SYSMEX pocH-100i User manual

AUTOMATED HEMATOLOGY ANALYZER
INSTRUCTIONS FOR USE
SYSMEX CORPORATION
KOBE, JAPAN
Copyright © 2005–2015 by SYSMEX CORPORATION
All rights reserved. No part of this Instructions for use may be
reproduced in any form or by any means whatsoever without
prior written permission of SYSMEX CORPORATION.
Code No. CG184474 en-uk
PRINTED IN JAPAN
Date of Last Revision: April 2015
Software Version: 01-23 and onwards

Overview and Initial settings
•  T he  poc H-10 0
i
isequippedwitharinsecup,and after aspiratinga sample orcontrolblood, thepiercer
(pipette)isautomaticallycleaned.Itisnotnecessarytowipethesamplepipette(aspiratingpiercer).
•
Operate the instrument as instructed. Reliability of test results cannot be guaranteed if instructions in this
manual are not followed. If the instrument fails to function properly as a result of either the user failing to
operatethesystemasspeciedinthemanualortheuser’sutilizationofaprogramnotspeciedbySysmex,
theproductwarrantywillnotapply.
• We reserve theright of continuous product enhancement. Design and specications may be subject to
change due to further product development.This may result in deviation of actual product properties
againstthepropertiesstatedinthismanual.
• Thecontentsofthescreensillustratedinthismanualmaydifferfromtheactualscreensdisplayedonthe
instrument.
• Datageneratedby thepocH-100
i
donotreplaceprofessionaljudgmentinthedeterminationofadiagno-
sisorinmonitoringpatienttherapy.
•The Sysmex pocH-100
i
 is an automated hematology analyzer for in vitro diagnostic use in clinical labo-
ratoriesandphysicianofcelaboratories.ThepocH-100
i
shallonlybeusedforinvitroanalysisofhuman
bloodorarticialcontrolblood.Anyotheruseisregardedasnon-specied.
Onlyreagentsandcleaningsolutionsstatedinthismanualarepermittedforuse.
Observeallcleaningandmaintenanceproceduresattherequiredintervals.
ⅠpocH-100i RevisedApril2015
CE-mark
INSTRUCTIONS FOR USE
Beforeoperatingtheinstrument,carefullyreadthismanual.
Keepthismanualforreference.Forfurtherinformation,pleasecontactyourSysmexrepresent-
ative.
Carefullyread"Safetyinformation"and"Measuresforpersonnel"page.7-2.
Forexplicationofwarningsignsusedinthemanualseechapter"Symbols"page.1.
AUTOMATED HEMATOLOGY ANALYZER
1. SYSTEM OVERVIEW,
TECHNICAL INFORMATION & SETUP
INTRODUCTION
ThesystemdescribedinthismanualismarkedwithaCE-markwhichconrmsthecompliance
withtheessentialrequirementsofthefollowingEuropeanDirectives:
98/79/EC(IVDDirective)
2011/65/EU(RoHSDirective)

Ⅱ
pocH-100i Revised June 2008
Operation
2. ANALYSIS
3. QUALITY CONTROL
Maintenance/Troubleshooting/Safety
4. CLEANING & MAINTENANCE
5. SETTINGS & CALIBRATION
6. TROUBLESHOOTING
7. SAFETY INFORMATION & WASTE DISPOSAL
8. INDEX

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INTRODUCTION
INTRODUCTION
pocH-100
i
Revised April 2013
ADDRESSES SYMBOLS
Head Office Japan
SYSMEX CORPORATION
1-5-1 Wakinohama-Kaigandori
Chuo-ku, Kobe 651-0073
JAPAN
Europe
European Representative
SYSMEX EUROPE GmbH
Bornbarch 1
22848 Norderstedt, Germany
Phone: [phone]
Fax: [phone]
Asia-Pacific
SYSMEX ASIA PACIFIC PTE LTD.
9 Tampines Grande, #06-18,
Singapore 528735
Phone: [phone]
Fax: [phone]
Americas
SYSMEX AMERICA, Inc.
577 Aptakisic Road
Lincolnshire, IL 60069, U.S.A.
Phone: [phone]
Fax: [phone]
• Ordering of supplies and replacement parts
To order supplies or replacement parts, please contact your
local Sysmex representative.
• Service and maintenance
Please contact the Service Department at your local Sysmex
representative.
Symbols to indicate biological risks, warnings and helpful information are presen-
ted throughout this manual to call to attention important information on safety
and handling. Non-compliance with this information compromises the safety fea-
tures incorporated in the analyzer.
Indicates the risk of serious injury or
death by biohazardous materials or
conditions.
Biological risks Warning
If this sign is ignored and the instru-
ment is operated incorrectly, there is a
potentially hazardous situation which
may result in injury of an operator.
If steps indicated by this sign are ig-
nored, analysis results may produce
erroneous data.
Incorrect analysis results
Indicates information which is useful in
operating the instrument.
Note
Indicates that the marked component
can be hot. Do not touch.
Warning, hot
High voltage exceeding 1 kV.
Danger, electric shock
Important
Indicates what you need to know in
order to maintain instrument perform-
ance and to prevent damage.
INTRODUCTION

