INSTRUCTION MANUAL

MERCK

Micrdab
200

Partnumber: 3086-342
Version: 1.0
Date: May 1994

Copyright: E. Merck, Darmstadt

MERCK MICROLAB 200

TABLE OF CONTENTS

1. SAFETY INSTRUCTIONS
GENERAL
WARNING SIGN

2. INSTALLATION
SHIPPING.

10
CONNECTIONS.. 10
ACCESSORY KIT. . 10
CONSUMABLES AND SPARE PARTS .

3. SYSTEM OVERVIEW
INTRODUCTION . 12
FRONT VIEW. 12
REAR VIEW. 12
OPTICAL BLOCK .
... 1 3
ANALYSER CONTROL. 13
QUALITY CONTROL . .. 1 4
SCREEN DISPLAY 14
PRINTER
KEYBOARD 14
SOFT KEYS .15

HARDWARE FUNCTION KEYS.. . 1 6

NUMERICAL AND ALPHA KEYS....
SIPPER SYSTEM

4. SYSTEM FUNCTION
SWITCH ON. 1 8
SET SYSTEM PARAMETERS...

MERCK MICROLAB 200

 5. PROGRAM MODE
OVERVIEW22

PROGRAMMING CONTROLS 22
PROGRAMMING/EDITING A TEST . ..23
END-POINT TEST 25
KINETIC TEST .. ..33
TWO-POINT TEST... .35
NON LINEAR TESTS. .36

6. RUN MODE
PERFORM TESTS37

TEST END
SEQUENCE44 SAMPLE BLANKING45

BICHROMATIC MEASUREMENTS46 RESULTS

PRESENTATION.. . .46

7. STATISTICS
INTRODUCTION .49

CONTROL
SURVEY ...50
LIST STATISTICS50 CLEAR STATISTICS52

8. REPLACEMENTS
REPLACING/ADJUSTING LAMP.53

REPLACING PAPER ROLL ..54

REPLACING FUSES55

MERCK MICROLAB 200

9. SERVICE AND MAINTENANCE
DAILY .56
OCCASIONALY 56
SERVICE
ABSORBANCE ON SCREEN . .57
DIAGNOSTICS . .58

10. TECHNICAL DATA

SPECIFICATIONS.. .59

APPENDIX 1 - COMMUNICATIONS
RS232 INTERFACE MENU........... .63
FORMAT 63
PIN CONFIGURATION . .65

APPENDIX 2 - FAULT FINDING

FLOWCELL .66
NO SAMPLE ASPIRATION 66
INSUFFICIENT SAMPLE ASPIRATION 67
COMMUNICATION ERRORS
RESULTS -67 NO
RESULTS .
BAD RESULTS .68
BLANK ERROR .69
GENERAL .69
TEMPERATURE. .69

APPENDIX 3 - CUSTOMER SERVICE

MERCK MICROLAB 200

 APPENDIX 4 - ORDER INFORMATION

TABLE OF FIGURES

Chapter 3
Front View 12
Rear View
12
Keyboard
lay-out
Sipper System
Chapter 4
Test
Selection
Utilities Menu
Program Menu 19
System Parameters Page 1
System Parameters Page 2 20 System Parameters Page
3.
RS 232 setting 20
Chapter 5
Utilities Menu . .22
Program Menu 22
Program Controls. 23
Delete Controls. .23
Delete Test . .24
Program Test . .24
Program Test Page 1 .24
Select Measuring Mode .25
Wavelength Selection........................................................26
MERCK MICROLAB 200
 Bichromatic Wavelength Selection 26
Temperature
Selection 27 Units
Selection Page 1 . .27
Units Selection Page 2..
Enter Reagent Blank High Limit . ..28
Program Test Page 2 28
Enter Calibrator High Absorbance . .28
Enter Calibrator Concentrations... 29
Program Test Page 3 ..30
Program
Test Page 4
31
Program
Test Page 5 Select Control .
Enter Control Target.....
Program Test Page .1 Kinetic. 33
Program Test Page 2 Kinetic........ .34
Program Test Page 3 Kinetic 35
Non Linear Calibration Curve .36

Chapter 6
Test Selection 37
Select Measuring System .37
Aspirating Water
.38 Flowcell
Blanking. .38
Measure Reagent Blank.
38
Measuring Reagent Blank.. ..39
Measure Calibrator
39 Calibrator

Result .40 Enter

Patient Name . .40
Patient Result
End-point Info .
Kinetic Info 42
Kinetic Measurement Plot 42
Control Outside Limit 43
Replicate Outside Limit . 43

MERCK MICROLAB 200

 Rinsing Procedure 44
End of Day Procedure... .44
Measure Reagent Blank/Blank. 45
Measure Reagent Blank/Sample 45
Normal Print-Out. 46
Extended Print-Out 47
Print-Out of Non-Linear Calibration Curve................... . .48
Chapter 7
Statistics Menu 49
Print-Out of Control Survey . 50
Select Statistics List.... - -.50
Statistical Data 51
Levey Jennings
Plot
Print-Out of Statistical Data .51
Clear Statistics Menu.... .................................................... 52
Warning. ..52
Select Clear Mode. 52
Chapter 8
Adjust Lamp 53
Lamp Block ..53
Loading Printer Paper .54
Replace fuses .55
Chapter 9
Service Menu . .57
Absorbance on Screen .....................................................57
Diagnostics Menu 58
Analyser Control .58

1. SAFETY INSTRUCTIONS

1 .1 GENERAL
The contents of this manual including all drawings, tables and graphic
representations are intellectual property of E. Merck.
MERCK MICROLAB 200
 Unauthorized commercial or non-commercial excerption or copying of
contents and use of this manual (in total or in pans) are strictly forbidden
unless the editor gives written permission.

This manual was written and reproduced with the utmost care. However,
errors IOL L.Je fully excluded. E. Merck assumes no responsibility for any
errors that may appear in this manual.

All product names that are mentioned in this manual are registered
trademarks. The manual describes the analyzer system Merck Microlab
200 and its software version V 1.00. Information in this document is
subject to change without prior notice.

The Merck Microlab 200 was produced and tested according to the
standards mentioned in the "Certificate of Conformity", which is included
in the package.

If you need any advice or if you have any questions, please refer to E.
Merck using the following address and telephone number:

E. Merck
Frankfurter Straße 250

64271 Darmstadt

GERMANY
Telephone: 06151/720

1.2 WARNING SIGN

MERCK MICROLAB 200

 This warning sign reminds the user of important items with respect to handling
and safety measures. The warning sign is located on the back panel of the
analyser and warns the user for the following:

-8-

MERCK MICROLAB 200

2. INSTALLATION

2.1 SHIPPING
The Merck Microlab 200 is shipped in one box, which contains:
• Merck Microlab 200
Accessories

The box should be carefully inspected for damage. If there is any major
damage, this should be reported to your supplier. Missing parts should be
reported immediately to E. Merck or their representative.

2.2 UNPACKING
Where the Merck Microlab 200 is to be unpacked and installed by trained
service personnel from E. Merck, the user should not attempt to unpack
the Merck Microlab 200 and accessories. Where the user is carrying out
the installation, the following steps should be followed:
Carefully open the boxes and remove the inserts which hold the
analyser in place.
Place the Merck Microlab 200 on a flat level surface.
Ensure that all accessories have been removed, before
discarding the packing box.

2.3 DIMENSIONS AND WEIGHT

Width 380
mm
Depth 390
mm
Height 140
mm
Weight approx. 7 kg
2.4 INSTRUMENT LOCATION
The Merck Microlab 200 is intended for indoor use. It should be located
on a flat surface, which is not exposed to vibration (i.e. centrifuges, etc.)
and direct sunlight.

2.5 POWER REQUIREMENTS

Line Voltage 110..240 V nominal, tolerance
10%
Line Frequency 50/60 Hz
Power 100 VA
Consumption

MERCK MICROLAB 200

 Installation category 11
The Merck Microlab 200 is, without any switching, suitable for the whole
specified voltage range of 110...240 V nominal.

-9-
The fuse holder is located in the mains switch block. at the rear panel of
the analyser.

To replace the fuses, pull out the fuse holder lid. The fuses will come out
together with the lid. Pull the fuses out of the lid and replace them with
the ones of the correct rating. Push back the lid.

For the 110...240 V range, 2 fuses of 2.5 A slow blow (T) 250 V should be
mounted.

Spare or replacement fuses are supplied with the Merck Microlab 200.

