Operating Instructions: Robert Riele GMBH & Co KG
Operating Instructions: Robert Riele GMBH & Co KG
SYMBOLS
The packaging material, the type plate on the instrument, and the manual may contain the following symbols or
abbreviations:
Manufactured by:
Biohazard
Samples containing material of human origin must be treated as potentially infectious.
The relevant laboratory guidelines on safe use must be observed.
Symbol for the marking of electrical and electronics devices according to § 7 ElektroG
INSTRUMENT APPROVALS
The Photometer 4040 meets the requirement stated in Directive 98/79/EC of the European Parliament and the
Council of the European Union (EU) on in vitro diagnostic medical devices. Furthermore, the Photometer 4040
is manufactured according to the special safety requirements for IVD medical devices stated in DIN EN 61010,
testified by TÜV Rheinland Group.
The Photometer 4040 fulfils the EMC immunity requirements for laboratory use equipment according to the
EMC standard EN 61326.
SAFETY INFORMATION
User qualification
Only appropriately trained operators are qualified to operate the device.
Environmental conditions
The Photometer 4040 is approved for indoor use only.
For further environmental conditions see chapter 11.1.
Patient ambience
The Photometer 4040 may not be used in the patient ambience.
Electrical Safety
This device was examined and left the factory in perfect technical condition. To preserve this and protect safe
and faultless operation, the user must follow the orders and remarks of this operating manual.
Connect the device to grounded power outlets only. All peripheral devices that are connected to the Photometer
4040 must comply with safety standard EN 60950. Before connecting read the documentation of the peripheral
devices.
Opening covers or removing parts of the instrument, except where this can be achieved manually without the
use of any tool, may expose voltage-carrying components. Connectors can be live, too. Never try to maintain or
repair an open instrument which is carrying voltage.
Repairs at the device including replacement of the Lithium battery may be carried out only by authorized
specialist staff. Through improper repairs the warranty extinguishes, and the user can be heavily jeopardized.
If suspected the device can no longer be operated safely, switch it off and take steps to ensure that no one will
subsequently attempt to use it.
Electromagnetic waves
Devices that emit electromagnetic waves may affect measured data, or cause the Photometer 4040 to
malfunction. Do not operate the following devices in the same room where the Photometer 4040 is installed:
mobile phone, transceiver, cordless phone, and other electrical devices that generate electromagnetic waves.
Reagents
Regarding reagents follow the safety as well as the operating instructions of the manufacturers.
Pay attention to the currently valid German “Gefahrstoffverordnung” (GefStoffV)!
Biological safety
Liquid waste is potentially biologically hazardous. Always wear gloves if handling those materials. Do not touch
parts of the device other than those specified. Consult the laboratory protocol for handling biohazardous
materials.
Pay attention to the currently valid German “Biostoffverordnung” (BioStoffV)!
Waste
Handle liquid waste properly, according to legislation on water pollution, and on the treatment of drainage and
waste matter.
MANUFACTURER’S WARRANTY
ROBERT RIELE GmbH & Co KG warrants Photometer 4040 against defects in material and workmanship.
For further information contact the local distributor.
At the end of the life or utilization time the device and the accessories can be given back to the manufacturer
with costs for an environmental waste disposal. The previous professional decontamination has to be proved
with a certificate.
ROBERT RIELE GmbH & Co KG maintains a quality management system according to DIN EN ISO 9001 and
DIN EN ISO 13485 certified by TÜV Rheinland Group.
CONTENTS
7 METHOD EDITOR.......................................................................................43
8 UTILITY PROGRAMS .................................................................................47
8.1 SELECTION OF UTILITY PROGRAMS .........................................................................................47
8.2 DESCRIPTION OF UTILITY PROGRAMS .....................................................................................48
8.2.1 Dark level adjustment................................................................................................................48
8.2.2 User name.................................................................................................................................48
8.2.3 Error list.....................................................................................................................................48
8.2.4 Deleting method ........................................................................................................................49
8.2.5 Language selection ...................................................................................................................49
8.2.6 Beep ON / OFF .........................................................................................................................49
8.2.7 Temperature control ON / OFF .................................................................................................49
8.2.8 Temperature calibration ............................................................................................................50
8.2.9 AD-Transducer readings ...........................................................................................................50
8.2.10 ADC dark current values..........................................................................................................50
8.2.11 Display test ..............................................................................................................................51
8.2.12 Printing device configuration....................................................................................................51
8.2.13 Real time clock ON / OFF ........................................................................................................52
8.2.14 Filter wheel test........................................................................................................................52
8.2.15 Temperature correction............................................................................................................52
8.2.16 Printing user defined methods .................................................................................................53
8.2.17 Laboratory name......................................................................................................................53
9 MAINTENANCE ...........................................................................................54
9.1 CLEANING INSTRUCTION ...............................................................................................................54
9.2 CALIBRATING MEASURING SYSTEM ............................................................................................54
9.3 CHANGING RIBBON.........................................................................................................................54
9.4 CHANGING PAPER ROLL ................................................................................................................54
9.5 REPLACEMENT OF LINE FUSES .................................................................................................55
This device, Photometer 4040, a programmable photometer for manual applications, is designed for In Vitro
Diagnostic (IVD) use by qualified laboratory staff.
