Biochemistry Analyser USER MANUAL
Contents
1. 0 501 D 3C 0 333 DELTA MINUTE RES 2 503 HIG 250 3 TEST CLEARED Version No 2 1 Effective Date Nov 2011 KINETIC RATE Filters510 nm UNITS MIL HIGH LOW LAG TIME 10 RDTIME 10 OF RD 3 QC HIGH QC LOW 5 DEL M prietest easylab 150 0 250 0 50 0 250 0 100 0 HIGH INIT ABS lt 2 000 0 800 S No ABS REMCON Bl 0 058 CALS 0 770 D2B 0 268 D 2C 0 131 DELTA MINUTE HIGH DELTA CALS 1 197 FACTOR 51 0 762 D1B 0 336 D 1C 0 298 DELTA MINUTE HIGH DELTA 150 0 CALS 1 902 NORM238 3 S2 0 768 D 2B 0 037 Page No 35 to 42 User Manual prietest easylab 10 4 End Point To create test in this mode Select Test 243 Press MENU Key Choose Test Enter Test Number to be recalled Enter 243 The instrument reads absorbance of the sample and calculates concentration using fed Factor or calculates the factor from concentration of the standard OPERATION Display How to operate Select Filter WU A tds to atado Ref 9 1 If YES blanking need to be Blank Y N done before running Standard or Factor NO Select Standard or Factor __ Ref 9 2 Unit Selection 9 3 Selection p Ref 9 4 Read Blank Standard Sample Instrument will wait till the temperature of cuvette reaches the set temperature Instrument will read the absorbance and calculate concentration and2. b Other Biohazard YES NO if YES Please specify Version No 2 1 Page No 41 to 42 Effective Date Nov 2011 User Manual prietest easylab 14 Packing List 7 3030nik Packing list of Biochemistry Analyser Model Name prietest easylab I I I I 5 Particulars Qty Tick 1 Power Cord 01 2 Thermal Paper Roll 02 i 3 Paper Roll Rod 01 4 Dust Cover 01 5 Optical Grade Reading Tubes 05 6 User Manual 01 START UP REAGENT KIT 7 Bilirubin T amp D BILTD 02 50 2 X 50 ml 01 8 Glucose GLUL 05 100 5X100 ml 01 9 02 50 2 X50 01 10 Creatinine CRJ A 02 50 2 50 01 11 Cholesterol CHO 01 50 1X 50 ml 01 12 GPT ALT GPT 01 25 1X25ml 01 13 Hemoglobin HBCMG 1000 1000 ml 01 I Sr No Packed by Signature I Date Version No 2 1 Effective Date Nov 2011 Page No 42 to 42
3. Idle Mode Set Time Y N Setting Time Set Printer Y N Setting Printer NO Ret 8 1 4 Exit Y N Exits to main menu Version No 2 1 Page No 20 to 42 Effective Date Nov 2011 User Manual prietest easylab 8 2 MENU Key This key is used to select the saved tests 8 2 1 Listing of saved test Press MENU Key Choose Test Enter Test Number 202 The Instrument will print a list of saved test 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 To complete the command data entry Version No 2 1 Page No 21 to 42 Effective Date Nov 2011 User Manual prietest easylab 9 GENERAL FUNCTIONS 9 1 Selecting Primary and Secondary Filters The instrument asks the operator to select the primary and secondary filters Select the filter using identification number given below In all modes the operation begins by asking the filter to be selected The following 6 filters have been provided Filter Identification Filter Key No Wavelength 340 nm 405 nm 510 nm 546 nm 578 nm 630 nm gt Operation After selecting programming mode instrument prompts for filter selection Choose Filter Enter required filter ID number and press Enter Choose Secondary Filter Press NO key and then Enter Key for Monochrom
4. you may to take measures to mitigate the interference 9 An advisory that the electromagnetic environment should be evaluated prior to operation of the device 10 Warning Do not use this device in close proximity to sources of strong Version No 2 1 Electromagnetic radiation e g unshielded international RF sources as these may interfere with the proper operation Page No 8 to 42 Effective Date Nov 2011 User Manual prietest easylab 3 INTRODUCTION 3 1 Description prietest easylab is pre programmed Biochemistry analyzer It measures the optical densities of samples and it uses algorithm to calculate results which are used for biochemical investigations It has direct access to stored programs It is intended for in vitro diagnostic use 3 2 Special Features 1 2 3 4 5 6 7 Version No 2 1 Effective temperature regulation system for 15 position dry block incubator Peltier controlled Optical Grade Reading Tube block Versatile calculation option by factor or standard concentration Robust in built 20 Column Thermal Printer with 384 stationary heads Unique circuitry for long lamp life 500 yl Optical Grade Reading Tube volume Built in stabilizer Page No 9 to 42 Effective Date Nov 2011 User Manual 3 3 Specifications prietest easylab Linear measurement range 0 000 to 3 000 Absorbance Units A Photometric Accuracy 2 96 or 0 007 whichever is hi
