3M Bair Paws Model 875 Operators Manual May 2013

Table of Contents Introduction to the 3M™ Bair Paws™ Patient Adjustable Warming System... 1 Bair Paws Model 875 Warming Unit... 1 Bair Paws Warming Gowns... 1 Important Information about the Bair Paws Model 875 Warming Unit... 2 Indications... 2 Definition of Symbols... 2 Explanation of Signal Word Consequences... 3 Contraindication... 3 WARNING:... 4 CAUTION:... 5 NOTICE:... 6 Proper Use and Maintenance... 6 Read Before Servicing Unit... 6 Preparing the Bair Paws Model 875 Warming Unit for Use... 7 Placing the Warming Unit on the Wall-mount Bracket... 7 Mounting the Warming Unit on an IV Pole... 8 Mounting the Warming Unit on a Bedrail... 9 Mounting the Warming Unit with a Rail-mount to the Wall... 10 Mounting the Warming Unit with a Suction Wall Mount Adapter... 11 Operating Information... 12 Instructions for Use... 12 Using the Handheld Temperature Controller... 14 Using the Holder for the Handheld Temperature Controller... 15 What to Do if the “Over-temp” Indicator Light lluminates and Audible Alarm Sounds... 15 General Maintenance... 16 Calibrating the Operating Temperatures... 16 Replacing the Filter... 16 Cleaning the Warming Unit, Handheld Controller, Hose, and Accessories... 16 Storage... 16 Technical Support and Customer Service... 17 U.S. Customer Service... 17 Outside of the USA... 17 When You Call for Technical Support... 17 Repair and Exchange... 17

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Technical Specifications... 18-19

Introduction to the 3M™ Bair Paws™ Patient Adjustable Warming System The 3MTM Bair PawsTM patient adjustable warming system consists of the Model 875 forcedair warming unit and disposable warming gowns. The Bair Paws Model 875 warming unit can provide comfort warming and prewarming to patients in preoperative settings. In postoperative settings the warming unit can provide comfort warming. This manual includes operating instructions and unit specifications for the Model 875 warming unit. Please refer to the Instructions for Use for more information about the gowns. The Bair Paws system should only be used by trained medical professionals.

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

Bair Paws Warming Gowns The Bair Paws single-use warming gown completely covers and surrounds the patient except for the head, hands and feet. The gown has an integral, channeled insert that delivers ambient and warm air through small perforations to warm the patient. Air channels and hose ports enable comfort and prewarming with a Bair Paws 800 series warming unit or clinical warming with a 3MTM Bair HuggerTM 500 or 700 series temperature management unit. The gown also has fastener strips on each shoulder that provide easy access to the patient’s arms and chest. The Bair Paws warming gowns are latex-free and are sized for pediatric and adult patients. For additional information on Bair Paws gowns, or other accessories visit us online at bairpaws.com 34-8714-4443-5

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Important Information about the Bair Paws Model 875 Warming Unit Indications The Model 875 warming unit is indicated for patient warming. This warming unit has been designed for use with the Bair Paws warming gowns in all preoperative and postoperative settings for pediatric and adult patients.

Definition of Symbols The following symbols may appear on the product, on the exterior packaging, or in the product labeling. Power on Increase temperature and airflow Over-temperature Temperature control An equipotentiality conductor other than a protective earth conductor or a neutral conductor, providing a direct connection between electrical equipment and the potential equalization busbar of the electrical installation. Please consult IEC 60601-1; 2005 for requirements. Fuse CAUTION Dangerous voltage Type BF equipment (patient applied) Voltage, alternating current (AC) Protective earth ground

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WARNING: 1. Do not use a forced-air warming device over transdermal medications; increased drug delivery, patient death, or injury may occur. 2. To reduce the risks associated with thermal energy hazards: • Do not continue use of the unit if the yellow Over-temp indicator light illuminates or an audible alarm sounds; contact a biomedical technician or call 3M Patient Warming technical service. • Use only the Bair Paws warming gowns with this warming unit. •

Do not warm patients with the warming unit’s hose alone. Always connect the hose to a Bair Paws warming gown before providing patient warming.

