The Geratherm SOS-Rescue Bag is a temperature controlled electric whole body warming system intended for use in preventing or treating the effects of hypothermia in adults while at the rescue scene or during transport by air or ground to a medical facility.

Device Description

The Geratherm SOS-Rescue Bag is made up of five major components: 1. Bag: The main functional element is 78.75 inches (200cm) by 31.5 inches (80 cm) comprised of two primary elements: (a) The bag is constructed like a sleeping bag with an actively warmed upper panel and insulated bottom panel. The upper warming cover uses electrically resistive woven carbon fiber elements to generate warmth. The warming elements are sandwiched between two layers of Dacron® polyester hollow fiber insulating fleece. Lastly, the polvester fleece/carbon fiber layers are encapsulated with a waterproof polyurethane / polyester cloth laminate outside layer. A permanently attached power is cable located near the upper corner of the active warming cover. The free end is plugged into the power control module via color-coded quick-connect power connectors. The top warming cover is permanently sewn along one entire side to the insulated "bottom" panel. This arrangement allows top panel to be folded over the patient and secured once the patient has been placed in a prone position on the bottom panel. The bottom panel has 9 (nine) handholds around its perimeter that lets rescue personnel carry or move a supine patient without the use of a stretcher. (b) A removable waterproof polyurethane / polyester cloth laminate protective liner is attached to the bag's inner surface. The protective cover is held in place to the bag's inner surfaces with Velcro® attachments. This attachment system permits easy removal for machine washing and disinfecting. 2. Control Module: The control module is a impact plastic housing that contains the electronic circuitry. The module regulates bag temperature through a feedback circuit employing two thermistor temperature sensing systems. Operator control is achieved through the use of four buttons located on the face of the module: an on button, off button, a 37° C (98.6°F) select button, and a 42° C (107.6°F) select button. The control module uses LED arrays to display both bag temperature and battery power status. Normal functions are monitored both through visual displays and audible signal. Power sources include the following: the auxiliary battery, an automotive type power supply outlet, or an aircraft power supply outlet. Either 12 volt DC automotive or 24-28 volt DC aircraft power sources may be used to power the unit. 3. Battery: The Geratherm SOS-Rescue Bag uses a sealed lead-acid gel rechargeable battery of 10-ampere hour capacity. 4. Cabling: The Geratherm SOS-Rescue Bag has a power cable permanently attached to the upper corner. The cable attaches directly to the Control Module, The cable supplying power to the power module has a color-coded quick connect on the module end and a connecter that fits the auxiliary battery or automotive/aircraft DC power outlets on the other. 5. AC Charger: The Geratherm SOS-Rescue Bag employs a 12 volt, DC, 2ampere hour output battery charger to charge the battery or maintain full battery status. The charger may be used with either 110 or 240 Volt, 50 or 60 Hertz, AC input electric current.

