User Manual - eazy CLOT- 4.53
Contents
1. has to be inserted completely Ensure stirrer inside the cuvette before placing the cuvette in measurement chamber Ensure the required quantity of sample in cuvette as per Reagent Pack Insert Fig 2 Sampie _ Stirrer Lock the cover by pressing down ward as shown below b 9 Fig 3 Display will Show Dispense Reagent 6 Reagent adding procedure If 1ml pipette is us ed for dispensing reagent then Shift the slider on the left side and put the Reagent through the big hole Slider Hole for 1ml Pipette dispensing Fig 4 If 100 50pl pipetteis used for dispensing reagent then shift the slider on the right side and put the reagent through the small hole Hole for 100 50uL Slider Pipette dispensing Fig 5 Version No 4 53 Effective Date Nov 2011 Page 15 of 29 eazy CLOT USER MANUAL 7 Insert the pipette straight in to the dispensing hole Ref Fig 6 Pipette Fig 6 8 Dispense the reagent when Dispense Reagent message comes on display 9 Display will showmessage PLEASE WAIT Indicating the measurement has started After clot detection this message will disappear and instrument will show the clotting time Version No 4 53 Effective Date Nov 2011 Page 16 of 29 eazy CLOT USER MANUAL 7 Precautions Version 4 53 Keep the place dry and clean Check MAINS grounding properly Use original packaging for transpor2. Choose Tesi Enter 132 press Enter Key Clinic Name Y N Select Arrow Keys 4 amp 6 to select Alphabets by moving curser ABCDEFGHIJKLMN NO Press Enter after selection and proceed Press Enter twice at last alphabet FIRST SCREEN OF INSTRUMENT A maximum number of 15 characters can be entered Version No 4 53 Effective Date Nov 2011 Page 20 of 29 eazy CLOT USER MANUAL 8 10 Motor ON check Press MENU Key Choose Test Enter 199 Press Enter Key To check continuous rotation of stirrer 8 11 Deleting all Tests Press MENU Key Choose Test Enter 200 Press Enter Key Programmed memory of all tests gets erased To delete particular test press menu key and select that particular test and press ENTER to delete it 8 12 Selection of Language Press MENU Key Choose Test Enter 254 Press Enter Key Language option Y N will displayed on screen with following options LANGUAGE OPTION 1 ENG 2 POR 3 SPA 4 ZFREN To select the language press the numberand ENTER key 8 13 List of Test Numbers Test Numbers Ue 132 To Enter Clinic Name 200 Version No 4 53 Effective Date Nov 2011 Page 21 of 29 eazy CLOT USER MANUAL 9 Programming Modes 9 1 Clot Time Mode Instrument measures only time there is no calculation this mode is used to can Run APTT PT Tests Press CLOT TIME key RENOVE CVT ELOS i ie d LID PRESS ENTER i Warning Cuvette ho
3. SOME OF THE TIPS FOR CAREFUL USAGE OF PRINTER ARE AS FOLLOWS 1 Do not pull the paper when loaded 2 Lift the paper lever carefully and load the paper 3 Keep the instrument clean and dust free eazy CLOT gives line feed automatically whenever it is necessary for clear reading like a While powering on b In between character lines However user also can give additional line feed to move the paper forward by a character line How to insert the paper Insert the thermal paper roll by placing the sensitive side facing down The sensitive paper side is recognizable by its smoother face Before inserting the paper After inserting the paper Version No 4 53 Effective Date Nov 2011 Page 11 of 29 eazy CLOT USER MANUAL Step 3 Printer setting operations Press MENU key under Programming Mode Incase of any problems in thermal printer following message will displayed SET PRINTER PR ENTER Check for paper and printer cover and press SKIP PRINTER PR YES 2 ENTER again to start printer User may operate the instrument by disabling the printer Press YES to disable the printer after above message To Set Printer again use following steps 1 Press FUNC key Delete test Y N Press NO key Set printer Y N Press YES key Step 4 Keyboard check Check key board by pressing MENU key first and all other keys later one should get a beep and either alpha numerical or numerical should appear on display Step
