DeRoyal Temperature Therapy Blankets User Guide User Guide

TEMPERATURE THERAPY PROTOCOLS

Treatment

Period:

Day:

Through

Day:

Day:

Through

Day:

Day:

Through

Day:

DeRoyal Industries, Inc. | 200 DeBusk Lane | Powell, TN 37849 USA |800.DEROYAL | 865.938.7828 | deroyal.com

Instructions for Use

Frequency/

Duration:

Type of

Barrier:

Inspect Skin

Every:

Single Patient Use OnlyRX Only

Inspection

Method:

Temperature Therapy Blankets

blood flow before, during and/or after use of temperature therapy. ALWAYS
review your patient-specific instructions and all product information with
the patient. IMMEDIATELY DISCONTINUE use of temperature therapy if your
patient experiences, at the treatment site, any change in skin condition or
appearance, including burning, numbness, tingling, discoloration, itching,
blisters, welts, irritation; temporary loss of normal motor function; or increased
pain, redness or swelling.

SAFETY ALERT FOR PATIENTS! TEMPERATURE THERAPY CAN CAUSE THERMAL
INJURY, INCLUDING SERIOUS HEAT OR COLD-INDUCED INJURIES.

temperature therapy without a prescription from your healthcare provider.
DO NOT use temperature therapy if you have not read and understood all unit
and therapy blanket warnings, contraindications and the Instructions for Use
or if you do not feel you are appropriately trained on the use of temperature
therapy. DO NOT use temperature therapy if your healthcare provider has not
provided you with specific written instructions on (1) how long and how often
to use temperature therapy during individual therapy sessions, (2) mandatory
use of a wrap to serve as a barrier between the skin and therapy blanket, (3)
correct therapy blanket application, (4) how and when to inspect skin, and (5)
total length of treatment with the unit. DO NOT use temperature therapy if you
do not understand the instructions or product information provided by your
healthcare provider. DO NOT use temperature therapy if you are not able to
inspect the condition of your skin underneath the therapy blanket on at least
an hourly basis or as otherwise recommended by your healthcare provider.

IMMEDIATELY DISCONTINUE use of temperature therapy and CONTACT
YOUR HEALTHCARE PROVIDER if you experience, at the treatment site,

any change in skin condition or appearance, including burning, numbness,
tingling, discoloration, itching, blisters, welts, irritation; temporary loss of
normal motor function; or increased pain, redness or swelling.

DO NOT use

INDICATIONS FOR USE – WHEN TO USE TEMPERATURE THERAPY
Cold Therapy. Use of cold therapy is intended to be prescribed by

a properly licensed practitioner to temporarily reduce pain and
swelling resulting from injury to or surgery to areas such as the
shoulder, knee and back.

Hot Therapy. Use of hot therapy is intended to be prescribed by a
properly licensed practitioner to temporarily increase blood circulation
and lessen muscle soreness or stiffness during rehabilitation.

Product Availability: Therapy blankets are available in both
sterile and non-sterile versions. Not intended to be sterilized by
user.

Any other uses of this product are not recommended.

Ask your doctor whether you can use compression or mild
exercise to ensure adequate blood flow to the affected area
before, during and/or after use of temperature therapy.

DO NOT use until you have completely read these Instructions for

Use.

SAFETY ALERT FOR HEALTHCARE PROVIDERS! TEMPERATURE THERAPY
CAN CAUSE THERMAL INJURY, INCLUDING SERIOUS HEAT OR COLD­INDUCED INJURIES, IF NOT PROPERLY PRESCRIBED. DO NOT prescribe

temperature therapy if you have not read and understood all unit and therapy
blanket warnings, contraindications and the Instructions for Use or if you
do not feel you are appropriately trained on the use of temperature therapy.
ALWAYS consider the individual patient’s medical history in comparison
to the warnings and contraindications prior to prescribing temperature
therapy. ALWAYS provide the patient with specific written instructions on
the (1) frequency and duration of use during individual therapy sessions, (2)
mandatory use of a skin barrier, (3) correct therapy blanket application, (4)
methods and frequency of skin inspection, (5) total length of treatment and,
when appropriate, (6) use of compression or mild exercise to ensure adequate

CONTRAINDICATIONS – WHEN NOT TO USE COLD THERAPY
DO NOT use cold therapy on patients with any of the following

contraindications:

• History of cold injury, frostbite or adverse reactions to cold therapy.

• Incoherent due to sedation, anesthesia, coma or sleep.

• Decreased skin sensitivity or localized circulation or wound healing
problems, including those caused by multiple surgical procedures.

• Circulatory syndromes due to Raynaud’s disease, Buerger’s
disease, peripheral vascular disease, vasopastic disorders, or
hypercoagulable clotting disorders.

• Hand/wrist or foot/ankle surgery exhibiting polyneuropathy.

• Hypersensitivity to cold.

• Children 12 and under.

• Local tissue infection.

• Diabetes.

If you have any of the above contraindications, ask your
healthcare provider for alternate treatments.

