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    Manual book Epithod 616

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    238 views24 pages

    Manual Book Epithod 616

    Uploaded by

    Irvanda ENVIOUS

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
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    DxGen* Epithod’616 Measuring System User Manual contains through installation, testing , and maintenance needed to use Epithod*616 Analyzer. Please read user manual carefully and become familiar with it before starting the Epithod®616 Analyzer. TABLE OF CONTENTS INSTRUCTION Intended use x Assay principle and procedure 1 Contents 2 Description of analyzer 2 GETTING STARTED Installing your analyzer 3 Setting your analyzer 3 Knowing your Home screen 4 CONFIGURATION Setting the configuration 56 DATA 7 TROUBLE SHOOTING 8 MAINTENANCE AND WARRANTY 9-10 SYMBOL a0, TEST PROCEDURE Starting up the HbA1c test 11. Knowing your Test Home screen 12-13 Preparing the HbA1c test (WB) 14 Performing the HbA1c test (WB) 15-17 Performing the HbA\1c test (Control) 18 TECHNICAL SPECIFICATION 19-21 INSTRUCTION Intended use Epithod®616 Measuring System Is intended for in vitro diagnostic (IVD) use to determine Glycated Hemoglobin (HDAC) and Glycated Albumin (GA) quantitatively from human blood. Its useful for the entire stage of clabetes care from the initial assessment of diabetes to post diagnosis treatment of glycemiccontrol. Assay principle and procedure Methodology of Epithod®616 Analyzer is reflectance bi-chromatic photometry for point-of-care testing (POCT). Epithod®616 Test Kits applies the boronate affinity principle for the determination of the percentage of HbAdc in human whole blood ‘and Glycated Albumin in human serum or plasma. This analyzer is only applicable in combination with Epithod®616 HbAic Test Kit and Epithod®616 GA Test Kit. Epithod®616 measuring system is only for professional use in clinic or laboratory. Epithod®616 HbAlc Test Kit consists of reagent 1 (R1), washing buffer 1 (W4), and cartridge. Testing requires auxiliaries such as safety lancet for finger puncture, capillary tube for blood sip-in, pipette and pipette tips. The whole blood from either capillary or venous collected by capillary tube is mixed with R1 and the mixture is left to stand for 2 minutes of incubation. Cell lysing and precipitation of total Hb occur and nanoencapsulated blue-dyed boronic acid conjugate binds to the glycated residues of HbAtc. Both precipitated glycated and non-glycated Hb are collected by dropping R1 mixture end the excess boronic acid conjugate is removed by dropping Wi on cartridge. The analyzer measures the reflectance intensities of total Hb (red) and HbA (blue) and the result is reported as value of NGSP (%), IFCC (mmo/mol), and eAG (mg/dl, mmol/L). Calculate the ratio between both intensities is proportional to the percentage of HbAIcin thesample. Epithod*616 GA Test Kit consists of reagent 1 (R1), washing buffer 1 (WA), ‘cartridge 1. for Albumin and reagent 2 (R2), washing buffer 2 (WW2), cartridge 2 for Glycated Albumin. Testing requires auxiliaries such as safety lancet for finger puncture, capillary tube for serum or plasma sip-in, pipette and pipette tips. The ‘serum of plasma 's mixed with R1 containing preciptation agents and indicator bromocresol green (BCG) for albumin. The mixture i left to stand for 2 minutes of incubation. Simultaneously, the serum or plasma is mixed with R2 containing precipitation agents and nanoencapsulated yellow-cyed boronic acid conjugate for Glycated Albumin. The mixture is left to stand for 5 minutes of incubation. The R1 and R2 mixtures are loaded to cartridge 1 and 2, respectively. Precipitated 8CGalburin and the conjugated-bound Giycated Albumin remains on the filter memibrane and any excess of indicator and boronic acid conjugate is removed by dropping W1 and W2 on cartridge, respectively. The analyzer measures the reflectance intensities of the total Albumin (blue) and Glycated Albumin (yellow). Galculate the ratio between both intensities is proportional to the percentage of Glycated Albumin in the sample. INSTRUCTION /1 Contents Analyzer Set ‘Auaillaries (Sold separately) DAralyier QD capillay tubes A. @ Adapter Qsafetylancet @ Printer paper Pipette 25p @ Superior card Pertti (Lone-sampingtip,yelow tp) @ Maal ‘Test Kit (HbAAc) Test Kit (Albumin/Glycated Albumin) @ ma(reagents) @a na reagent ,2) © wa (washing butters) Qw1, wa (Washing buter3,2) @ carvisge Deansieyes,2 @ termeard @rem ead © insertpaper Gower paper Description of analyzer © @ ® | @ { ® ® a @ @| Speaker Sounds voice guide and beep @)| Touch screen | Selects menu through touch @| Home button | Moves Home screen by press @/ Try Loads a cartridge into the analyzer for testing | @| Printer Prints test result | |®| Power switch | Turns the power on or off @| AC port taerioe bao SOS ete on / DC: 120, 304) INSTRUCTION /2 GETTING STARTED Installing your analyzer Place your Epithod®616 Analyzer on a dry, clean, stable and horizontal surface. The analyzer is for normal indoor user. Check the ambient temperature and leave the analyzer at the operating temperature of 15 ~ 35 °C (59 ~ 95 “F) before use, ‘The analyzer donot piace on the following : trong magnetic field igh humidity and temperature * Direct sunlight * Vibrations * Airconditioner and heater if the analyzer is operated outside of the specified ambient temperature, error ‘message wl be shown, Pace the analyzer at operating temperature and wal ateest 1 minutes until the message disappeared. Setting your analyzer 1. Plug the AC adapter into the back of the analyzer. 