5. NATI icis cie ccisceacceinccse eee neuve cuin ein eve aude Cra 28 12 1 DECONTAMINATION PROCEDURE 28 12 2 PURPOSE OF DECONTAMINATION aasin ua eren rh ha RE RN eee DAR CA EE TE VAR ER Ue a EFE Tenn 28 12 3 GENERAL CONSIDERATIONS wisi Sos cotta eere ep et redi v uH aesti re eo ir e EST P epar ain 28 12 4 PROCEDURE 5 rt pae eet MET a 28 13 SAFETY CLEARANCE CERTI FI 28 T4 PACKING BES 2522 G 28 Version No 2 1 Page No 3 to 42 Effective Date Nov 2011 User Manual prietest easylab The contents of this manual with all figures tables and graphics are intellectual property of ROBONIK INDIA PVT LTD Unauthorized commercial or non commercial excerption or copying of contents and use of this manual in total or in parts are strictly forbidden unless the editor gives written permission for it prietest easylab manual was written and produced with the utmost care However errors cannot be fully excluded Robonik does not take any responsibility and accepts no liabilities of any kind that may occur because of errors in the manual Manufacturer ROBONIK INDIA PVT LTD A 374 TTC MIDC Mahape Navi Mumbai 400710 INDIA Tel 91 22 67829700 Fax 491 22 678
6. TU 21 KEY x on ent t et Ee Et I EE Lat eee Poe A ot eae e ee 21 Version No 2 1 Page No 2 to 42 Effective Date Nov 2011 User Manual prietest easylab 9 GENERAL FUNCTIONS 22 9 1 SELECTING PRIMARY AND SECONDARY FILTERS 22 9 2 SELECTION OF STANDARD OR 2 2 2 0 0000000 0000000000000000000000 eise siiis en eise sse enin 23 SEN gc PLE 23 9 4 NORMAL VALUE 2 0 100 ennt nnn essen nene nsn ess ne ese nsi eser enne rns 24 9 5 BASE LINE 0 ene essen nn 24 10 PROGRAMMING 25 702 lt TN 25 10 2 FIXED TIME MODE e ee eir er en daa 28 10 3 KINETIC RATE MODE directe eere dr ec tpe ex eta eO e E e EE elt 28 10 4 ENDPOINT erede cierres esee eve detener 28 11 TROUBLE SHOOTING eeeeee annu 28 11 1 MEMORY CORRUPTS 2 nectit dr nec enean cider chides 28 11 2 ERRORMESSAGES 5 ci tv eder rd eti Da 28 12 DECONTAMI
7. minutes and seconds in 24 hr format 9 Press ENTER key 10 The instrument goes back to idle position 6 10 To Enter Clinic Name 1 Press MENU Key 2 Choose Test 3 Enter 205 press ENTER Key 4 Clinic Name Y N 5 Press Yes key 6 ABCDEFGHIJKLMN 7 Select the characters using arrow keys Key No 4 and 6 confirm by pressing ENTER on blinking character Conclude by pressing ENTER key twice at the last character a maximum number of 15 characters can be entered 6 11 Optical Grade Reading Tube Insertion Procedure Optical path direction is as shown in the diagram below Optical Grade Reading Tube should be inserted gt Test Tube ALight path Front View Section Version No 2 1 Page No 17 to 42 Effective Date Nov 2011 User Manual prietest easylab 6 12 Check Lamp Amplitude 1 Press MENU key 2 CHOOSE TEST 3 Press 201 and press ENTER Key 4 instrument shall print lamp amplitude in the following format 340 Amplitude 405 Amplitude 545 Amplitude 510 Amplitude 578 Amplitude 630 Amplitude The amplitude should be in the range of 3 000 to 11 000 without Optical Grade Reading Tube Press CLEAR to come back to the Main screen 6 13 Readings Check Checking of readings should be done through controls Reading should be with range specified in data sheet of controls care should be taken while preparing and pipetting controls and reagents reagent and control expiry dates need to be checked 1 Switc
8. reference and automatically adjusts the reference Now instrument is ready for reading samples Version No 2 1 Page No 24 to 42 Effective Date Nov 2011 User Manual prietest easylab 10 PROGRAMMING MODE 10 1 Absorbance med The instrument reads and prints the monochromatic and Bichromatic Absorbance at the user selected wavelength Filter Identification Filter Key No Wavelength 340 nm 405 nm 510 nm 546 nm 578 nm 630 nm OPERATION Press ABS key to enter the mode After selecting programming mode instrument prompts for filter selection Display Choose Filter Enter required filter ID number and press Enter Choose Secondary Filter Press Filter ID to select Press NO key and then Enter Key for Monochromatic Reading Proceed to Next Stage Read Sample Sample Printout ABSORBANCE Filt 4 Displays Prints the Absorbance value along S No ABS REM CON with Sample numbers Continue till all samples read S1 1 160 S2 2 173 TEST CLEARED Version No 2 1 Page No 25 to 42 Effective Date Nov 2011 User Manual Recalling the test Prietest easylab Biochemistry Analyzer consists of 23 different tests 11 tests are present on the keypad whereas remaining 12 tests can be programmed by selecting MENU key amp Followed by Test Number 1 Direct access tests by Keypad There are 11 different preprogrammed test
