User's Guide

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5.5 Additional requirements for warning and safety notices
Side effects that are generally observed with therapeutic light in the
near infrared wavelength and which are described in the literature.
Even though this type of treatment is generally very safe, negative
effects may occur. As a consequence of light therapy, patients can
complain of irritability, headaches, eye strain, sleep disturbances and
insomnia. Mild visual side effects are not unusual but remit promptly.
However, since light therapy is as safe as it is effective, there are no
known long-term side effects of this form of light therapy. Other than
averting your eyes from the laser’s red or infrared light, the FDA has
found no other red flags or adverse side effects. Because the light
emitted does not cause your skin to burn, there is no risk of pain except
under certain conditions.
This is why there are no side effects associated specifically with
OrthoPulse®. Resulting from the risk analysis, we thus conclude that
the OrthoPulse® does not contain foreseeable risks of unacceptable
levels. The device is designed and manufactured such that, when used
as intended, it will not compromise the conditions of safety of the
patients and operator, and any remaining risk is managed with a high
level of protection of health and safety.
Based on the individual/overall risk/benefit analysis carried out for all
identified risks we thus conclude that the OrthoPulse® does not con-
tain foreseeable risks of unacceptable levels. The device is designed and
manufactured such that, when used as intended, it will not compromise
the conditions of safety of the patients and operator, and any remaining
risk is managed with a high level of protection of health and safety.
BIOLUX will continue to monitor the risks associated with the use of
this product throughout the product lifecycle, including manufacturing,
inspection and testing, complaint handling, non-conformance reports,
post-market clinical follow-up, clinical evaluation, post market surveil-
lance, product changes, and management reviews.
5.6 Power Adapter Specification
Standard power adapter with USB A outlet shall be used to power the
charger case via USB cable; power supply output: Voltage - 5V, Current
up to 2A.
5.7 Warnings and Safety Notices
United States Federal law and other national regulations restrict this
device to sale by or on the order of a doctor. Biolux Technology cannot
be held responsible for any damage or injury resulting from a failure to
follow the directions in this user guide. Ensure that you are entirely famil-
iar with the correct procedures for operating the appliance before use.
ATTENTION:
• Use only as directed. OrthoPulse® must be used under the direction
or supervision of an orthodontist or dentist.
• Discontinue use if you have an allergic reaction to OrthoPulse® or
its accessories and seek medical opinion.
• Chewing or clenching on the bite pad may damage the device, or
lead to a choking hazard.
During use, bite gently on the bite pad.
• Staring at the near-infrared light source may cause eye irritation. Do
not stare directly at the mouthpiece.
• Avoid knocking, hitting or pulling your OrthoPulse® with force. Rough
handling may cause damage. Discontinue use if damage is suspected.
• The charging case and cable may be a tripping hazard. Plug in near
the wall outlet on a stable flat surface.