3M Bair Hugger Model 875 Operators Manual

1 Table of Contents Introduction to the 3M™ Bair Hugger™ Temperature Management System... 3 Bair Hugger Model 875 Patient Adjustable Warming Unit ... 3 Bair Hugger Warming Gowns ... 3 Indications... 3 Definition of Symbols ... 3 Contraindications, Warnings, Cautions and Notices ... 4 Explanation of Signal Word Consequences... 4 Contraindication ... 4 WARNING:... 4 CAUTION: ... 4 NOTICE: ... 5 Proper Use and Maintenance... 5 Read Before Servicing Patient Adjustable Warming Unit ... 5 Preparing the Bair Hugger Model 875 Patient Adjustable Warming Unit for Use ... 5 Placing the Patient Adjustable Warming Unit on the Wall-mount Bracket ... 6 Mounting the Patient Adjustable Warming Unit on an IV Pole ... 6 Mounting the Patient Adjustable Warming Unit on a Bedrail ... 6 Mounting the Patient Adjustable Warming Unit with a Rail-mount to the Wall ... 6 Mounting the Patient Adjustable Warming Unit with a Suction Wall Mount Adapter ... 6 Operating Information...7 Instructions for Use ...7 Using the Handheld Temperature Controller ...7 Using the Holder for the Handheld Temperature Controller ... 8 What to Do if the “Over-temp” Indicator Light illuminates and the Audible Alarm Sounds ... 8 General Maintenance ... 8 Calibrating the Operating Temperatures ... 8 Replacing the Filter ... 8 Cleaning Instructions... 8 Storage ... 8 Technical Support and Customer Service ... 8 U.S. Customer Service ... 8 OUTSIDE OF THE USA ... 8 When You Call for Technical Support ... 8 Repair and Exchange ... 9 Technical Specifications ... 9

TOC / 34-8718-8813-6

1

1 3M™ Bair Hugger™ Model 875 Patient Adjustable Warming Unit Operator’s Manual Introduction to the 3M™ Bair Hugger™ Temperature Management System The Bair Hugger temperature management system consists of the Model 875 patient adjustable warming unit and a single-use Bair Hugger warming gown. The Model 875 patient adjustable warming unit can provide prewarming and/or comfort warming to patients in preoperative settings. In postoperative settings the patient adjustable warming unit can provide comfort warming. This manual includes operating instructions and the patient adjustable warming unit specifications for the Model 875 patient adjustable warming unit. Please refer to the Instructions for Use for more information about the Bair Hugger gowns.

Bair Hugger Model 875 Patient Adjustable Warming Unit The Model 875 patient adjustable warming unit has the following key elements: a blower, a heating element, and a handheld temperature controller. The patient adjustable warming unit delivers warmed air through a hose that is connected to a port in a Bair Hugger gown. The patient or clinician can adjust the air temperature and airflow using the handheld temperature controller.

System System

Power on

Increase temperature and airflow

Over-temperature

Temperature control

An equipotentiality conductor other than a protective earth conductor or a neutral conductor, providing a direct connection between electrical equipment and the potential equalization busbar of the electrical installation. Please consult IEC 60601-1.

MODEL

875

Fuse

Bair Hugger Warming Gowns The single-use warming gown completely covers and surrounds the patient except for the head, hands and feet. The gown has an integral, channeled insert that delivers ambient and warm air through small perforations to warm the patient. Air channels and hose ports enable prewarming and/or comfort with the Model 875 patient adjustable warming unit or clinical warming with a 3M™ Bair Hugger™ 500 or 700 series warming unit. The gown also has fastener strips on each shoulder that provide easy access to the patient’s arms and chest. The Bair Hugger warming gowns are not made with natural rubber latex and are sized for pediatric and adult patients. For additional information on Bair Hugger gowns or other accessories visit us online at bairhugger.com

Indications The Model 875 patient adjustable warming unit is indicated for patient warming. This patient adjustable warming unit has been designed for use with the Bair Hugger warming gowns in all preoperative and postoperative settings for pediatric and adult patients. •

The Bair Hugger patient adjustable warming system should only be used by trained medical professionals.

•

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

Definition of Symbols

CAUTION

Dangerous voltage

Type BF equipment (patient applied)

Voltage, alternating current (AC)

Protective earth ground

No free hosing

Date of manufacture

Manufacturer

This system is subject to 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.

Consult instructions for use

The following symbols may appear on the product, on the exterior packaging, or in the product labeling. Follow instructions for use

GB / 34-8718-8813-6

3

1 3M™ Bair Hugger™ Model 875 Patient Adjustable Warming Unit Operator’s Manual Introduction to the 3M™ Bair Hugger™ Temperature Management System The Bair Hugger temperature management system consists of the Model 875 patient adjustable warming unit and a single-use Bair Hugger warming gown. The Model 875 patient adjustable warming unit can provide prewarming and/or comfort warming to patients in preoperative settings. In postoperative settings the patient adjustable warming unit can provide comfort warming. This manual includes operating instructions and the patient adjustable warming unit specifications for the Model 875 patient adjustable warming unit. Please refer to the Instructions for Use for more information about the Bair Hugger gowns.

Bair Hugger Model 875 Patient Adjustable Warming Unit The Model 875 patient adjustable warming unit has the following key elements: a blower, a heating element, and a handheld temperature controller. The patient adjustable warming unit delivers warmed air through a hose that is connected to a port in a Bair Hugger gown. The patient or clinician can adjust the air temperature and airflow using the handheld temperature controller.

System System

Power on

Increase temperature and airflow

Over-temperature

Temperature control

An equipotentiality conductor other than a protective earth conductor or a neutral conductor, providing a direct connection between electrical equipment and the potential equalization busbar of the electrical installation. Please consult IEC 60601-1.

MODEL

875

Fuse

Bair Hugger Warming Gowns The single-use warming gown completely covers and surrounds the patient except for the head, hands and feet. The gown has an integral, channeled insert that delivers ambient and warm air through small perforations to warm the patient. Air channels and hose ports enable prewarming and/or comfort with the Model 875 patient adjustable warming unit or clinical warming with a 3M™ Bair Hugger™ 500 or 700 series warming unit. The gown also has fastener strips on each shoulder that provide easy access to the patient’s arms and chest. The Bair Hugger warming gowns are not made with natural rubber latex and are sized for pediatric and adult patients. For additional information on Bair Hugger gowns or other accessories visit us online at bairhugger.com

Indications The Model 875 patient adjustable warming unit is indicated for patient warming. This patient adjustable warming unit has been designed for use with the Bair Hugger warming gowns in all preoperative and postoperative settings for pediatric and adult patients. •

The Bair Hugger patient adjustable warming system should only be used by trained medical professionals.

•

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

Definition of Symbols

CAUTION

Dangerous voltage

Type BF equipment (patient applied)

Voltage, alternating current (AC)

Protective earth ground

No free hosing

Date of manufacture

Manufacturer

This system is subject to 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.

Consult instructions for use

The following symbols may appear on the product, on the exterior packaging, or in the product labeling. Follow instructions for use

GB / 34-8718-8813-6

3

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

Keep dry

Temperature limit

•

Do not use upper warming gown hose port if upper body extended inserts have been removed.

•

Do not use this patient adjustable warming unit with any other manufacturer’s gown. Use only with a 3M Bair Hugger gown.

•

The handheld temperature controller must be at its maximum (warmest) setting when calibrating; otherwise, temperature settings may be inaccurate.

•

Do not calibrate the patient adjustable warming unit above 43°C.

To reduce the risk of patient injury or death due to ! WARNING: altered drug delivery:

Contraindications, Warnings, Cautions and Notices Explanation of Signal Word Consequences

! WARNING:

Indicates a hazardous situation which, if not avoided, could result in death or serious injury.

•

•

Indicates a hazardous situation which, if not avoided, could result in minor or moderate injury.

•

Do not leave children and other vulnerable patient populations unattended while using a Bair Hugger patient adjustable warming unit.

•

Do not allow children and other vulnerable patients to handle the handheld temperature controller without supervision to prevent controller’s electrical cord from becoming entangled around the patient.

