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HEARTSTART MRx - Frank`s Hospital Workshop

1. Therapy PCA Therapy Control HV Charging Circuit HV CAP Red Therapy Capacitor HV CAP White 7 7 Therapy Port HV Apex Assembly HV Sternum Bi Phasic H Bridge Pacing Circuitry Patient Isolation Relays 10 Pin Ribbon EtCO2 Module Filter Detector EtCO2 Connector Holder RJ 45 LAN Connector DB 9 Serial Connector os LNAILVd Signal and Data Flow Figure 88 Signal and Data Flow Schematic LED Ext lt q IN O Power mounted on Display Assembly Keys l Softkeys Display Menu Select Up Down mounted on Display Assembly p Assembly Info Alarm Suspend Lead Select T A A 3 D gt AY i ribbon cable Fr Ke a U fad Buttons CHARGE l 4 SHOCK mounted on Processor PC Video SYNC rise ex oe PCMCIA card slot Data Card slot circuit Backlight lt q __________ mounted on Processor PCA Keys Pos _ 4 wire aes yt i a circuits o E flex circuit m Processor PCA RFU gt pI O D Data 2 S Indicator _ am a lt 4 Control Analog ECG flex circuit 9 9 wires Printer PCA
2. 2 Secure the battery with the cable tie wrap Cut off the excess tie wrap 3 Replace the Processor PCA See Processor PCA on page 123 4 Close the case Closing the case on page 176 After Repair Run Performance Verification and Safety testing as described in the Performance Verification chapter 132 Printer Connector PCA Preparation 1 Remove the Printer See Printer Assembly on page 93 2 Open and separate the case See Opening the case on page 102 3 Position the front case Lay the front case on the work surface with the display facing down and the printer in the lower left corner Removal 1 Disconnect the Printer PCA a Unplug the 10 wire bundle by pulling straight down away from the PCA 1 b Unplug the 2 wire bundle by pushing up on the latch and pulling out 2 2 Remove the screws Loosen and remove the two T 10 screws 3 Lift up the Printer Connector PCA Lift the PCA up off the back of the printer well Figure 56 Removing the Printer PCA i bw J x N i ier y ee 7 pT A 133 Replacement 1 Place the Printer Connector PCA in position Align the printer connector with the hole in the printer well and lower the PCA into position with the foam gasket side down The two locating posts on the back of the well should protrude through the PCA 2 Install the screws Replace and tighten the two T
3. 9 Print the Device Info to ensure the product version or language is correct See Printing the Device Information on page 16 14 10 Affix the appropriate label found in the Software Support Tool kit to battery compartment B as show in Figure 9 Additionally make sure that the customer has the Instructions for Use found on the User Documentation CD that matches the product version Figure 9 Rear case labels P 2 m3538A AN A Er See 2 M3538A 3539 A 7 N Primary label Product Version label SH B2 04 00 S NOTE The label that you apply to the device is in the format Xx xx This is functionally equivalent to the X xx Product Version that appears on the Device Info and Software Upgrade screens and the printed device information report For example product version B2 04 is functionally equivalent to B 04 15 Printing the Device Information You can print detailed information on product versions and board and module levels from the Print Device Info menu option This option is available from the Other menu in clinical modes To print the device information l 2 3 4 5 Be sure a battery charged to at least 20 is in place or that external power is connected Turn the Therapy Knob to Monitor Press the Menu Select button to access the Main menu From the Main menu select Other From the Other menu select Print
4. Figure 74 Removing the CO Module M3535 69181 bj Q Replacing the CO Tubing and Intake Receptacle 1 Attach the O ring to the first groove of the intake receptacle as shown in Figure 72 2 Connect the CO exhaust tube and intake receptacle See Figure 72 a Connect the exhaust tube to the CO outlet port 1 b Make sure that the small face of the CO intake receptacle is towards you and the large face is towards the rear case c Connect the CO intake receptacle making sure that it locks into the snaps in the rear case 2 3 Route the tubing through the rear case according to the path shown in Figure 72 3 NOTE Make sure you place the CO intake receptacle wires under the tube when routing them through the case as shown in Figure 75 Create less slack in area 1 to maximize the service loop in area 2 4 Replace the CO compartment door See CO2 Compartment Door on page 167 5 Replace the plastic shield Figure 75 Rear Case Plastic Shield and Service Loop Create less slack here Maximize service loop 6 Replace the Therapy PCA See Therapy PCA on page 154 7 Replace the CO module See Replacing the CO Module below 8 Replace the Power PCA See Power PCA on page 148 165 Replacing the CO Module 1 Place the CO module into position For the M3535 69103 module position the CO module into the module tray with the tab locate
5. on page 102 2 Position the front case Lay the front case on the work surface with the display facing down and the printer in the lower left corner Removal 1 Disconnect the speaker and microphone from the Processor PCA Unplug the four wire connector by pulling straight up 1 2 Remove the screw Loosen and remove the T 10 screw that fastens the plastic shield and bracket to the case 3 Remove the shield and bracket Lift the shield and bracket straight up 2 4 Note the position of the speaker microphone and the cables for each The speaker lays forward against the speaker support at an angle The microphone fits into an appropriately shaped recess in the case See Figure 43 5 Remove the speaker and microphone Neither is attached to the case simply pull both straight up Figure 43 Removing the Speaker and Microphone 111 Replacement 1 Place the speaker and microphone into position a Position the speaker connections at the bottom as shown in Figure 43 There are two ribs at the bottom of the speaker support the speaker sits on top of the ridges b Place the microphone into its recess Align the microphone wires with the notch in the recess 2 Place the shield and bracket in position Make sure the red and black 4 wire bundle and the white 2 wire bundle pass under the bracket as shown in Figure 43 Replace the screw and tighten 4 Connect the speaker microphone assembly Con
6. For telephone assistance call the Response Center nearest to you or visit our website at www medical philips com cms and follow the links for CMS Response Center Our Biomed On Line site can be found at http bol medical philips com Table 24 Response Center Phone Numbers Canada 800 323 2280 United States of America 800 548 8833 European International Sales Sins ng Hong Kong 852 2876 7578 Macau 0800 923 India New Delhi 011 6295 9734 Mumbai 022 5691 2463 2431 Calcutta 033 485 3718 Chennai 044 823 2461 Bangalore 080 5091 911 Hyderabad 040 5578 7974 Japan 02 3445 9010 Thailand 02 614 3569 81 Repair Notes The following sections give details of how to successfully work with the internal assemblies of the HeartStart MRx Safety Precautions WARNING Remove all power sources AC battery DC before opening the device Failure to do so may allow the device to charge without warning and could result in serious injury or death CAUTION Take the necessary precautions to guard against shock or injury before you conduct monitor defibrillator tests or repairs e Only properly trained technicians should service the device e The device can contain deadly voltages even if the device is turned off e Make sure the device is disarmed To disarm the defibrillator press Disarm If the Shock button has not been pressed within the time period specified in the Time to Auto Disarm Configuration
7. Manual Op Check 2 pE DS as lan Functional Checks Performance Verif Tests quowidinby IS L 47 Figure 20 RFU Indicator Hourglass Turn Therapy Knob to Monitor Is screen blank Yes Turn Therapy Knob to AED Voice prompt heard INOP displayed No Yes Replace Display assembly Take appropriate action Run Operational Check if necessary Check Status log Troubleshoot device using tables if necessary Run Performance Verification tests Place device back in service 48 Figure 21 RFU Indicator Blinking X With Chirp Blinking X with chirp Insert charged battery 20 Capacity or external power supply RFU displays Hourglass Yes Turn on device Run Operational Check Check Status log Troubleshoot device using tables if necessary Repair if necessary Run Performance Verification tests if necessa Place device back in service Figure 22 RFU Indicator Blinking X No Chirp Blinking X no chirp Insert charged battery 20 Capacity RFU displays Hourglass Run Operational Check Yes Check Status log Troubleshoot device using tables if necessary Repair if necessary Run Performance Verification tests if necessa Place device back in service 50 Figure 23 RFU Indicator Solid X With Chirp Solid X with chirp Turn on device ECG message disp
8. Pause Event Review Disarm Energy Selection Front panel Therapy Knob Charge Control Front panel button button on external paddles Shock Control Front panel button buttons on external or switched internal paddles Synchronized Control Front panel SYNC button Indicators Text Prompts Audio Alerts QRS Beeper Battery Status Ready For Use External Power Sync Mode Armed Indicators Charging tone charge done tone flashing shock button and energy level indicated on display AED Mode AED Energy Profile 150 Joules nominal into a 50 ohm test load Text and Voice Prompts Extensive text audible messages guide user through configured protocol AED Controls On off Shock Indicators Monitor display messages and prompts voice prompts battery status Ready For Use external power Armed Indicators Charging tone charged tone flashing shock button and energy level indicated on display ECG Analysis Evaluates patient ECG and signal quality to determine if a shock is appropriate and evaluates connection impedance for proper defibrillation pad contact Shockable Rhythms Ventricular fibrillation and certain ventricular tachycardias including ventricular flutter and polymorphic ventricular tachycardia 251 Shock Advisory Algorithm Sensitivity and Specificity Meets AAMI DF 39 Table 41 AED ECG Analsysis Performance Shockable Rhythm 600 Meets AAMI DF39 requirement and AHA Ventricular Fibrillation recommendation sensit
9. Pediatric No N ON NN RS gt gt AJ A 9O O 9 00 ASS Al AN AN N ee AIAI ART AR RR I N W E et E eee ee PISIM ALR SI SIS SA SIS Sl amp gt gt pl gt amp S gt JO N N N 228 Table 39 Supplies Continued Multi Patient Comfort Cuffs Small Adult Multi Patient Comfort Cuffs Adult Multi Patient Comfort Cuffs Large Adult Disposable Blood Pressure Cuffs SIS alal IPN N A BR oD gt gt gt Soft Single Patient Disposable Cuff Infant Soft Single Patient Disposable Cuff Pediatric Soft Single Patient Disposable Cuff Small Adult Soft Single Patient Disposable Cuff Adult Soft Single Patient Disposable Cuff Adult X Long Soft Single Patient Disposable Cuff Large Adult Soft Single Patient Disposable Cuff Large Adult X Long Soft Single Patient Disposable Cuff Thigh z z z z z z z z AJAJ A AIAI AI ATIA VAATAJAT AJAT AJ Vi TREERE rts gt gt gt gt gt gt gt gt Reusable SpO Sensors Reusable SpO Sensor Adult finger Reusable SpO Sensor Pediatric Small Adult Reusable SpO Sensor Adult thumb Reusable SpO Sensor Adult ear clip S Z S SIZ Sl oloel Sls WW AX o No gt gt gt gt gt Reusable SpO Sensor Infant SpO Extension Cable and Adapter Cable SpO Extension Cable 2 m 6 5 ft Nellcor SpO Sensor Adapter Cable 1 1 m 3 6 ft use with M1903 4B Data Card Data Card an
10. Printer functional description 243 ordering replacement 216 repair 93 test 194 Printer Connector PCA functional description 243 ordering replacement 215 repair 133 Printing troubleshooting 74 Processor PCA functional description 239 key component tracking 229 ordering replacement 214 repair 123 R Ready For Use indicator See RFU indicator Rear case internal assemblies 144 ordering replacement 220 overview 145 repair 174 Reassembly 83 Repair philosophy 9 80 Replacement parts ordering 212 RFU indicator Automated test results 36 definition 2 ordering replacement 216 repair 138 status 35 troubleshooting flowcharts 48 52 S Safety tests 208 Schematics ECG signal flow 238 signal and data flow 237 system level interconnections 236 Serial number entering 128 Service telephone assistance 81 285 Service Mode accessing 10 functions 12 Main menu 11 navigating in 11 password 10 tests 192 Servicing cable assembly placement 83 instrument reassembly 83 Software Support tool ordering 214 using 13 131 Software upgrades 13 Speaker microphone ordering replacement 216 repair 111 SpO2 functional check 201 SpO PCA functional description 247 ordering replacement 215 repair 115 troubleshooting 67 Startup errors 62 Status log accessing 55 additional solutions 58 clearing 55 errors 57 59 printing 56 Supplies ordering 212 part numbers 224 Synchronized cardioversion test 206 T Test and
11. e Password to access Service Mode 27689 e NBP manometer expansion chamber volume 250 ml 10 or an NBP cuff can be used NOTE Ifyou are using an NBP cuff make sure it is wrapped around a solid object e CO calibration gases and regulator cal 1 gas 15210 64010 5 CO2 cal 2 gas 15210 64020 10 CO cal gas flow regulator M2267A electronic flowmeter M1026 60144 Gas calibration equipment cal tube 13907A FilterLine set M1920A local barometric pressure rating or reading received from a reliable local source airport regional weather station or hospital weather station which is located at the same altitude as the hospital or EMS service calculator NOTE In addition to the items listed above the calibration procedures require tubing and connectors typically found in a biomedical engineering shop 18 Checking the NBP Module NBP These instructions describe how to test the NBP measurement function A complete test consists of the following activities which are described in detail in this chapter NBP Check Page Setup 19 Check the status displays 20 Test the accuracy 21 Test for leaks 21 Test the linearity 22 Calibrate the NBP Measurement 22 Run an Operational Check 22 Each of the procedures assumes the monitor defibrillator the manometer and the expansion chamber are still set up as they were at the end of the previous test If all results are as described the device passes
12. 263 Table 42 Monitor Defibrillator and Battery Symbols Continued Alarms are disabled Recyclable material Protected against ingress of solid foreign objects gt 12 5mm in diameter Protected against access to hazardous parts with a finger Protected against splashing water Protected against ingress of solid foreign objects gt 12 5mm in diameter Protected against access to hazardous parts with a finger 264 Table 43 lists the meaning of the symbols appearing on the shipping carton Table 43 HeartStart MRx Shipping Carton Symbols Atmospheric pressure range Temperature range Relative humidity range Recyclable paper product Right side up 265 Safety Considerations The following general warnings and cautions apply to use of the HeartStart MRx Additional warning and cautions specific to a particular feature are provided in the appropriate section General WARNING Remove all power sources AC battery DC before opening the device Failure to do so may allow the device to charge without warning and could result in serious injury or death WARNING HeartStart MRx service should only be performed by qualified service personnel in accordance with the HeartStart MRx MRx Service Manual WARNING The HeartStart MRx MRx is not intended to be deployed in settings or situations that promote use by untrained personnel Operation by untrained personnel can result in inju
13. Screw the large nut onto the back of the Therapy port Be careful not to cross thread the metal nut on the plastic connector b Tighten the nut against the metal plate 4 Replace the Therapy PCA See Therapy PCA on page 154 5 Replace the Therapy capacitor See Therapy Capacitor on page 146 6 Replace the Power PCA See Power PCA on page 148 7 Close the case See Closing the case on page 176 After Repair Run Performance Verification and Safety testing as described in the Performance Verification chapter 159 NBP Module The NBP and CO modules are mounted onto a tray To replace either module you need to remove the tray first then replace the individual module Preparation 1 Open and separate the case See Opening the case on page 102 2 Position the rear case Lay the rear case on the work surface with the PCAs facing up and the Therapy port on the right 3 Remove the Therapy capacitor See Therapy Capacitor on page 146 4 Remove the NBP and CO module tray See NBP and CO2 Module Tray on page 152 Removal Remove the NBP module and shield a Loosen and remove the 4 T 10 screws b Lift the NBP module and shield straight up out of the module tray Figure 71 Removing the NBP Module Replacement 1 Place the NBP module and shield into position Position the NBP module and shield into the module tray 2 Replace the screws and tighten 3 Rep
14. Some of the illustrations show only the 50 mm printer as the procedure for both printers are the same Preparation 1 Turn the device off 2 Disconnect all external power and remove all batteries 3 Wait at least one full minute before proceeding This allows time for the internal power supplies to discharge stored energy Removal 1 Open the printer and remove the paper a Push in the printer door latch and open the printer door b For the 75 mm printer pull up on the white plastic cover holding the paper roll to remove it c Remove the paper 2 Loosen the screws Loosen the two captive Phillips screws at the back of the printer being careful not to damage the wires Close the door slightly to improve access to the screws Figure 29 shows the screws on the 50 mm printer The screws are in the same location for the 75 mm printer Figure 29 Printer Screws AED Screws 93 94 3 Remove the printer Remove the printer by grasping the inside and pulling it straight out of the printer well Figure 30 Removing the Printer Replacement 1 Slide in the printer a Slide the printer straight into the printer well For the 75 mm printer turn the printer so that the printed circuit assembly is to the right as you face the device b Push in gently until it is fully seated 2 Tighten the screws Open the printer door and tighten the two screws For the 75 mm printer access the screws through the scr
