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Paingone Qalm - Intended Use; Contraindications, Warnings & Cautions

Paingone Qalm
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5
Date of Manufacture: indicates the date which the medical
device was manufactured. This is included within the serial
number found on the travel case, either as “E/Year/Number”
(YY/123456) or “E/Month/Year/Number” (MM/YY/123456).
CE Mark
This medical device is indicated for home use.
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.
IP22

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