9. that initialization is complete If a printer is enabled model name the time and the date will be printed 3 Ifthe correct date and time are not displayed switch off the instrument and switch ON again 4 Once initialization is over a lamp located within the instrument will glow This lamp requires 90 seconds for stabilization 5 instrument is now IDLE mode and ready for use 6 7 Printer setting Operations Press MENU key under Programming Mode In case of any problems in thermal printer following message will displayed SET PRINTER PR ENTER SKIP PRINTER PR YES User may operate the instrument by disable the printer To Set Printer 1 Press FUNC key 2 Set time Y N 3 Press No key 4 Set printer Y N 5 Press Yes key 6 Printer on Y N 7 Press No key to switch off the printer Press YES key to switch On the printer Version No 2 1 Page No 16 to 42 Effective Date Nov 2011 User Manual prietest easylab 6 8 Keyboard Check Check keyboard by pressing MENU key first and all other keys later one should get a beep and either Alphanumerical or Numerical should appear on display 6 9 Setting Date and Time Setting of date and time can be done with the help of FUNC key 1 Press FUNC key 2 Set time Y N 3 Press Yes key 4 The instrument displays DATE DD MM YY 5 Enter date month and year in the same format 6 Press ENTER key 7 The instrument displays TIME HH MM SS 8 Enter hour
10. 29701 Email sales robonikindia com Website www robonik in prietest easylab version 2 1 Version No 2 1 Page No 4 to 42 Effective Date Nov 2011 User Manual prietest easylab BSc NNN Ne Version No 2 1 Effective Date Nov 2011 gt List of Preprogrammed Tests Glucose Urea Creatinine Hemoglobin Cholesterol SGPT SGOT Albumin Total Protein Total Bilirubin Direct Bilirubin Alkaline Phosphatase Uric Acid Triglycerides Urea UV Amylase Gamma GT Phosphorus Micro Protein Calcium Ars Ill Calcium OCPC HDL Cholesterol Chloride Page No 5 to 42 User Manual prietest easylab 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 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 a
11. ACTOR 100 0 HIGH 300 0 UNITS mmo L LOW lt 80 0 HIGH gt 250 0 LAG TIME 5 LOW lt 50 0 RDTIME 20 LAG TIME 5 OF RD RDTIME 20 QC HIGH 300 0 OF RD QC LOW 100 0 QC HIGH 250 0 HIGH INIT ABS lt QC LOW 50 0 ABS 2 000 HIGH INIT ABS DELTA 2 000 ABS 2 000 S No ABS REM CON DELTA 1 500 S No ABS REM CON BL1 0 026 CALS 1 135 1 1 311 DELTA CALS 0 176 0 0 FACTOR 283 82 RES 0 059 LOW 5 9 S 1 1 159 S2 1275 1 1 316 3 1 732 DELTA RES 0 157 LOW 44 7 DELTA 5 2 1 167 RES 0 456 LOW 45 6 2 1 717 DELTA RES 0 55 NORM 156 2 5 3 0 108 2 463 DELTA RES 2 355 668 4 RES 2 750 275 0 TEST CLEARED Version No 2 1 Page No 32 to 42 Effective Date Nov 2011 User Manual prietest easylab 10 3 Kinetic Rate Mode To create test in this mode select Test No 242 Press MENU Key Choose Test Enter Test Number to be recalled Multiple readings maximum 15 are taken at set temperature at regular intervals and change in absorbance per minute is calculated Concentration Activity of enzyme are calculated from the factor fed by the user or by using calibrator Enter 242 OPERATION Display How to operate Select Filter Ref 9 1 If YES blanking need to be Blank Y N done before running Standard or Factor Select Standard or Factor Ref 9 2 Unit Selection Ref 9 3 Normal Value Selection Select the Lag time in sec Select the Total Read time Select Corresponding Number Keys I
12. ERATION Display How to operate Select Filter ER Ref 9 1 If YES blanking need to be Blank Y N done before running Standard or Factor Ref 9 2 Unit Selection Et ENE Ref 9 3 Normal Value Selection b EU EO EA Ref 9 4 Select the Lag time Enter Selecting the Number Keys Select the Read Interval time 7777777 Select Corresponding Number Keys min 3 Seconds Continued on next page Version No 2 1 Page No 30 to 42 Effective Date Nov 2011 User Manual prietest easylab Continued from previous page YES m Enter Maximum Initial Absorbance High Initial ABS Y N and press ENTER NO Enter Maximum Initial Abs Low Initial ABS Y N Enter Minimum Enter Minimum Initial Abs initial Absorbance and press ENTER Delta Max Y N Press YES to select Delta YES Absorbance and NO to proceed Enter maximum Delta and press ENTER Available only if factor is selected Referencing esee ie E HI edd tee nda Ref 9 5 Read Blank Standard Sample Instrument will wait till the temperature of cuvette reaches the set temperature Instrument will read the absorbance and calculate concentration and then displays prints in following format Version No 2 1 Page No 31 to 42 Effective Date Nov 2011 User Manual prietest easylab Sample Print out WITH STANDARD WITH FACTOR FIXED TIME Filters 630 nm FIXED TIME CAL1 50 0 Filters 630 nm UNITS umo L F