15. TA en A Speaker Alarm Pause button Event Summary Soft keys 4 total Navigation button button enu Select button Right Side Figure 2 Right side view Left Side Figure 3 Left side view CO Inlet Port CO Outlet Port NBP Port ECG Port SpO Port RJ11 Telephone Jack ECG Out Sync Jack Rear Figure 4 Rear view ee ED 2 A Bed Rail Hook Mount Battery AC Compartment B Battery Compartment A PHILIPS LANI Connection i RS 232 Serial j T Battery AC Power Module DC Power Input NOTE The LAN port is for factory use only Top Figure 5 Top view Top access panel PCMCIA card slots Internal memory card slot General Service Information Keep the following points in mind when servicing this product Installation The HeartStart MRx does not require installation The Instructions for Use describes the setup required before placing the device into service as well as configuration options All setup activities are designed to be performed by personnel trained in the proper operation of the product To obtain a copy of the Instructions for Use and other MRx documentation go to www medical philips com goto productdocumentation Display Menus To display a menu press the Menu Select button Then use the up A or down V Navigation buttons to scroll through the available choices until the desired selection is highlighted To activate the
16. gt gt gt gt a Wr WIN S oS gt gt Monitoring Electrodes High Tack Foam ECG Electrodes 5 electrodes pack 60 packs case Intubated Circuits a N N NS gt Filter Line Set Adult Pediatric 25 sets per case Filter Line H Set Adult Pediatric 25 sets per case Filter Line H Set Infant Neonatal yellow coded 25 sets per case Non Intubated Dual Purpose Circuits CO O3 Smart CapnoLine Pediatric CO O3 Smart CapnoLine Adult CO O Non Intubated Single Purpose Circuits CO2 CE RCE Re DINJIN v S gt gt gt A N N VA j Vi N N N oO gt gt Smart CapnoLine Pediatric CO Smart CapnoLine Adult CO NBP Interconnect Tubing Adult Pressure Interconnect Cable 1 5 M 5 ft Adult Pressure Interconnect Cable 3 M 10 ft Reusable Blood Pressure Cuffs Reusable NBP Cuff Kit 3 sizes Pediatric Adult Large adult Reusable NBP Cuff Kit 5 sizes Infant Pediatric Adult Large adult Thigh Traditional Reusable Cuff Infant Traditional Reusable Cuff Pediatric Traditional Reusable Cuff Adult Traditional Reusable Cuff Large adult Traditional Reusable Cuff Thigh Antimicrobial Coated Reusable Cuff Infant Antimicrobial Coated Reusable Cuff Pediatric Antimicrobial Coated Reusable Cuff Small Adult Antimicrobial Coated Reusable Cuff Adult Antimicrobial Coated Reusable Cuff Large Adult Antimicrobial Coated Reusable Cuff Thigh Multi Patient Comfort Cuffs
17. on page 13 12 Device Info To view information about the device 1 From the Service Mode Main menu select Device Info Figure 7 Device Info Screen 02 Mar 2003 10 52 A__ e Service pevice nro Model Number M3536A Serial Number US00100320 Options Sp0O2 CO2 NBP Language American English Main Service Software Support Tool To install software onto the device or to change the device s language 1 Be sure an AC power module or battery charged to at least 20 is in place 2 Insert the Software Support Tool into the data card slot 3 From the Service Mode Main menu select Software Upgrade 4 Select the appropriate product version 5 Press the Upgrade soft key The software is installed on the device This process takes a few minutes While the software is being updated progress messages are displayed and the Main Service soft key is disabled 13 NOTE Be careful not to interrupt the software installation process by removing the power source or turning the device off Figure 8 Software Upgrade Screen 02 Mar 2003 10 52 A__ e Service SOFTWARE UPGRADE HeartStart MRx Version B 04 00 Upgrade American English Main Prev Next Service Item Item Upgrade 6 When the software or language installation process is complete turn the device off and on 7 Run an Operational Check 8 Review the Operational Check results to ensure all tests have passed See Operational Check on page 39
18. saturation reads between 95 100 then SpO check passes NBP Measurement Take a blood pressure If you are able to complete a NM x measurement on yourself or measurement the NBP Example NM p another person page 201 check passes Using an ECG simulator If all data within limits all E x perform Leads ECG and checks pass Example E p Pads cable ECG test page e Waveform clear on 201 display HR correct on display and matches defib analyzer at 2 data points 30 and 200 bpm HR alarm works Leads off indicators perform as expected Cycles through different views then ECG test passes 185 Table 29 Test and Inspection Matrix Continued Pacing Test P Using a defibrillator All data within limits all P x analyzer perform the Pacing checks pass Example P p test page 205 70 ppm 30 mA 30 mA 5 mA 180 ppm 160 mA 160 mA 16mA then Pacing test passes Synchronized Cardioversion Using an ECG simulator If all data within limits all SC x SC and defibrillator analyzer checks pass Example SC p perform the Synchronized Sync markers appear on the display at the peak or on the falling side of the QRS complex cardioversion test page 206 Shock delivered on next QRS Shock delivered 6J 2J If applicable strip prints with the correct information on it Delay between the peak of the QRS and the delivered shock is lt 30 ms If clinicians use an extern
19. 10 wire cables e SpO logic and patient isolation e Measurement of device temperature Monitoring of overall system health and control of the RFU indicator 239 Therapy PCA The Therapy PCA has responsibility for the following functions e Charging the capacitor to the correct energy level and keeping the capacitor charged to the correct level as directed by the Processor PCA e Delivering defibrillator shocks and controlling the waveform as directed by the Processor PCA e Disarming discharging the capacitor e Internal load to absorb disarmed energy e Generation of pacing waveforms as directed by the Processor PCA e Electrical interface to the NBP module CO module RS232 serial port and LAN port e Sensing the paddle ID resistor to identify the type of paddles pads connected Power PCA The Power PCA performs the following functions e Supplies 3 3V 5V and 12V system power e Charges batteries e Analog front end for ECG from the pads paddles e Impedance measurement for the Patient Contact Indicator PCI function e Monitoring the overall system power including detecting installed batteries or the presence of external power and selecting power sources Battery Connector PCA The Battery Connector PCA provides the contacts with which the batteries and AC power module mate It is an interconnection PCA only and has no active circuitry Power Batteries The HeartStart MRx can be configured with two ba
20. 119 7 Remove the RFU Indicator See Ready For Use Indicator on page 138 8 Remove the front panel buttons See Front Panel Buttons on page 140 Replacement 1 Replace the front panel buttons See Front Panel Buttons on page 140 2 Replace the RFU Indicator See Ready For Use Indicator on page 138 141 3 Replace the Therapy switch See Therapy Switch on page 119 4 Replace the Display assembly See Display Assembly on page 135 5 Replace the Processor PCA and SpO PCA together Leave the SpO2 PCA in place on the Processor PCA then replace the Processor PCA in the Front Case See Processor PCA on page 123 6 Replace the measurement module panel See Measurement Module Panel on page 117 7 Replace the Printer PCA See Printer Connector PCA on page 133 8 Replace the Speaker Microphone Assembly See Speaker and Microphone Assembly on page 111 9 Close the case See Closing the case on page 176 10 Replace the Therapy Knob See Therapy Knob on page 90 11 Replace the printer See Printer Assembly on page 93 142 12 Affix the new labels See Labels on page 91 for information on removal and replacement procedures See Software Support Tool on page 13 for information on where to affix product version labels Figure 60 Front case complete After Repair Run Performance Verification and Safety tes
21. 2 5 Connect the small ribbon cable 6 Replace the plastic shield Figure 79 Rear Case Plastic Shield and Service Loop 7 Replace the CO compartment door See CO2 Compartment Door on page 167 8 Replace the Therapy PCA See Therapy PCA on page 154 9 Replace the NBP and CO module tray See NBP and CO2 Module Tray on page 152 10 Replace the Therapy capacitor See Therapy Capacitor on page 146 172 11 Replace the Power PCA See Power PCA on page 148 12 Close the case See Closing the case on page 176 After Repair Run Performance Verification and Safety testing as described in the Performance Verification chapter 173 Rear Case Assembly The rear case replacement involves moving existing parts from the old case to the new and replacing the labels Preparation 1 Open and separate the case See Opening the case on page 102 2 Position the rear case Lay the rear case on the work surface with the PCAs facing up and the Therapy port on the right Removal 1 Remove the Therapy capacitor See Therapy Capacitor on page 146 2 Remove the Power PCA See Power PCA on page 148 3 Remove the NBP and CO module tray See NBP and CO2 Module Tray on page 152 4 Remove the Therapy PCA See Therapy PCA on page 154 5 Remove the Therapy port See Therapy Port on page 158 6 Remove the CO tubing and int
22. 2 multifunction electrode pads Lead Fault LEAD OFF message and dashed line appear on the display if an electrode or lead becomes disconnected Pad Fault Dashed line appears on the display if a pad becomes disconnected Heart Rate Display Digital readout on display from 15 to 300 bpm with an accuracy of 10 Heart Rate Arrhythmia Alarms HR Asystole VFIB VTACH VTACH Extreme Tachy Extreme Brady PVC rate Pacer Not Capture Pacer Not Pacing Hands Free Defibrillation Patient Cable Length e M3508A 2 2 m 7 ft e M3507A 2 2 m 7 ft ECG Cable Length 2 7 m 9 ft 252 Common Mode Rejection Greater than 90 dB measured per AAMI standard for cardiac monitors EC 13 ECG Size 2 5 5 10 20 40 mm mV autogain Frequency Response e AC Line Filter 60 Hz or 50 Hz e Pads ECG for Display Monitor 15 40 Hz or EMS 1 30 Hz e Pads ECG for Printer Monitor 15 40 Hz or EMS 1 30 Hz e Leads ECG for Display Monitor 15 40 Hz or EMS 1 30 Hz e Leads ECG for Printer Diagnostic 05 150 Hz or Monitor 15 40 Hz or EMS 1 30 Hz Patient Isolation defibrillation proof e ECG Type CF SpO Type CF EtCO Type CF e NBP Type CF External Defib Type BF e Internal Defib Type CF Other Considerations The HeartStart MRx is suitable for use in the presence of electrosurgery Burn hazard protection is provided via a 1K current limiting resistor contained in each ECG lead wire 253 Displa
23. 3 Close the case See Closing the case on page 176 After Repair Run Performance Verification and Safety testing as described in the Performance Verification chapter 168 Battery Connector PCA Preparation 1 Open and separate the case See Opening the case on page 102 2 Position the rear case Lay the rear case on the work surface with the PCAs facing up and the Therapy port on the right 3 Remove the Power PCA See Power PCA on page 148 4 Remove the Therapy capacitor See Therapy Capacitor on page 146 5 Remove the NBP and CO module tray See NBP and CO2 Module Tray on page 152 NOTE If the device does not have the NBP or CO modules simply unscrew the tray and slide it out 6 Remove the Therapy PCA See Therapy PCA on page 154 7 Remove the plastic shield Remove the plastic shield from the rear case and place it to the side You will need to replace this 8 Remove the CO compartment door See CO2 Compartment Door on page 167 169 9 Disconnect the CO exhaust tube 1 10 Disconnect the CO intake receptacle 2 Using your index fingers open the two plastic snaps From the outside of the case push the receptacle out with your thumb Figure 77 Disconnecting the CO Tubing and Intake Receptacle TOP Va o umm i T X Ba E Na 170 Removal 1 Disconnect the small ribbon cable from the Battery connector PCA 1 2 Remove
24. CO module has reached Replace CO module and CO internal recommended end of life tubing intake receptacle wires and tubing 69 Defibrillation Problems Table 16 Defibrillation Problems Symptom Possible Cause Suggested Solution Charging Problems Wont charge in Manual e Paddles not connected e Check restore connection Defib Mode using Charge properly button on paddles Paddles defective Confirm paddles problem by connecting Pads and attempting to charge device using Charge button on the MRx Replace paddles if needed Problem with internal Check restore connections between connections Therapy port and Therapy PCA and between Therapy PCA and Processor PCA Therapy port defective Replace Therapy port Therapy PCA defective Replace Therapy PCA Failure on Processor PCA Replace Processor PCA 70 Table 16 Defibrillation Problems Continued Symptom Wont charge in Manual Defib Mode using Charge button on MRx Wont charge in AED Mode but charges in Manual Defib Mode Doesn t charge to energy setting on Therapy switch Failure of front panel button Therapy PCA defective Failure on Processor PCA Failure in pads ECG front end Failure on Processor PCA Therapy Knob has been replaced and installed incorrectly Therapy switch failure Therapy PCA defective Failure on Processor PCA Possible Cause Suggested Solution e Therapy cable Connect paddles or pads Check to see
25. Do not keep the cuff pressurized for more than 3 minutes The NBP module times out if the pressure is greater than 5mmHg for 180 seconds The valve opens and the pressure drops To reset the module exit Service Mode and press the Start NBP soft key The inop Cuff not deflated is displayed Access the NBP Service screen again to start the calibration Test the accuracy 1 Connect the NBP tubing to the NBP port on the monitor defibrillator and connect the test manometer and expansion chamber to the tubing See Figure 11 Figure 11 NBP Test Setup Expansion Chamber Tubing To NBP port Manometer 2 Pressurize the expansion chamber to approximately 280 mmHg 3 When the pressure stabilizes compare the displayed pressure reading to the pressure indicated by the manometer 4 If the difference between the manometer and the displayed pressure is gt 2mmHg perform the steps in Calibrate the NBP Measurement on page 22 Test for leaks 1 Pressurize the expansion chamber to approximately 280 mmHg 2 Watch the displayed pressure for 60 seconds 3 At the end of this 60 seconds record the pressure drop Any pressure drop observed should be lt 6 mmHg 4 Ifthe pressure decreases by more than 6 mmHg there is a leak Replace the NBP tubing and cuff and try the leakage test again If the pressure still decreases by more than 6 mmHg begin troubleshooting and repairing the device as needed 5 Release the pressure in the cuff be
26. Ece Electrodes z ici EGG Out 2 wires Sa D ECG rN y v a om Control 4 A EA a 3 SpO Signal SpO PCA Power 2 wires Qo Lag flex circuit c gt flex z S m circuit Control Data Power lan Sp02 D O 50 pin ribbon cable sensor 5 Printer D tubing e NBP Module z frien nes NBP 2 NBP Cuff Interconnect 5 K J Tubing EE Control Power eN EtCO EtCO2 inlet a san PCA n Oe ower ee M d ane Data ribbon TO Filter Line outlet oaule Power cable Es 93 gr Tray Detection tubing i g A 2 A e z m9 _ ge O e Bb Power a a N A N P i High Voltage C E Aone Q 4 A Analog ECG gt DC Power E 52 2 wires Module j gt 52 Therapy PCA J a N 2 w Pads W A gg Paddles Anal ECG a fo Sensing p eo on N Defib Pads 9 wires 5 a AC Power i Module gt Xe yw _ Battery PCA 2 i _ k q Li lon Battery alee ESTESE STEE Therapy Pack E w C a Capacitor ew Paddles 237 ECG Signal Flow Figure 89 LNAILVd 238 ECG Out Control Analog S O PCA lq Data f p 2 Power Spo Signal Nidan flex flex circuit circuit SpO SpO2 Sensor Cable tubing NBP Module NBP NBP Cuff Interconnect Tubing Santen Control Data niet Data Power EtCO ee i ECO gt EtCO2 tubing EtCO Power Control 40 pin Filter Line Connector ubing 2 Data ribbon Filter Line outlet Module Power cable Detect
27. Inspection matrix 184 Therapy capacitor discharging 105 key component tracking 229 ordering replacement 216 repair 146 Therapy Knob ordering replacement 221 repair 90 Therapy PCA functional description 240 key component tracking 229 ordering replacement 215 repair 154 Therapy port key component tracking 229 ordering replacement 217 repair 158 286 Therapy switch key component tracking 229 ordering replacement 216 repair 119 Tools repair 85 troubleshooting 34 Troubleshooting U audio 75 audio tones 54 CO module 68 controls 76 defibrillation 70 display 75 ECG monitoring leads 64 ECG monitoring pads paddles 65 external data card 77 general monitoring 63 internal memory 77 methodology 45 NBP module 66 pacing 73 printing 74 RFU indicator 48 52 SpO PCA 67 startup errors 62 status log 55 test coverage 47 Upgrades yv available options 8 software 13 Visual Inspection 191 W Weekly tests 36
28. Invalid request 12L Transmit HTTP client error 12L Transmit Modem Connection Lost 12LXmit Network Transmission Failed Connection Interrupted Unreachable 12LXmit Server Transmission Failed Cannot reach server Transmission Failed Server unknown DNS query failure 12LXmit Server 60 the Serial Phone Profile settings is incorrect Data transfer service is unavailable on the phone Wrong number The PPP User Name or PPP Password under the Serial Profile Phone settings is incorrect The server User Name or Password is incorrect The network is down The server connection has timed out The phone is disconnected TCP IP Failure The web server has rejected the data The network is down No server or the connection has been lost e The DNS has timed out or there has been a failure in the DNS Status Log Error Possible Causes Suggested Solutions The Dial String under e Work with your cell phone provider to ensure that the Dial string is correct Work with your cell phone provider to ensure that your cell phone plan has data transfer capability Check the number and re send Modify the Serial Phone Profile setting as needed Modify the Hub settings as needed Check with your ISP to see if your service is down Re send the 12 lead report Check that the phone is connected to the serial cable and that the serial cable is connected to the
