Service Manual - HotDog Patient Warming
Contents
1. 0 o o 0 o o 0 o 0 0 o o 0 o o 0 2 WO QN a a a A A HR Q WO WO o 0 o 0 m m o 0 iN o o 0 4 0 EY Un 00000000000000000 mA N o O O O 0 ON ON o2. 0 Maintenance amp Testing Testing of Indicator Light Function Electrical Safety Checks and Functional Testing Cleaning Cleaning General Cleaning Controller Cleaning Warming Devices Troubleshooting Error Codes Technical Support amp Customer Service Definition of Symbols Accessory Part Numbers Specifications Electromagnetic Compatibility EMC 0 0 o o 0 o 0 0 0 o o 0 o 0 o 0 o o 0 o 0 o 0 o 0 0 o
3. 0 m 0 m EN o 0 o o 0 Service Manual Hot Dog Controller Models WCOx Page 3 INTRODUCTION The Hot Dog Patient Warming System consists of the Hot Dog Controller reusable warming devices e g Warming Blankets and accessories This manual includes maintenance instructions and specifications for the Hot Dog Controller Models WCOX and VOXX For information about Hot Dog warming devices and accessories refer to the User Manual provided with each device accessory The Hot Dog Controller is designed to help maintain normothermia in patients before during and after surgical procedures and to help prevent unintended hypothermia The system is powered and controlled by an electronic control unit Warming devices e g blankets are powered at low voltage ensuring safety for patients and operators Warming temperatures are controlled automatically to user selected levels and over temperature safety shut offs are integrated into the controller as well as into each warming device The Hot Dog Controller can be placed on a flat surface mounted on an IV pole or suspended from the OR table gurney rail using optional hooks The Hot Dog Patient Warming System can be operated continuously to maintain uniform heat over the patient It is the respon
4. Guidance and Manufacturer s Declaration Electromagnetic Immunity The Hot Dog Patient Warming System is intended for use in the electromagnetic environment specified below The customer or the user of the Hot Dog Patient Warming System should assure that it is used in such an environment IEC 60601 Electromagnetic Environment Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 NOTEUT isthe a c mains voltage prior to application of the test level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines kV line s to line s 2 kV line s to earth 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT gt 95 dip in UT for 5 sec 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV line s to line s 2 kV line s to earth 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT gt 95 dip in UT for 5 sec Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humi
5. Patient Warming System Controller Models WCOx Service Manual Forward to the Biomedical Engineering Department For information on operating the Hot Dog Patient Warming System refer to the User Manual Manufactured by EU Authorized Repr ntative Augustine Temperature Management Emergo Europe 6581 City West Parkway Molenstraat 15 Eden Prairie MN 55344 USA 2513 BH The Hague TEL 952 465 3500 The Netherlands FAX 952 465 3501 TEL 31 0 70 345 8570 www hotdogwarming com FAX 31 0 70 346 7299 Service Manual Hot Dog Controller Models WCOx Contents Introduction o 0 Contraindications o 0 Warnings Caution o 0 o o o Proper Use and Maintenance Read Before Servicing Equipment Initial Setup amp Assembly Contents Assembly Procedure Mounting the Hot Dog Controller to an IV Pole Overview of Control Panel amp Operating Modes Alarms o o
6. Turn the Mains Power Switch to ON and observe for the following proper start up sequence a Alllights illuminate briefly b The Mains Power ON light remains illuminated while the other lights illuminate one by one in the following order 1 6 2 3 4 5 Temperature in Range Alarm A Alarm B 43 40 3J c Allof the lights will illuminate simultaneously and then the unit will emit an audible tone d After the sequence completes only the Mains Power ON Light remains illuminated 3 If this sequence varies or is incomplete contact Technical Support see page 16 Service Manual Hot Dog Controller Models WCOx Page 11 Electrical Safety Checks and Functional Testing Frequency These tests should be completed once every 12 months or more frequently if required by hospital guidelines Tools Equipment Test fixture Ref A104 Warming Blanket Cable Ref HDPCI A101 or A102 Ground continuity tester Leakage current tester Calibrated fast reacting thermocouple and meter optional Hot Dog Warming Blanket optional Method l Perform Testing of Indicator Light Function as described on the previous page 2 Perform the following tests on the Controller per standard institutional protocol A Ground continuity B Connect a Warming Blanket to the Controller and test leakage current to ensure the maximum leakage current does not exceed the requirements in Table 1 Note The equi
