcodes not readable, see Sample prep. (%1)


Some barcodes are not readable. Check in the menu Sample Prep. which tubes were not read.
%1 - not readable positions

42 Test %1 not defined for control plasma %2


A quality check is integrated in the normal routine. The test selected is not defined for this check.
%1 - test abbreviation
%2 - name of control plasma

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43 Lot No. %1 not found


Message from reagent database. Lot-No. X scanned with hand scanner does not exist. Please check
the manual entries of the Lot-No.
%1 - lot number of control plasma

44 Control plasma %1 is defined twice


Two control plasmas have the same name. Please change one of the two names. You cannot exit the
pro- gram item until you have changed the names. Caution: even blank characters are recognized as
names for control plasma!
%1 - name of control plasma

45 Up volume is too great (max. %1)


Incorrect value has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indica- ted value.
%1 - max. value

46 Down vol. for %1 pos. is too great (max. %2)


Incorrect value has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indica- ted value.
%1 - „high“ | „low“
%2 - max. value

47 Down vol. for cuvette is too great (max. %1, %2)


Incorrect value has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indica- ted value.
%1 - max. value
%2 - „single“ | „double“

48 Please enter test for definition of liquid


The reagent setting of the volume table in the menu “Test parameters” has no test abbreviation. Please
enter the corresponding abbreviation.

49 Dilution volume setting %1 not defined


Volume setting for dilution X (e.g. 1:4) not defined. Copy files “dilu*” from param_default to param or
reinstall the software.
%1 - dilution, e.g. „1:2“, „1:4“ or „1:5“

50 Derived test %1 is not possible


Incorrect test abbreviation has been entered in the menu “Test parameter”. After attempting to leave
the menu with ESC, the message appears with detailed information. Check and correct the entries
according to the indicated information.
%1 - test abbreviation

51 Derived test %1 is not selected


A deactivated test abbreviation has been entered in the menu “Test parameter”. After attempting to
leave the menu with ESC, the message appears with detailed information. Check and correct the
entries according to the indicated information. Activate the test in menu “Test selection”.
%1 - test abbreviation

52 Block %1 in working station is not yet ready


The plasma rack was removed from the system before processing was completed. Please reinsert the
plasma rack.
%1 - rack key number

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53 Definition of parameter for derived test %1 not ok


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries for main test
and derived test according to the indicated information.
%1 - test abbreviation

54 rack %1 is full, no free prepositions


Sample prep: rack is full, scan of new samples is not possible.
%1 - rack key number

55 %1 is too small (min. %2)


The calibration value is too small. It must be greater than the indicated value.
%1 - „Min. value“ | „Max. value“
%2 - indicated value

56 %1 is too great (max. %2)


The calibration value is too great. It must be less than the indicated value.
%1 - „Min. value“ | „Max. value“
%2 - indicated value

57 %1 column: value is too small (min. %2)


Calibration table: the value in column left or right is too small. Enter a higher value than the indicated
value.
%1 - „First“ | „Second“
%2 - indicated value

58 %1 column: value is too great (max. %2)


Calibration table: the value in column left or right is too great. Enter a smaller value than the indicated
value.
%1 - „First“|“Second“
%2 - indicated value

59 Reference value must be greater %1


The start value in the production of calibration curves is too small. Enter a greater value than the
indicated value.
%1 - indicated value

60 ISI < Min. ISI value (min. %1)


The ISI value entered in the “calibration curves” menu item for production of calibration curves is too
small. Enter a greater value than the indicated value.
%1 - indicated value

61 ISI > Max. ISI value (max. %1)


The ISI value entered in the “Calibration Curves” menu item for production of calibration curves is too
great. Enter a smaller value than the indicated value.
%1 - indicated value

62 Value is too small (min. %1)


Incorrect value has been entered in the menu “Test parameter” or „calibration“. After attempting to
leave the menu with ESC, the message appears with detailed information. Check and correct the
entries according to the indicated value.
%1 - indicated value

63 Value is too great (max. %1)


Incorrect value has been entered in the menu “Test parameter” or „calibration“. After attempting to
leave the menu with ESC, the message appears with detailed information. Check and correct the
entries according to the indicated value.
%1 - indicated value

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64 Too many tests are selected (max. %1)


In sample prep too many tests are selected for one sample. Delete one or more tests. In Maintenance
“Test selection” too many tests are selected for one reagent block. Spread the tests on multiple
blocks.
%1 - indicated value

65 Reagent block not defined (max. %1)


An unspecified reagent block was selected. Check via Maintenance „System parameter“.
%1 - indicated value

66 This value must be empty: end of table is %1 value


When making manual entries into the calibration table, another value below the limit value (0) has
been ente- red. Please delete the value entered or change the line containing the limit value.
%1 - indicated value

67 Test %1 is not selected


A requested test in not selected. Check test selection and reagent block in “Maintenance”.
%1 - test abbreviation

68 Serial pipetting not possible


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indica- ted information.

69 add 1ml of 5% bleach in wash station.+ ENTER for start


When selecting the “Needle Clean” menu item in “Hardware”, the wash station must be filled
with bleach before the second cleaning stage. Please fill with bleach.

70 Value not ok (%1)


Incorrect value has been entered in the menu “Test parameter” or “barcode parameter”. After
attempting to leave the menu with ESC, the message appears with detailed information. Check and
correct the entries according to the indicated value.
%1 - indicated value(s)

71 For predilution please pipette the buffer first


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indica- ted information.

72 Volume setting for predilution is not ok (%1 lines)


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indica- ted information.
%1 - indicated value

73 Up volume of %1 must be greater 0


Incorrect value has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indica- ted value.
%1 - liquid abbreviation of buffer or plasma

74 Down volume of %1 must be 0


Incorrect value has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indica- ted value.
%1 - liquid abbreviation of buffer

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75 Wash or clean in predilution %1 line not possible (must be empty)


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indica- ted information.
%1 - indicated value

76 Only normal pipetting possible


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated information.

77 Incubation in predilution pipetting not possible (must be 0)


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated information.

78 For predilution please pipett plasma in predil cuvette


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated information.

79 Down vol. for predil cuv. is too small (min. %1)


Incorrect value has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated value.
%1 - indicated value

80 Down vol. for predil cuv. is too great (max. %1)


Incorrect value has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated value.
%1 - indicated value

81 Down volume > Up volume (%1) not possible


Incorrect value has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated value.
%1 - indicated value

82 %1. line: please pipett predil. plasma in cuvette


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated information.
%1 - line number

83 Down volume of %1 must be greater 0


Incorrect value has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated value.
%1 - liquid abbreviation of buffer, plasma or reagent e.c.

84 Up volume of pr. plasma too great (%1)


Incorrect value has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated value.
%1 - indicated value

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85 Pipetting of predilution not possible


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated information.

86 Chromogenic coagulation %1 not possible


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated information.
%1 - indicated value „coagulation type (unit)“

87 Following test %1 is not possible


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated information.
%1 - test abbreviation

88 Following test %1 is not selected


A deactivated test abbreviation has been entered in the menu “Test parameter”. After attempting to
leave the menu with ESC, the message appears with detailed information. Check and correct the
entries according to the indicated information. Activate the test in menu “Test selection”.
%1 - test abbreviation

89 No test found with reagent %1


Menu “Run Control”.

90 Please read values for reagent %1


Menu “Run Control”.

91 Rotor%1 is not in working station %2


When pressing „Start Scan“ the rotor has not been placed in the device (error code Y). Please put the
rotor in the corresponding position.
%1 - „“|“left“|“right“ //““=empty for one reagent workstation
%2 - empty

92 Rotor %1 home not ok %2


When pressing „Start Scan“ the rotor has not reached the “Home position” (error code Y). Please
check whether the rotor is meshing correctly with the toothed gear or whether the bar code in the
“home position” is dirty.
%1 - rotor key number
%2 - (received answer from device)

93 No patients in Rotor %1 (%2)


When scanning the samples, no samples were found in rotor X (error code Y). Please check if the
barcodes on the plasma tubes are aligned correctly and the rotor turns smoothly.
%1 - rotor key number
%2 - rotor error code, received answer from device

94 Patient barcode in prep. %1 is not ok (%2)


The Sample barcode in position X was scanned in previous scan. Before pipetting the actual scan
process of this sample X ends with an error (error code Y). Please check the barcodes on the plasma
tubes.
%1 - rotor key number and prep. number
%2 - rotor error code, received answer from device

95 Rotor: parameter error %1


A rotor error occurred. Check the scanner position and adjustment via “Adjusting program”.
%1 - rotor key number: received answer from device

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96 Test %1 not possible: has self depending tests


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated information.
%1 - test abbreviation

97 Test %1 is depending on test %2


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated information.
%1 - test abbreviation
%2 - test abbreviation

98 Calibration not possible: depending on test %1


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated information.
%1 - test abbreviation

99 Test %1 depending on test %2 not possible


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated information.
%1 - test abbreviation
%2 - test abbreviation

100 Depending tests for calculation type %1


not possible. Incorrect setting has been entered in the menu “Test parameter”. After attempting to
leave the menu with ESC, the message appears with detailed information. Check and correct the
entries according to the indicated information.
%1 - indicated value

101 Pipetting liquid %1 into position %2


not possible. Incorrect setting has been entered in the menu “Test parameter”. After attempting to
leave the menu with ESC, the message appears with detailed information. Check and correct the
entries according to the indicated information.
%1 - liquid abbreviation
%2 - position:

102 Coagulation type of derived test %1 not ok


Incorrect setting has been entered in the menu “Test parameter, detection”. After attempting to leave
the menu with ESC, the message appears with detailed information. Check and correct the entries
according to the indicated information.
%1 - test abbreviation

103 Too many records selected (max.%1)


The maximum amount of data possible for printing or sending has been exceeded (maximum X).
Select data according to the indicated information.
%1 - indicated value

104 Wash sequence needed


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated information.

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105 Wash sequence %1 in last line of table not possible (must be without ’C’)
Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indica- ted information.
%1 - indicated value

106 Please put %1 mm cup on the wash station and


press <ENTER>. When selecting the “Needle check” menu item in “Hardware”, the wash station must
be topped with the test cup before the second stage. Please put the test cup on the wash station.
%1 - indicated value

107 Sample in prep. %1 not found %2


During pipetting process the sample tube at position X was removed. Please provide the sample.
%1 - rotor key number and prep. number
%2 - empty

108 Dilution %1 not possible: volume setting of plasma without dilution


Calibration: dilutions 4:1, 3:1, 2:1 not possible. Requires plasma dilution in volume setting. Check
plasma pipetting in volume table via menu „Test parameter“ or use other dilutions.
%1 - dilution

109 %1 could not be mounted


The USB stick can not be recognized by the system. Remove the USB stick and insert it again.
%1 - copy device,

110 No tests on %1 found


No test was found on the USB stick that could be copied to the system. Copy tests on the USB and try
again.
%1 - copy device

111 Device not ok (%1)


Accessing linux device X (e.g. USB stick) not possible. Check device names in profile. Local.
%1 - copy device

112 Error from script %1


Internal error from copy script. Check device names in profile. Local. Reinstall software.
%1 - script name

113 No %1 found (%2)


No USB stick found. Please insert the USB stick.
%1 - copy device
%2 - USB Stick

114 Too many %1s found (%2)


Remove all USB sticks and external disks from PC and try again.
%1 - copy device, e.g. USB stick
%2 - USB Stick count

115 %1 position difference too large


“Hardware/Cuvette Rack Adjust”: the tolerance of position X differences is too large. Check via
adjusting/sampler positions.
%1 - axis „X“, „Y“ or „Z“

116 %1 column: not all values ascending


The values entered in the column left/right of the calibration table must be entered in ascending order
to be able to manually produce calibration curves. Please correct this value.
%1 - „First“ | „Second“

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117 %1 column: two values are equal


Two equal values have been entered in the column left/right of the calibration table in order to
manually produce calibration curves. The values must be different. Please correct this value.
%1 - „First“ | „Second“

118 %1 column: not all values descending


The values entered in the column left/right of the calibration table must be entered in descending order
to be able to manually produce calibration curves. Please correct this value.
%1 - „First“ | „Second“

119 Key permitted only in main menu (press ESC)


The key just pressed is not permitted in the current menu. Press the ESC key to go back until you
reach the main menu. Reselect the key you pressed previously.

120 Test not available


A test for which there are no abbreviations has been entered in the “Sample Prep” or “Reagent Block”
menu item. Check possible abbreviations in Maintenance “Test Selection”

121 Menu entrance not permitted, check calibration data via Manual, Curve
Selecting of “Calibration Curve” not possible. Create Calibration curve via Calibration “Manual, Curve”.

122 LED Test not possible


The LED’s cannot be tested during the current routine. Press F3 and wait until the current pipetting
process is complete. You can then test the LED’s in the “Hardware” menu.

