operationmanual - Merlin Medical

OPERATION MANUAL
Instrument Manufacturer:
ABW Medizin und Technik GmbH
Lagesche Str.15
32657 Lemgo
Germany
IVD
MC and MERLIN are registered trademarks of ABW Medizin und Technik GmbH
www.merlinmedical.net
Release 16_77
© 2004-2014 ABW Medizin und Technik, D-32657 Lemgo
This manual including all its parts is copyrighted. Any deployment beyond the strict rules of the
copyright law is prohibited and liable to prosecution without prior allowance of ABW Medizin und
Technik GmbH. This applies especially for copying, translating, microfilming and storing and data
processing in electronic systems.
Registered trademarks and names are usually not indicated as such. The absence of such
marking does not mean that it is a free name in the sense of the trademark law.
SAFETY INSTRUCTIONS
Symbols used on the MERLINmedical haemostasis instruments and consumables
Symbol
Meaning
Used on / in
2
Do not reuse
Balls & cuvettes
In-Vitro Diagnostics Device
Operation manuals
IVD
Biological risks
MC 1
MC 4
MC 10
plus
plus
Consult instructions for use
MC 1
MC 4
MC 10
plus
plus
LOT
Batch code number
Manufactured by
Label
”serial number”
Balls & cuvettes
MC 1
MC 4
MC 10
plus
plus
Use by date:
YYYY-MM
Balls & Cuvettes
Temperature limits for storage
Balls & Cuvettes
Back of instrument
MC 1
MC 4
MC 10
Power supply unit
plus
plus
TABLE OF CONTENTS
1.
Introduction........................................................................................................................................................ 3
1.1 ......... Guarantee ................................................................................................................................................... 3
1.2 ......... Purpose of use .......................................................................................................................................... 4
1.3 ......... Specifications ............................................................................................................................................. 4
1.3.1 ..... Correlation, precision & verification ................................................................................... 4
1.4 ......... Measuring principles ............................................................................................................................... 5
1.4.1 ..... Mechanical measuring principle .......................................................................................... 5
1.4.2 ..... Optical measuring principle ................................................................................................... 5
1.5 ......... Specifications ............................................................................................................................................. 6
1.6 ......... Views of the MC 10 .............................................................................................................................. 7
1.7 ......... Views of a 3-Volumen-microliter pipette ............................................................................................ 9
1.8 ......... Views of a HandyStep pipette ........................................................................................................... 10
plus
®
2.
Installation ........................................................................................................................................................ 11
2.1 ......... Unpacking ................................................................................................................................................ 11
2.2 ......... Content / Scope of delivery ................................................................................................................ 11
2.3 ......... Consumables and accessories .......................................................................................................... 11
2.4 ......... Location of the instrument.................................................................................................................. 12
2.5 ......... Connections demand ............................................................................................................................ 13
2.6 ......... Connection of the device ..................................................................................................................... 13
3.
Function .............................................................................................................................................................. 14
3.1 ......... Menu structure ...................................................................................................................................... 14
3.2 ......... Performance test .................................................................................................................................. 15
3.2.1 ..... Testing of a measurement resp. of an incubation ....................................................... 17
3.3 ......... Test parameter ...................................................................................................................................... 19
3.4 ......... Test evaluation / calculation .............................................................................................................. 21
3.4.1 ..... Mechanical measurements (ball method) ..................................................................... 21
3.4.2 ..... Optical measurements ........................................................................................................ 22
3.5 ......... Settings menu......................................................................................................................................... 24
3.5.1 ..... Date and time......................................................................................................................... 24
3.5.2 ..... Factory settings ..................................................................................................................... 25
3.5.3 ..... Software version ................................................................................................................... 25
3.5.4 ..... Language ................................................................................................................................. 25
3.5.5 ..... Print setting ............................................................................................................................ 25
3.5.6 ..... Print result lists ..................................................................................................................... 25
3.5.7 ..... Barcode scanner .................................................................................................................. 25
3.5.8 ..... Online setup ............................................................................................................................ 26
3.5.9 ..... Measurement settings ........................................................................................................ 26
3.5.9.1 . ............ Forced incubation ..................................................................................................... 26
3.5.9.2 . ............ Channel auto reset ................................................................................................... 26
3.5.9.3 . ............ Interval mode ............................................................................................................. 27
3.5.9.3.1 .......... Waiting time ............................................................................................................... 27
3.6 ......... Patient memory...................................................................................................................................... 27
3.7 ......... Service menu .......................................................................................................................................... 28
4.
Pipetting technique ................................................................................................................................. 29
4.1 ......... Precision and correctness .................................................................................................................. 29
4.1.1 ..... Pipetting with a microliter pipette .................................................................................... 29
4.1.2 ..... Volume selection on automatic microliter pipette....................................................... 30
4.1.3 ..... Pipetting with a HandyStep dispenser ........................................................................... 30
4.1.4 ..... Volume selection on the HandyStep dispenser .......................................................... 30
®
®
1
4.2 ......... Sample absorption (microliter pipette) ............................................................................................ 31
4.3 ......... Sample dispensing (microliter pipette) ............................................................................................ 32
4.4 ......... Dispension of reagent 1 (microlitre pipette or HandyStep pipette)....................................... 33
4.5 ......... Dispension of start reagent (microlitre pipette or HandyStep pipette) ................................ 34
®
®
5.
Operation........................................................................................................................................................... 35
5.1 ......... Keyboard layout ...................................................................................................................................... 35
5.2 ......... Switch on the device ............................................................................................................................. 35
5.3 ......... Measurement of parameters with one reagent component .................................................... 37
5.4 ......... Measurement of parameters with two reagent components .................................................. 39
5.5 ......... Measurement of parameters in the optical test position .......................................................... 40
5.6 ......... Stopping of an incubation time .......................................................................................................... 41
5.7 ......... Stopping after a mistakenly start of a measurement ................................................................. 41
5.8 ......... Switch off the device ............................................................................................................................. 41
6.
7.
Warning hints for the operation ................................................................................................ 42
Handling hints ............................................................................................................................................... 43
7.1 ......... Handling of the reagent ....................................................................................................................... 43
7.2 ......... Handling of the cuvettes ...................................................................................................................... 43
7.3 ......... Handling of the testing material ........................................................................................................ 43
8.
9.
Quality control............................................................................................................................................... 44
Maintenance .................................................................................................................................................. 44
9.1 ......... Maintenance by user ............................................................................................................................ 44
9.2 ......... System self-test ...................................................................................................................................... 45
9.2.1 ..... Automatic self-tests after switching on the device ..................................................... 45
9.2.2 ..... Cycle tests during measuring mode ................................................................................ 45
10.
Errors.................................................................................................................................................................... 46
10.1....... Analytical errors ..................................................................................................................................... 46
10.2....... System errors......................................................................................................................................... 51
11.
12.
13.
14.
Addition printer ........................................................................................................................................... 52
Barcode Scanner ...................................................................................................................................... 52
Appendix I Verification document.......................................................................................................... 53
Appendix II Declaration of conformity ................................................................................................... 54
Before using the MC 10plus study the instruction manual carefully.
This manual shall convey you an extensive comprehension for the operating mode of the
MC 10plus for enabling you to use all functions of the device.
Reproduction of this manual
This document contains proprietary information that is protected by copyright. All rights are
reserved. No part of this document may be photocopied, reproduced, or translated to another
language without the prior written consent of ABW Medizin und Technik GmbH.
2
1.
Introduction
1.1
Guarantee
The company ABW Medizin und Technik GmbH, called ABW in the following, grants the first buyer that
the of ABW purchased instruments are free of material and processing failures under normal
utilisation.
This guarantee applies for one year as of date of invoice of the first purchase (the “period of
guarantee”).
Should failures occur within the period of guarantee please contact the ABW-customer service
immediately (Fon: +495261_927 294). When contacting the customer service important information
as e.g. the detailed description of the defect as well as instrument type and ID-number of the MC 10 plus
have to be communicated.
The customer service is available for questions concerning guarantee from Monday until Friday from
8:30 a.m. until 5:00 p.m. (public holidays excluded). ABW charges the customer for repair of defects
beyond the period of guarantee as well as for the repair of defects which are not covered by the
guarantee according to the at that point of time valid costs for work and material.
Following defects which essentially require a repair are excluded from this guarantee:
Defects which are
a)
b)
c)
d)
e)
not within the period of guarantee and not communicated within one
week after occurring to ABW
caused by chemical decomposition or corrosion
described in the manual of ABW
the consequence of maintenance works, repairs or modifications of
not by ABW authorised staff
caused by an application beyond the intended purpose or by an
accident.
The liability of the manufacturer for any kind of damages due to the delivery, installation, application,
repair and maintenance of the instrument within or beyond this guarantee is - at ABW’s own
discretion - restricted exclusively to the repair or to the replacement of the instrument. ABW is not
liable for the injury of third persons, secondary or consequential damages or losses in profit.
The replaced parts become automatically property of ABW.
The of ABW manufactured instruments may only be used with power supply units which are supplied
by the manufacturer and which are expressively intended for this use.
THE ABOVE GUARANTEE IS THE SOLE WARRANTY FOR THE INSTRUMENT OF ABW. ALL OTHER
EXPRESSLY OR SILENT PROMISES, INCLUDING PROMISES WITH REGARD TO THE MARKET
SUITABILITY OR THE SUITABILITY FOR A CERTIN PURPOSE ARE EXCLUDED.
© by ABW Medizin und Technik GMBH 2014
3
1.2
Purpose of use
The MC 10plus is a semi-automatic mechanical and optical (optionally) detection system which is used
for the determination of prothrombin times (PT), activated partial thrombo plastin times (aPTT) and
fibrinogen concentrations as well as other clotting and chromogenic tests whereas the output are
measuring results in view of quality. In connection with suitable reagents plasmas and also full blood
specimen can be measured.
