VibraCool IFU-003 Reusable Relief Device Instruction Manual

June 5, 2024
VibraCool

Simple serious relief.
Developed by a physician, VibraCool® is a reusable device for the temporary relief of minor aches and pains.

  • Recovery
  • Tendinitis
  • Overuse injuries
  • Acute muscle pain
    VibraCool.com

VibraCool® is a personal consumer use product intended to be used by a single user. VibraCool® is a therapeutic vibrator and icepack. IFU-003 Rev 00 VibraCool Instructions for Use 12.17.2021

Indications For Use:

Controls pain associated with injections (venipuncture, IV starts, cosmetic procedures) and the temporary relief of minor injuries (muscle aches or tendinitis, splinters and bee stings). Also intended to treat myofascial pain caused by trigger points, restricted motion, and muscle tension.
Warnings:
For intended use only
• Direct or prolonged application of ice could vasoconstrict or alter lab values.
Contraindications:
Do not use in the presence of unexplained calf pain. Consult a physician.

  • This device should not be used over swollen or inflamed areas or skin eruptions.
  • Do not place directly on a thermal burn
  • Do not use an ice pack with underlying sensitivities to ice or cold (e.g. Sickle Cell Disease, Reynaud’s Disease).

Cautions:
Store wings in a cool, dry place.

  • Wings must be frozen solid for the best effect. – Do not use dry ice to freeze wings unless supervised by a healthcare professional
  • Do not puncture ice pack chambers.
  • Discard if leaking.
  • Do not ingest gel.
  • Keep out of reach of children or pets.
  • Do not use with neuropathy, CRPS, or sensitivities to ice.

VibraCool® Includes:

  • All VibraCool® kits include 2 AAA batteries (installed) and all items are latex free and reusable.
  • Knee/Ankle includes 28″ neoprene compression wrap and one 4-chamber ice pack.
  • Elbow/Wrist includes 20″ neoprene D-ring compression wrap and one 2-chamber ice pack.
  • Plantar includes a velcro strap and one ice pack.
  • Flex includes 50″ flex strap, one 2-chamber ice pack, one heat pack

Note: To transport, place ice packs between two commercial cold packs (sold separately by independent retailers) to maintain frozen temperature.

VibraCool® Directions For Use:

Place ice packs in the freezer until frozen solid. Remove ice packs just prior to use. Use VibraCool unit only on clean, unbroken skin. To optimize relief of chronic pain, use VibraCool 2-3x daily until the pain is relieved, then use whenever chronic overuse pain flares up.
Ice Packs:
Ice packs will stay frozen for 20 minutes at room temperature. For best pain relief, the ice packs must be frozen solid to avoid absorbing vibration.
VibraCool ice packs are reversible. Face the blue or smooth side of the ice pack toward the skin for more numbing power. If sensitive to cold, the soft side of the ice pack should face the skin.
Tip: For longer icing, prepare additional ice packs (sold separately).
Store ice packs in the freezer. The gel inside ice may deteriorate if not stored properly.
ice packs do not contain Ethylene Glycol, aka “anti-freeze.”

How to use VibraCool” Extended Knee/Ankle:

  1. Put VibraCooV vibration unit into neoprene pouch on neoprene compression strap.
  2. Place frozen ice pack underneath the strap and secure it snugly over the area of pain.
  3. Activate vibration with toggle switch.

For Knee or Iliotibial (IT) Band Pain :
Apply directly to pain using a neoprene compression strap to secure in place.
For IT Band pain, apply above the knee joint, toward the outer aspect of the knee joint. For the jumper’s knee, apply below the kneecap.
For Ankle Pain: Apply directly to the painful area on the ankle, using a neoprene compression strap to secure in place.
For Headache s: For headaches due to occipital neuralgia, the neoprene cuff for the Extended Knee/Ankle Unit may be used, placing the unit directly on the site of pain and wrapping the strap around the head to hold in place.

How to use VibraCool” EasyFit for Elbow/Wrist

  1. Put VibraCool’s vibration unit into the neoprene pouch on the neoprene compression strap.
  2. Place a frozen ice pack underneath the strap and secure it snugly over the area of pain.
  3. Activate vibration by firmly pressing the button on top of the unit for 1.5 to 2 seconds. The unit has an automatic shutoff after 10 minutes of constant use. Press the button a second time if an additional 10 minutes of vibration is desired or recommended by a medical professional.

