3M Bair Hugger Model 775 Operators Manual

1 3M™ Bair Hugger™ Warming Unit Model 775 Operator’s Manual Introduction Description of the 3M™ Bair Hugger™ Temperature Management System The Bair Hugger temperature management system consists of a Model 775 warming unit (with optional rolling stand, and other accessories) along with a 3M warming blanket, Bair Hugger warming gown, or the 3M™ Ranger™ 241 blood/fluid warming set. The Bair Hugger warming unit is attached to the warming blanket or warming gown by means of a flexible hose. Warm air is generated in the warming unit and flows through the warming unit hose and into the blanket or gown. Depending on the model, the 3M blanket or gown is placed either around, over, or underneath the patient. Small perforations on the blanket or gown allow the warm air to be dispersed over the patient. For blood/fluid warming applications, the Model 241 blood/fluid warming set is inserted in the warming unit hose. When the warming unit is turned ON and a temperature setting is selected, warm air flows over the Model 241 tubing and warmed blood/fluid exits from the distal end of the tubing. For additional information on 3M blankets, gowns, the 241 warming set, or other accessories visit us online at bairhugger.com. This manual includes operating instructions and warming unit specifications for the Model 775 warming unit. You can use the Model 775 warming unit in all clinical settings where the patient may feel too warm or too cold; including the operating room to provide patient temperature management. For information about using 3M blankets, gowns or the 241 blood/fluid warming set with the Model 775 warming unit, refer to the respective Instructions for Use.

Voltage, alternating current (AC)

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.

Protective earth ground

No free hosing

High fan setting

Low fan setting

Non-explosion proof

Indications The Bair Hugger temperature management system is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to feel too warm or too cold. The temperature management system can be used with adult and pediatric patients. •

The Bair Hugger temperature management system should only be used by trained medical professionals.

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

Consult instructions for use

Follow instructions for use

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

Definition of Symbols The following symbols may appear on the product’s labeling or exterior packaging. An equipotentiality plug (grounded) 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 for requirements.

Fuse

Attention; see instructions for use

Keep dry

Temperature limit

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

Type BF equipment (patient applied)

Date of manufacture

Manufacturer

GB / 34-8718-8811-0

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

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

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! CONTRAINDICATION: To reduce the risk of thermal injury:

! WARNING: To reduce the risk of injury due to patient falls:

! WARNING: To reduce the risk of thermal injury:

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

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

Do not use a warming blanket/gown to transfer or move the patient.

The Bair Hugger Model 775 warming unit has been designed to operate safely ONLY with 3M disposable warming products. Use with other products may cause thermal injury. To the full extent permitted by law, the manufacturer and/or importer declines all responsibility for thermal injury resulting from the warming unit being used in conjunction with non-3M products.

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

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

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

Do not treat patients with the warming unit hose alone. Always attach the hose to a 3M warming blanket/gown before providing warming therapy.

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Do not allow the power cord to get wet.

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

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Do not disassemble the warming unit unless you are a qualified service technician. There are electrically live parts within the warming unit when it is connected to a power source.

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Connect each warming unit being tested to a separate power source.

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

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

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

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

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Do not place the non-perforated side of the warming blanket/gown on the patient. Always place the perforated side (with the small holes) directly on top of the patient in contact with the patient’s skin.

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! CAUTION: To reduce the risk of cross‑contamination: •

Do not connect a torn or damaged warming blanket/gown to the warming unit.

Except for specific Bair Hugger warming blanket models, 3M warming blankets/gowns are not sterile. Each warming blanket/gown is intended for single patient use ONLY. Placing a sheet between the warming blanket/gown and the patient does not prevent contamination of the product.

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For over-body warming blankets and gowns; do not place patient securement device (i.e. safety strap or tape) over the warming blanket/gown.

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

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For underbody or side channel warming blankets; if a securement device (i.e. safety strap, tape) is used, ensure the warming channels are not occluded.

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

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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.

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Do not operate the Bair Hugger warming unit with the hose detached from the 3M warming blanket/gown. The Bair Hugger warming unit is intended to be used with the hose properly attached to its corresponding warming blanket/gown and in accordance with good practices for operating room sterile technique.

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Do not place the warming blanket/gown directly over a dispersive electrode pad.

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

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Do not continue 241 blood/fluid warming therapy if the red Over-temp indicator light illuminates and the alarm sounds. Immediately stop fluid flow, and discard the blood/ fluid warming set. Unplug the warming unit, and contact a qualified service technician.