• Do not allow the patient to lie on the warming unit hose or allow the hose to contact the patient’s skin during patient warming. • Do not connect a Bair Paws gown to the warming unit if it has been cut or damaged. • Monitor the patient’s 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 per institutional protocol and 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. • Do not leave pediatric patients unattended while warming with a Bair Paws 800 series warming system. 3. To reduce the risks associated with entanglement: • Position the temperature controller cord and the hose away from the patient’s neck or shoulders. • Do not allow pediatric patients to handle or adjust the temperature controller without supervision. 4. To reduce the risks associated with hazardous voltage and fire: • Do not modify or service this device, and do not open the warming unit case – there are no user- serviceable parts. Contact 3M Patient Warming Technical Support at 1-800733-7775. • Examine the warming unit for damage before each use. Never operate the equipment if the warming unit, power cord, plug, or any component is visibly damaged. Contact 3M Patient Warming Technical Support at 1-800-733-7775. • 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.

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• Do not allow the power cord to get wet. • Remove the warming unit from service and contact 3M Patient Warming Technical Support at 1-800-773-7775 if the warming unit is subjected to a large fluid spill (e.g. I.V. or blood bag). • This equipment must only be connected to a supply mains with protective earth. • Connect power plug only to receptacles marked “Hospital Only” or “Hospital Grade”. 5. To reduce the risks associated with cross contamination: • Do not use the warming unit in an operating room. • Gowns are intended for single-use only. 6. To reduce the risks associated with fire: • Always follow standard safety protocols when using high intensity heat sources near a Bair Paws gown.

CAUTION: 1. To reduce the risks associated with impact or property damage: • Initiate patient warming only after the warming unit is safely placed on a hard surface or securely mounted. • Do not use a Bair Paws gown to transfer or move the patient; injury may result. 2. To reduce the risks associated with environmental contamination: • Follow applicable regulations when disposing of this device or any of its electronic components. 3. To reduce the risks associated with thermal energy: • Do not cut the gown, and do not connect the gown to a warming unit if the fabric is torn or cut; air channels could be damaged. • Avoid rolling, gathering, bunching or compressing the air-channel insert of the gown as this can occlude airflow and reduce warming of the patient. Extend the insert to its full length for optimal heat transfer when connected to a warming unit. 4. To reduce the risk associated with impact or tripping: • Do not use the Bair Paws pediatric gown unless the patient is over 102 cm (40 inches) tall. 5. To reduce the risks associated with pinching or device damage of the suction wall mount adapter: • Only hold the front of the adapter when increasing/decreasing the expander. • Overtorquing the suction wall mount adapter may cause device damage.

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NOTICE: 1. The Bair Paws warming unit meets the international electronic interference requirements. If radio frequency interference with monitoring equipment occurs, connect the warming 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. Do not place the warming unit on a soft or uneven surface, such as a bed; this may cause the air intake to become blocked, compromising the unit’s performance. 4. Do not immerse any part of the Bair Paws warming unit in liquid while cleaning it. 5. Do not use a dripping wet cloth to clean the warming unit. 6. Do not use harsh solvents to clean the warming unit. 7. 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 products other than Bair Paws warming gowns.

Proper Use and Maintenance Arizant Healthcare Inc., a 3M company assumes no responsibility for the reliability, performance, or safety of the unit if: • modifications or repairs are performed by unqualified personnel, •

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

•

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

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

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

Placing the Warming Unit on the Wall-mount Bracket 1. Snap the warming unit into position by sliding the clip on the back of the warming unit into the groove of the wall-mount bracket. The assembly will click when the clip is fully seated in the wall-mount bracket. 2. Lift the warming unit straight up to remove it from the wall-mount bracket. N: It may be necessary to gently strike the case bottom in an upward fashion with the palm of your hand to release the clip from the wall-mount bracket.

Wall-mount bracket

Case bottom

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Mounting the Warming Unit on an IV Pole CAUTION: To prevent tipping, mount the Model 875 warming unit on an IV pole at a height that ensures stability. We recommend mounting the warming unit no higher than 44 in. (112 cm) from the floor on an IV pole with a minimum wheelbase radius of 14 in. (35.6 cm). Failure to do so may result in IV pole tipping, leading to potential catheter site trauma and other patient injuries. 1. Position the IV pole-mount at the desired height on the IV pole. 2. Turn the clamp knob on the IV pole-mount clockwise to tighten the clamp to the pole. 3. Snap the warming unit into position by sliding the clip on the back of the warming unit into the groove of the IV pole-mount. The assembly will click when the clip is fully seated in the IV pole-mount.

