3M Bair Hugger Model 370 Operators Manual Rev 34-8719-8362-2 Aug 2016

Revision History Revision

Reason for Change

Pages Affected

Date

370096 A

New Revision - First Release

All

May 2012

370096 B

Languages Added

25-155

May 2012

370096 C

Added specifications and added languages

All

Feb 2013

202052 A

Update company address

All

May 2013

34-8714-3113-5

Update product description

34-8719-8362-2

Update to new Bair Hugger Logo and Circular font layout

Mar 2014

All

August 2016

Temperature Monitoring System

Temperature Monitoring System Model 370 Operator’s Manual

1 English... 1

7 Svenska... 121

2 Français... 21

8 Dansk...139

3 Deutsch... 41

9 Norsk... 157

4 Italiano... 61

0 Suomi... 175

5 Español... 81

- Português...193

6 Nederlands... 101

TOC / 34-8719-8362-2

iii

1 Table of Contents Section 1: Introduction ... 3 About this manual ... 3 Intended use ... 3 Safety information and symbols... 3 Explanation of signal word consequences ... 4 Proper use and maintenance ...5 Read before servicing equipment ...5 Section 2: Overview and Operation ... 6 Description of the 3M™ Bair Hugger™ temperature monitoring system ... 6 Back of control unit ... 8 Front of control unit ... 8 Setting up the control unit ... 8 Instructions for use ... 9 To change temperature unit display (Celsius or Fahrenheit) ...10 Shutting down the control unit ...10 Section 3: Display Panel ... 11 Display screens ... 11 Start-up... 11 Standby ... 11 Ready ... 11 Equilibration ... 11 Running ... 12 Control unit error... 12 Sensor error ... 12 Section 4: Troubleshooting ... 12 On Mode ... 12 Displays ... 13 Errors... 14 Section 5: General Maintenance, Storage and Service... 14 Cleaning Procedure ... 14 Storage ... 14 Service ... 14 Section 6: Technical Service and Order Placement... 15 When you call for technical support ... 15 Technical service and order placement ... 15 Section 7: Specifications ... 15 Physical characteristics...18 Electrical characteristics ...18 Temperature characteristics ...18 Performance characteristics ...18 Environmental conditions ...18 List of Bair Hugger Accessories and Cables ...19

GB / 34-8719-8362-2

1

1 3M™ Bair Hugger™ Temperature Monitoring System Model 370 Operator’s Manual

Section 1: Introduction About this manual ... 3 Intended use ... 3 Safety information and symbols... 3 Explanation of signal word consequences ... 4 Proper use and maintenance ...5 Read before servicing equipment ...5

About this manual This Operator’s Manual describes the setup, use, and maintenance of the 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.

This system is subject to the European WEEE Directive 2002/96/EC. This product contains electrical and electronic components and must not be disposed of using standard refuse collection. Please consult local directives for disposal of electrical and electronic equipment.

Intended use Measure, monitor, and trend body temperature of adult and pediatric patients.

Defibrillation-proof type CF applied part

Safety information and symbols Date of manufacture

Class II equipment

Manufacturer

Authorized Representative in the European Community

Single use only CAUTION: Recycle to avoid environmental contamination This product contains recyclable parts. For information on recycling please contact your nearest 3M Service Center for advice.

Container quantity

CAUTION Direct current

See accompanying documents

3

GB / 34-8719-8362-2

4395459 Description: 3M TM Bair Hugger™ Temperature Monitoring System Model 370 Operator’s Manual - Part 1 Base File Name: PA: 34871983622.indb Book GA: Software: InDesign CC 2014 SGS Contact: Email: Printer: Printer Location: Supplier:

PROCESS BLACK

PROCESS CYAN

PROCESS MAGENTA

Supersedes#:XX-XXXX-XXXX-X Structure#:XX-XXXXX Cat/Product#: Model 370 Reference: #### Requester: Debra Staack Die # / Doc. Size: 5.5" x 8.5"

PROCESS YELLOW

PANTONE 280

3

Item Spec#: 34-8719-8362-2

PANTONE 267

10.17.16 PU MD370_Operator’s Manual_34-8719-2523-5 (4395459), update 34#s, indicated changes and Final Release

kmh

1 3M™ Bair Hugger™ Temperature Monitoring System Model 370 Operator’s Manual

Section 1: Introduction About this manual ... 3 Intended use ... 3 Safety information and symbols... 3 Explanation of signal word consequences ... 4 Proper use and maintenance ...5 Read before servicing equipment ...5

About this manual This Operator’s Manual describes the setup, use, and maintenance of the 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.

This system is subject to the European WEEE Directive 2002/96/EC. This product contains electrical and electronic components and must not be disposed of using standard refuse collection. Please consult local directives for disposal of electrical and electronic equipment.

Intended use Measure, monitor, and trend body temperature of adult and pediatric patients.

Defibrillation-proof type CF applied part

Safety information and symbols Date of manufacture

Class II equipment

Manufacturer

Authorized Representative in the European Community

Single use only CAUTION: Recycle to avoid environmental contamination This product contains recyclable parts. For information on recycling please contact your nearest 3M Service Center for advice.

Container quantity

CAUTION Direct current

See accompanying documents

3

GB / 34-8719-8362-2

4395459 Description: 3M TM Bair Hugger™ Temperature Monitoring System Model 370 Operator’s Manual - Part 1 Base File Name: PA: 34871983622.indb Book GA: Software: InDesign CC 2014 SGS Contact: Email: Printer: Printer Location: Supplier:

PROCESS BLACK

PROCESS CYAN

PROCESS MAGENTA

Supersedes#:XX-XXXX-XXXX-X Structure#:XX-XXXXX Cat/Product#: Model 370 Reference: #### Requester: Debra Staack Die # / Doc. Size: 5.5" x 8.5"

PROCESS YELLOW

PANTONE 280

3

Item Spec#: 34-8719-8362-2

PANTONE 267

10.17.16 PU MD370_Operator’s Manual_34-8719-2523-5 (4395459), update 34#s, indicated changes and Final Release

kmh

•

Use only the power supply specified for this product and certified for the country of use.

•

Use only a properly grounded power outlet; do not use extension cords or multiple portable socket outlets.

Follow instructions for use

Keep dry

Hardware temperature limits

•

Do not allow the power supply to get wet.

•

Do not use the control unit when it appears the unit or system components are damaged. Contact 3M technical support at 1-800-228-3957.

•

Do not service or modify the power supply, control unit, cables, sensor, or any part of the temperature monitoring system. There are no user serviceable parts.

Sensor temperature limits

Explanation of signal word consequences

! !

WARNING: Indicates a hazardous situation which, if not avoided, could result in death or serious injury. CAUTION: Indicates a hazardous situation which, if not avoided, could result in minor or moderate injury.

NOTICE: Indicates a situation which, if not avoided, could result in property damage only.

!

•

WARNING: To reduce the risks associated with hazardous voltage, fire, and thermal energy hazards: •

•

•

!

Use ONLY Bair Hugger temperature monitoring system components (sensors, cables, and power supply). Do not substitute other devices for the control unit, sensor, cables, or power supply. Do not use the Bair Hugger temperature monitoring system (sensor, control unit, cables, or cords) in an MRI environment. Do not connect the monitor output of the device to a non-CF rated monitor input.

