soovu 01000 Wearable Pain Relief Owner’s Manual

soovu 01000 Wearable Pain Relief

INTRODUCTION

Welcome to the Soovu HeatWave™ Therapy System. Please read this manual carefully before using the system for the first time. Keep these instructions in a safe place for future reference. For assistance, please contact help@soovu.com.

INDICATIONS FOR USE

The Soovu HeatWave Therapy System is indicated to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis; the temporary relief of muscle spasms, minor sprains and strains, and minor muscular back pain; the temporary relief of menstrual discomfort; the relaxation of muscles; and the temporary increase of local circulation where applied.

SAFETY INFORMATION

WARNING

Read this entire manual and the Quick Start Guide before using the System.

• Use this System only for its indicated uses as described in this manual.
• Do not use this System if the package or any part of the system is damaged. Contact Customer Success at help@soovu.com.
• If your condition persists or worsens, if you develop new symptoms, or if you think you may have a serious medical problem, seek immediate medical attention.
• If you experience pain or if your skin develops permanent redness, blisters or burns, immediately stop using the System and seek medical help. Contact Customer Success at help@soovu.com.
• Do not immerse Soovu Pods, Charging Cradle or Cable in water. Always unplug the Charging Cradle before cleaning and make sure it is dry before plugging back in.
• The Soovu Pods and Charging Cradles are not user-serviceable. Attempting repairs will void the warranty. Contact Customer Success at help@soovu.com.
• Only use the Cable that is provided with the System.
• If the Soovu Pod feels uncomfortably hot, reduce the temperature using the Soovu Mobile App or remove the Pod from your body.
• The Adhesive Rings are disposable, intended for individual use, and intended for up to 16 hours of continuous use.
• Do not apply the Soovu Pods or Adhesive Rings over:
  • An existing burn or over broken skin such as an open wound or a healing wound.
  • Any part of your body that has nerve damage (such as diabetic neuropathy) that reduces your ability to feel hot, cold or touch.
  • Any part of your body with poor circulation.
  • Your face or over your eyes.
  • Your genital areas.
  • Within 6″ of implanted devices such as pacemakers, pumps or stimulators.
  • An area where you have applied a topical pain treatment that causes your skin to be hot (such as capsaicin creams) or cool (such as menthol creams).

CAUTION

Cautions alert the user to important information regarding the use of the Soovu Pod.

The safety and effectiveness of this System for pregnant women have not been established.

• Keep the Charging Cradle free of debris and dust.
• The Soovu Pods contain a medical-grade Lithium Polymer battery
• Do not disassemble the Soovu Pod, the battery is not replaceable and there are no user-serviceable components inside.
• Modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
• Do not dispose of the product by putting it in a fire.
• Do not leave the Soovu Pod in a high-temperature environment such as near a flame; doing so may cause the Pod to overheat, ignite and/or rupture.
• Only apply the Soovu Pod on parts of your body that are flat such that the Pod’s entire heating surface is in contact with your skin.
• Do not use this product with oils, liniment, salve, or ointment preparations as skin burns can result.
• The Soovu App may periodically instruct you to change the location of the Pods. To avoid skin damage, you should relocate the Pods to a non-overlapping area of your skin when instructed.
• Use only the hypoallergenic, latex-free Adhesive Rings supplied by Soovu. Do not attempt to affix the Soovu Pod to your body using any other mechanism such as tape or glue.
• Only apply Adhesive Rings to clean and dry skin.
• If a persistent rash or abrasion develops, stop using the Soovu Pod and Adhesive Rings and consult your physician.
• To avoid possible skin irritation:
  • Adhesive Rings should be removed within 24 hours of initial application.
  • Adhesive Rings should be applied to slightly different locations each day to avoid excessive exposure to one place on your skin.

DEVICE DESCRIPTION

The Soovu HeatWave Therapy System is a drug-free wearable device and companion mobile app that uses pulsed heat for the safe and temporary relief of pain.\

INTENDED USE AND CONTRAINDICATIONS

This product is intended to be used by adults only. Do not use this system:

• While sleeping.
• On a child or an animal.
• On a person who is unconscious.
• On a person with a medical condition in which heat or pain cannot be felt on the skin.
• On an open wound or compromised skin (i.e. sunburn, rash).
• Within 6″ of the site of an active implantable (i.e. pacemaker, defibrillator).