The sample and also the reagents are added manually with a suitable calibrated pipette. The time
keeping until the detection of the coagulation is done automatically. On the base of correct parameters
and correct entering of the curves the coagulation times are converted into corresponding results.
1.3
Performance data
The precision of the tests carried out with the MC 10plus is not depending on the instrument but on the
sample receipt, sample handling as well as the precision of the employed sample and reagent
distribution system.
1.3.1 Correlation and precision
An investigation for the evidence of the equivalence of the MC 10plus to another commercial mechanical
coagulation analyser has been done by a nameable German reagent producer with PT-, aPTT-, Fib-, TZ-,
AT3- and D-Dimer measurements. Please ask ABW to get more information.
4
1.4
Measuring principles
1.4.1 Mechanical measuring principle
Special cuvettes with a steel ball inside are place on the measuring positions in instrument related
racks. As the measuring block is sloping slightly the ball always remains due to gravity at the deepest
point of the cuvette. In the height of this point there is a magnetic sensor. At first the sample is
pipetted into a measuring cuvette, then – if required – the first reagent is added and the incubation is
started. The instrument turns the cuvette with the adjusted speed around the longitudinal axis. When
the incubation is finished (parameter specific) the start reagent is added and the measurement is
start simultaneously. When the coagulation begins the growing clot pulls the ball out of the basic
position and the magnetic sensor detects a magnetic impulse which causes the end of the
measurement.
cuvette
measuring
block
ball
sensor
measuring
cell
1.4.2 Optical measuring principle
The photometry is basing on the fact that a part of the passing light (UV-VIS = UV and visible field ca.
200 - 900 nm wave length) is reduced through the liquid test sample. Here the own colouration of the
probe or the colouration of the probe by adding suitable reagents is used.The course of the colouration
is stored in the MC 10plus and evaluated by a special software according the test requirements.
photometer principle:
5
plasma before
clot formation
plasma after
clot formation
1.5
Specifications
Type
:
Coagulation analyser / bench top device
RS 232
:
unidirectional
Measuring principle
:
mechanical + optionally optical measuring method
Number of measuring channels
:
10 + 1
Display
:
graphic presentation
Sample pipetting stations
:
20 (2 racks with each 10 cuvettes; at room temp.)
Cuvette pre-heating stations
(if required also employable as
reagent pipetting station)
:
10 (1 rack with 10 cuvettes)
Pre-heated storing position for
start reagent pipette
:
2
Pipette storing position at
room temperature
:
1
Drills 14.5 x 85.0 mm
for reagent pre-heating
:
5
Drills 11.5 x 75.0 mm
for reagent pre-heating
:
5
Dimensions
:
430 x 590 x 170 mm (L-W-H)
Weight
:
15 kgs
Power
primary
:
100 VAC - 240 VAC
50 / 60 Hz
Power
secondary
:
24V
Power consumption
:
70 VA
Measuring block temperature
:
37.3°C (+/- 0.5°C)
Measuring period
:
4.5 – 999.9 seconds
Motor turning speed
:
MC 10plus micro
MC 10plus macro
50 r.p.m.
40 r.p.m.
6
1.6
Views of the MC 10
plus
1
2
4
3
5
6
7
8
Component
Function / Description
1. Sample pipetting
pre-pipetting for further measurements
2. Graphic display
display of the keyboard layout, programme and result
display
3. Function keys
keys for data entering, their functions are shown in the
display above
4. Start pipette
different kinds of start pipettes can be used (red storing
position = heated).
5. Optical measuring position
(as option) for diverse chromogenic tests
6. Signal lamps with activating keys
depending on the condition of the system respectively of
the measuring positions above green, yellow or red
7. Reagent and cuvette
pre-heating station
reagent pre-heating positions for reagent and
cuvettes and for the preparation of the intended tests
8. Measuring positions
position in which the start reagent is added and which
the clotting time is measured
7
2
1
5
3
6
4
7
Component
Function / Description
1. On- / off-switch
main switch of the MC 10plus
2. Low voltage socket
for connecting the instrument with the external power
supply unit
3. Pipette sockets
for the connection of automatic pipettes with contact
line
4. RS 232 interface
plug-in for external printer
5. Barcode scanner connection
for external barcode scanner
6. PC
online-connection for the purpose of Software Updates
7. LIS
online-connection for external laboratory EDP
Laboratory Information System
8
1.7
Views of a 3-volume microlitre pipette
1
Component
2
3
4
Function / description
1. Pipetting key
For filling and dispensing start reagent. If a measuring
position activating key has been pressed at the MC
10plus the time keeping can be started by pressing the
pipetting key until the first stop.
2. Pipette contact line
For the connection of the automatic pipette with the
analyser.
3. Ejector cap
Removing of used pipette tips
4. Switch for volume selection
When the pipetting key (no.1) is pushed down
completely the pipetting volume can be adjusted with
this switch (50, 100 or 200 µl)
9
1.8
Views of a Handystep pipette
1
3
2
4
Component
Function / description
1. Dispensing lever
For dispensing reagent. If start reagent has been
absorbed and a measuring position activating key has
been pressed at the MC 10plus the time keeping can be
started by pressing the dispensing lever (automatic
pipette).
2. Locking / Filling lever
For absorbing reagent. For inserting a combitips pull
down
3. Sliding switch for volume selection
For adjusting the pipetting volume (please see pipette
back)
4. Combitip
Adjust volume of the combitips and adjust the sliding
switch for volume selection (no. 3) to pipetting volume
10
2.
Installation
2.1 Unpacking
The MC 10plus is transported in a cardboard which shall protect the instrument from transport
damages. Remove the analyser and the accessories carefully from the cardboard. If you detect
any obvious damages you have to record them on the delivery note. The carrier and your ABWcontact person have to be informed accordingly and immediately.
2.2
Content / Scope of delivery
Please take care that following items have been delivered:
MC 10plus coagulation analyser
Power supply unit
Power cable
2 Sample racks
2.3
Consumables and accessories
Consumables / description
MC cuvettes and balls micro
MC cuvettes and balls macro
Reagent tubes plastic (14.5 mm x 80.0 mm)
Coagulometer tubes plastic
Thermo paper
Cat.-No.
Z05120
Z05100
832158
833118
851057
Packing unit
1,000
1,000
300
500
5
Accessories / description
Automatic pipette Handystep® with start cable
Ball dispenser micro
Ball dispenser macro
Printer
Sample holder MC 10
CoagView®-Software (for data transmission)
Lysis-Programme (for Lysis-evaluation)
Barcodescanner
Cat.-No.
P20010
Z11000
Z10000
H10000
C00300
S20000
S10000
240001
Packing unit
1
1
1
1
1
1
1
1
The in 2.3 Consumables and Accessories mentioned articles are not part of the MC 10plus
scope of delivery. The comsumables can be ordered according to the user’s requirements. An
automatic pipette ensures that the time keeping is started simultaneously with adding the
start reagent. If the manual start key is used for starting the time keeping the reagent can be
dispensed with any pipette which can dispense the correct volume for the according test.
11
2.4
Location of the instrument
1.
Place the MC 10plus on a plane, stable, vibration- and dust-free work surface which is deep and
wide enough to ensure the air circulation of the instrument. For ensuring a sufficient cooling of
the analyser the distance between instrument and wall respectively to another object has to be
at least 10 cm. The instrument should not be placed next to centrifuges or other instruments
which could cause vibrations.
Minimum space requirements:
width
79 cm
depth
53 cm
(width of the instrument:
(depth of the instrument:
59 cm)
43 cm)
2.
Position the MC 10plus in an area with low humidity and little variations in temperature. The
device should not be placed directly under ventilation shafts which cause strong draughts.
3.
Place the MC 10plus in an area which is protected from direct sun light.
4.
The distance between the analyser and the socket may not exceed 3 m. Other instruments
with high power consumption and which are frequently switched on and off as e.g. centrifuges,
air conditionings or refrigerators should not be connected to the same circuit. When switching
on and off such instruments the voltage drop can be strong enough to have a negative effect
on the proper operation of the MC 10plus.
Attention!
If the user is electrified a discharge may happen at the MC 10plus. This
discharge has no influence on the function of the MC 10plus.
12
2.5
Connection demands
1.
Before the electrical installation is carried out it has to be ensured that the operating voltage of
the supplied power supply unit corresponds with the existing mains voltage (100 VAC – 240
VAC).
2.
Only employ the with the MC 10plus supplied suitable external power supply unit, otherwise the
analyser could be damaged.
3.
It is recommended that all repairs beyond the periodical maintenance and little setting are
carried out by the ABW-customer service.
4.
If the instrument is not used as advised in the manual the safe operation is not granted and the
guarantee expires.
5.
The instrument may not be connected to an extension lead.
6.
The total length of the mains connection may not exceed 3 meters.
Warning!
Only the original external power supply (100 VAC – 240 VAC) which is
delivered with the MC 10plus may be used, otherwise the analyser
could be damaged.
2.6
Connection of the device
1.
Connect the low voltage cable of the power supply unit with the low voltage plug at the back of
the instrument.
2.
Insert the plug of the power supply unit into a socket.
3.
If an automatic pipette is used connect the pipette contact line to one of the according sockets
at the back of the MC 10plus.
4.
If an additional printer is used connect the data line of the printer with the RS-232 interface
(chapter 1.6).
or
If you require an online connection then the EDP-data line has to be connected with the RS-232
interface.
5.
The data line for the external printer or for the online connection may not be longer than 3
meters.
6.
If an external barcode scanner shall be used connect the contact line of the scanner with the
socket for the scanner (chapter 1.6).
13
Switch on
3.