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

! CONTRAINDICATION: To reduce the risk of thermal injury: •

Do not apply heat to lower extremities during aortic cross-clamping. Thermal injury may occur if heat is applied to ischemic limbs.

! WARNING: To reduce the risk of thermal Injury: •

•

•

Do not treat patients with the Bair Hugger patient adjustable warming unit hose alone. Always attach the hose to a Bair Hugger warming gown before providing warming therapy.

Do not disassemble the patient adjustable warming unit unless you are a qualified service technician. There are electrically live parts within the patient adjustable warming unit when it is connected to a power source, even when the handheld controller is in the OFF position.

•

•

Do not allow the patient adjustable warming unit hose to directly contact the patient’s skin during warming therapy.

Keep power cord visible and accessible at all times. The plug on the power cord serves as the disconnect device.

•

•

Do not leave children and other vulnerable patient populations unattended during warming therapy.

Only connect to outlets marked “Hospital only,” “Hospital Grade,” or a reliable grounded outlet.

•

•

Do not leave patients with poor perfusion unmonitored during prolonged warming therapy.

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

•

Do not allow the power cord to get wet.

•

Do not use the Bair Hugger 800 series patient adjustable warming unit in the operating room.

•

•

Do not continue warming therapy if the red Over-temp indicator light illuminates and the alarm sounds. Unplug the patient adjustable warming unit and contact a qualified service technician.

Do not use the patient adjustable warming unit when it appears the patient adjustable warming unit, power cord or any component is damaged. Contact 3M Technical Support.

•

Do not connect the warming gown to the patient adjustable warming unit if the fabric has been cut as air channels could be damaged.

•

Do not place patient securement device (i.e. safety strap or tape) over the warming gown.

•

Do not place warming insert directly over a dispersive electrode pad. Ensure that the blood pressure cuff, ECG, IV or other lines or cords are not between the upper sleeve insert and the gown prior to deploying the upper sleeve warming insert(s), as this could result in tearing of the insert during deployment. (Flex gown only)

•

Follow applicable regulations when disposing of this warming unit or any of its electrical components.

•

Do not attempt to clean the air filter as it may be contaminated from use. Discard the filter in a manner consistent with institutional protocol.

To reduce the risk of hypothermia and ensure ! CAUTION: optimal heat transfer: •

Always extend the warming gown insert to its full length when connected to a warming unit.

•

Do not tape, roll, gather, bunch, or compress the inflated air-channel insert of the gown as these actions can occlude airflow and reduce warming of the patient.

•

!

Do not cover gown with more than one sheet.

CAUTION: To reduce the risk of cross-contamination: •

This warming gown is not sterile and is intended for single patient use ONLY. Placing a sheet between the warming gown and the patient does not prevent contamination of the product.

3M™ Bair Hugger™ Model 875 Patient Adjustable Warming Unit – Operator’s Manual

compatibility (EMC) information provided in the Guidance and Manufacturer’s Declaration. •

•

Do not use the Bair Hugger pediatric warming gown unless the patient is over 102 cm (40 inches) tall.

•

If mounted on an IV pole, the distance from the bottom of the patient adjustable warming unit to the floor must be less than 44” (112 cm) and the IV pole wheelbase diameter must be at least 28” (71 cm) to prevent tipping.

•

When using the suction wall mount adapter, only hold the front of the adapter when increasing/decreasing the expander to prevent pinching fingers.

1.

The patient adjustable warming unit meets the international electronic interference requirements. If radio frequency interference with monitoring equipment occurs, connect the patient adjustable warming unit to a different power source.

2.

To avoid Bair Hugger patient adjustable warming unit damage:

! CAUTION: To reduce the risk of fire: •

This product is classified as Class I Normal Flammability as defined by the Consumer product Safety Commission’s flammable fabric regulation, 16 CFR 1610. Follow standard safety protocols when using high intensity heat sources.

To reduce the risk of thermal injury, hyperthermia ! CAUTION: or hypothermia: •

•

3M recommends continuously monitoring core temperature. In the absence of continuous monitoring, monitor the temperature of patients who are incapable of reacting, communicating and/or who cannot sense temperature a minimum of every 15 minutes or according to institutional protocol. Monitor cutaneous responses of patients who are incapable of reacting, communicating and/or who cannot sense temperature a minimum of every 15 minutes or according to institutional protocol.

•

Adjust air temperature or discontinue warming therapy when the therapeutic goal is reached, if elevated temperatures are recorded or if there is an adverse cutaneous response in the warmed area.

•

Do not place the patient adjustable warming unit on a soft uneven surface, such as a bed, or a visibly wet surface as the air intake may become blocked and cause the patient adjustable warming unit to overheat, compromising the patient adjustable warming unit’s performance.

•

Perform all calibrations of the patient adjustable warming unit using a Model 90055 Temperature Test Kit.

•

Perform calibration testing at an ambient temperature similar to the area where the patient adjustable warming unit will be used.

•

The patient adjustable warming unit is intended for use in an ambient environment between 18 and 26°C (65 and 79°F).

To reduce the risk associated with ! CAUTION: electromagnetic interference (EMI) due to portable and mobile radio frequency (RF) communications equipment: •

The 3M Bair Hugger temperature management system has been tested to be resistant to both electromagnetic fields EMI and electrostatic discharge (ESD).

•

Install and put into service the 3M Bair Hugger temperature management system according to the electromagnetic

GB / 34-8718-8813-6

Should interference occur, move away from the portable or mobile RF communications equipment.

NOTICE:

! CAUTION: To reduce the risk of patient or caregiver injury:

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

Do not allow the patient to lie on the patient adjustable warming unit hose.

•

4

Do not allow the warming gown or head drape to cover the patient’s head or airway when patient is not mechanically ventilated.

! WARNING: To reduce the risk of strangulation:

NOTICE:

Clean the patient adjustable warming unit, handheld controller, and the outside of the warming unit hose after each patient use. See “Cleaning Instructions” on page 8.

Do not use a warming gown over transdermal medication patches.

To reduce the risk of injury due to interference ! WARNING. with ventilation:

! CAUTION:

•

•

Do not immerse the patient adjustable warming unit, patient adjustable warming unit parts, or accessories in any liquid or subject them to any sterilization process.

•

Do not use cleaning solutions with greater than 80% alcohol or solvents, including acetone and thinner, to clean the patient adjustable warming unit or hose. Solvents may damage the labels and other plastic parts.

•

Do not modify this equipment without authorization from the manufacturer.

•

Over torqueing the suction wall mount adapter may cause device damage.

Proper Use and Maintenance 3M assumes no responsibility for the reliability, performance, or safety of the patient adjustable warming unit if: •

Modifications or repairs are performed by unqualified personnel,

•

The patient adjustable warming patient adjustable warming unit is used in a manner other than that described in the Operator’s Manual, or

•

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

Read Before Servicing Patient Adjustable Warming Unit All repair, calibration, and servicing of the Model 875 patient adjustable warming unit must be performed by qualified, medical equipment service technicians who are familiar with good practice for medical device repair. If the patient adjustable warming unit does not require the manufacturer’s attention, we will ship replacement parts to your location. Perform all repairs and maintenance in accordance with the instructions provided with the replacement parts.

Preparing the Bair Hugger Model 875 Patient Adjustable Warming Unit for Use Before you begin using the patient adjustable warming unit, make sure that it is safely placed on a flat, hard surface such as a table, or securely mounted on a wall, IV pole, suction wall mount adapter, or bedrail. Do not place the patient adjustable warming unit on ! Caution: a soft uneven surface, such as a bed, or a visibly wet surface as the air intake may become blocked and cause the patient adjustable warming unit to overheat, compromising the patient adjustable warming unit’s performance. A wall-mount bracket is shipped with every patient adjustable warming unit; the brackets for mounting the patient adjustable warming unit to an IV pole, bedrail, or a suction wall mount adapter are available separately. Please contact your local sales representative or call 3M customer service at 1-800-228-3957 for more information about ordering mounting brackets and adapter. The following instructions for mounting the patient adjustable warming unit assume that the brackets have already been attached to the wall or to the patient adjustable warming unit.

5

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

Keep dry

Temperature limit

•

Do not use upper warming gown hose port if upper body extended inserts have been removed.

