IFU (User Manual) - HotDog Patient Warming
Contents
1. PATIENT WARMING Patient Warming System Controller Model WC5X User Manual Manufactured by EU Authorized Representative Augustine Temperature Management Emergo Europe 6581 City West Parkway Eden Prairie MN 55344 USA TEL 952 465 3500 FAX 952 465 3501 www hotdogwarming com Molenstraat 15 2513 BH The Hague The Netherlands TEL 31 0 70 345 8570 FAX 31 0 70 346 7299 0086 User Manual Hot Dog Patient Warming System Controller Page 2 Contents oduc nere tee EE 3 Device DescpipHtoll oec RM IMEEM MEM LM mM 3 Indications ato BI e p 3 C OBfFaTndicattOHls o onoce iore aee NNaP ee te a ite OR LIMES oo Qs LE Ceu Coe dead ane 3 Warno Soest ps cies asa a utto iintois ie datets ttal t ser des tese aaa 4 C OUO ariar n ctr can due p SUCH en alan toca M A cert aa SD 4 PPT o PRINTS d ERE RR ET T cata TR S 5 Proper Use and NESBIGBABee o dened as daatashas os em tte etnia E E a e Ani cuts dd 6 Initial SECU A Asse ND ausi seii paited to Ht E eiusm asti ce settle api Rc ad 6 CONO shed aera en ec canto dua tole tdt iiec tod spei testet ott oceano 6 Mounting the Hot Dog Controller to an IV Pole ccc cccceesseesesesessseessessssceeeeaaeeeeeeeeeeeeees T Control Panel Features amp Operating Modes ccccccccesssssssssssssecceceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeees 8 ZUIGUBIS ea EE ge aide ub d ntum E assa enu teh enna netstat sn E A aoa 9 EOC OIE perpe2. Number Manufacture Date Transport and storage humidity range EU Authorized Return to Authorized Equipotential i Representative Representative Temperature Sensor Conforms to European Medical Device Directive 93 42 EEC Keep Dry QWTER Ty Medical Equipment Classified by Intertek Testing Services NA Inc with respect to electric shock fire and mechanical J hazards only in accordance with UL 60601 1 Classified under the Medical Device Directive 93 42 EEC as a Class IIb C US Are device ACCESSORY PART NUMBERS The following cable part numbers are used with the Hot Dog Patient Warming System A101 Hot Dog Warming Blanket Cable 4m 13ft A112 Hot Dog Mattress Cable 4m 13ft User Manual Hot Dog Patient Warming System Controller Page 17 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 hung on a OR gurney rail using optional hanging hooks Temperature Characteristics Temperature Control a Micro processor Operating Temperatures i Blanket Ports A and B adjustable in 1 C increments 37 to 43 1 07C 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 2 1 8 F Safety System Ports A and B Warming Blanket Primary Over t
3. 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 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 User Manual Hot Dog Patient Warming System Controller Page 15 TECHNICAL SUPPORT amp CUSTOMER SERVICE 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 Management 6581 City West Parkway Eden Prairie MN 55344 USA TEL 952 465 3500 FAX 952 465 3501 www hotdogwarming com User Manual Hot Dog Patient Warming System Controller Page 16 DEFINITION OF PRODUCT SYMBOLS us Mains P Do Not Place Under Patient This Side Up ains Power On Indicator This Side Down Heating Area A Attention consult accompanying documents BF Patient Applied Part Serial Number according to IEC60601 1 i Transport and storage Temperature Temperature in Range P ui p temperature range P Adjustment Reference Number Lot
4. MC 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 The Hot Dog Patient Warming System uses RF energy only for its internal function Therefore its RF emissions are ver RF emissions CISPR 11 Group 1 id pda i Md 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 Harmonic emissions IEC 61000 3 2 all establishments other than domestic and those directly connected to the public low voltage power supply network Voltage fluctuations flicker ortis that supplies buildings used for domestic purposes emissions IEC 61000 3 3 j User Manual Hot Dog Patient Warming System Cont
5. N CSA C22 2 No 601 1 EN 55011 TER TE CS W ITE 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 ll 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 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 User Manual Hot Dog Patient Warming System Controller Page 19 ELECTROMAGNETIC COMPATIBILITY EMC The Hot Dog Patient Warming System requires special precautions regarding E
6. cal procedures and to help prevent unintended hypothermia The system is powered and controlled by an electronic control unit Warming devices 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 under or over the patient depending on which warming device accessory 1s 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 1s 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 cro
7. der pressurized bony prominences Care should be taken to place the patient s body in contact with the labeled sensor on the Warming Mattress 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 DO NOT place the Warming Mattress over a table joint that will move during surgery DO NOT use on OR tables wider than 20 inches 50 8 cm DO NOT use the Warming Mattress as a stand alone patient pressure relief system 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 DO NOT fold or wrinkle the Warming Mattress during use as localized heat build up may occur in the overlapped area DO NOT use the Warming Mattress when pressure injury is a concern DO NOT X ray or MRI through the white labeling or edges of the Warming Mattress DO NOT allow patient fluid lines to be placed between the Warming Mattress and Warming Blanket or other warming equipment DO NOT position the patient s head directly on the Warming Mattress 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 User Manual Hot Dog Patient Warming System Controller Page 6 PROPER USE AND MAINTENANCE Do not op
8. echnical Support see page 15 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 User Manual Hot Dog Patient Warming System Controller Page 13 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 ammoniu