AI/ML Overview

The Geratherm® SOS-Rescue Bag is a thermal regulating system designed to prevent and counteract accidental hypothermia. The acceptance criteria and supporting studies are detailed below:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Criteria	Acceptance Criteria (typically implied by predicate device or standards)	Reported Device Performance (Geratherm® SOS-Rescue Bag)
Indications for Use	Preventing/counteracting hypothermia	Preventing / counteracting hypothermia in accident victims and patients during transport.
Function	Low-level distributed heat to patient	Low-level distributed heat to patient.
Heat Delivery Mechanism	Conduction	Conduction
Heat Source	Electrically generated heat	Resistive carbon fiber cloth in an insulated cover.
Electrical Requirements	Compatible with transport power sources (e.g., 12VDC)	12 VDC & 24-28 VDC @ 7 Amp (compatible with auxiliary, automotive, and aircraft power).
Heating Element Power	Sufficient to provide therapeutic warmth	120 W (max)
Heat Presented to Patient / Temperature Control	Thermostatically controlled at therapeutic temperature(s)	Regulated 37° C (98.6° F) or, Regulated 42° C (107.6° F).
User Heat Output Control	User selectable temperature settings	Regulated 37° C or Regulated 42° C.
Thermal Temperature Cutoff	Safety mechanism for over-temperature	37° C (98.6° F) or, 42° C (107.6° F) (implies a safety cutoff at the set temperature).
Alarms	Indication of device status/faults	Audible and Visual (for normal functions/monitoring).
Circuit Protection	Protection against electrical hazards	Multiple fault sensors, circuit breaker and fused controller.
Internal Diagnostics	Self-monitoring for operational integrity	Continuous automatic self-testing.
Safety Agency Approvals	Recognized safety certifications	TUV Munich.
EMC Compatibility Testing	Compliance with electromagnetic compatibility standards	IEC 601-1-2.
Cross-Contamination Protection	Measures to prevent infection	Disposable single-use liner.
Cytotoxicity	Biocompatibility	L 929-Proliferation; EN 30993-5,-12; OSI 10993-5,-12; LM SOP 4-06-01.
Controller Diagnostic Display	User interface for monitoring device status	Cover temperature, battery power level, fault detection, fault identification.
Bag Material	Durable and insulating	Polyurethane film and Dacron® Polyester cloth laminate with Dacron® hollow filament fleece interior.
Control Unit Construction	Robust for intended use environment	High Impact Polycarbonate.
Bag Cleaning	Practical cleaning methods	Machine wash - protective cover. Hand wash bag.
System Weight	Practical for transport	9.6 lbs (4.35 kg) /w control unit.
Disinfection	Compatible with suitable cleaning agents	Suitable for spray or sponge applied water-based disinfectants.
Overall Performance	Perform according to specifications and be substantially equivalent to predicate device for safety and effectiveness.	Performed according to specification and compared favorably to the Predicate Device. No new issues of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

The documentation refers to one formal clinical evaluation:

Clinical Study: "Effectiveness of Resistive Heating Compared With Passive Warming in Treating Hypothermia Associated With Minor Trauma: A Randomized Trial" by Alexander Kober et al., published in Mayo Clinic Proc. 2001:76:369-375.
- Sample Size: Not explicitly stated in the provided text, but it is a "Randomized Trial," implying a statistically significant number of participants.
- Data Provenance: The study was conducted at the Mayo Clinic, indicating a U.S. prospective clinical trial setting. The text states "Patients who were transported with Geratherm (Thermamed) electric / carbon fiber active warming systems experienced significantly lower degrees of hypothermia than those who were transported using passive warming techniques." This indicates the study was likely comparing outcomes between an active warming group (using the Geratherm device) and a passive warming (control) group.

Additional "Verification of Operation Under Non-Laboratory Conditions" was reported by:

SAMU 38 - Helicopter Mountain Rescue, Grenoble, France
ADAC Helicopter Rescueservice, Munich, Germany
Royal Dutch Army, Helicopter Catastrophe Rescueteam, Netherlands
REGA - Mountain rescue service, REGA - Centre Zürich Airport, Zürich, Switzerland

These appear to be field evaluations and practical use cases rather than formal clinical trials with specific sample sizes. The provenance is primarily European (France, Germany, Netherlands, Switzerland). These are likely retrospective reports of device use or observational studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

For the formal clinical study:

The cited paper authors are: Alexander Kober, MD; Thomas Scheck, BS; Béla Fülesdi, MD; Frank Lieba, BS; Wolfgang Vlach, BS; Alexander Friedman, MD; & Daniel I. Sessler, MD.
The primary qualification listed is MD (Medical Doctor) for several authors, with others holding BS (Bachelor of Science). Daniel I. Sessler, MD, is a well-known expert in perioperative thermoregulation. Their collective expertise as medical professionals and researchers would have established the ground truth (e.g., patient hypothermia status, temperature measurements, observed outcomes) in the clinical trial.

For the "Verification of Operation Under Non-Laboratory Conditions":

The "experts" would implicitly be the medical and rescue personnel from the listed organizations (SAMU 38, ADAC, Royal Dutch Army, REGA). Their qualifications would be those of trained medical and rescue professionals involved in acute patient care and transport in challenging environments. The number of such personnel or specific individuals is not stated.

