SYSMEX SA-90 Manuel utilisateur
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
3/46
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
Table of Contents
SA-90 Instructions for Use
5/46
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
Table of Contents
SA-90 Instructions for Use
6/46
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
SA-90 Instructions for Use
7/46
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: +49 40 5 27 26-0 / Fax: +49 40 5 27 26-100
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: +65-6221-3629 / Fax: +65-6221-3687
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
SA-90 Instructions for Use
8/46
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
Chapter 1 Introduction
SA-90 Instructions for Use
9/46
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)
Chapter 1 Introduction
SA-90 Instructions for Use
10/46
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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