Parasym tVNS User manual
Parasym™ tVNS Device
Quick Start Guide
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hello
Welcome to your new Parasym tVNS device
These instructions show you how to setup your Parasym device, and gets
you on a schedule specific for you, that you can use every day. Two AA
alkaline batteries are included so you can start straight away.
Before using your device, please make sure you have read all the
precautions, warnings and safety information, followed by the guidance for
proper setup. If in doubt of the suitability of the Parasym device, consult your
doctor before use.
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WARNINGS AND PRECAUTIONS
Warnings
- 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 driving, 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. Any electrodes that have current densities exceeding 2 mA/cm2 may
require special attention of the operator.
- Potential hazard from simultaneous connection of a patient to a high frequency surgical ME
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 ME 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 (HCP) 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.
- Consult with your HCP before use because the device may cause changes in cardiac rhythm.
Safety and efficacy of the Parasym device have not been evaluated in the following patients, and
therefore it is not indicated for:
- 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), known severe coronary artery disease or recent
myocardial infarction (within 5 years).
- Patients with diagnosed bradycardia or an irregular heart rhythm.
- 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.
- Pediatric patients.
- Pregnant women.
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Precautions
Before Use:
- You must read the Parasym Instructions for Use before using Parasym. However, reading the
Instructions for Use may not be enough to fully explain the safe and effective use of the device.
Ask your HCP or contact Parasym support 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 these Instructions for Use or as otherwise directed by your
HCP.
- Remove 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 with another person.
Do not use Parasym if:
- The skin on the tragus is broken or cracked.
- The device casing is cracked, dented, or appears to be damaged.
Discontinue use if you experience:
- Lightheadedness, dizziness, or chest pain.
- Excessive skin irritation.
Caring for Your Device:
- Do not pull leadwires to remove electrode.
- Keep Parasym away from water or other liquids.
- Keep Parasym away from steam as moisture may damage the device.
- Store Parasym in a safe location out of reach of children.
- Do not place the unit close to excessive heat.
- Do not open or take apart the case, or attempt to repair or modify the device. There are no user
serviceable parts. If the device is not working, contact Parasym support.
- Use only the specified batteries: 2x 1.5 volt AA Alkaline. Use of any other battery could damage
the unit.
- Remove the batteries from the unit, when it is not used for a long time.
- Keep the unit away from sources of high magnetic fields such as TV’S, microwave ovens and hi-fi
speakers, as these may affect the LCD screen.
If the device seems to malfunction, when possible, contact Parasym support for assistance. Parasym
support cannot provide medical assistance.
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POTENTIAL RISKS AND COMPLICATIONS
The Parasym device is considered low risk when used in accordance with the instructions for use. A low
incidence of skin irritation has been reported from using the Parasym device. No serious adverse events
have been reported. If you experience any side effects from device use stop treatment immediately. If in
doubt, contact your healthcare provider.
A 2018 systematic review analysed 1322 participants (across 51 studies) who received transcutaneous
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vagus nerve stimulation. NOTE: this review analysed studies using multiple different tVNS methodologies
so the results cannot be extrapolated to the Parasym device and are included only as reference
information for tVNS.
The review found that only only 2.6% of participants discontinued use due to side effects, where the most
common side effect reported was skin irritation at the stimulation site which typically ceased shortly after
use.
The following side effects were reported in this review with use of transcutaneous vagus nerve stimulation
devices:
Tingling/pain/redness/itching at the site of electrode placement during long term application (16.7%)
Lightheadedness/dizziness (1.4%)
Fatigue (0.5%)
Shortness of breath (0.4%)
Voice alteration/hoarseness (0.3%)
Abnormal heart rhythm (0.3%)
IF IN DOUBT CONSULT YOUR DOCTOR OR HCP.