Function
3.1
Menu structure
Welcome display:
MERLIN MC 10
plus
(Version 1.7: 11.03.2007)
Start menu
Measure mode
Testparameter
Settings menu
Patient memory
Service menu
Workmode Menu
Testparameter (PIN)
Settings-Menu (PIN)
Patient memory
Running number
Input patient ID
Emergency
Quit
PT
Date and Time
Adjustment of date
and system time
Default-Parameters
Load default settings
Software-Version
Language)
English
German
Chinese
Print settings
Print the settings of the
settings-menu
Print result list
Search results in the
memory and print them
resp. send them online
Barcode-Scanner
Adjust / select barcode
scanner
Online Setup
Adjust parameter for
data transmission
Measure setup
Force incubation
meas.ch. auto reset
Suggest patient-ID
Interval-mode
Quit
Quit settings-menu
Search Pat.ID
PTT
FIB
TZ
Select test
FAK, FP1, FP2 and FP3:
PT
PTT
FIB
TZ
FAK
FP 1
FP 2
FP 3
Emergeny
Photometer
Quit
Emergency
Photometer
Running number
Test
Input
starting no.:
PT
1
Print by Pat.ID
Print by date
Send online by Pat.ID
Send online by date
Delete
Quit
Measure mode
14
3.2
Performance test
The correct operation of the instrument should be examined by means of a performance test
prior to the intended use of the analyser.
All functions of the MC 10plus are called up with the control keys below the display.
Ensure that no used cuvette is in the optical measuring position.
Switch on the MC 10plus at the on / off-switch at the back side.
The MC 10plus makes a signal tone and the display is lighted up and the signal lamps under the
measuring positions light up yellow-orange. Watch the display.
After approx. 15 sec. the display changes automatically from the welcome display to the start
menu. The signal lamps do no longer light up.
Start menu
Measure mode
Test parameter
Settings-menu
Patient memory
Service menue
Select „Measure mode“ by means of the arrow keys and confirm by pressing the ENTER-key.
You have to communicate the MC 10plus now in the work mode menu whether a running
number or a Pat.-ID shall be used for the sample test result identification.
In addition to these possibilities an urgent sample can be defined as “Emergency“, for which
two parameters have been defined before (chapter 3.3) in order to ensure a quickest possible
measurement.
Workmode menu
Running number
Input Pat.-ID
Emergency
Quit
Select the required patient definition with the arrow keys and confirm with ENTER.
15
Now defined which test shall be carried out. You can select the according parameter with the
arrow keys and confirm your selection with the ENTER-key.
Select test
PT
PTT
FIB
TZ
FAK
FP 1
FP 2
FP 3
Quit
If you wish to work with a running number for the sample identification you have to enter a
start number for the first sample to be measured. The MC 10plus suggests number one. (if an
identification via Pat.-ID is required skip the next display).
Running number
Test:
Input starting no.:
PT
1
Confirm the input with the ENTER-key. Then you get automatically to the measuring
programme. Here the signal lamps light up green constantly.
MZ
1
12
13
14
15
16
17
18
19
20
21
Measuring mode
TEMP = 37.3°C
Pat.-ID
PROG
TIME RESULT INFO
STOP
STOP
STOP
STOP
STOP
STOP
STOP
STOP
STOP
STOP
INIT
F1 = AUTO
F3 = DELETE
A measurement can not be started before the measuring block has reached the programmed
temperature. If the temperature is not yet reached then “TEMP” will flash in the upper right
corner when you try to start a measurement.
16
3.2.1 Testing of a measurement resp. of an incubation
Before patient samples are measured the procedure of such measurement should be
simulated. If a patient-ID is required for the sample identification, every ID has to be entered
before the measurement in the according measuring channel and confirmed with ENTER
(when using a running number this input has to be skipped). For a measurement test load one
rack with new balls and cuvettes and insert the cuvettes with the rack into the measuring
positions. The MC 10plus can process the in the test parameters (chapter 3.3) stored testspecific incubation time in two different ways:
a) Force incubation time (chapter 3.5.9): a measurement can only be started if the testspecific incubation time has been carried out before in this measuring position resp. in the
inserted cuvette with sample and reagent. Activate the according measuring position
(signal lamp below the measuring position constantly lighting up green) by pressing the
according activation key and start the incubation time by pressing the key “Incub Start“;
now the signal lamp of this measuring channel lights up yellow-orange. PLEASE NOTE – in
this mode an incubation is obligatory, i.e. an abort is not possible. 5 seconds before the end
of the adjusted incubation time (chapter 3.3) the MC 10plus gives acoustic signals. When the
incubation is finished the according measuring position can be prepared for the test start
with the key below. The start reagent has to be added within the next 5 seconds which is
shown by blinking of the related display line and by the assigned now green blinking signal
lamp. When a measurement has been started in a measuring channel (by using an
automatic start pipette this happens automatically) the green signal lamp below this
measuring position changes its colour and blinks red. After a test period of ca. 5 seconds
the clotting reaction can be simulated by slightly lifting the cuvette, the signal lamps
constantly lights up red after the clotting result detection. If a further measurement shall
be done in a measuring position in which already a measurement has been carried out
before this measuring position has to be reset by repressing the according measuring
position key. By pressing the key F3 on the keyboard all measuring positions can be reset
simultaneously.
b) Not force incubation time (chapter 3.5.9): Here you also have the possibility to work with a
test-specific incubation time, but this incubation time is not obligatory. Activate the
according measuring position (signal lamp below the measuring position constantly lighting
up green) by pressing the according activating key and start the incubation time with the
key “Incub Start“; the signal lamp of this measuring channel now light up yellow-orange. In
this mode it is possible to abort the incubation time by pressing again the according
activating key and then to start the measurement, but for precision reasons this is not
recommended. 5 seconds before the end of the adjusted incubation time (chapter 3.3) the
MC 10plus gives acoustic signals. When the incubation is finished or has been aborted the
according measuring position can be prepared for the test start with the key below the
17
measuring channel. The start reagent has to be added within the next 5 seconds which is
shown by blinking of the related display line and by the assigned green signal lamp. When a
measurement has been start in a measuring channel (by using an automatic start pipette
this happens automatically) the green signal lamp below this measuring position changes
its colour and flashes up red. After a test period of ca. 5 seconds the clotting reaction can
be simulated by slightly lifting the cuvette, the signal lamps constantly lights up red after
the clotting result detection. If a further measurement shall be done in a measuring
position in which already a measurement has been carried out before this measuring
position has to be reset by repressing the according measuring position key. By pressing
the key F3 on the keyboard all measuring positions can be reset simultaneously.
By pressing the F1 key you can switch on an automatic activation for the mechanical
measuring positions. After pipetting with an automatic pipette the next free measuring position
will then be prepared / activated for the measurement start. This automatic activation can
also be switched on by keeping the activation key of the mechanical measuring position, which
is the next position to be pipetted, pressed down until all following measurements have been
started.
By pressing the key ESC measurement and incubations can be aborted. Confirm the abort with
the ENTER-key.
For quitting the measure mode press once again the ESC-key.
When leaving the measure mode the signal lamps will keep the actual colour. The signal lamps
also keep their colour during the following operations until you re-enter the measure mode.
18
3.3
Test parameters
After switching on the analyser select the menu test parameter in the start menu by using the arrow
keys and confirm your selection by pressing ENTER. (The test parameter menu is protected by a PIN
and can only be entered by instructed staff).
Start menu
Measure mode
Test parameter
Settings menu
Patient memory
Service menu
Here different parameter specifications can be determined. By selecting the parameter to be modified
via the arrow keys and by confirming with ENTER you get into the display of the according parameter.
Depending on the parameter following settings can be done:
Test name
Incubation time
Result format
Calibration
Calculation
Result unit
Calibration value
INR-Calculation
INR-Std.-Value
ISI-Value
Ball or optical method
Single or double
Deviation (VC)
Start delay
Timeout time
PT
PT, NT or TT
several values1)
lin/rezi
%
max + min
YES / NO
value2)
value3)
FP 1
PTT
PTT
FIB
TZ
FIB
TZ
30, 40, 50, 60,...
number of digits before and after decimal point
several values1)
log/log
sec.
g/L.
sec.
max + min
ball (mechanical)
single / double
freely adjustable
freely adjustable between 3,5 and 30 seconds
freely adjustable (depending on result format)
FAK
FAK
sev. values1)
log/lin
sec.
max + min
-
FP 2
FP 3
Emergency Photometer
Test name
freely programmable
this
this
parameter parameter
Incubation time
30, 40, 50, 60,...
reverts to
reverts to
Result format
number of digits before and after decimal point
two other
one other
Calibration
several values1)
parameters parameter
Calculation
several calculation formulas
Result unitt
freely programmable
Calibration value
max + min
INR-calculation
YES / NO
INR-Std.
value2)
ISI-value
value3)
Ball or optical method
ball (mechanical) or optical
Single or double
single / double
double
Deviation (VC)
freely adjustable
(6%)
Start delay
freely adjustable between 3,5 and 30 seconds
Timeout time
freely adjustable (depending on result format)
1) These values have to be determined by the operator himself by means of suitable calibration material
19
2) These values have to be calculated by the operator resp. the MC 10 suggests this value
3) These values have to be taken from the package insert of the reagent Packungsbeilage
plus
For modifying these settings please press the left arrow key. Select the parameter setting which you
wish to modify by pressing ENTER and change the setting with the arrow or numerical keys. By
pressing the ENTER-key you confirm your input. By pressing the DEL-key the last input is deleted.
The MC 10plus automatically calculates the INR-standard value by means of the
programmed calibration curve and suggests the calculated value (in brackets).
The parameters which have been programmed as emergency are alway carried out in double
determination in the emergency mode. A test result can only be released when then deviation of both
single measurements does not exceed 6 % as it is fixed in the regulations of the
Federal Medical Association (RILIBÄK). If a parameter is carried out in general in double determination
and if it has been programmed as emergency parameter, then the deviation, which has been defined in
the test parameter setting, will bet he basis for the double determination of the emergency results.
