Augustine Surgical HotDog U101 User manual

1
HotDog Patient
Warming Mattresses
Models U1XX, U2XX and U3XX
Instructions for Use
Manufactured by: EU Authorized Representative: MDR Importer:
Augustine Temperature Management
7656 West 78th Street
Bloomington, MN 55439 USA
TEL: [phone]
FAX: [phone]
EMAIL: [e-mail]
www.hotdogwarming.com
NL-AR-000000116
TEL (31) (0) 70 345-8570
FAX (31) (0) 70 346-7299
MedEnvoy Global BV
Prinses Margrietplantsoen 33 – Suite 123
2595 AM The Hague
The Netherlands
NL-IM-000000248
TEL
:[phone]

User Manual: HotDog Patient Warming Mattresses Page 2
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DEVICE DESCRIPTION
HotDog Warming Mattresses, including OR table pad and table pad overlays (U1XX, U2XX and U3XX)
(“Warming Mattresses”) are components of the HotDog Temperature Management System (“System”) and
can be used with HotDog Controller Models WC5X or WC77, Warming Mattresses provide under-body
patient warming at a specified and uniform temperature. An internal temperature sensor provides output to the
Controller to maintain the specified temperature. Warming Mattress overlays, although not stand-alone
pressure-relief devices, include a built-in pressure relief pad and are water- and solvent-resistant. All seams
are fully sealed to allow for easy cleaning and disinfection.
These instructions apply to the following part numbers:
HotDog Product Description
Part
Number Qty/Pkg
Compatible
Controllers
Underbody Warming Mattress,
82 cm (32in)
U101 1 WC77, WC52
Underbody Warming Mattress,
127 cm (50in)
U102 1 WC77, WC52
Pediatric Underbody Warming Mattress
74 cm (29in)
U220 1 WC77, WC52
Trendelenburg Warming Mattress,
89 cm (35in)
U300 1 WC77, WC52
A112 cables are available separately.
INDICATIONS FOR USE
The HotDog Temperature Management System is intended to prevent or treat hypothermia and to provide
warmth to patients. The System should be used in circumstances in which patients may not maintain a state of
normothermia. The System can be used with adult and pediatric patients. Warming Mattress are designed to
provide pressure relief, although overlays are not stand-alone pressure-relief devices. The System can be used
with adult and pediatric patients. The Pediatric Underbody Warming Mattress is intended for use with
pediatric patients.
The System is intended primarily for use in hospitals and surgical centers including, without limitation,
operating rooms, recovery rooms, emergency rooms, burn units and on other 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.
 Do not use Warming Mattresses with other under-patient thermal management systems.
WARMING MATTRESS WARNINGS
 Explosion Hazard – Do not use Warming Mattresses in the presence of flammable anesthetics or highly
oxygen-enriched environments such as hyperbaric chambers, oxygen tents, etc.
 Inspect System components prior to each use for signs of damage or excessive wear such as cuts, holes, or
loose electrical connections or cold areas. If signs of wear are evident or if the warming device has been
subjected to extreme physical force (e.g. pinched by clamps or run over by carts), do not use the device
until it has been inspected by technical staff.
 Do not continue to use the System if the over-temperature indicator and/or any other alarms continue to
sound after reset. Refer to the “Alarms and Alerts” section of this manual for more information.
 Warming Mattresses are not sterile.
CAUTION
Federal law (USA) restricts these devices to sale by or on the order of a licensed healthcare professional.

