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2. D3 16 5 z 81 aa 14 D De q8 E g q e DP1 11 w r sl 82 A el amp A sel D2 i E2 De 7 F2 A e A el amp 1 2 12 Do DP a f 3 D1 Ai seca Z LN524GA D2 13 3 3 53 qa D SEGB gt 4 D4 w 193 SEGC 155 4 5 e IDA SHUT SEGD 15 7 E E pehe sear 2 St pa D7 7 26 8 ag ID7 DATA SEGG ie 9 18 10 a MODE DE 3 B1 11 WRITE Dr 7 A zl o d 12 DE Los A 7 D De 13 DS hy T 1a E 14 A D 173 f 7 A 15 D Las zy e 16 D2 Ce A DP1 Di rg CON16 ag TOM7218AIPI 10 sl 82 v el t ct E el 22 ig 8 c2 c3 ca 3 E De al Gelle ES 1 1 1 2 DP2 LN524GA Figure 41 Display Printed Circuit Board Schematic Diagram 81 Index A Accessories 63 Alarm silence 7 Alarm test 7 28 B BF classification 7 C Canadian Standards Association 7 Cautions 2 Chassis assembly replacement 50 Clean exterior surfaces 27 Clean heater plates 27 Contra indications 5 Cover assembly replacement 30 D Dimensions 55 Display PCB assembly replacement 38 Disposable fluid warming cassettes 63 Disposal of fluid sets 66 Door assembly replacement 46 Drip proof 7 E Electrical safety check 28 El
3. rrnrrnnnnannnrrnnnnnnnnrennnnrnnnrrnnnnrnnnrrnnnernnnrrnnnnennnrrnnneenn 25 Preventive MANE El 27 Seice and HA vrede 29 10 00110 E E EE E A 29 Modu e RE 29 Replacement Level Support coooooccconnccconoccccoonccnononcnnnnnccnnnncnnnn cn cnn nn nana nc cnn nc cnn anna 30 Cover Assembly Replacement ccccccceeeseeeeeceeeeeeeeceaeeeseaeeesesaeteseeeesenaeessaeees 30 Fuse ee Eu 34 IV Pole Mount Replacement sorarsan inaari aa na a a 35 Main PCB Assembly Replacement rrnnnnnvnnnnnrrnnnnnnvnrnnrrvnnnnnnnrnrrrennnnnnrrrrrneennnnerenn 36 Display PCB Assembly Replacement rrnnnnnnrnnnnnvnnnenvrnnnnnvnnnnrrnnnnnrnnnennrensnnrnnernnne 38 Rear Panel Assembly Replacement AA 41 Door Assembly Replacement coconnocccccnnncocccccnnnanonccnna nan n cc rra nar r cc cnn rr 46 Warmflo Model FW 538 i Contents Chassis Assembly Replacement rrrnrnnrnnnnnrnnnnnrnnnnnnvnnnnrrvnnnnnnnrsrrnennnnnerrrrnesnnnnnnnn 50 et re 11010 RE TN 55 Bil Et IT 55 Le EE 55 Technical Specifications 55 Transportation and Storage occccincccnnncccnncccnnnnncccononcnnnnn cn narran rca rar 56 Performance Requirements ooocncccccnnncccccnnnnnoncccnnnnnnnn cnn nn nnrn cnn nan nnnn cnn rra 56 ene 56 Manufacturer s Declaration renrannvrvnnnnnnnnvvnnnnnnnnvrnnnnnnnnnnnnnnnnnnnnnnnnnrsnnnnnnnerennnnnn 59 Spare Parts and Accessories EE 63 INTOQUCION ae 63 Disposable Fluid Warming Sets mennrnnnnnvnnnenvrnnnnnvnnnrnrrnnnnrnnnnrnrnnrnn
4. Class I on AC power Degree of protection Type BF Applied part Mode of operation Continuous Resistant to liquid ingress EN 60601 1 sub clause 44 6 for class IPXO ordinary Specifications Table 4 Model FW 538 Compliance Item Compliant With Degree of Safety in presence of a flammable anaesthetic UL 2601 1 sub clause 5 5 Not suitable Applied label to indicate Type BF applied part EN 60601 1 Symbol 2 of Table DII of Appendix D Equipotential lug symbol to indicate a potential equalization conductor EN 60601 1 Symbol 9 of Table DI of Appendix D Attention symbol consult accompanying documentation EN 60601 1 Symbols 14 of Table DI of Appendix D External case made with non conductive plastic EN 60601 1 sub clause 16 a No holes in case top EN 60601 1 sub clause 16 b Rigid case EN 60601 1 sub clause 21 a Case mechanically strong EN 60601 1 sub clause 21 b Case handle EN 60601 1 sub clause 21 c Resistant to rough handling EN 60601 1 sub clause 21 6 Tip tilt test EN 60601 1 sub clause 24 1 Resistant to liquid ingress due to spills EN 60601 1 sub clause 44 3 as modified by EN 865 clause 4 Environmental EN 60601 1 sub clause 44 5 Cleaning EN 60601 1 sub clause 44 7 Case surface made of non toxic materials EN 60601 1 sub clause 48 Case resistant to heat and fire EN
5. Description AD 500FW Infusor 500 ml AD 1000FW Infusor 1000 ml AD 1500FW Infusor 500 amp 1000 ml Mounted AD 2000FW Infusor Dual 1000 ml Mounted If the FW 538 fluid warming system is used with a surgical irrigation pump or an automatic pressure infusor carefully read the accessory directions for use and all warnings precautions and specifications before using the equipment with the FW 538 Warmflo Model FW 538 63 Spare Parts and Accessories Spare Parts and Accessories 64 Description Part Number Ped Air filter mount bracket 067045 2 Chassis assembly 520 0006SP 5 Cover assembly 128 0017SP 1 Door assembly 520 0010SP 6 Fuse 0 063A 50 volt 128 5002 Display PCB assembly 520 0014SP 7 Main PCB assembly 520 0017SP12 3 Wire cover plug 128 5018SP Power cord 14 ft 901 1502SP Rear panel assembly 128 0009SP 4 Replacement filter for WF 250 SF 150 surgical set IV pole screw 128 2039 8 PCB assembly screws 128 2036 Rear panel attachment screws 128 2031 Strain relief 128 2020 Spare Parts and Accessories Figure 37 Spare Parts 65 Warmflo Model FW 538 Spare Parts and Accessories Disposal of Fluid Sets Fluid sets should be disposed using the hospital standard procedure for disposing of blood products Disposal Of Fluid Warming System Nellcor recommends that the institution follow local governing ordinances
6. e Over Temperature Alarm Check on page 13 Display PCB Assembly Replacement The replacement display PCB assembly comes assembled with e 1 display PCB e 1 16 pin connector e 1 16 conductor ribbon cable 38 Service and Repair The tools required for this procedure are Tool Parameters Use Hex driver 9 64 inch Phillips screwdriver 1 Torque driver wrench 6 inch Ibs 15 cm kg 5 inch lbs 13 cm kg Use the following procedure to replace the display PCB assembly 1 Warmflo Model FW 538 Turn the FW 538 off by pressing the power switch located at the back of the unit to 0 Unplug the FW 538 from AC power Disconnect the power cord from the FW 538 Remove the FW 538 cover See Cover Assembly Replacement on page 30 Disconnect the cover assembly cables from the main pcb See Figure 19 1 Keypad cable connection 2 Display cable connection Figure 19 Cover Assembly Cable Connections 39 Service and Repair 6 Remove the screws holding the display assembly to the cover See Figure 20 1 Cover assembly 2 Display PCB assembly Figure 20 Display Assembly Screws 7 Remove the display PCB assembly 8 Discard the removed display PCB in accordance with local regulations 9 Install the new display assembly in the cover assembly The screws should be torqued to 5 inch lbs 13 cm kg See Figure 20 10 Connect the cover assembly cables to the main PCB
7. 2 Unplug the FW 538 from AC power 3 Remove the power cord from the FW 538 4 Remove the FW 538 cover See Cover Assembly Replacement on page 30 36 Service and Repair 5 Disconnect all cables from the main PCB assembly See Figure 16 1 J12 2 J10 3 J14 4 J9 5 J4 6 J3 7 J1 8 J2 Figure 16 Main PCB Cable Connections 6 Remove the screws holding the main PCB assembly to the chassis assembly See Figure 17 Figure 17 Main PCB Screws 7 Carefully lift the main PCB assembly from the chassis assembly 8 Discard the removed main PCB assembly in accordance with local regulations 9 Install the new main PCB assembly in the FW 538 The screws should be torqued to 3 inch Ibs 8 cm kg See Figure 17 Warmflo Model FW 538 37 Service and Repair 10 Connect all cables to the main PCB assembly See Figure 18 1 J12 2 Jl4 3 J10 4 J9 5 J4 6 J3 7 J1 8 J2 Figure 18 Main PCB Cable Connections 11 Replace the cover assembly on the FW 538 See Cover Assembly Replacement step 12 on page 33 12 Perform the following checks test to verify proper operation of the FW 538 prior to returning the unit into service Test 1 Zone Heating Monitoring on page 9 e Test 2 Individual Thermistor Monitoring on page 9 e Test 3 Automatic Thermistor Zone Monitoring on page 10 e Output Temperature Test on page 10
8. 3 Warmflo FW 538 The FW 538 fluid warming system is designed for use in medical environments under the direction of a physician to warm blood intravenous IV and irrigation fluids The FW 538 fluid warming system uses a heat exchanger cassette that is inserted between microprocessor controlled heater plates located within the warmer housing The dry heat process is safe reliable and requires little warm up time There are a variety of disposable blood and fluid administration sets available for use in routine surgery standard intravenous warming and irrigation applications Introduction The FW 538 fluid warming system may be used as a gravity flow device or in conjunction with automatic and manual pressure infusors and irrigation pumps to deliver fluids Figure 4 Warmflo Model FW 538 with WF 250 Surgery Set A Warmflo pressure infusor or irrigation pump optional WF 250 heat exchanger cassette Warmflo model FW 538 Roller clamp Air eliminator chamber with filter Dual injection port Introduction System Symbols The following symbols are used on the FW 538 unit On Off O a vull Alarm Test Alarm Silence Underwriters Laboratories Inc Shock Hazard BF Classification GR Canadian Standards Association IPXZ Drip Proof DA Refer to Instructions for Use y Equipotential Terminal ground Warmflo Model FW 538 7 Blank Page Performance Verification Int
9. 3 A p 2 2v2 22 d 47K 74HC27 Y 1 e vec e Dr cis SS 1 74HC367N Di vizc 3 S ar DISABLE E D I 15 S Sey 2 gt Br m 7 8 4 Jo io Ea _ o 12 74HC27 4 13 14 Ras ab 15 te Hove cs S An 1 MAX202CPD t f ke RS 232 EE 1 I Y Po v i a e x s gt gt wer NE 07 Je e ca aa cas cas ca Ce ar Ce Cao as cs aa co I AI 5 1 a 1 1 1 1 a 1 e k a Figure 39 4 4 4 4 4 GND i Main Control Board Schematic Diagram Sheet 1 of 2 77 Theory of Operation DC POWER SUPPLY Ka LM340T 5 CS Vec GI on LZ e FOR 220 240 VAC INPUT CUT J2 AND J3 o FB 2 FOR 100 120 VAC INPUT CUT J1 c5 amp e a D Fl Op DI 470 1 See 10 S B a RXES0 i LINE 2 1 5 SK 4 E NEUTRAL oi J E d FAN a 1 16A 240 VAC Slo Blo a n och E 2k SN Power Input JR zs De DFO KC nwa ohm 275V 8 e BRIDGE s Ohms 423 Gs Prem SPW 1100 nm TRANSFORMER HEATER ENAB
10. 60601 1 sub clause 59 2 b Fuse holder EN 60601 1 sub clause 59 3 Exterior markings EN 60601 1 sub clause 6 1 6 3 and 6 4 Front panel and case labeling EN 60878 EN 980 ISO 7000 EN 60417 1 EN 60417 2 Button spacing ISO 7250 Year of manufacture symbol EN 980 Conductive coating and polymeric materials UL 2601 1 clause 55 Operation during physical shock EN 60068 2 27 at 100 g Operation during vibration EN 60068 2 6 and EN 60068 2 34 Warmflo Model FW 538 57 Specifications 58 Table 4 Model FW 538 Compliance Item Compliant With Electromagnetic Compatibility EN 60601 1 sub clause 36 EN 60601 1 2 second edition Radiated and conducted emissions EN 55011 Group 1 Class B Harmonic emissions EN 61000 3 2 Electrostatic discharge immunity EN 61000 4 2 level 3 table top equipment Radiated radio frequency electromagnetic field immunity EN 61000 4 3 at 3V m Electrical fast transient burst immunity EN 61000 4 4 level 3 Table 10 Surge immunity EN 61000 4 5 level 3 FDA Reviewer s Guide Conducted EMI susceptibility EN 61000 4 6 at 3 Vrms Power frequency magnetic fields EN 61000 4 8 at 3 Vrms Operation with line voltage variations EN 61000 4 11 Table 7 Operation with electrical line voltage variations FDA Reviewer s Guide Radiated magnetic field emiss