2.6 ENVIRONMENTAL REQUIREMENTS

Ambient temperaLure
Maximum relative humidity 80% at temperatures up
to
31 oc, linear decreasing to
65% at 35 oc

Altitude up to 3000 m
Pollution degree 2 (in accordance with
IEC 664)
2.7 CONNECTIONS
The mains connector should have a solid ground connection, to assure
safety and trouble free operation of the Merck Microlab 200.

The optional DPIJ 411 Il-printer should be connected via the connector
marked "PRINTER" at the rear side. Other printers or data collection
systems have to be connected to the connector marked "RS232".
The DPIJ 411 Il-printer is available in two options: one with its own AC
adapter and one without. In the first case, simply connect the power
cable to the mains. In the other case, connect the power cable with the
small connector to the 5 V DC power outlet which is located on the rear
panel of the Microlab 200 (see figure 3-2 on p. 12).

With the parallel Centronics connection no settings are required in the

analyser. When a printer or data collection system is connected via the
serial RS232 interface, settings should be made in the System Parameters
(see chapter 4).
MERCK MICROLAB 200
 The pin configuration of the connectors and the format of the serial data
string is explained in Appendix 1.

2.8 ACCESSORY KIT

3086-147 Instruction manual (English/German/Spanish)
6000-836 Mains cable (220 V)
3348-174 Fuse 2.5 A slow blow (2 pcs) for 250 V
3380-018 Spare Quartz iodine lamp 12 V/2() W
3069-034 Dust cover
1513-002 PVC tube 4 x 6
1573-001 Silicone tube 0.8 x 2.4

2.9 CONSUMABLES AND SPARE PARTS

3380-018 Quartz iodine lamp 12 V/20 W
3348-174 Fuse 2.5 A slow blow (2 pcs) for 250 V
—075 Suction tube
6000-970 Sipper pipe
3073-020 Thermal paper (2 pcs) for DPU 41 1 Il

MERCK MICROLAB 200

 -11-

3. SYSTEM OVERVIEW

3.1 INTRODUCTION
The Merck Microlab 200 is an analyser capable of meeting all the manual
or discrete demands of the clinical laboratory. The Merck Microlab 200
has been designed with flexibility in mind, to cater for the urgent
demands of the medical as well as laboratory staff. The advanced
software is user orientated and friendly to meet the individual
requirements of the Clinical
Laboratory.

3.1.1 FRONT VIEW

Figure 3-1
Sipper-LED
Front View

Sipper tube

Sipper button Keyboard

3.1.2 REAR VIEW

Figure 3-2

MERCK MICROLAB 200

 Rear view Printer connection cable

3.2 OPTICAL BLOCK

The measurement takes place in a micro flowcell. The measurement
volume is only 32 Ill. The reagent sample mixture is aspirated into the
flowcell by a bellows pump. The volume is continuously programmable up
to 1500 gl- The flowcell is designed for low sample-to-sample carry over,
allowing the use of small volumes. Typically the mixture volumes used
will be in the range 350...500 "l. A flush mode is provided to wash the
flowcell thoroughly between different assays.

The flowcell is electronically thermostatted by means of Peltier elements.

The construction and materials used, makes the temperature response
very rapidly.

Thp mpaq: Irarnpnt tpmnaratl tro ran ha cut At DC, nr -Q7 00.

The wavelength of the light used for the measurement is selected by

means of high quality narrow band interference filters, mounted in a
filterwheel. The filterwheel is controlled by the program and
measurement can be either monochromatic or bichromatic.

As standard 6 filters are mounted, with the following wavelengths: 340,

405, 505, 546, 578 and 620 nm.

The lightsource used is a long-life quartz Iodine lamp.

3.3 ANALYSER CONTROL

The Merck Microlab 200 can be programmed for 40 different test
methods. After the parameters of a test have been programmed, the
information on how to perform the test is displayed on the screen. In fact

MERCK MICROLAB 200

 it is the Merck Microlab 200 that guides the user step by step through the
necessary test procedures.

Battery backup saves the programmed parameters for at least 30 days

after the instrument is switched off.

Depending on the parameters programmed for each test, the analyser

selects the temperature, delay time, measurement mode and time,
calculates the result and prints a report. Two types of reports are
available:
Standard reports which provides patient information, names
and results of each requested test, plus flagging of high/low
results and non-linear kinetic results.
Extended reports include, in addition to that above, starting and
end-point absorbances, initial kinetic absorbance and
kinetic reaction rates in AAbs/min, % of non-linearity and
calculation factors.

-13-

MERCK MICROLAB 200

3.4 QUALITY CONTROL
The system is programmed to allow two quality control surveys for each
test. The system calculates the mean, standard deviation and coefficient
of variation on a maximum of 30 controls measured. This information is
displayed on the first page of the statistics program and the results can be
printed. If the PAGE key is pressed, then a Levey-Jennings plot of the
results is displayed on the screen. The PRINT key can be pressed to obtain
a print-out. An automatic print out will be made every 30 results.

3.5 SCREEN DISPLAY

The display used is a high contrast Liquid Crystal Display (LCD). It can
16 linag of PO characters each and can disolav araohics as well. A
contrast control allows the display to be adapted to the viewing angle of
the operator. The potentiometer is located on the rear panel.

3.6 PRINTER
The Merck Microlab 200 can be equipped with an external 40 column
printer. Once the analyser is switched ON, check that the paper is loaded.
For paper loading, refer to chapter 8.2 The printer uses special thermal
paper.

3.7 KEYBOARD
The keyboard consists of 6 softkeys, 4 hardware function keys, and a
QWERTY-alphanumerical keyboard. The softkeys are directly located
under the LCD screen. The function of these keys is projected on the
screen with the first 3 or 4 letters of the functions.

Figure 3-3
Keyboard lay-out

Screen Display

-16- MERCK MICROLAB 200

 Softkeys

Hardware
Function Keys

Alphanumerical
Keyboard

3.7.1 SOFT KEYS

Selects (re)calibration for the assay in progress.

MERCK MICROLAB 200

 Starts the system to calculate a non linear curve after the measurement
CALC of the calibrators.

CHNG Gives the possibility to change the data of a calibration curve.

Selects the control measurement mode. The measured results will be

CONI added automatically to the statistical memory used for the Quality
Control calculations, programmed in the Microlab 200.

Refer to CONI
CON2
This function is used to delete data. This can be a complete programmed
DELE test, patient or control data.

When starting a measurement this function will change the replication to

DUPL a duplicate test.

END This function is used to start the End of Day Procedure (see chapter 6.2).

If it is necessary to look into the details of a measurement, this function

INFO will switch to the info screen on which all available information
concerning the sample is given, including a plot of kinetic test.

This function has the same effect as TEST, but is used in other modes (e.g.
MEAS Statistics etc.) and is used to return to the Test Selection Menu.

Allows the entry of a patient name in the measurement mode. This name
NAME will be printed with the result. The name can contain up to 15 characters.

This function is used to give a negative answer to a question from the

NO system or to deselect a calibrator in the Program Mode.

Allows the entry of a patient identification number during a

NUMB measurement. This number will be printed with the result. The number
can be alpha numeric and can be up to 8 characters long.

This key is used to change display pages, when the user is

PAGE entering/reviewing data consisting of more than one screen page.

After operating this function the printer will print the information present
PRIN on the screen. If this information is contained in more pages, all the pages
are printed.

Must be pressed to continue with the test after calculation of a

RDY calibration curve.

-15-
REAG This will force the Merck Microlab 200 in a (re)measurement of the Reagent Blank.

RPT During measurement this function is used to repeat a measurement. Mean

calculations will be done with the new result. This function is also used to

-18- MERCK MICROLAB 200

 return to the test programming after the non-linear curve has been
plotted.

SING When starting a measurement this function will change the replication to a single
test.

SKIP During measurement this function is used to move fotward in the analyses
sequence, without measuring the requested reagent or sample. SKIP is
also used to override a program sequence.

TEST This function is used to return to the Test Selection Menu.

TRIP When starting a measurement this function will change the replication to a triplicate
test.

UTIL Operating this function will return the system to the Utilities Menu.

YES This function is used to give a positive answer to a question from the
system.

3.7.2 HARDWARE FUNCTION KEYS

Starts (re)measurement on what is present in the flowcell without
ABS sipping, or what is present in the cuvette. The sequence number will be
increased by 1 and patient data will be erased. If ABS is selected after
operating the PREV function, sequence number and patient data will be
maintained.
FLUSH Pressing this control will switch on the sipper pump in a continuous
mode, pumping 1500 VI. Pressing the key again will stop the pumping
action at the end of a complete cycle.