The device is useable e.g. for wet clinical-chemical analyses. The solution can be measured in glass or
disposable cuvettes placing one after the other. To make the measuring solution the optimal temperature, the
use of glass cuvettes is recommended.
The solution is quickly and exactly heated to 37 °C in the measuring cell as well as in the incubation block with 2
positions.
For different measuring methods several programmed methods with open parameters are available (chapter 5 -
MEASUREMENT WITH BASIC METHODS and chapter 13 - METHOD LIST).
15 basic methods with open parameters are available in the device (chapter 5 - MEASUREMENT WITH
BASIC METHODS and chapter 13 - METHOD LIST).
Beside this up to 230 free methods - built up on the basic methods - can be created and stored with a method
editor (chapter 7 - METHOD EDITOR) by the user. The list of methods can be printed out (chapter 8.2.16 -
Printing user defined methods).
Up to 50 nonlinear calibration curves with maximal 20 sets of points can be stored (chapter 5.9 - Multi-
standard tools).
For the different measuring tasks the device has a capacity for up to 250 pre-programmed test variants with
fixed parameters.
Normally the device has optical filters of 340, 405, 492, 546, 578 and 623 nm wavelength. Three more filters like
e.g. 670 nm can be built in.
Normally the device is operated by a membrane keyboard. External operation is possible by a serial data
interface (chapter 5.7 - Serial interface utilities).
The result is shown on a 32-digit lighted display. The device has a built-in printer and a serial data interface.
According to a GLP conformal documentation the name of lab and user can be printed out as well as transferred
to EDP (chapter 8.2.17 – Laboratory name and 8.2.2 - User name).
Results of patients can be managed in the memory of Photometer 4040 (chapter 5.10 - Patient data
management).
Photometer 4040 supports the download of the operating system using FLASH MEMORY technology. So new
features of software development can easily be updated without any manipulation on hardware level (see
chapter 5.7 -Serial interface utilities: Download to FLASH MEMORY).
In the unlikely case of a fault which cannot be located or remedied by the user, the device can be checked by
built-in utilities for function test and faulty remedy. This guarantees fast, accurate help and easy repair.
For a listing of used terms and text see chapter 5.3 - ABBREVIATIONS.
2 INSTALLATION
2.1 DELIVERY
After careful unpacking check if the device is in perfect condition. Check that the box contains all the following
items:
In the event of damage during transit, contact the local distributor. Store the packaging carefully for the
case of a possibly necessary return.
If the device has been exposed to marked changes in temperature and/or humidity, wait for it to acclimatize
sufficiently before operating.
2.3 INSTALLATION
The Photometer 4040 operates at any line voltage between 90 VAC and 264 VAC at 50/60 Hz without adjustment.
The device plug of the mains cable must be put into the mains cable socket at the back of the device and the
mains plug of the mains cable must be put into a grounded mains socket.
For combined operation with external devices (PC, printer) read the relating documentation. Pay atten-
tion to the above safety instructions. Switch these devices on at first.
Switch the photometer on by pressing the mains switch at the back of the device.
PHOTOMETER 4040 ... Type of device and version number is displayed. Parallel to this, type of device
V2.xa dd.mm.yy D and version number is printed in case of an activated printer.
TEMP. 37C <> Display in case of an activated temperature control. It disappears after reaching
PLEASE WAIT B of 37 °C.
Proceeding to next display with [BREAK] is possible.
METHOD NO. After this the level for program selection appears.
INPUT 1-250
The program selection is carried out in accordance with chapter 4 - SELECTION
OF MEASURING PROGRAMS
The device is heated up and ready for measurement after around 15 minutes. At first the heating is switched off.
If the user wishes to work later with tempered measuring solution, it is recommended to switch on the heating
now to stabilize itself parallel to the warming up of the device. Switch on the heating directly by utility program
(chapter 8.2.7 -Temperature control ON / OFF) or indirectly by selection of a method with programmed warming
up (for details see chapter 5.1 - GENERAL NOTES).
If errors appear during operation, first of all they have to be confirmed with [ENTER] before remedying (see
chapter 10 - ERROR MESSAGE / CORRECTION).
If required, a dark level adjustment can also be executed at this time according to chapter 8.2.1 - Dark level
adjustment.
• Put this tip into the guide below the ribbon cassette.
• Press [LF] several times for line-feed until the paper has passed the tear-off edge.
• Put printer paper reel into the axis guide.
• Take paper through the crack of the printer cover and close the printer with the cover.
3 OPERATING ELEMENTS
3.1 FRONT
working area
keyboard
3.2 BACK
lid
working area
cuvettes
3.4 DISPLAY
3.5 KEYBOARD
NORMAL OPERATION
Key/-combination Function Chapter
MODE FUNCTIONS
Key/-combination Function Chapter
METHOD NO. A method can be called directly in the level for program selection by input of the
INPUT 1-250 method number (see also chapter 2.3 - INSTALLATION and chapter 13 -
METHOD LIST). Confirm with [ENTER].
It can also be selected indirectly by repeated pushing of [+/-], so that the methods
are scrolled till the required method is reached.
[BREAK] has a general break function for all methods and subroutines back to the level for program selection.
