Hyperice X Knee Contrast Therapy Device Black Instruction Manual

Hyperice X Knee Contrast Therapy Device Black

Product Information

The Hyperice X is a thermoelectric heater/cooler device designed to provide temporary pain relief, reduce inflammation (cold therapy), soothe stiff joints, and relax muscles (hot therapy) in the treated areas. The device features an electronics box, loops, modules, straps, and a kneecap ring (for knee device) or shoulder straps (for shoulder device). It is intended for stationary use, but users can walk short distances without needing to remove the device.

Important Safety Instructions

• Read the entire instruction manual before using the Hyperice X.
• No modification of this equipment is allowed.
• The Hyperice X contains a lithium-ion battery which must be disposed of safely at an appropriate e-waste disposal or recycling facility.
• Save this manual for future reference.

Product Symbols

• IP22: Degree of protection against ingress of water
• Level of protection type BF equipment: On product
• Double insulation: On charger
• Direct current: On product
• Alternating current: In manual
• Manufacturer’s name and address: On product
• Date of manufacture: On product
• Separate collection for waste electrical and electronic equipment: On product
• Serial number of the console: On product
• Fragile, handle with care: On package
• Keep dry: On package
• This side up: On package
• Keep away from sunlight: On package
• 93%RH: Transportation & storage humidity limitation
• 10%RH, 1060hPa, 700hPa: Transportation & storage atmospheric pressure limitation
• Transportation & storage temperature limitation: On package
• Place in and out of standby mode: On product
• Do not wash, dry clean, tumble dry, bleach, or iron: On product tag
• EU RF transmitter symbol: In manual and on product
• Warning symbol: To identify a hazard that may lead to death or serious injury (in manual)
• Caution symbol: To indicate the need for the user to consult the instructions for important cautionary information (in manual)
• Tip to provide guidance: To make use easier (in manual and on product)
• Refer to instruction manual: On product

Risks and Benefits

The risks and benefits of using the Hyperice X device are similar to traditional hot/cold therapy methods such as ice or heat compress. If the temperature feels uncomfortable during treatment, you can reduce the intensity or stop the session. Benefits include temporary pain and inflammation relief, as well as soothing joints and relaxing muscles in the treatment area.

Illustrations

Hyperice X – Knee Device

1. Electronics Box
2. Loops
3. Modules
4. Straps
5. Kneecap Ring

Hyperice X – Knee Electronics Box

6. Charging Light
7. Charging Port
8. Power Button
9. Status Light

Hyperice X – Shoulder Device

1. Loops
2. Modules
3. Electronics Box
4. Straps

Hyperice X – Shoulder Electronics Box

5. Status Light
6. Power Button
7. Charging Port
8. Charging Light

IMPORTANT SAFETY INSTRUCTIONS
Read the entire instruction manual before using the Hyperice X.

⚠ WARNING! No modification of this equipment is allowed.
⚠ WARNING! If you experience severe pain, any unusual symptoms, or want to remove the device in an emergency during use:

• Stop the temperature control by pressing the power button.
• Remove the device from your body.
• Promptly consult your licensed healthcare practitioner, as required.
• Use heated surfaces carefully. Always start at lowest heat setting to determine how your skin reacts to elevated temperatures.
• Do not use on an infant or invalid or on a sleeping or unconscious person. Do not use on insensitive skin or on a person with poor blood circulation. Check the skin in contact with the heated area of the device frequently during first or on new temperature level. Immediately remove from body aand turn off at first sign of discomfort.
• This device must not be used by persons insensitive to heat and other very vulnerable persons who are unable to react to overheating.
• Consult your physician if you have a pre-existing medical condition that might prevent you from using this device. Please do not use the Hyperice X, or any heat or massage device without first obtaining approval from your doctor if any of the following apply: Pregnancy, diabetes with complications such as neuropathy or retinal damage, wear of pacemakers, recent surgery, epilepsy or migraines, herniated disks, spondylolisthesis, spondylolysis, or spondylosis, recent joint replacements or IUDs, metal pins or plates or any concerns about your physical health. Frail individuals and children should be accompanied by an adult when using any heat or massage device. These contraindications do not mean that you are not able to use this device, but we do advise you to consult a doctor first.

CAUTION!