7. to 80 MHz d 0 35VP 80MHzto 800 MHz d 0 7VP 800 MHzto 2 5 GHz Radiated RF 10 V m where P is the maximum output power rating of IEC 61000 4 3 80 MHz to 2 5 GHz the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol 7 NOTE 1 At 80MHzand 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Hot Dog Patient Warming System is used exceeds the applicable RF compliance level above the Hot Dog Patient Warming System should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or reloc
8. with warming ensure that surgical prep solution instructions for use are followed Proper Use and Maintenance Do not open the Hot Dog Controller There are no user serviceable parts If service is required contact Technical Support see page 16 The manufacturer assumes no responsibility for the reliability performance or safety of the Hot Dog Patient Warming System if the following events occur e The Controller is disassembled or serviced by an unauthorized person e The patient warming system components are used in a manner other than described in the User Manuals Service Manual Hot Dog Controller Models WCOx Page 5 e The Controller is installed in an environment that does not meet the appropriate electrical and grounding requirements e Controller is grounded and should not be attached to un grounded tables intended for use with a hyfrecator or equivalent devices Read Before Servicing Equipment Repair preventive maintenance safety testing and servicing of the Patient Warming System requires the skill of qualified medical equipment service technicians who are familiar with good practice for medical device repair Do not open the Hot Dog Controller There are no user serviceable parts If service is required contact Technical Support see page 16 Perform all maintenance activities in accordance with the instructions in this service manual INITIAL SETUP amp ASSEMBLY Contents The following components ar
9. EMC information provided in this User Manual Warning e Use of accessories and cables other than those specified may result in increased emissions or decreased immunity of the Hot Dog Patient Warming System e The Hot Dog Patient Warming System should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary carefully observe the Hot Dog Patient Warming System to verify that it operates normally in this configuration Guidance and Manufacturer s Declaration Electromagnetic Emissions The Hot Dog Patient Warming System is intended for use in the electromagnetic environment specified below The customer or user of the Hot Dog Patient Warming System should assure that it is used in such an environment Emissonstet Compliance Electromagnetic Environment Guidance The Hot Dog Patient Warming System uses RF energy only for its internal function Therefore its RF emissions are very RS OMS ious low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 The Hot Dog Patient Warming System is suitable for use in Harmionicemissions 1EC61000 32 all establishments other than domestic and those directly connected to the public low voltage power supply network Voltage fluctuations flicker Complies that supplies buildings used for domestic purposes emissions IEC 61000 3 3 Service Manual Hot Dog Controller Models WCOx Page 21
10. Service Manual Hot Dog Controller Models WCOx Page 18 Dimensions Weight Mounting Temperature Characteristics Recommended Operating Environment Temperature Control Operating Temperatures Safety System Primary Over temp Alarm Secondary Over temp Alarm Over current M onitoring Port A Port B Over current Protection Electrical Characteristics Leakage Current Power Consumption Power Cord Device Ratings Fuses Certifications SPECIFICATIONS cont d Classification 29 21 cm high x 13 97 cm deep x 19 69 cm wide 11 5 high x 5 5 deep x 7 75 wide 3 6 kg 8 0 Ib Can be clamped to an IV pole 15 C to 25 C M icro processor Average temperature at the Warming Blanket High 43 1 0 C 109 4 1 8 F Medium 40 1 0 C 104 1 8 F Low ST EL 98 6 1 8 F High Alarm sounds at 44 C 1 C Independent electronic circuit shuts the heater off if the Warming Blanket temperature reaches 46 C IC 12 amps max 1 amps max Dual input fused lines Meets UL 2601 1 and IEC 60601 1 requirements for Class Type BF equipment Peak 580 W 4 6 m 15 ft Input 100 240 VAC 50 60 Hz 600VA Output A 48 VDC 500 VA M ax Output B 48 VDC 80 VA Max T6 3AL250V 2 x 5x20mm IEC 60601 1 EN 60601 1 2 UL 60601 1 CAN CSA C22 2 No 601 1 EN 55011 CS Classified under IEC 60601 1 Guidelines and other national versions of the Guidelines as Class Type BF Ordinary equipment C
