Humidity Limitation: indicates the humidity
limits to which the medical device can be safely
exposed.
Atmospheric Pressure: indicates the
atmospheric limits to which the medical device
can be safely exposed.
Lot Number: indicates the manufacturer's batch
code so that the batch or lot can be identified.
Serial Number: indicates the manufacturer's
serial number so that a specific medical device
can be identified.
Catalogue Number: indicates the
manufacturer's catalogue number so that the
device can be identified.
Do not dispose in household waste.
Manufacturer Symbol
Date of Manufacture: indicates the date which
the medical device was manufactured. This is
included within the serial number found on the
device (usually on the back of the device), either
as "E/Year/Number" (YY/123456) or "E/Month/
Year/Number" (MM/YY/123456).
CE Mark
Medical Device
This medical device is indicated for home use.
Importer Symbol
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This medical device is not water resistant and
should be protected from liquids.
The first number 2: Protected against access to
hazardous parts with a finger, and the jointed
test finger of 12 mm ø, 80 mm length, shall have
adequate clearance from hazardous parts, and
protected against solid foreign objects of 12.5
mm ø and greater.
The second number 2: Protected against
vertically falling water drops when enclosure is
tilted up to 15˚. Vertically falling drops shall have
no harmful effects when the enclosure is tilted at
any angle up to 15˚ on either side of the vertical.
Notes are used to provide clarification or
recommendation.
A Warning is used when failure to follow the
instructions may result in serious injury or death.
A Caution is used when failure to follow the
instructions may result in a minor or moderate
injury, or damage to the device or other
property.
A Contraindication is used when a device should
not be used because the risk of use clearly
outweighs any foreseeable benefits and may
result in serious injury or death.
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