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Device Guide
Is Pulsetto Safe?
The Pulsetto device is FCC-certified. This means that Pulsetto is approved for well-being use and compliant with the strict laws of the Federal Communication Commission (FCC).
The FCC certification ensures that:
- Pulsetto is based on scientific evidence
- The Pulsetto is safe to use
For additional information, please refer to the disclaimer.
Pulsetto technology uses the lowest Bluetooth energy ultra-low radiofrequency energy (ULRE) – which safely passes into the body.
Is Pulsetto A Medical Device?
Pulsetto is considered a general wellness device. It doesn’t claim to diagnose, treat, cure, or prevent any medical condition. Always consult your medical provider regarding any medical concerns.
What effects can I expect from the vagus nerve stimulation?
Stimulating the vagus nerve increases its activity, resulting in a drop in heart rate, an increase in HRV (heart rate variability) within 3–4 weeks, and the activation of the parasympathetic nervous system. This makes you calmer, less stressed, less anxious, and results in better sleep.
Some factors could affect your results, however. If your HRV is under 50, it is too low, meaning you can have issues with your gut, ability to relax, blood pressure, and several other things. If it is around 80, it is very good. And 100, of course, means it’s perfect.
How do I set up the Pulsetto device?
Please turn to our Quick Start Guide
Contraindications Of Using Pulsetto
Contraindications include but are not limited to:
- Users with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
- Users with a metallic device such as a stent, bone plate, or bone screw implanted at or near their neck
- Users who are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
The safety and efficacy of Pulsetto have not been evaluated in the following users or situations:
- Users with uncontrolled hypertension, hypotension, bradycardia, or tachycardia
- Users with a history of baseline cardiac disease or atherosclerotic cardiovascular disease, including congestive heart failure, known severe coronary artery disease, or recent myocardial infarction (within 5 years)
- Users with a history of abnormal baseline ECG, prolonged QT interval, or arrhythmia
- Users who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
- Pediatric users
- Pregnant women
- Users with active cancer or cancer in remission
- Users with abnormal cervical anatomy
- Users with a history of brain tumor, aneurysm, bleed, or head trauma
- Users with a history of syncope or seizures
Pulsetto offers 5 main programs that use different frequencies and vibration periods to stimulate the Vagus nerve
Stress
The Stress program operates via an nb-VNS device that uses a polyphasic rectangular waveform with a 4500 Hz pulse frequency. The pulses repeat in bursts at a 25 Hz rate. The voltage and current settings are set to maximize safety and efficacy. This program could help in alleviating stress by gently stimulating the vagus nerve, which plays a vital role in the parasympathetic nervous system. This might induce a relaxation response, reducing the production of stress hormones like cortisol. It can be a helpful tool for stress management, promoting better mental health and overall well-being.
Anxiety
The Anxiety program, similar to the Stress program, utilizes a polyphasic rectangular waveform but with a slightly increased frequency of 4750 Hz. The aim is to tailor stimulation that targets the specific pathways within the vagus nerve system that are associated with anxiety. By influencing these nerve fibers, the program might help mitigate anxiety symptoms, providing a non-pharmacological option for anxiety management.
Sleep
The Sleep program mirrors the parameters of the Anxiety program but is designed to interact with the sections of the vagus nerve that impact sleep regulation. By stimulating these areas, the program might aid in the initiation and maintenance of sleep. This could be particularly beneficial for those suffering from insomnia or other sleep disorders.
Burnout
The Burnout program incorporates a higher pulse frequency of 5200 Hz and a slightly shorter pulse width, utilizing an asymmetrical biphasic balanced rectangular waveform. The increased frequency and shorter pulse width might offer more intense stimulation, potentially helping to overcome the mental and physical fatigue associated with burnout. By targeting the vagus nerve, it might help rebalance the nervous system, potentially leading to improved energy levels and mental clarity.
Pain Management
The Pain Management program operates at a pulse frequency of 4900 Hz and emits pulses in bursts at a rate of 30 Hz. The asymmetrical biphasic balanced rectangular waveform and larger pulse width might ensure a more profound stimulation of the vagus nerve. The program might assist in pain relief by affecting pain perception pathways within the brain, blocking or minimizing the transmission of pain signals. This could offer a non-invasive and non-addictive method for managing various types of pain.
Frequently Asked Questions
What program should I use for my condition?
As Pulsetto is not a medical organization and is not classified as a medical device, we are unable to provide advice on specific programs, intensities, or usage frequency. Before purchasing Pulsetto, consult with your healthcare provider. If you have questions or need additional information, contact us at info@pulsetto.tech.
How often can I use Pulsetto?
There are no restrictions on daily device use. However, it is advised to use it 2-3 times a day and take a 45-60 minute break between sessions.
How many programs a day can I use?
There are no restrictions on the number of different programs you can run each day. However, we recommend selecting 1-3 programs that suit you best and sticking to them. For instance, consider using the Stress Program in the morning, during the lunch break, and the Sleep Program 30 minutes before bedtime.
What are the differences between the programs?
The Pulsetto device utilizes various frequencies and vibration periods to influence the Vagus nerve differently based on the intended goal.
Is it normal to feel pain during some programs?
The Pulsetto sensation should be a minor tickling; it should not be painful. Adjust the intensity, stimulate only one side, or switch to a different program if you experience discomfort.