2. Plug the power supply cord into the AC adapter and intoa electrical outlet. 3. Press the power switch to tum on the analyzer, main logo will be shown on the screen. 4. The analyzer is ready for use when the Home screen is displayed. Use the adapter which s offered with analyzer from manufacturer ony. ‘Adapter speaification are folowings : * Input : AC100-240V, 50 ~ 60H, 1.54 ; Class Il / Output: 12V,3.08 * Input pin :2 pins C8, Output connector 55 «2.5mm + efufil the requirements of [EC60950-1 :2005+Al+A2, Power supply cords 2-pole without earthling contact and It is included with adapter. Maia nse fara enor mesa ilbasPOMN aon ‘use the analyzer minutes, the analyzer enters the auto: le. Ifyou dort use the aalver over 2hus the analy turns of automaticly, GETTING STARTED /3 Knowing your Home screen Home screen consists of status bar, log-in/out, test, data, and configuration, Sone wn ¥ sie A Statusbar: Anpearsdate/time. item, general setting information SB Log.inout: Changes the oparatoriO (210) Test: Accesses to HAL and GA test mode oan 0 Data: Manages the data E Configuration = Aecessesto general setting supervisor setting, and instruction ei7Hei9 o#80 >| Date /time B41 | Voice/Beep/Printon | Noitem card Hw | \oice/Beep/Printoft | HDAC mm Selected item with tem card | B. Log-in /out EE: Log-in Losin * Touch’ IE: ’ or ‘Test’ on the Home screen. + Appear Log-in pop-up window on the screen. + Enter OD and PIN. Fae seh OR ©-B sould authorities ested Renee ‘Configuration page) Hyouenter incorrect 01D or PIN, Log-out sre ai * OD appears on the Home screen. + Ifyou want to change O-1D, touch’ >". C. Configuration : See ‘Configuration’ page 5 ~ 6. D. Test See ‘Test procedure’ page 11 ~ 18. E, Data : See ‘Data’ page 7. (GETTING STARTED /4 CONFIGURATION Setting the configuration * Configuration screen consists of general setting, supervisor setting, and instruction, 1.General Setting ara ¥ ©) + Drag the bar to adjust the brightness and voice ‘cea Serre volume. i + Touch the language box and select the language from the list (Englshis the default) * Touch the date/time bax pop-up window will be shown). Select the displayed format (3 types} ese Select date, time, and PM or AM. me « ~Touch ‘OK’ vm + Tum on/off the beep or printer. + Touch ‘Back to save changes. \bice, beep, and printer icon in the status bar is changed ME scxanciotiereert ating 2. Supervisor Setting a ea #8) «Insert the supervisor card into the top of the analyzer suremusonsariie ‘and touch ‘Supervisor setting’ cmowt « Remove the supervsor cau and touch ‘Back to ext the ‘Supervisorsetting’ ‘(Manufacturer offers a supervisor card toaccess the analyzer. es oe ee CONFIGURATION /5 A. OAD Registration (Only authorized user from supervisor can perform the testand manage the data. aaa Fes) a)Add * Touch ‘Add’ to register a new O-ID. * Enter the information about operator and select the = authority for the test item. * Touch ‘Save’ or ‘Cancel’ Sy, eee + Choose one or multiple circle boxes and touch ‘Delete’ toremovethe O.1D. edit * Touch a desired row, + Edit the name, PIN or authority. + Touch ‘Save’ or ‘Cancel’ 23 letters and numbers can be entered. You con use the barcode reader instead of entering O.1D. 0:10 is saved up to 100. if memory is ful, “Ber=m==o+" will be shown. B. Turn on/off the O-1D and PAD functions ‘The ID functions are disabled as a default setting (See “Test procedure’ page 11). * O-1D on : Requires Log-in before testing and managing the data * O-1D off: Doesn’t require Log-in before testing and managing the data. + PD on : Requires patient information for testing. + PAD off : Doesn’t require patient information for testing. ‘To.use the O-ID function, atleast one O-1D must be registered. User CAN NOT use the function of network and ETC. These mades are the ONLY forthe manufacturer, ‘CONFIGURATION /6 DATA Epithod®616 Analyzer stores the patient (20,000) and control (500) results in separate records. The analyzer shows the latest data first. Operator who gets the authority can recall 100 results of one patient by searching P-ID_ * Touch ‘DATA’ on the Home screen. + Search the P-1D or choose desired data‘ which are actvted acorengtothe operators author + The table includes the date/time, P-D, item, and result (6) for HbAlcand GA. + The table includes the date/time, Lot No,, range, item, and resut (96) for control. -Hisan abbreviation for HbAlc -Gis an abbreviation for Glycated Albumin. + Touch’... ’ toseemoreresults on the next page. You can check where they are through the page icon | -* ). + To print single or multiple data, choose circle boxes and Ey touch ‘Print’, + You can seethe more detail information about patient by touchingthe result. + Report includes the date/time, O-1D, P4D, name, gender, birth, LotNo,, item, sample, and results for HDALc or GA. “Report includes the date/time 0D, Lot No,, item, sample, Lot No. (control), range, and result for control. oNA/7 TROUBLE SHOOTING ‘When the error message is displayed, please take following action. Ifthe problem is not solved out, contact the local distributor, Message Action to take f= Insert the supervisor card into the top of the analyzer and then ‘touch ‘supervisor setting’. Ye Place the analyzer at operating temperature (15 ~35°C)and wait ‘ Me) at least 10 minutes unti the message disappeared. Checkthe cartridge and repeat the test withnew testkit or check thedesired test tern. Repeat the test with new test kit. Ifthe problem persists, reboot ‘theanalyzer and run control test. Repeat the test with new test kit. Ifthe problem persists, reboot ‘theanalyeer and run control test. FM) Sere tre carege and touch scat or Save onthe estsceen Remove the caridge and touch pop-up window on the booting screen, --- ‘TROUBLESHOOTING /8 MAINTENANCE AND WARRANTY No special maintenance need for the analyzer. Avoid large temperature and humid variations and place the analyzer on dry, clean and horizontal surface. Cleaning ‘Tum off the analyzer before cleaning, Wipe the surface of analyzer and touch screen using a lint-free cloth dampened water or mild detergent. To disinfect the analyzer, ‘wpeall exposed surface with disinfectant tissues or with a lint-free cloth dampened a antiseptics solution. Ethyl or isopropyl alcohol (60 ~ 70 %) are recommended antiseptics for cleaning. Remove the residual cleaner. Do not wipe with the harsh abrasives. Precaution and warning + Epithod*616 Analyzer is only used for in vitro diagnostics in clinic or laboratory. + Tum the power off and unplug the power supply when not in use. + Usea suitable adapter. tf not, it may cause damagetto the analyzer. + Use for only normal indoor concition and do not operate the analyzer outside the stated ambient temperature range (15~35°C). + Donot open the cartridge tray manually. + Donot insert any objects into the tray besides given cartridge. + To prevent the contamination, wear gloves and do not re-use disposable products. + Avoid the testing around extremely high or low ambient condition, + Dont touch the screen with sharp items or give extemal impact. + Donot self repair the analyzer. + Donot disassemble and modify the analyzer. Storage, transport, and operating condition Analyzer | “estkit Operating | atanspor, | Opertina |g tanstort Temperature] 15~35°C -20~ 60°C 15~35°C Humidity | 15~7596RH | 15~75%RH | 15~759%RH | 15~759%RH Altitude: <3000m 700~1050hPa - - Disposal For correct disposal according to the Directive 2012/19/EU (WEEE), contact your local distributor. [MAINTENANCE AND WARRANTY / 9 Warranty DxGen Corp. guarantees @ warranty period (12 months) from the delivery date to ‘the user for analyzer. Test kits guaranteed until the expiry date. For this period its guaranteed that the analyzer works within quality requirements valid on the date of manufacture release. DxGen Corp. is prepared to compensate for faulty material or malfunctions within tthe limitations of the warranty. The warrant is limited to providing a replacement Epithod®616 Analyzer. ‘Tampering with the internal components, damage due to operating errors, misuse and overlooking essential information with respect to warnings and precautions described in this User Manual wil invalidate the warranty. ‘The acknowledgment of claims shall immediately be reported to your local distributor, SYMBOL The packaging box, labels and instruction for use for Epithod°616 Analyzer contains the following symbols or abbreviations : IVD | | in vitro diagnostic medical device SN | | Setialnumber [LOT] | Batch code |REF} | Catalogue number A |remperaure triton [EGRRER|| authorzed turopean Representatwe B3 |Usety CE | Exropean Conformity XZ |contanssuicentiorerotess | AC | (ETeBOET went) @ [oveerane DC tse cen) [11a] | consult operating instructions 1/O© | Powerswitch on / off ZA, | Cation, corsuit accompanying documents tall | Meetacirer [MAINTENANCE AND WARRANTY /10 TEST PROCEDURE Starting up the HbA1c test Place the Epithod*616 HbAlc Test Kit under operating conditions before use and tum on Epthod®616 Analyzer. Prepare R1, W1, cartridge and auxiliaries. (capillary tube; 5 pl, pipette; 25 kl, pipette tips, safety lancet and alcohol swap) 1, Touch ‘Test’ on the Home screen. 2. Calibrate analyzer calbration IF calibration is failed, “@) error message’ will be shown, 3. Insert the item card for HbAlc l = Lot No. anditem are filled automatically. 4.Enter the test information (P-1D, Lot No, item, sample, incubation time) a. O-1D is filed out N/A. we a

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