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USER MANUAL eazy CLOT

1. nce enun u S Aun E ILI DN AN IM NICE IDE D M M LIN a 18 S3JCEEAR KEY anatina ve ti tatit tatit tutt eeu 18 8 4 ENTER KEY nne tuna tetendit nsu 18 8 5 TIMER KEY NO 8 enit aee tuse eredi etico a eet D Fed eee CU PE E ede e as P S uu aG 18 8 0 SAVING EST setti ods salons t diae dedu Cari Cu te da ete Cade t dif i ES 18 SU ISAMPOAMPEPEUDE e aga cua ui verre siters sistat raved essct bom Saw aun cic wast Su n aaa aaa 19 8 8 LISTING OE SAVED TEST 6 aza aa aa u e ca t Casert Che e a ese leche ea Ta oe aba CL ide e ia Toa eee e Cae pda Coe EE ELE ho ae ETUR 19 8 9 TO ENTER CEINIC aaa Ga aG aa a ma 19 STO MOTTO R ON CHECK siet aaa Sens SSS SS SSS SS SSS S SSS SSS SS te eee aaa 20 SI ADEE TING AL DE ESS ap oak spa pn RENE CERE US 20 8 12 SELECTION OE EANGUAGE g L aca aa A EE EE PR B ET A E RR EFRON REN RA EAE 20 8 13 LAST OF VEST NUMBERS idit ocaacdel eren ate e tota erano da Letra edad eet dle a rna debe ebd Ta ev kasd erat vot dle Lr sa luasnya 20 9 PROGRAMMING MODES cwississcvccscsscveccnsscvsvessscheccnenchevensscheccneschsvensschbsevisch venschbsanischevevanchbbesischdvssincbincniscnsvensscnte 21 OA FCLOT LIMES MODE etes u eID Berea orci Siena 21 9 27INR MODE Z7 MODE ZS S SA a LA aee lei 21 9 3 MULTI STANDARD MODE FIBRINOGEN MODE Ie eene ee een nnne eee ee tr
2. 7 calibrators can be selected It plots the graphs of clot time v s concentration based on best fit Linear method with Log Log scale This mode is used to run fibrinogen and factor assay test Press Multi Std key i Select Unit Enter specific UNIT UNIT KEY Se PREECE ES SS Sa 1 number to select correct unit wai 3 mum mEa L You can enter the clot time for given number of calibrator directly without running calibrators MIL See oa Enter Concentrations S s ss ofall calibrators Cuvette holder i pau lag REMOVE CUVT CLOS Plot Graph Y N LID PRESS ENTER i Insert Calibrator i Cuvettes one by PLACE CUVETTE togettheclottime READ CAL 1 2 of calibrators ume E EAP AND PRESS ENTER Plot Graph Y N By pressing YES we Accept Test Y N can save the clot times of calibrators aes Loma arem dirum Seem mn a rud Sc DISPENSE REAGENT Press FUNC Save Test Y N key to save test poly eet YES i Remove cuvette before REM CUV PRES ENT YES M NE Name Test Y N ABCDEFGH purum Eid cm eem mue i 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 4 Effective Date August 2010 Page 22 of 26 eazy CLOT USER MANUAL Sample Graph Printout in
3. AND STORAGE 8 4 1 GENERAL WARNINGS iir rin etaed ri raa eee ead er das c Fl aed a s aea rad e eo dead a ebd aeta ad eda dosi e tad as a Roda abe daa o M EM Rosada 8 D OSPAOKINGR S EIE iE M s 8 4 33 INSTRUMENT TRANSPORTA TION taytataqa kutay E ERE E E E EN LO UNES NEEDS E UN EE 8 4 4 STORAGEOETHEINSTRUMENT 2 g ull ba ra dao et n an eaa daa a De Leda epa u eran bata a d aaa eod L 8 5 INSTALLATION AND START UP INSTRUCTION S 9 Dele INSTALIGATION deb Euboea te ri ettet i l a PER LE LE nu la 9 5 2 START UBP INSTRUGCEION de etse ede boston t ua ul ger Q u 10 6 INSTRUMENT DESCRIPTION P tee t eese eo e eeu e a qa Na Pe ore Rh ee euo ere as ee UE UTE 12 6 1 PERSPECTIVE VIEW RRRRRRRRRRRRRRRRMMMMMMMMMMMMMMEMMMMMEMMMMMENNEEEEEEMMMEEEMMMMMMMEEEMMMMMMMEEEMMMMMMMMMMMMMMMMMMMMMKMN 12 62 ds a Rua ua rela aces aa a iS ba aaa aa aaa ENCE RAs AAR AEE 13 6 3 DISPENSING HOLES 315 4 13 6 4 OPERATING 3 14 Z PRECAUTIONS G PNEU 16 8 GENERAL OPERATIONS 17 S L PRESS FUNG BY feci aceite Daci ar dt Te edid cia 17
4. has started After clot detection this message will disappear and instrument will show the clotting time Version No 4 4 Effective Date August 2010 Page 15 of 26 eazy CLOT USER MANUAL 7 Precautions Version No 4 4 Keep the place dry and clean Check all the grounding wires properly Use original packaging for transportation 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 dispense the reagent Use preferably yellow and blue tips of good quality for dispensing Reagent Refer to pack insert with the Reagent and follow instruction of reagent manufacturer For routine screening procedures use total of 150 ul volume During critical assays when factor factors concentration is depleted During therapeutic dose adjustment use total volume of 300 ul instead of 150ul to minimize CV Cuvettes are specially design to read both micro and macro volumes Effective Date August 2010 Page 16 of 26 eazy CLOT USER MANUAL 8 General Operations 8 1 PRESS FUNC KEY Programming Mode Idle Mode Save Test Y N Name Test Y N YES Delete Test Y N NO Deleting Test YES Set Time Y N NO Date DD MM YY Time HH MM SS T YES Set Printer Y N Press YES to enabl
