SYSMEX SA-90 User manual

Option Sampler
SA-90
Instructions for Use
Code No. CP756512 en
PRINTED IN JAPAN
Date of Last Revision: 09/2021
Document Version: 5.0
Software Version: 0 onwards
© SYSMEX CORPORATION

Revision History
SA-90 Instructions for Use
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Revision History
07/2018
Initial issue
Document Version: 1.0
Software Version: 0
01/2019
Document Version: 2.0
Software Version: 0
02/2020
Document Version: 3.0
Software Version: 0
08/2020
Document Version: 4.0
Software Version: 0
06/2021
Document Version: 4.1
Software Version: 0
09/2021
Document Version: 5.0
Software Version: 0
Changes are listed below:
Other changes:
- Improvement of text representation.
Revised section Page
Chapter 1 Introduction 7, 8
1.1 Intended purpose 8
2.6.1 Waste disposal 16
2.6.2 Decontamination 17
2.9 Notice to the user 20
8.1 Cleaning 35

Revision History
SA-90 Instructions for Use
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Table of Contents
SA-90 Instructions for Use
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Table of Contents
Revision History 3
Chapter 1 Introduction 7
1.1 Intended purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.2 Overview of the system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.3 About the manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.4 Symbols used in the manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.5 Symbols related to the products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.6 Trademarks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Chapter 2 Safety Information 13
2.1 General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.2 Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.3 Electromagnetic compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.4 Avoiding infections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2.5 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2.6 Disposal of materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
2.7 Operators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
2.8 Markings on the instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.9 Notice to the user . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Chapter 3 Part Names and Functions 21
3.1 SA-90 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.2 WG-90 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Chapter 4 Supplies, Accessories, and Options 23
4.1 Supply parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4.2 Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Chapter 5 Installation 25
5.1 Points to note about installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
5.2 Installation space . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
5.3 Installation environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
5.4 Grounding. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Chapter 6 Instrument Specifications 29
6.1 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
6.2 Supported sample tubes and sample racks . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

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Chapter 7 Basic Operation 31
7.1 Flow of basic operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
7.2 Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
7.3 Turning off the power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
7.4 Flow of sample racks in the transportation system . . . . . . . . . . . . . . . . . . . . . . 33
Chapter 8 Maintenance 35
8.1 Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
8.2 Replacing fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Chapter 9 Troubleshooting 37
9.1 Causes of errors and remedial actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Appendix 39
GNU General Public License . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Index 45

Chapter 1 Introduction
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Chapter 1 Introduction
Thank you for purchasing the Option Sampler SA-90.
Please read this manual carefully before operating this product.
In this manual, the Option Sampler SA-90 is abbreviated as "SA-90".
Keep this manual in a safe place for future reference.
In vitro diagnostic medical device
Contact Addresses
1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan
Authorized Representatives
Europe, Middle East and Africa
Bornbarch 1, 22848 Norderstedt, Germany
Phone: [phone] / Fax: [phone]
Responsible person for United Kingdom of Great Britain and Northern Ireland
Oxford Gene Technology (Operations) Ltd.
Begbroke Science Park, Begbroke Hill, Woodstock Road,
Begbroke, Oxfordshire, OX5 1PF, UK
Asia-Pacific
9 Tampines Grande #06-18 Singapore 528735
Phone: [phone] / Fax: [phone]
Ordering of Supplies and Replacement Part
If you need to order supplies or replacement parts, please contact your
authorized local representative.
Service and Maintenance
Please contact your authorized local representative.
The system described in this manual is marked with the CE mark, which
confirms compliance with the applicable requirements of:
• Regulation (EU) 2017/746 on in vitro diagnostic medical devices
• Directive 2011/65/EU on the restriction of the use of certain hazardous
substances in electrical and electronic equipment and its related amending
directives including (EU) 2015/863 amending Annex II of Directive 2011/65/
EU
The system described in this manual is compliant with the Medical Devices
Regulations 2002.

