Hinge Health Enso User manual

User Manual
Hinge Health Enso
Transcutaneous nerve stimulator for pain relief

Indications for Use 2
Warnings and Precautions 4
Introduction 8
Setting Up Your Enso 9
Using Your Enso 12
Ending treatment 13
Resuming treatment 14
Switching devices 15
Storing the gel pad 16
Hinge Health App compatibility 16
Table of Contents
Checking battery 16
Bluetooth range 17
Gel pad care 17
Troubleshooting 18
Contact Us 21
Appendix A: Technical specifications 22
Appendix B: Label symbols 24
Appendix C: Radio information 26
Appendix D: Electromagnetic compatibility 27
Appendix E: Parts and accessories 33

2
Indications for Use
The Hinge Health Enso device is intended for the symptomatic relief and
management of chronic pain. It provides temporary relief of pain associated
with sore and aching muscles stemming from strains in the shoulder, waist,
back, neck, upper extremities (arms), and lower extremities (legs). Enso gel
pads should be applied to the normal, healthy, dry, clean skin of adult patients.

3

4
Contraindications
› Do not use this device if you have a cardiac pacemaker,
implanted defibrillator, or other implanted metallic or
electronic device. Such use could cause electric shock,
burns, electrical interference, or death.
› Do not use if you are pregnant.
› Device is not intended for use with children.
Warnings
› Do not apply stimulation across your chest; the
introduction of electrical current to the area may cause
rhythm disturbances in your heart, which could be lethal.
› Do not apply stimulation near the eyes or to the side or
front of the neck, head, or face.
› Do not apply stimulation over your throat, which could
cause severe muscle spasms resulting in closure of your
airway, diculty breathing, or adverse eects on heart
rhythm or blood pressure.
› 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).
Warnings and Precautions
› Do not apply stimulation over or near cancerous lesions.
› Do not apply stimulation in the presence of electronic
monitoring equipment (e.g., cardiac monitors, ECG alarms),
which may not operate properly when Enso is in use.
› Do not apply stimulation when in the bath or shower to
avoid risk of shock.
› Do not apply stimulation while sleeping.
› Do not apply stimulation while driving or operating
machinery or during any activity when electrical stimulation
can put you at risk of injury.
› Do not allow the device or any of its accessories to get wet.
Do not immerse them in water or other liquids, which could
damage the device and accessories.
› Do not use the device on children. It has not been evaluated
for pediatric use.
› Apply stimulation only to normal, intact, clean, healthy skin
to avoid causing an infection.
› Remove gel pads between treatments.

5
› Attach gel pads to the protective liner between uses, and
store in a clean place to avoid contamination.
› Ensure the gel pad lays flat along the surface of the skin.
Sweat or intense exercise/activity can cause gel pad to
detach and generate a shock.
› If your pain does not improve, stop using the device and
consult with your physician.
› If you have had medical or physical treatment for your pain,
consult with your physician before using this device to avoid
issues with contraindications.
› Consult with your physician before using this device, as
it may cause lethal rhythm disturbances in the heart in
susceptible individuals.
› Do not insert sharp objects into, disassemble, or tamper
with the device in any way, as the electronics inside may
pose a safety risk.
› Do not use or integrate with accessories, detachable parts,
or materials not described in the User Manual, which could
cause a risk of injury.
› Do not use with gel pads past their expiration date, which
could cause discomfort or unpleasant sensations.
› Consult your doctor about the use of the stimulator if you
recently had surgery or are planning to have surgery, as
stimulation may disrupt the healing process.
› If you are under the care of a physician, consult with your
physician before using the device to avoid misuse.

