SYSMEX XW-100 Manual

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

Pa
g
e 3 of 32
Table of Contents
XW-100 Automated Hematology Analyzer
Intended Use
Intended Operators
Summary
Cautions and Warnings Cautions Electrical
Cautions and Warnings Biohazard
XW Reagents, XW CELLCLEANand XW QC CHECK
Description
XW QC CHECK Intended Use
Handling
Storage / Stability
XW-100 Instrument
Use and Function
Installation Procedures and Requirements
Specifications and Stability
Operating Instructions
Calibration Procedures
Limitations
Specimen Collection and Preparation
Specimen Storage
Step-by-Step Procedure
Time Restrictions
Accessories Required (provided)
Materials Required but not Provided
Cleanup of Spills
Daily Cleaning and Disinfecting
Packaging Symbols
Good Laboratory Practice
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
A
pp
endix A: XW-100 Cleanin
g
Lo
g
Tem
p
late
Page
4
4
4
4
5
5
5
6
6
7
7
7
8
8
8
9
9
10
11
11
11
11
12
12
13
13
14
17
18
18
18
22
30
30
30
31

Pa
g
e 4 of 32
XW-100 Automated Hematology Analyzer
Intended Use
The XW-100 Automated Hematology Analyzer (XW-100) is a quantitative automated hematology
analyzer intended for in vitro diagnostic use to classify and enumerate the following parameters for
venous whole blood anti-coagulated with K2/K3EDTA: WBC, RBC, HGB, HCT, MCV, PLT, LYM%,
Other WBC%, NEUT%, LYM#, Other WBC#, NEUT#. It is not for use in diagnosing or monitoring
patients with primary or secondary chronic hematologic diseases/disorders, oncology patients, critically
ill patients, or children under the age of 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. This technology may be
variously referred to as Direct Current, (DC) or impedance. The analyzer uses a human whole
blood specimen and produces results for 12 hematology parameters including the basic CBC,
three part WBC differential and MCV.
Cautions and Warnings
Electrical
•NEVER insert the power plug into power sockets other than AC100-240 V. Please note
that the analyzer must be grounded.
•Avoid damage to the power cord. Unplug by gripping the plug NOT by pulling the cord.
•If the analyzer emits unusual odors or smoke or if it leaks fluids, switch the analyzer off,
unplug the power cord and contact the Sysmex Technical Assistance Center (TAC)
immediately.
•Do not spill blood or other fluids on or inside the analyzer. Do not place metal objects
such as staples or paper clips on the analyzer as these could cause a short circuit.
•In the event of a short circuit switch the analyzer off, unplug the power cord and contact
the Sysmex Technical Assistance Center (TAC) immediately.

Pa
g
e 5 of 32
Biohazard
•All parts and surfaces of the analyzer as well as QC vials and contents must be regarded
as potentially infectious due to its contact with blood. To avoid infection:
o Use protective lab coat, eye protection and disposable gloves when operating or
maintaining the analyzer.
o NEVER touch the analyzer, accessories or waste fluids with bare hands.
o Should you inadvertently come in contact with potentially infectious materials or
surfaces immediately rinse the affected skin area thoroughly with water and
follow your facilities prescribed cleaning and decontaminationprocedures.
o After completion of work with the analyzer wash your hands thoroughly with
soap and water or a disinfectant hand cleanser.
XW pack D and XW pack L Reagents, XW CELLCLEAN
TM
, and XW QC CHECK
TM
Description
XW pack D, (2 x 2L) is a proprietary reagent which is used to blank the system, dilute the whole
blood sample prior to analysis and rinse the analyzed sample out of the system post analysis.
This reagent is shipped fully reconstituted and ready for use.
XW pack L (2 x 250mL) is a proprietary reagent which is used to lyse RBCs during the testing
process to determine WBC and Hemoglobin parameters. This reagent is shipped fully
reconstituted and ready for use.
XW CELLCLEAN
TM
is a proprietary single use weekly care fluid which keeps the
aspiration pipette, sample path, and rinse cup clean and operational.
•20 single use tubes per box
•Note: Weekly care must be performed every seven calendar days. The system will
not process patient samples until weekly care is performed.
•XW CELLCLEAN
TM
is shipped fully reconstituted and ready for use.
XW QC CHECK
TM
, (2 vials of each level per package) is a proprietary 3 level control which
is performed to verify correct system performance.
•XW QC CHECK
TM
is shipped fully reconstituted and ready for use.
Intended Use:
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.
•Other WBC%/# is comprised of eosinophils, basophils and monocytes.
•Two vials of each level are included. The first vial (primary) has sufficient fill quantity
and should be used each testing day until a new lot arrives unless the primary vial is lost
or broken.

