XS-1000i and XS-800i Instructions for Use Feb 2006

Table of Contents

Table of Contents Chapter 1 1.1 1.2 1.3 1.4 1.5 1.6

Chapter 2 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 2.11 2.12 2.13 2.14

Revised February 2006

Reagents... 4-1

General Information... 4-1 CELLPACK ... 4-1 STROMATOLYSER-4DL... 4-2 STROMATOLYSER-4DS ... 4-2 SULFOLYSER ... 4-3 CELLCLEAN ... 4-3 e-CHECK ... 4-4 Labeling... 4-4 Symbols used on the labels ... 4-5

Chapter 5 5.1 5.2 5.3 5.4 5.5

Design and Function ... 3-1

Overview... 3-1 XS-1000i/XS-800i Main Unit ... 3-2 Information Processing Unit (IPU) ... 3-6 Sampler Unit (Optional for XS-1000i)... 3-9 System Status Display Field... 3-9 Analysis mode ... 3-10

Chapter 4 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9

Safety Information... 2-1

Intended Use ... 2-1 General Information... 2-1 Set Up ... 2-2 Electromagnetic compatibility (EMC) ... 2-2 Avoidance of Infection ... 2-2 Handling of reagents ... 2-3 Quality Control Materials ... 2-4 Laser ... 2-4 Maintenance... 2-5 Disposal of the waste, disposables and instruments... 2-5 Markings on the instrument ... 2-6 Personnel ... 2-10 Computer Virus ... 2-10 HOST Connection ... 2-10

Chapter 3 3.1 3.2 3.3 3.4 3.5 3.6

Introduction ... 1-1

Hazard Information in this Manual... 1-3 Protected Names... 1-4 Analysis Parameters... 1-4 Abbreviations used throughout this manual ... 1-5 Device Overview... 1-5 Reference Intervals ... 1-5

Before Using... 5-1

Storage prior to transport and installation ... 5-1 Preparation ... 5-1 Peripheral Equipment ... 5-1 Additional Components ... 5-2 Basic Equipment Settings ... 5-2

Sysmex XS-1000i/XS-800i Instructions for Use

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Table of Contents

Chapter 6 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9 6.10 6.11 6.12 6.13 6.14

Chapter 7 7.1 7.2 7.3 7.4 7.5 7.6

Calibration ... 8-1

Samples Used for Calibration ... 8-1 Establishing the Reference Values ... 8-1 Automatic calibration ... 8-1 Displaying the Last Sample Data... 8-6 Manual calibration ... 8-6 Calibration history... 8-8

Chapter 9 9.1 9.2 9.3 9.4 9.5 9.6

Quality Control ... 7-1

Quality Control Material ... 7-1 Method... 7-1 Preparation ... 7-1 QC Chart Display Screen ... 7-2 QC Chart ... 7-7 Execute QC analysis ... 7-19

Chapter 8 8.1 8.2 8.3 8.4 8.5 8.6

Operation... 6-1

Overview of Operation ... 6-1 Passwords ... 6-2 Screen Composition and Menu Tree ... 6-3 Alarm sound ... 6-6 Checks prior to turning power on... 6-6 Turning on the power ... 6-8 Auto Report ... 6-8 QC ... 6-10 Analysis mode ... 6-10 Conditions for samples to be analyzed... 6-11 Analysis of samples... 6-11 Ending of sample analysis (shutdown) ... 6-43 Sleep (timer) mode ... 6-45 Main Unit Help ... 6-46

Cleaning/Maintenance... 9-1

Maintenance and inspection schedule ... 9-2 Daily maintenance ... 9-2 Monthly maintenance ... 9-3 As-needed maintenance... 9-5 Supplies Replacement... 9-15 XS-1000i/XS-800i Maintenance and Inspection Checklist ... 9-30

Chapter 10 Troubleshooting ... 10-1

Revised February 2006

10.1 Error message list... 10-2 10.2 Troubleshooting Guide... 10-7 10.3 Test ... 10-24

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Sysmex XS-1000i/XS-800i Instructions for Use