123 Mixing ball(s) from cuvette is missing


There is a ball missing in the cuvette rack. The test is repeated automatically.

124 Needle is not in Wash Position


When exiting “hardware”, the needle must be moved into the wash position. Select the “Wash Station”
item.

125 Prime Pumps and Needle Clean not possible


The “Prime Pumps” and “Needle clean” menu item cannot be activated when the distilled water is
empty.
Refill the water tank. Check the water sensor via Adjusting.

126 Hardware test not possible


The programs of the “Hardware” menu item cannot be selected during the routine. Press F3 and wait
until the current pipetting process is complete.?

127 Volume table for single test is empty


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indica- ted information.

128 Position %1 for buffers only %2


Incorrect setting has been entered in the menu “Reagent Block”. After attempting to leave the menu
with ESC, the message appears. Check and correct the entries according to the indicated information.
%1 - position number
%2 - empty

129 Control plasma %1 not defined


A quality check is integrated in the normal routine. This message is displayed if the control plasma has
not been defined. Change the name if you have incorrectly typed it, or delete the request.
%1 - name of control plasma

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130 Values are not ok


The Q.C. limits in the check values for high, average and low are not correct, e.g. the average value is
less than the value for low. Check and correct your entries.

131 No Curve for this calculation type


Calibration: this calculation type works without calibration curve. Check the calculation settings in
menu “Test para-meters”.

132 Clear Track not finished


The “Hardware” menu item cannot be exited if the process of ejecting the rack has not been
completed.

133 In the first three lines must be a right value


When manually producing the calibration curve, the values for the first three calibration points must be
entered in the calibration table. Please enter the missing values.

134 In the first two lines must be a right value


When manually producing the calibration curve, the values for the first two calibration points must be
entered in the calibration table (chromogenic tests). Please enter the missing values.

135 Normal < Min. Calibration value


The normal time entered in the calibration table to manually and automatically produce calibration
curves is too low. Please correct your entry.

136 Normal > Max. Calibration value


The normal time entered in the calibration table to manually and automatically produce calibration
curves is too high. Please correct your entry.

137 Only one standard print possible


After attempting to leave the menu “system parameter” with ESC, the message appears. Please select
just one type of standard print.

138 Press <ENTER> to end the needle clean


The “Needle clean” menu item in “Hardware” can be quit after a sufficient cleaning time by pressing
ENTER.

139 Volume table for duplicate test is empty


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated information.

140 Please read first control plasma


When scanning control plasma data using a hand-held scanner, the message appears with detailed
information. Check and correct the entries according to the indicated information.

141 Please read first name of reagent


When scanning control plasma data using a hand-held scanner, the message appears with detailed
information. Check and correct the entries according to the indicated information.

142 Please scan <END> for next line


When scanning control plasma data using a hand-held scanner, the message appears with detailed
information. Check and correct the entries according to the indicated information.

143 Lot number missing


When scanning control plasma data using a hand-held scanner, the message appears with detailed
information. Check and correct the entries according to the indicated information.

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144 To register the patients please press <F3> first


During the routine, you can place new samples in the rotor once the current rack has been fully
pipetted.
145 SCAN permitted only in main or plasma-prep menu
The start button is not permitted in the current menu. Press the ESC key to go back until you reach
the main or plasma prep menu. Press start button again.

146 LIS communication error (already in work, or ready)


The host computer sends tests for a sample. The actual sample has been processed or is just
processing.
Wait until sample processing is finished, press F6 to delete the finished tests and reactivate with F5.

147 Calculation type only duplicate test possible


Incorrect setting has been entered in the menu “Test parameter”, calculation type rat1:2. After
attempting to leave the menu with ESC, the message appears with detailed information. Check and
correct the entries according to the indicated information.

148 Please put test cup on the wash station and press <ENTER>
When selecting the “Needle check” menu item in “Hardware”, the wash station must be topped with
the test cup before the second stage. Please put the test cup on the wash station.

149 Please press <ENTER> for end of needle check


The needle check is hereby ended.

150 Needle check is not finished


Press F4; follow the instructions in the message box.

151 Please remove test cup from wash station and


press <ENTER>. Remove the test cup from the wash station and check the volume.

152 Please wait


Please wait until the process has been completed.

153 Error: Copy not ok


An error occurred during copying from or to USB stick.

154 First unit is not ok


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated information.

155 success
Message appears after copying successfully.

156 Second parameter must be empty


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated information.

157 Second parameter can be NorISI or empty


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated information.

158 Second unit is not ok


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated information.

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159 Second print format is not ok


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated information.

160 Second unit must be empty


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated information.

161 Second print format must be empty


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated information.

162 LIS is switched off in system parameters


When sending to the HOST with F5 it is ascertained that the communication is turned off. To work with
HOST, it is required that the communication is turned on.

163 Printer is switched off in system parameters


When attempting to print, it was ascertained that the printer is switched off in the system parameters.
To print, it is required that the printer is switched on.

164 Please wait: copying


Message during copying data.

165 CurISI can not be first parameter


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated information.

166 Attention: you are working without Checksum


After attempting to leave the menu “system parameter” with ESC, the message appears. Ensure that a
checksum on the host connection is not necessary.

167 Error: thrombolyzer device and host device equal not possible
Check system parameter setting in maintenance. Use different devices for system and host.

168 Attention: needle drives to manual clean position,


don’t grab into work area! When selecting “Hardware/Maintenance, Needle Clean manually” the
System warns with this message. Wait until the needle is in the manual clean position.

169 Attention: wipe needle only from top to bottom!


When selecting “Hardware/Maintenance, Needle Clean manually” this message appears. Wipe the
needle only from top to bottom.

170 Liquid %1 %2 is missing %3


The reagent for a test has not been defined in the “reagent block” menu item or has not been scanned
and inserted in the reagent area. The system cannot undertake the test. Check the reagent block
selection and settings. Scan the appropriate reagent.
%1 - liquid abbreviation
%2 - test abbreviation or empty for plasma
%3 - „ „|“left“|“right“ =empty for one reagent workstation

171 Control plasma %1 not found %2


There is no or too less control plasma. Please provide control plasma.
%1 - prep. Number
%2 -“left“|“right“ „plasma rack“|“reagent station“ =empty for one workstation

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172 Plasma %1 not found %2


The sample has not been placed in the sample preparation system or too less liquid. The sample not
found is identified by EF10.
%1 - prep. number
%2 - left“|“right“|rack key-nr „plasma rack“ =empty for one workstation

173 Not enough of liquid %1 %2 (%3) (low level)


A reagent for a test will only suffice for the cuvette rack which has just been started. Please
provide the reagent needed at the corresponding position.
%1 - liquid abbreviation
%2 - test abbreviation
%3 - prep. number „“|, „left“|, „right“ =empty for one reagent workstation; „

174 Liquid %1 %2 not found (%3)


All defined spaces of a reagent for test are below the “low level”. The system can no longer perform
this test.
Please provide the reagent needed at the corresponding positions.
%1 - liquid abbreviation
%2 - test abbreviation
%3 - (“left“|“right“ „reagent rack“) =empty for one sampler; Level check:
%1 - “left“|“right“ „reagent pos.“ =empty for one sampler
%2 - prep. number
%3 - received error answer

175 No patient data in block %1 and %2


When pressing start no new samples ordered or no new patient data was recorded after “Scan”.
Please enter the new sample orders or provide new samples.
%1 - key number of plasma rack
%2 - key number of plasma rack

176 Interface %1 not ok! Please Exit!


PC interface not accessible. Check interface and login again.
%1 - interface of device or host

177 Measuring channel %1 too dark (%2)


The specified measuring channel is too dark. Please clean the measuring block. Check via “Adjusting/
Optics”.
%1 - channel number
%2 - wave length „405nm“| 620nm“

178 Measuring channel %1 too bright (%2)


The specified measuring channel is too bright (chromogenic tests). Please clean the measuring block.
Check via “Adjusting/Optics”.
%1 - channel number
%2 - wave length „405nm“| 620nm“

179 Measuring channel %1 too dark (%2) (difference to mean)


The specified measuring channel deviates too much from the other measuring channels in the dark
range (chromo-genic tests). Please clean the measuring block. Check via “Adjusting/Optics”.
%1 - channel number
%2 - wave length „405nm“| 620nm“

180 Measuring channel %1 too bright (%2) (difference to mean)


The specified measuring channel deviates too much from the other measuring channels in the bright
range (chromogenic tests). Please clean the measuring block. Check via “Adjusting/Optics”.
%1 - channel number
%2 - wave length „405nm“| 620nm“

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181 File %1 not found. Press F4


Missing parameter file X (e.g. sys-par.txt): restore it or recreate it and login again.
%1 - parameter file name

182 File %1 not saved. Press F4


Parameter file X (e.g. sys-par.txt) could not be written: check access rights via file manager and login
again.
%1 - parameter file name

183 No patient data in block %1


Only tests or only ID numbers were entered in sample prep. Enter the missing ID numbers or tests.
%1 - key number of plasma rack

184 Place plasma block %1 in working station and press F2


When changing from one plasma rack to another this message appears. Please insert the plasma
block.
%1 - key number of plasma rack

185 Predilution rack %1 is full. Please change it


The last cuvettes were used in the predilution rack. Please change the predilution rack, so the next
predilution can be pipetted without delay.
%1 - predilution rack number

186 Calibration for test %1 is not ok, verify via Calibration, Manual, Curve
The calibration curve for one test is not OK. The current standard curve for this test must be validated.
After changing the “Test parameter” this message appears and the curve must be validated, even if
the test does not need a calibration curve.
%1 - test abbreviation

187 Version of %1 task not ok.


Not all parts of the software are of the same version. Delete previous installation, reinstall software.
%1 - task name

188 Read error in file %1. Press F4.


Some missing fields in parameter file (e.g. sys-par.txt). Check settings in maintenance or reinstall the
parameters.
%1 - parameter file name

189 Volume table for test %1 is not ok


Some wrong fields in parameter file for test X (e.g. test-par-00.txt). Incorrect setting has been entered
in the menu “Test parameter”. Check and correct the entries, reinstall software.
%1 - test abbreviation

190 Predilution plasma in cuvette %1 not found


The Dilution could not be found in the predilution vial. Check whether the predilution stick is inserted
and needle sensor via “Adjusting”.
%1 - predilution cuvette number

191 Cuvette %1 for predilution not free


A liquid has been detected in a predilution vial, which must be empty. Please place unused predilution
vials in the station at position X.
%1 - predilution cuvette number

192 Definition of parameter for test %1 is not ok


Some wrong fields in parameter file for test X (e.g. test-par-00.txt). Incorrect setting has been entered
in the menu “Test parameter”. Check and correct the entries, reinstall software.
%1 - test abbreviation

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193 Definition of parameter for following test %1 not ok


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated information.
%1 - test abbreviation

194 Rotor%1 overload (prep. %2)


Rotor blocked while routinely driving to position X. Please check whether the rotor can be turned by
hand or whether the rotor is being hampered from turning by foreign bodies.
%1 - rotor key number
%2 - prep. number

195 Rotor%1 timeout (prep. %2)


During the routine, the rotor does not run correctly (driving to position X). Please check whether the
rotor can be turned by hand, or if it is blocked.
%1 -rotor key number
%2 - prep. number

196 Timer for liquid %1 %2 expires (prep. %2)


The onboard stability of a reagent expired. Please provide new reagent.
%1 - liquid abbreviation
%2 - test abbreviation
%3 - <prep. number>

197 ERROR on Rotor Scanner%1 (%2)! Please Exit!


A rotor error occurred. This message require the routine software to be quit and restarted for initialize
rotor. Check rotor via adjusting.
%1 - <rotor key number>
%2 - <received error code>

198 File %1 not found. Please exit the system!


Missing parameter file (e.g. barc-par.txt). Please restore it or recreate it.
%1 - <parameter file name>

199 Barcode in prep. %1 not readable (1st time)


The first scanning attempt for the sample position X during the routine was not successful. This
message is not displayed on screen, but it is saved in the error database for service purposes.
%1 - <rotor_key_number> <prep_number>

200 Wrong barcode in prep. %1 (1st time)


The first scanning attempt of the sample position X during the routine was not successful. This
message is not displayed on screen, but it is saved in the error database for service purposes.
%1 - <rotor_key_number> <prep_number>

201 Rotor error: waiting of rotor %1, answer from rotor (%2)! %3 Please Exit!

202 Transport of strip backwards not ok (%1) %2


An error has occurred when transporting a cuvette rack from the measuring block back to the
pipetting position. This message require the routine software to be quit and re-started! After the
restart, ensure that there are no more racks in the transport channel (except the rack in Waiting
position) up to the point of rack ejection on the measuring block. If this is the case, remove them
manually. Check sensors and motors and cuvette transport via “Adjusting”.
%1 - <motor name>
%2 - <received error answer>

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203 Error in file %1. Press F4 and check parameters! %2


Format error in file X (e.g. sys-par.txt). Please check inter-face and login again.
%1 - <parameter file name>
%2 - empty

204 Measuring channel %1 too dark (LEDs off) %2


--not used--

205 Measuring channel %1 too bright (LEDs off) %2


--not used--

206 Plasma %1 not found (sc%2)


The plasma aliquot could not be found in cuvette strip (secondary cup Y). Check needle sensor via
“Adjus- ting”.
%1 - <prep_number>
%2 - <secondary cup number>

207 Plasma %1 not found (level sc%2, %3µl missing)


The plasma aliquot could not be found in cuvette strip (secondary cup Y). The amount in the mixing
chamber (secondary cup) is too low. Check arm position, needle sensor and the pipetting system.
Communication with SAMPLER not ok (X). Please exit the software
%1 - <prep_number>
%2 - <secondary cup number>
%3 - <plasma aliquot>

208 Communication with SAMPLER%1 not ok (%2).


Please exit the software The communication with the specimen distributor was disturbed. This
message require the routine software to be quit and restarted for initialize the sampler.
%1 -“left“|“right“ empty for one sampler
%2 - <received error code>

209 %1 device ID mismatch (%2). Please Exit!