The input screen for the test parameters is always the same. If a parameter does not require a
certain point (as e.g. the INR-data input the PTT) then this input field is hidden respectively skipped. This
means that this point can not be modified (e.g. the measurement method for PT, PTT, FIB, TZ and
FAK). If nevertheless such a modification should be required then this test has to be set up as freely
programmable test (FP1, FP2 or FP3).
The selected parameter can be printed by pressing the key F1.
By pressing the ENTER-key after the last input the modification of the test parameter programming is
saved. You call up the test parameter with the left arrow key again for modifying it or you leave this
screen with the right arrow key.
20
3.4
Test evaluation / calculation
3.4.1
Mechanical measurements (ball method)
The procedure of establishing the test value itself is always the same for all tests which have to
be carried out with the mechanical method. The time from adding the start reagent until clot
formation, through which the ball is pulled away from its basic position, is measured. In general
the measured time is converted into a parameter-specific unit whereas the graduation of the
measure axes in the conversion coordinate system can be different.
Example: calibration curve PT
(axes graduation log/log)
seconds
100
10
1
1
10
100
percent %
Furthermore the measured time of the PT can also be converted to the INR-value. Therefore it
is necessary to have either the INR-standard value which can be calculated by means of a selfestablished calibration curve or the by the MC 10plus suggested value which is calculated by
means of the entered calibration curve. This value is displayed in brackets in the test
parameters after the input for the INR-standard. Also the analyser-specific ISI-value which is
stated on the reagent package insert is required for the INR-calculation.
The calculation is carried out as follows:
INR=
21
(
measured time of the test material
INR-standard value
)
ISI
3.4.2
Optical measurements
For the optical test method there are five different kinds of detecting a clotting reaction
respectively the from that resulting test value determination. Here the test time also always
starts by adding the start reagent but the test procedures are different.
General:
For all following test procedures 405 or 650 nm wave length can be selected and for all test
methods the start delay and timeout time are freely programmable.
After completion of the measurement the curve can be displayed by pressing the key F2.
Clot 1:
After the start delay time the mean value of the last 10 test values (the determination of all 10
values takes 1 sec.) is calculated. This value is the basic value. After a freely selectable
extinction modification of 20, 30, 50 or 70 mOD there is a stop. The concentration is
calculated by comparison with a standard curve.
Clot 2:
After the end of the start delay time a straight line (horizontal) is searched. This straight line
represents the basic value. After a freely selectable extinction modification of 20, 30, 50 or 70
mOD there is a stop. The concentration is calculated by comparison with a standard curve.
Example for Clot 1
Test points of an optical clotting measurement
(e.g. 405nm 20mOD straight)
Test value in mOD
140
120
100
80
8 identical
measurements
60
20mOD
40
20
Test value
0
0
20
40
60
80
100
120
Time in sec.
Clot 3:
After the end of the start delay time the mean value is searched at first (as for Clot 1). The
course is observed. If this value becomes lower this value is taken as basic value. Always the
lowest value is the basic value. After a freely selectable extinction modification of 20, 30, 50 or
70 mOD there is a stop. The concentration is calculated by comparison with a standard curve.
22
Chromogenic:
After a freely selectable interval (10 / 20 / 30 sec. or 20 / 40 / 60 sec. or 30 / 60 / 90
sec.) the extinction modifications are measured. The modification is calculated in mOD/min.
The concentration is calculated by comparison with a standard curve.
Example for chromogenic measurement
Test points of an optical clotting measurement
(measurement by 30-60-90 seconds)
Test value in mOD
200
150
100
50
1st test
0
0
20
2nd test
40
60
3rd test
80
100
120
Time in sec.
Delta E:
The first test value is established after the end of the start delay time as for Clot 1. The second
value is established after the timeout time. The modification is displayed in mOD. The
concentration is calculated by comparison with a standard curve.
Example for time measurement Delta E
Test points of an optical clotting measurement
(measurement by defined time)
Test value in mOD
200
150
Test value
100
50
defined test time
0
0
20
40
60
80
100
120
Time in sec.
Ensure the correct kind of calculation resp. measurement when entering the test parameters.
The correct test method is stated on the reagent package insert. For questions please approach
your contact person, the reagent supplier or the company ABW.
23
3.5
Settings menu
After switching on the analyser select the menu settings menu in the start menu by using the arrow
keys and confirm your selection by pressing ENTER. (The settings menu is protected by a PIN and can
only be entered by instructed staff).
Start menu
Measure mode
Test parameter
Settings menu
Patient memory
Service menu
In this menu different user-specific system settings can be made. If the settings menu has been
selected following screen appears:
Settings menu
Date and time
Default-Parameters
Software-Version
Language
Print settings
Print result list
Barcode Scanner
Online-Setup
Measure set-up
Quit
3.5.1
Date and time
After selection of this point with the arrow keys and after confirming the selection by pressing
ENTER you reach the mask where the system date and time can be modified. The actual
system date is displayed in the upper line. In the lines below you can modify date, month and
year by using the arrow and numerical keys. Every input has to be confirmed with the ENTERkey.
The actual time is displayed below the date settings. You can modify the time also with the
arrow and numerical keys. Every input has to be confirmed with the ENTER-key.
You can quit the date and time setting mask via the ESC-key.
24
3.5.2 Default parameters
In the MC 10plus some basic settings as e.g. a calibration curve for PT, incubation times and so
on are programmed. Through these settings the instrument can be reset to the starting
values.
Please note: If you confirm this point with the left arrow key
then all your parameter inputs are deleted
3.5.3
Software-Version
In this mask the actual software version is displayed. After confirmation the checksum of all
inputs is checked and displayed. By pressing the ESC-key you get back to the settings menu.
3.5.4
Language
It is possible to programme the MC 10plus with the required language of a country. For the time
being following languages can be adjusted with the arrow keys:
English
German
Chinese
Further languages can be programmed after consulting the manufacturer.
3.5.5
Print settings
The user-specific settings as e.g. calibration curves and other parameter settings can by
printed with an external printer. For printing these settings please select this point with the
arrow keys and confirm the print-out by pressing the left arrow key. By pressing the ESC-key
you return to the settings menu.
3.5.6
Print result list
The MC 10plus has a test value memory in which the last 1,000 test values can be saved. If you
select this point with the arrow keys, the patient-ID resp. The running number can be entered
via the keyboard. By this the entry in question can be called up, printed or sent online once
again. For calling up a test result block or for resending or printing is the first and last patientID has to be entered and confirmed with the ENTER-key. By pressing the ESC-key you return to
the settings menu.
3.5.7
Barcode Scanner
In this menu the available barcode scanner and the barcode settings are
programmed. The according scanner and the settings can be selected with the arrow keys.
Then confirm the input by pressing the ENTER-key. For this setting please contact your
responsible IT-manager.
25
Operation breakdown with the barcode scanner:
When all adjustments for the barcode scanner have been effected in the settings menu the
measurement procedure can be started:
At first the counter has to be activated by pressing the according preselection key. Then the
barcode has to be entered with the barcode scanner or manually within the next 5 sec. Thus
all IDs are assigned resp. the working list is established. If a wrong ID-number has been
entered then it can be selected directly and deleted with the key DEL.
3.5.8
Online setup
For the online connection of the MC 10plus the settings for the data communication with the
host (LIS) can be adjusted in this menu. If you have any questions concerning these settings
please contact your responsible IT-manager, ABW (Fon: +495261_927294) or a person in
charge who has been instructed by the manufacturer.
3.5.9
Measure setup
When „Suggest patient ID“ is displayed you can choose YES or NO. If you choose YES the
instrument suggests the last patient ID + 1, if you choose NO no ID will be suggested.
3.5.9.1
Forced incubation
In this menu you can force the incubation which is programmed for the measure mode. This
means an incubation must take place before a measurement can be carried out in the
according measurement position (chapter 3.2.1).
3.5.9.2
Channel autoreset
Furthermore you can reset the measuring positions in this menu point by pressing the
according measure channel selection key once only under measure channel autorest. Thereby
this measuring position is activated for a new measurement the keys F1 (autom. measure
channel activation) and F3 (measure channel reset of all measure channels) are not active in
this case.
26
3.5.9.3
Interval mode
In order to test also very unstable clots with lowest fibrin concentrations the MC 10 can also
be operated in a switchable interval mode. If the interval mode is switched on (interval start
greater than zero), the operation changes from the continuous rotation of the measuring
position to an interval mode after the previously adjusted start time. The interval start can be
holded up and accelerated whereas the according adjustment has to be made before. The
pulse time is always 1.5 sec respectively one rotation.
3.5.9.3.1 Waiting time
The stop time depends on the up to now measured time and on the adjusted percentage
increase „waiting time“. During the waiting times no measurements are possible and the CV of
the expected test results increases proportionally to the input of the percentage increase of
the waiting time whereas the probability of detecting also lowest fibrin concentrations is
increasing.
Example:
Interval start = 60 Sek.
Waiting time = 10%
6,0 sec.
6,75 sec
7,58 sec.
8,48 sec
9,48 sec. and so on
Rotation of the
measuring position
adjusted
nterval-start
Measuring position
“waits” (is pausing)
1,5 sec.
time
3.6
Patient memory
In the patient memory you can revert to the patient-ID-numbers as well as to the individual test results.
Search patient-ID:
For calling up a certain patient-ID you can enter it directly via the numerical keys, count up and down
with the arrow key  and  or read in via the barcode scanner.
The first test result of the patient in questions is displayed und you have following options:
Print patient:
send online:
continue searching:
input patient-ID:
press F1
press F2
press 
press 
With the -key the next result of this patient can be displayed. In this way all results of a patient can be
called up one after another.
27
Print by patient-ID:
With this menu item the patient results can be printed.
Before the printout the patient-ID can be entered via the numerical keys, counted up and down with the
arrow keys  and  or read in with the barcode scanner. Then the print command can be given with
the ENTER-key .
Print by date:
All results of all patients of a defined date are printed.