In principle, reports and inputs to the method have to be confirmed with [ENTER]. With [BREAK] all methods
can be broken off. New start according to chapter 4 - SELECTION OF MEASURING PROGRAMS. Measuring
is generally triggered by [RESULT], zero measuring by [ZERO].
• Deviations from normal operation, caused by the device or by the user, e.g. the programmed
upper limit was exceeded by the measurement, are notified by “ERROR”. They have always to be
confirmed with [ENTER] (chapter 10 - ERROR MESSAGE / CORRECTION).
TEMP. 37C <> Display in case of an activated temperature control. It disappears after
PLEASE WAIT B reaching of temperature.
Proceeding to next display with [BREAK] is possible.
The heating can also be switched on/off manually by utility program 7 (chapter 8.2.7).
• After switching on the heating it lasts around 10 minutes till a constant temperature of 37 °C is
reached.
• Indicator for the heating process, and so for a not yet constant temperature, is a flashing cursor at the
utmost right position in the upper display line and an asterisk (*) at the utmost right position in the
corresponding print line.
• For a quick mode of operation all temperature-sensitive samples, reagents and washing solutions
should be externally temperated by Incubator T12 (REF 500-002) or a water bath.
• Instead of being measured, the reagent blank can also be entered via the keyboard or put on zero.
• In favor of a homogeneous solution the input of a delay before a measuring is possible at all methods.
0.302 0.299 The first line shows the absorbance 1 and 2 of the standard.
0.303 E/+/0 The second line shows the absorbance 3 of the standard.
With [ENTER] the average of all values is calculated. Values with 0 are
ignored and excluded from the calculation. The resulting factor is
calculated on the average of the standard.
• The determined resulting factor of a standard measuring is saved together with the corresponding
method number. After renewed selection of a method number the resulting factor is offered as
„Old STD“.
• Nonlinear calibration is used for those sample constituents where assay absorbance at different
concentrations forms a nonlinear but reproducible plot. At least three (maximum 20) calibrators are
required for nonlinear calibration (chapter 5.9 - Multi-standard tools).
In each time interval (Delta or ∆t) the difference between the relating absorbance values as well as the gradient
of the curve are calculated.
To obtain the alteration per minute ∆AS,Minute the gradients must be averaged. This is done by a simple linear
regression calculation also giving an indicator for the linearity of the test. This indicator is called the coefficient of
correlation R. For practical reasons, the square of the coefficient of correlation R^2 is taken in a Kinetic
calculation. The value of R^2 can vary between 0 and 1. An R^2 value of 1 indicates perfect linearity and a
value of 0 indicates absolute non-linearity. Already values < 0.9 indicate a bad linearity and therefore an
incorrect test.
In practice, linear tests show values of R^2 near to 1. In the example for method 11 (Kinetic with Factor) values
of R^2 ≥ 0,998 are permitted. Results with smaller R^2 values could be caused by temperature instability,
pollution, expired reagents, unfavorable delay time, etc.
For a better monitoring the number of deltas (deltas or ∆t) should be bigger than specified for the manual
procedure. The classic three-minutes-test with three deltas of 60 s can be replaced by 15 deltas of 12s.
MODE FUNCTIONS Selection level of the mode functions: Selecting the desired mode function by
direct selection i.e. input of the number key in question (see table) or by scrolling
through all mode functions with [+] ... [+]. Confirm with [ENTER].
Exit the selection level of the mode functions and change back to the course of
method with [BREAK].
After working off a mode function the return is carried out to the course of
method.
MODE FUNCTIONS
Key/-combination Function Chapter
5.3 ABBREVIATIONS
C ......................................... Concentration
CST ...................................... Concentration of standard
∆ARB,Minute ............................ At Kinetic: Change of reagent blank per minute (measured in ∆A / min)
∆AS,Minute .............................. At Kinetic: Change of sample per minute (measured in ∆A / min)
F.......................................... Factor
FTK ..................................... Fixed Time Kinetic
S, ST ................................... Standard
STb ..................................... Standard blank
The calculation procedures, on which all methods are traceable from the list of methods, are mentioned in the following table. Criterion is the characteristic
of the calculation procedure (see below). For detailed description of the respectively accompanying course of method see chapter 5.5 - DESCRIPTION OF METHOD
4040e_23.doc / 05.04.07
COURSES
Page 19
CP 9 chapter 5.5.9 FTK/F/Rb Fixed Time with Factor C = F ∗ ( |AS,0 - AS,1| - |ARB,0 - ARB,1| ) given / entering ent./meas.
CP 10 chapter 5.5.10 FTK/S/Rb Fixed Time with Standard C = F ∗ ( |AS,0 - AS,1| - |ARB,0 - ARB,1| ) F = CST / (|AST,0-AST,1|-|ARB,0-ARB,1|) ent./meas.
CP 11 chapter 5.5.11 KIN/F/Rb Kinetic with Factor C = F ∗ ( ∆AS,Minute - ∆ARB,Minute ) given / entering ent./meas.
CP 12 chapter 5.5.12 KIN/S/Rb Kinetic with Standard C = F ∗ ( ∆AS,Minute - ∆ARB,Minute ) F = CST / ( ∆AST,Minute - ∆ARB,Minute ) ent./meas.