11. ating the Hot Dog Patient Warming System b Over the frequency range 150 kHz to 80 M Hz field strengths should be less than 3 V m Service Manual Hot Dog Controller Models WCOx Page 23 Recommended separation distances between portable and mobile RF communications equipment and the Hot Dog Patient Warming System The Hot Dog Patient Warming System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Hot Dog Patient Warming System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Hot Dog Patient Warming System as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum output power of transmitter 150 kHz to 80 MHz 80 M Hz to 800 MHz 800 MHz to 2 5 GHz dp d 0 35VP d 074P For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 M Hz and 800 M Hz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Elect
12. axis approximately 6 directly out from the back of the blanket connector and indicated with a white target symbol see Figure 5 Figure 5 Sensor Symbol Fold the Warming Blanket back on itself black face to black face so that the thermocouple is between the two layers of the heated blanket Ensure that the blanket layers are pressed together in the location of the thermocouple Place a 750 to 1000gm weight such as a small book or notebook over the sensor location to ensure that the pad remains folded and that there is good contact between the sensor and the folded blanket Figure 6 Figure 6 Warming Blanket Test Configuration THERMOCOUPLE READER 2 3 Turn the Mains Power Switch to the ON position After completing the startup sequence Service Manual Hot Dog Controller Models WCOx Page 14 supply power to the Warming Blanket by connecting the Warming Blanket power cable to the Controller The Mains Power ON light will already be illuminated No other lights should be illuminated on the Controller 4 Select the temperature to be verified If checking all set points start with the low temperature setting 5 After the Temperature in Range Light illuminates allow the temperature to stabilize for 3 minutes NOTE A temperature overshoot will be noted when testing this way which is normal 6 Check the reading of the thermocouple The temperature should be within 1 C of the set point temperature including the ad
13. c germicidal detergent quaternary ammonium detergent and accelerated hydrogen peroxide e g Virox Cleaners that Service Manual Hot Dog Controller Models WCOx Page 15 contain iodine may cause surface discoloration and are therefore NOT recommended for routine cleaning Cleaning Controller Frequency As needed Tools Equipment e Sponge or soft cloth e Mild detergent or anti microbial spray e Dry soft cloth Method 1 Disconnect the Controller from the power source before cleaning 2 Wipe unit with moistened sponge or soft cloth avoid pushing fluids into any openings 3 Dry with a separate soft cloth Cleaning Warming Devices Frequency Clean between patient use and when the warming device appears soiled Method Clean the warming devices following protocols for non critical medical devices that may contact intact skin Examples of similar devices are blood pressure cuffs exam table covers operating room table pads and surgical supports Cleaning steps are described in the User Manual provided with the warming device Note that the cleaning instructions are general recommendations and are not meant to replace hospital specific cleaning protocols Service Manual Hot Dog Controller Models WCOx Page 16 TROUBLESHOOTI NG ERROR CODES Primary over temp When the temperature exceeds one degree above nominal including tolerances audible and visual alarms are initiated and power is removed from the output The alar
14. ditional tolerance of the thermocouple meter which is usually 1 7 Repeat steps 4 6 for the next temperature setting if required CLEANI NG Cleaning General Warnings e DO NOT use a dripping wet cloth and DO NOT immerse Hot Dog components in liquid Moisture will damage the components and thermal injury may result Precautions e DO NOT use pure harsh solvents e g MEK acetone etc to clean Hot Dog components Solvents may damage plastic parts labeling and product finish e DO NOT use high level disinfectants e g gluteraldehyde peracetic acid The U S Centers for Disease Control CDC recommends against the use of high level disinfectants for cleaning environmental surfaces that may contact the patient since the chemicals are highly toxic e DO NOT spray cleaning solutions into electrical connectors Recommended cleaners Alcohol based disinfectants are easiest to use since they are fast acting and can be either sprayed or wiped on The following list of alcohol based cleaners is provided for reference only and is not an endorsement of the manufacturers or their cleaning products Ecolab Incidin Liquid Incides N Incidin Foam Incidin Sun Mikro Bak III Merz Pursept A Xpress Pursept Foam Mucocit A Economy and Lysoform Aerodesin 2000 Lysoform Spray Other cleaners that have been tested and are compatible with the outer surfaces of Hot Dog components include sodium hypochlorite diluted bleach phenoli
