AL2-RE-014-00
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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
®
TEC™ 6 Cryo Module, please replace the corresponding section of
the operating manual according to the table below.
Section
Change details
Table of contents
Change “6.2 Service Life and Maintenance” to “6.2 Expected
Life and Maintenance”.
Add 8. Symbols.
Add 8.1 Key for Symbols.
1.1 Intended Use
- Add a statement that the instrument is an in vitro diagnostic
medical device.
The instrument is an in vitro diagnostic medical device.
- Add safe disposal method of data to the disposal method of
the instrument.
Erase the data in the instrument completely. In order to avoid
problems including information leakage, restoring the instrument to
the factory setting is recommended. For information on how to
restore the instrument to the factory setting, please contact the
Sakura Finetek Technical Support representative.
1.2
Safety Precautions
- Add measures to be taken when the instrument is damaged.
WARNINGS:
Do not use the instrument if it is damaged, even if it can be operated.
Failure to do so may result in injury or electric shock accident.
- Add cautions when using the instrument.
CAUTIONS:
Do not use the instrument unless you are trained or have knowledge
of the instrument.
