3M Bair Hugger Model 370 Installation and Service Manual Rev 34-8718-8800-3 March 2016

1 Table of Contents Section 1: Introduction ... 1 About this manual ... 1 Intended use ... 1 Safety information and symbols... 1 Proper use and maintenance ... 4 Read before servicing equipment ... 4 Description of the temperature monitoring system ...5 How it works...5 Section 2: Installation and Instructions for Use ... 6 Mounting the control unit ... 6 Instructions for use ...7 To change temperature unit display (Celsius or Fahrenheit) ... 8 Shutting down the control unit ... 9 Section 3: Display Panel ... 9 Display screens ... 9 Section 4: Troubleshooting ...10 On Mode ...10 Displays ...10 Errors... 11 Section 5: Calibration Verification Stick... 11 Calibration verification frequency ... 11 Tools and equipment ... 11 Verification of controller ... 11 Verification of monitor output ... 12 Optional: Verify resistance of verification stick ... 14 Section 6: General Maintenance ... 14 Cleaning and disinfecting procedure ... 14 Storage ... 14 Service ... 15 Section 7: Specifications ... 15 Physical characteristics... 15 Electrical characteristics ...16 Temperature characteristics ...16 Performance characteristics ...16 Environmental conditions ...16

v

TOC / 34-8718-8800-3

4395459 Description: 3M TM Bair Hugger™ Temperature Monitoring System Model 370 Installation and Service Manual Base File Name: PA: 37871888003.indd GA: Software: InDesign CC 2014 SGS Contact: Email: Printer: Printer Location: Supplier:

PROCESS BLACK

PROCESS CYAN

PROCESS MAGENTA

Item Spec#: 34-8718-8800-3 Supersedes#:XX-XXXX-XXXX-X

08.06.16 NEW - PU previous file, convert to Circular fonts.

TN

08.24.16 Make changes per RA proof report & final release.

TN

Structure#:XX-XXXXX Cat/Product#: XXXX Reference: #### Requester: Debra Stackk Die # / Doc. Size: 5.5" x 8.5"

PROCESS YELLOW

PANTONE 267C

2

PANTONE 280C

PDF Scaled to 80%

Revision History Revision

Reason for Change

Pages Affected

Date

202305A

New Revision - First Release

All

March 2013

34-8714-3118-4

Update calibration information

15-16

March 2014

34-8718-8800-3

Update for rebranding

All

March 2016

TOC / 34-8718-8800-3

iii

Section 1: Introduction About this manual ... 1 Intended use ... 1 Safety information and symbols... 1 Explanation of signal word consequences ...2 Proper use and maintenance ... 4 Read before servicing equipment ... 4 Description of the temperature monitoring system ...5 How it works...5

About this manual This Installation and Service Manual describes the setup and maintenance of the 3M™ Bair Hugger™ temperature monitoring system. The temperature monitoring system is to be used by healthcare professionals in clinical environments only. Read and follow all instructions, labeling and accompanying documents supplied with the temperature monitoring system. Failure to follow instructions could lead to misuse of the device, device malfunction, or patient injury.

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

Safety information and symbols Date of manufacture

Manufacturer

Single use only

Container quantity

CAUTION

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.

Defibrillation-proof type CF applied part

3M™ Bair Hugger™ Model 370 Temperature Monitoring System – Installation and Service Manual

GB / 34-8718-8800-3

1

1 Table of Contents Section 1: Introduction ... 1 About this manual ... 1 Intended use ... 1 Safety information and symbols... 1 Proper use and maintenance ... 4 Read before servicing equipment ... 4 Description of the temperature monitoring system ...5 How it works...5 Section 2: Installation and Instructions for Use ... 6 Mounting the control unit ... 6 Instructions for use ...7 To change temperature unit display (Celsius or Fahrenheit) ... 8 Shutting down the control unit ... 9 Section 3: Display Panel ... 9 Display screens ... 9 Section 4: Troubleshooting ...10 On Mode ...10 Displays ...10 Errors... 11 Section 5: Calibration Verification Stick... 11 Calibration verification frequency ... 11 Tools and equipment ... 11 Verification of controller ... 11 Verification of monitor output ... 12 Optional: Verify resistance of verification stick ... 14 Section 6: General Maintenance ... 14 Cleaning and disinfecting procedure ... 14 Storage ... 14 Service ... 15 Section 7: Specifications ... 15 Physical characteristics... 15 Electrical characteristics ...16 Temperature characteristics ...16 Performance characteristics ...16 Environmental conditions ...16

v

TOC / 34-8718-8800-3

4395459 Description: 3M TM Bair Hugger™ Temperature Monitoring System Model 370 Installation and Service Manual Base File Name: PA: 37871888003.indd GA: Software: InDesign CC 2014 SGS Contact: Email: Printer: Printer Location: Supplier:

