Service Manual - HotDog Patient Warming
Contents
1. Separation distance according to frequency of transmitter Rated maximum output m power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2VP d 0 35VP d 0 74P 0 01 0 12 0 04 0 07 0 1 0 37 0 11 0 22 1 1 2 0 35 0 70 10 3 7 1 1 2 2 100 12 3 5 7 0 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 MHz and 800 MHz the separation distance for 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 HotDog 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 2256EN Revision G 10 19 20112. PATIENT WARMING Patient Warming System Controller Model WC5X 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 Representative 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 0086 Service Manual Hot Dog Patient Warming System Page 2 Contents O A o anes 3 Indications e ai 3 CONTAMINA A NAAA a at 3 A o O 3 A o a 4 Precautions 5 28 ms cect tease a anes ss aut sata sua Gashstaka tetas Manat uea gts ETE a a aa 4 Propet Use and Maintenance ica A A a ER GE aT 5 Read Before Servicing Equipment s c0 ecjccasateseaasenascesavteiessactasassev ccctaianneiareatieeans 6 AAA A datieeaatbaiech Bacau anmedum an teewnteances 6 A ie Ss A a Pate a a Fa a toa Rs Se ca ek ah ea a 6 Assembly Procede idilio pipi dla 6 Mounting the Hot Dog Controller to an IV Pole ooooonccnnnccinocinocaconoconnnonanconncconocancnonnnos 7 Overview of Control Panel amp Operating Modes cooooonocnnocnconcnononcconaconocnno nono nooo noconocnnnnonnnos 9 O O Saeed GOA E 10 Maintenance amp Tesi 11 Testing of Indicator Light FURIOSA AAA A AAA 11 Electrical Safety Checks and Functional Testing oonconncnncn
3. Open Ground 0 5 Open Neutral 0 5 Open Ground amp Open Neutral 0 5 3 Perform Functional Testing described on the following pages Service Manual Hot Dog Patient Warming System Page 13 Functional Testing Method for Controller Use a Temperature Test Fixture Ref A115 to perform the steps outlined below The Test Fixture simulates a Warming Blanket that is operating at 43 C Ifa failure is observed during any of these steps call customer service Step Test Method Test Result 1 Using a standard blanket cable The Controller will emit an audible tone and the Mains Power ON Ref HDPC1 A101 or A102 Indicator will illuminate The LED readout associated with the port connect the test fixture to the under test will show two dashes indicating a device is attached Controller 2 Press the Temperature Adjust The set point will display on the LED readout The display will be Button on the Controller once constant to indicate that temperature is in range The heater for the port under test to indicator LED on the test fixture may flash intermittently or not at select the highest temperature all which is normal setting 3 Press the Temperature Low The set point displayed on the Controller LED readout should flash button on the test fixture to and the LED at the top of the test fixture should illuminate to simulate a cold warming indicate that power is being applied to the test
4. 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 relocating the Hot Dog Patient Warming System Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Service Manual Hot Dog Patient Warming System Page 24 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
5. the audible alarm will sound and all Alarm Lights will illuminate Power will be lifted from all ports Turn the Controller off to reset If all ports alarm again after a reset was performed discontinue use of the Controller and refer the unit to biomedical engineering Alarm Port D and E If the accessory attached to Port D or E exceeds the pre set current limit an audible alarm sounds and the Alarm Light illuminates red Power is removed from the port Disconnect the accessory from Port D and E to reset the alarm Service Manual Hot Dog Patient Warming System Page 11 e Ifthe alarm occurs when connecting an accessory to the Controller disconnect the accessory and replace it with another accessory e Ifthe alarm occurs during use and the Alarm Light illuminates steadily disconnect the accessory and replace with another accessory MAINTENANCE amp TESTING Testing of Indicator 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 Turn the Mains Power Switch to ON and observe for the following proper start up sequence a Individual LED s power up sequentially b Segmented displays power up as individual units sequentially left
6. 2 1 8 F Primary Over temp Alarm Ports A and B Warming Blanket Alarm sounds at set point 1 C Port C Warming Mattress Alarm sounds at set point 1 C Secondary Over temp Alarm Ports A and B Warming Blanket Independent electronic circuit shuts the heater off if the Warming Blanket temperature reaches set point 3 C Port C Warming Mattress ndependent electronic circuit shuts the heater off if the Warming Mattress temperature reaches set point 2 5 C Time out timer f warming device does not reach set temperature within 10 minutes the controller will alarm Six hour timer f a warming device is left at a steady setting for six hours the controller will discontinue power to warming device Over current limits PortA 10 amps max Port B 10 amps max Port C 5 amps Port D 3 amps Port E 3 amps System 14 6 amps System Over current Protection Dual input fused lines Service Manual Hot Dog Patient Warming System Page 20 Electrical Characteristics Leakage Current Meets UL 2601 1 and IEC 60601 1 requirements for Class Type BF equipment Power Consumption 850W maximum Power Cord 4 6 m 15 ft Device Ratings Input 100 240 VAC 50 60 Hz 850VA Output A amp B 48 VDC 480 VA Max each Output C 240 VA Max Output D amp E 48 VDC 144 VA Max each Fuses Environmental Conditions T10A
