Glossary Of Symbols - 3M ESPE Paradigm DeepCure Mode D'emploi

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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.

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. Paradigm DeepCure 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 Paradigm DeepCure 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 Paradigm DeepCure

treatment unless adequate safety measures, such

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 Paradigm

DeepCure 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 Paradigm DeepCure 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").