2
18. Individuals with a history of retinal disease should
seek advice from their ophthalmologist prior to
operating the device. In operating the Elipar 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 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
device, 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 devices,
move the device to a different location.The EMC
manufacturer´s declaration and the recommended
separation distances between portable and mobile
RF communications equipment and the Elipar 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
Battery power level
Icon to identify electric and electronic devices.
The device must be collected and disposed of
separately
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.
7. Condensation resulting from the device being
transferred 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 Deutsch-
land GmbH may open the device housing and
repair the device.
15. Elipar 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 in patients with a history of photo
-
biological reactions (including individuals with
urticaria solaris or erythropoietic protoporphyria) or
who are currently on photosensitizing medication
(including 8-methoxypsoralen or dimethylchloro-
tetracycline).
17. Individuals with a history of cataract surgery may
be particularly sensitive to the exposure to light
and should be discouraged from Elipar treatment
unless adequate safety measures, such as the
use of protective goggles to remove blue light, are
undertaken.
