Important Information; Information About The Device; Application And Classification; Liability - bon E-30 Instruction Manual

2 Important information

2 Important information
Manufacturer: bon Optic Vertriebsgesellschaft mbH · Stellmacherstr. 14 · D- 23556 Lübeck

2.1 Information about the device

Name of device: bon E-30

2.2 Application and classification

The refraction unit bon E-30 serves as a carrier to which ophthalmological devices such as
slit lamps and ophthalmometers can be attached. These devices may be adjusted in front of
the patient who came for a medical examination.
The refraction unit bon E-30 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
accepts liability for the safety, reliability and performance of the device if
installation and 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 the national
legislation.
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 asembled, changed or repaired by an unauthorised person, if it is improperly
maintained or not used as described in 2.2, the manufacturer is no longer liable.

2.4 Scope of delivery

1 x refraction unit bon E-30 as per agreed equipment
1 x remote control
1 x mains cable (for equipment types without wall terminal box)
1 x instruction manual
bon E-30
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