9. emp Alarm 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 Independent electronic circuit shuts the heater off if the Warming Mattress temperature reaches set point 2 5 C Time out timer If warming device does not reach set temperature within 10 minutes the controller will alarm Six hour timer If a warming device is left at a steady setting for six hours the controller will discontinue power to warming device Over current limits System Over current Protection Dual input fused lines User Manual Hot Dog Patient Warming System Controller Page 18 Electrical Characteristics Leakage Current Meets UL 2601 1 and IEC 60601 1 requirements for Class Type BF equipment Device Ratings f 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 T10AL250V 2 x 5x20mm Environmental Conditions Environmental Conditions for Transport Temperature 20 C to 60 C and Storage Humidity 20 to 80 Keep Dry Environmental Conditions for Use Temperature 15 C to 25 C Humidity 20 to 80 Classification and Standards Certifications IEC 60601 1 EN 60601 1 2 UL 60601 1 CA
10. emperature Port Over current System Over current Sensor failure Over Temperature Array Alarm 6 hour time out timer 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 Cable connecting warming device to Controller is disconnected or power is removed at mains When the temperature exceeds 46 C audible and visual alarms are initiated The alarm will reset when the device is unplugged or power is removed at mains 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 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 When system current draw exceeds a predetermined level audible and visual alarms are initiated The alarm will reset when power is removed at mains 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 In warming devices equipped with an over temperature
11. en the Hot Dog Controller There are no user serviceable parts If service is required contact Technical Support see page 15 The manufacturer assumes no responsibility for the reliability performance or safety of the Hot Dog Patient Warming System if the following events occur The Controller is disassembled or serviced by an unauthorized person The Patient Warming System components are used in a manner other than described in the User Manuals The Controller is installed in an environment that does not meet the appropriate electrical and grounding requirements The Controller is grounded and should not be attached to un grounded tables intended for use with a hyfrecator or equivalent devices INITIAL SETUP amp ASSEMBLY Contents The following components are included in the Hot Dog Controller box 1 Hot Dog Controller Model WC5X 1 IV pole adapter and mounting hardware Mains power cord I CD containing User Manual and Service Manual 1 Hot Dog Warming Blanket Cable P N A101 Reusable Hot Dog accessories e g Warming Blankets Warming Mattresses connecting cables OR table gurney rail hooks and Hot Dog Disposable Sheets are sold separately User Manual Hot Dog Patient Warming System Controller Page 7 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
12. erature has been reached 7 Monitor the patient s temperature regularly Adjust the temperature setting of the Hot Dog Controller as necessary to maintain the desired patient temperature 8 When patient warming therapy is complete turn the Mains Power Switch to OFF 9 After use disconnect the Hot Dog Controller from the electrical outlet 10 Discard disposable accessories following standard hospital procedure Clean the reusable warming device as instructed in the User Manual provided with the device User Manual Hot Dog Patient Warming System Controller Page 12 MAINTENANCE amp CLEANING 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 to right 3 After the lights illuminate in sequence the software version is displayed for approximately 2 seconds 4 After the sequence completes only the Mains Power ON Light remains illuminated 5 Ifthis sequence varies or is incomplete contact T
13. es and cables other than those specified in Hot Dog User Manuals 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 CAUTIONS Federal law USA restricts this device to sale by or on the order of a licensed healthcare professional User Manual Hot Dog Patient Warming System Controller Page 5 PRECAUTIONS General Use under the direct supervision of a clinician Monitor the patient s vital signs regularly during warming according to institutional protocol If vital sign instability occurs notify the clinician Care should be taken when using multiple warming methods 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 Ensure that the Warming Mattress is securely fastened to the table The use of gel pads between the Warming Mattress and the patient is not recommended gel pads may cause a loss of warming performance Always use a patient barrier between the patient and the Warming Mattress Care should be taken to alleviate or remove the risk of heating skin un
14. f the transmitter Recommended separation distance d 1 24P Conducted RF 3 Vrms d 0 354 P 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 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 NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a 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 veri
15. fy normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Hot Dog Patient Warming System b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m User Manual Hot Dog Patient Warming System Controller Page 22 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 m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz dedo d 035J P d 0 74P power of transmitter 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 a
16. ive humidity 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 NOTE UT is the a c mains voltage prior to application of the test level User Manual Hot Dog Patient Warming System Controller Page 21 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 1 Electromagnetic Environment Immunity Test Compliance Level f 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 o