PROCESS BLACK

PROCESS CYAN

PROCESS MAGENTA

Item Spec#: 34-8718-8800-3 Supersedes#:XX-XXXX-XXXX-X

08.06.16 NEW - PU previous file, convert to Circular fonts.

TN

08.24.16 Make changes per RA proof report & final release.

TN

Structure#:XX-XXXXX Cat/Product#: XXXX Reference: #### Requester: Debra Stackk Die # / Doc. Size: 5.5" x 8.5"

PROCESS YELLOW

PANTONE 267C

2

PANTONE 280C

PDF Scaled to 80%

Section 1: Introduction About this manual ... 1 Intended use ... 1 Safety information and symbols... 1 Explanation of signal word consequences ...2 Proper use and maintenance ... 4 Read before servicing equipment ... 4 Description of the temperature monitoring system ...5 How it works...5

About this manual This Installation and Service Manual describes the setup and maintenance of the 3M™ Bair Hugger™ temperature monitoring system. The temperature monitoring system is to be used by healthcare professionals in clinical environments only. Read and follow all instructions, labeling and accompanying documents supplied with the temperature monitoring system. Failure to follow instructions could lead to misuse of the device, device malfunction, or patient injury.

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

Safety information and symbols Date of manufacture

Manufacturer

Single use only

Container quantity

CAUTION

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.

Defibrillation-proof type CF applied part

3M™ Bair Hugger™ Model 370 Temperature Monitoring System – Installation and Service Manual

GB / 34-8718-8800-3

1

•

Do not use the 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.

Class II equipment

Authorized Representative in the European Community

!

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

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

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.

•

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.

•

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.

•

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.

Direct current

See accompanying documents

!

WARNING: To reduce the risks associated with fire: •

Consult operator’s manual

!

Keep dry

Hardware temperature limits

!

WARNING: To reduce the risks associate 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 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.

•

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

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 access to critical patient information or equipment do not mount the control unit: •

To a surface that is not flat or clean.

•

Over air vents of other equipment.

•

Over controls, displays, or buttons of other equipment.

•

Over speakers or alarms of other equipment.

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

2

Use ONLY with 3M 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.

3M™ Bair Hugger™ Model 370 Temperature Monitoring System – Installation and Service Manual

!

This 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 exposure to biohazards: •

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.

!

WARNING: To reduce the risks associated with entanglement:

!

CAUTION: To reduce the risks associated with skin maceration:

!

CAUTION: To reduce the risks associated with cross-contamination:

!

CAUTION: To reduce the risks associated with injury:

•

•

•

•

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

Do not use the sensor on damaged or compromised skin.

Clean the sensor cable before connecting to a new sensor.

Mount the control unit at a height no higher than 84” (213 cm).

GB / 34-8718-8800-3

3

•

Do not use the 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.

Class II equipment

Authorized Representative in the European Community

!

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

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

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.

•

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.

•

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.

•

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.

Direct current

See accompanying documents

!

WARNING: To reduce the risks associated with fire: •

Consult operator’s manual

!

Keep dry

Hardware temperature limits

!

WARNING: To reduce the risks associate 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 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.

•

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

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 access to critical patient information or equipment do not mount the control unit: •

To a surface that is not flat or clean.

•

Over air vents of other equipment.

•

Over controls, displays, or buttons of other equipment.

•

Over speakers or alarms of other equipment.

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

2

Use ONLY with 3M 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.

3M™ Bair Hugger™ Model 370 Temperature Monitoring System – Installation and Service Manual

!

This 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 exposure to biohazards: •

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.

!

WARNING: To reduce the risks associated with entanglement:

!

CAUTION: To reduce the risks associated with skin maceration:

!

CAUTION: To reduce the risks associated with cross-contamination:

!

