SYSMEX SA-90 Instructions For Use Manual
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SYSMEX SA-90 Instructions For Use Manual

SYSMEX SA-90 Instructions For Use Manual

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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

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  • Page 1 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...

  • Page 3: Revision History

    Software Version: 0 Changes are listed below: Revised section Page 7, 8 Chapter 1 Introduction 1.1 Intended purpose 2.6.1 Waste disposal 2.6.2 Decontamination 2.9 Notice to the user 8.1 Cleaning Other changes: - Improvement of text representation. 3/46 SA-90 Instructions for Use...
  • Page 4 Revision History 4/46 SA-90 Instructions for Use...

  • Page 5: Table Of Contents

    SA-90 ........
  • Page 6 GNU General Public License ..........39 Index 6/46 SA-90 Instructions for Use...

  • Page 7: 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...

  • Page 8: Intended Purpose

    Chapter 1 Introduction 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...
  • Page 9 CN-3000, CN-6000, CN-3500 or CN-6500. 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.

  • Page 10: About The Manual

    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. 10/46 SA-90 Instructions for Use...

  • Page 11: Symbols Related To The Products

    Use by Keep dry Batch code Stacking limit by number Catalogue number Fragile, handle with care Do not reuse Corrugated recycles Corrugated recycles Sufficient for * Based on SJ/T 11364 national standard of China. Contents 11/46 SA-90 Instructions for Use...

  • Page 12: Trademarks

    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.

  • Page 13: Chapter 2 Safety Information

    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. 13/46 SA-90 Instructions for Use...

  • Page 14: Installation

    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. 14/46 SA-90 Instructions for Use...

  • Page 15: Avoiding Infections

    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. 15/46 SA-90 Instructions for Use...

  • Page 16: Disposal Of Materials

    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. 16/46 SA-90 Instructions for Use...

  • Page 17: Operators

    • 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. 17/46 SA-90 Instructions for Use...

  • Page 18: Markings On The Instrument

    • 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. 18/46 SA-90 Instructions for Use...
  • Page 19 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. 19/46 SA-90 Instructions for Use...

  • Page 20: Notice To The User

    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: vigilance@sysmex-europe.com, or by post to Sysmex Europe GmbH, Bornbarch 1, 22848 Norderstedt, Germany.

  • Page 21: Chapter 3 Part Names And Functions

    Rack feed-in arm Feeds sample racks that have completed analysis from the transport line to the rack collector. Rack feed-out arm Feeds sample racks on the transport line out to the CN-3000, CN-6000, CN-3500 or CN-6500. 21/46 SA-90 Instructions for Use...
  • Page 22 Chapter 3 Part Names and Functions Sampler connector Connects the SA-90 to the CN-3000, CN-6000, CN-3500 or CN-6500 sampler. Fuse holder Use a 250 V 3.15 A (time lag) fuse. Main power switch Switches the main power of the instrument on/off. This instrument can be operated with the main power supply switch always on.

  • Page 23: Supplies, Accessories, And Options

    34891013 Washer Square M6 (FE) AK366737 Mark No.591 AX880901 50T032H Fuse SA-90 Supplies (EXP) Part number Item name Quantity CF240052 SA-90 IFU (EN) BP804420 CDR_Assy No.318 (1SA9X) AP617836 Holder_Assy No.442 (EXP) 26594365 NSEDT-PC-S-MP4P-2SB568B/AB (LAN cable) 23/46 SA-90 Instructions for Use...

  • Page 24: Options

    Mount No.10141 AJ869708 Guide No.2256 BP880441 Guide No.2388 BG543514 Spacer No.1103 BK721170 Cover No.5492 WG-90 Supplies Part number Item name Quantity BL435748 Holder_Assy No.154 4.2 Options Monitor Arm Part number Item name Quantity CF385324 Kit No.542 24/46 SA-90 Instructions for Use...

  • Page 25: Chapter 5 Installation

    Width (mm) Height (mm) Depth (mm) Weight (kg) SA-90 1,026 Wagon Product name Width (mm) Height (mm) Depth (mm) Weight (kg) WG-90 The dimensions and weight of the WG-90 do not include the monitor arm. 25/46 SA-90 Instructions for Use...
  • Page 26 Chapter 5 Installation System configuration example (with wagon) (CN-3000 or CN-6000 1 unit, SA-90 1 unit, WG-90 1 unit) Product name Width (mm) Height (mm) Depth (mm) Weight (kg) CN-3000 System 1,060 1,350 1,030 CN-6000 System 1,060 1,350 1,030 Warning Install the instrument in a location where the power cable can be immediately disconnected from the power outlet in the event that unusual odors or smoke are emitted.

  • Page 27: Installation Environment

    • Use caution not to exceed the capacity of the outlet. Otherwise, a fire may result. Caution Use the Sysmex-specified power cable. Do not use the Sysmex-specified power cable for any equipment other than the instrument. 27/46 SA-90 Instructions for Use...
  • Page 28 Chapter 5 Installation 28/46 SA-90 Instructions for Use...