Pa
g
e 6 of 32
•XW QC CHECK should be placed on standing order for delivery every 28 days when the
analyzer is in use.
•Note: QC must be performed asfollows:
o Every 8 hours of instrument use
o When a new lot of reagent is used
o After completing weekly care (NOTE, a description of weekly care can be
found in the Operators QuickGuide)
•The system will prompt users when QC is required and will not allow patient samples to
be tested until QC is performed.
Handling
•Follow the on-screen XW QC CHECK vial mixing instructions correctly; DO NOT
shake.
•All reagents, XW CELLCLEANTM and QC materials are fully reconstituted and are
ready for use upon arrival.
•Read and follow all labeling on reagents, XW CELLCLEANTM and QC materials prior
to use.
•Avoid direct contact with reagents, XW CELLCLEANTM and QC materials.
•In case of eye contact with reagents, XW CELLCLEANTM or 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 CELLCLEANTM and QC materials can
be downloaded from the Sysmex Customer Resource Center website
https://www.sysmex.com/us/en/Pages/default.aspx
•DO NOT store reagents or QC on top of the analyzer.
•Reagents in use should be placed next to the analyzer, not ontop.
•If reagents spill near the power cord or other electronic appliances there is a risk of
electrical shock. Switch the instrument off and unplug the power cord before cleaning up
the spill and decontaminating the spillarea.
•Be aware of and observe precautions and warning labels on the analyzer.
Storage / Stability
•All XW-100 reagents, XW CELLCLEANTM and XW QC CHECKTM should be stored
at room temperature (59° - 77° F or 15 – 25° C).
•Store XW CELLCLEANTM in the light protective box it was shipped in until use.

Pa
g
e 7 of 32
•Keep extra reagent, XW CELLCLEANTM and XW QC CHECKTM stored in a
clean, dry location.
•The analyzer will not allow the use of reagents, XW CELLCLEANTM or XW QC
CHECKTM that are past their expiration date, open container stability limit or container
cycle limit.
XW-100 Instrument
Use and Function
•Installation of the analyzer must be performed by following the XW-100 Start-up Quick
Guide then proceeding to the on-screendirections.
•Operators must keep hair, fingers and clothing away from the sample door.
•Operators must NEVER remove the analyzer’s outer housing.
•Operators must complete the XW-100 on-line registration prior to operating the analyzer.
Installation Procedures and Requirements
•The analyzer must be installed in a clean dry location close to power and away from
direct sunlight, water or excessive draft. The space must be adequate in size for the
analyzer itself and reagents which sit beside. The analyzer measures 7.3” (W) x18.1”
(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.
•The analyzer SHOULD NOT be operated at temperatures below 12°C (54°F) or above
33°C (91°F), a relative humidity below 30% or above 85% or atmospheric pressure
below 1.02 PSI (roughly 10,000 feet above sea level) or above 1.5 PSI (below sea
level).
Specifications and stability
•Day-to-Day; XW QC CHECK run for 18 days was determined to be:
o WBC; ≤3.5%
o RBC; ≤2.0%
o Hemoglobin; ≤1.5%
o Hematocrit; ≤2.0%
o Platelet; ≤6.0%

Pa
g
e 8 of 32
Fluctuations of 10% voltage do not affect XW-100 results
Operating Instructions
Once weekly care and QC requirements have been satisfied, the analyzer will show the “ready
for testing” screen. The instrument requests the operator to confirm a purple top collection tube was
used. The operator should answer “Continue,” and follow the on-screen prompts. Follow all
instructions on the results printout.
Calibration Procedures
The XW-100 requires no on-site calibration. The system is shipped factory calibrated and ready
for installation and operation. When the system requires calibration, due to the uncorrectable
failure to pass QC, Sysmex will ship a replacement system. After the first-time start-up
procedure, performance of weekly care and 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 furtheranalysis.
•Some patient samples will require a repeat in order to confirm results for parameter(s)
that are outside normal limits. Should you elect not to repeat the initial test, the analyzer
WILL NOT print any results. If the repeat test does not correlate with the first test results
to a statistically acceptable degree, the result will not be printed. The Clinician is advised
that further testing isrecommended.
•Some patient samples will generate flags caused by various interfering substances. When
flags are present, one or more parameter results could be inaccurate or questionable. In
such cases the potentially affected parameter results will not print. The Clinician must
refer to the XW-100 Clinician’s Quick Guide for more information as to the causes and
recommended actions in suchinstances.
•Samples that are known or subsequently determined to be grossly lipemic or hemolyzed
must not be tested on the analyzer as they will generate incomplete results (some