CAUTION: To reduce the risks associated with injury:

•

•

•

•

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

Do not use the sensor on damaged or compromised skin.

Clean the sensor cable before connecting to a new sensor.

Mount the control unit at a height no higher than 84” (213 cm).

GB / 34-8718-8800-3

3

Use the provided hook-and-loop or foam adhesive to secure the control unit stand to any hard, flat surface (use only the 3M provided/specified control unit mounting materials).

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.

4.

To avoid temperature monitoring system damage that may impact performance: •

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.

Description of the temperature monitoring system The temperature monitoring system measures the core temperature of the patient. The system is comprised of the 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.

Monitor Cable

Power Supply

3M™ Bair Hugger™ Control Unit SO R

•

PAT T SEN IEN

Sensor Cable

•

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 6: General Maintenance” on page 14.

•

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

5.

The sensor is not made with natural latex material.

6.

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

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.

7.

To reduce the risks associated with environmental contamination follow applicable regulations when disposing of this device or any of its electronic components.

8.

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

m Syste oring e Monit eratur Temp

Temperature Sensor Sensor Connector

Figure 1-1: Temperature Monitoring System

How it works The temperature monitoring system uses zero-heat-flux thermometry to accurately measure a person’s core temperature as characterized in Figure 1-2 below. 1) The temperature monitoring system gently warms the sensor creating an isothermal pathway 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 sensor reaches equilibrium with the patient’s core temperature, the control unit displays an accurate, noninvasive measurement of the patient’s core temperature. Skin Surface

Deep Tissue

1) Placement and connection

3M 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.

•

The control unit is not maintained in accordance with the procedures described in the Service and Installation Manual.

Temperature Sensor

2) Equilibration - isothermal zone development

Read before servicing equipment All repair, calibration, and servicing of temperature monitoring system requires the skill of a qualified, medical equipment service technician who is familiar with good practice for medical device repair. If service does not require the manufacturer’s attention, the Model 370 Installation and Service Manual provides the technical information needed to service the control unit. Perform all repairs and maintenance in accordance with the instructions in the Installation and Service Manual. For additional service information, please contact 3M technical support.

3) Equilibrated - isothermal zone established Figure 1-2: Isothermal tunnel formation with zero-heat-flux technology

Control Unit The control unit displays non-invasive core temperature measurements obtained from the 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 and equilibration is complete, the control unit reads up to the last two hours of stored temperature data and displays the temperature

4

3M™ Bair Hugger™ Model 370 Temperature Monitoring System – Installation and Service Manual

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5

Use the provided hook-and-loop or foam adhesive to secure the control unit stand to any hard, flat surface (use only the 3M provided/specified control unit mounting materials).

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.

4.

To avoid temperature monitoring system damage that may impact performance: •

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.

Description of the temperature monitoring system The temperature monitoring system measures the core temperature of the patient. The system is comprised of the 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.

Monitor Cable

Power Supply

3M™ Bair Hugger™ Control Unit SO R

•

PAT T SEN IEN

Sensor Cable

•

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 6: General Maintenance” on page 14.

•

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

5.

The sensor is not made with natural latex material.

6.

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

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.

7.

To reduce the risks associated with environmental contamination follow applicable regulations when disposing of this device or any of its electronic components.

8.

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

m Syste oring e Monit eratur Temp

Temperature Sensor Sensor Connector

Figure 1-1: Temperature Monitoring System

How it works The temperature monitoring system uses zero-heat-flux thermometry to accurately measure a person’s core temperature as characterized in Figure 1-2 below. 1) The temperature monitoring system gently warms the sensor creating an isothermal pathway 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 sensor reaches equilibrium with the patient’s core temperature, the control unit displays an accurate, noninvasive measurement of the patient’s core temperature. Skin Surface

Deep Tissue

1) Placement and connection

3M 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.

•

The control unit is not maintained in accordance with the procedures described in the Service and Installation Manual.

Temperature Sensor

2) Equilibration - isothermal zone development

Read before servicing equipment All repair, calibration, and servicing of temperature monitoring system requires the skill of a qualified, medical equipment service technician who is familiar with good practice for medical device repair. If service does not require the manufacturer’s attention, the Model 370 Installation and Service Manual provides the technical information needed to service the control unit. Perform all repairs and maintenance in accordance with the instructions in the Installation and Service Manual. For additional service information, please contact 3M technical support.