4. Adjudication Method (for the test set)

The provided text for the Kober et al. study describes it as a "Randomized Trial." While specific adjudication methods (e.g., 2+1, 3+1 consensus) are not detailed in this summary, in a randomized controlled trial, the primary "ground truth" for efficacy (e.g., body temperature, incidence of hypothermia) is typically established through direct, objective physiological measurements. The study's results indicating "significantly lower degrees of hypothermia" suggest statistically analyzed objective data rather than subjective expert consensus on "truth."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The clinical study cited is a "Randomized Trial" comparing an active warming device against passive warming techniques directly on patients, focusing on physiological outcomes (hypothermia levels). MRMC studies are typically used for evaluating diagnostic imaging systems where multiple readers interpret cases and their performance is compared.
Effect Size (if applicable): Since it was not an MRMC study, an effect size for human readers improving with AI vs. without AI assistance is not applicable here. However, the study did find that patients in the active warming group (using Geratherm) "experienced significantly lower degrees of hypothermia" compared to the passive warming group, indicating a clinical effectiveness for the device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense. The non-clinical performance data details numerous standards (e.g., EMC, Medical Safety IEC 60601-1, IEC 60601-2-35, ISO 13485) and specific tests (e.g., Cytotoxicity) that the device underwent. These are standalone tests of the device's physical, electrical, and material properties and performance against established specifications, without human interaction in the performance measurement itself.
The "Verification of Operation Under Non-Laboratory Conditions" also reports on the device's ability to "prevent or reduce hypothermia" in real-world scenarios, which implies the device's standalone functional performance was observed and confirmed by various rescue organizations.

7. The Type of Ground Truth Used

Clinical Study (Kober et al.): The ground truth was primarily outcomes data and physiological measurements, specifically the degree of hypothermia experienced by patients. This would involve objective temperature readings and potentially other patient vital signs or clinical assessments.
Non-Clinical Studies & Standards: The ground truth was based on adherence to international standards (e.g., IEC, EN, ISO, UL) for safety, electrical performance, biocompatibility, and electromagnetic compatibility, as well as the device's ability to meet its own specifications for temperature regulation and alarm functions.
Field Verification: The "Verification of Operation Under Non-Laboratory Conditions" implies observational outcomes data from real-world usage, where the device was found to "prevent or reduce hypothermia" by the rescue organizations.

8. The Sample Size for the Training Set

This information is not applicable. The Geratherm SOS-Rescue Bag is a medical device for therapeutic warming, not an AI/machine learning system. Therefore, there is no "training set" of data in the context of machine learning model development. The device's design and functionality are based on engineering principles and established medical knowledge, not data-driven training.

9. How the Ground Truth for the Training Set Was Established

This information is also not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image shows a logo with the letters 'RG' stacked on top of each other. Below the letters, there is a zig-zag line. Underneath the zig-zag line, the words 'medical DIAGNOSTICS' are written in a smaller font. The logo appears to be for a medical diagnostics company.

051336 RG Medical Diagnostics

JUN 2 9 2006

510(k) Premarket Notification Summary

Geratherm® SOS-Rescue Bag

Common Name - Warming Bag Classification name- Thermal Regulating System (870.5900) Predicate Device - ChillBuster™ Portable Electric Blanket (Thermogear, Inc. K991684)

The following material presents the 510 (k) Summary for the Geratherm® SOS-Rescue Bag

21130 Bridge Street • Southfield, MI 48034 Phone: 888-596-9498 ● Fax: 248-750-0187 ● Website: www.rgmd.com

Section 5 nage 1 of 7

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Premarket (510K) Summary

Submitter Information

RG Enterprises, Inc. (dba) RG Medical Diagnostics 21130 Bridge Street Southfield. MI 48034 888-596-9498 Date Prepared 04/01/05

Device Name:

Proprietary name: Geratherm SOS-Rescue Bag (Thermamed "Smartcare") Common name: Hypothermic Therapy System CDRH Product Regulation: Thermal Regulation System (21 CFR, 870.5900)

Establishment Registration Number: 1835242

Classification: II (DWJ)

Predicate Device:

RG Medical Diagnostics, 21130 Bridge Street, Southfield, Michigan, 48034 has designated The Chillbuster™ Portable Electric Blanket System, Model 8001, manufactured by Thermogear, Inc. 18005 Lower Boones Ferry Rd., Togart, OR 977224 as the Predicate Device for the Geratherm SOS-Rescue Bag, manufactured by Geratherm AG, Fahrenheitstrasse 1, D-98716 Geschwenda/Germany.