CP 13 chapter 5.5.13 TRANSM. Transmission in %
CP 14 chapter 5.5.14 C/Fdelta Difference with Factor C = F ∗ ( ∆AS2-Sb2 - ∆AS1-Sb1 ) given / entering meas.
CP 15 chapter 5.5.15 C / F 3 WL Meas. with 3 wavelengths C [mg/dl]= 168 * A415nm – 84 * A380nm
– 84 * A450nm meas.
*) Explanations:
CP-No. ................................................. Number of the calculation procedure (see also chapter 7 - METHOD EDITOR)
Description ........................................... Refer to the description of the corresponding method course
Characteristic ....................................... Characteristic of the calculation procedure (see also chapter 7 - METHOD EDITOR and chapter 13 - METHOD LIST)
Calculation formula .............................. Calculation basis of basic method, abbreviations and formula sign (chapter 5.3 - ABBREVIATIONS)
Rb ........................................................ Reagent blank
ent./meas.. ........................................... Reagent blank can be entered or measured
At first the device runs through preparatory measuring till a sequence starts which recurs for every further test.
5.5.4 Concentration Measurement with Factor, Sample Blank and Reagent Blank
Method at which the difference of reagent blank ARB and blank of reagent blank ARBB regarding the amount is
subtracted of the difference of sample value AS and sample blank ASB regarding the amount, and this difference
is multiplied with a given factor F.
The sample blank ASB is measured before every test. The reagent blank ARB is entered or measured once.
5.5.8 Concentration Measurement with Standard, Sample Blank and Reagent Blank
Method at which the difference of reagent blank ARB and blank of reagent blank ARBB regarding the amount is
subtracted of the difference of sample value AS and sample blank ASB regarding the amount and this difference
is multiplied with a factor F which is determined by measuring of a standard solution with known concentration
CST and under consideration of standard blank ASTB and the difference of reagent blank ARB and blank of
reagent blank ARBB
The sample blank ASB is measured before every test. The reagent blank ARB is entered or measured once.
While performing the course the dialog asks for the use of a reagent blank. The default value is OFF. To
continue without reagent blank press [ENTER].
Abbreviations at printout:
Rb[A] Initial value of Rb in absorbance
DELTA ABS Difference between both measurements in absorbance
Column „ABS.“ Initial value of Kinetic in absorbance
Column „RESULT“ Result of Kinetic under consideration of Rb
While performing the course the dialog asks for the use of a reagent blank. The default value is OFF. To
continue without reagent blank press [ENTER].
Abbreviations at printout:
Rb[A] Initial value of Rb in absorbance
DELTA ABS Difference between both measurements in absorbance
ST[A] Initial value of standard in absorbance
Column „ABS.“ Initial value of Kinetic in absorbance
Column „RESULT“ Result of Kinetic under consideration of Rb
While performing the course the dialog asks for the use of a reagent blank. The default value is OFF. To
continue without reagent blank press [ENTER].
Abbreviations at printout:
Rb[A] Initial value of Rb in absorbance
DELTA ABS Result in ∆A / min, generated from the first up to the last measurement in absorbance
DELTA REG Result in ∆A / min, generated from a regression calculation
R^2 Square of correlation coefficient shows the linearity of the test
Column „ABS.“ Initial value of Kinetic in absorbance
Column „RESULT“ Result of Kinetic under consideration of Rb
While performing the course the dialog asks for the use of a reagent blank. The default value is OFF. To
continue without reagent blank press [ENTER].
Abbreviations at printout:
Rb[A] Initial value of Rb in absorbance
DELTA ABS Result in ∆A / min, generated from the first up to the last measurement in absorbance
DELTA REG Result in ∆A / min, generated from a regression calculation
R^2 Square of correlation coefficient shows the linearity of the test
ST/KIN 1 … ST/KIN 3 Result of standard 1 ... 3 in ∆A / min
Column „ABS.“ Initial value of Kinetic in absorbance
Column „RESULT“ Result of Kinetic under consideration of Rb
PRINTER ON The present status of the printer is displayed in the first line.
1/ON 0/OFF Activate printer by [1] or deactivate by [0].
With [BREAK] the setting is taken temporarily up to next switching on.
With [ENTER] the status is stored.
MENU SER. 1-5/+ • Item [1]: Activate or deactivate external printer with serial interface by [1]
• Item [2]: Activate or deactivate EDP by [2]
• Item [3]: Activate remote control by [3]
• Item [4]: Select baud rate of serial interface by [4]
• Item [5]: Download of operating system to FLASH MEMORY by [5]
Select item.
Item 2: EDP
EDP OFF The present status of the EDP interface is displayed in the first line.
1/ON 0/OFF Activate EDP by [1] or deactivate by [0].
With a suitable program the Photometer 4040 can be remote controlled by a PC,
connected by a 1:1 data cable (REF 501-002) to the RS-232 serial interface.
The sample numbering can start with any number between 0 and 99. The
modification of numbering can be carried out also during a sequence of
measurement. The new numbering gets effective after triggering of a measuring.