PAPER Advances the printer paper several lines.

PRIME Operating this key will activate the sipper system for 1 cycle at the
programmed volume, without starting a measurement.

3.7.3 NUMERICAL AND ALPHA KEYS

CLEAR This key clears an entry during data entry.

ENTER This key is used to confirm an entry via the keyboard.

MERCK MICROLAB 200

 11 11 The minus key is used to enter a number as a negative. This is used for instance
for decreasing kinetic reactions, in order to obtain a positive result. The
minus key can also be used to include a "dash" in names etc.

Backspace when entering data via the keyboard.

opace when entertng data Via the keyboard.

3.8 SIPPER SYSTEM

When the bar below the Sipper Tube is pressed, the Sipper Pump is
activated. Shortly after aspiration of the sample, the measurement takes
place.

The red LED above the Sipper Tube indicates the status of the pump
action: i.e. continuously burning means aspirating, flashing means
dispens
ing to
the
Waste
Bottle.

Figure 3-3
Sipper System

Sipper-
LED

Sipper

-20- MERCK MICROLAB 200

 tube

¯ 17_

4. SYSTEM FUNCTION

This section describes the operation to be performed on the Merck

Microlab 200 before the instrument is used for routine operation.

4.1 SWITCH ON
Switch on the mains power to the analyser. As soon as the Merck Microlab
200 is switched on it performs a self-check after which the following
screen is displayed (this screen is the main screen of the analyser):

Figure 4-1
Test Selection
NICROLAD2ee
T E S T S E L EC T I ON
G L UCO S E
OALT
AST

MERCK MICROLAB 200

 When the Microlab 200 is switched on for the first time, figure 4-2 is
displayed. The system parameters then must be checked. This is done by
the routine SET SYSTEM PARAMETERS.

4.2 SET SYSTEM PARAMETERS

After pressing the UTIL key, the following screen is displayed:

Figure 4-2
Utilities MICROLRB288
Menu
UTILITIES
MEQSURENODE
P R O GR A N N O D E

OS I Q T I S T
I C S S ERV I C E

-22- MERCK MICROLAB 200

 Select 2-PROGRAM MODE and the Program Menu is displayed.
Figure 4- 3
Program Menu
1 5 R UG 9 4 1 5 : 3 8
P R O GR A N N O D
E

n SYS T E N P ARA N E T E R
S a C O N TR O L S
OTESTPARnNETER
S

NE-AS
Pressing MEAS will result in a return to
the Measuring Mode.
Select I-SYSTEM PARAMETERS and the list of system parameters will be
displayed, starting at the initial page.

figure 4-4
System Parameters 1 5 A U G 9 41 5 : 3
Page 1
8
SYSTENPQRQNETE
R S PI
n DRTE/T IXE 1 5
9 4
1
5
3
8
I-DATE/TIME
a PR INT ER To change the date and time press 1
O A IR P U R G E 2 5 from the System Parameters Menu.
PROG
step through the DAY, MONTH, YEAR,
HOUR and MINUTE by pressing
ENTER and change if necessary. Out of range entries are not accepted.
2-PRINTER
By pressing 2, the printer can be switched OFF and ON.
3-AIR PURGE
An automatic air purge can be selectedby entering a volume between O and
50 "l.
Setting this parameter will result in sampling the programmed air volume
after the measurement is finished, thus providing a better separation
between the samples.

MERCK MICROLAB 200 -23-

 By pressing PAGE, page 2 of the system parameters will be displayed.
I-FILTER SETTING
The Merck Microlab 200 is supplied with a standard set of 6 filters: 340,
405, 505, 546, 578 and 620 nm. The two positions marked are empty and
can be mounted with optional extra filters. By selecting I-FILTER SETTING
the user may change a value if a new filter is fitted.
Skip through the wavelength values by pressing ENTER until the desired
position is reached. Add the wavelength by keying in the right value
followed by ENTER.
figure 4-5
System Parameters 15AU694 15:31
Page SYSTEMPQRAXET 2

ERS
F I LTER S E T T I NG
POS1 34ePOS2 4
85POS3 585
POS4 8
POS5 546
POS6 578
P OS 7 628
P OS 8

By pressing PAGE the third page of the system parameters will be visible.
I-LAB NAME
The operator can enter the laboratory name here, which will then appear
on the result print-out and the statistics print-out.

Figure 4-6
System Parameters
1 5 R UG 9 4 15:31
Page SYS T E X PARAN 3
ETERSP3
LRBNANE
RESEARC
H
aLnNGUnGE
ENG L I SH
Rs232INTERFACE
2-LANGUAGE
PR06 The Merck Microlab 200 is a multi-

-24- MERCK MICROLAB 200

 lingual instrument. By pressing 2, a choice can be made between English,
German and Spanish.
3-RS232 INTERFACE
Selecting item 3 will give a special page containing the information of the
RS232 interface.
Figure 4-7
RS 232 Setting 1 5 R UG 9 4 15:31
SYSTENPQRANET
ERS

O FF
STOPBITS

'IIS/cHAR 5
O P n R I T ','
9ann The format (OFF-PRINTER-
COMPUTER), stop bits, bits/character
and parity can be altered to meet the
communication protocol of the host computer. This is achieved by
pressing the appropriate number. The baud rate however is fixed at 2400.
Information about the computer protocol is shown in Appendix 1.
When all parameters have been set, press MEAS to return to the Test
Selection Menu.

MERCK MICROLAB 200 -25-

5. PROGRAM MODE

5.1 OVERVIEW
The Merck Microlab 200 has been designed to provide flexibility in test
measurement, as well as a high degree of accuracy. There are 40 spaces
available for users to program their own test parameters. Tests already
programmed may be overwritten if necessary.

It is important, when the Merck Microlab 200 is new and the memory is
empty, to program the instrument in the right sequence:
System Parameters e Control Material
Test Parameters
Programming of the System Parameters is described in chapter 4 of this
manual.

5.2 PROGRAMMING CONTROLS

Press UTIL in the Test Selection Menu to obtain the Utilities Menu.

Figure 5-1
MICROLQB2ee
Utilities
Menu UTILITIES
NEQSURENODE
PROGRAMNODE
SIRTISTICS S E R V I
CE

Select 2-PROGRAM MODE to obtain the Program Menu:

-26- MERCK MICROLAB 200

 Figure 5-2 15AUG94
Program Menu
PROGRANNOD
Select 2-CONTROLS after which the
E following screen is displayed:
Figure 5-3 n SYSTENPQRQKEIE
Program Controls
R S a C O N TR O L S
OTESTPARQXETER
S

In total there are 15 free positions available, divided over 2 pages.

Select a free position to program a new control. The Merck Microlab 200
will ask to enter the name and the batch number of the control. Values
and limits are programmed during the programming of test parameters of
a test.
To re-program a control position, it first has to be deleted. Select DELE to
obtain the Delete Control Screen:

Figure 5- 4
Delete 1 5 RUG 16:eB
Controls
DELETECONTROL
S
BATCH-NR
n O R NA L 9 9 9 8 5 Q
BNORKAL345

PRIN Press PROG to return to the Program

Menu or MEAS to return to the Test
Selection Menu.

5.3 PROGRAMMING/EDITING A TEST

Follow the sequence as described in Programming Controls but select
3TEST PARAMETERS and the Test Survey Screen will be displayed.

MERCK MICROLAB 200 -27-

 The 40 tests are grouped into 4 blocks of tests. Each page contains 10
tests.

-28- MERCK MICROLAB 200

 By pressing DELE a test can be deleted. The mode line on top of the
screen will change into "DELETE TEST". PROG will return the operator to
the Test Selection Menu in the
Program Mode.

Figure 5- 5
Delete
Test

The Test Survey Menu consists of a total of 40 positions, of which only

blocks of 10 tests can be displayed at the time. The other pages can be
displayed by pressing the PAGE key.

Figure 5-6
Program Test 15QUG94
PROGRAXTEST
nGLUCOS
Ea
OALT

PRIN DELE
Select a free position or a position to
be changed from the Test Survey
Menu.

The following screen is displayed:

MERCK MICROLAB 200

 Figure 5-7
Program Test
1 5 R UG P R T E S
Page 1 OGRAM T
nRNE E
MODE N D P O 1 'I T
FILT 34e
25
ER
TEMP
Uh I T S
R-BLA
By pressing I-NAME the test name
NK (up to 8 characters) can be entered
or changed. If the name is correct, press ENTER.
Select 2-MODE to change the measuring mode of this test.