  • Page 29: Chapter 6 Instrument Specifications

    55 dB or less During analysis: 60 dB or less Storage conditions Ambient temperature: -10 to 60 °C Relative humidity: 30 to 95 % (no condensation) Air pressure: 70 to 106 kPa Safety standards IEC61010-1:2010, IEC61010-2-101:2015, IEC 61010-2-081:2015 29/46 SA-90 Instructions for Use...

  • Page 30: Supported Sample Tubes And Sample Racks

    For details, see the CN-3000, CN-6000, CN-3500 or CN-6500 "Instructions for Use". ( CN-3000 and CN-6000 Instructions for Use, "Chapter 11: 11.4.2 Usable sample tubes") ( CN-3500 and CN-6500 Instructions for Use, "Chapter 11: 11.5.2 Usable sample tubes") 30/46 SA-90 Instructions for Use...

  • Page 31: Chapter 7 Basic Operation

    To use the instrument, connection settings must be configured on the CN-3000, CN-6000, CN-3500 or CN-6500. ( CN-3000 and CN-6000 Instructions for Use, "Chapter 13: 13.2.22 Option sampler connection settings") ( CN-3500 and CN-6500 Instructions for Use, "Chapter 13: 13.2.22 Option sampler connection settings") 31/46 SA-90 Instructions for Use...

  • Page 32: Startup

    After the instrument starts, connection to the CN-3000, CN-6000, CN-3500 or CN-6500 is performed periodically. 7.2.3 Executing mechanical initialization The mechanical units move to their initial positions and a system check is performed. 7.3 Turning off the power Turn off the main power switch. 32/46 SA-90 Instructions for Use...

  • Page 33: Flow Of Sample Racks In The Transportation System

    • If the sample rack is oriented in the wrong direction or the protrusion does not fit into the groove, the sample rack may topple. • There is a risk of instrument malfunction if the sample rack is inserted in front of the arrow on the rack feeder. 33/46 SA-90 Instructions for Use...
  • Page 34 Remove the sample rack once it has been transported to the rack collector. The sample rack is analyzed on the CN-3000, CN-6000, CN-3500 or CN-6500 and then transported to the left sampler pool of the SA-90. The sample rack is transported from the left sampler pool to the rack collector.

  • Page 35: Chapter 8 Maintenance

    There is a risk of electrical shock. 8.2 Replacing fuses Fuses are used in the SA-90 to protect against a surge in current. If a fuse blows in the SA-90, follow the steps below to replace the blown fuse. Risk of infection When replacing a fuse, always wear protective gloves, a protective mask, protective eyewear, and a lab coat, and use the specified tools and replacement part.
  • Page 36 Type AX880901 50T032H Time lag Follow the steps below to replace a fuse in SA-90. Turn off the main power switch. For the location of the main power switch, see Chapter 3. ( P.21 "Chapter 3: 3.1 SA-90") Unplug the power cable from the rear side of the main unit.

  • Page 37: Chapter 9 Troubleshooting

    9.1 Causes of errors and remedial actions If an error occurs on the SA-90, the IPU of the CN-3000, CN-6000, CN-3500 or CN-6500 will sound an alarm and display the [Help] dialog box. Resolve the error as instructed in the displayed message.
  • Page 38 Chapter 9 Troubleshooting 38/46 SA-90 Instructions for Use...

  • Page 39: Appendix

    To prevent this, we have made it clear that any patent must be licensed for everyone's free use or not licensed at all. The precise terms and conditions for copying, distribution and modification follow. 39/46 SA-90 Instructions for Use...
  • Page 40 In addition, mere aggregation of another work not based on the Program with the Program (or with a work based on the Program) on a volume of a storage or distribution medium does not bring the other work under the scope of this License. 40/46 SA-90 Instructions for Use...
  • Page 41 If any portion of this section is held invalid or unenforceable under any particular circumstance, the balance of the section is intended to apply and the section as a whole is intended to apply in other circumstances. 41/46 SA-90 Instructions for Use...
  • Page 42 OR LOSSES SUSTAINED BY YOU OR THIRD PARTIES OR A FAILURE OF THE PROGRAM TO OPERATE WITH ANY OTHER PROGRAMS), EVEN IF SUCH HOLDER OR OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. 42/46 SA-90 Instructions for Use...
  • Page 43 This General Public License does not permit incorporating your program into proprietary programs. If your program is a subroutine library, you may consider it more useful to permit linking proprietary applications with the library. If this is what you want to do, use the GNU Library GeneralPublic License instead of this License. 43/46 SA-90 Instructions for Use...
  • Page 44 Appendix 44/46 SA-90 Instructions for Use...
  • Page 45 Instrument specifications ........29 Intended purpose ..........8 Introduction ............7 Maintenance ..........15 Manual ...............10 Markings on the instrument........18 Mechanical initialization ........32 Operators ............17 Options...............24 Overview of the system........8 Part names and functions ........21 SA-90.............21 WG-90 ............22 45/46 SA-90 Instructions for Use...
  • Page 46 Index 46/46 SA-90 Instructions for Use...

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