15. dity should be at least 30 96 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the Hot Dog Patient Warming System requires continued operation during power mains interruptions it is recommended that the Hot Dog Patient Warming System be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Service Manual Hot Dog Controller Models WCOx Page 22 Guidance and Manufacturer s Declaration Electromagnetic Immunity cont d The Hot Dog Patient Warming System is intended for use in the electromagnetic environment specified below The customer or the user of the Hot Dog Patient Warming System should assure that it is used in such an environment IEC 60601 LEE td Electromagnetic Environment Test Level Guidance Portable and mobile RF communications equipment should be used no closer to any part of the Hot Dog Patient Warming System including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance dsi2JP Immunity Test Conducted RF 3 Vrms IEC 61000 4 6 150 kHz
16. e included in the Hot Dog Controller box e Hot Dog Controller Model WCOX or VOXX e IV pole adapter and mounting hardware e Mains power cord e CD containing User Manual and Service Manual e Hot Dog Warming Blanket Cable P N A101 Reusable Hot Dog accessories e g Warming Blankets Warming Mattress connecting cables OR table gurney rail hooks with mounting hardware and Hot Dog Disposable Sheets are sold separately Assembly Procedure 1 Remove all items from the box and discard packaging per institutional protocol 2 Loosen and remove the two cord retainer screws and the cord retainer see Figure 1 the cord retainer is located on the back of the Controller 3 Firmly insert the mains power cord into the receptacle on the back of the Controller 4 Place the cord retainer over the strain relief of the mains power cord replace both screws and tighten to secure the cord retainer see Figure 1 Figure 1 Cord Retainer Assembly Service Manual Hot Dog Controller Models WCOx Page 6 Mounting the Hot Dog Controller to an IV Pole To mount the Hot Dog Controller to an IV pole place the Controller IV pole adapter around the IV pole and turn the clamp handle clockwise until securely tightened Figure 2 To remove the Controller from the IV pole turn the clamp handle counterclockwise until the unit releases Caution To prevent the IV pole from tipping the Controller must be attached at a height tha
17. emperature falls to within 1 C of the selected set point the alarm will shut off and normal function will be restored If the Alarm Port A Light illuminates steadily and the alarm continues to sound turn the Mains Power Switch to the OFF position and disconnect the Warming Blanket from the Controller e If Alarm Port A occurs when connecting a Warming Blanket to the Controller disconnect the Warming Blanket and replace it with another Warming Blanket Alarm Port B If the accessory attached to Port B exceeds the pre set current limit an audible alarm sounds and the Alarm Port B Light illuminates red Power is removed from the port Disconnect the accessory from Port B to reset the alarm Service Manual Hot Dog Controller Models WCOx Page 10 e If Alarm Port B occurs when connecting an accessory to the Controller disconnect the accessory and replace it with another accessory e If Alarm Port B occurs during use and the Alarm Port B Light illuminates steadily disconnect the accessory and replace with another accessory MAI NTENANCE amp TESTI NG Testing of I ndicator Light Function Frequency This test should be completed upon initial equipment check in and once every 12 months or more frequently if required by hospital guidelines Method 1 Insert the Hot Dog Controller power plug into a properly grounded hospital grade electrical outlet and confirm that NO cables or devices are connected to any of the ports 2