Table of Contents

Chapter 11 Technical Information ... 11-1 11.1 XS-1000i Dimensions, weight, throughput ... 11-1 11.2 XS-800i Dimensions, weight, throughput ... 11-1 11.3 XS-1000i/XS-800i performance/specifications... 11-1 11.4 Possible Sample Interferences ... 11-5 11.5 Interface protocol... 11-6 11.6 Program version ... 11-6 11.7 Functional descriptions... 11-6 11.8 Unpacking Checklist ... 11-22 11.9 Check Before Installation... 11-24 11.10 Grounding... 11-24 11.11 Installation Environment ... 11-24 11.12 Installation Space ... 11-25

Chapter 12 Warranty... 12-1

Revised February 2006

Chapter 13 Index... 13-1

Sysmex XS-1000i/XS-800i Instructions for Use

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Table of Contents

Revised February 2006

Blank page

IV

Sysmex XS-1000i/XS-800i Instructions for Use

CHAPTER 1

Introduction

1. Introduction • The Sysmex XS-1000i and XS-800i are automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XS-1000i and XS-800i can analyze and output the results of 24 (for Europe, or 21 for Americas) parameters of a blood sample. • The Sysmex XS-1000i and XS-800i perform analysis of WBC and differential with an optical detector block based on the flow cytometry method, using a semiconductor laser. The RBC’s and platelets are analyzed by the RBC detector using the Hydro Dynamic Focusing method. Analysis data is displayed on the Information Processing Unit (IPU). Hemoglobin (HGB) is analyzed by the HGB detector based on the SLS hemoglobin detection method. • The screens shown in these instructions are XS-1000i screens. On the XS-800i screens, XS-800i is displayed for the instrument name at the top left of the screen, and for the Main Unit model name at the lower left. Any other differences will be described in detail on each occasion. Analysis parameters and principles are the same for the XS-1000i and the XS-800i. • The XS-1000i and XS-800i are compact instruments, and their operations are easy to learn. For each operating step, online help is available for support. Quality control material is used to monitor the performance of the analyzer over time. • The XS-1000i and XS-800i are equipped with a rinse cup to provide automatic cleaning of the sample probe after sample or control blood aspiration. It is not necessary to wipe the sample probe. • Sysmex instrumentation generates minimal noise. To ensure quiet laboratory operations during non-operating, the compressor can be switched off. • Using individual settings, the user can adapt the instrument to their needs or existing laboratory conditions. • Before operating XS-1000i and XS-800i, read this manual carefully. Pay special attention to the safety information. Keep this manual for future reference. • For further information, please contact the Sysmex representative in your country.

Note:

Revised February 2006

• Data generated by the XS-1000i and XS-800i is not intended to replace professional judgment in the determination of a diagnosis or in monitoring patient therapy. • Operate the instrument as instructed. Reliability of test results cannot be guaranteed if there are any deviations from the instructions in this manual. If the instrument fails to function properly as a result of either the user’s operation not specified in the manual or the user's utilization of a program not specified by Sysmex, the product warranty would not apply.

Sysmex XS-1000i/XS-800i Instructions for Use

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CHAPTER 1

Introduction

Contact Address Manufacturer SYSMEX CORPORATION 1-5-1 Wakinohama-Kaigandori Chuo-ku, Kobe 651-0073 JAPAN Authorized Representative

EC

REP

European Representative SYSMEX EUROPE GmbH Bornbarch 1 D – 22848 Norderstedt, Germany Phone: +49 40 5 27 26-0 Fax: +49 40 5 27 26-100

Americas SYSMEX AMERICA, Inc. 1 Nelson C. White Parkway, Mundelein, IL 60060 U.S.A. Phone: +1-847-996-4500 Fax: +1-847-996-4505 Asia-Pacific SYSMEX ASIA PACIFIC PTE LTD. 2 Woodlands Sector 1, #01-06 Woodlands Spectrum, Singapore 738068 Phone: +65-6221-3629 Fax: +65-6221-3687 Ordering of Supplies and Replacement Parts If you need to order supplies or replacement parts, please contact your local Sysmex representative.

