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Augustine Surgical HotDog U501 Instructions For Use Manual

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HotDog
Warming Mattress + Return Electrode
Models U501 and U502
Instructions for Use
Manufactured by:
Augustine Temperature Management
7656 West 78
th
Street
Bloomington, MN 55439 USA
TEL: 952.465.3500
FAX: 952.465.3501
EMAIL: cs@augsurg.com
www.hotdogwarming.com
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Summary of Contents for Augustine Surgical HotDog U501

  • Page 1 HotDog Warming Mattress + Return Electrode Models U501 and U502 Instructions for Use Manufactured by: Augustine Temperature Management 7656 West 78 Street Bloomington, MN 55439 USA TEL: 952.465.3500 FAX: 952.465.3501 EMAIL: cs@augsurg.com www.hotdogwarming.com...
  • Page 2: Device Description

    User Manual: HotDog Patient Warming Mattresses Page 2 DEVICE DESCRIPTION HotDog Warming Mattresses + Return Electrode are components of the HotDog Temperature Management System (“System”) and can only be used with HotDog Controller Model WC77 to provide under-body patient warming at a specified and uniform temperature.
  • Page 3 Page 3 Instructions for Use: HotDog Patient Warming Mattresses California Proposition 65 Warning: The medical devices and products mentioned in this IFU may contain • chemicals including Urethane, which is known to the State of California to cause cancer, birth defects, or other reproductive harm.
  • Page 4 User Manual: HotDog Patient Warming Mattresses Page 4 1. Inspect the surface of the Warming Mattress for damage (e.g., cuts, tears, creases). Do not use the device if it is damaged. 2. Place the Warming Mattress on top of the padded operating table. (Image 1.) Ensure that “THIS SIDE UP”...
  • Page 5 Page 5 Instructions for Use: HotDog Patient Warming Mattresses 7. Turn the Controller on and select the desired temperature setting to begin warming. Allow up to 10 minutes for Warming Mattress to reach set point. The time to reach the set-point temperature from 23 C +/-2 C is less than 10 minutes.
  • Page 6 User Manual: HotDog Patient Warming Mattresses Page 6 (Figure 15.) RETURN ELECTRODE MATTRESS CONTRAINDICATIONS (FOR CONTRAINDICATIONS SPECIFIC TO USE OF WARMING MATTRESS FUNCTION SEE PAGE 2) Do not use the Warming Mattress + Return Electrode with pediatric patients. It is for adult patient use •...
  • Page 7 Page 7 Instructions for Use: HotDog Patient Warming Mattresses RETURN ELECTRODE CAUTIONS (FOR CAUTIONS SPECIFIC TO USE OF WARMING MATTRESS FUNCTION SEE PAGE 3) Federal law (USA) restricts these devices to sale by or on the order of a licensed healthcare physician. •...
  • Page 8 User Manual: HotDog Patient Warming Mattresses Page 8 The Warming Mattress + Return Electrode and A136 cable are compliant with IEC-60601-2-2 only in the following parameters: Frequency Cut Power COAG Power [kHz] [watts] [watts] 300-600 0-300 0-120 CARE AND MAINTENANCE - GENERAL Do not continue to use a Warming Mattress + Return Electrode beyond the labeled expiration date, found on •...
  • Page 9: Definition Of Symbols

    Page 9 Instructions for Use: HotDog Patient Warming Mattresses containing cleaners may cause discoloration of the surface material and are, therefore, NOT recommended for routine cleaning. Dry thoroughly before use. Caution: Do not place the Warming Mattress + Return Electrode in an autoclave, sterilizer, automatic washer-disinfector or any other high-temperature system as this may damage the device.
  • Page 10 User Manual: HotDog Patient Warming Mattresses Page 10 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. HotDog is a trademark of Augustine Temperature Management, registered in the U.S. Patent & Trademark Office. Devices are protected by some or all of the following patents: (US Patents 7,543,344;...

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