INSIDE THE BOX

Unpack and familiarize yourself with the System

INTRODUCTION TO THE SOOVU POD

Top Side and SmileWave™
The SmileWave on the top of the Soovu is a light bar with lights that shine during various operations. Each color and pattern combination has a different meaning. Orange flowing Pods are charging. Green steady Charging is complete. Blue slow flashing Pod is ready to pair. Yellow quick flashing Battery is low. Teal or purple flowing Identifies Pod 1 and Pod 2. Red quick flashing Pod has a malfunction. Contact help@soovu.com.

Bottom Side
The Soovu Pod sits on the Charging Cradle with the Charging Contacts coupling with the Cradle. The Heating Surface emits heat onto the skin only when a HeatWave session is running.

DEFINITION OF TERMS

Adhesive Backing: The peel-away layer that is removed to expose the adhesive on the Adhesive Ring.
Adhesive Ring: The disposable that attaches to the Soovu Pod on one side and your skin on the other sticky side.
HeatWaveTM: Series of heat pulses delivered by the Soovu Pod over a period of time.
Soovu App: Companion mobile application downloaded to the User’s smartphone that supports pairing with the Soovu Pods.
Soovu Pods: Wearable devices that attach to the skin and deliver pulsed heat.
System: The collection of components including the Soovu Pods, Charging Cradle, Cable, Adhesive Rings, and Soovu App.

SYSTEM OPERATIONS OVERVIEW

1. Fully charge your Soovu Pods before first use. Soovu Pods will not operate until initially charged.
2. Download the Soovu App to your smartphone. Create an account in the Soovu App and follow the instructions in the App to pair it with your Soovu Pods.
3. Set up your HeatWave session using the App. Input the location of the pain area you will be treating. Choose the program, duration, and temperature of the Soovu Pods. A session lasts between 10 and 30 minutes.
4. Apply the Soovu Pods to your body using the Adhesive Rings and then start the HeatWave session.
5. At the end of the HeatWave session, there is a 5-minute cooldown. You may start another session after the cool-down period ends.
6. To avoid skin irritation, remove the Soovu Pods and Adhesive Rings from your body after you have completed your HeatWave sessions for the day.

GETTING STARTED WITH THE SOOVU PODS

IMPORTANT: Prior to first use, each Soovu Pod must be placed into the Charging Cradle and fully charged. Soovu Pods will not operate until first charged.

Charging your Soovu Pod

1. Be sure the Soovu Pods are free from damage, stickers, and other material before use.
2. Plug the Cable into the Charging Cradle. Connect the Cable to a 5W (minimum) USB power adapter such as you would use to charge your smartphone and then plug into a wall outlet or power strip.
3. Place the Soovu Pods in the Charging Cradle. Be sure the Charging Cradle is free of debris and dust.
4. The SmileWave has flowing orange lights while charging and turns to solid green when charging is complete. If the SmileWave does not light up at all, firmly press the Soovu Pod into the Charging Cradle to ensure good charging contact.

Place Soovu Pods in the Charging Cradle to charge

Starting the App

1. Account Creation. Download the Soovu App and create an account using your name, email address, and password. You will need to review and agree to the Terms of Service before proceeding.
2. Verify your Account through the options provided. Sign into the App after you verify your account.

Pairing Pods with your Phone

1. Be sure your phone’s Bluetooth is turned on. Go to your phone’s Settings to turn on Bluetooth.
2. To start the pairing process, place one Soovu Pod in the Charging Cradle. The Charging Cradle should be plugged in and resting on a flat, stable surface.
3. Tap the top of the Soovu Pod, once every second, until the SmileWave turns blue. When it turns blue, your Soovu Pod is ready to pair with your phone.
4. Accept the pairing request that appears on the App to complete the pairing process.
5. The SmileWave will then flash a teal to identify the Soovu that was just paired with your App.
6. Pair the second Soovu Pod once you have finished pairing the first Pod. Before attempting to pair the second Pod, remove the first Pod from the Charging Cradle. The second Pod will flash purple when it is paired.

RUNNING THE HEATWAVE SESSION

IMPORTANT: The Soovu App may periodically instruct you to change the location of the Pods. To avoid skin damage, you should relocate the Pods to a non-overlapping area of your skin when instructed.

You are advised to pay attention to how you feel during the HeatWave session and to monitor your skin after each session During the session, if you feel the Soovu Pod is too hot or you experience pain or discomfort, lower the temperature of the Pod or stop the session and remove or relocate the Pod. After a HeatWave session, some people will experience some temporary redness on the skin where the Pod was located. This redness will normally fade after a few hours. If you have an area of redness that does not fade after a few hours and/or you feel a burning sensation, stop using the product. Continuing to use the product could result in a burn injury. Please contact Customer Success at help@soovu.com or reach us via chat in the Soovu App.
Do not apply a Soovu Pod or an Adhesive Ring on:

• An existing burn or over broken skin such as an open wound or a healing wound.
• Any part of your body that has nerve damage (such as diabetic neuropathy) that reduces your ability to feel hot, cold or touch.
• Any part of your body with poor circulation.
• Your face or over your eyes.
• Your genital areas.
• Parts of your body within 6” of implanted devices such as pacemakers, pumps or stimulators.
• An area where you have applied a topical pain treatment that causes your skin to be hot (such as capsaicin creams) or cool (such as menthol creams).