A multi-standard method - built up on the basic methods - can be created and stored with the method editor
(chapter 7 - METHOD EDITOR). The prototype of the method (basic method) has to be a calculation procedure
based on endpoint with factor (CP 1, 2, 3 and 4), fixed time kinetic with factor (CP 9) or kinetic with factor
(CP 11). The new method has to be saved marked “MULTI STD” in the range of method number 20 to 249.
For the programmed method a calibration curve is assigned with the same number. Up to 50 nonlinear
calibration curves with maximal 20 sets of points (calibrators) can be stored.
A special mode function opens a submenu with four multi-standard tools (chapter 5.2 - MODE FUNCTIONS).
Select item.
CURVE NO. 20 The number of the pre-selected calibration curve (e.g. 20) is displayed. Confirm
NEXT KEY E/B/# with [ENTER] or change the number according to another existing calibration
curve.
METHOD NO. The main menu is displayed. The system is prepared in a special mode for
creating the selected calibration curve.
INPUT 1-250
With the following basic methods using standards the calibrators can be
measured. The special mode is again switched off by selection of a method not
listed.
Insert blank.
Press [ZERO].
Now the Photometer 4040 is ready to measure all calibrators one after the other.
Insert the first calibrator. Press [RESULT].
M: 20 A: 0.301 In the first line the number of the calibration curve (e.g. M: 20) and the
P: 1 C: 60 absorbance of the calibrator (e.g. A: 0.301) is displayed.
In the second line the number of the data point (e.g. P: 1) and the concentration
of the calibrator (e.g. C: 60) ) is displayed.
The number of the data point can be edited between 1 and 20.
NEW STANDARD With [ENTER] the value is stored as actual data point. On parallel a print-out with
all data is created (see below: Print-out of calibration procedure).
#
The next calibrator can be measured and stored as data point.
After the last measurement and storing of calibrator the procedure can be finished
by [BREAK], [BREAK].
CURVE STORE The calibration curve is stored with [1] or canceled with [0].
0/NO 1/YES In case of storing the set of data points will be sorted by ascending absorbance.
CURVE: 20
STANDARD: 60
MEASURE BLANK
ST[A] 1: 0.302
ST[A] 2: 0.304
ST[A] 3: 0.301
ST[A] : 0.302
DATA POINT: 1
STANDARD: 30
ST[A] 1: 0.601
ST[A] 2: 0.602
ST[A] 3: 0.599
ST[A] : 0.600
DATA POINT: 2
STANDARD: 15
ST[A] 1: 0.920
ST[A] 2: 0.922
ST[A] 3: 0.919
ST[A] : 0.920
DATA POINT: 3
STANDARD: 7.5
ST[A] 1: 1.160
ST[A] 2: 1.162
ST[A] 3: 1.157
ST[A] : 1.160
DATA POINT: 4
STANDARD: 3.25
ST[A] 1: 1.501
ST[A] 2: 1.499
ST[A] 3: 1.504
ST[A] : 1.501
DATA POINT: 5
CURVE NO. 20 The number of the pre-selected calibration curve (e.g. 20) is displayed. Confirm
NEXT KEY E/B/# with [ENTER] or change the contents equivalent to another existing calibration
curve.
M20 05.29.02 5 Displayed is e.g. the existing curve 20, created on 05.29.02, based on five given
NEXT KEY E/B data points.
Confirmation with [ENTER] skips to the next curve or finishes the procedure.
PHOTOMETER 4040
DATE: 11.10.04
TIME: 17:34:25
METHOD 20: DEMO
PROGRAM: 1
FACTOR: 1.000
WAVELENGTH: 405nm
TEMPERATURE: OFF
DELAY: 1s
UNIT: ng/dl
MULTI STD
MEASURE BLANK
3 1.303 5.526
Result with a concentration out of range. 4 1.570 <<<>>>
5 0.308 59.340
Result with a concentration out of range. 6 0.292 <<<>>>
86 12.5 mg/dl Within a course the two digit numerator of results is used as patient number.
Before measuring a sample enter patient number by using the MODE-function
MEASURE SAMPLE
[MODE] [NUM] (see chapter 5.8 - Changing Sample Numerator).
SAMPLE NO. Last patient number was e.g. 86. Confirm this number with [ENTER],
86 23 or enter current patient number, e.g. 23, and confirm with [ENTER].
23 12.9 mg/dl Store result by [1] or skip over without storing by [0].
STORE ? 0/N 1/Y
Select item.
P-MODE OFF The present status of the patient mode is displayed in the first line.
1/ON 0/OFF Activate patient mode by [1] or deactivate by [0].
In case of a deactivated patients mode no more items are shown in the menu.
No results can be lost by deactivating patient mode.
Confirm with [ENTER].
PATIENT NO. The last selected patient number is shown in the second line (e.g. 6).
Enter desired patient number (e.g. 20).
6 20
Confirm with [ENTER].
The print-out of results is started:
PATIENT NO.: 20
DATE: 12.11.02
METHOD 55: tBIL.dcp
100 mg/dl
DATE: 12.12.02
METHOD 55: tBIL.dcp
104 mg/dl
DATE: 12.14.02
METHOD 55: tBIL.dcp
102 mg/dl
DATE: 12.15.02
METHOD 73: CAmtb
5.4 mg/dl
DATE: 12.16.02
METHOD 55: tBIL.dcp
101 mg/dl
DATE: 12.17.02
METHOD 73: CAmtb
5.1 mg/dl
At select [1]:
ARE YOU SURE ? With [0] quit without deleting.
