Frequently Asked Questions and Troubleshooting

Before use:

• Check warnings and contraindications.

• You must read the Parasym™ instructions before using the device. However, reading the instructions for use may not be enough to fully explain the safe and effective use of the device. Please ask your healthcare provider or contact us if you have any questions about how to use the device or require any further clarification of these instructions.

• Only use Parasym™ as described in the instructions for use or as otherwise directed by your healthcare provider.

• Remove all jewelry that may interfere with the electrode location (earrings etc.) before using Parasym™.

• Always carefully examine the device for any signs of damage or defects before use.

• Do not strip the batteries’ outer seal when inserting (for risk of short-circuiting), this can be avoided by taking care when inserting.

• Do not share your Parasym™ device with another person.

• Patients with an active implantable medical device, such as a cardiac pacemaker, hearing aid implant, or any implanted metallic or electronic device.

• Patients with a history of baseline cardiac disease or atherosclerotic cardiovascular disease, including congestive heart failure (CHF), severe coronary artery disease or recent myocardial infarction (within 5 years).

• Patients with diagnosed bradycardia.

• Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy).

• Patients diagnosed with narrowing of the arteries (carotid atherosclerosis).

• Patients whose pain syndromes are undiagnosed.

• Paediatric patients.

• Pregnant women.

Read these instructions carefully to ensure proper use of the Parasym™ device:

• Do not inhale or swallow small parts.

• Do not wrap the lead wire around the neck.

• Do not apply stimulation in the bath or shower or while sleeping.

• Do not get the Parasym™ device wet.

• Do not apply stimulation while drilling, operating machinery, or during any activity in which electrical stimulation can put the patient at risk of injury.

• Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins).

• Do not apply stimulation over, or in proximity to, cancerous lesions.

• Do not apply stimulation over the patient’s neck or mouth because this could cause severe muscle spasms resulting in closure of the airway, difficulty in breathing, or adverse effects on heart rhythm or blood pressure.

• Do not apply stimulation across the patient’s chest, because the introduction of electrical current into the chest may cause rhythm disturbances to the patient’s heart, which could be lethal.

• Do not apply electrodes near the thorax because the introduction of electrical current may increase the risk of cardiac fibrillation.

• Stimulation should not be applied across or through the head, directly on the eyes, covering the mouth, on the front of the neck, (especially the carotid sinus), or from electrodes placed on the chest and the upper back or crossing over the heart.

• Use this device only with the electrodes and accessories recommended by the manufacturer as using others may be unsafe.

• Potential hazard from simultaneous connection of a patient to a high frequency surgical equipment and the device that may result in burns and possible damage to the device.

• Operation in close proximity (e.g. 1 m) to a shortwave or microwave therapy equipment may produce instability in the stimulator output.

• The long-term effects of the chronic use of the device have not been evaluated. Contact your healthcare provider if your symptoms worsen.

• Electronic monitoring equipment such as EKG alarms may not operate properly when the Parasym™ device is in close proximity while being used.

Parasym™ works by stimulating the auricular branch of the vagus nerve with targeted micro pulses of electrical current through a specially designed electrode that connects to the tragus of the outer ear. Through the Parasym™ device, it is possible to achieve safe and effective non-invasive vagus nerve stimulation.

60-90 minutes* daily (*recommended).

• This can be achieved by pressing the timer button to “60-90 min”. The device will automatically shut down after 60 minutes.

• Please find a convenient time each day, using the treatment at the same time each day, for consistency.

• Daily treatment sessions with the Parasym™ device may be used as often as necessary but for most people it is best to treat between once a day and twice a week. Results usually improve and last longer with additional treatments.

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Adverse effects are usually rare, mild and resolve shortly after treatment is completed.

• Tingling/pain/redness/itching at the site of electrode placement during long term application.

• Burn at the stimulation site if used continuously at a high intensity

• Light-headedness/dizziness

• FatigueShortness of breath

• Headaches

• Abnormal heart rhythm

• Sweating

• Tinnitus

• Diarrhoea

  If you do not experience a response to treatment within one month, consult your health care provider or us.

  If in doubt, please contact your healthcare provider.

It is common for sensory thresholds to change throughout sessions as well as between sessions. This is because the variables that affect conductivity which causes the perception of the stimulation and establishes a sensory level, can vary depending on the time of day, skin conductivity and stress levels etc.

You should be able to feel a mild tingling or pulsing sensation at your tragus* although it is common to become used to this sensation.*Note: The tragus is a sensitive area on the inner side of the external ear. It is important not to over-stimulate the area with too high an intensity level or for an extended period.

You and your healthcare provider should discuss your ongoing treatment routine, including the use of any additional therapies and/or medications. It is important to always follow your healthcare provider’s recommendations about your medications.

The metal used on the electrode is a gold-plated copper.

You can request by emailing [email protected] or by registering your device at www.parasym.co.

If the device does not appear to be operating as expected, please refer below to determine the cause. Should none of these measures correct the problem, please contact us.

Parasym™ does not function at all

• Check the batteries are inserted correctly.

• Replace batteries.

The Parasym™ device switches off unexpectedly

This is likely to be the power-save function. If no buttons are pressed and the intensity level is zero, the unit will power-off automatically after a few minutes. 

There is no stimulus (simulation) from one channel

• Check the Intensity is set above zero.

• Check the lead is inserted into the unit correctly, firmly in the socket.

• Check the lead is in CH1 (when controlling channel 1). 

• Check the position of the ear clip with the skin, both metal plates should be firmly pressed against the skin.

This product is warranted to be free from manufacturing defects for 2 years from date of purchase for the Parasym device and 3 months for the Parasym electrode; Parasym electrodes are considered consumables and with regular use can require replacement. Optimal design and functioning of electrodes requires a balance of technical requirements, this includes the balance of biocompatible and conductive materials which can decrease over time with use.

This warranty is void if the product is modified or altered, is subject to misuse or abuse; damaged in transit; lack of responsible care; is dropped; if an incorrect battery has been fitted; if the unit has been immersed in water; if damage occurs by reason of failure to follow the written instructions in the IFU booklet received; or if product repairs are carried out without authority from Parasym Ltd.