29. MRx Monitor Defibrillator monitor defibrillator device Noninvasive Blood Pressure NBP End tidal carbon dioxide EtCO Carbon dioxide CO Pulse Oximetry SpO ii Table of Contents 1 Introduction Who Should Use This Manual 1 Overview 1 Features and Capabilities 2 Tour of the Device 3 Right Side 4 Left Side 5 Rear 6 Top 7 General Service Information 8 Installation 8 Display Menus 8 Passwords 8 Upgrades 8 Preventive Maintenance 8 Repair Philosophy 9 Accessing Service Mode 10 Navigating in Service Mode 11 Service Mode Functions 12 Other Resources 16 2 Maintenance i7 Overview 17 Maintenance Tools and Equipment 18 Checking the NBP Module 19 NBP 19 Checking the CO Module 23 CO2 23 3 Troubleshooting 33 Overview 33 Troubleshooting Tools and Equipment 34 Obtaining Replacement Parts 34 Ready For Use Indicator 35 Automated Tests 36 Automated Test Summary 36 iii Operational Check 39 Operational Check Report 43 Operational Check Summary 44 Service Mode Tests 44 Troubleshooting Methodology 45 Troubleshooting Flowcharts 47 Troubleshooting Tables 53 Audio Tones 54 Status Log Errors 55 Startup Errors 62 General Problems 63 ECG Monitoring Problems 64 NBP Monitoring Problems 66 SpO Monitoring Problems 67 CO Monitoring Problems 68 Defibrillation Problems 70 Pacing Problems T3 Printing Problems 74 Display Problems 75 Audio Problems 75 Controls Problems 76 Internal Memory Problems 77 External Data Ca
30. Parts The tables of replacement parts are organized as follows Topic Page Topic Page Electrical Assemblies 214 Labels 222 Processor PCA 214 Instruction Label Sets 222 Other Replacement PCAs 215 Hazardous Shock Warning Label Set 223 Other Electrical Assemblies 216 Branding Label Set 223 Individual Electrical Parts 216 Speaker Label Set 225 External Electrical Components 217 Connector Label Set 223 Internal Cables 218 Supplies and Accessories 224 Paddles 219 Key Components 223 Mechanical Assemblies 220 Replacement Mechanical Assemblies 220 Individual Mechanical Parts 221 213 Electrical Assemblies The following tables list all the electrical field replaceable assemblies Processor PCA The replacement Processor PCA includes the clock battery backup the battery cable s tie wrap ProGold wipes for the battery terminals and connectors and the fan assembly All Processor PCAs are American English part number 453563478461 M3535 68101 Order the appropriate Software Support Tool to set the Processor PCA to the correct language NOTE The Processor PCA is a Key Component that requires tracking See Table 40 on on page 229 Table 30 Software Support Tool Traditional Cantonese Chinese Blank card for SoftServer use 214 Other Replacement PCAs These PCAs come with specific parts as noted Table 31 Replacement PCAs SpO PCA 453563476681 M3535 69100 Power PCA 453563478491 M3535 68109 Therapy PCA 453563478481 M3535
31. Pressure 156 mmHg Cell Pressure 756 mmHg Ambient Pressure Main Calibration Check Servico O w Check the Status Display 24 l Check the CO Operating Hours You are directed to replace the CO module after 15 000 hours of operating time If the number of hours is more than 15 000 the message Replacement recommended is displayed See CO Module on page 162 for instructions on replacing the CO module Check calibration status Displays the date of the last calibration The CO module should be calibrated every year or after 4000 hours If more than one year has passed or the module has operated more than 4000 hours since the last calibration the message Calibration recommended is displayed Perform all of the actions described in this section beginning with Ambient Pressure 3 Check the ambient and cell pressure Obtain a reliable measurement of local barometric pressure reference value This is typically available from a local airport weather station or the internet Be sure the reading is taken at the same altitude as the monitor defibrillator is at now Check that the monitor defibrillator s internal setting of ambient atmospheric pressure barometric pressure is within 12 mmHg of the reference value If the ambient pressure is not within 12 mmHg of the reference value adjust it through the Ambient Pressure menu If the ambient pressure is within 12 mmHg of the reference value procee
32. Therapy Knob and soft keys page 193 Run printer test page 194 Controls test C Printer Pr Run the NBP Calibration check page 196 NBP Cal Check NC CO Cal Check CO Run the CO Calibration check page 197 184 Vix Example V p If no unusual damage no corrosion no missing items then Visual Inspection passes OC x Example OC p If Pass reported on all tests applicable to the device configuration and options then Operational Check Passes SLX Example SL p If no errors then status log passes Assuming the log has been cleared after the last successful Operational Check If all keys respond as Gx expected then Controls test Example C p passes Pr x Example Pr p If print quality is adequate no stray marks or lines and print speed 25 mm 5 1 25mm If print speed configured for 25 mm OR print speed 50 mm 5 2 5mm If print speed configured for 50 mm then Printer test passes NC x Example N p If all data passes within limits then NBP calibration check passes CO x Example CO p If all data passes within limits then CO calibration check passes Table 29 Test and Inspection Matrix Continued Functional Checks In normal Operating Mode perform the following functional checks SpO Sp Using the SpO sensor If pleth wave is clear pulse SP x perform SpO check page rate is displayed and Example Sp p 201
33. ___ AC DC Power amp Cord ____ Printer Paper _ Data Card ____ SpO2 Sensor NBP Cuffs amp Tubing Inspected by Press the Print soft key when the Operational Check is complete to print an additional copy of the report 43 Operational Check Summary The Operational Check summary lists the results from the last 60 operational checks To view the Operational Check summary 1 Turn the Therapy Knob to Monitor or Exit Service Mode if applicable 2 Press the Menu Select button 3 Using the Navigation buttons select Other and press the Menu Select button 4 Select Operational Check and press the Menu Select button 5 Select Op Check Summary and press the Menu Select button The message Leaving Normal Operating Mode Patient Monitoring is Off To return to Normal Operating Mode press the Exit Softkey appears The Operational Check Summary screen is displayed 6 Press the Print soft key to print the report Service Mode Tests These tests include manual interaction on tests such as the display and controls These tests help you to isolate any problems with the device See Service Mode Tests on page 192 for more information on Service Mode tests 44 Troubleshooting Methodology We recommend using the methodology described on the following pages to isolate and repair problems with the HeartStart MRx 1 Decontaminate the device using local decontamination procedures Refer to the nstructions for U
34. appear on the screen or printed report Figure 17 Operational Check Screen 02 Mar 2003 10 52 C ET Operational Check Model Number M3535A Serial Number US00108360 Last Operational Check 01 Mar 2003 9 35 Pass Display Test Pass General System Test Pass Audio Test Pass Leads ECG Test Pass ECG Cable Pads Paddles ECG Test Pass Pads Pacer Test Pass Defib Test Pass External Paddles Pass Internal Paddles Pass Pads Battery Compartment A Test Pass Cal Recommended Battery Compartment B Test Pass pO2 Test In Progress NBP Test CO2 Test Printer Test Exit Op Check WARNING Be sure to safely discharge internal and external paddles tested during the Operational Check as 40 described in Table 4 Table 4 Operational Check Tests A test pattern is displayed the display is filled with black then white then red from top to bottom then green from left to right General System Tests internal clock battery power supply and internal memory card The voice prompt No Shock Delivered is annunciated Leads ECG Tests leads ECG acquisition and if attached the ECG cable The recommended practice is to run the test with the ECG cable attached Pads Paddles ECG Checks ECG acquisition through pad paddles Tests pacing functionality and delivers a paced pulse into a 50 Pacer only runs if the option pen ohm test load Did you see the test pattern correctly
35. be 200J 15 3 Check the printed strip from the MRx The energy setting should be 200J The delivered energy should be 200 15 and will be printed on the strip if the device is configured to print on shock 4 Repeat the test using paddles pressing the Shock button on the paddles in Step Ic Defibrillator Disarm Test These instructions describe how to test the disarm function Setup 1 Insert a battery charged to at least 20 and disconnect the AC power cord 2 Connect the Pads cable to the MRx 3 Connect the defibrillator analyzer to the Pads cable 4 Set the analyzer to measure delivered energy If needed reset the analyzer s display to read 0 Test the Disarm Softkey 1 Charge to 200J a Turn the MRx s Therapy Knob to 200J b Press the Charge button to charge the MRx 2 Press the Disarm softkey The MRx should disarm itself by discharging into an internal load resistor 3 Check the results Verify that the Defib Disarmed message appears on the MRx Verify that the charge tone stopped 4 Check the analyzer readings Read the delivered energy indicated by the defibrillator analyzer It should be 0J or be blank 204 Pacer Test These instructions describe how to test the pacing function Only run this test if the Pacing option is installed on the monitor defibrillator If all results are as described the device passes the test If there is any failure begin troubleshooting and repairi
36. card is corrupt Internal Memory Failure Patient data cannot be stored Run an Operational Check and check the inop appears every time the in internal memory because status log If an Internal Memory error is device is turned on the internal memory card is listed replace the internal memory card not recognized External Data Card Problems Table 23 External Data Card Problems Possible Causes Suggested Solution Incompatible data card Data card is not compatible Use only Philips M3545A data cards message with the HeartStart MRx Data Card Full message The data card has reached Insert a new data card or erase data from the capacity card Doesn t copy data to data Data card full or corrupted Replace data card card No Data Card present Sufficient time not Insert data card Once inserted wait 5 message allowed for data card seconds before trying to access the data recognition card Data card failure Replace data card Data card not seated Replace Processor PCA properly due to bent pins Processor PCA failure Replace Processor PCA Ti 4 Repair This chapter describes how to repair the HeartStart MRx monitor defibrillator Details are provided on disassembling the device removing and replacing subassemblies and reassembling the device These instructions are intended for use only by service providers who are specifically trained to service the HeartStart MRx Overview This chapter is
37. changes in the patient s condition Monitor Mode also provides an optional 12 Lead ECG function enabling you to preview acquire store and print 12 lead ECG reports with or without analysis interpretation Manual Defib Mode offers simple 3 step defibrillation You analyze the patient s ECG and if appropriate 1 select an energy setting 2 charge and 3 deliver the shock Defibrillation may be performed using paddles or multifunction electrode pads Manual Defib Mode also allows you to perform synchronized cardioversion and internal defibrillation In AED Mode the HeartStart MRx analyzes the patient s ECG and determines whether a shock is advised Voice prompts guide you through the 3 step defibrillation process providing easy to follow instructions and patient information Voice prompts are reinforced by messages that appear on the display Both Manual Defib and AED Mode incorporate the Philips low energy SMART Biphasic waveform for defibrillation Optional Pacer Mode offers noninvasive transcutaneous pacing therapy Pace pulses are delivered through multifunction electrode pads using a monophasic waveform The HeartStart MRx is powered by rechargeable lithium ion batteries Available battery power is easily determined by viewing the convenient battery power indicators located on the device display or by checking the indicators on the battery itself Additionally an external AC or DC power supply may be applied as a seco
38. clinicians use an external monitor as the ECG source you must verify that the external monitor and the HeartStart MRx combination will deliver a synchronized shock within 60 ms of the peak of the R wave Use a 1 mV QRS complex with a QRS width of 40 ms This performance cannot be guaranteed with all commercially available monitors TIP 206 Setup 1 Set up the defibrillator analyzer a Connect the ECG cable and the Pads cable to the HeartStart MRx b Connect the ECG cable to the analyzer c Connect the Pads cable to the analyzer d Set the analyzer to take a synchronized measurement 1mV amplitude at some nominal rate e g 60 bpm 2 Set up the MRx a Turn the Therapy Knob to 1 10 joules b Press the Sync button Check that a Sync message appears in the upper right corner of Wave Sector 1 Check Display Shock Print 1 Check the displayed waveform Verify that sync markers appear on the display at or near the peak of the QRS complex Adjust the size of the displayed ECG as needed to view it more clearly To adjust the size of the displayed ECG access the following menus Main Waves Wavel II II size 2 Check shock delivery a Select an energy of 6J Press the Charge button then press and hold the Shock button until the shock is delivered at next QRS b Verify on the defibrillator analyzer that the shock was delivered and was 6J 2J c Ifthe device is configured to do so verify that it prints a
39. cycles lt 5 Ur gt 95 dip in Ur for 5 sec Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 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 Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment 273 Table 46 Electromagnetic Immunity Life Supporting Functions Conducted RF IEC 61000 4 6 Portable and mobile RF communications equipment should be used no closer to any part of the HeartStart MRx including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter 3 Vrms Recommended Separation Distance 150 kHz to 80 MHz 3 Vrms outside ISM bands d 12 P 10 Vrms Recommended Separation Distance 150 kHz to 80 MHz 10 Vrms in ISM bands A 1 2 JP Table 46 Electromagnetic Immunity Life Supporting Functions Continued Radiated RF IEC 61000 4 3 80 MHz to 2 5 GHz d P 80 MHz to 800 MHz d 2 34 P 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitters specified output
40. described in the Performance Verification chapter 90 Labels There are six groups of labels for the HeartStart MRx the Instruction label set the Hazardous Shock Warning label set the Branding label set Speaker label set the Connector label set and the Product Version label Each set of labels is one sheet containing all the labels in that set Instruction Label Sets There is one instruction label set for each language See Labels on page 222 for part numbers This set includes labels for e Therapy Knob with and without Pacing NOTE Fach Instruction label set includes a label for devices with pacing and a label for devices without pacing You must ensure that you place the correct label on the device e Paddles instructions left and right side e Paddles warning e Cap plate instructions e Cap plate warnings e Battery ID e Service warning Hazardous Shock Warning Label Set The Hazardous Shock Warning Label set is affixed to the Power PCA shield and under the Paddle tray or cap plate Branding Label Set The branding label is affixed to the front of the device directly below the center of the display Speaker Label Set The speaker label is affixed to the speaker Connector Label Set This label set is shipped as part of the rear case field replacement kit It includes the labels for the battery AC power DC in connector network connectors and patient connector Therapy port Product Version Lab
41. e Providing digital data to the Processor PCA 248 8 Specifications and Safety This chapter describes the specifications and safety features of the HeartStart MRx monitor defibrillator Specifications General Dimensions with pads 31 5 cm W x 21 0 cm D x 29 5 cm H 12 4 in x 8 3 in x 11 7 in Dimensions with paddles 34 0 cm W x 21 0 cm D x 34 5 cm H 13 4 in x 8 3 in x 13 6 in Weight Less than 13 2 lbs including pads pads cable battery and full roll of paper Incremental weight of external standard paddles and paddle tray is less than 2 5 lbs Additional battery weighs less than 1 6 lbs Defibrillator Waveform Biphasic Truncated Exponential Waveform parameters adjusted as a function of patient impedance Shock Delivery Via multifunction electrode pads or paddles 249 250 Delivered Energy Accuracy Selected Nominal Delivered Energy vs Patient Impedance Accuracy Energy Load Impedance ohms 100 125 150 175 itp ff fo ox fa a ia foo a0 i i ts sm 55 so or oa faa oe ox Far e pepo p foe fae fa Fa o fa po fs pa pa fox Far a fete fe fe fo fe io far 15 Charge Time Less than 5 seconds to 200 Joules with a new fully charged Lithium Ion battery pack at 25 C Less than 15 seconds when operating without a battery using the M3539A AC power module alone at 90 100 rated mains voltage Less than 15 seconds with a new fully charged Lithium Ion battery p
42. expected CO value tolerance mmHg example 0 07 X 73 6 mmHg 5 2 mmHg In this example the reading displayed with 10 cal gas must be 73 6 mmHg 5 2 mmHg or between 68 4 mmHg and 78 8 mmHg Compare the displayed CO value to the allowable range of values If the displayed value falls within the allowable range the device has passed its accuracy test If the displayed value does not fall within the allowable range the CO measurement module needs to be calibrated Perform the steps under CO Calibration on page 30 then begin again at step 1 Return to the CO Service screen by pressing the Done soft key CO Calibration If you haven t already done so perform the following three steps before proceeding with the calibration 1 30 The monitor defibrillator must be operating and a FilterLine connected to the CO Inlet port for at least 20 minutes prior to starting this test From the CO Service menu select Calibration Check and press the Menu Select button The CO Calibration screen is displayed Wait until the display indicates the autozero is finished before proceeding Calibration 4 Connect the 5 calibration gas and regulator if needed to the CO Inlet port Turn on the gas 5 Wait until the displayed CO value is stable 6 Press the Calibrate soft key 1 The screen prompts you for the value of cal gas being used Acceptable values are from 4 to 6 The recommended value is 5 which is