The software does not match the hardware. Quit the software and restart.
%1 - subcontroller
%2 - <received error code>

210 %1 with wrong hardware version %2. Please Exit!


The hardware does not match the current software. (sub-controller X). Update hardware.
%1 - subcontroller (e.g. TMC )
%2 - ( received error code )

211 %1 with wrong software version (%2). Please Exit!


The software does not match the required software version. (subcontroller X). Update subcontroller
via “Adjusting”
%1 - subcontroller
%2 - received error code

212 No communication %1. Please restart the system


This message can be caused by the following: The connection between the system and the PC is
missing or defective. The system is not switched on. Some connections inside the system are not OK.
Check cables (subcon-troller X).
%1 - subcontroller

213 Barcode in prep. %1 not readable %2


During scanning bar code in position X not readable. Check the sample position in the rotor; check the
quali- ty of the bar code.

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214 Wrong barcode in prep. %1 %2


During pipetting the barcode in position X is another than scanned before. Check the sample position
in rotor; check the quality of the barcode.

215 Attention: check results and sample in prep. %1!


A result has an error flag. Check the sample, and the measurement values for plausibility. If necessary,
repeat.

216 Unexpected RESET from %1!


Please restart the system. Communication with subcontroller X failed. Check power supply, cables
and fuses.
%1 - subcontroller

217 Unexpected ANSWER from %1 (%2)!


Please restart the system. Communication with subcontroller X failed with errorcode Y.
%1 - subcontroller (e.g. TMC ) or <“Sampler“ |“Sampler left“|“Sampler right“|“Elevator“|“RC-
Plasma“|“RC- Reagent“>
%2 - <received error code> or <sendet command>|<received data>

218 Unexpected EVENT from %1 (%2)!


Please restart the system. Communication with subcontroller X failed with errorcode Y.
%1 - subcontroller or <“Sampler“ |“Sampler left“|“Sampler right“|“Elevator“|“RC-Plasma“|“RC-
Reagent“>
%2 - <received error code>

219 Unexpected BOOT-LOADER message


from %1 %2! Please Exit! Communication with subcontroller X failed (message Y). Update firmware of
subcontroller X via adjusting.
%1 - subcontroller (e.g. TMC )
%2 - (<received error code>)

220 File %1 not found. Please exit the system and call service!
Missing parameter file X (e.g. sampler)
%1 - parameter file name

221 Error in file %1. Please exit the system and call service!
Format error in file X (e.g. sys-par.txt)
%1 - parameter file name

222 Position error z (1st time) in %1 %2


A sampler error on z axis occurred, which could be corrected. (position X). This message is not
displayed on screen, but it is saved in the error database for service purposes.
%1 - needle positions
%2 - empty

Possible needle positions:


▪ plasma positions: |“left“|“right“|rack key number „plasma pos“ prep number
▪ reagent position: |“left“|“right“ „reagent pos“ prep number
▪ predilution station: „predilution pos“ prep number
▪ cuvette rack: |“left“|“right“ „cuvette“ „high“|“low“|“s.c.“ prep number
▪ clean position: |“left“|“right“ „clean pos.“ prep number
▪ wash position: |“left“|“right“ „wash position.“
▪ test position: |“left“|“right“ „test position.“
▪ cuvette rack reference: |“left“|“right“ „strip reference pos.“

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223 ATTENTION: arm z position not ok in %1 %2


A sampler error occurred, which could not be corrected automatically (position X). Press F4. The arm
must now move to its “Home Position” and then drive to the correct position. Should this error occur
frequently, check via adjusting.
%1 - needle positions
%2 - empty

Possible needle positions:


▪ plasma positions: |“left“|“right“|rack key number „plasma pos“ prep number
▪ reagent position: |“left“|“right“ „reagent pos“ prep number
▪ predilution station: „predilution pos“ prep number
▪ cuvette rack: |“left“|“right“ „cuvette“ „high“|“low“|“s.c.“ prep number
▪ clean position: |“left“|“right“ „clean pos.“ prep number
▪ wash position: |“left“|“right“ „wash position.“
▪ test position: |“left“|“right“ „test position.“
▪ cuvette rack reference: |“left“|“right“ „strip reference pos.“

224 Rotor%1 position error (%2) (1st time)


A rotor positioning error occurred, which could be corrected (position X). This message is not displayed
on screen, but it is saved in the error database for service purposes.
%1 - rotor key number
%2 - received error code

225 Rotor %1 position error (%2). Press F4


A rotor positioning error occurred, which could not be corrected automatically (position X). Press F4.
The rotor must now move to its “Home Position” and then drive to the correct position. Should this
error occur frequently, check via adjusting rotor.
%1 - Rotor key number
%2 - received error code

226 Rotor(%1) reflector foil not found(%2)! Please check, press F4, SCAN
A rotor positioning error occurred during initializing/scanning procedure. Check position of reflector foil.
Press o. The rotor must now move to its “Home Position”. Should this error occur frequently, check via
adjusting rotor.
%1 - rotor key number
%2 - received error code

227 Error on Baseboard (%1). Please Exit!


An error on the baseboard (power supply etc.) occurred. Check power supply, cables and fuses.
%1 - Power Main Fail, received error code “ | „Power Second Fail, received error code “ | „a
Fuse is gone, received error code “
228 Position error x/y (1st time) in %1
A sampler error on x/y axis occurred, which could be corrected (position X).
This message is not displayed on screen, but it is saved in the error database for service purposes.
%1 - needle positions

Possible needle positions:


▪ plasma positions: |“left“|“right“|rack key number „plasma pos“ prep number
▪ reagent position: |“left“|“right“ „reagent pos“ prep number
▪ predilution station: „predilution pos“ prep number
▪ cuvette rack: |“left“|“right“ „cuvette“ „high“|“low“|“s.c.“ prep number
▪ clean position: |“left“|“right“ „clean pos.“ prep number
▪ wash position: |“left“|“right“ „wash position.“
▪ test position: |“left“|“right“ „test position.“
▪ cuvette rack reference: |“left“|“right“ „strip reference pos.“

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229 ATTENTION: arm x/y position not ok in %1 %2


A sampler error on x/y axis occurred, which could not be corrected automatically (position X).
Press F4. The arm must now move to its “Home Position” and then drive to the correct
position. Should this error occur frequently, check via adjusting.
%1 - needle positions
%2 - empty

Possible needle positions:


▪ plasma positions: |“left“|“right“|rack key number „plasma pos“ prep number
▪ reagent position: |“left“|“right“ „reagent pos“ prep number
▪ predilution station: „predilution pos“ prep number
▪ cuvette rack: |“left“|“right“ „cuvette“ „high“|“low“|“s.c.“ prep number
▪ clean position: |“left“|“right“ „clean pos.“ prep number
▪ wash position: |“left“|“right“ „wash position.“
▪ test position: |“left“|“right“ „test position.“
▪ cuvette rack reference: |“left“|“right“ „strip reference pos.“

230 Printer not ready


Check status of printer. Check connection. Reactivate printer with CTRL+PRTSC.

231 No communication. Please restart the system (%1)


The communication between the system and PC is missing or defective. Check power supply, cables
and fuses.
%1 - received error code

232 Wash station overflow %1


There is an overflow in the wash station. Press F4. If the message appears again, please exit the
routine. The mes-sage suggests a defective waste water pump or a blocked waste water filter.
%1 - „left“ | „right“ =empty for one sampler

233 No water in wash station %1


There is no water in the wash station. Press F4. If the message appears again, please exit the routine.
The message suggests a defective fresh water pump, a blocked fresh water filter or a defective fresh
water valve.
%1 - | „left“ | „right“ =empty for one sampler

234 Needle Cleaner not found %1 (%2)


The Clean is too less. Refill the Clean. In “Hardware/Needle clean” no bleach has been filled in the
wash station for the needle cleaning function. Please add the bleach.
%1 „left“ | „right“=empty for one sampler;
%2 - „clean“
235 Water pressure too low: call service

236 Cuvette holder empty (sensor not ok) %1


There are no more cuvette racks in the cuvette register or any racks have jammed. Please refill with
cuvette racks and ensure that the racks are loose.
%1 - empty

237 Check cuvette position at pipetting station %1 %2


Check the position of the rack in the pipetting station. If the error reoccurs, check the sensors and
motors via “Adjusting”.
%1 - empty
%2 – empty

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238 Calibration curve failed


The process of automatically producing a calibration curve could not be completed successfully. If you
have allowed a protocol to be printed, you can view the individual values of duplicate cases. Otherwise,
the values can be read off the “process check”. Enter the values manually in the calibration curve or
repeat the process of automatically producing a calibration curve.

239 Chromogenic tests not possible


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated information.

240 LEDs too dark (%1)


The LEDs are too dark or the measuring block is dirty. Clean the measuring block; check optics via
“Adjusting”.
%1 <received error code>

241 LEDs too bright (%1)


The LEDs are too bright. Check optics via “Adjusting”.
%1 <received error code>

242 LEDs ok %1
The LEDs are OK. The message appears once the lamp has been checked in the “Hardware“ menu
“LED Test“.
%1 - <received value>

243 LEDs will fail soon %1 (call service)


Check via “Adjusting” / “Optics”; clean measuring block.
%1 „405nm“|“620nm“: received error code

244 Predilution buffer not found %1


There is no buffer liquid detected during predilution for fully automatic calibration.
%1 - predilution prep number “left“|“right“ =empty for one sampler; „

245 Measuring block not in incu. position (%1)


The measuring block has not moved all the way to the entry position (horizontal). Check the cuvette
rack transport area.
%1 - received error code

246 Measuring block not in meas. position (%1)


The measuring block does not move completely into the measuring position (vertically). Check the
cuvette rack transport area.
%1 - received error code
247 Cuvette rack empty, please refill (%1)
There are no more cuvette racks in the cuvette register or any racks have jammed. Please refill with
cuvette racks and ensure that the racks are loose. //_OVERLOAD //_WAIT_NO_STRIP
%1 - received error code

248 Cuvette transport error (pipette pos.) %1 (%2)


An error has occurred at the pipetting position during rack transport. This message require the routine
soft- ware to be quit and restarted! After the restart, ensure that there are no more racks in the
transport channel (except the rack in Waiting position) up to the point of rack ejection on the
measuring block. If this is the case, remove them manually. Check sensors and motors via
“Adjusting”.
%1 “left“|“right“ =empty for one sampler
%2 <received error code>

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249 Cuvette transport error (1st incub.pos.) (%1) %2


An error has occurred at the “Incubation 1” position during rack transport. This message require the
routine software to be quit and restarted! After the restart, ensure that there are no more racks in the
transport channel (except the rack in Waiting position) up to the point of rack ejection on the
measuring block. If this is the case, remove them manually. Check sensors and motors via
“Adjusting”. //_OVERLOAD
%1 - <received error code>
%2 - empty

250 Cuvette transport error (2nd incub.pos.) (%1) %2


An error has occurred at the “Incubation 2” position during rack transport. This message require the
routine software to be quit and restarted! After the restart, ensure that there are no more racks in the
transport channel (except the rack in Waiting position) up to the point of rack ejection on the
measuring block. If this is the case, remove them manually. Check sensors and motors via
“Adjusting”. //_OVERLOAD
%1 - <received error code>
%2 - empty

251 Cuvette transport error (3rd incub.pos.) (%1) %2


An error has occurred at the “Incubation 3” position during rack transport. This message require the
routine software to be quit and restarted! After the restart, ensure that there are no more racks in the
transport channel (except the rack in Waiting position) up to the point of rack ejection on the
measuring block. If this is the case, remove them manually. Check sensors and motors via
“Adjusting”. //_OVERLOAD
%1 - <received error code>
%2 - empty

252 Cuvette transport error (meas. block) (%1) %2


An error has occurred at the “measuring block” position during rack transport. Check rack ejection on
the measuring block and empty the waste container. This message require the routine software to be
quit and restarted! After the restart, ensure that there are no more racks in the transport channel
(except the rack in Waiting position) up to the point of rack ejection on the measuring block. If this is
the case, remove them manually. Check sensors and motors via “Adjusting”. //_OVERLOAD
%1 - <received error code>
%2 - empty

253 Cuvette transport error (< 2 ) (%1)


An error has occurred when transporting the rack into the measuring block. This message require the
routine software to be quit and restarted! After the restart, ensure that there are no more racks in the
transport channel (except the rack in Waiting position) up to the point of rack ejection on the
measuring block. If this is the case, remove them manually. Check sensors and motors via
“Adjusting”. //_MBL_OCCUPIED
%1 - <received error code>
254 Cuvette jam in measuring block (press F4) (%1)
An error has occurred during ejection out of the measuring block. This message require the routine
software to be quit and restarted! After the restart, ensure that there are no more racks in the
transport channel (except the rack in Waiting position) up to the point of rack ejection on the
measuring block. If this is the case, remove them manually. Check sensors and motors via
“Adjusting”. //_OVERLOAD
%1 -<received error code>

255 Calibration plasma not found %1


One of the Calibration vials or the Reference plasma contains no plasma or insufficient plasma.
%1 - <rack type> <““|“left“|“right“> <prep.number>

256 Not enough needle cleaner %1 (low level)


The needle cleaner is nearly empty. Provide cleaner.
%1 - <prep.number> <““|“left“|“right“>

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257 L.I.S communication error


There is some error in the link to the host computer. The system cannot transmit its results or receive
its tests automatically. Once the routine has been quit, you can highlight the data measured in the
“Result” menu item and transmit it to the host computer. Reactivate LIS communication with
CTRL+F5.

