370 Operators Manual Nov 2020

Section 1: Introduction This Operator’s Manual describes the setup, use, and maintenance of the 3M™ Bair Hugger™ temperature monitoring system. The temperature monitoring system and the manual are to be used by healthcare professionals in clinical environments only. Read and follow all instructions, labeling, and accompanying documents supplied with this temperature monitoring system. Failure to follow instructions could lead to misuse of the device, device malfunction, or patient injury.

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

This product is intended to be used by trained medical professionals in a clinical/surgical setting.

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

Safety information and symbols Symbol Glossary Symbol Title

Symbol

Description and Reference

Manufacturer

Indicates the medical device manufacturer. Source: ISO 15223, 5.1.1

Authorized Representative in European Community

Indicates the authorized representative in the European Community. Source: ISO 15223, 5.1.2, 2014/35/EU, and/or 2014/30/EU

Date of Manufacture

Indicates the date when the medical device was manufactured. Source: ISO 15223, 5.1.3

Catalogue number

Indicates the manufacturer’s catalogue number so that the medical device can be identified. Source : ISO 15223, 5.1.6

Serial number

Indicates the manufacturer’s serial number so that a specific medical device can be identified. Source: ISO 15223, 5.1 .7

Keep dry

Indicates a medical device that needs to be protected from moisture. Source: ISO 15223, 5.3.4

Do not re-use

Indicates a medical device that is intended for one use or for use on a single patient during a single procedure. Source: ISO 15223, 5.4.2

Consult instructions for use

Indicates the need for the user to consult the instructions for use. Source: ISO 15223, 5.4.3

Caution

Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself. Source: ISO 15223, 5.4.4

Medical Device

Indicates the item is a medical device. Source: ISO 15223, 5.7.7

Unique device identifier

Indicates a carrier that contains Unique Device Identifier information. Source: ISO 15223, 5.7.10

Importer

Indicates the entity importing the medical device into the locale. Source: ISO 15223, 5.1.8

CE Mark

Indicates conformity to all applicable European Union Regulations and Directives with notified body involvement.

UL Classified

Indicates product was evaluated and Listed by UL for the USA and Canada.

Recycle

Indicates trash bin or container is for materials to be recycled

2

Follow instructions for use

To signify that the instructions for use must be followed. Source: ISO 7010-M002

Defibrillation-proof type CF applied part

To identify a defibrillation-proof type CF applied part complying with IEC 606011. Source: IEC 60417-5336

Direct current

To indicate on the rating plate that the equipment is suitable for direct current only or to identify relevant terminals. Source: IEC 60417-5031

Class II equipment

To identify equipment meeting the safety requirements for Class II equipment per IEC 61140. Source: IEC/TR 60878

Recycle electronic equipment

DO NOT throw this unit into a municipal trash bin when this unit has reached the end of its lifetime. Please recycle. Source: Directive 2012/19/EC on waste electrical and electronic equipment (WEEE)

Australian Radio Communications License

Indicates product complies with applicable Australian regulatory requirements. Source: AS/NZS 4417.1:2012

INMETRO

.Indicates product complies with the Brazilian standards

For more information see, HCBGregulatory.3M.com

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: •

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 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.

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

Always keep power supply visible and accessible. 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 your local 3M technical support representative.

•

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.

WARNING: To reduce the risks associated with fire: •

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.

3

•

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.

•

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

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: •

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

CAUTION: To reduce the risks associated with skin maceration: •

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 injury: •

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

•

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

CAUTION: 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 and 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.

CAUTION: To reduce the risks associated with electromagnetic compatibility: •

Consult the troubleshooting guide found in Section 5 of this manual if performance of the system is degraded due to the Electromagnetic Disturbances.

NOTICE 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.

To avoid temperature monitoring system damage that may impact performance:

4

•

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, use a dripping wet cloth for cleaning, or subject them to any sterilization process.

•

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

•

Cleaning should be performed in accordance with hospital practices for cleaning OR equipment. After every use wipe the device surfaces, cords, and cables. Avoid getting liquid into electronic ports.

Use a damp soft cloth and a hospital approved mild detergent, germicidal disposable wipes, disinfecting towelettes, or antimicrobial spray. The following active ingredients are acceptable for cleaning: o

Oxidizers (e.g. 10% Bleach)

o

Quaternary Ammonium compounds (e.g. 3M™ Quat Disinfectant Cleaner)

o

Phenolics (e.g. 3M™ Phenolic Disinfectant Cleaner)

o

Alcohols (e.g. 70% Isopropyl Alcohol)

o

For full cleaning procedures see “Section 6: General maintenance, Storage and Service.”

