XS Series PM Standard Procedure

Sysmex Corporation
Customer Support Headquarters

3rd edition August 11, 2014

 (3rd edition)
Note：
Before the PM, it is recommended to review PM purpose and procedure with Operator (on the phone)
This review and scheduling with the lead operator or lab supervisor is very important. This review
occurs before the PM and can be done via phone or in person. Who, what, when, why, and how of the
PM should be clear to both parties at the conclusion of this review.

The key items that must be discussed include, but are not limited to the following:

1) Explain that the purpose of the PM is to reduce customer downtime by inspecting the instrument for
potential issues that cause failures, to verify proper operation, and to help the customer maintain the
instrument. Each of these steps helps reduce unscheduled failures and insures that the instrument is
producing accurate results so that the customer can feel confident.

2) Explain the steps involved with the PM. These include the operator interview, instrument inspection,
PM part replacement, instrument adjustments and operational review. The day you begin the PM, you
must inform the customer of the PM status if the PM is incomplete prior to your departure.

3) Ask the customer if the instrument is experiencing any issues. This will help you determine if any
additional parts are needed. In addition, query the operator as to their supply of consumable parts.
During the PM some of these parts can be replaced using the customer’s parts, at no-charge. Customer
consumable parts are listed in the IFU.

4) Schedule the PM visit. Give the operator an estimated time for the PM completion. If any scheduling
conflicts arise that prevents the starting of the PM – Notify the customer as soon as possible.

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XS Series PM check list

Item to be checked Schedule Check Comments

Data
Control material or sample data
verification □
verification
before PM
Vacuum Line Clean vacuum lines □
Replace waste chamber 1 drain Every 3 years or 60,000
□
tube (PV2) cycles
Replace waste chamber 2 drain Every 3 years or 60,000
□
tube (PV1) cycles
Tubing Replace rinse cup drain tube Every 3 years or 60,000
□
(PV3) cycles
Clean charging line tube □
Clean Filter No.13 2 locations
Clean charging line nipple □
WBC Chamber Clean WBC chamber □
Clean drain line and filter
Waste Clean waste chamber 1 and 2 □
Chamber Clean trap chamber □
RBC/HGB
Clean drain line and filter
Chamber
Whole Blood Every 3 years or 60,000
Replace whole blood pump □
Pump cycles
Every 3 years or 60,000
Sheath Syringe Replace sheath syringe □
cycles
Replace pipette Every 30,000 cycles □
Aspiration Unit Clean pipette □
(XS-800i, XS- Replace whole blood tubing Every 3 years □
500i)□ Pipette position adjustment □
Lubricate mechanical unit □
Replace piercer Every 30,000 cycles □
Aspiration Unit Replace whole blood tubing Every 3 years □
(XS-1000i, XS- Piercer position adjustment □
900i)□ Clean tray □
Lubricate mechanical unit □
Sampler Clean sampler unit interior □
（Not connected
口） Lubricate mechanical unit □
0.06MPa verification □
Pneumatic -0.03MPa verification □
Replace air pump Every 30,000 cycles □
Clean RBC transducer □
RBC Detector Drain isolation chamber □
Clean inside RBC detector □
Execute air bubble removal
□
FCM Detector sequence
Execute rinse flowcell sequence □
Execute monthly cleaning
Other Hydraulic □
sequence
Software Adjust HGB and blood aspiration
□
Adjustment sensor blank level
Software Adjust blood aspiration sensor
□
Adjustment gain

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Item to be checked Schedule Check Comments

Adjust RBC clog level □

Clean instrument interior □
Interior
Instrument
Lubricate mechanism □

Clean monitor and exterior

□
surface of instrument
Execute scan disk □
IPU Defrag HDD □
Check program version □

Check laser current

Check optical alignment □
Data
verification Sensitivity adjustment □
after PM Check control material data or
□
sample data
Clean exterior surface of
□
Exterior instrument
Instrument Clean option equipment (Printer,
□
etc.)
Operation Reset maintenance cycle count □
Review Operation testing □
* Description in “Schedule” is for general case. Schedule may vary depending on the instruments condition.
* Items to be checked with blank for “Schedule” is recommended to be checked every PM.
* When FSR replaces parts other than recommendations in PM procedure or FSR intends to replace parts at next
PM, the information should be described in “Comments”.