3) Equilibrated - isothermal zone established Figure 1-2: Isothermal tunnel formation with zero-heat-flux technology

Control Unit The control unit displays non-invasive core temperature measurements obtained from the 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 and equilibration is complete, the control unit reads up to the last two hours of stored temperature data and displays the temperature

4

3M™ Bair Hugger™ Model 370 Temperature Monitoring System – Installation and Service Manual

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5

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 1-1: Monitor Cables) to the back of the control unit and to the input on the patient monitor. Patient Monitor Connector Cables

Figure 2-1: Control Unit Mounting Configuration

Table 1-1: Monitor Cables

Temperature Sensor

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 2-2). The display on the control unit will change to the ready screen (See “Ready” on page 9 ) once it confirms the sensor connection.

WARNING: To reduce the risks associated with access to critical patient information or equipment do not mount the control unit: •

To a surface that is not flat or clean.

•

Over air vents of other equipment.

•

Over controls, displays, or buttons of other equipment.

•

Over speakers or alarms of other equipment.

Mounting the control unit

!

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.

4.

Remove backing liners on the sensor to expose adhesive (Figure 2-3).

5.

Position the sensor cable away from the patient’s face and apply the sensor to the patient’s forehead above the orbital ridge (Figure 2-4).

System

!

1.

oring

Section 2: Installation and Instructions for Use

Instructions for use Temp eratur e Monit

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. When 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 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.

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

CAUTION: To reduce the risks associated with injury: •

Mount the control unit at a height no higher than 84” (213 cm).

•

Use the provided hook-and-loop or foam adhesive to secure the control unit stand to any hard, flat surface (use only the 3M provided/specified control unit mounting materials).

Figure 2-3: Remove the backing liners

Note: Confirm the hook-and-loop is securely fastened together before mounting the control unit to a surface.

g System

ure

1.

Temperat

Monitorin

Recommend: Clean surface with a 70% mixture of isopropyl alcohol and water prior to applying the provided hook-and-loop or foam adhesive. The control unit’s height and orientation can be adjusted by loosening/tightening the control unit stand knob on the back of the unit. Figure 2-4: Apply the sensor to the patient’s forehead

6

3M™ Bair Hugger™ Model 370 Temperature Monitoring System – Installation and Service Manual

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7

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 1-1: Monitor Cables) to the back of the control unit and to the input on the patient monitor. Patient Monitor Connector Cables

Figure 2-1: Control Unit Mounting Configuration

Table 1-1: Monitor Cables

Temperature Sensor

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 2-2). The display on the control unit will change to the ready screen (See “Ready” on page 9 ) once it confirms the sensor connection.

WARNING: To reduce the risks associated with access to critical patient information or equipment do not mount the control unit: •

To a surface that is not flat or clean.

•

Over air vents of other equipment.

•

Over controls, displays, or buttons of other equipment.

•

Over speakers or alarms of other equipment.

Mounting the control unit

!

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.

4.

Remove backing liners on the sensor to expose adhesive (Figure 2-3).

5.

Position the sensor cable away from the patient’s face and apply the sensor to the patient’s forehead above the orbital ridge (Figure 2-4).

System

!

1.

oring

Section 2: Installation and Instructions for Use

Instructions for use Temp eratur e Monit

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. When 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 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.

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

CAUTION: To reduce the risks associated with injury: •

Mount the control unit at a height no higher than 84” (213 cm).

•

Use the provided hook-and-loop or foam adhesive to secure the control unit stand to any hard, flat surface (use only the 3M provided/specified control unit mounting materials).

Figure 2-3: Remove the backing liners

Note: Confirm the hook-and-loop is securely fastened together before mounting the control unit to a surface.

g System

ure

1.

Temperat

Monitorin

Recommend: Clean surface with a 70% mixture of isopropyl alcohol and water prior to applying the provided hook-and-loop or foam adhesive. The control unit’s height and orientation can be adjusted by loosening/tightening the control unit stand knob on the back of the unit. Figure 2-4: Apply the sensor to the patient’s forehead

6

3M™ Bair Hugger™ Model 370 Temperature Monitoring System – Installation and Service Manual

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7

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 9).

