Getting Started with OrthoPulse®

Create a patient record on OrthoPulse® Connect

1. Login to OrthoPulse-connect 🡪 https://orthopulse.com/connect
(Username and password provided at registration)

2. Click on “Add a new patient”

3. Enter patient and treatment information
(if you enter a birthdate for children under the age of 18 – you will need to enter the contact details of a guardian)
Optionally you can enter the Serial number of the device which the patient will get – and pair it to the patient (if you leave that field blank – the patient will have to pair his OrthoPulse® by scanning the QR code on his first login to the OrthoPulse® Patient App) – the serial number can be found on the back of the charging box or on the label of the OrthoPulse® box

4. After clicking “Save” instructions for downloading the app will be sent to the patient

For more detailed information please download the “Patient Registration Instructions”

5. Hand out the OrthoPulse® to the patient on the first day of his treatment

6. Instruct the patient on the use and care of OrthoPulse® and the OrthoPulse® Patient App

In case you or the patient has issues or needs assistance please contact our support team by email to: support@orthopulse.com

What can we help you with?

Treatment

What histological evidence do you have that support osteoblastic and osteoclastic response to OrthoPulse®?

We have listed a number of published in vitro and in vivo studies in our OrthoPulse® Scientific and Clinical Dossier that show significant osteoblastic and osteoclastic response (proliferation and activity, respectively) to PBM.

Are there any contraindications for using OrthoPulse®?

OrthoPulse® use has the following contraindications:

  • Use of osteoporosis drugs
  • Use of drugs that may cause photosensitivity
  • Photosensitivity
  • Poor oral hygiene
  • Acute oral infection or periodontal disease
  • Epilepsy
Can OrthoPulse® be used after an extraction to help accelerate the healing process?

It is not recommended that patients use OrthoPulse® on surgery sites, to avoid accelerated bone healing, maturation, and densification. OrthoPulse® treatment can begin as soon as orthodontic treatment has started and tooth movement is activated.

Should OrthoPulse® be used while waiting for additional or refinment aligners?

No. OrthoPulse® treatment is not recommended when teeth are not actively moving, as it may result in a potential for bone maturation. Therefore, it is recommended that patients do not use OrthoPulse® during any waiting periods between aligners.

What if treatment doesn’t start / the status light does not turn blue?

Ensure that the status light is green when you pick up the OrthoPulse® from the charging case before starting treatment. This confirms that there is sufficient battery charge. If the status light is yellow, return the OrthoPulse® to the charging case to recharge. Yellow indicates a low battery charge. Typically, the battery will recharge in about 3 hours.

What if I see a defect / wear and tear on my device?

If you see any damage or wear and tear on the device, discontinue use and contact your doctor.

What if treatment doesn’t start / the status light does not turn blue?

Ensure that the status light is green when you pick up the OrthoPulse® from the charging case before starting treatment. This confirms that there is sufficient battery charge. If the status light is yellow, return the OrthoPulse® to the charging case to recharge. Yellow indicates a low battery charge. Typically, the battery will recharge in about 3 hours.

I hear of Invisalign patients switching 14 day aligners faster without using an acceleration procedure or device. Are these patients at a higher risk of root resorption? Of course it must be uncomfortable as well?

We would expect more pain and poorer tracking, and perhaps more root resorption. Some patients can switch more frequently, but not everyone.

Is there evidence that OrthoPulse decreased orthodontic tooth pain?

There are numerous published articles in the literature that demonstrate OrthoPulse® and its effect on reducing orthodontic pain.

How much effect does OrthoPulse® have after leveling and aligning?

OrthoPulse® accelerates tooth movement throughout orthodontic treatment.

Can OrthoPulse® be used during phase 1 treatment for say one year, take a two year gap, then used again to complete phase 2 treatment?

Yes. The effect of OrthoPulse® is maintained as long as the device is in use. There is no reason to use OrthoPulse® during any period in which there is no active tooth movement, but use can be stopped and resumed as needed during a lengthy treatment.