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For the Bair Hugger flex warming gown; 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.

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

Do not use a warming blanket/gown over transdermal medication patches.

To reduce the risk of injury due to interference ! WARNING: with ventilation: Do not allow the warming blanket/gown or head drape to cover the patient’s head or airway when the patient is not mechanically ventilated.

If mounted on an IV pole, the distance from the bottom of the 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.

! CAUTION: To reduce the risk of fire: •

Do not perform the over-temperature detection system test while the warming unit is being used for warming therapy.

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

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3M warming blankets and gowns are classified as Class I Normal Flammability as defined by the Consumer Product Safety Commissions 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.

3M™Bair Hugger™ Model 775 Warming Unit – Operator’s Manual

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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 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 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 warming unit to overheat, compromising the warming unit’s performance. Perform all temperature testing of the warming unit with a 3M Model 22110 temperature test unit.

Overview and Operation Carrying handle

Alphanumeric display

To reduce the risk associated with ! CAUTION: electromagnetic interference (EMI) due to portable and

Control Panel

mobile radio frequency (RF) communications equipment: •

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

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Install and put into service the 3M Bair Hugger temperature management system according to the electromagnetic compatibility (EMC) information provided in the Guidance and Manufacturer’s Declaration.

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

Figure A. Model 775 Warming Unit – front view

IV pole clamp

Hose

Notices 1.

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

2.

To avoid warming unit damage: •

Use proper Electrostatic Discharge (ESD) procedures when performing maintenance.

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Do not modify this equipment without authorization from the manufacturer.

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

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

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

Modifications or repairs are performed by unqualified personnel.

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

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

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The warming unit not maintained in accordance with the procedures described in the Service Manual.

Read Before Servicing Equipment All repair, calibration and servicing of the warming unit require the skill of a qualified, medical equipment service technician who is familiar with good practice for medical device repair. If service does not require the manufacturer’s attention, the Model 775 Service Manual provides the technical information needed to service the warming unit. Perform all repairs and maintenance in accordance with the instructions in the Service Manual. For additional service information please contact 3M technical support. GB / 34-8718-8811-0

Power cord connection

Hose connection

Figure B. Model 775 Warming Unit – rear view

Warming Unit Power‑On‑Reset The Model 775 warming unit automatically performs the following power-on-reset sequence after you connect the warming unit to a properly grounded power source: •

Performs all self-test functions.

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Illuminates indicator lights and all pixels in the alphanumeric display momentarily.

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Displays the text “MD 700’s” and the software revision level in the alphanumeric display.

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Sounds the alarm (three low-level clicks).

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Enters the Standby mode with the high fan setting selected by default.

Note: The low fan setting indicator light will not illuminate during power up. If the warming unit loses power for less than 1 second, the warming unit software will return the warming unit to the operating mode you selected prior to the power loss. However, if the warming unit loses power for longer than 1 second, the warming unit software will reset when you restore power. The warming unit will then enter the Standby mode with the high fan setting selected by default.

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Overview of Control Panel

TEMP IN RANGE INDICATOR LIGHT

Alphanumeric Display

Temperature Modes

TEMPERATURE

MODEL

HIGH

775

43 C

AIR FLOW

High Fan Setting Low Fan Setting

MEDIUM

38 C

32 C

TEMP IN RANGE

AMBIENT

FAULT INDICATOR LIGHT When a system fault occurs, the amber Fault indicator light flashes and an audible alarm sounds. Please refer to What to Do in Case of a Fault Condition on page 7 for additional information.

UNDER‑TEMP FAULT

LOW

System

The Temp in Range indicator light illuminates when the temperature at the blanket or gown end of the hose is ±1.5°C of the selected setting; this indicator light does not illuminate in the ambient mode.

FAULT OVER TEMP

STANDBY

Figure C. Model 775 Warming Unit Control Panel

ALPHANUMERIC DISPLAY The alphanumeric display shows the temperature at the end of the Bair Hugger warming unit hose in degrees Celsius.

TEMPERATURE MODES •

Press the 32˚C (Low), 38˚C (Med), or 43˚C (High) button to select the desired temperature.

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Press the Ambient button to supply room temperature air.

When you select a temperature mode, the following events occur: •

Corresponding temperature indicator and fan setting lights illuminate.

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Blower operates at selected fan speed.

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Temperature at the end of the hose appears in the alphanumeric display.

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Heater activates except in ambient mode.

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Temperature mode timer and hour meter activate.

