User manual coagulyzer 1 GB v1 1

Máy đông máu hdsd máy xét nghiệm đông máu bán tự động Coagulyzer , máy xét nghiệm đo các chỉ số đông máu PT, PTT, FIB các thành phần cơ bản trong đông máu Máy đông máu hdsd máy xét nghiệm đông máu bán tự động Coagulyzer , máy xét nghiệm đo các chỉ số đông máu PT, PTT, FIB các thành phần cơ bản trong đông máu Máy đông máu hdsd máy xét nghiệm đông máu bán tự động Coagulyzer , máy xét nghiệm đo các chỉ số đông máu PT, PTT, FIB các thành phần cơ bản trong đông máu Máy đông máu hdsd máy xét nghiệm đông máu bán tự động Coagulyzer , máy xét nghiệm đo các chỉ số đông máu PT, PTT, FIB các thành phần cơ bản trong đông máu

User Manual ® Coagulyzer For in-vitro diagnostic use only! Liability Disclaimer Analyticon Biotechnologies AG makes no express or implied warranty regarding this manual, its quality, performance, or appropriate use regarding any type of specific procedure Furthermore, this manual may be modified by Analyticon Biotechnologies AG without notice and without implying any obligation or liability on the part of the company Software Copyrights All software for the Coagulyzer (in the following Analyzer-Software) is the user and instrument control Software for the Coagulyzer and is the intellectual property of the initial manufacturer Intellectual property rights shall remain with the initial manufacturer Analyticon Biotechnologies AG is entitled to use the Analyzer-Software and the printed accompanying material Any violation of property rights or copyright or trademark or using conditions may be subject to legal action The initial manufacturer reserves the rights to modify the software, hardware and documentation without any prior written notice Intellectual Property Analyticon Biotechnologies AG Coagulyzer is registered trademark of Analyticon Biotechnologies AG No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translation into any language (human or computer) in any form, or by any means whatsoever, without the prior written permission of Analyticon Biotechnologies AG in behalf of the initial manufacturer Any reference to products, documentation, articles within this publication not expressly described as property of the initial manufacturer and Analyticon Biotechnologies AG shall be considered as intellectual property of the publishing company of this certain product, documentation and or article Revision History Version Manual Date (mm/dd/yy) Analyser Software-Version Release - 1.0 03/23/11 V2.14 1.1 08/25/11 V2.14 Analyticon Biotechnologies AG Am Mühlenberg 10 35104 Lichtenfels Germany Initial version CONTENTS TABLE OF CONTENTS INTRODUCTION 1.1 1.2 1.3 1.4 Application Instrument Description Hazard and Precautions Standard Symbols INSTALLATION 2.1 2.2 2.3 Connect an external printer Measuring Principle Reagents 10 SOFTWARE 11 3.1 3.2 3.3 Software overview 12 Flow Chart of different application methods 13 Method Parameters 14 OPERATION 15 4.1 Steps for Instrument Operation 15 4.1.1 4.1.2 4.1.3 4.1.4 4.2 Turn on analyser 15 STANDBY 16 How to measure 17 How to change methods 19 Method Parameterization 20 4.2.1 4.2.2 4.2.3 4.2.4 4.2.5 4.2.6 4.2.7 4.2.8 PT-parameterization 20 aPTT - parameterization 25 Fibrinogen G [g/l] - parameterization 28 Fibrinogen MG [mg/dl] - parameterization 31 Thrombin time parameterization 31 Intrinsic Factor parameterization 31 Extrinsic Factor – parameterization 31 Utilities 32 4.2.8.1 Menu printer 32 4.2.8.2 Menu computer 33 4.2.8.3 Menu beeper 33 4.2.8.4 Menu clock 33 4.2.8.5 Menu calibrate temp 34 4.2.8.6 Menu secret number 35 4.2.8.7 Menu cuvette test 35 4.3 Printer 36 SAFETY IN OPERATION 40 5.1 Maintenance and Hygiene 40 4.3.1 Sample print-outs PT and calibration 37 5.1.1 Disposal of the Analyser 40 5.2 Errors 41 5.2.1 5.2.2 5.2.3 5.2.4 5.2.5 Application errors 41 Error Messages 42 Errors during operation 43 Warnings 43 How to change fuses 43 APPENDIX 44 6.1 6.2 6.3 6.4 6.5 Disposables 44 Materials Supplied 44 Technical Data 45 Safety Specifications 47 Mathematics 48 Coagulyzer –Operators Manual 1.1 Page INTRODUCTION INTRODUCTION 1.1 Application The instrument type Coagulyzer (in the following titled as analyser) as described in this manual is an opto-mechanical coagulation analyser which applies the turbodensitometric measuring principle All routine coagulometric clotting tests such as Prothrombin time, activated and partial Thromboplastin time, Fibrinogen, and single factor assays can be performed with these types of instrument For in-vitro diagnostic use only! 1.2 Instrument Description The analyser is constructed in modular units A liquid crystal display with one row and characters has been integrated for visual communication The arrow keys ◄ / ► allow the operator to select the next step in the menu The numbers are for the entry of method parameters The Enter key is used to confirm