7. L250V 2 x 5x20mm Environmental Conditions for Transport and Storage Temperature 20 C to 60 C Humidity 20 to 80 Keep Dry Environmental Conditions for Use Classification and Standards Temperature 15 C to 25 C Humidity 20 to 80 Certifications IEC 60601 1 EN 60601 1 2 UL 60601 1 CAN CSA C22 2 No 601 1 EN 55011 TERT SE TEO Classification Classified under IEC 60601 1 Guidelines and other national versions of the Guidelines as Class Type BF Ordinary equipment Continuous operation Not suitable for use in presence of flammable anesthetic 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 Medical Device Directive 93 42 EEC as a Class IIb device Classified under the Canadian Medical Device Regulation as Class II Diagnostics A qualified technician can perform general system testing The Controller has no user serviceable parts Important Information This device complies with the EMC 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 e
8. Representative Mm i Bl E e Return to Authorized Representative y So KA e Q so Temperature Sensor o 08 o Conforms to European Medical Device Directive 93 42 EEC TERTE lb Medical 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 Medical 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 Part Number Description A101 Hot Dog Warming Blankets Cable 4m 13ft Service Manual Hot Dog Patient Warming System Page 19 Part Number Description A112 Hot Dog Mattress Cable 4m 13ft SPECIFICATIONS Physical Characteristics Dimensions 33 cm high x 14 0 cm deep x 19 7 cm wide13 high x 5 5 deep x 7 75 wide Weight 5 kg 11 Ibs Mounting Can be placed on a horizontal flat surface i e table top clamped to an IV pole or Temperature Characteristics hung on a OR gurney rail using optional hanging hooks Temperature Control Micro processor Operating Temperatures Safety System Blanket Ports A and B adjustable in 1 C increments 37 to 43 1 0 C 98 6 to 109 4 1 8 F Mattress Port C adjustable in 1 C increments 35 to 39 1 0 C 95 to 102
9. a port an audible beep will sound and the display will show two dashes Press the Temperature Adjust Button for the desired port until the desired temperature is displayed The temperature can be selected in one degree increments from 37 43 C for Ports A and B Warming Blankets and 35 39 C for Port C Warming Mattresses The designated warming temperature will flash until the selected temperature is achieved at which time the selected temperature will steadily display Port A Band C Ports A and B are used only for Hot Dog Warming Blankets and Port C is used only for Hot Dog Warming Mattresses When a warming device is plugged into the Controller an audible beep indicates that the control and over temperature sensors are present and functioning properly Port D and E Ports D and E supply a 48V output for future approved Hot Dog accessories Alarms Alarm Port A B and C If the warming device temperature exceeds one degree above set point or other fault conditions exist an audible alarm sounds and the Alarm Light illuminates red for the port that is alarming The Controller will automatically discontinue power to that warming device When the operating temperature falls to within 1 C of the selected set point the alarm will shut off and normal function will be restored If the Alarm Light illuminates steadily and the alarm continues to sound disconnect the warming device from the Controller If the Controller senses an over current
10. aution should be taken when using electric warming devices with HF surgical instruments or endocardial catheters in respect to potential equalization Service Manual Hot Dog Patient Warming System Page 4 e Inspect Hot Dog components prior to use for signs of damage or excessive wear such as cuts holes or loose electrical connections If signs of wear are evident do not use the product until it is inspected by technical staff e DONOT continue to use the 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 Warming Mattress e The Hot Dog Warming Mattress is not sterile Where necessary take appropriate precautions to protect the sterile field Accessories and Other Equipment e Accessories and cables other than those specified in the Instructions for Use 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 non recommended configuration Caution Federal law USA restricts this device to
