Nerivio theranica Remote Electrical Neuromodulation Device User Guide
- June 9, 2024
- Nerivio
Table of Contents
theranica Remote Electrical
Neuromodulation Device
User Guide
Getting Started
Thank you for using Nerivio
remote electrical neuromodulation device. Your new device will help with the
relief of your migraine symptoms. Before using the device, review all the
product instructions and the interactive tutorials in the Nerivio app The
QuickStart guide and the interactive tutorials give you quick access to
important aspects and limitations of the device. You should keep the
QuickStart guide available for future reference. The user manual includes all
safety information and instructions for use. The user manual is available in
the help screen of the Nerivio app or at
www.nerivio.com. A printable copy of the user manual
can be requested by contacting Theranica at
support@nerivio.com. Refer to
www.nerivio.com for a complete listing of clinical
data and adverse events information.
NOTE: Nerivio is a prescription device. Use this device only if you have
a valid prescription and after consulting with your health care professional.
Use the device according to the indication for use described in this guide.
Conditions for Use
Indication for use
The Nerivio is indicated for acute treatment of migraine with or without aura
in patients 12 years of age or older. It is a prescription use, self-
administered device for use in the home environment at the onset of migraine
headache or aura.
Contraindications (Who should not use the device?)
- The device should not be used by people with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
- The device should not be used by people with uncontrolled epilepsy.
- The device should not be used by people with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device. Such use could cause electric shock, electrical interference or serious injuries or medical conditions.
Important Safety Information
Warning: indicates a potentially hazardous situation which, if not
avoided, could result in serious injury or death.
Do not attempt to perform any procedure before carefully reading all the
instructions
Do not use the device on the heart, chest, neck, head or any other body
location other than the upper arm, because this could cause severe muscle
spasms resulting in closure of your airway, difficulty in breathing, or
adverse effects on heart rhythm or blood pressure
Do not use the device over skin conditions, such as open wounds or
rashes, or over swollen, red, infected or inflamed areas or skin eruptions or
fragile skin on your upper arm at the treatment location
Do not share the device with other people. The device is intended to be
used by a single person to avoid skin disease or any transmissible disease
** Do not disassemble, crush, incinerate or short-circuit the battery. This
could cause a fire, injury, burns, or other hazards
Precaution: indicates a potentially hazardous situation which, if not
avoided, may result in minor or moderate injury to the user or patient or
damage to the equipment or other property.
** Federal Law restricts this device to sale by or on the order of a
physician
The device should not be applied over areas of skin that lack normal
sensation. If one upper arm is insensitive to physical sensation, use the
other upper arm
Do not use the device over or in proximity to cancerous lesions
Do not use the device on an arm with a metallic implant. In such cases,
consider using it on the other upper arm
Do not use the device simultaneously with another electrical stimulation
device
Do not use the device while driving, cycling, or operating any vehicle
or machinery
Do not use the device on wet skin or when bathing, showering, during
exercise, while sweating or in high humidity
Do not use the device in the presence of electronic monitoring equipment
(e.g., cardiac monitors, ECG alarms)
Do not use the device in a magnetic resonance imaging (MRI) environment
The long-term effects of chronic use of the device are unknown
The device has not been evaluated for use in pregnant women and people
less than 12 years of age
The safety and effectiveness of the device have not been evaluated for
the preventive treatment of migraine headache
Do not use the device past expiration date Check the device for damages,
debris and contamination.
If the device is damaged, dirty or has any debris, please do not use it
and contact the manufacturer’s customer support
If the device was damaged, do not touch exposed electronics
Do not use the device if the electrodes become significantly dirty or
damaged
Keep the device under the recommended environmental conditions specified
in user manual to avoid any damage to the device
Do not start a treatment before placing the device on your arm In case
of device malfunction, remove the device from your arm and contact customer
support
It is recommended that your smartphone will be protected by a password
(or other security mechanism) to refrain from unwanted people to activate the
device
Interference to Bluetooth connectivity may occur in the vicinity of
equipment emitting RF (e.g. microwave, routers, Wi-Fi devices)
To minimize moisture loss, when unused, the electrodes should be covered
with the provided protective film and the device should be stored in its
original package
Do not expose the device to moisture and/or high humidity. If exposed,
dry the device as soon as possible
Before or after a treatment, rub the electrodes with your finger using a
drop of water to improve their adhesiveness
Do not clean the device with soap, alcohol, submerge in water, or scrub
with abrasive material
Do not disassemble or modify the device by yourself
Do not attempt to recharge or detach the battery
Keep the device out of the reach of infants, toddlers, children and pets
The device uses Bluetooth technology: it may therefore be interfered by
other equipment utilizing RF technology, even if the other equipment complies
with CISPR emission requirements
The device should not be used adjacent to or stacked with other
equipment and if adjacent or stacked use is necessary, the Nerivio° should be
observed to verify normal operation in the configuration in which it will be
used
** Do not use devices which generate strong electrical or electromagnetic
fields, near the Nerivio° device. This may result in incorrect operation of
the device and create a potentially unsafe situation. In order to reduce the
risk of EM interference, it is recommended to keep a minimum distance of 30 cm
(12 inches) between the device and other electromagnetically radiating
devices. Verify correct operation of the device in case the distance is
shorter. During the immunity tests the device operated normally.
Adverse Reactions**
During the treatment you might experience a temporary sensation of warmth,
local tingling, numbness in the arm, pain in the arm, or redness of the skin,
which should disappear shortly after the end of the treatment.