How much variation is there in patient response to OrthoPulse®?

Patient response to PBM is dependent on a few factors, including:

  • There is variation in response based on individual biology and anatomy.
  • OrthoPulse® compliance; if a patient does not carry out treatments as frequently as is prescribe by his or her doctor, the patient will be exposed to less light from OrthoPulse® and will not experience its maximum effects
  • Correct placement and OrthoPulse® exposure; OrthoPulse® must be exposed over the correct area in order to produce an effect in that area. For example, if the goal is to distalize molars, one must ensure exposure over the molar roots.
  • (for aligners only) Aligner wear compliance; if a patients are not wearing his or her aligners as prescribed by his or her doctor, teeth wil not track and will move slower regardless of OrthoPulse® exposure.
Are there best practice guidelines with OrthoPulse® use for different types of tooth movement, for example molar distalization?

Please refer to OrthoPulse® Clinical Guidelines and Best Practices, as it applies to all types of orthodontic treatment.

Are both low-level laser and light emitting diode (LED) therapy considered photobiomodulation therapy? How do they differ?

Photobiomodulation (PBM) encompasses treatment with either low-level lasers or light emitting diodes (LEDs). Therefore, although they differ both in the way light is generated and in power density, both PBM therapy techniques operate with the same biological mechanism of action.

When is the best time to do OrthoPulse® treatments?

We recommend that you complete your OrthoPulse® treatments around the same time each day in order to develop a sustainable habit.

Many patients find it helpful to do their OrthoPulse® treatments before bed so that they can “sleep through” any discomfort.

Should elastics be removed for OrthoPulse® treatment?

As elastics may interfere with proper OrthoPulse® placement, we recommend that patients remove their elastics while they are doing their OrthoPulse® treatment, and replace them immediately after.

Should clear aligners be removed for OrthoPulse® treatment?

It is recommended that patients do not wear clear aligners (i.e., Invisalign®) during OrthoPulse® treatments.

Can OrthoPulse® be used by those with a pacemaker?

At this point in time, we are not able to conclusively recommend that patients with pacemakers use OrthoPulse®. However, we are investigating this and will update this page with any new information.

What are the exact claims made that designate OrthoPulse® as a Class 2 medical device?

The device is approved as a class 2A medical device via Medical Device Directive 93/42/EEC, Annex V by the London-based British Standards Institute. U.S Food and Drug Administration (FDA) has cleared OrthoPulse® with the following indications for use: “The OrthoPulse® device is intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.”

Could the use of OrthoPulse® have any detrimental effect on young patients who are being treated with growth hormones?

No contraindication as far as we are aware.

Is there advice to stop OrthoPulse® treatment during taking of antibiotics (photosensitivity)?

No. Only ultraviolet (UV) light may cause problems with photosensitivity. OrthoPulse® emits infrared (IR) light, which causes no photosensitivity.

Is there any risk or concern using OrthoPulse® on patients who are being treated with biphosphonates for osteoporosis?

No. In fact this may be very helpful for these patients, as often they may have higher bone density and slower tooth movement.

Does Advil use affect osteoclastic activity? If so, does Advil also affect OrthoPulse® efficiency?

Long-term use of NSAIDS like Advil (Ibuprofen) has been shown to decrease osteoclastic activity, which may reduce the rate of orthodontic tooth movement with or without OrthoPulse®. Occasional or infrequent use of NSAIDS does not have that effect.

Is smoking a contraindication to OrthoPulse® use?

Not neccessarily. If a patient is a candidate for orthodontic treatment then they are a candidate for OrthoPulse®.

Some orthodontists seem to indicate that smoking reduces the rate of tooth movement. Can OrthoPulse® thus lead to a greater acceleration effect for smokers?

OrthoPulse® causes regional blood flow, so theoretically, yes. However, we do not have any evidence to prove this.

Are Botox injections a contraindication to OrthoPulse® use?

No contraindication as far as we are aware. Botox binds irreversibly to receptors and thus, PBM appears to have no effect on this mechanism.

