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Document code: AI8-IE-001-00
Supplement to the operating manual
®
Tissue-Tek Xpress
x120
Rapid Tissue Processor
This document is a supplement to the following applicable operating manual
in order to comply with IVDR requirements.
Document code
0004389-03 Rev.C
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 Xpress x120
- Page 1 Rapid Tissue Processor This document is a supplement to the following applicable operating manual in order to comply with IVDR requirements. Document code 0004389-03 Rev.C 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: AI8-IE-001-00 Revision history Version Date of revision Revision details Feb. 21, 2022 First version. - Page 3 AI8-IE-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 Tissue-Tek Xpress�� x120, please replace the corresponding section of the operating manual according to the table below. Section Details Manufactured for:...
- Page 4 AI8-IE-001-00 WARNING: Be careful of the handling the loading/unloading station containers. When setting/removing the loading station container and removing the unloading station container, handle with care so as not to spill the solution into the instrument. Failure to do so may cause fire or electric shock due to leak current and may also cause instrument malfunction.
- Page 5 AI8-IE-001-00 CAUTION: Do not open or close the door unnecessarily during the operation. Except as instructed in this operating manual or by the instrument, do not open/close the door unnecessarily. Also, do not leave the door open. Failure to do so may stop processing. CAUTION: Be careful of your head when opening the retort access door.
- Page 6 AI8-IE-001-00 CAUTION: Be careful of paraffin adhesion after cleaning the basket. If paraffin attached to the basket is brought into Retort #1 and Retort #2, it may cause instrument malfunction. Clean the basket sufficiently according to the instructions of this operating manual. CAUTION: Be careful of the basket hook when baskets are not used.
- Page 7 AI8-IE-001-00 Replace solutions at an appropriate time depending on the situation even if the number of cassettes is less than the limit of use or before the expiration date. Replace the solutions 1, 2, 3, 4, at the same time. - Add "Product disposal method"...
- Page 8 AI8-IE-001-00 CAUTION: Only networks protected by firewalls are suitable for integration of a network for the instrument. The Sakura Finetek Group shall not be responsible for any errors caused by integration into unprotected networks. CAUTION: Before connecting a USB flash memory, be sure to run a virus check on the USB memory device.
- Page 9 AI8-IE-001-00 P.1.13 Replace with "Major components and expected life." Replace with Product life: 7 years after shipment from manufacturer. Instrument Product When replacing consumables or options, use the parts specified in this Life manual. Use of other parts may result in malfunction or failure. Name of the major components Expected life Transfer and drive unit motor...
- Page 10 AI8-IE-001-00 P.1.13 - Replace Electrical Safety with the following. Safety Standards For Model 7720 – cETL Certification Complies with: UL 61010-1, CAN/CSA-C22.2 No. 61010-1, CAN/CSA-C22.2 No. 61010-2-010, IEC61010-2-010, CAN/CSA-C22.2 No. 61010-2-081, IEC61010-2-081, CAN/CSA-C22.2 No. 61010-2-101, IEC61010-2-101, FDA Registration (Regulation No. 864.3875) For Model 7721 –...
- Page 11 AI8-IE-001-00 The instrument is designed to operate in normal electromagnetic environment. In any other electromagnetic environments, use the instrument on user's own responsibility. P.9.1 - Add support contact information for Sakura Finetek Europe B.V. Where to Call for Service Contact us Products and Security Information Sakura Finetek Europe B.V.
- Page 12 AI8-IE-001-00 Keep dry Fragile, handle with care This way up Use by Do not stack Date of manufacture Temperature limitation Humidity limitation Keep away from sunlight Alternating current Power ON Power OFF Appendix - Add a Certificate of Decontamination sample on the next page. 10 / 11...
- Page 13 AI8-IE-001-00 Certificate of Decontamination (Sample) If you are returning any used medical device to Sakura Finetek Group, please provide the following information to help prevent contamination of other devices, etc., or living environment at our facility and the workers who will be working on/handling your device.