•

Do not use this patient adjustable warming unit with any other manufacturer’s gown. Use only with a 3M Bair Hugger gown.

•

The handheld temperature controller must be at its maximum (warmest) setting when calibrating; otherwise, temperature settings may be inaccurate.

•

Do not calibrate the patient adjustable warming unit above 43°C.

To reduce the risk of patient injury or death due to ! WARNING: altered drug delivery:

Contraindications, Warnings, Cautions and Notices Explanation of Signal Word Consequences

! WARNING:

Indicates a hazardous situation which, if not avoided, could result in death or serious injury.

•

•

Indicates a hazardous situation which, if not avoided, could result in minor or moderate injury.

•

Do not leave children and other vulnerable patient populations unattended while using a Bair Hugger patient adjustable warming unit.

•

Do not allow children and other vulnerable patients to handle the handheld temperature controller without supervision to prevent controller’s electrical cord from becoming entangled around the patient.

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

! CONTRAINDICATION: To reduce the risk of thermal injury: •

Do not apply heat to lower extremities during aortic cross-clamping. Thermal injury may occur if heat is applied to ischemic limbs.

! WARNING: To reduce the risk of thermal Injury: •

•

•

Do not treat patients with the Bair Hugger patient adjustable warming unit hose alone. Always attach the hose to a Bair Hugger warming gown before providing warming therapy.

Do not disassemble the patient adjustable warming unit unless you are a qualified service technician. There are electrically live parts within the patient adjustable warming unit when it is connected to a power source, even when the handheld controller is in the OFF position.

•

•

Do not allow the patient adjustable warming unit hose to directly contact the patient’s skin during warming therapy.

Keep power cord visible and accessible at all times. The plug on the power cord serves as the disconnect device.

•

•

Do not leave children and other vulnerable patient populations unattended during warming therapy.

Only connect to outlets marked “Hospital only,” “Hospital Grade,” or a reliable grounded outlet.

•

•

Do not leave patients with poor perfusion unmonitored during prolonged warming therapy.

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

•

Do not allow the power cord to get wet.

•

Do not use the Bair Hugger 800 series patient adjustable warming unit in the operating room.

•

•

Do not continue warming therapy if the red Over-temp indicator light illuminates and the alarm sounds. Unplug the patient adjustable warming unit and contact a qualified service technician.

Do not use the patient adjustable warming unit when it appears the patient adjustable warming unit, power cord or any component is damaged. Contact 3M Technical Support.

•

Do not connect the warming gown to the patient adjustable warming unit if the fabric has been cut as air channels could be damaged.

•

Do not place patient securement device (i.e. safety strap or tape) over the warming gown.

•

Do not place warming insert directly over a dispersive electrode pad. Ensure that the blood pressure cuff, ECG, IV or other lines or cords are not between the upper sleeve insert and the gown prior to deploying the upper sleeve warming insert(s), as this could result in tearing of the insert during deployment. (Flex gown only)

•

Follow applicable regulations when disposing of this warming unit or any of its electrical components.

•

Do not attempt to clean the air filter as it may be contaminated from use. Discard the filter in a manner consistent with institutional protocol.

To reduce the risk of hypothermia and ensure ! CAUTION: optimal heat transfer: •

Always extend the warming gown insert to its full length when connected to a warming unit.

•

Do not tape, roll, gather, bunch, or compress the inflated air-channel insert of the gown as these actions can occlude airflow and reduce warming of the patient.

•

!

Do not cover gown with more than one sheet.

CAUTION: To reduce the risk of cross-contamination: •

This warming gown is not sterile and is intended for single patient use ONLY. Placing a sheet between the warming gown and the patient does not prevent contamination of the product.

3M™ Bair Hugger™ Model 875 Patient Adjustable Warming Unit – Operator’s Manual

compatibility (EMC) information provided in the Guidance and Manufacturer’s Declaration. •

•

Do not use the Bair Hugger pediatric warming gown unless the patient is over 102 cm (40 inches) tall.

•

If mounted on an IV pole, the distance from the bottom of the patient adjustable warming unit to the floor must be less than 44” (112 cm) and the IV pole wheelbase diameter must be at least 28” (71 cm) to prevent tipping.

•

When using the suction wall mount adapter, only hold the front of the adapter when increasing/decreasing the expander to prevent pinching fingers.

1.

The patient adjustable warming unit meets the international electronic interference requirements. If radio frequency interference with monitoring equipment occurs, connect the patient adjustable warming unit to a different power source.

2.

To avoid Bair Hugger patient adjustable warming unit damage:

! CAUTION: To reduce the risk of fire: •

This product is classified as Class I Normal Flammability as defined by the Consumer product Safety Commission’s flammable fabric regulation, 16 CFR 1610. Follow standard safety protocols when using high intensity heat sources.

To reduce the risk of thermal injury, hyperthermia ! CAUTION: or hypothermia: •

•

3M recommends continuously monitoring core temperature. In the absence of continuous monitoring, monitor the temperature of patients who are incapable of reacting, communicating and/or who cannot sense temperature a minimum of every 15 minutes or according to institutional protocol. Monitor cutaneous responses of patients who are incapable of reacting, communicating and/or who cannot sense temperature a minimum of every 15 minutes or according to institutional protocol.

•

Adjust air temperature or discontinue warming therapy when the therapeutic goal is reached, if elevated temperatures are recorded or if there is an adverse cutaneous response in the warmed area.

•

Do not place the patient adjustable warming unit on a soft uneven surface, such as a bed, or a visibly wet surface as the air intake may become blocked and cause the patient adjustable warming unit to overheat, compromising the patient adjustable warming unit’s performance.

•

Perform all calibrations of the patient adjustable warming unit using a Model 90055 Temperature Test Kit.

•

Perform calibration testing at an ambient temperature similar to the area where the patient adjustable warming unit will be used.

•

The patient adjustable warming unit is intended for use in an ambient environment between 18 and 26°C (65 and 79°F).

To reduce the risk associated with ! CAUTION: electromagnetic interference (EMI) due to portable and mobile radio frequency (RF) communications equipment: •

The 3M Bair Hugger temperature management system has been tested to be resistant to both electromagnetic fields EMI and electrostatic discharge (ESD).

•

Install and put into service the 3M Bair Hugger temperature management system according to the electromagnetic

GB / 34-8718-8813-6

Should interference occur, move away from the portable or mobile RF communications equipment.

NOTICE:

! CAUTION: To reduce the risk of patient or caregiver injury:

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

Do not allow the patient to lie on the patient adjustable warming unit hose.

•

4

Do not allow the warming gown or head drape to cover the patient’s head or airway when patient is not mechanically ventilated.

! WARNING: To reduce the risk of strangulation:

NOTICE:

Clean the patient adjustable warming unit, handheld controller, and the outside of the warming unit hose after each patient use. See “Cleaning Instructions” on page 8.

Do not use a warming gown over transdermal medication patches.

To reduce the risk of injury due to interference ! WARNING. with ventilation:

! CAUTION:

•

•

Do not immerse the patient adjustable warming unit, patient adjustable warming unit parts, or accessories in any liquid or subject them to any sterilization process.

•

Do not use cleaning solutions with greater than 80% alcohol or solvents, including acetone and thinner, to clean the patient adjustable warming unit or hose. Solvents may damage the labels and other plastic parts.

•

Do not modify this equipment without authorization from the manufacturer.

•

Over torqueing the suction wall mount adapter may cause device damage.

Proper Use and Maintenance 3M assumes no responsibility for the reliability, performance, or safety of the patient adjustable warming unit if: •

Modifications or repairs are performed by unqualified personnel,

•

The patient adjustable warming patient adjustable warming unit is used in a manner other than that described in the Operator’s Manual, or

•

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

Read Before Servicing Patient Adjustable Warming Unit All repair, calibration, and servicing of the Model 875 patient adjustable warming unit must be performed by qualified, medical equipment service technicians who are familiar with good practice for medical device repair. If the patient adjustable warming unit does not require the manufacturer’s attention, we will ship replacement parts to your location. Perform all repairs and maintenance in accordance with the instructions provided with the replacement parts.

