3M ESPE Elipar DeepCure-S, Руководство по эксплуатации

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19. Individuals with a history of retinal disease should
seek advice from their ophthalmologist prior to
operating the unit. In operating the Elipar DeepCure-S
unit, this group of individuals must take extreme
care and comply with any and all safety precautions
(including the use of suitable light-filtering safety
goggles).
20. This unit has been developed and tested in
accordance with the relevant EMC regulations and
standards. It is in conformity with legal requirements.
Since various factors such as power supply, wiring,
and the ambient conditions at the place of operation
can affect the EMC properties of the unit, the possi-
bility that, under unfavorable conditions, there will
be EMC disruptions cannot be completely excluded.
If you should notice problems in the operation of this
or other units, move the unit to a different location.
The EMC manufacturer’s declaration and the recom -
mended separation distances between portable
and mobile RF communications equipment and the
Elipar DeepCure-S unit are listed in the appendix.
21. Prior to each use of the unit ensure that the emitted
light intensity is sufficient to safely guarantee poly-
merization. Use the light testing area integrated into
the charger for this purpose.
Glossary of Symbols
Follow instructions for use.
Attention, Consult Accompanying Documents
Type B Equipment -
Protection against electric shock
Protection Class II - double insulated
93/42/EEC
Regulatory Compliance Mark for Australia
and New Zealand
Battery power level
Icon to identify electric and electronic devices.
The unit must be collected and disposed of
separately.
Product Description
Elipar DeepCure-S is a high-performance LED light
source for polymerization of dental materials. It consists
of a charger and a wireless handpiece powered by a
rechargeable battery. The device is a medical electrical
device in accordance with IEC 60601-1 and is available
as a tabletop device. Wall mounting is not possible.
has to be seen as an applied part. The use of other
light guides may result in a reduction or increase in
the light intensity. The product’s warranty does not
cover any damage resulting from the use of third-
party light guides.
8. Condensation resulting from the unit being trans -
ferred from a cold to a warm environment may be
a potential risk. Hence, the unit should be turned on
only after it is completely equilibrated to ambient
temperature.
9. In order to avoid electric shock do not introduce any
objects into the unit with the exception of replace-
ment parts handled in accordance with the Operating
Instructions.
10. Use only genuine 3M ESPE parts when replacing
defective components as directed in these Operating
Instructions. The product’s warranty does not cover
any damage resulting from the use of third-party
replacement parts.
11. Should you have any reason to suspect the safety of
the unit to be compromised, the unit must be taken
out of operation and labeled accordingly to prevent
third parties from inadvertently using a possibly
defective unit. Safety may be compromised, e.g.,
if the unit malfunctions or is noticeably damaged.
12. Keep solvents, flammable liquids, and sources of
intense heat away from the unit as they may damage
the plastic housing of the charger, the seals, or the
cover on the operating buttons.
13. Do not operate the unit in the proximity of flammable
mixtures.
14. Do not allow cleaning agents to enter the unit as
this may short-circuit the unit or cause potentially
dangerous malfunction.
15. Only service centers authorized by 3M Deutsch-
land GmbH may open the unit housing and repair
the device.
16. Elipar DeepCure-S must not be used in patients, or
by users, with heart pacemaker implants who have
been advised to be cautious with regard to their
exposure to small electrical devices.
17. Do not use Elipar DeepCure-S in patients with a
history of photobiological reactions (including
individuals with urticaria solaris or erythropoetic
protoporphyria) or who are currently on photo -
sensitizing medication (including 8-methoxypsoralen
or dimethylchlorotetracycline).
18. Individuals with a history of cataract surgery may be
particularly sensitive to the exposure to light and
should be discouraged from Elipar DeepCure-S
treatment unless adequate safety measures, such
as the use of protective goggles to remove blue
light, are undertaken.