Chapter 1 Introduction
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1.1 Intended purpose
Option Sampler SA-90 is a sampler for Sysmex automated blood coagulation analyzer, and is used by healthcare
professionals and properly trained personnel.
1.2 Overview of the system
SA-90 connects to the Sysmex Automated Blood Coagulation Analyzer CN-3000 (CN-3000), Automated Blood
Coagulation Analyzer CN-6000 (CN-6000) , Automated Blood Coagulation Analyzer CN-3500 (CN-3500) or
Automated Blood Coagulation Analyzer CN-6500 (CN-6500) in order to increase sample loading capacity to 120
samples.
1.2.1 External view
Example: SA-90 and WG-90 connected to the CN-3000 or CN-6000
CN-3000 or CN-6000
SA-90
WG-90

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1.2.2 System configuration
The system consists of the following units.
Names and functions are indicated in the table below:
No. Name Function
(1) SA-90 • A maximum of 20 sample racks can be placed at the same time.
• The sample racks are transported to the right sampler pool of the
CN-3000, CN-6000, CN-3500 or CN-6500.
• The sample racks are received from the left sampler pool of the
CN-3000, CN-6000, CN-3500 or CN-6500.
(2) WG-90 • This is a dedicated wagon connected to the rack feeder and rack
collector of the SA-90.
• The IPU monitor for the CN-3000, CN-6000, CN-3500 or CN-6500
can be installed on the wagon.
• 2 CA CLEAN II containers (5 L), or 1 plastic tank (20 L) can be
utilized from the reagent storage compartment beneath.
IPU
HUB
Example: CN-3000 or CN-6000
Standard sampler
(2) (1)

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1.3 About the manual
1.3.1 Points to note about the manuals
• This manual assumes that you have read the CN-3000, CN-6000, CN-3500 or CN-6500 Instructions for Use.
• You may not reprint the contents of the manuals in whole or in part without permission.
• The names of patients, doctors, etc., mentioned in the manuals do not represent actual people in any way.
• Images in these Instructions for Use related to the product are for illustration purposes only and may not
exactly match with what is found on the product itself.
• While we have taken all possible precautions to ensure quality in the content of this manual, please contact
the Service Department of your authorized local representative if you find any errors or omissions.
1.4 Symbols used in the manual
Risk of infection
Indicates a risk of pathogen infection that may ultimately lead to death if the user fails to observe the
indicated instructions.
Warning
Indicates a risk of death, serious injury, or serious property damage if the user fails to observe the indicated
instructions.
Caution
Indicates a risk of injury, incorrect output results, or property damage if the user fails to observe the
indicated instructions.
Information
Indicates information for the purpose of maintaining instrument performance and preventing damage.
Note:
Indicates useful information when using the instrument.

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1.5 Symbols related to the products
In vitro diagnostic medical device Date of manufacture
Manufacturer Serial number
Authorised Representative in the
European Community Environmental protection use period
Consult instructions for use Keep away from sunlight
Temperature limitation Use no hooks
Biological risks This way up
Use by Keep dry
Batch code Stacking limit by number
Catalogue number Fragile, handle with care
Do not reuse Corrugated recycles
Sufficient for
Corrugated recycles*
* Based on SJ/T 11364 national
standard of China.
Contents

Chapter 1 Introduction
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1.6 Trademarks
• Sysmex is a registered trademark of SYSMEX CORPORATION, Japan.
• CA CLEAN II is a trademark of SYSMEX CORPORATION, Japan.
• Other company names and product names in this manual are the registered trademarks or trademarks of their
respective owners.
The fact that a trademark is not explicitly indicated in this manual does not authorize its use.
TM and ® are not explicitly indicated in the manuals.

Chapter 2 Safety Information
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Chapter 2 Safety Information
This chapter describes the precautions for using the instrument safely and correctly.
2.1 General information
Warning
• Keep fingers, loose clothing, and hair away from the instrument during operation.
Risk of an injury from being caught or crushed.
• Take care not to spill blood, reagent, drop wire staples or paper clips, etc. into the instrument.
Risk of a short circuit or smoke.
• Operators should not touch any electrical circuitry inside the instrument.
The danger of electrical shock is particularly high when one’s hands are wet.
• Do not damage the power cable, place heavy objects on it or pull it with excessive force.
Risk of fire or shock due to an electrical short or broken wiring.
• Should the instrument emit any unusual odors or smoke, turn the main switch off immediately and unplug
the power cable from the AC power outlet. Contact your authorized local representative.
Failure to do so may cause fire, electrical shock, or injury.
• If you cannot turn off the power in an emergency, unplug the power cable and contact your authorized
local representative.
Risk of fire, electrical shock, or injury.
Caution
• Never touch the sample rack while the instrument is working.
Touching a sample rack or a sample tube especially when the rack is moving could cause sample
spillage.
• Do not lean against the instrument.
If the instrument receives an impact, it may be damaged or fall over.
• Do not place any object on top of the instrument.
Doing so could prevent the sample rack from being transported, which may lead to incorrect analysis.
cTÜVus mark indicates that the equipment is tested and certified to comply with the electrical
and fire safety regulations controlled by the US and Canadian governments.
Those tests were conducted thoroughly by TÜV Rheinland that is accredited as a Nationally
Recognized Testing Laboratory (NRTL) by OSHA (The Occupational Safety and Health
Administration) in the United States, and by SCC (Standards Council of Canada) in Canada.

