HotDog B107 User manual

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.

Instructions for Use: HotDogTM Head Warming Wrap Page 4
Cleaning—General
Clean and disinfect the Head Warming Wrap between patient uses if it appears visibly soiled. If the Warming
Wrap is not visibly soiled, disinfection at the end of the operating day is recommended. Follow protocols for
non-critical, non-sterile medical devices that may contact intact skin. Examples of similar devices include
blood pressure cuffs, exam table covers, operating room table pads and surgical supports.
In general, alcohol-based disinfectants are easiest to use since they are fast acting and can be sprayed or wiped
on the wrap. Other cleaners that are compatible with the outer surfaces of the wrap include sodium
hypochlorite (diluted bleach), phenolic germicidal detergent, and quaternary ammonium detergent. Iodine-
containing cleaners may cause discoloration of the surface material and are therefore NOT recommended for
routine cleaning. Hydrogen peroxide-based cleaning solutions are NOT recommended because the vapors
degrade the 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 to get into the electrical connector.
2. If visible soiling is present, remove before applying a disinfectant. Scrub the affected area with
detergent, using a soft brush or sponge to remove organic matter. Rinse the surface of the wrap using
a dampened cloth. Do not immerse the wrap in liquids.
3. Apply a low or intermediate level disinfectant to the entire wrap by spraying or wiping. Follow the
disinfectant manufacturer’s application instructions.
4. Dry thoroughly before use.
ALARMS
All alarm conditions are classified as Medium Priority Technical Alarms. If an alarm occurs, unplug the
device to reset the controller. If Alarm Lights illuminate after a reset was performed, discontinue use and
refer the system to Biomedical Engineering. Refer to Controller IFU for specific information on the Error
Codes displayed.

Page 5 Instructions for Use: HotDogTM 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 [phone]
FAX [phone]
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)