11. and recycling instructions regarding disposal or recycling of device components Fluid warming sets cannot be recycled The FW 538 fluid warming system contains no toxic materials 66 Packing for Shipment Introduction To ship the FW 538 for any reason follow the instructions in this section Returning the FW 538 Contact Nellcor s Technical Services Department or your local Nellcor representative for shipping instructions including a Returned Goods Authorization RGA number Unless otherwise instructed by Nellcor s Technical Services Department it is not necessary to return accessory items with the FW 538 Pack the FW 538 in its original shipping carton If the original carton is not available use a suitable carton with appropriate packing material to protect it during shipping Return the FW 538 by any shipping method that provides proof of delivery General Instructions Pack the FW 538 carefully Failure to follow the instructions in this section may result in loss or damage not covered by any applicable Nellcor warranty If the original shipping carton is not available use another suitable carton North American customers may call Nellcor s Technical Services Department to obtain a shipping carton Prior to shipping the FW538 contact your supplier or local Nellcor office Technical Services Department for a returned goods authorization number Mark the shipping carton and any shipping documents with the re
12. assembly See Figure 21 1 Keypad cable connection 2 Display cable connection Figure 21 Cover Assembly Cable Connections 40 Service and Repair 11 Install the cover assembly on the FW 538 See Cover Assembly Replacement step 13 on page 33 12 Perform the following checks test to verify proper operation of the FW 538 prior to returning the unit into service Test 1 Zone Heating Monitoring on page 9 Test 2 Individual Thermistor Monitoring on page 9 Test 43 Automatic Thermistor Zone Monitoring on page 10 Output Temperature Test on page 10 Over Temperature Alarm Check on page 13 Rear Panel Assembly Replacement Warmflo Model FW 538 The replacement rear panel assembly comes assembled with 1 rear panel 1 fan assembly 1 equipment label 1 equipment serial number label 1 3 position connector 1 6 Amp circuit breaker 1 6 Amp input filter 1 equipotential pin 2 6 mm thin nuts 2 6 mm lock washers 1 color code washer 1 ground label 1 3 inch 7 6 cm brown wire assembly 1 3 inch 7 6 cm blue wire assembly 1 5 25 inch 13 34 cm brown wire assembly 41 Service and Repair e 1 5 25 inch 13 34 cm blue wire assembly e 2 4 5 inch 11 4 cm green yellow wire assemblies The tools required for this procedure are Tool Parameters Use Hex driver 9 64 inch Phillips screwdriver 1 Socket 10 mm Torque
13. cm kg Use the following procedure to replace the cover assembly 1 Turn the FW 538 off by pressing the power switch located at the back of the unit to 0 2 Unplug the FW 538 from AC power 3 Disconnect the power cord from the rear of the FW 538 30 Service and Repair 4 Remove the filter mounting bracket from the cover assembly using a 1 4 inch hex driver See Figure 8 Figure 8 Filter Mounting Bracket Removal 5 Remove the IV pole mounting bracket using a 1 4 inch allen wrench See Figure 9 Figure 9 IV Mounting Bracket Removal Warmflo Model FW 538 31 Service and Repair lifting the cover off of the unit Do not put excessive pressure on the Caution The cover is attached to the main pcb by two cables Use care when 6 connecting cables 6 Lift the cover assembly off of the FW 538 7 Disconnect the keypad cable from the main PCB assembly See Figure 10 item 1 Figure 10 Cover Assembly Cable Connections 8 Disconnect the display PCB assembly cable from the main PCB assembly See Figure 10 item 2 9 Remove the display PCB assembly from the cover assembly See Figure 11 1 Cover assembly 2 Display PCB assembly Figure 11 Display PCB Assembly Removal 10 Discard the old cover assembly in accordance with local regulations 32 Service and Repair 11 Install the display PCB assembly into the new cover assembly The screws should be torqued to 5 inch lbs
14. distance 1 2NPower EN 61000 4 3 80 MHz 80 MHz to 800 MHz 800 MHz 3 V m 3 V m distance 2 3NPower 800 MHz 800 MHz to 2 5 GHz 2 5 GHz Conducted RF 3 Vrms 3 Vrms distance 1 2 Power EN 61000 4 6 150 kHz 150 kHz to 80 MHz 80 MHz Note 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 survey 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 FW 538 is used exceeds the applicable RF compliance level above the FW 538 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the FW 538 Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Interference may occur in the vicinity of equipment marked with the following symbol tn Warmflo Model FW 538 61 Specifications 62 Table 8 Recommended Separation Distances Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the FW 538 EN 60601 1 2 Frequency of 26 MHz to 80 MHz to 800 MHz
15. driver wrench 3 inch lbs 8 cm kg 40 inch lbs 102 cm kg Use the following procedure to replace the rear panel assembly 1 42 Turn the FW 538 off by pressing the power switch located at the back of the unit to 0 Unplug the FW 538 from AC power Disconnect the power cord from the FW 538 Remove the FW 538 cover assembly See Cover Assembly Replacement on page 30 Place the cover assembly in a safe place Disconnect the rear panel assembly cables from the main PCB assembly See Figure 22 1 J4 2 J3 Service and Repair Figure 22 Rear Panel Cable Connections Note On some of the FW 538 units the equipment label covers the rear panel assembly screws 7 Remove the rear panel assembly equipment label See Figure 23 item 1 Figure 23 Rear Panel assembly there will still be two green yellow wires attached to the 6 Caution When the rear panel assembly is unscrewed from the chassis chassis Do not place undue stress on these wires 8 Remove the rear panel assembly from the chassis assembly See Figure 24 Figure 24 Rear Panel Screws Warmflo Model FW 538 43 Service and Repair 9 Disconnect the two small green yellow wires attached to the chassis assembly from the rear panel assembly equipotential terminal See Figure 25 1 Equipotential terminal 2 Green yellow wire 3 Green yellow wire Figure 25 Rear Panel Ground 10 Discard the removed re
16. from the microcontroller if the temperature exceeds 45 C 1 C A continuous audible alarm and display of temperature preceded by the letter H HXX X indicate this condition If a fault code is reported the display will alternate between the temperature and the reported fault code The secondary over temperature protection is hardware implemented The over temperature reference signal OT REF HI is formed by the voltage divider circuit which consists of R23 5760 ohms 1 and R21 4530 ohms 0 1 the output of which is applied to the comparator U15 pin 13 which disables the heaters If current to the heaters is detected this condition is not recoverable without turning off the unit If the condition is due to preheated fluid or overshoot Warmflo Model FW 538 73 Theory of Operation due to an abrupt stoppage of flow the unit will resume operation when the fluid temperature falls below the temperature setting Under Temperature Operation Display Board Keyboard When the output temperature is 3 C or more below set point for ten seconds a short beep will sound every five seconds and the display will flash with the first digit displaying L to indicate an under temperature condition but the warmers will continue operation The display board is connected by a ribbon cable to J10 of the main circuit board The display consists of a four digit green LED Each segment of the leading digit is addressable b
17. is turned on it enters a start up test mode The software executes a test of the following microprocessor components RAM US ROM U25 Warmflo Model FW 538 71 Theory of Operation e CPU registers e watchdog U30 e NVRAM Non Volatile RAM U19 If one of these tests fails an appropriate fault code in the format F_ indicates the condition and an alarm will sound For fault code values refer to Table 2 on page 20 If a fault code is displayed the unit must be turned off and then restarted If the fault has been resolved the unit will then proceed through the sequence of startup tests As start up proceeds the following events occur e Each thermistor is checked for open short and within range conditions Each heater is tested to ensure that current flow is under software control and that the power triacs operate correctly e If all test results are normal the unit conducts an LED display test All segments for each digit are displayed and held for 2 3 seconds e The software version number is then displayed The user should verify that all segments are displayed during this time The unit then enters the preheat mode during which a running dash line is displayed e When the default temperature set point is reached 38 C is displayed At this point the unit enters normal operational mode Heater Control Circuitry 72 The power for the heaters is supplied through
18. model 6510 Turn on the thermocouple temperature monitor Use the roller clamp 3 on the cassette outlet tube to adjust the fluid flow to 100 25 ml per minute while the button on the WI 48 B is depressed Note This flow may be measured by timing fluid collection in a small graduated cylinder Allow the fluid to flow for 1 minute before taking readings The average fluid output temperature should be 38 C 2 C at 100 25 ml per minute as measured by the temperature probe If the above performance cannot be met refer to Troubleshooting on page 19 Over Temperature Alarm Check This procedure verifies the operation of the alarm system when an over temperature condition is detected during operation of the FW 538 In addition to the FW 538 fluid warming system the following equipment is required bag and its heated contents WARNING Liquid at 55 65 C is a burn hazard Use care in handling the IV e WF 8860 test kit part number 8860 which contains Cassette and tubing WI 48 high flow wound irrigator e Saline IV bags 2 Cool one bag to 8 10 C heat second bag to 55 65 C e IV pole The following equipment is optional Warmflo Model FW 538 13 Performance Verification e Warmflo pressure infusor s or Warmflo irrigation pump s e Graduated cylinder e Mon a therm temperature monitor model 6510 or equivalent type T thermocouple temperature monitor and reusable TAB instrument cable part number 50
