Sakura Seiki Tissue-Tek Glas g2 Owner's manual

Document code: AI0-IF-025-00
Supplement to the operating manual
Tissue-Tek® GlasTM 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: [phone]

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

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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® GlasTM g2, please replace the corresponding section of the operating
manual according to the table below.
Section Details
P. 1.2
Safety precautions
- Add that the instrument is an in vitro diagnostic medical device.
The instrument is an in vitro diagnostic medical device.
- Delete the symbol of "HOT SURFACE."
- Add the following symbol and the description.
Be careful not to put your hands into the moving part to prevent
inclusion when using, inspecting, or disassembling the
instrument with this symbol.
- Change 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 consumables or options, use the parts specified in this
manual. Use of other parts may result in malfunction or failure.
Name of the major
components
Expected life
Drive unit 8 years (Slide fingers are consumables.)
Controller board 5 years
Switching power supply 5 years
Pump for cover glass
suction
8 years (Diaphragms and reed valves are
consumables.)
Solenoid valve for cover
glass suction
8 years
Dispensing pump 8 years
Detection sensor 5 years
Vacuum fluorescent
display
8 years

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* 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

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P. 4.11
End of
Coverslipping
- Add a caution when removing the storage rack.
When removing the storage rack, be careful not to tilt the storage rack
in the direction of the cut. Doing so may cause the slide to fall.
P. 4.14
Coverslipped
condition
- Add measures to be taken when air bubbles enter.
If air bubbles still enter after taking the above measures, there may be
an abnormality in the discharge path of the inclusion agent. In such
cases, contact our support line or your distributor.
P. 5.1
Inspection Methods
and Cleaning
- Add a caution about glass fragments during cleaning.
Be careful of glass fragments when cleaning.
P. 5.2
Care of the
Instrument
- Add "Cleaning of the basket."
Clean the basket with water or neutral detergent. If the solution
adheres to the instrument and the color or stain is difficult to remove,
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 one after
2 weeks as a guide (the number of processed slide glasses: about
3000).
*
If the instrument is connected to an exhaust system of the facility,
periodic replacement is not needed, but they should be checked
periodically and replaced if necessary.
- Add "Expiration date of consumables" section.
Make sure that the consumables are used within the expiration date.
- Slide finger: Replace the slide finger when it is damaged or after 2
years as a guide.
- Cover glass suction pad: Replace the pad with a new one when it is
damaged or after one year as a guide.
- Cover glass suction pump diaphragm: Replace with a new one
every year as a guide.

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- 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.
* When the remaining battery is low, a message appears on the
standby screen.
P. 6.1
General information
- Add "
If a serious incident occurs, please contact the regulatory
authority in your country and Sakura Finetek Group."
P. 6.4
Add Service
information
- Add the following as a section of Service information.
Where to Call for Service
If located within the United States, contact the Technical Support
Department of Sakura Finetek USA., Inc. 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: [e-mail]
phone: [phone]
In countries other than the above, contact the nearest authorized Sakura
instrument distributor or representative for service information and
assistance.
P. B.1
Warning
- Add product disposal methods.
Dispose of the instrument in accordance with the regulations and
guidelines in each country.
- Add cautions for instrument operating environment.
This product complies with the emission and immunity requirements
of EN 61326-1 and EN 61326-2-6.
This equipment is not intended for use in residential environments and
may not provide adequate protection to radio reception in such
environments.

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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.
Electromagnetic environment should be evaluated prior to the operation
of the device.
Do not use this device in proximity to sources of strong electromagnetic
radiation (e.g. unshielded intentional RF sources), as these can
interfere with proper operation.
- Add descriptions about power cords.
Be sure to use the supplied power cord. Failure to use the supplied
power cord may cause electric shock or malfunction. Particularly, using
a power cord with low capacity may cause fire or electric shock.
- Change in cautions when opening/closing 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 changes
depending on the solutions used and the ambient temperature. The
following shows the emissions per unit time as a reference. Based on
this value and the volume, check that the ventilation rate is such that it
meets the required value for the operating environment concentration at
the installation site. If there is no ventilation system, use a φ38 mm or
φ75 mm exhaust hose to discharge the gas outdoors.
Maximum gas emissions per unit time (reference)
Xylene: 2.0×10-3 (m3/h)
- Add disposal methods of consumables.
Dispose of the activated carbon filters and the supplied consumables
in accordance with national or local regulations. If you have any
questions, please contact our support line or your distributor.

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- 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.
P. C.1
Notes on use
- Add cautions when opening/closing the cover.
Open the cover fully and make sure that the cover stops.
If the cover
is not fully opened, it may not hold and may close. If the
cover is not maintained in the fully open position, the cover may fall during
operation and may 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 station of Tissue-Tek® GlasTM g2.
P. D.1
Bar Code Reader
- Change the Operating Temperature to the following.
0 to 40°C (32 to 104°F)
P. Add E.1 after D.4
- Add "Symbols" section and the following details.
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

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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
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

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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.

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Certificate of Decontamination (Sample)
End of document.
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. Fill out this Certificate of Decontamination and return it with the device.
If the device is not accompanied by this certificate, we will not unpack or repair the instrument. If the returned
medical device is deemed hazardous by Sakura Finetek Group, we will return the device to you immediately.
The cost of shipment will be borne by you.
 Date:
 Institution name:
 Equipment information
[Instrument name] [Model] [Serial number]
 Please answer the following questions regarding the usage status. (Circle where applicable. Use the Remarks field, if
necessary.)
Question Answer Remarks
1. Has this device been used at 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 this device been used in a room where articles used in
connection with infectious diseases are disposed of? Yes No
6. Has this device been used in a room where research on special
viruses is conducted?
Yes No
7. Has this device been used in a room where articles used in
connection with special viruses are disposed of? Yes No
 Please answer questions regarding disinfection.
Whenever possible, please return the device after cleaning/disinfecting it using general disinfectant, primarily in areas
that likely came in contact with tissues, operators, etc.
Examples of general disinfectants: Disinfecting alcohol, 70% isopropanol, biguanide alcohol, benzalkonium chloride,
Chlorhexidine
1. Date of disinfection
2. Method of disinfection
 Remarks