3M Bair Hugger Model 775 Operators Manual July 2013

Bair Hugger

Temperature Management Unit Model 775

Operator’s Manual English

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Table of Contents Introduction � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � Description of the Total Temperature Management™ System � � � � � � � � � � � � � � Indications � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � Definition of Symbols � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � Explanation of Signal Word Consequences � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � Contraindications � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � Warnings � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � Cautions � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � Notices� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � Proper Use and Maintenance � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � Read Before Servicing Equipment � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �

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Overview and Operation � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 6 Unit Power-On-Reset � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 6 Overview of Control Panel � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 7 Mounting the Temperature Management Unit to an IV Pole � � � � � � � � � � � � � � 9 Instructions for Use � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 10 Viewing the Temperature Mode Timer � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 11 What to Do in Case of an Over-Temperature Condition � � � � � � � � � � � � � � � � � 11 What to Do in Case of a Fault Condition � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 11 General Maintenance and Storage � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 12 Cleaning the Cabinet and Hose � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 12 Storage � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 12 Technical Service and Order Placement � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � Technical Service � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � When You Call for Technical Support � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � In-Warranty Repair and Exchange � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �

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Specifications � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 14

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Bair Hugger Model 775 Temperature Management Unit Operator’s Manual

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Introduction Description of the Total Temperature Management™ System The 3MTM Bair HuggerTM brand Total Temperature Management system consists of a Model 775 forced-air temperature management unit (with optional rolling stand, and other accessories) and disposable components, including Bair Hugger forced-air blankets, 3MTM Bair PawsTM patient warming gowns and the 3MTM 241TM blood/fluid warming set. The Bair Hugger warming unit is attached to the blanket or gown by means of a flexible hose. Warm air is generated in the unit and flows through the hose and into the blanket or gown. Depending on the model, the 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 fluid warming applications, the Model 241 blood/fluid warming set is inserted in the warming unit hose. When the unit is turned ON and a temperature setting is selected, warm air flows over the Model 241 tubing and warmed fluid exits from the distal end of the tubing. For additional information on Bair Hugger blankets, Bair Paws gowns, the 241 warming set, or other accessories visit us online at bairhugger.com or bairpaws.com. This manual includes operating instructions and unit specifications for the Model 775 temperature management unit. You can use the Model 775 temperature management unit in all clinical settings where the patient may become too warm or too cold; including the operating room to provide patient temperature management. For information about using Bair Hugger blankets, Bair Paws gowns, or the 241 blood/fluid warming set with the Model 775 temperature management unit, refer to the “Instructions for Use” included with each of these disposable components. The Bair Hugger system should only be used by trained medical professionals.

Indications The Bair Hugger total 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 become too warm or too cold. The temperature management system can be used with adult and pediatric patients.

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; 2005 for requirements. Fuse Type BF equipment (patient applied)

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Bair Hugger Model 775 Temperature Management Unit Operator’s Manual

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Explanation of Signal Word Consequences warning:

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

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

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

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

WarnIngS 1.

Do not leave patients with poor perfusion unmonitored during prolonged warming therapy sessions. Thermal injury may result.

2.

The Bair Hugger temperature management unit has been designed to operate safely ONLY with 3M Patient Warming disposable components. 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 unit being used in conjunction with non-3M Patient Warming products.)

3.

Do not warm patients with the temperature management unit hose alone. Thermal injury may result. Always connect the hose to a Bair Hugger blanket or Bair Paws gown before providing therapy.

4.

Do not place the non-perforated side of the blanket on the patient. Thermal injury may result. Always place the perforated side (the side with small holes) towards the patient.

5.

Do not continue temperature management therapy if the Over-temp indicator light illuminates and the alarm sounds. Thermal injury may result. Unplug the unit, and contact a qualified service technician.

6.

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

7.

Do not use a forced-air warming device over transdermal medication. Increased drug delivery and patient injury or death may occur.

8.

Do not allow the patient to lie on the warming unit hose or allow the hose to directly contact the patient’s skin during patient warming; thermal injury may result.