19. power triacs whose drivers are isolated from the microprocessor by zero crossing type opto couplers U1 U2 and U4 The microprocessor senses when current is being drawn through the heaters Heater current detect circuitry includes transformer T1 diodes D7 and D8 and comparator U15B The voltage induced in the secondary of the transformer T1 is clamped by D7 and D8 This circuit limits the output swing to one diode drop voltage This voltage is applied to the inputs of the comparator LM393 which in turn sends a CURRENT_SENS signal to U21 80C5552 microcontroller with an 11 0592 MHz crystal The microcontroller initiates a HEATER_SET signal which is applied to the EXTERNAL OT U10 Output from U10 is the HEATER EN signal which reflects the status of the master triac This signal may be set HIGH triac disabled by the EXT_OT signal provided by hardware The HEATER_EN master enable signal controls the U3 optoisolator which in turn powers the HEATER DRIVERS and HEATER CURRENT SENSOR circuit After heater current is Theory of Operation detected the microcontrollor initiates an on off test of each triac through signals DRV ZN1 DRV ZN3 Port 1 of U21 which are applied to the octal buffer U13 in sequence The HEATER OC from U21 enables or disables the buffer U13 Temperature Sensing Circuitry Four thermistors SENS_ZN1 SENS ZN2 SENS ZN3 and Lower Plate are embedded in the heater plates using a highly heat conductive eclectic
20. squeeze until the drip chamber is half full of fluid B b Close the pinch clamp E c Turn the saline bag right side up and hang the bag from the IV pole hook at least one 1 meter from the warming unit or install it in a Warmflo pressure infusor or irrigation pump 3 Open the pinch clamp E and use this line to spike the 55 65 C saline IV bag Install the 55 65 C saline IV bag as follows Note The Mon a therm monitor and temperature probe may be used to determine the temperature of the pre warmed IV solution a Hold both the saline bag and the drip chamber upside down Squeeze the saline bag to push air from the bag into the drip chamber Continue to squeeze until the drip chamber is half full of fluid b Close the indicated pinch clamp c Turn the saline bag right side up and hang the bag from the IV pole hook at least one 1 meter above the warming unit or install it in a Warmflo pressure infusor or irrigation pump 3 Close the roller clamp 3 on the cassette outlet tube 15 Performance Verification 10 11 12 13 14 15 16 17 18 19 Pinch the ball in the air vent tube on the air elimination chamber Saline solution will begin to flow from the bag into the 8860 test cassette set Allow the chamber to fill 3 4 to the top with saline solution Do not allow solution to rise into the air vent tube Tap the air elimination chamber to release micro bubbles from th
21. to Transmitter 80 MHz 800 MHz 2 5 GHz Equation d 1 2 P d 1 2 P d 2 3vp Rated Maximum Separation Separation Separation Output Power of Distance in Distance in Distance in Transmitter in Meters Meters Meters Watts 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the separation distance can be estimated using the equation in the corresponding column where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Spare Parts and Accessories Introduction The following Warmflo disposable fluid warming cassettes pressure infusors and spare parts are approved for use with the FW 538 fluid warming system Other fluid cassettes may be available Contact Nellcor s Technical Service or your local representative or check the internet at http www mallinckrodt com respiratory resp Serv_Supp Apartweb main PartAcceMenu html Disposable Fluid Warming Sets Part Number Description SF 150 WF 250 replacement filter WF 100 Cassette Fluid Warming WF 250 Cassette Surgical Fluid Warming 8860 Test Cassette Kit WF 8860 Infusors and Irrigators Part Number
22. 13 cm kg See Figure 11 12 Connect the display PCB assembly cable and the keypad cable to the main PCB assembly See Figure 12 1 Keypad cable connection 2 Display cable connection Figure 12 Cover Assembly Cable Connections 13 Place the cover assembly on the FW 538 unit 14 Install the IN pole mount bracket on the FW 538 The screws should be torqued to 6 inch lbs 15 cm kg See Figure 13 Figure 13 IV Mounting Bracket Removal Warmflo Model FW 538 33 Service and Repair 15 Install the filter mounting bracket from the cover assembly The screws should be torqued to 6 inch lbs 15 cm kg See Figure 14 Figure 14 Filter Mounting Bracket Removal 16 Perform the following checks test to verify proper operation of the FW 538 prior to returning the unit into service Test 1 Zone Heating Monitoring on page 9 e Test 2 Individual Thermistor Monitoring on page 9 e Test 3 Automatic Thermistor Zone Monitoring on page 10 e Output Temperature Test on page 10 e Over Temperature Alarm Check on page 13 Fuse Replacement The tools required for this procedure are Tool Parameters Use Hex driver 9 64 inch Torque driver wrench 6 inch Ibs 15 cm kg Use the following procedure to replace the FW 538 fuse 34 Service and Repair 1 Turn the FW 538 off by pressing the power switch located at the back of the unit to 0 2 Unplug the FW 538 from AC power 3 Remov
23. 2 0065 zs PoR m an o Eo Gs d zg EZ Figure 6 Setup for Over Temperature Alarm Function Check Referring to Figure 6 set up the FW 538 to verify the operation of the over temperature alarm 1 Turn the Warmflo fluid warming system power switch located at the rear of the unit to the ON position The control panel will display the start up test mode followed by the software revision number When the temperature set point is displayed 38 C default the unit is ready for operation Warm fo Model FW 538 Performance Verification Push the door latch button on the fluid warming system to open the cassette door The door will open approximately 1 2 inch 1 27 cm Slide a clean WF 8860 test cassette into the door opening until it is fully inserted Close the door by firmly lifting up on the door until it clicks into position This is indicated by the appearance of a green band on the top edge of the door latch button Note To ensure that the door is closed pull out on the door latch button until the green band is visible Close the pinch clamp E Mount the air elimination chamber into the holder on the side of the FW 538 Open the pinch clamp EY and use this line to spike the 8 10 saline IV bag Install the 8 10 C saline IV bag as follows a Hold both the saline bag and the drip chamber upside down Squeeze the saline bag to push air from the bag into the drip chamber Continue to
24. 9 e Test 3 Automatic Thermistor Zone Monitoring on page 10 Output Temperature Test on page 10 e Over Temperature Alarm Check on page 13 Chassis Assembly Replacement The replacement chassis assembly comes assembled with e 1 molded chassis e 6 threaded inserts e 5 4 x 3 8 flat head self tapping screws e upper heater plate assembly 50 Warm fo Model FW 538 Service and Repair The tools required for this procedure are Tool Parameters Use Hex driver 9 64 inch Phillips screwdriver 1 Use the following procedure to replace the chassis assembly 1 Turn the FW 538 off by pressing the power switch located at the back of the unit to 0 Unplug the FW 538 from AC power Remove the power cord from the FW 538 Remove the FW 538 cover assembly See Cover Assembly Replacement on page 30 Remove the rear panel assembly from the chassis See Rear Panel Assembly Replacement on page 41 Remove the main PCB assembly See Main PCB Assembly Replacement on page 36 Remove the door assembly See Door Assembly Replacement on page 46 51 Service and Repair 8 9 10 52 Remove the upper heater plate from the main chassis See Figure 36 1 Upper Heater Plate Figure 36 Upper Heater Assembly Discard the old chassis assembly in accordance with local regulations Install upper heater plate in the new chassis assembly See Figure 36 Install the door asse
25. ARNING Grounding reliability can only be achieved when the fluid warmer is connected to an equivalent receptacle marked HOSPITAL ONLY or HOSPITAL GRADE WARNING If a malfunction occurs in the fluid warmer discontinue use Notify your sales service center of the malfunction The unit must be serviced by an authorized service technician WARNING Cassette pressures above 300 mmHg may cause hemolysis Excessive pressures may burst the cassette Safety Information Cautions Cautions are identified by the CAUTION symbol shown above A caution alerts you to exercise care necessary for the safe and effective use of the FW 538 Caution Do not store liquids on top of the fluid warmer Caution Use only Warm lo disposable fluid warming sets with the fluid warmer Caution Do not use the fluid warmer with preheated fluids Fluids preheated above 44 C may activate the heater safety mechanism causing the high temperature alarm to activate 990 Notes 9 Notes are identified by the Note symbol shown above Notes provide additional helpful information Disposable Fluid Warming Set Warnings amp Cautions WARNING Refer to the instructions for use provided with all disposable fluid warming sets prior to use Warmflo Model FW 538 Safety Information Caution To avoid potential kinks in the fluid line at point 1 Figure 1 below route the fluid line through the channel in the filter mou
26. LE vee o x 7 KR 1 6 We we o TA o ca Ce as R33 Da Q5015L5 E S j 1 a mo E aa a ees 2 1N4148 SS SS ZERO CROSS y CIRCUIT D8 e MOC3063 T 1N4148 HEATER DRIVERS 1 6 RIS vec o A Los NT 601515 HEATER CURRENT DETECT 7 y o VAN 2 2 4 3 EA UPPER HEATER ua ZERO vee o CROSS ae CIRCUIT n MOC3065T Zone 1 Y Zone 3 1 6 R14 Zones 2 Su vec o we 3 4 10K vise mo A ou Heater Common co LM393N RAT ane Y N waa Q6015L5 Burndy HEADER Kei 2 4 3 HN UG CURRENT_SENS 7 100K iii u2 ZERO P gt CROSS CIRCUIT S gt MOC3065T R37 ma 680 we o 1 6 d Y Su o d Y sZA Q6015L5 HEATER_SET gt Y Ro K y 2 4 3 oy ut ZERO CROSS arcum MOC3065T EXTERNAL OVER Power Connections uio TEMPERATURE Se Si LOWER HEATER D PARTID 5V Ground EXT OT B j us 24 12 74HCOO u9 3 2 3 ug 14 7 S HEATER EN u12 14 7 Burndy HEADER u3 u13 20 10 2 18 DRV_ZNI gt 7 18 mw Lo U15 8 4 DRV_ZN2 cae m Uu i gt el me mm oh 19 8 5 184 14 u21 2 36837 DRV_ZN3 21 mm GE m L E u23 20 10 r im m D y ve 16 15 TT y U25 28 14 SS 1 pqg 16 n3 u26 16 NA HEATER_OC gt 1 q 26 Vee 5V 1 2 u27 16 8 T4HC244N HEEN gt S 4 U28 16 8 7 8 u29 16 8 OT REF E 9 10 u30 8 4 n 12 CURRENT SENS y 13 14 CEXT OT 15 16 HEATER SET TEST uio uio AA ee mt yooo 9 4 se S f A Figure 40 Le La Main Control Board Schematic Diagram Sheet 2 of 2 79 Theory of Operation