Send online by patient-ID:
With this function you can send the patient date to the connected PC.
Send online by date:
With this function you can send the data of a prior defined date to the connected PC.
Delete:
With the delete function the memory of the instrument is deleted completely (all test results). The
moment of deletion depends on the internal laboratory organisation. It is recommended to carry out
the deletion procedure every morning before start of work.
Altogether up to 1,000 results can be stored whereby the storing procedure is basing on the FIFOprinciple (first-in-first-out). When result no. 1,001 is stored the result no. 1 is deleted automatically
from the memory.
3.7
Service-menu
After switching on the analyser select the menu service menu in the start menu by using the arrow
keys and confirm your selection by pressing ENTER. (The service menu is protected by a PIN and can
only be entered by instructed staff).
In this menu you can - with the support of the manufacturer - you can modify instrument specific
parameters as e.g. measuring block temperature, measuring channel turning speed etc. The service
menu can only be opened after prior consultation with the manufacturer.
28
4.
Pipetting technique
4.1
Precision and correctness
The accuracy of the MC 10plus depends on the correctness and precision with which sample
and reagents are pipetted.
4.1.1 Pipetting with a microlitre pipette
Tests can either be carried out with manual micro litre pipettes or with automatic pipettes
which are equipped with a contact line. If an automatic pipette is used for dispensing the start
reagent the time keeper will be started automatically as soon as the reagent is dispensed. If
the start reagent is dispensed with a manual microlitre pipette the time keeper has to be
started simultaneously by pressing one of the two manual start keys which are located next to
the activating keys for the measuring channels.
It is imperative that a suitable pipette tip is used for the pipette. Only the for the according
pipette recommended tips should be used.
Pipette tips with out of shape connection pieces should be removed. Bent or otherwise
damaged pipette tips should also be disposed of. The tip opening must not be blocked.
Place a pipette tip on the pipette cone. For fixing the tip push it slightly to the top and turn it to
the right. If the tip is not fixed at the pipette the precision can be affected negatively. For fixing
the tip on the automatic pipette (accessory item) the tip has to be turned to the right
(clockwise) in order to avoid that the shaft tip loosens.
Most of the pipettes have 2 dispense positions. The first position is the calibrated volume for
the pipette and is used for the absorption of the sample respectively the reagent. The second
position is used for the dispense in order to ensure the complete dispense of the tip content.
The automatic pipette (available as accessory item) is equipped with a lateral pipette switch in
contrast to most usual pipettes which have a button on top of the pipette (chapter 1.7). For
pushing the switch place your thumb over the switch and press it down. The pipette has the
two above described positions.
In order to avoid a contamination of reagent (if the same pipette is used for both sample and
reagent) the tip has to be exchanged between the dispense of sample and reagent. The
automatic microlitre pipette is equipped with an ejector cap at the upper end. For disposing the
tip just press the yellow cap.
In order to avoid a cross contamination of samples a new tip should be used for every sample.
For pipetting citrated whole blood this procedure is stipulated.
29
4.1.2 Volume selection on automatic microlitre pipette
Press down the lateral grey pipette switch into the first position and keep it pressed.
Turn the silver adjusting button until the requested volume appears in the window at the top of
the pipette. The pipette can be adjusted for absorbing and dispensing 50, 100 or 200 µl.
4.1.3 Pipetting with a Handystep dispenser
Tests can either be carried out with a manual or an automatic Handystep dispenser which are
equipped with a contact line or which are wireless. If an automatic Handystep pipette is used
for dispensing the start reagent the time keeper is started automatically as soon as the
reagent is dispensed. If a manual Handystep pipette is used for dispensing the start reagent
the time keeper has to be started simultaneously by pressing one of the two manual start keys
which are located next to the activating keys for the measuring channels.
It is important that only combitips which are suitable for the Handystep pipette are employed.
Only combitips which are recommended for the according Handystep pipette should be
employed.
Combitips with out of shape connection pieces should be removed. Bent or otherwise damaged
combitips should also be disposed of. The tip opening must not be blocked.
For mounting a combitip push down the locking / filling lever of the Handystep pipette to the
lower stop. Pull out the locking / filling lever slightly and swing it out. Then insert the tipp and
swing the locking / filling lever back to lock the tip. If you dip not the tip 3 – 10 mm into the
start reagent the liquid can be absorbed by raising the locking / filling lever slowly to prevent
cavitation.
4.1.4
Volume selection on the Handystep dispenser
Adjust the Handystep pipette with the sliding switch for volume selection according to the
inserted combitip respectively the required dispense quantity of the start reagent (therefore
regard the chart on the back of the Handystep pipette). For the reason of precision the first
start reagent dispense should be discarded.
No matter which type of pipette is employed: the pipetting precision is proportional to the
correctness and precision of the test results.
30
4.2
Sample absorption (microlitre pipette)
Press down the pipetting key until the first stop. Hold it and immerse the tip ca. 2 - 3 mm into
the sample resp. the reagent. If plasma is pipetted directly from a centrifuged sample tube it
has to be granted that the tip does not get into touch with the cruor. So you ensure that the
aspiration of erythrocytes or blood platelets is avoided. If a reagent in the form of particles is
pipetted, the reagent should be mixed up very well before the pipetting procedure.
Let the pipetting key slide back slowly in order to let the sample / reagent flow constantly into
the pipetting tip. A slow absorption ensures that the correct volume gets into the tip. A sudden
release of the pipetting key may cause the absorption of a wrong volume. Furthermore a
certain part of the sample / reagent may get into the pipette piston which may cause a
contamination of the following samples / reagent. If liquid has been aspirated into the pipette
piston the pipette has to be unscrewed and cleaned. Otherwise the pipette blocks and does not
aspirate reliably.
If the tip is filled no drops may leak. If this happens anyhow either the tip is not connected
correctly or he pipette has to be serviced. In this case exchange the tip. If the problem is not
sorted out the pipette may not be used before it has been inspected.
31
4.3
Sample dispense (microlitre pipette)
The sample should be dispensed in the 12 o’clock position of the cuvette (please see picture).
Aim with the pipette at the 12 o’clock position. Position the tip approximately 3 – 4 mm over
the bottom of the cuvette. Press down the pipette switch until the first position and keep it
pressed 1 – 2 seconds for letting the remaining content accumulated down in the tip. Press
the switch down until the second stop. By this the sample residuals in the pipette are
dispensed. In order to avoid bubble formations and splashes the tip has to be positioned in
such a distance to the bottom of the cuvette that it is in the sample at the end of the
distribution procedure. Alternatively you can hold the tip to the side wall of the cuvette
approximately 3 – 4 mm above the bottom of the cuvette and you then press down the switch
slowly into the first position. Wait 1 – 2 seconds and press then the pipetting key until the
second stop. For the sample distribution the tip should not touch the upper part of the side wall
of the cuvette. Any part of the sample that sticks at the upper part of the side wall of the
cuvette is not involved in the coagulation reaction.
pipette tip
pipette tip
cuvette
testing material
(12 o’clock)
ball (6 o’clock)
32
4.4
Dispense of reagent 1 (microlitre pipette or Handystep pipette)
(can be pipetted in the measuring cell and as well in the cuvette pre-heating station)
During tests for which more than one reagent is used the first reagent should be dispensed in
the 9 o’clock position of the cuvette (please see picture). Go with the pipette into the 9 o’clock
position. Position the tip 2 – 3 mm above the bottom of the cuvette.
Press down the pipetting key until the first stop and hold it down for 1 –2 seconds in order to
let the remaining content accumulate down in the tip. Press down the pipetting key until the
second stop. In order to avoid bubble formations and splashes the tip has to be positioned in
such a distance to the bottom of the cuvette that it is not in touch with the test material of the
distribution procedure. Alternatively you can hold the tip to the side wall of the cuvette
approximately 3 – 4 mm above the bottom of the cuvette and then you press down the
pipetting key slowly until the first stop. Wait 1 – 2 seconds and press then the pipetting key
down to the second. In order to avoid a contamination of the reagent during the following
pipetting procedures of the reagents it has to be taken care that the tip does not touch the
already dispensed sample (not if this reagent has already been added in the cuvette preheating station).
pipette tip
cuvette
testing
material
(12 o’clock)
distribution of the
first reagent
(9 o’clock)
ball
ball
distribution of the
first reagent
(9 o’clock)
view from the front
33
view from the side
4.5
Dispense of start reagent (microlitre pipette or Handystep pipette)
The start reagent sets off the coagulation reaction as soon as it is added. It should be
dispensed directly to the right of the ball. Through this positioning it is ensured that the reagent
and the other components of this mixture are mixed immediately. Hold the pipette obliquely
from the right and aim with the pipette tip at the right side of the ball. Position the tip
approximately 5 – 6 mm above the ball and press the pipetting key into until the last stop. The
distribution should not be carried out so fast that the reagent splashes out of the cuvette. In
order to avoid a contamination of the reagent during the following reagent pipetting
procedures it has to be taken care that the tip does not touch the already dispensed sample
and / or the already dispensed reagent. You can find a detailed illustration of the possible
automatic pipettes in chapters 1.7 and 1.8.
pipette tip
cuvette
distribution of the
start reagent
(right side of the ball)
distribution of the
first reagent
(9 o’clock)
testing material
(12 o’clock)
ball
9 o’clock position
view from the front
view from the side
34
5.
Operation
5.1
Keyboard layout
All functions of the MC 10plus can be called up with the keyboard (under the display)
5.2
Switch on the instrument
Switch on the MC 10plus with the ON-/Off-switch on the back of the instrument.
The MC 10plus makes a signal tone and the display is lighted up and the signal lamps under the
measuring positions light up yellow-orange. Watch the display.
After approx. 15 sec. the display changes automatically from the welcome display to the start
menu. The signal lamps do no longer light up.