Statement of Substantial Equivalence:

Geratherm SOS-Rescue Bag is substantially equivalent to:

ChillBuster™ Portable Electric Blanket (Thermogear, Inc K991684)

Description of Device:

The Geratherm SOS-Rescue Bag is made up of five major components:

Bag: The main functional element is 78.75 inches (200cm) by 31.5 inches (80 cm) comprised of two primary elements:

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(a) The bag is constructed like a sleeping bag with an actively warmed upper panel and insulated bottom panel. The upper warming cover uses electrically resistive woven carbon fiber elements to generate warmth. The warming elements are sandwiched between two layers of Dacron® polyester hollow fiber insulating fleece. Lastly, the polvester fleece/carbon fiber layers are encapsulated with a waterproof polyurethane / polyester cloth laminate outside layer. A permanently attached power is cable located near the upper corner of the active warming cover. The free end is plugged into the power control module via color-coded quick-connect power connectors. The top warming cover is permanently sewn along one entire side to the insulated "bottom" panel. This arrangement allows top panel to be folded over the patient and secured once the patient has been placed in a prone position on the bottom panel. The bottom panel has 9 (nine) handholds around its perimeter that lets rescue personnel carry or move a supine patient without the use of a stretcher. (b) A removable waterproof polyurethane / polyester cloth laminate protective liner is attached to the bag's inner surface. The protective cover is held in place to the bag's inner surfaces with Velcro® attachments. This attachment system permits easy removal for machine washing and disinfecting.

Control Module: The control module is a impact plastic housing that contains the electronic circuitry. The module regulates bag temperature through a feedback circuit employing two thermistor temperature sensing systems. Operator control is achieved through the use of four buttons located on the face of the module: an on button, off button, a 37° C (98.6°F) select button, and a 42° C (107.6°F) select button. The control module uses LED arrays to display both bag temperature and battery power status. Normal functions are monitored both through visual displays and audible signal. Power sources include the following: the auxiliary battery, an automotive type power supply outlet, or an aircraft power supply outlet. Either 12 volt DC automotive or 24-28 volt DC aircraft power sources may be used to power the unit.
Battery: The Geratherm SOS-Rescue Bag uses a sealed lead-acid gel rechargeable battery of 10-ampere hour capacity.
Cabling: The Geratherm SOS-Rescue Bag has a power cable permanently attached to the upper corner. The cable attaches directly to the Control Module, The cable supplying power to the power module has a color-coded quick connect on the module end and a connecter that fits the auxiliary battery or automotive/aircraft DC power outlets on the other.
AC Charger: The Geratherm SOS-Rescue Bag employs a 12 volt, DC, 2ampere hour output battery charger to charge the battery or maintain full battery status. The charger may be used with either 110 or 240 Volt, 50 or 60 Hertz, AC input electric current.

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Intended Use

The Geratherm® SOS-Rescue Bag is designed to prevent and counteract accidental hypothermia in accident victims and patients who are being transported with or without a stretcher, by ambulance, rotary or fixed wing aircraft. Using the Geratherm® SOS Rescue Bag System lowers susceptibility to shock caused by the cold. In addition, patients experience a subjective reduced perception of pain.

Non-Clinical Performance Data

The studies reported in this subsection were conducted by CE-LAB GmbH, iMG gGmbH, TREO Electrooptik GmbH, and TÜV GmbH

The Geratherm SOS-Rescue Bag has been tested to the following Standards: standards:
General Medical Safety:

EMC Specification EN 60601-1-2:2001. NATO Standard DCS01, DCE01. Generic Specification of SPAME ( Special Purpose Aeromedical Equipment) Issue 3, page 16, No. 62 (vibration). IEC 60601-1:1990 + A1:1993 + A2:1995 IEC 60601-2-35:1996 EN 60601-2-32:1996 CE 0118 ISO 13485:2003 UL AWM Style 1007 & 1589 UL VW-1 FT

Clinical Performance Data

A formal clinical evaluation was performed at the Mayo Clinic comparing passive warming and active warming using Geratherm resistive carbon fiber electrical warming technology.

Alexander Kober, MD; Thomas Scheck, BS; Béla Fülesdi, MD; Frank Lieba, BS: Wolfgang Vlach, BS: Alexander Friedman, MD: & Daniel I. Sessler, MD . "Effectiveness of Resistive Heating Compared With Passive Warming in Treating Hypothermia Associated With Minor Trauma: A Randomized Trial," Mayo Clinic Proc. 2001:76:369-375

Results: Patients who were transported with Geratherm (Thermamed) electric / carbon fiber active warming systems experienced significantly lower degrees of hypothermia than those who were transported using passive warming techniques.