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2.2 Installation
2.3 Electromagnetic compatibility (EMC)
This instrument complies with the following IEC (EN) standards:
• IEC61326-2-6:2012 (EN61326-2-6:2013)
Electrical equipment for measurement, control and laboratory use - EMC requirements
• EMI (Electromagnetic Interference) For this standard the requirements of class A are fulfilled.
• EMS (Electromagnetic Susceptibility)
For this standard the minimum requirements with regards to susceptibility are fulfilled.
• This equipment has been designed and tested to CISPR11 Class A. In a domestic environment it may cause a
radio interference, in which case, you may need to take measures to mitigate the interference. The electromagnetic
environment should be evaluated prior to operation of the device. Do not use this device in close proximity to
sources of strong electromagnetic radiation (e.g. unshielded intentional RF sources), as these may interfere with
the proper operation.
Warning
• The unpacking of the instrument, installation, and initial operation checks will be performed by your
authorized local representative.
• This instrument must not be connected to a power outlet rated at anything other than AC 100 to 240 V.
The instrument must be grounded.
Otherwise, fire or electric shock may result.
• When connecting accessories and peripherals, always turn the power off first.
Otherwise, electrical shock or instrument failure may result.
Caution
• Install the instrument in a location where it will not be exposed to water.
• Install the instrument in a location where it will not be adversely affected by heat, humidity, dust, or direct
sunlight.
• Make sure the instrument is not exposed to strong vibrations or impacts.
• Install the instrument in a well-ventilated area.
• Do not install the instrument near devices that emit electrical interference, such as a radio or centrifugal
device.
• Do not install the instrument close to stores of chemical substances or other sources of gas emissions.
• Do not use this instrument in any operating environment which has electroconductive gases, flammable
gases, oxygen, hydrogen, or anesthetics that include other flammable gases.
• Install the instrument in an indoor environment.
This instrument is designed for indoor use only.
• Once the installation is completed, securely fix the instrument by locking adjuster feet.

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2.4 Avoiding infections
2.5 Maintenance
Risk of infection
• When performing any task on the instrument, such as testing, maintenance, preparation, or post
processing, be sure to wear adequate personal protective equipment, such as protective gloves, a
protective mask, protective eyewear, and a lab coat. When finished, wash your hands with a disinfectant.
There is a risk of pathogen infection.
• Never touch waste, or parts that have come in contact with waste, with your bare hands.
If you inadvertently come in contact with potentially infective materials or surfaces, immediately rinse
your skin off with a large volume of water, then follow your laboratory's prescribed cleaning and
decontamination procedures.
• Take appropriate care in handling samples and quality control materials. If something should get in your
eyes or an open wound, rinse it off with a large volume of water and immediately contact your physician.
Risk of infection
Always wear protective gloves, a protective mask, protective eyewear, and a lab coat when performing
inspection/maintenance/cleaning work on the instrument. When finished, wash your hands with a
disinfectant.
There is a risk of pathogen infection.
Information
When performing maintenance, use only the tools specially authorized by Sysmex.

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2.6 Disposal of materials
2.6.1 Waste disposal
Risk of infection
After becoming waste at the end-of-life, this instrument and its accessories are regarded as infectious.
They are therefore exempted from EU directive 2012/19/EU (Waste Electrical and Electronic Equipment
Directive) and may not be collected by public recycling to prevent possible risk of infection of personnel
working at those recycling facilities.
Warning
• Do not dispose of the instrument, accessories, and consumables via public recycling.
• Incineration of contaminated parts is recommended.
• Please contact your authorized local representative to receive further instructions for disposal.
Follow local legal requirements at all times.
Caution
Waste fluid from the instrument may contain dangerous substances and the decision about disposal is
made by the local water authority.
Waste end-of-life equipment should not be disposed of as unsorted municipal waste. It should be
collected separately.

