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"F.H. Papenmeier GmbH & Co. KG ”is abbreviated to“ Papenmeier ”in the following.
Intended use
According to EU regulation 2017/745 (MDR), this product is an active class I medical device.
This medical product is used to compensate for the handicap of severely visually impaired or
blind people.
The Medical Device Law Implementation Act (MPDG) applies to this medical device from
May 26th, 2021.
The Medical Device Operator Ordinance (MPBetreibV) must be observed.
This product may only be used in residential and commercial areas.
In medical facilities, this product may only be used in offices.
The expected service life of the medical device is 7 years.
In order to achieve the expected service life of the product, a complete professional cleaning
by the technical service of Papenmeier is recommended at intervals of a maximum of 2
years. This service is chargeable.
Safety instructions
This user manual must be read carefully before using the medical device.
The medical device may only be put into operation by the operator if
•
this medical device has been subjected to a functional test by Papenmeier or an
authorized person at the place of operation, and
•
The user has been instructed by Papenmeier or an authorized person using the
instructions for use and safety-related information.
The product may only be commissioned by trained personnel.
Evidence of instruction must be provided by the operator.
The device may only be put into operation if there is no visible damage to the device or the
supply lines and no malfunctions are to be expected.
Summary of Contents for RehaTechnik BRAILLEX EL Series
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