Revised February 2006

Service and Maintenance Please contact the Service Department of local Sysmex representative.

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CHAPTER 1

Introduction

1.1 Hazard Information in this Manual Note, Important, Caution, and Warning statements are presented throughout this manual to call attention to important safety and operational information. Noncompliance with this information compromises the safety features incorporated in the analyzer.

Risk of infection Indicates the presence of a biohazardous material or condition.

Warning! High risk. Ignoring this warning could result in personal injury to the operator.

Caution, Hot! Indicates a potential risk of burns or other physical damage in the event of incorrect operation or failure to observe the content.

Caution! Average risk. Ignoring this warning could result in property damage. To avoid damage and incorrect measuring results.

Important! Minor risk. Considerations that should be observed when operating this instrument.

Caution!

Revised February 2006

Indicates a potential risk of physical damage of functions of the instrument caused by static electricity discharge from the human body, in the event of incorrect operation or failure to observe the content.

Note: Background information and practical tips.

Sysmex XS-1000i/XS-800i Instructions for Use

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CHAPTER 1

Introduction

1.2 Protected Names • Sysmex is a registered trademark of SYSMEX CORPORATION, Japan. • CELLPACK, CELLCLEAN, e-CHECK, STROMATOLYSER-4DL, -4DS, SULFOLYSER are trademarks of SYSMEX CORPORATION. • Cubitainer is a registered trademark of Hedwin Corporation. • ISBT128 (International Society of Blood Transfusion) is copyrighted by and is used under License Agreement with ICCBBA, Inc. The fact that a trademark is not explicitly mentioned in this manual does not authorize its use.

1.3 Analysis Parameters

Revised February 2006

The XS-1000i/XS-800i provides results for the following parameters: WBC Number of all leukocytes RBC Number of all erythrocytes HGB Hemoglobin concentration HCT Hematocrit value: Erythrocyte ratio of total blood volume MCV Mean erythrocyte volume in total sample MCH Mean hemoglobin volume per RBC MCHC Mean hemoglobin concentration of erythrocytes PLT Number of all platelets NEUT% Neutrophil Percent LYMPH% Lymphocyte Percent MONO% Monocyte Percent EO% Eosinophil Percent BASO% Basophil Percent NEUT# Neutrophil Count LYMPH# Lymphocyte Count MONO# Monocyte Count EO# Eosinophil Count BASO# Basophil Count RDW-SD Calculated distribution width of erythrocytes, standard deviation RDW-CV Calculated distribution width of erythrocytes, coefficient of variation PDW Calculated distribution width of platelets MPV Mean platelet volume P-LCR Platelet-Large Cell Ratio PCT Plateletcrit IG% Immature Granulocyte Percent (Research only) IG# Immature Granulocyte Count (Research only)

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Sysmex XS-1000i/XS-800i Instructions for Use

CHAPTER 1

Introduction

1.4 Abbreviations used throughout this manual CBC dL EPK FCM FFD FFS fL µL pg QC SLS

Complete Blood Count deciliter (0.1 liter) CELLPACK Flow cytometry STROMATOLYSER-4DL STROMATOLYSER-4DS femtoliter (10-15 liter) microliter (10-6 liter) picogram (10-12 gram) Quality Control SULFOLYSER

1.5 Device Overview • The XS-1000i/XS-800i is automated hematology analyzer equipped with 5 part differential functionality. The device performs measurements via flow cytometry using a semiconductor laser and via SLS hemoglobin methodology. The RBCs and platelets are analyzed by the RBC detector using the Hydro Dynamic Focusing method. The XS-1000i/XS-800i is structured with the principal components as follows: • XS-1000i/XS-800i Main Unit: measures & controls samples. • Information Processing Unit (IPU): Processes data generated by the measuring device. • Model variations and their features are shown below.