• Do not attempt to take apart the device. The device has no user-serviceable parts. When service or repairs are required, please contact customer service at +1.949.565.4994.
• Only use the power supply provided with the device. Using a different power supply may cause the device to operate incorrectly.
• To avoid risk of electric shock, do not use the device near water, such as near a bathtub, kitchen sink, laundry tub, or swimming pool.
• To avoid damage and risk of electric shock, never spill liquid of any kind on the device.
• Do not place the device, power supply, or any accessories where they could be damaged, present a fall hazard, or become an obstruction to others.
• Keep the module vents and power inlet free of debris.
• To avoid damage and decreased performance, do not block or cover module vents.
• If the power supply is damaged, the device is dropped or damaged, liquid is spilled on the device, or the device does not operate normally when the operating instructions are followed, turn the device off by pushing the device’s power button and then unplugging the device from the wall outlet. Contact customer service at +1.949.565.4994 for assistance.
• Do not puncture or otherwise damage the device. This may cause the device to operate incorrectly.
• To avoid risk of strangulation, do not leave a baby or child unattended with the power supply.
• Choking hazard, small parts. Keep away from small children.
• Do not leave the device, power supply, or any accessories where they could be damaged by children, pets, pests, or liquids. If you suspect your electronics box is damaged, contact customer service at +1.949.565.4994 for assistance.
• Do not allow lint or dust to accumulate on the modules. If lint or dust accumulates, wipe down the device with a dry cloth and clear hard-to-reach areas with compressed air before use.
• The IPX2 classification means the electronics box is protected against dripping water.
• The expected service life of the device and the integrated battery is two years.
• Do not hold the unit by the electronics box or modules.
• Please do not use the Hyperice X, or any contrast therapy device, without first obtaining approval from your physician if any of the following apply: are under the care of a physician or have a contraindication requiring the use of any medical device, if you are experiencing inflammation, an infection, pain of unknown origin, bleeding (internal or external) at or near the site of application, if you have a wound at or near the site of application, have sensitive skin, have bone fractures or dislocations at or near the site of application.
• Do not use the Hyperice X device near eyes, nose, mouth, or ears. Keep away from hair.
• Use by unconscious or incapacitated persons may be dangerous without supervision.
• Make sure the charging port on the electronics box is always easily accessible in order to disconnect power if required.
• The device has a heated surface. Persons sensitive to heat must be careful when using the device.
• Use only on a dry clean surface of the body as shown on instructional material.
• Do not use Hyperice X on wet skin or over topical ointment, especially ones that contain heat producing ingredients as skin burns could result.
• Use a thin fabric, clothing or thin towel between product and skin to reduce chance of burns.
• Do not place any metallic objects between Hyperice X and body, including pins or other metallic fasteners to fasten the Hyperice X.

The Hyperice X contains a lithium-ion battery which must be complied with safely at an appropriate e-waste disposal or recycling facility.
Save this manual for future reference.

| Level of protection type BF equipment| On product
| Double insulation| On charger
| Direct current| On product
| Alternating current| In manual
| Manufacturer’s name and address| On product
| Date of manufacture| On product
| Separate collection for waste electrical and electronic equipment| On product
| Serial number of the console| On product
| Fragile, handle with care| On package
| Keep dry| On package
| This side up| On package
| Keep away from sunlight| On package
| Transportation & storage humidity limitation| On package
| Transportation & storage atmospheric pressure limitation| On package
| Transportation & storage temperature limitation| On package
| Place in and out of standby mode| On product
| Do not wash| On product tag
| Do not dry clean| On product tag
| Do not tumble dry| On product tag
| Do not bleach| On product tag
| Do not iron| On product tag
| EU RF transmitter symbol| In manual
| The Bluetooth® figure mark| On product
| Warning symbol to identify a hazard that may lead to death or serious injury| In manual and on product
| Caution symbol to indicate the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical electronics box itself| In manual
| Tip to provide guidance to make use easier. Risk to user is considered negligible.| In manual
| Refer to instruction manual| On product

Indications for Use
The Hyperice X device is a thermoelectric heater / cooler indicated to temporarily numb pain and relieve inflammation (cold) & soothe stiff joints and relax muscles (hot) in the treated areas. The device will monitor the cold/heat temperature and will adjust the temperature intensity based on estimated body temperature. Hyperice X is intended to be used in a stationary position, but user may walk short distances without needing to remove the device.

