6 - Ardus Medical
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1. SYSTEM TIME TO 100 F 37 7 C 17 secs Bair Hugger Model 505 and Model 500 OR Temperature Management Units Operator s Manual OPERATING TEMPERATURES Air temperatures reaching the patient are approxi mately 2 C lower than the listed temperatures Average temperatures at the end of the hose assuming the back pressure of a Bair Hugger warming blanket or an Arizant Healthcare tem perature test unit HIGH 43 3 C 109 4 5 4 F MED 38 3 C 100 4 5 4 F LOW 32 3 C 89 6 5 4 F Safety System THERMOSTAT Independent bulb and capillary OVERCURRENT PROTECTION Dual fused input lines ALARM SYSTEM Over heat flashing red light with audible alarm heater shuts down CERTIFICATIONS UL 544 CSA C22 2 No 125 IEC 601 1 IEC 601 1 2 EN55014 AS 3200 1990 CLASSIFICATION Classified under IEC 601 1 Guidelines as Class I Type BE Ordinary equipment Continuous operation Electrical Characteristics BLOWER MOTOR Operating speed 2650 rpm Airflow 28 30 cfm POWER CONSUMPTION Peak 1000W Average 500W LEAKAGE CURRENT lt 100pA HEATING ELEMENT 850W Resistive POWER CORD 15 foot SJT 3 cond 10A 4 6 meter HAR 3 cond 10A DEVICE RATINGS 110 120 VAC 60 Hz 9 5 Amperes or 220 240 VAC 50 Hz 4 5 Amperes or 100 VAC 50 60 Hz 10 Amperes FUSES 10A 200mA and 500mA 110 120 VAC Units 6 3A 100mA and 500mA 220 240 VAC Units 10A 160mA and 400mA 100 VAC Units DIAGNOSTICS2. Figure K Attaching the Model 505 Figure L Storing the Model 505 unit hose unit hose Attaching and Storing the Model 505 Unit Hose The Model 505 unit has a unique snap fit hose This extended length swivel hose adapted for 241 fluid warming attaches by inserting the flange end at a 45 angle in the grooved blower outlet and snapping the hose into place Press the white tab on the blower outlet to release the hose When storing the Model 505 unit insert the hose clip tab in the hanger slot near the blower outlet Isolation switch Figure M Isolation Switch on the Model 500 OR unit Isolation Switch The isolation switch allows you to disconnect the temperature management unit from the power source without removing the power cord from the wall receptacle The isolation switch is located on the back of the Model 500 OR unit The isolation switch must be in the ON position before the unit will operate The Model 505 unit does not have an isolation switch CAUTION To disconnect the Model 505 unit from the power source remove the power cord from the English 9 10 English Bair Hugger Model 505 and Model 500 OR Temperature Management Units Operator s Manual wall receptacle Keep the area around the receptacle clear of obstructions Optional Features This section discusses optional features for Bair Hugger temperature management units For more details about these features please call Arizant
3. 2 Use a damp soft cloth and a mild detergent to clean the unit cabinet Dry with a separate soft cloth CAUTION e Do not use a dripping wet cloth to clean the cabinet Moisture may seep into the electrical contacts damaging the components e Do not use alcohol or other solvents to clean the cabinet Solvents may damage the labels and other plastic parts Technical Service and Order Placement USA WORLDWIDE TEL 1 952 947 1200 FAX 1 952 947 1400 1 800 733 7775 WITHIN EUROPE TEL 49 4154 9934 0 FAX 49 4154 9934 20 0800 100 1236 Toll free in Germany 0800 100 1324 Toll free in Germany In Warranty Repair and Exchange Replacement parts to correct a problem are delivered at no charge To return a device to Arizant Healthcare Inc for service first obtain a Return Authorization RA number from a technical service representative Please use this number on all correspondence when returning a device for service A shipping carton will be delivered to you at no charge if needed Call your local supplier or sales rep resentative to inquire about loaner devices while your device is being serviced When You Call for Technical Support Remember we will need to know the serial number of your unit when you call us On Model 505 units the serial number label is affixed to the rear panel On the Model 500 OR unit the serial number label is affixed to the galvanized pan on the underside of the unit 12 English Bair Hugger Model 50