4. of copre te E AA 8 11 DELETING ALL TESTS 8 12 SELECTION OF LANGUAGE e e n EGET RS ope e 21 8 13 LIST OF TEST NUMBERS vena aE EER EAER ORAE e i e cU Re eder 21 jMUOUEP 22 042 PERCENTAGE PT MODE DE LAB re 25 10 TROUBLE SHOOTING 1 616065 0084 000066 eR P ds Qe 006496666666 ARN NOSE re esp Pe aun 27 TL DECONTAMINATION Becr 28 DECONTAMINATION 22226 dier beret br ii eet ecd fere ta Ee ERR 28 11 2 PURPOSE OF DECONTAMINATION sccsssssssessessesessessessescscessessessecessensesssesscseesessescessesseacseessessesessessesseaeseessesseeeseenecnseseens 28 11 3 GENERAL CONSIDERATIONS c ccscsssssesesscssessescsscssescssessessesseccsscsscsscscsscsscsscseseesscsscassscsscsscseacsssaecsesecsecseeascacsecsseseeaeeeeaees 28 11 4 PROCEDURE 12 SAFETY CLEARANCE ivvsssiscssiscsascessescovessccesasevevideavnecsvessonsvecebsees Fee Ine 29 Version No 4 53 Effective Date Nov 2011 Page 2 of 29 eazy CLOT USER MANUAL 1 General Information 1 1 Warranty Information Each Instrument is completely tested and guaranteed for twelve months from delivery The warranty applies to all the mechanical and electrical parts It is valid only for proper installation
5. use and maintenance in compliance with the instructions given in this manual ROBONIK will at its discretion repair or replace parts which may be found defective in the warranty period The warranty does not include any responsibility for direct or indirect personal and or material damages caused by improper use or maintenance of the instrument Parts that are inherently subject to deterioration are excluded from the warranty In case of defects due to misuse of the instrument any incidental expenses like travel and man hour service charges will be charged extra 1 2 Technical Service Robonik is always accessible to the customers for any kind of information about installation use maintenance etc While asking for service please refer to this manual and report the printed serial number on the identification label Only qualified technicians are entitled to fix the instrument the user as described in this manual should carry out ordinary maintenance Robonik technical service or an authorized service center with specialized technicians with suitable instrumentation and original spare parts are always available for extraordinary maintenance repair under a yearly maintenance contract or on specific demand 1 3 Disposal instruction In case of removal or disposal of instrument following instructions need to be followed e Do not dispose in municipal waste follow local regulations for instrument disposal e Plastic parts Elec
6. Packing Transport and Storage 4 1 General warnings Instrument has to be decontaminated before packing for transportation 4 2 Packing Packaging is needed whenever it is to be transported or shipped by courier or other means To pack the instrument follow the instructions as below described Decontaminate the instrument as explained IN Decontamination chapter Refer Index for page no of this manual Place the instrument into the original packaging box Instrument has to be properly protected by plastic protective material Put copy of safety clearance certificate copy of Safety Clearance certificate is attached at the end of this manual Mark the package with address instrument identification and warning labels 4 3 Instrument transportation The transportation of the instrument in unpacked condition must be limited within the room where it is used to avoid damage 4 4 Storage of thelnstrument Before storing the instrument for a long period pack it carefully as described above and store indoors Relative humidity has to be less than 85 and temperature between 10 c to 60 c Version No 4 53 Effective Date Nov 2011 Page 9 of 29 eazy CLOT USER MANUAL 5 Installation and start up instructions 5 1 Installation Step 1 Unpacking instructions Unpack the instrument Follow the symbols shown on outer packaging Check accessories as per packing list dispatch with the instrument Kindly store all packing m
