Explanation Of Signal Word Consequences; Contraindication; Warning; Caution - 3M Bair Hugger 675 Service Manual

Do not operate the Bair Hugger warming unit with the hose
detached from the 3M warming blanket/gown
Maximum safe working load of combination of warming unit
mounted on Rolling Cart accessory.

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.
NOTICE: Indicates a situation which, if not avoided, could result in property
damage only.

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:
• The Bair Hugger warming unit Model 675 has been designed to
operate safely ONLY with 3M disposable warming blankets and
gowns. Use with other products may cause thermal injury. To the
full extent permitted by law, the manufacturer and/or importer
declines all responsibility for thermal injury resulting from the
warming unit being used in conjunction with non-3M warming
blankets and gowns. (See www.bairhugger.com for list of
3M disposable warming blankets and gowns.)
• Do not treat patients with the Bair Hugger warming unit hose alone.
Always attach the hose to a 3M warming blanket/gown before
providing warming therapy.
• Do not place the non-perforated side of the warming blanket/gown on the
patient. Always place the perforated side (with the small holes) directly on top of
the patient in contact with the patient's skin.
• Do not place the warming blanket/gown directly over a dispersive
electrode pad.
• For the Bair Hugger flex warming gown; ensure that the blood pressure cuff,
ECG, IV or other lines or cords are not between the upper sleeve insert and the
gown prior to deploying the upper sleeve warming insert(s), as this could result
in tearing of the insert during deployment.
• For over-body warming blankets and gowns; do not place patient securement
device (i.e. safety strap or tape) over the warming blanket/gown.
• For underbody or side channel warming blankets; if a securement device (i.e.
safety strap, tape) is used, ensure the warming channels are not occluded.
• Do not allow the patient to lie on the warming unit hose.
• Do not allow the warming unit hose to directly contact the patient's skin during
warming therapy.
• Do not connect a torn or damaged warming blanket/gown to the warming unit.
• Do not leave patients with poor perfusion unmonitored during prolonged
warming therapy.
• Do not leave neonates, infants, children, and other vulnerable patient
populations unattended during warming therapy.
• Do not continue warming therapy if the red Over-temp symbol illuminates
and the alarm sounds. Unplug the warming unit and contact a qualified
service technician.
• Do not perform the over-temperature detection system test while the warming
unit is being used for warming therapy.
WARNING: To reduce the risk of patient injury or death due to altered
drug delivery:
• Do not use a warming blanket/gown over transdermal medication patches.
WARNING: To reduce the risk of injury due to interference with ventilation
• Do not allow the warming blanket/gown 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/gown to transfer or move the patient.
WARNING: To reduce the risks associated with hazardous voltage and fire
• Keep power cord visible and accessible at all times. The plug on the power cord
serves as the disconnect device.
• Only connect to outlets marked "Hospital only," "Hospital Grade," or a reliable
grounded outlet.
• Use only the 3M supplied power cord specified for this product and certified for
the country of use.
• Do not allow the power cord to get wet.
• Do not use the warming unit when it appears the warming unit, power cord or
any component is damaged. Contact 3M Technical Support.
4
• Do not disassemble the warming unit unless you are a qualified service
technician. There are electrically live parts within the unit when it is connected
to a power source.
• Connect each warming unit being tested to a separate power source.
• Do not attempt to replace the filter while the warming unit is in use.

CAUTION:

To reduce the risk of cross-contamination:
• Except for specific Bair Hugger warming blanket models, 3M warming blankets/
gowns are not sterile. Each warming blanket/gown is intended for single patient
use ONLY. Placing a sheet between the warming blanket/gown and the patient
does not prevent contamination of the product.
• Follow applicable regulations when disposing of this warming unit or any of its
electrical components.
• Clean the warming unit and the outside of the warming unit hose after
each patient use. See the "Cleaning Instructions" section under "General
Maintenance and Storage".
• Do not attempt to clean the air filter as it may be contaminated from use.
Discard the filter in a manner consistent with institutional protocol.
• Do not operate the Bair Hugger warming unit with the hose detached
from the 3M warming blanket/gown. The Bair Hugger warming
unit is intended to be used with the hose properly attached to its
corresponding warming blanket/gown and in accordance with good
practices for operating room sterile technique.
CAUTION: To reduce the risk of fire:
• 3M warming blankets and gowns are classified as Class I Normal Flammability
as defined by the Consumer Product Safety Commissions flammable fabric
regulation, 16 CFR 1610. Follow standard safety protocols when using high
intensity heat sources.
CAUTION: To reduce the risk of patient or caregiver injury:
• If mounted on an IV pole, the distance from the bottom of the warming unit to
the floor must be less than 44" (112 cm) and the IV pole wheelbase diameter
must be at least 28" (71 cm) to prevent tipping.
• Do not place the warming unit and rolling cart on an inclined surface of more
than 7 degrees with rear caster facing downward angle.
• Do not attempt to move the rolling cart when the front casters are locked.
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 therapy when the therapeutic goal
is reached, if elevated temperatures are recorded or if there is an adverse
cutaneous response in the warmed area.
• Do not place the warming unit on a soft uneven surface, such as a bed, or
a visibly wet surface as the air intake may become blocked and cause the
warming unit to overheat, compromising the warming unit's performance.
• Perform all temperature testing of the warming unit with a 3M Model
22110 temperature test unit.
• Only use 3M-supplied power cord with the warming unit.
CAUTION: To reduce the risk associated with electromagnetic
interference (EMI) due to portable and mobile radio frequency (RF)
communications equipment:
• The 3M Bair Hugger temperature management system has been tested to be
resistant to both EMI and electrostatic discharge (ESD).
• Install and put into service the 3M Bair Hugger temperature management
system according to the electromagnetic compatibility (EMC) information
provided in the Guidance and Manufacturer›s Declaration.
• Should interference occur, move away from the portable or mobile RF
communications equipment.

NOTICES

1. The Bair Hugger warming unit meets medical electronic interference requirements.
If radio frequency interference with other equipment should occur, connect the
warming unit to a different power source.
2. To avoid warming unit damage:
• Use proper Electrostatic Discharge (ESD) procedures when
performing maintenance.
• Do not modify this equipment without authorization from the manufacturer.
• Do not immerse the warming unit, warming unit parts or accessories in any
liquid or subject them to any sterilization process.
• Do not use cleaning solutions with greater than 80% alcohol or solvents,
including acetone and thinner, to clean the warming unit or hose. Solvents may
damage the labels and other plastic parts.
3M™ Bair Hugger Model 675 Warming Unit – Service Manual