Section 1: Introduction; Indications For Use; Patient Population And Settings; Safety Information And Symbols - 3M Bair Hugger 370 Manuel D'utilisation

Section 1: Introduction

This Operator's Manual describes the setup, use, and maintenance of the 3M™ Bair Hugger™ temperature
monitoring system. The temperature monitoring system and the manual are to be used by healthcare professionals
in clinical environments only. Read and follow all instructions, labeling, and accompanying documents supplied
with this temperature monitoring system. Failure to follow instructions could lead to misuse of the device, device
malfunction, or patient injury.
Indications for use
Measure, monitor, and trend body temperature of adult and pediatric patients.
This product is intended to be used by trained medical professionals in a clinical/surgical setting.

Patient Population and Settings

Adult and pediatric patients being treated in operating rooms, emergency departments, and other departments in
the hospital setting where patient temperature management is required.

Safety information and symbols

Symbol Glossary
Symbol Title
Manufacturer
Authorized Representative in
European Community
Date of Manufacture
Catalogue number
Serial number
Keep dry
Do not re-use
Consult instructions for use
Caution
Medical Device
Unique device identifier
Importer
CE Mark
UL Classified
Recycle
2
Symbol Description and Reference
Indicates the medical device manufacturer. Source: ISO 15223, 5.1.1
Indicates the authorized representative in the European Community. Source: ISO
15223, 5.1.2, 2014/35/EU, and/or 2014/30/EU
Indicates the date when the medical device was manufactured. Source: ISO
15223, 5.1.3
Indicates the manufacturer's catalogue number so that the medical device can be
identified. Source : ISO 15223, 5.1.6
Indicates the manufacturer's serial number so that a specific medical device can
be identified. Source: ISO 15223, 5.1 .7
Indicates a medical device that needs to be protected from moisture. Source: ISO
15223, 5.3.4
Indicates a medical device that is intended for one use or for use on a single
patient during a single procedure. Source: ISO 15223, 5.4.2
Indicates the need for the user to consult the instructions for use. Source: ISO
15223, 5.4.3
Indicates the need for the user to consult the instructions for use for important
cautionary information such as warnings and precautions that cannot, for a
variety of reasons, be presented on the medical device itself. Source: ISO 15223,
5.4.4
Indicates the item is a medical device. Source: ISO 15223, 5.7.7
Indicates a carrier that contains Unique Device Identifier information. Source: ISO
15223, 5.7.10
Indicates the entity importing the medical device into the locale. Source: ISO
15223, 5.1.8
Indicates conformity to all applicable European Union Regulations and Directives
with notified body involvement.
Indicates product was evaluated and Listed by UL for the USA and Canada.
Indicates trash bin or container is for materials to be recycled