2 Important information
bon SL-85
GA bon SL-85 Rev 1.0 E 211005.doc
4/20
2 Important information
2.1 System information
Name of Device
: bon SL-85
Manufacturer
: bon
Optic Vertriebsgesellschaft mbH
Stellmacherstraße 14
D- 23556 Lübeck
2.2 Application and classification
2.2.1 Application (appropriate use)
The slit lamp bon SL-85 is used to examine the structures at the front of the eye.
2.2.2 Classification
The slit lamp bon SL-85 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 slit lamp 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.