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【Each Adjustment Target】

Item to be adjusted Target Before adjustment After adjustment
HGB Blank Level (Ambient temperature：～
19.9℃)
2500±300
Blood Aspiration Sensor (Ambient temperature：
Blank Level 20.0～24.9℃)
3000±300
(Ambient temperature：
25.0℃～)
3500±300
Blood Aspiration Sensor e-CHECK (LEVEL2)
Gain HGB assay ( )
X105±50
Sensitivity Adjustment Control assay sheet (Lot. NO. )
ＤＩＦＦ-X Target±3ch
FSC-X Target±2ch
DIFF-Y (using human 43.5±3.0
blood)

【Other Verification Item】

Item to be verified Target Verified value
Laser Current Limit value (　　　) X 95%
Program Version －
*Refer to QC chart and sample explorer for sensitivity value, control and sample data result confirmation.

Service report
No.
Customer site
Instrument model XS Series Serial No.
Date
Inspector

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XS Series PM Standard Procedure
【Necessary Jig and control material】
Parts code Description Remarks
－ e-CHECK Control blood
CX472678 Latex 4207A Latex for optical alignment
521-8653-6 Latex A-7312 Latex for optical alignment

Labor
Item to be checked Procedure
Time
Measure normal human blood or control
Data verification Control material or sample data material on either/both manual and sampler
10min
before PM verification mode. Record the average data result or QC
chart.
Disconnect vacuum line connected to waste
chamber 1, and aspirate ethanol from it. After
Vacuum Line Clean vacuum lines 10min
cleaning, disassemble trap chamber located in
right side to clean it.
Replace waste chamber 1 drain tube
Replace Pharmed_BPT_3 X 5 on PV2.
(PV2)
Replace waste chamber 1 drain tube
Replace Pharmed_BPT_3 X 5 on PV1.
(PV1)
Replace rinse cup drain tube (PV3) Replace Pharmed_BPT_3 X 5 on PV3.
Disconnect Pharmed tubing from nipple of
bottom of MV34 and connect it with an injector
Tubing 20min piston containing CELLCLEAN. Clean the line
Clean charging line tube
by moving liquid surface inside up and down 20
times. In addition, disconnect tubing from MV34
and MV33 to clean them.
Remove Filter No. 13 from mixing chamber
drain line and reaction chamber drain line and
Clean Filter No.13
clean them, using an injector piston containing
CELLCLEAN.
Clean charging line nipple 5min Clean nipples with cleaning wire.
Clean inside reaction chamber with gauze
Clean WBC chamber 10min
dampened with CELLCLEAN.
WBC Chamber Disconnect WBC chamber drain line tube to
connect it with injector piston containing
Clean drain line and filter 5min CELLCLEAN. Clean drain line by moving liquid
surface inside up and down 20 times.
Disassemble and clean filter as needed.
Clean inside waste chamber and float switch
Clean waste chamber 1 and 2
with gauze dampened with CELLCLEAN.
Waste Chamber 10min
Clean inside trap chamber with gauze
Clean trap chamber
dampened with distilled water.
Disconnect RBC chamber drain line tube to
connect it with injector piston containing
RBC/HGB
Clean drain line and filter 5min CELLCLEAN. Clean drain line by moving liquid
Chamber
surface inside up and down 20 times.
Disassemble and clean filter as needed.
Whole Blood
Replace whole blood pump 15min Replace Cylinder NO.50 Assy.
Pump
Sheath Syringe Replace sheath syringe 15min Replace Syringe Complete No.8 Assy.