4. titled Jsolation Switch This indicator must be illuminated for any functions to operate Bair Hugger Model 505 and Model 500 OR Temperature Management Units Operator s Manual English 7 Bair Hugger Warming Unit Model 505 TEMP INRANGE E C OVER HEAT MAINPOWER E C HIGH 43 c CC mep as c SYSTEM ON STANDBY EH Low 32 c TEMP SELECT Figure H Control panel of the Model 505 unit Control Panel Features of the Model 505 Temperature Management Unit TEMPERATURE IN RANGE INDICATOR The temperature in range indicator illuminates when the output air temperature is within the range of the selected level MAIN POWER INDICATOR The main power indicator illuminates when the unit is connected to a power source This indicator must be illuminated for any functions to operate SYSTEM ON STANDBY Push this button to turn the unit either ON or OFF The indicator directly above the switch illuminates when the unit is ON OVER HEAT INDICATOR The Over Heat Indicator illuminates and an audible alarm sounds when an over temperature condition is detected To reset turn the unit OFF and then ON using the System ON STANDBY button Also refer to the Warnings section of this manual TEMPERATURE INDICATORS The temperature indicators illuminate up to the selected temperature level When the unit is initially turned on none of these indicators are illuminated and ambient air will be delivered TEMPERATU
5. unit to a properly grounded power source 4 If so equipped turn the Isolation Switch to the ON position see the section titled Isolation Switch 5 Press the System ON OFF button to turn the unit ON and select the appropriate temperature setting 6 Place a cotton blanket over the Bair Hugger blanket for maximum effectiveness 7 Monitor the patient s temperature at least every 10 to 20 minutes and adjust the temperature setting of the unit as required Folding handle Figure D Model 505 temperature Figure E Model 505 unit Figure E Model 500 OR temperature management unit attached to an IV pole management unit Temperature Management Units The temperature management unit uses a high efficiency motor a heating element and a solid state temperature control to create a continuous flow of warm air to the blanket Models 500 OR and 505 are designed for safe use in all areas including the operating room The folding handle on the Model 500 OR unit can be placed in two positions The handle is moved forward and down for the folded position it is pushed up and back for the upright position In the folded position the unit can be rolled out of the way for example under the operating table during warming therapy and it can be stored more conveniently when warming therapy is completed The upright position allows the unit to be easily transported between clinical areas The Model 505 temperature mana
6. 5 and Model 500 OR Temperature Management Units Operator s Manual Figure A Serial number label on Model 505 Specifications 500 OR Physical Characteristics DIMENSIONS 24 in high x 16 in deep x 14 in wide 61 cm high x 41 cm deep x 36 cm wide WEIGHT 43 lb 19 5 ke MOUNTING Supplied with swivel casters floor use only RELATIVE NOISE LEVEL 52 decibels HOSE Detachable flexible washable compatible with Bair Hugger 241 fluid warming system FILTRATION SYSTEM 0 2uM level RECOMMENDED FILTER CHANGE Every 6 months or 500 hours of use Temperature Characteristics TEMPERATURE CONTROL Electronically controlled using a thermocouple sensor HEAT GENERATED 1800 BTUs average SYSTEM TIME TO 100 F 37 7 C 35 secs Serial number label Figure B Serial number label on Model 500 OR 505 Physical Characteristics DIMENSIONS 13 in high x 10 in deep x 11 in wide 33 cm high x 25 cm deep x 28 cm wide WEIGHT 13 6 lb 6 2 kg MOUNTING IV pole clamp bedrail hook with safety strap can be placed on hard surface RELATIVE NOISE LEVEL 53 decibels HOSE Detachable flexible washable compatible with Bair Hugger 241 fluid warming system FILTRATION SYSTEM 0 2uM level RECOMMENDED FILTER CHANGE Every 6 months or 500 hours of use Temperature Characteristics TEMPERATURE CONTROL Electronically controlled using a thermocouple sensor HEAT GENERATED 1800 BTUs average
7. 6 146 412 6 129 936 6 126 681 6 126 393 6 036 722 5 997 572 5 968 084 5 964 792 5 928 274 5 824 025 5 800 489 5 773 275 5 733 318 5 697 963 5 674 269 5 658 325 5 620 482 5 545 194 5 405 371 5 350 417 5 336 250 5 324 320 5 300 102 5 300 101 5 184 612 5 044 364 4 572 188 Japan 2 561 326 Canada 1 325 484 EPO 0 311 336 Australia 756 900 Other patents pending 200977A 01 04
