SYSMEX XW-100 Instructions For Use Manual
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SYSMEX XW-100 Instructions For Use Manual

Automated hematology analyzer
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Automated Hematology Analyzer
Sysmex XW
-100
TM
Instructions for Use Manual
KOBE, JAPAN
Code No. BM057433 en-am
PRINTED IN JAPAN
Date of Issue: 05/2018
Document Version: 1.1
© SYSMEX CORPORATION 2017-2018
Software Version: Ver.1

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Summary of Contents for SYSMEX XW-100

  • Page 1 Automated Hematology Analyzer Sysmex XW -100 Instructions for Use Manual KOBE, JAPAN Code No. BM057433 en-am PRINTED IN JAPAN Date of Issue: 05/2018 Document Version: 1.1 © SYSMEX CORPORATION 2017-2018 Software Version: Ver.1...

  • Page 3: Table Of Contents

    Test Principle Explanation of Flagging System Printing of Results Quality Control Expected Values Reference Intervals Performance Characteristics Cybersecurity Considerations for IT Coordinators Distributor Antivirus Software for Computers Connected to Sysmex Analyzers Appendix A: XW-100 Cleaning Log Template Page 3 of 32...

  • Page 4: Intended Use

    2. Intended Operators Intended operators of the Sysmex XW-100 must have at a minimum an earned high school diploma or equivalent. Summary The XW-100 is an electrical resistance type blood cell counter.

  • Page 5: Cautions And Warnings Biohazard

    The XW QC CHECK is a stabilized whole blood matrix designed for statistical process control of the Sysmex XW-100 automated hematology analyzer. It is not intended for calibration of the analyzer. Assayed parameters include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, LYM%, Other WBC%, NEUT%, LYM#, Other WBC#, NEUT#, RDW-SD, RDW-CV and MPV.

  • Page 6: Handling

    QC rinse thoroughly with water and consult a physician immediately. Observe the recommendations in the downloadable Safety Data Sheet (SDS). • SDS sheets for XW-100 reagents, XW CELLCLEAN and QC materials can be downloaded from the Sysmex Customer Resource Center website https://www.sysmex.com/us/en/Pages/default.aspx...

  • Page 7: Xw-100 Instrument Use And Function

    The analyzer measures 7.3” (W) x 18.1” (D) x 13.8” (H) and weighs 38lbs. • To install the system, follow first the steps from the XW-100 Start-up Quick Guide, then the on-screen installation instructions.

  • Page 8: Operating Instructions

    QC, the replacement system is ready to operate. Limitations • The XW-100 generated results should be used as an adjunct to other clinical findings. Should any results be inconsistent with other clinical findings or past CBC test results, the Clinician is advised to redraw and retest the patient or send the patient sample to a reference laboratory for further analysis.

  • Page 9: Specimen Collection And Preparation

    • Patients less than 2 years of age MUST NOT be tested on the analyzer because the performance characteristics for this age range have not been determined. Specimen Collection and Preparation • The XW-100 analyzer accepts standard 12-15 mm, 2 – 4mL draw purple top vacuum tubes. Both K and K EDTA are acceptable.

  • Page 10: Step-By-Step Procedure

    Step-by-Step Procedure 1. Follow the XW-100 Start-up Quick Guide and on-screen instructions if you are installing and operating the system for the first time or the system has been powered down and moved or powered down for over 15 minutes, (as instructed by the system on-screen prompts).

  • Page 11: Time Restrictions

    • Full time and dedicated high speed internet connection • Clorox Wipes o This product is safe for use on the Sysmex XW-100, however, any product with EPA registration number of 67619-12 can be used on the device. o This product can be purchased at local grocery or convenience store.

  • Page 12: Daily Cleaning And Disinfecting

    2. Using a new Clorox Wipe clean and disinfect the system outer housing, display, exterior of the sample chamber and the white sample adapter used for testing on the XW-100 every day. Wipe down all surface areas with a different new Clorox Wipe to disinfect.

  • Page 13: Good Laboratory Practice

    Good Laboratory Practice Some waived tests have potential for serious health impacts if performed incorrectly. To decrease the risk of erroneous results, the test needs to be performed correctly, by trained personnel and in an environment where good laboratory practices are followed. Some examples of Good Laboratory Practice include: •...

  • Page 14: Explanation Of Flagging System

    LOWER discriminator and UPPER discriminator are between 2 - 6 fL and 12 - 30 fL, respectively, and are automatically determined by the microcomputer. Explanation of Flagging System Blood cells are counted and fall into designated discriminators into histograms. Those cells outside of the outer discriminators or if there is no clear separation between cell types will prompt the flagging system of the device.
  • Page 15 WBC DIFF Higher TROUGH Presence of CML or other • Retest the same discriminator, the immature granulocytes, increased sample. If the separates the monocytes, eosinophils, basophils, retest confirms Other WBC and unlysed RBC, aged samples, the flag, send the neutrophils, increased Other WBC population, sample to a cannot be...
  • Page 16 List of RBC Error Flags Type of Description Probable Sample Cause Suggested Histogram Action Flag Relative Presence of fragmented RBC, •Retest the same frequency for large PLT, PLT aggregation or sample. If the micro-erythrocytes, electronic retest confirms discriminator noise. the flag, send the sample to a (LD) exceeds the reference lab.