11. ble and visual alarms are initiated The alarm will reset when the device is unplugged or power is removed at mains E2 on affected port Failure to reach temp Time to Temperature When the system does not achieve 43 C within 10 minutes audible and visual alarms are initiated The alarm will reset when the device is unplugged or power is removed at mains E3 on affected port Port Over current When port current draw exceeds a predetermined level audible and visual alarms are initiated The alarm will reset when the device is unplugged or power is removed at mains E3 on all ports System Over current When system current draw exceeds a predetermined level audible and visual alarms are initiated The alarm will reset when power is removed at mains E4 on affected port 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 device ES on affected port Over Temperature Array Alarm In warming devices equipped with an over temperature array local overheating caused by folding of the warming blanket will initiate visual and audible alarms The alarm will reset when the device is unplugged or power is removed at mains N A 6 hour time out time
12. 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 under or over the patient depending on which warming device accessory is selected It is the responsibility 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 DONOT 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 C
13. 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 Patient Warming System Page 17 TROUBLESHOOTING ERROR CODES Error Code Alarm Mode Description EE on all ports System failure Contact technical support El on affected port Primary over temp When the temperature exceeds one degree above set point audible and visual alarms are initiated and power is removed from the output The alarm will reset when e Temperature is within acceptable limits 1 C or e Cable connecting warming device to Controller is disconnected or power is removed at mains Secondary over temp When the temperature exceeds 46 C audi
14. eight 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 gt HERMOCOUPLE POSITIONED BETWEEN B T LAYERS LANKE Turn the Mains Power Switch to the ON position Supply power to the Warming Blanket by connecting the Warming Blanket power cable to the Controller The Controller will emit an audible tone and the Mains Power ON Indicator will illuminate Select the temperature to be verified If checking all set points start with the low temperature setting After the warming device reaches set point indicated when the set point readout is no longer flashing allow the temperature to stabilize for an additional 3 minutes NOTE A temperature overshoot will be noted when testing this way which is normal Check the reading of the thermocouple The temperature should be within 1 C of the set point temperature including the additional tolerance of the thermocouple meter which is usually 1 C Repeat steps 4 6 for the next temperature setting if required Service Manual Hot Dog Patient Warming System Page 15 CLEANING 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 u
15. et the appropriate electrical and grounding requirements e The Controller is grounded and should not be attached to un grounded tables intended for use with a hyfrecator or equivalent devices Service Manual Hot Dog Patient Warming System Page 6 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 18 Perform all maintenance activities in accordance with the instructions in this service manual INITIAL SETUP 8 ASSEMBLY Contents The following components are included in the Hot Dog Controller box e 1 Hot Dog Controller Model WC5X e 1 IV pole adapter and mounting hardware e 1 Mains power cord e 1 CD containing User Manual and Service Manual e 1 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
16. fixture the blanket 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 4 Press the Temperature High The Controller alarm indicator for the port under test should button on the test fixture to illuminate an audible alarm should sound and the LED readout trigger the primary over should indicate error code E1 Release the button and the temperature alarm Controller should return to in range as described in step 2 5 Press the Primary Short The Controller alarm indicator for the port under test should button on the test fixture to illuminate an audible alarm should sound and the LED readout simulate a shorted primary should indicate error code E4 Release the button and the sensor Controller should return to in range as described in step 2 6 Press the Primary Open The Controller alarm indicator for the port under test should button on the test fixture to illuminate an audible alarm should sound and the LED readout simulate an open primary should indicate error code E4 Release the button and the alarm sensor state should be latched Unplug the test fixture cord to clear the alarm Plug the test fixture cord back in to prepare for the next step 7 Press the Secondary Open The Controller alarm indicator for the port under test should button on the test fixture to illuminate a
17. 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 Service Manual Hot Dog Patient Warming System Page 7 Figure 1 Cord Retainer Assembly Cord retainer screws 2 Cord retainer Mains Power Cord 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 that 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 Patient Warming System Page 8 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 fro