27. Warmf 0 Warm flo Fluid Warming System Model FW 538 SERVICE MANUAL Nellcor Puritan Bennett Inc is an affiliate of Tyco Healthcare Warmflo is a registered trademark of Nellcor Puritan Bennett Covered by the following patent 5 381 510 Contents EEE EEE tact eeeeetieeds i A lt P iii ME A L A A A E T E E iv Safety Information E 1 Warnings and Cautions merrrernnrrnnenvrnrnnrrnnnnnennnnrrnnnennenrnnrnnnsnnnnennrrnnennnensnrrnensnneneenn 1 elle E 1 E le EE 2 NOTES encore occidente VEE de ad at as catenin 2 Disposable Fluid Warming Set Warnings amp Cautions rannnnvnnnorrnnnnnnrnnnnrrnnnnnnnnnnn 2 A a A 5 Indications TOF USE EEE 5 ene Deele 5 le BEE 5 E Ee EE H Performance Verification ios 9 IAtrOdueti n sasssa ted 9 PN 9 Test 1 Zone Heating Monitoring rrrerennnonnrrrnnrnrnnrrnnnnnennrnnnnnrenrnnnrsrennnnnn 9 Test 2 Individual Thermistor Monitoring rerrrennrvnnnnnonnrrrnnnnrnnnrnnnrnnnnnnnen 9 Test 3 Automatic Thermistor Zone Monitoring cooooccccccnnonccccccnnacccccnnnnn 10 System Testing EE 10 Output Temperature Test oonncinnicccnnnicnnnncccccnnnnnnnn cnc nnnr nana 10 Equipment Required for Output Temperature Check rrrrnnnrrrrnrrrnnvrnnnrnnn 10 Test Procedure cuina AAA 11 Over Temperature Alarm Check rrrannrnnnenrrvnnnnrnnnervnnnnnnrnnrnnrenennrnnnrnnressnnrnnsennenn 13 Troubleshooting EE 19 Problems pacto adds 19 KE Oe 24 Electromagnetic Interference
28. a Oe Tower Plate Sensor 10 DRV ZN1 bes 7 Pa PO 4 AD4 S 14 3 p m 7 AB L q ve PIVEN Posos L 13 4 An KEYED A 2 DRV_ZN2 bes wel DACH PO 6 AD6 30 16 1 e PO m 2 maca PO7 AD7 15 2 ce 20 49 2 TEST DRV_ZN3 a Fam D ra 7 tie Zz zl PSR AE La ver D 3 ne PSEN Le TAST Di 1 77 24 de PAUS 45 T t vec AT29C256 12PC D2 1 w i mn E I S 7 2 om ai e as pme Fa S y D De HEATER_SET 2 Pao rann Lo D7 T FG sm P21 A09 bg 8 HEATER_OC lt a Damp rang 9 57 mam Ne 1 10 CURRENT SENS E 2 xc vs L p vec n 34 WE vss 7 48 o _ _ 12 HEATER_EN gt XTAL2 XTALI A Ne Pia us he 3 E 8 9 gt 8005524A88 S n Pa EE e D mo 32 E ss E A be 74HCO0 5 35 DISPLA H d H H a a Ys Ve 7 3 D os Lg em Ye E p Le 11 0592 MHz A ca v P 21 as os 74HC138N CH D 197 N alulalwuin VW a Dr u26 e 23882082 aK op a9 19 DIS Am B a 2222220 20 22272228 WATCHDOG en OE Bs Bag We eme elzlelslelelele TONE o v rile CURRENT SENS EXTERNAL OVER LD uns Lt ES CC Wa SET us d HEATER_OC ie oa E CSPUP 9 1 DI E lt sk Lach 5 gl unen O po S Ll rms Configuration wou O STORE vec LK RESET Vcc X24C44P u30 15 7 g ah a3 JMP5 6 2 ol as SRST TD Mr an id 5 eer rst mmer OT_REF_HI gt 47 SPEAKER 0ohm Ds1232 Lower Plate Cutto Ve V disable V reset 3 2 RAD m m SJ m wm Li Ee 7 5 um mm Im Ce a a e RESET GA 144 6 as u BI 2A1 22 5 2N3904
29. alloy which allows rapid sensing of zone temperature Thermistors 1 2 and 3 are connected to the Main Circuit board through connector J6 The lower plate thermistor is connected to the Main Circuit board through connector J9 Each sensor is located in the voltage divider circuitry which comprises a precision resistor 5760 ohms 0 1 and the corresponding temperature sensor The output signal from each voltage divider circuit is monitored by the microprocessor s analog to digital converter P5 0 2 P5 6 All four thermistors monitor the temperature of the heater plates The output fluid temperature is affected by both the rate of fluid flow through the cassette and the length of the tubing between the fluid warming system and the patient Over Temperature Operation If an output temperature of 44 5 C 1 C is detected for greater than two seconds the heater plates will be disabled an intermittent audible alarm will sound and a display of temperature preceded by the letter H will indicate over temperature condition At this point all heaters are disabled and the master triac is turned off All of the heater triacs are then tested If any heaters are still producing current the program will enter the FAULT mode an audible alarm will sound and the appropriate fault code will indicate the condition Secondary Over Temperature Protection The fluid warming system provides a secondary over temperature shutdown separate
30. ar panel assembly in accordance with local regulations 11 Install the two green yellow wires on the replacement rear panel equipotential terminal The nuts should be torqued to 40 inch lbs 102 cm kg See Figure 25 and Figure 26 gt E 3 4 A 1 Green yellow wire to chassis 2 Green yellow wire to chassis 3 Green yellow wire to J3 4 Green yellow wire to filter Figure 26 Equipotential Terminal Wiring 44 Service and Repair 12 Connect the replacement rear panel assembly to the chassis assembly The screws should be torqued to 3 inch Ibs 8 cm kg See Figure 27 Figure 27 Rear Panel Assembly Connection 13 Connect the rear panel assembly cables to the main PCB assembly See Figure 28 Figure 28 Rear Panel Assembly Cable Connections 14 Install the cover assembly on the FW 538 See Cover Assembly Replacement step 13 on page 33 15 Perform the following checks test to verify proper operation of the FW 538 prior to returning the unit into service Test 1 Zone Heating Monitoring on page 9 e Test 2 Individual Thermistor Monitoring on page 9 e Test 3 Automatic Thermistor Zone Monitoring on page 10 e Output Temperature Test on page 10 Warmflo Model FW 538 45 Service and Repair e Over Temperature Alarm Check on page 13 Door Assembly Replacement The replacement door assembly comes assembled with e 1 molded door e 13 4 x 38 flat head self tapping sc
31. at the end of this section The FW 538 is used to warm fluids that are gravity fed or pressure infusor fed The fluid warming system heats fluid as it flows through a fluid warming cassette The cassette is inserted between two heater plates that are Tufram coated for surface protection Maximum heat transfer is achieved when the cassette and heater plates are clean and the cassette expands due to a slight downstream resistance creating effective surface contact with the heater plates The top heater plate contains three heater elements and three thermistors temperature sensors The bottom heater plate contains three heater elements and one thermistor temperature sensors The fluid warming system software monitors the temperature and duty cycle of the three heater zones and regulates the fluid temperature by turning the heaters on and off as needed to maintain the fluid SET POINT temperature The default SET POINT is 38 C The temperature control range is from 28 C to 42 C The preset temperature set point is continuously displayed in the format rounded to the nearest 0 5 degree The reading is updated approximately once every second The major components of the FW 538 fluid warming system are two heater plates with four embedded temperature sensors e keyboard main circuit board e display circuit board Schematics for the circuit boards are at the back of this section Main Circuit Board Start Up When the unit
32. be powered from an EN 60 dip in 60 dip in uninterruptible power supply 61000 4 11 Ur for 5 Ur for 5 cycles or battery cycles 70 Ur 70 Ur 30 dip in 30 dip in Ur for 25 Ur for 25 cycles cycles lt 5 Ur lt 5 Ur 95 dipin 95 dip in Ur for 5 Ur for 5 sec sec Power 3 A m 3 A m It may be necessary to frequency position the FW 538 further 50 60 Hz from the sources of power magnetic frequency magnetic fields or field to install magnetic shielding The power frequency EN magnetic field should be 61000 4 8 measured in the intended installation location to assure that it is sufficiently low Note UT is the AC mains voltage prior to application of the test level Specifications Table 7 Electromagnetic Immunity RF Portable Equipment For portable and mobile communication equipment The FW 538 is suitable for use in the specified electromagnetic environment The customer and or user of the FW 538 should assure that it is used in an electromagnetic environment as described below Immunity aaa 4 2 Compliance Electromagnetic Test Level Environment Guidance Test Level Portable and mobile RF communications equipment should be used no closer to any part of the FW 538 including cables than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter Recommended Separation Distance Radiated RF 3 V m 3 V m
33. ble 2 System Fault Codes Fault Code Problem Solution FAULT CODE F_01 Defective or wrong e Replace main PCB EPROM assembly See Main PCB Assembly Replacement on page 36 FAULT CODE F_02 Defective RAM Replace main PCB assembly See Main PCB Assembly Replacement on page 36 FAULT CODE F_04 Defective NVRAM Replace main PCB assembly See Main PCB Assembly Replacement on page 36 FAULT CODE F_05 Membrane panel switch Push the button again is stuck Restart the unit Replace cover assembly if problem persists See Cover Assembly Replacement on page 30 FAULT CODE F_08 Microprocessor failure Replace main PCB assembly See Main PCB Assembly Replacement on page 36 20 Troubleshooting Table 2 System Fault Codes Continued Fault Code Problem Solution FAULT CODE F 09 OT REF offset out of range Voltage Reference error Replace main PCB assembly See Main PCB Assembly Replacement on page 36 FAULT CODE F 10 EXT OT failure Replace main PCB assembly See Main PCB Assembly Replacement on page 36 FAULT CODE F 11 Heater Zone 1 thermistor failure Thermistor in Zone I is open or shorted possibly caused by a loose connector J6 on main board Push J6 connector all the way down See Main PCB Assembly Replacement on page 36 Defective thermistor Replace chassis assembly See Chassis Assembly Replacement on page 50 If the previous two steps don
34. ccoccccnonoconcncnannancnnnnannnnn 34 Fuse Local idos 35 Main PCB Cable Connections ooocccinccccccocccnnnoccccnonnnannn cc connnnnnnn cnn 37 Main PGB SCrew E 37 Main PCB Cable Connections cooococinccccccocccnnnoccccnannnn ano nc cnn nnnnnna caninos 38 Cover Assembly Cable Connections cococccococnnonocacnnonoconancnnccnnnanons 39 Display Assembly SCrews ruannrrnrnrrrnnnnnvnnnnrrrnnnnnnnrnnrnvnnnnnennnrrnnnennene 40 Cover Assembly Cable Connections oooocinnccccnocccnnnocccnonccnnnanannnnncnns 40 Rear Panel Cable Connections rrrarnnrrnrnnrrnnnnvrvnnnrrnnnrnvnnrnnrnnnnnnnen 43 A sees a eee GE 43 Rear Panel Gcrews A 43 Rear Panel Ground cccccccccccnoccnconcconononcnann conan cnn nan cnn nan rra 44 Equipotential Terminal Wiring ooooonnnnnnnnnnnnccnnnnonnncccnnnnnanannnnnnannnnos 44 Rear Panel Assembly Connecton 45 Rear Panel Assembly Cable Connections oooocccconoocccccconaonncccnannns 45 Door Assembly Cable Connechons 47 Door Assembly PIN ascos 47 Door Assembly Cable Retainer arnrnnrnnrnnnnnnvnnrnrrnnnnnrnnrnrrennnnvnnnennn 48 Door Assembly Cable Routing ooococonccccnncccnnnccccnoncnnnanaccconnncnana canon 48 Cable Retainer Placement 49 Door Assembly Pin Installation ssosnronnnronnnrrrnnnonnnrrnnrnrnnnrrnnrrrnnnr 49 Door Assembly Cable Connechons 50 Upper Heater Assembly A 52 Spare Pats EE ae de haldvesstavees 65 PACKING D 68 Increasing Decreasing Temperature oooonoccccconnnocccccnnnnancccn