  • Page 17: Printing Of Results

    List of PLT Error Flags Type of Description Probable Sample Cause Suggested Histogram Action Flag Relative Effects of cryoglobulins, •Retest the same frequency for fragmented RBC or cellular sample. If the fragments of WBcs, electronic retest confirms discriminator noise. the flag, send the sample to a (LD) exceeds the reference lab.

  • Page 18: Quality Control

    Results are additionally flagged as ALERT when they fall below or above the ranges established for the affected parameter. Reference Intervals – Whole Blood The following are the Reference Intervals for the XW-100: Page 18 of 32...
  • Page 19 Table 1: Pediatric Reference Ranges XW-100 Proposed Sample Range PARAMETER Units Pediatric Reference Range N=27 (≥2 - <12yrs) 4.8-13.5 5.0-11.2 x 10³/µL 4.2-5.4 4.22-5.32 x 10⁶/µL 10.5-16.0 11.7-15.1 g/dL 29.0-48.0 35.4-42.8 76.0-99.0 78.2-89.3 163-369 219-345 x 10³/µL 1.92-8.64 1.90-6.70 NEUT# x 10³/µL...
  • Page 20 Table 2: Adolescent Reference Ranges Proposed XW-100 Sample Range PARAMETER Units Adolescent Reference Range (≥12 - <21yrs) Central 95% Interval N=96 4.80-10.60 x 10³/µL 4.8-10.80 (4.80,10.46) 4.45-5.75 x 10⁶/µL 4.2-6.10 (4.46,5.69) 12.3-17.1 g/dL 12.0-18.0 (12.5, 16.6) 37.0-50.1 37.0-52.0 (37.4, 49.4) 81.0-96.0...
  • Page 21 Table 3: Adult Reference Ranges Adult Reference Adult Male Range Adult Female Range Parameters Units Range (≥21yrs) And 95% CI And 95% CI (N=116) (N=52) (N=64) 4.5-9.9 4.1-9.7 x 10³/µL 3.9-10.4 (4.5,9.7) (4.2,9.4) 4.02-6.01 3.95-5.61 x 10⁶/µL 3.71-5.52 (4.07,5.91) (3.96,5.27) 12.4-17.3 11.4-16.0 g/dL...

  • Page 22: Performance Characteristics

    Performance Characteristics Table 4 Performance/ specifications of the Sysmex XW-100 Ambient temperature 15°C-25°C (59°F-77°F) Operating environment (relative humidity) 30%-85% Storage conditions (transportation) Drained and packed in special box Power supply 100-240 VAC ( + 10%) Power consumption 150 VA or less Protection type 250V 3.15A fuse protected...
  • Page 23 Linearity (when RBC < 7.00 x 10 /µL) WBC 1.0-9.9 x 10 /µL; + 0.3 x 10 /µL or less 10.0-99.9 x 10 /µL; + 3% or less RBC 0.3-0.99 x 10 /µL; + 0.03% x 10 /µL or less 1.00-7.00 x 10 /µL;...
  • Page 24 100 and the pocH-100i. The study was conducted with standard laboratory operators for the pocH-100i and POC operators in a POC setting for the XW-100 at 3 different clinical sites. The estimation of the difference was determined as described in CLSI EP09-A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples.
  • Page 25 Short-term imprecision of the XW-100 instrument parameters was evaluated by POC operators in the POC setting in accordance with CLSI EP5-A2 approved guideline using ten replicates of residual whole blood at 3 different clinical sites. The XW-100 meets CV% limits as defined in the table below.
  • Page 26 Table 6 (continued) Precision Repeatability Summary XW-100 Whole Blood Repeatability Site 1 Site 2 Site 3 CV% Limit Measurand Sample Mean CV% Mean CV% Mean CV% CV% LYMPH% <15.0% 27.49 0.84 3.04 27.99 0.95 3.38 27.80 1.18 4.26 <15.0% 35.56 2.91...
  • Page 27 The results were determined by analysis of variance (ANOVA) in accordance with CLSI EP 05-A2 approved guideline and meet the acceptance criteria as defined in the table below. Table 7 XW-100 Reproducibility Summary XW-100 Reproducibility Summary XW QC CHECK Acceptance...
  • Page 28 Table 7 (continued) XW-100 Reproducibility Summary XW-100 Reproducibility Summary Acceptance Within Run Between Run Between Day Between Site Total XW QC CHECK Criteria Measurand Level Mean SD %CV SD %CV SD %CV SD %CV %CV 56.80 2.759 4.86 0.000 0.00 1.454 2.56 1.079 1.90...
  • Page 29 2. XW pack D 2. Dilutes sample to bring cell concentrations into the measureable range. 3. XW QC CHECK 3. Evaluates the accuracy and precision of the XW-100 analyzer. It is not intended for calibration of the analyzer. Page 29 of 32...

  • Page 30: Cybersecurity Considerations For It Coordinators

    Cybersecurity Considerations for IT Coordinators: During operation, the XW-100 system requires access to the Sysmex SNCS server via broad band internet. For cybersecurity reasons Sysmex recommends the XW-100 be connected to the internet via a firewall protected Large Area Network (LAN) with appropriate anti- malware software installed. In order to connect...

  • Page 31: Appendix A: Xw-100 Cleaning Log Template

    Page 31 of 32...
  • Page 32 Page 32 of 32...

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