13. F RD 4 LOW lt 12 000 B LOW INIT ABS gt S No ABS REM CON C1 200 0 ABSM 1 000 B DELTA MI 0 229 FACTOR 1746 NORMAL VALUE HIGH gt 40 000 LOW 0 000 7 SGOT 8 ALBUMIN 9 TOTAL PROT SGOT ALBUMIN TOTAL PROT Filters 340 nm 507 Filters 630 nm Filters 545 nm 37 DEGREE 37 DEGREE 37 DEGREE MODE KINETIC RA MODE END POINT MODE END POINT KFACTOR 1 000 UNITS g dL UNITS g dL UNITS U L NORMAL VALUE NORMAL VALUE LAG TIME 60 HIGH gt 5 200 HIGH gt 8 800 RD TIME 60 LOW 3 500 LOW 6 600 OF RD 4 S No ABS REMCON S No ABS REM CON LOW INIT ABS gt B B ABSM 1 000 C1 4 0 C1 6 0 DELTA MI 0 229 FACTOR 1746 NORMAL VALUE HIGH gt 38 000 LOW lt 0 000 10 T BILL 11 D BILL T BILL 50 D BILL Filters 545 wg Filters 545 nm mu 37 DEGREE E15 37 DEGREE mu MODE DIFERNTIAL MODE DIFFERENTIAL FACTOR 1 000 1 000 UNITS mg dL UNITS mg dL LAG TIME LAG TIME FACTOR 14 000 FACTOR 14 000 NORMAL VALUE NORMAL VALUE HIGH gt 1 100 HIGH gt 0 250 LOW lt 0 000 LOW lt 0 000 Version No 2 1 Effective Date Nov 2011 Page No 27 to 42 User Manual prietest easylab 2 To recall a test which is accessed by selecting MENU option Above 11 tests are present on the keypad Whereas remaining 12 tests can be accessed by selecting the option present on the screen a Recalling of Saved Test Press MENU Key Choose Test Enter Test Number to be recalled Store Test Y
14. LUCOSE CREAT 4 6 gt HB 9 ALBUMIN TOT PRO 1 GLUCOSE YES key To directly access Glucose test or to select Yes option 2 UREA key To directly access Urea test 3 CREAT key To directly access Creatinine test 4 key To directly run Hemoglobin test 5 CHOL Key To directly run Cholesterol test 6 SGPT key To directly run SGPT test 7 SGOT key To directly run SGOT test 8 ALBUMIN key to directly run Albumin test 9 TOT PRO key To directly run Total Protein test 10 T BIL NO key To directly access Total Bilirubin test or to select No option 11 D BIL key To directly run Direct Bilirubin test 12 ABS key to run the Absorbance mode by selecting any filter 13 FUNC key To do different functions like date amp time setting printer On Off etc 14 MENU key To recall the test stored at number from 12 to 23 15 CLEAR key To stop any current running function and go back to main screen 16 ENTER key to start the selected function Version No 2 1 Page No 13 to 42 Effective Date Nov 2011 User Manual prietest easylab 5 2 Instrument Working Principle Instrument functional sequence 1 Switch ON and program the instrument 2 Start the test 3 The measures and the calculations are carried out according to the assay Method 4 At the end of the cycle the results are printable and at the same time they are
15. LUE C1 40 0 HIGH 90 000 HIGH 55 000 LOW 0 000 LOW 0 000 18 PHOSP 19 MICRO PRO 20 CALCIUM ARSEN PHOSP MICRO PRO CALCIUM ARSEN Filters 340 nm Filters 630 nm Filters 630 nm 37 DEGREE 37 DEGREE 37 DEGREE MODE END POINT UNITS mg dL NORMAL VALUE HIGH 4 500 LOW lt 2 700 S No ABS REM CON MODE END POINT UNITS mg dL NORMAL VALUE HIGH gt 14 000 LOW lt 1 000 S No ABS REM CON MODE END POINT UNITS mg dL NORMAL VALUE HIGH gt 10 300 LOW lt 8 600 S No ABS REM CON B B B C1 5 0 C1 50 0 C1 10 0 21 CALCIUM OCPC 22 HDL CHOLE 23 CHLORIDE CALCIUM OCPC HDL CHOLE CHLORIDE Filters 578 nm Filters 510 nm Filters 510 nm 37 DEGREE 37 DEGREE 37 DEGREE MODE END POINT UNITS mg dL NORMAL VALUE HIGH gt 10 300 LOW lt 8 600 S No ABS REM CON B C1 8 0 MODE END POINT UNITS mg dL NORMAL VALUE HIGH 60 000 LOW lt 40 000 S No ABS REM CON B 1 50 0 MODE END POINT UNITS mmo L NORMAL VALUE HIGH 107 000 LOW 98 000 S No ABS REM CON B C1 100 0 Version No 2 1 Effective Date Nov 2011 Page No 29 to 42 User Manual prietest easylab 10 2 Fixed Time Mode To create test in this mode select Test No 241 Press MENU Key Choose Test Enter Test Number to be recalled Change in absorbance of sample is taken at programmed time interval and concentration is calculated either from the factor fed by the user or using standard Enter 241 OP