Sample tube

Cap piercer

Sampler (with ID reader)

Optional hand-held bar code reader

XS-1000i

Open & Closed

Yes

Optional

Optional

XS-800i

Open

No

No

Optional

1.6 Reference Intervals Reference intervals (Normal Population Reference Ranges) were developed for the XS-1000i/XS-800i using normal individuals. The range for each parameter is calculated for 95% confidence intervals. Range for Females n = 133

Range for Males n = 182

Units

WBC

3.98 - 10.04

4.23 - 9.07

x103/µL

NEUT%

34.0 - 71.1

34.0 - 67.9

%

LYMPH%

19.3 - 51.7

21.8 - 53.1

%

MONO%

4.7 - 12.5

5.3 - 12.2

%

Revised February 2006

Parameter

Sysmex XS-1000i/XS-800i Instructions for Use

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CHAPTER 1

Introduction

Range for Females n = 133

Range for Males n = 182

Units

EO%

0.7 - 5.8

0.8 - 7.0

%

BASO%

0.1 - 1.2

0.2 - 1.2

%

NEUT#

1.56 - 6.13

1.78 - 5.38

x103/µL

LYMPH#

1.18 - 3.74

1.32 - 3.57

x103/µL

MONO#

0.24 - 0.36

0.30 - 0.82

x103/µL

EO#

0.04 - 0.36

0.04 - 0.54

x103/µL

BASO#

0.01 - 0.08

0.01- 0.08

x103/µL

RBC

3.93 - 5.22

4.63 - 6.08

x106/µL

HGB

11.2 - 15.7

13.7 - 17.5

g/dL

HCT

34.1 - 44.9

40.1 - 51.0

%

MCV

79.4 - 94.8

79.0 - 92.2

fL

MCH

25.6 - 32.2

25.7 - 32.2

pg

MCHC

32.2 - 35.5

32.3 - 36.5

g/dL

RDW-CV

11.7 - 14.4

11.6 - 14.4

%

RDW-SD

36.4 - 46.3

35.1 - 43.9

fL

PLT

182 - 369

163 - 337

x103/µL

Parameter

Note:

Revised February 2006

Sysmex recommends that each laboratory establish its own expected reference intervals based upon the laboratory’s patient population encountered during daily operation. Expected reference intervals may vary due to the differences in sex, age, diet, fluid intake, geographic location, etc. The CLSI Document C28-A “How to Define and Determine Reference Intervals in the Clinical Laboratory; Approved Guideline” contains guidelines for determining reference values and intervals for quantitative clinical laboratory tests.

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Sysmex XS-1000i/XS-800i Instructions for Use

CHAPTER 2

Safety Information

2. Safety Information 2.1 Intended Use The Sysmex XS (XS-1000i / XS-800i) is an Automated Hematology Analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratory. Operate the instrument as instructed. Reliability of test results cannot be guaranteed if there are any deviations from the instructions in this manual. Use only the reagents mentioned in this manual. If the instrument fails to function properly as a result of either the user's operation not specified in the manual or the user's utilization of a program not specified by Sysmex, the product warranty would not apply.

2.2 General Information Read the manual before operating the XS-1000i/XS-800i. Keep this manual for future reference.

Warning!

Revised February 2006

• The unpacking, setup and confirmation of correct initial operation is performed under the direction of Sysmex technical service. • Take care to keep long hair, fingers and clothing away from rotating parts. • Should the instrument emit any unusual odors or smoke, turn the main switch OFF immediately and unplug the power cable. Contact Sysmex service representative. Using the instrument any further bears the risk of fire, electrical shock or personal injury. • Do not spill blood samples or reagents onto the instrument and take care not to let anything metal, such as needles and/or clips get into it. Doing so could cause a short-circuit. Should the instrument malfunction, turn the main switch OFF immediately and unplug the power cable. Contact Sysmex service representative. • The operator should not touch any electrical circuitry inside the cover. The danger of electrical shock is particularly high when one's hands are wet. • This instrument must not be connected to a power outlet rated at anything other than specified in the rated plate. Please note that the instrument must be grounded. Failure to do so may cause a fire or electrical shock. • Avoid damage to the power cable: do not place any heavy object on the power cable or pull on it. Doing so may cause a fire or shock due to electrical short or broken wiring. • Switch OFF the power supply before connecting any peripheral devices (host computer, printer). This is to prevent electrical shock hazard.

