Smiths Medical level 1 Operator's Manual page 11

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During use, do not position the convective warmer such that it is difficult to disconnect the power
cord from the wall or from the warmer. Thermal injury may occur if the device cannot be powered off
easily if needed.
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In compliance with safety standard IEC 80601-2-35, there is a possible risk of electrical shock, burns,
or electromagnetic interference with the use of High Frequency surgical instruments or endocardial
catheters in the presence of active Heating Devices.
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The convective warmer meets the international electrical interference requirements of EN 60601-1-2.
MRI, Portable and mobile RF communications equipment, and other such devices can affect
the convective warmer.
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Do not operate the convective warmer in the presence of a flammable anesthetic mixture with air,
oxygen, or nitrous oxide. The risk of explosion exists if the device is operated in a potentially
explosive environment.
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To prevent fire hazard and possible damage to the convective warmer, use only fuses specified. Only
competent personnel knowledgeable in the safety procedures required for servicing live primary
MAINS parts shall be allowed to open the enclosure.
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If so equipped, ensure that the convective warmer IV pole mounting clamp is properly tightened
before each use. Failure to securely mount the convective warmer onto the IV pole may cause it to
slide down the IV pole, and injure the patient or user.
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Do not perform maintenance while the convective warmer is operating. Risk of thermal injury exists
if the device is operating.
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This device can only be used in conjunction with a Smiths Medical convective warming blanket. For
the safe operation of this device, the user must follow all warnings, precautions, and instructions
provided in the Instructions for Use supplied with the compatible convective warming blanket,
in addition to this Operator's Manual.
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Continuously monitor patient's body core temperature, vital signs, and observe cutaneous response
at regular intervals to prevent thermal injury. If erythema or instability in vital signs is evident,
decrease the temperature setting or discontinue use of convective warming therapy.
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To prevent thermal injury in hypotensive or hypoperfused patients, observe cutaneous response
more frequently. Reduce the temperature setting or discontinue use of convective warming therapy
if instability in vital signs or erythema occurs.
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If the patient's nose or mouth is positioned against the convective warming blanket or the plastic
drape, closely monitor the patient's breathing to prevent suffocation injury.
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Cover all open wounds in contact with the convective warming blanket to prevent airborne
contamination.
S E C T I O N 3
Warnings
Level 1®
CONVECTIVE WARMER
• I m p o r t a n t S a f e t y I n f o r m a t i o n
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