Clip

Clamp knob

IV pole-mount

IV pole

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Mounting the Warming Unit on a Bedrail 1. If the warming unit is not already connected to the rail-mount, slide the clip on the back of the warming unit into the groove of the rail-mount. The assembly will click when the clip is fully seated in the rail-mount. 2. Hang the Model 875 warming unit on a bedrail by the hooks on the rail-mount. 3. Wrap the safety strap around the bedrail and connect the end to the fastener on the strap. The safety strap will prevent the warming unit from falling if the unit is inadvertently dislodged from the bedrail.

Bedrail

Rail-mount

Safety strap

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Mounting the Warming Unit with a Rail-mount to the Wall CAUTION: The rail-to-wall bracket is intended for use only with a Bair Paws 800 series warming unit. 1. If the warming unit is not already connected to the rail-mount, slide the clip on the back of the warming unit into the groove of the rail-mount. The assembly will click when the clip is fully seated in the rail-mount. 2. Hook the warming unit with the attached rail-mount to the rail-to-wall bracket. 3. Lift the warming unit straight up to remove it from the rail-to-wall bracket.

Rail-to-wall bracket

Rail-mount

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Mounting the Warming Unit with a Suction Wall Mount Adapter 1. Slide the Bair Paws suction wall mount adapter into the suction wall bracket. If the adapter is too large to fit, remove the expand spacer. 2. Increase the expander on the Bair Paws suction wall mount adapter by gently turning the screw counter clockwise until the adapter is securely fastened (torque < 10 in-lbs). The adapter should not be able to move in any direction within the suction wall bracket once fastened. CAUTION: Overtorquing may cause device damage. CAUTION: To prevent pinching, only hold the front of the adapter when increasing decreasing the expander.

3. Slide the Bair Paws 875 warming unit into the suction wall mount adapter.

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Operating Information Instructions for Use The instructions below describe how to use the Bair Paws Model 875 warming unit with a Bair Paws gown. For more information about the Bair Paws warming gowns, refer to the Instructions for Use that is shipped with the warming gowns. 1. Instruct your patient to put the warming gown on so the opening is in the back. The gown has ties on the side and back of the neck. The gown should be tied loosely to help the air circulate in the gown insert. 2. Connect the warming unit hose to the warming gown by performing the following steps. a. Squeeze and hold the two buttons on the sides of the hose nozzle. b. Insert the nozzle into the properly sized hose port in the warming gown. Refer to the Instructions for Use that is shipped with the warming gowns for hose port location. c. Release the buttons to lock the hose nozzle in place. 3. Connect the warming unit to a proper power source. 4. Turn the knob on the temperature controller clockwise to turn the warming unit ON. When you turn the warming unit on, the heater and blower activate. Also, the “Power On” indicator light on the warming unit illuminates. 5. Allow the patient to adjust the temperature to a comfortable level. The temperature and airflow are adjusted by turning the knob on the temperature controller. The temperature adjustment varies from approximately ambient to 43±3°C. The maximum temperature is 46°C before the Over-temp indicator light illuminates and audible alarm sounds.

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43ºC

6. To disconnect the hose nozzle from the warming gown, press the two buttons on the sides of the nozzle and withdraw the nozzle from the hose port. 7. Store the warming unit hose by inserting it into the hose holder at top of unit. 8. Unplug the temperature management unit to disconnect the warming unit from power source. Hose holder

Warming unit hose

43 C º

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

When the knob is in position A, the warming unit is OFF.

•

As the knob is rotated from position A to B, the knob clicks and the warming unit turns on LOW AIRFLOW and LOW HEAT.

•

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

•

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

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43ºC

43ºC

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43ºC

Using the Holder for the Handheld Temperature Controller Store the handheld temperature controller in the controller holder to help prevent cord clutter around the patient and accidental damage to the warming unit. 1. Press the holder onto the warming unit hose so it is within the patient’s reach. WARNING: To reduce the risks associated with thermal energy and entanglement: Do not leave pediatric patients unattended while warming with a Bair Paws 800 series warming system. • Do not allow pediatric patients to handle or adjust the temperature controller without supervision. •

2. Slide the temperature controller into the holder. It should fit securely with the dial facing the patient. Warming unit hose Temperature controller

Controller holder

43ºC

What to Do if the “Over-temp” Indicator Light lluminates and Audible Alarm Sounds If the “Over-temp” indicator light illuminates, it means that the warming unit is delivering air at a higher temperature than the unit is calibrated to deliver. When an over-temperature condition occurs, the color indicator light illuminates, an audible alarm will sound, and the heater will automatically turn off (the blower will continue to run). You should perform the following steps: 1. Discontinue patient warming. • Turn the warming unit OFF. • Disconnect the warming unit hose from the Bair Paws warming gown. 2. Unplug the warming unit from the power source and wait 5 minutes. 3. Reconnect the warming unit to a proper power source. 4. Turn the warming unit ON and select the maximum airflow and temperature setting by turning the controller knob completely clockwise.

