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Instructions for Use: HotDog

TM

 Head Warming Wrap

DEFINITION OF SYMBOLS

 

Attention, consult 
accompanying 
documents.

Natural Latex Free

BF Patient Applied Part 
according to IEC60601-
1. 

Serial Number

Reference Number

Lot Number

Manufacture Date

Use only with HotDog Patient 
Warming Controller.

Store as directed in 
instructions for use. 

Temperature Sensor

Keep Dry

Conforms to European 
Medical Device 
Directive 93/42/EEC.

Transport and Storage 
Humidity Range

Transport and Storage 
Temperature Range

Return to Authorized 
Representative

Not Sterile

Protect from sharp objects. 
Discontinue use if product is 
cut or damaged.

Do Not Place Under 
Patient

Do not use after YYYY-MM-
DD

Manufacturer

Medical Device restricted 
to sale by or on the order 
of a physician

See IFU for Warnings

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, and mechanical 
hazards only, in accordance with UL 60601-1. Classified under the Medical Device Directive (93/42/EEC) as a Class IIb 
device.

Manufactured by:

EU Authorized Representative:

Augustine Temperature Management, LLC

6581 City West Parkway

Eden Prairie, MN 55344 USA

TEL 952.465.3500

FAX 952.465.3501

www.hotdogwarming.com

Tel: (31) (0) 70 345-8570

Fax: (31) (0) 70 346-7299

HotDog is a trademark of Augustine Temperature Management, registered in the U.S. Patent & Trademark Office. 

  Patents Pending.

©2020 Augustine Temperature Management, LLC.  All rights reserved.

P/N 1746EU Rev I (11/2020) 

Содержание B107

Страница 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...

Страница 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 ...

Страница 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 ...

Страница 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 ...

Страница 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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