Preparing the Bair Hugger Model 875 Patient Adjustable Warming Unit for Use Before you begin using the patient adjustable warming unit, make sure that it is safely placed on a flat, hard surface such as a table, or securely mounted on a wall, IV pole, suction wall mount adapter, or bedrail. Do not place the patient adjustable warming unit on ! Caution: a soft uneven surface, such as a bed, or a visibly wet surface as the air intake may become blocked and cause the patient adjustable warming unit to overheat, compromising the patient adjustable warming unit’s performance. A wall-mount bracket is shipped with every patient adjustable warming unit; the brackets for mounting the patient adjustable warming unit to an IV pole, bedrail, or a suction wall mount adapter are available separately. Please contact your local sales representative or call 3M customer service at 1-800-228-3957 for more information about ordering mounting brackets and adapter. The following instructions for mounting the patient adjustable warming unit assume that the brackets have already been attached to the wall or to the patient adjustable warming unit.

5

Placing the Patient Adjustable Warming Unit on the Wall-mount Bracket

2.

Hang the Model 875 patient adjustable warming unit on a bedrail by the hooks on the rail-mount.

1.

Snap the patient adjustable warming unit into position by sliding the clip on the back of the patient adjustable warming unit into the groove of the wall-mount bracket. The assembly will click when the clip is fully seated in the wall-mount bracket.

3.

Wrap the safety strap around the bedrail and connect the end to the fastener on the strap. The safety strap will prevent the patient adjustable warming unit from falling if the unit is inadvertently dislodged from the bedrail.

2.

Lift the patient adjustable warming unit straight up to remove it from the wall-mount bracket.

Bedrail

airflow are adjusted by turning the knob on the handheld temperature controller. The temperature adjustment varies from approximately ambient to 43±3°C. The maximum temperature is 46°C before the Over-temp indicator light illuminates and audible alarm sounds.

Do not leave children and other vulnerable patient ! Warning: populations unattended while using a Bair Hugger patient

Rail mount

adjustable warming unit.

Note: It may be necessary to gently strike the case bottom in an upward fashion with the palm of your hand to release the clip from the wall-mount bracket.

3. Safety strap

Slide the patient adjustable warming unit into the suction wall mount adapter.

Do not allow children and other vulnerable patients to ! Warning: handle the handheld temperature controller without supervision to prevent controller’s electrical cord from becoming entangled around the patient.

! Caution: Patient Monitoring Recommendations:

System System

•

3M recommends continuously monitoring core temperature. In the absence of continuous monitoring, monitor the temperature of patients who are incapable of reacting, communicating and/or who cannot sense temperature a minimum of every 15 minutes or according to institutional protocol.

•

Monitor cutaneous responses of patients who are incapable of reacting, communicating and/or who cannot sense temperature a minimum of every 15 minutes or according to institutional protocol.

•

Adjust air temperature or discontinue warming therapy when the therapeutic goal is reached, if elevated temperatures are recorded or if there is an adverse cutaneous response in the warmed area.

MODEL

875

System System

System System

Wall mount bracket MODEL

875 MODEL

875

Mounting the Patient Adjustable Warming Unit with a Rail-mount to the Wall Case bottom

Note: The rail-to-wall bracket is intended for use only with a Bair Hugger 800 series patient adjustable warming unit.

Operating Information

1.

Instructions for Use

Mounting the Patient Adjustable Warming Unit on an IV Pole

If mounted on an IV pole, the distance from the ! Caution: bottom of the patient adjustable warming unit to the floor must

1.

If the patient adjustable warming unit is not already connected to the rail mount, slide the clip on the back of the patient adjustable warming unit into the groove of the rail-mount. The assembly will click when the clip is fully seated in the rail-mount.

be less than 44” (112 cm) and the IV pole wheelbase diameter must be at least 28” (71 cm) to prevent tipping.

2.

Hook the patient adjustable warming unit with the attached rail-mount to the rail-to-wall bracket.

To prevent tipping, clamp the Model 875 patient adjustable warming unit to an IV pole at a height that provides stability. Clamping the patient adjustable warming unit no higher than 44” (112 cm) from the floor on an IV pole with a minimum 28” (71 cm) diameter wheelbase.

3.

Lift the patient adjustable warming unit straight up to remove it from the rail-to-wall bracket.

2.

Turn the clamp knob on the IV pole-mount clockwise to tighten the clamp to the pole.

3.

Snap the patient adjustable warming unit into position by sliding the clip on the back of the patient adjustable warming unit into the groove of the IV pole-mount. The assembly will click when the clip is fully seated in the IV pole-mount.

The instructions below describe how to use the Bair Hugger patient adjustable warming unit Model 875 with a Bair Hugger warming gown. For more information about the Bair Hugger warming gowns, refer to the Instructions for Use that is shipped with the warming gowns. 1.

Rail to Wall Bracket

2.

Instruct your patient to put the warming gown on so the opening is in the back. The gown has ties on the side and back of the neck. The gown should be tied loosely to help the air circulate in the gown insert. Connect the patient adjustable warming unit hose to the warming gown by performing the following steps. •

Rail Mount MODEL

Clip

1.

Slide the Bair Hugger suction wall mount adapter into the suction wall bracket. If the adapter is too large to fit, remove the expand spacer.

2.

Increase the expander on the Bair Hugger suction wall mount adapter by gently turning the screw counter clockwise until the adapter is securely fastened (torque < 10 in-lbs). The adapter should not be able to move in any direction within the suction wall bracket once fastened.

MODEL

875

IV pole mount IV pole

Mounting the Patient Adjustable Warming Unit on a Bedrail 1.

6

If the patient adjustable warming unit is not already connected to the rail-mount, slide the clip on the back of the patient adjustable warming unit into the groove of the rail-mount. The assembly will click when the clip is fully seated in the rail-mount.

7.

Store the patient adjustable warming unit hose by inserting it into the hose holder at top of patient adjustable warming unit.

8.

Unplug the patient adjustable warming unit to disconnect the patient adjustable warming unit from power source. Hose holder

Squeeze and hold the two buttons on the sides of the hose nozzle.

•

Insert the nozzle into the open hose port in the warming gown.

•

Connect the patient adjustable warming unit to a proper power source.

4.

Turn the knob on the handheld temperature controller clockwise to turn the patient adjustable warming unit ON. When you turn the patient adjustable warming unit on, the heater and blower activate. Also, the “Power On” indicator light on the patient adjustable warming unit illuminates.

expander to prevent pinching fingers.

3M™ Bair Hugger™ Model 875 Patient Adjustable Warming Unit – Operator’s Manual

5.

Warming unit hose

System

System

MODEL

875

Release the buttons to lock the hose nozzle in place.

3.

When using the suction wall mount adapter, only ! Caution: hold the front of the adapter when increasing/decreasing the Notice: Over torqueing may cause device damage.

Connect the warming unit hose to the Bair Hugger warming gown’s lower right hose port.

•

Mounting the Patient Adjustable Warming Unit with a Suction Wall Mount Adapter

Clamp knob

Turn the knob on the handheld temperature controller counter-clockwise until it clicks to discontinue warming therapy. To disconnect the hose nozzle from the warming gown, press the two buttons on the sides of the nozzle and withdraw the nozzle from the hose port.

System System

875

System System

6.

Allow the patient to adjust the temperature to a comfortable level. The temperature and

GB / 34-8718-8813-6

Using the Handheld Temperature Controller System

After the hose has been connected to the Bair Hugger gown, the patient can adjust the air temperature and airflow by turning the knob on the handheld temperature controller. The following list explains how the patient adjustable warming unit will operate when the knob is placed in the specified position shown in the figure. •

When the knob is in position A, the patient adjustable warming unit is off.

7

Placing the Patient Adjustable Warming Unit on the Wall-mount Bracket

2.

Hang the Model 875 patient adjustable warming unit on a bedrail by the hooks on the rail-mount.

1.

Snap the patient adjustable warming unit into position by sliding the clip on the back of the patient adjustable warming unit into the groove of the wall-mount bracket. The assembly will click when the clip is fully seated in the wall-mount bracket.

3.

Wrap the safety strap around the bedrail and connect the end to the fastener on the strap. The safety strap will prevent the patient adjustable warming unit from falling if the unit is inadvertently dislodged from the bedrail.