8. Afizant Healthcare bright ideas that work www ardusmedical com Bair Hugger Model 505 and Model 500 0R Temperature Management Units Operator sM anual Betriebshandbuch fur Bair Hugger Temperaturmanagement Gerate Modell 505 und 500 OR Manuel de l utilisateur pour les appareils de gestion de la temp rature Bair Hugger mod le 505 et mod le 500 OR Manuale d uso delle unita di gestione della temperatura Bair Hugger modello 505 e modelli della serie 500 Manual del usuario para las unidades de control de temperatura Bair Hugger modelos 505 y 500 0OR Manual do utilizador das unidades de gestao de temperatura Bair Hugger Modelo 505 e Modelo 500 0R Bair Hugger Temperatuurregelunits model 505 en model 500 OR Gebruikshandleiding Brugsanvisning til Bair Hugger temperatur reguleringsenheder Model 505 og Model 500 0OR Bruksanvisning till Bair Hugger modell 505 och 500 OR temperaturstyrenhet Brukerhandbok for Bair Hugger temperatur behandlingsenhet modell 505 og 500 0R Bair Hugger lampotilansaatolaitteen mallit 505 ja 500 0R k ytt j n opas IWHNVA 5S GOLVdGsad0 GsaVUIIA GIVd Bair Hugger Model 505 and Model 500 0R Temperature Management Units Operator sM anual 1 English 19 Deutsch 37 gdCIdTIE 73 Espa ol 91 Portugu s 109 Nederlands 127 Dansk 145 Svenska 163 Norsk 181 Suomi 2 English 10 11 11 11 12 14 Bair Hugger Model 505 and Model 500 OR T
9. Healthcare Inc or your local distributor IV pole Be SS Blanket Dispenser Figure N Temperature management Figure O Temperature management unit with IV pole option unit with blanket dispenser IV POLE Model 500 OR unit has a port that accommodates an Arizant Healthcare IV pole BLANKET DISPENSER The blanket dispenser is available for use on the Series 500 units This dispenser attaches to the unit Standard length without swivel option replacement only Standard length with swivel option replacement only Extended length with swivel option note keyway Standard length 241 fluid warming hose replacement for 500 series only Extended length 241 fluid warming hose note keyway standard for 500 series only Figure P Hose assemblies HOSE ASSEMBLIES Temperature management hose assemblies are available in five options The keyway on the extended length hose matches a keyway on units specifically calibrated for the extended length hose option to ensure the delivery of proper temperature to the patient Model 505 units are only available with a snap fit extended length 241 fluid warming hose assembly Bair Hugger Model 505 and Model 500 OR Temperature Management Units Operator s Manual English 11 described in Attaching and Storing the Model 505 Warming Unit Hose General Maintenance Cabinet Cleaning 1 Disconnect the temperature management unit from the power source before cleaning
10. Over heat test can be performed by the bio medical group OPERATING TEMPERATURES Air temperatures reaching the patient are approxi mately 2 C lower than the listed temperatures Average temperatures at the end of the hose assuming the back pressure of a Bair Hugger warming blanket or an Arizant Healthcare tem perature test unit HIGH 43 3 C 109 4 5 4 F MED 38 3 C 100 4 5 4 F LOW 32 3 C 89 6 5 4 F Safety System THERMOSTAT Independent bulb and capillary OVERCURRENT PROTECTION Dual fused input lines ALARM SYSTEM Over heat flashing red light with audible alarm heater shuts down CERTIFICATIONS UL 544 CSA C22 2 No 125 IEC 601 1 IEC 601 1 2 EN55014 AS 3200 1990 CLASSIFICATION Classified under IEC 601 1 Guidelines as Class I Type BE Ordinary equipment Continuous operation Electrical Characteristics BLOWER MOTOR Operating Se 3150 rpm Airflow 28 30 cfm POWER CONSUMPTION Peak 1000W Average 450W LEAKAGE CURRENT lt 100pA HEATING ELEMENT 850W Resistive POWER CORD 15 foot SJT 3 cond 10A 4 6 meter HAR 3 cond 10A DEVICE RATINGS 110 120 VAC 60 Hz 9 5 Amperes or 220 240 VAC 50 Hz 4 5 Amperes or 100 VAC 50 60 Hz 10 Amperes FUSES 10A 200mA and 500mA 110 120 VAC Units 6 3A 100mA and 500mA 220 240 VAC Units 10A 160mA and 400mA 100 VAC Units DIAGNOSTICS Over heat test can be performed by the bio medical group English 13 14 En
11. RE SELECT Push this button to increase the temperature setting level by level to the desired setting When the 8 English Bair Hugger Model 505 and Model 500 OR Temperature Management Units Operator s Manual temperature Se HIGH push he button again to return to delivery of ambient air lt 44 inches Figure I Model 505 unit attached to Figure J Model 505 unit attached to an IV pole a bedrail Mounting the Model 505 Temperature Management Unit USING AN IV POLE The Model 505 unit clamps easily to an IV pole see Figure I Simply turn the handle clockwise to tighten the clamp onto an IV pole counterclockwise to release WARNING To prevent tipping clamp the Model 505 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 14 35 6 cm radius wheelbase Failure to do so may result in IV pole tipping catheter site trauma and patient injury USING A BEDRAIL The Model 505 unit can also hang on the edge of a bed The safety strap is designed to loop around the bedrail keeping the Model 505 unit safely suspended even if the unit is inadvertently dislodged from the bedrail see Figure J Bair Hugger Model 505 and Model 500 OR Temperature Management Units Operator s Manual Insert flange in Press this tab groove and snap to release hose into place Hang hose clip tab in this slot for storage