6
Adverse reactions
› In rare cases, you may experience skin irritation or burns beneath
a gel pad applied to your skin. If you experience an adverse reaction, please stop
using the device and consult your physician.
Warnings and Precautions

7
Precautions
› To prevent increased chances of skin irritation or infection,
discard gel pads after 30 uses.
› Transcutaneous electrical nerve stimulation is not eective
for pain of central origin, including headache.
› Pain reduction is dependent on pain area being treated
› The long-term eects of electrical stimulation
are unknown.
› Since the eects of stimulation of the brain are unknown,
stimulation should not be applied on your head.
› The safety of electrical stimulation during pregnancy has
not been established.
› You may experience skin irritation or hypersensitivity due to
the electrical stimulation or electrical conductive
medium gel.
› If you have suspected or diagnosed heart disease, you
should follow all precautions recommended by
your physician.
› If you have suspected or diagnosed epilepsy, you should
follow all precautions recommended by your physician.
› If you have a tendency to bleed internally, such as following
an injury or fracture, please use the device with caution.
› Use caution if stimulation is applied over a menstruating
uterus or if pregnant.
› Use caution if stimulation is applied over areas of
skin that lack normal sensation.
› Keep this device out of the reach of children.
› Use the device only with Enso-branded gel pads
and accessories.
› No modification of the Enso device is allowed.
› Patients with particularly small limbs or body parts may
be at increased risk of discomfort from the electrical
pulses delivered by Enso.
› Changes or modifications not expressly approved by the
party responsible for compliance could void the user’s
authority to operate the equipment.

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How does Enso work?
Enso is designed to deliver electrical pulses through the skin and produce natural
pain relieving endorphins.
What does it feel like?
Enso treatment may feel dierent to each user. It may feel like a light tingling
sensation. At stronger intensities, it may feel like a strong tingling sensation
combined with a massaging sensation.
Introduction
1) Enso Device 2) Gel Pads x 3 3) Charger 4) AC Adapter 5) Nylon Bag
Old Versions
New Versions 01/25/22
Old Versions
New Versions 01/25/22
Old Versions
New Versions 01/25/22
Old Versions
New Versions 01/25/22
Old Versions
New Versions 01/25/22
What’s included?
(large or standard)

9
5) Nylon Bag
Setting Up Your Enso
Charging Enso
› Enso arrives already charged. To charge your Enso, position
it on the charger so that it attaches magnetically.
› Plug the charger into the AC adapter, and then plug the AC
adapter into a wall outlet.
› For a quick charge, charge Enso for 30 minutes.
For a full charge, charge Enso for one hour.
› Enso will last around 3 hours on a full charge.
Fully
charged
Charging Low battery
Solid Green
LED
Pulsing Green
LED
Pulsing Red
LED
Old Versions
New Versions 01/25/22
Old Versions
New Versions 01/25/22
Old Versions
New Versions 01/25/22

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Pairing Enso
› Open the Hinge Health app and tap “Set Up Enso”
on the home screen.
› Make sure Bluetooth is enabled. If it isn’t, select “allow”
when the app asks permission to use the
phone’s Bluetooth.
› Put Enso on your phone screen with the six-digit code
facing you. Tap the button to confirm.
› Input the six-digit pin when prompted to do so.
› Flip Enso over to confirm that the status light on
Enso is displaying solid green. Bluetooth is now
successfully connected.
Setting Up Your Enso
Downlod the Hinge Helth pp
› Enso is controlled wirelessly using the Hinge Helth pp
on your iPhone or Android device.
›To download the app:
On your iPhone or Android device tke  picture of the
QR code below or open the Apple App Store or Google
Ply Store nd serch for “Hinge Helth.”

11
Placing the Gel Pad
› Remove a gel pad from its pouch.
› Position your Enso device onto the black tray of the gel pad
until it attaches magnetically.
› Remove the protective liner. Save the protective liner and
use it to store the gel pad between uses.
› Grip the center tray and position it directly over your
pain area or the source of your pain.
› Use your hand to smooth out the surface of the gel pad
so it securely adheres to your skin.
(Large gel pad shown. Your kit may alternatively include standard
gel pads).

12
Using your Enso
Starting treatment
Tap the + button to start treatment and to increase treatment intensity.
Recommended treatment time
For optimal results, use Enso for at least 1 hour per session. Studies show that
using Enso for at least 1 hour a day provides eective relief. Experiment with
placement and usage times to find what works best for you.
Recommended intensity
The app provides recommended intensity levels for dierent body areas. For
optimal results, try to increase intensity to be as close to the recommended level
as you feel comfortable doing.