2.

Lift the patient adjustable warming unit straight up to remove it from the wall-mount bracket.

Bedrail

airflow are adjusted by turning the knob on the handheld temperature controller. The temperature adjustment varies from approximately ambient to 43±3°C. The maximum temperature is 46°C before the Over-temp indicator light illuminates and audible alarm sounds.

Do not leave children and other vulnerable patient ! Warning: populations unattended while using a Bair Hugger patient

Rail mount

adjustable warming unit.

Note: It may be necessary to gently strike the case bottom in an upward fashion with the palm of your hand to release the clip from the wall-mount bracket.

3. Safety strap

Slide the patient adjustable warming unit into the suction wall mount adapter.

Do not allow children and other vulnerable patients to ! Warning: handle the handheld temperature controller without supervision to prevent controller’s electrical cord from becoming entangled around the patient.

! Caution: Patient Monitoring Recommendations:

System System

•

3M recommends continuously monitoring core temperature. In the absence of continuous monitoring, monitor the temperature of patients who are incapable of reacting, communicating and/or who cannot sense temperature a minimum of every 15 minutes or according to institutional protocol.

•

Monitor cutaneous responses of patients who are incapable of reacting, communicating and/or who cannot sense temperature a minimum of every 15 minutes or according to institutional protocol.

•

Adjust air temperature or discontinue warming therapy when the therapeutic goal is reached, if elevated temperatures are recorded or if there is an adverse cutaneous response in the warmed area.

MODEL

875

System System

System System

Wall mount bracket MODEL

875 MODEL

875

Mounting the Patient Adjustable Warming Unit with a Rail-mount to the Wall Case bottom

Note: The rail-to-wall bracket is intended for use only with a Bair Hugger 800 series patient adjustable warming unit.

Operating Information

1.

Instructions for Use

Mounting the Patient Adjustable Warming Unit on an IV Pole

If mounted on an IV pole, the distance from the ! Caution: bottom of the patient adjustable warming unit to the floor must

1.

If the patient adjustable warming unit is not already connected to the rail mount, slide the clip on the back of the patient adjustable warming unit into the groove of the rail-mount. The assembly will click when the clip is fully seated in the rail-mount.

be less than 44” (112 cm) and the IV pole wheelbase diameter must be at least 28” (71 cm) to prevent tipping.

2.

Hook the patient adjustable warming unit with the attached rail-mount to the rail-to-wall bracket.

To prevent tipping, clamp the Model 875 patient adjustable warming unit to an IV pole at a height that provides stability. Clamping the patient adjustable warming unit no higher than 44” (112 cm) from the floor on an IV pole with a minimum 28” (71 cm) diameter wheelbase.

3.

Lift the patient adjustable warming unit straight up to remove it from the rail-to-wall bracket.

2.

Turn the clamp knob on the IV pole-mount clockwise to tighten the clamp to the pole.

3.

Snap the patient adjustable warming unit into position by sliding the clip on the back of the patient adjustable warming unit into the groove of the IV pole-mount. The assembly will click when the clip is fully seated in the IV pole-mount.

The instructions below describe how to use the Bair Hugger patient adjustable warming unit Model 875 with a Bair Hugger warming gown. For more information about the Bair Hugger warming gowns, refer to the Instructions for Use that is shipped with the warming gowns. 1.

Rail to Wall Bracket

2.

Instruct your patient to put the warming gown on so the opening is in the back. The gown has ties on the side and back of the neck. The gown should be tied loosely to help the air circulate in the gown insert. Connect the patient adjustable warming unit hose to the warming gown by performing the following steps. •

Rail Mount MODEL

Clip

1.

Slide the Bair Hugger suction wall mount adapter into the suction wall bracket. If the adapter is too large to fit, remove the expand spacer.

2.

Increase the expander on the Bair Hugger suction wall mount adapter by gently turning the screw counter clockwise until the adapter is securely fastened (torque < 10 in-lbs). The adapter should not be able to move in any direction within the suction wall bracket once fastened.

MODEL

875

IV pole mount IV pole

Mounting the Patient Adjustable Warming Unit on a Bedrail 1.

6

If the patient adjustable warming unit is not already connected to the rail-mount, slide the clip on the back of the patient adjustable warming unit into the groove of the rail-mount. The assembly will click when the clip is fully seated in the rail-mount.

7.

Store the patient adjustable warming unit hose by inserting it into the hose holder at top of patient adjustable warming unit.

8.

Unplug the patient adjustable warming unit to disconnect the patient adjustable warming unit from power source. Hose holder

Squeeze and hold the two buttons on the sides of the hose nozzle.

•

Insert the nozzle into the open hose port in the warming gown.

•

Connect the patient adjustable warming unit to a proper power source.

4.

Turn the knob on the handheld temperature controller clockwise to turn the patient adjustable warming unit ON. When you turn the patient adjustable warming unit on, the heater and blower activate. Also, the “Power On” indicator light on the patient adjustable warming unit illuminates.

expander to prevent pinching fingers.

3M™ Bair Hugger™ Model 875 Patient Adjustable Warming Unit – Operator’s Manual

5.

Warming unit hose

System

System

MODEL

875

Release the buttons to lock the hose nozzle in place.

3.

When using the suction wall mount adapter, only ! Caution: hold the front of the adapter when increasing/decreasing the Notice: Over torqueing may cause device damage.

Connect the warming unit hose to the Bair Hugger warming gown’s lower right hose port.

•

Mounting the Patient Adjustable Warming Unit with a Suction Wall Mount Adapter

Clamp knob

Turn the knob on the handheld temperature controller counter-clockwise until it clicks to discontinue warming therapy. To disconnect the hose nozzle from the warming gown, press the two buttons on the sides of the nozzle and withdraw the nozzle from the hose port.

System System

875

System System

6.

Allow the patient to adjust the temperature to a comfortable level. The temperature and

GB / 34-8718-8813-6

Using the Handheld Temperature Controller System

After the hose has been connected to the Bair Hugger gown, the patient can adjust the air temperature and airflow by turning the knob on the handheld temperature controller. The following list explains how the patient adjustable warming unit will operate when the knob is placed in the specified position shown in the figure. •

When the knob is in position A, the patient adjustable warming unit is off.

7

•

As the knob is rotated from position A to B, the knob clicks and the patient adjustable warming unit turns on low airflow and low heat.

•

As the knob rotates clockwise, the blower’s airflow and temperature increases.

•

At position C, the patient adjustable warming unit is on HIGH HEAT and HIGH AIRFLOW. The air temperature will stabilize at 43±3°C (109±5.4°F).

2.

Unplug the patient adjustable warming unit from the power source and wait 5 minutes.

The serial number is located on the back of the patient adjustable warming unit.

Safety System Characteristics

3.

Reconnect the patient adjustable warming unit to a proper power source.

Repair and Exchange

Independent electronic and heater (electromechanical)

4.

Turn the patient adjustable warming unit on and select the maximum airflow and temperature setting by turning the handheld temperature controller knob completely clockwise.

5.

Allow the patient adjustable warming unit to run for at least 5 minutes. •

If the “Over-temp” light illuminates again, return the patient adjustable warming unit to 3M Patient Warming for service.

•

Otherwise, reconnect the patient adjustable warming unit hose to the Bair Hugger gown to resume patient warming.

Call 3M Patient Warming customer service if your Model 875 patient adjustable warming unit requires service. A customer service representative will give you a Return Authorization (RA) number. Please use this RA number on all correspondence concerning your patient adjustable warming unit. Your customer service representative will also send a shipping carton to you at no charge upon request.

System

Using the Holder for the Handheld Temperature Controller Store the handheld temperature controller in the controller holder to help prevent cord clutter around the patient and accidental damage to the patient adjustable warming unit. Press the controller holder onto the patient adjustable warming unit hose so it is within the patient’s reach. 1.

Slide the handheld temperature controller into the holder. It should fit securely with the dial facing the patient.

Warming unit hose

Controller holder

System

Calibrating the Operating Temperatures

DIMENSIONS OF HANDHELD TEMPERATURE CONTROLLER

1.

8

Discontinue patient warming. •

Turn the patient adjustable warming unit off.

