Parasym Nurosym User manual

Nurosym™
Instructions for Use
Privileged and confidential | Parasym Ltd | 1

hello
Welcome to your new Nurosym device
These instructions show you how to set up your Nurosym device, and get
you on a schedule specific for you, that you can use every day.
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 Nurosym device,
consult your doctor before use.
The Nurosym Neuromodulation device is intended to provide non-invasive Auricular VNS delivered
through the tragus. The Nurosym device is indicated for the treatment of symptoms associated with
Depression, Anxiety, Pain and Insomnia.
Privileged and confidential | Parasym Ltd | 2

Contents
Item Name
Quantity
Model / SKU / Version
Nurosym Device
1
II
Charging Cable
1
RC01
Earpiece
1
RE01R
Carry Case
1
RFC01
Instruction for use
1
3.2
Do not use accessories and detachable parts not specified or authorized by the
manufacturer as it may cause damage to the unit or danger to the user or patients.
Privileged and confidential | Parasym Ltd | 3

WARNINGS AND PRECAUTIONS
Warnings
- Read these instructions carefully to ensure proper use of the Nurosym 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 Nurosym 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.
- 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 earpiece 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 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.
- Contact your healthcare provider if your symptoms worsen.
- Electronic monitoring equipment, such as ECG alarms, may not operate properly when the
Nurosym device is in close proximity while being used.
Contraindications:
- Patients with an active implantable medical device, such as a cardiac pacemaker, hearing aid
implant, or any implanted metallic or electronic device
- Patients with known 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.
- Pediatric patients.
- Pregnant women.
Privileged and confidential | Parasym Ltd | 4

Precautions
Before Use:
- You must read the Nurosym Instructions for Use before using Nurosym. 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 Nurosym support if you have any questions about how to
use the device or require any further clarification of these Instructions.
- Only use Nurosym as described in these Instructions for Use or as otherwise directed by your
HCP.
- Remove jewellry that may interfere with the electrode location (earrings etc.) before using
Nurosym.
- 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 Nurosym with another person.
Do not use Nurosym 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 the electrode.
- Keep Nurosym away from water or other liquids.
- Keep Nurosym away from steam as moisture may damage the device.
- Store Nurosym 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 Nurosym support.
- 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 LED screen.
If the device seems to malfunction, when possible, contact Nurosym support for assistance. Nurosym
support cannot provide medical assistance.
Side Effects Associated with Nurosym
Nurosym has the highest safety profile of VNS technology, with 0 serious adverse events reported in
clinical study. Side effects are rare and typically resolve immediately after the stimulation is
complete.The most common side effects include:
Application site discomfort
Application site irritation/redness
Tingling on the skin where the device is applied (paresthesia/dysesthesia)
Potential Risks and Complications associated with vagus nerve stimulation
The following risks and complications have been associated with other devices delivering vagus nerve
stimulation including surgically implanted devices, and may potentially occur with Nurosym. In clinical
Privileged and confidential | Parasym Ltd | 5

studies, reported 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
Fatigue
Shortness of breath
Headaches
Abnormal heart rhythm
Sweating
Fatigue
Tinnitus
Diarrhea
If you do not experience a response to treatment within one month, consult your health care
practitioner, authorized Nurosym distributor, or Parasym Ltd.
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
At least 30min is required for the device to warm from the minimum storage temperature between
uses until it is ready for intended use. At least 30 min is required for the device to cool from the
maximum storage temperature between uses until it is ready for intended use.
Privileged and confidential | Parasym Ltd | 6

Device Diagrams
Stimulator Unit
Earpiece electrode
Earpiece placement
Charging cable
Privileged and confidential | Parasym Ltd | 7

Display and controls.
Privileged and confidential | Parasym Ltd | 8

1. Plug charging cable into Nurosym Device
Make sure the device is fully charged before first use.
↑
↑
Privileged and confidential | Parasym Ltd | 9

2. Insert earpiece lead into Nurosym Device.
↑
Privileged and confidential | Parasym Ltd | 10

3. Clip the earpiece to the tragus of the right ear.
Wrap the malleable wire behind the ear.
Privileged and confidential | Parasym Ltd | 11