Risks and Benefits
The risks and benefits of using the Hyperice X device are the same as using traditional hot/cold therapy mediums such as an ice or heat compress. If the temperature of
the treatment area feels uncomfortable, you can reduce the intensity or stop the session. Like using an ice or heat compress, the benefits include temporary pain and inflammation relief, as well as soothing joints and relaxing muscles in the treatment area.

Operating Instructions

WARNING!
Before Operating this Device: Read all warnings at the beginning of this manual. If you do not understand the operating instructions, contact Hyperice at +1.949.565.4994

Set up the Device

• To charge the device before use: Plug the power supply into an electrical outlet and then into the Hyperice X device.
  This device is equipped with a lithium ion battery. The battery automatically charges when the power supply is connected to the Hyperice X device and an electrical outlet.

• Step 1: Follow the instructions included in the “Quick Start Guide” for how to place the device on the desired body part.

• Step 2: Download the free Hyperice App on an iOS or Android device. Open the Hyperice App, create an account, and pair your device

• Step 3: Press the power button on the device. Status light will pulse green.

Connecting to the Hyperice App
To connect your device to the Hyperice App via Bluetooth® make sure that your device is turned on, Bluetooth® is turned on in your phone, and your device is within close proximity. Select a routine within the Hyperice App and if prompted tap “Scan for Devices.” Select your device when it pops up on the screen. HyperSmart™ will automatically start your device. If you need to adjust the temperature or duration of your routine, simply open the Hyperice App and change the settings to your preference.

Operating Offline Mode
To enable offline mode press ON/OFF button to activate the device. The LED will pulse green, signifying standby mode. Once the device is turned on, hold ON/OFF button for two seconds to enter offline mode, LED will turn blue (defaults to cold). Then, quickly press ON/OFF button to cycle through modes: cold (blue LED), hot (orange LED), contrast (purple LED). Once the desired mode is selected, the device will start automatically after two seconds. The cold mode will last for 15 minutes at the coldest setting. The hot mode will last 15 minutes at the medium setting. The contrast mode will last 20 minutes, alternating between cold and hot for 5 minutes each. In the case of a low battery or device error, the LED will flash yellow.

Turn Off the Device
To turn off the device, press the power button and confirm that the LED is off. The device will turn itself off after idling for five minutes.

Caring for the Device
Cleaning the Device

• Wipe down the treatment pad with a damp, clean cloth.
• Dry thoroughly with a clean cloth.
• Do not machine wash or dry.
• Do not dry clean.

Maintaining the Device
The device and power supply require no routine maintenance or service except for the care in this section.

Storing the Device
Make sure the device is powered off and battery charger is not attached. Store in a clean, cool, dry place, not in direct sunlight, when not in use.

Replacement Parts
Please call customer service at +1.949.565.4994 or visit our website at hyperice.com for information regarding available replacement parts and accessories.

Technical Information

Do not attempt to take apart the device. The device has no user-serviceable parts. There are no user-replaceable fuses.

Bluetooth® Wireless Technology
The Bluetooth word mark and logos are owned by Bluetooth SIG, Inc., and any use of such marks by Hyperice is under license. In the unlikely event of loss of a stable Bluetooth connection, the device will attempt to re-establish its connection automatically. The Hyperice X device is completely autonomous, and will continue operating normally, even during a loss of connectivity. If this device does cause interference, which can be determined by turning the device off and on, the user is encouraged to try to correct the interference by reorienting or relocating the device, increasing the separation between equipment and the device, or connecting the device to a different outlet on a circuit if it is plugged in.
The Hyperice X device uses Bluetooth 5.0 wireless technology with the following radio specifications:

FCC ID: 2AWOM-1040001 – IC: 26209-1040001

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.
This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.

Internal Battery Information
This device is equipped with a rechargeable lithium ion battery. The internal battery is designed to allow use of Hyperice X anywhere—even when power outlets are not available. The Hyperice X device may need to be plugged in before first use. The battery will provide power for approximately 90 minutes of continuous use (of cold therapy). It takes approximately three hours to fully charge the battery when the device is plugged in and not in use.

The rechargeable lithium ion battery is intended to be changed only by authorized service personnel with the use of a special service tool.