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.

8.

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

Section 3: Display Panel

Shutting down the control unit

Transferring the patient and sensor 1.

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 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.

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 9).

4.

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

Removing the sensor 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 2-5). NOTE: Do not use the sensor tab to remove the sensor from the patient.

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

NOTE: If needed, use an alcohol swab along the sensor edge to help remove the sensor from the patient. 3.

Display screens

Ready 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.

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

SN - 000000000

To change temperature unit display (Celsius or Fahrenheit) 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.

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.

Figure 2-5: Remove the sensor

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. °C/°F Temperature Display Button

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

E-xx

Figure 2-6: Temperature Display Button

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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 9).

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.

8.

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

Section 3: Display Panel

Shutting down the control unit

Transferring the patient and sensor 1.

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 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.

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 9).

4.

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

Removing the sensor 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 2-5). NOTE: Do not use the sensor tab to remove the sensor from the patient.

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

NOTE: If needed, use an alcohol swab along the sensor edge to help remove the sensor from the patient. 3.

Display screens

Ready 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.

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

SN - 000000000

To change temperature unit display (Celsius or Fahrenheit) 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.

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.

Figure 2-5: Remove the sensor

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. °C/°F Temperature Display Button

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

E-xx

Figure 2-6: Temperature Display Button

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Errors

Sensor error The sensor error screen displays when there is a temperature sensor or cable error. See “Section 4: Troubleshooting” on pages 10 and 11 for details.

Error Screen

Condition

Cause

Action

E-1 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 E-xx

Section 4: Troubleshooting

Cable failure.

Replace sensor cable. Contact 3M technical support.

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

E-100 and up

Control unit failure.

On Mode Condition

Cause

Action

Control unit does not power up.

Control 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.

Control unit failure.

Contact 3M technical support.

Allow 30-60 seconds for the unit to reset.

E-xx

Reconnect the control unit to the power source to determine if the control unit reset or if it is a permanent error. Discontinue use of the control unit. Contact a biomedical technician.

Displays 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.

36 7

Section 5: Calibration Verification Stick Calibration verification frequency Every 12 months or according to institutional protocol.

Tools and equipment

Control unit failure.

Discontinue use of unit. Contact 3M technical support.

Control unit may still be equilibrating.

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

Verification of controller

Control unit failure.

Contact 3M technical support.

1.

Connect the power supply to the back of the control unit (see Figure 5-1: Back of Control Unit). Plug the power supply into an appropriate outlet. The standby screen will illuminate.

2.

Connect the sensor cable to the front of the control unit (see Figure 5-2: Front of Control Unit).

SN - 000000000

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

Disconnect the control unit from power source.

C

•

Calibration verification stick(s)

•

Multi-meter (Minimum accuracy of 0.05% of measurement + two digits at 4½ digits of resolution)

36°

Patient temperature does not appear on the patient monitor. 36 9 C 39 37 35

36 0

C

The patient’s temperature output on the control unit and patient monitor differs by more than +/-0.2°C.

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.

Monitor Cable Port

Stand Knob

Contact 3M technical support. 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. Replace monitor cable.

°C/°F Temperature Display Button Digital Port (used by 3M personnel only)

Verify monitor output (see Section 5).

Power Input Port

Contact 3M technical support. Figure 5-1: Back of Control Unit

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Errors

Sensor error The sensor error screen displays when there is a temperature sensor or cable error. See “Section 4: Troubleshooting” on pages 10 and 11 for details.

Error Screen

Condition

Cause

Action

E-1 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 E-xx

Section 4: Troubleshooting

Cable failure.

Replace sensor cable. Contact 3M technical support.

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

E-100 and up

Control unit failure.

On Mode Condition

Cause

Action

Control unit does not power up.

Control 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.

Control unit failure.

Contact 3M technical support.

Allow 30-60 seconds for the unit to reset.

E-xx

Reconnect the control unit to the power source to determine if the control unit reset or if it is a permanent error. Discontinue use of the control unit. Contact a biomedical technician.

Displays 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.

36 7

Section 5: Calibration Verification Stick Calibration verification frequency Every 12 months or according to institutional protocol.

Tools and equipment

Control unit failure.

Discontinue use of unit. Contact 3M technical support.

Control unit may still be equilibrating.