0/NO 1/YES With [1] quit with deleting.
PATIENT NO. The last selected patient number is shown in the second line (e.g. 6).
Input desired patient number (e.g. 20).
6 20
Confirm with [ENTER].
5/ 4 20/ 12 75/ 3
17/ 14 89/ 1 46/ 27
LAMP OFF By [MODE] [1] the halogen lamp can be switched off temporarily to extend the
lifetime.
LAMP OFF Deactivate the lamp protection by any key. After 60 s Photometer 4040 is again
59s ready for measuring.
DISPLAY DESCRIPTION
Method selection:
METHOD NO. See chapter 4 - SELECTION OF MEASURING PROGRAMS
INPUT 1-250
Method selection:
M1 The method M1 – C/F is selected.
C/F See chapter 4 - SELECTION OF MEASURING PROGRAMS
Filter selection:
M1 FILTER Select actual wavelength by [ENTER].
F1 340NM +-# Change wavelength by [+], [-] or numeric key [#].
Temperature selection:
M1 TEMPERATURE Switch temperature ON or OFF by [+], [-] or numeric key [#].
0 OFF +-#
Delay selection:
M1 DELAY Enter the value in seconds by numeric key [#].
s #
DISPLAY DESCRIPTION
While performing the course the dialog asks for the use of a reagent
RB OFF blank.
1/ON 0/OFF The default value is OFF.
To continue without reagent blank press [ENTER].
Sample no. 1:
1 0.701 R[ ] Initial value of absorbance: 0.701
DELTA 1 5d1
Sample no. 1:
1 -0.021 /MIN. Delta 3 in absorbance / minute: -0.021
DELTA 3 5d1
7 METHOD EDITOR
Based on the 15 calculation procedures, up to 230 user-defined methods can be created and saved.
Break of method editor and change back to program selection with [BREAK] at any time. So the program can be
used like a viewer.
Every input has to be confirmed with [ENTER].
Changing of attributes of the fixed defined methods in the range of 1 up to 19 is not possible.
SOURCE 1 Enter the number of the method (e.g. 1 -> C/F, see chapter 13.1 - BASIC
INPUT 1-250 METHODS) which is to become the prototype (SOURCE) of the new method.
Confirm with [ENTER].
TARGET 20 Enter the number of the new method (TARGET e.g. 20).
INPUT 20-249 Confirm with [ENTER].
A corresponding error message (ERROR 16) is carried out if the space of method
memory is already occupied. When required, the method in question can be
erased (Utility program 8.2.4 - Deleting method) and the space of method
memory can be occupied newly.
In the range of 20 up to 249 an existing method can be changed by using the
same number for the prototype method as for the new method.
COPY ? • Item [1]: The new method will be created as method 20.
0/NO 1/YES Method 20 is identical with method 1. The operation will be
finished.
• Item [0]: The procedure allows constructing the new method with different
attributes. The queue of attributes is dependent on the attributes of
the prototype. Generally default inputs can be confirmed by
[ENTER] or replaced by new inputs.
Select item.
Item 0:
PROG. C/F 1 Input of name of new method ( e.g. ABC ). The string is limited to eight
NAME ABC characters.
The number keys are each occupied four times (see TEXT EDITOR LEVEL).
The desired character is selected by repeated push of the corresponding key.
With key [WASH / A ↔ a]: Change between capital and lower letters
(flashing cursor = lower letters)
With key [ • / Chr. →]: Change of the cursor to the next input position
With key [ENTER]: Accepting and ending the input
Correction of input: By change of the cursor beyond the last place
and new input as of the first place
PROG. Input of unit of new method ( e.g. g/l ). The string is limited to six characters.
UNIT g/l The input is done by the same procedure like creating the name (see above).
PROG.FILTER Input of wavelength of new method ( e.g. 340 nm ) by [+], [-] or numeric key [#].
F1 340NM +-#
1 / ON:
PROG.TIME/DELTA Input of time per delta in the range of 4 up to 255 (e.g. 20).
0s 20 s #
PROG.MIN.R^2 Input of low limit of the correlation coefficient R^2 (e.g. 0.998) for linearity control.
0 0.998 # A zero deactivates this option.
If the measured value falls below the entered one, the error message
"ERROR R^2" is shown.
PROG.MAX.UNITS Enter upper limit of the measurement result in Units with right plus or minus sign
0 0 # (+ climbing / - falling Kinetic).
A zero deactivates this option.
If the measured value exceeds the entered one, the error message "ERROR
MAX.UNITS" is shown, at Kinetics additionally "ERROR+/-".
PROG.MULTI STD • Item [0]: The new method can only work with one factor or one standard.
0/NO 1/YES The method editor finishes his work.
• Item [1]: The new method works with several standards based on polygonal
interpolation. Maximum 20 data points (standards P1 up to P20)
can be used as given data points.
Measuring of standards:
Finish the procedure with [BREAK].