4.

The sensor is not made with natural rubber latex.

5.

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.

Section 2: Overview and Operation 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.

Monitor Cable

Power Supply

SO R

3M™ Bair Hugger™ Control Unit

PAT T SEN IEN

Sensor Cable

Tem

perat

ure

Mo

nit

ori

ng

Sys

tem

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

Operating Principle 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. 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. Skin Surface

Temperature Sensor

Deep Tissue

1) Placement and connection 5

2) Equilibration - isothermal zone development

3) Equilibrated - isothermal zone established Figure 2-2: Isothermal zone 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 and equilibration is achieved, 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. To transmit data from the temperature monitoring system to the patient’s monitor, simply connect the appropriate monitor cable between the back of the control units 3.5mm diameter X 14mm monitor jack and the YSI-400 type input on the patient monitor. Front of control unit

m

toring re Moni eratu Temp

Syste

Figure 2-3: Front of Control Unit

Back of control unit 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. 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.

Stand Knob

Digital Port (used by 3M personnel only)

°C/°F Temperature Display Button Monitor Cable Port (3.5mm Ø X 14mm)

Power Input Port Figure 2-4: Back of Control Unit

6

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. When the patient is transferred from one location to another, the sensor cable is disconnected from the sensor, leaving the sensor 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.

Section 3: Installation and Instruction for Use Installing the Control Unit 1.

NOTE: Temperature input on patient monitor is typically labeled T1 or T2.

The control unit must be properly installed and mounted by qualified personnel.

Instructions for use

NOTE:

1.

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.

2.

Use an alcohol wipe to clean and disinfect the patient’s forehead at the intended sensor application site. 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 (see Figure 3-2). The display on the control unit will change to the ready screen once it confirms the sensor connection.

•

The sensor and control unit are suitable for use in the patient environment.

•

Clean mounting surfaces with a 70% mixture of isopropyl alcohol and water prior to applying the provided hook-and-loop or foam adhesive.

•

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

•

The control unit’s height and orientation can be adjusted by loosening/tightening the control unit stand knob on the back of the unit.

Tem pera ture Mon itoring Syst em

Figure 3-2: Connect the sensor to the sensor cable Figure 3-1: Control Unit Mounting Configuration

4. 2.

Connect the power supply to the back of the control unit’s power input port (see Figure 2-4). Plug the power supply into an appropriate outlet. The start-up screen will illuminate then transition to the standby screen.

3.

Connect the sensor cable mini DIN connector end to the front of the control unit (see Figure 2-3).

Remove backing liner on the sensor to expose adhesive (see Figure 3-3). Do not bend sensor when removing backing liner.

NOTE: Orient sensor cable connector aligning its “key” with the associated recessed feature in the control unit. 4.

If desired, use a monitor cable to connect the control unit to the patient monitor via the monitor port on the back of the control unit (see Figure 2-4).

Figure 3-3: Remove the backing liner

7

5.

Position the sensor cable away from the patient’s face and apply the sensor to the patient’s forehead above the orbital ridge, on either side, avoiding the frontal sinus. (see Figure 3-4). Sensor Tab

Figure 3-5: Remove the sensor Figure 3-4: Apply the sensor to the patient’s forehead

1.

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.

2.

The control unit will sense patient attachment after several seconds and the control unit display will change to the equilibration screen.

3.

The patient’s temperature will display on the patient monitor once equilibrium is reached.

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 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.

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.

4.

The patient’s temperature will display on the patient monitor once equilibrium is reached.

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 3-5). NOTE: Do not use the sensor tab to remove the sensor from the patient. NOTE: If needed, use an alcohol swab along the sensor edge to help remove the sensor from the patient.

3.

8

Discard the sensor and clean the sensor cable.

Display temperature units (Celsius or Fahrenheit) The control unit can display temperature measurements in either Celsius or Fahrenheit. The unit is factory preset to Celsius. To change the display temperature units push the temperature display button on the back of the control unit (see Figure 2-4) while the control unit is powered on. NOTE: The trend display is always shown in Celsius.

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.