!

Keep power supply visible and accessible at all times. The plug on the power supply serves as the disconnect device. The power outlet shall be as close as practical and shall be easily accessible.

The temperature monitoring system is not suitable for use in the presence of a flammable anesthetic mixture with air nitrous oxide.

WARNING: To reduce the risks associated with pressure, and crushed or entangled cords and connectors: •

Do not allow the patient to lie on any sensor cable or connector.

•

Always position cables and cords away from the patient’s body.

•

Do not use a headband or other device to secure the sensor to the patient.

WARNING: To reduce the risks associated with incorrect system or sensor use: •

Limit use of the sensor to 24 hours. Extended use may compromise skin, cause degradation of material or performance.

•

Avoid exposing the temperature monitoring sensor, sensor cable, power supply, and control unit to surgical skin surface preparation solutions or other fluids.

•

Use an additional independent thermometer to measure body temperature during intentional hyperthermia or hypothermia therapy.

•

Confirm unanticipated temperature reading with an independent thermometer, if needed.

•

Do not reposition the sensor; repositioning may weaken the sensor adhesive, damage the sensor, or compromise the device performance.

WARNING: To reduce the risks associated with hazardous voltage and fire: •

4

!

The control unit is to be attached to other equipment by authorized service personnel only. Do not re-install or re-locate the control unit.

WARNING: To reduce the risks associated with fire: •

WARNING: To reduce the risks associated with access to critical patient information or equipment: •

!

!

3M™ Bair Hugger™ Temperature Monitoring System Model 370 – Operator’s Manual

•

!

!

•

Follow facilities policies and procedures for disposal of contaminated materials.

•

Always perform the decontamination procedure prior to returning the temperature monitoring system for service and prior to disposal.

Do not leave pediatric patients unattended while using the temperature monitoring system.

Do not use the sensor on damaged or compromised skin.

CAUTION: To reduce the risks associated with cross-contamination: Clean the sensor cable before connecting to a new sensor.

CAUTION: To reduce the risks associated with impact and facility medical device damage: •

•

!

•

Do not store the control unit and system components in a wet or damp place.

•

Do not spray cleaning solutions onto the control unit or into the sensor cable connector.

•

Do not immerse the control unit or system components in any liquid or subject them to any sterilization process.

•

Do not use solvents such as acetone or thinner to clean the control unit; avoid abrasive cleaners.

•

Clean control unit exterior with a damp soft cloth and 70% mixture of isopropyl alcohol and water. For full cleaning procedures see “Section 5: General Maintenance, Storage and Service” on page 14.

•

Do not immerse any of the devices or use a dripping wet cloth for cleaning.

CAUTION: To reduce the risks associated with skin maceration:

•

!

To avoid temperature monitoring system damage that may impact performance:

WARNING: To reduce the risks associated with entanglement:

•

!

4.

WARNING: To reduce the risks associated with exposure to biohazards:

•

!

Avoid placing the sensor in the center of the forehead as this may affect sensor accuracy.

Do not use the control unit as a handle to transport or to move the device to which it is attached. Do not initiate temperature monitoring unless the control unit is safely placed on a hard, flat surface or is securely mounted.

CAUTION: To reduce the risks associated with environmental contamination: •

Follow applicable regulations when disposing of this device or any of its electronic components.

5.

The sensor is not made with natural rubber latex.

6.

To the full extent permitted by law, the manufacturer and/or importer declines all responsibility for injury resulting from the unit being used in conjunction with unapproved system components.

Proper use and maintenance 3M Health Care assumes no responsibility for the reliability, performance, or safety of the temperature monitoring system if the following events occur: •

Modifications or repairs are performed by unqualified personnel.

•

The control unit is used in a manner other than that described in the Operator’s Manual.

•

The control unit is installed in an environment that does not meet the appropriate electrical requirements.

NOTICES 1.

The temperature monitoring system meets medical electronic interference requirements. If radio frequency interference with other equipment should occur, connect the unit to a different power source.

2.

Protection against electrostatic discharge (ESD) is important when working with the temperature monitoring system. Always be mindful of the immediate work area and any potentially hazardous ESD situations that could impact temperature monitoring system performance.

3.

Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare professional.

GB / 34-8719-8362-2

Read before servicing equipment •

All repair, calibration, and servicing of this equipment must be performed by 3M.

•

There are no user serviceable parts inside the equipment or power supply.

5

•

Use only the power supply specified for this product and certified for the country of use.

•

Use only a properly grounded power outlet; do not use extension cords or multiple portable socket outlets.

Follow instructions for use

Keep dry

Hardware temperature limits

•

Do not allow the power supply to get wet.

•

Do not use the control unit when it appears the unit or system components are damaged. Contact 3M technical support at 1-800-228-3957.

•

Do not service or modify the power supply, control unit, cables, sensor, or any part of the temperature monitoring system. There are no user serviceable parts.

Sensor temperature limits

Explanation of signal word consequences

! !

WARNING: Indicates a hazardous situation which, if not avoided, could result in death or serious injury. CAUTION: Indicates a hazardous situation which, if not avoided, could result in minor or moderate injury.

NOTICE: Indicates a situation which, if not avoided, could result in property damage only.

!

•

WARNING: To reduce the risks associated with hazardous voltage, fire, and thermal energy hazards: •

•

•

!

Use ONLY Bair Hugger temperature monitoring system components (sensors, cables, and power supply). Do not substitute other devices for the control unit, sensor, cables, or power supply. Do not use the Bair Hugger temperature monitoring system (sensor, control unit, cables, or cords) in an MRI environment. Do not connect the monitor output of the device to a non-CF rated monitor input.

!

Keep power supply visible and accessible at all times. The plug on the power supply serves as the disconnect device. The power outlet shall be as close as practical and shall be easily accessible.

The temperature monitoring system is not suitable for use in the presence of a flammable anesthetic mixture with air nitrous oxide.

WARNING: To reduce the risks associated with pressure, and crushed or entangled cords and connectors: •

Do not allow the patient to lie on any sensor cable or connector.

•

Always position cables and cords away from the patient’s body.

•

Do not use a headband or other device to secure the sensor to the patient.

WARNING: To reduce the risks associated with incorrect system or sensor use: •

Limit use of the sensor to 24 hours. Extended use may compromise skin, cause degradation of material or performance.

•

Avoid exposing the temperature monitoring sensor, sensor cable, power supply, and control unit to surgical skin surface preparation solutions or other fluids.

•

Use an additional independent thermometer to measure body temperature during intentional hyperthermia or hypothermia therapy.

•

Confirm unanticipated temperature reading with an independent thermometer, if needed.

•

Do not reposition the sensor; repositioning may weaken the sensor adhesive, damage the sensor, or compromise the device performance.

WARNING: To reduce the risks associated with hazardous voltage and fire: •

4

!

The control unit is to be attached to other equipment by authorized service personnel only. Do not re-install or re-locate the control unit.

WARNING: To reduce the risks associated with fire: •

WARNING: To reduce the risks associated with access to critical patient information or equipment: •

!

!

3M™ Bair Hugger™ Temperature Monitoring System Model 370 – Operator’s Manual

•

!