•

Disconnect the patient adjustable warming unit hose from the Bair Hugger warming gown.

MOUNTING OPTIONS Wall mount bracket, IV pole clamp, suction wall mount adapter and rail-mount bracket with safety strap.

HOSE Detachable, flexible, and wipe able. 78 in. long x

Cleaning Instructions

1.5 in. wide; 198 cm long x 3.8 cm wide

1.

Disconnect the patient adjustable warming unit from the power source before cleaning.

FILTRATION SYSTEM

Cleaning should be performed in accordance with hospital practices for cleaning equipment. After every use; wipe the warming unit, the handheld temperature controller, the outside of the warming unit hose, and any other surfaces that may have been touched. Use a damp, soft cloth and a hospital approved mild detergent, germicidal disposable wipes, disinfecting towelettes, or antimicrobial spray.

RECOMMENDED FILTER CHANGE

Let air dry or dry with a separate clean soft cloth.

HEAT GENERATED

•

If the “Over-temp” indicator light illuminates, it means that the patient adjustable warming unit is delivering air at a higher temperature than the patient adjustable warming unit is calibrated to deliver. When an over-temperature condition occurs, the color indicator light illuminates, an audible alarm will sound, and the heater will automatically turn off (the blower will continue to run). You should perform the following steps:

57.9 dBA 7.0 lb; 3.2 kg.

Notice:

Unplug the patient adjustable warming unit and contact a qualified service technician.

RELATIVE NOISE LEVEL

Replace the filter every six months or sooner if necessary. To order a replacement filter, contact 3M Patient Warming customer service using either of the telephone numbers listed below. Instructions for replacing the filter will be included with the replacement filter.

3.

Do not continue warming therapy if the red ! Warning: Over-temp indicator light illuminates and the alarm sounds.

6.4 cm wide x 14.7 cm long

WEIGHT OF PATIENT ADJUSTABLE WARMING UNIT

Handheld temperature controller

What to Do if the “Over-temp” Indicator Light illuminates and the Audible Alarm Sounds

2.5 in. wide x 5.8 in. long

Replacing the Filter

2.

•

Dust filter included. Change at least every 6 months. Temperature Characteristics

TEMPERATURE CONTROL Electronically controlled using integrated circuit sensor.

AVERAGE OPERATING TEMPERATURES AT THE END OF THE HOSE

Do not immerse the Bair Hugger patient adjustable warming unit, patient adjustable warming unit parts, or accessories in any liquid or subject them to any sterilization process.

-20°C to 60°C (-4°F to 140°F)

Store all components in a cool, dry place when not in use.

Technical Support and Customer Service U.S. Customer Service TEL: 800-228-3957

OUTSIDE OF THE USA Contact your local 3M Patient Warming representative.

When You Call for Technical Support Please be ready to give the technical support representative the serial number of your Bair Hugger patient adjustable warming unit.

3M™ Bair Hugger™ Model 875 Patient Adjustable Warming Unit – Operator’s Manual

Fault: amber Fault indication flashes, alarm sounds. IEC 60601-1; IEC/EN 60601-1-2; UL 60601-1; CAN/CSA-C22.2, No.601.1; EN 55011; EN 80601-2-35.

CLASSIFICATIONS MEDICAL - GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601-1; CAN/CSA-C22.2, No.601.1; ANSI/AAMI ES60601-1:2005 CSA-C22.2 No. 60601-1:08; EN 80601-2-35; Control No.4HZ8 Classified under IEC 60601-1 Guidelines (and other national versions of the Guidelines) as Class I, Type BF, Ordinary equipment, Continuous operation. Not suitable for use in the presence of flammable anesthetic mixtures with air or with oxygen or nitrous oxide. Classified by Underwriters Laboratories Inc. with respect to electric shock, fire and mechanical hazards only, in accordance with UL 60601-1, EN 80601-2-35 and in accordance with Canadian/CSA C22.2, No. 601.1. Classified under the Medical Device Directive as a Class IIb device. 3M™ Bair Hugger™ Patient Adjustable Warming Unit, Model 875 ESD Precautions Protection against electrostatic discharge (ESD) is important when working with the 3M Bair Hugger Patient Adjustable Warming Unit, Model 875. Always be mindful of the immediate work area and any potentially hazardous ESD situations that could impact the Model 875 performance. 3M™ Bair Hugger™ Patient Adjustable Warming Unit, Model 875 Use Environment This product is to be used in a Hospital environment only. Use of this product in a residential environment is strictly prohibited.

1000 BTU/hr (average)

Do not use cleaning solutions with greater than 80% alcohol or solvents, including acetone and thinner, to clean the patient adjustable warming unit or hose. Solvents may damage the labels and other plastic parts.

Storage

Over-temperature protection: color indicator light illuminates, audible alarm sounds, and heater shuts down (blower continues to run).

CERTIFICATIONS

33 cm high x 10.2 cm deep x 19.6 cm wide

consistent with institutional protocol.

SAFETY FEATURE

ALARM SYSTEM

General Maintenance

Do not attempt to clean the air filter as it may ! Caution: be contaminated from use. Discard the filter in a manner

Dual input fused line.

Physical Characteristics DIMENSIONS OF PATIENT ADJUSTABLE WARMING UNIT

System

Calibrate the operating temperatures of the Model 875 patient adjustable warming unit (1) after performing a service procedure and (2) routinely every six months. Perform the calibration in a similar environment temperature to where the Model 875 will be used. You will need a Bair Hugger temperature test kit Model 90055 to perform the calibration. Calibration instructions are included with the test kit.

OVERCURRENT PROTECTION

Technical Specifications

13 in. high x 4 in. deep x 7.7 in. wide System

THERMOSTAT

User adjustable from: ambient to 43±3°C (109±5.4°F)

STORAGE/TRANSPORT TEMPERATURE Store all components in a cool, dry place when not in use.

RECOMMENDED OPERATING ENVIRONMENT •

Indoor use

•

Ambient temperature range of 18°C to 26°C (64°F to 79°F)

•

Altitude up to 2000m

•

Maximum, relative humidity up to 90%

•

Main supply voltage fluctuations up to ±10% of the voltage

•

Overvoltage category II (of IEC standard 60364-4-443) level of transient over voltages present in the mains supply

•

Rated pollution degree of 2

GB / 34-8718-8813-6

9

•

As the knob is rotated from position A to B, the knob clicks and the patient adjustable warming unit turns on low airflow and low heat.

•

As the knob rotates clockwise, the blower’s airflow and temperature increases.

•

At position C, the patient adjustable warming unit is on HIGH HEAT and HIGH AIRFLOW. The air temperature will stabilize at 43±3°C (109±5.4°F).

2.

Unplug the patient adjustable warming unit from the power source and wait 5 minutes.

The serial number is located on the back of the patient adjustable warming unit.

Safety System Characteristics

3.

Reconnect the patient adjustable warming unit to a proper power source.

Repair and Exchange

Independent electronic and heater (electromechanical)

4.

Turn the patient adjustable warming unit on and select the maximum airflow and temperature setting by turning the handheld temperature controller knob completely clockwise.

5.

Allow the patient adjustable warming unit to run for at least 5 minutes. •

If the “Over-temp” light illuminates again, return the patient adjustable warming unit to 3M Patient Warming for service.

•

Otherwise, reconnect the patient adjustable warming unit hose to the Bair Hugger gown to resume patient warming.

Call 3M Patient Warming customer service if your Model 875 patient adjustable warming unit requires service. A customer service representative will give you a Return Authorization (RA) number. Please use this RA number on all correspondence concerning your patient adjustable warming unit. Your customer service representative will also send a shipping carton to you at no charge upon request.

System

Using the Holder for the Handheld Temperature Controller Store the handheld temperature controller in the controller holder to help prevent cord clutter around the patient and accidental damage to the patient adjustable warming unit. Press the controller holder onto the patient adjustable warming unit hose so it is within the patient’s reach. 1.

Slide the handheld temperature controller into the holder. It should fit securely with the dial facing the patient.

Warming unit hose

Controller holder

System

Calibrating the Operating Temperatures

DIMENSIONS OF HANDHELD TEMPERATURE CONTROLLER

1.

8

Discontinue patient warming. •

Turn the patient adjustable warming unit off.

