BIOLUX OrthoPulse User manual
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User Guide
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Contents
1. Introduction
1.1 About OrthoPulse®........................................ 4
1.2 Intended Use / Indications for Use ......................... 4
1.3 Contraindications for Use .................................. 6
2. How to Use
2.1 Steps and Schedule for Use ................................ 6
2.2 Charging ................................................. 7
2.3 Status Light Guide ........................................ 8
2.4 OrthoPulse®App .......................................... 8
3. Care and Maintenance
3.1 Cleaning .................................................. 9
3.2 Storage .................................................. 9
3.3 Service Life ............................................... 9
3.4 Replacement ............................................. 9
3.5 Environmental Protection Disposal ........................ 10
4. Support
4.1 Orthodontic Treatment ................................... 10
4.2 Device Inquiries .......................................... 10
4.3 Troubleshooting ......................................... 10
4.4 Warranties .............................................. 10
5. Safety
5.1 Technical Description and Classifications .................. 12
5.2 Environmental Conditions ................................ 12
5.3 EMC Compliance Statement .............................. 12
5.4 Electromagnetic Compatibility ............................ 15
5.5 Additional requirements for warning and safety notices .... 18
5.6 Power Adaptor Specification .............................. 18
5.7 Warnings and Safety Notices ............................. 18
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2Quick Start
Ensure that all package contents are enclosed and
that there is no visible damage
Inside Your OrthoPulse®Box
1 2
1Charging Case
The OrthoPulse® device is
inside the charger case.
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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 ordentist. Biolux Technology isnot
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.
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Performance claims:
• Current orthodontic mechanics optimize the process of tooth move-
ment, and now OrthoPulse® will allow for the optimization of the
biology of tooth movement
• Acceleration of the treatment time by up to 50%
• Pain reduction up to 70%
• No increase of root resorption compared to standard orthodontic
treatment
Clinical Benefit:
• Patient satisfaction: comfortable treatment that can help reduce
discomfort associated with orthodontic treatment
• Reducedorthodontictreatment time:fast and convenientself-treat-
ment session
• Facilitates orthodontic tooth movement
Clinical Evaluations of OrthoPulse®
Clinical testing of the OrthoPulse® device with orthodontic treatment
demonstrated that the device may accelerate tooth movement and
may decrease treatment time. Two primary clinical studies of the intra-
oral OrthoPulse® demonstrated device performance for its intended
use; the device may accelerate orthodontic movement of teeth and
may reduce the overall treatment time for the patient when used in
conjunction with traditional orthodontic treatment with brackets and
wires or aligners.
In a cross-over study where subjects served as their own control, 21
subjects (mean age 34.9 years) who used OrthoPulse® with aligners
were evaluated. Eligibility criteria included requiring that the sub-
jects have permanent dentition, mild to moderate crowding with no
labiolingually displaced teeth, Class I or Class II by 1/2 cusp or less,
good oral hygiene, and be non-smoking. Subjects who were preg-
nant, enrolled in another study, had periodontally involved teeth, used
bisphosphonates during the study or had spaces between anterior
teeth were excluded. Perimeter measurement analysis was used to
evaluate each patient’s rate of tooth movement during baseline and
OrthoPulse® periods in the mandibular arch. The degree of external
apical root resorption was also investigated. Study subjects were fol-
lowed from the start of orthodontic aligner treatment for 6 months.
Results demonstrated statistically significant faster tooth movement
compared to baseline (p=0.024), achieving the primary effectiveness
objective of the study. There were no serious adverse events, and
no root resorption, gingival recession or pathological tooth mobility
reported throughout the study.
OrthoPulse® was also evaluated in conjunction with brackets and
wires in a controlled study of 33 subjects (mean age 25.0 years).
