Operators Manual
24 Pages
Preview
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3 Bair Hugger
Temperature Management Unit Model 750
Operator’s Manual English3 Français23 Deutsch43 Italiano63 Español83 Nederlands103 Svenska123 Dansk143 Norsk163 Suomi183 Português203 Ελληνικά223 Polski243 Magyar263 Česky283 Lietuvių Kalba
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Русский323 Türkçe343 简体中文363 383
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3 Bair Hugger
Temperature Management Unit Model 750
Operator’s Manual
English3
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Bair Hugger Model 750 Temperature Management Unit Operator’s Manual
Table of Contents Introduction �����������������������������������������������������������������������
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Description of the Total Temperature Management™ System����������������������
7
Indications��������������������������������������������������������������������
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Definition of Symbols����������������������������������������������������������
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Explanation of Signal Word Consequences��������������������������������������
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Contraindications�������������������������������������������������������������
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Warnings���������������������������������������������������������������������
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Cautions��������������������������������������������������������������������� 10 Notices���������������������������������������������������������������������� 11 Proper Use and Maintenance�������������������������������������������������� 11 Read Before Servicing Equipment���������������������������������������������� 11 Overview and Operation����������������������������������������������������������� 12 Unit Power-On-Reset��������������������������������������������������������� 12 Overview of Control Panel���������������������������������������������������� 13 Mounting the Temperature Management Unit to an IV Pole���������������������
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Instructions for Use����������������������������������������������������������� 16 Viewing the Temperature Mode Timer����������������������������������������� 17 What to Do in Case of an Over-Temperature Condition������������������������� 17 What to Do in Case of a Fault Condition�������������������������������������� 17 General Maintenance and Storage �������������������������������������������������� 18 Cleaning the Cabinet and Hose������������������������������������������������ 18 Storage����������������������������������������������������������������������� 18 Technical Support and Customer Service�������������������������������������������� 19 When You Call for Technical Support������������������������������������������ 19 In-Warranty Repair and Exchange��������������������������������������������� 19 Specifications���������������������������������������������������������������������� 20
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Bair Hugger Model 750 Temperature Management Unit Operator’s Manual
Introduction Description of the Total Temperature Management™ System The 3MTM Bair HuggerTM brand Total Temperature ManagementTM system consists of a Model 750 forced-air temperature management unit (also available with rolling stand and sheet clip) 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 delivered to the skin surface of the patient. For fluid warming applications, the Model 241 blood/fluid warming set is inserted in the warming unit hose. When 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. This manual includes operating instructions and unit specifications for the Model 750 temperature management unit. You can use the Model 750 temperature management unit in all clinical settings 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 750 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 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.
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Bair Hugger Model 750 Temperature Management Unit Operator’s Manual
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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 Caution Attention, consult appropriate documents Nonexplosion proof Type BF equipment (patient applied)
VAC V
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 Consult operator's manual Consult 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. Date of manufacture Manufacturer Keep dry Temperature limit
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Bair Hugger Model 750 Temperature Management Unit Operator’s Manual
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.
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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. 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. 12. 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. 13. 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. 14. 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. 15. Do not modify this equipment without authorization of the manufacturer. 16. To ground this Bair Hugger warming unit, only connect to receptacles marked “Hospital Only,” “Hospital Grade,” or a reliable grounded outlet.
CAUTIONS 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.
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Bair Hugger Model 750 Temperature Management Unit Operator’s Manual
5. To prevent tipping, clamp the Model 750 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. 6. Electrical shock hazard. Do not disassemble the temperature management unit unless you are a qualified service technician. There are electrically live parts with in 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.
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 of 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 750 Service Manual provides the technical information needed to service the unit, or 3M Patient Warming will provide that information on request. Perform all repairs and maintenance in accordance with the instructions in the Service Manual.
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Overview and Operation Alphanumeric display
Carrying handle
Hose
Power cord retainer
User interface Labels
IV pole clamp
IV pole stabilizer
Figure A. Model 750 temperature management unit– front view
Power cord inlet
Hose outlet
Figure B. Model 750 temperature management unit – rear view
Unit Power-On-Reset The Model 750 temperature management unit proceeds through the following power-onreset sequence after you connect the unit to a 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. 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.
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Bair Hugger Model 750 Temperature Management Unit Operator’s Manual
Overview of Control Panel
h hig 43˚C
d me
temp in range
l
38˚C ow
32˚C
fault over-temp
Model 750 ambient
standby
Figure C. Model 750 temperature management unit control panel
alphanumeric display
The alphanumeric display shows the temperature at the blanket end of the temperature management unit hose in degrees Celsius. temperature modes
• Press the Low (32°C), Med (38°C), or High (43°C) 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 indicator light illuminates. • Blower operates. • Temperature at the blanket end of the hose appears in the alphanumeric display. • Heater activates except in Ambient mode. • The timer resets itself every time you select a different temperature mode.
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Bair Hugger Model 750 Temperature Management Unit Operator’s Manual
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standby
When the unit is in Low (32°C), Med (38°C), High (43°C), 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. temp in range indicator light
The Temp in Range indicator light illuminates when the temperature at the blanket 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 17 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. Please refer to What to Do in Case of an Over-Temperature Condition on page 17 for additional information.
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Bair Hugger Model 750 Temperature Management Unit Operator’s Manual
Mounting the Temperature Management Unit to an IV Pole caution
To prevent tipping, clamp the Model 750 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 750 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. See Figure D.
IV pole clamp handle
Figure D.
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Instructions for Use The instructions below describe how to operate the Model 750 temperature management unit. For information about using Bair Hugger blankets, Bair Paws gowns, or the 241 blood/fluid warming set with the Model 750 temperature management unit, refer to the Instructions for Use included with each of these disposable components. 1. If the Model 750 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 temperature management unit on a soft or uneven 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 operating in Standby mode and the Standby indicator light will illuminate. 4. Press the appropriate button to select the desired temperature. 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 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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Bair Hugger Model 750 Temperature Management Unit Operator’s Manual
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 for the current temperature mode, and hold it for 3 seconds. 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, but 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 750 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 control panel will not respond to commands, but 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 Store all components in a cool, dry place when not in use.
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Bair Hugger Model 750 Temperature Management Unit Operator’s Manual
Technical Support and Customer Service USA, Worldwide TEL: 800-733-7775 952-947-1200
FAX: 800-775-0002 952-947-1400
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 or side of the Bair Hugger temperature management unit.
In-Warranty Repair and Exchange USA Call 3M Patient Warming customer service if your Model 750 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 750 Service Manual.
Worldwide Contact your local distributor concerning in-warranty repair and exchange.
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