258 Cuvette position error (%1 sen.):


stop testing %2 The rack has not reached the pipetting position correctly. This message require the
routine software to be quit and restarted! After the restart, ensure that there are no more racks in the
transport channel (except the rack in Waiting position) up to the point of rack ejection on the
measuring block. If this is the case, remove them manually. Check sensors, motors and the magnetic
lifter via “Adjusting”.

259 Cuvette position error (meas.Blck>16): stop testing %1


No rack has arrived in the measuring block within the time specified. This message require the routine
soft- ware to be quit and restarted! After the restart, ensure that there are no more racks in the
transport channel (except the rack in Waiting position) up to the point of rack ejection on the
measuring block. If this is the case, remove them manually. Check sensors, motors and the magnetic
lifter via “Adjusting”.

260 Software version mismatch.


Please exit the software. Not all parts of the software are of the same version. Please reinstall soft-
ware and login again.

261 Liquid level sensing error %1 %2


The needle sensor is not stable. Please check if the needle is mounted correctly and check sensor via
“Adjusting”. This message is not displayed on screen, but it is saved in the error database for service
purposes.
%1 - <“left“|“right“>
%2 - empty

262 Database memory error. No more patients can be stored


Make sure that no unauthorized characters sent from the host. Restart database, restore database or
delete database.

263 LEDs fail


--not used--l

264 LEDs unstable

265 LEDs fail. Please Exit!


The LEDs are defective. Replace the photometer LED board.

266 LEDs unstable. Please Exit!


--not used--
267 %1 rotor not defined
The rotor is not defined. Check System parameter via “Maintenance”.
%1 - <“Left“|“Right“>

268 Incubation type not ok. Please Exit! %1


Check connection of incubation. Check version of incubation.
%1 - empty

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269 Measuring block: no strip arrived (%1)%2


An interruption has occurred while transporting the rack within the incubation, and the rack has not
reached the measuring block. Check if the rack has jammed in the incubation or a transport motor in
the incubation is defective. See message 273.
%1 - <received error code>
%2 - empty

270 Measuring block: motor defect (%1) %2


The rack was detected by the flow sensor of the transport motor in the measuring block, but there was
no op- tical change (dark) at channel 4. The transport motor in the measuring block is defective. See
message 273.
%1 - <received error code>
%2 - empty

271 Measuring block: LEDs fail (%1)


After measuring the rack was transported out of the measuring block to the solid waste but there was
no optical signal (bright) at channel 4. Check whether the solid waste container is full so the rack can
not ejected.
Check optics via Adjusting. See message 273.
%1 - (<received error code>)

272 Strip backwards wait position not arrived (%1) %2


Transport was interrupted when transporting the rack back into its wait position. The rack did not reach
the wait position. Check transport motors and sensors in the incubation via Adjusting. See message
273.
%1 - <received error code>
%2 - empty

273 Transport of strips not ok. Please Exit! (%1)


The previous four error messages lead to this message if F4 is pressed. Quit the program and restart
it. A red warning window appears in the working area of the program. Follow the instructions provided
in this warning window. Note the following in the warning window: A: Always wait until the “system
ready” message appears in the message box. B: Correctly enter the password and confirm by
pressing ENTER.
%1 - <received error code> or empty

274 Transport of strips not ok: accepted


If the red warning window has been correctly confirmed, this message only appears in the database. If
the red window reappears after several restarts, check transport motors via “Adjusting”.

275 Needle sensor %1 unstable (1st time)


The needle sensor could not calibrate itself when first searching for liquids. A second attempt is
undertaken automatically. This message is not displayed on screen, but it is saved in the error
database for service purposes.
%1 - <““ |“left“|“right“> =empty for one sampler;

276 Needle sensor %1 unstable, please check


During the second calibration, the needle sensor is still not in the working area and cannot detect any
liquid. Check if the needle is not mounted correctly. Check if the sensor cable is defective or not
mounted correctly and check sensor via “Adjusting”.
%1 - <““ |“left“|“right“> =empty for one sampler;

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277 ATTENTION: dilutor position not ok. Please Exit!


The dilutor cannot correctly guide the syringe. The encoder has, therefore, created an error message.
The main menu must be quit and restarted. Please use only the original dilutor syringe greased with
silicon.
Check the Dilutor for mechanical or electrical malfunction via “Adjusting”.

278 Measuring block not in incu. position. Please Exit! (%1)


Quit the routine and restart the system. Check the measuring module, waste container and cuvette
ejection.
%1 - <received error code>

279 %1: unknown EVENT from %2! (%3)


Communication problems between the system modules and the PC. Quit the software and restart.
Update the module via “Adjusting”.
%1 - task name
%2 - subcontroller
%3 - <received data>

280 %1: unknown ANSWER from %2! (%3)


Communication problems between the system modules and the PC. Quit the software and restart.
Update the module via “Adjusting”.
%1 - task name
%2 - subcontroller
%3 - <received data>

281 %1: wrong ANSWER received! (%2)


Communication problems between the system modules and the PC. Quit the software and restart.
Update the module via “Adjusting”.
%1 - <“Sampler“ |“Sampler left“|“Sampler right“|“Elevator“|“RC-Plasma“|“RC-Reagent“>
%2 - <sendet command>|<received data>

282 %1: undefined ANSWER received! (%2)


Communication problems between the system modules and the PC. Quit the software and restart.
Update the module via “Adjusting”.
%1 - <“Sampler“ |“Sampler left“|“Sampler right“|“Elevator“|“RC-Plasma“|“RC-Reagent“>
%2 - <sendet command>|<received data>

283 %1: command ANSWER missing! (%2)


Communication problems between the system modules and the PC. Quit the software and restart.
Update the module via “Adjusting”.
%1 - <“Sampler“ |“Sampler left“|“Sampler right“|“Elevator“|“RC-Plasma“|“RC-Reagent“>
%2 - <sendet command>|<received data>

284 %1: wrong EVENT received! (%2)


Communication problems between the system modules and the PC. Quit the software and restart.
Update the module via “Adjusting”.
%1 - <“Sampler“ |“Sampler left“|“Sampler right“|“Elevator“|“RC-Plasma“|“RC-Reagent“>
%2 - <sendet command>|<received data>

285 %1: undefined EVENT received! (%2)


Communication problems between the system modules and the PC. Quit the software and restart.
Update the module via “Adjusting”.
%1 - <“Sampler“ |“Sampler left“|“Sampler right“|“Elevator“|“RC-Plasma“|“RC-Reagent“>
%2 - <sendet command>|<received data>

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286 %1: command EVENT missing! (%2)


Communication problems between the system modules and the PC. Quit the software and restart.
Update the module via “Adjusting”.
%1 - <“Sampler“ |“Sampler left“|“Sampler right“|“Elevator“|“RC-Plasma“|“RC-Reagent“>
%2 - <sendet command>|<received data>

287 %1: too many EVENTs! (%2)


Communication problems between the system modules and the PC. Quit the software and restart.
Update the module via “Adjusting”.
%1 - <“Sampler“ |“Sampler left“|“Sampler right“|“Elevator“|“RC-Plasma“|“RC-Reagent“>
%2 - <sendet command>|<received data>

288 %1: unexpected end of command received! (%2)


Communication problems between the system modules and the PC. Quit the software and restart.
Update the module via “Adjusting”.
%1 - <“Sampler“ |“Sampler left“|“Sampler right“|“Elevator“|“RC-Plasma“|“RC-Reagent“>
%2 - <sendet command>|<received data>

289 %1: end of command not received! %2


Communication problems between the system modules and the PC. Quit the software and restart.
Update the module via “Adjusting”.
%1 - <“Sampler“ |“Sampler left“|“Sampler right“|“Elevator“|“RC-Plasma“|“RC-Reagent“>
%2 - (<sendet command>|<received data>)

290 %1: busy error! (%2)


Communication problems between the system modules and the PC. Quit the software and restart.
Update the module via “Adjusting”.
%1 - <“Sampler“ |“Sampler left“|“Sampler right“|“Elevator“|“RC-Plasma“|“RC-Reagent“>
%2 - <sendet command>|<received data>

291 %1: encoder%2 error at STOP! (%3)


A sampler positioning error (X-, Y- or Z-Axis) occurred. The sampler must now move to its “Home
Position” and then drive to the correct position. If this error occurs frequently, check axes and Sampler
encoder via adjusting Liquid system.
%1 - <“Sampler“ |“Sampler left“|“Sampler right“|“Elevator“|“Elevator< motor name>“||“<Motor name>“
>
%2 - <“ X“|“ Y“|“ Z“|“ W“|““Elevator“>
%3 - <received error code>

292 %1: encoder%2 positioning error! %3


A sampler positioning error (X-, Y- or Z-Axis) occurred. The sampler must now move to its “Home
Position” and then drive to the correct position. If this error occurs frequently, check axes and Sampler
encoder via adjusting Liquid system.
%1 - <“Sampler“ |“Sampler left“|“Sampler right“|“Elevator“|“Elevator< motor name>“|“Motor < motor
name>“ >
%2 - <“ X“|“ Y“|“ Z“|“ W“|““Elevator“>
%3 - (<received error code>)

293 %1: encoder error%2 was not in home! %3


A sampler positioning error (X-, Y- or Z-Axis) occurred. The sampler must now move to its “Home
Position” and then drive to the correct position. If this error occurs frequently, check axes and Sampler
encoder via adjusting Liquid system.
%1 - <“Sampler“ |“Sampler left“|“Sampler right“|“Elevator“|“Elevator< motor name>“|“Motor name>“ >
%2 - <“ X“|“ Y“|“ Z“|“ W“|““Elevator“|““>
%3 - (<received error code>)

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294 %1: encoder positioning error%2 not in home! (%3)


A sampler positioning error (X-, Y- or Z-Axis) occurred. The sampler must now move to its “Home
Position” and then drive to the correct position. If this error occurs frequently, check axes and Sampler
encoder via adjusting Liquid system.
%1 - <“Sampler“ |“Sampler left“|“Sampler right“>
%2 - <“ X“|“ Y“|“ Z“|“ W“>
%3 - <received error code>

295 %1: encoder error timeout at driving%2! (%3)


A sampler positioning error (X-, Y- or Z-Axis) occurred. The sampler must now move to its “Home
Position” and then drive to the correct position. If this error occurs frequently, check axes and Sampler
encoder via adjusting Liquid system.
%1 - <“Sampler“ |“Sampler left“|“Sampler right“|“Elevator“|“Elevator< motor name>“|“Motor < motor
name>“ >
%2 - <“ X“|“ Y“|“ Z“|“ W“|““Elevator“|““>
%3 - <received error code>

296 %1: error at needle tuning! (%2)


Check the needle fixture. Check cables and electronics. Readjust the needle sensor via “Adjusting”.
%1 - <“Sampler“ |“Sampler left“|“Sampler right“>
%2 - <received error code>

297 %1: error finger found! (%2)


