6474523 Hyperice-X Knee Contrast Therapy Device Instruction Manual

6474523 Hyperice-X Knee Contrast Therapy Device

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.

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-toreach 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 orM 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 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.

Symbol

| Description|

Location

---|---|---

IP22

| Degree of protection against ingress of water| On product
| 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. 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.

Illustrations

Hyperice X Device

❶ Electronics Box
❷ Straps
❸ Loops
❹ Modules
❺ Kneecap Ring

Electronics Box

❻ Charging Light
❼ Charging Port
❽ Power Button
❾ Status Light

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: Place the device directly on skin. Place the electronics box on your thigh. Align colored ring to kneecap.

• Step 2: Fasten straps so the device is snug against the skin. See “Troubleshooting” if straps are not sized correctly.

• Step 3: Download the free Hyperice App on an iOS or Android device. Open the Hyperice App, create an account, and pair your device

• Step 4: 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. HyperSmartTM 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.

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.

Using the Minimizers

If the device straps are too long use the minimizers to get a custom fit.

Attach the minimizers:

With minimizers in place:

Using the Extenders

If the device straps are too short use the extenders to get a  custom fit.

Attach the extenders:

With extenders in place:

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

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.

IC: 26209-1040001

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 dimensions: 12.5″ x 10″ x 1.5″
• Hyperice X weight: 2 lbs · Hyperice X electrical requirement: 9V 6A
• Temperature (operating): +41° F to 104° F [+5° C to +40° C]
• Temperature (storage): -13° F to +158° F [-25° C to +70° C]
• Relative Humidity (operating): 15% to 90%, non-condensing
• Relative Humidity (storage): -25ºC without relative humidity control; +70º C at relative humidity up to 93%, non-condensing
• Atmospheric pressure (storage and transportation): 190hPa to 1060hPa
• Atmospheric pressure (operating): 700hPa to 1060hPa

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 GTM 96600-5409-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 electroamagnetic site survey , should be less than the compliance level inb each frequency range .
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

| 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

0.01

| 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

Plug the device into the charger to charge the battery.
Download the Hyperice App and pair your Hyperice X device.
The straps are too short.| Extenders are not installed.| Open the “Extender 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.
Device does not get cold enough.| Adjust temperature setting within app
Cold therapy expectations are too extreme.
Air flow to modules is being blocked.
The device has been damaged| The device is sustaining optimum therapy temperatures, which is NOT ice cold.
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.
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 Information

Hyperice Limited One-Year Warranty
The Hyperice X is warranted by Hyperice Inc., a California corporation (“Hyperice”), against manufacturing defects in material and workmanship for a period of one year from the date of purchase from Hyperice. In the event of any such defect occurring during the warranty period, Hyperice will, at its option, (a) correct the defect by repair or by replacement of the applicable part or component that fails as a result of such defect, without charge for parts and labor; or (b) replace the electronics box with one of the same or then current design.

The foregoing Warranties do not cover normal wear and tear or cosmetic damage, and are void if the electronics box and/or the attachments and other accessories (collectively, the “product”) are not used in accordance with the user manual, are otherwise misused or modified in any way, and/or are repaired or altered by anyone other than an authorized service representative of Hyperice. These Warranties expressly exclude transportation, shipping, or insurance costs, or defects, damages, or failure resulting from misuse, abuse, improper or abnormal usage, or neglect.

EXCEPT AS PROVIDED ABOVE, HYPERICE MAKES NO EXPRESS WARRANTIES OR ANY IMPLIED WARRANTIES, INCLUDING THOSE OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE, AND ARE LIMITED IN DURATION AS STATED ABOVE. EXCEPT AS EXPRESSLY STATED ABOVE, HYPERICE SHALL HAVE NO LIABILITY OR RESPONSIBILITY TO ITS CUSTOMER OR ANY OTHER PERSON OR ENTITY WITH RESPECT TO ANY LIABILITY, LOSS, OR DAMAGE CAUSED DIRECTLY OR INDIRECTLY BY USE OR PERFORMANCE OF THE PRODUCT OR ARISING OUT OF THE USE OR INABILITY TO USE THE PRODUCT OR ANY BREACH OF THESE WARRANTIES, INCLUDING BUT NOT LIMITED TO ANY DAMAGES RESULTING FROM INCONVENIENCE, LOSS OF TIME, PROPERTY, OR INCOME, OR ANY INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES OF ANY KIND.

Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitations or exclusions may not apply to you. These Warranties give you specific legal rights, and you may also have other rights, which vary from state to state. In the event of a product defect covered by the foregoing Warranties during the applicable warranty period, contact Hyperice at +1.949.565.4994 or [email protected].

All replaced parts and products become the property of Hyperice. New or reconditioned parts and products may be used in the performance of Warranty service. Repaired or replaced parts and products are warranted for the remainder of the original warranty period only. You will be charged for repair or replacement of parts and products made after the expiration of the applicable Warranty period.

Return Policy

This policy is only applicable if you are an end user and you purchased the equipment directly from Hyperice. In the unlikely event that you are not satisfied with your purchase, you may return it within thirty (30) days of the purchase date. All returns and exchanges are subject to the conditions listed below.

• Returns and exchanges must have a Return Merchandise Authorization (RMA) number. Obtain an RMA number by contacting us at +1.949.565.4994 or [email protected]. Returned items without an RMA number will not be eligible for a credit to your account.
• Returns must be shipped within 30 days of the purchase date; exchanges must be shipped within 14 days of the purchase date.
• Products and packaging must be returned in new and undamaged condition. Any products showing signs of wear or being soiled in any way will be deemed “unacceptable,” and you will be so notified. Unacceptable returns and/or exchanges may be reshipped to you following payment of an inspection/shipping fee.
• Returned items will be subject to a 7.5% restocking fee. A returned item is an item that is being sent back for a refund.
• If you refuse delivery of your order for any reason, you will be refunded the cost of your order less shipping fees.
• All partial or full refunds will be posted to the credit card used for purchase.
• Hyperice is not responsible for items lost or damaged during shipping.

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.

Hyperice, Inc., 525 Technology Drive, Suite 100, Irvine, California 92618 USA
Copyright 2021 © Hyperice, Inc. All rights reserved.
60-00525 Rev 2

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