Consult with your healthcare professional if these reactions persist, if the
migraine headache worsens, if an allergic reaction occurs, or if there are any
other concerns. If a serious incident that is related to the device has
occurred, please report it to the manufacturer and the competent authority of
the Member State in which you are established.
Package Contents
|
---|---
1 Nerivio® device.
The device is good for 12 treatments| 1 Carrying bag
|
1 Armband| 1 Armband extension
What Does the Treatment Feel Like?
The device transmits electrical pulses. You may feel a strong sensation at
first, but it will typically fade to a comfortable level after a couple of
minutes.
Preparation
Step 1: Installing the Nerivio app
- Download and install the Nerivio® app from the App Store or Google Play.
- Open the app and create an account (or sign in). Follow the app instructions.
Step 2: Connecting the device to the app
- Enable Bluetooth on your smartphone.
- Turn on the device. A slow flashing (mostly on) green light indicates the device is on.
- Connect the device to the app using the app instructions. The device and the smartphone should be in proximity of less than 1 inch (-2.5 cm). You will be notified when a connection has been established. A fast flashing green light indicates that the device is connected to the app.
Using Your Device
Step 1: Place the device on your arm and wrap the armband around it
Remove tight-fitting clothing or tight rolled-up sleeve from one of your arms.
Do not place the device on cloths. The device should be applied on normal,
intact, clean, dry, healthy skin.
-
Turn on the device.
-
Remove the protective film and save it for device storage.
-
Place the device on the outer upper arm. The device should be located midway between the elbow and the shoulder.
-
Adjust the armband to your size. There are 4 sizes you can choose from (S, M, L, XL). Attach the extension to the armband for L and XL sizes.
-
Insert the strap to the buckle of your size.
-
Wrap the armband around the device on your arm and fasten the strap. The armband will improve the contact between the device and your skin.
Step 2: Start a treatment session
For effective results, the treatments should be initiated as early as possible
and always within 60 minutes of migraine headache or aura onset.
-
Make sure the device is on, open the app and confirm the device is connected successfully.
-
Touch ‘Start’. The treatment has now begun and will stop automatically after 45 minutes. A slow flashing (mostly off) green light indicates that the device is stimulating.
-
Set the treatment intensity level so it feels strong yet comfortable and not painful. This is important to maximize the clinical benefit of the treatment.
• Start increasing the stimulation intensity using the ‘+’ button.
• When the stimulation is painful and/or uncomfortable, reduce the intensity to the previous level using the ‘-‘ button. -
During the treatment, questions on your migraine symptoms will be automatically displayed. You can record your migraine symptoms in the diary or skip this by touching ‘Skip’.
-
You can pause the treatment session for 5 minutes by touching the pause button. Touch ‘Resume treatment’ to continue or ‘Stop treatment’ to stop the current treatment session. Each session can only be paused 3 times.
-
To stop the treatment, touch the pause button and then touch ‘Stop treatment’.
-
When the treatment is completed, remove the armband and the device from your arm. The device will turn off automatically one minute after the session has ended (the green light will turn off).
-
Apply the protective film on the electrodes and place the device in its box or in the travel bag to store it for next use.
Maintenance & Cleaning:
The device can be cleaned with a dry cloth (except for the electrodes).
If the electrodes begin losing adhesion, gently rubbing one or two drops of
water onto the gel surface may extend usage.
To minimize moisture loss, when unused, the electrodes should be covered with
the provided protective film and the device should be stored in its original
package.
The armband can be washed with water and soap only. No bleach products should
be used. Do not tumble dry. Do not iron.
Product Performance:
Pulse Width: 400 pS (max)
Freq.: 100-120 Hz (max)
Current: 40 mA (max)
Bi-phasic symmetrical waveform
Need Help?
For troubleshooting or if you require further assistance, please refer to the
user manual in the help screen of the app or contact customer support:
support@nerivio.com
1-937-637-4846 or
1-866-637-4846
www.nerivioscorn
support@nerivio.com
Smartphone requirements:
- At least 4.7 inches multi-touchscreen with at least 720×1280 pixels resolution
- CPU of 1 GHz or more, internal memory of 2GB or more, and internal storage of at least 16GB
- Connectivity capabilities of BT4.0 or above – Supported operating systems — iOS versions 13 or newer and Android versions 7 or newer.
Please refer to www.nerivio.com for the most updated
smartphone requirements
Storage conditions:
Temperature range: 50’F-80.6’F (+10° to +27° C)
Relative humidity range: 40%-50%, with no condensing
Atmospheric pressure: 70-106 kPa
Manufacturer and registration holder:
Theranica Bio-Electronics LTD. 4 Ha-Omanut St., Netanya 4250438, Israel
Approved by the Ministry of Health, Medical devices unit. Registration No.:
32100001 Made in Israel
Authorized Representative in the EU:
CEpartner4U BV
Esdoornlaan 13, 3951 DB Maarn, The Netherlands
Tel.: +31 343 442.524, Fax: +31 343 442 162
Email: office@CEpartner4U.nl
|
---|---
www.nerivio.com| 0344
©2018 Theranica Bio-Electronics LTD. (“Theranica”). All rights reserved.
Theranica reserves the right to revise this guide and make changes in its
content without notice. For complete, up-to-date terms, conditions and
warnings please refer to the user manual or contact us at
support@nerivio.com
Product warranty information can be found at
www.nerivio.com
LBL-NM-0015-3.4, Rev. 3.4, July 2022
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>