The needle sensor detects too early. Check the needle fixture. Check the cables, readjust the needle
sensor, check the needle position via “Adjusting”.
%1 - <“Sampler“ |“Sampler left“|“Sampler right“>
%2 - <received error code>

298 %1: unknown error! (%2)


Communication problems between the system modules and the PC. Quit the software and restart.
%1 - <“Sampler“ |“Sampler left“|“Sampler right“|“Elevator“|“RC-Plasma“|“RC-Reagent“>
%2 - <sendet command>|<received data>

299 ANSWER from %1: parameter error in command %2! (%3)


Communication problems between the system modules and the PC. Quit the software and restart.
Update the module via “Adjusting”.
%1 - <“Sampler“ |“Sampler left“|“Sampler right“|“Elevator“|“RC-Plasma“|“RC-Reagent“>
%2 - <sendet command>
%3 - <received data>

300 ANSWER from %1: unknown command %2! (%3)


Communication problems between the system modules and the PC. Quit the software and restart.
Update the module via “Adjusting”.
%1 - <“Sampler“ |“Sampler left“|“Sampler right“|“Elevator“|“RC-Plasma“|“RC-Reagent“>
%2 - <sendet command>
%3 - <received data>

301 %1: all floors are free! (%2)


An error has occurred during movement of the cuvette rack. Quit the software and restart. This
message require the routine software to be quit and restarted! After the restart, ensure that there are
no more racks in the transport channel (except the rack in Waiting position) up to the point of rack
ejection on the measuring block. If this is the case, remove them manually. Check sensors and
motors via “Adjusting”.
%1 - <“Motor name>
%2 - <received error code>

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302 %1: all floors are occupied! (%2)


An error has occurred during movement of the cuvette rack. Quit the software and restart. This
message require the routine software to be quit and restarted! After the restart, ensure that there are
no more racks in the transport channel (except the rack in Waiting position) up to the point of rack
ejection on the measuring block. If this is the case, remove them manually. Check sensors and
motors via “Adjusting”.
%1 - <“Motor < motor name> (Elevator)“
%2 - <received error code>
303 %1: no strip in floor%2! (%3)
An error has occurred during movement of the cuvette rack. Quit the software and restart. This
message require the routine software to be quit and restarted! After the restart, ensure that there are
no more racks in the transport channel (except the rack in Waiting position) up to the point of rack
ejection on the measuring block. If this is the case, remove them manually. Check sensors and
motors via “Adjusting”.
%1 - <“Motor < motor name> (Elevator)“
%3 - <received error code>

304 %1: driving to floor%s! (%2)


-- not used --
%1 - <“Motor < motor name> (Elevator)“
%2 - <floor number>
%3 - <received data>

305 %1: motor timeout! (%2)


An error has occurred during movement of the cuvette rack. Quit the software and restart. This
message require the routine software to be quit and restarted! After the restart, ensure that there are
no more racks in the transport channel (except the rack in Waiting position) up to the point of rack
ejection on the measuring block. If this is the case, remove them manually. Check sensors and
motors via “Adjusting”.
%1 - <“Motor < motor name>
%2 - <received error code>

306 %1: motor overload! (%2)


An error has occurred during movement of the cuvette rack. Quit the software and restart. This
message require the routine software to be quit and restarted! After the restart, ensure that there are
no more racks in the transport channel (except the rack in Waiting position) up to the point of rack
ejection on the measuring block. If this is the case, remove them manually. Check sensors and
motors via “Adjusting”.
%1 - < motor name>
%2 - <received error code>

307 Waste open! %1


--not used--

308 Waste closed! %1


--not used--

309 %1 with wrong device mode (%2). Please Exit!


Communication problems between the system modules and the PC. Quit the software and restart.
Update the module via “Adjusting”.
%1 - subcontroller
%2 - <error device mode>

310 LIS is enabled via LAN


In „Maintenance“ System parameters menu item „Host communication“ LAN has been selected.
Transfer Data via F5 is not possible, the F5 key is not active.

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311 Sampler%1: needle not ok! Please restart the system and check the needle via ‚Needle
check‘
The plasma aliquot could not be found in cuvette rack. The amount in the mixing chamber (secondary
cup) is too low. This situation indicates the instrument that the needle is blocked, and the
measurement is stopped. Check needle, needle fixture and cable. Check the pipetting system and
arm position. Check needle sensor via „Adjusting“.
%1 - < “left“|“right“> empty for one sampler;

312 Sampler%1: error at driving X/Y, restricted area! (%2)


Unable to reach the defined position in time. Movement interrupted. Check sampler position via
“Adjusting”.
%1 - <“left“|“right“> empty for one sampler;
%2 - <received error code>

313 Sampler%1: error at driving X/Y, wash pumps on! (%2)


Movement interrupted. Quit and restart the software.
%1 - < empty> < “left“|“right“>
%2 - <received error code>

314 Cuvette rack transport error into incubation! (%1)


An error has occurred during rack transport. This message require the routine software to be quit and
restarted! After the restart, ensure that there are no more racks in the transport channel (except the
rack in Waiting position) up to the point of rack ejection on the measuring block. If this is the case,
remove them manually.
Check sensors and motors via “Adjusting”.
%1 - <received error code>

315 Cuvette rack transport not ok. Remove cuvette rack via Hardware/Elevator (%1)
An error has occurred during rack transport. Select “Waste cuvette bar” in the menu item
“Maintenance, Incubator”. If the analyzer does not eject the cuvette bar try “Withdraw cuvette bar from
incubator”. The analyzer attempts to move the cuvette bar out of the Incubator. Remove the cuvette
bar from the analyzer. This message require the routine software to be quit and restarted! After the
restart, ensure that there are no more racks in the transport channel (except the rack in Waiting
position) up to the point of rack ejection on the measuring block. If this is the case, remove them
manually. Check sensors and motors via “Adjusting”.
%1 - <received error code>

316 Elevator is not in ‚Home‘ position


Please drive the elevator in home position.

317 Cuvette rack transport backwards into incubation (2nd try) (%1)
An error has occurred during rack transport, which could be corrected. This message is not displayed
on screen, but it is saved in the error database for service purposes. Check sensors and motors via
“Adjusting”.
%1 - <received error code>

318 Calibration or liquid validation for test %1 not ok: verify via Calibration
The calibration curve for one test is not OK. The current standard curve for this test must be validated.
After changing the “Test parameter” this message appears and the curve must be validated, even if
the test does not need a calibration curve.
%1 - <test abbreviation>

319 Volume Setting must start with BU or PL


Incorrect setting has been entered in the menu “Test parameter”. After attempting to leave the menu
with ESC, the message appears with detailed information. Check and correct the entries according to
the indicated information.

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320 %1 error driving %2 %3 is not in ‚home‘ position (%4)


When testing the sample rack transport in the Adjusting program the transport driver must be in home
position. Please press “All Home” first. ???azl
%1 - <“RC-Plasma“
%2 - <“insertion“|“scan“
%3 - <“scan“|“pipett“>
%4 - <received error code>

321 %1 error driving %2 home first (%3)


When testing the sample rack transport in the Adjusting program the transport driver must be in home
position. Please press “All Home” first.???azl
%1 - <“RC-Plasma“
%2 - <“insertion“|“scan“|“pipett“
%3 - <received error code>

322 %1 error driving %2 timeout (%3)


A sample rack transport error occurred. Check the sample rack transport area for jammed racks.
%1 - <“RC-Plasma“> // „ RC-Plasma“=<global_txt_42>
%2 - <“insertion“|“scan“|“pipett“>
%3 - <received error code>

323 %1 error driving %2 overload (%3)


A sample rack transport error occurred. Check the sample rack transport area for jammed racks.
%1 - <“RC-Plasma“> // „ RC-Plasma“=<global_txt_42>
%2 - <“insertion“|“scan“|“pipett“>
%3 - <received error code>

324 %1 rack ID is empty (%2)


The sample rack ID is not readable. Please check the sample rack barcode.
%1 - <“RC-Plasma“|“RC-Reagent“>
%2 - <received error code>

325 %1 rack ID is not readable (%2)


The sample rack ID is not readable. Please check the sample rack barcode.
%1 - <“RC-Plasma“|“RC-Reagent“
%2 - <received error code>

326 %1 rack ID is not ok (length) (%2)


The sample rack ID is not readable. Please check the sample rack barcode.
%1 - <“RC-Plasma“|“RC-Reagent“
%2 - <received error code>

327 %1 rack ID is not ok (checksum) (%2)


The sample rack ID is not readable. Please check the sample rack barcode.
%1 - <“RC-Plasma“
%2 - <received error code>

328 %1 rack ID is not ok (second character must be 0) (%2)


The sample rack ID is not readable. Please check the sample rack barcode.
%1 - <“RC-Plasma“
%2 - <received error code>

329 %1 rack ID is not ok (range: %2) (%3)


The sample rack ID is not readable. Please check the sample rack barcode.
%1 - <“RC-Plasma“
%2 - <min.value>...<max. value>
%3 - <received error code>

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330 %1 error driving %2 (%3)


A sample rack transport error occurred. Check the sample rack transport area for jammed racks.
%1 - <“RC-Plasma“
%2 - <“insertion“|“scan“|“pipett“|“tray“
%3 - <received error code>

331 %1 rack ID is not ok (%2) (allowed char. ‚0‘..‘9‘, ‚A‘..‘F‘) %2


The sample rack ID is not readable. Please check the sample rack barcode.
%1 - <RC-Reagent>
%2 - <received data>

332 %1 position %2 barcode is not readable (%3)


The barcode in one position of the reagent rack has not been scanned successfully. Please check the
reagent barcode.
%1 - <RC-Reagent>
%2 - <prep. number>
%3 - <received data>

333 %1 position %2 barcode is not ok (length) (%3)


The barcode in one position of the reagent rack has not been scanned successfully. Please check the
barcode parameters in “Maintenance”.
%1 - <RC-Reagent>
%2 - <prep. number>
%3 - <received data>

334 %1 position %2 barcode is not ok (checksum) (%3)


The barcode in one position of the reagent rack has not been scanned successfully. Please check the
barcode parameters in “Maintenance”.
%1 - <RC-Reagent>
%2 - <prep. number>
%3 - <received data>

335 %1 position %2 barcode is not ok (allowed char. ‚1‘..‘8‘) (%3)


The barcode in one position of the reagent rack has not been scanned successfully. Please check the
barcode parameters in “Maintenance”.
%1 - <RC-Reagent>
%2 - <prep. number>
%3 - <received data>

336 %1 position %2 barcode is not ok (month too great) (%3)


The barcode in one position of the reagent rack has not been scanned successfully. Please check the
barcode parameters in “Maintenance”.
%1 - <RC-Reagent>:
%2 - <prep. number>
%3 - <received data>

337 %1 position %2 barcode is not ok (year too great) (%3)


The barcode in one position of the reagent rack has not been scanned successfully. Please check the
barcode parameters in “Maintenance”.
%1 - <RC-Reagent>
%2 - <prep. number>
%3 - <received data>

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338 Liquid not ok: abbreviation of liquid is empty %1


Incorrect setting has been entered in the menu “reagent set up”, “calibration set up” or “QC set up”.
After leaving the menu with ESC, the message appears with detailed information. When recalling the
menu, the cursor goes to the position of incorrect entry. Check and correct the entries according to the
indicated information.
%1 - empty

339 Liquid not ok: test of liquid is empty %1


Incorrect setting has been entered in the menu “reagent set up”, “calibration set up” or “QC set up”.
After leaving the menu with ESC, the message appears with detailed information. When recalling the
menu, the cursor goes to the position of incorrect entry. Check and correct the entries according to the
indicated information.
%1 - empty

340 Liquid not ok: name of liquid is empty %1


Incorrect setting has been entered in the menu “reagent set up”, “calibration set up” or “QC set up”.
After leaving the menu with ESC, the message appears with detailed information. When recalling the
menu, the cursor goes to the position of incorrect entry. Check and correct the entries according to the
indicated information.
%1 - empty

341 Liquid not ok: manufacturer is empty %1


Incorrect setting has been entered in the menu “reagent set up”, “calibration set up” or “QC set up”.
After leaving the menu with ESC, the message appears with detailed information. When recalling the
menu, the cursor goes to the position of incorrect entry. Check and correct the entries according to the
indicated information.
%1 - empty

342 Liquid not ok: type is empty %1


Incorrect setting has been entered in the menu “reagent set up”, “calibration set up” or “QC set up”.
After leaving the menu with ESC, the message appears with detailed information. When recalling the
menu, the cursor goes to the position of incorrect entry. Check and correct the entries according to the
indicated information.
%1 - empty

343 Liquid not ok: liquid Id is empty %1


Incorrect setting has been entered in the menu “reagent set up”, “calibration set up” or “QC set up”.
After leaving the menu with ESC, the message appears with detailed information. When recalling the
menu, the cursor goes to the position of incorrect entry. Check and correct the entries according to the
indicated information.
%1 - empty

