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Instructions for Use: HotDog

TM

 Head Warming Wrap Page 2

PRECAUTIONS

Use under the direct supervision of a clinician. 

Monitor the patient’s vital signs regularly during warming according to institutional protocol. If vital sign 
instability occurs, notify the clinician.

Care should be taken when using multiple warming methods.

Dispose of the blankets per local regulations. 

The risk of skin irritation caused by pooling of surgical prep solutions under the patient may increase with 
warming; follow surgical prep solution instructions.

Always use a barrier, such as a hair net, between the patient and the Head Warming Wrap.

Head Warming Wrap placement should be considered during X-ray imaging as the white labeling and internal 
wiring located primarily along the edges of the device may appear in images.

Summary of Contents for B107

Page 1: ...may result Examples include tissue distal to aortic cross clamping or when vasoconstrictive drugs would lead to severe prolonged vasoconstriction DO NOT warm patients receiving transdermal medication increased drug delivery may occur WARNINGS EXPLOSION HAZARD DO NOT use the HotDog Controller or Head Warming Wrap in the presence of flammable anesthetics or oxygen enriched environments such as hyper...

Page 2: ...multiple warming methods Dispose of the blankets per local regulations The risk of skin irritation caused by pooling of surgical prep solutions under the patient may increase with warming follow surgical prep solution instructions Always use a barrier such as a hair net between the patient and the Head Warming Wrap Head Warming Wrap placement should be considered during X ray imaging as the white ...

Page 3: ... When use of the Head Warming Wrap is complete clean the Head Warming Wrap as necessary See Care and Maintenance section below CARE AND MAINTENANCE DO NOT continue to use the Head Warming Wrap beyond the labeled expiration date DO NOT launder or sterilize as this may damage the Head Warming Wrap DO NOT immerse the Head Warming Wrap in liquids DO NOT use high level disinfectants e g gluteraldehyde ...

Page 4: ...he conductive fabric heaters Dry thoroughly before use Caution DO NOT place the Head Warming Wrap in an autoclave sterilizer automatic washer disinfector or any other high temperature system as this may damage the product Cleaning Disinfection Steps The cleaning steps below are general recommendations and are not meant to replace hospital specific cleaning protocols 1 DO NOT allow cleaning fluids ...

Page 5: ...ngs Medical Device See electronic IFU on website at URL provided EU Authorized Representative IPX2 Protected against dripping water when tilted up to 15 Vertically dripping water shall have no harmful effect when the enclosure is tilted at an angle up to 15 from its normal position The Controller Medical Equipment Classified by Intertek Testing Services NA Inc with respect to electric shock fire a...

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