2 Important information
bon E-50
GA bon E-50 Rev 1.0 E 211005.doc
4/15
2 Important information
2.1 System information
Name of device
: bon E-50
Manufacturer
: bon
Optic Vertriebsgesellschaft mbH
Stellmacherstraße 14
D- 23556 Lübeck
2.2 Application and classification
2.2.1 Application (appropriate use)
The bon E-50 refraction unit is used for holding ophthalmologic apparatus such as slit lamps
and ophthalmometers. These instruments can be positioned in front of the patient for the
purposes of an examination.
2.2.2 Classification
The bon E-50 refraction unit is a Class 1 non-invasive, active medical device in accordance
with the classification regulations of Directive 93/42/EWG on medical devices (MDD).
2.3 Liability
The refraction unit is manufactured according to the current technical status and the
recognised safety regulations and is tested in accordance with strict quality criteria.
bon Optic only accepts liability for the safety, reliability and performance of the device if
any changes or repairs have been carried out by a person authorised by bon Optic to
do so.
the power supply to which the device is connected corresponds to
DIN VDE 0100-710.
the device is operated in accordance with these operating instructions.
the operator complies to the Ordinance on the Operation of Medical Devices
(MPBetreibV).
If the system is assembled, changed or repaired by an unauthorised person, if it is improperly
maintained or not used as described in 2.2.1, the manufacturer is no longer liable.
