HotDog B107 Manuals

HEAD WARMING WRAP INSTRUCTIONS FOR USE INTRODUCTION The HotDog Head Warming Wrap is an accessory for the HotDog Patient Warming System. These instructions apply to the following catalog numbers: HotDog Accessory Catalog Number Quantity Head Warming Wrap B107 B507 1 HotDog Head Warming Wrap cables are provided separately. INDICATIONS FOR USE The HotDog Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The HotDog Patient Warming System should be used in circumstances in which patients may not maintain a state of normothermia. The HotDog Patient Warming System is intended primarily for use in hospitals and surgical centers including, without limitation, operating, recovery and emergency rooms and on medical/surgical floors. CONTRAINDICATIONS  DO NOT warm ischemic or non-perfused tissue; thermal injury 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 hyperbaric chambers, oxygen tents, etc.  DO NOT place the heated area of the Head Warming Wrap under the patient.  Inspect the Head Warming Wrap prior to use for signs of damage or excessive wear such as cuts, holes, or loose electrical connections. If signs of wear are evident, do not use the Head Warming Wrap until it is inspected by technical staff.  DO NOT continue to use the HotDog Patient Warming System if the over-temperature indicator and/or alarm continue to sound after reset.  The Head Warming Wrap is not sterile.  Use only with HotDog Controllers. CAUTION Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare professional. Instructions for Use: HotDogTM 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. Page 3 Instructions for Use: HotDogTM Head Warming Wrap INSTRUCTIONS FOR USE 1. Inspect the surface of the Head Warming Wrap for damage (e.g., cuts, holes, loose electrical connections). Do not use the Head Warming Wrap if it is damaged. 2. Place the Head Warming Wrap around the patient’s head. Warning: DO NOT place the heated area of the Head Warming Wrap under the patient. 3. Insert one end of the electrical cable into the appropriate port on the HotDog Controller. Controller Model Port WC0X A WC5X A or B WC71 A WC77 A, B, C or D 4. Insert the other end of the cable into the electrical connector on the Head Warming Wrap. 5. Turn the HotDog Controller on and select the desired temperature setting to begin warming. The time to reach the set-point temperature from 23 C +/-2 C is less than 10 minutes. If the Head Warming Wrap does not reach the selected temperature within 10 minutes an alarm will sound (Refer to the HotDog Controller User Manual.) 6. If the HotDog Controller alarm sounds when the Head Warming Wrap is connected, do not use the Head Warming Wrap until the alarm condition is resolved. (Refer to the “Alarms” section.) 7. 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 and peracetic acid) or hydrogen peroxide-based solutions to clean the Head Warming Wrap.  DO NOT spray cleaning solutions into the electrical connector.  DO NOT use cleaning or disinfection methods different from those recommended in the Instructions for Use without first checking with an authorized service representative to ensure that the proposed methods will not damage the equipment.  DO NOT use the Head Warming Wrap if it shows signs of damage or excessive wear such as cuts, holes, or loose electrical connectors. Technical staff should perform inspection, such as electrical leakage and resistance testing, to determine if it is safe for use.  DO NOT disassemble the Head Warming Wrap; the product contains no serviceable parts. If service is required, call an authorized service representative for assistance. Storage Store the Head Warming Wrap in a dry place and in a manner that prevents it from being cut or crushed.