Safety Instructions For Use - OCULUS Pentacam AXL Instruction Manual

4 Safety Instructions
4.2

Safety Instructions for Use

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Attention
Personal injury or property damage due to improper operation

Observe the following safety instructions.
Personal injury or property damage due to equipment modifications that
could jeopardize safety

No modifications may be made to this device without the permission
of the manufacturer. Only the OCULUS service and authorized
dealers are allowed
to modify the device or the associated lifting table

to install software and software updates.

Any serious-incident that has occurred in relation to the device should be
reported to the manufacturer (vigilance@oculus.de) and the competent
authority of the region in which the user and/or patient is established.
Instructions for Operating Personnel

Make certain that the Pentacam® AXL is used exclusively in clinics
and by eye specialists and opticians (trained staff etc.). It must be
used in the area designated for carrying out examinations.
For this reason the device may only be operated by personnel
instructed to do so, who, with appropriate training, knowledge and
practical experience, are able to ensure proper handling of the
device.
Transport and Storage Instructions
Refer to the notes in sec. 16, page
Instructions for Setup and Connection

Only OCULUS or an authorized dealer is allowed to set up and to
connect the Pentacam® AXL.

Do not use or store the Pentacam® AXL in rooms that are humid, see
sec. 16, page 68.

Keep the Pentacam® AXL away from water that may drip, splash or
spray on it, and make sure that no liquids can get into the
Pentacam® AXL. Do not place any containers holding liquids in the
vicinity of the Pentacam® AXL.

Germany: Only operate the Pentacam® AXL in rooms used for
medical purposes after they have been set up according to the VDE
Regulation 0100-710.
Instruction Manual Pentacam® AXL (G/70100/EN 1121 Rev04)
68.