ss0es27 -—s sysmex EIGHTCHECK™-3WP X-TRA Hematology control for Sysmex analyzers with 3-part differentials iN Intended use EIGHTCHECK-3P X-TRA isa stabilized whole blood matrix designed fr statistical process contral of Sysmex hematology ‘analyzers. This product is for In vitro use only, by laboratory professionals or appropriately talned personnel ‘Summary and principle EIGHTCHECK-3WP XTRA is used for control and calibration \eification of Sysmex analyzers with 3part WBC diferent. tis ol however, intended fr actual caliration ofthese analyzers Use af stabilized cell preparations for monitoring hematology instrumentation ian established procedure. When handled lke 2 patient sample and analyzed inthe QC Analysis Mode of» properly ‘alibrated and functioning analyzer, EIGHTCHECK-3P X-TRA will provide values within the expected ranges indicated onthe assay sheet Components EIGHTCHECK-3WP X-TRA contains the following: stabilized red bood cel components), stabilized white blood cel components) and staiized platelet components) ina preservative medium. ‘Warnings and precautions EIGHTCHECK-3WP X-TRA is for in vitro diagnostic use only by laboratory professionals or appropriately trained personnel, Do not Injector ingest. all human source material used to manufacture EIGHTCHECK-3W X-TRA was non-reactive for antigens to Hepatitis B (H8sAg) negative by tests fr antibodies to HIV (HIV-VHIV-2) and Hepatitis C (HCV), non-reactive for HIV-1 RNA and HCV RNA by licensed Nucielc Acid Tests (NAT), and non-reactive to Serological ‘est for Syphilis (ST) using techniques specified by the Us. Food and Drug Adminstration. Because no known test method can assure complete absence of human pathogens, EIGHTCHECK-3WP XTRA shouldbe handled with appropriate precautions Storage and shelf life of unopened product EIGHTCHECK-3WVP X-TRA is to be stored closed at 28°C. Avoid freezing this materia. When stored propery, the unopened product can be used unt the exication date stated onthe abel onthe vil. torage butsde the recommended temperature range causes damage tothe product. Do not use damaged material for control or calibration verification, Storage and shelf life after first opening ‘Opened and recapped val and vals whose caps have been pierced will retain stability for 14 days if stored at 2-8 °C after being recapped Indications of product deterioration IFEIGHTCHECK-3W X-TRA fails to perform within expected cesults as indicated onthe assay sheet, there may be a problem with ether ‘the control blood the reagents ar the instrument in use, Proceed a5 faliows ‘Check the reagents system is within the expration dates, not contaminated ané properly stored Determine if the analyzer is operating properly and does not requir cleaning o maintenance ‘Verify that EIGHTCHECK SWP TRA within the expiration date and that the vial has not been frozen 4. Analyze anew vil of EIGHTCHECK-3WP X-TRA, Use within anys For assistance contact Sysmex Technical Assistance Cente or your authorized astibutor Procedure 1. Remove aval of EIGHTCHECK SP X-TRA frm the refrigerator, end ela to room temperature (1530 °C) for minutes before use. 2. Hold the vial verily and ral each val between the palms of he hands for-20 seconds 5 Coatinue ta mix by holding the vial EB bythe ends between the tum and firger, rapidly leverting the 8 ‘al 20 tines end-over-end sing os avery quick turning motion of the wrist, 4 Analyze immediately after mixing. Subsequent analyses during this test period may be performed by inverting the val times prior instrument analy. 5. Process EIGHTCHECK-3WP XTRA in the instrument QC Analysis Mode according to the Sysmex analyzes Instructions for Use, ‘The perceable septum inthe vial ap allows for sampler anal 6. Return to refrigerated (28°) storage 7. Steps 1-6 must be repeated upon removing the sample from the tefrgerator for the enti open-vil time period regerdless of the ‘method of analysis open tube, cap piercing, auto sample ot ‘manual sample) Performance characteristics and limitations ‘The mean assay values for each parameter of EIGHTCHECK-3WP XTRA are derived from replicate analyzes on whole blood calibrated Instrumentation. The assay values ae obtained using instrument ‘manufacturer's recommended reagents. The values obtained on EIGHTCHECK-3W/ XTRA should be