Page 3 Instructions for Use: HotDog Patient Warming Mattresses
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WARMING MATTRESS 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.
 Exercise caution when using multiple warming methods.
 Ensure that Warming Mattresses are securely fastened to the table with “THIS SIDE UP” labeling
facing up.
 The risk of skin irritation caused by pooling of surgical prep solutions under the patient may increase with
warming; ensure that surgical prep solution instructions for use are followed.
 Gel pad placement between Warming Mattresses and the patient is not recommended; gel pads may cause
a loss of warming performance.
 Always use a thin barrier between the patient and Warming Mattresses.
 Position the patient on flat Warming Mattress.
 Do not use Warming Mattresses when the risk of pressure injury cannot be mitigated. Take extra
precaution to alleviate pressure under bony prominences when warming under the patient.
 Maintain contact between the patient and the labeled sensor on Warming Mattress.
 Do not use operating table clamps or similar devices on Warming Mattresses as they may cause damage
to the device and result in loss of the heating function and/or localized heat build-up in the damaged area.
 Do not place Warming Mattresses over a table joint that will move during surgery.
 Do not use Warming Mattress Overlays as a stand-alone patient pressure relief system.
 Do not place any hard objects (e.g., mattress cables, EKG cables, hard cautery return pads, patient fluid
lines, etc.) between Warming Mattress and the patient.
 Do not fold Warming Mattresses during use, as localized heat may build-up.
 Adjust placement of Warming Mattress during X-rays as the internal wiring, located primarily along the
edges of the device, and the sensor with associated wire may appear in images.
 Do not place fluid lines under Warming Mattresses or between Warming Mattresses and other warming
devices.
 Do not position the patient’s head directly on Warming Mattress.
 Do not partially cover the Warming Mattress with thick insulation unless sensor is also covered, or
product damage may occur.
 This device should not be disposed of with general waste at end of life. Follow local regulations for
disposal. The device does not pose any potential hazard.
 Any serious incident that has occurred in relation to this device should be reported to the manufacturer
and the competent authority of the country in which it occurred.
INSTRUCTIONS FOR USE
Follow BEST practices to achieve optimal results, as described in part MT302 BEST Results Poster
(downloadable at hotdogwarming.com under Brochures). Use only with HotDog Controllers, models WC5X
or WC77.
1. Inspect the surface of Warming Mattress for damage (e.g., cuts, tears, creases). Do not use the device if it
is damaged.
2. Place Warming Mattress on the padded operating table. Note: For U300, align the device’s perineal cutout
with OR table mattress perineal cutout in Trendelenburg positioning.
Note: Ensure “THIS SIDE UP” labeling faces up.
3. Attach Warming Mattress straps to the operating table.
Warning: Ensure that the straps on each side of the device are firmly secure. If the straps are not
secure, the device can slide off the table, resulting in patient injury.

User Manual: HotDog Patient Warming Mattresses Page 4
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4. Place a thin barrier over the entire surface of Warming Mattress. Note: For U300 in Trendelenburg
positioning, the A30X WaffleGrip accessory functions as the thin barrier.
Note: For U220 (Pediatric Warming Mattress) users.
- U220 are intended for use with patients < 20 kg.
- Ensure the patient is on top of the warming panel, over the sensor. (Figure 1.)
Use a thin barrier between the patient and the mattress (Figure 3.).
(Figure 1.)
- Use the two foam guides below the warming panel to locate the sensor (Figure 2.) and ensure placement of
the
patient on top of the warming panel over the sensor and on top of the thin barrier. (Figure 3.)
(Figure 2.) (Figure 3.)
- Place any patient-positioning devices under the patient below the warming panel. (Figure 4.)
Do not place patient under the warming panel.
(Figure 4.)
5. Insert the blue Mattress Cable (PN A112) into the Mattress Connector.
Note: Do not force the connector into the socket. Align the red dots on each connector and gently push
the connectors together. You will feel a click when the connectors engage.
6. Insert the other end of the blue Mattress Cable (PN A112) into the blue port on the Controller.
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. If the device does not reach the selected temperature within 10 minutes, an
alarm will sound (Refer to the HotDog Controller User and Technical Manual.)
8. If the Controller alarm sounds when Warming Mattress are connected, do not use the device until the
alarm condition is resolved. (Refer to the “Alarms” section.)
9. At the conclusion of warming, clean Warming Mattress as necessary. (Refer to “Care and Maintenance”
section.)
10. To disconnect the Mattress Cable, grip the connector bodies and pull them apart (Figure 2).
Note: Do not pull on cables or attempt to rotate or unscrew connectors. Bending or twisting the
cables or connectors may result in damage to the wires or the connector pins.
CARE AND MAINTENANCE
 Do not continue to use Warming Mattresses beyond the labeled expiration date, found on the cable.
 Do not launder or sterilize as this may damage Warming Mattresses.
 Do not immerse Warming Mattresses in liquids.
 Do not use high-level disinfectants (e.g., gluteraldehyde and peracetic acid) or hydrogen peroxide-based
solutions to clean Warming Mattresses.
warming panel foam guides
sensor