CONTRAINDICATIONS – WHEN NOT TO USE HOT THERAPY
DO NOT use hot therapy on patients with any of the following

contraindications:

• History of heat injury or adverse reactions to hot therapy.

• Incoherent due to sedation, anesthesia, coma or sleep.

• Decreased skin sensitivity or localized circulation or wound
healing problems.

• Arteriosclerosis or atherosclerosis.

• Abdomen of women who are pregnant.

• Localized malignancy in treatment area.

• Hypersensitivity to heat.

• Local tissue infection, swelling or inflammation.

If you have any of the above contraindications, ask your
healthcare provider for alternate treatments.

PRECAUTIONS

• Condensation on therapy blankets and couplings may occur when
in use depending on the air temperature and temperature at the
treatment site. This is normal; however, DO NOT continue use if
skin barrier becomes moist. Change to dry barrier as necessary.

• Product should not be used if sterile packaging is damaged or
opened or if shelf-life has expired.

Instructions for Use

1. Place blanket on affected extremity with the
felt side facing away from the skin. NOTE:
With the exception of the ankle and lumbar
blankets, tubes should face downward.

2. Pull straps around the affected extremity and
securely attach the hook and loop closures
for a snug comfortable fit. NOTE: Not all
blankets are packaged with straps. An
elastic bandage or DeRoyal foam wrap can
also be used.

3. Re-adjust as necessary.

4. Initiate therapy as described in ‘Instructions for Use’ included in temperature

therapy unit.

WARRANTY

DEROYAL PRODUCTS ARE WARRANTED FOR NINETY (90) DAYS FROM
THE DATE OF SHIPMENT FROM DEROYAL AS TO PRODUCT QUALITY AND
WORKMANSHIP. DEROYAL’S WRITTEN WARRANTIES ARE GIVEN IN LIEU OF
ANY IMPLIED WARRANTIES, INCLUDING WARRANTIES OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE.

Shoulder

Hip

Knee

Lumbar

TROUBLESHOOTING

Problem Solution

No water flow to therapy
blanket.

Check for hose kinks or folds in
therapy blanket.

WARNINGS

!

• Read and understand all unit and therapy blanket warnings,
contraindications, precautions and the Instructions for Use
prior to using temperature therapy.

• Can cause thermal injury, including serious heat or cold­induced injury. IMMEDIATELY DISCONTINUE and CONTACT
YOUR HEALTHCARE PROVIDER if you experience, at the
treatment site, any change in skin condition or appearance,
including burning, numbness, tingling, discoloration, itching,
blisters, welts, irritation; temporary loss of normal motor
function; or increased pain, redness or swelling.

• This therapy blanket is prescription (Rx) only. DO NOT use this
therapy blanket without a prescription from a properly licensed
practitioner. Use of temperature therapy without a prescription
or failure to follow or understand the prescription may result in
serious injury, including frostbite and tissue necrosis.

• DO NOT use if you are not able to inspect the condition of
the skin underneath the therapy blanket on at least an hourly
basis. However, due to individual differences in sensitivity and
susceptibility to cold and hot temperatures, ALWAYS observe
the treatment area as recommended by your healthcare
provider.

• DO NOT apply therapy blanket underneath a fiberglass or
plaster cast or other dressing, wrapping or bracing that would
prevent the patient from checking the skin under the therapy
blanket.

• DO NOT let any part of the therapy blanket touch the skin or
an open wound. ALWAYS use a barrier between the skin and
the therapy blanket. If a sterile dressing has been applied to
the treatment site that does not completely cover the skin
under the therapy blanket, use an additional barrier. Use of a
barrier with a non-sterile blanket does not prevent possible
contamination. Application of the therapy blanket directly on
the skin may result in serious injury, including frostbite and
tissue necrosis.

• ALWAYS check for moisture on the barrier between the skin
and the therapy blanket. Because moisture on the barrier may
create colder temperatures on the skin and result in serious
injury, immediately discontinue use if moisture is present on
the barrier. Change to dry barrier as necessary.

• DO NOT use a therapy blanket that is damaged or is leaking
water as this may result in serious injury, including infection
and tissue necrosis. ALWAYS check for a secure connection
between the unit and therapy blanket. ALWAYS check for any
leaks at the start of every individual therapy session.

• DO NOT use this therapy blanket with any unit other than a
DeRoyal brand unit.

• ALWAYS follow the healthcare provider’s directions for (1)
how long and how often to use during individual therapy
sessions, (2) mandatory use of a wrap to serve as a barrier
between the skin and therapy blanket, (3) correct therapy
blanket application, (4) how and when to inspect skin, and (5)
total length of treatment. Failure to follow or understand the
directions may result in serious injury, including frostbite and
tissue necrosis.

• This thearapy blanket is intended for single-patient use.
Secondary use can cause serious injury, including infection.

• DO NOT use in the presence of flammable anesthetics or other
flammable materials. Such use may result in serious injury due
to the risk of explosion.

• No modifications of this equipment allowed.

• Cables and hoses may cause strangulation hazard. Keep out of
reach of children.

©2015 DeRoyal Industries, Inc. All Rights Reserved.
Part #43-00409N Revised 1/15