344 Liquid %1: manufacturer is already defined as %2


Incorrect setting has been entered in the menu “reagent set up”, “calibration set up” or “QC set up”.
After leaving the menu with ESC, the message appears with detailed information. When recalling the
menu, the cursor goes to the position of incorrect entry. Check and correct the entries according to the
indicated information.
%1 - <name of liquid>
%2 - <indicated value>

345 Liquid %1: type is already defined as %2


Incorrect setting has been entered in the menu “reagent set up”, “calibration set up” or “QC set up”.
After leaving the menu with ESC, the message appears with detailed information. When recalling the
menu, the cursor goes to the position of incorrect en
%1 - <name of liquid>
%2 - <indicated value>

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346 Liquid %1: liquid Id is already defined as %2


Incorrect setting has been entered in the menu “reagent set up”, “calibration set up” or “QC set up”.
After leaving the menu with ESC, the message appears with detailed information. When recalling the
menu, the cursor goes to the position of incorrect entry. Check and correct the entries according to the
indicated information.
%1 - <name of liquid>
%2 - <indicated value>

347 Test %1: liquid %2 %3 is not defined


Incorrect setting has been entered in the menu “reagent set up”, “calibration set up” or “QC set up”.
After leaving the menu with ESC, the message appears with detailed information. When recalling the
menu, the cursor goes to the position of incorrect entry. Check and correct the entries according to the
indicated information. The requested liquid is defined in pipetting table, but not in „..set up“.
%1 - <test abbreviation>
%2 - <liquid abbreviation>
%3 - <liquid test abbreviation>

348 Liquid %1: manufacturer %2 is already defined for %3


Incorrect setting has been entered in the menu “reagent set up”, “calibration set up” or “QC set up”.
After leaving the menu with ESC, the message appears with detailed information. When recalling the
menu, the cursor goes to the position of incorrect entry. Check and correct the entries according to the
indicated information.
%1 - <name of liquid>
%2 - <indicated value>
%3 - <name of liquid>

349 Liquid %1: type %2 is already defined for %3


Incorrect setting has been entered in the menu “reagent set up”, “calibration set up” or “QC set up”.
After leaving the menu with ESC, the message appears with detailed information. When recalling the
menu, the cursor goes to the position of incorrect entry. Check and correct the entries according to the
indicated information.
%1 - <name of liquid>
%2 - <indicated value>
%3 - <name of liquid>

350 Liquid %1: liquid Id %2 is already defined for %3


Incorrect setting has been entered in the menu “reagent set up”, “calibration set up” or “QC set up”.
After leaving the menu with ESC, the message appears with detailed information. When recalling the
menu, the cursor goes to the position of incorrect entry. Check and correct the entries according to the
indicated information.
%1 - <name of liquid>
%2 - <indicated value>
%3 - <name of liquid>

351 Reagent setup for test %1 not ok %2


Incorrect setting has been entered in the menu “reagent set up”, “calibration set up” or “QC set up”.
After leaving the menu with ESC, the message appears with detailed information. When recalling the
menu, the cursor goes to the position of incorrect entry. Check and correct the entries according to the
indicated information.
%1 - <test abbreviation>
%2 - empty

352 Reagent setup not ok. Please exit!


Incorrect setting has been entered in the menu “reagent set up”, “calibration set up” or “QC set up”.
After leaving the menu with ESC, the message appears with detailed information. When recalling the
menu, the cursor goes to the position of incorrect entry. Check and correct the entries according to the
indicated information.

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353 %1 only one type allowed (%2) %3


--- not used ---
Scanning of reagent rack: the barcodes are not from one type.
%1 - <RC-Reagent>
%2 - <indicated value>
%3 - empty

354 %1 different lot no. for the same liquid not allowed
Incorrect setting has been entered in the menu “reagent set up”, “calibration set up” or “QC set up”.
After leaving the menu with ESC, the message appears with detailed information. When recalling the
menu, the cursor goes to the position of incorrect entry. Check and correct the entries according to the
indicated information.
%1 - <“Test“> <test abbreviation>“

355 %1 position %2 reagent is not defined %3


An unknown reagent has been scanned and inserted. Please define the reagent in the menu “reagent
set up”.
%1 - <RC-Reagent>
%2 - <prep. number>
%3 - empty

356 %1 position %2 control plasma is not defined %3


An unknown control plasma has been scanned and in-serted. Please define the QC in the menu “QC
set up”.
%1 - <RC-Reagent>
%2 - <prep. number>
%3 - empty

357 %1 position %2 calibration plasma is not defined %3


An unknown calibration plasma has been scanned and inserted. Please define the calibration plasma
in the menu “calibration set up”.
%1 - <RC-Reagent>
%2 - <prep. number>
%3 - empty

358 %1 position %2 date expired, bottle not usable


An expired reagent has been scanned and inserted. The reagent will be used but all results are
flagged (EF81).
%1 - <RC-Reagent>
%2 - <prep. number>

359 Reagent setup for universal liquids not ok


Incorrect setting has been entered in the menu “reagent set up”. After leaving the menu with ESC, the
message appears with detailed information. When recalling the menu, the cursor goes to the position
of incorrect entry. Check and correct the entries according to the indicated information.

360 %1 position %2 %3 must be mixed: place in mixed position, please


A stirred required reagent has been placed in a unmixed position. Place on a mixed position.
%1 - <RC-Reagent>
%2 - <prep. number>
%3 - <name of liquid>

361 %1 position %2 %3 must be cooled: place in cooled position, please


A cooled required reagent has been placed in the uncooled reagent area. Place in the cooled reagent
area.
%1 - <RC-Reagent>
%2 - <prep. number>
%3 - <name of liquid>

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362 %1 position %2 %3 must be not cooled: place in not cooled position, please
An uncooled required reagent has been placed in the cooled reagent area. Place in the uncooled
reagent area
%1 - <RC-Reagent>
%2 - <prep. number>
%3 - <name of liquid> // empty or name of liquid, e.g. name of calibration or control plasma

363 Password ok
The password has been accepted.

364 Password not ok


The password has not been accepted. Enter the right password.

365 Passwords not ok (one or both empty)


The password has not been accepted. Enter the right password two times.

366 Passwords not ok (different)


The password has not been accepted. Enter the right password two times.

367 Calibration setup for test %1 not ok %2


Incorrect setting has been entered in the menu “calibration set up”. After leaving the menu with ESC,
the message appears with detailed information. When recalling the menu, the cursor goes to the
position of incorrect entry. Check and correct the entries according to the indicated information.
%1 - <test abbreviation> // e.g. „A“, „B“, ...
%2 - empty or <number> <liquid abbreviation>

368 Calibration setup not ok. Please exit!


Incorrect setting has been entered in the menu “calibration set up”. After leaving the menu with ESC,
the message appears with detailed information. When recalling the menu, the cursor goes to the
position of incorrect entry. Check and correct the entries according to the indicated information.

369 Liquid not ok: type %1 not possible %2


--- not used ---
Incorrect setting has been entered in the menu “reagent set up”. After leaving the menu with ESC, the
message appears with detailed information. When recalling the menu, the cursor goes to the position
of incorrect entry. Check and correct the entries according to the indicated information.
%1 - <indicated value>

370 Needle rack tray open %1


--- not used ---
The rack output is open. Please press the rack output button again to close.
%1 - empty

371 Needle rack tray closed %1


--- not used ---
The rack output is closed. The routine can be started.
%1 - empty

372 Needle rack tray nearly full (%1)


The sample output buffer is nearly full. Dispose of soon the finished racks.
%1 - <received data>

373 Needle rack tray full (%1)


The sample output buffer is full. Dispose of the finished racks.
%1 - <received data>

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374 Reagent cover is not present %1


The reagent cover is not on the reagent area. Put the cover on the reagent area.
%1 - empty

375 Reagent cover is not present (arm stopped) %1


The reagent cover is not on the reagent area. Put the cover on the reagent area.
%1 - empty

376 %1 position %2 with new pseq. %3 for liquid %4


A new reagent, calibration plasma or control plasma (new PSN) has been scanned and inserted.
Check the package insert whether it has to be calibrated and for the new reference values.
%1 - <RC-Reagent>
%2 - <prep. number>
%3 - <indicated value>
%4 - <name of liquid>

377 %1 error driving %2 (%3). Please exit!


A sample rack transport error occurred. Check the sample rack transport area for jammed racks.
%1 - <“RC-Plasma“>
%2 - <“insertion“|“scan“|“pipett“|“tray“
%3 - <received error code>

378 Scan ‚%1 rack‘ with empty cups in pos. %2 and insert in %3 reagent station
After “Start Calibration” the system informs, how many calibration vials for the dilutions in which
positions are required and in “Maintenance/Check volume” for the dispensed liquid. Insert the
specified vials in the rack, scan and load the rack in the reagent slot.
%1 - <“8 / 10“|“10“> // rack type
%2 - <indicated position(s)>
%3 - <““ |“left“> =empty for one reagent station;

379 Scan ‚%1 rack‘ with plasma dilutions in pos. %2 and insert in %3 reagent station
After “Start Calibration” the system informs, how many calibration vials for the dilutions in which
positions are required. Insert the specified vials in the rack, scan and load the rack in the reagent slot.
%1 - <“8 / 10“|“10“> // rack type
%2 - <indicated position(s)>
%3 - <““ |“left“> =empty for one reagent station;

380 Reagent rack %1 %2 is not present


While running routine a reagent rack has been removed. Scan and replace the reagent rack.
%1 - <indicated rack position>
%2 - <““ |“left“ |“right“> =empty for one reagent station;

381 Reagent rack %1 %2 is not present (arm stopped)


While pipetting a reagent rack has been removed. Scan and replace the reagent rack.
%1 - <indicated rack position>
%2 - <““ |“left“ |“right“> =empty for one reagent station

382 Wrong reagent rack in position %1 %2 inserted


While running routine a reagent rack has been removed and another reagent rack has been placed in
this reagent slot. Scan and place the same rack as before the “Routine start”.
%1 - <indicated rack position number>
%2 - <““ |“left“ |“right“> =empty for one reagent station

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383 Reagent rack in wrong position %1 %2 inserted (needed in position %3)


While running routine a reagent rack has been removed, scanned and inserted in another reagent slot
as before the “Routine start”. Place the rack in the specified position.
%1 - <rack position number>
%2 - <““ |“left“ |“right“> =empty for one reagent station
%3 - <indicated rack position number>

384 Wrong liquid %1 in position %2 (needs %3) inserted


While running routine a reagent rack has been removed, another reagent has been inserted in a
position on the rack as before the “Routine start”. Place the reagent in the specified position.
%1 - <name of liquid>
%2 - <prep. number>
%3 - <indicated liquid name>

385 Liquid %1 missing in position %2


While running routine a reagent from a reagent rack has been removed, scanned and inserted back.
Replace the reagent or a new bottle of the same reagent in the specified position.
%1 - <indicated liquid name>
%2 - <prep. number>

386 Needles are not in Wash Position


When exiting “Maintenance”, the needles must be moved into the wash position. Select the “Wash
Position” item.

387 Reagent rack not scanned %1 %2


While running routine a reagent rack has been inserted without scanning. Scan and insert the reagent
rack.
%1 - empty
%2 - empty

388 Quality control setup for test %1 not ok %2


Incorrect setting has been entered in the menu “QC set up”. After leaving the menu with ESC, the
message appears with detailed information. When recalling the menu, the cursor goes to the position
of incorrect entry. Check and correct the entries according to the indicated information.
%1 - <test abbreviation>
%2 - empty

389 Quality control setup not ok. Please exit!


Incorrect setting has been entered in the menu “QC set up”. After leaving the menu with ESC, the
message appears with detailed information. When recalling the menu, the cursor goes to the position
of incorrect entry. Check and correct the entries according to the indicated information.

