- Frank`s Hospital Workshop
Contents
1. Betriebshandbuch f r Bair Hugger Temperaturmanagement Gerdte Modell 505 Manuel de l utilisateur pour les appareils de gestion de la temp rature Bair Hugger Mod le 505 Manuale d uso delle unit di gestione della temperatura Bair Hugger Modello 505 Manual del usuario para las unidades de control de temperatura Bair Hugger Modelo 505 Manual do utilizador das unidades de gest o de temperatura Bair Hugger Modelo 505 Bair Hugger Temperatuurregelunit Model 505 Gebruikshandleiding Brugsanvisning til Bair Hugger temperaturreguleringsenheder Model 505 Bair Hugger Temperature Management Unit Model 505 Operator s Manual Bruksanvisning till Bair Hugger Modell 505 temperaturstyrenhet Brukerhandbok for Bair Hugger temperatur behandlingsenhet Modell 505 Bair Hugger l mp tilans t laitteen Malli 505 k ytt j n opas Eyyerpi to Xp on Bair Hugger Movada taye pion BepuoKpadiac Movrt o 505 ARE AP HE 7 IVS0S tee Instrukcja Obstugi Dmuchawy Bair Hugger Model 505 urz dzenia do aktywnego przeciwdzia ania hipotermii Bair Hugger 505 sz Modell h m rs klet szab lyoz egys g haszn lati utas t sa N vod k obsluze jednotky regulace teploty Bair Hugger typ 505 Operatoriaus Vadovas Bair Hugger Modelis 505 Temperat ros reguliavimo prietaisas PyKoBOnCTBO no ac Stau Bair Hugger Mogenb 505 Ycrpo cTBo ynpaBnenna TeMnepatypon REAM 505 Bair Hugg2. Symbols 13 Bair Hugger Model 505 Temperature Management Unit 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 disposable components including Bair Hugger forced air blankets Bair Paws patient warming gowns and the 241 blood fluid warming set You can use the Model 505 temperature management unit in all clinical settings including the operating room to provide patient temperature management This manual includes operating instructions and unit specifications for the Model 505 forced air temperature management unit For information about using Bair Hugger blankets Bair Paws gowns or the 241 blood fluid warming set with Bair Hugger units refer to the Instructions for Use included with each of these disposable components 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 Contraindications Do not apply heat to lower extremities during aortic cross clamping Thermal
3. for storage Figure G Attaching the Model 505 unit hose Figure H Storing the Model 505 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 English 200977E 10 English Bair Hugger Model 505 Temperature Management Unit Operator s Manual General Maintenance Cabinet Cleaning 1 Disconnect the temperature management unit from the power source before cleaning 2 Use a damp soft cloth and a mild detergent to clean the unit cabinet Dry with a separate soft cloth Caution Do not use a dripping wet cloth to clean the cabinet Moisture may seep into the electrical contacts damaging the components 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 0800 100 1324 Toll free in Germany Toll free in Germany In Warranty Repair and Exchange Replacement parts to correct a problem ar
4. injury may occur if heat is applied to ischemic limbs English 200977E 4 English Wa 1 Bair Hugger Model 505 Temperature Management Unit Operator s Manual rnings Do not leave patients with poor perfusion unmonitored during prolonged warming therapy sessions Thermal injury may result The Bair Hugger temperature management unit has been designed to operate safely ONLY with Arizant Healthcare 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 Arizant Healthcare products injury may result Always connect the hose to a Bair Hugger blanket or Bair Paws Do not warm patients with the temperature management unit hose alone Thermal N gown before providing therapy Do not place the non perforated side of the blanket on the patient Thermal injury may result Always place the perforated side that is with small holes towards the patient 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 Do not continue 241 blood fluid warming therapy if the over heat indicator light illuminates and the alarm sounds Immediately stop fluid flow and discard the blood fluid warming set Unplug