Matched controls (based on subjects’ age, initial crowding, eligibility
criteria) were retrospectively selected before any data analysis of the
OrthoPulse® subjects. Eligibility criteria included requiring that the
subjects have permanent dentition, mild to moderate crowding with
no labiolingually displaced teeth, Class I or Class II by 1/2 cusp or less,
good oral hygiene, and be non-smoking. Subjects who were pregnant,
enrolled in another study, had periodontally involved teeth, used bis-
phosphonates during the study or had spaces between anterior teeth
were excluded. There were no differences between groups in terms of
gender, ethnicity, age, and initial crowding. The rate of tooth move-
ment was measured using the change in Little’s Irregularity Index
measurements in both groups to evaluate OrthoPulse® use with fixed
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orthodontic appliances. Root resorption was determined by use of
panoramic dental X-rays collected before treatment and after 6
months of treatment. Results demonstrated that subjects treated
with OrthoPulse® showed a statistically significantly faster rate of
tooth movement (p<0.001) compared to the control group, achieving
the primary effectiveness objective of the study. There were no seri-
ous adverse events, and no gingival recession or pathological tooth
mobility reported throughout the study. Data demonstrated the
absence of external apical root resorption with OrthoPulse® use, and
that there is no device effect of accelerated tooth movement on tooth
root integrity.
Several additional clinical studies were also conducted with prototype
and final OrthoPulse® devices to supplement the clinical findings
observed in the primary studies, and results consistently confirmed
device performance for its indicated use.
Therefore, results from the clinical studies demonstrate that subjects
treated with OrthoPulse® achieve statistically significantly faster
rates of tooth movement than control. The amount of change in an
individual’s tooth movement rate during OrthoPulse® daily treatment
may be dependent upon their specific biology and treatment plan. For
clear aligners, only Invisalign brand aligners have been examined with
daily OrthoPulse® use. Results with other brands of aligners may vary.
1.3 Contraindications for Use
• Use of osteoporosis drugs
• Use of drugs that may cause photosensitivity
• Photosensitivity1
• Poor oral hygiene
• Acute oral infection, active periodontal disease or oral cancer
• Epilepsy
A dental professional should be consulted prior to use if any of these
situations are suspected.
2. How to Use
2.1 Steps and Schedule for Use
An OrthoPulse® treatment takes five minutes per arch for a total of
ten minutes daily.2It is recommended to select the same time every-
day to do your treatment.
Caution: To maximize the life of your device and to avoid
potential overheating of the device do not use the OrthoPulse®
device for more than two 5-minute sessions subsequently.
The status light guide is available on the bottom of the OrthoPulse®
charging case.
Typically, it takes two to three weeks to develop a habit, so be patient.
Some patients prefer to set up OrthoPulse® next to their bed, so they
can do treatments first thing upon rising or prior to sleeping.
1A condition in which the skin becomes very sensitive to sunlight
or other forms of ultraviolet light and may burn easily.
2there are no benefits of doing more than 2 sessions.
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6 h
5 min
5 min
You may pause the treatment
for up to 20 seconds by simply
removing the device from your
mouth. If you pause for more than
20 seconds, the treatment will
abort and you will have to restart
your OrthoPulse® treatment.
Applied Part
To use your OrthoPulse®,
complete the six steps below:
1. Remove the OrthoPulse® from the charging case,
this will wake the device from sleep mode. The
status light will display green upon waking when
the battery has sufficient charge to complete a
treatment. If a yellow light appears, return it to the
charging case. Refer to the LED indicator on the
next page or on the charger case bottom label.
2. Place the OrthoPulse® device in your mouth, cen-
tering it between the front teeth.
3. Bite down gently to hold it in place. The device
will beep twice and the status light will turn blue
indicating that the treatment has started. A warm,
pleasant sensation can be felt during treatment.
The device has temperature management system,
if the temperature exceeds 48 °C the treatment
will be paused for cooling, the treatment will be
auto resumed after several seconds.
4. Once the treatment is complete, the device will beep three times
continuously and the blue status light will start pulsing.
5. Flip the device and repeat steps 2 through 4 to treat the other jaw.
6. Return the device to the plugged-in charging case to re-charge the
device after treatment.
TIP: Avoid loud background noise during treatment to ensure you hear
the aural indicators.
During the treatment, the device controller (box outside the mouth)
could reach a temperature above 41 °C, patient’s lip may contact the
device controller during the treatment. In case the heat exceeds the
patient’s comfort level the device can be removed from the mouth to
trigger the cooling mode by pausing the treatment.
Warning: Do not use the device under direct sunlight, or in an
environment with ambient temp above 30 °C.
There is no clinical benefit or any additional risk to the patient in the
case the device reaches 41 °C temperature. The device Firmware has
safety features that pause the treatment or cease the device opera-
tion in the case of overheating.
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2.2 Charging
Using the tethered USB cable to connect the charging case to a power
adaptor and plug it into a power outlet to charge the device. You can
use any USB power adapter, e.g. of your mobile phone.