!

•

Follow facilities policies and procedures for disposal of contaminated materials.

•

Always perform the decontamination procedure prior to returning the temperature monitoring system for service and prior to disposal.

Do not leave pediatric patients unattended while using the temperature monitoring system.

Do not use the sensor on damaged or compromised skin.

CAUTION: To reduce the risks associated with cross-contamination: Clean the sensor cable before connecting to a new sensor.

CAUTION: To reduce the risks associated with impact and facility medical device damage: •

•

!

•

Do not store the control unit and system components in a wet or damp place.

•

Do not spray cleaning solutions onto the control unit or into the sensor cable connector.

•

Do not immerse the control unit or system components in any liquid or subject them to any sterilization process.

•

Do not use solvents such as acetone or thinner to clean the control unit; avoid abrasive cleaners.

•

Clean control unit exterior with a damp soft cloth and 70% mixture of isopropyl alcohol and water. For full cleaning procedures see “Section 5: General Maintenance, Storage and Service” on page 14.

•

Do not immerse any of the devices or use a dripping wet cloth for cleaning.

CAUTION: To reduce the risks associated with skin maceration:

•

!

To avoid temperature monitoring system damage that may impact performance:

WARNING: To reduce the risks associated with entanglement:

•

!

4.

WARNING: To reduce the risks associated with exposure to biohazards:

•

!

Avoid placing the sensor in the center of the forehead as this may affect sensor accuracy.

Do not use the control unit as a handle to transport or to move the device to which it is attached. Do not initiate temperature monitoring unless the control unit is safely placed on a hard, flat surface or is securely mounted.

CAUTION: To reduce the risks associated with environmental contamination: •

Follow applicable regulations when disposing of this device or any of its electronic components.

5.

The sensor is not made with natural rubber latex.

6.

To the full extent permitted by law, the manufacturer and/or importer declines all responsibility for injury resulting from the unit being used in conjunction with unapproved system components.

Proper use and maintenance 3M Health Care assumes no responsibility for the reliability, performance, or safety of the temperature monitoring system if the following events occur: •

Modifications or repairs are performed by unqualified personnel.

•

The control unit is used in a manner other than that described in the Operator’s Manual.

•

The control unit is installed in an environment that does not meet the appropriate electrical requirements.

NOTICES 1.

The temperature monitoring system meets medical electronic interference requirements. If radio frequency interference with other equipment should occur, connect the unit to a different power source.

2.

Protection against electrostatic discharge (ESD) is important when working with the temperature monitoring system. Always be mindful of the immediate work area and any potentially hazardous ESD situations that could impact temperature monitoring system performance.

3.

Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare professional.

GB / 34-8719-8362-2

Read before servicing equipment •

All repair, calibration, and servicing of this equipment must be performed by 3M.

•

There are no user serviceable parts inside the equipment or power supply.

5

Section 2: Overview and Operation

Skin Surface

Temperature Sensor

Description of the 3M™ Bair Hugger™ temperature monitoring system ... 6 Back of control unit ... 8

Deep Tissue

1) Placement and connection

Front of control unit ... 8 Setting up the control unit ... 8 Instructions for use ... 9 To change temperature unit display (Celsius or Fahrenheit) ...10 Shutting down the control unit ...10

2) Equilibration - isothermal zone development

Description of the 3M™ Bair Hugger™ temperature monitoring system The 3M Bair Hugger temperature monitoring system measures the core temperature of the patient. The system is comprised of a sensor, which connects to the control unit through the sensor cable, a power supply, and an optional monitor cable. For additional sensors, sensor cable, power supply, control unit stand, monitor cable, hook-and-loop, or foam adhesive, contact 3M.

How does it work? The 3M Bair Hugger temperature monitoring system uses zero-heat-flux thermometry to accurately measure a person’s core temperature as characterized in Figure 2-2 below. 1) The 3M Bair Hugger temperature monitoring system gently warms the sensor creating an isothermal zone under the sensor. 2) Once equilibrated to the core temperature, skin-surface heat loss to the environment is prevented and a zero-heat-flux condition is established. 3) When the temperature sensor reaches equilibrium with the patient’s core temperature, the control unit displays an accurate, noninvasive measurement of the patient’s core temperature.

Monitor Cable

3) Equilibrated - isothermal zone established Figure 2-2: Isothermal tunnel formation with zero-heat-flux technology

The 3M™ Bair Hugger™ control unit The control unit displays noninvasive core temperature measurements obtained from the temperature sensor. The current temperature is displayed numerically, and previous temperature data is displayed graphically as a temperature trend graph. When the sensor is plugged into the sensor cable, the control unit reads up to the last two hours of stored temperature data and displays the temperature trend graph. Disconnections of the sensor from the sensor cable are indicated by

gaps in the temperature trend graph. The current temperature measurement can be continuously transmitted to a patient vital signs monitor through the optional monitor cable using a standard YSI-400 type input. To transmit data from the temperature monitoring system to the patient’s monitor, simply connect the appropriate monitor cable (see Table 2-1: Monitor Cables) to the back of the control unit and to the input on the patient monitor.

Patient Monitor Connector Cables

Power Supply

SO R

3M™ Bair Hugger™ Control Unit

PAT T SEN IEN

Sensor Cable

Table 2-1: Monitor Cables

tem

ring nito re Mo atu per Tem

Sys

Temperature Sensor Sensor Connector Figure 2-1: Bair Hugger Temperature Monitoring System

6

3M™ Bair Hugger™ Temperature Monitoring System Model 370 – Operator’s Manual

The 3M™ Bair Hugger™ sensor The sensor is constructed of two layers of medical grade foam and a flexible circuit which contains a resistive warming circuit, two calibrated thermistors, and nonvolatile memory. The information that generates the temperature trend graph is stored on the sensor. If the patient is transferred from one location to another, the sensor is disconnected from the sensor cable so the sensor is left in place on the patient. The sensor may be reconnected

GB / 34-8719-8362-2

to a different sensor cable and control unit when the patient arrives at the next point of care. Once the sensor is reconnected to the sensor cable, the system will begin to reequilibrate and will regenerate the stored temperature trend graph and display the patient’s current temperature. The act of disconnecting and reconnecting the sensor from the sensor cable is indicated by a gap in the temperature trend graph.

7

Section 2: Overview and Operation

Skin Surface

Temperature Sensor

Description of the 3M™ Bair Hugger™ temperature monitoring system ... 6 Back of control unit ... 8

Deep Tissue

1) Placement and connection

Front of control unit ... 8 Setting up the control unit ... 8 Instructions for use ... 9 To change temperature unit display (Celsius or Fahrenheit) ...10 Shutting down the control unit ...10

2) Equilibration - isothermal zone development

Description of the 3M™ Bair Hugger™ temperature monitoring system The 3M Bair Hugger temperature monitoring system measures the core temperature of the patient. The system is comprised of a sensor, which connects to the control unit through the sensor cable, a power supply, and an optional monitor cable. For additional sensors, sensor cable, power supply, control unit stand, monitor cable, hook-and-loop, or foam adhesive, contact 3M.