•

Disconnect the patient adjustable warming unit hose from the Bair Hugger warming gown.

MOUNTING OPTIONS Wall mount bracket, IV pole clamp, suction wall mount adapter and rail-mount bracket with safety strap.

HOSE Detachable, flexible, and wipe able. 78 in. long x

Cleaning Instructions

1.5 in. wide; 198 cm long x 3.8 cm wide

1.

Disconnect the patient adjustable warming unit from the power source before cleaning.

FILTRATION SYSTEM

Cleaning should be performed in accordance with hospital practices for cleaning equipment. After every use; wipe the warming unit, the handheld temperature controller, the outside of the warming unit hose, and any other surfaces that may have been touched. Use a damp, soft cloth and a hospital approved mild detergent, germicidal disposable wipes, disinfecting towelettes, or antimicrobial spray.

RECOMMENDED FILTER CHANGE

Let air dry or dry with a separate clean soft cloth.

HEAT GENERATED

•

If the “Over-temp” indicator light illuminates, it means that the patient adjustable warming unit is delivering air at a higher temperature than the patient adjustable warming unit is calibrated to deliver. When an over-temperature condition occurs, the color indicator light illuminates, an audible alarm will sound, and the heater will automatically turn off (the blower will continue to run). You should perform the following steps:

57.9 dBA 7.0 lb; 3.2 kg.

Notice:

Unplug the patient adjustable warming unit and contact a qualified service technician.

RELATIVE NOISE LEVEL

Replace the filter every six months or sooner if necessary. To order a replacement filter, contact 3M Patient Warming customer service using either of the telephone numbers listed below. Instructions for replacing the filter will be included with the replacement filter.

3.

Do not continue warming therapy if the red ! Warning: Over-temp indicator light illuminates and the alarm sounds.

6.4 cm wide x 14.7 cm long

WEIGHT OF PATIENT ADJUSTABLE WARMING UNIT

Handheld temperature controller

What to Do if the “Over-temp” Indicator Light illuminates and the Audible Alarm Sounds

2.5 in. wide x 5.8 in. long

Replacing the Filter

2.

•

Dust filter included. Change at least every 6 months. Temperature Characteristics

TEMPERATURE CONTROL Electronically controlled using integrated circuit sensor.

AVERAGE OPERATING TEMPERATURES AT THE END OF THE HOSE

Do not immerse the Bair Hugger patient adjustable warming unit, patient adjustable warming unit parts, or accessories in any liquid or subject them to any sterilization process.

-20°C to 60°C (-4°F to 140°F)

Store all components in a cool, dry place when not in use.

Technical Support and Customer Service U.S. Customer Service TEL: 800-228-3957

OUTSIDE OF THE USA Contact your local 3M Patient Warming representative.

When You Call for Technical Support Please be ready to give the technical support representative the serial number of your Bair Hugger patient adjustable warming unit.

3M™ Bair Hugger™ Model 875 Patient Adjustable Warming Unit – Operator’s Manual

Fault: amber Fault indication flashes, alarm sounds. IEC 60601-1; IEC/EN 60601-1-2; UL 60601-1; CAN/CSA-C22.2, No.601.1; EN 55011; EN 80601-2-35.

CLASSIFICATIONS MEDICAL - GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601-1; CAN/CSA-C22.2, No.601.1; ANSI/AAMI ES60601-1:2005 CSA-C22.2 No. 60601-1:08; EN 80601-2-35; Control No.4HZ8 Classified under IEC 60601-1 Guidelines (and other national versions of the Guidelines) as Class I, Type BF, Ordinary equipment, Continuous operation. Not suitable for use in the presence of flammable anesthetic mixtures with air or with oxygen or nitrous oxide. Classified by Underwriters Laboratories Inc. with respect to electric shock, fire and mechanical hazards only, in accordance with UL 60601-1, EN 80601-2-35 and in accordance with Canadian/CSA C22.2, No. 601.1. Classified under the Medical Device Directive as a Class IIb device. 3M™ Bair Hugger™ Patient Adjustable Warming Unit, Model 875 ESD Precautions Protection against electrostatic discharge (ESD) is important when working with the 3M Bair Hugger Patient Adjustable Warming Unit, Model 875. Always be mindful of the immediate work area and any potentially hazardous ESD situations that could impact the Model 875 performance. 3M™ Bair Hugger™ Patient Adjustable Warming Unit, Model 875 Use Environment This product is to be used in a Hospital environment only. Use of this product in a residential environment is strictly prohibited.

1000 BTU/hr (average)

Do not use cleaning solutions with greater than 80% alcohol or solvents, including acetone and thinner, to clean the patient adjustable warming unit or hose. Solvents may damage the labels and other plastic parts.

Storage

Over-temperature protection: color indicator light illuminates, audible alarm sounds, and heater shuts down (blower continues to run).

CERTIFICATIONS

33 cm high x 10.2 cm deep x 19.6 cm wide

consistent with institutional protocol.

SAFETY FEATURE

ALARM SYSTEM

General Maintenance

Do not attempt to clean the air filter as it may ! Caution: be contaminated from use. Discard the filter in a manner

Dual input fused line.

Physical Characteristics DIMENSIONS OF PATIENT ADJUSTABLE WARMING UNIT

System

Calibrate the operating temperatures of the Model 875 patient adjustable warming unit (1) after performing a service procedure and (2) routinely every six months. Perform the calibration in a similar environment temperature to where the Model 875 will be used. You will need a Bair Hugger temperature test kit Model 90055 to perform the calibration. Calibration instructions are included with the test kit.

OVERCURRENT PROTECTION

Technical Specifications

13 in. high x 4 in. deep x 7.7 in. wide System

THERMOSTAT

User adjustable from: ambient to 43±3°C (109±5.4°F)

STORAGE/TRANSPORT TEMPERATURE Store all components in a cool, dry place when not in use.

RECOMMENDED OPERATING ENVIRONMENT •

Indoor use

•

Ambient temperature range of 18°C to 26°C (64°F to 79°F)

•

Altitude up to 2000m

•

Maximum, relative humidity up to 90%

•

Main supply voltage fluctuations up to ±10% of the voltage

•

Overvoltage category II (of IEC standard 60364-4-443) level of transient over voltages present in the mains supply

•

Rated pollution degree of 2

GB / 34-8718-8813-6

9

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

Manufacturer’s Declaration – Electromagnetic Immunity – Not Life-Supporting

The 3M™ Bair Hugger™ Patient Adjustable Warming Unit, Model 875 is intended for use in the electromagnetic environment specified below. The customer or the user of the 3M Bair Hugger Patient Adjustable Warming Unit, Model 875 should assure that it is used in such an environment.

The 3M™ Bair Hugger™ Patient Adjustable Warming Unit, Model 875 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the 3M Bair Hugger Patient Adjustable Warming Unit, Model 875 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the 3M Bair Hugger Patient Adjustable Warming Unit, Model 875 as recommended below, according to the maximum output power of the communications equipment.

Emissions test RF emissions

Compliance Group 1

CISPR 11 RF emissions

Electromagnetic Environment - Guidance The 3M Bair Hugger Patient Adjustable Warming Unit, Model 875 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 3M Bair Hugger Patient Adjustable Warming Unit, Model 875 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

CISPR 11 Harmonic emissions

Class A

Flicker emissions

Complies

Rated maximum output power of transmitter (W)

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The 3M Bair Hugger Patient Adjustable Warming Unit, Model 875 is intended for use in the electromagnetic environment specified below. The customer or the user of the 3M Bair Hugger Patient Adjustable Warming Unit, Model 875 should assure that it is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance Level

Electrostatic discharge (ESD)

±6 kV contact

±6 kV contact

±8 kV air

±8 kV air

Electrical fast transient/ burst

±2 kV for power supply lines

±2 kV for power supply lines

±1 kV for input/output lines

±1 kV for input/output lines

Surge

Voltage dips, short interruptions and voltage variations on power supply input lines

Electromagnetic Environment - Guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Separation distance according to frequency of transmitter (in meters) 150 kHz to 80 MHz

80 MHz to 800MHz

d = [3.5 ÷ V1]√P

d = [3.5 ÷ E1]√P

800 MHz to 2,5 GHz d = [7 ÷ E1]√P

0.01

0.12 m (5 inches)

0.12 m (5 inches)

0.23 m (10 inches)

0.1

0.37 m (15 inches)

0.37 m (15 inches)

0.74 m (2.5 feet)

1

1.17 m (3.9 feet)

1.17 m (3.9 feet)

2.30 m (7.8 feet)

10

3.69 m (12.3 feet)

3.69 m (12.3 feet)

7.37 m (24.5 feet)

100

11.67 m (38.9)

11.67 m (38.9)

23.30 m (77.8 feet)

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1 – At 80 MHz and 800 MHz, the separation distance for the higher frequency applies. Note 2 – These guidelines may not apply is all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Note 3 – V1 is the value from the conducted RF immunity test and E1 is the value from the radiated RF immunity test.

