User's Guide

OR PURSUANT TO STATUTE), THEN BIOLUX’S AGGREGATE LIABILITY

WILL BE LIMITED TO AN AMOUNT EQUAL TO THE PURCHASE PRICE

PAID FOR THE ORTHOPULSE®.

The exclusion of certain conditions and warranties and time limitation

of certain liability is prohibited in some jurisdiction, so these limita-

tions and exclusions may not apply to some purchasers. This limited

warranty is governed solely by the laws of the Republic of Austria,

excluding any rules of private international law or the conflict of laws

which would lead to the application of any other laws; the courts of

Vienna, 1st district, Austria shall have exclusive jurisdiction over any

claims relating to this limited warranty.

Biolux has US and international patents pending for OrthoPulse® and

the accompanying technology. Patented orthopulse.com/patents

The Biolux logo, OrthoPulse® , Light Accelerated Orthodontics™, and

the collection of these marks are trademarks of Biolux.

Manufacturers Liability

Biolux Technology assumes no responsibility for any damage, loss,

or claims which may result from: failure to follow the instructions

contained in this manual; malfunction due to unauthorized repairs

or modifications. Use of the OrthoPulse® equipment is entirely the

responsibility of the operator.

5. Safety

5.1 Technical Description and Classifications

The following is a technical description of OrthoPulse®. It is intended

to provide all data essential for safe operation, transport and storage

as well as permissible environmental conditions and electrical safety

classifications.

WARNING: No modification or servicing of this equipment is

allowed.

• OrthoPulse® is considered to be an applied part according to the IEC

60601-1 3rd Ed. OrthoPulse® is classified as a Type BF applied part.

• Protection Class: Class II equipment.

• OrthoPulse® LEDs operate at 850 nm wavelength, 61 mW/cm

output power, corresponding to 18.3 J/cm

Ingress Protection Class:

• OrthoPulse® is rated as IP37, is tool proof and submersible in water

up to 1 m deep for up to 30 minutes.

• Charging case is rated as IP32, is tool proof and resistant to dripping

water while tilted 15°.

5.2 Environmental Conditions

Environmental Operating Conditions:

• Ambient temperature range: 5°C to 30°C

• Relative humidity range: 15 to 90% non- condensing

• Atmospheric pressure range: 700 to 1060 hPa

It is normal that the OrthoPulse® device will warm up during the treat-