User Guide 1
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.2 Charging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inside Your OrthoPulse® Box Ensure that all package contents are enclosed and that there is no visible damage 1 2 2 Quick Start 1 Charging Case The OrthoPulse® device is inside the charger case.
1. Introduction 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. 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.
Clinical Performance For Fixed Appliances: • No increase of root resorption compared to standard orthodontic treatment • 54% reduction in time to achieve anterior alignment • 26% increase in rate of space closure in adults • 73% reduction of peak pain compared to sham-controls • Two-fold faster rate of tooth movement during alignment 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.
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. were excluded. There were no differences between groups in terms of gender, ethnicity, age, and initial crowding.
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. 5 min 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.
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. 2.3 Status Light Guide Pick up the OrthoPulse® to check the status light before your treatment. Approximately three hours are needed to fully recharge the OrthoPulse® device. A green status light will indicate a sufficient battery charge to complete two treatment sessions.
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. 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 The app is compatible with iOS and Android products. iOS Compatibility: Requires iOS 14.0 or higher. Android Compatibility: Devices running Android 11.
3.3 Service Life OrthoPulse® should last for the duration of your orthodontic treatment. The device should last for up to two years of continuous use if used with care. 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.
• 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: info@bioluxtec.com Web: orthopulse.
5. Safety OR PURSUANT TO STATUTE), THEN BIOLUX’S AGGREGATE LIABILITY WILL BE LIMITED TO AN AMOUNT EQUAL TO THE PURCHASE PRICE PAID FOR THE ORTHOPULSE®. 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.
not occur in a particular installation.
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 installation.
Electromagnetic Emissions* 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 frequency whichever is higher1 Complies Conducted Emissions 1 The Conducted Emissions are measured on the phase and Neutral Power lines in the 0.
Electromagnetic Immunity* 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.
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.
• 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. provider or patient account linked to your name or contact information (an “Account”), we collect the registration information that is shared with us.
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 services 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, s
Where Is This Information Processed? We process information collected via the Online Services/OrthoPulse® App in and subject to the laws of the EUROPEAN UNION, which may not provide the same level protection for your information as your home country. In addition, we may transfer your information outside the European Union to our affiliates, business partners, and service providers located in other countries.
Australian Distributor Kerr Australia Pty. Ltd., Unit 6, 12 Mars Road, Lane Cove West, NSW 2066, Australia The Data Protection Authority is the responsible authority in Austria. Biolux Technology GmbH Neubaugasse 31, 3462 Absdorf, Austria Email: info@bioluxtec.
GLOSSARY OF APPLICABLE SYMBOLS Federal law restricts this device to sale by or on the order of a doctor Manufacturer 10 min Device has 10 minutes treatment time, 24 hours Off time Date of manufacture SN Serial number Direct current REF Catalog Number Single patient multiple use Class II Equipment General Caution Sign Medical device 30 °C 86 °F Environmental temperature limit for use Follow the instructions °C 1 °F Shipping and storage temperature range Refer to instruction manual Ke
Questions? orthopulse.