43. foam from the sheet metal The black foam protects the cables during shipment 2 Place the Display assembly into position Lower the Display assembly into position into the front case Be sure the metal housing fits down over the molded posts in the front case Make sure that no cables are trapped underneath 3 Replace the screws Replace and tighten the 11 T 10 screws 4 Replace the Processor PCA See Processor PCA on page 123 5 Replace the measurement module panel See Measurement Module Panel on page 117 6 Close the case See Closing the case on page 176 After Repair Run Performance Verification and Safety testing as described in the Performance Verification chapter 137 Ready For Use Indicator Preparation 1 Open and separate the case See Opening the case on page 102 2 Position the front case Lay the front case on the work surface with the display facing down and the printer in the lower left corner 3 Remove the Processor PCA See Processor PCA on page 123 Removal 1 Pull up the alignment tabs Using a small screwdriver on the black rubber piece lift the RFU Indicator out of the white tab 2 Lift out the RFU Indicator Lift up on the right end of the RFU Indicator and slide it out from under the retaining catch Lift it out of the case Figure 59 Removing the RFU Indicator NS N ROIC N gt Replacement 1 Remove the protective plasti
44. for every 1 mmHg above 40 mmHg Values read at sea level after gt 20 min warm up The accuracy specification is maintained to within 4 for the following gas mixtures all values are in Vol 0 to 97 5 0 to 100 According to EN864 Rise Time 190 ms maximum 10ml min Delay Time 2 7 seconds typical System Response Time 2 9 seconds typical Sample Flow Rate Nominally 50 ml min 7 5 ml min 257 Microstreaam CO Humidity Correction Factor BTPS Body Temperature and Pressure Saturated 37 C 750mmHg 100 humidity or 47mmHg is the humidity correction factor for the Microstream CO readings The formula for the correction calculation is Perps FCO X Pb 47 FCO X 0 94 Where FCO2 fractional concentration of CO in dry gas Foo CO 100 Pb ambient pressure Alarm Range e Low Limit 10 to 94 mmHg Adult Pediatric e High Limit 20 to 95 mmHg Adult Pediatric AwRR Range 0 to 150 rpm Resolution 1 rpm Accuracy e Oto 40 rpm 1 rpm e 41 to 70 rpm 2 rpm e 71 to 100 rpm 3 rpm e 101 to 150 rpm 5 rpm Alarm Range e Low Limit 0 to 95 rpm Adult Pediatric e High Limit 10 to 100 rpm Adult Pediatric Apnea Alarm 10 40 seconds in increments of 5 258 Calibration Gas for CO Measurement System Ingredients 5 Carbon Dioxide 21 Oxygen 74 Nitrogen Cylinder Size BD Method of Preparation Gravimetric Blend Tolerance 0 03 Accuracy 0 03 absolute Moisture 10 PPM Maximu
45. for signals coming in on the 3 5 or 10 lead ECG cable The ECG signal picked up by the ECG monitoring electrodes is carried by the ECG cable to the ECG port and then to the Processor PCA There it is amplified filtered and digitized The Processor PCA then performs digital signal processing on the ECG data and is responsible for e Formatting and presenting the ECG to the display and to the printer e Counting heart rate and generating heart rate alarms e Reporting on the status of the patient connection and alerting the user to measurement problems e Arrhythmia analysis and alarms 243 Pads Paddles ECG The ECG signal picked up by the paddles or disposable defibrillation pads is carried by the cable to the Therapy port via the Therapy PCA and then to the Power PCA There it is amplified filtered digitized and passed across a patient isolation barrier before being passed to the Processor PCA via a large ribbon cable The Processor PCA then performs digital signal processing on the ECG data and is responsible for e ECG waveform analysis and Shock Advisory in AED Mode e Formatting and presenting the ECG to the display and to the printer e Counting heart rate and generating heart rate alarms e Reporting on the status of the patient connection Patient impedance functions The HeartStart MRx measures patient impedance in two ways an impedance measurement before the shock and a impedance measurement during the
46. including defibrillation pacing and ECG acquisition Fail NC Hourglass A non critical failure was detected Non critical failures do not impact life saving functionality Fail BF Blinking X The battery is not charged to the minimum level 20 there is no battery present or a battery failure was detected 38 Respond to the RFU indicator as described in Troubleshooting Flowcharts on page 47 Press the Exit Summary soft key An inop statement indicating the failure is displayed You can also note the time of the failed test then check the Status log for failures logged at approximately the time of the test Refer to the Troubleshooting Tables in this chapter for the action to take The message will continue to display in all modes until the problem is corrected Refer to the Instructions for Use for a complete set of user prompts and messages Charge the battery as soon as possible and or replace the battery with a charged battery Charging may be done in the HeartStart MRx by connecting to AC DC power or in a Philips approved battery support system Operational Check NOTE Operational Checks should be performed at regular intervals to supplement the hourly daily and weekly Automated Tests executed by the MRx Automated Tests provide adequate assurance that the device is in a functional state of readiness Operational Checks supplement the Automated Tests by verifying therapy cables t
47. level control of all modules and subsystems e Control of power up and power down sequences e Storage of configuration selections made by the user e Storage of operating software including data for generating display formats and graphics e All user interface functions including Generation and control of tones and audio prompts and detecting of front panel button presses Generation and formatting of information for the display and printer Control of indicator LEDs for Shock button backlight and External Power e Storage of information on the data card e Supervision of defibrillation functions on the Therapy PCA including Initiating a capacitor charge sequence Secondary monitoring of capacitor voltage Initiating a shock delivery sequence Controlling therapy isolation and internal paddles relays e Control of pacing functions on the Therapy PCA including Initiation of each pace pulse Monitoring pacing current delivered Controlling enabling of pacing and pacing isolation relays e Control of the ECG front ends on the Processor PCA Leads ECG and Power PCA Paddles Pads ECG e All ECG processing including filtering beat detection and rhythm analysis e Setting various alarm limits HR SpO etc and generating alarms when those limits are violated e Interconnection site for ECG leads cable ECG out cable and SpO PCA e ECG analog front end for ECG from 3 5 and 12 lead
48. more information To run the Operational Check 1 Insert a battery charged to at least 20 Attach a Pads or Paddles therapy cable Attach an ECG cable 2 3 4 Turn the Therapy Knob to Monitor 5 Press the Menu Select button 6 Using the Navigation buttons select Other and press the Menu Select button You can run Operational Check from the Other menu in Monitor Mode or from the Service Mode Main menu the Operational Check is the same in both modes When you exit the Operational Check from Service Mode you are returned to Monitor Mode 7 Select Operational Check and press the Menu Select button 8 Select Run Operational Check and press the Menu Select button Leaving Normal Operating Mode Patient Monitoring is Off To return to Normal Operating Mode press the Exit Softkey appears 9 Press the Menu Select button to acknowledge the message 10 Carefully read and respond to the Operational Check prompts for each test Screen prompts are accompanied by an audio prompt to alert you of a message that should be acknowledged before proceeding with the rest of the Operational Check 39 NOTE When a response is required use the Navigation buttons to select your answer and the Menu Select button to confirm your choice Table 4 shows the tests in the order in which they are performed explains the prompts that may appear and describes the actions you should take if any Options that are not on the device do not
49. of mean pressure from waveform systolic and diastolic data The SpO PCA serves as the interface to the SpO sensor including e Generation and control of voltages to drive the LEDs in the sensor e Receiving and processing the signals from the SpO sensor e Derivation of the SpO waveform SpO value and pulse rate e Providing the digital SpO value to the Processor PCA The SpO signal from the sensor is carried by the external SpO cable to the SpO port and then to the SpO PCA There it is analyzed to derive SpO saturation level pulse rate and the waveform This information is then passed to the Processor PCA via a flex circuit Power for the SpO PCA and sensor is provided by the Processor PCA via this same flex circuit The Processor PCA provides patient isolation and the power supply for SpO gt 247 The Processor PCA is then responsible for e Formatting and presenting the O saturation level pulse rate and waveform to the display e Generating O saturation level alarms e Reporting on the status of the sensor and its connections and alerting the user to measurement problems CO Module The CO module performs the following functions e Pumping the gas sample from the sidestream port into the measurement cell e Controlling the light source and the detector inside the measurement cell e Sensing the CO level e Generating the CO value and waveform e Sensing whether a FilterLine is plugged into the device
50. options 129 printing 16 viewing 13 283 Discharging power supply capacitors 102 therapy capacitor 105 Display troubleshooting 75 Display assembly functional description 241 key component tracking 229 ordering replacement 216 repair 135 Disposal 84 E ECG functional check 201 ECG monitoring leads functional description 243 troubleshooting 64 ECG monitoring pads paddles functional description 244 troubleshooting 65 External assemblies 86 External data card functional description 247 troubleshooting 77 External data card holder ordering replacement 221 External paddles key component tracking 230 External repairs required testing level 180 F Fail BF 38 Fail CF 38 Fail NC 38 Fan assembly ordering replacement 216 repair 121 Flex circuit connections 82 handling 83 Front case internal assemblies 107 ordering replacement 220 overview 108 repair 141 Front panel buttons ordering replacement 221 repair 140 Functional checks 200 G General monitoring troubleshooting 63 284 H Handle ordering replacement 220 Handle and cap plate ordering replacement 220 repair 100 Hourly tests 36 I Internal assemblies front case 107 Internal cables ordering replacement 218 Internal connections checking 83 Internal disposable paddles key component tracking 230 Internal memory troubleshooting 77 Internal memory card ordering replacement 216 repair 113 Internal paddles key compone
51. organized into the following sections Topic Who Should Perform Repairs Repair Philosophy Repair Notes Repair Tools and Equipment Key Components External Assemblies Page 80 80 82 85 85 86 Topic Opening the case Internal Assemblies Front Case Internal Assemblies Rear Case Closing the case Page 102 107 144 176 79 Who Should Perform Repairs Only qualified technical personnel who have been trained in the safe and proper servicing of the HeartStart MRx should open the monitor defibrillator case remove and replace components or make adjustments If your medical facility does not have qualified technical personnel contact the Response Center or your local Philips representative WARNING HeartStart MRx service should only be performed by qualified service personnel in accordance with the HeartStart MRx Service Manual Repair Philosophy The repair philosophy of the HeartStart MRx is subassembly replacement Examples of subassemblies are the printer the Processor PCA and selected connectors and other items Repairs that involve replacing individual components on a PCA are not supported CAUTION Individual component replacement should not be attempted Component level repair is inadvisable due to the extensive use of surface mount technology and the high parts density on the circuit boards Unauthorized component replacement can impair performance of the HeartStart MRx Calling for Service
52. port on your cell phone The cell phone s RS232 port hardware is incompatible Work with your cell phone provider to choose a phone that is compatible The serial cable is Work with your cell phone provider to obtain a serial cable that connects to your phone with a 9 pin D serial cable connection defective or incompatible The cell phone is not set up properly Work with your cell phone provider to ensure that the cell phone is set up as a modem using the RS232 port Configure Failed 12LXmit Device The Configuration String under the Serial Phone Profile settings is not Work with your cell phone provider to ensure that the Configuration String is correct correct No Dial tone 12LXmit Dialing e The cell phone is not Check that the phone is connected to the serial cable and that the serial cable is connected to the RS232 port on the MRx connected properly e Cell phone service is unavailable e Check that the cellular signal strength is sufficient 59 Table 8 12 Lead Transmission Status Log Errors Continued Error Message Connect Failed 12LXmit Dialing Transmission Failed Connection Failed Disconnect Failed 12LXmit Dialing Invalid Password User pw failure 12LXmit Network User pw failure 12LXmit Server PPP Attach Timeout 12LXmit Network Transmission Failed Request Timeout 12LXmit Server Partial transmission 12L Transmit
53. present on components and connections exposed during device disassembly Use extreme caution while the device cover is removed CAUTION Be sure to work in a static free environment Use an electrostatic wrist band The work surface and area surrounding it must be static free Use an antistatic pad which is grounded per the manufacturer s instructions 1 Remove accessory pouches if present See Accessory Pouches on page 87 2 Remove the bed rail hook mount if present See Bedrail Hook Mount on page 89 3 Remove the paddle tray or handle and cap plate See Paddle Tray on page 95 or Handle and Cap Plate on page 100 4 Lay the device down Lay the device on a padded work surface with the display facing down and the bottom of the device nearest to you 102 5 Remove the case screws a Loosen the seven T15 screws in the back of the case Figure 37 Case screws b Hold the case halves together with your hands and turn the device over so the display is facing up The case screws will fall out of their holes as you do this c Once the screws are all out and accounted for stand the device on the work surface with the display facing you 103 6 Open the case a Swing the front case away from the rear case separating the therapy port side first Be careful not to pull on the cables that connect them You may need to use some force to separate the halves b Ifyou are having difficu
54. see additional failures if any run an Operational Check and check the status log Solid red X without a_ No power or device failure cannot turn Insert a charged battery or connect to AC DC periodic chirp on power Begin troubleshooting as described in Troubleshooting Methodology on page 45 NOTE The RFU indicator briefly displays a solid red X when initially turning on the device switching between clinical and non clinical operating modes and at the start of any Automated test 35 Automated Tests NOTE The HeartStart MRx performs many maintenance activities independently including three tests that run automatically at regularly scheduled intervals while the device is off to assess operational performance and alert you if a problem exists Results of tests associated with critical functionality of the device are reported through the Ready For Use indicator and the Automated Test Summary report Results are also reported through inop statements on the display when the HeartStart MRx is turned on Table 2 provides a brief explanation of the tests and lists the frequency with which each test is performed Table 2 Automatic Self Tests Hourly Tests batteries internal power supplies and internal memory Daily between 11 00 PM and Tests batteries internal power supplies internal memory 1 00 AM internal clock battery defibrillation pacing ECG SpO EtCO NBP and printer The defibrillatio
55. selection press the Menu Select button Press Exit to close the menu without activating a selection Passwords In order to access different modes within the monitor defibrillator a password is required The passwords are listed below e Service Mode 27689 e Configuration Mode 387466 Upgrades Upgrades are available to add specific functionality to the device after purchase These upgrades are e M3530A SpO e M3531A NBP e M3532A CO e M3533A Pacing e M3534A 12 Lead Option B02 12 lead acquisition Option B03 12 lead transmission Option B04 75 mm printer e M4760A Handle and Cap Plate e M5527A External paddles e M4765A Hardware Upgrade Option B01 Version B hardware that supports 12 lead transmission Consult your sales representative dealer or distributor for the latest details Preventive Maintenance Preventive maintenance and periodic operational checks are intended to be performed by the user Both topics are covered in the Maintenance chapter of the Instructions for Use The Maintenance chapter of this manual provides procedures for the CO and NBP calibration procedures which are intended to be performed by qualified service personnel Care So OP a coueron Repair Philosophy Monitor Defibrillator The repair philosophy of the HeartStart MRx is subassembly replacement Examples of subassemblies are the printer the Processor Printed Circuit Assembly PCA Therapy PCA and selected connectors and other item