7. 29 eazy CLOT USER MANUAL 11 Decontamination 11 1 Decontamination Procedure If the instrument is to be shipped after being exposed to potentially hazardous material it should be decontaminated The following procedure outlines how to decontaminate the instrument before packaging and shipment 11 2 Purpose of Decontamination Decontamination minimizes the risk to all who come in contact with the instrument during shipping handling and servicing 11 3 General Considerations e Any laboratory instrument that has been used for clinical analysis is considered a biohazard and should be decontaminated prior to handling Intact skin is generally considered an effective barrier against infectious Organisms however small abrasions and cuts may not be always being visible Prophylactic gloves must be worn when handling instruments that have not been decontaminated Gloved hands should be considered contaminated at all times and must be kept away from eyes mouth and nose at all times e Mucous membranes are considered prime entry routes form infectious agents Wear eye protection and a surgical mask when there is a possibility of aerosols e Eating and drinking while decontaminating instruments is not advisable 11 4 Procedure e solution of 5 Sodium Hypo Chlorite NaOCL solution Bleach is used Commercial bleach is 5 NaOCL household bleach is 3 NaOCL When using commercial bleach use a 10 1 mixture if using household ble
8. 5 Setting Date and Time Setting of date and time can be done with the help of FUNC key Press FUNC key Delete test Y N Press NO key Set TIME Y N Press YES key Enter date month and year in the same format Press ENTER key TIME HH MM SS Enter hour minutes and seconds in 24 hr format Press ENTER key H The instrument goes back to idle position Version No 4 53 Effective Date Nov 2011 Page 12 of 29 eazy CLOT USER MANUAL 6 Instrument Description Components of different views of the below pictured instrument 6 1 Perspective View Front view Display Alphanumerical keypad Printer Incubation Block Measurement Chamber 1 2 3 4 5 Rear View ON OFF SWITCH RS232 POT Contrast POT Version 4 53 Effective Date 2011 Page 13 of 29 eazy CLOT USER MANUAL 6 2 Keypad 6 3 Dispensing Holes Description e Press the right side of the measurement chamber as shown in Fig1 100 ul pipette dispensing hole 1 ml pipette dispensing hole Fig 1 Sliding cover holder Sliding Cover Version No 4 53 Effective Date Nov 2011 Page 14 of 29 eazy CLOT USER MANUAL 6 4 Operating Procedure Refer chapter 9 for operating Modes Follow the below steps when Display will Show PLACE CUVETTE 1 2 3 4 Lift the Chamber cover as shown in the figure Fig2 below Put the cuvette in the cuvette holder inside the chamber as shownin the figure Fig 2
9. Hs Sec C1 12 309 180 0 t2 15 00 50 0 cr 72 40 25 8 C4 of 12 8 5L 3969 ipm cT A aT i 45 3755 i oe pc LE div DM Page 26 of 29 USER MANUAL eazy CLOT 10 Trouble Shooting ERROR MESSAGES Memory over range SKIP PRIN PR YES SET PRI amp PR ENT Lamp Intensity Poor Other ERRORS No consistency in Reading Random readings stops at 1 0 sec Junk characters in 4 line of Initial display screen Version 4 53 Effective Date Nov 2011 USER MANUAL CORRECTIVE ACTION If Number of saved tests exceeds 40 tests then delete the unwanted tests and save the test 1 Check printer paper or printer cover properly placed 2 Refer to Printer setting in Start Up Instructions 1 When display shows REMOVE CUVT CLOS LID PRESS ENTER ensure cuvette should not be there NOTE While referencing cuvette should notbe there 2 Choose test 128 to see the lamp amplitude value It should not be below 3 000 CORRECTIVE ACTION 1 Check stirrer inside the cuvette 2 Follow the reagent volume as specified in Pack Insert 3 Cuvette base should be uniform it should not shake from its position 4 Check for incubation instructions as per reagent pack inserts 1 Check cuvette is inserted completely It should not shakeinside cuvette holder Choose MENU and test no 254 press YES and option for Language Refer 8 12 Page 27 of
10. the given warnings are not followed This symbol indicates a portion which is particularly important and should be studied carefully This symbol indicates a Protective Earth or Ground terminal General Symbols js Jg Symbol for Manufacturer Symbol for IN VITRO DIAGNOSTIC MEDICAL DEVICE Symbol for AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY 2 2 Use of the instrument Version No 4 53 Effective Date Nov 2011 Page 4 of 29 eazy CLOT USER MANUAL The instrument has to be used for the designed purposes under specified conditi ons following proper procedures and safety rules by qualified personnel THIS MANUAL CONTAINS INSTRUCTIONS FOR OPERATION BY QUALIFIED PERSONNEL