Product Specifications

• Hyperice X Knee dimensions: 12.5” x 10” x 1.5” [31.75 x 25.4 x 3.81 cm]
• Hyperice X Knee weight: 2 lbs [0.91 kg]
• Hyperice X Shoulder dimensions: 13.5” x 11” x 1.5” [34.3 x 27.94 x 3.81 cm]
• Hyperice X Shoulder weight: 2 lbs [0.91 kg]
• Hyperice X electrical requirement: 9V 6A
• Temperature (operating): +41° F to +86° F [+5° C to +30° C]
• Temperature (storage): -13° F to +158° F [-25° C to +70° C]
• Relative Humidity (operating): 15% to 90%, non-condensing
• Relative Humidity (storage): -13º F [-25º C] without relative humidity control; + 158º F [+70º C] at relative humidity up to 93%, non-condensing
• Atmospheric pressure (storage and transportation): 190hPa to 1060hPa
• Atmospheric pressure (operating): 700hPa to 1060hPa
• Temperature of applied part: cooling +45° to +55° F [+7° to +13° C]; heating +109° to +1 13° F [+43° to +45° C]

AC/DC Adapter

WARNING! Only use either the AC-DC adapter model number GTM96600-5409-T2provided with the device.

• Input: 100-240 VAC, 50-60Hz, 1.5A per GlobTek model number GTM96600-5409-T2
• Output: 9V DC 6A, 54W Max per GlobTek model number GTM96600-5409-T2

Or the AC-DC adapter model number GSM60B09 provided with the device.

• Input: 100-240 VAC, 50/60Hz, 1.4-0.7A per MeanWell model number GSM60B09
• Output: 9V DC 6A, 54W Max per MeanWell model number GSM60B09

Using a different adapter may cause the device to not operate correctly.

Electromagnetic Compatibility
The information contained in this section (such as separation distances) is in general specifically written regarding Hyperice X. The numbers provided will not guarantee faultless operation but should provide reasonable assurance of such. This information may not be applicable to other medical electrical equipment; older equipment may be particularly susceptible to interference.

General Notes
Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in this document and the remainder of the instructions for use of this electronics box. Portable and mobile RF communications equipment can affect medical electrical equipment. Cables and accessories not specified within the instructions for use are not authorized. Using other cables and/or accessories may adversely impact safety, performance, and electromagnetic compatibility (increased emission and decreased immunity). Care should be taken if the equipment is used adjacent to or stacked with other equipment; if adjacent or stacked use is inevitable, the equipment should be observed to verify normal operation in the configuration in which it will be used.

Electromagnetic Emissions
This equipment is intended for use in the electromagnetic environment specified below. The user of this equipment should assure that it is used in such an environment.

Electromagnetic Immunity
This equipment is intended for use in the electromagnetic environment specified below. The user of this equipment should assure that it is used in such an environment.

Immunity Against| IEC 60601-1-2 Test Level| Compliance Level (of this electronics box)| Electromagnetic Environment
---|---|---|---
Electrostatic discharge, ESD (IEC 61000-4-2)| Contact Discharge: ± 8 kV
Air Discharge: ± 15 kV| ± 8 kV
± 15 kV| Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be kept at levels to reduce electrostatic charge to suitable levels.
Electrical fast transients/ bursts (IEC 61000-4-4)| Power Supply Lines: ± 2 kV Input DC Power Ports ± 2 kV Signal Input/ Output Lines: ± 1 kV| ± 2 kV
± 2 kV
± 1 kV| Mains power quality should be that of a typical commercial or hospital environment.
RF Proximity (IEC 61000-4-3)|

385 Pulse

Modulation, 18 Hz 450 FM + 5Hz
deviation: 1 kHz sine
710
745
780 Pulse Modulation: 217 Hz
810
870
930 Pulse
Modulation: 18 Hz
1720
1845
1970 Pulse Modulation: 217 Hz
2450 Pulse Modulation: 217 Hz
5240
5500
5785 Pulse Modulation: 217 Hz

| 27 V/m
28 V/m
9 V/m
28 V/m
28 V/m
28 V/m
9 V/m| Equipment with high RF emissions should be kept at a distance to reduce the likelihood of interference.