56. shock Before the Shock The HeartStart MRx makes a small signal AC impedance measurement at 32 kHz in the steady state situation before a shock is delivered This measurement is used to detect Pads Off and Paddles Off It is also used for the Patient Contact Indicator PCI function in which the quality of the contact the paddles are making with the patient is indicated on an LED bar graph on the Sternum paddle During the Shock The HeartStart MRx also makes an impedance measurement during shock delivery This impedance is derived from measurements of voltage and current and is reported on the printed event summary The device uses the value of the impedance to adjust the phase durations of the biphasic waveform and to provide the optimal waveform delivery This information is also used to abort the shock Since one measurement is a small signal AC measurement of impedance and the other is a high voltage high current measurement of impedance it is normal and expected for the two measurements to produce slightly different numerical results Defibrillation Charging 244 The following sections describe the defibrillation functions There are three basic events that can initiate a charging cycle e In AED Mode when the Processor PCA shock advisory analysis algorithm determines from the pads ECG waveform that a shock is needed e In Manual Defib Mode with either pads or paddles when the front panel Charge button is pressed the
57. that portion of the test Return to the Service Mode Main menu by pressing the Main Service soft key If there is any failure begin troubleshooting and repairing the device as needed See Troubleshooting on page 33 Setup 1 Access the Service Mode Main menu as described in Accessing Service Mode on page 10 2 From the Service Mode Main menu select NBP The NBP Service screen is displayed 19 NOTE You will hear a high pitch tone when you access the NBP Service screen this is normal operation Figure 10 NBP Service Screen VENA ye Ca eS Service NBP Cycle Counter 50 010 Replacement recommended Last Calibration 2 May 2004 Calibration recommended Pressure In Cuff 23 mmHg Main Service Calibrate Check the status displays 20 l Check the cycle counter Check the number of measurement cycles shown on the screen If the NBP module has executed more then 50 000 cycles replacement is recommended See NBP Module on page 160 for instructions on replacing the NBP module Following replacement run the required Performance Verification and Safety Tests see Required Testing Levels on page 180 Check the calibration status If the screen indicates that calibration is recommended perform all of the actions described in this chapter beginning with Test the accuracy The calibration status is automatically reset at the successful completion of a calibration NBP Safety Timeout
58. the AC line cord is unplugged Once the source is located attempt to attenuate the EMC coupling path by distancing the monitor defibrillator from the source as much as possible If assistance is needed call your local service representative Restrictions for Use Artifact on the ECG and parameter waveforms caused by electromagnetic interference should be evaluated by a physician or physician authorized personnel to determine if it will negatively impact patient diagnosis or treatment Emissions and Immunity 270 The HeartStart MRx is designed and tested to comply with the radiated and conducted emissions requirement of international and national standards IEC 60601 1 2 2001 and EN 60601 1 2 2002 See Tables 44 through 48 for detailed information regarding declaration and guidance WARNING The use of accessories transducers and cables other than those specified may result in increased emissions or decreased immunity of the HeartStart MRx NOTE The list of cables transducers and other accessories with which Philips claims compliance with the emissions and immunity requirements of IEC standard 60601 1 2 are listed in the Supplies and Accessories section of Parts and Accessories on page 211 The local area network LAN connector of the HeartStart MRx is marked with the y ASN label The pins of connectors marked with this warning symbol should not be touched or connections made to until the following precaution is take
59. the case See Opening the case on page 102 2 Position the rear case Lay the rear case on the work surface with the PCAs facing up and the Therapy port on the right 3 Remove the Therapy capacitor See Therapy Capacitor on page 146 4 Remove the NBP and CO module tray See NBP and CO2 Module Tray on page 152 Removing the CO Tubing and Intake Receptacle 162 1 Remove the Power PCA See Power PCA on page 148 2 Remove the Therapy PCA See Therapy PCA on page 154 3 Remove the plastic shield Remove the plastic shield from the rear case and place it to the side You will need to replace this 4 Remove the CO compartment door See CO2 Compartment Door on page 167 5 Disconnect the CO exhaust tube Figure 72 1 6 Disconnect the CO intake receptacle Figure 72 2 Using your index fingers open the two plastic snaps From the outside of the case push the receptacle out with your thumb Figure 72 Disconnecting the CO Tubing and Intake Receptacle O ring groove 163 164 Removing the CO Module 1 Remove the CO module from the module tray a For the M3535 69103 module loosen and remove the 4 T 10 screws on the module plate See Figure 73 For the M3535 69181 module loosen and remove the 4 T 10 screws See Figure 74 b Lift the CO Module straight up out of the tray Figure 73 Removing the CO Module M3535 69103 bj E aN
60. the default oe Using the Navigation buttons set the correct cal gas value then press the Menu Select button 9 When you have selected the correct cal gas value the monitor defibrillator begins an auto calibration sequence and the screen displays the message CO calibration in progress Do not remove the gas until the monitor defibrillator is finished as indicated by the screen prompts Calibration Verification 10 Ifit is not already connected connect the 5 calibration gas and regulator if needed to the CO Inlet port Turn on the gas 11 Wait until the displayed CO value is stable 12 Check the displayed CO value against the expected value calculated earlier The displayed value should match the expected value within the tolerance calculated earlier 13 Disconnect the 5 gas and connect the 10 gas 14 Wait until the displayed CO value is stable 15 Check the displayed CO value against the expected value calculated earlier The displayed value should match the expected value within the tolerance calculated earlier If both the 5 and 10 values are correct the device has been successfully calibrated If either value is not within tolerance repeat the calibration beginning at step 1 If the device fails the Calibration Verification a second time replace the CO module See CO Module on page 162 Run an Operational Check You must run an operational check after calibrating the CO module in order for the cal
61. the hole e While holding the plate at an angle connect the spade connector from the red wire to the tab 2 Figure 32 Installing the Tray Plates 96 2 Connect the paddle tray to the device a Connect the spade connector from the black wire to the tab with the black wire on the resistor 1 b Connect the spade connector from the red wire to the tab with the red wire on the resistor 2 Figure 33 Connecting the Paddle Tray 3 Place the paddle tray into position on the device Line up the screw holes in the paddle tray and tray plates with the threaded inserts on the device Be careful not to pinch the wires under the threaded inserts 4 Replace the screws Replace the 4 T 15 screws and tighten After Repair Run Performance Verification and Safety testing as described in the Performance Verification chapter 97 Paddle Tray 50 ohm Load Resistor The 50 ohm load resistor comes pre assembled in the paddle tray However if it fails you can replace it using the following procedures Preparation 1 Turn the device off 2 Disconnect all external power and remove all batteries 3 Remove the paddle tray See Paddle Tray on page 95 Removal 1 Disconnect the spade connectors from the paddle tray tabs 2 Unscrew the 2 T 10 screws 3 Lift the 50 ohm load resistor out of the paddle tray 98 Replacement 1 Place the 50 ohm load resistor into the paddle tray Make sure that the
62. the screws Loosen and remove the 3 T 10 screws Disconnect the 8 wire bundle from the Battery Connector PCA 2 4 Remove the Battery Connector PCA Gently grasp the white 8 wire bundle connector and pull up while tilting the PCA towards you Use your other hand to wiggle and lift the PCA out from under the Therapy port and rear case Figure 78 Removing the Battery Connector PCA Replacement 1 Place the Battery Connector PCA into position a Hold the PCA by the white 8 wire bundle connector and slide the end nearest the CO compartment door under the plastic posts b Tilt the PCA towards you and wiggle it to position the PCA into the rear case lining up its holes with the posts in the rear case Guide it down over the case posts 2 Replace the screws Install the 3 T 10 screws and tighten 171 3 Connect the CO exhaust tube and intake receptacle See Figure 77 a Connect the exhaust tube to the CO outlet port b Make sure that the small face of the CO intake receptacle is towards you and the large face is towards the rear case c Connect the CO intake receptacle making sure that it locks into the snaps in the rear case 4 Route the tubing through the rear case according to the path shown in Figure 77 3 NOTE Make sure you place the CO intake receptacle wires under the tube when routing them through the case as shown in Figure 79 Create less slack in area 1 to maximize the service loop in area
63. 10 screws 3 Connect the Printer Connector PCA a Connect the 10 wire bundle to the Printer Connector PCA by pushing straight up toward the PCA b Connect the 2 wire bundle to the Printer Connector PCA by pushing in until the latch clicks 4 Close the case See Closing the case on page 176 5 Replace the printer See Printer Assembly on page 93 After Repair Run Performance Verification and Safety testing as described in the Performance Verification chapter 134 Display Assembly The Display assembly contains all keypads the Inverter PCA the display shield and the metal frame Preparation 1 Open and separate the case See Opening the case on page 102 2 Position the front case Lay the front case on the work surface with the display facing down and the printer in the lower left corner 3 Remove the measurement module panel See Measurement Module Panel on page 117 4 Remove the Processor PCA See Processor PCA on page 123 Removal 1 Remove the screws Loosen and remove the 11 T 10 screws as shown in Figure 58 Do not remove the bottom 3 screws as they connect the shield to the display Figure 57 Display Screws 135 136 2 Lift the Display assembly Lift the Display assembly straight up out of the case Figure 58 Removing the Display A h Cn ZAD EA AN IN SSX Wa o 4 are ON SSS eee Replacement 1 Remove the rectangular piece of black
64. 15 driver shaft should be at least 3 5 inches 90 mm long and less than 0 4 inches 10 mm in diameter to reach down to recessed case screws e Slip joint pliers or adjustable open end wrench e Straight bladed screwdriver e Nut driver 5 16 or small adjustable wrench e 2 Phillips screwdriver shaft at least 5 long e Straight tip needle nose pliers or tweezers e Bent tip needle nose pliers whose jaws are covered with a soft material such as plastic tubing or tape e Fine nose wire cutters e Utility knife e Paper clip e Clip leads at least 2 each approx 10 18 e Voltmeter e Software Support tool see Table 30 on page 214 for part numbers e Defibrillator Discharge Tool M2475 69573 Key Components Replacement assemblies marked with an asterisk in the Replacement Parts tables contain one or more Key Components Key Components require detailed tracking by recording the key component part number and either the key component s date code or its serial number This data must be recorded for both the failed assembly and the replacement assembly Philips service personnel must record this information on the Customer Service Order CSO The Key Components that are part of the replacement assemblies are listed in Table 40 on page 229 85 External Assemblies 86 This section describes how to remove and replace assemblies that are external to the case You do not need to open the case for any of
65. 43 ECG Monitoring Functions 243 Defibrillation 244 Transcutaneous Pacing 246 Audio 246 Data Storage 247 Clock Backup Battery 247 NBP Module 247 SpO PCA 247 CO Module 248 Vil 8 Specifications and Safety 249 Specifications 249 General 249 Defibrillator 249 ECG and Arrhythmia Monitoring 252 Display 254 Battery 254 Thermal Array Printer 255 Noninvasive Pacing 255 SpO2 Pulse Oximetry 256 NBP 256 EtCO2 257 AwRR 258 Calibration Gas for CO Measurement System 259 12 Lead ECG 259 Patient Data Storage 259 Environmental M3535A 259 Environmental M353G6A 261 Symbol Definitions 263 Safety Considerations 266 General 266 Defibrillation 268 Battery 268 Electromagnetic Compatibility 270 Reducing Electromagnetic Interference 270 Restrictions for Use 270 Emissions and Immunity 270 Guidance and Manufacturer s Declaration 271 Waveforms 278 1 Index 283 Introduction This Service Manual provides the information needed to successfully service the M3535A M3536A HeartStart MRx monitor defibrillator This manual provides you with information on troubleshooting repairing and performance verification and safety testing of the monitor defibrillator There is also information on the theory of operation maintenance procedures and ordering parts and supplies Who Should Use This Manual The intended users of this manual are technical personnel who have been trained in the safe and proper servicing of the HeartStart MRx To as
66. 63478421 M3535 69148 Power PCA N A with wires 50 ohm load resistor 453563478431 M3535 69149 Paddle pockets N A assembly 218 MS O E Paddles For the convenience of Philips field personnel a selected subset of the external paddles have been made available through normal parts ordering channels These numbers are for the use of Philips personnel only Customers and non Philips repair personnel should refer to Supplies and Accessories on page 224 Table 35 Paddles Paddle assembly standard 453563476981 M3535 69130 Includes labels Paddle assembly water resistant 453563476991 M3535 69131 Includes labels Items marked with an asterisk are Key Components which require tracking See Table 40 on on page 229 219 Mechanical Assemblies These assemblies come with specific parts as noted Replacement Mechanical Assemblies Table 36 Replacement Mechanical Assemblies Front Case assembly 453563476961 M3535 69128 also order localized Instruction label set Rear Case assembly 453563476891 M3535 69121 Bedrail Hook mount 453563476901 M3535 69122 Handle assembly grey 453563476911 M3535 69123 To order colored handles see Table 39 CO Door Kit 453563476741 M3535 69112 CO Recess Blank off Kit 453563476751 M3535 69113 Paddle Tray assembly 453563477001 M3535 69132 Includes color ID labels Handle and Cap Plate assembly 453563477011 M3535 69133 220 Individual Mechanical Parts Table 37 Mec
67. 68108 Battery Connector PCA 453563476861 M3535 69120 Includes battery power signal cable and battery power cable Printer Connector PCA 453563476781 M3535 69115 Items marked with an asterisk are Key Components which require tracking See Table 40 on on page 229 215 Other Electrical Assemblies These assemblies come with specific parts as noted Table 32 Other Electrical Assemblies AC power module 453563481151 M3535 69171 NBP module 453563476761 M3535 69104 CO module 453564016141 for A 01 and A 02 M3535 69181 for A xx devices devices M3535 69103 for B xx devices 453563476731 for A 03 and B xx devices RFU indicator 453563476691 M3535 69110 Display assembly 453563476721 M3535 69102 Includes Inverter PCA and cable Display cable Also order Knob 453563476791 M3535 69116 PCMCIA Hole Plug assembly with 453563478421 M3535 69148 wires 50 ohm load resistor assembly 453563478431 M3535 69149 Items marked with an asterisk are Key Components which require tracking See Table 40 on on page 229 Individual Electrical Parts Clock lithium battery replacement 453563377901 M3500 69565 Includes battery ProGold wipes and cable tie wrap internal memory card o M3535 69178 216 External Electrical Components These components are visible outside of the case and the user interacts with them Table 33 External Components Therapy Port 453563338311 M3500 69562 Me
68. 71 Medium Disposable Switchless Internal Paddles 9 OO 9 ioe Q pd NO N pd VA Small Disposable Switchless Internal Paddles ECG Cables 3 lead ECG Trunk Cable AAMI 3 lead ECG Set with Snaps AAMI 3 lead ECG Trunk Cable IEC 3 lead ECG Set with Snaps IEC 5 lead ECG Trunk Cable AAMI 5 lead ECG Set with Snaps AAMI 5 lead ECG Trunk Cable IEC 5 lead ECG Set with Snaps IEC 10 lead ECG Trunk Cable 12 pin Connector for 3 Lead and 12 Lead use 3 wire Lead Set with Snap AAMI Add 7 wire Lead Set for 12 Lead use AAMI 3 wire Lead Set with Snap IEC Add 7 wire Lead Set for 12 Lead use IEC Combiner Plug for 3 wire Lead Set for use with M3526A M3528A i UW Uh Uh aU I WW Oo Go OG OO m lel Rl eR Wy Pvt ue a AIAI AIAI AIAI ONE ONT A wWINININININI NINININI Re CO SO OO orn GI NIN OI AI OT Ns OI N gt gt gt gt gt a a eld ald r a Be 226 Table 39 Supplies Continued 10 lead ECG Patient Trunk Cable 12 pin connector for 5 Lead and 12 Lead use 10 electrode Cable Set extremities grabber use with M1976A AAMI 10 electrode Cable Set chest grabber use with M1968A AAMI 10 electrode Cable Set extremities grabber use with M1978A IEC 10 electrode Cable set chest grabber use with M1971A IEC Sync Cable 12 pin Sync Cable 8 feet 12 pin Sync Cable 25 feet lt 5 Oo S S oS NSE NTN aD amp CO GI CO O gt
