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2 Identification
& Intended Use
2.1 Identification
Accessories for medical devices made
in Switzerland by Bien-Air Dental SA.
Type
Connection, as per ISO 9168 type 3.
COUPLING LK rapid connection for den-
tal turbines and 360° rotation for 4-way
fitting.
Classification
Class IIa according to European Direc-
tive 93/42/EEC relating to medical
devices.
This medical device accessory com-
plies with the legislation in force.
2.2 Intended use
Product intended for professional use
only.
For use in dentistry. Intended to be con-
nected to compatible COUPLING LK
dental turbines.
Any use of this medical device acces-
sory outside of its intended use is pro-
hibited and may prove dangerous.
3 Precautions
for use
This medical device accessory must be
used by a competent person, in particu-
lar in compliance with the legal provi-
sions in force regarding occupational
safety, health and accident prevention
measures, and these instructions for
use.
According to these measures, the user
has the following obligations:
• To only use devices that are in perfect
working order. In the event of irregu-
lar operation, excessive vibrations,
abnormal heating or other signs sug-
gesting that the device is malfunc-
tioning, work must be suspended
immediately.
• In this case, contact a repair centre
approved by Bien-Air Dental SA.
• make sure that this medical device
accessory is used only for the pur-
pose for which it is intended, protect
yourself and patients and third par-
ties from all danger and avoid con-
tamination by the product.
CAUTION
Install the device on an appropriate
mounting to protect yourself, the
patient or third parties against the risk
of injury or infection.
CAUTION
To
avoid
adversely
device's service life, ensure purified,
dry compressed air is used.
Ensure the quality of the air and water
being supplied through regular mainte-
nance of the compressor and the filtra-
tion systems.
Note : Using unfiltered hard water will
speed up the blockage of the hoses, cou-
plings and spray diffusers.
CAUTION
The creepage distances and air clear-
ances for this accessory comply with
the requirements of the standard IEC
60601-1 (basic safety for medical elec-
trical equipment).
affecting
the
3
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