How does it work? The 3M Bair Hugger temperature monitoring system uses zero-heat-flux thermometry to accurately measure a person’s core temperature as characterized in Figure 2-2 below. 1) The 3M Bair Hugger temperature monitoring system gently warms the sensor creating an isothermal zone under the sensor. 2) Once equilibrated to the core temperature, skin-surface heat loss to the environment is prevented and a zero-heat-flux condition is established. 3) When the temperature sensor reaches equilibrium with the patient’s core temperature, the control unit displays an accurate, noninvasive measurement of the patient’s core temperature.

Monitor Cable

3) Equilibrated - isothermal zone established Figure 2-2: Isothermal tunnel formation with zero-heat-flux technology

The 3M™ Bair Hugger™ control unit The control unit displays noninvasive core temperature measurements obtained from the temperature sensor. The current temperature is displayed numerically, and previous temperature data is displayed graphically as a temperature trend graph. When the sensor is plugged into the sensor cable, the control unit reads up to the last two hours of stored temperature data and displays the temperature trend graph. Disconnections of the sensor from the sensor cable are indicated by

gaps in the temperature trend graph. The current temperature measurement can be continuously transmitted to a patient vital signs monitor through the optional monitor cable using a standard YSI-400 type input. To transmit data from the temperature monitoring system to the patient’s monitor, simply connect the appropriate monitor cable (see Table 2-1: Monitor Cables) to the back of the control unit and to the input on the patient monitor.

Patient Monitor Connector Cables

Power Supply

SO R

3M™ Bair Hugger™ Control Unit

PAT T SEN IEN

Sensor Cable

Table 2-1: Monitor Cables

tem

ring nito re Mo atu per Tem

Sys

Temperature Sensor Sensor Connector Figure 2-1: Bair Hugger Temperature Monitoring System

6

3M™ Bair Hugger™ Temperature Monitoring System Model 370 – Operator’s Manual

The 3M™ Bair Hugger™ sensor The sensor is constructed of two layers of medical grade foam and a flexible circuit which contains a resistive warming circuit, two calibrated thermistors, and nonvolatile memory. The information that generates the temperature trend graph is stored on the sensor. If the patient is transferred from one location to another, the sensor is disconnected from the sensor cable so the sensor is left in place on the patient. The sensor may be reconnected

GB / 34-8719-8362-2

to a different sensor cable and control unit when the patient arrives at the next point of care. Once the sensor is reconnected to the sensor cable, the system will begin to reequilibrate and will regenerate the stored temperature trend graph and display the patient’s current temperature. The act of disconnecting and reconnecting the sensor from the sensor cable is indicated by a gap in the temperature trend graph.

7

2.

Use an alcohol wipe to clean and disinfect the patient’s forehead above the orbital ridge. Allow the patient’s forehead to completely dry.

3.

Connect the sensor to the sensor cable connector. Ensure the sensor tab is properly connected and is fully inserted into the sensor cable (Figure 2-5). The display on the control unit will change to the ready screen (See “Ready” on page 11) once it confirms the sensor connection.

Stand Knob Digital Port (used by 3M personnel only)

°C/°F Temperature Display Button

Monitor Cable Port

Power Input Port Figure 2-3: Back of Control Unit

The digital port is used only by 3M Health Care personnel for testing purposes and to access variables within the control unit.

Figure 2-7: Apply the sensor to the patient’s forehead

6.

Gently press the edge of the sensor to ensure good adhesion with the skin. OPTIONAL: Support the sensor cable with the provided sensor cable clip.

7.

The control unit will sense patient attachment after several seconds and the control unit display will change to the equilibration screen (see “Equilibration” on page 11).

8.

The patient’s temperature will display on the patient monitor once equilibrium is reached (approximately three minutes).

Temp eratu re

The monitor cable port provides a resistance that corresponds to a YSI-400 thermistor at the displayed temperature. It is electrically isolated from the control unit.

Moni toring Syste m

Front of control unit

m

oring e Monit eratur Temp

Syste

Figure 2-5: Connect the sensor to the sensor cable

4.

Transferring the patient and sensor 1.

Remove backing liners on the sensor to expose adhesive (Figure 2-6).

2.

Carefully reconnect a sensor cable and control unit to the sensor once transfer is complete.

3.

The control unit will sense patient attachment after several seconds and the control unit display will change to the equilibration screen (see “Equilibration” on page 11).

4.

The patient’s temperature will display on the patient monitor once equilibrium is reached (approximately three minutes).

Setting up the control unit The control unit must be properly installed and mounted by qualified personnel. NOTE: The sensor and control unit are suitable for use in the patient environment. 2.

Connect the power supply to the back of the control unit (see Figure 2-3: Back of Control Unit). Plug the power supply into an appropriate outlet. The standby screen will illuminate.

3.

Connect the sensor cable to the front of the control unit. See Figure 2-4: Front of Control Unit for proper orientation and connection.

4.

If desired, use the provided monitor cable to connect the control unit to the patient monitor (see Figure 2-3: Back of Control Unit). NOTE: Temperature input on patient monitor typically labelled T1 or T2.

8

3M™ Bair Hugger™ Temperature Monitoring System Model 370 – Operator’s Manual

Prior to moving the patient, disconnect the sensor cable from the sensor. The sensor may be left on the patient and reconnected to another system once patient transfer is complete. NOTE: The 3M™ Bair Hugger™ sensor contains integrated memory that captures up to two hours of temperature data in five minute intervals. The sensor will retain these temperatures and history.

Figure 2-4: Front of Control Unit

1.

Position the sensor cable away from the patient’s face and apply the sensor to the patient’s forehead above the orbital ridge (Figure 2-7).

g System

Ensure the system power supply is connected to the back of the control unit and the power supply is plugged into an appropriate outlet. If desired, ensure the provided monitor cable is connected to the back of the control unit and to the YSI-400 type input on the patient monitor.

Monitorin

1.

ture

Instructions for use

To view information and connections on the back of the control unit, assure that controller is viewed from a distance no further than 15” (38 cm) from the operator.

Tempera

5.

Back of control unit

Figure 2-6: Remove the backing liners

GB / 34-8719-8362-2

9

2.

Use an alcohol wipe to clean and disinfect the patient’s forehead above the orbital ridge. Allow the patient’s forehead to completely dry.

3.

Connect the sensor to the sensor cable connector. Ensure the sensor tab is properly connected and is fully inserted into the sensor cable (Figure 2-5). The display on the control unit will change to the ready screen (See “Ready” on page 11) once it confirms the sensor connection.

Stand Knob Digital Port (used by 3M personnel only)

°C/°F Temperature Display Button

Monitor Cable Port

Power Input Port Figure 2-3: Back of Control Unit

The digital port is used only by 3M Health Care personnel for testing purposes and to access variables within the control unit.

Figure 2-7: Apply the sensor to the patient’s forehead

6.

Gently press the edge of the sensor to ensure good adhesion with the skin. OPTIONAL: Support the sensor cable with the provided sensor cable clip.

7.

The control unit will sense patient attachment after several seconds and the control unit display will change to the equilibration screen (see “Equilibration” on page 11).

8.

The patient’s temperature will display on the patient monitor once equilibrium is reached (approximately three minutes).