Environmental Conditions:
Temperature :
Operating: 5 ~ 40 ℃
Storage : -25 ~ 70 ℃
R.H.ambient :
Operating: 15% ~ 93% RH
Storage : 0% ~ 93% RH
Altitude :
Operating: 700hPa to 1060hPA
Storage : 500hPa to 1060hPA
1 Redgrave, J., Day, D., Leung, H., Laud, P. J., Ali, A., Lindert, R., & Majid, A. (2018). Safety and
tolerability of Transcutaneous Vagus Nerve stimulation in humans; a systematic review. Brain stimulation,
11(6), 1225-1238.
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Instructions For Use
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Electrode Placement
Connect the electrode to the tragus of
the left ear, running the cable behind
the neck over the right shoulder.
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Quick Start Guide
1. Insert the two AA alkaline batteries
Take care in doing this, be careful not to strip the material covering the
batteries as this can lead to a short circuit.
2. Plug the lead included into channel 1
3. Electrode Placement
3.1. Clip the electrode to your left tragus
(See diagram on Page 8) - Make sure this is a good connection with both
gold plates having a firm contact with the skin
4. Push the Power Button
5. You can now input the settings for your treatment (see next page)
Note: It is recommended to incorporate into your daily routine, keeping the time of day for
each session consistent.
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Parasym Settings
(a) Pulse Rate = 25 Hz
(b) Pulse Width = 250 μs
(c) Intensity = See section below
(d) Recommended Time = 60m/day
Mode: Const
Waveform =
1. Adjust the settings with the corresponding +/- buttons to match the
display shown above. (Reference diagram on page 9)
2. We recommend 60 minutes of use per day. This can be achieved by
pressing the timer button to ‘60 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.
3. Press the Power button to switch off the device after finishing the
treatment.
Note: When the batteries are low, the battery symbol will flash indicating
that the batteries should be replaced. Batteries typically last well over 1 year.
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(c) Finding your Intensity level
After setup, repeat for each treatment session
1. Ensure electrode has a firm connection to the left tragus (See p.7 image).
2. Using the up arrow on the left of the keypad, for channel 1, slowly
increase the intensity by 1 level every 2 seconds to the point where a
tingling is felt on the tragus, going to a maximum of Level 36.
Take care in doing this as it can be difficult to perceive the stimulation at first
and perception of sensation may be sudden. If the stimulation is painful at
first perception, turn the device off, then turn the device on and repeat this
step to find a lower intensity.
Note: If no stimulation is felt at Level 36, apply a small amount of moisture to the
tragus and repeat step 2 again making sure to start from Level 0. Altering the Hz
(pulse rate), between 1 and 25 Hz can help with finding the sensory threshold, as
well as moving the earclip into a more firm position. If all of the above fails, please
contact us for further instructions.
6. Once the sensory threshold has been found, decrease the intensity to 1
level below this level. This is now set at the therapeutic level you can use for
treatment. If sensitivity increases during the course of treatment, you can
reduce intensity accordingly.
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Common Intensity Questions
My stimulation intensity changes frequently throughout my treatment
session, is this ok?
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 perception of the stimulation and
establishes a sensory level, can vary depending on time of day, skin
conductivity and stress levels etc.
Should I be able to feel the stimulation during my session?
Stimulation intensity for your treatment session should be one level
below the sensory level where it can be perceived or felt. For most
people this is between Level 1 - Level 15, however some people need
to go to the maximum to find their sensory threshold and then
gradually reduce to their optimal therapeutic threshold.
Note: The tragus is a sensitive area and it is important not to over-stimulate
with too high an intensity or for too long a period of time.
Will I still need to take medications?
You and your healthcare provider (HCP) should discuss your ongoing
treatment routine, including the use of any additional therapies and/or
medications. It is important to always follow your HCP’s
recommendations about your medications.
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Troubleshooting
If the unit does not appear to be operating correctly, refer below to
determine the cause. Should none of these measures correct the problem,
please contact your supplier.
The unit does not function at all
Check the batteries are inserted correctly.
Replace batteries.
Unit 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 wire is inserted into the unit correctly, firmly in the
socket.