Start menu
Measure mode
Test parameter
Settings-menu
Patient memory
Service menu
Select „Measure mode“ by means of the arrow keys and confirm by pressing the ENTER-key.
You have to communicate the MC 10plus now in the work mode menu whether a running
number or a Pat.-ID shall be used for the sample test result identification.
In addition to these possibilities an urgent sample can be defined as “Emergency“, for which
two parameters have been defined before (chapter 3.3) in order to ensure a quickest possible
measurement.
Workmode menu
Running number
Input Pat.-ID
Emergency
Quit
Select the required patient definition with the arrow keys and confirm with ENTER.
35
Now define the test to be carried out. You can select the according parameter with the arrow
keys and confirm your selection with the ENTER-key.
Select test
PT
PTT
FIB
TZ
FAK
FP 1
FP 2
FP 3
Quit
If you wish to work with a running number for the sample identification you have to enter a
start number for the first sample to be measured. The MC 10plus suggests number one. (if an
identification via Pat.-ID is required skip the next display).
Running number
Test:
PT
Input stsarting no.: 1
Confirm the input with the ENTER-key. Then you get automatically to the measuring
programme. Here the signal lamps light up green constantly.
A measurement can not be started before the measuring block has reached the programmed
temperature. If the temperature is not yet reached then “TEMP” will flash in the upper right
corner when you try to start a measurement.
MZ
1
12
13
14
15
16
17
18
19
20
21
Measuring mode TEMP = 37.3°C
Pat.-ID PROG
TIME RESULT INFO
STOP
STOP
STOP
STOP
STOP
STOP
STOP
STOP
STOP
STOP
INIT
F1 = AUTO
F3 = DELETE
36
5.3
Measurement of parameters with one reagent component
The instrument employs especially manufactured cuvettes and steel balls. Load a rack with
new cuvettes and balls and insert the rack with the cuvettes and balls into the pre-heating
stations for cuvettes above the measuring positions. Into cuvettes which has been positioned in
these pre-heating stations only then reagent is pipetted if the parameter consists of two
reagent substances (e.g. aPTT). The MC 10plus can process the test-related incubations time
which is programmed in the test parameters (chapter 3.3) in two different ways:
a) Force incubation time (chapter 3.5.9): if a measurement shall be carried out the rack with
the pre-heated cuvettes has to be positioned in the measuring channel row and the
measurement respectively the measuring channel has to be activated by pressing the
according activating key which is located under the measuring position. The activation for
this measuring channel is now active for 5 seconds which is indicated by flashing of the
according display line and the assigned greed signal lamp. The sample has to be pipetted
within this period of time and the incubation time keeper has to be started by pressing the
key “Incub Start” (on the left side of the activation keys) simultaneously. PLEASE NOTE – in
this mode an incubation is obligatory, i.e. an abort is not possible. When a measurement
has been start in a measuring channel the green signal lamp below this measuring position
changes its colour and flashes up constantly yellow-orange. 5 seconds before the end of the
in the settings menu selected incubation time (chapter 3.3) the MC 10plus signalizes
acoustically the end of this step in order to remind to pipette the start reagent and to start
the measurement. Then the measuring programme has to be activated again by pressing
the activating key under the measuring position. The activation for this measuring position is
now active for 5 seconds which is indicated by of the according display line and the assigned
greed signal lamp. The measurement can be started within these 5 seconds (assigned
display line and according green signal lamp). This happens automatically by adding the
(start) reagent (f no automatic pipette is used for adding the start reagent the
measurement has to be started by pressing one of the two manual start keys which are left
and right from the measuring position activating keys). The signal display changes its colour
and flashed red. The instrument automatically stops the measurement as soon as a clot is
formed. The signal display now lights up constantly red. For preparing a new measurement
press the activating key under the according measuring position or reset all measuring
positions simultaneously by pressing the F3-key (reset of all measuring positions with the
F3-key is not supported during automatic channel reset (chapter 3.5.9)).
Please ensure that the start reagent to be pipetted has
been pre-heated to 37°C in order to avoid incorrect
results. The pre-heating happens (according to the
employed start pipette) either in the tip of the Handystep
pipette (if the Handystep pipette has been stored in the
according pre-heating position) or in a reagent tube which
has been placed in a reagent pre-heating position.
37
b) Not force incubation time (chapter 3.5.9): If a measurement shall be carried out the rack
with the pre-heated cuvettes has to be inserted in the measuring position row and the
measurement respectively the measuring position has to be activated by pressing the
activating key under the measuring position. The activation for this measuring position is
now for 5 seconds active which is indicated by flashing up of the assigned display line and
the according green signal lamp. Within this period the sample has to be pipetted and the
incubation time keeper has to be started with the key “Incub Start“ (on the left side of the
activating keys). If an incubation starts in a measuring position the green signal lamp under
this measuring position starts its colour and lights up constantly yellow-orange. In this mode
the incubation can be aborted by pressing once again the according measuring position
activating key. For the reason of precision a premature incubation abort is not advised. 5
seconds before the end of the in the settings menu selected incubation time (chapter 3.3)
the MC 10plus signalizes acoustically the end of this step in order to remind to pipette the
start reagent and to start the measurement. If the incubation is finished or has been
aborted the measuring programme has to be activated again by pressing the activating key
under the measuring position. The activation for this measuring position is now active for 5
seconds which is indicated by of the according display line and the assigned greed signal
lamp. The measurement can be started within these 5 seconds (assigned display line and
according green signal lamp). This happens automatically by adding the (start) reagent (f no
automatic pipette is used for adding the start reagent the measurement has to be started
by pressing one of the two manual start keys which are left and right from the measuring
position activating keys). The signal display changes its colour and flashed red. The
instrument automatically stops the measurement as soon as a clot is formed. The signal
display now lights up constantly red. For preparing a new measurement press the activating
key under the according measuring position or reset all measuring positions simultaneously
by pressing the F3-key (reset of all measuring positions with the F3-key is not supported
during automatic channel reset(chapter 3.5.9)).
Example:
You wish determine the PT of a patient sample. Therefore load a rack with new
cuvettes and balls and place these cuvettes with the rack into the cuvette pre-heating stations
above the measuring position (see chapter 1.6 Views). Prepare the reagent according to the
package insert and aspirate it with the Handystep pipette respectively position the reagent in a
14.5 x 85 mm plastic tube in the measuring / pre-heating position above the cuvette preheating positions. Insert the rack with the pre-heated cuvettes into the measuring positions.
Then activate the measuring programme with the activating key under the measuring position
of the sample which has to be tested. Please note that the programme remains active only for
5 seconds. Pipette the plasma (50 µl for the MC 10plus micro, the volume may probably be
reduced – please consult the manufacturer) and start the incubation time keeper by pressing
the key “Incub Start“ which is on the left side of the activating keys, simultaneously. 5 seconds
before the end of the incubation time MC 10plus gives 5 acoustic signals ( 1 per second). Within
this period of time (5 seconds) the pre-heated reagent (100 µl for the MC 10plus micro) can be
aspirated with the pipette. If a Handystep pipette is used the reagent is pre-heated directly in
the pipette as the pipette is pre-heated in the according pipette storing position. After the end
of the incubation the measuring programme has to be activated again by pressing the
activating key under the measuring position. Again the programme remains active for only 5
seconds. Start the measurement by adding the start reagent with these 5 seconds into the
cuvette (if no automatic start pipette is used one of the two manual start keys on the right and
left side of the activating keys have to be pressed simultaneously with the dispense of the start
38
reagent). The measurement is stopped automatically when a coagulation reaction starts
respectively when a clot is formed.
According to the parameter and the settings the result can be converted to another result
unit.
Please regard the instructions (chapter 4) for pipetting plasma and reagent.
For preparing the next measurement press the activating key below the according measuring
position or reset all measuring positions simultaneously by pressing the F3-key (reset of all
measuring positions with the F3-key is not supported during automatic channel reset(chapter
3.5.9)).
5.4
Measurement of parameters with two reagent components
On the whole measurements of parameters with two reagent components (e.g. aPTT) do not
differ from measurements of parameters with one reagent component. Nevertheless you can
pipette the first reagent into the measuring cuvettes when these are still in the pre-heating
positions above the measuring positions, i.e. before the cuvette is changed over to the
measuring position. Please regard the parameter-related incubations time and then proceed
as described in chapter 5.3.
39
5.5
Measurement of parameters in the optical measuring position
If optical tests have to be carried out it has to be ensured that no used cuvette is in the optical
measuring position of the MC 10plus when it is switched on. If this can not be granted switch off
the instrument once again for the reason of security, remove the cuvette from optical
measuring position and switch on the analyser again.
The measurement of parameters in the optical measuring differs from measurements in the
mechanical measurement positions as follows:
a) The activating key of the measuring position is not located directly under the measuring
position but in the keyboard right from the right arrow key.
b) A total sample / reagent volume of at least 300 µl has to be reached ifor ensuring a
correct measurement.
Before a photometrical test can be carried out it has to be programmed as freely
programmable test (FP1, FP2 or FP3) in the test parameters (chapter 3.3). It is possible to
select a freely programmable test as photometrical test which can be run parallel to to
mechanical tests. Please ensure the correct input of the calculation formula (chapter 3.4 when
programming the test.
The measuring position activating key F1 is not activated for the photometrical measuring
position. The automatic measuring position reset has full function when this feature has been
adjusted accordingly in the settings menu.
40
5.6
Stopping of an incubation time
If the incubation time keeper of a measuring position has been started by mistake an abort can
be caused by pressing the measuring activating key once again. By doing so this measuring
position is prepared for the measurement start simultaneously. If the user has entered “Yes”
for the point “Force incubation time” in the settings menu prior to the measurement an abort
of the incubation is not possible.
5.7
Stopping after a mistakenly start of a measurement
If the measurement has been started mistakenly or the time keeping has not been stopped
automatically for other reasons the measurement can be stopped at any time by inserting a
new cuvette with ball into the measuring position. Let the cuvette turn approximately 5
seconds, then lift it slightly respectively remove this cuvette.