Approximatelythreehoursareneeded tofullyrechargetheOrthoPulse®
device. A green status light will indicate a sufficient battery charge to
complete two treatment sessions. When the device is fully charged, the
status light will turn off and the device will sleep automatically.
Two sessions can be completed on one full charge. The device must be
recharged after each 10-minute treatment. If the status light is solid
yellow, the device needs to be recharged prior to use.
CAUTION: Place the OrthoPulse® on a stable flat surface and
out of the way to avoid tripping hazards.
2.3 Status Light Guide
Pick up the OrthoPulse® to check the status light before your treat-
ment.
Ready for treatment
Low battery, not ready
Error, consult your dentist
In hand
Treatment started
Treatment completed
Treatment paused
x2
In treatment
Charging
Error
Charging completed
Charger case status
Charging, ready
Charging, not ready
Fully charged, ready
Restarting
Ready for Bluetooth®
Syncing
In charging case
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2.4 OrthoPulse® App (Optional)
Biolux has developed an app to help patients and doctors follow their
OrthoPulse® treatment compliance, stay motivated, and achieve great
smiles faster.
The app is compatible with iOS and Android products. iOS Compatibil-
ity: Requires iOS 14.0 or higher. Android Compatibility: Devices running
Android 11.0 or higher with Bluetooth® LE (4.0).
In order to use the OrthoPulse® app, your orthodontist or dentist must
first create a patient account for you. After that you can download the
OrthoPulse® App from the Apple App store or Google Play Store by
simply searching for „orthopulse”. After installation you can login with
the email address you provided to the doctor as username and will
then be prompted to select a password. After login you need to “pair”
your OrthoPulse® to your account. This is simply done by scanning the
QR Code on the bottom of the charger. If your doctor did not set up
an account for you or you have troubles using the app, please contact
Upon logging in, the app will start searching for your OrthoPulse®
device with which to sync. In order for the sync to take place, both
your mobile device and OrthoPulse® must be in Bluetooth® mode, and
there must be a stable internet connection. To activate Bluetooth®
mode on your OrthoPulse®, pick it up and place it back down on the
charging case so that the status light displays purple.
If no communication is achieved between OrthoPulse® and the app
within 60 seconds, Bluetooth® will time out after 60 seconds and you
will have to reactivate Bluetooth® mode on your OrthoPulse®.
Note, that for using Bluetooth service for synching with the app you
need to allow the OrthoPulse® app to use location services during use.
3. Care and Maintenance
3.1 Cleaning
Itis notnecessary to cleanOrthoPulse® aftereveryuse. It isrecommend
that patients rinse the mouthpiece under warm water once a week and
set it to air dry on the charging case. Hold the OrthoPulse® device by
the white plastic housing – do not hold it by the silicone mouthpiece.
CAUTION: The OrthoPulse® device is NOT dishwasher safe.
CAUTION: Avoid rinsing the white plastic housing of the
OrthoPulse® device.
CAUTION: The charging case is not water resistant and should
not be rinsed or submerged in water. The charging case should be
used in a dry environment, inside, and kept away from water.
3.2 Storage
Store your OrthoPulse® in its charging case when not in use. This will
prevent damage.
The OrthoPulse® device should be stored in a cool, dry place away from
direct sunlight. Avoid storing your OrthoPulse® in locations where it
may be exposed to extreme temperatures.
CAUTION: The OrthoPulse® should be stored out of the reach
of young children or pets; it is not a toy.
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3.3 Service Life
OrthoPulse® should last for the duration of your orthodontic treat-
ment. The device should last for up to two years of continuous use if
used with care.
The OrthoPulse® device contains a lithium polymer battery that will
lose charge over time if not re-charged. The OrthoPulse® device
should be fully charged within three months of delivery and should be
fully charged prior to first use. To maintain battery life, do not let the
battery completely discharge.
3.4 Replacement
No component of the OrthoPulse® device is user- serviceable or
-replaceable. During the course of treatment, no OrthoPulse® compo-
nents should require replacement. Bite marks and other wear marks
that become present in the mouthpiece over time are normal, and do
not require replacement. However, they may be indications that you
are biting or clenching too hard during your OrthoPulse® treatment. If
there are punctures, or any of the internal surfaces of the mouthpiece
become exposed, stop using the OrthoPulse® immediately and con-
tact [email protected].