Pa
g
e 9 of 32
parameters results will not be printed). Such samples must be sent out to a reference
laboratory.
•Collection tubes other than purple top EDTA tubes MUST NOT be used.
•Patients less than 2 years of age MUST NOT be tested on the analyzer becausethe
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 K2 and K3 EDTA are acceptable. Tubes other than purple top EDTA tubes
MUST NOT be used.
•Blood should be collected following the tube manufacturer’s instructions for minimum
fill volume and well mixed post draw to distribute the anti-coagulant.
•Good phlebotomy and biohazard safety practices should be observed at all times.
•Operators must label the specimen correctly and/or only accept a properly labeled specimen
from another staff member for testing on the XW-100.
•All parts and surfaces of the analyzer as well as QC vials and contents must be regarded
as potentially infectious due to its contact with blood. To avoid infection:
o Use protective lab coat, eye protection and disposable gloves when operating or
maintaining the analyzer.
o Disposable gloves should be removed after operating or maintaining the analyzer
to perform other duties. When returning to operate or maintain the analyzer, a
new pair of disposable gloves should be used.
o NEVER touch the analyzer, accessories or waste fluids with bare hands.
o Should you inadvertently come in contact with potentially infectious materials or
surfaces immediately rinse the affected skin area thoroughly with water and
follow your facilities prescribed cleaning and decontaminationprocedures.
o After completion of work with the analyzer wash your hands thoroughly with
soap and water or a disinfectant hand cleanser.
•Minimum blood fill volumes for use on the analyzer are 1mL for 12-15 mm vacuum
tubes. Running tubes with lower than minimum fill volume will result in suppressed
values for test parameters.
•Test samples containing various interfering substances or rare cells and samples from
patients with various pathological conditions can initially generate compromised results.
In these cases, the system prints result flags and does not print numerical results. Refer to
the XW-100 Clinician’s Quick Guide for additional information.
Specimen Storage
•It is recommended that samples be tested on the analyzer immediately following
collection, however properly collected samples can be stored at either room temperature
or refrigerated and run subsequently on the analyzer. Whole blood samples stored at

Pa
g
e 10 of 32
room temperature (59 - 77° F or 15 – 25°C ) are stable for up to 8 hours and samples
stored refrigerated (36 - 46° F or 2 - 8° C) are stable for up to 36 hours. Specimens that
have been stored refrigerated should be warmed as instructed by the analyzer prior to
running. Any specimen that has been stored should be mixed thoroughly as instructed by
the analyzer prior to running.
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).
2. Bring the system to ready status by performing Weekly Instrument Care and QC (if
necessary as indicated by on-screenprompts)
3. Ensure that the sample:
a. It is not from patients with primary or secondary chronic hematologic
diseases/disorders, oncology patients, critically ill patients, or children under the
age of 2.
b. Is a 12-15 mm, 2 – 4 mL draw vacuum tube, (as pictured on the systemready
screen).
c.
Is a purple top K2 or K3EDTA tube.
4. Has sufficient fill volume; 1mLfor vacuum tubes.
5. Press “Continue” when the instrument requests the operator to confirm a purple top
collection tube was used.
6. Enter your operator ID, a unique patient identifier number (which may be any
combination of up to 9alpha/numeric characters with no more than 2 alpha and 7
numeric characters) and the patient’s date of birth.
7. Open the sample door and insert the correct tube adapter into the system (follow on-
screen prompts).
8. Follow the on-screen prompts to begintesting
a. Is not cold to the touch, (follow on-screen instructions)
b. Is properly mixed (follow on-screeninstructions)
9. Insert the sample collection tube into the adapter and close the sample door.
10. Follow any additional on-screen instructions and deliver the results printout to the
ordering Clinician.