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Labor
Item to be checked Procedure
Time
Replace pipette 20min Replace Pipette NO.70.
Clean surface of pipette with gauze dampened
Clean pipette 5min
Aspiration Unit with CELLCLEAN.
(XS-800i, XS- Replace whole blood tubing 10min Replace Teflon Tube 1.8X0.8.
500i) Adjust pipette position.
Pipette position adjustment 20min
（Refer to chapter 4 in SM）
Lubricate mechanical unit 5min Lubricate aspiration unit mechanism.
Replace Piercer Set NO.7.
Replace piercer 20min
(Refer to chapter 9 in IFU)
Replace whole blood tubing 10min Replace Teflon Tube 1.8X0.8.
Aspiration Unit
(XS-1000i, XS- Adjust piercer position.
Piercer position adjustment 20min
900i) （Refer to chapter 4 in SM）
Clean tray using distilled water.
Clean tray 5min
(Refer to chapter 9 in IFU)
Lubricate mechanical unit 5min Lubricate aspiration unit mechanism.
Remove sampler cover and clean inside of
Sampler Clean sampler unit interior
5min sampler unit.
（Not connected）
Lubricate mechanical unit Lubricate sampler mechanism.
0.06MPa verification Check pressure and vacuum from IPU
5min program.
Pneumatic -0.03MPa verification （Refer to chapter 10 in IFU）
Replace Air Pump No.1.
Replace air pump 10min
(Refer to chapter 9 in IFU)
Apply CELLCLEAN on brush and clean
Clean RBC transducer aperture on RBC transducer with it.
(Refer to chapter 9 in IFU)
5～ Execute RBC isolation chamber drain
RBC Detector
Drain isolation chamber 10min sequence.
(Refer to chapter 9 in IFU)
Clean inside RBC detector Clean inside of RBC detector.
Execute air bubble removal sequence in
Execute air bubble removal sequence 10min maintenance sequence.
(Refer to chapter 9 in IFU)
FCM Detector
Execute rinse flowcell sequence in
Execute rinse flowcell sequence 10min maintenance sequence.
(Refer to chapter 9 in IFU)
Execute monthly rinse sequence in
Other Hydraulic Execute monthly cleaning sequence 15min maintenance sequence.
(Refer to chapter 9 in IFU)
Adjust blank level depending on ambient
Adjust HGB and blood aspiration
5min temperature.
sensor blank level
(Refer to chapter 4 in SM)
Software
Adjust blood aspiration sensor gain level.
Adjustment Adjust blood aspiration sensor gain 5min
(Refer to chapter 4 in SM)
Adjust RBC Clogs to 99±1.
Adjust RBC clog level 5min
(Refer to chapter 4 in SM)
Remove exterior cover and clean inside
Clean instrument interior 10min
Interior instrument.
Instrument Lubricate mechanical parts, such as whole
Lubricate mechanism 3min
blood pump, sheath syringe unit and so on.
Clean monitor and exterior surface of Wipe all exterior surfaces and IPU monitor with
instrument a gauze dampened with ethanol.
Execute scan disk Execute scan disk.
Defrag HDD 10～ Defrag HDD.
IPU
15min
Confirm program version on HELP screen of
Check program version
IPU program.

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Labor
Item to be checked Procedure
Time
Check optical alignment 10 Check optical alignment using latex.
Check laser current min Check laser current on IPU program.
Measure control blood and adjust sensitivity.
Data Verification Sensitivity adjustment 5min
(Refer to chapter 4 in SM)
after PM Check measured data using normal human
Check control material data or sample 10～ blood or control blood which is used before PM.
data 20min When using control blood, confirm that results
are within assay range.
Exterior Clean exterior surface of instrument Wipe all exterior surfaces with gauze
10min
Instrument Clean option equipment (Printer etc) dampened with ethanol.
Reset cycle count of cleaning and replacing
Reset maintenance cycle count
10～ parts on maintenance menu.
Operation Review
20min Verify that instrument measures sample without
Operation testing
any errors after restarting instrument.

* Time is approximate and may vary depending on instruments condition.

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XS Series Replacement Parts List

Schedule(Year)
Parts code Description
0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0
442-6485-1 Tube Pharmed_BPT_3 X 5 ○ ○
Cylinder NO.50 Assy
043-0212-0 ○ ○
(C2/XS)
Syringe No.8 Complete
943-2232-4 ○ ○
Assy　(C2/XT)
442-5418-8 Teflon Tube 1.8 X 0.8 ○ ○

441-1648-9 Pipette NO.70 *1 30,000 cycles each

051-0481-9 Piercer Set NO.7 (PM) *2 30,000 cycles each

051-0471-1 Air Pump Set NO.1 (PM) 30,000 cycles each

*1 XS-800i, XS-500i
*2 XS-1000i, XS-900i

* “Schedule” is only general case. It may vary depending on instruments condition.

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 (3rd edition)
Revision History

Edition Revision date Revision Contents

1st edition February 23rd , English version has been released.
2010
2nd edition April 21, 2014 Checklist format has been revised from MS Excel to MS
word.
3rd edition August 11, 2014  Blood Aspiration Sensor Gain has been corrected from
“X105±20” to “X105±50”.
 Added reference to XS-500i and XS-900i in “Aspiration
Unit”.
 Added “Clean Filter No.13” to “Tubing” section.

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