ONLY A qualified user has to make sure that the environmental condition is suitable the installation is correct the use and maintenance are proper according to the general safety rules as well as to the particular precautions described in the manual However he is not entitled to repair the instrument A qualified technician is entitled to maintain and fix the instrument according to the instructions given using the original spare parts Maintain room temperature and humidity as specified in the manual The instrument has to be used as described in this manual If it is not use the protection provided by the instrument may be impaired Alterations to the instrument are strictly prohibited The user is liable a
11. USER MANUAL eazy CLOT USER MANUAL 9 4 Percentage PT mode PT In PT mode maximum 7calibrators can be selected it plots the graphs of clot time v s 96 concentration based on best fit Linear method Press PT key Enter the ISI value given in ISI Index reagent manual Enter Normal patient s Enter MNPT Time Prothrombin Time or control time Enter of Cals Maximum 7 Calibrators ENT 1 CAL TIME You can enter the clot time for given number of calibrator directly without running calibrators ENT 2 CAL TIME CAL 1 Enter 96 concentrations of all calibrators CAL 2 PLOT GRAPH Y N REMOVE CUVT CLOS Cuvette holder should be empty at this LID PRESS ENTER i PLACE CUVETTE Insert sample cuvette Remove cuvette before pressing enter key DISPENSE REAGENT REM CUV PRES ENT Press key to save test YE Name Test Y N S ABCDEFG CLEAR Press CLEAR key to Select the characters using come out of test arrow keys confirm by pressing ENTER on blinking character Saved directly as Conclude by pressing ENTER key twice at the last character Serial No of test without name Version No 4 53 Effective Date Nov 2011 Page 25 of 29 eazy CLOT Version No 4 53 Effective Date Nov 2011 eam qm i F E T ENT OGL 15 8 EHTSCRL TIME 244 61 3 C L 100 0 CAL 58 8 812 M CAL4 12 8 a um L NEAR MED
12. Y No 8 Press Timer ke NO MESSA z SET TIMER Y N RESET TIMERS Y N i Reset both Set Time 1 SET TIMER 1 Y N N YES O SET TIMER 2 Y N Enter the required incubation time and press ENTER key Once the time is completed the instrument will start beeping Intermediately press clear key once to stop beeping s tnl du eie en ee Ea Dus a a a d d etm 8 6 SAVING TEST To save the programmed test under any programming Mode Press FUNC key Display How to Operate Save Test Y N Press YES Key Yes Press YES Kev to Enter Name Name Tests Y N Test Number will be printed on the paper Save Test ABCDEF GHB aN without name Select Arrow Keys 4 amp 6 to select Alphabets by moving curser Press Enter after selection and proceed Press Enter twice at last alphabet Version No 4 53 Effective Date Nov 2011 Page 19 of 29 eazy CLOT USER MANUAL 8 7 Lamp Amplitude Press MENU Key Choose Test Enter 128 Press Enter Key Lamp amplitude will displayed on screen and can take printout It should be between 3 to 8 8 8 Listing of saved test Choose Test Press MENU Key Enter 129 and press ENTER key H Test Number The instrument will print a list of all saved tests Recalling of saved test Choose Test Test Number Press MENU Key Enter the test numberto be recalled H 8 9 To Enter clinic name Press MENU Key
13. ach a 6 1 mixture is required This is a caustic solution It is important to wear gloves and eye protection when handling it e Wipe down the carrier and all exposed surfaces of the unit with the bleach solution Remove the top shroud of the instrument and wipe down the top surface of the instrument base as well as the inside of the top shroud e Reassemble the unit and discard the used gloves and towels Version No 4 53 Effective Date Nov 2011 Page 28 of 29 eazy CLOT USER MANUAL 12 SAFETY CLEARANCE CERTIFICATE Please complete all information requests on this form prior to returning the instrument to the manufacturer or your local distributor for servicing repairs or return Thank you for your co operation Customer A Address qd Position Dep Tel Country Fax Post Code Model No Serial No Accessories Return Date of Purchase if known Report Fault Has the equipment been exposed to any of the following delete as applicable a Blood body fluids pathological specimens YES NO If YES please specify b Other Biohazard YES NO If YES Please specify Version No 4 53 Effective Date Nov 2011 Page 29 of 29