18. m the OR table gurney rail using these optional hooks Note Hook location may vary depending on model Service Manual Hot Dog Patient Warming System Page 9 OVERVIEW OF CONTROL PANEL amp OPERATING MODES Figure 4 Hot Dog Model WC5X Controls A Mains Power ON Light B Temp Adjust Buttons 3 C Temp Setting Displays 3 D Alarm Lights 5 E Serial Number F IV Pole Clamp G Power Entry Module Fuse Drawer Mains Power Switch Power Plug H Cord Retainer Patient Warming System Ports A 8 B Port C Ports D amp E Used only for Hot Dog Used only for Hot Dog 48V output for Warming Blankets Warming Mattresses future approved Hot Dog accessories Service Manual Hot Dog Patient Warming System Page 10 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 displays will illuminate briefly and the Controller will beep Afterwards the software version is displayed for approximately 2 seconds 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 Display When a warming device is plugged into
19. n audible alarm should sound and the LED readout simulate an open secondary should indicate error code E4 Release the button and the alarm sensor state should be latched Unplug test fixture cord to clear the alarm Plug the test fixture cord back in to prepare for the next step 8 Press the Secondary Short The Controller alarm indicator for the port under test should button on the test fixture to simulate a shorted primary sensor or secondary over temperature illuminate an audible alarm should sound and the LED readout should indicate error code E4 Release the button and the alarm state should be latched Unplug test fixture cord to clear the alarm Service Manual Hot Dog Patient Warming System Page 14 Functional Testing for Blanket and Controller 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 18 l Tape a calibrated fast reacting thermocouple to the patient facing surface of the Warming Blanket directly over the sensor marking 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 w
20. ocnnccnocononcnnncononononnonnnnnnons 12 A E le ate 15 Cleaning CONT Ales co ii SA A zii 15 CA Cita 16 Cleaning Warming Devi e 16 Troubleshooting ECO CIS RAS 17 Technical Support amp Customer EVI ii 18 Definition OFS DO li AE RRT E EA RAE EE A aa 18 Accessory Part A caca 18 SpecificatONS nii ne E E E E RE R EN E T A a 19 Electromagnetic Compatibility EMC sisacssccssacecsesssvatccasavdastasacqsneatanesdach eatdosbindystacaeuecsds 21 Service Manual Hot Dog Patient Warming System Page 3 INTRODUCTION The Hot Dog Patient Warming System consists of the Hot Dog Controller reusable warming devices e g Warming Blankets Warming Mattresses and accessories This manual includes maintenance instructions and specifications for the Hot Dog Controller Model WC5X 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 mattress 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
21. quipment 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 Patient Warming System Page 21 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 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 Emissions test Compliance Electromagnetic Environment Guidance The Hot Dog Patient Warming System uses RF energy only RF emissions CISPR 11 Group 1 for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearb
22. r If a warming device is left operating for 6 hours with no changes to set point power will be removed three short audible chirps will sound and the alarm Indicators will flash continuously Pressing the temperature select button will clear the alarm and re start normal operation Service Manual Hot Dog Patient Warming System TECHNICAL SUPPORT 8 CUSTOMER SERVICE Page 18 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 Technical Support amp Customer Service Augustine Temperature Management 6581 City West Parkway Eden Prairie MN 55344 USA TEL 952 465 3500 FAX 952 465 3501 www hotdogwarming com DEFINITION OF SYMBOLS ttt be Mains Power On Do Not Pl Under Patient This Side U o Not Place Under Patien is Side Up indicator tid This Side D NN Heating A Al is Side Down eating Area arm M Attention consult Reference Number Lot Number accompanying documents gt BF Patient Applied Part according to IEC60601 1 Serial Number Manufacture Date 5 Transport and storage Temperature Temperature in Range temperature range Adjustment Reg Transport and storage Keep Dry p 8 Fuse humidity range y Equipotential yas a EU Authorized
23. ronment specified below The customer or the user of the Hot Dog Patient Warming System should assure that it is used in such an environment gt IEC 60601 3 Electromagnetic Environment Immunity Test Compliance Level y 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 d 1 2VP Conducted RF 3 Vrms 3V d 0 35VP 80 MHz to 800 MHz IEC 61000 4 6 150 kHz to 80 MHz d 0 7VP 800 MHz to 2 5 GHz where P is the maximum output power rating of Radiated RF 10 V m 10 V m 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 IEC 61000 4 3 80 MHz to 2 5 GHz Interference may occur in the vicinity of equipment marked with the following symbol gt NOTE 1 At 80 MHz and 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
