3M ESPE Elipar S10 Mode D'emploi page 4

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 S10 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 S10 in patients with a history of
photobiological reactions (including individuals with
urticaria solaris or erythropoietic protoporphyria) or
who are currently on photosensitizing medication
(including 8-methoxypsoralen or dimethylchloro -
tetracycline).
18. Individuals with a history of cataract surgery may be
particularly sensitive to the exposure to light and
should be discouraged from Elipar S10 treatment
unless adequate safety measures, such as the
use of protective goggles to remove blue light, are
undertaken.
19. Individuals with a history of retinal disease should
seek advice from their ophthalmologist prior to
operating the unit. In operating the Elipar S10 unit,
this group of individuals must take extreme care and
2
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 require-
ments. 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 possibility 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 declara-
tion and the recommended separation distances
between portable and mobile RF communications
equipment and the Elipar S10 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
Battery power level
Icon to identify electric and electronic devices.
The unit must be collected and disposed of
separately.
Product Description
Elipar S10 is a high-performance light source for poly-
merization 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.
The light source is a high-performance light-emitting
diode (LED). In contrast to halogen lights, the emitted
light specifically covers the light wavelength between
430 and 480 nm, the relevant range e.g. for camphor
quinone-containing products.