Surges on AC mains lines (IEC 61000-4-5)

|

Common Mode: ± 2 kV
Differential Mode: ± 1 kV

| ± 2 kV
± 1 kV| Mains power quality should be that of a typical commercial or hospital environment.
Power frequency magnetic field 50/60 Hz
(IEC 61000-4-8)| 30 A/m| 30 A/m| Equipment that emits high levels of power line magnetic fields (in excess of 3A/m) should be kept at a distance to reduce the likelihood of interference.
Voltage dips and short interruptions on AC mains input lines
(IEC 61000-4-11)| Dip > 95%, 0.5 cycles Dip > 95%, 1 cycle Dip 30%, 25 cycles (50 Hz)
30 cycles (60 Hz)
Drops >95%, 250
cycles (50 Hz)
300 cycles (60 Hz)| 0.5 cycles
1 cycle
25 cycles
(50 Hz)
30 cycles
(60 Hz)
250 cycles
(50 Hz)
300 cycles
(60 Hz)| Mains power should be that of a typical commercial or hospital environment. If you require continued operation during power mains interruptions, ensure that batteries are installed and charged. Ensure that battery life exceeds longest anticipated

power outages or provide additional uninterruptible power source.

This equipment is intended for use in the electromagnetic environment specified below. The customer or the user of this equipment should assure that it is used in such an environment.

Immunity Test| IEC 60601 Test Level| Compliance Level| Electromagnetic Environment – Guidance
---|---|---|---
Conducted RF
RF coupled into lines (IEC 61000-4-6)Radiated RF
(IEC 61000-4-3)| 150 kHz to 80 MHz

outside ISM bandsa

150 kHz to 80 MHz

in ISM bandsa

| 3 Vrms| Portable and mobile RF communications equipment should be used no closer to any part of the equipment, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter as below. Recommended separation distance:
d=1.2/V1]√P
d=1.2/√P 80 MHz to 800MHz
d=2.3√P 800 MHz to 2.5 GHz
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:

a The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
b 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. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the equipment is used exceeds the applicable RF compliance level above, the equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the equipment.

Recommended Separation Distances
Recommended separation distances between portable and mobile RF communications equipment and the Hyperice X electronics box.

Rated maximum output power of transmitter W

0.01

| Separation distance according to frequency of transmitters in meters
---|---
150 kHz – 80 MHz d=1.2/V1]√P| 80 MHz to 800MHz d=1.2/V1]√P| 800 MHz to 2.5 GHz d=2.3√P
0.12| 0.12| 0.23
0.1| 0.38| 0.38| 0.73
1| 1.2| 1.2| 2.3
10| 3.8| 3.8| 7.3
100| 12| 12| 23

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.

Note 1: At 80 MHz and 800 MHz, the separation distance for 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.

Equipment Classification

• Protection against electric shock: Class II/internally powered equipment
• Degree of protection against electric shock: Type BF applied part (Hyperice X device)
• Ingress protection: IP22
• Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide
• Continuous operation

Troubleshooting

Box” and follow the instructions in the box.
The straps are too long.| Minimizers are not installed.| Open the “Minimizer Box” and follow the instructions.
Adjust temperature setting within app| The device is sustaining optimum therapy temperatures, which is NOT ice cold.
Device does not get cold enough.| Cold therapy expectations are too extreme.
Air flow to modules is being blocked.| Do not use device under pants, blankets, or anything that may restrict air flow to the device. If modules appear full of debris, attempt to clear with compressed air WHILE DEVICE IS NOT IN USE.
The device has been damaged| Contact Customer Service. Do not attempt to disassemble or fix device.
Device is not responding.| Firmware may have crashed.|

Reset the device by plugging in the wall charger and holding the power button down for 10 seconds.

Low Battery| Battery needs to be charged.| Plug in the electronics box to charge the battery.
Cannot

establish or

maintain a

Bluetooth

connection

| Bluetooth is turned off.| Turn on Bluetooth on the phone

attempting to pair with the

Hyperice X unit.

Call Hyperice customer service at +1.949.565.4994 if further assistance is needed.
Warranty
This product is covered by a limited warranty from Hyperice. Please visit hyperice.com/warranty to review the warranty in your country.

hyperice.com

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.
Please read the product label within half a meter.

 NormaTec Industries, LP
480 Pleasant Street, Suits A200, Watertown, MA 02472
Copyright 2022 © Hyperice, Inc. All rights reserved.
70-00139 Rev 1

References

• hyperice.com
• hyperice.com/

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