The next screen allows the measuring mode to be selected:

Figure 5-
1 5 RUG 9 4 16:e1 8
Select Measuring
Mode P R O GRA M T E S
T

KINETIC
2 ENDPO1"w

KINETIC
This selection is mainly used for enzyme activity tests. The reaction is
monitored during the whole programmed measuring time, at intervals of
0.5 second. The measurement is checked for linearity. If the non-linearity
is greater than the set limit for NON-LIN (see Chapter 5.3.2) and
AAbs/min is > 15 mAbs/min, there will be a warning message both on the
screen and on the printout.
ENDPOINT
This selection is used for measurement of normal endpoint reactions. The
endpoint of the reaction has normally been reached outside the analyzer
before the measurement run has started. Actual measurement is
performed in 2 seconds.
TWOPOINT
This selection is used for kinetic substrate measurements or kinetic
measurements where linearity check is not needed.

-30- MERCK MICROLAB 200

 5.3.1 ENDPOINT TEST
For this example press 2-ENDPOINT. All parameters are described in
sequence of appearance on the several pages of the Program Mode. In
practice the sequence of programming is not important and can be
selected as required.
The next item on Page 1 of the screen is:
3-FILTER
Select by pressing the right numbers for the primary and secondary
wavelengths.

figure 5-
9 Wavelength
Selection

After selecting the first wavelength, the following screen is displayed:

Figure 5-
1 5 A U G 94 16:e1
10 Bichromatic
Wavelength PROGRAM
TEST

•a
348 n 348
0585
546 546
57 8 578
6 2 e6 2 e oe
Selection

MERCK MICROLAB 200 -31-

 4-TEMPERATURE
The following screen is
displayed:

Figure 5-
11
Temperature
Selection

Select the right measuring temperature.

5-UNITS
The first of 2 screens appears, containing units as displayed:
Figure 5-12
Units Selection
15QUG94 16:82
Page P R O GRQ N T E S 1
T

Changing page can be done

by pressing the PAGE key.

Figure 5-
13
Units
Selection

-32- MERCK MICROLAB 200

 Page 2

Select the right unit by pressing the appropriate number-

6-REAGENT BLANK
By pressing 6 the reagent blank toggles between YES and NO. If YES is
selected, the operator has the possibility to enter a low and high
absorbance limit.
Figure 5-
15nUG94 16:e2
14
Enter Reagent Blank PRO6RAN
High Limit T
GLUCOSE
MODE ENDPOINT

FILTER 546
TE M P 25
UN I T S
R - B L A H K Y ES
If the reagent blank during the measurement is outside this limit a warning
appears on the screen C IA").

Press PAGE to obtain the second page of test parameters. The following
screen is displayed•
Figure 5-15
15AUG94 16:e2
Program Test
Page
PROGRAMTES 2
T
CRL-NANE

O S - B LA N K N O
PRIN

I-CAL -NAME
By pressing 1 the Calibrator Program Sequence is entered.

MERCK MICROLAB 200 -33-

 Figure 5-
16 16:e2
Enter P R O G RA M
Calibrator
High T
Absorbance CAL-NAME GLUC5.8
1 The operator has now the ability to
enter the calibrator's name, the
-c o n c number of calibrators, the
concentration of the calibrators, the
-R E P repetition of the calibrators and a high
H -Abs 1 5 B or low absorbance limit of the (first)
calibrator.
FACTOR 1
To deselect a calibrator, use the
S - B LA N K function key NO at the Calibrator Name
position. The name of the calibrator will change into "none"

If the number of calibrators is higher than 1 the following screen is

displayed:

figure 5-17
Enter Calibrator
1 5 RUG 9 4 16:e2
concentration

1.8Abs8.88
B
88B
5 . e A b s e A b s 8 8 . 88B
e.øee

Enter the concentrations of the

MIP REV
calibrators in the first column. If the
absorbances of the calibrators are known, they can be entered in the
second column. If they are unknown, they must be measured. The values
remain in memory.

The PREV function key can be used to return to a previously entered value
in the list

If there are values present in the absorbance column and the

programming of the test is finished, the Merck Microlab 200 will
automatically calculate a calibration curve. This calibration curve will be
calculated as straight as possible through the available points. The
accuracy of the curve after the calculation can be changed by pressing
CHNG (see chapter 5.4).

-34- MERCK MICROLAB 200

 2-FACTOR
If a factor is to be entered press 2 and enter the factor value. The factor
may consist of a 5 digit number with a decimal point. If the reaction is a
decreasing reaction, the factor should be entered starting with a minus
sign

The position of the decimal point in the factor will be used to set
the decimal point in the final result.
3-S-BLANK
Press 3 to toggle sample blank between YES and NO. If YES is selected the
Merck Microlab 200 expects 2 different sample-/reagent mixtures to
calculate 1 test result. The first mixture is subtracted from the second
mixture. This means that the first mixture always has to be the blank
mixture.

MERCK MICROLAB 200 -35-

 Press PAGE obtain page of
to the third test parameters.

Figure 5-18
1 5 AUG 9 4 16:e
PR OGR Q
NnDELRY 3
O V O LUM E T ES
T
4
2

Program Test

I-DELAY
Press 1 to enter the delay time in seconds. The delay time determines the
time from the moment the sample is in the flowcell until the actual
measurement starts. This time is needed to stabilize the reaction mixture
in the flowcell.
MEAS TIME
For end-point tests the measuring time is fixed at 2 seconds and this can
not be changed
3-VOLUME
This parameter determines the volume in gl which will be taken up. A
value between 350 and 1500 gl can be selected.
to the fourth test parameters:

-36- MERCK MICROLAB 200

 Press PAGE obtain page of
Figure 5-
19 Program
Test
Page 4

I-TEST REP
Press 1 to change the test repetition. The maximum number can be 3. If 2
or 3 is selected, the maximum deviation (in units) must be entered as well.

The Merck Microlab 200 will give a warning ("Du) if the deviation of the
duplicate or triplicate set of samples is higher than this number.
2-REF-LOW
By pressing 2 the pathological low level (in units) of a test can be set. If a
test result is lower than this level, the result will be flagged with an
both on the display and the printout.
3-REF-HIGH
By pressing 3 the pathological high value (in units) can be set. If a test
result is higher than this level, the result will be flagged with an IIH", both
on the display and the printout.

If both levels are not entered, the result will not be checked on reference
limits.
4- L-ABS
This parameter sets the lowest possible absorbance for this test.
5- H-ABS
This parameter sets the highest possible absorbance for this test.

MERCK MICROLAB 200 -37-

 Press PAGE obtain page of
These 2 parameters are mainly used to set a window between which the
absorbance of the test has to be measured.
to the fifth screen is
displayed:

Figure 5-20
Program Test 15QU694 16:e
PROGRR test parameters. The following
4 In this screen CONTROL 1 and
N
TES CONTROL 2 for the current test can
CONTROL be ected.
T
Press 1 to select CONTROL 1. The
aCnN1ROL following screen is displayed
showing the available
preprogrammed controls (see
PRI"
chapter 5.2):

PROG
Figure 5-21 1 5 A U G 94 16:e4
Select Control PRO 6 R A N T E S
T
BATCH-NR
1nocontrolanOR
NAL 9 998 5 O n B N O R X
AL345

PRIN
Select the control to be used for this particular test after which the
following screen is displayed•

-38- MERCK MICROLAB 200

 Press PAGE obtain page of

Figure 5-22
Enter Control Target
15AUG94 16:e4
PRO 6 RAN T E S T
nCONTROL-INORM
RL
-BQTCH-NR 9
9985
-TARGET
-L - L I N I T8
The name and the batch number of
-H-LIWIT the control are automatically entered
CONTROL in the first and second position.

SKIP

MERCK MICROLAB 200 -39-

 Enter the target, low and high limit of the control. The correct values can
be obtained from the enclosures of commercially available control sera.
2-CONTROL 2
The same sequence as for CONTROL 1 must be followed for CONTROL 2.

Once the MEAS key has been pressed the Test Selection Menu will be
shown.

5.3.2 KINETIC TEST

To program a kinetic method enter test name as described in chapter
5.3.1 and select "KINETIC" from the method selection screen.

Figure 5-23
Program Test
1 5 RUG 94 16:e5
PRO GRAM T ES T
Kinetic
RST
NODE KINETIC
NO"-LIRF
I L T E R3 4 e
T EMP 37
B UN I TS a R - B L
ANKYES
Entry is exactly the same as for the
1. 5 endpoint method described in the
previous section, although there are a
eø few exceptions:
2. 3 e e 2-MODE
When the selected measuring mode is kinetic, the Microlab 200 asks to
enter a value for non-linearity (in percent). When the dAbs/min is higher
than 0.015 and non-linearity is greater than the given percentage, a
nonlinearity error is generated. When AAbs/min is lower than 0.015,
there is no check on non-linearity.
3-FILTER
Bichromatic measurement is not possible in kinetic tests. In the
wavelength selection screen it will be impossible to enter a wavelength
from the second column.