18. lays will illuminate briefly and the Controller will beep The Mains Power ON Light will illuminate and the Controller will remain idle until a warming device is plugged in When the unit is ON and idle 1 e no Temperature Setting Lights are illuminated no power is applied to the warming device and no alarm conditions are indicated Temperature Adjust Button Temperature Setting Lights Press the Temperature Adjust Button until the desired high 43 C medium 40 C or low 37 C temperature is selected as indicated by the illuminated Temperature Setting light The designated warming temperature will be reached within 5 minutes Temp in Range Light The green Temperature in Range light will illuminate when the temperature of the Warming Blanket is 1 C of the selected temperature setting Port A Port A should only be used for connection to a Hot Dog Warming Blanket When a Warming Blanket is plugged into the Controller an audible beep indicates that the control and over temperature sensors safety device are present and functioning properly and the device is ready for use Port B Port B is a 48V output for future approved Hot Dog accessories Alarms Alarm Port A If the Warming Blanket temperature exceeds one degree above set point or other fault conditions exist an audible alarm sounds and the Alarm Port A Light illuminates red The Controller will automatically discontinue power to the Warming Blanket When the operating t
19. les or loose electrical connections If signs of wear are evident do not use the product until it is inspected by technical staff e NOT continue to use Hot Dog Patient Warming System if the over temperature indicator and or alarm continue to sound after reset See alarm section of this manual Warming Blanket e DO NOT place Hot Dog Warming Blankets under the patient The Warming Mattress and disposable sheets are the only accessories designed for use under the patient Accessories and Other Equipment e Accessories and cables other than those specified in the User Manual may result in increased emissions or decreased immunity of the Hot Dog Patient Warming system e Hot Dog Patient Warming System should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary carefully observe the Hot Dog Patient Warming System to verify that it operates normally in this non recommended configuration Caution Federal law USA restricts this device to sale by or on the order of a licensed healthcare professional Precautions e Use under the direct supervision of a clinician e Monitor the patient s vital signs regularly during warming according to institutional protocol If vital sign instability occurs notify the clinician e Care should be taken when using multiple warming methods e The risk of skin irritation caused by pooling of surgical prep solutions under the patient may increase
20. lluminate to indicate that power is being applied to the test fixture the alternating on off shows the duty cycle applied by the Controller Release the button and the Controller should return to in range as described in step 2 Press the Temperature High The A alarm light should be illuminated an audible alarm button 5 on the test fixture to should sound and the In Range LED should turn off Release trigger the primary the button and the Controller should return to in range as over temperature alarm described in step 2 Note Steps 5 thru 9 do not require a temperature to be set The alarm states are absolute and will trigger whether the blanket is being used or not Press the Primary Short button The A alarm light should be illuminated and an audible alarm 1 on the test fixture to simulate a should sound Release the button and the Controller should shorted primary sensor return to in range as described in step 2 Press the Primary Open button The A alarm light should be illuminated and an audible alarm 2 on the test fixture to simulate should sound Release the button and the alarm state should an open primary sensor be latched Unplug the test fixture cord to clear the alarm Plug the test fixture cord back in to prepare for the next step Press the Secondary Open The A alarm light should be illuminated and an audible alarm button 4 on the test fixture t
21. m will reset when e Temperature is within acceptable limits x 1 C e Cable connecting Warming Blanket to Controller is disconnected e Power is removed at mains Secondary over temp When the temperature exceeds 46 C audible and visual alarms are initiated The alarm will reset when e Cable connecting Warming Blanket to Controller is disconnected e Power is removed at mains Over current When current draw exceeds a predetermined level audible and visual alarms are initiated The alarm will reset when e Power is removed at mains Failure to reach temp When the system does not achieve 43 C within 10 minutes audible and visual alarms are initiated The alarm will reset when e Cable connecting Warming Blanket to Controller is disconnected e Power is removed at mains Sensor failure When either sensor is opened or shorted audible and visual alarms are initiated and power is removed from output If both sensors are opened or shorted no alarms are Initiated power Is removed from output and the temperature selector switch becomes inactive e Replace the Warming Blanket Fold Detect If the Warming Blanket is folded back on itself such that a local over temperature condition occurs audible and visual alarms are initiated The alarm will reset when e Temperature in folded area has cooled and e Cable connecting Warming Blanket to Controller is disconnected or e Power is removed at mains TECHNICAL SUPPORT amp CUSTOMER SERVICE Ser