390 Liquid not ok: lot no. is empty %1


Incorrect setting has been entered in the menu “reagent set up”, “calibration set up” or “QC set up”.
After leaving the menu with ESC, the message appears with detailed information. When recalling the
menu, the cursor goes to the position of incorrect entry. Check and correct the entries according to the
indicated information.
%1 - empty

391 Same control plasma only one time per test allowed %1
Two control plasmas with the same name has been entered in the menu “QC set up”. Please change
one of the two names.
%1 - empty

392 Too many controls selected for start (max. %1)


Too many controls have been selected. Please select only so many controls according to the indicated
information.
%1 - <indicated value>

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393 Liquid not ok: date expired %1


Incorrect setting has been entered in the menu “reagent set up”, “calibration set up” or “QC set up”.
After leaving the menu with ESC, the message appears with detailed information. When recalling the
menu, the cursor goes to the position of incorrect entry. Check and correct the entries according to the
indicated information.
%1 - empty

394 Liquid%1 not ok: expiry date is already defined as %2


Incorrect setting has been entered in the menu “reagent set up”, “calibration set up” or “QC set up”.
After leaving the menu with ESC, the message appears with detailed information. When recalling the
menu, the cursor goes to the position of incorrect entry. Check and correct the entries according to the
indicated information.
%1 - empty
%2 - <indicated value>

395 Two or more bottles of same control plasma %1 not allowed (pos. %2)
Two or more bottles of same control plasma has been scanned and inserted. Please insert only one
bottle.
%1 - <name of control plasma>
%2 - <prep. number>

396 Elevator not in Home. Remove all cuvette racks. Press <ENTER> %1
Elevator movement interrupted. Quit the software and restart. Check elevator encoder and home
position via “Adjusting”.
%1 - empty

397 Remove all cuvette racks. Press <ENTER> %1


When selecting “Maintenance, Incubator, Strip backwards out of incubator ” this message appears.
Remove all cuvette racks.
%1 - empty

398 Measuring block not in meas. position. Please Exit! (%1)


The measuring block is not in measuring position. This message require the routine software to be
quit and restarted. After the restart, ensure that there are no racks in the transport channel (except the
rack in Waiting position) up to the point of rack ejection on the measuring block. If this is the case,
remove them manually.
Check sensors and motors via “Adjusting”.
%1 - <received error code>

399 Test %1: control plasma %2 with new pseq. %3. Please check target values!
A new control plasma (new PSN) has been scanned and inserted. Enter the new target values
according to
the package insert.
%1 - <test abbreviation> // e.g. „A“, „B“, .
%2 - <name of control plasma>
%3 - <indicated value>

400 Test %1: calibration plasma %2 with new pseq. %3.


Please check Ref values!
A new calibration plasma (new PSN) has been scanned and inserted. Enter the new reference values
according to the package insert.
%1 - <test abbreviation> // e.g. „A“, „B“, ...
%2 - <name of calibration plasma>
%3 - <indicated value>

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401 %1 different pseq. for the same liquid not allowed


Incorrect setting has been entered in the menu “reagent set up”, “calibration set up” or “QC set up”.
After leaving the menu with ESC, the message appears with detailed information. When recalling the
menu, the cursor goes to the position of incorrect entry. Check and correct the entries according to the
indicated information.
%1 - <RC-Reagent>

402 %1: wash volume ok %2


In the menu maintenance “Volume check” the needle check the pipetted liquid level automatically. The
volume is ok
--- not more used ----
%1 - <“Sampler“ |“Sampler left“|“Sampler right“>
%2 - empty

403 %1: wash volume not ok %2


In the menu maintenance “Volume check” the needle check the pipetted liquid level automatically.
The volume is not ok. Please check whether the needle is blocked. Check the tube for leaks and the
tube connection.
%1 - <“Sampler“ |“Sampler left“|“Sampler right“>
%2 - empty

404 %1 scan not ok (%2 positions not possible) %3


Incorrect reagent rack scanned. Please scan again.
%1 - <RC-Reagent>
%2 - <received number>
%3 - empty

405 %1 new reagent rack found. Please scan again (3 times)! %2


A new reagent rack has been scanned. Please scan 3 times to save this reagent rack in the Database.
%1 - <RC-Reagent>
%2 - (<received rack rfid>, <received number rack positions>)

406 %1: reagent rack known with (%2 positions). Please scan again! (%3)
Incorrect reagent rack scanned. Please scan again.
%1 - <RC-Reagent>
%2 - <indicated number of positions>
%3 - <received rack rfid> <received number rack positions>

407 ASTM parameter for test %1 not ok %2


Incorrect setting has been entered in the menu “Maintenance, System parameters, Host
communication”. Check and correct the entries according to the indicated information.
%1 - <test abbreviation> // e.g. „A“, „B“,
%2 - empty

408 ASTM parameter not ok. Please exit!


Incorrect setting has been entered in the menu “Maintenance, System parameters, Host
communication”. Check and correct the entries according to the indicated information

409 ASTM test not ok: number %1 already defined %2


Incorrect setting has been entered in the menu “Maintenance, System parameters, Host
communication”. Check and correct the entries according to the indicated information.
%1 - <indicated number>
%2 - (test <test abbreviation>) // e.g. „A“, „B“, ...

410 ASTM test not ok: unit is empty %1


Incorrect setting has been entered in the menu “Maintenance, System parameters, Host
communication”. Check and correct the entries according to the indicated information.
%1 - empty

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411 Host online


The Host communication is ok.

412 %1: programming of scanner barcode parameters failed. Please exit! (%2)
Incorrect setting has been entered in the menu “Maintenance, Barcode types“, Host communication”.
Check and correct the entries.
%1 - <“RC-Plasma“|“RC-Reagent“
%2 - <received error code>

413 %1 position %2 liquid is not defined %3


Scanned reagent is not defined in the menu “reagent set up”, “calibration set up” or “QC set up”.
Please enter this liquid in min. one of these menus or remove the bottle.
%1 - <RC-Reagent>
%2 - <prep. number>
%3 - (m:<manufact.>, t:<type>, rId:<reagent Id>) // scanned values

414 %1 position %2 empty cups only in ‚%3 rack‘ possible %4


The calibration vials has been scanned and inserted in an 6 position rack. Please use only the 8- or
10-position rack for the calibration vials.
%1 - <RC-Reagent>
%2 - <prep. number>
%3 - „8, 10“
%4 - (m:<manufact.>, t:<type>, rId:<reagent Id>) // scanned values

415 %1: constantly busy during init. Please Exit! %2


Communication problems between the system modules and the PC. Quit the software and restart.
Update the module via “Adjusting”.
%1 - „TRC“
%2 - empty

416 Copy not allowed: channel types different! %1


This message occurs only in „Maintenance“ / „Test to/from X“ if channel type of tests are different.
%1 - <test level of copy test>; <test level of actual test>

417 Liquid%1 not ok: abbreviation of liquid is already defined as %2


Incorrect setting has been entered in the menu “reagent set up” or “calibration set up”. After leaving
the menu with ESC, the message appears with detailed information. When recalling the menu, the
cursor goes to the position of incorrect entry. Check and correct the entries according to the indicated
information. (If the name of the liquids is the same, then the Liq-No. must also be the same)
%1 - empty
%2 - ‚<liquid abbreviation>‘

418 Liquid%1 not ok: test of liquid is already defined as %2


Incorrect setting has been entered in the menu “reagent set up” or “calibration set up”. After leaving
the menu with ESC, the message appears with detailed information. When recalling the menu, the
cursor goes to the position of incorrect entry. Check and correct the entries according to the indicated
information.
%1 - empty
%2 - ‚<test abbreviation>‘

419 Liquid%1 not ok: lot no. of liquid is already defined as %2


Incorrect setting has been entered in the menu “reagent set up” or “calibration set up”. After leaving
the menu with ESC, the message appears with detailed information. When recalling the menu, the
cursor goes to the position of incorrect entry. Check and correct the entries according to the indicated
information.
%1 - empty
%2 - ‚<lot number>‘

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420 Liquid%1 not ok: name of liquid is already defined as %2


Incorrect setting has been entered in the menu “reagent set up” or “calibration set up”. After leaving
the menu with ESC, the message appears with detailed information. When recalling the menu, the
cursor goes to the position of incorrect entry. Check and correct the entries according to the indicated
information.
%1 - empty
%2 - ‚<name of liquid>‘

421 Liquid%1 not ok: stability time of liquid is already defined as %2


Incorrect setting has been entered in the menu “reagent set up” or “calibration set up”. After leaving
the menu with ESC, the message appears with detailed information. When recalling the menu, the
cursor goes to the position of incorrect entry. Check and correct the entries according to the indicated
information.
%1 - empty
%2 - ‚<stability time of liquid>‘

422 Liquid%1 in reagent preparation %2 not defined %3


Incorrect setting has been entered in the menu „reagent block“. After leaving the menu with ESC, the
message appears with detailed information. Check and correct the entries according to the indicated
information. Liquid must be defined in menu “reagent set up” or “calibration set up”.
%1 - ‚<liquid name>‘ // e.g. „RE A“, „BU“, „BU A“
%2 - <prep. number>
%3 - empty

423 In the first %1 lines must be a right value


Incorrect setting has been entered in the menu „Calibration“ value table for test with calibrator set.
After leaving the menu with ESC, the message appears with detailed information. Check and correct
the entries according to the indicated information. The value table must have a line for each in menu
“calibration set up” defined liquid.
%1 - <indicated value>

424 %1 different pseq. in one calibrator set not allowed %2


m) Incorrect setting has been entered in the menu “calibration set up”. After leaving the menu with
ESC, the message appears with detailed information. When recalling the menu, the cursor goes to
the position of incorrect entry. Check and correct the entries according to the indicated information.
e) A calibration plasma with different pseg has been scanned. Please scan calibrator set with the
equal pseg. (defined in the menu “calibration set up”).
%1 - m): <“Test“><“ ‚“><test abbreviation>
%1 - e): <“RC-Reagent“:><“ „><“pos.“><“ „><prep number>
%2 - m): empty
%2 - e): <“(„><“Test“><“ „><test abbreviation>

425 %1 different manufacturer in one calibrator set not allowed %2


A calibration plasma with different manufacturer has been scanned. Please scan calibrator set with the
equal manufacturer. (defined in the menu “calibration set up”).
%1 - m): <“Test“><“ ‚“><test abbreviation>
%1 - e): <“RC-Reagent“:><“pos.“><prep number>
%2 - m): empty
%2 - e): <“Test“><test abbreviation>

426 %1 different type in one calibrator set not allowed %2


A calibration plasma with different liquid type has been scanned. Please scan calibrator set with the
equal liquid type. (defined in the menu “calibration set up”).
%1 - m): <“Test“><test abbreviation>
%1 - e): <“RC-Reagent“:><“pos.“><prep number>
%2 - m): empty
%2 - e): <“Test“><test abbreviation>

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427 %1 different expiry date in one calibrator set not allowed %2


A calibration plasma with different expiry date has been scanned. Please scan calibrator set with the
equal expiry date. (defined in the menu “calibration set up”).
%1 - m): <“Test“><test abbreviation>
%1 - e): <“RC-Reagent“:><“pos.“><prep number>
%2 - m): empty
%2 - e): test abbreviation e.g. „A“, „B“

428 %1 equal liquid Id in one calibrator set not allowed %2


A calibrator set with two equal liquids has been scanned. Please scan calibrator set with the liquids
defined in the menu “calibration set up”.
%1 - m): <“Test“><test abbreviation>“
%1 - e): <“RC-Reagent“:><“pos.“><prep number;
%2 - m): empty
%2 - e): <“Test“><test abbreviation>

429 Scan ‚%1 rack‘ with 1ml of 5% bleach in cal.vial in pos. %2, insert in %3 reag. st.
>ENTER
When selecting the “Needle clean” menu item in “Maintenance”, the bleach must be inserted in the
reagent station. Follow the instructions in the message box.
%1 - <“10“>
%2 - prep. number
%3 - <““ |“left“ |“right“> =empty for one reagent station;

430 Test %1 needs for calibration %2 calibration plasma %3


Incorrect setting has been entered in the menu “calibration set up”. After leaving the menu with ESC,
the message appears with detailed information. When recalling the menu, the cursor goes to the
position of incorrect entry. Check and correct the entries according to the indicated information.
%1 - ‚<test abbreviation>
%2 - indicated value
%3 - empty

431 Calibration type ‚%1‘ not possible %2


This message occurs at <ENTER> in menu „Calibration“ on button „Calibrator set“(„Automatic“), „Uni
calibrator“(„Fully Aut.“) or „RE-CAL“. If in menu „calibration set up“ calibrator set defined, fully
calibration not possible and vice versa.
%1 - <“Automatic“ |“Fully Aut.“ |“RE-CAL“> // „Automatic“
%2 - empty

432 Please open the cover now %


This message occurs at <ENTER> in menu „Main“ on button „Maintenance“ („Hardware“) if cover
present.
%1 - empty

433 Please close the cover now %1


This message occurs at leaving menu „Maintenance“ („Hardware“) if cover not present.
%1 - empty

434 Menu entrance not permitted,


calibration not available This message occurs at <ENTER> in „Calibration“ menu on button „Curve“ if
channel closed and calibration not ok.

435 Copy not possible, calibration status not ok


This message occurs at key <F10> in „Results“/“Calibration“ if calibration status not „Valid“.

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436 Lot no. not ok %1 %2


This message occurs if entered „Lot no“ (lot_nr_2) in reagent scan menu is not o.k. (not allowed char
of length not o.k.).
%1 - empty
%2 - empty

437 %1 position %2 calibration plasma is not defined in test %3


This message occurs in „Calibration“ menu if at starting of calibration wrong calibration plasma is
scanned (from other test).
%1 - <RC-Reagent>
%2 - <prep number>
%3 - <test abbreviation>‘ // e.g. „A“, „B“, ...

