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AI0-IF-025-00
1/9
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
TM
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