5. per packing list dispatch with the instrument Kindly store all packing materials 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 4 Effective Date August 2010 Page 9 of 26 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 switch ON again The instrument is now in IDLE mode and ready for use Step 2 Thermal printer The eazy CLOT comes with built in 20 columns Therm
6. 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 Electronic 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 34 v de Tervuren bte 44 B 1040 Brussels BELGIUM MAHAPE NAVI MUMBAI 400710 Tel 32 2 7
7. to enter clinic name Uniform mixing of Sample amp Reagent with magnetic stirrer Version No 4 4 Effective Date August 2010 Page 6 of 26 eazy CLOT 3 3 Specifications USER MANUAL Measuring System Photometric Optical measurement Photodiode Cuvette Volume 150 ul Minimum Measurement Volume Sample amp reagent mixing With magnetic stirrer Dry block incubator Number of cuvette Holders 10 1 Test tube holder Temperature 37 2 channels for programming incubation time Light source LED Warm Up Time 90 secs Display Four line LCD back lit 4 X 20 characters Printer Built in thermal printer 20 column Memory 32 KB Non Volatile RAM Battery backup supporting 35 open tests Analysis mode CLOT TIME INR PT MULTI STD FIB Results displayed in Seconds Ratio INR automatically calculated Concentration RS232 Serial Port 2400 baud 1 start 8 data 1 stop no parity bits Power Wattage Voltage 50 Watts 115 230 Volts 50 60 Hz Operating position On horizontal flat rigid and vibration free surface Operating conditions Temperature Relative humidity From 18 c to 35 c Up to 85 96 Storage conditions Temperature Relative humidity From 10 c to 60 c Up to 85 95 Enclosure ABS Fire retardant Size cms 20X30X 10 IX b X h Weight Approx 3 Kgs Version No 4 4 Effective Da
8. 2 below 2 Put the cuvette in the cuvette holder inside the chamber as shown in the figure Fig 2 Cuvette has to be inserted completely 3 Ensure stirrer inside the cuvette before placing the cuvette in measurement chamber 4 Ensure the required quantity of sample in cuvette as per Reagent Pack Insert Fig 2 g E E _ Cuvette me b 5 Lock the cover by pressing down ward as shown below Fig 3 Display will Show Dispense Reagent 6 Reagent adding procedure If 1ml pipette is used 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 Y ba NG P IM z If 100 50pl pipette is 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 i un Fig 5 d Version No 4 4 Effective Date August 2010 Page 14 of 26 eazy CLOT USER MANUAL 7 While putting the Reagent insert the pipette straight in to the dispensing hole Ref Fig 6 Pipette k Fig 6 8 Display will show the When it displays 1 it gives the beep Dispense the reagent when it gives the beep 9 Display will show message PLEASE WAIT Indicating the measurement
9. 32 59 54 INDIA Fax 32 2 732 60 03 E Mail mail obelis net Tel 91 22 67829700 Fax 91 22 67829701 Email sales robonikindia com Website www robonik in Version No 4 4 Effective Date August 2010 Page 3 of 26 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 q p gt 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 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 75E 18 Version No 4 4 Symbol for Manufactu
10. Multistandard Mode MULT SID JHITS SHTLCOL TINE 9 8 EMTZC L TINE fos EHTSCEL TIIE 15 4 ENTSCSL TIVE 26 5 ENTECAL TIYE 9 2 Celt 36 2 Cale 204 2 DALJ 104 9 Cals 202 0 NUR DEI GH ED 2 T Sec FEM COR GJ 22 0 05 9 15 40 1062 0 C4 20 50 625 0 75 49 20 832 0 43 20 x 6 i x 10 792 t 2 0804 1513 dtes Version No 4 4 Effective Date August 2010 Page 23 of 26 eazy CLOT USER MANUAL 10 Trouble Shooting ERROR MESSAGES CORRECTIVE ACTION If Number of saved tests exceeds 40 tests then delete Memory over range the unwanted tests and save the test SKIP PRIN PR YES 1 Check printer paper or printer cover properly placed SET PRI amp PR ENT 2 Refer to Printer setting in Start Up Instructions 1 Check whether cuvette is present while referencing when display shows CLOSE THE LID AND PRESS ENTER l l U NOTE While referencing cuvette should not be there 2 Choose test 128 to see the lamp amplitude value It should not be below 3 000 Other ERRORS CORRECTIVE ACTION 1 Check stirrer inside the cuvette 2 Follow the reagent volume as specified in Pack Insert No consistency in Reading 3 Follow Reagent dispensing procedure carefully Put the pipette straight and remove immediately in straight direction do not shake Cuvette should not shake from its position 1 Follow Reagent dispe
