3M ESPE Elipar DeepCure-L, Operating Instructions Manual

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as the use of protective goggles to remove blue
light, are undertaken.
18. Individuals with a history of retinal disease should
seek advice from their ophthalmologist prior to
operating the device. In operating the Elipar
DeepCure-L device, 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).
19. This device 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 device, the
possibility that, under unfavorable conditions, there
will be EMC disruptions cannot be completely
excluded. If you should notice problems in the opera-
tion of this or other devices, move the device 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 DeepCure-L unit are listed
in the appendix.
20. Prior to each use of the device ensure that the
emitted light intensity is sufficient to safely guarantee
polymerization. Check the light guide and the light
guide mounting hole to make sure they are clean.
If necessary, the light guide mounting hole and
the light guide can be cleaned as described in the
section “Maintenance and Care” (see also the
section “Measurement of Light Intensity”).
Glossary of Symbols
Follow instructions for use
Attention, consult accompanying documents
Type B Equipment -
Protection against electric shock
Protection Class II - double insulated
Use in closed spaces only
93/42/EEC
Regulatory Compliance Mark for Australia
and New Zealand
Battery power level
Icon to identify electric and electronic devices.
The device must be collected and disposed of
separately
The light guide has to be seen as an applied part.
The use of other light guides may result in a reduc-
tion or increase in the light intensity. The product’s
warranty does not cover any damage resulting from
the use of third-party light guides.
7. Condensation resulting from the device being trans-
ferred from a cold to a warm environment may be a
potential risk. Never begin operating the device until
it has reached the ambient temperature.
8. In order to avoid electric shock, do not introduce
any objects into the device with the exception of
replacement parts handled in accordance with the
Operating Instructions.
9. 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.
10. Should you have any reason to suspect the safety
of the device to be compromised, the device must
be taken out of operation and labeled accordingly
to prevent third parties from inadvertently using
a possibly defective device. Safety may be
compromised, e.g., if the device malfunctions or
is noticeably damaged.
11. Keep solvents, flammable liquids, and sources of
intense heat away from the device as they may
damage the plastic housing of the device, the seals,
or the operating buttons.
12. Do not operate the device in the proximity of
flammable mixtures.
13. Do not allow any cleaning agents to enter the device
during cleaning as they could cause an electrical
short or a dangerous malfunction.
14. Only service centers authorized by 3M Deutschland
GmbH may open the device housing and repair the
device.
15. Elipar DeepCure-L 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.
16. Do not use Elipar DeepCure-L in patients with a
history of photobiological reactions (including
individuals with urticaria solaris or erythropoietic
protoporphyria) or who are currently on photo -
sensitizing medication (including 8-methoxypsoralen
or dimethylchlorotetracycline).
17. Individuals with a history of cataract surgery may
be particularly sensitive to the exposure to light and
should be discouraged from Elipar DeepCure-L
treatment unless adequate safety measures, such