User's Guide

4
1. Introduction
1.1 About OrthoPulse®
OrthoPulse® is an established device that uses low levels of light
energy to stimulate the bone surrounding the roots of your teeth
which may reduce treatment time for braces or clear aligners.
OrthoPulse® uses low intensity near infra-red light technology to
gently facilitate orthodontic tooth movement.
For further information about the clinical benefits and supporting
research, please visit orthopulse.com
OrthoPulse® therapeutic device has a Mouthpiece with treatment
LEDs and a controller housing with battery and electronics. The Ortho-
Pulse® device does not have an on/off switch. Wake the device by
removing it from the charging case.
1.2 Intended Use /Indications for Use
The OrthoPulse® device is intended to accelerate orthodontic move-
ment of teeth and reduce the overall treatment time for the patient.
The device is intended to be used in conjunction with traditional ortho-
dontic treatment with brackets and wires or aligners.
A patient shall use the OrthoPulse® device themself by following the
orthodontist or dentist by the prescribed treatment plan. The Ortho-
Pulse® device does not require any servicing or maintenance, the
patient shall charge the device prior to the first use and after each daily
treatment.
OrthoPulse® is operated under prescription by your orthodontist or
dentist. Your prescribing orthodontist or dentist will provide instruc-
tions on how to use OrthoPulse® device.
Please direct questions regarding your orthodontic treatment plan
toward your prescribing orthodontist or dentist. Biolux Technology is not
authorized and unable to make representations related to patient-spe-
cific treatment and/or provide orthodontic treatment advice.
WARNING: OrthoPulse® is a single patient prescription device.
Do not use the OrthoPulse® appliance on multiple patients. Use
by an individual without the proper issuance from an orthodontist
may result in unintended consequences, including the possible
transmission of viral and bacterial infective agents.
The medical device can be used in any patients if not contraindicated
to treat the indications mentioned in section 1.3.
United States and Hong Kong Indications for Use
The OrthoPulse® device is intended for use during orthodontic treat-
ment. It is used in conjunction with brackets and wires or aligners and
helps facilitate minor anterior tooth movement.
OrthoPulse® is operated under prescription by your orthodontist or
dentist. Your prescribing orthodontist or dentist will provide instruc-
tions on how to use your OrthoPulse® device. Your orthodontist or
dentist should assess the fit of your orthodontic appliance (aligners or
brackets and wires) at every follow up visit to ensure that your teeth are
progressing at an appropriate rate, including assessments of pressure,
pain, air gaps, etc., as applicable.
Please direct questions regarding your orthodontic treatment plan
toward your prescribing orthodontist or dentist. Biolux Technology is
not authorized and unable to make representations related to patient-
specific treatment and/or provide orthodontic treatment advice.