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INTRODUCTION
INTRODUCTION
Abbreviations
•CBC :CompleteBloodcellCount
•LD :LowerDiscriminator
•LL :LowerLimit
•PD :Pre-dilutedmode
•QC :QualityControl
•T1 :TroughDiscriminator1
•T2 :TroughDiscriminator2
•UD :UpperDiscriminator
•UL :UpperLimit
•WB :WholeBloodmode
Unit
•dL :deciliter(0.1liter)
•fL :femtoliter(10-15liter)
•μL :microliter(10-6liter)
•pg :picogram(10-12gram)
Analysis parameters
This instrument provides results for the following parameters:
•WBC:Numberofleukocytes
•RBC :Numberoferythrocytes
•HGB :Hemoglobin concentration
•HCT :Hematocritvalue:Erythrocyteratiooftotalbloodvolume
•MCV:Meancorpuscularvolume
•MCH:Meancorpuscularhemoglobin
•MCHC : Meancorpuscularhemoglobinconcentration
•PLT :Numberofplatelets
•LYM%/W-SCR:%ofsmallleukocytestototalWBC
 Theyareassumedtobeequivalenttolymphocytes(whitecell-smallcellratio).
•MXD%/W-MCR:%ofmiddleleukocytestototalWBC
They are assumed to be equivalent to monocytes, eosinophils, and basophils
(whitecell-middlecellratio).
•NEUT%/W-LCR:%oflargeleukocytestototalWBC
 Theyareassumedtobeequivalenttoneutrophils(whitecell-largecellratio).
•LYM#/W-SCC:Absolutenumberofsmallleukocytes
 Theyareassumedtobeequivalenttolymphocytes(whitecell-smallcellcount).
•MXD#/W-MCC:Absolutenumberofmiddleleukocytes
They are assumed to be equivalent to monocytes, eosinophils, and basophils
 (whitecell-middlecellcount).
•NEUT#/W-LCC:Absolutenumberoflargeleukocytes
 Theyareassumedtobeequivalenttoneutrophils(whitecell-largecellcount).
•RDW-SD:Calculateddistributionwidthoferythrocytes,standarddeviation
ABBREVIATIONS / UNITS
•RDW-CV:Calculateddistributionwidthoferythrocytes,coefcientofvariation
•PDW :Calculateddistributionwidthofplatelets
•MPV:Meanplateletvolume
•P-LCR:Ratiooflargeplatelets(volumeexceeding12fL)tothetotalnumberof
platelets
When analyzing in the pre-diluted mode, only the following eight parameters are
output: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT.
Sysmex, pocH-100
i
, pocH-pack 65, pocH-pack 65XL and EIGHTCHECK are registered
trademarks of SYSMEX CORPORATION.
•CELLCLEANisatrademarkofSYSMEXCORPORATION.
•CAPIJECTisaregisteredtrademarkofTerumo Corporation.
•ETHERNETisaregisteredtrademarkofXeroxCorporation.
•MICROTAINERisaregisteredtrademarkofBectonDickinsonCompany.
•  S A R S T E D T, S-MONOVETTEandMICROVETTEareregisteredtrademarksofWalter
Sarstedt Geräte und Verbrauchsmaterial für Medizin und Wissenschaft.
•ISBT128(InternationalSocietyofBloodTransfusion)iscopyrightedbyandusedunder
License Agreement with ICCBBA, Inc.
•LinuxisaregisteredtrademarkortrademarkofLinusTorvaldsinU.S.A.andothercoun-
tries.
All other trademarks not explicitly mentioned in this manual belong to their respective
owners. Sysmex does not authorize their use.
NAMES
pocH-100i Revised February 2011