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2.6.2 Decontamination
2.7 Operators
Warning
Before decontaminating the instrument, be sure to turn off the power supply and unplug the power cord.
This is necessary to avoid the risk of electric shock. When cleaning the instrument, always wear adequate
personal protective equipment, such as protective gloves, a protective mask, protective eyewear, and a lab
coat. After decontamination, wash your hands carefully with antiseptic solution first and with soap
afterwards. Do not decontaminate the instrument's internal components. Internal decontamination should
only be executed by your authorized local representative.
Information
• Decontamination of the instrument’s outer surfaces should be performed in the following situations:
- Immediately after contamination with potentially infectious material
- In advance of repair or maintenance by your authorized local representative
• Wear adequate personal protective equipment, such as protective gloves, a protective mask, protective
eyewear, and a lab coat.
• Wipe and clean contaminated surfaces with a common pH-neutral detergent solution until all visible
traces of contaminants, such as dried blood or urine, are removed.
• Wipe the contaminated surfaces by using one of the following disinfectants* and allow adequate contact
time:
- Sodium hypochlorite (between 0.05 % and 0.5 %)
- 70% ethanol or 70% isopropyl alcohol
• Wipe the surfaces with a wet cloth dampened with distilled water to remove any remaining disinfectant
on the surfaces.
• Take care to prevent moisture from reaching the inside of the instrument.
• Take care to avoid applying any liquid close to or on the instrument’s touchscreen.
• As a final step, wipe the instrument with a dry disposable cloth.
* Make sure that you wet a cloth with the disinfectant before use. Do not apply the solutions directly to the
instrument surfaces. Doing so may cause damage to the surfaces or failure of the instrument. Although
the use of these solutions may cause some discoloration of the instrument coating, this does not affect
the use, safety, or performance of the instrument itself.
Caution
• The instrument must only be used by properly trained personnel.
• In the event that a malfunction of the instrument occurs, take the measures indicated in the manual.
Further resolution should be referred to your authorized local representative.

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2.8 Markings on the instrument
SA-90
(1)
(2)
Risk of infection
There is a risk of infection from pathogens and other contaminants if any part or surface of the instrument is
touched.
Warning
• Do not insert your hand or other object into the rack feed-in arm while it is in operation.
There is a risk of injury.
• Do not place a sample rack on the transport line.
The sample rack may not be transported correctly.
Warning
• To place a sample rack, insert the sample rack so that the protrusion on the right side of the rack feeder
fits into the groove on the sample rack.
There is a risk of the sample rack toppling.
• When moving a sample rack from the rack collector to the front of the instrument, hold the center of the
sample rack and slide gently.
There is a risk of the sample rack toppling.
Top view Rear view
(4)
(1)
(2)
(3)

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(3)
(4)
WG-90
(1)
(2)
Warning
• Do not insert your hand or other object into the rack feed-out arm while it is in operation.
There is a risk of injury.
• Do not feed a sample rack into the right pool of the CN-3000, CN-6000, CN-3500 or CN-6500 during
transportation.
There is a risk of the sample rack toppling.
Warning
• To avoid electrical shock, always unplug the power cable before servicing.
There is a risk of electrical shock.
• Replace the fuse only with a fuse of the specified type and rating.
There is a risk of smoke emission and fire.
Risk of infection
There is a risk of infection from pathogens and other contaminants if any part or surface of the instrument is
touched.
Warning
When closing the door, take care not to pinch your fingers.
There is a risk of injury.
(1) (2)

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2.9 Notice to the user
For a patient or user or third party in the European Union and in countries with identical regulatory regime (Regulation
2017/746/EU on In vitro Diagnostic Medical Devices); if, during the use of this device or as a result of its use, a
serious incident has occurred, please report it to the manufacturer and/or its authorized representative in the
European Union and to your national competent authority.
Reports to the authorized representative in the European Union, Sysmex Europe GmbH, must be sent by email to:
[email protected], or by post to Sysmex Europe GmbH, Bornbarch 1, 22848 Norderstedt, Germany.