Section 4: Display Panel 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 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

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 complete in approximately five 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. 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.

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

Sensor error The sensor error screen displays when there is a temperature sensor or cable error. See “Section 5: Troubleshooting”.

E-xx

9

Section 5: Troubleshooting 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.

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.

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.

SN - 000000000

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

36 7

C

36°

Patient temperature does not appear on the patient monitor.

Contact 3M technical service.

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

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. Verify monitor output (see Section 5 of the Installation and Preventive Maintenance Manual). Contact 3M technical service.

10

Errors Error Code

Error Code Description

Troubleshooting Steps Sensor and/or Cable Error Codes

E-xx

E-1

Broken heating element in sensor

E-3

Corrupted sensor data

E-4

No uses remaining on sensor

E-5

No time remaining on sensor

E-6

Broken heating element in sensor

E-7

Broken heating element in sensor

E-8

Error writing trend data

E-9

No time remaining on sensor

E-10

Unknown sensor

E-11

Corrupted sensor data

E-12

Corrupted sensor data

E-13

Time limit exceeded in calibration

E-14

Skin temperature sensor is out of range

E-15

Heater temperature sensor is out of range

E-16

Skin and heater temperature sensor difference is too great

E-17

Broken heating element in sensor

E-18

Corrupted sensor data

E-20

Sensor authentication error

E-21

Sensor checksum error

E-22

Unknown sensor type

E-23

Sensor and hardware data mismatch

E-24

Skin temperature sensor is out of range

E-25

Broken skin or heater temperature sensor

Step 1. Disconnect and reconnect temperature sensor

Step 2. If error persists, restart unit by unplugging power supply cable

Step 3. If error persists, replace temperature sensor

Step 4. If error persists, replace sensor cable

If error persists, contact your 3M representative

Please do NOT unplug the connection between the sensor cable and the control unit (mini-din plug) when troubleshooting Steps 1, 2, &3.

11

Control Unit Error Codes

E-xx

E-100

Control unit is unable to regulate heating element on sensor

E-101

No system calibration

E-102

Bad state transition

E-103

Temperature output from control unit is out of range

E-104

Temperature output from control unit is out of range

E-105

Temperature output from control unit is out of range

Step 1. Restart unit by unplugging power supply from back of hardware unit. Wait 10-15 seconds before plugging power supply cord back in.

Step 2. If error persists, discontinue use and replace hardware unit

Section 6: General Maintenance, Storage, and Service Cleaning and Disinfecting 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.

Cleaning should be performed in accordance with hospital practices for cleaning OR equipment. After every use wipe the device surfaces, cords and cables. Avoid getting liquid into electronic ports. Use a damp, soft cloth and a hospital approved mild detergent, germicidal disposable wipes, disinfecting towelettes, or antimicrobial spray. The following active ingredients are acceptable for use in cleaning the warming unit: •

3.

Oxidizers (e.g. 10% Bleach)

•

Quaternary Ammonium Compounds (e.g. 3M™ Quat Disinfectant Cleaner)

•

Phenolics (e.g. 3M™ Phenolic Disinfectant Cleaner)

•

Alcohols (e.g. 70% Isopropyl Alcohol)

Let air dry.

Calibration Frequency

Every 12 months or according to the institutional protocol.

Tools and Equipment 1.

Calibration verification stick(s)

2.

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

Verification Procedure (Control Unit) 1.

Connect the power supply to the control unit.

2.

Connect the sensor cable to the front of the control unit.

3.

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

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4.

The control unit screen shows the actual calibrated thermistor readings for the skin and heater thermistors respectively (see Figure 6-1).

Figure 6-1: 36°C (96.8°F) Calibration Screens (Celsius and Fahrenheit)

5.

Verify that the reference temperature for each calibrated thermistor matches the displayed value (see Table 6-1). 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) Table 6-1: Display Output

6.

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.

Verification Procedure (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.

2.

Connect the sensor cable to the front of the control unit.

3.

Plug the monitor cable to the monitor port on the back of the control unit.

4.

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

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 6-2).

13

Patient Monitor Connector Cables 1 Verify resistance from contact one to each 2 contact two.

1 2

1 2

1

2

1 2

8.

Confirm the reading on the multi-meter matches the value in Table 6-3. If more than one reference temperature is required by your institution, verify using additional calibration verification sticks.