16. N YES The Instrument will use the stored value Proceed for Reading Test will have to be run using new calibrators MODE KINETIC RA K FACTOR 1 000 UNITS U L LAG TIME 60 RD TIME 60 RD 4 HIGH INIT ABS ABSM 0 800 DELTA MI 0 258 2712 NORMAL VALUE HIGH gt 147 000 LOW 44 000 MODE END POINT UNITS mg dL NORMAL VALUE HIGH gt 8 200 LOW lt 2 300 S No ABS REM CON B 1 6 0 12 ALP 13 URIC ACID 14 TRIGLY ALP URIC ACID TRIGLY Filters 405 Filters 510 nm Filters 510 nm 37 DEGREE 37 DEGREE 37 DEGREE MODE END POINT UNITS mg dL NORMAL VALUE HIGH 200 000 LOW 150 000 S No ABS REM CON B 1 200 0 Version No 2 1 Effective Date Nov 2011 Page No 28 to 42 User Manual prietest easylab 15 UREA UV 16 AMYLASE 17 GAMMA GT UREA UV AMYLASE GAMMA GT Filters 340 nm Filters 405 nm Filters 405 nm 37 DEGREE 37 DEGREE 37 DEGREE MODE FIXED TIME UNITS mg dL LAG TIME 30 RD TIME 60 LOW INIT ABS ABSM 1 000 DELTA 0 500 MODE KINETIC RA FACTOR 1 000 5 U L LAG TIME 120 RD TIME 60 OF RD 4 HIGH INIT ABS MODE KINETIC RA K FACTOR 1 000 UNITS U L LAG TIME 60 RD TIME 60 OF RD 4 HIGH INIT ABS NORMAL VALUE ABSM 0 400 ABSM 0 800 HIGH gt 43 000 DELTA MI 4 0250 DELTA MI 0 452 LOW lt 13 000 FACTOR 3954 FACTOR 2211 S No ABS REM CON NORMAL VALUE NORMAL VA
17. User Manual prietest easylab prietest easylab Biochemistry Analyser USER MANUAL N ROBONIK INDIA PVT LTD A 374 TTC MIDC Mahape Navi Mumbai 400 710 INDIA Tel 91 22 67829700 Fax 91 22 67829701 Email sales robonikindia com Website www robonik in Version No 2 1 Page No 1 to 42 Effective Date Nov 2011 User Manual prietest easylab TABLE OF CONTENTS LIST OF PREPROGRAMMED 5 1 GENERAL INFORMA HON da 6 1 1 WARRANTY 11111111 nnne a nsn ss siis siiis ae siii sisse se ene 6 1 2 TECHNICAL SERVICE e dau DU e Pec 6 1 9 DISPOSAL INSTRUGTION 55 err re a Pec 6 dE sa teks buio fe 6 2 GENERAL SAFETY WARNINGS 4 7 2 1 DANGER WARNINGS 65 7 2 2 USE OF THE INSTRUMENT eei pen da cere de eed ee PUR Qu uu 8 S INTRODUCTION mo M 9 DESCRIPTION e eite Edo cete ality ei
18. VE GROUNDING 5 esae ne peter ere p 15 6 5 THERMAL PRINTER Siete ecce cute per terere er e eere e pete vi 15 6 6 START UP INSTRU GTIONS ec eda ree che re D 16 PRINTER SETTING OPERATIONS etude e rer eI onus ere e eere ue EL 16 6 82 KEYBOARD GHEGCK RE RO M ect Deae ve e ee ette Dee E erede repre va 17 6 9 SETTING DATEAND TIME derer eere rede eee Goad ta eoe per ev 17 6 10 CEINIC 17 6 11 OPTICAL GRADE READING TUBE INSERTION PROCEDURE 17 6 12 CHECK LAMP AMPLITUDE IN aeo eta e Va UOTA oar 18 6 13 READINGS CHECK int 18 4 250 UE ax ln HEN VE x eu SU CUR x Tua HE n CURA 19 8 GENERAL KEY OPERATION CORR adco 20 Bet RUNG KEYS obo LBS 20 8 2 MENU KEY tet io E Es uL IM I LL 21 8 2 1 LISTING OF SAVED TEST 0 002 1 0 1 1 sensa E 21 B SICLEAR dicum
19. ae rev dug Ma TRUE OD 9 3 2 SPECIAE FEATURES a vel quoad eri evi urere dae dere eee t caesa 9 3 39 SPECIFICATIONS zv cie sii tee Qoo e dide red vedi erede 10 4 PACKING TRANSPORT AND 5 2 22 2 2 1 11 4 1 CIH BU LLMNem 11 412 feld CER ERR UMME 11 4 3 INSTRUMENT TRANSPORTATION 5 re 11 4 4 STORAGE OF THE INSTR MENT 11 5 INSTRUMENT DESCRIPTION 2 yas E oen sas oa raa rece cUrce dne aPs 12 5 13PERSPECTIVE VIEW ertt testet ento eee ertt diss itn deest ee od a 12 A FRONT VIEW REM 12 OLD A MM 12 I vcs ne eredi etu e Li dre dea cet diede ceres 13 5 2 INSTRUMENT WORKING 14 6 INSTALLATION PROCEDURE AND VERIFICATION CRITERIA 15 6 T UNPACKING INSTRUCTIONS de a eerte rper eere e Ce PE d Ede dT 15 6 2 3PEACING THE INSTRUMENT ee pea Do ete deeper 15 6 3 POWER SUPPLY REQUIREMENTS 15 6 4 PROTECTI
20. atic Reading Press Filter ID to select Proceed to Next Stage Version No 2 1 Page No 22 to 42 Effective Date Nov 2011 User Manual prietest easylab 9 2 Selection of Standard or Factor prietest easylaB nas the flexibility to calculate the results by 1 Standard concentration method 2 Factor Method ENTER FACTOR VALUE YES No of Cals Enter the number or standards required to be run Minimum 1 m maximum 7 standard can be run Enter the concentration value or standard Proceed to Next Stage 9 3 Units Units can be selected by using the corresponding number key UNIT Key No UNIT 1 U L 2 U ml 3 mU ml 4 mEq L 5 MIL 6 mmo l 7 umo L 8 nmo L 9 96 ug mL g dL 10 G L 11 Mg dl 12 Ug dl 13 G dl 14 Ug ml Version No 2 1 Page No 23 to 42 Effective Date Nov 2011 User Manual prietest easylab 9 4 Normal Value Selection Enter the Normal range of the test prietest easylab calculates the results and validates with normal ranges and flags the remarks accordingly Enter Normal Value Y N 7 77 Press YES for normal range and NO to proceed Enter High Value and press ENTER dert Enter Low Value and press ENTER 9 5 Base Line Referencing After the lamp warm up instrument prompts for REFERENCE indicates the user to remove the cuvette from optical path if any amp close lid The instrument reads air as