69. 76 is affixed to the Power PCA and under the Paddle tray or cap plate Branding Label Set The branding label 12NC 453563478941 5x5 M3535 69154 is affixed to the front of the device directly below the center of the display Speaker Label Set The speaker label 1L2NC 453564000881 5x5 M3535 69179 is affixed to the speaker Connector Label Set This label set is only available as part of the rear case field replacement kit 223 Supplies and Accessories Approved supplies and accessories for the HeartStart MRx are listed in the following table Table 39 Supplies Upgrades 12 Lead Upgrade Option B02 12 lead acquisition Option B03 12 lead transmission Option B04 75 mm printer Handle and Cap Plate Upgrade External Paddles with Paddle Tray Option C01 Standard Paddles Option C02 Water Resistant Paddles Hardware Upgrade Option B01 Version B hardware that supports 12 lead transmission Paper M3530A M3531A M3532A M3533A M3534A M4760A M5527A M4765A 50 mm Chemical Thermal Paper gray grid 1 box 10 rolls 50 mm Chemical Thermal Paper gray grid 1 box 80 rolls 75 mm Chemical Thermal Paper Gray Grid 10 rolls 75 mm Chemical Thermal Paper Gray Grid 80 rolls Color Handle includes handle and label Carrying Case 989803138171 989803138181 TORN S 2 RR VA Vi ala sga 224 Table 39 Supplies Continued Defibrillation Pads Pads Cables and Test Load white twist
70. 79 Overview 179 Required Testing Levels 180 External Repairs Replacements 180 Printer Replacement 181 Internal Repairs 181 Verification Test Equipment 182 Test and Inspection Matrix 184 Performance Verification Procedures 190 Visual Inspection 191 Service Mode Tests 192 Functional Checks 200 Safety Tests 208 6 Parts and Accessories 211 Overview 211 Parts and Accessories Notes 212 Ordering Replacement Parts 212 Ordering Supplies and Accessories 212 Key Component Tracking 212 Replacement Parts 213 Electrical Assemblies 214 Processor PCA 214 Other Replacement PCAs 215 Other Electrical Assemblies 216 Individual Electrical Parts 216 External Electrical Components 17 Internal Cables 218 Paddles 219 Mechanical Assemblies 220 Replacement Mechanical Assemblies 220 Individual Mechanical Parts 221 Labels 222 Instruction Label Sets 222 Hazardous Shock Warning Label Set 223 Branding Label Set 223 Speaker Label Set 223 Connector Label Set 223 Supplies and Accessories 224 Key Components 229 vi 7 Theory of Operation 233 Overview 233 Schematic Diagrams 235 System Level Interconnections 236 Signal and Data Flow 237 ECG Signal Flow 238 Functional Descriptions 239 Processor PCA 239 Therapy PCA 240 Power PCA 240 Battery Connector PCA 240 Power Batteries 240 Display Assembly 241 Indicators 242 RFU Indicator 242 Front Panel Buttons 242 Therapy Knob 242 Paddle Indicators and Controls 242 Printer Assembly and Printer Connector PCA 2
71. Applied Parts 1 ECG leads IEC Type CF Source a Normal Condition both AC line connections and earth ground intact Should be lt 10 uA Record as eee b Single Fault Condition separately open neutral and open earth each in turn Should be lt 50 uA Record as fff Sink a Single Fault Condition is with AC Mains voltage on Applied Parts both AC line connections and earth ground intact Should be lt 50 uA Record as ggg 2 External Paddles pads IEC type BF Source a Normal Condition both AC line connections and earth ground intact Should be lt 100 uA Record as hhh b Single Fault Condition separately open neutral and open earth each in turn Should be lt 500 uA Record as iii Sink a Single Fault Condition with AC Mains voltage on Applied Parts both AC line connections and earth ground intact Should be lt 5000 uA Record as jjj 209 6 Parts and Accessories This chapter provides information on ordering replacement parts supplies and accessories for the HeartStart MRx monitor defibrillator Information on Key Component tracking is also provided Overview This chapter is organized into the following sections Topic Page Parts and Accessories Notes Ala Replacement Parts 213 Electrical Assemblies 214 External Electrical Components 214 Internal Cables 218 Paddles 219 Mechanical Assemblies 220 Labels 222 Supplies and Accessories 224 K
72. Check page 207 then Paddles test passes Example Pa p 187 Table 29 Test and Inspection Matrix Continued Safety Tests Using a Safety Analyzer Note All leakage current tests include both Normal and Reverse Polarity Conditions Report worst case values AC Mains S1 Chassis Leakage S2 Patient Lead Leakage S3 188 Earth Leakage Current NC Normal Condition aaa page 208 Earth Leakage Current SF Single Fault open neutral bbbb page 208 Use ECG Out Sync jack as ground NC Normal Condition cc page 208 Single Fault condition dd page 208 ECG Patient Cable page 209 Source Normal Condition eee Source Single Fault condition open earth open neutral fff With Mains on applied part Single Fault condition 888 If Normal Condition Maximum leakage current lt 300 uA UL 120 VAC lt 500 uA IEC 240 VAC If Single Fault Maximum leakage current lt 1000 uA then Earth Leakage Safety test passes If Normal Condition Maximum leakage current lt 100 uA then Chassis Leakage test passes If Single Fault Maximum leakage current lt 300 uA UL lt 500 uA IEC If readings are as expected lt 50 uA then ECG Patient Cable Leakage Safety test passes S1 x aaalbbbb Example S1 p 125 800 S2 x ccldd Example S2 p 99 299 Example S3 p 9 49 49 100 500 5000 Table 29 Test and Inspection Matrix Co
73. Date Code Module AC Power Module M3535 69171 AC Power Module M3535 60995 Date Code Assembly 453563481151 231 7 Theory of Operation This chapter provides functional descriptions of the components contained in the HeartStart MRx These descriptions are at the functional block level This chapter also provides system level interconnection and signal and data flow schematics Overview This chapter is organized into the following sections Topic Page Schematic Diagrams 235 Functional Descriptions 239 Processor PCA 239 Therapy PCA 240 Power PCA 240 Battery Connector PCA 240 Power Batteries 240 Display Assembly 241 Indicators 242 RFU Indicator 242 Front Panel Buttons 242 Therapy Knob 242 Paddle Indicators and Controls 242 Printer Assembly and Printer Connector PCA 243 ECG Monitoring Functions 243 Defibrillation 244 Transcutaneous Pacing 246 Audio 246 Data Storage 247 233 Clock Backup Battery 247 NBP Module 247 SpO PCA 247 CO Module 248 234 Schematic Diagrams The following diagrams show the system level interconnection and signal and data flow schematics 235 System Level Interconnections 8 Pin Ribbon Cable RFU Indicator 4 Wire Flat Flex Circuit Keypad Assembly x lt i 5 it iL w i r iL g wo fo es Microphone Speaker Speaker Microphone Assembly 236 v G a External Data E Card og mo RE 8 S
74. Device Info Detailed information about the device is printed Other Resources 16 For additional information on the HeartStart MRx refer to the following Learning Products e HeartStart MRx Instructions for Use M3535 91900 e HeartStart MRx Service Training Video M3535 89300 NTSC M3535 89310 PAL e HeartStart MRx Lithium Ion Battery Characteristics and Care Application Note M3535 91930 Other documentation can be found on the Philips website at www medical philips com goto productdocumentation 2 Maintenance This chapter describes how to perform routine maintenance on the HeartStart MRx monitor defibrillator Overview Most routine maintenance is performed by the user This includes e Performing operational checks e Replacing paper e Charging and maintaining the lithium ion battery e Cleaning Refer to the Instructions for Use for detailed information on these maintenance procedures Service personnel are responsible for the following routine maintenance e Yearly calibration or every 10 000 cycles of the Noninvasive Blood Pressure NBP module e Yearly calibration or every 4000 hours of the End tidal Carbon Dioxide EtCO module This chapter provides the following information Topic Page Maintenance Tools and Equipment 18 Checking the NBP Module 19 Checking the CO Module 23 17 Maintenance Tools and Equipment You will need the following equipment to perform the yearly calibration procedures
75. Did You Hear No Shock Delivered Connect ECG Cable Cable Connected or Test Without Cable Detach Leads if the ECG cable is connected to a patient or the leads are shorted together Disconnect ECG Cable if the test fails with the cable connected Remove Paddles from Holders Place Paddles in Holders Connect Pads Paddles Cable Connect Therapy Cable e Connect Pads Cable if the Pads cable is not detected is not detected Use the navigation buttons to respond Yes or No Then press the Menu Select button e Attach Test Load ifa test load Connect the test load to the Use the navigation buttons to respond Yes or No Then press the Menu Select button Connect an ECG cable and select Cable Connected or Test Without Cable Make sure the leads are not attached to a patient a simulator or touching each other e Disconnect the ECG cable Note If testing paddles make sure that they are secured in their pockets If the PCI LEDs light adjust the paddles in the pockets If the LEDs continue to light clean the paddle electrode surfaces Remove the paddles from the holders Place the paddles in the holders Attach the Pads or Paddles cable typically used e Connect the Pads cable to the MRx if prompted Pads cable if prompted 41 Table 4 Operational Check Tests Continued Battery A Battery B Checks the capacity and calibration status of the bat
76. Eg Bi Internal Memory Card Dual 68 Pin 2x34 PCMCIA Connector Modem Card Fan Assembly J3 J11 Display Backlight Inverter PCA Color LCD Display 31Wire Flat Flex Cable Battery Clock Backup Processor PCA Instrument Control ECG Processing 12 Lead ECG Circuitry Display Control LAN Interface Audio Circuitry SpO2 Control EtCO2 Control NBP Control Printer Control Time of Day Clock Self Test Circuitry 12 Lead ECG Input 14 Wire Flat Flex Circuit y ECG Output Cable Printer Assembly Figure 87 System Interconnection Schematic Printer Connector PCA J5 10 J18 Print Key Shock Key J16 18 SpO2 PCA 8 Pin Flat Flex Circuit 50 Pin Ribbon Cable Ribbon Cable Assembly 40 Pin Ribbon Cable Measurement Module Panel AC Power Module Assembly NC NC 18VDC GND Lithium lon Battery Assembly 15VDC SMB GND J4 J5 Battery Connector PCA J10 J8 10 Pin Ribbon Cable Power PCA Power Source Switching Battery Charging 3 3V 5V 12V Power Supplies Pads Paddles ECG Circuit Power Cable NBP Module AirTubing J3 HV Sternum DC Power Input Receptacle Paddle Pockets and 50 Ohm Resistor
77. M3500 69564 Therapy Capacitor 010879 0005 Serial Number and Assembly 453563338331 Date Code Therapy Switch M4735 66564 Switch Assembly M4735 60018 Date Code Assembly 453563345221 Ports Therapy Port M3500 69562 Therapy Port M3500 62601 Date Code 453563338311 229 Table 40 Key Components Continued Supplies amp Accessories External Defibrillation Paddles 4 External Paddle M3535 69130 External Paddles M3542 61999 Assembly Standard 453563476981 Standard M3543 61999 Serial Number and Date Code External Paddle M3535 69131 External Paddles Assembly Water 453563476991 Water Resistant Date Code Resistant Internal Defibrillation Paddles 7 5 cm Switchless M1741A Internal Paddles 6 0 cm Switchless M1742A Internal Paddles 4 5 cm Switchless M1743A Internal Paddles 2 8 cm Switchless M1744A Internal Paddles 7 5 cm Switched M4741A Internal Paddles 6 0 cm Switched M4742A Internal Paddles 4 5 cm Switched M4743A Internal Paddles 2 8 cm Switched M4744A Internal Paddles Internal Paddles M4740A Adapter Cable Internal Disposable Defibrillation Paddles 7 5 cm Switchless M1741A Date Code Internal Paddles 6 0 cm Switchless M1742A Date Code Internal Paddles 4 5 cm Switchless M1743A Date Code Internal Paddles 2 8 cm Switchless M1744A Date Code Internal Paddles M4741A Two Date Codes paddles connector 7 5 cm Switched Internal Paddles 6 0 cm Switched Internal
78. Main Service 11 Enter the options key using the Navigation buttons to scroll through the letters and numbers Press the Menu Select button to complete each selection Select Cancel or backspace to cancel a selection When the options key has been entered the corresponding product options are displayed 12 Select Done when you have finished entering the options key 13 Repeat steps 10 through 12 for each options key 14 Check the information on the screen to ensure it is correct especially the options If you clear or change the serial number the options are cleared and you must re enter them Installing the Software The HeartStart MRx and all Processor PCA field kits ship in American English with the latest product version If you need to change device s language follow these steps 15 Insert the Software Support Tool into the data card slot 16 Select Software Upgrade from the Service Mode Main menu 17 Select the appropriate software version 18 Press the Upgrade soft key The software is installed on the device This process takes a few minutes While the software is being updated progress messages are displayed and the Main Service soft key is disabled NOTE Be careful not to interrupt the software installation process by removing the power source or turning the device off Figure 55 Installing Software 02 Mar 2003 10 52 CO e Service SOFTWARE UPGRADE HeartStart MRx Version B 04 00 Upgrade Ameri
79. Off or Cable Off due to Charges OK but disarms spontaneously Pads paddles losing contact with patient Pads paddles failure Pads cable failure Replace paddles or pads and pads cable Therapy PCA failure e Replace Therapy PCA Processor PCA failure e Replace Processor PCA Doesn t measure its own Therapy PCA failure e Replace Therapy PCA delivered energy correctly Pacing Problems Table 17 Pacing Problems Symptom Possible Causes Suggested Solution Doesnt deliver correct e Failure on Therapy PCA Replace Therapy PCA current into pacer tester or delivers no current at all e Processor PCA failure e Replace Processor PCA Doesnt measure its own Failure on Therapy PCA Replace Therapy PCA delivered current correctly Doesn t pace at correct rate Processor PCA failure Replace Processor PCA Pacer Equip Malfunction Pacer hardware failure Replace Therapy PCA 73 Printing Problems Table 18 Printing Prolems Possible Causes Suggested Solution Printer Malfunction The printer is faulty or there If the error repeats replace the printer is a problem communicating assembly with the printer Paper won t move e Paper improperly loaded Reload paper or clear jam If paper is wet or jammed or paper is replace with fresh dry roll wet Printer failure Replace printer Paper moves but printing is Door improperly latched Check door latch faint or absent Dirty printhead Clea
80. PCA using pliers if necessary 8 2 Remove the Therapy capacitor Slide the Therapy capacitor out of the tray Figure 62 Removing the Therapy Capacitor Replacement 1 Place the Therapy Capacitor into position a The new capacitor comes with a shorting bar connecting the two terminals Disconnect the shorting bar b Make sure the Therapy capacitor wires are parallel to the case and clear of the foam and that the red wire is on top c Place the side with the wires into the tray first and slide the Therapy capacitor into the tray 2 Connect the Therapy capacitor to the Therapy PCA a Connect the red wire to the connector labelled red on the Therapy PCA making sure that the orientation is the same as that shown in Figure 62 b Loop the white wire through the clip and plug it into the connector labelled white on the Therapy PCA 3 Close the case See Closing the case on page 176 After Repair Run Performance Verification and Safety testing as described in the Performance Verification chapter 147 Power PCA 148 Preparation 1 Open and separate the case See Opening the case on page 102 2 Position the rear case Lay the rear case on the work surface with the PCAs facing up and the Therapy port on the right Removal 1 Disconnect all cables See Figure 63 and Table 26 on page 149 The connections may be removed in any order The order in Table 26 begins with the left edge of the P
81. PHILIPS HEARTSTART MRx MONITOR DEFIBRILLATOR Di n UST 40 91 gy HEARTSTART MRx Service Manual NEES Si Ss M3536A About This Edition Edition 4 Printed in the USA Publication number M3535 90900 The information in this document applies to the HeartStart MRx product version indicated below This information is subject to change without notice Philips shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing performance or use of this material Edition History 1 A 00 A 01 December 2003 B 03 and earlier November 2004 Copyright Copyright 2005 Koninklijke Philips Electronics N V E December 2003 A 02 and earlier June 2004 All rights are reserved Permission is granted to copy and distribute this document for your organization s internal educational use Reproduction and or distribution outside your organization in whole or in part is prohibited without the prior written consent of the copyright holder SMART Biphasic is a registered trademark of Philips FilterLine is a registered trademark of Oridion Medical Ltd Use of supplies or accessories other than those recommended by Philips may compromise product performance THIS PRODUCT IS NOT INTENDED FOR HOME USE IN THE U S FEDERAL LAW RESTRICTS THIS DEVICE TO SALE ON OR BY THE ORDER OF A PHYSICIAN Notice Medical Device Directive The HeartStart MR
82. Paddles M4742A Two Date Codes paddles connector 4 5 cm Switched Internal Paddles M4743A Two Date Codes paddles connector 2 8 cm Switched Internal Paddles M4744A Two Date Codes paddles connector Internal Paddles Adapter Cable M4740 61601 Date Code Large Disposable 989803127121 989803127121 Lot Batch Number Switched Internal Paddles Large Disposable Switched Internal Paddles Medium Disposable 989803127131 989803127131 Lot Batch Number Switched Internal Paddles Medium Disposable Switched Internal Paddles 989803127141 Lot Batch Number 989803127141 Small Disposable Switched Internal Paddles Small Disposable Switched Internal Paddles 230 Table 40 Key Components Continued Large Disposable 989803127151 Large Disposable 989803127151 Lot Batch Number Switchless Internal Switchless Internal Paddles Paddles Medium Disposable 989803127161 Medium Disposable 989803127161 Lot Batch Number Switchless Internal Switchless Internal Paddles Paddles Small Disposable 989803127171 Small Disposable 989803127171 Lot Batch Number Switchless Internal Switchless Internal Paddles Paddles Defib Pads Cable M3507A Defib Pads Cable M3507 60007 Date Code barrel connector barrel connector Defib Pads Cable M3508A Defib Pads Cable M3508 60008 Date Code plug connector plug connector Battery AC Power Module Lithium Ion Battery M3538A Lithium Ion Battery M3535 60994