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Temp in range indicator light illuminates when the temperature at the blanket end of the hose is within +/1.5°C of the selected setting; this indicator light does not illuminate in the ambient mode.

If the warming unit senses an under-temperature condition, the amber Fault indicator light flashes and an audible alarm sounds. Please refer to What to Do in Case of a Fault Condition on page 7 for additional information.

OVER‑TEMP INDICATOR LIGHT If the warming unit senses an over-temperature condition, the red Over‑temp indicator light flashes and an alarm sounds. Please refer to What to Do in Case of an Over‑Temperature Condition on page 7 for additional information.

Mounting the Warming Unit to an IV Pole To prevent tipping, clamp the Model 775 warming unit to an IV pole at a height that provides stability. Clamp the warming unit no higher than 44” (112 cm) from the floor on an IV pole with a minimum 28” (71 cm) diameter wheelbase. If mounted on an IV pole, the distance from the ! Caution: bottom of the 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.

METHOD To mount the Model 775 warming unit to an IV pole, simply turn the clamp handle clockwise to tighten the clamp on the IV pole and counterclockwise to release it. Ensure the IV pole bumper rests against the pole. See Figure D. Clamp Handle

AIRFLOW MODES The Model 775 warming unit has two preset fan speed settings: a default or high fan setting ( ) and a reduced or low fan setting ( ). The Model 775 warming unit will reset/default to the high fan setting each time the warming unit is powered up or Standby is selected. The low fan setting ( ) may be pre-selected while in Standby prior to selecting the desired temperature.

44 in. (112 cm) maximum

IV Pole Bumper

STANDBY Upon power up, the warming unit defaults to Standby and the high fan setting. When the warming unit is in 32˚C (Low), 38˚C (Med), or 43˚C (High) or Ambient mode, press the Standby button to place the warming unit in Standby mode. When you select the Standby mode, the following events occur:

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Standby indicator light illuminates.

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Blower and heater are turned OFF.

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Alphanumeric display deactivates.

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Alarm and fault detection functions remain active.

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Operating timer pauses.

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Airflow mode resets/defaults to the high fan setting.

28 in. (71 cm) minimum Figure D. Model 775 warming unit on an IV Pole

3M™Bair Hugger™ Model 775 Warming Unit – Operator’s Manual

INSTRUCTIONS FOR USE The instructions below describe how to operate the Model 775 warming unit. For information about using 3M blankets, gowns, or the 241 blood/fluid warming set with the Model 775 warming unit, refer to the respective Instructions for Use. 1.

If the Model 775 warming unit is not mounted on an IV pole or Bair Hugger rolling stand, place the warming unit on a flat, hard, dry surface, such as a table, before beginning warming therapy.

Do not place the warming unit on a soft uneven ! Caution: surface, such as a bed, or a visibly wet surface as the air

intake may become blocked and cause the warming unit to overheat, compromising the warming unit’s performance.

2.

Insert the end of the Bair Hugger warming unit hose in the warming blanket or gown hose port. Use a twisting motion to ensure a snug fit. A visual marker is located around the mid-section of the hose end to guide the depth of hose insertion. (Figures E). Support the hose to ensure secure attachment.

Do not treat patients with the Bair Hugger ! Warning: warming unit hose alone. Always attach the hose to a Bair Hugger warming blanket/gown before providing warming therapy. Hose

5.

Press the Standby button when warming therapy is complete. Disconnect the warming unit hose from the warming blanket/ gown and discard the blanket/gown per hospital policy.

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Unplug the warming unit to disconnect it from the power source.

Note: At any time, the fan speed setting can be switched between ) and low fan setting ( ) by pressing the high fan setting ( corresponding button. However, these buttons will not place the warming unit into Standby.

Viewing the Temperature Mode Timer The temperature mode timer records the amount of time the warming unit has been operating in the selected temperature mode. The timer resets itself every time you select a different temperature mode. To view the temperature mode timer, press the button and hold for 3 seconds for the current temperature mode. The alphanumeric display will show the temperature mode time, then go back to showing the temperature mode setting.

What to Do in Case of an Over‑Temperature Condition If an over-temperature condition occurs, the red Over‑temp indicator light flashes and an audible alarm sounds and the warming unit automatically turns OFF the heater, blower, and operating mode indicator lights. A fault code appears in the alphanumeric display. Note: Pressing any button will silence the alarm.

IF AN OVER‑TEMPERATURE CONDITION OCCURS:

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

sounds. Unplug the warming unit and contact a qualified service technician.

