SYSMEX BK265455 User manual

XW™-100 AUTOMATED HEMATOLOGY ANALYZER
CLIA WAIVED
OPERATOR'S QUICK GUIDE
BEYOND A BETTER BOX™
Code No. BK265455 en-am
PRINTED IN JAPAN
Date of Last Revision: 12/2022
Document Version: 3.0
Software Version: Ver.1© SYSMEX CORPORATION

2
XW-100 GENERAL CARE
Daily Cleaning and Disinfecting
NOTE: The following must be cleaned and disinfected every day that patient samples are tested to prevent the
spread of infection:
• XW-100 cover and display
• Exterior of the sample chamber
• White sample adapter used for testing
1. Put on personal protective equipment (PPE); disposable gloves, eye protection, and lab coat.
2. Clean any soiling from the following with two new, separate Clorox® Wipes:
• All surfaces of the adapter
• All surfaces of the XW-100
3. Allow the disinfected areas to sit for at least one minute, then wipe down all areas with a towelette moistened
with water.
4. Dispose of all cleaning materials in a biohazard container. Allow surfaces to air dry prior to use.
Periodic Cleaning - Waste Container Cap
NOTE: The waste container cap must be cleaned and disinfected after
each time the waste is emptied, or disposal cycle, to prevent the spread
of infection.
1. Put on disposable gloves, eye protection, and lab coat.
2. Remove the waste cap, and empty or discard the waste container
following your laboratory's rules for biohazardous waste material.
3. Place the waste cap on an empty waste container.
4. Wipe down all accessible areas on the waste cap thoroughly with a
new Clorox® Wipe.
Periodic Cleaning - Adapters
NOTE: Clean if blood or QC material is spilled onto either adapter.
1. Put on disposable gloves, eye protection, and lab coat.
2. Remove the adapter from the XW-100.
3. With a new Clorox® Wipe, remove any blood or dirt from adapter.
4. Rinse the adapter with water and allow it to air dry prior to running
additional samples.
Weekly Instrument Care
• Every 7 days, the XW-100 will instruct the user to
perform weekly care using XW CELLCLEANTM
(comes in a single-use tube, and is ready to use)
• Weekly care may be scheduled at any time; press
the [ >] key on the "Ready" screen, then select [General Care].
• Once care is completed, the XW-100 provides a reminder at the same time, every 7 days thereafter.

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XW-100 QUALITY CONTROL & STORAGE
Quality Control
Sysmex XW QC CHECKTM is a set of simulated whole blood samples. We run QC CHECK on the XW-100 to
ensure the system is performing correctly.
• Sysmex will ship XW QC CHECK every 28 days. Upon arrival, unpack and store the container at room
temperature.
• DO NOT freeze or expose the vials to excessive heat.
• The rst vial is the "primary" vial to use each day testing is performed. The second vial is the "back-up" vial
to use if the primary vial is broken, or if the XW-100 prompts for a new unused vial following a QC failure.
• There is sucient quantity of XW QC CHECK to perform QC daily until the next lot arrives. When the
new lot arrives, discontinue using the current lot and begin using the new lot immediately.
• The XW-100 requires the successful performance of all three levels of XW QC CHECK every eight hours
when testing is being performed.
• When the screen displays "QC check is required," follow the on-screen instructions using the green
adapter.
Storage Requirements
• All XW-100 reagents, XW CELLCLEANTM, and XW QC CHECK must be
stored at room temperature (59° to 77° F or 15° to 25° C).
• Store XW CELLCLEAN in the box it was shipped in, until use.
• Keep the extra reagent, XW CELLCLEAN, and XW QC CHECK in a clean,
dry location.
• The analyzer will not allow the use of reagents, XW CELLCLEAN, or XW
QC CHECK that are past their expiration date, open container stability, or container cycle time.
XW QC CHECK Disposal Procedure
• This product must not be thrown away in regular garbage. Instead,
throw away with infectious medical waste.
• Disposal by incineration is recommended. Requirements of applicable
local regulations must be considered.
Specimen Storage
• It is recommended that samples be tested immediately following collection. However, samples may be stored
at either room temperature or refrigerated and then run on the analyzer.
• Whole blood samples stored at room temperature (59° to 77° F or 15° to 25° C) are stable for up to 8 hours.
Samples stored refrigerated (36° to 46° F or 2° to 8° C) are stable for up to 36 hours.
• Specimens that have been refrigerated must be warmed as instructed by the XW-100 before running. Any
specimen that has been stored must be mixed thoroughly as instructed by the XW-100 prior to running.

