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Document code: AI0-IF-025-00 

 

   

 
 
 
 
 
 
 
 
 
 
 
 
 
 

Supplement to the operating manual

 

 
 
 
 
 
 
 
 
 
 
 

Tissue-Tek

®

 Glas

TM

 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 

 

Summary of Contents for Tissue-Tek Glas g2

Page 1: ...mated 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 ...

Page 2: ...Document code AI0 IF 025 00 Revision history Version Date of revision Revision details 00 Mar 15 2022 First version ...

Page 3: ...ange the description of BIOHAZARD symbol Be sure to wear protective gears gloves masks goggles etc to prevent infection when using inspecting or disassembling the instrument labeled with this symbol Also wash your hands thoroughly after finishing the work P 1 7 Specifications Add Major components and expected life section Product life 8 years after shipment from manufacturer When replacing consuma...

Page 4: ...SA C22 2 No 61010 1 UL 61010 2 101 CSA C22 2 No 61010 2 101 For Model 6501 Amendment of Pharmaceutical Affairs Law JIS C 1010 1 JIS C 1010 2 101 JIS C1806 2 6 JIS T 14971 ISO 13485 IEC 62366 IEC 62304 For Model 6502 CE Marking Regulation EU 2017 746 EN 61010 1 EN 61010 2 101 EN 61326 2 6 EN 62366 IEC 62304 EN ISO 18113 1 EN ISO 18113 3 EN ISO 14971 Directive 2011 65 EU EU 2015 863 P 2 1 Installati...

Page 5: ... soak the instrument in a commercial chemical cleaner for staining solution or bleach cleaner both concentrations are as specified by the commercial product and then wash it with a neutral detergent Also stains may not be completely removed even after cleaning Change the statement of Carbon filter replacement frequency to the following Activated carbon filter Replace the carbon filter with a new o...

Page 6: ...c by calling toll free 1 800 725 8723 8723 Menu Option 2 If located within the EU contact the following Contact us Products and Security Information Sakura Finetek Europe B V Flemingweg 10a 2408 AV Alphen aan den Rijn NL URL https www sakura eu e mail support sakura eu phone 31 0 88 592 00 90 In countries other than the above contact the nearest authorized Sakura instrument distributor or represen...

Page 7: ...ing the cover When opening closing a cover or a door be careful not to pinch your body a hand etc between the fixed and moving parts of a cover or between a cover and a door etc Your hand may be pinched and injured P B 2 Cautions Add Check that the facility has a ventilation system a local exhaust system or an exhaust port to the outdoors The amount of volatile gas emitted from the instrument chan...

Page 8: ...cause injury Add a caution on preventing injuries from slide glass When the slide glass or the cover glass is broken or falls into the instrument remove all glass fragments while being careful not to cut yourself P C 2 Notes on use Add a caution for connecting with Tissue Tek Prisma Plus When connecting the instrument with Tissue Tek Prisma Plus confirm that the lid is not set on the loading stati...

Page 9: ...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 P the forth page of the cover P ⅲ TABLE OF CONTENTS P 1 1 General Description P 2 7 Link System P 4 17 How to Operate the Replace Tissue Tek Prisma with the following Tissue Tek Prisma Plus ...

Page 10: ...AI0 IF 025 00 8 9 Tissue Tek Glas g2 when Linked to the Tissue Tek Prisma Slide Stainer P 4 18 4 19 How to start the Prisma Appendix Add a Certificate of Decontamination sample on the next page ...

Page 11: ...t a hospital where legally designated communicable diseases are treated Yes No 2 Has this device been used in a ward where patients of legally designated communicable diseases are staying Yes No 3 Has this device been used in a room where pathological work on infectious diseases is conducted Yes No 4 Has this device been used in a room where testing of infectious diseases is conducted Yes No 5 Has...

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