83. RS232 port on the MRx Re send the 12 lead report If still unsuccessful check the MRx configuration settings Check the MRx and thel2 Lead Transfer Station to ensure that the correct product versions are installed Check that the cellular signal strength is sufficient Re send the 12 lead report Check that the phone is connected to the serial cable and that the serial cable is connected to the RS232 port on the MRx Re send the 12 lead report Work with your ISP to ensure the Serial Phone Profile and Hub settings are correct Table 8 12 Lead Transmission Status Log Errors Continued Transmission Failed Bad URL Format There isa problem Work with your ISP to ensure the Serial Phone Settings Configured 12LXmit Server with the Server URL Profile and Hub settings are correct Incorrectly Proxy user name Bad proxy settings 12LXmit Server non password Bad user pw settings 12LXmit Server 61 Startup Errors This section discusses errors that can occur at startup Table 9 Startup Errors Message Suggested Solution Critical Failure Detected Service unit e Check the status log e Reload software Device serial number has not been entered Service Enter the device s serial number See Entering the Serial unit Number and Enabling Options on page 128 for more information None Hourglass appears on RFU indicator but e Remove all power sources AC DC and or battery device app
84. ack at 25 C depleted by up to 15 200 Joule discharges Less than 25 seconds from initial power on with a new fully charged Lithium Ion battery pack at 25 C depleted by up to 15 200 Joule discharges Less than 25 seconds from initial power on when operating without a battery using the M3539A AC power module alone at 90 100 rated mains voltage Less than 30 seconds from initiation of rhythm analysis AED Mode with a new fully charged Lithium Ion battery pack at 25 C depleted by up to 15 200 Joule discharges Less than 30 seconds from initiation of rhythm analysis AED Mode when operating without a battery using the M3539A AC power module alone at 90 100 rated mains voltage e Less than 40 seconds from initial power on AED Mode with a new fully charged Lithium Ion battery pack at 25 C depleted by up to 15 200 Joule discharges e Less than 40 seconds from initial power on AED Mode when operating without a battery using the M3539A AC power module alone at 90 100 rated mains voltage Patient Impedance Range e Minimum 25 Ohm external defibrillation 15 Ohm internal defibrillation e Maximum 180 Ohm Note Actual functional range may exceed the above values Manual Defib Mode Manual Output Energy Selected 1 10 15 20 30 50 70 100 120 150 170 200 Joules maximum energy limited to 50J with internal paddles Controls On Off Therapy Knob Charge Shock Sync Print Mark Event ECG Lead Select Alarm
85. ake receptacle See Removing the CO Tubing and Intake Receptacle on page 162 7 Remove the CO compartment door See CO2 Compartment Door on page 167 8 Remove the Battery Connector PCA See Battery Connector PCA on page 169 Replacement 1 Replace the Battery Connector PCA See Battery Connector PCA on page 169 2 Replace the CO compartment door See CO2 Compartment Door on page 167 3 Replace the CO tubing and intake receptacle See Replacing the CO Tubing and Intake Receptacle on page 165 4 Replace the Therapy port See Therapy Port on page 158 5 Replace the Therapy PCA See Therapy PCA on page 154 174 6 Replace the NBP and CO module tray See NBP and CO2 Module Tray on page 152 7 Replace the Power PCA See Power PCA on page 148 8 Replace the Therapy capacitor See Therapy Capacitor on page 146 Figure 80 Rear Case Complete 9 Close the case See Closing the case on page 176 10 Affix the new labels to the back of the case See Labels on page 91 After Repair Run Performance Verification and Safety testing as described in the Performance Verification chapter 175 Closing the case 1 Recheck the connections Make sure all connections are fully seated and latched 2 Get the device ready for assembly a Place the device on a smooth flat surface in a clamshell orientation 3 Connect the front to re
86. al monitor as the ECG source verify that the external monitor and the HeartStart MRx combination will deliver a synchronized shock within 60 ms of the peak of the R wave then Synchronized cardioversion test passes 186 Table 29 Test and Inspection Matrix Continued Defibrillator Test AC Using only AC power and a If all data within limits all DA x Power DA defibrillator analyzer run the checks pass Example DA p Defibrillator Test AC Power at 200 Joules page 203 if AC Power used in normal operation Measured by Defibrillator Analyzer Delivered energy Displayed by MRx Energy setting 200 OJ Delivered energy Actual delivered energy 15 then Defibrillator Measurement test passes Defibrillator Test Battery Using only battery power _ If all data within limits all DB x Power DB run the Defibrillator Test at checks pass Example DB p 200 Joules page 203 Measured by Defibrillator Analyzer Delivered energy Displayed by MRx Energy setting 200 OJ Delivered energy Actual delivered energy 15 then Defibrillator Measurement test passes Defibrillator Run the Defibrillator e Verify that the monitor D x Disarm Test D Disarm Test page 204 defibrillator disarmed Example D p e Verify that the charge tone stopped then the Defibrillator Disarm test passes Paddles Safety Check Pa Perform Paddles Safety If PCI flashes as expected Pa x
87. ar case wires and cables a Connect the NBP tubing to the measurement module panel Route the tubing as shown in Figure 81 1 b Connect the two ribbon cables to the Processor PCA by pushing in the connectors and closing the latches 2 3 c Connect the 2 wire bundle from the Printer to the Power PCA 4 Figure 81 Front to Rear Case Connections 176 4 Fit the case halves together a Lift up the front case and align with rear case b Fold the ribbon cables down over the Therapy capacitor and under the Power PCA connectors NOTE tis very important to fold the ribbon cables down to ensure that the case halves fit together properly Figure 82 Folded Ribbon Cables 5 Place the device on its back and ensure that the case halves line up all around the device Work the halves together gently as the case gasket is delicate 6 Replace the case screws a Replace and secure the seven I 15 screws 7 Replace the paddle tray or handle and cap plate See Paddle Tray on page 95 or Handle and Cap Plate on page 100 8 Replace the bedrail hook mount if present See Bedrail Hook Mount on page 89 After Repair Run Performance Verification and Safety testing as described in the Performance Verification chapter 177 5 Performance Verification This chapter describes how to verify the performance of the HeartStart MRx monitor defibrillator after repairs are complete Overview This chapter
88. ard has been adopted in Europe as the European Norm EN 60601 1 2 The EMC standards describe tests for both emitted and received interference Emission tests deal with interference generated by the device being tested WARNING Radio frequency RF interference from nearby transmitting devices may degrade performance of the HeartStart MRx Electromagnetic compatibility with surrounding devices should be assessed prior to using the defibrillator Fixed portable and mobile radio frequency communications equipment can affect the performance of medical equipment See Table 48 for the minimum recommended separation distance between RF communications equipment and the HeartStart MRx Reducing Electromagnetic Interference The HeartStart MRx and associated accessories may be susceptible to interference from other RF energy sources and continuous repetitive power line bursts Examples of other sources of RF interference are medical devices cellular products information technology equipment and radio television transmission Should interference be encountered as demonstrated by artifact on the ECG or dramatic variations in parameter measurement values attempt to locate the source Assess e Is the interference intermittent or constant e Does the interference occur only in certain locations e Does the interference occur only when in close proximity to certain medical devices e Do parameter measurement values change dramatically when
89. ardware malfunction Replace NBP module NBP Calibration Overdue The NBP module should be Calibrate the NBP module See calibrated once a year or Checking the NBP Module on page 19 every 10 000 cycles NBP Measurement Failed A measurement value could Check accuracy as described in Checking not be obtained the NBP Module on page 19 Calibrate if needed NBP Service Required The NBP module has Replace NBP module reached its end of life defined as 50 000 cycles Measurement cycle doesn t Problem with internal Check internal tubing Reconnect replace start tubing connections as needed Failure of front panel Run Controls test in Service Mode to button confirm Replace Display assembly if needed e NBP module failure Replace NBP module e Processor PCA failure Replace Processor PCA Pump operates cuff inflates NBP module failure Replace NBP module normally but cuff will not deflate Reading inaccurate e NBP module needs Check accuracy as described in Checking calibration the NBP Module on page 19 Calibrate if needed e NBP module failure Replace NBP module 66 SpO Monitoring Problems Table 14 SpO Monitoring Problems Possible Causes Suggested Solution SpO Sensor Malfunction The SpO sensor or cable is Try another sensor and cable Numeric is replaced with e If this does not clear the message replace a SpO PCA e Replace measurement module pan
90. arging purposes WARNING Never crush penetrate or attempt to open these or any lithium ion batteries Never incinerate these or any lithium ion batteries High case temperatures resulting from abuse of the battery could cause physical injury Rupture of the battery pack may cause venting and flame CAUTION Due to their high energy density these batteries can deliver significant power Use care when working with or testing these or any lithium ion batteries Do not short circuit the terminals NOTE When the battery is removed from the HeartStart MRx it disconnects power to the output terminal Thus it is not possible to test the battery with a voltmeter Display Assembly The Display assembly contains the e LCD display 640 by 480 pixel color flat panel display illuminated by cold cathode florescent lamps e Backlight Inverter The power for the display backlight is provided by a Backlight Inverter PCA LCD Display All display functions are handled by the Processor PCA Display formats graphics waveforms numeric values and messages are all generated and formatted by the Processor PCA using either data it has or data it receives from other parts of the device The LCD display accepts this digital data from the Processor and maps it into pixels on the display Backlight Inverter The display also contains a backlight which is powered by the Backlight Inverter PCA The Backlight Inverter PCA converts DC current
91. as it can go 4 Place the Processor PCA in position Guide the cables out of the way Line up the holes in the Processor PCA with the threaded standoffs underneath Make sure there are no cables or wires trapped underneath the PCA 5 Replace the screws a Replace the 7 T10 screws and tighten b Replace the shoulder screw and tighten 6 Replace the SpO PCA See SpO PCA on page 115 7 Replace the measurement module panel See Measurement Module Panel on page 117 127 8 Connect the Processor PCA Refer to Figure 52 and Table 25 on page 125 The order in Table 25 begins with the left edge of the Processor PCA and then works around the front case in a clockwise direction Figure 52 Replacing the Processor PCA 9 Close the device See Closing the case on page 176 10 Replace the data card tray Entering the Serial Number and Enabling Options After you have replaced the Processor PCA you must enter the device s serial number in the HeartStart MRx for it to be operational If the serial number is not entered the device powers up with the message Device serial number has not been entered Service unit Normal operation is not possible and the device powers up into Service Mode where you can enter the serial number Additionally if you enter the options key incorrectly the device s options will not function To enter the serial number and enable options 1 Turn the device off 2 D
92. ase See Opening the case on page 102 2 Position the rear case Lay the rear case on the work surface with the PCAs facing up and the Therapy port on the right 3 Remove the Power PCA See Power PCA on page 148 4 Remove the Therapy capacitor See Therapy Capacitor on page 146 5 Remove the Therapy PCA See Therapy PCA on page 154 Removal 1 Remove the plastic shield Remove the plastic shield from the rear case and place it to the side You will need to replace this when you finish replacing the Therapy port 1 Unscrew the nut Using a wrench unscrew the large nut on the back of the Therapy port 2 Remove the hardware Remove the large nut and metal plate from the Therapy port Guide the wires and connectors through the nut and plate Turn the 9 pin connector so it passes through sideways 3 Remove the Therapy port Slide the Therapy port out of its hole in the case Guide the wires and connectors through the hole Figure 70 Therapy port 158 Replacement 1 Replace the Therapy port a Install the O ring onto the Therapy port b Slide the Therapy port into its hole in the case Guide the wires and connectors through the hole 2 Replace the hardware a Replace the metal plate and then the large nut onto the Therapy port b Guide the wires and connectors through the plate and the nut Turn the 9 pin connector so it passes through end first 3 Tighten the nut a
93. asurement module panel 453563476801 M3535 69105 ECG ECG Out RJ11 453563476811 M3535 69106 ECG ECG Out RJ11 SpO 453563476821 M3535 69107 ECG ECG Out RJ11 SPO NBP Items marked with an asterisk are Key Components which require tracking See Table 40 on on page 229 217 Internal Cables The following table lists the orderable cables Table 34 Internal Cables Display cable 453563478281 M3535 69134 Processor PCA Display assembly Case Interconnect 453563478411 M3535 69147 Processor PCA Power PCA cable Therapy PCA Contains the following cables Therapy PCA cable Processor Power cable Battery Power Signal 453563478301 M3535 69136 Power PCA Battery PCA cable Battery Power cable 453563478381 M3535 69144 Power PCA Battery PCA Therapy Power High 453563478351 M3535 69141 Power PCA Therapy PCA Current cable Therapy Power Power 453563478361 M3535 69142 Power PCA Therapy PCA Signals cable Therapy Power High 453563478371 M3535 69143 Power PCA Therapy PCA Voltage cable Printer Power cable 453563478401 M3535 69146 Power PCA Printer PCA Printer Data cable 453563478391 M3535 69145 Processor PCA Printer PCA RJ11 Cable 453563478311 M3535 69137 small PCA on PCMCIA Measurement module aluminum plate panel CO module cable 453563478321 M3535 69138 Therapy PCA CO module NBP module cable 453563478331 M3535 69139 Therapy PCA NBP module DC cable 453563478441 M3535 69150 Power PCA PCMCIA Hole plug 4535
94. ate code or expiration date and condition PASS Accessories and supplies are those specified by Philips Electrodes and pads are within their expiration date and appear usable For single use items packaging is unopened and shows no tears or punctures No corrosion is visible on connector sockets electrodes or pads Check Monitor Defibrillator l Inspect the device on all sides looking for Signs of mechanical damage to the case switches speaker cover display or printer Loose or missing hardware Evidence of liquid spill Open the printer door and clean out any accumulation using gloves and an approved cleaner Also check for residue in the patient connectors on either side of the device ECG SpO ECG Out CO therapy port Residue on the thermal printhead Printer roller wear Damage to connector pins or corrosion on the pins or debris in the connectors 2 Inspect the paddles power cord battery cables and sensors for signs of the following Wear or damage to paddles cables and adapters Wear or damage to patient cables and associated strain reliefs Wear or damage to power cord and associated strain relief PASS Only normal wear no damage serious enough to inhibit performance No corrosion visible 191 Service Mode Tests The following tests are available from Service Mode e Operational Check e NBP and CO calibration checks e Controls test e Printer test Service M
95. ater testing performed with cables connected to the device EMC Complies with the requirements of standard EN 60601 1 2 2001 Safety Complies with the requirements of applicable safety standards Other Considerations e The HeartStart MRx is not suitable for use in the presence of concentrated oxygen or a flammable anesthetic mixture with air oxygen or nitrous oxide e Hazards arising from software errors were minimized by the product s compliance with the software requirements contained in EN 60601 1 4 1996 Mode of Operation Continuous 261 AC Line Powered 100 240 VAC 50 60 Hz 1 0 46 A Class 1 Battery Powered 14 8 V Rechargeable Lithium Ion DC Powered e Input 11 32 VDC 11 A e Output 18 V 5 A 90 W 262 Symbol Definitions Table 42 lists the meaning of each symbol shown on the HeartStart MRx and the M3538A battery Table 42 Monitor Defibrillator and Battery Symbols Defibrillation Shock Attention See operating instructions in Instructions for Use Meets IEC type BF leakage current requirements and is defibrillator protected Patient Applied Part is isolated and defib proof suitable for direct patient contact except the heart or major arteries Meets IEC type CF leakage current requirements and is defibrillator protected Patient Applied Part is isolated and defib proof suitable for direct patient contact except the heart or major arteries Alarms are active Alarms are paused
