Safety & Contraindications
General Disclaimer: We provide information about our medical and wellness devices. While we make every effort to make sure the information is accurate and informative, the information does not take the place of professional or medical advice. This information is for general purposes only. Providing this information does not constitute the practice of medicine, nursing or other professional healthcare services, including the provision of medical advice. No doctor patient relationship is formed. The use of this information or any material from our website or marketing materials is based upon clinical trials, peer-reviewed manuscripts and the experience of our customers and may not be relevant for some individual circumstances. Accordingly, this information is not intended to be a substitute for professional advice, diagnosis, or treatment. Users should not disregard or delay in obtaining medical advice for any medical conditions that they may have, and they should seek the advice of their healthcare professionals for any such conditions.
A level of caution should be exercised by all customers, especially those with co-morbidities (see table below), when using any form of light therapy including a our device. Customers can also have these conditions silently without being aware of them. There is always a risk of producing unwanted side-effects, including mild and transient nausea, vomiting, dizziness and vertigo. If these symptoms arise, please wait until they pass before changing position with caution. It is important to recognise these symptoms, cease using your Our device immediately and seek medical advice if symptoms persist. If a customer is aware of such underlying conditions before commencing light therapy, then they are advised to get medical clearance from their doctor before commencing therapy with a Our device, and to reach out to our Clinical Support team via cnvlaser99@hotmail.com
Requirements
Circumstance
Recommended Action
Clinical Reasoning
Under medical care for diseases involving photosensitivity or receiving photosensitizing medications
Seek medical clearance before commencing therapy and treat with caution.
These medications increase sensitivity to light therapy treatment.
Prescription medications (including for Parkinson’s)*
Do not make any changes to a patient’s medication unless they increase photosensitivity. Discuss with your prescribing healthcare practitioner first.
Our devices are designed to complement all pre-existing therapies.
Patients suffering from extreme sensitivity to light (incl vestibular migraine; epilepsy)
Do not treat with light therapy devices.
Risk of invoking a deleterious episode.
Pregnancy
Do not treat with light therapy devices.
Insufficient supporting evidence, even-though no negative episodes have been documented.
Heart conditions*
Treat with caution** and seek medical clearance before commencing therapy.
Light therapy might temporarily increase autonomic symptoms, including dizziness, light-headedness, tremor and heart rate. If this happens, patients should immediately contact Clinical Support at cnvlaser99@hotmail.com .
Thrombosis including DVT
Do not treat directly over the site of thrombosis and seek medical clearance before commencing treatment.
Insufficient supporting evidence, even though no negative episodes have been documented.
Aneurysms (including intra-cerebral aneurysms and abdominoaortic aneurysms)
Seek medical clearance before commencing therapy and treat with caution.
Light therapy might temporarily increase autonomic symptoms, including dizziness, light-headedness, tremor and heart rate. If this happens, patients should immediately contact Clinical Support at cnvlaser99@hotmail.com .
Deep Brain Stimulation (DBS)
Do not treat with Our helmet.
Insufficient supporting evidence, even-though no negative episodes have been documented.
History of acute psychiatric episodes, severe hypermobility (incl Ehlers Danlos); acute polyarthritic disorders*
Seek medical clearance and treat under the supervision of a clinician.
Insufficient supporting evidence, even-though no negative episodes have been documented.
Hypermobility and polyarthritic conditions are often accompanied by dysautonomia.
Patient should commence a 1-2 week, half of recommended dosage under clinical supervision*.
Rheumatoid Arthritis*
Treat with caution.
Insufficient supporting evidence, even-though no negative episodes have been documented. Patient should commence a 1-2 week, half of recommended dosage under clinical supervision*.
Stroke or history of stroke or transient ischemic attack (TIA)
If you have previously had a stroke or transient ischemic attack (TIA), do not treat with the the device. Some independent medical practitioners may offer post-stroke rehabilitation using the the device, however this is only administered under their close supervision and guidance.
Light therapy improves circulation, which may cause further functional or structural deficit.
Tumour site (active primary or secondary)
Never treat over an active tumour site. Seek medical clearance before commencing treatment.
Insufficient supporting evidence, even though no negative episodes have been documented.
Acute head trauma and concussion
Seek medical clearance before commencing treatment.
Internal bleeding may develop over the following days and weeks after a head trauma and may be asymptomatic. As light therapy improves circulation, this can cause further functional or structural deficit, even though no negative episodes have been documented.
Migraines*
Treat with caution.
Do not apply treatment during an acute migraine episode.Seek medical clearance before commencing treatment.
Light therapy improves circulation, which may cause further functional or structural deficit during a migraine episode, even though no negative episodes have been documented.
Acute, severe head pain
Seek medical clearance or emergency services before commencing treatment.
Light therapy improves circulation, which may cause further functional or structural deficit during a migraine episode, even though no negative episodes have been documented.
Sunburn
Do not treat directly over the sunburnt area
Light therapy may cause further skin exacerbation.
* The incidence of dysautonomia is a common complication in several disorders and has been observed in customers suffering from Parkinson’s, migraine, cervicogenic headaches, fibromyalgia, hypermobility syndromes, psychiatric disorders, Irritable Bowel Syndrome, epilepsy, and acute polyarthritic conditions. Symptoms may include dizziness, vertigo, nausea, low blood pressure, and visual disturbances. If dysautonomia symptoms are noted during the initial 2-4 treatments with a our device, we recommend ceasing treatment and immediately contacting Clinical Support at cnvlaser99@hotmail.com . Usually, these symptoms are transient and dissipate after a 3-5 day complete rest period, followed by gradual reintroduction of the therapy under clinical supervision.
** Patient’s with a pacemaker should exercise extra caution and avoid placing the laser over their chest/heart region, even though no negative episodes have been documented.
***Please do not treat directly over thyroid, glands, genitalia or eyes at any time. There is insufficient supporting evidence for the treatment of these regions.
