Solea 100 User Manual
Solea 100 User Manual
User manual
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Table of contents
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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
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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!
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.
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Graphic symbols
ON (Main switch)
Keep steel balls out of magnetic fields! (Speakers, CRT, monitors etc.)
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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.
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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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.
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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
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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
ID Description
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ID Description
1. Cuvette rack register
1
2. Cuvette rack transport rail
3. Pipetting position 2 3 4
4. Measuring unit
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.
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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.
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.
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.
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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 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.
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
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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
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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
Access rights 37
Standard user interface 37
Restricted user interface 37
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.
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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ATTENTION!
Make sure that an “electric ground” is also connected.
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.
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.
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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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
▪ 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 ...“.
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.
ATTENTION!
Use only original product to guarantee the functionality of the analyzer
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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
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
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
Cursor keys
w x y z Chooses the next/previous menu, table cell, row or field Menus Tables, Lists
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Cursor keys
] 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.
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bi
Reactivates the printer. Main Menu
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 .
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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.
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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.
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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
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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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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.
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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.
IMPORTANT!
Do not use IDA for small reagent container.
▪ mix.: Mixing Position. The reagent can be stirred by using a magnetic stirrer.
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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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.
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.
ATTENTION!
Never place foreign objects, e.g. coins, under the reagent receptacles.
WARNING!
Warning of a biological hazard.
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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.
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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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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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▪ 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.
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.
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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.
Place the control plasma and all reagents in the correct positions. Press m to start the precision run.
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.
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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.
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.
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.
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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.
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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
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.
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Table of contents
Overview 90
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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:
Specific maintenance
The following maintenance actions should be performed when required:
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Daily care
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 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.
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Weekly care
Required material:
▪ 1 ml bleach 5%
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.
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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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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NOTICE!
Check the container frequently regarding fungal attack or other
contaminations. Clean the container firmly or change the
container.
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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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.
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.
To exit the hardware action panel, choose WASH POSITION. The needle moves to the wash position.
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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.
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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.
ATTENTION!
When removing the tube, tightly hold on to the needle’s black 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.
Remove
▪ Select HARDAWRE>SAMPLER > SYRINGE >CHANGE POSITION and press e
The syringe plunger moves to its lower position for syringe
remove.
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▪ 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.
▪ 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
Sampler 109
Needle misses correct pipetting positions 109
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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PC and communication
Help:
▪ Check Power supply ,Fuses, cables
▪ Open the adjusting program
▪ Check firmware via Eproms
Help:
▪ Open the adjusting program.
▪ Update firmware via. Eproms.
▪ Check Power supply ,Fuses, cables.
▪ Check the keypad via comterm.
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).
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
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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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.
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.
Help:
Check that needle is assembled correctly.
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
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.
Help:
Check the panel sheet which covers the trench of the
plunger support. It may scratch to the dilutor base plate.
Help:
Replace tube.
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IMPORTANT!
Following any service to the dilutor/tubing/needle system the following checks must be performed on
the HARDWARE menu:
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Wash station
General:
The wash station’s rinse cycle is software controlled by the needle sensor.
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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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
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
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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Help
▪ Check the dispensing and liquid system.
▪ Check the reagent and plasma.
▪ Check positions of the calibration plasma. If using a calibrator set.
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”).
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
Messages 125
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NOTICE!
See also main screen in routine program F1 - help window. The result error flags you will find there as
well.
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.
9 Sample removed
During rescanning of the barcode before pipetting, a free position was found.
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
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.
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.
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44 No signal (derived)
Too less reaction signal to calculate a derived Fibrinogen result. Choose the standard fibrinogen test.
50 Duplication error
The two measured values of duplication are outside the programmed Tolerance in menu Test
Parameters.
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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.
68 Same results
All results within one cuvette rack are identical.
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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.
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“
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.
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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.
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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
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121 Menu entrance not permitted, check calibration data via Manual, Curve
Selecting of “Calibration Curve” not possible. Create Calibration curve via Calibration “Manual, Curve”.
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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.
155 success
Message appears after copying successfully.
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167 Error: thrombolyzer device and host device equal not possible
Check system parameter setting in maintenance. Use different devices for system and host.
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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
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201 Rotor error: waiting of rotor %1, answer from rotor (%2)! %3 Please Exit!
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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
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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
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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>
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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;
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>
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>
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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>“
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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.
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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;
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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
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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
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>
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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>
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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>
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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;
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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
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
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Example:
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.
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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.
<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>,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.
BIOLABO S.A.S
BIOLABO S.A.S
Accessories
Table of contents
Delivery Package 174
Optional Accessories 175
Recommended Spare Parts 175
Consumables 175
BIOLABO S.A.S
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
BIOLABO S.A.S
Optional Accessories
Cat.-No. Description
691-4440D Barcode scanner USB
018-112 Desktop PC (Debian)
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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SUP/MAN/0030 - Version 1 - 20/02/2024
Index
This chapter include an alphabetical list of names and topics along with the number of pages which
they are mentioned or described.
BIOLABO S.A.S
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
Personal Notes:
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