11. al Printer User has to take proper care to handle this delicate instrument 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 4 Effective Date August 2010 Page 10 of 26 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 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
12. e printer and NO to disable Setting Printer Exit to Main menu Exit Y N Version No 4 4 Effective Date August 2010 Page 17 of 26 eazy CLOT USER MANUAL 8 2 Menu Key This key is used to select the test numbers 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 KEY No 8 Press Timer ke Crestere yn pe foe ie is No i Initial screen NO SET TIMER 2 Y N Enter the required incubation time and press i ENTER key Once the time is completed the instrument will start beeping Intermediately press i clear key once to stop beeping i 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 ABCDEFGHIJKLMN without name Select Arrow Keys 4 6 to select Alphabets by moving curser Press Enter atter selection and proceed Press Enter twice at last alphabet Version No 4 4 Effective Date August 2010 Page 18 of 26 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 Listin
13. eazy CLOT USER MANUAL USER MANUAL eazy CLOT ACTIVATED CLOT TIME MACHINE K ROBONIK INDIA PVT LTD A 374 TTC MIDC Industrial Area Mahape Navi Mumbai 400 710 INDIA Tel 91 22 67829700 Fax 91 22 67829701 Email sales robonikindia com Website www robonik in Version No 4 4 Effective Date August 2010 Page 1 of 26 eazy CLOT USER MANUAL TABLE OF CONTENTS Lx GENERATPTEINFORMATIQNG GG u D Q S S Q E Q i Sa G ass 3 1 1 WARRANTY INFORMATIONS ave ues D da be ME RR A Ee A E Er 3 1 2 TECHNICAL aiite maaa asha ae meto hua aqhay u aq haqa 3 JS DISPOSAL INSTRUCTION sensisse sia uui OUS eec OO ESS oes OES SS SEIN is Setia 3 LA SCONPIAGISIM C ntes MOUSE ld MIL EMI UE 3 2 WARNINGS 2 W i i eo ex S i W i 4 2 1 DANGER WARNINGS O M ODS n nq a unu u ea eT LE E aO 4 2 2 USE OF THE INSTRUMENT a nas nas 5 JS INTRODUCTION Sau Q e G a Wa a a w Way Way TSA Sas 6 DESCRIPTION teo oe 6 3 27 SPECIAL BAT URES cu eu m amu SUI EON UNI UENIUNT ENTUM UN I NIU To LS 6 3 3 SPECIFICATIONS ss cn Q au a l a soe Ea ra asan uuu ns 7 4 PACKING TRANSPORT
14. ecify Version No 4 4 Effective Date August 2010 Page 26 of 26
15. either alpha numerical or numerical should appear on display Step 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 DATE DD MM YY 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 The instrument goes back to idle position Version No 4 4 Effective Date August 2010 Page 11 of 26 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 Oe oN Rear View ON OFF SWITCH RS232 POT m ME e SMPS o o Contrast POT Version No 4 4 Effective Date August 2010 Page 12 of 26 eazy CLOT USER MANUAL 6 2 Keypad 6 3 Dispensing Holes Description e Press on the right side of the measurement chamber as shown in Fig1 100 ul pipette dispensing hole 1 ml pipette dispensing hole Fig 1 PRESS Sliding cover holder Sliding Cover Version No 4 4 Effective Date August 2010 Page 13 of 26 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 Lift the Chamber cover as shown in the figure Fig
16. ennen nnne nenas esse enne rennes esee 22 10 TROUBLE SHOOTING 24 DECONTAMINATIOQN ese ee eue den ae obe vaso be Pee e e Ce ve awe dee ee eoe pev Ead 25 11 DEGONTAMINATION PROCEDURE 25 11 2 PURPOSE OF DECONTAMINATION n naa rbd ao eaa Ea saa read Ea sa desi dae abd aee Lara re 25 11 3 GENERAL CONSIDERATIONS nn eene n enn sss s enne e einn sse ese sensn nasse sese enin sse terre ness entra nen 25 S S SSL bus cu ucu u rm sisi ed potes Shu mam De M Pp I des IIR Sci LN cR 25 I2 SAFETY CLEARANCE CERTIFICATE wivssicsssvsieccsevsssssseccscesssssssestecssssssessiscssassisessnsssacssvsseebunssasessessesosseacssesiese 26 Version No 4 4 Effective Date August 2010 Page 2 of 26 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 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