21. available at the RS232 serial port output The diagram representing the main functional elements of the instrument AMPLIFIER 1 LAMP 2 LENS PRINTER KEYPAD 3 INTERFERENTIAL FILTERS VOLTAGE FREQUENCY CONVERTER 4 OPTICAL GRADE READING TUBE 5 PHOTODETECTOR MICRO White light produced by the lamp is focused into a beam by the lens It is passed through the Interference filter to get monochromatic light This further passes through the sample Part of DISPLAY the light is absorbed by the sample the remaining light is transmitted The transmitted light is focused onto the photodiode The photodiode converts the received light in to an electrical signal that is transformed into digital form from which the microprocessor calculates the optical density taking in account of the blank and bi chromatic selection Version No 2 1 Page No 14 to 42 Effective Date Nov 2011 User Manual prietest easylab 6 Installation Procedure and Verification Criteria 6 1 Unpacking Instructions Check accessories as per packing list Kindly store all packing materials so as to use it to repack and ship for maintenance or servicing 6 2 Placing the Instrument 1 The instrument has to be placed on a level bench 2 Room temperature has to be between 10 and 35 with a relative humidity below 8596 3 Protect it from direct sunshine 6 3 Power Supply Requirements Once the in
22. d a surgical mask when there is a possibility of aerosols Eating and drinking while decontaminating instruments is not advisable 12 4 Procedure 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 Version No 2 1 Page No 40 to 42 Effective Date Nov 2011 User Manual prietest easylab 13 SAFETY CLEARANCE CERTIFI CATE 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 Dept Tel Country Post Code Model No Serial No Accessories Returned Date of Purchase if known Complaint 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
23. e used to inform the user of the safety rules q S ESS 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 1 1 Version No 2 1 Symbol for Manufacturer Symbol for VITRO DIAGNOSTIC MEDICAL DEVICE Symbol for AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY Page No 7 to 42 Effective Date Nov 2011 User Manual prietest easylab 2 2 Use of the Instrument The instrument has to be used for the designed purposes under specified conditions following proper procedures and safety rule
24. gher from 0 to 1 5 A 3 96 from 1 5 Ato 3 0 A Drift 0 007 A hr Optical measurement Photodiode Filters Type of filter Interference Filter Selection Automatic by Stepper Motor Optical Grade Reading Tube Volume 500 yl Temperature of Optical Grade Reading Tube Block Method By Peltier Control Temperature 37 C Dry Block Incubator Number of Optical Grade Reading Tube Temperature 15 Optical Grade Reading Tubes 37 Light Source Tungsten Halogen Warm up time 90 Sec Display Four Line LCD back lit 4 X 20 Characters Printer Built in thermal printer 20 columns Concentration Calculation By factor or by Standard Power Wattage 50 Watts Voltage 115 230 Volts 10 50 60 Hz Operating Position On horizontal flat rigid amp 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 50 Up to 85 96 Enclosure ABS Fire retardant Size cm 33 29 X 13 5 IX b Xs Weight Approx 5 Kg Version No 2 1 Effective Date Nov 2011 Page No 10 to 42 User Manual prietest easylab 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 courie