an entry or a selection The parameter memory is accessed with the Mode-key Any procedure can be cancelled or stopped with the Esc-key The measuring channel is integrated into the 37.4°C incubation block with position for reagent bottle and positions for cuvettes Immediately after the analyser has been switched on, an adjustment provides cuvette detection According to the instructions on the display cuvette in or cuvette out, place a cuvette into the measuring channel or remove a cuvette from the measuring channel The next step during a run is always shown in the display A measurement is automatically started by adding the reagent to a sample cuvette Results can be printed via on optional, external printer or can be read from the display The connector for the external power adapter is located at the back side of the analyser The external power adapter can be connected to the mains with a voltage range from 100V - 240V, 47 - 63Hz Via the connection to the main voltage the analyser is automatically switched on or off For data output an RS 232 C 6-pin interface is also located on the back side of the analyser Coagulyzer –Operators Manual 1.1 Page INTRODUCTION The Analyser Figure No The Analyser Description Power and printer interfaces in the back Display line, Characters Membrane keypad with keys: Reset, Start, - 9, Mode, Enter, ESC, ◄, ► Incubation block 37°C: - positions for cuvettes - position for reagent bottle - measuring channel with light protection cap Name plate (underneath) Coagulyzer –Operators Manual 1.1 Page INTRODUCTION Description of keys Figure Membrane keypads Arrow-key left, right ◄ select display to the left ► select display to the right, set decimal point Esc-key Switch from measuring to STANDBY Exit a submenu Enter-key Confirm selection, advance printer paper Number-keys Enter parameters 0-key A print-out of the respective parameters for the selected method is generated by pressing during measuring Mode-key Calibration Menu selection, analyser settings, and method parameterization Exit a menu and save entered or modified data Start-key: manual testing Start sample incubation timer Sample adjustment Manual test start Manual test stop Reset-Key, reset testing, Break of run, adjustment of sample Coagulyzer –Operators Manual 1.1 Page INTRODUCTION 1.3 Hazard and Precautions The caution and safety regulations in this operator’s manual meet international classification; see also Chapter 1.4 Standard Symbols Symbol warns of a risk of injury or of a risk to life (for example by electrical shock) Symbol warns of a risk of injury or of the instrument being severely damaged Symbol introduces rules to be observed The following caution and safety regulations must be observed at all times: Electrical safety Check that the operating voltage is set correctly before you connect the device to the main power supply To connect the device to the power supply, use only sockets which are grounded in order to keep the risk of an electrical shock as low as possible Use only grounded extension cables Never remove protective guards or secured components since you could expose electrically live parts in this way Electrical connection contacts (plugs, sockets, etc.) can be electrically live Even after a device has been switched off, components (e.g capacitators) can be under voltage as the result of an electrical charge All current carrying parts are sources of danger for an electrical shock Surfaces (floors, work table) must not be moist when you are working with any electrical device Carry out only the maintenance work and/or the replacement of parts described in these operating instructions Unauthorized work on the device can lead to the guarantee obligation becoming null and void with necessary expensive service work to correct it All work which requires the analyser to be opened may only be carried out by a technician who is familiar with the risks related thereto Fire and explosion hazards Do not place any flammable or hazardous explosive material in the proximity of the analyser Coagulyzer –Operators Manual 1.1 Page INTRODUCTION Mechanical safety (Analyser is operating) Never open screw-fixed housing parts! There is always the risk of injury Samples/Reagents Risk of infections Avoid any contact between samples and/or test reagents with skin or mucous membranes and any contact with parts of the instrument that come into contact with samples/reagents All consumables, e.g cuvettes, reagent vessels, pipette tips that may be used to transfer liquid samples and reagents should be considered to be potentially infectious If specimens are spilled on the system, wipe them off at once and disinfect the instrument (see Chapter 5.1 Maintenance and Hygiene) Reagents may cause irritation to the skin and mucous membranes Always follow the manufacturer’s instructions for