Page 5 Instructions for Use: HotDog Patient Warming Mattresses
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 Do not spray cleaning solutions into the electrical connector.
 Do not use cleaning or disinfection methods different from those recommended in the User Manual without
first checking with an authorized service representative to ensure that the proposed methods will not damage
the equipment.
 Do not use Warming Mattresses if they show signs of damage or excessive wear such as cuts, holes or loose
electrical connectors. Technical staff should inspect devices to determine if they are safe for use.
 Do not disassemble Warming Mattresses; the devices have no user- serviceable parts. If service is required,
call an authorized service representative for assistance.
 Do not fold and crease the Warming Mattress sharply or fold repeatedly in the same location.
STORAGE
 Store Warming Mattresses in a dry place, and do not allow the devices to be cut or crushed.
 Do not freeze Warming Mattresses; store at room temperature.
Note: If Warming Mattresses have been exposed to freezing temperatures, do not bend or roll the
devices as this may result in cracks to the pressure-relief foam. Allow the devices to reach room
temperature prior to handling.
 Do not store any other objects on top of Warming Mattresses.
 Do not fold or sharply bend Warming Mattresses; the recommended storage configuration is flat
(preferred) or rolled.
CLEANING - GENERAL
Clean and disinfect the Warming Mattress between patient uses if the device appears visibly soiled. If the
device 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.
Hydrogen peroxide-based cleaning solutions are NOT recommended because the vapors degrade the
conductive fabric heaters.
In general, alcohol-based disinfectants are easiest to use since they are fast-acting and can be either sprayed or
wiped on the device. Other cleaners that are compatible with the outer surface of the device 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. Dry thoroughly before use.
Caution: Do not place the Warming Mattress in an autoclave, sterilizer, automatic washer-disinfector
or any other high-temperature system as this may damage the device.
CLEANING AND 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 Warming Mattress using a
dampened cloth. Do not immerse the device in liquids.
3. Apply a low- or intermediate-level disinfectant to the entire surface of Warming Mattresses by spraying or
wiping. Follow the disinfectant manufacturer’s application instructions to ensure disinfection.
4. Dry thoroughly before use.

User Manual: HotDog Patient Warming Mattresses Page 6
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ALARMS
All alarm conditions in the Controller are classified as Medium Priority Technical Alarms. If an alarm occurs,
unplug the device to reset the Controller. Check the Warming Mattress and attempt to resolve the alarm. If
Alarm Lights illuminate after a reset is performed, discontinue use and refer the system to Biomedical
Engineering. Refer to the Controller User and Technical Manual for specific information on the Error Codes
displayed.
DEFINITION OF SYMBOLS
Attention, consult
accompanying documents.
Place under patient with this
side up
BF Patient Applied Part
according to IEC60601-1.
Serial Number Reference Number
Do not use after
YYYY-MM-DD
Manufacture Date Unique Device Identifier Do not submerge
Temperature Sensor Keep Dry
Conforms to European
Medical Device Regulation
2017/745
Transport and Storage
Humidity Range
Transport and Storage
Temperature Range
Separate treatment from
general waste at end of
life. See Precautions for
details.
Natural Latex Free Not Sterile
Protect from sharp objects.
Discontinue use if product
is cut or damaged.
Manufacturer
Consult the electronic
instructions for use on the
website at the URL provided.
EU Authorized
Representative
Medical Device
See IFU for Warnings and
Precautions
Medical Device restricted to
sale by or on the order of a
physician
MDR Importer
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.
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; 7,714,255; 7,851,729; 7,786,408; 8,062,343; 8,283,602;
8,604,391; 8,624,164; 8,772,676; 8,986,359; 9,962,122; 9,668,303; 10,154,543; 10,201,935; 10,206,248; 10,506,668; PCT Patent EP
2,062,460) . Other patents are pending.
©2022 Augustine Temperature Management, LLC. All rights reserved. P/N 2064EU Rev J (01/2022)