How to Apply the Soovu Pods

Before applying the Soovu Pods to your body, decide where you will wear them.
Possible locations:
You can place the Soovu Pods almost anywhere on your body including your back, shoulders, neck, hips, buttocks, hamstrings, quadriceps, and calves. Be sure to place the Soovu Pods in an area that has a flat surface to ensure the Heating Surface makes full contact with the skin. For areas you should not place the Soovu Pods, see Page 8 of this Manual.
Recommendations:

• Place one Pod directly over the area of pain.
• Place second Pod near the pain or laterally on your body across from the pain (for example, if you put one Pod on the left side of your back, put the other Pod on the right side.)
• Try placing the Pods in different areas around the pain to determine what works best for you.

Application Steps:

1. Peel away the Adhesive Backing from the Adhesive Ring.
2. Press the sticky side of the Adhesive Ring firmly against your skin. If you need to reposition the Adhesive Ring, you may peel it off and reapply it.
3. Attach the Soovu Pod, with its underside facing you, onto the Adhesive Ring. You should hear and feel the Soovu Pod snap into the Adhesive Ring, held there by a magnet

Customizing the HeatWave Session

1. Tap Pain Location.
   To set up the HeatWave session, tap the location on the body on the screen where you are experiencing pain or discomfort. You can pinch and zoom on the screen to change the size of the body. You can only choose one location at a time.

2. Customize Session.
   Once your Soovu Pods are in place on your body, tap ‘Next’. Then, select the heat program you would like to use, the duration of the session, and the peak temperature of the session.

3. Start HeatWave Session.
   Tap “Start” when you are ready to begin the session.

During the HeatWaveTM Session
Depending on the duration of the HeatWave session you selected, heat will pulse from the Soovu Pods for 10, 20, or 30 minutes. Adjusting the Temperature You may adjust the temperature of all Soovu Pods or individual Pods during the HeatWave session.

• The available temperature settings are: Low 107.6 +/- 1.8°F; Med 109.4 +/- 1.8°F; High 111.2 +/- 1.8°F; Max 113 +/- 1.8°F
• To adjust the temperature of all Pods, swipe up on the screen. Then select a different temperature from the options shown in the bottom half of the screen.
• To adjust the temperature of an individual
  Pod, tap the “Edit” button or tap on one of the
  Pod symbols on the screen and then select a
  different temperature for an individual Pod.

Relaxation Videos & Audio
The Soovu App includes a relaxation video and audio track to enjoy during the HeatWave session.

• Tap the speaker icon in the upper right corner to turn on the volume. Tap again to turn it off.
• Swipe down to maximize the video.
• Swipe up to minimize the video.

Warning

If the Soovu Pod(s) feels uncomfortably hot, reduce the temperature or simply remove the Pod(s) from your body and stop the session.

Stopping the HeatWave Session

The Soovu Pods will automatically stop heating after 10, 20, or 30 minutes depending on the duration of the session you selected. You can end the HeatWave session at any point by tapping the ‘Stop’ button at the bottom of the screen. When the HeatWave session is over, the Pods will enter a 5 minute cool down period. Many users get several hours of relief from one session. During the cool down, evaluate how you feel before beginning another session.

Removing the Soovu Pods

When you are ready to remove your Pods, pull each Soovu Pod off its Adhesive Ring and store it in a safe place, ideally back on the Charging Cradle. When you are ready to remove the Adhesive Ring from your body, carefully peel it away from your skin and throw it out in the household trash. If there is a metal recycling program in your location, you may be able to recycle the metal ring. Check with your local recycling program to confirm.

Warning
To avoid possible skin irritation, Adhesive Rings should be removed within 24 hours of initial application.

CLEANING & STORAGE

To clean your Soovu Pods, wipe them off with a damp cloth. It is not necessary to use cleaning solutions. The Soovu Pods should not be submerged in water; however, the Pod is tested for accidental submersion to 1 meter for up to 30 seconds. Do not use your Soovu Pods until they are completely dry. To clean your Charging Cradle and Cable, unplug them and wipe them with a dry cloth.