35. display a fault code only when one is detected The NVRAM storage holds the most recent 16 fault codes With the jumper connecting pin to pin 2 the display shows the most recent fault code in the format F_ Press the increase button to cycle through all the stored fault codes in a round robin fashion After reviewing the fault codes remove the jumper while the unit is on clearing all of the fault codes Install the jumper on only one pin Turn off the unit When the unit is restarted it will return to normal operation mode and will display a fault code only when one is detected Electromagnetic Interference Warmflo Model FW 538 This device has been tested and found to comply with the limits for medical devices to the IEC 60601 1 2 1993 These limits are designed to provide reasonable protection against harmful interference in a typical medical installation However because of the proliferation of radio frequency transmitting equipment and other sources of electrical noise in the healthcare environment it is possible that high levels of such interference due to close proximity or strength of a source may result in disruption of performance of this device This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with these instructions may cause harmful interference with other devices in the vicinity Disruption or interference may be evidenced by cessation of operation
36. e enclosed filter screen Attach the female Luer end of the high flow wound irrigator WI 48 to the male Luer end of a clean WF 8860 test cassette 5 Open the roller clamp 3 and depress the button on the WI 48 to purge the air from the high flow wound irrigator tubing Close the roller clamp G after air has been fully purged Activate the internal test mode of the fluid warming system by simultaneously pressing the Increase and Decrease temperature buttons for five seconds Select Test Mode 2 individual thermistor monitoring by pressing the Increase temperature button until the number 2 is briefly displayed in the first LED of the fluid warmer display Press the Decrease temperature button to select Zone 3 monitoring When the segment on the right side of the first LED is illuminated Zone 3 monitoring is active Zone 3 Open the pinch clamp y below the 8 10 C bag Use the roller clamp 3 on the cassette outlet tube to adjust the fluid flow to 100 25 ml per minute while the button 3 on the WI 48 is depressed graduated cylinder Q Note This flow rate may be measured by timing fluid collection in a small 20 21 Allow the 8 10 C fluid to flow for one minute Close the pinch clamp 3 stopping the flow of 8 10 C fluid through the system Performance Verification 22 Open the pinch clamp below the 50 65 C saline bag and depress the button Dl on the WI 48 to allow the pre warmed fluid to flow
37. e clamps are open Cassette door will not open The cassette is full of fluid and or under pressure Close the red clamp at the heat exchanger to release pressure on the cassette Release the fluid downstream Spring mechanism inside door is broken The Warmflo unit provides an emergency technique to remove the cassette if normal procedures do not open the door Locate the hole in the middle part of the bottom of the door It can be felt with a finger Insert a 2 Phillips screwdriver Push until door opens See Figure 31 on page 48 19 Troubleshooting Table 1 System Problems and Solutions Continued Symptom Observe Solution Fluid output The temperature set point e Adjust the temperature set temperature is too low is too low point to the desired setting The fluid flow is being e Ensure all clamps above restricted above the heat the heat exchanger for the exchanger spike in use are open Excessive high flow rate Reducing the flow rate will increase warming efficiency Heater plates are dirty Open the cassette door and clean the heater plates according to instructions in Preventive Maintenance on page 27 Over Temperature Pre warmed fluids were Do not use pre warmed Alarm used fluids High flow rate stopped Unit will cool and alarm suddenly will reset automatically Low Temperature Excessive high flow rate Reduce the flow rate Alarm Ta
38. e located on either side of the set point display Pressing the alarm test causes a simulation of an over temperature alarm followed by a low temperature alarm Normal operation automatically resumes within ten seconds after the test The alarm silence button silences any alarm except the secondary over temperature alarm for a two minute period If the condition persists after the timeout has elapsed the audible alarm will sound again Note The secondary over temperature alarm cannot be silenced with this button The unit must be turned off and allowed to cool 75 Blank Page Ring Tip Shield Theory of Operation
39. e the FW 538 cover See Cover Assembly Replacement on page 30 4 Remove the fuse and insert a new fuse See Figure 15 1 Fuse Location Figure 15 Fuse Location 5 Replace cover assembly See Cover Assembly Replacement on page 30 6 Perform the following checks test to verify proper operation of the FW 538 prior to returning the unit into service Test 1 Zone Heating Monitoring on page 9 e Test 2 Individual Thermistor Monitoring on page 9 e Test 3 Automatic Thermistor Zone Monitoring on page 10 e Output Temperature Test on page 10 e Over Temperature Alarm Check on page 13 IV Pole Mount Replacement Use the following procedure to replace the IV pole mounting bracket 1 Remove the IV pole mounting bracket See Cover Assembly Replacement step 5 on page 31 2 Install the new IV pole mounting bracket See Cover Assembly Replacement step 14 on page 33 Warmflo Model FW 538 35 Service and Repair Main PCB Assembly Replacement The main PCB assembly comes assembled with e 1 universal control PCB e 1 0 032A fuse e 2 jumpers JMP2 and JMP3 The tools required for this procedure are Tool Parameters Use Hex driver 9 64 inch Phillips screwdriver 1 Torque driver wrench 6 inch lbs 15 cm kg 3 inch lbs 8 cm kg Use the following procedure to replace the main PCB assembly 1 Turn the FW 538 off by pressing the power switch located at the back of the unit to 0
40. ectromagnetic Emissions 59 Electromagnetic interference 25 Electrostatic Immunity 61 F Fault codes F 01 20 F 02 20 F 04 20 F 05 20 F 08 20 F 0921 F 1021 F 1121 F 1221 Warmflo Model FW 538 F 1322 F_17 22 F_20 22 F_21 23 F 2223 F 23 23 F 30 23 F 31 23 F 3225 F 41 24 F 42 24 F 43 24 F 44 24 F 45 24 F 46 24 Fluid sets 66 Fluid warming sets 63 Fuse 64 Fuse replacement 34 I I V pole mount replacement 35 Indications for use 5 M Main PCB assembly replacement 36 Manufacturer s Declaration 59 N NVRAM mode 24 O Output temperature check 10 Output temperature performance check 28 Over temperature alarm check 13 P Performance requirements 56 Performance verification 9 Preventive maintenance 27 83 Index R Rear panel assembly replacement 41 Recommended Separation Distances 62 Repacking in a Different Carton 69 Repacking in Original Carton 67 Repair 29 Replacement chassis assembly 50 cover assembly 30 display PCB assembly 38 fuse 34 I V pole mount 35 main PCB assembly 36 rear panel assembly 41 Resolving electromagnetic interference 25 Returning the N 595 67 S Safety information 1 Service 29 Shock hazard 7 Shock Hazard BF Classification 7 Spare parts 63 Specifications 55 Storage 56 Symbols 7 System testing 10 T Technical specifications 55 Theory of operation 71 Transportation 56 Troubleshooting 19 U Underwriters laboratories 7 W Warnings 1 W
41. eight 55 84 Y NELLCOR Tyco Healthcare Group LP Nellcor Puritan Bennett Division 4280 Hacienda Drive Pleasanton CA 94588 USA Toll Free 1 800 635 5276 O 2003 Nellcor Puritan Bennett Inc All rights reserved Rx ONLY 067719A 1003 tyco Healthcare
42. embly Replacement on page 46 If previous two steps don t resolve problem replace main PCB assembly See Main PCB Assembly Replacement on page 36 FAULT CODE F_20 Heater Enable failure Temperature higher than 44 5 C is sensed Shut down the unit Wait for 5 minutes Restart the unit If problem persists replace the main PCB assembly See Main PCB Assembly Replacement on page 36 22 Warm fo Model FW 538 Troubleshooting Table 2 System Fault Codes Continued Fault Code Problem Solution FAULT CODE F 21 Triac Zone 1 failure Heater Zone 1 does not turn on during initialization Shut down the unit Wait for 5 minutes Restart the unit Defective Triac Q6 or Optoisolator U4 Replace main PCB assembly See Main PCB Assembly Replacement on page 36 FAULT CODE F 22 Triac Zone 2 failure Heater Zone 2 does not turn on during initialization Shut down the unit Wait for 5 minutes Restart the unit Defective Triac Q4 or Optoisolator U2 Replace main PCB assembly See Main PCB Assembly Replacement on page 36 FAULT CODE F 23 Triac Zone 3 failure Heater Zone 3 does not turn on during initialization Shut down the unit Wait for 5 minutes Restart the unit Defective Triac Q2 or Optoisolator U1 Replace main PCB assembly See Main PCB Assembly Replacement on page 36 FAULT CODE F_30 Heater Zone failed preheat test A D channel failed preheat wa
43. ently selected zone 1 2 3 or lower plate using the same method as in test 2 above The remaining three LEDs display the temperature of that zone The zone number cycles automatically at a 1 Hz rate round robin from zones 1 to the lower plate System Testing There are two system performance checks for the FW 538 fluid warmer The first check verifies the output temperature of fluid passing through a WF 8860 test cassette The second check confirms that the over temperature alarm is functioning properly Output Temperature Test Equipment Required for Output Temperature Check This procedure checks the output temperature of fluid passing through a test cassette installed in the FW 538 In addition to the FW 538 fluid warming system the following equipment will be required e WF 8860 test kit part number 8860 which contains Cassette and tubing Myocardial thermocouple temperature probe WI 48 high flow wound irrigator e Reusable TAB instrument cable part number 502 0065 e Mon a therm temperature monitor model 6510 or equivalent type T thermocouple temperature monitor e Saline IV bag The following equipment is optional e Warmflo pressure infusor or Warmflo irrigation pump e Graduated cylinder Performance Verification Test Procedure Figure 5 Setup for Output Temperature Check Referring to Figure 5 check the output temperature of the FW 538 system 1 Turn the Warmflo fluid warmi