14. aterials so as to use it to repack and ship for maintenance or servicing NOTE The user manual should be carefully read before startup to ensure an error free operation Step 2 Placing the instrument The instrument has to be placed on a level bench Room temperature has to be between 18 and 35 C with a relative humidity below 85 Protect it from direct sunshine Step 3 Power supply requirements Once the instrument has been placed plug it into a power source by the locally available approved plug in cable Power cord should be CE CSA and UL marked Voltage 115 230 V 10 60 50Hz Step 4 Protective Grounding Warning Please make sure that electrical power source is properly grounded Version No 4 53 Effective Date Nov 2011 Page 10 of 29 eazy CLOT USER MANUAL 5 2 Start Up Instruction Step 1 Switch on the instrument The instrument will display the model name The instrument initializes all the parameters internally and carries out a power on self test It then displays ROBONIK and the time indicating that initialization is complete If a printer is enabled model name the time and the date will be printed If the correct date and time are not displayed switch off the instrument and switchON again The instrument is now in IDLE mode and ready for use Step 2 Thermal printer The eazy CLOT comes with builtin 20 columns Thermal Printer User has to take proper care to handle this delicate instrument
15. centrations BE NO RUE E d i Cuvette holder Shoudbeemplyat REMOVE CUVT CLOS Plot Graph this time been LID PRESS ENTER eae p Stored Test Y N Insert Calibrator Cuvettes by one PLACE CUVETTE 1 i to get the clot time 7 E i calibrators i ES CLOSE THE LID Ad mm AND PRESS ENTER Plot Graph Y N Accept Test VIN in save the cbt es Accept Test Y N can save the clot times of calibrators Insert Sample 1 PLACE CUVETTE DISPENSE REAGENT 1 Press FUNC Save Test Y N i Remove cuvette before s REM CUV PRES ENT YES YES NEN oL doo RE Name Test Y N ABCDEFGH Select the characters using arrow keys confirm by pressing ENTER on blinking character Conclude by pressing ENTER key twice at the last character Version No 4 53 Effective Date Nov 2011 Page 23 of 29 eazy CLOT Sample Graph Printout in Multistandard Mode Version No 4 53 Effective Date Nov 2011 MULT SID JHITS JA TINE gt EHTZC L TINE les ENTICSL TIHE 12 4 ENT4CSL 26 5 ENTECML TIYE fI 04 1 28 0 GaL 204 8 CALS 794 2 Cals 22 8 ALS 582 8 zho Sec FEM COn Ci 5 990 23 0 C2 7 39 20 9 C3 12 40 205 0 C4 25 0 68 0 92 48 20 0 2 0 43 cir 42 010 2 90 x 10 792 i 22 500 13 4504 i 2 2 29 t 2 4438 2 00M 152 Page 24 of 29
16. d clotting factors Results are both printed and displayed in seconds and in concentration Data is printed and stored with RATIO and INR values Prints and stores calibration graph Dry block incubator for 37 degree centigrade with multi timer Facility to enter clinic name Uniform mixing of Sample amp Reagent with magnetic stirrer Version No 4 53 Effective Date Nov 2011 Page 6 of 29 eazy CLOT 3 3 Specifications Measuring System Optical measurement Cuvette Volume Minimum Measurement Volume Sample amp reagent mixing Dry block incubator Number of cuvette Holders Temperature Timer Light source Display Printer Memory Analysis mode Results displayed in RS232 Serial Port Power Wattage Voltage Operating position Operating conditions Temperature Relative humidity Storage conditions Temperature Relative humidity Enclosure Size cms Weight Approx Version No 4 53 Effective Date Nov 2011 USER MANUAL Photometric Photodiode 150 ul With magnetic stirrer 10 1 Test tube holder 37 2 channels for programming incubation time LED Four line LCD back lit 4 X 20 characters Built in thermal printer 20 column 32 KB Non Volatile RAM Battery backup supporting 35 open tests CLOT TIME INR PT MULTI STD FIB Seconds Ratio INR automatically calculated Concentration 2400 baud 1 start 8 data 1 stop no parity bits 50 Watt