9.

Reusable blankets made from woven fabric, or blankets without discrete, visible holes, can cause the safety system of this unit to fail, which may result in serious thermal injury. This warming unit has been designed to operate safely ONLY with Bair Hugger blankets and Bair Paws gowns.

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10. Do not connect a Bair Hugger blanket, 241 blood/fluid warmer, or Bair Paws gown to the warming unit if it has been cut or damaged; thermal injury may result. 11.

Do not use a Bair Hugger blanket to transfer or move the patient; injury may result. To reduce the risks associated with hazardous voltage and fire: • keep power cord visible and accessible at all times. The plug on the power cord serves as the disconnect device. The wall socket outlet shall be as close as practical and shall be easily accessible. • 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 warming unit when it appears the warming unit, power cord or any component is damaged. Contact 3M Patient Warming Technical Support at 1-800-733-7775. • this equipment must only be connected to a supply mains with protective earth.

12. To reduce the risks associated with exposure to biohazards always perform the decontamination procedure prior to returning the warmer for service and prior to disposal. 13. Do not retain the patient using a warming blanket alone, as injury may result. Use a draw, sheet safety strap, or other means to retain the patient. 14. Do not modify this equipment without authorization of the manufacturer. 15.

To ground the Bair Hugger warming unit, only connect to receptacles marked “Hospital Only,” “Hospital Grade,” or a reliable grounded outlet.

1.

Except for specific blanket models, Bair Hugger blankets are not sterile and are all intended for single patient use ONLY. Placing a sheet between the Bair Hugger blanket and the patient does not prevent contamination of this product.

2.

Monitor the temperature and cutaneous response of patients who are incapable of reacting, communicating and/or who are without a sense of feeling every 10-20 minutes or according to institutional protocol. Monitor the patient’s vital signs regularly. Adjust air temperature or discontinue therapy when the therapeutic goal is reached or if vital sign instability occurs. Notify physician of vital sign instability immediately.

3.

Do not leave pediatric patients unattended during therapy.

4.

Do not initiate temperature management therapy unless the temperature management unit is free from mechanical damage and is safely placed on a hard surface or securely mounted. Otherwise, injury may result.

5.

To prevent tipping, clamp the Model 775 temperature management unit to an IV pole at a height that provides stability. We recommend clamping the unit no higher than 44" (112 cm) on an IV pole with a minimum 28" (71 cm) diameter wheelbase. Failure to do so may result in IV pole tipping, catheter site trauma, and patient injury.

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CauTIOnS

Bair Hugger Model 775 Temperature Management Unit Operator’s Manual

6.

Electrical shock hazard. Do not disassemble the temperature management unit unless you are a qualified service technician. There are electrically live parts within the unit when it is connected to a power source, even when the unit is in Standby mode.

7.

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

5

nOTICES 1.

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

2.

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

3.

To avoid Bair Hugger warming unit damage: • do not immerse the Bair Hugger warming unit or warming unit parts or accessories in any liquid or subject them to any sterilization process. • do not use solvents such as acetone or thinner to clean the warming unit; avoid abrasive cleaners. • clean warming unit exterior with soft cloth using plain water or a mild, all-purpose or nonabrasive cleaner.

Proper use and Maintenance 3M Patient Warming assumes no responsibility for the reliability, performance, or safety of the temperature management unit if the following events occur: • Modifications or repairs are performed by unqualified personnel. • The unit is used in a manner other than that described in the Operator’s or Service Manual. • The unit is installed in an environment that does not meet the appropriate electrical and grounding requirements.

read Before Servicing Equipment All repair, calibration and servicing of the temperature management 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 unit. Perform all repairs and maintenance in accordance with the instructions in the Service Manual. For additional service information please contact 3M Patient Warming technical service.