In case of other damage or unforeseen wear and tear, please contact
WARNING: Do not tamper with or attempt to repair your
OrthoPulse® or its charging case.
for replacement or repair. Prior to use, inspect OrthoPulse® for notice-
able signs of damage or wear. Do not substitute any parts or materials
in the device.
3.5 Environmental Protection Disposal
The user guide and packaging are recyclable and should be disposed
of with other recyclable paper products. To preserve the environment
and protect human health, the device should not be disposed of with
normal household waste.
Dispose of your device and charging case with tethered USB cable by
delivering them to a designated collection point for the recycling of
waste electrical and electronic equipment.
WARNING: Never incinerate OrthoPulse®, expose to exces-
sive heat, short circuit or cause any similar action to the battery.
Mishandling the battery may cause burns, fire or explosion.
Contact your local waste authorities, your household waste disposal
regarding disposal.
4. Support
4.1 Orthodontic Treatment
Please contact your orthodontist or dentist directly for all inquires
regarding your treatment.
4.2 Device Inquiries
Please contact the OrthoPulse® Support Team:
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• for assistance in setting up, using or maintaining your OrthoPulse®
• to report unexpected operation or events
• for technical assistance and any concerns specifically related to
OrthoPulse® or its accessories
Manufacturer Contact Information:
Biolux Technology GmbH, Neubaugasse 31, 3462 Absdorf, Austria
Email: [email protected]
Web: orthopulse.com
4.3 Troubleshooting
Visit the FAQ section on the OrthoPulse® website, available here:
http://www.orthopulse.com/patients/support
4.4 Warranties
Limited Warranty: Biolux Technology (Biolux) warrants to the origi-
nal purchaser that the OrthoPulse® device will be free from defects
in material and workmanship for one (1) year from the date of the
original purchase from Biolux or its authorized resellers. This limited
warranty is non-transferrable. If the OrthoPulse® is defective during
the warranty period, the purchaser’s sole and exclusive remedy, and
Biolux’s sole obligation, will be (at Biolux’s discretion) to: repair the
OrthoPulse® to conform to its specifications; replace the OrthoPulse®
with a comparable product; or refund to the purchaser the original
price paid for the OrthoPulse®. Repaired or replaced products or parts
may be new or reconditioned, and are subject to this limited warranty
through the end of the original warranty period. To obtain warranty
service, the purchaser must: contact the prescribing orthodontist or
dentist. This warranty does not apply if the defect or malfunction in the
OrthoPulse® was caused by misuse, neglect, unauthorized attempts
to open, repair or modify the OrthoPulse®, use of the OrthoPulse®
with accessories or other products that are not authorized by Biolux,
or any cause other than the intended normal use of the OrthoPulse®.
Any presumption of lack of conformity shall be excluded.
Non-warranty work is charged at the minimum repair rate effective
at the time the OrthoPulse® is returned to Biolux. All repairs include a
complete functional test using factory test fixtures.
EXCLUSIONS: TO THE FULL EXTENT ALLOWED BY LAW, THIS LIMITED
WARRANTY IS THE PURCHASER’S SOLE AND EXCLUSIVE REMEDY,
AND NO OTHER WARRANTIES, CONDITIONS, OR GUARANTEES OF
ANY KINDS SHALL APPLY, WHETHER STATUTORY, WRITTEN, ORALLY
EXPRESSED OR IMPLIED; INCLUDING WITHOUT LIMITATION WAR-
RANTIES, CONDITIONS OR GUARANTEES OF MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE, PERFORMANCE, QUALITY,
OR DURABILITY, ALL OF WHICH ARE DISCLAIMED. IN NO EVENT WILL
BIOLUX BE LIABLE FOR ANY SPECIAL, EXTRAORDINARY, INDIRECT OR
CONSEQUENTIAL DAMAGES OF ANY KIND WHATSOEVER, INCLUDING
WITHOUT LIMITATION DAMAGES FOR LOSS OF DATA, LOST PROF-
ITS, LOSS OF OPPORTUNITY, BUSINESS INTERRUPTION, PERSONAL
INJURY OR DEATH, OR ANY OTHER LOSS ARISING OUT OF, RELATING
TO, OR IN CONNECTION WITH THE ORTHOPULSE®, EVEN IF BIOLUX IS
ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
LIABILITY LIMITATIONS: IF, AS A RESULT OF OR IN CONNECTION
WITH ANY USE OF THE ORTHOPULSE®, BIOLUX BECOMES LIABLE
TO THE PURCHASER OR ANY OTHER PERSON FOR ANY DAMAGES,
LOSSES, COSTS, EXPENSES, OR OTHER LIABILITIES WHATSOEVER,
AND REGARDLESS OF THE FORM OF ACTION (IN CONTRACT, TORT
12
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.