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

Verification of controller

Control unit failure.

Contact 3M technical support.

1.

Connect the power supply to the back of the control unit (see Figure 5-1: Back of Control Unit). Plug the power supply into an appropriate outlet. The standby screen will illuminate.

2.

Connect the sensor cable to the front of the control unit (see Figure 5-2: Front of Control Unit).

SN - 000000000

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

Disconnect the control unit from power source.

C

•

Calibration verification stick(s)

•

Multi-meter (Minimum accuracy of 0.05% of measurement + two digits at 4½ digits of resolution)

36°

Patient temperature does not appear on the patient monitor. 36 9 C 39 37 35

36 0

C

The patient’s temperature output on the control unit and patient monitor differs by more than +/-0.2°C.

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.

Monitor Cable Port

Stand Knob

Contact 3M technical support. 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. Replace monitor cable.

°C/°F Temperature Display Button Digital Port (used by 3M personnel only)

Verify monitor output (see Section 5).

Power Input Port

Contact 3M technical support. Figure 5-1: Back of Control Unit

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toring re Moni eratu Temp

Syste

5.

Wait for the control unit to calibrate and start emulating data. The internal relay will “click” and the display will refresh when the emulation is active.

6.

Set the multi-meter to the 2000 ohm range. Note: Zero the multi-meter as necessary for all resistance measurements.

7.

Hold the digital multi-meter leads to contacts one and two as shown in Table 5-2: Monitor Cables. Patient Monitor Connector Cables

m

1

Verify resistance from contact one to each 2 contact two.

1 2

Figure 5-2: Front of Control Unit

3.

Connect the system calibration verification stick to the sensor cable. Ensure the verification stick is fully inserted into the sensor cable.

4.

The screen shows the actual calibrated thermistor readings for the skin and heater thermistors (see Figure 3: 36°C (96.8°F) Calibration Screens). Verify that the reference temperature for each calibrated thermistor matches the displayed value (see Table 5-1: Display Output). If more than one reference temperature is required by your institution, verify using additional calibration verification sticks. Temperature

Display Output

31°C

31.0 ± 0.1°C (87.8 ± 0.2°F)

36°C

36.0 ± 0.1°C (96.8 ± 0.2°F)

41°C

41.0 ± 0.1°C (105.8 ± 0.2°F)

1 2

1

2

1

Table 5-1: Display Output

5.

If the reference temperatures are outside of the acceptable limits, discontinue use of the temperature monitoring system. Contact 3M technical support. If the reference temperatures are within acceptable limits, continue with verification of monitor output if the control unit is connected to and used in conjunction with a facility monitor.

2 Table 5-2: Monitor Cables

8.

Confirm the reading on the multi-meter matches the value in Table 5-3: Monitor Output. If more than one reference temperature is required by your institution, verify using additional calibration verification sticks. Temperature

Monitor Output

31°C

1739 ± 15 Ω

36°C

1412 ± 12 Ω

41°C

1152 ± 10 Ω Table 5-3: Monitor Output

Figure 5-3: 36°C (96.8°F) Calibration Screens (Celsius and Fahrenheit)

Verification of monitor output For control units that are connected to and used in conjunction with a facility monitor. 1.

Connect the power supply to the back of the control unit (see Figure 5-1: Back of Control Unit). Plug the power supply into an appropriate outlet. The standby screen will illuminate.

2.

Connect the sensor cable to the front of the control unit (see Figure 5-2: Front of Control Unit).

3.

Plug the monitor cable to the monitor port on the back of the control unit (see Figure 5-1: Back of Control Unit).

4.

Connect the system calibration verification stick to the sensor cable. Ensure the verification stick is fully inserted into the sensor cable.

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3M™ Bair Hugger™ Model 370 Temperature Monitoring System – Installation and Service Manual

9.

If the reference reading on the multi-meter is outside of the acceptable limits, discontinue use of the temperature monitoring system. Contact 3M technical support. If the reference reading on the multi-meter is within acceptable limits, continue with verifying the resistance of the verification stick(s) (if required by your institution).

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toring re Moni eratu Temp

Syste

5.

Wait for the control unit to calibrate and start emulating data. The internal relay will “click” and the display will refresh when the emulation is active.

6.

Set the multi-meter to the 2000 ohm range. Note: Zero the multi-meter as necessary for all resistance measurements.