Temp eratu re

The monitor cable port provides a resistance that corresponds to a YSI-400 thermistor at the displayed temperature. It is electrically isolated from the control unit.

Moni toring Syste m

Front of control unit

m

oring e Monit eratur Temp

Syste

Figure 2-5: Connect the sensor to the sensor cable

4.

Transferring the patient and sensor 1.

Remove backing liners on the sensor to expose adhesive (Figure 2-6).

2.

Carefully reconnect a sensor cable and control unit to the sensor once transfer is complete.

3.

The control unit will sense patient attachment after several seconds and the control unit display will change to the equilibration screen (see “Equilibration” on page 11).

4.

The patient’s temperature will display on the patient monitor once equilibrium is reached (approximately three minutes).

Setting up the control unit The control unit must be properly installed and mounted by qualified personnel. NOTE: The sensor and control unit are suitable for use in the patient environment. 2.

Connect the power supply to the back of the control unit (see Figure 2-3: Back of Control Unit). Plug the power supply into an appropriate outlet. The standby screen will illuminate.

3.

Connect the sensor cable to the front of the control unit. See Figure 2-4: Front of Control Unit for proper orientation and connection.

4.

If desired, use the provided monitor cable to connect the control unit to the patient monitor (see Figure 2-3: Back of Control Unit). NOTE: Temperature input on patient monitor typically labelled T1 or T2.

8

3M™ Bair Hugger™ Temperature Monitoring System Model 370 – Operator’s Manual

Prior to moving the patient, disconnect the sensor cable from the sensor. The sensor may be left on the patient and reconnected to another system once patient transfer is complete. NOTE: The 3M™ Bair Hugger™ sensor contains integrated memory that captures up to two hours of temperature data in five minute intervals. The sensor will retain these temperatures and history.

Figure 2-4: Front of Control Unit

1.

Position the sensor cable away from the patient’s face and apply the sensor to the patient’s forehead above the orbital ridge (Figure 2-7).

g System

Ensure the system power supply is connected to the back of the control unit and the power supply is plugged into an appropriate outlet. If desired, ensure the provided monitor cable is connected to the back of the control unit and to the YSI-400 type input on the patient monitor.

Monitorin

1.

ture

Instructions for use

To view information and connections on the back of the control unit, assure that controller is viewed from a distance no further than 15” (38 cm) from the operator.

Tempera

5.

Back of control unit

Figure 2-6: Remove the backing liners

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9

Removing the sensor

3.

1.

Disconnect the sensor cable from the sensor. Disconnect the sensor cable clip from the bed or sheet, if used.

2.

Starting at the edge of the sensor, gently remove the sensor from the patient (Figure 2-8). NOTE: Do not use the sensor tab to remove the sensor from the patient.

Discard the sensor and clean the sensor cable. (See Section 5: General Maintenance, Storage and Service for details).

Section 3: Display Panel Display screens ... 11 Start-up ... 11 Standby ... 11

Sensor Tab

NOTE: If needed, use an alcohol swab along the sensor edge to help remove the sensor from the patient.

Ready ... 11 Equilibration ... 11 Running... 12 Control unit error... 12 Sensor error ... 12

Figure 2-8: Remove the sensor

To change temperature unit display (Celsius or Fahrenheit) The control unit can display temperature measurements in either Celsius or Fahrenheit. The unit will be factory preset to Celsius. 1.

Plug the control unit into an appropriate outlet.

2.

Push the temperature display button on the back of the control unit to change to the desired measurement scale. NOTE: The trend display is always shown in Celsius.

Display screens Start-up The start-up screen displays for approximately five seconds when the control unit is initially powered ON. The revision number of the control unit software is also displayed. FW-x.x.xxx

Standby The system graphic is displayed when the unit is not in use.

Temperature Monitoring System

Ready °C/°F Temperature Display Button

The ready screen displays the serial number of the sensor and indicates the sensor cable and sensor are properly attached to the control unit. The sensor is now ready to be attached to the patient. SN - 000000000

Figure 2-9: Temperature Display Button

Shutting down the control unit The plug on the power supply serves as the disconnect device. Turn the control unit on and off by plugging or unplugging the power supply from the wall outlet. The power outlet shall be as close as practical and shall be easily accessible.

Equilibration A flashing yellow temperature display indicates the sensor has been connected to the patient and to the control unit and is in the process of equilibration. The graph below the temperature output indicates the progress of equilibration. This process will take approximately three minutes. If you see a temperature in the upper left hand corner of the screen that is the last recorded temperature that has been captured by the sensor on the patient’s head. The sensor captures and records a temperature every five minutes.

36 9 C 39 37 35

36 0

C

After the equilibration is complete, the patient’s body temperature is displayed on the control unit in bold white numbers and can be automatically transmitted to the patient monitor via the monitor cable.

10

3M™ Bair Hugger™ Temperature Monitoring System Model 370 – Operator’s Manual

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11

Removing the sensor

3.

1.

Disconnect the sensor cable from the sensor. Disconnect the sensor cable clip from the bed or sheet, if used.

2.

Starting at the edge of the sensor, gently remove the sensor from the patient (Figure 2-8). NOTE: Do not use the sensor tab to remove the sensor from the patient.

Discard the sensor and clean the sensor cable. (See Section 5: General Maintenance, Storage and Service for details).

Section 3: Display Panel Display screens ... 11 Start-up ... 11 Standby ... 11

Sensor Tab

NOTE: If needed, use an alcohol swab along the sensor edge to help remove the sensor from the patient.

Ready ... 11 Equilibration ... 11 Running... 12 Control unit error... 12 Sensor error ... 12

Figure 2-8: Remove the sensor

To change temperature unit display (Celsius or Fahrenheit) The control unit can display temperature measurements in either Celsius or Fahrenheit. The unit will be factory preset to Celsius. 1.

Plug the control unit into an appropriate outlet.

2.

Push the temperature display button on the back of the control unit to change to the desired measurement scale. NOTE: The trend display is always shown in Celsius.

Display screens Start-up The start-up screen displays for approximately five seconds when the control unit is initially powered ON. The revision number of the control unit software is also displayed. FW-x.x.xxx

Standby The system graphic is displayed when the unit is not in use.

Temperature Monitoring System

Ready °C/°F Temperature Display Button

The ready screen displays the serial number of the sensor and indicates the sensor cable and sensor are properly attached to the control unit. The sensor is now ready to be attached to the patient. SN - 000000000

Figure 2-9: Temperature Display Button

Shutting down the control unit The plug on the power supply serves as the disconnect device. Turn the control unit on and off by plugging or unplugging the power supply from the wall outlet. The power outlet shall be as close as practical and shall be easily accessible.

Equilibration A flashing yellow temperature display indicates the sensor has been connected to the patient and to the control unit and is in the process of equilibration. The graph below the temperature output indicates the progress of equilibration. This process will take approximately three minutes. If you see a temperature in the upper left hand corner of the screen that is the last recorded temperature that has been captured by the sensor on the patient’s head. The sensor captures and records a temperature every five minutes.

36 9 C 39 37 35

36 0

C

After the equilibration is complete, the patient’s body temperature is displayed on the control unit in bold white numbers and can be automatically transmitted to the patient monitor via the monitor cable.