correct use given in the literature accompanying the reagent Dispose of spent samples and waste reagents and all consumables that have come into contact with them after completion of the measurements strictly in accordance with statutory directives and laboratory guidelines Wear gloves! There is the risk of infection Accuracy and precision of the measured results In order to ensure a flawless operation of the analyser measure control samples and watch the function of the instrument closely Faulty measurement results may result in an incorrect diagnosis or range danger for patient Restrictions for samples and reagents Resistance of cuvettes to organic solvents cannot be guaranteed For this reason, organic solvents should not be used unless they have been expressly permitted Only use the original manufacturer’s cuvettes and mixers! Use cuvettes and mixers once only! Prior of each measurement ensure a mixer is added to each cuvette User qualification The analyser should only be operated by trained personnel Ask you local dealer or distributor for further information on the availability of user trainings Coagulyzer –Operators Manual 1.1 Page INTRODUCTION 1.4 Standard Symbols A large number of symbols are used in this Operator’s Manual, on the instrument itself, and on available accessories and consumables Their meanings are given below: Manufacturer Order Number In Vitro Diagnostic Medical Device Serial Number CE Conformity Protect From Sunlight Refer to Operators Manual Recyclable Biological Risk Caution Temperature Limitation Danger Humidity Limitation Important Information Do Not Reuse Separate collection, handling and disposal for waste electrical and electronic equipment and its components Batch Code Electric Shock Warning Fuse Coagulyzer –Operators Manual 1.1 Page INSTALLATION INSTALLATION Remove the analyser from its packaging and verify that the accessories kit is complete Please notify your distributor immediately in the event that the shipment was incomplete Refer also to chapter 6.2 Materials Supplied Proceed as follows to install the analyser: • Prior to installation of the analyser read the instructions under chapter 1.3 Hazard and Precautions • Place the analyser in a position that it is not exposed to excess humidity, any explosive gases, or magnetic influences • Connect the power adapter between the analyser and a power supply (100V - 240V) free from interferences by large power users such as elevators and centrifuges • Use only the included original AC power adapter • Use only original cuvettes and stir bars which will assure proper operation of the instrument Switch on the analyser • Connect the external power adapter with the analyser • Connect the external power adapter with the mains; automatically the analyser is switched on Figure 2.1 Analyser connections Connect an external printer • Connect the data-cable between the analyser and the printer Ask your dealer for recommended printer types • Connect the power adapter to the printer (see figure 3) The printer will be set ON by connecting to the mains • Refer to chapter 4.2.8.1 Menu printer for proper printer setting Never operate the printer without paper! Read the instructions manual from the manufacturer of the printer for further details Coagulyzer –Operators Manual 1.1 Page OPERATION • Enter the current hour, minute, and second and press Enter 4.2.8.5 Menu calibrate temp You can adjust the temperature of the incubation block with this menu If you have accessed the menu and you not wish to adjust, press Esc to exit the menu When does the temperature have to be readjusted? You must readjust when the temperature of the incubation block deviates more than +/- 1°C measured with a calibrated digital thermometer Position for adjustment: The lower right cuvette position of the incubation block Refer to chapter 1.2 Instrument Description, figure If you like to verify or adjust the temperature, the cuvette at this position must be filled with 400 µl bi-distilled water Measuring tools: Digital multimeter with 1/2-digit display For example Voltkraft M-4650B and temperature measurement adapter for multimeter, e.g Fluke 80T150U, output in °C To verify the temperature place the measuring sensor into the cuvette position which is filled with bi-distilled water • Check the temperature after approx 10 If a temperature adjustment is necessary: • Select and press Enter to confirm selection < calib > The following display appears: int 37.4 Example! ext 37.4 • Wait until the temperature in the display has stabilized internally to 37.4 °C • Next enter the temperature displayed by the digital thermometer via the numerical keypad The entry will be displayed under extern • Press Enter to confirm the entry • Wait until the temperature has stabilized at 37.4 °C on the display intern As soon as the temperature has