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5. Allow the warming unit to run for at least 5 minutes. • If the “Over-temp” light illuminates again, return the warming unit to 3M Patient Warming for service. • Otherwise, reconnect the warming unit hose to the Bair Paws gown to resume patient warming.

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

Replacing the Filter Replace the filter every six months or sooner if necessary. To order a replacement filter, contact 3M Patient Warming customer service using either of the telephone numbers listed on page 17. Instructions for replacing the filter will be included with the replacement filter.

Cleaning the Warming Unit, Handheld Controller, Hose, and Accessories NOTICE: To avoid device damage: • Do not immerse any part of the Bair Paws warming unit in liquid. •

Do not use a dripping wet cloth to clean the warming unit.

•

Do not use harsh solvents to clean the warming unit.

M 1. Disconnect the warming unit from the power source before cleaning. 2. Wipe the cabinet, the temperature controller, and the outside of the hose with a damp, soft cloth and a mild cleaning solution or antimicrobial spray. 3. Dry with a separate soft cloth.

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

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

Outside of the USA Contact your local 3M Patient Warming representative.

When You Call for Technical Support Please be ready to give the technical support representative the serial number of your Bair Paws warming unit. The serial number is located on the back of the unit.

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

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Technical Specifications Physical Characteristics    

13 in. high x 4 in. deep x 7.7 in. wide 33 cm high x 10.2 cm deep x 19.6 cm wide

   

2.5 in. wide x 5.8 in. long 6.4 cm wide x 14.7 cm long

  

57.9 dBA

   

7.0 lb; 3.2 kg.

 

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



Detachable, flexible, and wipeable. 78 in. long x 1.5 in. wide; 198 cm long x 3.8 cm wide

 

Dust filter included.

  

Change at least every 6 months.

Temperature Characteristics  

Electronically controlled using integrated circuit sensor.

 

1000 BTU/hr (average)

        

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

/ 

-20°C to 60°C (-4°F to 140°F) Store all components in a cool, dry place when not in use.

R  

• Indoor use • Ambient temperature range of 18°C to 26°C (64°F to 79°F) • Altitude up to 2000m • Maximum, relative humidity up to 90% • Main supply voltage fluctuations up to ±10% of the voltage • Overvoltage category II (of IEC standard 60364-4-443) level of transient overvoltages present in the mains supply

• Rated pollution degree of 2

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Safety System Characteristics 

Independent electronic and heater (electromechanical)

 

Dual input fused line.

 

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

 

Fault: amber Fault indication flashes, alarm sounds.



IEC -; IEC/EN --; UL -; CAN/CSAC., N..; EN ; EN --.



MEDICAL - GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601-1; CAN/CSA-C22.2, No.601.1; ANSI/AAMI ES60601-1:2005 CSA-C22.2 No. 60601-1:08; EN 80601-2-35; Control No.4HZ8 Classified under IEC 60601-1 Guidelines (and other national versions of the Guidelines) as Class I, Type BF, Ordinary equipment, Continuous operation. Not suitable for use in the presence of flammable anesthetic mixtures with air or with oxygen or nitrous oxide. Classified by Underwriters Laboratories Inc. with respect to electric shock, fire and mechanical hazards only, in accordance with UL 60601-1, EN 80601-2-35 and in accordance with Canadian/CSA C22.2, No. 601.1. Classified under the Medical Device Directive as a Class IIb device.

Electrical Characteristics Airflow: 7-13 cfm (3.3-6.1 L ⁄ S)

 

Peak: 600W, Average: 340W

 

Meets IEC 60601-1 and UL 60601-1 requirements

 

480W Resistive

 

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

 

100-120 VAC, 50/60 Hz, 4.6A 220-240 VAC, 50/60 Hz, 2.8 A



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

  

32" from hose collar, 4 cond., Max. voltage: 5V

English

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 