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Overview and Operation Alphanumeric display

Carrying handle

Control Panel

Figure A. Model 775 temperature management unit – front view

IV pole clamp Hose

Power cord connection

Hose connection

Figure B. Model 775 temperature management unit – rear view

unit Power-On-reset The Model 775 temperature management unit automatically performs the following power-on-reset sequence after you connect the unit to a properly grounded power source: • Performs all self-test functions. • Illuminates indicator lights and all pixels in the alphanumeric display momentarily. • Displays the text “MD 700’s” and the software revision level in the alphanumeric display. • Sounds the alarm (three low-level clicks). • 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.

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If the temperature management unit loses power for less than 1 second, the unit’s software will return the unit to the operating mode you selected prior to the power loss. However, if the temperature management unit loses power for longer than 1 second, the unit’s software will reset when you restore power. The unit will then enter the Standby mode.

Bair Hugger Model 775 Temperature Management Unit Operator’s Manual

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Overview of Control Panel Temperature Modes

Alphanumeric Display HIG

H

High Fan Setting

43˚C D ME

Low Fan Setting

W LO

Model 775 TEMP IN RANGE

AMBIENT

FAULT OVER TEMP

STANDBY

Figure C. Model 775 temperature management unit control panel

alphanumeric display

The alphanumeric display shows the temperature at the Bair Hugger blanket or Bair Paws gown end of the temperature management 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. • 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. • Blower operates at selected fan speed. • Fan setting indicator light illuminates. • Temperature at the blanket or gown end of the hose appears in the alphanumeric display. • Heater activates except in Ambient mode. • Temperature mode timer activates (or resets itself if changing from one temperature mode to another).

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airflow modes

The Model 775 has two preset fan speed settings: a default or high fan setting ( ) and a reduced or low fan setting ( ). The Model 775 will reset/default to the high fan setting each time the 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. standby

Upon power up, the warming unit defaults to Standby and the high fan setting. When the unit is in 32˚C (Low), 38˚C (Med), or 43˚C (High) or Ambient mode, press the Standby button to place the unit in Standby mode. When you select the Standby mode, the following events occur: • Standby indicator light illuminates. • Blower and heater are turned OFF. • Alphanumeric display deactivates. • Alarm and fault detection functions remain active. • Operating timer pauses. • Airflow mode resets/defaults to the high fan setting. temp in range indicator light

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 indicator light

When a system fault occurs, the amber Fault indicator light flashes and an alarm sounds. Please refer to What to Do in Case of a Fault Condition on page 11 for additional information. over-temp indicator light

If the unit senses an over-temperature condition, the red Over-temp indicator light flashes and an alarm sounds.

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Please refer to What to Do in Case of an Over-Temperature Condition on page 11 for additional information.

Bair Hugger Model 775 Temperature Management Unit Operator’s Manual

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Mounting the Temperature Management unit to an IV Pole caution

To prevent tipping, clamp the Model 775 temperature management unit to an IV pole at a height that provides stability. We recommend clamping the unit no higher than 44" (112 cm) from the floor on an IV pole with a minimum 28" (71 cm) diameter wheelbase. Failure to do so may result in IV pole tipping, catheter site trauma and patient injury. method

To mount the Model 775 temperature management 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

44 in. (112 cm) maximum IV Pole Bumper

28 in. (71 cm) minimum

Figure D. Model 775 on an IV Pole

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Instructions for use The instructions below describe how to operate the Model 775 temperature management unit. For information about using Bair Hugger blankets, Bair Paws gowns, or the 241 blood/fluid warming set with the Model 775 unit, refer to the Instructions for Use included with each of these disposable components. 1.

If the Model 775 temperature management unit is not mounted on an IV pole or Bair Hugger rolling stand, place the unit on a flat, hard, dry surface, such as a table, before beginning temperature management therapy. Do not place the unit on a soft, uneven or visibly wet surface such as a bed, or the air intake may become blocked and cause the unit to overheat.

2.

Insert the end of the temperature management unit hose into the hose port of a Bair Hugger blanket or Bair Paws gown. Use a twisting motion to ensure a snug fit. A visual marker (Figure E) is located around the mid section of the hose end to guide the depth of hose insertion. Figure E.

