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Document Code: AJ5-RE-001-00
Supplement to the operating manual
®
Cyto-Tek
2500
Cytocentrifuge
This document is a supplement to the following applicable operating manual
in order to comply with IVDR requirements.
Document code
0007129-01 Rev.C
0007129-01 Rev.D
Manufacturer: Sakura Seiki Co., Ltd.
75-5 Imojiya, Chikuma-city, Nagano 387-0015, Japan
www.sakurajp.com
Tel: 81-26-272-2381
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Summary of Contents for Sakura Seiki Cyto-Tek 2500
- Page 1 2500 Cytocentrifuge This document is a supplement to the following applicable operating manual in order to comply with IVDR requirements. Document code 0007129-01 Rev.C 0007129-01 Rev.D Manufacturer: Sakura Seiki Co., Ltd. 75-5 Imojiya, Chikuma-city, Nagano 387-0015, Japan www.sakurajp.com Tel: 81-26-272-2381...
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Page 2: Revision History
Document Code: AJ5-RE-001-00 Revision history Version Date of Revision details revision Mar.14 First version. 2022... - Page 3 AJ5-RE-001-00 In order to comply with Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), changes as shown in the table below are made. When using Cyto-Tek ® 2500, please replace the corresponding section of the operating manual according to the table below. Section Change details TABLE OF...
- Page 4 AJ5-RE-001-00 -Change “Law” to “Rules and Regulations“ EN Applicable - Add the following table. Standards Rules and Regulations CE Marking Regulation (EU) 2017/746 Directive 2011/65/EU + (EU)/2015/863 EN 61010-1 Electrical safety EN 61010-2-101 evaluation EN 61010-2-020 Risk management EN ISO 14971 Medical device EN 62304 software...
- Page 5 AJ5-RE-001-00 4. CARE OF THE - Add remarks to the Disinfection/Sterilization table. INSTRUMENT Component Additional remarks Bowl Lid When the part is disinfected 5 times a week under the specified disinfection conditions with the specified chemical solution, the expected life is 3 years. When the part is sterilized once a week under the specified sterilization conditions, the expected life is 3 years (number of treatments: 160 times or...
- Page 6 AJ5-RE-001-00 Bowl Lid The bowl lid gasket and the V-shape Gasket gasket are consumables. When V-shape Gasket disinfection is performed 5 days a week, and sterilization is performed once a week, the expected life is 1 year. - Add support for serious incidents. Troubleshooting If a serious life-threatening incident occurs, please contact the Charts...
- Page 7 AJ5-RE-001-00 - Add a section related to expected life. Expected Life Product life: 8 years after manufacture and shipment Conditions: The precautions and the maintenance/inspection items provided in the operating manual and the instructions for use must be observed, and the daily inspections and maintenance inspections must be performed on a regular basis.
- Page 8 AJ5-RE-001-00 6.1.2 Warnings - Add an item related to electromagnetic interference. The instrument is designed and tested in accordance with Class A of CISPR11. The instrument may cause electromagnetic interference in a home environment. In such cases, you may have to take measures to mitigate the interference.
- Page 9 AJ5-RE-001-00 7.1 Key for Symbols - Add symbols and their meanings. Catalog number Batch code in vitro diagnostic medical device Use by Manufacturer Consult instructions for use European Conformity Authorized representative in the European Community New waste (WEEE) Caution, consult accompanying documents Keep dry Fragile, handle with care This way up...
- Page 10 AJ5-RE-001-00 7.1 Key for Symbols - Add symbols and their meanings. Keep away from sunlight Biological risks Flammable reagents, solvents and cleaning agents The product uses a Laser beam UK conformity assessed General mandatory action sign General prohibition sign Alternating current Power ON Power OFF 8 / 9...
- Page 11 AJ5-RE-001-00 Certificate of Decontamination (Sample) End of document 9 / 9...