Do not continue 241 blood/fluid warming therapy ! Warning: if the red Over-temp indicator light illuminates and the alarm Insert marker Figure E. 3.

4.

Connect the warming unit to a properly grounded power source. The warming unit will be in Standby mode and the Standby indicator light will illuminate. The high fan setting ( ) will be pre-selected by default with its indicator light illuminated. The low fan setting ( ) may be pre-selected prior to selecting the desired temperature mode. Press the appropriate button (i.e., 32˚C, 38˚C, 43˚C, or Ambient) to select the desired temperature. This will turn the blower and heater ON. When the warming unit reaches the selected temperature, the Temp in Range indicator light will illuminate; this indicator light does not illuminate in the Ambient mode.

! Caution: Patient Monitoring Recommendations: •

sounds. Immediately stop fluid flow, and discard the blood/fluid warming set. Unplug the warming unit, and contact a qualified service technician.

Hose port

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.

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Discontinue all warming therapy. If you are using the 241 blood/ fluid warming set, immediately stop fluid flow and discard the blood/fluid warming set.

2.

Press any button on the control panel to silence the alarm.

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Unplug the warming unit.

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Replace warming unit. Do not attempt to restart or reset the warming unit.

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Contact a qualified service technician.

What to Do If a Fault Condition occurs The Model 775 warming unit software recognizes several non-hazardous conditions and reports those conditions as faults. When a system fault occurs, the software stores the fault code in memory, the amber Fault indicator light flashes, and an alarm sounds. The warming unit automatically turns the heater, blower, and operating mode indicator lights OFF. The control panel will not respond to commands. Note: Pressing any button will silence the alarm.

IF A FAULT CONDITION OCCURS: 1.

Unplug the warming unit and wait for 30-60 seconds.

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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.

2.

Reconnect the warming unit to a grounded power source. The warming unit will perform the normal power-on-reset sequence and then enter the Standby mode.

3.

Reselect the temperature setting.

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

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If the warming unit does not return to normal operation, contact a qualified service technician.

GB / 34-8718-8811-0

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General Maintenance and Storage

Specifications

Cleaning Instructions

Physical Characteristics DIMENSIONS

1.

Disconnect the warming unit from the power source before cleaning.

2.

Cleaning should be performed in accordance with hospital practices for cleaning OR equipment. After every use; wipe the warming unit, 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.

3.

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

Notice: •

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13" high x 13" deep x 14" wide (33 cm high x 33 cm deep x 36 cm wide)

WEIGHT 16 lb (7.3kg)

RELATIVE NOISE LEVEL 53 dBA (High fan setting) 48 dBA (Low fan setting)

HOSE Flexible, compatible with the Ranger 241 blood/fluid warming set.

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

Length: 80" (203 cm)

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

* See Frequently Asked Questions on Filtration (p. 243)

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

Technical Service and Order Placement USA +1-800-733-7775

OUTSIDE USA Contact your local service provider or distributor.

When You Call for Technical Support We will need to know the serial number of your Bair Hugger warming unit. The serial number label is located on the back of the warming unit.

In‑Warranty Repair and Exchange

UNIT INTAKE FILTER MERV 14*

RECOMMENDED FILTER CHANGE Every 12 months or 500 hours of use.

MOUNTING Can be clamped to an IV pole, placed on a hard surface, or mounted to the rolling stand accessory.

Temperature Characteristics RECOMMENDED OPERATING ENVIRONMENT TEMPERATURE 15°C-25°C

HUMIDITY Max relative humidity 80% (up to 31°C) decreasing linearly to 50% relative humidity at 40°C.

ALTITUDE Max 2,000m

USA

TEMPERATURE CONTROL

Call 3M customer service if your Model 775 warming unit requires factory service. A customer service representative will give you a Return Authorization (RA) number. Please use this RA number on all correspondence concerning your warming unit. Your customer service representative will also send a shipping carton to you at no charge, if needed. Call your local supplier or sales representative to inquire about borrowing a warming unit while we service your warming unit. For more detailed instructions on returning warming units for service, please refer to the Model 775 Service Manual.

Electronically controlled

OUTSIDE OF THE USA

MED:38° ± 1.5°C (100.4° ± 2.7°F)

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

LOW:32° ± 1.5°C (89.6° ± 2.7°F)

HEAT GENERATED High fan setting: 1600 BTU/hr (average), 470 W (average) Low fan setting: 1330 BTU/hr (average), 390 W (average)

OPERATING TEMPERATURES Average temperatures at the end of the hose: HIGH:43° ± 1.5°C (109.4° ± 2.7°F)

TIME TO REACH OPERATING TEMPERATURE 2 - 5 minutes (dependent on blanket model) Time required for the contact surface temperature to heat up from 23 ± 2°C to 37°C (73 ± 2°F to 99°F).