TROUBLESHOOTING

your smartphone.** On your smartphone, navigate to the Bluetooth settings page and make sure Bluetooth is turned on.

Soovu Pod(s) may be out of range of your smartphone. Move your Soovu Pods closer to your smartphone.

Battery charge on Soovu Pods may be insufficient. If the Soovu Pods are not charged enough, the App may not be able to connect with them. Place the Soovu Pods in the Charging Cradle until the SmileWave shines green and charging is complete.

HeatWaveTM Session stopped unexpectedly| Battery charge on Soovu Pods may be insufficient. Place the Soovu Pods on the Charging Cradle until the SmileWave turns green and charging is complete.

Soovu Pod(s) may be in the mandatory 5 minute cool down period. After each HeatWave session, the Soovu Pods cool down and you may not begin another session until the 5-minute cool down period is over. Many users get several hours of relief from one session. Evaluate how you feel before beginning another session.

Soovu Pod(s) may have detected an issue during the HeatWave Session.

In this circumstance, the Soovu Pod will shut down during the session. Press ‘Stop’ on the session screen in the Soovu App and start a new session. Contact help@soovu.com if the issue does not resolve itself.

Charging does not start when the Soovu Pod is placed in the Charging Cradle| The connection between the Soovu Pod and the Charging Cradle may be poor. Remove the Pod from the Charging Cradle and put it back in the Charging Cradle to improve contact between the Pod and the Charging Cradle. Be sure the Charging Cradle is fully plugged in and free of dirt or lint.

The SmileWave will have flowing orange lights while charging and turn solid green when charging is complete. If the SmileWave does not light up at all, firmly press the Soovu Pod into the Charging Cradle to ensure good charging contact.

Soovu Pod should restart itself automatically.

If the error persists, contact help@soovu.com for more assistance.

Soovu Pod(s) show blue flashing lights for pairing, but I do not wish to pair right now.| The Soovu Pod can accidentally go into “pairing mode” if it is bumped while on the Charging Cradle. If you see the flashing blue SmileWave, there is no need to take action. The SmileWave will stop flashing and the Soovu Pod will end pairing mode after 60 seconds.
I want to let someone else try my Soovu Pods.| Another person may try your Soovu Pods by downloading the Soovu App, creating his/her own account, and pairing his/her smartphone with the Pods.

Be sure to unpair the Pods from the current phone before pairing Pods with a new phone.

Tap the button on the bottom of the screen that says “Devices.” Tap “Edit Soovu.”

Tap “Remove” to unpair the Pod from your phone.

Other issue not listed.| Email help@soovu.com for more assistance.

SPECIFICATIONS

Operating Environment Specifications

• Soovu Pod operating temperature range: +10°C to +40°C. Do not expose the Soovu Pod to excessive heat.
• Soovu Pod operating relative humidity range: 15 – 75%
• Soovu Pod liquid ingress protection rate: IP67, which means it can withstand accidental splashes, sustained use in the shower, exposure to rain, or a moderately dusty environment.
• Charging Cradle ingress protection level: rated for liquid and dust ingress protection of IP21. Keep the
• Cradle in an environment that is relatively dry and free of dust and dirt.

Soovu Pod Physical Specifications

• Weight: 33 grams H x W x D: 52 x 52 x 12mm
• Biocompatibility: The Soovu Pod is constructed of materials that are compliant with applicable biocompatibility requirements of ISO 10993-1.

Electrical Specifications

• Heating Device powered with rechargeable LiPo battery: 500mA @ 5V, 2.5W
• Charging Cradle Rated Input: 1A, DC5V
• Required minimum power supply: AC Adapter Input: 110 – 120VAC, Output: 1A @ 5V, 5W

FCC Compliance
This device complies with part 15 of the 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.

Product Disposal
At the end of their two-year operating life, the Soovu Pods and Cradle must be disposed of properly. The WEEE symbol on the Soovu Pod and Cradle indicates that the product must not be disposed of with normal household waste. Instead such marked waste equipment must be disposed of by arranging to return to a designated collection point for the recycling of waste electrical and electronic equipment (e-cycle or e-cycling). Separating and recycling this waste equipment at time of disposal will help to conserve natural resources and ensure that the equipment is recycled in a manner that protects human health and the environment.

REFERENCES

Manufactured by Soovu Labs, Inc. Covered by U.S. patents 7,871,427; 8,579,953; 8,702,775; 9,937,072; and 10,188,547. Other patents pending worldwide.

CONTACT INFORMATION

Soovu Labs, Inc. 2439 8th Ave North Seattle WA 98109 help@soovu.com

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