MERCK MICROLAB 200

 6-R-BLANK
The hidden units used for kinetic calculations is AAbs/min.
The Low and High Absorbance limits of the reagent blank are the absolute
absorbance values that the initial absorbance of the reagent blank has to
fall within.

Press PAGE to obtain the second page of the test parameters.

Figure 5-24
ProgramTest
Page 2
Kinetic

I-CAL-NAME
Usually kinetic methods need a factor, and calibrators are only used in
exceptional cases. When a calibrator is selected, the values of AAbs (in
twopoint mode) or AAbs/min (in kinetic mode) have to be entered for -
LAbs and -H-Abs.
2-FACTOR
For a decreasing absorbance, place a MINUS sign in front of the factor. For
an increasing absorbance simply enter the factor.
3-S-BLANK
This selection of sample blank is used for enzyme activity tests with a
sample dependent, non-specific blank reaction.

MERCK MICROLAB 200 -41-

 Press PAGE to obtain the third page of test parameters after which the
following screen is displayed:
Figure 5-
25
Program
Test
Page 3

Kinetic

I-DELAY
To reach the programmed temperature in the flowcell of the reaction
mixture, the following minimum delay times are necessary:
25 oc 10 sec.
30 oc 12 sec. 37 oc 15
sec.

The maximum programmable delay time is 999 seconds.

2-MEAS TIME
For kinetic tests the measuring time can be programmed in intervals of 2
seconds with a maximum of 998 seconds. Concerning the measuring
times please refer to the application sheet or to the package insert.

The Merck Microlab 200 always reports a reaction in AA/min, irrespective

of the measuring time program.

5.3.3 TWO-POINT
The process of programming for a two-point test is identical to the
options as listed under kinetic test.

The Merck Microlab 200 in this case does not calculate a rate reaction of
AAbs/min, but uses the difference in absorbance between the two
measuring points (dAbs).

MERCK MICROLAB 200

 5.4 NON LINEAR TESTS
When more than one calibrator has been programmed for a test, the
Merck Microlab 200 will automatically calculate a calibration curve. Values
can be entered manually or they can be obtained by means of
measurements. After calculation, the calibration curve is displayed:
Figure 5-26
Non Linear Calibration
Curve

The analyser is capable of producing a calibration curve from a series of up

to 10 standards. The mathematical approach is that of a cubic spline fit. A
3rd degree regression curve is calculated through each grouping of 3
successive calibration points and the complete combination of the derived
curve is fitted together to produce 1 curve.

The cubic spline fit does not always produce the best results with the
calibration curves which show an inherent logarithmic relationship. In
these cases, the software has been designed to systematically test the
absorbance/concentration data against both logarithmic and an inverse
logarithmic function in order to obtain the best fit.

In total, 25 different approaches are tried, including various polynomial

equations, to obtain the best universal solution and the most "linear"
relationship between absorbance and concentration.

Once the "best fit curve" has been established, various smoothness factors
are applied to obtain the required accuracy of fit.

The required accuracy is user-selectable in percentage terms and may be

changed at any time without the need of having to re-run the standards.

Changing the calibration curve can be done by pressing CHNG, after which
a new accuracy percentage can be entered. The higher this figure, the
straighter the curve will be.

Pressing RPT will allow the possibility of reprogramming the test.

MERCK MICROLAB 200 -43-

6. RUN MODE

6.1 PERFORM TESTS

After switching on the Merck Microlab 200, the Test Selection Screen is
displayed:

Figure 6-1
Test Selection
N I C R O L RD 2 e e
TESTSELECTIO
N
G L UCO S E
O A LT
n AS T

40 test positions are available, divided into 4 pages of 10 tests each. The
different pages can be selected by pressing the PAGE key. Select the test
to be performed by entering the corresponding number. The following
screen is displayed:

Figure 6-2
Select Measuring System
1 5 a U 6 94 89:45
GLUCOSE

N E Q SUR E
SINGLETEST

measure
IRW JEST

When the test replication factor (as programmed in the testparameters)

is higher than 1, the message "duplicate test" or "triplicate test" will
appear. If the selected temperature is not yet reached the message "wait
for stabilizat . " is displayed instead of "measure water".

The replication factor can be changed by pressing DUPL or TRIP.

MERCK MICROLAB 200

 To perform a blank, hold a tube containing water under the sipper tubing
and press the SIPPER button. If the waste bottle is full, an audible alarm
will be given. The following sequence of screens is displayed:

Figure 6-3
Aspirating Water 15AUG94 e9:45

a s a n

Figure 6-4
Flowcell
15AUG e9:45
Blanking GLUCOSE

k n

If the test parameters for this test requires a reagent blank the Merck
Microlab 200 will ask to measure this reagent blank:
Figure 6-5
Measure Reagent Blank
1 5 RUG 9 4 e9:46

measrereaent
TEST

If the replication factor has been set higher than 1, the reversed bottom line
will read "measure reagent 1", "measure reagent 2" , etc.

MERCK MICROLAB 200 -45-

 Place the reagent blank under the sipper tube and press the sipper
button. The Merck Microlab 200 will aspirate the reagent blank and will
measure it. The following screen is displayed:

Figure 6-6
Measuring Reagent Blank 15QUG94 e9:46
GLUCOSE
RERGENT

The absorbance of the reagent blank is now displayed and printed. If the
test parameters of this test contains a calibrator, the Merck Microlab 200
now asks to measure this calibrator.

figure 6- 15RUG94 e9:46 7

Measure
Calibrator GLUCOS
E
RRNEREAGENT
B.115

•easureGLUC5.e
SKIP INFO wr Ttsr

If the test contains more than one calibrator the analyser asks for the
complete set of calibrators to be measured in turn.

MERCK MICROLAB 200

 After measurement of the calibrator screen Figure 5-8 is displayed.
figure 6-9
Calibrator Result

The Merck Microlab 200 now asks to measure a sample. A "1" in the
measure sample line means that this is the first measurement of a duplicate
or triplicate measurement.

By pressing NAME or NUMB the name and/or the number of this sample
can be changed. After pressing the NAME button, the following screen is
displayed:

Figure6-10
Enter Patient Name

The following entries can be made on this screen:

Entering a patient's name
Forcing the Microlab 200 to perform a new reagent blank
measurement (REAG)
Forcing the instrument to do a new calibration (CAL)
Measuring of Control 1 or 2 (CONI, CON2)
These items can be selected by pressing the corresponding softkey. If an
item was not programmed in the system parameters, this item will not
apperar as a softkey. For instance, if no control samples were programmed,
the softkeys CONI and CON2 will not appear.

MERCK MICROLAB 200 -47-

 Measure the reaction mixture. The following screen is displayed:

Figure 6-
11 1 5 R U 6 94 89:49
Patient Result GLUCOS
E
R R M E HO L L A ND
37 5
H 43.6
• CH E C K R E S U L T S
•

If the results of the reagent blank, the

neasuresaR1e
INFO TEST
calibrator, or the patient are outside
the analytical limits the message
*CHECK RESULTS* is displayed. The Merck Microlab 200 will also inform
the operator if a duplicate or triplicate sample is outside the programmed
limits.

By pressing INFO a second screen, containing all background information

of this sample, is displayed:

Figure 6-12
1 5 9 U 6 94 e9:49
GLUCOS
E

R E 96 B L 15
F R C T OR 26.3
RESULT 34.5
ABS 12

TEST

MERCK MICROLAB 200

 End-point Info

When the test mode is kinetic the following screen, which contains some
extra measurement parameters, will be displayed:
Figure 6-13
Kinetic Info

Pressing PRIN will result in a print-out of the extended measuring

parameters.

If the test mode was kinetic or two-point a graphic representation can be

displayed by pressing PAGE:

Figure 6-14
Kinetic Measurement

MERCK MICROLAB 200 -49-

 Plot

This screen contains a plot of the measurement and can be printed

together with all the background information of this test by pressing the
PRIN key. The curve is auto-scaling with respect to absorbances as well as
time.
By pressing RPT a test can be repeated.

