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AI0-IF-025-00 

2/9 

*  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. 

P. 1.7 

Operating 

Conditions 

-

 

Add the following items. 

Altitude: 2000 m or lower 

Relative humidity 10 to 85% RH (non-condensing) 

Electric shock protection: Class I 

Overvoltage Category: II 

Pollution degree: 2 

Location of instrument use: Indoor use 

Storage environment conditions: Ambient temperature -10 to 60°C 

 

-

 

Replace Electrical Safety statement with the following. 

For Model 6500 / 6503 – 

cETL Certification 

UL 61010-1, CAN/CSA-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 

Installation & setup 

-

 

Add "Environment conditions for instrument installation." 

A space allowing at least 40 cm on the left side of the instrument. 

A space allowing at least 50 cm above the instrument. 

A space allowing at least 40 cm in front of the instrument. 

A space allowing at least 10 cm around the other side of the instrument. 

(On the right side of the instrument, only when it is not connected to a 

staining instrument.) 

P. 2.2 

Installation & setup 

-

 

Add an option. 

SG Guide 4(1) for SFE, product code N94-450-00 

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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