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pocH-100
i
Revised February 2011
INTRODUCTION
INTRODUCTION
TECHNICAL BASICS
•The calculation of indices is based on international principles in hematology.
•The method for counting blood cells is based on the electric resistance detection prin-
ciple.
• Hemoglobin concentration is determined by a photometric measuring method.
FUNCTIONAL DESCRIPTION
A N A LYS I S
Anexactvolumeofsampleisaspiratedwiththeaspiratingpiercer(pipette).
Thisvolumeofthesampleisthentransferred(togetherwithadenedvolumeofdilu-
ent)tothemixingchamberandfromthereautomaticallytothetransducer.
All parameters are analyzed using the same transducer in the order:
(1)WBC/HGBand(2)R B C / P LT.
ForWBC/HGBanalysis,theWBC/HGBlyseisaddedtothemeasuringchambertopro-
vide further dilution and hemolysis of the sample‘s RBC.
This process takes about ten seconds.
During this reaction period, the erythrocytes are dissolved under the influence of the
lysis, hemoglobin is released and is converted into red methemoglobin. The leukocytes
remain intact.
Thevolumeandnumberoftheleukocytes(WBC)aredeterminedbytheDCdetection
method. In the HGB detector, the hemoglobin concentration is photometrically meas-
ured.
ForRBC/PLTanalysis,thedilutedsampleistransferredfromthemixingchambertothe
transducer, and the volume and blood cell count for erythrocytes and platelets are ana-
lyzed by the DC detection method.
WARRANTY
All Sysmex instruments are warranted against defective material or workmanship for a
period of one year, commencing on the installation date on the customer‘s premises
This warranty does not cover any defect, malfunction or damage due to:
•Accident,neglectorwillfulmistreatmentoftheproduct;
•Failuretouse,operate,serviceormaintaintheproductinaccordancewiththeapplica-
bleSysmexInstructionsforUse;
•Failuretousetheappropriatereagentsandconsumablesspeciedfortheproduct.
INTRODUCTION

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INTRODUCTION
INTRODUCTION
pocH-100i Revised June 2008

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1
1-1
1.SYSTEM OVERVIEW,TECHNICAL INFORMATION & SETUP : CONTENTS
1.1. SYSTEM OVERVIEW 1-2
1.1.1. The instrument 1-2
1.1.2. The reagents 1-4
1.2. TECHNICAL INFORMATION 1-6
1.2.1. Performance characteristic - Specifications 1-6
1.2.2. System limitations - Interferences 1-8
1.3. SETUP 1-9
1.3.1. Check parts 1-9
1.3.2. Optional adapters 1-10
1.3.3. Insert paper roll 1-11
1.3.4. Connect the pocH-pack 65/pocH-pack 65XL 1-12
1.3.5. Barcode reader (optional) 1-13
1.3.6. Power cord 1-14
1.3.7. Switch ON 1-14
1.3.8. Set language 1-15
1.3.9. Date & Time 1-16
1.3.10. LCD contrast 1-17
1.3.11. Sample collection tube 1-18
pocH-100
i
Revised February 2011
INTRODUCTION
SYSTEM OVERVIEW, TECHNICAL INFORMATION & SETUP

2345678 1
1-2
Before starting setup and analysis, please read through the following overview to get familiar with the instrument‘s parts and their description.
Open button
System fuses
AC power supply
Float switch connector
for waste bottle
Lysing reagent
inlet nipple
Diluent inlet nipple
Sample position
Adjust LCD screen contrast.
Press to open the sample po-
sition compartment.
AC 10 0 V
AC 240 V
Monitors the level in the waste bottle.
Aspirates lyse reagent.
Aspirates diluent.
Holds the adapter for the
analysis sample tube.
1.1.1.The instrument
1.1. SYSTEM OVERVIEW
Waste outlet nipple
Discharges waste.
Contrast adjustment knob
pocH-100
i
Revised June 2008
INTRODUCTION
SYSTEM OVERVIEW, TECHNICAL INFORMATION & SETUP
Color LCD screen

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1
1-3
Main power switch
Serial port
Card slot
Built in thermal printer
Detector
RBC transducer, WBC transducer
and Hemoglobin detector
Rinse cup
Rinses the piercer (pipette) to
avoid sample-to-sample carry-
over.
Aspirates WB/PD blood samples.
Communication with host computer, etc.
9-pin D-SUB serial interface connector
(communication with host computer,
etc.)
Aspirating piercer (pipette)
1.1.SYSTEM OVERVIEW
Inserts a program card specified
by Sysmex.
Socket for Barcode-Reader
Socket for LAN
Tr a p c h a m b e r
In case of malfunction, avoids
reagents’ reflux into the vacuum
pump.
1.1.1.The instrument
pocH-100
i
Revised February 2011
SYSTEM OVERVIEW, TECHNICAL INFORMATION & SETUP
INTRODUCTION