STORE ? Select [1] for storing all parameters of the method and finishing the procedure.
0/NO 1/YES Continue with 5.9 - Multi-standard tools.
Editing of standards:
General operation:
With [+] or [-] skip to the next data point.
With [Z] the selected data point is deleted. The values of A and C show: -00000
With [ENTER] the input of the current value is accepted.
With [BREAK] the procedure of input is finished.
Continue with inputs including the last standard. Maximum 20 standards can be
entered.
Finish the input with [BREAK].
A printing of data table and curve can be done (see chapter 5.9 - Multi-standard
tools: Graphic print-out of curve).
8 UTILITY PROGRAMS
8.1 SELECTION OF UTILITY PROGRAMS
METHOD NO. Method selection: change to utility program selection with [MODE].
INPUT 1-250
Confirm with [MODE].
INPUT 1-n/+ Utility program selection: direct selection of required utility program, i.e. input of
UTILITIES concerning identity no. (see table) and confirming with [ENTER], or by scrolling
through all utility programs with [+] ... [+].
Break of utility program selection and return to program selection with [BREAK].
A utility program can be broken off with [BREAK] at any time with return to the
selection of utility programs.
DARK ADJ. U1 Automatically all eight sensitivity levels (V0...V7) are calibrated in succession at
V0 82 simultaneous display of the dark value.
USER NO. +- 1 The last user is the default name (e.g. Tom).
Tom Select current user from 0 up to 5 by [+] or [-].
In case of selecting user 0 no additional line is in the print-out.
Confirm with [ENTER].
USER NAME +- 2 Edit the name of the user number e.g. 2 in the second line.
Maria For a description of input of names see chapter 7 – METHOD EDITOR.
ERROR LIST U3 Confirm with [ENTER] for showing the errors subsequently
UTILITIES or confirm with [LF] for printing the errors.
In case of [ENTER]:
ERROR LIST U3
The error no. 10 is dated 07.23.01. The error code is 8.
10*07.23.01* 8 Continue with [ENTER] to show next error.
The error no. 1 is the error occurred at last.
Boost operation is deactivated. Activating with [1], deactivating again with [0].
BOOST OFF Accept the displayed status with [ENTER].
1/ON 0/OFF
ADC COUNTS U9 On the second line the current sensitivity level (e.g. 0) in the range 0…7 is shown
0 4711 F1 on the left and the current AD-transducer value (e.g. 4711) in the middle. On the
right the actual filter position (e.g. F1) is shown.
The current sensitivity level can be changed by numeric keys [0] up to [7].
The filter position can be changed by [MODE] and a numeric key [1] up to [9].
Filter positions 1 up to 9 are used for interference filters.
Filter position 0 is used for dark position of filter wheel.
On the second line the sensitivity level in the range 0…7 is shown on the left.
ADC DARK U10 The corresponding saved dark values are shown.
0 18300
Selection of another sensitivity level by pushing the corresponding number key.
******ACTUAL*SETS*******
DATE: 03.04.07
TIME: 16:25:27
PHOTOMETER 4040 # 1000
V2.3a 03.04.07 D /1.0
PCB LAYOUT a
ADC DARK
0: 17669 1: 17671
2: 17675 3: 17680
4: 17689 5: 17706
6: 17736 7: 17789
TEMPERATURE REQUIRED
37C 14000 3000
FILTER
0: DDD 1: 340
2: 405 3: 492
4: 546 5: 578
6: 623 7: 999
8: 999 9: 999
BATTERY: OK
ADC CORRECT. 75
BOOST NM 390
EDP ON STX-ETX-BCC
LANGUAGE GB
BEEP ON
PROGR. METHODS 0
The real time clock is activated. Deactivating with [0], activating again with [1].
CLOCK ON Accept the displayed status with [ENTER].
1/ON 0/OFF
Enter month, day, year, hour, minute and second. Confirm each entry with
DATE 07 25 01 [ENTER].
TIME 20 11 00
Confirm with [ENTER].
On the second line the current filter position (e.g. F2) and the stored wavelength
F-WHEEL TEST U14 (e.g. 405 nm) is shown.
F2 405NM 47MS Finish the test with [BREAK].
Enter new temperature value and confirm with [ENTER] or finish operation with
REQUIRED 37C
[BREAK]. The display shows for example the value 3000 (default) for the
3000
temperature level 37 °C.
Finish the test with [BREAK].
LAB. NAME U17 Edit the name of the laboratory in the second line.
xxxxx For a description of input of names see chapter 7 – METHOD EDITOR.
9 MAINTENANCE
This chapter informs the user about necessary maintenance.
If no error-free operation of the device can be achieved, the service should be informed. Repairs at the
device may be accomplished only by authorized technical personnel. In addition inappropriate repairs endanger
the operator and lead to expiring the warranty.
Liquid waste is potentially biologically hazardous. Always wear gloves if handling those materials. Do not
touch parts of the device other than those specified. Consult the laboratory protocol for handling biohazardous
materials.
Take care that no liquid runs into the device! There is no protection against penetrating liquids
(Code IP X0).
