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Summary of Contents for Merlin medical MC10 PLUS
- Page 1 O P E R A T I O N M A N U A L Instrument Manufacturer: ABW Medizin und Technik GmbH&Co KG Lagesche Str.15 32657 Lemgo Germany MC and MERLIN are registered trademarks of ABW Medizin und Technik GmbH & Co KG www.merlinmedical.net Release 16_77...
- Page 2 © 2004-2020 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 & Co KG. This applies especially for copying, translating, microfilming and storing and data processing in electronic systems.
- Page 3 SAFETY INSTRUCTIONS Symbols used on the MERLINmedical haemostasis instruments and consumables Symbol Meaning Used on / in Do not reuse Balls & cuvettes In-Vitro Diagnostics Device Operation manuals MC 1 plus Biological risks MC 4 plus MC 10 MC 1 Consult instructions for use MC 4 plus...
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Page 4: Table Of Contents
TABLE OF CONTENTS 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 .. - Page 5 4.1.4 ..Volume selection on the HandyStep ® dispenser ..........30 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 ..
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Page 6: Introduction
Introduction 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”). -
Page 7: Purpose Of Use
Purpose of use The MC 10 plus 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. -
Page 8: Measuring Principles
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. -
Page 9: Specifications
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 10 (1 rack with 10 cuvettes) (if required also employable as... -
Page 10: Views Of The Mc 10 1.7
plus Views of the MC 10 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. -
Page 11: Plus
Component Function / Description 1. On- / off-switch main switch of the MC 10 plus 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. - Page 12 Laboratory Information System Views of a 3-volume microlitre pipette Component Function / description 1. Pipetting key For filling and dispensing start reagent. If a measuring position activating key has been pressed at the MC plus the time keeping can be started by pressing the pipetting key until the first stop.
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Page 13: Views Of A Handystep ® Pipette
Views of a Handystep pipette 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 10 plus the time keeping can be started by pressing the dispensing lever (automatic pipette). - Page 14 4. Combitip Adjust volume of the combitips and adjust the sliding switch for volume selection (no. 3) to pipetting volume...
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Page 15: Installation
Installation 2.1 Unpacking The MC 10 plus 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 ABW- contact person have to be informed accordingly and immediately. -
Page 16: Location Of The Instrument
Location of the instrument Place the MC 10 plus 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. -
Page 17: Connections Demand
Connection demands 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). Only employ the with the MC 10 plus supplied suitable external power supply unit, otherwise the analyser could be damaged. -
Page 18: Function
Switch on Function Welcome display: Menu structure MERLIN MC 10 plus (Version 1.7: 11.03.2007) Start menu Measure mode Testparameter Settings menu Patient memory Service menu Settings-Menu (PIN) Patient memory Testparameter (PIN) Workmode Menu Date and Time Search Pat.ID Running number Adjustment of date Input patient ID and system time... -
Page 19: Performance Test
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 10 plus are called up with the control keys below the display. Ensure that no used cuvette is in the optical measuring position. - Page 20 Select the required patient definition with the arrow keys and confirm with ENTER. 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 FP 1 FP 2 FP 3...
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Page 21: 3.2.1 Testing Of A Measurement Resp. Of An Incubation
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). - Page 22 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.
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Page 23: Test Parameter
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... - Page 24 1) These values have to be determined by the operator himself by means of suitable calibration material 2) These values have to be calculated by the operator resp. the MC 10 suggests this value plus 3) These values have to be taken from the package insert of the reagent Packungsbeilage For modifying these settings please press the left arrow key.
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Page 25: Test Evaluation / Calculation
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. -
Page 26: Optical Measurements
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. - Page 27 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)
- Page 28 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.