-42-

MERCK MICROLAB 200

 If a control value is outside its limits, the following screen is displayed:

Figure 6-15
Control Outside Limits 159UG94 e9:49

NRMENORNRL

34.5
CKRESULT.

measures
a
INFO
If the deviation of a duplicate or
TESr
triplicate control sample is bigger
than the preprogrammed limit in the test parameters, the following
screen is displayed:

Figure 6-16
1 5 R UG 9 4 89:49
Replicate Outside Limit
GLUCOSE
hRNENOR
NQL

34.5
REPLICATE
sa
NAB TEST
When RPT is pressed the sample can
be re-measured and a new average is calculated.

MERCK MICROLAB 200

6.2 TEST END SEQUENCE
Press TEST at the end of the measurement sequence. The following
screen is displayed:

Figure 6-
17 15 e9:55
Rinsing Procedure RINSINGPROCEDU
RE
F L U S H T 11 E F L O ' C E L
LDETERGENT

PLACEBOTTLEUN
D ER
S i P P E R T UB E
END
If another test method is to be
performed immediately after this measurement sequence, the flowcell
must be cleaned first with detergent and rinsed afterwards with water.
Place a bottle with a 5% detergent solution (e.g. Extran MA 01, Merck art.
number 1.07555.) under the sipper tube and press GO. The flowcell is
cleaned for about 2 minutes. After this the Merck Microlab 200 asks to
place a bottle with water under the sipper tube. The flowcell is rinsed with
water for about 1 minute.

If no other test is to be performed, the END OF DAY procedure must be

started. Press END to start the procedure. The following screen appears:

Figure 6-
18
1 5 RU G 9 4 16:3e
End of Day Procedure ENDOF PROCEDU
RE
FLUSHTHEFLO'CE
LL
WITHDETERGENT

PLACEBOTTLEUN
D ER S I P P E R T U B E
TEST
Place a bottle with detergent solution
under the sipper tube and press GO. The Merck Microlab 200 will now
automatically clean the flowcell for about 10 minutes; afterwards the
flowcell is rinsed with water for 2 minutes.
The end of day procedure is finished with a message to switch off the
instrument.

MERCK MICROLAB 200

-44-
6.3 SAMPLE BLANKING
To run a test with sample blanks, the procedure is the same as a normal
test.

Select the test to be run. After the measurement of water the following
screen is displayed:
Figure 6-19
1 5 R UG 9 4 1 6 : 4B
Measure Reagent Blank
(Blank)

m e as ure r e a e
nt
SKIP TEST
Place the blank reagent mixture under
the sipper tube, and press the SIPPER button. The following screen will be
displayed:

Figure 6-20
15RU694 16:4B
Measure Reagent Blank
(Sample)

"RN E RE RE ENT
B . 855 A b s

m e a s u re r e a e n
t
Place the active reagent mixture under
the sipper tube and press the SIPPER button.
The instrument will now come up with the question: "measure calibrator
bl" or "measure sample bl'i. This means that an inactive calibrator or
sample mixture has to be put under the sipper tube. In case TEST REP was
set to a number higher than 1, the message "measure calibrator bll'l or
"measure sample bll t' will appear.

The next question will be: "measure calibrator epil or "measure sarnple
ep", which means that the active mixture has to be put under the sipper
tubing.

The last two procedures will be repeated each time by first entering the
sample blank and secondly the sample. Pressing RPT will result in the
measurement of a complete set of samples, i.e. sample blank and sample.

MERCK MICROLAB 200 -53-

6.4 BICHROMATIC MEASUREMENTS
When in the test parameters of the test the second wavelength is selected
for an end-point test, the Merck Microlab 200 automatically measures the
reaction mixture at 2 different wavelengths. Each actual measurement
takes 2 seconds and some time is needed to change the filter. The results
of the 2 measurements are subtracted. This value is then used in the
further calculations.

6.5 RESULTS PRESENTATION

An automatic output from the printer
is reproduced below.

figure 6-
vrrAL RESEARCH
21
Normal Print-
15 AUG 94 16:07
Out 15 GLUCOSE mmol/l

REPG.BL. dA 0.001
o .287

CALC. FACTOR: 19.45

D. DUCK

F
aå5 15.41
RABBIT

Possible flags in front of the results are:

H result above reference limit set in test parameters

L result below reference limit set in test parameters A
absorbance outside high or low absorbance levels nl
non linearity greater than set limit (only if the reaction
is greater than 0.015 Abs/min) control result above
limit set in test parameters control result below limit set
in test parameters
D duplicate out of range

MERCK MICROLAB 200

 If the operator presses the PRN key during a check in the info screen during
the measurement, the following print out
is reproduced:

Figure
VITAL RBEARCH
6-22
Extended Print-
15 AUG 94 16:25
Out
D. DUCK
432 85

FACTOR -1746

RBIJLT 05 L
ABS 1 .188
4bs/m i n -o .020

In addition to the flags mentioned above, the following information can be

displayed:
Absorbance blank
Delta absorbance/minute blank (AAb%l/min)
Absorbance
Delta absorbance/minute sample (AAbs/min)
% Non linearity
Reagent blank/blank
Reagent blank
Factor

MERCK MICROLAB 200 -55-

 An example of a print out from a test which has a non linear calibration
curve, is reproduced below.

Figure
6-23
Print-Out of Non-
Linear
1. O Abs
Calibration 2. 10 Abs 0.151
Curve 25 Abs o .371
4. Abs 0 .966
s. 150 Abs 1 .420
CURVE OF IRON

ACCURACY: 0.3%

The printer may be switched off as described in Set System

Parameters. For the insertion of a paper roll see chapter 8,
REPLACEMENTS.

-48-

7. STATISTICS

7.1 INTRODUCTION
The statistics program is located under position 3 of the Utilities Menu.
This program gives the possibility of statistical evaluation of controls
measured on the Merck Microlab 200.

For all 40 test programs in the unit, two controls can be defined, which can
be selected from 15 different control sera.

MERCK MICROLAB 200

 The system will store the last 30 results on a rotating basis, so that as
each new value is added, the oldest value is deleted. After each 30
results, an automatic print-out of the Levey-Jennings plot is made.
The statistical data that are available include:
Mean
Coefficient of Variation (CV)
Standard deviation
Number of analyses
Levey-Jennings Plot
The Levey-Jennings Plot displays the high and low ranges. The most recent
data are displayed on the right hand side of the screen. All data can be
printed out including the graphics plot.

Select option 3-STATISTICS from the Utilities Menu. The statistics screen is
then displayed:
Figure 7-1
Statistics Menu

7.2 CONTROL SURVEY

Key I-CONTROL SURVEY. This part of the program is used to get an
overview of the controls used.

The Merck Microlab 200 will print all programmed controls. The printer
can be stopped by pressing STOP.

This is an example of a print out:

MERCK MICROLAB 200 -57-

 figure 7-
2 15 AUG 94 16:ÜB
Print-Out of Control
Survey CONTROL SURVEY

BATCH
no control
2 NORML 99985 a
ABNORMAL 845

7.3 LIST STATISTICS

Figure
7-3
1 5 RUG 9 4
Select Statistics List
L1STSIQTISTICS
TESTS
ONETEST

SIRI

After keying 2-LIST STATISTICS, the following menu is displayed:

This part is used to print out statistical information. When I-ALL TESTS is
selected, a full statistical report, sorted per control, including Levey-
Jennings Plot over the last 30 results, is printed.

If 2-0NE TEST is selected, a specification from the test panel must be

made.The following screen is displayed after selection of a test.

MERCK MICROLAB 200

 Figure 7-4
Statistical Data 15 17:e1
s1Q11ST
1
G L UC O S E CON T
RO L 1
H O R NA L 9998
5
6.4
These data can be printed by pressing
L-LIM 6.1 PRIN. By pressing PAGE a graphic
r LIMIT 6.7
e
p N EA N 6.4
r
S.D 8.85
e
s 8
e 9
n
t
ation is shown:

figure 7-5
Levy Jennings Plot

When PRIN is pressed, the Merck Microlab 200 will print a full statistical
report, including Levey-Jennings Plot over the last 30 results. Values
outside the limits are shown as arrows (t or l ).

MERCK MICROLAB 200 -59-

 Figure
7-6
Print-Out of Statistical 15 AUG 94 17:01
Data
LIST STATISTIæ

GLUCOSE
NORMAL 99985 TARGET6.4
L-LIMIT6. 1 H- LIMIT6.7
MEAN6.4
S.D.O . 05
C.V.0.84
9

MERCK MICROLAB 200

7.4 CLEAR STATISTICS
After pressing 3-CLEAR STATISTICS in the Statistic Menu, the following
screen is displayed:

Figure
7-7
Clear Statistics
Menu

Selecting I-ALL TESTS will result in deleting all statistical data, but not
before the operator has confirmed it on a warning screen.