Check the lead wire is in Channel 1 (when controlling channel 1).
Check position of the earclip with the skin, where both metal plates
are firmly pressed against the skin.
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Speak to one of our support team
Reach out to us via our support messaging widget on our website
www.parasym.co and we’ll get right back to you.
You can also email us directly at [email protected] and this will also go
through to our support team.
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Cleaning and Maintenance
Replace batteries as soon as flashing symbol appears. Care should be taken
to not get moisture in the internal circuitry or inside the battery
compartment. No other user maintenance of the main unit is required.
1. Clean your device before use.
2. The case and lead wires can be cleaned by wiping with a damp cloth and
a solution of mild soap and water. Wipe dry. This must be done when the
device is switched off and the earclip electrode is not connected to the
unit.
3. Do not immerse the device in water.
4. Do not use any other cleaning solution than soap and water.
Testing the Device
The device can be tested by making sure the batteries are in the device
correctly, pressing the power button where the LCD screen should turn on
and remain on.
Testing the Electrode
The electrode can be tested before each treatment session with the
standard sensory and therapeutic threshold protocol found in the Quick
Start Section. On the CONST mode (Constant stimulation) there should be a
constant tingling or sensation of stimulation. If this is intermittent, there may
be a fault in the lead. If there is a fault or if electrode is found to no longer
work, please contact Parasym Support.
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Key points to note
●Do not raise the stimulation intensity level to where there is pain or
discomfort on the tragus.
●For safety reasons, only use alkaline batteries in the device.
●Turn the unit off before applying or removing the electrode.
●Make sure the earclip is plugged firmly into Channel 1 (the left
channel). Make sure that intensity is set on Channel 1 (the left side of
the display).
●To help take the weight off the connection and increase mobility, you
can arrange the lead behind your neck and over the right shoulder (as
shown in the image on page 8).
Note: the safety and efficacy of the Parasym device has not been
established in individuals with: Implantable medical devices, a history of
cardiac disease or arrhythmia, diagnosed narrowing of the arteries (carotid
atherosclerosis), bradycardia (an abnormally low resting heart rate),
pregnant women and pediatric patients.
Discontinue use if you experience:
●Lightheadedness, dizziness, chest pain, or excessive skin irritation
Reactions such as irritation at the stimulation site are rare. If this does
occur, and becomes unpleasant, stop the stimulation. The irritation or
discomfort should cease shortly after stopping stimulation. If skin
irritation persists, discontinue use and consult your doctor.
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Original Accessory
The unit must be used only with the original type of accessories.
Replacement earclip electrodes are available from your supplier.
List of Accessory:
● 2 X 1.5 volt AA Alkaline
● 1 X earclip electrode (Model: GE-1)
Parasym Specification
Output:
Maximum 36 mA (average value/Pulse Width100μS) across 500
Ohm load, RMS Value 6.08mA
Pulse Width:
From 50μS to 250μS adjustable
Pulse rate:
From 1Hz to 150Hz Adjustable
Waveform:
Symmetrical Biphasic rectangular
Asymmetrical Biphasic rectangular
Monophasic rectangular
Mode:
5 Modes are available
Mode A—Constant Stimulation
Mode B—Burst I
Two train per second, 250ms on, 250ms off; 25 pulses within
one train, pulse width=200μS
Mode C—Burst II
Two train per second, 250ms on, 250ms off;
Pulse width and Pulse rate are selectable
Mode D—Pulse width modulation
Pulse width modulated from 100μS to 250μS within 6 seconds
and then back to 100μS in the next 6 seconds. Pulse rate is
selectable
Mode E—Pulse rate and Pulse width Modulation
Frequency increase from 50Hz to 100Hz while pulse width
decrease from 200μS to 60μS within 5 seconds
Treatment Timer:
Continuous, 15min, 30min, 45min, 60min, 90min
Applied Part:
Earclip electrode: Gold plated metal
Expected service life
5 years
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