12. e Inc REFER TO SERVICE MANUAL Perform all repairs and maintenance in accordance with the instructions in the Service Manual SAFETY INSPECTION Perform a safety inspection after making repairs to the temperature management unit and before returning the unit to service A safety inspection must include a test of the operating temperatures described in the Service Manual the Over Heat Alarm system as well as a leakage current test PROPER USE AND MAINTENANCE Arizant Healthcare Inc assumes no responsibility for the reliability performance or safety of the equipment if e Modifications or repairs are performed by unauthorized personnel e The equipment is used in a manner other than that described in the Operation or Service Manuals e The equipment is installed in an environment that does not meet the relevant grounding requirements Setup and Operation The Bair Hugger Total Temperature Management System is easy to set up and to use Follow the instructions provided with each blanket for specific information 1 Place the Bair Hugger blanket on the patient with the perforated side the side with small holes against the patient s skin Figure C 2 Insert the hose of the temperature management unit in the hose port on the blanket Use a twisting motion to ensure a snug fit see Figure C Bair Hugger Model 505 and Model 500 OR Temperature Management Units Operator s Manual English 5 3 Connect the
13. emperature Management Units Operator s Manual Table of Contents Introduction Description of the Total Temperature Management System Indications for Use Contraindications Warnings Precautions Important Information Read Before Servicing Equipment Setup and Operation Temperature Management Units Control Panel Features of the Model 500 OR Temperature Management Unit Control Panel Features of the Model 505 Temperature Management Unit Mounting the Model 505 Temperature Management Unit Attaching and Storing the Model 505 Hose Isolation Switch Optional Features General Maintenance Cabinet Cleaning Technical Service and Order Placement Specifications Definition of Symbols Bair Hugger Model 505 and Model 500 OR Temperature Management Units Operator s Manual English 3 Introduction Description of the Total Temperature Management System The Bair Hugger brand Total Temperature Management System consists of a Bair Hugger forced air temperature management unit with available rolling stand and sheet clip and Bair Hugger dispos able components including forced air blankets and the 241 blood fluid warming set The system is intended for use in all clinical settings including the operating room This manual includes operating instructions and unit specifications for the Model 505 and Model 500 OR forced air temperature management units For information about using Bair Hugger blan kets or the 241 blood fluid warming set
14. gement unit can be attached to an IV pole or to the railing on a bed 6 English Bair Hugger Model 505 and Model 500 0OR Temperature Management Units Operator s Manual OVER HEAT HIGH 43 C MED 38 C LOW 32 C AMBIENT SYSTEM ON OFF MAIN POWER Figure G Control panel of the Model 500 OR temperature management unit Control Panel Features of the Model 500 OR Temperature Management Unit OVER HEAT INDICATOR The Over Heat Indicator illuminates and an audible alarm sounds when an over temperature condition is detected To reset turn the unit OFF and then ON either by the System ON OFF but ton see Figure G or by the Isolation Switch see the section titled Jsolation Switch Also refer to the Warnings section of this manual TEMPERATURE INDICATORS The indicator bar illuminates up to the selected temperature level When the unit is initially turned on the AMBIENT temperature level is automatically selected TEMPERATURE SELECT Push this button to increase the temperature setting level by level to the desired setting When the temperature setting is at HIGH push the button again to return the setting to AMBIENT SYSTEM ON OFF Push this button to turn the unit either ON or OFE The indicator directly above the switch illuminates when the unit is ON MAIN POWER INDICATOR The main power indicator illuminates when main power is applied to the unit and the Isolation Switch is in the ON position see the section