25. h on the instrument The instrument will display the model name 2 The instrument initializes all the parameters internally and carries out a power on self test It then displays model name and the time indicating that initialization is complete If a printer is enabled model name the time and the date will be printed 3 If the correct date and time are not displayed switch off the instrument and switch ON again 4 Once initialization is over a lamp located within the instrument will glow This lamp requires 90 seconds for stabilization 5 The instrument is now IDLE mode and ready for use Version No 2 1 Page No 18 to 42 Effective Date Nov 2011 1 2 4 5 7 8 User Manual prietest easylab 7 PRECAUTIONS Keep the place dry and clean Check all the grounding wires properly Repeat the readings if Absorbance is more than 2 0 A Use original packaging for transportation Use clean Optical Grade Reading Tube Check the blank absorbance of the Optical Grade Reading Tube at regular intervals Check the temperature of Optical Grade Reading Tube block at regular intervals especially before running kinetic and fixed time tests Check the linearity of the instrument at regular intervals using standards Do not take reading when the lid is open rsion No 2 1 Page No 19 to 42 Effective Date Nov 2011 User Manual prietest easylab 8 GENERAL KEY OPERATION 8 1 FUNC Key
26. n sec Multiple readings maximum 15 are No of Reading temperature at regular Press YES to enter Initial High Initial ABS Y N Absorbance and NO to proceed YES Continued on next page Version No 2 1 Page No 33 to 42 Effective Date Nov 2011 User Manual prietest easylab Continued from previous page YES High Initial ABS Y N Enter Maximum Initial Absorbance and press ENTER Enter Maximum Initial Abs Low Initial ABS Y N Enter Minimum initial AbSorbance and press ENTER Enter Minimum Initial Abs Max Delta Min selection Press YES to select Delta Absorbance and NO to proceed Delta and press ENTER Read Blank Standard Sample Instrument will wait till the temperature of cuvette reaches the set temperature Instrument will read the absorbance and calculate concentration and then displays prints in following format Version No 2 1 Page No 34 to 42 Effective Date Nov 2011 User Manual Sample Printout KINETIC RATE Filters 510 nm FACTOR 100 0 UNITS mEq L HIGH 200 0 LOW 100 0 LAG TIME 10 RD TIME 10 OFRD 3 QC HIGH 200 0 QC LOW 100 0 HIGH INIT ABS ABS 1 000 DEL M 1 600 S No ABS REM CON BL1 0 028 51 1 019 D1B 0 171 D1C 0 118 DELTA MINUTE RES 0 870 LOW 87 0 52 0 804 D 2B 0 330 D 2C 0 052 DELTA MINUTE RES 1 147 NORM 114 7 53 0 834
27. nd 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 no 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 s 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 1 Do not dispose in municipal waste follow local regulations for instrument disposal 2 Plastic parts Electronic PCBs and components can be recycled so return back the instrument to manufacturer 1 4 Contacts Manufacturer ROBONIK INDIA PVT LTD A 374 TTC MIDC Industrial Area NAVI MUMBAI 400710 INDIA Tel 491 22 67829700 Fax 491 22 67829701 Email sales robonikindia com Website www robonik in Version No 2 1 Page No 6 to 42 Effective Date Nov 2011 User Manual prietest easylab 2 GENERAL SAFETY WARNINGS 2 1 Danger Warnings Symbols The following symbols ar
28. ng Tube and press ENTER key In case Instrument remains idle for more than 10 minutes The lamp will Lamp Off press Enter switched off automatically Press ENTER key to proceed SKIP PRIN PR YES Refer to Chapter 6 5 Thermal SET PRI amp PR ENT Printer Version No 2 1 Page No 39 to 42 Effective Date Nov 2011 User Manual prietest easylab 12 DECONTAMI NATI ON 12 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 12 2 Purpose of Decontamination Decontamination minimizes the risk to all who come in contact with the instrument during shipping handling and servicing 12 3 General Considerations 1 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 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 2 Mucous membranes are considered prime entry routes for infectious agents Wear eye protection an
29. r or other means To pack the instrument follow the instructions as below described 1 Decontaminate the instrument as explained in Chapter No 11 Decontamination of this manual 2 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 3 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 8596 and temperature between 0 and 50 c Version No 2 1 Page No 11 to 42 Effective Date Nov 2011 User Manual prietest easylab 5 INSTRUMENT DESCRIPTION Components of different views of the below pictured instrument 5 1 Perspective View a Front View Incubator Printer Optical Grade Reading Tube Chamber Display 6 Rear View ON OFF Switch RS 232 gt e 9 ontrast 2 2 Cooling Mains Fan Input Version No 2 1 Page No 12 to 42 Effective Date Nov 2011 User Manual prietest easylab c Keypad 1 YES 3 G