7.

Hold the digital multi-meter leads to contacts one and two as shown in Table 5-2: Monitor Cables. Patient Monitor Connector Cables

m

1

Verify resistance from contact one to each 2 contact two.

1 2

Figure 5-2: Front of Control Unit

3.

Connect the system calibration verification stick to the sensor cable. Ensure the verification stick is fully inserted into the sensor cable.

4.

The screen shows the actual calibrated thermistor readings for the skin and heater thermistors (see Figure 3: 36°C (96.8°F) Calibration Screens). Verify that the reference temperature for each calibrated thermistor matches the displayed value (see Table 5-1: Display Output). If more than one reference temperature is required by your institution, verify using additional calibration verification sticks. Temperature

Display Output

31°C

31.0 ± 0.1°C (87.8 ± 0.2°F)

36°C

36.0 ± 0.1°C (96.8 ± 0.2°F)

41°C

41.0 ± 0.1°C (105.8 ± 0.2°F)

1 2

1

2

1

Table 5-1: Display Output

5.

If the reference temperatures are outside of the acceptable limits, discontinue use of the temperature monitoring system. Contact 3M technical support. If the reference temperatures are within acceptable limits, continue with verification of monitor output if the control unit is connected to and used in conjunction with a facility monitor.

2 Table 5-2: Monitor Cables

8.

Confirm the reading on the multi-meter matches the value in Table 5-3: Monitor Output. If more than one reference temperature is required by your institution, verify using additional calibration verification sticks. Temperature

Monitor Output

31°C

1739 ± 15 Ω

36°C

1412 ± 12 Ω

41°C

1152 ± 10 Ω Table 5-3: Monitor Output

Figure 5-3: 36°C (96.8°F) Calibration Screens (Celsius and Fahrenheit)

Verification of monitor output For control units that are connected to and used in conjunction with a facility monitor. 1.

Connect the power supply to the back of the control unit (see Figure 5-1: Back of Control Unit). Plug the power supply into an appropriate outlet. The standby screen will illuminate.

2.

Connect the sensor cable to the front of the control unit (see Figure 5-2: Front of Control Unit).

3.

Plug the monitor cable to the monitor port on the back of the control unit (see Figure 5-1: Back of Control Unit).

4.

Connect the system calibration verification stick to the sensor cable. Ensure the verification stick is fully inserted into the sensor cable.

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3M™ Bair Hugger™ Model 370 Temperature Monitoring System – Installation and Service Manual

9.

If the reference reading on the multi-meter is outside of the acceptable limits, discontinue use of the temperature monitoring system. Contact 3M technical support. If the reference reading on the multi-meter is within acceptable limits, continue with verifying the resistance of the verification stick(s) (if required by your institution).

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Optional: Verify resistance of verification stick

Technical Support and Order Placement

Note: Verifying the resistance of the verification stick requires a high precision multi-meter. Specification of multi-meter must be able to read 0.01% of reading + 0.001% of range at 5½ digits of resolution.

USA

1.

Set the multi-meter to the 10,000 ohm range. Note: Zero the multi-meter as necessary for all resistance measurements.

OUTSIDE OF THE USA

2.

Hold the digital multi-meter leads to pads one and three (see Figure 5-4: Calibration Verification Stick).

When You Call for Technical Support

3

TEL:

800-733-7775

Contact your local 3M representative.

We will need to know the serial number of your control unit when you call us. The serial number label is located on the back of the unit.

1

4

In-Warranty Repair and Exchange

5

USA

6

Call 3M technical support if your control unit requires factory service. A technical support representative will give you a Return Authorization (RA) number. Please use this RA number on all correspondence concerning your control unit.

2

OUTSIDE THE USA Figure 5-4: Calibration Verification Stick

3.

Confirm the reading on the multi-meter matches the value in Table 5-4: Resistance. Resistance

31°C

8,200.0 ± 4.4 Ω

Physical characteristics

36°C

6,800.0 ± 4.1 Ω

41°C

5,600.0 ± 3.4 Ω

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

Table 5-4: Resistance

Repeat with pads one and five.

5.

If the reference reading on the multi-meter is outside of the acceptable limits, discontinue use of the calibration verification stick. Contact 3M technical support. If the reading on the multi-meter is within acceptable limits, the calibration verification stick is within calibration limits.

