The applicable national legal regulations must be observed during the use of the
device, in particular the following:
▪ Applicable regulations governing the connection and start-up of medical devi‐
ces.
▪ Current occupational safety regulations.
▪ Current accident prevention regulations.
The overarching guidelines and/or national laws, national regulations and the
rules of technology applicable to the startup and use of the KaVo product for the
intended purpose are to be applied and complied with.
Compliance with the requirements of IEC 62638 (VDE 0701/0702) concerning
product safety upon start-up, changes, and repair as well as in repeat examina‐
tions is required. Caution: Electrical safety checks have to be carried out by pro‐
fessionals in electrical engineering or by individuals trained in electrical engineer‐
ing and supervised by a professional in electrical engineering. A professional in
electrical engineering is defined to be anyone whose training, knowledge and ex‐
perience as well as knowledge of the pertinent regulations allow him or her to as‐
sess and recognise possible hazards. The professional in electrical engineering in
charge of testing has to make a decision whether nor not further individual tests
are required in order to attain the safety target. If safety deficiencies or damage
is/are detected during the re-test, the testing process must be discontinued and
the device must be labelled accordingly and blocked from further use or submitted
for repair of the defect.
DANGER
Explosion hazard.
Risk of fatal injury.
▶ Do not use KaVo product in areas subject an explosion hazard.
Note
Any waste which is generated must be recycled or disposed of in strict compli‐
ance with all applicable national regulations in a manner which is safe both for
people and the environment.
If you have any questions regarding proper disposal of the KaVo product, please
contact the KaVo branch.
This product is licensed for indoor use only.
The following persons are authorised to repair and service the KaVo product:
▪ Technicians of KaVo branch offices after appropriate product training.
▪ Specifically KaVo-trained technicians of KaVo franchised dealers.
2.2.2
Product-specific
The KaVoDSEclinical type 5197 is used for the training and vocational training of
dentistry students at universities and for advanced dentist training at advanced
training institutes, clinics, and universities.
It must not be used to treat humans.
Instructions for use DSEclinical Typ 5197 / DSEclinical Typ 5197eH
2 Safety | 2.2 Purpose – Proper use
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