Augustine Surgical HotDog U530 Instructions For Use Manual

Warming mattress + return electrode

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HotDog

Warming Mattress + Return Electrode

Models U501, U502, and U530

Instructions for Use

Manufactured by:

Augustine Temperature Management

15305 Minnetonka Blvd

Minnetonka, MN 55345

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 U530

Page 1 HotDog Warming Mattress + Return Electrode Models U501, U502, and U530 Instructions for Use Manufactured by: Augustine Temperature Management 15305 Minnetonka Blvd Minnetonka, MN 55345 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 + Return Electrode 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 + Return Electrode 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 + Return Electrode Page 6 Image 20 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 Not all Electrosurgical Units (ESUs, Generators) are compatible with this Warming Mattress + Return • Electrode. Augustine Surgical maintains a list of compatible generators. Confirm compatibility before use. RETURN ELECTRODE MATTRESS PRECAUTIONS (FOR PRECAUTIONS SPECIFIC TO USE OF WARMING MATTRESS FUNCTION, SEE PAGE 3) Use under the direct supervision of a clinician.
Page 8 User Manual: HotDog Patient Warming Mattresses + Return Electrode Page 8 Flammable agents used for cleaning or disinfecting, or as adhesive solvents, should be allowed to evaporate • before beginning electrosurgery. Avoid the pooling of flammable solutions under the patient or in body depressions such as the umbilicus •...
Page 9 Page 9 Instructions for Use: HotDog Patient Warming Mattresses STORAGE - GENERAL Store a Warming Mattress + Return Electrode in a dry place, and do not allow the devices to be cut or crushed. • Do not freeze a Warming Mattress + Return Electrode; store at room temperature. •...
Page 10 User Manual: HotDog Patient Warming Mattresses + Return Electrode Page 10 DEFINITION OF SYMBOLS Attention, consult Place under patient with this BF Patient Applied Part accompanying documents. side up according to IEC60601-1. Do not use after Serial Number Reference Number YYYY-MM-DD Manufacture Date Unique Device Identifier...
Page 11 Page 11 Instructions for Use: HotDog Patient Warming Mattresses 46.5 47.5 48.5 49.5 50.5 1. As a capacitive neutral electrode (NE), contact capacitance shall be no less than 4 nF over the frequency Return Electrode range of 300-600 kHz, tested per IEC 60601-2-2 ed6.0, clause 201.15.101.6 Electrosurgical Unit (ESU, Generator) Compatibility As indicated, the HotDog Return Electrode Mattress is restricted to use with isolated monopolar electrosurgical generators.
Page 12 User Manual: HotDog Patient Warming Mattresses + Return Electrode Page 12 including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The HotDog™ System is intended for use in the electromagnetic environment specified below. The customer or user of the HotDog System should assure that it is used in such an environment.
Page 13 Page 13 Instructions for Use: HotDog Patient Warming Mattresses Guidance and Manufacturer’s Declaration – Electromagnetic Immunity (cont’d) The HotDog™ Patient Warming System is intended for use in the electromagnetic environment specified below. The customer or the user of the HotDog Patient Warming System should assure that it is used in such an environment. IEC 60601 Electromagnetic Environment –...
Page 14 User Manual: HotDog Patient Warming Mattresses + Return Electrode Page 14 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

This manual is also suitable for:

Hotdog u501 Hotdog u502