Monitor Output

Temperature 31°C

1739 ± 15 Ω

36°C

1412 ± 12 Ω

41°C

1152 ± 10 Ω Table 6-3: Monitor Output

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).

Optional: Verify resistance of verification stick 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. 1.

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

3

1

4

2.

Hold the digital multi-meter leads to pads one and three (see Figure 6-2).

5

3.

Confirm the reading on the multi-meter matches the value in Table 6-4: Resistance.

6 2

Figure 6-2: Calibration Verification Stick

14

Temperature

Resistance

31°C

8,200.0 ± 4.4 Ω

36°C

6,800.0 ± 4.1 Ω

41°C

5,600.0 ± 3.4 Ω Table 6-4: Resistance

4.

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.

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

Service All service and repair must be performed by 3M or an authorized service technician. There are no user serviceable parts inside the equipment or power supply. Call 3M Customer Service at 1-800-733-7775 (US only) or your local 3M representative for service information. 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 this 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 this manual.

Section 7: Technical Service and Order Placement When you call for technical support Have the control unit serial number, software number, and error code ready when you call for technical support. The serial number label is located on the back of the control unit next to “SN” symbol. The software number displays on the control unit when the control unit is first connected to a power (in the Start-up display screen). Please report a serious incident occurring in relation to the device to 3M and the local competent authority (EU) or local regulatory authority.

Technical service and order placement 3M Helpline at 1-800-228-3957 (USA only) or your local 3M representative (Worldwide).

In-Warranty Repair and Exchange USA 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.

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

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Section 8: 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 RF Emissions CISPR 11 Harmonics

Class A

IEC 61000-3-2 Flicker

Complies

IEC 61000-3-3

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.

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

3V/m

3 V/m 80 MHz to 2.5 GHz

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

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.

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Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment – Guidance

ESD

±8kV Contact

±6kV Contact

IEC 61000-4-2

±15kV 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

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

Test guidance from IEC 610002-2 Annex BB.4

Test guidance from IEC 61000-2-2 Annex BB.4

Equipment operating at 100% power within proximity of the power supply, EUT, and accessories.

Power Frequency 50/60Hz

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. 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.

Magnetic Field IEC 61000-4-8 Radiated RF electromagnetic fields and electromagnetic disturbances created by HF surgical equipment IEC6100-4-3 and IEC61000-2-2

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)

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

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Physical characteristics

Electrical characteristics

Medical electrical equipment includes the control unit and the power supply.

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

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

Output; 5 VDC

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 Protection against electric shock: Class II Medical Electrical Equipment with Type CF defibrillationproof applied part Protection against ingress of water: Ordinary equipment (IPX0) Mode of operation: Continuous operation MEDICAL-GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES 606011:2005+ AMD: 2012, CAN/ CSA-C22.2 NO. 60601-1: (2008) + (2014), IEC 60601-1-6:2010 (Third Edition) + A1:2013, ISO 80601-256:2009 (First Edition); Control No.4HZ8 Accuracy 25°C to 43°C ± 0.2°C Sensor Material Medical grade foam and adhesive PET flexible circuit Recommended Calibration Check Every 12 months or according to institutional protocol. Sensor Shelf Life 36 months Digital Port (used by 3M personnel only) 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.

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

Temperature characteristics Over-temperature cutoff 43°C - Skin thermistor reading 44.5°C - Heater thermistor reading

Performance characteristics Clinical thermometer mode of operation Direct mode Equilibration time/Response time Approximately five minutes Measurement locations Patient’s lateral forehead above the orbital ridge Measurement range 25°C - 43°C Measurement readout Celsius or Fahrenheit Leakage current Meets leakage current requirements in accordance with IEC 60601-1.

Environmental conditions Ambient temperature range 10°C to 40°C (50°F to 104°F) Storage and transport temperature range -20°C to 60°C (-4°F to 140°F) Store all components at room temperature and in a dry place when not in use. Operating humidity 10 to 75% RH, noncondensing Atmospheric pressure range 80 kPa to 106 kPa (12 PSI to 15 PSI) Oxygen environment The sensor only is suitable for use in the presence of an oxygen enriched environment.