44. epartment at Tyco Healthcare Group LP Nellcor Puritan Bennett Division 4280 Hacienda Drive Pleasanton CA 94588 1 800 635 5267 Introduction The FW 538 can be disassembled down to all major component parts including e Chassis assembly e Cover assembly e Door assembly e Fuse e PCBs WARNING Before attempting to open or disassemble the FW 538 A disconnect the FW 538 from AC power Caution Observe ESD electrostatic discharge precautions when working within the unit Warmflo Model FW 538 29 Service and Repair Replacement Level Support The replacement level supported for this product is to the printed circuit board PCB and major subassembly level Once you isolate a suspected PCB follow the procedures below to replace the PCB with a known good PCB Check to see if the trouble symptom disappears and that the FW 538 passes all performance tests If the trouble symptom persists swap back the replacement PCB with the suspected malfunctioning PCB the original PCB that was installed when you started troubleshooting and continue troubleshooting as directed in Troubleshooting on page 19 Cover Assembly Replacement The replacement cover assembly comes assembled with e 1 molded cover e 1 key pad e 1 warning label The tools required for this procedure are Tool Parameters Use Hex driver 9 64 inch Phillips screwdriver 1 Torque driver wrench 6 inch Ibs 15 cm kg 5 inch lbs 13
45. ions RE 101 Army 7cm of MIL STD 461E Magnetic field susceptibility RS 101 in MIL STD 461E Quasi static electric field susceptibility FDA Reviewer s Guide Manufacturer s Declaration A Warmflo Model FW 538 Specifications WARNING The use of accessories and cables other than those specified may result in increased emission and or decreased immunity of the FW 538 Table 5 Electromagnetic Emissions The FW 538 is suitable for use in the specified electromagnetic environment The customer and or user of the FW 538 should assure that it is used in an electromagnetic environment as described below Emissions Electromagnetic Environment Compliance Test Guidance RF emission Group I The FW 538 must emit electromagnetic CISPR 11 energy in order to perform its intended function Nearby electronic equipment may be affected RF emissions Class B The FW 538 is suitable for use in all CISPR 11 establishments Harmonic Complies emissions EN 61000 3 2 Table 6 Electromagnetic Immunity The FW 538 is suitable for use in the specified electromagnetic environment The customer and or user of the FW 538 should assure that it is used in an electromagnetic environment as described below e EN S Immunity Compliance Electromagnetic 60601 1 2 e Test Level Environment Guidance Test Level Electrostatic 6 kV 6 kV contact Floor should be wood discharge contact concrete
46. mbly on the new chassis assembly See Door Assembly Replacement step 11 on page 48 Install the main PCB assembly on the chassis assembly See Main PCB Assembly Replacement step 9 on page 37 Install the rear panel on the chassis See See Rear Panel Assembly Replacement step 11 on page 44 Install the cover assembly See See Cover Assembly Replacement step 11 on page 33 Perform the following checks test to verify proper operation of the FW 538 prior to returning the unit into service Test 1 Zone Heating Monitoring on page 9 Warm fo Model FW 538 Service and Repair Test 2 Individual Thermistor Monitoring on page 9 Test 43 Automatic Thermistor Zone Monitoring on page 10 Output Temperature Test on page 10 Over Temperature Alarm Check on page 13 53 Blank Page Specifications Dimensions Weight Height 4 75 inches 12 cm Width 5 75 inches 14 5 cm Depth 11 inches 28 cm 8 pounds 3 63 kg Technical Specifications Warmflo Model FW 538 Complies with Standards IEC 601 1 UL 2601 C22 2 No 601 1 M90 Supply voltage 115 Volts AC Operating frequency 50 to 60 Hz Maximum operating current 12 Amperes Maximum heating power 1 440 Watts Warmer circuit breaker rating 12 Amperes Electrical equipment class Class 1 equipment Patient applied part Type BF equipment Heat transfer method Dry Heat Temperature control range 28 0 C to 42 0 C Default set
47. ng system power switch located at the rear of the unit to the ON position The control panel will display the start up test mode followed by the software revision number When the temperature set point is displayed 38 C default the unit is ready for operation 2 Push the door latch button on the fluid warming system to open the cassette door The door will open approximately 1 2 inch 1 27 cm Warmflo Model FW 538 11 Performance Verification Q 10 11 12 13 14 Slide a clean WF 8860 test cassette into the door opening until it is fully inserted Close the door by firmly lifting up on the door until it clicks into position This is indicated by the appearance of a green band on the top edge of the door latch button Note To ensure that the door is closed pull out on the door latch button until the green band is visible Close the clamp indicated 3 Mount the air elimination chamber into the holder on the side of the FW 538 Open the clamp indicated Y and use this line to spike the saline IV bag Hold both the saline bag and the drip chamber E upside down Squeeze the saline bag to push air from the bag into the drip chamber Continue to squeeze until the drip chamber is half full of fluid Turn the saline bag right side up and hang the bag from the IV pole hook or install it in the Warmflo pressure infusor or irrigation pump Close the roller clamp 3 on the cassette outlet tube Open
48. nnnanccnnnnnnns 74 Main Control Board Schematic Diagram Sheet 1 of 2 77 Main Control Board Schematic Diagram Sheet 2 of 2 79 Display Printed Circuit Board Schematic Diagram rsrrrnrnnrnnnennnnn 81 iii Contents Tables Table Table Table Table Table Table Table Table OND TONT System Problems and Solutions ooooccconnoccccccononnncccnnnnnnnncnnnarnncnnnnns 19 System Fault COMES rieures 20 System Preventative Maintenance rrrrnnnrvvnnnrnnvrvrnrrnnnrrvenrrnnnrvesrrrnnn 27 Model FW 538 Compliance rrrnnnnrrnnnnnvnnnnvrnnnnnnnnnnvrrennnnnnnrnrrnnnennnnnnn 56 Electromagnetic EM SS ONS nn n nan n cnn nana 59 Electromagnetic Immunity nn an ann cnn rra 59 Electromagnetic Immunity RF Portable Equipment 61 Recommended Separation Distances cccceccceeeeteeeeeeeeeeeneeeees 62 Safety Information Warnings and Cautions Warnings gt PPP P Warmflo Model FW 538 A Warnings in this manual are identified by the WARNING symbol shown above A warning alerts you to potentially serious outcomes death injury or adverse events to the user or the patient WARNING Possible electrical shock hazard The warming unit should only by serviced by a qualified technician If a qualified technician is not available please notify your sales service center WARNING The fluid warmer must be plugged into a properly grounded 115 volt AC power source W
49. nting bracket as shown A 1 Potential kink area 2 Filter mounting bracket 3 Filter 4 Slide tubing through channel Figure 1 Filter and Filter Mount Caution Do not attempt to prime the disposable fluid set while the heat exchanger cassette is outside the fluid warmer or while the door is not latched Caution If the fluid set has primed before the heat exchanger cassette is inserted into the fluid warmer open all clamps distal to the heat exchanger cassette and allow the cassette to relax before attempting to insert the cassette Caution After use turn off the automated pressure infusor or release pressure cuffs if used Always close the red pinch clamp Figure 2 prior to removing the heat exchanger cassette from the fluid Safety Information warmer Failure to do so could result in rupturing the heat exchanger cassette 1 Red clamp 2 Heat exchanger cassette Figure 2 WF 250 Heat Exchanger Cassette Introduction Indications for Use The FW 538 fluid warming system is used to provide safe and effective warming of fluids such as blood blood products physiologic fluids and irrigation fluids The FW 538 can be used for all types of surgical procedures and operations that require warmed fluids administered to patients Contra Indications Description Warmflo Model FW 538 There are no known contra indications for use of this device Figure
50. oonocccncccnnnoncccnnccnn conc nnnncc naar nn 75 NN 83 Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8 Figure 9 Figure 10 Figure 11 Figure 12 Figure 13 Figure 14 Figure 15 Figure 16 Figure 17 Figure 18 Figure 19 Figure 20 Figure 21 Figure 22 Figure 23 Figure 24 Figure 25 Figure 26 Figure 27 Figure 28 Figure 29 Figure 30 Figure 31 Figure 32 Figure 33 Figure 34 Figure 35 Figure 36 Figure 37 Figure 38 Figure 39 Figure 40 Figure 41 Figure 42 Warmflo Model FW 538 Contents Filter and Filter Mount occoonooccccnnononcncninnancnn conan cnn nn nano cnn nn naar 3 WF 250 Heat Exchanger Cassette 4 Warmtlo FW 538 rassinn asasena aaia aa a iaaa daa 5 Warmflo Model FW 538 with WF 250 Surgery Gei 6 Setup for Output Temperature Check 11 Setup for Over Temperature Alarm Function Check 14 Accessing Heater Plates rronnnrrnnnvnnnnrnnnnvnnnennrnnvnnnannnnnnnneeennnnnenee 27 Filter Mounting Bracket Removal rnrnnnnnnonnvnnnnnvnnnrrnnnvennnrnnnvnrnnnnnn 31 IV Mounting Bracket Hemova cnn 31 Cover Assembly Cable Connections oooocinnccccnncccnnnoccccncccnnnananannncno 32 Display PCB Assembly Removal ooooccoiniccconocicononcccnnonnnnanoconanancnnnnnos 32 Cover Assembly Cable Connections ooococccoccccnoconocnnononananonnccnnnanon 33 IV Mounting Bracket Hemouval nana nn 33 Filter Mounting Bracket Removal oocoooocccccon
51. or ceramic tile If ESD 8 KV air floors are covered with 8 KV air synthetic material the EN relative humidity should be 61000 4 2 at least 30 Electric fast 2 kV for 2 kV for Mains power quality should transient power power supply be that of a typical burst supply lines lines commercial and or hospital environment EN 1 kV for 1 kV for 61000 4 4 input output input output lines lines Note UT is the AC mains voltage prior to application of the test level 59 Specifications 60 Table 6 Electromagnetic Immunity The FW 538 is suitable for use in the specified electromagnetic environment The customer and or user of the FW 538 should assure that it is used in an electromagnetic environment as described below i EN e Immunity 60601 1 2 Compliance Electromagnetic Test Level Environment Guidance Test Level Surge 1 kV 1 kV Mains power quality should differential differential be that of a typical EN mode mode commercial and or hospital 61000 4 5 environment 2 kV 2 kV common common mode mode Voltage lt 5 Ur lt 5 Ur Mains power quality should dips short be that of a typical interruption gt 95 dip gt 95 dip in commercial and or hospital s and in U7 for Un for 0 5 environment If the user of voltage 0 5 T 1 be the FW 538 requires variations e pe continued operation during on power power mains interruption it supply 40 Ur SE is recommended that the SS SCH FW 538