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3M™ Bair Hugger™ Temperature Monitoring System Model 370 – Operator’s Manual

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11

Displays

Running The running screen displays the deep tissue temperature of the patient in white. The trend graph at the bottom of the screen displays the last two hours of the patient’s temperature in five minute increments. The bars on the graph will begin filling from the right with the 36°C always visible. The blue bars indicate that the temperature dropped below 36°C (white indicates the temperature is above 36°C).

36 7

C

36°

Control unit error

Condition

Cause

Action

“Ready” screen continues to display while sensor is adhered to the patient.

Sensor not properly adhered to the patient.

Make sure the sensor is connected to the patient.

Low patient temperature (below 30°C).

Press and hold the °C/°F button on the back of the control unit for five seconds to force the control unit into equilibration mode. The patient’s temperature will then display.

Control unit failure.

Discontinue use of unit. Contact 3M technical service.

Control unit may still be equilibrating.

Wait until the control unit has finished equilibration. Continue use.

Control unit failure.

Contact 3M technical service.

Control unit may still be equilibrating.

Wait until the control unit has finished equilibration. Continue use.

Monitor cable is not plugged in.

Make sure the monitor cable is plugged into the control unit and patient monitor.

Cable failure.

Replace monitor cable.

Control unit failure.

Contact 3M technical service after use.

Cable failure.

Make sure the monitor cable is securely plugged into the control unit and patient monitor.

The control unit error screen displays when there is a system error. Discontinue use of unit. Contact a biomedical technician. SN - 000000000

E-xx “Running” screen does not appear on the control unit.

Sensor error The sensor error screen displays when there is a temperature sensor or cable error. See “Section 4: Troubleshooting” on page 12 for details.

36 7 E-xx

C

36°

Patient temperature does not appear on the patient monitor.

Section 4: Troubleshooting

36 9 C

On Mode ... 12 Displays ... 13

39 37 35

36 0

C

Errors... 14

The following conditions are listed in the order of which troubleshooting actions should be performed.

On Mode Condition

Cause

Action

Unit does not power up.

Unit is not plugged in, or power supply is not plugged into an appropriate outlet.

Make sure the power supply is plugged into the control unit. Make sure the control unit is plugged into an appropriate power outlet.

Unit failure.

Contact 3M technical service.

12

3M™ Bair Hugger™ Temperature Monitoring System Model 370 – Operator’s Manual

The patient’s temperature output on the control unit and patient monitor is > +/-0.2°C.

Contact 3M technical service.

Replace monitor cable. Verify monitor output (see Section 5 of the Installation and Service Manual). Contact 3M technical service.

GB / 34-8719-8362-2

13

Displays

Running The running screen displays the deep tissue temperature of the patient in white. The trend graph at the bottom of the screen displays the last two hours of the patient’s temperature in five minute increments. The bars on the graph will begin filling from the right with the 36°C always visible. The blue bars indicate that the temperature dropped below 36°C (white indicates the temperature is above 36°C).

36 7

C

36°

Control unit error

Condition

Cause

Action

“Ready” screen continues to display while sensor is adhered to the patient.

Sensor not properly adhered to the patient.

Make sure the sensor is connected to the patient.

Low patient temperature (below 30°C).

Press and hold the °C/°F button on the back of the control unit for five seconds to force the control unit into equilibration mode. The patient’s temperature will then display.

Control unit failure.

Discontinue use of unit. Contact 3M technical service.

Control unit may still be equilibrating.

Wait until the control unit has finished equilibration. Continue use.

Control unit failure.

Contact 3M technical service.

Control unit may still be equilibrating.

Wait until the control unit has finished equilibration. Continue use.

Monitor cable is not plugged in.

Make sure the monitor cable is plugged into the control unit and patient monitor.

Cable failure.

Replace monitor cable.

Control unit failure.

Contact 3M technical service after use.

Cable failure.

Make sure the monitor cable is securely plugged into the control unit and patient monitor.

The control unit error screen displays when there is a system error. Discontinue use of unit. Contact a biomedical technician. SN - 000000000

E-xx “Running” screen does not appear on the control unit.

Sensor error The sensor error screen displays when there is a temperature sensor or cable error. See “Section 4: Troubleshooting” on page 12 for details.

36 7 E-xx

C

36°

Patient temperature does not appear on the patient monitor.

Section 4: Troubleshooting

36 9 C

On Mode ... 12 Displays ... 13

39 37 35

36 0

C

Errors... 14

The following conditions are listed in the order of which troubleshooting actions should be performed.

On Mode Condition

Cause

Action

Unit does not power up.

Unit is not plugged in, or power supply is not plugged into an appropriate outlet.

Make sure the power supply is plugged into the control unit. Make sure the control unit is plugged into an appropriate power outlet.

Unit failure.

Contact 3M technical service.

12

3M™ Bair Hugger™ Temperature Monitoring System Model 370 – Operator’s Manual

The patient’s temperature output on the control unit and patient monitor is > +/-0.2°C.

Contact 3M technical service.

Replace monitor cable. Verify monitor output (see Section 5 of the Installation and Service Manual). Contact 3M technical service.

GB / 34-8719-8362-2

13

Errors

Section 6: Technical Service and Order Placement

Error Screen

Condition

Cause

Action

E-1 through E-16, E-18 through E-99

Sensor not properly connected to the sensor cable.

Make sure the sensor is connected to the sensor cable.

Sensor failure.

Replace sensor.

E-xx

Cable failure.

E-17

Technical service and order placement ... 15

Replace sensor cable. Contact 3M technical service.

When you call for technical support

Technical service and order placement

Sensor failure.

Replace sensor.

3M Helpline at 1-800-228-3957 (US) or your local 3M representative (Worldwide).

Cable failure.

Replace sensor cable.

Remember, we will need to know the serial number, software number and error code of your control unit when you call us. The serial number label is located on the back of the control unit. (The software number displays on the control unit when the control unit is connected to a power outlet.)

E-xx

Contact 3M technical service.

E-100 and up

When you call for technical support ... 15

Control unit failure.

Discontinue use of the control unit. Contact a biomedical technician.

Control unit failure.

Discontinue use of the control unit. Contact a biomedical technician.

E-xx

Section 7: Specifications Physical characteristics ...18 Electrical characteristics ...18 Temperature characteristics ...18

Section 5: General Maintenance, Storage and Service

Performance characteristics ...18 Environmental conditions ...18

Cleaning Procedure ... 14 Storage ... 14 Service ... 14

Cleaning Procedure

!

Storage

CAUTION: •

•

Do not immerse any of the devices or use a dripping wet cloth for cleaning. Moisture may seep inside the device and damage the electrical components and lead to incorrect temperature reporting. Do not spray cleaning solutions onto the control unit or into the sensor cable connector. Damage to the control unit or sensor cable connector may occur.

Cleaning the control unit and sensor cable Clean the control unit on an as-needed basis or per facility policies and procedures for cleaning electronic equipment. Clean the sensor cable between each use. 1.

Disconnect power supply from power outlet.

2.

Use a slightly damp soft cloth moistened with a mild, nonabrasive cleaning solution to clean the device surfaces, cords, and cables. Avoid getting liquid into electronic ports.

3.

Dry with a separate soft cloth.