List of Bair Hugger Accessories and Cables Component Sensor Cable

3M Catalog # 90106

Monitor Cable, 3.5mm to 6.35mm

90107

Monitor cable, 3.5mm to 3.5mm

90108

Temp. cable, Phillips to mini-phone

90130

Temp. cable, GE to mini-phone

90131

Temp. cable, Draeger to mini-phone

90132

Temp. cable, Spacelabs to mini-phone

90133

US Style Power Supply

90113

EU style power supply

90115

UK style power supply

90116

Bair Hugger Sensor Model 360

36000

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.

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Limited Warranty and Disclaimer 3M company warrants to the original end user (“User”) that (i) for three years from the date of shipment the 3M™ Bair Hugger™ temperature monitoring unit Model 370, including the Software included therein, and power supply, and (ii) for one year from the date of shipment the sensor cable and monitor cables, (collectively the “Unit”), will substantially perform in accordance with the Operator’s Manual, Installation & Service Manual, and Instructions for Use (“User Documentation”). The terms of this Warranty do not affect or prejudice the statutory rights of a purchaser acquiring the Unit otherwise than in the normal course of a business. THIS WARRANTY DOES NOT APPLY IF (A) THE UNIT HAS BEEN REPAIRED BY PERSONS NOT AUTHORIZED BY 3M; (B) THE UNIT HAS BEEN ALTERED, MODIFIED, MISUSED; (C) THE UNIT IS USED WITH NON-3M BAIR HUGGER TEMPERATURE MONITORING UNIT COMPONENTS OR USED WITH DISPOSABLE COMPONENTS OTHER THAN 3M BAIR HUGGER SENSORS; (D) THE UNIT OR A COMPONENT IS USED FOR OTHER USES; (E) THE UNIT HAS NOT BEEN MAINTAINED OR USED IN ACCORDANCE WITH USER DOCUMENTATION; OR (F) DAMAGE TO THE UNIT IS CAUSED BY NORMAL WEAR AND TEAR, NEGLIGENCE, ACCIDENT OR ABUSE. UNLESS PROHIBITED BY LAW, THIS WARRANTY IS MADE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING NOT BUT NOT LIMITED TO THE IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE, THE IMPLIED WARRANTY OF MERCHANTABILITY, OR ANY IMPLIED WARRANTY ARISING OUT OF A COURSE OF DEALING OR OF PERFORMANCE, CUSTOM OR USAGE OF TRADE. 3M DOES NOT WARRANT THAT THE SOFTWARE WILL FUNCTION ERROR FREE. FURTHER, THIS WARRANTY DOES NOT EXTEND RIGHTS TO ANYONE OTHER THAN A USER AND IS NONTRANSFERABLE. Use of the Unit can only be initiated and monitored by healthcare professionals whose skill and judgment determine the fitness of the Unit for any particular medical treatment. 3M DISCLAIMS RESPONSIBILITY FOR THE FITNESS OF THE UNIT FOR ANY PARTICULAR MEDICAL TREATMENT OR FOR ANY MEDICAL COMPLICATIONS RESULTING FROM THE USE OF THE UNIT.

Limitation of Liability UNLESS PROHIBITED BY LAW, 3M WILL NOT BE LIABLE TO USER OR OTHERS FOR ANY DIRECT, INDIRECT, CONSEQUENTIAL INCIDENTAL OR SPECIAL DAMAGES INCLUDING, FOR EXAMPLE, LOST PROFITS, BUSINESS, INVESTMENTS, OR OPPORTUNITIES EVEN IF 3M HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE. The parties agree that 3M’s total cumulative liability to User for direct damages for all causes under this Warranty shall not exceed the price paid for the Unit. Some states or countries may have laws which require liability rights different from those stated above. In such state or countries, the minimum required liability terms shall apply.

Limited Remedy If within the warranty periods set forth above the Unit does not conform to the express warranty set forth, 3M’s sole obligation and User’s sole remedy shall be, at 3M’s option, to repair or replace the nonconforming Unit pursuant to the terms below. The sensor cable component of the Unit will be repaired or replaced by 3M only once within the one-year limited warranty period. Repair or replacement of a Unit or a component part thereof under the terms of this Warranty in no way lengthens the limited warranty period. These are your exclusive remedies. You must promptly notify 3M within sixty (60) days of discovery of any suspected defect in a Unit. You must return the Unit in order for your warranty coverage to take effect. Shipping charges for returning the Unit will be the responsibility of 3M. Customer must contact 3M for return shipping instructions. Please call Customer Service at 1-800-733-7775.

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