within the expected ranges, Sysmex recommends that each laboratory use the targets ard limits provided on the assay sheet included with each lot of EIGHTCHECK-3WP X-TRA, or establish laboratory specifi targets and limits. The expected ranges listed onthe assay sheet represent estimates of inter-laboratory variation for each parameter Interlaboratory variation is usually accounted for by analyzer ‘albration, maintenance and operating technique. ‘A microscopic differential analysis of white blood cells cannot be accomplished with EIGHTCHECK-3WP X-TRA, The white cell ‘components have been treated to enhance thee stabiity. They will so stain to demonstrate typical cell morphology EIGHTCHECK-3WP X-TRA is intended for use only on Sysmex -part WAC diferental analyzers with Sysmex reagents EIGHTCHECK 2WP XTRA assay targets and limits are model specifc. They are established on Sysmex analyzers operating within manufacturer's specifications and using Sysmex ceagents. Reference methods ‘The assigned values for EIGHTCHECK-3WP X-TRA are determined by Sysmex 3-part WAC aferental analyzers that ar calibrated with fresh human blood against international conventional reference measurement procedures: WBC: Reference method for the enumeration of erythrocytes and leucocytes, ICSH Expert Panel on Cytometry, clin Lab Haematol. 1994; 16 131-138. Counts on 1500 dilations performed on SCC (Sem-automated Single Channel counter). 8 volumetric manometer semi-automated electronic Impedance cel counter REC:_Reference method forthe enumeration of erythrocytes and leucocytes, ICSH Expert Panel on Cytometry, Clin Lab Haematol. 1994; 16, 131-138. Counts on 150,000 dilutions performed on SCC (Ser-automated Single Channel counter). 1 agsrasasta.volumetic manometer semi-automated electronic impedance ‘ell counter. HB: Recommendation for eerence method for hemoglobinometry In human blood (\CSH standard 1995) and specication for international haemiglobincyaride standard (Ath edition), ISH Expert Panel on Haemoglobinomety,| Cin Pathal 1996; 49.2728 CLI HIS-A3: Reference and selected procedures for the ‘quantitative determination of hemoglobin in blood; Approved Standard ~ Third edition (2000), Photometry on 1:250 dilutions with appropriate reagent ((ecommended by van Kampen, Zsa). HT: CLSIHT-Ad: Procedure for determining Packed Cel Volume by the Microhematecrit Method; Approved Standard ~ Third edition 2000). PLT: Platelet counting by the RBC/Platelet Ratio Method ~ A Reference method, ICSH Expert Panel on Cytometry ad ISLH Task Force on Platelet Counting, Am} Clin Pathol 200%: 15, 460-468, Determined from the RBC/PLT rato performed by Nuorescence flow cytometry with platelets labeled with monoclonal antibodies, Disposal procedures. This product should not be disposed in general waste but shouldbe disposed with infectious medical wast. Disposal by incineration’ recommended, Requirements of aplicable local regulations must be Considered Literature references 1. Henry, | Clinical Diagnostic and Management by Laboratory ‘Methods £417, 8, Saunders. Philadelphia, PA 1984 2. Wintrobe, M.M. ‘Clinical Hematology’, 8h Edition, Lea and Febigr, Philadelphia 191 3. Department of Labor, Occupational Safety and Health Administration, 29 CFR PART 1910. 1030; Occupational Exposure to Bloodborne Pathogens: Final Rule ‘Manufacturer tui Sysmex Corporation {154 Wakinohama-Kaigandon, Chuorku, Kobe 651.0073 japan "Producer" on OEM-Basis STRECK 70025. 109th Stret La Vista, NE ET28, USA, Distributed by: OO sya Ameren ne: S77 Aptaksi Rood Lincolnshire, 1 60089, USA, Product information EIGHICHECKSWPXTRA 20 mL vial Date of issue or revision (03/2023,Rev. 20 Printed in USA REF] 7) een hE Catalogue number Invitro clagnostc medical device Manufacturer Consul instructions for use Temperature lntation Useby Batch code Biological risks 2 aasrasastwe. sysmex EIGHTCHECK™-3WP X-TRA HEMATOLOGY CONTROL pocH-100/ ™ ———EEE See aeeee wre frst Der be ee" mmimamtrimewen nmin em ms oo} oo IMAI] > © AEN A AE recon ee] oo) AIAN AIO |} <=] ©] QO Wf} ef ==) 0 ee of 62) IMIINNINM EMU |} ===} 2) LUN Hy) ==} 2) CN il heres veo) of EIEN |) ==) =>) Wy} =} i pew ovo) 7) ANNO |) °°] AT WY} >) =} ] pve cee) sf MIEN |) ==] EEA AT | ===) =>] A noweioa oe <5? 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