STORAGE/TRANSPORT TEMPERATURE -20°C to 45°C (-4°F to 113°F) Store all components in a cool, dry place when not in use.

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3M™Bair Hugger™ Model 775 Warming Unit – Operator’s Manual

Safety System THERMOSTAT Independent electronic circuit; thermal cutoff shuts the heater OFF to ensure hose end air remains below 56°C (53°C ± 3°C typical); back-up over-temperature detection at warming unit hose inlet.

ALARM SYSTEM Over-temperature (≤56°C, 53°C ± 3°C typical): red Over‑Temp indicator light flashes, alarm sounds, heater and blower shut down, operating indicator lights turn OFF, and control panel becomes unresponsive.

FAULT Amber Fault indicator light flashes, alarm sounds.

OVERCURRENT PROTECTION Dual input fused lines.

Electrical Characteristics HEATING ELEMENT 1400 W Resistive

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

BLOWER MOTOR Operating speed: 4,700 rpm (high fan setting) 4,100 rpm (low fan setting) Airflow: up to 48 cfm or 23 L/s

POWER CONSUMPTION Peak: 1550 W

POWER CORD 15 ft., SJT, 3 cond., 13 A 15 ft., SJT, 3 cond., 15 A 4.6 m, HAR, 3 cond., 10 A

DEVICE RATINGS 110-120 VAC, 50/60 Hz, 11.7 A, or 220-240 VAC, 50/60 Hz, 7.2 A, or 100 VAC, 50/60 Hz, 15 A

FUSES TYPE Fast acting ceramic fuses, 250 VAC

AMP RATING 12 A (110 - 120 VAC) 8 A (220 - 240 VAC) 15 A (100 VAC)

OPERATING SPEED F (Fast Acting)

BREAKING CAPACITY 15 A, 12 A: 750 A @ 250 Vac 15 A, 12 A: 10,000 A @ 125 Vac 8 A: 200 A @ 250 Vac 8 A: 10,000 A @ 125 Vac

CERTIFICATIONS IEC 60601-1; IEC/EN 60601-1-2; UL 60601-1; CAN/CSA-C22.2, No.601.1; EN 55011; EN 80601-2-35

Average: 800 W

GB / 34-8718-8811-0

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CLASSIFICATION Guidance and manufacturer’s declaration – electromagnetic emissions The Model 775 warming unit is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 775 warming unit should assure that it is used in such an environment. Emissions test RF emissions

Compliance Group 1

The Model 775 warming unit 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 Model 775 warming unit 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 RF emissions CISPR 11 Harmonic emissions

Electromagnetic environment ‑ guidance

Class A

IEC 61000-3-2 Voltage fluctuations/

Complies

Flicker emissions IEC 61000-3-3

Guidance and manufacturer’s declaration – electromagnetic immunity The Model 775 warming unit is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 775 warming unit should assure that it is used in such an environment. Immunity Test Electrostatic discharge (ESD)

IEC 60601 test level

Compliance level

±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

IEC 61000-4-4

±1 kV for input/output lines

±1 kV for input/output lines

Surge

±1 kV line to line

±1 kV line to line

IEC 61000-4-5

±2 kV line(s) to earth

±2 kV line(s) to earth

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

<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

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

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

3 A/m

3 A/m

IEC 61000-4-2

IEC 61000-4-11

Power frequency (50/60 Hz) magnetic field

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%. 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 Model 775 warming unit requires continued operation during power mains interruptions, it is recommended that the Model 775 warming unit be powered from an uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

IEC 61000-4-8 NOTE UT is the a.c. mains voltage prior to application of the test level.