All rights reserved.
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/cm2
output power, corresponding to 18.3 J/cm2
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-
13
ment or after charging and can reach up to 41°C. To prevent overheat-
ing and prolong its life let the device cool down to ambient tempera-
ture before use.
CAUTION:Do not use the OrthoPulse® device for more than
two 5-minute sessions subsequently. It may cause the device to
overheat.
CAUTION:Ensure the device is not warm after it is charged
before starting treatment.
Transport and Storage Conditions:
• Minimum ambient temperature: -25°C
• Maximum ambient temperature: 70°C
• Maximum humidity: 90% non-condensing
• Storage pressure range 700 to 1060 hPa
WARNING: The device shall not be used in conditions beyond
the listed above only! The patient shall check the device for any
visual defects prior to performing the treatment.
5.3 EMC Compliance Statement
This device has been tested and found to comply with the limits for a
Class B digital device, pursuant to part 15 of the FCC rules. These limits
are designed to provide reasonable protection against harmful interfer-
ence in a residential setting. This device generates, uses and can radi-
ate radio- frequency energy and, if not installed and used in accordance
with the instructions, may cause harmful interference to radio com-
munications. However, there is no guarantee that interference will
not occur in a particular installation. If this device does cause harmful
interference to radio or television reception, which can be determined
by turning the device off and on, the user is encouraged to try one or
more of the following measures:
• Reorient or relocate the device or the receiver
• Increase the distance between the device and the receiver
• Connect the device to an outlet on a circuit different from that to
which the receiver is connected
• Consult the manufacturer or an experienced broadcast engineer/
technician for help
Be aware that portable and mobile radio-frequency communications
equipment (for example, mobile phones, iPads) may affect the opera-
tion of this device; take appropriate precautions during operation.
Accessories
To maintain electromagnetic compatibility (EMC) within limits, the
device must be used with the cables and accessories specified by Biolux.
The use of accessories or cables other than those specified or supplied
may result in increased emissions or decreased immunity of the device.
Radio-Frequency Transmitter
OrthoPulse® contains a Bluetooth LE transmitter module that oper-
ates at 2.4 GHz. This module is active only when the device is placed in
the charging case and the Ready for Bluetooth indicator is on.
This equipment has been tested and found to comply with the
limits for a Class B digital device, pursuant to part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against
harmful interference in a residential installation.
14
This equipment generates, uses and can radiate radio frequency energy
and, if not installed and used in accordance with the instructions, may
cause harmful interference to radio communications. However, there
is no guarantee that interference will not occur in a particular instal-
lation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equip-
ment off and on, the user is encouraged to try to correct the interfer-
ence by one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that
to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help
This device complies with part 15 of the FCC rules. Operation is subject
to the following two conditions: (1) This device may not cause harmful
interference, and (2) This device must accept any interference received,
including interference that may cause undesired operation.
Transmitter Module Certifications*
CE: Complies with Radio Equipment Directive, RED
2014/53/EU
FCC Limited Modular Certification 15.212 FCC
#2A6CA-OPi
Canada: IC #28421-OPi
Bluetooth SIG certified #D060368
USA – User Information*
OrthoPulse® contains transmitter module FCC ID:
2A6CA-OPi.
This device complies with part 15 of the FCC rules. Operation is subject
to the following two conditions: (1) This device may not cause harmful
interference, and (2) This device must accept any interference received,
including interference that may cause undesired operation.
CAUTION:Any changes or modifications not expressly
approved by the party responsible for compliance could void the
user’s authority to operate the equipment.
Canada – User Information
OrthoPulse® contains transmitter module IC ID: 28421-OPi.
This device complies with Industry Canada licence- exempt RSS stan-
dard(s). Operation is subject to the following two conditions: (1) this
device may not cause interference, and (2) this device must accept any
interference, including interference that may cause undesired opera-
tion of the device.