Section 6: General Maintenance Cleaning and disinfecting procedure Caution: To reduce the risks associated with cross-contamination: •

Section 7: Specifications

Temperature

4.

!

Contact your local distributor concerning in-warranty repair and exchange.

Clean the sensor cable before connecting to a new sensor.

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.

Disinfecting the sensor cable

7.1 cm (2.8 in) wide, 4.3 cm (1.7 in) deep Weight of Control Unit 128 g (4.5 oz) Dimensions of Sensor 4.1 cm (1.6 in) diameter, 0.5 cm (0.2 in) thick Length of the Sensor Cable 400 cm (158 in) Classification 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; Control No. 4HZ8. No.4HZ8 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. 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. Accuracy 25°C to 43°C ± 0.2°C

1.

Clean the devices as described above.

Sensor Material Medical grade foam and adhesive

2.

Wipe down the control unit and cable using a damp soft cloth and 70% isopropyl alcohol solution. Avoid getting liquid into electronic ports.

PET flexible circuit

3.

Dry with a separate soft cloth.

Recommended Calibration Check Every 12 months or according to institutional protocol.

Storage Notice: Do not store the control unit and system components in a wet or damp place. Damage to the electrical components may occur.

Sensor Shelf Life 36 months

Store all components at room temperature and in a dry place when not in use.

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Optional: Verify resistance of verification stick

Technical Support and Order Placement

Note: Verifying the resistance of the verification stick requires a high precision multi-meter. Specification of multi-meter must be able to read 0.01% of reading + 0.001% of range at 5½ digits of resolution.

USA

1.

Set the multi-meter to the 10,000 ohm range. Note: Zero the multi-meter as necessary for all resistance measurements.

OUTSIDE OF THE USA

2.

Hold the digital multi-meter leads to pads one and three (see Figure 5-4: Calibration Verification Stick).

When You Call for Technical Support

3

TEL:

800-733-7775

Contact your local 3M representative.

We will need to know the serial number of your control unit when you call us. The serial number label is located on the back of the unit.

1

4

In-Warranty Repair and Exchange

5

USA

6

Call 3M technical support if your control unit requires factory service. A technical support representative will give you a Return Authorization (RA) number. Please use this RA number on all correspondence concerning your control unit.

2

OUTSIDE THE USA Figure 5-4: Calibration Verification Stick

3.

Confirm the reading on the multi-meter matches the value in Table 5-4: Resistance. Resistance

31°C

8,200.0 ± 4.4 Ω

Physical characteristics

36°C

6,800.0 ± 4.1 Ω

41°C

5,600.0 ± 3.4 Ω

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

Table 5-4: Resistance

Repeat with pads one and five.

5.

If the reference reading on the multi-meter is outside of the acceptable limits, discontinue use of the calibration verification stick. Contact 3M technical support. If the reading on the multi-meter is within acceptable limits, the calibration verification stick is within calibration limits.

Section 6: General Maintenance Cleaning and disinfecting procedure Caution: To reduce the risks associated with cross-contamination: •

Section 7: Specifications

Temperature

4.

!

Contact your local distributor concerning in-warranty repair and exchange.

Clean the sensor cable before connecting to a new sensor.

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.

Disinfecting the sensor cable

7.1 cm (2.8 in) wide, 4.3 cm (1.7 in) deep Weight of Control Unit 128 g (4.5 oz) Dimensions of Sensor 4.1 cm (1.6 in) diameter, 0.5 cm (0.2 in) thick Length of the Sensor Cable 400 cm (158 in) Classification 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; Control No. 4HZ8. No.4HZ8 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. 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. Accuracy 25°C to 43°C ± 0.2°C

1.

Clean the devices as described above.

Sensor Material Medical grade foam and adhesive

2.

Wipe down the control unit and cable using a damp soft cloth and 70% isopropyl alcohol solution. Avoid getting liquid into electronic ports.

PET flexible circuit

3.

Dry with a separate soft cloth.

Recommended Calibration Check Every 12 months or according to institutional protocol.

Storage Notice: Do not store the control unit and system components in a wet or damp place. Damage to the electrical components may occur.

Sensor Shelf Life 36 months

Store all components at room temperature and in a dry place when not in use.

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