5. and servicing of the temperature management unit requires the skill of qualified 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 Healthcare 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 Modifications or repairs are performed by unauthorized personnel The equipment is used in a manner other than that described in the Operation or Service Manuals The equipment is installed in an environment that does not meet the relevant grounding requirements English 200977E 6 English Bair Hugger Model 505 Temperature Management Unit Operator s Manual Set up and Operation The Bair Hugger brand Total Temperature Management system is easy to set up and to use Follow the instructions provided with each Ba
6. e 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 representative 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 Figure J Serial number label on Model 505 Arizant Healthcare Inc Bair Hugger Model 505 Temperature Management Unit Operator s Manual English 11 Specifications Physical Characteristics DIMENSIONS WEIGHT MOUNTING RELATIVE NOISE LEVEL HOSE FILTRATION SYSTEM RECOMMENDED FILTER CHANGE Temperature Characteristics TEMPERATURE CONTROL HEAT GENERATED SYSTEM TIME TO 100 F 37 7 C OPERATING TEMPERATURES English 200977E 13 in high x 10 in deep x 11 in wide 33 cm high x 25 cm deep x 28 cm wide 13 6 lb 6 2 kg IV pole clamp bedrail hook with safety strap can be placed on hard surface 53 decibels Detachable flexible washable compatible with the 241 fluid warming system 0 2uM level Every 6 months or 500 hours of use Electronically controlled using a t
7. ement unit can be attached to an IV pole or to the railing on a bed Bair Hugger Warming Unit Model 505 TEMP INRANGE D ET OVER HEAT MAINPOWER T C HiGH 43 c C MED 38 C C SYSTEM ON STANDBY CH Low ane TEMP SELECT Figure D 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 TEMPERATURE SELECT Push this button to increase the temperature setting level by level to the desired setting When the temperature setting
8. er SES Total Temperature Management System Bair Hugger Temperature Management Unit Model 505 Operator s Manual English 1 Deutsch 15 Francais 29 Italiano 43 Espa ol 57 Portugu s 71 Nederlands 85 Dansk 99 Svenska 113 Norsk 127 Sumoi 141 EXAnVikd 155 D A 169 Polski 183 Magyar 197 Cesky 211 Lietuviy Kalba 225 Pycckun 237 wiz 249 Table of Gontents Int oduction asso shan Ee EE sa sassa sss asua us as 3 Description of the Total Temperature Management System 3 Indications 3 C OEMAINGICAUIONS 2548 deeg tio eds oe ans awa dea eee ewan gees tae 3 WAapDni igsu leri Seet E ENEE a apuq Gb ire aa tae EEN eto dhe See Cp Seeds 4 VE EE EES 4 INGE ES sees ok REG SALA Saat e upah de eh Act et o ah ata Riel 5 Read Before Servicing Equipment cis Ae A 604584 need awe eee Rae ore ee 5 Set up and Operation 6 Temperature Management Unit 123 erch ies cd iota ieee ieee 7 Control Panel Features of the Model 505 Temperature Management Unit 7 Mounting the Model 505 Temperature Management Unit 8 Attaching and Storing the Model 505 Unit Hose 9 General Maintenance A ve VK EIERE EE EELER KENE KEE 10 Technical Service and Order Placement 10 In Warranty Repair and Exchange e WEIER drone ENEE See 10 When You Call for Technical SUpport sessi ceire SC ged terised 10 Specifications cs ainsi u u kasus assia EE 11 Definition of
9. hermocouple sensor 1800 BTUs average 17 secs Air temperatures reaching the patient are approximately 2 C lower than the listed temperatures Average temperatures at the end of the hose HIGH 43 C 3 C 109 4 F 5 4 F MED 38 C 3 C 100 4 F 5 4 F LOW 32 C 3 C 89 6 F 5 4 F Safety System THERMOSTAT OVERCURRENT PROTECTION ALARM SYSTEM CERTIFICATIONS CLASSIFICATION Electrical Characteristics BLOWER MOTOR POWER CONSUMPTION LEAKAGE CURRENT HEATING ELEMENT POWER CORD DEVICE RATINGS FUSES DIAGNOSTICS Bair Hugger Model 505 Temperature Management Unit Operator s Manual Independent bulb and capillary Dual fused input lines Over heat flashing red light with audible alarm heater shuts down IEC 60601 1 EN 60601 1 2 UL 60601 1 CAN CSA C22 2 No 601 1 EN 55011 ASTM F2196 02 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 ASTM F2196 02 and Canadian CSA C22 2 No 601 1 Operating speed 3150 rpm Airflow 28 30 cfm Peak 1000W Average 450W lt 100pA 850W Resistive 15 foot SJT 3 cond 10A 4 6 meter HAR 3 c