Is multiple sclerosis a contraindication to OrthoPulse® use?

No contraindication as far as we are aware.

Device

If the wavelength of the light produced by OrthoPulse is 850nm, which is in the near-infrared range and should be invisible to the human eye, why can I see it ?

LEDs, similar to lasers, are not monochromatic, i.e. not a narrow wavelength. The wavelength of 850nm is the PEAK point of the spectrum. Normal distribution of the light is +/- 80nm on either side of 850nm. Human visual acuity varies but some slight red will be visible to most people, especially if the device is in a darkened room or in shadow.

Can OrthoPulse® be shared by family members?

A device should not be shared with or used by more than one patient in its lifetime. This is for hygienic reasons, but the warranty coverage may also be compromised. OrthoPulse® is designed to be used by one patient only, so Biolux may not be able to support the warranty agreement if used differently than intended.

Use of an OrthoPulse® by more than one patient will also affect:

  • Compliance tracking
  • Battery levels and charging times
What if I need to replace a patient’s device while they are in my office?

If a patient is in the office for their scheduled follow-up and you observe a device error, you can replace the device if you have the inventory. If this is the case, please be sure to:

1. sync the problematic device
2. confirm that the device is in error by checking the device log in the app
3. pair the patient’s new device in the app by clicking the gear icon
4. contact us at support@orthopulse.com to make arrangements to ship the problematic device back to us and get your office a replacement

How long does a battery charge last?

You can complete one 10-minute treatment (5 minutes each for upper and lower arches) if the status light is green after waking the device. The OrthoPulse® device should be placed in its charging case to charge its battery after each use. If the status light is solid yellow or pulsing yellow, the battery charge is insufficient for a full treatment, and it will require further charging.

How long does it take to fully charge the battery?

It will take approximately 6 hours to fully charge the battery. However, we recommend that the device be stored in its plugged-in charging case.

Does the device need to be cleaned after each use?

No, it is not necessary to clean OrthoPulse® after every use. We recommend that patients rinse the device under warm water once a week and set it to air dry on the charging case.
Make sure to hold the OrthoPulse® by the white plastic housing – do not hold it by the silicone mouthpiece.

The status light is not turning on when the device is picked up off the charging case.

If the status light does not turn on at all, this indicates that the battery is completely depleted. Plug the charging case into a power source to charge the battery for 6 hours. You may also hear the device chirp and see the status light cycle through the colour spectrum indicating a reset.

Why can't I see the light coming out from the OrthoPulse® mouthpiece LED arrays?

OrthoPulse® LED arrays generate near-infrared light, which is almost completely invisible to the human eye. In a darkened room you may see a slight red glow from the array as it pulses when you pick the device out of the charging case.

The status light is not turning on when the device is picked up off the charging case?

If the status light does not turn on at all, this indicates that the battery is completely depleted. Plug the charging case into a power source to charge the battery for 6 hours. You may also hear the device chirp and see the status light cycle through the colour spectrum indicating a reset.

Are there any restrictions when traveling with OrthoPulse®?

No – you can easily travel with your OrthoPulse®. We recommend the device be locked in its charging case and packed in carry-on luggage so that a regular treatment schedule is not disrupted.

The OrthoPulse® internal battery is completely safe for travel and contained securely in compliance with Lithium Metal Battery Regulations.

Is OrthoPulse® latex-free?

The OrthoPulse® mouthpiece is manufactured from 100% medical grade silicone. It is not made with natural rubber latex.

What do the status light colours indicate?

The pulsing yellow status light indicates that the device is in the process of charging but still does not have sufficient charge to do a treatment. Allow the unit to complete its charge before attempting treatment. When ready for treatment, the status light will show green; and when fully charged, the status light will turn off completely. You may also see the status light guide on the underside of the charging case.

The solid yellow status light indicates that the device does not have sufficient charge to do a treatment. Allow the unit to complete its charge before attempting treatment. Typically, this takes 3–6 hours. When ready for treatment, the status light will show green; and when fully charged, the status light will turn off completely.