4. Choose your session time.
Press and hold the power button for 3 seconds. The display will show the
number of minutes for your session.
Notes: The treatment time is displayed. Adjust by pressing +/- and press
ENTER to confirm session duration, you will then progress to choosing
intensity level (Step 5)
Privileged and confidential | Parasym Ltd | 12

5. Choose your intensity level.
The display will show the intensity level.
A. Ensure the earpiece has a firm connection to the right tragus.
B. Slowly increase Intensity by one level per second. Take care not to
rush this process. Stop as soon as you feel a light tingling sensation.
C. Adjust from here aiming to feel a comfortable pulsing. If you
experience any pain, lower the Intensity right away. If the sensation
is sharp, you may need to adjust the placement of your earpiece.
D. Each user’s preferred Intensity level will vary and more Intensity is
not necessarily better.
E. Once you find a comfortable level, press ENTER to begin your
session. You may want to adjust the level again during your session,
this is normal and can be done at any time (see 6.1).
Privileged and confidential | Parasym Ltd | 13

6. Nurosym is on.
The blue LED light indicates that the device is on and delivering current.
Privileged and confidential | Parasym Ltd | 14

6.1 Changing Intensity during a session.
To change Intensity during a session:
Press any button to wake the device
1. Double-press the Enter Button to unlock the device.
2. Amend Intensity by +/- buttons.
3. Confirm by pressing Enter. This will resume the session.
Privileged and confidential | Parasym Ltd | 15

Nurosym Mode
Nurosym is preset to the optimal mode for your treatment.
Reset Nurosym
1. Press any button to wake the device
2. Press and hold [power button] + [minus “-” button] for 5 seconds
3. The screen will flash twice. This indicates the device has been
reset.
Session Time
Pressing any button will wake the device to show the display.
During a session, the display will show how long is left in minutes.
Here the display shows ‘30’ minutes remaining.
Privileged and confidential | Parasym Ltd | 16

Pausing a session
1. Press any button to wake the device
2. Press the power button once. The rightmost LED will flash.
※The remaining time shows the light turning off to the left as the
treatment time decreases
Here the display shows ‘30’, indicating there is 30 minutes left of a
recommended 60 minutes session. All LEDs will be displayed at the
beginning of the session, and will gradually decrease throughout the
session proportional to the time remaining. When the device is paused,
the rightmost LED will flash and the blue light will turn off to indicate no
current being delivered.
The session will resume and the blue light will turn back on.
Privileged and confidential | Parasym Ltd | 17

Battery Indicator
A fully charged battery should run for at least 7 hours.
The display will indicate a low battery with the below example.
When the device is powered on, ‘Lo’ will be shown on the display, with a
single flashing LED to indicate low battery.
When the battery symbol on the LCD screen flashes, it is time to charge
the battery.
Privileged and confidential | Parasym Ltd | 18

Built-in rechargeable lithium battery specification:
Manufacturer: Shenzhen WeAction Electronics Co., Ltd
Model:WEL 703048
Rating: DC 3.7 V,900mAH
Battery precautions
Replacement of lithium or fuel cells can cause unacceptable risk.
If there is a problem with the battery, it must be returned to your supplier for repair.
This product is equipped with a Lithium-ion battery. Failure to follow these instructions could cause the
lithium-ion battery to leak acid, become hot, explode or ignite and cause injury and /or damage:
Do NOT expose to temperatures over 60°C (140F)
Do NOT put, store or leave it near sources of heat, in direct strong sunlight, in a high temperature
location, in a pressurized container or in a microwave oven.
Warning: Do not use accessories and detachable parts not specified or authorized by the
manufacturer, doing so may cause damage to the unit or danger to the user or patients.
Privileged and confidential | Parasym Ltd | 19

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 variables including but not limited
to; time of day, skin conductivity and stress levels.
Should I be able to feel the stimulation during my session?
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 and it is important not to
over-stimulate with too high an intensity or for too long a period of time.
Warning: It is recommended not to use the device for more than 60
minutes at a 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.
Privileged and confidential | Parasym Ltd | 20