14

Notice: Do not store the control unit and system components in a wet or damp place. Damage to the electrical components may occur. Store all components at room temperature and in a dry place when not in use.

List of Bair Hugger Accessories and Cables ...19 SPECIFICATIONS: Guidance and Manufacturer’s Declaration - Emissions The 3M™ Bair Hugger™ Temperature Monitoring System is intended for use in the electromagnetic environment specified below. The customer or user of the Temperature Monitoring System should ensure that it is used in such an environment. Emissions Test

Compliance

Electromagnetic Environment – Guidance

RF Emissions

Group 1

The Temperature Monitoring System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Class B

The Temperature Monitoring System is suitable for use in all establishments, including domestic, and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

CISPR 11

Service

RF Emissions

All service must be performed by 3M Health Care or an authorized service technician. Call 3M Customer Service at 1-800-733-7775 or your local 3M representative for service information.

CISPR 11

3M™ Bair Hugger™ Temperature Monitoring System Model 370 – Operator’s Manual

Harmonics

Class A

IEC 61000-3-2 Flicker

Complies

IEC 61000-3-3

GB / 34-8719-8362-2

15

Errors

Section 6: Technical Service and Order Placement

Error Screen

Condition

Cause

Action

E-1 through E-16, E-18 through E-99

Sensor not properly connected to the sensor cable.

Make sure the sensor is connected to the sensor cable.

Sensor failure.

Replace sensor.

E-xx

Cable failure.

E-17

Technical service and order placement ... 15

Replace sensor cable. Contact 3M technical service.

When you call for technical support

Technical service and order placement

Sensor failure.

Replace sensor.

3M Helpline at 1-800-228-3957 (US) or your local 3M representative (Worldwide).

Cable failure.

Replace sensor cable.

Remember, we will need to know the serial number, software number and error code of your control unit when you call us. The serial number label is located on the back of the control unit. (The software number displays on the control unit when the control unit is connected to a power outlet.)

E-xx

Contact 3M technical service.

E-100 and up

When you call for technical support ... 15

Control unit failure.

Discontinue use of the control unit. Contact a biomedical technician.

Control unit failure.

Discontinue use of the control unit. Contact a biomedical technician.

E-xx

Section 7: Specifications Physical characteristics ...18 Electrical characteristics ...18 Temperature characteristics ...18

Section 5: General Maintenance, Storage and Service

Performance characteristics ...18 Environmental conditions ...18

Cleaning Procedure ... 14 Storage ... 14 Service ... 14

Cleaning Procedure

!

Storage

CAUTION: •

•

Do not immerse any of the devices or use a dripping wet cloth for cleaning. Moisture may seep inside the device and damage the electrical components and lead to incorrect temperature reporting. Do not spray cleaning solutions onto the control unit or into the sensor cable connector. Damage to the control unit or sensor cable connector may occur.

Cleaning the control unit and sensor cable Clean the control unit on an as-needed basis or per facility policies and procedures for cleaning electronic equipment. Clean the sensor cable between each use. 1.

Disconnect power supply from power outlet.

2.

Use a slightly damp soft cloth moistened with a mild, nonabrasive cleaning solution to clean the device surfaces, cords, and cables. Avoid getting liquid into electronic ports.

3.

Dry with a separate soft cloth.

14

Notice: Do not store the control unit and system components in a wet or damp place. Damage to the electrical components may occur. Store all components at room temperature and in a dry place when not in use.

List of Bair Hugger Accessories and Cables ...19 SPECIFICATIONS: Guidance and Manufacturer’s Declaration - Emissions The 3M™ Bair Hugger™ Temperature Monitoring System is intended for use in the electromagnetic environment specified below. The customer or user of the Temperature Monitoring System should ensure that it is used in such an environment. Emissions Test

Compliance

Electromagnetic Environment – Guidance

RF Emissions

Group 1

The Temperature Monitoring System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Class B

The Temperature Monitoring System is suitable for use in all establishments, including domestic, and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

CISPR 11

Service

RF Emissions

All service must be performed by 3M Health Care or an authorized service technician. Call 3M Customer Service at 1-800-733-7775 or your local 3M representative for service information.

CISPR 11

3M™ Bair Hugger™ Temperature Monitoring System Model 370 – Operator’s Manual

Harmonics

Class A

IEC 61000-3-2 Flicker

Complies

IEC 61000-3-3

GB / 34-8719-8362-2

15

Guidance and Manufacturer’s Declaration - Emissions

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment – Guidance

The 3M™ Bair Hugger™ Temperature Monitoring System is intended for use in the electromagnetic environment specified below. The customer or user of the Temperature Monitoring System should ensure that it is used in such an environment.

ESD

±6kV Contact

±6kV Contact

IEC 61000-4-2

±8kV Air

±8kV Air

Floors should be wood, concrete or ceramic tile. If floors are synthetic, the r/h should be at least 30%

EFT

±2kV Mains

±2kV Mains

IEC 61000-4-4

±1kV I/Os

±1kV I/Os

Surge

±1kV Differential

±1kV Differential

IEC 61000-4-5

±2kV Common

±2kV Common

Voltage Dips/ Dropout IEC 61000-4-11

>95% Dip for 0.5 Cycle

>95% Dip for 0.5 Cycle

60% Dip for 5 Cycles

60% Dip for 5 Cycles

30% Dip for 25 Cycles

30% Dip for 25 Cycles

>95% Dip for 5 Seconds

>95% Dip for 5 Seconds

3A/m

3A/m

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment – Guidance

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3Vrms

Portable and mobile communications equipment should be separated from the Temperature Monitoring System by no less than the distances calculated/listed below:

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3V/m

D=1.2 D= 1.2

(80 to 800 MHz)

D= 2.3

(800 MHz to 2.5 GHz)

Where P is the max power in watts and D is the recommended separation distance in meters. Field strengths from fixed transmitters, as determined by an electromagnetic site survey, should be less than the compliance levels (V1 and E1).

Power Frequency 50/60Hz

Interference may occur in the vicinity of equipment containing a transmitter.

Magnetic Field IEC 61000-4-8

Guidance and Manufacturer’s Declaration –Immunity The 3M™ Bair Hugger™ Temperature Monitoring System is intended for use in the electromagnetic environment specified below. The customer or user of the Temperature Monitoring System should ensure that it is used in such an environment.

3M™ Bair Hugger™ Temperature Monitoring System Model 370 – Operator’s Manual

Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the Temperature Monitoring System requires continued operation during power mains interruptions, it is recommended that the Temperature Monitoring System be powered from an uninterruptible power supply or battery.

Power frequency magnetic fields should be that of a typical commercial or hospital environment.

Recommended Separations Distances The 3M™ Bair Hugger™ Temperature Monitoring System is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the Temperature Monitoring System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the Temperature Monitoring System as recommended below, according to the maximum output power of the communications equipment.

Max Output Power (Watts)

16

Mains power quality should be that of a typical commercial or hospital environment.

Separation (m) 150kHz to 80MHz

Separation (m) 80 to 800MHz

Separation (m) 800MHz to 2.5GHz

D=1.2

D=1.2

D=2.3

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

GB / 34-8719-8362-2

17

Guidance and Manufacturer’s Declaration - Emissions

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment – Guidance

The 3M™ Bair Hugger™ Temperature Monitoring System is intended for use in the electromagnetic environment specified below. The customer or user of the Temperature Monitoring System should ensure that it is used in such an environment.

