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Document code： AL2-RE-014-00
Supplement to the operating manual
®
TM
Tissue-Tek
TEC
6
Cryo Module
This document is a supplement to the following applicable operating
manual in order to comply with IVDR requirements.
Document code
M01-022E-02 Rev.A
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 Tissue-Tek TEC 6
- Page 1 ® Tissue-Tek Cryo Module This document is a supplement to the following applicable operating manual in order to comply with IVDR requirements. Document code M01-022E-02 Rev.A 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： AL2-RE-014-00 Revision history Version Date of Revision details revision Mar. 15, First version. 2022... - Page 3 AL2-RE-014-00 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 Tissue-Tek TEC™ 6 Cryo Module, please replace the corresponding section of the operating manual according to the table below. Section Change details Table of contents...
- Page 4 AL2-RE-014-00 1.4.2 Specifications -Change “Law” to “Rules and Regulations“ -Change “Medical equipment software” to “Medical device software” -Replace Regulatory and applicable standards of TEC 6-CM-E2 with the following -Rules and Regulations CE Marking Regulation (EU) 2017/746 Directive 2011/65/EU + (EU)/2015/863 - Electrical safety evaluation EN 61010-1 EN 61010-2-101...
- Page 5 AL2-RE-014-00 - Add symbols and their meanings. Key for Symbols 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 6 AL2-RE-014-00 Date of manufacture Temperature limitation Humidity limitation 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 Appendix - Add support contact information for EU.