21130 Bridge Street · Southfield, MI 48034 Phone: 888-596-9498 • Fax: 248-750-0187 • Website: www.rgmd.com Section 5, page 4 of 7

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Verification of Operation Under Non-Laboratory Conditions

The Geratherm SOS-Rescue Bag was tested according to the Operating Manual.and was found to prevent or reduce hypothermia by the following organizations:

CE 0118

SAMU 38 - Helicopter Mountain Rescue, Grenoble, France

ADAC Helicopter Helicopter Rescueservice, Munich, Germany

Royal Dutch Army, Helicopter Catastrophe Rescueteam, Netherlands

REGA - Mountain rescue service, REGA - Centre Zürich Airport, Zürich, Switzerland

Conclusions Drawn from Clinical and Non-Clinical Testing

The Geratherm SOS-Rescue Bag performed according to specification and compared favorably to the Predicate Device. No new issues of safety or effectiveness were found to arise in the Geratherm SOS-Rescue Bag when compared to the Predicate Device.

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Features	Geratherm® SOS-Rescue Bag	ChillBuster™ Model 8001
Indications for Use	preventing / counteracting hypothermia	preventing / counteracting hypothermia
Function	low-level distributed heat to patient	low-level distributed heat to patient
Heat Delivery Mechanism	conduction	conduction
Heat Source	resistive carbon fiber cloth in insulated cover	thermal wire in blanket
Electrical Requirements	12 VDC & 24-28 VDC @ 7 Amp	12 VDC @ 3.2 Amp
Heating Element Power	120 W (max)	40 W (approx)
Heat Presented to Patient	37° C (98.6° F) or, 42° C (107.6° F)	105° F
User Heat Output Control	Regulated 37° C or, Regulated 42° C	Un-calibrated continuous 20W-40W
Thermal Temperature Cutoff	37° C (98.6° F) or, 42° C (107.6° F)	105° F
Alarms	Audible and Visual	none disclosed
Circuit Protection	multiple fault sensors, circuit breaker and fused controller	Fused positive battery lead
Internal Diagnostics	Continuous automatic self testing	none disclosed
Safety Agency Approvals	TUV Munich	TUV Rheinland
EMC Compatibility Testing	IEC 601-1-2	IEC 601-1-2
Cross-Contamination Protection	Disposable single use liner	Disposable single use liner
Cytotoxicity	L 929-Proliferation; EN 30993-5,-12; OSI 10993-5,-12; LM SOP 4-06-01
Controller Diagnostic Display	cover temperature, battery power level, fault detection, fault identification
Bag Material	polyurethane film and Dacron® Polyester cloth laminate with Dacron® hollow filament fleece interior	Oxford nylon and nylon acrylic
Control Unit Construction	High Impact Polycarbonate	Flame retardant polycarbonate
Bag Cleaning	Machine wash - protective cover. Hand wash bag.	Machine wash and dry
System Weight	9.6 lbs (4.35 kg) /w control unit	8 lbs
Disinfection	Suitable for spray or sponge applied water based disinfectants	No information

Comparison of Technological Characteristics ( SOS-Rescue Bag vs Predicate device)

21130 Bridge Street

Section 5, page 6 of 7

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 2006

R.G. Enterprises, Inc. c/o Mr. Ronald G. Letoutneau President 21130 Bridge Street Southfield, MI 48034

Re: K051336

Geratherm SOS-Rescue Bag Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II (Two) Product Code: DWJ Dated: June 21, 2006 Received: June 23, 2006

Dear Mr. Letoutneau:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments. or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may. therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices. good manufacturing practice. labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning vour device in the Federal Register.

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Page 2 -- Mr. Ronald G. Letoutneau

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

. . . . . . .

Sincerely yours.

Duna R. bohner

ABram D. Zuckerman, M.D. -Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K051336

Device Name: Geratherm SOS-Rescue Bag

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Lochner

Division Sign-Off) Division Sign-Olf)
Division of Cardiovascular Devices

510(k) Number Koss (336

Page 1 of

Section 12. page 2 of 2

Regulation Number and Section

§ 870.5900 Thermal regulating system.

(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).