HOTDOG U Series Mattresses Instruction Manual

Instruction Manual for HOTDOG models including: U101, U102, U220, U300, U Series Mattresses, U Series, Mattresses

2064EN rev N

Dan Grewe

Manuals, Quality, and Other - HotDog Patient Warming

File Info : application/pdf, 7 Pages, 1.60MB

2064EN-rev-N

HotDog Patient Warming Mattresses Models U1XX, U2XX and U3XX Instructions for Use

Manufactured by: Augustine Temperature Management 15305 Minnetonka Blvd Minnetonka, MN 55345 USA TEL: 952.465.3500 FAX: 952.465.3501 EMAIL: cs@augsurg.com www.hotdogwarming.com

EU Authorized Representative:
Emergo Europe B.V. Westervoortsedijk 60 6827 AT Arnhem The Netherlands NL-AR-000000116

MDR Importer:
MedEnvoy Global BV Prinses Margrietplantsoen 33 Suite 123 2595 AM The Hague The Netherlands NL-IM-000000248

User Manual: HotDog Patient Warming Mattresses

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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

Compatible

Number Qty/Pkg Controllers

Underbody Warming Mattress, 82 cm (32in)

U101

Underbody Warming Mattress, 127 cm (50in)

U102

Pediatric Underbody Warming Mattress 74 cm (29in)

U220

Trendelenburg Warming Mattress, 89 cm (35in)

U300

A112 cables are available separately.

WC77, WC52

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.

TARGET PATIENT GROUP
The System can be used with adult or pediatric patients in circumstances in which patients may not be able to maintain a state of normothermia.

INTENDED USE The System is designed to compensate for body heat loss before, during, and after surgery, and in other situations in which patients may not be able to maintain a state of normothermia.
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.
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Instructions for Use: HotDog Patient Warming Mattresses

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. California Proposition 65 Warning: The medical devices and products mentioned in this IFU may contain
chemicals including Urethane or PVC, which is known to the State of California to cause cancer, birth defects, or other reproductive harm. For more information go to, www.p65warnings.ca.gov

CAUTION Federal law (USA) restricts these devices to sale by or on the order of a licensed healthcare professional.

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.
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User Manual: HotDog Patient Warming Mattresses

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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.

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.).

sensor

(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.)

warming panel

foam guides

(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.

5. Insert the blue Mattress Cable (PN A112) into the Mattress Connector.
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(Figure 4.)

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Instructions for Use: HotDog Patient Warming Mattresses

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. 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 noncritical, 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.
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User Manual: HotDog Patient Warming Mattresses

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Hydrogen peroxide-based cleaning solutions should NOT be used 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. Iodinecontaining 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.
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.

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DEFINITION OF SYMBOLS

Instructions for Use: HotDog Patient Warming Mattresses

Attention, consult accompanying documents. Serial Number Manufacture Date Temperature Sensor Transport and Storage Humidity Range
Natural Latex Free
Manufacturer
Medical Device
MDR Importer

Place under patient with this side up
Reference Number
Unique Device Identifier
Keep Dry
Transport and Storage Temperature Range
Not Sterile
Consult the electronic instructions for use on the website at the URL provided. See IFU for Warnings and Precautions

BF Patient Applied Part according to IEC60601-1.
Do not use after YYYY-MM-DD
Do not submerge
Conforms to European Medical Device Regulation 2017/745 Separate treatment from general waste at end of life. See Precautions for details.
Protect from sharp objects. Discontinue use if product is cut or damaged.
EU Authorized Representative
Medical Device restricted to sale by or on the order of a physician

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 European Medical Device Regulation 2017/745 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.

P/N 2064EN Rev N (02/2024)

References

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