15. glish Bair Hugger Model 505 and Model 500 OR Temperature Management Units Operator s Manual Definition of Symbols ON STANDBY ON used on isolation switch OFF used on isolation switch ON OFF push button switch Temperature Control Equipotentiality plug Ground Fuse Attention see appropriate documents Non Explosion Proof Dangerous Voltage POP leo Type BF Equipment patient applied lt 5 eo Voltage Alternating Current AC IWHNVAN 5 GOLVdGsad0 GaVUIIA GIVd Afizant Healthcare bright ideas that work 0470 Authorized Representative in the European Community as defined in Article 14 of the Medical Device Directive 93 42 EEC Actamed Limited Calder Island Way Wakefield WF2 7AW United Kingdom e TEL 44 1924 200550 FAX 44 1924 200518 2003 2004 Arizant Healthcare Inc All rights reserved 10393 West 70th Street Eden Prairie MN 55344 USA TEL 800 733 7775 e 952 947 1200 e FAX 800 775 0002 e 952 947 1400 www arizanthealthcare com Bair Hugger 241 Total Temperature Management and the Bair Hugger and Arizant logos are trademarks of Arizant Healthcare Inc registered or pending in the U S Patent amp Trademark Office and in other countries Bair Hugger temperature management products may be covered by one or more of the following patents US 6 355 915 6 309 409 6 309 408 6 290 716 6 287 327 6 254 337 6 241 755 6 228 107 6 210 428 6 203 567 6 176 870 6 168 612
16. n the therapeutic goal is reached or if vital sign instability occurs Notify physician immediately of vital sign instability e To prevent suffocation from misuse do not leave children or infants unattended when administering Bair Hugger therapy e See CONTRAINDICATIONS and WARNINGS before administering therapy Read this Operation Manual blanket instructions and 241 fluid warming set package instructions before use Important Information EXPLOSION HAZARD Do not use in the presence of flammable anesthetics A _ English Bair Hugger Model 505 and Model 500 0R Temperature Management Units Operator s Manual ELECTRICAL SHOCK HAZARD Do not disassemble the temperature management unit refer to authorized technical personnel There are electrically live parts within the unit when it is connected to the power source even when the switches are in the OFF position ELECTRICAL INTERFERENCE If radio frequency interference with monitoring equipment should occur connect the temperature management unit to a different power source Read Before Servicing Equipment The repair calibration and servicing of the temperature management unit requires the skill of quali fied technical personnel who are familiar with good practice for medical device repair If service is designated as not requiring the manufacturer s attention the technical information is provided in the Service Manual or will be provided upon request by Arizant Healthcar
17. with Bair Hugger units refer to the Instructions for Use included with each of these disposable components Indications for Use The Bair Hugger brand Total Temperature Management System is intended to prevent and treat hypothermia and to provide warmth to cold or shivering patients In addition the system should be used whenever conditions exist that could cause patients to become cold Contraindications Do not apply heat to lower extremities during aortic cross clamping Thermal injury may occur if heat is applied to ischemic limbs Warnings e Do not use Bair Hugger units with any forced air blanket or cover other than Bair Hugger blankets Thermal injury may result e Do not warm patients with the Bair Hugger unit hose alone Thermal injury may result Always attach the hose to a Bair Hugger blanket before providing skin surface warming therapy e Do not continue therapy if the Over Heat warning light illuminates and the audible alarm sounds Thermal injury may result Turn the temperature management OFF and contact qualified technical personnel If using 241 fluid warming immediately stop fluid flow and discard the fluid warming set e Do not initiate therapy unless the Model 505 temperature management unit is securely mounted or injury may result Precautions e Monitor the patients temperature at least every 10 to 20 minutes and monitor the patient s vital signs regularly Reduce air temperature or discontinue therapy whe
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