stabilized at 37.4 °C on the display intern the value must be compared with the value measured with the digital multimeter If the internal and external values are identical temperature adjustment has been completed Otherwise the procedure has to be repeated • Press Esc All values will be stored by the analyser Coagulyzer –Operators Manual 1.1 Page 34 OPERATION 4.2.8.6 Menu secret number < sec no > • Press Enter to confirm selection In the menu you are able to select a code number to restrict access to the parameter menus A number in the range between 00001 and 65535 can be chosen Once a sec.no has been selected the following display will appear: 11111< cret no (0=none) You can overwrite the number preset by the manufacturer • Press Enter to save the new number A print-out of secret number as well as serial number follows (printer mode: AUTO) Analyser name ser no C1770711 secret no=xxxxx - Sample print-out! x= number If zero is entered and saved instead of a number the secret number will not be queried when a parameter menu has been selected The entry must be completed with Enter if a secret number shorter digit is stored Without entering a secret number the customer can: - perform tests - change the test method without use of the secret number Once you have entered the secret number, you can - perform calibration of tests - perform settings and controls under UTILITIES and all its submenus 4.2.8.7 Menu cuvette test < cuvet > • Press Enter to confirm selection You can control the function of the automatic cuvette detection with this menu CUV-TEST cuv Coagulyzer –Operators Manual 1.1 Page 35 OPERATION If no cuvette is located in the measuring channel the display ( -) appears If a cuvette was placed in the measuring channel, the display cuv appears The display will show the respective status once a cuvette is placed into or removed from the analyser • Press Enter to leave the menu 4.3 Printer It is possible to link an external printer (optional) to the analyser, refer to chapter 2.1 Connect an external printer The connection to the printer shall be done via the RS 232C interface of the analyser Ask your local dealer for recommended printer models Coagulyzer –Operators Manual 1.1 Page 36 OPERATION 4.3.1 Sample print-outs PT and calibration General print-outs Once a method has been selected the programmed calibration curve parameters will be printed followed by the results The print-out is automatic as soon as a result has been obtained by the measuring channel Print-out of all parameters A print-out of all programmed test parameters can be generated as described in chapter 4.2.8 Utilities ======================= PARAMETER-PROTOCOL ( 980 Bytes) 1-channel V X.xx, mm/dd/yy math-vers V XX.xx actual date & time: 08.05.08, 14:44:00 [dd.mm.yy, hh.mm.ss] device-specific: -ser.no j582074 secret no = 11111 ntc_soll = 509 - global: Analyser name Dealer name parameter-ID: F1890078 Printer AUTO computer OFF Header OFF Beeper ON cuv detection ON method PT - method store PT Serial number of analyser Global Parameter Stored method parameter for PT cuv remove detection OFF filter.no = mode SINGLE incubat = 60 s start-reagent: Lot reagent = 100 ul 1st convers INTERPOLAT: 2nd convers INR ISI = 1.05 100.0 50.0 25.0 10.0 % 11.6 % 17.7 % 29.9 % 66.6 method store aPTT s s s s Coagulyzer –Operators Manual 1.1 Page 37 OPERATION print-out of method parameters If you press when the analyser is in the measuring mode, a parameter print-out for the selected method is generated print-outs PT PT Documentation Example: Conversions via a 4-point calibration curve in % and INR - method store PT actual date 08.05.08 cuv remove detection OFF Automatic cuvette detection mode DOUBLE coef.var = % incubat = 60 s Double determination Coefficient of variation Sample incubation time start-reagent: Lot 101xxx reagent = 100 ul Reagent lot no Reagent start volume 1st convers INTERPOLAT 2nd convers INR ISI = 1.05 conversion, calib curve / interpolation conversion INR ISI-constant 100.0%= 11.6 s 50.0%= 17.7 s 25.0%= 29.9 s 10.0%= 66.6 s results: Calibration curve points PT patient _ 08.05.08, 10:52:55 time = 12.0 s time = 12.8 s Mean = 12.4 s INR = 1.7 % = 88.4% Method Patient name Date, Time 1st measured time 2nd measured time Mean of measured times Conversion to INR Conversion to PT % Coagulyzer –Operators Manual 1.1 Page 38 OPERATION PT documentation Example: Conversion via Factor calibration curve in % and INR - method store PT actual date 08.05.08 cuv remove detection OFF Automatic cuvette detection mode DOUBLE coef.var = % incubat = 60 s Double determination Coefficient of variation Sample incubation time start-reagent: Lot 101xxx reagent = 100 ul Reagent lot no Reagent start volume 1st convers QUICK FACTOR 2nd convers INR 100% = 11.8s factor = 52 ISI = 1.05 results: PT patient _ 08.05.08, 12:58:38 time = 11.7 s time = 12.1 s Mean = 11.9 s INR = 1.01 quick = 98.1% Coagulyzer –Operators Manual 1.1 Method Patient name Date, Time 1st measured time 2nd measured time Mean of measured times Conversion to INR Conversion to PT % Page 39 SAFETY IN OPERATION SAFETY IN OPERATION 5.1 Maintenance and Hygiene Do not use organic acids for cleaning the instrument Always use the surface cleaning agents recommended by the specialist trade for this purpose Always use a moist cloth; not spray on or pour on any liquids, as they can affect the correct function of the instrument or damage it Keep the instrument free from dust and liquid spillages When not used for a prolonged period, place a dust cover over the instrument or place it in a cabinet If liquid has been spilled on the instrument, remove the contamination with a clean, absorbent non-woven cloth considering all applicable hygienic requirements If liquid has accidentally entered, or been pipetted into a measuring channel, remove the liquid with a pipette and then clean the measuring channel with a lint-free cloth Please consider all applicable hygienic requirements Contact our technical service if subsequent control measurements not produce the expected result The analyser is fitted with a lithium battery type Li-Mn CR 2430 (life approx years) It should be replaced by an authorised service operator after years at the latest Otherwise a faultless operation cannot be guaranteed The light protection caps are considered to be potentially contaminated therefore the manufacturer recommends to replace the light protection caps once a year Ask you local dealer or the manufacturer for further information 5.1.1 Disposal of the Analyser The following must be considered when disposing of the analyser: – The upper and lower part of the housing is made of polyurethane foam – Mechanical parts are predominantly made of aluminium and precious metals – Electronic parts must be disposed of in accordance with national directives for the disposal of electrical parts – For the safety of the operating personnel make sure the analyser has been disinfected before disposal Coagulyzer –Operators Manual 1.1 Page 40 SAFETY IN OPERATION 5.2 Errors Errors can be generated by the user and/or the system itself The analyser displays error messages and warnings in the display If the printer has been activated these messages will be printed 5.2.1 Application errors Application errors may cause error messages Possible causes are: - Air bubbles were created during pipetting - Pipetting was performed directly into the measuring channel without cuvette - The wrong pipette tips were used - The pipetted volume is incorrect (for variable Pipettes) - The pipetting process was too slow and the angle incorrect - The temperature of the start reagent deviates from 37°C - The reagent has been placed incorrectly - The sample or control is too old - No stir bar has been placed into the cuvette - Reagents have been carried over (PT or Fibrinogen reagent) - A reagent with the wrong lot number has been used - The reagent has not been used according to the package insert - The reagent used does not correspond to the method selected - No or an incorrect calibration curve is available - Errors appeared during the sample collection or centrifugation - No stirrer is placed into the reagent vial - Method parameters relevant for measuring are incorrect Should any of these errors occur and they are recognized in time, they must be remedied immediately Certain of these errors can only be recognized when determining control plasmas As a result we recommend running control plasma on a daily basis prior to running routine determinations Cancel incubation / measurement: By pressing the Reset-key, any process on the measuring channel can be cancelled Coagulyzer –Operators Manual 1.1 Page 41 SAFETY IN OPERATION 5.2.2 Error Messages Error message (Display) Cause Remedy BREAK timeout the maximum measuring time has been exceeded Probably no clotting found; optical test for clots; repeat test BREAK dark preparation for measurement is too turbid Dilute plasma or mix reagent BREAK top lim exceeded measuring range (too high) possibly caused by air bubbles repeat test BREAK bot lim exceeded measuring range (too low) repeat test BREAK motor mixer motor error occurred contact technical service BREAK noise loud noise after sample adjustment Check for air bubbles or other particles BREAK drift measured curve drifted after reagent has been added check sample for air bubbles break measurement cancelled with Reset Caused by user! break jump Measuring break because of a measuring value jump (no clotting) Repeat test and if necessary contact technical Service break readjust message is displayed if the light value is too dark during the adjustment phase Repeat test and dilute plasma if necessary mg/dl