Safety, Warnings & Cautions; Transport And Storage Conditions - SDI radii xpert Gebrauchsanweisung

SAFETY, WARNINGS & CAUTIONS
Use of the Radii Xpert is restricted to qualifi ed medical professionals in accordance with the safety instructions below:
1. Do not open or alter the Radii Xpert in anyway. Only dealers authorised by SDI Ltd may open the housing and repair
the device.
2. Do not introduce any objects into the unit with the exception of replacement parts handled in accordance with this manual.
SHOCK HAZARD
3. Only charge the Radii Xpert handpiece in the Radii Xpert charger.
4. Connect the power plug into a suitable grounded and approved outlet.
5. Always unplug the power to the charger during cleaning of the unit.
6. Do not use damaged power cord.
7. Should you have any reason to suspect the safety of the Radii Xpert to be compromised, the unit must be taken out of
operation and appropriately labelled to prevent third parties from inadvertently using a potential defective unit.
1. The Radii Xpert emits a high intensity light and must only be used as indicated in this manual.
2. Do not look directly into the light source.
3. Operator, assistants and patient must always wear appropriate blue light blocking eye protection or use a blue light
HIGH INTENSITY
blocking light shield.
LIGHT
4. Restrict exposure to the oral cavity in which clinical treatment is intended.
5. Avoid direct contact of curing tip with soft tissues and mucosa.
1. Radii Xpert can only be operated with the supplied LED tip and is not compatible with previous Radii model
of LED attachments.
2. Condensation resulting from unit being transferred from a cold to a warm environment may be a potential risk.
The unit should only be turned on after it is completely equilibrated to ambient temperature.
CAUTION
3. Use only genuine SDI Ltd parts when replacing defective components as directed in this manual.
4. Do not operate the unit in the proximity of fl ammable mixtures.
5. Keep solvents, fl ammable liquids and sources of intense heat away from the unit as they may damage the
plastic housing.
6. Do not allow cleaning agents to enter the Radii Xpert as this may short circuit the unit.
7. Do not use the Radii Xpert in patients or by users:
a. with heart pacemaker implants who have been advised to be cautious with regard to their exposure to small electrical
devices.
b. with a history of photo biological reactions (including individuals with urticaria solaris or erythropoietic protoporphyria)
or who are currently on photo-sensitising medication (including 8-methoxypsoralen or dimethylchlorotetracycline).
c. who have history of retinal disease.
d. who have had surgery for eye cataracts.
Seek advice from their prescribing medical practitioner prior to operating the Radii Xpert on these patients.
8. Prior to each use of the Radii Xpert, ensure that the emitted intensity is suffi cient to safely guarantee polymerization.
9. The Radii Xpert was developed and tested in accordance to relevant EMC regulations and standards to conform with legal
requirements. Due to variables that may exist within the work environment, such as power supply, wiring and the ambient
conditions that can affect the EMC properties of the Radii Xpert, EMC disruption may occur. If this happens, move the unit
to a different location.
10. SDI Ltd accepts no liability for any damage resulting from the use of the Radii Xpert for any other purpose than the
polymerization of light-cured dental materials.

TRANSPORT AND STORAGE CONDITIONS

40° C
+
Ambient
104°F
+
0° C
temperature:
32°F
2 2
85%
Relative Atmospheric
max
humidity: pressure:
10%
1.0 atm
1060
hPa
0.5 atm
500
hPa