52. or incorrect functioning If this occurs the site of use should be surveyed to determine the source of this disruption and actions taken to eliminate the source The user is encouraged to try to correct the interference by one or more of the following measures Turn equipment in the vicinity off and on to isolate the offending equipment e Reorient or relocate the other receiving device Increase the separation between the interfering equipment and this equipment e Ifassistance is required contact Nellcor s Technical Service Department or your local representative 25 Blank Page Preventive Maintenance liquids 9066Pp WARNING Electrical shock hazard Disconnect the unit from AC power prior to cleaning Thoroughly dry before returning to service Caution Do not scratch the heater plates Do not use abrasive materials or treated polishing cloth Caution To prevent equipment damage do not autoclave or immerse in Note For easy access to the heater plates with cassette door in open position push the release button on the bottom of the unit The door will swing open approximately 3 inches 7 62 cm See Figure 7 below Figure 7 Accessing Heater Plates The following preventive maintenance procedures are recommended Table 3 System Preventative Maintenance Action Frequency Method Clean exterior surfaces As required with use Use warm mild soap water and soft cloth Heater plate
53. or using pre warmed saline solution of slightly lower temperature 9 9 25 If the fluid warming system fails to properly enter the over temperature alarm condition and or fails to demonstrate both audible and visual over temperature alarms immediately remove the unit from service Notify your sales service center of the malfunction The unit must be serviced by an authorized service technician Warmflo Model FW 538 17 Blank Page Troubleshooting Problems Warmflo Model FW 538 If the solutions in this section fail to correct the problem contact Nellcor s Technical Service Department 1 800 635 5267 or your local representative Table 1 System Problems and Solutions Symptom Observe Solution The LED display is dark AC power cord is not plugged in Plug in the power cord Power switch is not turned on Turn the power switch on rear panel to ON 1 Fuse is blown Open enclosure and replace fuse See Fuse Replacement on page 34 LED connector is loose Push down LED connector into the J10 receptacle on the main circuit board See Display PCB Assembly Replacement on page 38 Cassette door will not engage latch The cassette is full of fluid and the tubing clamps are closed Close the red clamp at the heat exchanger to release pressure on the cassette Release the fluid downstream If transferring a cassette from one warmer to another be sure the red and whit
54. point temperature 38 0 C Low temperature alarm 3 0 C below set point High temperature alarm 44 5 C Secondary heater disable 45 0 C Display screen Four digit green LED Fluid ingress protection Drip Proof IPX2 55 Specifications Operating temperature range 50 F to 86 F 10 C to 30 C Operating relative humidity 10 to 95 non condensing Operating elevation 0 to 10 000 feet 0 to 3 048 meters Mode of operation Continuous Transportation and Storage Ambient temperature 13 F to 131 F 25 C to 55 C Relative humidity 10 to 95 non condensing Elevation 0 to 10 000 feet 0 to 3 048 meters Performance Requirements Compliance 56 1 10 C fluid at the input of the cassette must be warmed to a minimum of 35 C at four feet 1 2 meters past the air trap with a 38 C temperature set point This applies to a flow rate range of 15 to 250 ml minute 20 C fluid at the input of the cassette must be warmed to a minimum of 35 C at four feet 1 2 meters past the air trap with a 38 C temperature set point This applies to a flow rate range of 15 to 250 ml minute Table 4 Model FW 538 Compliance Item Compliant With Equipment classification Safety Standards EN 60601 1 same as EN60601 1 CSA 601 1 UL 2601 1 EN 60601 2 35 EN 60601 1 2 second edition Type of protection
55. r assembly cables through the bottom of the chassis assembly See Figure 32 Figure 32 Door Assembly Cable Routing 10 Discard the removed door assembly in accordance with local regulations 11 Route replacement door assembly cables through the bottom of the chassis assembly See Figure 32 12 Place the new door assembly into the chassis assembly and position it as shown in Figure 33 48 Service and Repair 13 Install the cable retainer into the chassis assembly See Figure 33 The cable retainer slot should be placed on the chassis assembly support and the cable retainer pressed into place 1 Chassis assembly support 2 Cable retainer Figure 33 Cable Retainer Placement 14 Slide the door assembly into position with the door assembly pin holes aligned and insert the pin See Figure 34 Figure 34 Door Assembly Pin Installation Warmflo Model FW 538 49 Service and Repair 15 Reconnect the door assembly cables to the main pcb See Figure 35 Figure 35 Door Assembly Cable Connections 16 Install the rear panel assembly See Rear Panel Assembly Replacement step 11 on page 44 17 Install the cover assembly on the FW 538 See Cover Assembly Replacement step 13 on page 33 18 Perform the following checks test to verify proper operation of the FW 538 prior to returning the unit into service Test 1 Zone Heating Monitoring on page 9 e Test 2 Individual Thermistor Monitoring on page
56. rews e 1 lower heat plate assembly e I spring latch assembly e 1 push bottom spring e 1 door limiter spring e 1 bottom molded door e 1 molded door limiter e 1 molded right latch e 1 molded button e 1 molded left latch The tools required for this procedure are Tool Parameters Use Hex driver 9 64 inch Phillips screwdriver 1 Use the following procedure to replace the door assembly 1 Turn the FW 538 off by pressing the power switch located at the back of the unit to 0 2 Unplug the FW 538 from AC power 3 Remove the power cord from the FW 538 4 Remove the FW 538 cover assembly See Cover Assembly Replacement on page 30 46 Service and Repair 5 Remove the rear panel from the chassis See Rear Panel Assembly Replacement on page 41 6 Disconnect door assembly cables from the chassis assembly See Figure 29 1 J9 2 32 Figure 29 Door Assembly Cable Connections 7 Remove the door assembly pin from the chassis assembly See Figure 30 Figure 30 Door Assembly Pin 3 Note It is not necessary to remove the main pcb from the chassis assembly Warmflo Model FW 538 47 Service and Repair 8 Remove the cable retainer from the chassis assembly See Figure 31 The cable retainer should be pushed from the top of the chassis assembly 1 Door Release 2 Cable Retainer Figure 31 Door Assembly Cable Retainer 9 Slide the doo
57. rmer test Temperature higher than 42 C is sensed during preheat test Cassette with preheated fluid is used Shut down the unit Wait for 5 minutes Restart the unit Defective thermistor in Zone 1 Replace main PCB assembly See Main PCB Assembly Replacement on page 36 FAULT CODE F_31 Heater Zone 2 failed preheat test A D channel 2 failed preheat warmer test Temperature higher than 42 C is sensed during preheat test Cassette with preheated fluid is used Shut down the unit Wait for 5 minutes Restart the unit Defective thermistor in Zone 2 Replace main PCB assembly See Main PCB Assembly Replacement on page 36 FAULT CODE F_32 Heater Zone 3 failed preheat test A D channel 3 failed preheat warmer test Temperature higher than 42 C is sensed during preheat test Cassette with preheated fluid is used Shut down the unit Wait for 5 minutes Restart the unit Defective thermistor in Zone 3 Replace main PCB assembly See Main PCB Assembly Replacement on page 36 23 Troubleshooting Table 2 System Fault Codes Continued Fault Code Problem Solution FAULT CODE F 41 Heater control failure e Shut down the unit Wait Heater is stuck on for 5 minutes Restart the unit Defective Triac Replace main PCB assembly See Main PCB Assembly Replacement on page 36 FAULT CODE F 42 Heater Zone 1 turn on Shut down the unit Wait failure Heater Zone 1 for 5 minutes Re
58. rnnnrnrrensnnrnssennne 63 Infusors and Irrigators seseseniionk o 63 Spare Parts and ACcessories cccccceseseeeceeeeeeeeeeeeeeaeeeeeaneeceeeeeeeaaaeseeeeeeeeaeeesenes 64 Disposal of Fluid Sets siririca odaia ea ai a a aE aiia aa 66 Disposal Of Fluid Warming System uarnrnnnonvrnnnnnvnnnrnvrnnnnrrnnnrrrenrnnrnnnrnrrennnnrnnsennne 66 Packing for Shipment E 67 151010 Haten ET 67 Returning the FW 538 cocina 67 General Instructions oooonccninnnnnnnnncconncncnnn cocoa nr 67 Repacking in Original Carton oooccccncccnnncccnnncccnononnnnoncncnnnn cnn nnn cn nnn rca anar cnn rca nnann cnn 67 Repacking in a Different Carton oonccccnnnnicnnncccnnnccnnnnccccnnnnnnnnnn cc nara nnnn crac annn nan 69 Theory of Operation E 71 INTOUCIO EE 71 Main Circuit Board Start UP s sensi cti siaii a aiana KAE 71 Heater Control Circuitry ooooonccnnncccnnonccnnnncccnnnnnnn nan c conan cnn nan n cnn rca nn nn nnn rra 72 Temperature Sensing Circuitry coooconcccnnnnonnnncccnnncccnn cacon 73 Over Temperature Operation ooccccinnncnnnncccnnnnonnnncnccnonnnnnanann nn 73 Secondary Over Temperature Protection urnrrrnrnrrnnnnnvnnrnrrvnnnnnnnnrnrrennnnrnnnrnnenn 73 Under Temperature Operation rrrnnnnnvnnervrvnnnrnonnrnrnnnnnrnnnrnnrensnrnnnsnnnenrnnrnnennnnerenn 74 Display Board icon lili 74 NG 0140 E E E E e da 74 Temperature Adjustment oooococcccnonccoconononccononnnonocononononecononnnnnnnn cnn nnnne cn nn nnnnne cn nana 74 Alarm Control Buttons o