10. ir Hugger blanket or Bair Paws gown for specific information 1 Place the blanket or gown on the patient with the perforated side the side with small holes against the patients skin 2 Insert the hose of the temperature management unit in the hose port on the blanket or gown Use a twisting motion to ensure a snug fit see Figure A 3 Connect the unit to a properly grounded power source 4 Press the System ON OFF button to turn the unit ON and select the appropriate temperature setting 5 You may place a cotton blanket over the blanket or gown for maximum effectiveness Figure A 6 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 CS CC i W q Figure B Model 505 unit attached to a Figure C Model 505 unit attached to bedrail an IV pole Arizant Healthcare Inc Bair Hugger Model 505 Temperature Management Unit Operator s Manual English 7 Temperature Management Unit 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 or gown It is designed for safe use in all areas including the operating room The Model 505 temperature manag
11. is at HIGH push the button again to return to delivery of ambient air English 200977E 8 English Bair Hugger Model 505 Temperature Management Unit Operator s Manual SS N Ge D K ww qq N D lt 44 in 112 cm Figure E Model 505 unit attached to an IV pole Figure F Model 505 unit attached to 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 E Simply turn the handle clockwise to tighten the clamp onto an IV pole counterclockwise to release Warning To prevent tipping clamp the Model 505 temperature management unit to an IV pole at a height that provides stability We recommend clamping the unit no higher than 44 in 112 cm from the floor on an IV pole with a minimum 28 in 71 cm diameter wheelbase Failure to do so may result in IV pole tipping catheter site trauma and the 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 F Arizant Healthcare Inc Bair Hugger Model 505 Temperature Management Unit Operator s Manual English 9 Press this tab to release hose Insert flange in groove and snap into place Hang hose clip tab in this slot
12. ond 10A 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 10A 200mA 110 120 VAC Units 6 3A 100mA 220 240 VAC Units 15A 160mA 100 VAC Units Over heat test can be performed by the biomedical group Arizant Healthcare Inc Bair Hugger Model 505 Temperature Management Unit Operator s Manual Definition of Symbols DON SPP P EES ER English 200977E 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 Dangerous Voltage Type BF Equipment patient applied Voltage Alternating Current AC Special Refuse discard separately Protective earth ground No free hosing English 13
13. ot leave pediatric patients unattended during therapy Do not initiate temperature management therapy unless the temperature management unit is safely placed on a hard surface or securely mounted Otherwise injury may result To prevent tipping clamp the Model 505 temperature management unit to an IV pole at a height that provides stability We recommend clamping the unit no higher than 44 in 112 cm from the floor on an IV pole with a minimum 28 in 71 cm diameter wheelbase Failure to do so may result in IV pole tipping catheter site trauma and the patient injury Arizant Healthcare Inc Bair Hugger Model 505 Temperature Management Unit Operator s Manual English 5 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 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 reliably ground this Bair Hugger warming unit only connect to receptacles marked Hospital Only or Hospital Grade Read Before Servicing Equipment The repair calibration
14. the temperature management unit and contact a qualified service technician Do not use a forced air warming device over transdermal medication Increased drug delivery and patient injury or death may occur 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 Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Resuable 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 safety ONLY with Bair Hugger blankets or Bair Paws gowns 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 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 Do n
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