17. er Clinic Name 199 Continuous movement of Stirrer can be Observed 200 To delete all the Tests 254 To Select Language Version No 4 4 Effective Date August 2010 Page 20 of 26 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 REMOVE CUVT CLOS evt RM D pau ur Eua ro MEE E LID PRESS ENTER Warning Cuvette holder should be empty at this time WAR DERE 1 After dispensing reagent stirrer will start moving and PLEASE WAIT please wait message on display i L 1 i 1 i 2 o Z 3 lt c lt D o o Q 7 o 2 ITI 2 m ITI lt REM CUV PRES ENT 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 1 Enter ISI Index value as given in reagent manual Enter Normal Patient s Prothrombin time or Control 1 time as Normalization REMOVE CUVT CLOS LID PRESS ENTER please wait message on display i K T ka IL LA maqaspa ae eI een ELE E n Version No 4 4 Effective Date August 2010 Page 21 of 26 eazy CLOT USER MANUAL 9 3 Multi Standard Mode Fibrinogen Mode In multi standard mode maximum
18. g of saved test Choose Test Press MENU Key Enter 129 and press ENTER key Test Number The instrument will print a list of all saved tests Recalling of saved test Choose Test Enter the test number to be recalled Test Number 8 9 To Enter clinic name Press MENU Key Choose Test Clinic Name Y N YES ABCDEFGHIJKLMN NO Press Enter after selection and proceed Press MENU Key Enter 132 press Enter Key Select Arrow Keys 4 amp 6 to select Alphabets by moving curser Press Enter twice at last alphabet FIRST SCREEN INSTRUMENT OF a maximum number of 15 characters can be entered Version No 4 4 Effective Date August 2010 Page 19 of 26 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 EN ENGLISH 2 GERMAN 3 SPANISH 4 FRENCH To select the language press the number and ENTER key 8 13 List of Test Numbers Test Numbers Use 128 Lamp Amplitude 129 Listing of Save Tests 132 To Ent
19. ing and drinking while decontaminating instruments is not advisable 11 4 Procedure Version No 4 4 A 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 bleach a 6 1 mixture is required This is a caustic solution It is important to wear gloves and eye protection when handling it 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 Reassemble the unit and discard the used gloves and towels Effective Date August 2010 Page 25 of 26 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 Contact Address Position Dept _ Tel Country LLL 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 sp
20. nsing procedure carefully Put the pipette straight and remove immediately in Random readings stops at 1 0 sec straight direction do not shake 2 Check cuvette is inserted completely It should not be loose in cuvette holder Version No 4 4 Effective Date August 2010 Page 24 of 26 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 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 Mucous membranes are considered prime entry routes form infectious agents Wear eye protection and a surgical mask when there is a possibility of aerosols Eat
21. repair the instrument using original spare parts will carry out the maintenance e This IVD equipment complies with the emission and immunity requirements as per IEC 61326 series e 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 e An advisory that the electromagnetic environment should be evaluated prior to operation of the device e 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 Version No 4 4 Effective Date August 2010 Page 5 of 26 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 and 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
22. rer Symbol for IN VITRO DIAGNOSTIC MEDICAL DEVICE Symbol for AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY Effective Date August 2010 Page 4 of 26 eazy CLOT USER MANUAL 2 2 Use of the instrument The instrument has to be used for the designed purposes under specified conditions 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 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 and solely responsible for any improper modification to the instrument and for the consequences derived as a result e Should the instrument need extraordinary maintenance contact ROBONIK service or an authorized service center Specialized technicians who will be able to
23. te August 2010 Page 7 of 26 eazy CLOT USER MANUAL 4 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 the instrument 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 1 0 c to 60 c Version No 4 4 Effective Date August 2010 Page 8 of 26 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

USER MANUAL eazy CLOT

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