A solid blue status light indicates that treatment is in progress. When a treatment session is complete, the blue status light will start to flash and the device will beep as follows: beep-beep-beep … beep-beep-beep … beep-beep-beep… If you pause a treatment mid-session, the blue status light will start to blink and the device will start a slow, repeating beep.

App

How do I log into the app?

Use the email address and password you created when you set up your OrthoPulse® account. If you do not remember your password, or if your account was set up by an agent, you may click “Forgot Password” to reset your password.

How do I sync OrthoPulse® with the app?

OrthoPulse® will automatically go into Bluetooth® broadcasting mode for 60 seconds when replaced in the charging case. This is indicated by a solid purple status light. Ensure that you have Bluetooth® enabled in the settings on your iOS device. The device will sync with the app when the device is in broadcasting mode and the app is running. Syncing is indicated by the status light blinking purple on the OrthoPulse® device.

How do I download the OrthoPulse® app?

You can download the OrthoPulse® app by clicking one of the links below:


If you did not receive the welcome email please check your spam or junk folder. Be sure to add info@bioluxresearch.com to your contacts. If you still didn’t receive it, please contact your doctor.

What do I need to do when a patient has finished treatment?

Open the patient in the app and click the gear icon to open their patient settings.

Click “Complete Treatment” – a brief questionnaire will pop up prompting you to provide some feedback on the case.

The patient will then be moved to your “Completed” list and their treatment information will be archived.

I forgot my OrthoPulse ID Password?

Tap “Forgot Password” on the login screen in the app.

Make sure that you entered your email address correctly.

If you do not receive a password reset email, try quitting the app and trying again.

Troubleshooting

Why doesn't my OrthoPulse® seem to charge?

If your OrthoPulse® has been on the charger for more than six hours and it is still displaying a yellow light when you pick it up, your device may not be charging properly. Possible at-home solutions include:

  • Using a different micro-USB cable (any android cable will work).
  • Using a different outlet in your home.
  • If you are using the first Generation of OrthoPulse devices that have a detachable USB/micro USB cable, try to change to a different cable.
  • If you are using the first Generation of OrthoPulse devices that have a detachable USB cable, disconnect the USB cable from the charging case, wait 15 seconds, then reconnect the cable to the charging case.
  • If you are using the first Generation of OrthoPulse devices that have a detachable USB cable – Wiggling the micro-USB cable to achieve a better fit in the device’s charging port. It’s possible the cable is not properly seated in the port.
  • Resetting the device.
  • If your OrthoPulse® has been on the charger for more than six hours and it is still displaying a slowly fading yellow light when on the charger, your device is charging.
  • Wait for the device to complete charging.
  • Perform a reset on the device.
Why does the status light on my OrthoPulse® show as blinking red when I pick it up?

A blinking red light typically suggests that an error has occurred. Solving the issue can often be done by attempting the following:

  • Reset the device and check if the status light continues to blink red. If there is no blinking red light, then the device should be functional.
  • Sync the device.

If the status light continues to blink red, contact OrthoPulse® Customer Support.

Why won't my OrthoPulse® sync with the app?

To ensure that your OrthoPulse® is able to connect with the app, both your tablet/phone and OrthoPulse® must be in Bluetooth mode and the OrthoPulse® App needs to be running.

Check that the device is ready to transmit in Bluetooth mode. You can activate your device’s Bluetooth mode by picking it up and placing it back down on the charging case (a purple status light will be visible).

If this does not work, you may need to reset your device.

Please note that your OrthoPulse® must be paired to your patient account in order for the sync to take place. If you are unsure if your device is paired or not, please contact support@orthopulse.com with your serial number and doctor information.

How can I reset the device?

This is done by lifting the OrthoPulse® off the charging tray and replacing it 3-4 times consecutively. When successful, the status light will cycle through the color spectrum and you will hear the device beep. You may have to complete the reset one or two times.

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