For preparing a new measurement press the activating key below the measuring position in question
or reset all measuring positions simultaneously by pressing the F3-key.
5.8
Switching off the device
If the analyser is not employed for a longer period of time it is recommended to switch off the
instrument by pressing the on-/off-switch at the back off the housing.
41
6.0
Warning hints for the operation
ATTENTION!
Used cuvettes are highly bio-hazardous and should be handled in compliance with the
in the laboratory valid safety instructions for the
dispose of bio-hazardous material.
WARNING!
Only the with the MC 10plus supplied suitable external power supply unit
(100 VAC – 240 VAC) should be used, otherwise the analyser could be damaged.
WARNING!
The length of the power lead and of the data cable to the online computer respectively to
the external printer may not exceed 3 m.
ATTENTION!
The instrument may not be connected
to an extension lead.
ATTENTION!
The cuvettes are disposable items
which may not be reused.
2
ATTENTION!
After positioning the cuvettes in the instrument the operator is obliged to ascertain that
a ball is in the cuvette.
CAUTION!
After opening the cuvette packing the cuvettes and balls have to be
protected against dust, moisture and other pollutions. They have to be
kept dry and stored in a suitable and safe place.
ATTENTION!
This instrument is classified as an in-vitro-diagnostic device!
IVD
ATTENTION!
If the operator is electrified a discharge may happen at the measuring / pre-heating
block of the MC 10plus. This discharge does not influence the functions of the MC 10plus.
42
7.
Hints for the handling
7.1
Handling of the reagents
The reagent in questions has to be prepared exactly
according the instructions of the reagent supplier.
Therefore please see the package insert. All reagents
which have to be pre-heated, should be dispensed into a
reagent tube (14.5 x 85 mm), the tube should be stored in
the reagent pre-heating station prior to the pipetting. The
liquid level in the tube should not exceed the upper edge of
the reagent station. It takes approximately 15 minutes to
heat up the reagent to the required working temperature.
All reagents should be used prior to their stated expiry
date.
7.2
reagent
Handling of the cuvettes
The cuvette packing is created in such a way that the cuvette can be picked up at the long
paper strip and then inserted directly in the measuring station. Pull off the paper protector
after the insertion into the station.
The correct size and surface structure of the cuvettes are decisive for the proper test
performance. For achieving correct values the cuvettes have to be kept absolutely clean. The
cuvettes are designed for just one single use. The balls in the cuvettes are made of special
steel. Purity, weight, size surface structure and magnetic properties of the balls are decisive
for the proper test performance. The balls which are part of the scope of delivery have been
tested with regard to their compatibility with the test method of the analyser as well as to their
chemical neutrality under the employment with plasma and coagulation reagent. Rust, little
impurities and oil residues may have a strong impact on the coagulation test results.
The correct performance of cuvettes and balls of other manufacturers can not be granted.
Therefore cuvettes and balls of other manufacturers may not be employed.
7.3
Handling of the testing material
The taking of the blood from a patient has a decisive influence on quality and precision of the
results. Here it is imperative to use according special syringes. Furthermore it has to be
ensured that the procedure of taking the blood is not carried out too fast, i.e. the blood may not
be pulled into the syringe too fast as otherwise the for the clotting analysis important parts
could be destroyed.
43
8.
Quality control
A regularly carried out quality control is the best monitoring system for reliable test results.
For making sure that the results of the control probe and of the unknown probe are evaluated
under the same test conditions the control material should be included in every test run. The
recommendations of the reagent manufacturer concerning the quality control should serve as
a guideline for the quality control report. If the control results are out of the stipulated ranges
this could be a hint for a system error of which the cause should be investigated immediately.
Frequent sources of error and instructions for the troubleshooting are listed in chapter 10.1
“Analytical errors”.
9.
Maintenance
9.1
Maintenance by user
The rotation speed, the power of the magnet sensor and the temperature of the analyser have
been calibrated by the manufacturer before delivery. It is recommended to check the
temperature of the measuring / pre-heating block periodically with a usual calibrated
thermometer. The turning speed of the measuring cell can as well be checked from time to
time with a calibrated (stop) watch.
A general cleaning is the only maintenance procedure that has to be carried out regularly. It is
recommended to clean the instrument from time to time with a damp cloth for removing dust
and other materials. Blood, serum and reagent residues should be removed immediately.
Reagents can cause corrosion. Liquids that have been spilled over the pre-heating station or
the measuring cell must be removed at once. Spilled samples have to be considered as
potentially bio-hazardous and must be removed immediately in strict compliance with the
appropriate safety precautions for avoiding a contamination of the personnel. If a
decontamination of the MC 10plus is required wipe off the area in question with a paper cloth
which is moistened with a mild disinfectant.
In addition to this there are no routine maintenance procedures for the MC 10plus.
Ball that fell erroneously into the station can be removed easily by means of a magnet.
44
9.2
System self-test
9.2.1 Automatic self-tests after switching on the device:
1)
After switching on the main memory (RAM) of the controller is checked at first. Should
an error be detected „XRAMERR“ appears in the LCD-display.
2)
Then printer and scanner are initialised and the welcome message is printed out. The
procedure is displayed in the lower left corner of the display
3)
A signal tone can be heard and the welcome display appears.
4)
The check sum of all resident adjusted parameters is checked. If this is not ok the
default parameters are loaded. This is always the case when the instrument is
switched on the first time after it has been built. Thereafter the error message “Default
parameter loaded” appears for indicating that among others the calibration curve is
active again! The error number 2000 is stored in the error list (chapter 10.2)
5)
When changing into the measuring mode the ball sensors are inspected, they have to
be inactive then. If this is not the case the error message „Error: Ball-Sensor is not OK!“
appears. The error number 2100 is stored in the error list (chapter 10.2).
9.2.2 Cycle tests during measuring mode:
45
1)
The communication via the I2C-bus (internal data management) is surveyed. If an error
occurs the message „Error found, I2CErr“ is displayed and the error number 1000 is
stored in the error list (chapter 10.2).
2)
The actually measured temperature is surveyed. If it exceeds 50°C the heating is
switched off and the message „Error found, Temp = VALUE“ is displayed. The error
number 1100 is stored in the error list (chapter 10.2).
3)
The communication with the LCD-display is surveyed. If an error occurs the message
„Error found, LCDErr“ is displayed and the error number 1200 is stored in the error
list (chapter 10.2).
10.
Errors
10.1 Analytical Errors
Error type
Possible causes
Instrument error
The MC 10plus is not connected
with the power supply unit
resp. power supply unit is not
plugged into the power outlet.
Troubleshooting
Make sure that the power lead
Display is not lighted after
is fixed in the socket of the
switching on the instrument
power supply unit. Make sure
with main switch on the
that the power lead of the
backside of the device.
power supply unit is plugged in
a suitable power outlet.
Instrument error
Check the temperature of the
After switching on the
Temperature sensor is out of incubation stations with a
instrument with the main
order or thermostat is
suitable thermometer. Read
switch on the backside the
overheated.
the temperature after approx.
temperature does not stabilize
10-15 minutes. Contact the
at 37.3°C.
technical customer service of
ABW.
Controls within the reagent
Pre-analytical error
Commercial vacuum tubes
range.
Sample tube under- or
have to be filled completely to
Unexpected result of patient
overfilled.
ensure the correct blood-/
samples.
anticoagulant relation.
Pre-analytical error
Anticoagulant has to be
Wrong volume, wrong sample applied according to the
material (e.g. EDTA, heparin), reagent manufacturer’s
wrong concentration or too
instructions.
less anticoagulant
Pre-analytical error
Citrate volume has not been
Wrong relation of
adjusted for patients with
anticoagulant and blood.
higher (>55%) or lower
(<21%) haematocrit.
Pre-analytical error
Samples containing micro or
Clot in the sample
macro clots should not be
taken for tests.
Pre-analytical error
Turn round gently and mix very
The mixing of the samples has well, avoid mechanical trauma.
been carried out either not at
all or insufficiently or too hard.
Pre-analytical error
Blood should not be taken by
Contamination with heparin.
the heparin-lock-method or by
a heparinised tube.
46
Error type
Controls within the reagent
range.
Unexpected result of patient
samples.
Possible causes
Pre-analytical error
Delay of transport or
processing resp. the use of not
standardised methods for
transport, processing, storage
or analysis of the sample.
Pre-analytical error
Contact with glass.
Sample-related
Loss of factors V and VIII.
Sample-related
Wrong volume has been
selected.
Reagent-related
Contaminated reagent.
Reagent-related
Wrong reagent has been
used.
Reagent-related
Wrong reagent volume has
been used.
Reagent-related
Reconstitution with the wrong
diluent volume
Reagent-related
Reconstitution with another
diluent than the recommended
diluent.
Reagent-related
New reagent batch with
different reactivity.
47
Troubleshooting
Follow the instructions of the
manufacturer. Centrifuge the
specimen and keep the
correct relative centripetal
force and time. Don’t store
samples for more than 4
hours at room temperature
or in the refrigerator.
Transfer the plasma by
means of plastic transfer
pipettes into a plastic
storage tube.
Don’t warm up the sample
longer than 5 minutes at
37°C.
Follow the manufacturer’s
instructions.
Reconstitute a new reagent
or open a new bottle.
Follow the manufacturer’s
instructions.
Follow the manufacturer’s
instructions.
Follow the manufacturer’s
instructions.
Follow the manufacturer’s
instructions.
It is quite usual that slight
differences in reactivity exist
between different batches.
Reverify the reference range
and establish – if required –
a reference curve
Error type
Controls within the reagent
range.
Unexpected result of patient
samples.
Possible causes
Reagent-related
Reagent disintegration.
Troubleshooting
Is this the first of this delivery
employed reagent? Is the
storage temperature correct?