13
Adjusting treatment intensity
Once treatment intensity has been set, tap the + button to increase intensity. Tap
the – button to decrease intensity.
Ending treatment
At any time, tap the button on the treatment control screen, or the button on
the device, to end your treatment session
Note: always stop treatment before removing the gel pad to prevent
uncomfortable stinging
Battery status
The current battery status of Enso is displayed at the bottom right of the
treatment control screen.

14
During treatment
After starting a treatment session, you can go about your normal daily activities.
Enso may be worn under clothing or exposed. It is not waterproof, so do not shower,
bathe, or swim while wearing Enso.
Resuming treatment
Enso is designed to pause treatment if the gel pad or Enso device becomes
disconnected during treatment. If you reapply the gel pad or reattach Enso within
60 seconds, treatment will resume and the intensity level will gradually increase to
the previously set level.
Using your Enso

15
Switching devices
If you receive a replacement Enso, you can switch to the new Enso device by tapping
on the menu (i.e., three lines) located on the top right of the treatment control
screen. From the menu, tap switch devices. Follow the instructions to place the
new Enso device onto the phone screen with the six-digit code facing you. Tap
the button to confirm. Input the six-digit pin when prompted to do so. Flip Enso
over to confirm the status light on Enso is displaying solid green. Bluetooth is now
successfully connected.

16
Storing the gel pad
Place a gel pad onto its protective liner between uses to
preserve its life and to prevent contamination by dirt or dust.
App compatibility
› Hinge Health app is compatible with iPhones running iOS
12+ and most Android devices running Android 7+.
Useful Tips
Full charge
Solid
Green LED
Checking battery level, when not on charger
Press the gray power button on top of Enso to check the
current battery level while treatment is inactive.
On Enso, the battery light will display one of the following
when the status button is pressed:
Low
charge
Needs
charge
Pulsing
Amber LED
Pulsing
Red LED
Charged
Pulsing
Green LED
The Enso device LED light will display the following states:
Treatment
is on
Pulsing
Blue LED
Connected
Solid
Green LED

17
Power button
Press the power button to pair Enso with
the Hinge Health app or to stop treatment.
Bluetooth range
Enso has a Bluetooth range of around 30 feet depending
on environment and radio interference. If your iPhone or
Android device is out of your Enso device’s range during
treatment, treatment will continue but the Hinge Health app
controls will be suspended until your device is back in range.
Gel pad care
When a gel pad can no longer stick eectively to the body,
the risks of electrical discomfort from treatment and
skin infections may increase. Replace the gel pad when it
becomes dirty or when it does not stay fully adhered to your
skin. Always store gel pads in a cool, dark place between
uses. The temperature limits are 5° C to 27° C (41° F to 80.6°
F). The shelf life for gel pads is 12 months from the date of
manufacture.

18
I can’t pair my Enso.
It is recommended to place Enso on your phone’s screen
during pairing to ensure reliable pairing. Also, in your phone
settings, please make sure that Bluetooth is turned on. If
that doesn’t work, please contact us at help@hingehealth.
com.
I don’t see any lights on my Enso device.
This often means the battery is too low. For a quick charge,
charge Enso for 30 minutes. For a full charge, charge Enso
for one hour.
What should I do if the treatment feels like a
stinging sensation?
Stop treatment by pressing stop button in the app or press
the Enso power button. Reapply the gel pad more securely
onto your skin. If the gel pad is coming o your skin or has
become dirty, please use a new gel pad.
Troubleshooting
Treatment stopped and I noticed the status light on
my Enso device is displaying a blinking blue light.
What does this mean?
This indicates that Enso has poor contact with the gel pad
or the gel pad is not fully adhered to your skin. Make sure
the gel pad is completely adhered to your skin and reattach
Enso. If it is reattached within 60 seconds, treatment
will resume and gradually increase to the intensity set
previously.
What should I do if I get muscle cramps from
treatment?
Decrease treatment intensity by tapping the – button on
the treatment control screen of the Hinge Health app.
My skin is irritated or feels itchy after treatment.
In some cases, mild skin irritation may occur. Remove the
gel pad between treatments to allow your skin to breathe. If
this does not help, use a new gel pad.