24. sale by or on the order of a licensed healthcare professional Precautions General 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 with warming ensure that surgical prep solution instructions for use are followed Warming Mattress e Ensure that the Warming Mattress is securely fastened to the table e The use of gel pads between the Warming Mattress and the patient is not recommended gel pads may cause a loss of warming performance Service Manual Hot Dog Patient Warming System Page 5 e Always use a patient barrier between the patient and the Warming Mattress e Care should be taken to alleviate or remove the risk of heating skin under pressurized bony prominences e Care should be taken to place the patient s body in contact with the labeled sensor on the Warming Mattress e DO NOT use operating table clamps or similar devices on the Warming Mattress as they may cause damage to the product and result in loss of the heating function and or localized heat build up in the damaged area e DO NOT place the Warming Mattress over a table joint that will move during surgery e DO NOT use on OR tables wider
25. se 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 phenolic germicidal detergent quaternary ammonium detergent and accelerated hydrogen peroxide e g Virox Cleaners that contain iodine may cause surface discoloration and are therefore NOT recommended for routine cleaning Service Manual Hot Dog Patient Warming System Page 16 Cleaning Controller Frequency As needed Tools Equipment e Sponge or soft
26. than 20 inches 50 8 cm e DO NOT use the Warming Mattress as a stand alone patient pressure relief system e DO NOT place any hard objects e g mattress cables EKG cables hard cautery return pads patient fluid lines etc between the Warming Mattress and patient s body e DO NOT fold or wrinkle the Warming Mattress during use as localized heat build up may occur in the overlapped area e DO NOT use the Warming Mattress when pressure injury is a concern e DO NOT X ray or MRI through the white labeling or edges of the Warming Mattress e DO NOT allow patient fluid lines to be placed between the Warming Mattress and Warming Blanket or other warming equipment e DO NOT position the patient s head directly on the Warming Mattress e DO NOT allow the heated side of a Hot Dog Warming Blanket to come in continuous contact with the Warming Mattress when both devices are on 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 18 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 e The Controller is installed in an environment that does not me
27. to right 3 After the lights illuminate in sequence the unit will emit an audible tone and display the software revision on the Temp Setting Display for approximately 2 seconds 4 After the sequence completes only the Mains Power ON Light remains illuminated 5 If this sequence varies or is incomplete contact Technical Support see page 18 Service Manual Hot Dog Patient Warming System 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 A115 Warming Device Cable Ref HDPC1 A101 or A102 A112 Ground continuity tester Leakage current tester Calibrated fast reacting thermocouple and meter Hot Dog Warming Blanket or Warming Mattress optional Method 1 2 Perform the following tests on the Controller per standard institutional protocol Perform Testing of Indicator Light Function as described on the previous page 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 equipotential 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 mA Normal Normal 0 1 Reversed
28. y electronic equipment RF emissions CISPR 11 Class A The Hot Dog Patient Warming System is suitable for use in Harmonic emissions IEC 61000 3 2 Class A 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 Patient Warming System Page 22 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 Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast 2 kV for power 2 kV for power supply lines supply lines a transient burst ERF e Mains power quality should be that of a typical a or a or commercial or hospital environment IEC 61000 4 4 input output input output lines lines 1 kV line s to Surge 1 kV line s to line s line s Mains power qualit
29. y should be that of a typical IEC 61000 4 5 2 kV line s to earth 2 kV line s to commercial or hospital environment earth Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 lt 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 lt 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 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 lt 5 UT lt 5 UT gt 95 dip in UT gt 95 dip in UT for 5 sec for 5 sec Power frequency a 50 60 Hz Power frequency magnetic fields should be at TR 3 A m 3 A m levels characteristic of a typical location in a magnetic field typical commercial or hospital environment IEC 61000 4 8 NOTE UT is the a c mains voltage prior to application of the test level Service Manual Hot Dog Patient Warming System Page 23 Guidance and Manufacturer s Declaration Electromagnetic Immunity cont d The Hot Dog Patient Warming System is intended for use in the electromagnetic envi
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