5.4 Electromagnetic Compatibility
This device is intended for use in a HOME HEALTHCARE ENVIRONMENT.
This device emits energy in the infrared range for a predetermined
duration.
This device has a tethered USB cable with a maximum length of 4’ or
122 centimeters.
15
WARNING: Use of other accessories such as cables other than
the ones provided by Biolux Technology for this device may result
in increased electromagnetic emissions or decreased electromag-
netic immunity of this device and result in improper operation.
WARNING: Portable RF communications equipment (includ-
ing peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part of this
device, including cables provided by Biolux Technology. Otherwise,
degradation of the performance of this equipment could result.
16
Test or Measurement Standards Test Method Description Results
Radiated Emissions EN 60601-1-2:2015
Ed. 4
CISPR 11
EN 60601-1-11
EN 60601-2-57
EN 301 489-1
V2.1.1
ICES-003 Issue 6
CFR Title 47 FCC Part 15
ICES-003 Issu.6
Class B Limits
The radiated emissions
are measured in the
30-1000MHz range or up
to 5x the highest EUT fre-
quency whichever is higher1
Complies
Conducted Emissions The Conducted Emissions
are measured on the phase
and Neutral Power lines in
the 0.15 - 30.0 MHz range.
1Highest frequency generated by the device is 2.4GHz
Emission Test Compliance Comments
RF Emissions CISPR 11 Group 1 This device uses RF energy only for its internal
functions.
RF Emissions CISPR 11 Class B This device is predominantly intended for use
in a HOME HEALTHCARE ENVIROUNMNET
and to be connected to the PUBLIC
MAINS NETWORK
Harmonic Emissions EN 61000-3-2 Class A
Voltage Fluctuations/
Flicker Emissions
EN 61000-3-3
Class A
Electromagnetic Emissions*
17
Immunity Test Standard/Test Method Test Levels Compliance
Electrostatic Discharge IEC 61000-4-2 Air Discharge: ± 2, 4, 8, 15 kV
Contact Discharge: ± 8 kV
Complies
Radiated RF IEC 61000-4-3 10V/m, 80% AM @
1kHz, 30MHz to 2.5GHz,
Vertical and Horizontal
Polarizations
Complies
Immunity to Proximity Fields from RF Wireless
Communications Equipment
IEC 61000-4-3 9 V/m to 28 V/m @ 15
Frequencies 380 - 5800 MHz
Complies
Electrical Fast Transient/ Burst IEC 61000-4-4 AC Power Lines: ± 2 kV @ 100 kHz
Signal Lines: ± 1 kV @ 100 kHz
Complies
Surge IEC 61000-4-5 ±0.5, 1 kV line to line, 0°, 90°,180°, 270°
±0.5. 1, 2 kV line to earth, 0°, 90°,180°, 270°
Complies
Conducted RF IEC 61000-4-6 3Vrms, 0.15-80MHz, 80%
AM @ 1 kHz
6Vrms in ISM & Amateur
radio bands, 0.15-80MHz,
80% AM @ 1 kHz
Complies
Power Frequency Magnetic
Field
IEC 61000-4-8 30 A/m Complies
Voltage Dips IEC 61000-4-11 0 % UT; 0,5 cycle at 0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
0 % UT; 1 cycle
70 % UT; 25/30 cycles
Complies
Voltage Interruptions IEC 61000-4-11 0 % UT; 250/300 cycles Complies
NOTE: UT is the AC mains voltage prior to application of the test level.
Electromagnetic Immunity*
18
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.
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• Do not use the device while operating machinery or performing
complex tasks.
• Do not use with high frequency (HF) surgical equipment.
• Patients with an implanted cardiac pacemaker, defibrillator, or an
equivalent cardiac device should not use OrthoPulse® unless the
cardiac device is known to not be affected by magnetic fields.
Mobile app and OrthoPulse® device privacy policy
This Privacy Policy describes the ways in which Biolux Technology
(“we,” “our,” or “us”), collects, uses, and discloses information about
you through the OrthoPulse® and the associated OrthoPulse® mobile
application (the “OrthoPulse® App”). (We refer to the OrthoPulse® and
the OrthoPulse® App collectively as the “OrthoPulse® System”.) For
using an OrthoPulse® or the OrthoPulse® App, you have to consent to
the processing of your information as set forth in this Privacy Policy,
now and as amended by us. Your use of www.orthopulse.com and
io.bioluxresearch.com or OrthoPulse® Connect™ is governed by a sep-
arate privacy policy, which is available here: https://www.orthopulse.
com/privacy-policy and here, for patients under the age of majority
who require guardian/parental consent: https://io.bioluxresearch.com/
admin/doctor/consent/exampleassent
What Information Do We Collect?