17. eazy CLOT USER MANUAL USER MANUAL eazy CLOT ACTIVATED CLOT TIME MACHINE Version 4 53 J 6 ROBONIK INDIA PVT LTD A 374 TTC MIDC Industrial Area Mahape Navi Mumbai 400 710 INDIA Tel 91 22 67829700 Fax 491 22 67829701 Email sales robonikindia com Website www robonik in Version No 4 53 Effective Date Nov 2011 Page 1 of 29 eazy CLOT USER MANUAL TABLE OF CONTENTS I GENERALINFORMATION aisi eo HAV RUNDEN a TEN eir 3 Ll WARRANTY INFORMA TIONG 5 oi iririoe i OO p dor irre rio oto a Un con o 3 1 2 TECHNICAL SERVICE 1 3 DISPOSALINSTRUCTION 2 1 DANGER WARNINGS SYMBOLS 5 5 reise econtra VES RR NER sodas eR oe 4 2 2 SBOF THE INSTRUMENT ses EE AAE Seo eise oe Pee kr une rece Po 4 54558 ERR C 6 Eee eta ioi e et e ea eap b e OE Dr PAR ERR 6 3 2 SPBCIAL PEA TURES 5 5 enc eee oto bees d 6 3 3 SPECIFICATIONS 41 5 nor peo eta o iie aa nei i e sea RR ET SON UE CRY RETO rere ia ee o PER 7 Sd WORKINGPRINGIEEE 75 e RP e eae onse Ree Ep SEGUE 8 4 PACKING TRANSPORT AND STORAGE crees eene eene eene tene
18. lder should be empty at this time 1 1 Insert Sample Cuvette 1 After dispensing reagent stirrer will start moving and please wait message on display i as ad fac cw nna E ETEEN E E a dE En eS rey Note Remove cuvette before pressing ENTER KEY 9 2 INR Mode PT Mode Instrument measures clot time of sample and by calculation gives INR ratio INR mode is used to run the PT test Prothrombin Time Press INR key ISI INDEX Enter ISI Index value as given in reagent ma nual Enter Normal Patient s i Prothrombin time or Control time as Normalization REMOVE CUVT CLOS LID PRESS ENTER After dispensing reagent stirrer will start moving and please wait message on display i Version No 4 53 Effective Date Nov 2011 Page 22 of 29 eazy CLOT USER MANUAL 9 3 Multi Standard Mode Fibrinogen Mode In multistandard mode maximum 7 calibrators can be selected It plots the graphs of clot time v s concentration based on point to point method with normalscale This mode is used to run fibrinogen and factor assay test UNIT KEY Press Multi Std key i Select Unit Enter specific number to select correct unit UNIT b ui Enter No Of Cals 2 um mum You can enter the clot time for given 1 number of calibrator i directly without running calibrators L Enter Con
19. nd solely responsible for any improper modification to the instrument and for the consequences derived as a result Version No 4 53 Should the instrument need extraordinary maintenance contact ROBONIK service or an authorized service center Specialized technicians who will be able to repair the instrument using original spare parts will carry out the maintenance This IVD equipm ent complies with the emission and immunity requirements as per IEC 61326 series Warning This equipment has been designed and tested to CISPER11 Class A In a domestic environment it may cause radio interference in which case you may need to take measures to mitigate the interference An advisory that the electromagnetic environment should be evaluated prior to operation of the device Warning Do not use this device in close proximity to sources of strong electromagnetic radiation e g unshielded international RF sources as these may interfere with the proper operation Effective Date Nov 2011 Page 5 of 29 eazy CLOT USER MANUAL 3 Introduction 3 1 Description eazy CLOT is an Activated clot time machine with sophisticated on board software Its versatile and unique software supports most of the calculation required for interpretation of results It is a reliable high precision machine It is intended for in vitro diagnostic use 3 2 Special Features Designed to perform all routine tests such as PT APTT TT FIB an
20. o enean seen seen eee eo seen esee seen esee seen seen ee eee sense eene eea 9 4 Ir GENERALE WARNINGS ciae eR E eto P E ERO ER ED E E COR RR SAEED 9 AD PACKING 43r adesto n e a RAD REG DEBER UY GT EO ERE RUNE ER GUE IE ANE RES 9 4 3 INSTRUMENTTRANSPORTA TION sorrie KEKEE extent diee edet vie aeu e Ni 9 4 4 STORAGE OF THE INSTR MBNT 5 er Pee io eo epos o e REC TR e e tee Ee EN e REP 9 5 INSTALLATION AND START UP INSTRUCTIONS eee eene een eene toe en set eene eene eene seen seen seen eee 10 S1 INSTALLATION EP 10 5 2 START UP INSTRUCTION 6 LT PERSPECTIVE VIEW uocant eer eer 13 6 2 KEYPAD 8 GENERAL 18 8I PRESSEUNGRKEY eno POR RE D eo TD tren Um RET E TUER E 18 8 2 MENU KEY SS CE EARKEYS rre ere esate ESA BSAA AREAS AAS oe Bt en e II THES BALTEN TERS EY REOR ote Hes sted sb Es 8 5 TIMER KEY No 8 SEORSIM A Gg UNIO e SA S LAMPAAMPLITUDE eee eee 8 8 LISTING OF SAVED TEST cnt ettet e em aetate fe 20 8 10 M OTOR ON teste