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XW-100 SAMPLE PROCESSING
Sample Preparation
The blood sample must:
• Be collected in an EDTA-K2 or K3 (purple top) vacuum tube as shown on the instrument's display screen.
• Be run within 8 hours of having been drawn, if stored at room temperature, or within 36 hours if
refrigerated.
• Required sample volume: > 1 mL
Instrument Preparation
• If the screen displays "QC Required," refer to the Quality Control section of this Quick Guide.
• If the screen displays "General Care Required," refer to the General Care section of this Quick Guide.
(Continued on the next page)

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XW-100 SAMPLE PROCESSING
Sample Processing
1. Conrm purple top blood collection tube is
properly labeled.
NOTE:
This is the only sample tube with a purple top that
may be used.
WARNING/LIMITATIONS:
- Samples from children under 2 years of age must not
be tested.
2. Insert the white adapter, when prompted.
3. Enter the Operator ID.
4. Conrm the Operator ID.
5. Enter the Patient ID.
6. Conrm the Patient ID.
7. Enter the patient Date of Birth (DOB).
8. Conrm the patient DOB.
9. When asked if the collection tube is cold, touch
[Yes] or [No]; if [Yes], follow the on-screen
instructions to warm the collection tube.
(Continued on the next page)

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Sample Processing, continued from previous page
10. Follow the on-screen instructions to mix the
collection tube.
11. Insert the collection tube, then close the door.
12. Wait for the test cycle to complete.
Before inserting the tube: After inserting the tube:
Review Results
IMPORTANT:
• Deliver the printed test results promptly to the person who ordered the test. All test results must be
interpreted by a clinician.
• The thermal paper printout is NOT permanent; the operator must make a photocopy of the printout.
• If the operator is assigned the task of entering quantitative information into the electronic record, do so
carefully and double check the information to limit transcription errors.
XW-100 SAMPLE PROCESSING

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XW-100 SYSTEM COMPONENTS
XW-100
Power Cord Waste TubingEthernet Cable
Container Spout Kit
(XW pack D, XW pack L)
Reagent Tray Green Adapter White Adapter Thermal Paper
Barcode Reader
Waste Bottle XW pack D XW pack L XW CELLCLEAN XW QC CHECK

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Shutdown of the XW-100 is not required. If your laboratory would like to shutdown the instrument, please refer to
the Shutdown Quick Guide.
NOTE: Once shutdown has been performed, the following will need to be completed upon start up:
1. The internet connection will need to be reestablished.
2. New reagents will need to be scanned to replace existing reagents.
XW-100 INSTRUMENT SHUTDOWN

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XW-100 SAFETY INFORMATION
Waste Disposal
BIOLOGICAL RISKS:
Once used, this instrument and its accessories are considered biohazardous. Do NOT dispose of the instrument,
components, or waste in public trash containers. Please contact your Technical Assistant Center (TAC) for
instructions on instrument, component, and waste disposal.1-800-779-7639
EMC Information
• This instrument complies with IEC 61326-1 (Class B, Group 1, Industrial environment)
• This equipment might be used in areas other than laboratories.
• EMI (Electromagnetic Interference): For this standard the requirements of class B are fullled.
• EMS (Electromagnetic Susceptibility): For this standard the minimum requirements with regards to
susceptibility are fullled.
• It is the manufacturer’s responsibility to provide equipment electromagnetic compatibility information to
the customer or user.
• It is the user’s responsibility to ensure that a compatible electromagnetic environment for the equipment
can be maintained in order that the device will perform as intended.
• Use of this instrument in a dry environment, especially if synthetic materials are present (synthetic clothing,
carpets etc.) may cause damaging electrostatic discharges that may cause erroneous results.
• Do not use this device in proximity to sources of strong electromagnetic radiation (e.g., unshielded
intentional RF sources), as these can interfere with proper operation.
• If it is suspected that performance is aected by electromagnetic interference, correct operation may be
restored by increasing the distance between the equipment and the source of the interference.
• When XW-100 is installed, keep following distance between XW-100 and radio transmitter:
Radio transmitter Maximum power (W) Minimum separation distance (m)
Mobile phone
Wireless LAN
0.2W~ 0.9m~
Digital Convenience Radio 5W~ 4.5m~

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Instrument Failure
If the instrument fails, contact your Technical Assistant Center (TAC). Please note the ERROR CODE to help the
representative provide quick assistance.
1-800-779-7639
Equipment Operation and Ethernet Cable Connections
The connection of a non-shielded equipment interface cable to this equipment will invalidate the IEC Certication of
this device and may cause interference levels which exceed the limits established by the IEC for this equipment. It is the
responsibility of the user to obtain and use a shielded equipment interface cable with this device. Do not leave cables
connected to unused interfaces. Changes or modications not expressly approved by the manufacturer could void the
warranty for the equipment.
XW-100 SAFETY INFORMATION

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NOTES

Program availability varies by location. Programs and specification subject to change without notice.
Sysmex America, Inc.
577 Aptakisic Road
Lincolnshire, IL 60069, U.S.A.
Tel. [phone]
www.sysmex.com/us
Sysmex Corporation
1-5-1 Wakinohama-Kaigandori
Chuo-ku, Kobe 651-0073, Japan