22. o should sound Release the button and the alarm state should simulate an open secondary be latched Unplug test fixture cord to clear the alarm Plug sensor the test fixture cord back in to prepare for the next step Press the Secondary Short The A alarm light should be illuminated and an audible alarm button 3 on the test fixture to should sound Release the button and the alarm state should simulate a shorted primary sensor be latched Unplug test fixture cord to clear the alarm or secondary over temperature Press the Fold Detect button 7 The A alarm light should be illuminated and an audible alarm on the test fixture to simulate a should sound Release the button and the alarm state should local over temperature condition be latched Unplug test fixture cord to clear the alarm which could be created by inadvertent folding of a blanket Functional Testina for Blanket an ntroller Service Manual Hot Dog Controller Models WCOx Page 13 Use a Hot Dog Warming Blanket to perform the steps outlined below If a failure is observed during any of these steps repeat testing using a different Warming Blanket If failure is observed with the second Warming Blanket contact Technical Support see page 16 1 Tape a calibrated fast reacting thermocouple to the patient facing surface of the Warming Blanket directly over the sensor marking The sensor assembly which can be felt is located on the
23. ontinuous operation Not suitable for use in presence of flammable anesthetic Service Manual Hot Dog Controller Models WCOx Page 19 Diagnostics Transport Storage Important Information mixtures with air or with oxygen or nitrous oxide Classified by Intertek Testing Services NA Inc with respect to electric shock fire and mechanical hazards only in accordance with UL 60601 1 Classified under the M edical Device Directive 93 42 EEC as a Class Ilb device Classified under Canadian M edical Device Regulation as Class Il A qualified technician can perform general system testing The Controller has no user serviceable parts Temperature 20 C to 60 C Humidity 20 to 80 Keep Dry This device complies with the EM C requirements according to IEC 60601 1 2 Radio transmitting equipment cellular phones etc shall not be used in the close proximity of the device since this could influence the performances of the device Particular precaution must be considered during use of strong emission sources such as High Frequency surgical equipment and similar so that e g the HF cables are not routed on or near the device If in doubt contact a qualified technician or your local representative Service Manual Hot Dog Controller Models WCOx Page 20 ELECTROMAGNETIC COMPATIBILITY EMC The Hot Dog Patient Warming System requires special precautions regarding EMC and must be installed and put into service according to the
24. potential stud on the back of the Hot Dog Controller may be used as a grounding point for these tests Table 1 Maximum Allowable Leakage Current Current Polarity Condition Normal Open Ground amp Open Neutral 3 Perform Functional Testing described on the following pages Service Manual Hot Dog Controller Models WCOx Page 12 Functional Testing Method for Controller Use a Temperature Test Fixture Ref A104 to perform the steps outlined below The Test Fixture simulates a Warming Blanket that is operating at 43 C If a failure is observed during any of these steps call customer service Step TestMethod Using a standard blanket cable The Controller will emit an audible tone The M ains Power ON Ref HDPC1 A101 or A102 Indicator will already be illuminated The LED readout connect the test fixture to the associated with the port under test will show two dashes Controller indicating a device is attached Press the Temperature Adjust The 43 C and the Temperature in Range lights should Button on the Controller to select illuminate The Heater On indicator on the A104 test fixture 43 may flash intermittently or not at all which is normal Press the Temperature Low The Temperature in Range light on the Controller should go off button 6 on the test fixture to and the Heater On light at the top of the test fixture should simulate a cold warming blanket i