For device cleaning and surface decontamination purposes use commercial decontaminating solution which are
® ® ®
usually available in clinical chemistry laboratories like Mikrozid AF Liquid, Bacillol plus, 3 % Kohrsolin or
similar solutions. Switch off the device and disconnect it from the mains voltage. Then clean the device with soft
cloth and decontaminating solution.
mains switch
fuse holder
Erroneous input caused by the user (e.g. wrong method number or wrong factor) can be corrected by filling the
input field with any signs beyond the last position. The erroneous input is deleted and the input field is ready for
the correct input.
Error messages by the device are carried out either exclusively via a signal tone (chapter 10.2 – ACOUSTIC
ERROR MESSAGES) or as combination of signal tone and display (see below).
METHOD NO. 300 … or coded with an error number (chapter 10.4 – CODED ERROR
ERROR 3 MESSAGES).
ERROR MIN.UNITS The programmed low limit was under-run by the measurement.
ERROR MAX.UNITS The programmed upper limit was exceeded by the measurement.
ERROR R^2 At kinetic measuring the square of the correlation coefficient r lies below the
programmed low limit.
ERROR +/- At kinetic measuring the course of the kinetic is wrong (increasing / falling).
NO METHOD Selected method is not programmed. Select other method according to method
list.
5 dark value is absolutely too high (> 16 bit) or higher as the repeat dark level adjustment;
measurement, check lamp / filter; check blank
ADC overflow
6 all multiplexer positions are too bright/too dark at setting to repeat dark level adjustment;
zero check filter / lamp; check blank
7 mathematical overflow at measurement calculation check filter; check standard;
check measuring solution
8 check sum error in the data record of the dark offset repeat dark level adjustment
9 check sum error in the data record of the device basic setting automatic error remedy
(status, ADC correction)
10 division by a too small value (< 0.001 A) check filter; check standard; check
measuring solution
11 invalid calibration curve Select valid number
12 setting to zero not possible (zero value is < 32768 cycle) check lamp; check filter;
check zero solution
13 setting to zero not possible (zero value is > 983039 cycle) check lamp; check filter;
check zero solution
14 invalid standard measure valid standard solution
15 no parameter memory vacant (too little memory for nonlinear delete a no longer actual nonlinear
methods) method
16 method no. is occupied select other method no.; delete a no
longer actual nonlinear method
17 check sum error in the parameter memory (nonlinear method) program method newly
18 at calculation overflows in nonlinear method check factor; check parameter
19 clock malfunction
20 overflow at Kinetic check measuring solution
21 overflow at Kinetic check measuring solution
22 overflow at Kinetic check measuring solution
23 overflow at Kinetic check measuring solution
24 overflow at Kinetic check measuring solution
25 overflow at Kinetic check measuring solution
26 overflow at Kinetic check measuring solution
27 overflow at Kinetic check measuring solution
28 overflow at Kinetic check measuring solution
29 wrong input of deltas or time per delta restart method
30 battery empty contact service partner
31 communication: wrong data format contact service partner
32 communication: sent data not plausible / not interpretable contact service partner
33 communication: mentioned module does not answer in a check interconnecting cable; check
certain time mentioned module
34 communication: overflow send/receive buffer reduce amount of data at the
communication partner
35 Remote control: wrong method number external software problem
36 Remote control: unknown command external software problem
11 TECHNICAL DATA
The Photometer 4040 must be used in an environment that meets the following conditions:
• Temperature: +15 °C to +35 °C
• Relative humidity: 20 % to 85 %
• Not exposed to direct sunlight or other source of direct light (e.g. a spot light)
• Well-ventilated area
• Free from excessive dust
• Free from combustible gases
• Free from vibrations
• Free from electromagnetic wave interference
• Well-distanced from a machine generating a high frequency voltage (e.g. a centrifuge)
11.5 CERTIFICATES
EC Declaration of Conformity
ROBERT RIELE GmbH & Co KG declares under sole responsibility that the product:
to which this declaration relates is in conformity with the following standards or other normative documents:
EN 61326-1
EN 61010-1
EN 61010-2-101
following the provisions of Directive 89 / 336 / EWG (EMC) and 73 / 23 / EWG (LVD) as well as
98 /79 / EG (IVD).
W. Riele
Technical Specifications
Description according to DIN 58960 part 4
A Identification
DECLARATION OF CONFORMITY:
The above mentioned absorption photometer is in conformity with the following metrological description.
W. Riele
B Metrological description
OPTIC CONSTRUCTION
The path of rays is directed from right to left. Put in single cuvette accordingly.
REF Description
1706853001 Axis printer paper
0573655001 Cuvettes of optical glass, 4 pcs
501-002 Data cable serial interface
805-410 Disposable cuvettes, 1000 pcs
1704818001 Dust cover
5010-018 Fuses for line power, 10 pcs
0554871001 Halogen lamp 12V/20W
500-002 Incubator T12
0369624001 Interference filter 436nm
5010-670 Interference filter 670nm
(other wavelengths on request)
0552402001 Mains cable
4040-005 Operator’s manual
1268457001 Printer paper, 5 rolls
1010735001 Printer ribbon, 1 pc
0745235001 Printer ribbon, 5 pcs
090-064 Secondary test set, four-part, certified
090-063 Thermistor
1707574001 Top cover small for printer
Incubator T12
13 METHOD LIST