Mains power quality should be that of a typical commercial or hospital environment. Guidance and Manufacturer’s Declaration – Emissions Mains power quality should be that of a typical commercial or hospital environment.

The 3M™ Bair Hugger™ Patient Adjustable Warming Unit, Model 875 is intended for use in the electromagnetic environment specified below. The customer or user of the 3M Bair Hugger Patient Adjustable Warming Unit, Model 875 should ensure that it is used in such an environment.

±1 kV line to line

±1 kV line to line

±1 kV line(s) to earth

±1 kV line(s) to earth

<5% UT (>95% dip in UT) for 0,5 cycle

<5% UT (>95% dip in UT) for 0,5 cycle

40% UT (60% dip in UT) for 5 cycles

40% UT (60% dip in UT) for 5 cycles

70% UT (30% dip in UT) for 25 cycles

70% UT (30% dip in UT) for 25 cycles

D= 1.2√P (80 to 800 MHz)

<5% UT (>95% dip in UT) for 5 sec

<5% UT (>95% dip in UT) for 5 sec

Where P is the max power in watts and D is the recommended separation distance in meters.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the 3M Bair Hugger Patient Adjustable Warming Unit, Model 875 requires continued operation during power mains interruptions, it is recommended that the 3M Bair Hugger Patient Adjustable Warming Unit, Model 875 be powered from an uninterruptible power supply or a battery.

Immunity Test Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3

IEC 60601 Test Level

Compliance Level

3 Vrms

3 Vrms

150 kHz to 80 MHz

3 V/m

Electromagnetic Environment – Guidance

3 V/m

Portable and mobile communications equipment should be separated from the «Model» by no less than the distances calculated/listed below:

80 MHz to 2.5 GHz

D=1.2√P

D= 2.3√P (800 MHz to 2.5 GHz)

NOTE UT is the a.c. mains voltage prior to application of the test level.

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.

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Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

Manufacturer’s Declaration – Electromagnetic Immunity – Not Life-Supporting

The 3M™ Bair Hugger™ Patient Adjustable Warming Unit, Model 875 is intended for use in the electromagnetic environment specified below. The customer or the user of the 3M Bair Hugger Patient Adjustable Warming Unit, Model 875 should assure that it is used in such an environment.

The 3M™ Bair Hugger™ Patient Adjustable Warming Unit, Model 875 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the 3M Bair Hugger Patient Adjustable Warming Unit, Model 875 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the 3M Bair Hugger Patient Adjustable Warming Unit, Model 875 as recommended below, according to the maximum output power of the communications equipment.

Emissions test RF emissions

Compliance Group 1

CISPR 11 RF emissions

Electromagnetic Environment - Guidance The 3M Bair Hugger Patient Adjustable Warming Unit, Model 875 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 3M Bair Hugger Patient Adjustable Warming Unit, Model 875 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

CISPR 11 Harmonic emissions

Class A

Flicker emissions

Complies

Rated maximum output power of transmitter (W)

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The 3M Bair Hugger Patient Adjustable Warming Unit, Model 875 is intended for use in the electromagnetic environment specified below. The customer or the user of the 3M Bair Hugger Patient Adjustable Warming Unit, Model 875 should assure that it is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance Level

Electrostatic discharge (ESD)

±6 kV contact

±6 kV contact

±8 kV air

±8 kV air

Electrical fast transient/ burst

±2 kV for power supply lines

±2 kV for power supply lines

±1 kV for input/output lines

±1 kV for input/output lines

Surge

Voltage dips, short interruptions and voltage variations on power supply input lines

Electromagnetic Environment - Guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Separation distance according to frequency of transmitter (in meters) 150 kHz to 80 MHz

80 MHz to 800MHz

d = [3.5 ÷ V1]√P

d = [3.5 ÷ E1]√P

800 MHz to 2,5 GHz d = [7 ÷ E1]√P

0.01

0.12 m (5 inches)

0.12 m (5 inches)

0.23 m (10 inches)

0.1

0.37 m (15 inches)

0.37 m (15 inches)

0.74 m (2.5 feet)

1

1.17 m (3.9 feet)

1.17 m (3.9 feet)

2.30 m (7.8 feet)

10

3.69 m (12.3 feet)

3.69 m (12.3 feet)

7.37 m (24.5 feet)

100

11.67 m (38.9)

11.67 m (38.9)

23.30 m (77.8 feet)

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1 – At 80 MHz and 800 MHz, the separation distance for the higher frequency applies. Note 2 – These guidelines may not apply is all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Note 3 – V1 is the value from the conducted RF immunity test and E1 is the value from the radiated RF immunity test.

Mains power quality should be that of a typical commercial or hospital environment. Guidance and Manufacturer’s Declaration – Emissions Mains power quality should be that of a typical commercial or hospital environment.

The 3M™ Bair Hugger™ Patient Adjustable Warming Unit, Model 875 is intended for use in the electromagnetic environment specified below. The customer or user of the 3M Bair Hugger Patient Adjustable Warming Unit, Model 875 should ensure that it is used in such an environment.

±1 kV line to line

±1 kV line to line

±1 kV line(s) to earth

±1 kV line(s) to earth

<5% UT (>95% dip in UT) for 0,5 cycle

<5% UT (>95% dip in UT) for 0,5 cycle

40% UT (60% dip in UT) for 5 cycles

40% UT (60% dip in UT) for 5 cycles

70% UT (30% dip in UT) for 25 cycles

70% UT (30% dip in UT) for 25 cycles

D= 1.2√P (80 to 800 MHz)

<5% UT (>95% dip in UT) for 5 sec

<5% UT (>95% dip in UT) for 5 sec

Where P is the max power in watts and D is the recommended separation distance in meters.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the 3M Bair Hugger Patient Adjustable Warming Unit, Model 875 requires continued operation during power mains interruptions, it is recommended that the 3M Bair Hugger Patient Adjustable Warming Unit, Model 875 be powered from an uninterruptible power supply or a battery.

Immunity Test Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3

IEC 60601 Test Level

Compliance Level

3 Vrms

3 Vrms

150 kHz to 80 MHz

3 V/m

Electromagnetic Environment – Guidance

3 V/m

Portable and mobile communications equipment should be separated from the «Model» by no less than the distances calculated/listed below:

80 MHz to 2.5 GHz

D=1.2√P

D= 2.3√P (800 MHz to 2.5 GHz)

NOTE UT is the a.c. mains voltage prior to application of the test level.

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.

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Electrical Characteristics

DEVICE RATINGS

BLOWER MOTOR

100-120 VAC, 50/60 Hz, 4.6A

Airflow: 7-13 cfm (3.3-6.1 L/S)

220-240 VAC, 50/60 Hz, 2.8 A

POWER CONSUMPTION

FUSES

Peak: 600W, Average: 340W

Fast Acting, 6.0A (120 VAC); 4.0A (220-230 VAC), High Breaking Capacity

LEAKAGE CURRENT Meets IEC 60601-1 and UL 60601-1 requirements

HEATING ELEMENT

HANDHELD TEMPERATURE CONTROLLER CORD 32” from hose collar, 4 cond., Max. Voltage: 5V

480W Resistive

POWER CORD 15-foot, SJT, 3 cond., 15A 4.6 m, HAR, 3 cond., 10A

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3M™ Bair Hugger™ Model 875 Patient Adjustable Warming Unit – Operator’s Manual