25. romagnetic propagation is affected by absorption and reflection from structures objects and people Hot Dog is a trademark of Augustine Temperature Management registered in the U S Patent amp Trademark Office Patents pending 2010 Augustine Temperature Management All rights reserved P N 2294EN Revision C 4 26 2011
26. sibility of the user to determine whether warming is appropriate for each individual patient The Hot Dog Patient Warming System should not be used when clinical considerations indicate that warming of the patient is not advisable Indications for Use The Hot Dog Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients The Hot Dog Patient Warming System should be used in circumstances in which patients may not maintain a state of normothermia The System is intended primarily for use in hospitals and surgical centers including without limitation operating recovery and emergency rooms and on medical surgical floors Contraindications e DO NOT warm patients during aortic cross clamping thermal injury may result e DO NOT warm patients with ischemic or non perfused limbs thermal injury may result e DO NOT warm patients receiving transdermal medication increased drug delivery may occur Warnings e EXPLOSION HAZARD DO NOT use the Hot Dog Patient Warming System in the presence of flammable anesthetics or highly oxygen enriched environments such as hyperbaric chambers oxygen tents etc e Caution should be taken when using electric warming devices with HF surgical instruments Service Manual Hot Dog Controller Models WCOx Page 4 or endocardial catheters in respect to potential equalization e Inspect Hot Dog components prior to use for signs of damage or excessive wear such as cuts ho
27. t provides stability It is recommended to use an IV pole with a minimum wheelbase radius of 35 6 cm 14 in and to mount the Controller no higher than 112 cm 44 in from the floor Failure to properly mount the Controller may result in IV pole tipping catheter site trauma and patient injury Figure 2 Hot Dog Controller Mounted on an IV Pole Service Manual Hot Dog Controller Models WCOx Page 7 The Controller may also be suspended from the OR table gurney rail using optional hooks Figure 3 Figure 3 Optional OR Table Gurney Rail Hooks The Controller may be suspended from the OR table gurney rail using these optional hooks Note Hook location may vary depending on model Service Manual Hot Dog Controller Models WCOx Page 8 OVERVIEW OF CONTROL PANEL amp OPERATING MODES Figure 4 Hot Dog Model WCOX amp V0XX Controls if A Mains Power ON Light B Tamp in Range Light C Temp Adjust Button D Temp Setting Lights 3 E Alarm Port Light F Alarm Port B Light G Port Warming Blanket H Port B Auxiliary I 5erial Number J IV Pole Clam K Power Entry Module Fuse Drawer Mains Power Switch Power Plug L Cord Retainer Service Manual Hot Dog Controller Models WCOx Page 9 Mains Power Switch ON Power Indicator When the Hot Dog Controller is plugged into an electrical outlet and the Mains Power Switch on the back of the Controller is turned ON all disp
28. vice Manual Hot Dog Controller Models WCOx Page 17 Please have the serial number of your Hot Dog Controller when you call for technical support The serial number is located on the back of the Controller If it is necessary to return the Controller for service or repair contact your local supplier or sales representative Augustine Temperature M anagement 6581 City West Parkway Eden Prairie MN 55344 USA TEL 952 465 3500 FAX 952 465 3501 www hotdogwarming com DEFI NI TI ON OF SYMBOLS E Do Not Place Under Patient an This Side Up EN Mains Power On Indicator 111 9 Attention consult BF Patient Applied Part en according to IEC60601 1 Serial Number Temperature in Range storage Temperature Adjustment temperature range Manufacture Date Transport and storage Keep Dry humidity range EU Authorized Return to Authorized Equipotential Representative mm Representative Temperature Sensor Conforms to European M edical Device Directive 93 42 EEC M edical Equipment Classified by Intertek Testing Services NA Inc with respect to electric shock fire and mechanical hazards only in accordance with UL 60601 1 Classified under the M edical Device Directive 93 42 EEC as a Class IIb device ACCESSORY PART NUMBERS The following cable part numbers are used with the Hot Dog Patient Warming System A101 Hot Dog Warming Blankets Cable 4m 13ft SPECIFICATIONS Physical Characteristics
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