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Page 29: Settings Menu
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). -
Page 30: Software Version
3.5.2 Default parameters In the MC 10 plus 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... -
Page 31: Online Setup
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. -
Page 32: Interval Mode
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. -
Page 33: Service Menu
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 . -
Page 34: Pipetting Technique
Pipetting technique Precision and correctness The accuracy of the MC 10 plus 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. -
Page 35: Volume Selection On Automatic Microliter Pipette
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... -
Page 36: Sample Absorption (Microliter Pipette)
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. -
Page 37: Pipette
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 –... - Page 38 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).
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Page 39: Dispension Of Start Reagent
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. -
Page 40: Operation
Operation Keyboard layout All functions of the MC 10 plus can be called up with the keyboard (under the display) Switch on the instrument Switch on the MC 10 plus with the ON-/Off-switch on the back of the instrument. The MC 10 plus makes a signal tone and the display is lighted up and the signal lamps under the measuring positions light up yellow-orange. - Page 41 Select the required patient definition with the arrow keys and confirm with ENTER. 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 FP 1 FP 2 FP 3...
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Page 42: Measurement Of Parameters With One Reagent Component
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. - Page 43 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.
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Page 44: Measurement Of Parameters With Two Reagent Components
activating keys have to be pressed simultaneously with the dispense of the start 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. - Page 45 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 10 plus 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.
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Page 46: Stopping Of An Incubation Time
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”... -
Page 47: Warning Hints For The Operation
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 10 plus supplied suitable external power supply unit (100 VAC –... -
Page 48: Handling Of The Reagent
Hints for the handling 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. -
Page 49: Quality Control
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. -
Page 50: System Self-Test
System self-test 9.2.1 Automatic self-tests after switching on the device: 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. 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 A signal tone can be heard and the welcome display appears. -
Page 51: Errors
Errors 10.1 Analytical Errors Error type Possible causes Troubleshooting Instrument error Make sure that the power lead Display is not lighted after The MC 10 plus is not connected is fixed in the socket of the switching on the instrument with the power supply unit power supply unit. - Page 52 Error type Possible causes Troubleshooting Controls within the reagent Pre-analytical error Follow the instructions of the range. Delay of transport or manufacturer. Centrifuge the Unexpected result of patient processing resp. the use of not specimen and keep the samples. standardised methods for correct relative centripetal transport, processing, storage force and time.
- Page 53 Error type Possible causes Troubleshooting Controls within the reagent Reagent-related Is this the first of this delivery range. Reagent disintegration. employed reagent? Is the Unexpected result of patient storage temperature correct? samples. Reagent-related Don’t employ the reagent if the Reagent disintegration. reconstituted storage life of the non-reconstituted reagent is expired.
- Page 54 Error type Possible causes Troubleshooting Controls within the reagent Analytical error Follow the manufacturer’s range. Wrong incubation time instructions. Unexpected result of patient samples. Analytical error Follow the manufacturer’s Wrong test sequence. instructions. Irregular results within the Analytical error The pipette has to be main- test.
- Page 55 Error type Possible causes Troubleshooting Analytical error None or more balls than one Use one ball per cuvette. have been added. Irregular results within the Reagent-related Reconstitute a new reagent and test. Irregular or imprecise / or control material. Controls may be within or out reconstitution of the reagent of the reagent range.
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Page 56: System Errors
Error type Possible causes Troubleshooting A clot is formed but not Analytical error Make sure that the ball does not detected resp. timer does not No ball in the cuvette. fall out of the cuvette before stop. you position the cuvette in the measuring cell. -
Page 57: Addition Printer
Additional printer It is possible to connect the MC 10 plus 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 10 plus with the supplied cable. -
Page 58: Appendix I Verification Document
Appendix I Verification document The analyser to which this operation instruction is added has been test as described in the following: Instrument type MC 10 plus Version __________________________ Serial number __________________________ Temperature measuring / __________________________ pre-heating block Speed measuring cell __________________________ Test location __________________________... -
Page 59: Appendix Ii Declaration Of Conformity
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 & Co KG Name des Anbieters / Supplier’s name Lagesche Str.
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