30. s by qualified personnel THIS MANUAL CONTAINS INSTRUCTIONS FOR OPERATION BY QUALIFIED PERSONNEL ONLY 1 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 the user is not entitled to repair the instrument 2 A qualified technician is entitled to maintain and fix the instrument according to the Instructions given using the original spare parts 3 Maintain room temperature and humidity as specified in the manual 4 The instrument has to be used as described in this manual If it is not used then the Protection provided by the instrument may be impaired 5 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 6 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 7 This IVD equipment complies with the emission immunity requirements as 61326 series 8 Warning This equipment has been designed and tested to CISPER11 Class A In a domestic environment it may cause radio interference in which case
31. s present on keypad 1 key consists of Glucose test and Yes option Similarly UREA CREAT HB CHOL SGPT SGOT ALBUMIN TOT PRO T BIL and D BIL TESTS are present on the corresponding keys of the keyboard Whereas the 12 key consists of ABS mode User can Directly Access to the test created The prietest easylab test parameters of each test are shown as follows 1 GLUCOSE 2 UREA MOD 3 CREAT GLUCOSE UREA MOD CREAT Filters 510 nm Filters 578 Filters 510 37 DEGREE 37 DEGREE Ps 37 DEGREE Nu MODE END POINT MODE END POINT MODE FIXED TIME UNITS mg dL UNITS mg dL MEAT NORMAL VALUE NORMAL VALUE RD TIME 90 HIGH 110 000 HIGH 43 000 HIGH INIT ABS lt LOW 70 000 LOW 13 000 ABSM 0 400 S No ABS REM CON S No ABS REM CON DELTA 0 600 B B NORMAL VALUE C1 100 0 C1 40 0 HIGH 1 500 LOW 0 700 S No ABS REM CON C1 2 0 Version No 2 1 Effective Date Nov 2011 Page No 26 to 42 User Manual prietest easylab 4 HB 5 CHOLESTEROL 6 SGPT HB CHOLESTEROL SGPT Filters 545 nm Filters 510 nm Filters 340 nm Pu 37 DEGREE 37 DEGREE nuu 37 DEGREE MODE END POINT MODE END POINT MODE KINETIC RA KFACTOR 1 000 UNITS mg dL K FACTOR 1 000 UNITS g dL NORMAL VALUE UNITS U L FACTOR 36 800 HIGH gt 200 000 LAG TIME 60 NORMAL VALUE LOW 150 000 RD TIME 60 HIGH 16 300 S No ABS REM CON O
32. strument 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 115 230 Volts 10V 50 60 Hz 6 4 Protective Grounding Warning Please make sure that electrical power source is properly grounded 6 5 Thermal Printer Internal Printer Thermal Printer prietest easylab comes with a built in 20 column Thermal Printer User has to take proper care to handle this delicate instrument TIPS FOR CAREFUL USAGE OF PRINTER 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 prietest easylab gives line feed automatically wherever it is necessary for clear reading like a While powering on b In between character lines User may operate the instrument by disabling the printer from the utilities menu 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 Version No 2 1 Page No 15 to 42 Effective Date Nov 2011 User Manual prietest easylab Before inserting the paper After inserting the paper 6 6 Start up Instructions 1 Switch on the instrument The instrument will display the model name 2 instrument initializes all the parameters internally and carries out a power on self test It then displays model name the time indicating
33. then displays prints in following format Version No 2 1 Page No 36 to 42 Effective Date Nov 2011 User Manual Sample Print out WITH FACTOR END POINT Filters 340 nm FACTOR 100 0 UNITS U L HIGH 300 0 LOW 100 0 QC HIGH 300 0 QC LOW 100 0 S No ABS REM CON BL1 0 215 0 0 51 0 943 LOW 94 3 52 1 947 NORM194 7 5 3 gt 3 00 HIG 349 0 TEST CLEARED WITH STANDARD END POINT Filters 340 nm CALS 200 0 UNITS U ml HIGH 300 0 LOW 100 0 QC HIGH 300 0 QC LOW 100 0 S No ABS CON BL1 0 210 0 0 C1 1 961 200 0 FACTOR 101 96 S1 0 948 LOW 96 6 S2 1 965 NORM 200 3 53 gt 3 00 HIG 356 0 TEST CLEARED Version No 2 1 Effective Date Nov 2011 Page No 37 to 42 prietest easylab User Manual 11 TROUBLE SHOOTING 11 1 Memory Corrupts prietest easylab In case of memory corrupt Transfer all the test details to RAM memory to do this use following Steps Press Menu Key Enter Test No 197 Overwrite 1 23 Yes Will overwrite all Tests Version No 2 1 Effective Date Nov 2011 Page No 38 to 42 Note After doing this user has to re run the standards User Manual prietest easylab 11 2 Error Messages ERROR MESSAGES CORRECTIVE ACTION This error will come in Optical Grade Reading Tube mode while referencing Clear Optical Grade Reading Tube Remove the Optical Grade Readi
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