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Document code: AI0-IF-025-00
Supplement to the operating manual
®
TM
Tissue-Tek
Glas
g2
Automated Glass Coverslipper
This document is a supplement to the following applicable operating manual
in order to comply with IVDR requirements.
Document code
0002783-01 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 Tissue-Tek Glas g2
- Page 1 Glas Automated Glass Coverslipper This document is a supplement to the following applicable operating manual in order to comply with IVDR requirements. Document code 0002783-01 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: AI0-IF-025-00 Revision history Version Date of Revision details revision Mar. 15 First version 2022... - Page 3 AI0-IF-025-00 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 Glas g2, please replace the corresponding section of the operating manual according to the table below. Section Details P.
- Page 4 AI0-IF-025-00 * The product life of the instrument and the expected life of the main components listed here is not the warranty period, but an average number of years when the above conditions are met, so it will vary depending on the operating environment and the method of use. - Add the following items.
- Page 5 AI0-IF-025-00 - Add a caution when removing the storage rack. P. 4.11 End of When removing the storage rack, be careful not to tilt the storage rack Coverslipping in the direction of the cut. Doing so may cause the slide to fall. - Add measures to be taken when air bubbles enter.
- Page 6 AI0-IF-025-00 - Cover glass suction pump reed valve: Replace with a new one every year as a guide. - Various seal parts: Replace with new ones every three years as a guide. - Battery unit: Replace the battery unit with a new one when the remaining is low.
- Page 7 AI0-IF-025-00 This equipment is designed for use in a PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT. It is likely to perform incorrectly if used in a HOME HEALTHCARE ENVIRONMENT. If it is suspected that performance is affected by electromagnetic interference, correct operation may be restored by increasing the distance between the equipment and the source of the interference.
- Page 8 AI0-IF-025-00 - Add requirements for use of the instrument in conformity with laws and regulatory requirements. The instrument is not a local exhaust system. Also, the instrument does not have a sealed structure, so check the laws and regulatory requirements of your area to use and use the instrument under the conditions that meet various requirements.
- Page 9 AI0-IF-025-00 Keep dry Fragile, handle with care This way up Do not stack Serial Number 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...
- Page 10 AI0-IF-025-00 Tissue-Tek Glas g2 when Linked to the ® Tissue-Tek Prisma Slide Stainer P. 4.18 - 4.19 How to start the Prisma - Add a Certificate of Decontamination sample on the next page. Appendix...
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Page 11: Certificate Of Decontamination (Sample)
AI0-IF-025-00 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.