Sysmex XS-1000i/XS-800i Instructions for Use

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CHAPTER 2

Safety Information

2.3 Set Up

Caution! • The instrument should be installed in a well-ventilated location, away from water, dust, direct sunlight. Do not install in an area of elevated temperature and vibration. • The instrument must be located in a place where it will not be splashed by water. • Install the instrument in a location free from high temperature and humidity, dust and direct sunlight. • Install so it will be free of any strong shock or vibration. • Avoid installation of the instrument near devices that emit electrical interference, such as radio, centrifugal separator, etc. • Do not install this instrument in places where chemicals are stored or gas can develop. • Do not use this instrument in any operating environment which has electroconductive or flammable gases, including oxygen, hydrogen, and anesthesia. • This instrument was designed for indoor use only.

2.4 Electromagnetic compatibility (EMC) This instrument complies to the following IEC (EN) standards: • IEC 61326-1 + A1: 2002 (EN61326 +A1: 2002) • Equipment for measurement, control and laboratory use EMC - Requirements • EME (Electro-magnetic Emission) For this issue the requirements of class A are fulfilled. • EMI (Electro-magnetic Immunity) For this issue the minimum requirements with regards to immunity are fulfilled.

2.5 Avoidance of Infection

• In principle, all parts and surfaces of the instrument must be regarded as potentially infectious. • Never touch waste, or parts that have come in contact with waste, with your bare hands. • Should you inadvertently come in contact with potentially infective materials or surfaces, immediately rinse skin thoroughly with water, then follow your laboratory's prescribed cleaning and decontamination procedures. • Take appropriate care in handling samples. Use of protective garments and gloves is strongly recommended when operating, maintaining, servicing or repairing the instrument. If something should get in your eyes or an open wound, rinse thoroughly with water and then contact your doctor immediately. • Control blood must be regarded as potentially infectious. When performing quality controls, use protective garments and gloves. If something should get in your eyes or an open wound, rinse thoroughly with water and then contact your doctor immediately. • Take appropriate care in handling waste fluids. If you get them on your skin or clothes, wash them.

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Sysmex XS-1000i/XS-800i Instructions for Use

Revised February 2006

Risk of infection

CHAPTER 2

Safety Information

2.6 Handling of reagents

Warning! • Make sure the reagents used with the instruments are kept level or below the main unit of the instrument. Do not put reagents on top of the instrument. • Avoid direct contact with reagents. Reagents can cause irritation of the eyes, skin and mucous membranes. • Should you inadvertently come in contact with reagent, immediately rinse skin thoroughly with water. • If a reagent should get in your eyes, rinse thoroughly with water and contact your doctor immediately. • If a reagent is accidentally swallowed, vomit or induce vomiting by drinking copious amounts of warm, salty water and contact your doctor immediately. • CELLPACK diluent is a good electrical conductor. If diluent is spilled inadvertently near electrical cables or appliances, there is a risk of electrical shock. Switch the instrument off, unplug it and wipe-up the liquid. • CELLCLEAN is a strong alkaline cleaning agent. It should not come in contact with skin or clothing. If it happens nevertheless, rinse skin or clothing with plenty of water to avoid injury or damage, respectively. • CELLCLEAN contains sodium hypochlorite. If CELLCLEAN comes in contact with the instrument's surfaces, it will affect the surface finish and there is danger of corrosion. Immediately wipe up CELLCLEAN with a damp cloth.

Caution!

Revised February 2006

• Follow directions on reagent containers. • Avoid letting the reagent come in contact with dust, dirt or bacteria. • Reagents must not be used after their expiration date. • Handle reagents gently to avoid bubbling. Never shake reagents. Do not use reagents immediately after moving them. • Take care not to spill reagents. If a reagent is spilled, wipe up with a damp cloth.