ESD

±6kV Contact

±6kV Contact

IEC 61000-4-2

±8kV Air

±8kV Air

Floors should be wood, concrete or ceramic tile. If floors are synthetic, the r/h should be at least 30%

EFT

±2kV Mains

±2kV Mains

IEC 61000-4-4

±1kV I/Os

±1kV I/Os

Surge

±1kV Differential

±1kV Differential

IEC 61000-4-5

±2kV Common

±2kV Common

Voltage Dips/ Dropout IEC 61000-4-11

>95% Dip for 0.5 Cycle

>95% Dip for 0.5 Cycle

60% Dip for 5 Cycles

60% Dip for 5 Cycles

30% Dip for 25 Cycles

30% Dip for 25 Cycles

>95% Dip for 5 Seconds

>95% Dip for 5 Seconds

3A/m

3A/m

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment – Guidance

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3Vrms

Portable and mobile communications equipment should be separated from the Temperature Monitoring System by no less than the distances calculated/listed below:

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3V/m

D=1.2 D= 1.2

(80 to 800 MHz)

D= 2.3

(800 MHz to 2.5 GHz)

Where P is the max power in watts and D is the recommended separation distance in meters. Field strengths from fixed transmitters, as determined by an electromagnetic site survey, should be less than the compliance levels (V1 and E1).

Power Frequency 50/60Hz

Interference may occur in the vicinity of equipment containing a transmitter.

Magnetic Field IEC 61000-4-8

Guidance and Manufacturer’s Declaration –Immunity The 3M™ Bair Hugger™ Temperature Monitoring System is intended for use in the electromagnetic environment specified below. The customer or user of the Temperature Monitoring System should ensure that it is used in such an environment.

3M™ Bair Hugger™ Temperature Monitoring System Model 370 – Operator’s Manual

Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the Temperature Monitoring System requires continued operation during power mains interruptions, it is recommended that the Temperature Monitoring System be powered from an uninterruptible power supply or battery.

Power frequency magnetic fields should be that of a typical commercial or hospital environment.

Recommended Separations Distances The 3M™ Bair Hugger™ Temperature Monitoring System is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the Temperature Monitoring System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the Temperature Monitoring System as recommended below, according to the maximum output power of the communications equipment.

Max Output Power (Watts)

16

Mains power quality should be that of a typical commercial or hospital environment.

Separation (m) 150kHz to 80MHz

Separation (m) 80 to 800MHz

Separation (m) 800MHz to 2.5GHz

D=1.2

D=1.2

D=2.3

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

GB / 34-8719-8362-2

17

Physical characteristics

Electrical characteristics

Dimensions of Control Unit 9.3 cm (3.7 in) high, extendable to 11.4 cm (4.5 in) high

External power supply 100-240 VAC, 50-60 Hz

7.1 cm (2.8 in) wide, 4.3 cm (1.7 in) deep Weight of Control Unit 128 g (4.5 oz)

Output; 5 VDC

Model Number

Cable Length (m)

70-2007-9192-2

90106

Affinity Medical

MD370

4.0 ± 0.08

MD370

2.0 ± 0.03

90107

Monitor cable, 3.5mm to 3.5mm

70-2007-9194-8

90108

TLC Electronics

MD370

2.0 ± 0.03

Temp. cable, Phillips to mini-phone

70-2007-9206-0

90130

AMC&E

MD370

2.0 ± 0.075

Temp. cable, GE to mini-phone

70-2007-9205-2

90131

AMC&E

MD370

2.0 ± 0.075

Temp. cable, Draeger to mini-phone

70-2007-9204-5

90132

AMC&E

MD370

2.0 ± 0.075

Temp. cable, Spacelabs to mini-phone

70-2007-9207-8

90133

AMC&E

MD370

2.0 ± 0.075

US Style Power Supply

70-2007-9197-1

90113

FRIWO

MD370

3.0 ± 0.1

Measurement locations Patient’s lateral forehead above the orbital ridge

EU style power supply

70-2007-9198-9

90115

FRIWO

MD370

3.0 ± 0.1

UK style power supply

70-2007-9199-7

90116

FRIWO

MD370

3.0 ± 0.1

Measurement range 25°C - 43°C

Bair Hugger Sensor Model 36000

70-2007-9188-0

36000

3M

MD360

-

Measurement readout Celsius or Fahrenheit

WARNING: The use of ACCESSORIES and CABLES other than those specified, with the exception of accessories and cables sold by 3M as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the Bair Hugger system.

Over-temperature cutoff 43°C - Skin thermistor reading

Classification

44.5°C - Heater thermistor reading

Performance characteristics Equilibration time/Response time Approximately three minutes

Leakage current CF classification. Meets leakage current requirements in accordance with UL 60601-1 and EN60601-1.

Environmental conditions

Accuracy 25°C to 43°C ± 0.2°C

Ambient temperature range 10°C to 40°C (50°F to 104°F)

Sensor Material Medical grade foam and adhesive

Storage and transport temperature range -20°C to 60°C (-4°F to 140°F)

PET flexible circuit

Store all components at room temperature and in a dry place when not in use. Operating humidity 10 to 75% RH, noncondensing

Sensor Shelf Life 36 months

Atmospheric pressure range 80 kPa to 106 kPa (12 PSI to 15 PSI)

Digital Port Serial output 0 [-12 to +12] Monitor Cable Port Provides a resistance that corresponds to a YSI-400 thermistor at the displayed temperature. It is electrically isolated from the control unit.

18

Manufacturer

70-2007-9193-0

Length of the Sensor Cable 400 cm (158 in)

Recommended Calibration Check Every 12 months

3M Catalog #

TLC Electronics

Temperature characteristics

Classified by Underwriters Laboratories Inc. with respect to electric shock, fire, and mechanical hazards only, in accordance with UL 60601-1, IEC 60601-1, and Canadian/CSA C22.2 No. 601.1. ANSI/ AAMI ES 60601-1; 2005. EN60601-1.

Sensor Cable

Part Number

Monitor Cable, 3.5mm to 6.35mm

Dimensions of Sensor 4.1 cm (1.6 in) diameter, 0.5 cm (0.2 in) thick

Classified under IEC 60601-1 Guidelines (and other national versions of the Guidelines) as Class II, Type CF, Defibrillation-Proof, Ordinary Equipment. Conforms to EN12470. Not suitable for use in the presence of flammable anesthetic mixtures with air or nitrous oxide.

Component

Class II, double insulated medical grade Maximum heating power 2W

MEDICAL-GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601-1; CAN/ CSA-C22.2, No. 60601-1; ANSI/ AAMI ES60601-1:2005 CSA-C22.2 No.601-1:08; EN60601-1; Control No.4HZ8

List of Bair Hugger Accessories and Cables

Oxygen environment The sensor only is suitable for use in the presence of an oxygen enriched environment.

3M™ Bair Hugger™ Temperature Monitoring System Model 370 – Operator’s Manual

GB / 34-8719-8362-2

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