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)