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CHAPTER 2

Safety Information

2.7 Quality Control Materials

Caution! • Do not inject or ingest. • Follow directions on QC material containers. • Avoid letting the QC material come in contact with dust, dirt or bacteria. • QC materials must not be used after their expiration date. • Handle QC materials gently to avoid bubbling. Never shake reagents. Do not use QC materials immediately after moving them. • Take care not to spill QC materials. If a QC material is spilled, wipe up with a damp cloth.

2.8 Laser

Warning! The analyzer of the XS-1000i/XS-800i uses a semiconductor laser unit. This laser unit is shielded with a sealed box cover. The operator must not remove the cover. If one does remove the cover the unit is equipped with an interlock system that prevents laser oscillation. There is a danger causing eye pain or damage if one looks into the laser beam. Left side interior view

Revised February 2006

Laser Unit

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Safety Information

2.9 Maintenance

Risk of infection • Always wear protective garments and gloves when processing with the instrument and during maintenance. After completion of work, wash hands. The danger of contracting infectious from an infectious samples does exist. • All cleaning and maintenance procedures as described in this manual must be observed for optimal performance.

Important! When performing maintenance, use only the tools specially provided for such work.

2.10 Disposal of the waste, disposables and instruments

Risk of infection Use of protective garments and gloves is strongly recommended when handling waste fluid or instrument consumables. After finishing work, wash your hands. There is a risk of infection by pathogens, etc.

Warning!

Revised February 2006

Waste fluids, instrument consumables and other waste materials must be disposed of appropriately in accordance with local laws, with due consideration of medical, infectious and industrial wastes.

Sysmex XS-1000i/XS-800i Instructions for Use

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CHAPTER 2

Safety Information

2.11 Markings on the instrument Front of the Main Unit (1)

WARNING Do not remove this cover when the power to the Main Unit is ON. Doing so may result in injury.

(2)

RISK OF INFECTION In principle, all parts and surfaces of the instrument must be regarded as infectious.

(1) (2)

(XS-800i)

(2)

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Sysmex XS-1000i/XS-800i Instructions for Use

Revised February 2006

(XS-1000i)

CHAPTER 2

Safety Information

Right side of the Main Unit (1)

WARNING Do not put your fingers inside when the power to the Main Unit is ON. Doing so may result in injury.

(1)

(XS-1000i)

(1)

Revised February 2006

(XS-800i)

Sysmex XS-1000i/XS-800i Instructions for Use

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CHAPTER 2

Safety Information

Interior right side of the Main Unit (1)

WARNING • To avoid electrical shock, unplug the cord before servicing. Otherwise, electrical shock may result.

(2)

RISK OF INFECTION In principle, all parts and surfaces of the instrument must be regarded as infective.

(1) (1) (1) (1) (1)

(1)

(XS-1000i)

(XS-800i)

(1)

Revised February 2006

(2) (XS-1000i with Sampler)

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Safety Information

Top interior of the Main Unit (1)

WARNING To avoid electrical shock, unplug the cord before servicing. Failure to remove the cord prior to servicing may result in electrical shock.

(1)

(2) (2)

CAUTION, HOT! Do not touch the air pump directly because the surface is hot. There is a risk of burns.

Rear of the Main Unit (1) (1)

(1)

(2)

WARNING • To avoid electrical shock, unplug the cord before servicing. • Replace only with fuses of the specified type and current rating. FUSE RATING 5.0 A L 250 V (Time Lag low breaking capacity)

(3) (3) (2) (XS-1000i)

(XS-800i) (2)

RISK OF INFECTION In principle, all parts and surfaces of the instrument must be regarded as infective.

(3)

CAUTION! Revised February 2006

There is a potential risk of damage to parts of the instrument caused by static electricity discharged from the human body, in the event of incorrect operation or failure to observe the content.

Sysmex XS-1000i/XS-800i Instructions for Use

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