21. s 115 230 Volts 50 60 Hz On horizontal flat rigid and vibration free surface From 180 cto 35 c Up to 85 96 From 10 to 60 c Up to 85 96 ABS Fire retardant 20 X 30 X 10 IX b X h 3Kgs Page 7 of 29 eazy CLOT USER MANUAL 3 4 Working Principle The diagram below represents the main functional elements of the instrument Light produced by the white LED is passes through the reaction sample cuvette and falls on photodiode The reaction cuvettes having magnetic stirrer bead inside After dispensing the reagent the magnetic stirrer starts the stirring of mixture present in the cuvette When the thrombin generates fibrin monomer from fibrinogen the fibrin monomer begins to polymerize The growing polymer will take on light absorbing characteristics and ultimately resulting fibrin clot will be opaque This characteristic of the fibrin monomer polymerization is exploited in the system that measures the changing absorbance of the plasma sample and use that change in absorbance A to reflect the growing fibrin polymer This means the time to change the fibrin monomer to polymerize change in absorbance of plasma sample is the total clot time of that sample The system displays this time as a clot time of the sample 1 White LED 2 Reaction Sample Cuvette 3 Photo diode 4 Stirrer movement Motor 5 Stirrer bead Version 4 53 Effective Date 2011 Page 8 of 29 eazy CLOT USER MANUAL 4
22. tation Use clean Cuvettes If results are not reproducible check for the bubbles within reaction mixture and take corrective action Avoid getting bubbles within the reaction mixture which may lead to erroneous result Insert pipette tips straight down into the Cuvette and then dispensethe reagent Refer to pack insert with the Reagent and follow instruction ofreagent manufacturer For routine screening procedures use total of 150 ul volume During critical assays when factor amp ctors concentration is depleted During therapeutic dose adjustment use total volume of 300 ul instead of 150 to minimize CV Cuvettes are specially design to read bothmicro and macro volumes Effective Date Nov 2011 Page 17 of 29 eazy CLOT USER MANUAL 8 General Operations 8 1 PRESS FUNC KEY Idle Mode Programming Mode Save Test Y N Name Test Y N YES Delete Test Y N NO Deleting Tesi YES Set Time Y N NO Date DD MM YY Time HH MM SS YES Set Panter YIN Press YES to enable printer and NO to disable Setting Printer Version No 4 53 Effective Date Nov 2011 Page 18 of 29 eazy CLOT USER MANUAL 8 2 Menu Key This key is used to select the testnumbers 8 3 CLEAR Key Press twice to initialize the instrument Under data entry mode it will clear the entered data while pressing once 8 4 ENTER Key This key is used to complete the command or data entry 8 5 TIMER KE
23. tronic PCBs and components can be recycled so return back the instrument to manufacturer 1 4 Contacts Manufacturer European Authorized Representative ROBONIK INDIA PVT LTD Obelis s a A 374 TTC MIDC Industrial Area 2 n EUM MAHAPE NAVI MUMBAI 400710 Tel 32 2 732 59 54 INDIA Fax 32 2 732 60 03 E Mail mail Q obelis net Tel 491 22 67829700 Fax 491 22 67829701 Email sales robonikindia com Website www robonik in Version No 4 53 Effective Date Nov 2011 Page 3 of 29 eazy CLOT USER MANUAL 2 General Safety Warnings 2 1 Danger warnings symbols In this manual the following symbols are used to inform the user of the safety rules uc P This symbol indicates generic danger It means that serious damage can occur to the operator if described precautions are not observed This symbol indicates HIGH ELECTRIC VOLTAGE It is dangerous to touch any part having this label Only qualified operators can access these components after unplugging the instrument from the Supply This symbol indicates that the instrument involves the handling of samples which can be infected urine or human serum In this condition infection or contamination might occur Pay attention to the general safety warnings when in presence of such biological substances Use Protective clothes gloves and glasses This symbol in the user manual indicates that damages to the instrument or erroneous results could occur if
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