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3M™Bair Hugger™ Model 775 Warming Unit – Operator’s Manual

Guidance and manufacturer’s declaration – electromagnetic immunity The Model 775 warming unit is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 775 warming should assure that it is used in such an environment. Immunity Test

IEC 60601 test level

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2,5 GHz

Compliance level 3 Vrms

Electromagnetic environment ‑ guidance Portable and mobile RF communications equipment should be used no closer to any part of the Model 775 warming unit, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

3 V/m

Recommended separation distance d = 1.2 d = 1.2

80 MHz to 800 MHz

d = 2.3

800 MHz to 2,5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1

At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Model 775 warming unit is used exceeds the applicable RF compliance level above, the Model 775 warming unit should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Model 775 warming unit. a

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the Model 775 warming unit The Model 775 warming unit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Model 775 warming unit can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Model 775 warming unit as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W

Separation distance according to frequency of transmitter m 150 kHz to 80 MHz

80 MHz to 800MHz

800 MHz to 2,5 GHz

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

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) 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 range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

GB / 34-8718-8811-0

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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

DIAGNOSTICS A qualified service technician can perform over-temperature detection system testing, temperature output testing, operating temperature calibration, and fault code troubleshooting.

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.

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3M™Bair Hugger™ Model 775 Warming Unit – Operator’s Manual

Frequently Asked Questions (FAQ) on Filtration What filter is used in the 3M™ Bair Hugger™ Model 775 warming unit? The Model 775 uses the same filter media as has for many years been used with prior Bair Hugger -700series models. That filter media is classified on an industry-standard scale as MERV 14 at 48 CFM (cubic feet per minute) under ASHRAE Standard 2012-52.2: Method of Testing General Air Ventilation Air-Cleaning Devices for Removal Efficiency by Particle Size.1,2

What is a MERV rating? The Minimum Efficiency Reporting Value, or MERV, is a measurement scale to rate the efficiency of an air filter as a function of particle size based on the ASHRAE Standard 2012.1,2.1,2-52.2

What is the MERV rating recommended for operating rooms? ASHRAE Standard 2013-170, Ventilation of Health Care Facilities, provides standards and guidance on the design requirements for ventilation systems utilized in health care facilities.3 The standard recommends that operating rooms utilize a filter that is equivalent to MERV 14.3 This MERV rating is specific to the ventilation system in the hospital’s operating room.

What is the MERV rating recommended for patient warming devices in the operating room? There is no filtration standard for patient warming devices utilized within the operating room. The ASHRAE Standard is a standard used to assess filter efficiency in health care ventilation systems.

Is a HEPA filter necessary? No. We are not aware of any evidence or claim demonstrating that a HEPA filter improves patient safety.

What is the ASHRAE 52.2‑2012 standard? The American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) is a global organization focused on research, education and standards for heating, ventilation, air conditioning and refrigeration. The ASHRAE standard 20121,2-52.2 provides test methods for air intake filters to ensure standardization in classification and efficiency. For more information on ASHRAE, please visit www.ashrae.org.

1. ANSI/ASHRAE Standard 2012-52.2: Method of Testing General Air Ventilation Air-Cleaning Devices for Removal Efficiency by Particle Size. The American Society of Heating, Refrigerating and Air-Conditioning Engineers, Inc. © 2012 ASHRAE. ISSN 2336-1041. Available at http://www.ashrae.org. Accessed on 2016/7/6. 2. ANSI/ASHRAE Addenda a, b, and d to ANSI/ASHRAE Standard 2012-52.2. Method of Testing General Air Ventilation Air-Cleaning Devices for Removal Efficiency by Particle Size. The American Society of Heating, Refrigerating and Air-Conditioning Engineers, Inc. © 2015 ASHRAE. ISSN 2336-1041. Available at http://www.ashrae.org. Accessed on 2016/7/6. 3. ANSI/ASHRAE/ASHE Standard 2013-170: Ventilation of Health Care Facilities. The American Society of Heating, Refrigerating and AirConditioning Engineers, Inc. © 2013 ASHRAE. ISSN 2336-1041. Available at http://www.ashrae.org. Accessed on 2016/7/6.

Refer to the 3M™ Bair Hugger™ Model 775 warming unit Operator’s Manual for a complete list of instructions for use, preventative maintenance, warnings and cautions. For more information about the Bair Hugger warming system, please contact your 3M representative, call us at 3957-228-800-1 or visit www.bairhugger.com. 3M, BAIR HUGGER and the BAIR HUGGER logo are trademarks of 3M Company, used under license in Canada. © 3M 2016. All rights reserved.

FAQ / 0-8811-8718-34

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Made in the USA by 3M Health Care 2510 Conway Ave. St. Paul, MN 55144 U.S.A. 800-228-3957 | www.bairhugger.com 3M, BAIR HUGGER and the BAIR HUGGER logo are trademarks of 3M. Used under license in Canada. © 2016, 3M. All rights reserved. Issue Date: 2016-07 34-8718-8811-0

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