59. roduction The Warmflo FW 538 software provides three internal test modes After pressing the Increase and Decrease temperature buttons simultaneously for five seconds the unit enters the internal test mode A series of test modes are accessible in a round robin fashion by pressing the increase button When a test is initially entered its test number is displayed in the first LED while the other LEDs are blank The test number is displayed for one second Pressing the alarm silence button during any test will cause the program to return to normal operating mode Tests All temperatures displayed in the internal test modes are actual temperatures without rounding Test 1 Zone Heating Monitoring The first LED indicates which zones are heating The remaining three LEDs display the output temperature Test 2 Individual Thermistor Monitoring The first LED indicates the currently selected zone 1 2 3 lower plate The selected zone is displayed as an illuminated segment in the first LED These segments are mapped in the following way 4 1 Zone 2 2 Zone 3 A 3 3 Lower plate 4 Zone 1 Warmflo Model FW 538 9 Performance Verification The remaining three LEDs display the temperature of currently monitored zone Pressing the decrease button cycles the selected zone round robin from zone 1 to the lower plate Test 43 Automatic Thermistor Zone Monitoring The first LED indicates the curr
60. s must be smooth clean and free of surface imperfections to assure proper warming performance Clean heater plates Warmflo Model FW 538 As required if contaminated with blood or other fluids or debris Use soft cloth moistened with mild soapy water Wipe dry with clean soft cloth 27 Preventive Maintenance 28 Table 3 System Preventative Maintenance Continued Action Frequency Method Electrical safety check Prior to patient use and annually thereafter Refer to hospital standards Output temperature performance check Annually Refer to Performance Verification on page 9 Alarm test Annually May be tested prior to each use or at any time during use Press the Alarm Test button on the front control panel Anytime the unit is turned on audible and visual high and low temperature alarms will cycle for approximately 10 seconds then the unit will automatically return to normal operation Service and Repair by serviced by a qualified technician If a qualified technician is not available WARNING Possible electrical shock hazard The warming unit should only please notify your sales service center Information To obtain information about a warranty if any for this product contact Nellcor s Customer Services Department or your local Nellcor representative For technical support or to obtain service contact Nellcor s Customer Service D
61. start the does not turn on during unit run time Defective Triac Q6 or Optoisolator U4 Replace main PCB assembly FAULT CODE F 43 Heater Zone 2 turn on Shut down the unit Wait failure for 5 minutes Restart the unit Defective Triac Q4 or Optoisolator U2 Replace main PCB assembly FAULT CODE F 44 Heater Zone 3 turn on Shut down the unit Wait failure for 5 minutes Restart the unit Defective Triac Q2 or Optoisolator U1 Replace main PCB assembly See Main PCB Assembly Replacement on page 36 FAULT CODE F_45 External RAM test Replace main PCB board failure See Main PCB Assembly Replacement on page 36 FAULT CODE F_46 Thermistor test failure Shut down the unit Wait for 5 minutes Restart the unit Replace main PCB board See Main PCB Assembly Replacement on page 36 NVRAM Mode The system uses an NVRAM nonvolatile random access memory U19 chip for permanent storage of fault codes The microprocessor enters the NVRAM mode if the test pin J14 pin 1 is connected to ground J14 pin 2 If the jumper is installed between J14 pin 1 and pin 2 when the unit is powered on the last fault code stored in NVRAM is displayed Note Normal operation mode requires the jumper to be removed or to be installed on one pin only 24 Troubleshooting The unit is supplied with a jumper only on one pin of the J14 connector If the test pin is not installed the program will bypass the NVRAM mode and
62. t resolve problem replace main PCB assembly See Main PCB Assembly Replacement on page 36 FAULT CODE F_12 Heat Zone 2 thermistor failure Thermistor in Zone 2 is open or shorted possibly caused by a loose connector J6 on main board Push J6 connector all the way down See Main PCB Assembly Replacement on page 36 Defective thermistor Replace chassis assembly See Chassis Assembly Replacement on page 50 If previous two steps don t resolve problem replace main PCB assembly See Main PCB Assembly Replacement on page 36 Warmflo Model FW 538 21 Troubleshooting Table 2 Fault Code System Fault Codes Continued Problem Solution FAULT CODE F 13 Heater Zone 3 thermistor failure Thermistor in Zone 3 is open or shorted possibly caused by a loose connector J6 on main board Push J6 connector all the way down See Main PCB Assembly Replacement on page 36 Defective thermistor Replace chassis assembly See Chassis Assembly Replacement on page 50 If previous two steps don t resolve problem replace main PCB assembly See Main PCB Assembly Replacement on page 36 FAULT CODE F_17 Heater lower plate thermistor failure Thermistor in lower plate is open or shorted possibly caused by a loose connector J6 on main board Push J6 connector all the way down See Main PCB Assembly Replacement on page 36 Defective thermistor Replace door assembly See Door Ass
63. the clamp y below the saline bag Pinch the ball in the air vent tube on the air elimination chamber Saline solution will begin to flow from the bag into the WF 8860 test cassette set Allow the chamber to fill 3 4 to the top with saline solution Do not allow solution to rise into the air vent tube Tap the air elimination chamber to release micro bubbles from the enclosed filter screen Attach the female Luer end of the high flow wound irrigator WI 48 D to the male luer end of the WF 8860 test cassette Caution Use of the WF 8860 test cassette without the high flow wound 15 irrigator WI 48 attached may lead to higher than expected temperatures of the output fluid while running the output temperature check Open the roller clamp 3 and press the button on the WI 48 OB to open the line Allow solution to flow until air is purged from the high flow wound irrigator tubing 16 17 18 19 20 Q 21 22 Performance Verification Release the WI 48 button and close the roller clamp Insert the myocardial thermocouple temperature probe into the distal Y injection port J of the cassette set The probe should be carefully positioned inside the port so that fluid is flowing around the surface of the probe at its distal end Connect the temperature probe to the reusable TAB instrument cable O which in turn should be connected to a type T thermocouple temperature monitor W such as a Mon a therm
64. through the system 23 Observe the temperature at the Zone 3 thermistor on the display of the fluid warming system As the 55 65 C fluid flows through the test cassette the FW 538 heater plates absorb the excess heat driving their temperature above the set point of 38 C Two seconds after the temperature reaches 44 5 C 1 C the first over temperature alarm activates The heater plates are immediately disabled and an intermittent tone sounds at one second intervals If the temperature subsequently falls below 44 5 C and there is no system fault code reported the unit will resume normal operation Note If the unit is in the normal operating display mode when the first over temperature alarm sounds the display will read H44 5 1 0 C 24 Two seconds after the temperature exceeds 45 C 1 C the second over temperature alarm is activated This condition is indicated by a repetitive tone at one second intervals Note If the unit is in the normal operating display mode when the second over temperature alarm sounds the display will read H45 0 1 0 C and will alternate with the display of a fault code if appropriate Note If the temperature of the heater plates rises too quickly the first temperature alarm may not sound the intermittent beep Rather the first audible alarm may be a continuous tone signaling the second over temperature alarm that occurs above 45 C The procedure may be repeated using a slower flow rate
65. turned goods authorization RGA number Return the FW 538 by any method that provides proof of delivery Repacking in Original Carton If available use the original carton and packing materials See Figure 38 Pack the FW 538 as follows Warmflo Model FW 538 67 Packing for Shipment 1 Place the FW 538 and if necessary accessory items in original packaging 6 1 Packing insert 2 Poly bag 3 FW 538 4 Packing insert 5 Shipping carton 6 Power cord Figure 38 Packing 2 Place in shipping carton and seal carton with packing tape 68 Packing for Shipment 3 Label carton with shipping address return address and RGA number if applicable Repacking in a Different Carton Warmflo Model FW 538 If the original carton is not available use the following procedure to pack the FW 538 1 Place the FW 538 in a poly bag 2 Locate a corrugated cardboard shipping carton with a bursting strength of at least 200 pounds per square inch psi 3 Fill the bottom of the carton with at least 2 inches of packing material 4 Place the bagged unit on the layer of packing material and fill the box completely with packing material 5 Seal the carton with packing tape 6 Label the carton with the shipping address return address and RGA number if applicable 69 Blank Page Theory of Operation Introduction The schematic diagrams for the Theory of Operation are located
66. y the microprocessor In normal operating mode the first LED segment is blank and the remaining three digits display only numbers 0 9 The display is continuously on and updated at one second intervals The display will flash when the heater set point is being increased or decreased After no change for three seconds the display will stop blinking and display the set point The keyboard is attached to the main circuit board through connector J12 The user interface buttons are monitored at a rate of 10 Hz or greater The On Off Alarm Test and Alarm Silence buttons on the keyboard are used to control temperature set point and to check or silence the audible alarm Temperature Adjustment 74 Figure 39 Increasing Decreasing Temperature Alarm Control B Q Warmflo Model FW 538 Theory of Operation The temperature set point can be adjusted by pressing the increase or decrease button on the front panel located below the temperature set point display Pressing the increase button up arrow or decrease button down arrow will alter the set point in 0 5 degree increments to a maximum of 42 C or a minimum of 28 C An error tone is sounded if the set point is already at a limit value While the user is increasing or decreasing the temperature set point the display flashes After no change to the set point is made for three seconds the display stops flashing and displays the set point uttons The alarm test buttons ar

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