The information we collect from users is an essential component of
the OrthoPulse® System: Information You or Your Dental Provider
Share with Us: We and our service providers collect and store any
information that you provide to us, as well as information that is pro-
vided to us by your dentist, orthodontist or other treatment provider.
If you, your dentist, orthodontist or other treatment provider create a
provider or patient account linked to your name or contact information
(an “Account”), we collect the registration information that is shared
with us. We collect information when you contact us via the Ortho-
Pulse® App with a request, question, or comment. We collect infor-
mation about patients when dental providers create patient Accounts,
when patients access their Accounts via the OrthoPulse® App, and
when an OrthoPulse® syncs with the OrthoPulse® App. The informa-
tion provided to us may include, but is not limited to: (a) your name,
contact information, email address, mobile phone number, password,
OrthoPulse® device serial number, and other registration information;
(b) your personal details such as your age and gender; (c) orthodontic
treatment details such as your treatment start date or planned dura-
tion of treatment (d) information regarding your usage of the Ortho-
Pulse®, such as the date, time, and duration of your use; and (e) infor-
mation you provide us when you contact us with a request, question,
or comment. Even if you, as a patient, do not use the OrthoPulse® App,
your dental treatment provider may send us information regarding
your usage of your OrthoPulse® by syncing your OrthoPulse® with his
or her OrthoPulse® App.
Information Automatically Collected From You: We and our service
providers collect and store certain types of technical information from
your mobile device over time whenever you interact with us through
the OrthoPulse® App, such as: your Internet Protocol address; your
general geographic location (e.g., for purposes of determining your
time zone); your mobile device’s model, software version, IP address,
and network status; information about how and when you use the
OrthoPulse® App and/or your mobile device.
20
How Do We Use This Information?
We may use the information we collect for a number of purposes,
including, but not limited to: providing you and your dental provider
with information about your use of the OrthoPulse®; operating the
OrthoPulse® System, including providing to you the features and ser-
vices available through the OrthoPulse® App;
• providing you with information, services, or products you request
and responding to your inquiries;
• customizing your experience when using the OrthoPulse® System,
such as by providing personalized treatment options;
• monitoring the safety and efficacy of the OrthoPulse® System;
• generating and analyzing statistics about your use of the Ortho-
Pulse® System;
• providing you with information about the OrthoPulse® System or
required notices;
• delivering marketing communications, promotional materials, or
advertisements that may be of interest to you;
• improving the OrthoPulse® System and the services we provide; and
• detecting, preventing, and responding to fraud, intellectual property
infringement, violations of our Terms and Conditions, violations of
law, or other misuse of the OrthoPulse® System.
Sharing your Information
We may disclose the information we collect from you through the
OrthoPulse® System in the following circumstances:
Treatment Purposes: Information collected from patients, such as
information about usage of the OrthoPulse® System, may be disclosed
to your dental treatment provider.
Third-Party Service Providers: We may employ other companies and
individuals to perform certain business functions on our behalf. Exam-
ples include providing data hosting services, application development
services, and providing customer service support. These service pro-
viders may have access to information that we collect in order to per-
form services on our behalf.
As Required by Law: We may disclose information in order to comply
with legal obligations or requests, such as to comply with a subpoena or
other legal process, or to comply with government reporting obligations.
Protection of Rights: We may disclose the information we collect to
enforce or apply our Terms and Conditions and other agreements; or
protect the rights, property, or safety of the OrthoPulse® System, our
users, or others. This includes exchanging information with other com-
panies and organizations for fraud protection and credit-risk reduction.
This does not include selling, renting, sharing, or otherwise disclosing
information that reasonably identifies users for purposes other than
those addressed in this Privacy Policy.
In Connection with a Transaction: we may disclose the information we
collect to service providers, advisors, potential transactional partners,
or other third parties in connection with the consideration, negotiation,
or completion of a corporate transaction in which we are acquired by
or merged with another company or we sell, liquidate, or transfer all or
a portion of our assets.
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