17. m detergent and accelerated hydrogen peroxide e g Virox Cleaners that 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 User Manual Hot Dog Patient Warming System Controller Page 14 TROUBLESHOOTING ERROR CODES EE on all ports System failure Contact technical support E1 on affected port E2 on affected port E3 on affected port E3 on all ports E4 on affected port E5 on affected port Primary over temp Secondary over temp Failure to reach temp Time to T
18. n mere TON eee see NO RIC era uec cedi ne Ine ose UU pa ME Lv ent mtn can el rey ae ert re 10 oe on TOPDSe Case du darc uto een cp mice NS DEM Opener ae entree ee 11 Mantenan GS ANNs ceca o E E A OE 12 Tesune or Indicator Dicht Puncuons osito a a mM Ri 12 CIcanino Generdl sso ete er eed mates ke N eei A e Deni 12 CIcanimne Controllef vehe n See eee etm mE mem ta e emen p A rM 13 Clean o Watrimne Devices oom aot deis it t au edebant est inu Site tau 13 Technical Support amp Customer Seb5VI6Ce aiid steal eran edis iia 15 Detimtiomof Product Symbols om eet ete eons s ach ceri aes Sond ott Ud fida 16 Accessory Pare NUIDSETS a odit vetu em det t tetur lor avast ac aaah esu esu Us 16 SPECON S essetis Pte nen tar anette MK Crac d UD es 17 Electromagnetic Compatibility BMC uoo etie na edente perna DUO ud odia ond patte age e Ei teme e 19 User Manual Hot Dog Patient Warming System Controller Page 3 INTRODUCTION Device Description 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 use and 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 surgi
19. nd 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 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 2135EN Revision J 6 14 2012
20. og Patient Warming System Controller 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 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 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 B and 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 temperat
21. r If a warming device is left at a steady setting for six hours the controller will discontinue power to warming device User Manual Hot Dog Patient Warming System Controller Page 11 INSTRUCTIONS FOR USE The instructions below describe how to operate the Model WC5X Controller For information about Hot Dog warming devices and accessories refer to the User Manual provided with each device accessory 1 Mount the Hot Dog Controller on an IV pole or the OR table gurney rail refer to page 7 or place the device on a flat horizontal surface 2 Insert the Hot Dog Controller power plug into a properly grounded hospital grade electrical outlet Note The Controller is grounded and should not be attached to un grounded tables intended for use with a hyfrecator or equivalent devices 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 Position and secure the Hot Dog warming device e g Warming Blanket Warming Mattress following instructions in the User Manual provided with the device 5 Insert the warming device connecting cable into the proper port on the Controller Future approved Hot Dog accessories 6 Press the Temp Adjust Button that corresponds with the port being used until the desired temperature is set as indicated by the Temp Setting Display The display will flash until the temp
22. roller Page 20 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 Immunity Test Compliance Level i Test Level Guidance 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 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 96 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 96 UT gt 95 96 dip in UT for 0 5 cycle 40 96 UT 60 96 dip in UT for 5 cycles 70 UT 30 96 dip in UT for 25 cycles 5 96 UT gt 95 96 dip in UT for 5 sec Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relat
23. securely tightened Figure 1 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 1 Hot Dog Controller Mounted on an IV Pole The Controller may also be suspended from the OR table gurney rail using optional hooks Figure 2 Figure 2 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 User Manual Hot Dog Patient Warming System Controller Page 8 Control Panel Features amp Operating Modes Figure 3 Hot Dog Model WCSX 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 PortsA amp B Port C PortsD amp E Used only for Hot Dog Used only for Hot Dog 48V output for Warming Blankets Warming Mattresses future approved Hot Dog accessories User Manual Hot D
24. ss 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 User Manual Hot Dog Patient Warming System Controller Page 4 WARNINGS General 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 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 holes or loose electrical connections If signs of wear are evident do not use the product until it is inspected by technical staff e DO NOT continue to use the Hot Dog Patient Warming System if the over temperature indicator and or alarm continue to sound after reset Refer to the Alarm section of this manual for more information 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 Warming Mattress is not sterile Take appropriate precautions as necessary to protect the sterile field Accessories and Other Equipment e Accessori
25. ure sensors are present and functioning properly Port D and E Ports D and E supply a 48V output for future approved Hot Dog accessories at this time there are no accessories manufactured for use on these ports 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 1s 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 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 User Manual Hot Dog Patient Warming System Controller Page 10 Error Codes The Controller displays the following error codes on the Temperature Display for specific alarm conditions E3 on all ports System over current condition E4 on affected port Primary or secondary broken sensor alarm E5 on affected port Over temperature array alarm Six hour time
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