Insert marker

Hose Hose port

3.

Connect the temperature management unit to a properly grounded power source. The unit will be in Standby mode and the Standby indicator light will illuminate. ) will be pre-selected by default with its indicator light The high fan setting ( illuminated. The low fan setting ( ) may be pre-selected prior to selecting the desired temperature mode.

4.

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 unit reaches the selected temperature, the Temp in Range indicator light will illuminate; this indicator light does not illuminate in the Ambient mode.

5.

Monitor the temperature and cutaneous response of patients who are incapable of reacting, communicating and/or who are without a sense of feeling every 10-20 minutes or according to institutional protocol. Monitor the patient's vital signs regularly. Adjust air temperature or discontinue therapy when the therapeutic goal is reached or if vital sign instability occurs. Notify physician of vital sign instability immediately.

6.

Press the Standby button when temperature management therapy is complete and discard disposable components.

7.

Unplug the temperature management unit to disconnect it from the power source.

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

Bair Hugger Model 775 Temperature Management Unit Operator’s Manual

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Viewing the Temperature Mode Timer The temperature mode timer records the amount of time the temperature management 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 alarm sounds. The 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 an over-temperature condition occurs:

1.

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

2.

Unplug the temperature management unit.

3.

Contact a qualified service technician.

What to Do in Case of a Fault Condition The Model 775 temperature management unit’s 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 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 temperature management unit and wait for 5 minutes.

2.

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

3.

Reselect the temperature setting.

4.

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

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general Maintenance and Storage Cleaning the Cabinet and Hose warning

Do not immerse the cabinet or hose while cleaning. Moisture will damage the components, and thermal injury may result. cautions

• Do not use a dripping wet cloth to clean the cabinet. Moisture may seep into the electrical contacts and damage the components. • Do not use alcohol or other solvents to clean the cabinet. Solvents may damage the labels and other plastic parts. method

1.

Disconnect the temperature management unit from the power source before cleaning.

2.

Wipe the cabinet and the outside of the hose with a damp, soft cloth and a mild detergent or antimicrobial spray.

3.

Dry with a separate soft cloth.

Storage

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

Bair Hugger Model 775 Temperature Management Unit Operator’s Manual

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Technical Service and Order Placement Technical Service usa

TEL: +1-952-947-1200 +1-800-733-7775 FAX: +1-952-947-1400

order placement usa

TEL: +1-952-947-1200 +1-800-733-7775 FAX: +1-952-947-1400 +1-800-775-0002

When You Call for Technical Support We will need to know the serial number of your Bair Hugger temperature management unit when you call us. The serial number label is located on the back of the Bair Hugger temperature management unit.

In-Warranty repair and Exchange usa

Call 3M Patient Warming customer service if your Model 775 temperature management 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 temperature management 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 temperature management unit while we service your unit. For more detailed instructions on returning units for service, please refer to the Model 775 service manual. outside of the usa

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

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Specifications Physical Characteristics dimensions

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 Bair Hugger brand 241 blood/fluid warming system.

filtration system

High efficiency 0.2 µm air filter

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: Humidity: Altitude:

15°C-25°C Max relative humidity 80% (up to 31°C) decreasing linearly to 50% relative humidity at 40°C Max 2,000m

temperature control

Electronically controlled.

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 MED: 38° ± 1.5°C 100.4° ± 2.7°F LOW: 32° ± 1.5°C 89.6° ± 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.

Safety System thermostat

alarm system

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 hose inlet. 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, control panel becomes unresponsive. Fault: amber Fault indicator light flashes, alarm sounds. Dual input fused lines.

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overcurrent protection

Bair Hugger Model 775 Temperature Management Unit Operator’s Manual

15

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 Average: 800 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: Amp rating:

Fast acting ceramic fuses, 250 VAC 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 806012-35

classification

MEDICAL - GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601-1; CAN/CSAC22.2, 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.

diagnostics

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

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English 34-8714-4441-9

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