438 %1 position %2 scan of calibration plasma only in calibration possible %3


This message occurs if calibration plasma is scanned and „Calibration“ is not active. (not accepted).
%1 - <RC-Reagent>
%2 - <prep number>
%3 - empty

439 %1 position %2 scan of cal.vial only in calibration possible %3


This message occurs if cal.vial is scanned and „Calibration“ is not active. (not accepted).
%1 - <RC-Reagent>
%2 - <prep number>
%3 - empty

440 Calibration / liquid validation required for test %1 %2


This message occurs at leaving „Calibration setup“ or „Reagent setup“ if calibration or liquid validation
is necessary.
%1 - <test abbreviation>‘ // e.g. „A“, „B“, ...
%2 - empty

441 %1 column: please enter %2 values (min. %3, max. %4)


The values in the left column of the calibration table must be correct entered.
%1 - „Left“
%2 - number requested values
%3 - min. volume of value („0.0001“)
%4 - max. volume of value („9999.9“)

442 %1: %2 attempty(s) (%3)


Answer from Elevator.
%1 - <“Elevator“> // „Elevator“ = <glob_txt_38>
%2 - <number attempty(s)>
%3- <<received error code>

443 %1: blocked (%2)


This message occurs if cuvette rack blocks elevator.
%1 - <“Elevator“>
%2- <received error code>

444 Elevator type not ok: needed min. %1, present %2. Please Exit
This message occurs if elevator type version is smaller then needed.
%1 - needed min. version
%2 - present version

445 Please exchange Clean with maintenance adapter and press <ENTER> %1
This message occurs during needle check.
%1 - empty

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446 Please exchange maintenance adapter with Clean and press <ENTER> %1
This message occurs during needle check.
%1 - empty

447 Needle check in process %1


This message occurs as state during needle check.
%1 - empty

448 Put 16 mm cup with min. 1 ml 5% bleach in maintenance adapter and press <ENTER>
%1
When selecting the “Probe Clean” menu item in “Hardware”, the wash station must be filled with
bleach before the second cleaning stage. Please fill with bleach.
%1 - empty

449 To interrupt the incubation with bleach press <ENTER> %1


The “Probe clean” menu item in “Hardware” can be interrupted by pressing ENTER.
%1 - empty

450 %1: initialization of scanner failed. Please exit! (%2)


This message occurs if initialization of scanner is not ok.
%1 - <“RC-Plasma“|“RC-Reagent“>
%2 - <received error code>

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Transport motor error codes


These codes are identical for both the Routine program and the Adjusting program.
The motor error codes are displayed behind following messages (XXX stands for the motor error
code):
▪ 247 Cuvette rack empty, please refill XXX
▪ 248 Cuvette transport error (pipette pos.) XXX
▪ 249 Cuvette transport error (1st incub.pos.) XXX
▪ 250 Cuvette transport error (2nd incub.pos.) XXX
▪ 251 Cuvette transport error (3rd incub.pos.) XXX
▪ 252 Cuvette transport error (meas. block)
▪ 253 Cuvette transport error (< 2 ) XXX
▪ 254 Cuvette jam in measuring block (press F4) XXX
▪ 314 Cuvette rack transport not ok..

Example:

Cuvette rack empty, please refill (M0,10) [er247]

Explanation:
M0 The involved motor.
,10 Code of the specific problem
[er247] Message 247

NOTICE!
The motor number indicates as well the cuvette rack direction when the error appear.

Possible motor numbers

Hardware Motor ID: Motor number in software:


Forward: Backward:
STM Not sensored /
BMA M0 /
BMB M0 /
BMC M0 /
BMD M0 /
SM0A M1 M10
SM1A M2 M11
SM1B M2 M11
SM2A M3 M12
SM2B M3 M12
SM3A M4 M13
SM3B M4 M13
SM4 M5 M14
M7 insert M6 M15
eject M7 /

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Error codes:
In the following list, all possible motor error codes are described.
<Motor> is a place holder. The motor number is written instead in the message. F.e. „M3“
The list is divided into Three parts:
▪ Possible error codes which can appear in both directions.
▪ Possible error codes which can appear only in forward direction.
▪ Possible error codes which can appear only in backward direction.

Both directions
<Motor>,0 = OK
<Motor>,1 = Overload current: the motor is blocked and produces an overload current.

Only in forward direction


<Motor>,10 Rack transport from cuvette bar register (stack motor) to the wait position.
A rack has not arrived in the wait position Sensors 9 and 10 have are still closed.

<Motor>,20 Rack transported from the left wait position to the left pipetting position.
No rack in the wait position. Sensor 9 is closed.

<Motor>,21 Rack transported from the right wait position to the right pipetting position.
No rack in the wait position. Sensor 8 is still closed.

<Motor>,22 Rack transported from the left wait position to the left pipetting position.
A rack has not arrived in the left pipetting position. Sensor 9 is open.

<Motor>,23 Strip transported from the right wait position to the right pipetting position.
A rack has not arrived in the right pipetting position. Sensor 8 is open.

<Motor>,30 Rack transport in the measuring unit.


Overload current reached within 2 seconds. A cuvette bar is
still present on the measuring block. The rack is stuck.

<Motor>,31 Rack transport in the measuring unit. No overload current. Light values are OK.
Dark values were not reached, because no cuvette bar is present or is stuck.

<Motor>,32 Rack transport in the measuring unit.


Overload current. Light values are OK. Dark values were not reached. The
transport motor is defective and the rack can not be moved.

<Motor>,33 Rack transport in the measuring unit.


Light value not OK, regardless of the overload current check. LEDs are
defective.

<Motor>,34 Rack transport in the measuring unit


No overload current. Light value OK. Dark value was reached. The rack can
move through the photometer., because the lifting magnet is blocked.
Codes (backward direction of the cuvette rack):

Only in backward direction


<Motor>,40 Rack return in the wait position.
Rack return not possible Sensor is open. A cuvette rack is in the wait position.

<Motor>,41 Rack return in the wait position


Rack return not possible. Sensor is closed. Sensor 9 is open. A cuvette rack is
in the left pipetting position.

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<Motor>,42 Rack return in the wait position.


Sensor (left pipetting position) is already open. Cuvette bar is blocked. Sensor is
defective.

<Motor>,43 Rack return in the wait position.


A cuvette rack has not arrived in the wait position (only by forward direction).
Sensor is are closed

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Accessories

Table of contents
Delivery Package 174
Optional Accessories 175
Recommended Spare Parts 175
Consumables 175

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Delivery Package

Accessories:
Description Qty.
▪ Water container 5L x1
▪ Waste container 5L x1
▪ Cuvettes racks loader x1
▪ Cover for cuvettes racks loader x1
▪ Sample tray x1
▪ Reagents block x1
▪ Adapters 30 to 22mm x4
▪ Adapters 22 to 12mm x4
▪ Adapters 30 to 26mm x2
▪ Maintenance adapter x1
▪ Cover ejection hole x1
▪ Incubation cover x1
▪ USB cable(1m) x1
▪ Power cable x1
▪ Water sensor x1
▪ Tube (5mmx2m) x1
▪ Probe 250mm x1
▪ Cleaning stick x1
▪ Racks of predilution cuvettes x2
▪ USB key with software and instrument settings in an envelope x1
▪ BIOLABO user’s manual (English) x1

Computer:
▪ Box with a Linux based computer with program installed + power supply + cables x1
▪ Box with a monitor + power supply + DVI cable x1
▪ Box with a wireless keyboard + a wireless mouse x1

Consumables:
▪ Stacks of 29 cuvette racks (total of 464 tests) x2
▪ Analyzer cups 1.7ml (Hitachi) x20
▪ Plastic reagent containers 25mm x10
▪ Plastic reagent containers 30mm x10
▪ Micro magnetic stir bars (8x1.5mm) x10
▪ Bottle of cleaning solution x1

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Optional Accessories
Cat.-No. Description
691-4440D Barcode scanner USB
018-112 Desktop PC (Debian)

Recommended Spare Parts


Cat.-No. Description
361-200 Tube 5mm
400-106 Syringe Hamilton 0.5mL
401-985 Pipetting tube
401-950 Needle 250mm cpl.
401-889 Sensor cable

Consumables
Cat.-No. Description
054-320OD Cuvette racks for 2.320 Tests
CO0080 Analyzer cups 1.7 ml (Hitachi cups) - 1000 pcs.
S100CS Cleaning Solution - 50 vials of 20mL
050-6100D Reagent containers 25mm -100 pcs.
050-6110D Reagent containers 30mm -100 pcs.
055-200OD Clean Sticks
050-7100D Lids for 050-610 25mm - 25 pcs.
050-7110D Lids for 050-611 30mm - 25 pcs.
054-522OD Predilution Bars B - 25 pcs for 1000 tests
11898882 Magnetic Stirrer 8mm x 1.5mm - 10 pcs.

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Index
This chapter include an alphabetical list of names and topics along with the number of pages which
they are mentioned or described.

A Control button bar 20 F


Control position 18
Accessories 21 Controls 81 Filling the water container 95
Access rights Cooled 39 Fuses 20
37 Alarm off Cuvette 40, 76
button 20 Cuvette downholder 22
analyzer 12 Cuvette rack 22
Analyzer Function groups G
Cuvette rack register 16
15 Analyzer function Cuvette rack transport rail 16
units 16 Analyzer, left General Function description
Cuvette rack transport system 115 12
side 19 Cuvette rack transport unit 16 Graphic symbols 10
cycle depends on which test is
selected.
B Test point 17
H
Backup 85
Backup Database 85 Hardware 73
D HOST 19
Ball function 14
Daily Care 91
Dilutor 21
C Dispensing and liquid system 114 I

Calibration 59, 60, 61, 62, 63, Incubation cover 23


82 Intended use 12
E
Calibrator 60, 64
Change 76
Error 83
Cleaning the housing 96
Error codes 171 K
Cleaning the measuring
Errors 83
block 94
Exit 87 Kaolin suspension 25
Cleaning the needle
EXT. 19 Keys, Function 46
automati- cally 93
Clean position 18
Clean solution 25
Clean stick 24
Consumables 175
Control 82

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L processing,Sample 50
Protective signal bar 20 Stop button 20
LED 78 Protocol 83 Syringe 19, 77, 102
LEDs 78
Levey-Jennings chart 81
Liquid container 23, 24
Q T
Liquid waste container 24
List of Features 12 Test 74, 86
Location 35 QC 68, 69, 70
Quality 68 Transmit 80
Transport motor error codes
170
Turning 36
M
R
Mains connector 20
Mains switch 19 Re 66
Reactivate 67 U
Manual 66
Manual data entry 50 Reagent 39, 55, 56, 57, 76
Reagent area 39 User interface 38
Manually needle cleaning
96 Reagent block 17, 18
measurement, Precision Reagents 55
71 Recommended Spare Parts 175 V
Measuring results 116 Reference 59
measuring system 13 Refilling 58 Values, A/D 78
Messages 125 Regular maintenance 90 Vial 12 mm 23
Regular maintenance actions 91
Remove the protective cover 96
Removing air bubbles in the syrin-
N ge 95 W
Restricted 37
Needle 74, 75 Result error flags 120 Wash 77
Needle Clean 75 Results 79 Washing tank 40
Needle right sampler 24 Run 54 Wash station 17
Wash water
connector 19
Wash water
O S sensor 20
Waste water
Optional Accessories Sample 52 connector 19
175 Sample Prep 50 Water sensor
Sampler 74 25
Sampler area 17 Weekly Care 93
P Sampler arm (X/Y axis) 18 window, Main menu 45
Sample tray 17
Patients 80 Single 65
Patient Search 80 Software freeze 108
PC and Communication Specific maintenance 90
107 Specific maintenance actions 95
PC interface 20 Standard 37
Pipette tube & needle 18 Start 70
Pipetting position 16, 18 STAT 53
Predilution 40 Status 84
Predilution block 17
Predilution rack 22, 23
Preparations 36
Prime 77
Priming the fluid
system 95

BIOLABO S.A.S

SOLEA-100_USER-MANUAL_EN 177 / 181


SUP/MAN/0030 - Version 1 - 20/02/2024

Personal Notes:

BIOLABO S.A.S

SOLEA-100_USER-MANUAL_EN 178 / 181


SUP/MAN/0030 - Version 1 - 20/02/2024

BIOLABO S.A.S

SOLEA-100_USER-MANUAL_EN 179 / 181


SUP/MAN/0030 - Version 1 - 20/02/2024

BIOLABO S.A.S

SOLEA-100_USER-MANUAL_EN 180 / 181


SUP/MAN/0030 - Version 1 - 20/02/2024

Device of In Vitro Diagnostic intended for in vitro determination of coagulation.

Only for professional use - Respect the legislation in force.

Compliant with regulation 2017/746

This publication conforms to the Software Solea 100 coagulation analyzer


version 1.75 or higher.

BIOLABO S.A.S
SOLEA-100_USER-MANUAL_EN 181 / 181

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