Hinge Health Enso Transcutaneous nerve stimulator for pain relief User Manual
Table of Contents Indications for Use 2 Checking battery 16 Warnings and Precautions 4 Bluetooth range 17 Introduction 8 Gel pad care 17 Setting Up Your Enso 9 Troubleshooting 18 Using Your Enso 12 Contact Us 21 Ending treatment 13 Appendix A: Technical specifications 22 Resuming treatment 14 Appendix B: Label symbols 24 Switching devices 15 Appendix C: Radio information 26 Storing the gel pad 16 Appendix D: Electromagnetic comp
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.
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Warnings and Precautions 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.
› Attach gel pads to the protective liner between uses, and › Do not use with gel pads past their expiration date, which › Ensure the gel pad lays flat along the surface of the skin. › Consult your doctor about the use of the stimulator if you › If your pain does not improve, stop using the device and › If you are under the care of a physician, consult with your store in a clean place to avoid contamination. Sweat or intense exercise/activity can cause gel pad to detach and generate a shock.
Warnings and Precautions 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.
Precautions › To prevent increased chances of skin irritation or infection, discard gel pads after 30 uses. › Transcutaneous electrical nerve stimulation is not effective for pain of central origin, including headache. › 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. › Pain reduction is dependent on pain area being treated › Keep this device out of the reach of children.
Enso is designed to deliver electrical pulses through the skin and produce natural endorphins. pain relieving Old Versions What does it feel like? Enso treatment may feel different 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.
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.
Setting Up Your Enso Download the Hinge Health app › Enso is controlled wirelessly using the Hinge Health app on your iPhone or Android device. › To download the app: On your iPhone or Android device take a picture of the QR code below or open the Apple App Store or Google Play Store and search for “Hinge Health.” Pairing Enso › Open the Hinge Health app and tap “Set Up Enso” on the home screen. › Make sure Bluetooth is enabled.
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. (Large gel pad shown. Your kit may alternatively include standard gel pads).
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 effective relief. Experiment with placement and usage times to find what works best for you. Recommended intensity The app provides recommended intensity levels for different body areas.
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.
Using your Enso 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.
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.
Useful Tips Storing the gel pad Checking battery level, when not on charger Place a gel pad onto its protective liner between uses to preserve its life and to prevent contamination by dirt or dust. Press the gray power button on top of Enso to check the current battery level while treatment is inactive.
Bluetooth range Power button 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. Press the power button to pair Enso with the Hinge Health app or to stop treatment.
Troubleshooting 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.
How about maintenance or service for Enso? Your Enso device is designed to be maintenance free, and there are no userserviceable parts. Please contact us at help@hingehealth.com if your Enso device is not operating properly or if you need any assistance. Do not disassemble Enso or any of its accessories, as doing so may cause damage. Use only the provided AC adapter and charger to charge Enso. Using other AC adapters may damage Enso. Use a damp cloth to clean the outside of the Enso device.
Limitation of liability THE SERVICE IS PROVIDED “AS IS” AND “AS AVAILABLE” WITHOUT WARRANTY OF ANY KIND TO THE USER. EXCEPT TO THE EXTENT REQUIRED BY LAW, HINGE HEALTH EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES, INCLUDING, WITHOUT LIMITATION, MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
Contact Us help@hingehealth.com Hinge Health 455 Market Street Suite 700 San Francisco, CA 94105 (855) 902-2777 hingehealth.
Appendix A: Technical Specifications Power Output characteristics › Power Source: Internally powered by fixed, rechargeable › Waveform: Biphasic, asymmetrical battery › Battery Type: Lithium-polymer battery, 3.
Environmental Gel pads › Temperature, Operating: 5° C to 40° C › Type: Self-adhering, single-patient use, › Temperature, Transport and Storage: 5° C to 45° C (device); 5° C to 27° C (gel pads) › Atmospheric Pressure: 50kPa to 106kPa › Relative Humidity: 10% to 95% multiple applications › Materials: Hydrogel; silver ink; polyester film; cotton fabric › Number of Hydrogel Electrodes: Two › Water Ingress (device): IP22 › Electrode Area: 40.
Appendix B: Label Symbols Read user manual Type BF applied part Shelf life Ingress Protection rating Non-sterile 24 Temperature limits (Store and use between specified temperatures) Relative humidity limits Atmospheric pressure limits Manufacturer Class 2 equipment Immunity test / RF transmitters Warnings and cautions Serial number Part number
WEEE (Waste Electrical and Electronic Equipment) This symbol on the product means that used electrical and electronic products should not be mixed with general household waste, according to the Waste Electrical and Electronic Equipment (WEEE) Directive (2002/96/EC). For proper treatment, recovery, and recycling, please take this product to designated collection points, where it will be accepted free of charge.
Appendix C: Radio Information Enso device is FCC ID: 2AQLG-40895051 This device complies with part 15 of FCC rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation of the device. FCC RF radiation exposure statement This equipment complies with FCC radiation exposure limits for an uncontrolled environment.
Appendix D: Electromagnetic Compatibility Guidance and manufacturer’s declaration—electromagnetic emissions This device is intended for use in the electromagnetic environment specified below. The user of the device should assure that it is used in such an environment.
Guidance and manufacturer’s declaration—electromagnetic immunity This device is intended for use in the electromagnetic environment specified below. The user of the device should assure that it is used in such an environment.
Appendix D: Electromagnetic Compatibility Immunity test Conducted RF IEC610004-6 Electromagnetic environment–guidance 3 Vrms 150 kHz to 80 MHz Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2 √P d = 1.2 √P 80 MHz to 800 MHz d = 2.3 √P 800 MHz to 2.
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. A. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy.
Appendix D: Electromagnetic Compatibility Recommended separation distances between portable and mobile RF communications equipment and the device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Recommended separation distances between portable and mobile RF communications equipment and the device (continued) For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Appendix E: Parts and Accessories The following are the parts and accessories included with Enso. Please use these part numbers when requesting replacements.
PN 100-441
