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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 10

plus

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 10

plus

at the on / off-switch at the back side.

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. 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 10

plus

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

Содержание MC10 PLUS

Страница 1: ...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 IVD www merlinmedi...

Страница 2: ...ed 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 sy...

Страница 3: ...cs Device Operation manuals Biological risks MC 1 MC 4plus MC 10plus Consult instructions for use MC 1 MC 4plus MC 10plus LOT Batch code number Balls cuvettes Manufactured by MC 1 MC 4plus MC 10plus U...

Страница 4: ...erformance 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 measureme...

Страница 5: ...Handling of the cuvettes 43 7 3 Handling of the testing material 43 8 Quality control 44 9 Maintenance 44 9 1 Maintenance by user 44 9 2 System self test 45 9 2 1 Automatic self tests after switching...

Страница 6: ...repair are excluded from this guarantee Defects which are a not within the period of guarantee and not communicated within one week after occurring to ABW b caused by chemical decomposition or corrosi...

Страница 7: ...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 result...

Страница 8: ...c 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 magneti...

Страница 9: ...ttes if required also employable as reagent pipetting station Pre heated storing position for start reagent pipette 2 Pipette storing position at room temperature 1 Drills 14 5 x 85 0 mm 5 for reagent...

Страница 10: ...pettes 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 respect...

Страница 11: ...e 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 barc...

Страница 12: ...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...

Страница 13: ...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 reage...

Страница 14: ...11 4 Combitip Adjust volume of the combitips and adjust the sliding switch for volume selection no 3 to pipetting volume...

Страница 15: ...000 Reagent tubes plastic 14 5 mm x 80 0 mm 832158 300 Coagulometer tubes plastic 833118 500 Thermo paper 851057 5 Accessories description Cat No Packing unit Automatic pipette Handystep with start ca...

Страница 16: ...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...

Страница 17: ...g 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 volta...

Страница 18: ...e 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...

Страница 19: ...isplay 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 Pati...

Страница 20: ...ts number one if an identification via Pat ID is required skip the next display Running number Test PT Input starting no 1 Confirm the input with the ENTER key Then you get automatically to the measur...

Страница 21: ...s 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 pipet...

Страница 22: ...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 th...

Страница 23: ...log log lin Result unit sec g L sec sec Calibration value max min max min max min INR Calculation YES NO INR Std Value value2 ISI Value value3 Ball or optical method ball mechanical Single or double...

Страница 24: ...f both single measurements does not exceed 6 as it is fixed in the regulations of the Federal Medical Association RILIB K If a parameter is carried out in general in double determination and if it has...

Страница 25: ...urthermore 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 self established cal...

Страница 26: ...r 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 repr...

Страница 27: ...s established after the timeout time The modification is displayed in mOD The concentration is calculated by comparison with a standard curve Test points of an optical clotting measurement measurement...

Страница 28: ...ind 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 supp...

Страница 29: ...are 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 se...

Страница 30: ...rves 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...

Страница 31: ...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 I...

Страница 32: ...lly 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 75...

Страница 33: ...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 whereb...

Страница 34: ...he 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 t...

Страница 35: ...p 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 dam...

Страница 36: ...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 volu...

Страница 37: ...ormations 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...

Страница 38: ...s 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 si...

Страница 39: ...l 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...

Страница 40: ...elcome 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...

Страница 41: ...umber 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...

Страница 42: ...w 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 re...

Страница 43: ...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 accord...

Страница 44: ...ring 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 t...

Страница 45: ...ted 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 l has to be reached ifor ensuring a correct measurement Bef...

Страница 46: ...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...

Страница 47: ...ENTION The instrument may not be connected to an extension lead ATTENTION The cuvettes are disposable items which may not be reused ATTENTION After positioning the cuvettes in the instrument the opera...

Страница 48: ...e 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 prop...

Страница 49: ...ure 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...

Страница 50: ...ve 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 th...

Страница 51: ...nical customer service of ABW Controls within the reagent range Unexpected result of patient samples Pre analytical error Sample tube under or overfilled Commercial vacuum tubes have to be filled comp...

Страница 52: ...VIII Don t warm up the sample longer than 5 minutes at 37 C Sample related Wrong volume has been selected Follow the manufacturer s instructions Reagent related Contaminated reagent Reconstitute a new...

Страница 53: ...s instructions Sample related Contaminated reagent Don t touch the already dispensed samples reagents with the pipette tip Controls related Disintegrated or contaminated material Dissolve new control...

Страница 54: ...ered 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...

Страница 55: ...losed when it is not used Sample related Wrong taking and handling of the samples Check the integrity of the sample Inspect it with regard to micro clots haemolysis or other problems Ensure that the r...

Страница 56: ...mer insert a new cuvette with a new ball into the measuring cell Take the cuvette out of the measuring position after 10 seconds 9 2 System error If the instrument detects an error during its self tes...

Страница 57: ...he 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 t...

Страница 58: ...owing Instrument type Version Serial number Temperature measuring pre heating block Speed measuring cell Test location Test date Tester MC 10plus __________________________ __________________________...

Страница 59: ...4plus MC 10 plus 1 Sicherheit EN 61010 1 Sicherheitsbestimmungen f r elektrische Mess Steuer Regel und Laborger te Allgemeine Anforderungen EN 61010 2 101 Sicherheitsbestimmungen f r elektrische Mess...

Страница 60: ...54...

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