Figure 7-8
1 5 RUG 9 4 17:01
CLEARSTQTISTI
CS
YOU CLEARTHE
STnTISTICSOF
ALLTESTS
A R E YO U S U R E ?

VES

Warning

MERCK MICROLAB 200 -61-

 After selecting 2-0NE TEST, a selection from the test panel must be made.
After this selection, the following screen is displayed:

Figure 7-9
Select Clear Mode 17:
e2CLEARSTATI
STICS
youCRNCLERRTHE
ST9TISTICSOFT
ES T
6LUCOSE

n STQTISTICS A selection can be made to delete the

a O H L Y C O N TR O L statistics of control 1, control 2 or
1 O O N LY C O N TRO L both.
2

8. REPLACEMENTS

8.1 REPLACING /ADJUSTING LAMP

Proceed to the UTILITIES menu, and select 4-SERVICE, 2-ADJUST LAMP.
The following screen is displayed:

Figure 8-1
Adjust Lamp

Remove the sipper tube and remove the aspirate lever by simply pulling it
down from the black block.

-62- MERCK MICROLAB 200

 Remove the three mounting screws at the top of the rear panel (marked
with arrows), and gently take off the top cover by moving it towards the
front of the instrument and then lifting it. The cover can be placed on its
side, at the right hand side of the unit.

Figure 8-2
Lamp Block

Remove the lamp block completely by loosening screws 1 and 2. The lamp
block can be removed by lifting it out carefully.
Pull the lamp out of its lamp holder.

Insert a new lamp in the lamp holder.

Reinsert the lamp block in its place and lock screw 1.

Adjust screw block in its middle position with screw 3 (see Figure 8-2).
Then press GO.

Adjust screws 1 and 3 in sequence in order to obtain a minimum

absorbance reading. The absorbance is displayed in the upper right corner
of the display. Press END and fasten screw 2.

Carefully put the top cover back in position, lock the three mounting
screws at the rear panel and reinsert the sipper tube and aspirate lever.

8.2 REPLACING PAPER ROLL

Open the paper holder on top of the printer by pulling it backwards and
then lifting it up. Load the printer paper into the printer so that the paper
feed is from under the roll (see Figure 8-3).

MERCK MICROLAB 200 -63-

 Always use special thermal paper.
Figure 8-3

Loading printer paper

Press PAPER on the keyboard to load the paper.

8.3 REPLACING FUSES

The fuses are located at the rear panel of the analyser. They are mounted
in the fuse holder between the power switch and the mains cable
entrance. Pull out the fuse holder lid and the fuses can be replaced
easily.

Figure 8-4
Replace fuses

Fuse holder

The fuse holder will only take the European style 5x20mm glass fuses.

Should the fuse blow immediately again after replacement, never mount a
more powerful one, but contact your local service organization.

-64- MERCK MICROLAB 200

9. SERVICE AND MAINTENANCE

9.1 DAILY
The Merck Microlab 200 may be cleaned with a damp cloth and some
detergent. Make sure to remove the mains connector before cleaning and
take care that no water gets into the instrument.

The only daily maintenance of the Merck Microlab 200 is:

Check printer paper (if connected) and assure that there is
uay 1 um.
Empty waste container.
Follow the instructions on the screen at the end of the test
procedure and the end of the day procedure.

9.2 OCCASIONALLY
Sometimes due to insufficient washing or long periods of inactivity, the
silicon tubing in the pinch valve might get blocked, causing:
non aspirating of sample, or
liquid leakage from the pressure relief system of the pump, through
the outlet at the bottom of the instrument.
If this happens, proceed as follows:
Disconnect the instrument from the power outlet.
Remove the top cover (see Change Lamp)
Stretch the silicon tubing passing through the pinch valve and roll
between the fingers, trying to "unstick" the tubing in the pinch
area.
Check for correct operation before mounting the top cover. If the
Merck Microlab 200 functions properly, replace the cover. The
internal tubing system has to be replaced only once a year.
However, tubings might get polluted due to lack of maintenance,
and may cause damage to the instrument. When this is observed,
no warranty claims will be accepted.

MERCK MICROLAB 200 -65-

9.3 SERVICE
9.3.1 ABSORBANCE ON SCREEN
This mode can be used to read absorbances from different samples without
the use of a full program.
Select the Utilities Menu followed by 4-SERVICE. The following screen is
displayed:

Figure 9- 1
Service Menu
1 5 A UG 94 15:1B
SERVICE
nABSONSCREENaA
D J U S T L RNP
DIRGNOSTICS

NE-m

Select I-ABS ON SCREEN after which the following screen is displayed:

Figure 9- 1 5 RUG 9 4 15:1B 2

Absorbance on Screen
A BS O N S C R E E N
F I LTER
34 H e.436
4 85
585
5 46
578
62 e
Pressing ZERO will result in blanking the
8 37 absorbance reading.
rew
The wavelength and temperature can be
changed by pressing WAVE and TEMP. MEAS will bring the operator back to
the Test Selection screen.
9.3.2 DIAGNOSTICS
Select 3-DIAGNOSTICS from the Service Menu after which the screen
shown in Figure 9-3 is displayed:

-66- MERCK MICROLAB 200

 Figure 9-3
Diagnostics Menu 15AU694 15:15
DIAGNOSTICS
SOFT•nRERE
L
D A T E n Q N n LY S E R
CON TRO L a S 1 6 N Q L C O
NVERSION

In the first two lines the current software version and date and time of
release are displayed. The following features can be selected:
figure 9-4
Analyser Control

I-ANALYSER CONTROL
With the selections 1-5 all functions can be set and checked for proper
operation. On the second half of the screen, readings of the settings are
made. For example: when 2s-TEMPERATURE is set to 25, after a while the
reading TEMPERATURE will change from O to 1 indicating that the
selected temperature has been reached.
2-SIGNAL CONVERSION
This function is extensively described in the Service Manual and is for
service purposes only.

10. TECHNICAL DATA

10.1 SPECIFICATIONS
Lightsource

MERCK MICROLAB 200 -67-

 o Quartz-iodine lamp, 12V/20W
Wavelength range

o 330 to 900 nm o Wavelength selection automatic by 8 position

filterwheel

o 6 interference filters mounted as standard (340, 405, 505, 546,

578, and 620 rtm).

o 2 positions for optional filters as choice

Photometric range o -0.3 to 2.3
Absorbance
Resolution o Display: 1
mAbs o Internal: 0.1
mAbs
Linearity

o 0.5% at 2 Abs and 0.2% at 1 Abs

Drift

o After 30 min. warming up at O Abs: < 2 mAbs/h

Noise o < 0.3 mAbs at 2 Abs and 340 nm
Blanking o Automatic zero setting with water filled
flowcell Operator Interface o Graphic LCD display
of supertwisted type with 128 x 160 dots o Multi-
lingual dialogue via "soft-keys" o Keyboard with
wipe-off tactile keys

o (Optional) external alpha-numeric/graphic printer, with 40

columns

o Real time clock, displayed on the LCD and on print-out,

including time and date
Memory o Programmable parameters for 40 tests o

Calculated factors are stored and can be used again

o Measured reagent blank values are also stored and can be used
again

-68- MERCK MICROLAB 200

 o Rechargeable back-up battery to maintain the data for at least
30 days, when disconnected from the mains
Measuring modes o Continuous kinetic with

linearity check

o Bichromatic endpoint with/without reagent and/or sample blank

correction

o 2-point

o Single, duplicate or triplicate measurements o Plot of kinetic

absorbance curves

Calibration o Up to 10 standards for curve fitting o

Single, duplicate or triplicate measurements
Quality control o Up to 15 different controls can be defined,

2 per test

o Target values and confidence range can be programmed for each

control o Results outside these limits will be flagged
o The last 30 results of each control and test are stored for
evaluation

o Levey-Jennings plot over the last 30 results

Measuring time

o Programmable 2 to 998 s in increments of 2 s; for endpoint tests

fixed 2 s.
Delay time

o Programmable 0 to 999 s, provided the sum of measuring time and

the delay time does not exceed 999 s.
Flowcell o Metal (stainless steel), with quartz glass
windows o Measuring volume 32 gl
o Patented shape for bubble free filling and low sample cross
contamination o Minimum recommended sipping volume 350 gl
Temperature control

o By means of Peltier elements o Selectable temperatures: 25, 30

and 37 oc o Flowcell: accuracy 0.2 oc and precision 0.1 oc

MERCK MICROLAB 200 -69-

 Aspirator system o Internal pump of bellows type, made
out of PTFE o Driven by stepper motor o Back panel
connection for waste container
o Aspiration volume programmable in steps of 1 "l, up to a maximum
volume of 1500 gl
Interface o Centronics type parallel port, for connection of optional

printer

o RS232 type serial port, for connection of external data handling

equipment or serial type printer o Trigger input for external
sipper start signal
Mains

0 110 ... 240 VAC nominal, tolerance ± 10%; 50/60 Hz; 100 VA

o Installation category Il Environmental requirements

o ambient temperature: 10 ... 35 oc

o maximum relative humidity: 80% at temperatures up to 31 oc,

linear decreasing to 65% at 35 oc.