For Carpal Tunnel / Wrist Pain : Feed strap through D-ring, creating a loop. Partially tighten the strap. Position ice pack along the inside of the loop, against the unit pocket. Slide strap over the hand and position against the location of the pain. Tighten the strap and secure it snugly.
For Elbow Pain / Tendinitis: Apply directly over the painful area around the elbow. For Tennis Elbow (lateral epicondylitis), placement may be directly on or above the bony knob on the outside of the elbow joint.
For Golfer’s Elbow (Medial Epicondylitis): Placement may be directly on or above the bony bump on the inner part of the elbow or forearm.
How to use VibraCool®
Flex Back/Shoulder/Hip Unit

  1. Put VibraCool® vibration unit into neoprene pouch.
  2. Thread the latex-free strap through slots on the pouch.
  3. Attach either frozen ice pack or an activated heat pack beneath the elastic band. To activate the heat pack, bend the metal tab inside the heat pack back and forth until crystallization begins.
  4. Activate vibration with a toggle switch.
  5. Place over the painful area, then tie and adjust the strap as necessary to keep VibraCool® in place.

For Neck Pain
Apply to a painful area directly on the neck, near the base or on the location of tension. Hold with hand or against the pillow, DO NOT use any strap device on the neck area.

How to use VibraCool® Plantar:

  1. Feed strap, logo side up through the slot in the middle of the unit. Your strap may look different. Thread the end of the strap through the other side and through D-ring (if present).
  2. Place the cold pack on top of the curved side of the vibration unit that has the VibraCool logo. Thread the strap through the ice wing.
  3. Place foot on top of ice wing.
  4. Pull the strap in the opposite direction and wrap it around the ankle. Secure strap on velcro around the ankle or under the unit.
  5. Activate vibration with a toggle switch.

For General Aches and Pains:
Apply directly to aches, injuries, or myofascial trigger points for 10 minutes or longer. Not recommended for more than 20 minutes. Hold in place or attach to extremities with a hands-free strap or neoprene compression strap. For the back, shoulder, or hip pain, position under tight clothing to hold in place.
For Muscle Prep and Recovery:
Prior to exercise, wake up the muscles with 5 – 10 minutes of high-frequency vibration massage directly on the muscles with or without the ice or with a heat pack. After exercise, use vibration and ice together.
Type BF Applied Part
Environmental conditions:
Transport and storage between uses: -25 to 70 °C. 0-95% RH. 700-1060 hPa
Operating conditions:
5-40 °C. 15-95% RH 700-1060 hPa. 2000m altitude
US Patented British Patent No. 2455695 VC-2, VC-E, VC-K, VC-Plantar

  1. 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.

  2. Please note that changes or modifications of this product is not expressly approved by the party responsible for compliance and could void the user’s authority to operate the equipment.

  3. NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
    • Reorient or relocate the receiving antenna.
    • Increase the separation between the equipment and receiver.
    • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
    • Consult the dealer or an experienced radio/tv technician for help.

  4. 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. Pain Care Labs, 195 Arizona Ave
    • LWO8 NE Atlanta GA 30307
    877-805-2899 (Pain Care Labs Responsible Party in the USA.)

Cleaning:
VibraCool® is a personal consumer product intended to be used by a single user. VibraCool® may be cleaned with alcohol-based sanitation wipes. Do not autoclave. Do not immerse in liquid. Soiled ice packs should be disposed of and replaced.
Batteries:
Unscrew the back using a Phillips-head screwdriver to remove the back panel. VibraCool® is powered by 2 alkaline AAA batteries. Remove batteries if VibraCool® is not being used for an extended period of time.
Disposal:
Please contact your local authorities to determine the proper method of disposal of potentially biohazardous parts and accessories.

Troubleshooting:

With proper care, your VibraCool® should last for at least 1 year. With heavy use or extreme temperature fluctuations, batteries may need to be replaced more frequently. If the device stops working, replace the batteries. Press switch firmly for 1/2 second to activate or turn off.
DO NOT SERVICE WHILE IN USE

How To Order/Additional Information:

Please visit our website vibracool.com for a complete list of FAQs, other pain management tips, how-to videos, accessories, replacement parts, and more!
Warranty:
This product’s warranty covers every type of malfunction or defect that may appear or arise from normal use in the motor unit of the product for 3 years. The warranty for soft goods and other included products lasts 1 year from date of purchase. We will replace your product or refund your purchase. This warranty gives you specific legal rights, and you may also have other rights which vary from state to state.
Guarantee:
Previous medical history and intrinsic physiologic differences may make VibraCool® less effective for some people. If not completely satisfied, return within 30 days to place of purchase for a full refund, or contact us at the address below.

MMJ Labs, LLC dba Pain Care
Labs 322 Sutherland Place
Atlanta, GA 30307, U.S.A.
vibracool.com
[email protected]
877.805.2899

CS Lifesciences Europe Limited
The Black Church, St.
Mary’s Place Dublin 7, D07
P4AX, Ireland

References

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