Reagent-related
Reagent disintegration.
Don’t employ the reagent if the
reconstituted storage life of the
non-reconstituted reagent is
expired.
Reagent-related
The reagent should not be
Reagent disintegration due to stored in the analyser. When
too long heating in the reagent the test is completed remove
station.
the reagent from the
instrument, close and store the
reagent in compliance with the
manufacturer’s instructions.
Sample-related
Don’t touch the already
Contaminated reagent.
dispensed samples / reagents
with the pipette tip.
Controls-related
Dissolve new controls.
Disintegrated or contaminated Incorrect reconstituted control
material.
materials(s)! Reconstitute the
controls according to the
manufacturer’s instructions.
Only freshly deionised water
may be used for the
reconstruction.
Analytical error
A suitable tube has to be used.
Wrong reagent temperature. Please note that only such a
reagent volume may be
dispensed into the tube that
the filling height is not higher
than the pre-heating station.
Let the reagent come slowly to
room temperature (within 15 –
20 minutes). Some reagents
(thrombin reagent for
fibrinogen) may not be warmed
up, but they should be brought
to room temperature before
use. Please follow the
instructions of the reagent
manufacturer.
48
Error type
Controls within the reagent
range.
Unexpected result of patient
samples.
Irregular results within the
test.
Controls may be within or out
of the reagent range.
Possible causes
Analytical error
Wrong incubation time
Troubleshooting
Follow the manufacturer’s
instructions.
Analytical error
Wrong test sequence.
Analytical error
Imprecise manual pipetting of
sample and reagent.
Follow the manufacturer’s
instructions.
The pipette has to be maintained. The as accessory
available automatic pipette of
the MC 10plus is delivered with
manual. Please practise the
pipetting technique. The
instructions for the correct
pipetting technique are in
chapter 4 (pipetting).
Wrong dispensing position: it is
very important that the reagent
is always dispensed from the
same position. Please find the
instructions for the correct
pipetting technique in chapter
4 (pipetting).
Reagent in particle form has
not been mixed before
employment. Close the opening
of the tube with a cap or with
Parafilm™, turn round the tube
and mix it gently.
Sample and first reagent have
not been mixed. After sample
and reagent have been
dispensed take the cuvette out
of the pre-heating station and
sway it gently 5 or 6 times for
dispensing the mixture
constantly on the bottom of the
cuvette.
49
Error type
Analytical error
Irregular results within the
test.
Controls may be within or out
of the reagent range.
Possible causes
None or more balls than one
have been added.
Reagent-related
Irregular or imprecise
reconstitution of the reagent
or control material.
Reagent-related
Disintegrated reagent caused
by too long pre-heating
procedure in the reagent
station.
Reagent-related
Reagent concentration due to
vaporizing
Sample-related
Wrong taking and handling of
the samples.
Sample-related
No sample has been added.
Sample-related
Fibrinogen deficiency
Reagent-related
No reagent or wrong reagent
added.
Troubleshooting
Use one ball per cuvette.
Reconstitute a new reagent
and / or control material.
Remove the reagent from the
instrument when the analyses
are completed.
Reagent container has to be
closed when it is not used.
Check the integrity of the
sample. Inspect it with regard
to micro clots, haemolysis or
other problems. Ensure that
the relation of anticoagulant to
sample is correct (filled
completely). Take a new
sample.
If the results are irregular
again, check the clinical
condition of the patient. The
results of patients with
disseminated intravasal
coagulation (DIG) are usually
erratic. Take care that the
recommended storage
guidelines are followed.
Ensure that the sample has
been added.
Due to fibrinogen deficiency the
results of many clotting tests
are retarded essentially.
Make sure that the correct
reagents are employed.
50
Error type
A clot is formed but not
detected resp. timer does not
stop.
Possible causes
Analytical error
No ball in the cuvette.
Analytical error
Incorrect cuvette position.
Sample-related
A clot is formed within less
than 4.0 seconds.
9.2
Troubleshooting
Make sure that the ball does
not fall out of the cuvette before
you position the cuvette in the
measuring cell.
The ball is positioned above the
sensor. Make sure that the
bottom of the measuring cell is
not blocked by a ball or other
materials.
For fibrinogen tests use the
next higher dilution.
For stopping the timer insert a
new cuvette with a new ball into
the measuring cell. Take the
cuvette out of the measuring
position after 10 seconds.
System error
If the instrument detects an error during its self-test the error is indicated on the LCDDisplay. The device turns into a sleep mode and can only be waked up by switching it off and
on.
The instrument stores an error list with the last 15 errors. Every of the last 15 errors is
stored with date, time and error code. For printing out this list please contact the ABW–
Hotline (phone: +49 (0)5261 / 927 294).
Error-code
1000
1100
1200
2000
51
Meaning
I2C-Bus communication not OK (internal data management)
Temperature of the measuring block exceeds 50°C
LCD-display not OK
Check sum adjusted value are not OK, default values are loaded
11.
Additional printer
It is possible to connect the MC 10plus with an external printer (available as accessory) via the
serial 9-pole RS 232 interface. Please see the printer manual for detailed settings of the
printer.
Only the power supply unit which is delivered with the printer should be used.
The printer is connected to the MC 10plus with the supplied cable. Switch on the printer with the
main switch. When it is switched on the POWER lamp lights up.
The data are transmitted to the printer (when it is switched on) after the determination is
finished.
When the printer is switched off the data are not printed (they are also not printed when the
printer is switched on afterwards), but they can be printed later out of the printer buffer of the
MC 10plus (settings menu chapter 3.5).
The lamp flashes when paper has to be reloaded.
The selected test determines what is printed out. If PT has been selected the INR-value and the
percentage result are printed out in addition to the measured time. For all other tests only the
measured time is printed out. For all other tests the result is converted according the settings
in the test parameters or the measured time is printed out as sole result.
If the printer is in the OFF-status during the test procedure no data are transmitted. They can
be printed out from the printer buffer of the MC 10plus (see settings menu chapter 3.5) at a
later point of time.
More detailed description
and instructions for the use
of the Thermal Printer can
be found in the Thermal
Printer instruction booklet.
12.
Barcode scanner
For the connection of a barcode scanner, its settings and handling please see chapter 3.5.7.
52
13.
Appendix I
Verification document
The analyser to which this operation instruction is added
has been test as described in the following:
53
Instrument type
:
MC 10plus
Version
:
__________________________
Serial number
:
__________________________
Temperature measuring /
pre-heating block
:
__________________________
Speed measuring cell
:
__________________________
Test location
:
__________________________
Test date
:
__________________________
Tester
:
__________________________
EC Konformitätserklärung
EC Declaration of Conformity
Produktspezifikation / Product specification
Produktklassifikation / Product classification
In-vitro-Diagnostika / In-vitro diagnostics
Typ / Type
MC 1 / MC 1 plus / MC 4plus / MC 10 plus
Wir / We
ABW Medizin und Technik GmbH
Name des Anbieters / Supplier’s name
Lagesche Str. 15e, D-32657 Lemgo
Anschrift / Address
erklären in alleiniger Verantwortung, dass das oben genannte Produkt
declare under our sole responsibility that the product mentioned above
auf das sich die Erklärung bezieht, mit der / den folgenden Norm(en) oder normativen Dokument(en) übereinstimmt:
to which this declaration related is in conformity with the following standard(s) or other normative document(s):
nach folgenden Richtlinien und unter Anwendung der harmonisierten Normen entwickelt, konstruiert und produziert
worden ist:
to which this declaration relates, is in conformity with the following requirements:
Titel und / oder Nummer sowie Ausgabedatum der Norm(en) oder der anderen normativen Dokumente
Sicherheit:
EN 61010-1: Sicherheitsbestimmungen für elektrische Mess-, Steuer-, Regel und Laborgeräte:
Allgemeine Anforderungen
EN 61010-2-101: Sicherheitsbestimmungen für elektrische Mess-, Steuer-, Regel- und Laborgeräte:
Besondere Anforderungen an In-vitro-Diagnostik (IVD)-Medizingeräte
1.
2.
3.
4.
Safety:
EN 61010-1: Safety requirements for electrical equipment for measurement, control and laboratory
use: General requirements for safety
EN 61010-2-101: Safety requirements for electrical equipment for measurement, control and
laboratory use: Particular requirements for in-vitro-diagnostic (IVD)
EMV:
EN 61326-1: Elektromagnetische Verträglichkeit - Anforderungen
EMC:
EN 61326-1: Electromagnetic compatibility – Requirements
Risikomanagement:
DIN EN ISO 14971:3/2001: Medizinprodukte - Anwendung des Risikomanagement auf Medizinprodukte
Risk management:
DIN EN ISO 14971:3/2001: Medical devices - Application of risk management to medical devices
Informationen:
DIN EN 1041:4/98: Bereitstellung von Informationen durch den Hersteller eines Medizinproduktes
Information:
DIN EN 1041:4/98: Information supplied by the manufacturer with medical devices
Title and / or number and date of issue of the standard(s) or other nomative document(s)
(falls zutreffend) gemäß den Bestimmungen der Richtlinie(n) / (if applicable) following the provisions of the directive(s)
1.
2.
3.
4.
Anhang 1 der Richtlinie 98/79/EG über In-Vitro-Diagnostika
Geräte gem. Anhang III mit Ausnahme Abs. 6
Deutsches Medizinproduktegesetz
Richtlinie 80/181/EWG über die Einheit im Messwesen
Richtlinie RoHS 2011 / 65 / EU
Annex 1 of Directive 98/79/EC on in-vitro diagnostic
medical devices according Annex III exept Point 6
German medical product law
Directive 80/181/EEC relating to units of measurements
Directive RoHS 2011 / 65 / EU
Lemgo, April, 06th 2016
Ort und Datum der letzten Änderung
Place and date of issue of last amendment
Unterschrift der Geschäftsleitung
Signature of Managing Director
54
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