3M Bair Hugger 55000 Manual Download Page 1

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Large Pediatric Underbody Warming Blanket - Model 55000 /

Pediatric Underbody Warming Blanket - Model 55501

INSTRUCTIONS FOR USE

Indications for Use

The 3M™ Bair Hugger™ Temperature Management System is intended
to prevent and treat hypothermia. In addition, the temperature
management system can be used to provide patient thermal comfort
when conditions exist that may cause patients to feel too warm or too
cold. The temperature management system can be used with adult and
pediatric patients.

• NOT

STERILE.

•

Contraindications, Warnings and Cautions

Explanation of Signal Word Consequences

WARNING:

Indicates a hazardous situation which, if not avoided, could result in
death or serious injury.

CAUTION:

Indicates a hazardous situation which, if not avoided, could result in
minor or moderate injury.

CONTRAINDICATION: To reduce the risk of thermal injury:

• Do not apply heat to lower extremities during aortic

cross-clamping. Thermal injury may occur if heat is applied to
ischemic limbs.

WARNING: To reduce the risk of thermal injury:

• Do not treat patients with the Bair Hugger warming unit hose

alone. Always attach the hose to a Bair Hugger warming blanket
before providing warming therapy.

• Do not allow the patient to lie on the warming unit hose.

• Do not allow the patient’s arms or legs to rest on either

hose port.

• Do not allow the warming unit hose to directly contact the

patient’s skin during warming therapy.

• Do not leave neonates, infants, children and other vulnerable

patient populations unattended during warming therapy.

• Do not leave patients with poor perfusion unmonitored during

prolonged warming therapy.

• Do not place the non-perforated side of the warming blanket

on the patient. Always place the perforated side (with the small
holes) directly in contact with the patient’s skin.

• In the operating room, do not use this warming blanket with

any device other than a Bair Hugger 500 series, 700 series, or
675 warming unit.

• Do not use a Bair Hugger 200 series warming unit in the

operating room

• Do not use a Bair Hugger 800 series patient adjustable warming

unit with any Bair Hugger warming blanket.

• Do not continue warming therapy if the red Over-temp indicator

light illuminates and the alarm sounds. Unplug the warming unit
and contact a qualified service technician.

• If a securement device (i.e. safety strap, tape) is used, ensure the

warming channels are not occluded.

• Do not place the warming blanket directly over a dispersive

electrode pad.

WARNING: To reduce the risk of patient injury or death due to
altered drug delivery:

• Do not use a warming blanket over transdermal

medication patches.

WARNING: To reduce the risk of injury due to interference
with ventilation:

• Do not allow the warming blanket or head drape to cover

the patient’s head or airway when the patient is not
mechanically ventilated.

WARNING: To reduce the risk of injury due to patient falls:

• Do not use a warming blanket to transfer or move the patient.

CAUTION: To reduce the risk of cross-contamination:

• This warming blanket is not sterile and is intended for single

patient use ONLY. Placing a sheet between the warming blanket
and the patient does not prevent contamination of the product.

CAUTION: To reduce the risk of fire:

• This product is classified as Class I Normal Flammability

as defined by the Consumer product Safety Commission’s
flammable fabric regulation, 16 CFR 1610. Follow standard safety
protocols when using high intensity heat sources.

CAUTION: To reduce the risk of thermal injury:

• Do not use if primary packaging has been previously opened or

is damaged.

CAUTION: To reduce the risk of thermal injury, hyperthermia
or hypothermia:

• 3M recommends continuously monitoring core temperature. In

the absence of continuous monitoring, monitor the temperature
of patients who are incapable of reacting, communicating
and/or who cannot sense temperature a minimum of every
15 minutes or according to institutional protocol.

• Monitor cutaneous responses of patients who are incapable

of reacting, communicating and/or who cannot sense
temperature a minimum of every 15 minutes or according to
institutional protocol.

• Adjust air temperature or discontinue warming therapy when

the therapeutic goal is reached, if elevated temperatures are
recorded or if there is an adverse cutaneous response in the
warmed area.

Internal Use

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