O HILILuue. up LU OUUu o Pollution degree: 2 (in

accordance with IEC 664)

Dimensions

o Width 380 mm

o Depth 360 mm

o Height 140 mm o Weight 7 kg

-70- MERCK MICROLAB 200

APPENDIX 1 - COMMUNICATIONS

1.1 RS232 INTERFACE MENU

Format Off
Printer
Computer
Baud Rate 2400 fixed
stop Bits
1.5
2
Bits/Character 5
6
7
8
Parity No
Even
Odd

1.2 FORMAT
When PRINTER is selected, a serial external printer can be connected.
When COMPUTER is selected, an external EDP (Electronic Data Processor)
can be connected.

Each result is presented to the RS232 interface in the following format:

[STX] {Format-type[21; Sample type[l]; Name[151; Number[15]; Sequence
number[8]; Test-Repeatnumber[l]; Testnumber[2]; Test name[8];
Measuring result[6]; Result value[6]; Measuring units[61; Error mess-

The number of reserved bits is set between brackets ([ l).

The meaning of the different items is described on the next page.

STX Start of Text

MERCK MICROLAB 200 -71-

 Format type R (Result)
Sample type R: Reagent blank
S: Calibrator
C: Control
N: Normal sample
Name R: Space
S: Calibrator name
C: Control name
N: Patient name
Number R: Space S:
Space
C: Space
N: Patient number

Sequence number
S: Calibrator number (O 10)
N: Sequence number
Test Repeat number
R: Test Rep. number
S: Calibrator Rep. number (1 - 3)
C: Test Rep. number
N: Test Rep. number
Test number Test number (1st page O — 10, 2nd page 0 20, etc.)

Test name Test name

Measuring result Measured Absorbance value

R: O (Value is ignored) S:
Result value Calibrator Concentration
C: Result
N: Result

Measuring unit

Error Message A: Absorbance out of limits

NL=xx.x%: Non linearity > set limit
L: Result < Low limit
H: Result > High limit
< : Control < Low limit
> : Control > High limit
Carriage Return
New Line

ETX End of Text

-72- MERCK MICROLAB 200

 1.3 PIN CONFIGURATION
The pin configuration of the RS232 interface is:
1 and 7 Ground

2 Transmit Data (output)

3 Receive Data (input)
4 Request to send (output)
5 Clear to send (input)
6 Data set ready (input)
20 Data terminal ready (output)

MERCK MICROLAB 200 -73-

APPENDIX 2 - FAULT FINDING

In this appendix errors and their causes are described. Possible problems
are divided in 3 sections: Flowcell
Results
General
In case a given remedy does not solve the problem, please contact your
local service organisation.

2.1 FLOWCELL
2.1.1 NO SAMPLE ASPIRATION
System does not aspirate sample in any mode (also not in flush), but
the prime LED indicates normal operation and the pump seems to
operate normally.

CauseRemedy

Obstruction in the fluid system.
Check all tubing and flowcell for
any blockage.
In general, fluid system
obstruction only occurs if
polluted sample has been used
or insufficient cleaning has taken
place.

The aspirated sample flushes back from the sipper tube.

CauseRemedy

The waste tube through the Check the tubing, and resolve pinch valve is
blocked. blockage by removing the tube from the valve and stretching or
rolling it between your fingers. Thorough rinsing after operation will
prevent this problem.

-74- MERCK MICROLAB 200

2.1.2 INSUFFICIENT SAMPLE ASPIRATION
Insufficient sample aspiration in any mode.

Cause Remedy

Can also be caused by an
obstruction.
Leakage in fluid system.
See 2.1 .1 .
Check and tighten sipper
tube. Do not over tighten, as
excessive force may either
destroy the seal or strip the
threads of
the fittina.
Check the seals of the sipper
tube connections.
Check all tubings of the fluid
system, and also flowcell and
pump.

2.1.3 COMMUNICATION ERRORS

The instrument displays: Echo, Parity, Rx Overrun, CRC/Framing, or
Diluter Errors.

Cause Remedy

Errors in data transmission. Check all electrical connections.

Contact your local service
organisation.

2.2 RESULTS

2.2.1 NO RESULTS
In stead of a result, "ERROR" is printed or displayed on the screen
Cause Remedy

The result of (factor x (A)Abs) is The absorbance value of the

too large to be presented on the reagent/sample mixture is out of
screen.. range.
Check the factor.

MERCK MICROLAB 200

 Check if the calibration has
been performed correctly.
The reason for an unusually
high factor after calibration
may be:
flowcell is not filling correctly
Cause
Wrong wavelength is Program the correct wavelength programmed in Test
Parameters. and retry.
2.2.2 BAD RESULTS
Results not reproducible; positive and/or negative results
Cause
Remedy
No liquid in the flowcell during measurement due to:
Leakage of the sipper tube.
Programmed sipper volume is
too high.
Bad filling of the flowcell (air
bubbles).
Measurement results too low.
Cause
calibration on water instead
of a standard.
Check the mixture with the
help of the Service menu
(Signal Conversion). Use fresh
reagent.
Not enough light. This can be
checked in the Service Menu,
Signal Conversion (displays
LOW).
-76-
Too much light. This can be
checked in the Service Menu,
Signal Conversion (displays
HIGH).
Remedy
Check the connection of the
sipper tube.
Check the sipper volume.
Check the connection of the sip-
per tube. Clean the flowcell by
flushing with 5% detergent or
50% methanol.
Remedy
Result(s) zero or almost
zero
Check lamp (adjustment),
flowcell and filter. This can also
happen when measuring at an
incorrect wavelength. Check
Test Parameters.
The 'BLANK' is performed
incorrectly. Repeat the blank
procedure. Check filling of the
flowcell.
MERCK MICROLAB
 Delay before Measuring
kinetic temperature
measurement too low.
too short. Check and increase delay if
necessary.

Contact your local service organisation.

2.2.3 BLANK ERROR
After the blank procedure at the start of each test, Blank Error is
displayed.

Cause Remedy

No light or insufficient light. Check lamp and lamp

adjustment.
No water in the flowcell or dirty Flush water in the flowcell
flowcell. and/or check flowcell.
No filter inserted or defect
Too much light. filter.
Check filterwheel.

2.3 GENERAL
2.3.1 TEMPERATURE
"Temperature Errort is displayed on screen
Cause Remedy

The flowcell has not reached the
correct temperature within 30
seconds.
Ambient temperature too high
(>35 oc) or fan not running.
If the message is not disappear-
ing after a few measurements,
switch the instrument off and
on to reset the whole system.
Try again.
If the same happens, inform
your local service organisation.
Check fan, inform your local ser-
vice organisation when not
running.

Loose or wrongly connected Inform your local service or-

connectors from Peltier ganisation
elements or defect
temperature sensor.
-69-

MERCK MICROLAB 200

APPENDIX 3 CUSTOMER
SERVICE

German
E. Merck
Vertrieb Diagnostica
Deutschland Frankfurter Straße
250 64271 Darmstadt

Telephone: 06150/109059 Diagnostica Service

06150/109058 Technical Customer Support
Telefax: 06150/4772

MERCK MICROLAB 200

APPENDIX 4 - ORDER INFORMATION
Consumables and spare parts Microlab 200
3380-018 Quartz-lodine-Lamp 12V/20W
3348-174 Fuse, 2.5 A slow blow (2 pcs) for 250V
4104-075 Suction tube
6000-970 Sipper pipe

Optional Printer
6001-685 Thermal printer DPI-J 411 Il for 220 V
leGLIOIl power
6001-686 Thermal printer DPU 411 Il for 110 V
(incl. paper, connection cable and power cable)
3073-020 Thermal paper (2pcs) for DPI-J 411 I l
MERCK MICROLAB 200 -71-

-72- MERCK MICROLAB 200