96. ation 1 Remove either the paddle tray or handle and cap plate See Paddle Tray on page 95 or Handle and Cap Plate on page 100 2 Open and separate the case See Opening the case on page 102 3 Position the rear case Lay the rear case on the work surface with the PCAs facing up and the Therapy port on the right Removal 1 Disconnect the PCMCIA hole plug connector from the Power PCA Unplug the 2 wire bundle from the Power PCA Figure 42 Disconnecting the PCMCIA Hole Plug 2 wire bundle 2 Remove the PCMCIA hole plug Grasp the PCMCIA hole plug by the corner tab and pull up Use pliers if necessary Replacement 1 Guide the 2 wire bundle through the hole Make sure the wire is routed as show in Figure 42 2 Connect the 2 wire bundle to the Power PCA 109 3 Replace the PCMCIA hole plug a Press in all of the corners b Work your way around the plug pressing it into place 4 Close the case See Closing the case on page 176 5 Replace the paddle tray or handle and cap plate See Paddle Tray on page 95 or Handle and Cap Plate on page 100 After Repair Run Performance Verification and Safety testing as described in the Performance Verification chapter 110 Speaker and Microphone Assembly The speaker and microphone assembly can be removed without removing any other front case assemblies Preparation 1 Open and separate the case See Opening the case
97. ator Test AC Power At 200 J 203 Defibrillator Test Battery Power At 200 J 203 Defibrillator Disarm Test 204 Pacer Test 205 Synchronized Cardioversion Test 206 Paddles Safety Check 207 200 SpO2 Check This check only needs to be performed if SpO2 is installed 1 Connect the sensor Attach the SpO sensor to your finger and to the MRx 2 Check SpO3 a Turn the Therapy Knob to Monitor b The pleth wave should be clear c The SpO value displayed should be in the range of 95 100 If the value is less than 95 check that your finger is fully inserted into the sensor and properly positioned d The pulse rate should be displayed NBP Check Perform a blood pressure check on yourself or another person Make sure the measurement completes ECG Check This section describes how to check the operation of the ECG functions Each of the ECG checks assumes the device and the simulator are still set up as they were at the end of the previous ECG check Setup 1 Set up the simulator a Connect a Therapy cable and ECG cable to the MRx b Connect the ECG simulator to both the Therapy cable and the 3 or 5 lead ECG cable c Set the simulator for normal sinus rhythm NSR 1mV amplitude and 30 bpm 2 Set up the MRx Turn the Therapy Knob to Monitor Check ECG Display HR Leads Off 1 Check the waveform Verify that the waveform displays clearly Using the Lead Select button verify that the display shows a clea
98. black wires are closest to the handle 2 Place each screw through the ring terminal through the spade connector and through the metal bracket on the resistor Fasten to the threaded insert in the paddle tray 3 Make sure the wires and connectors are oriented as shown in Figure 34 4 Tuck the wires into the paddle tray Figure 34 Replacing the 50 ohm Load Resistor 5 Replace the paddle tray See Paddle Tray on page 95 After Repair Run Performance Verification and Safety testing as described in the Performance Verification chapter 99 Handle and Cap Plate Preparation 1 Turn the device off 2 Disconnect all external power and remove all batteries Removal 1 Remove the handle cover Lift up the notch with your fingernail or a screwdriver and push in on either side of the handle cover and lift up 2 Remove the screws located on either side of the handle Loosen and remove the 2 T 15 screws Remove the handle 4 Remove the cap plate Figure 35 Removing the Handle and Cap Plate 100 Replacement 1 Secure the PCMCIA hole plug wires Group the wires together and secure with the cable tie wrap Cut off any excess tie wrap Figure 36 PCMCIA Hole Plug Cable Tie Wrap 2 Replace the cap plate a Lay the cables flat against the PCMCIA hole plug being careful not to pinch the cables under the ridges on the cap plate b Line up the screw holes with the threaded inserts 3 Replace th
99. bleshooting problems with paddles try replacing the paddles first Table 11 ECG Monitoring Problems Leads Possible Causes Suggested Solution Flat line no waveform no Short in patient cable or Run the Operational Check with the ECG Leads Off message leads cable If the test fails run it without the ECG cable If the test passes replace the cable If the test fails Replace measurement module panel Replace Processor PCA Poor ECG signal quality Radio frequency Relocate or turn off equipment that may noisy trace wandering interference RFI is be causing RFI baseline etc from signal causing artifact acquired from monitoring Problem wihintetnal Be sure all internal cables are connected electrodes cables properly Check the cables from the measurement module panel to the Processor PCA Run the Operational Check with the ECG cable If the test fails run it without the ECG cable If the test passes replace the cable If the test fails replace Processor PCA Problem with measurement module panel Leads Off message even Open circuit in internal though ECG cable and leads Leads ECG wiring or front have been replaced and are end due to properly connected e Problem with Replace measurement module panel measurement module panel 64 Table 12 ECG Monitoring Problems Pads Paddles Possible Causes Suggested Solution Short in patient cable Run the Operational Check with the Pads cabl
100. bol o At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the HeartStart MRx is used exceeds the applicable RF compliance level above the HeartStart MRx should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the HeartStart MRx b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended Separation Distances The HeartStart MRx is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the HeartStart MRx can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the HeartStart MRx as recommended below according to the maximum output power of the communicati
101. bundle 3 6 Disconnect the CO intake tube from the CO module The intake tube has an arrow pointing towards the module and connects to the tube with the braided segment 4 7 Disconnect the CO exhaust tube from the CO module The exhaust tube has an arrow pointing away from the module and connects to the tube without the braid 5 8 Slide the tray out of the case 152 TIP NOTE Figure 66 Removing the NBP and CO Module Tray Replacement You may find it easier to slide the module tray in halfway until you connect the cables and tubes l 6 Connect the CO intake tube to CO the module The intake tube has an arrow pointing towards the module and connects to the tube with the braided segment Connect the CO exhaust tube to the CO module The exhaust tube has an arrow pointing away from the module and connects to the tube without the braid Connect the CO 3 wire bundle to the CO module connector If you are installing the M3535 69181 CO module make sure that you connect the CO 3 wire bundle to the CO module connector that is closest to the front of the device Connect the CO ribbon cable to the Therapy PCA Connect NBP 10 wire bundle to the Therapy PCA Slide the tray the rest of the way into the rear case Be careful not to pinch the wires or tubing between the Therapy PCA and the tray 7 Replace the 2 T 10 screws and tighten 8 Replace the Therapy capacitor See Therapy Capacitor o
102. button press is then detected and processed by the Processor PCA e In Manual Defib Mode with external paddles only when the Apex paddle Charge button is pressed the button press is transferred from the button to the Therapy PCA via the paddles cable The Therapy PCA transfers the button press to the Processor PCA via a large ribbon cable The button press is then detected and processed by the Processor PCA In all cases the charging cycle is initiated by the Processor PCA It directs the Therapy PCA to charge the Therapy capacitor to a specified level A controller on the Therapy PCA is responsible for all aspects of charging the Therapy capacitor to the specified level However the Processor PCA also monitors the voltage on the capacitor through a separate measurement circuit on the Therapy PCA and aborts the operation if the capacitor voltage is not consistent with the specified level When the Therapy PCA detects that the selected energy voltage level has been reached it stops charging It then continues to monitor the voltage on the capacitor and as the voltage bleeds down it resumes charging to top up the charge to the correct level Should a decision be made to change the selected energy to a lower value the user would turn the Therapy Knob to the desired setting At the lower energy setting the Processor PCA directs the Therapy PCA to charge to the new level The Therapy PCA then disarms completely discharges the capacitor and c
103. buttons and soft keys are detected and processed by the Processor PCA The Processor PCA then interacts with the other parts of the system as needed to respond to the soft key or button press Therapy Knob The Therapy Knob selects operation in either AED Mode or Manual DefibMode In Manual Defib Mode energy selection is made by rotating the Therapy Knob to the appropriate position The Therapy Knob operates an optical rotary switch The signals pass through the switch s ribbon cable and then on to the Processor PCA The Processor PCA then interacts with the other parts of the system as needed to respond to the setting of the Therapy Knob Paddle Indicators and Controls 242 External and switched internal paddles have a Shock button located on the paddles Additionally external paddles have a Charge button on the right hand paddle When the paddles are connected to the monitor defibrillator the paddle Shock button is active and the Shock button on the monitor defibrillator is disabled External paddles have a Patient Contact Indicator PCI located on the Sternum paddle The contact quality is indicated on the PCI using red orange and green LEDs Once proper contact has been made the PCI illuminates a green LED Printer Assembly and Printer Connector PCA The Printer assembly provides hard copy output of text waveforms event data etc The printer module receives print commands from the Processor PCA and drives the printhead and pa
104. c from the LCD 2 Place the RFU Indicator in position Slide the left end of the RFU Indicator under the retaining catch Line up the tabs with the alignment slots 138 3 Press the tabs into place Using a small screwdriver press each flexible tab down into the alignment slot until it reaches the bottom of the slot 4 Replace the Processor PCA See Processor PCA on page 123 5 Close the case See Closing the case on page 176 After Repair Run Performance Verification and Safety testing as described in the Performance Verification chapter 139 Front Panel Buttons Preparation 1 Open and separate the case See Opening the case on page 102 2 Position the front case Lay the front case on the work surface with the display facing down and the printer in the lower left corner 3 Remove the Processor PCA See Processor PCA on page 123 Removal 1 Remove the buttons Grasp each button and pull out from the case NOTE If your device has a white hollow plastic insert for the Shock button discard it and use the clear plastic insert that comes in the replacement kit If your device already has the clear plastic Shock button insert you can re use it and discard the one that came in the kit Keep the plastic inserts for the other buttons for replacement Replacement 1 Place the buttons in position Slide each plastic insert into its button Be sure it slides in all the way 2 Ins
105. can English Main Prev Next Service Item Item Upgrade 19 When the software installation process is complete turn the device off and on After Repair Restore the customer s configuration settings from the data card Run Performance Verification and Safety testing as described in the Performance Verification chapter 131 Clock Battery The clock lithium battery resides on the Processor PCA A cable tie wrap and a package of ProGold wipes are included in the replacement kit Make sure you clean the contact clips and the new battery terminals with a ProGold wipe and replace the cable tie wrap that holds the battery in place Preparation 1 Open and separate the case See Opening the case on page 102 2 Position the front case Lay the front case on the work surface with the display facing down and the printer in the lower left corner 3 Remove the Processor PCA See Processor PCA on page 123 Removal 1 Remove the battery from the Processor PCA a Using a pair of fine nose wire cutters cut and remove the cable tie wrap that holds the battery in place b Remove the battery from the holder Cleaning 1 Thoroughly clean the contact clips and new battery terminals with a ProGold wipe Replacement 1 Insert the new battery into the holder CAUTION Make sure that you install the new battery with the correct orientation Follow the polarity markings on the battery holder under the battery
106. ck Pull wiggle present wire with plastic shield if present modem Pull out 8 wire bundle Display Push on latch pull straight out flex circuit Display Pull or pry straight up flex circuit Display Pull up on latch to release pull flex circuit Display Pull up on latch to release pull 4 wire bundle Speaker microphone Pull wiggle use needle nose pliers if necessary 10 wire bundle Printer PCA Pull wiggle use needle nose pliers if necessary 4 Remove the screws a Loosen and remove the 7 T10 screws b Loosen and remove the shoulder screw using the T 10 driver 125 126 Figure 51 Processor PCA Screws S EB S KN XQ SS f ITA ee EE a UD OUJ 5 Lift the Processor PCA out of the case a Be careful to guide the many cables out of the way so the Processor PCA can be lifted clear b Leave the clock lithium battery in place when returning the PCA for repair This helps preserve information for factory troubleshooting 6 Remove the internal memory card Press the black eject button and pull the card out Replacement 1 Install the clock lithium battery See Clock Battery on page 132 2 Install the replacement fan assembly See Fan Assembly on page 121 3 Replace the internal memory card a Insert the internal memory card into the slot farthest from the fan a Align the card so that the CE label is facing the Processor PCA b Push the card into the slot as far
107. creen 02 Mar 2003 10 52 A__h Ef utomated Test Summary 02 Mar 03 10 45 02 Mar 03 01 Mar 03 28 Feb 03 27 Feb 03 26 Feb 03 25 Feb 03 24 Feb 03 17 Feb 03 10 Feb 03 03 Feb 03 27 Jan 03 20 Jan 03 13 Jan 03 06 Jan 03 30 Dec 02 23 Dec 02 16 Dec 02 09 Dec 02 02 Dec 02 25 Nov 02 18 Nov 02 11 Nov 02 04 Nov 02 28 Oct 02 21 Oct 02 14 Oct 02 07 Oct 02 30 Sep 02 23 Sep 02 Exit Summary Weekly Pass Fail NC 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 30 16 Sep 02 09 Sep 02 02 Sep 02 26 Aug 02 19 Aug 02 12 Aug 02 05 Aug 02 29 Jul 02 22 Jul 02 15 Jul 02 08 Jul 02 01 Jul 02 24 Jun 02 17 Jun 02 10 Jun 02 03 Jun 02 27 May 02 20 May 02 13 May 02 06 May 02 29 Apr 02 22 Apr 02 15 Apr 02 08 Apr 02 01 Apr 02 25 Mar 02 18 Mar 02 11 Mar 02 04 Mar 02 25 Feb 02 2 00 2 00 2 00 2 00 2 00 2 00 2 00 2 00 2 00 2 00 2 00 2 00 2 00 2 00 2 00 2 00 2 00 2 00 2 00 2 00 2 00 2 00 2 00 2 00 2 00 2 00 2 00 2 00 2 00 2 00 Weekly Weekly Weekly Weekly Weekly Weekly Weekly Weekly Weekly Weekly Weekly Weekly Weekly Weekly Weekly Weekly Weekly Weekly Weekly Weekly Weekly Weekly Weekly Weekly Weekly Weekly Weekly Weekly Weekly Weekly 37 Table 3 ATS Results Fail C Solid Red X A critical failure was detected Critical accompanied failures impact life saving functionality by a chirp
108. d Tray Data Card Tray Z z EE AJA Oo gt gt lt a GIG nln EIG gt gt Power Lithium Ion Battery AC Power Module DC Power Module DC Power Module mounting bracket 2 Bay Battery Support System for Lithium Ion Batteries Se el DIAT WWNi Oo Go CO ATAT A won SIME NMI _ RW LY Go O O G oo gt Sl gt gt ee x a 989803135331 4 Bay Battery Support System for Lithium Ion Batteries 989803135341 4 Bay Battery Support System for Sealed Lead Acid and Lithium Ion Batteries Items marked with an asterisk are Key Components which require tracking See Table 40 on on page 229 Key Components Key Components require tracking as indicated in the following table Record the part number and either the date code or serial number for both the failed component and the replacement competent Table 40 Key Components Electrical Assemblies Processor PCA M3535 68101 Processor PCA M3535 60200 Serial Number 453563478461 Power PCA M3535 68109 Power PCA M3535 60140 Serial Number 453563478491 Other Replacement PCAs Therapy PCA M3535 68108 Therapy PCA M3535 60110 Serial Number 453563478481 Battery PCA M3535 69120 Battery Connector M3535 60130 Date Code 453563476861 PCA Other Electrical Assemblies Display Assembly M3535 69102 TFT Display M3535 60996 Serial Number 453563478471 Switch Assembly M3535 60987 Date Code Inverter PCA M3535 60997 Serial Number Therapy Capacitor
109. d in the upper left side of the tray as shown in Figure 73 For the M3535 69181 module position the CO module into the tray as shown in Figure 74 2 Replace the screws and tighten 3 Replace the NBP and CO module tray See NBP and CO2 Module Tray on page 152 4 Replace the Therapy capacitor See Therapy Capacitor on page 146 5 Close the case See Closing the case on page 176 After Repair Run Performance Verification and Safety testing as described in the Performance Verification chapter 166 CO Compartment Door Preparation 1 Open and separate the case See Opening the case on page 102 2 Position the rear case Lay the rear case on the work surface with the PCAs facing up and the Therapy port on the right Removal 1 Remove the door a Look down the tapered hole and slide the door past until you see the snap tab It is the bar in the middle when viewed through the tapered hole b Using a straightened paper clip push on the snap tab to release the door 1 2 Remove the spring Replacement 1 Place the spring into the recess and rotate the free end clockwise until it catches behind the post Make sure that the spring is seated in the recess 2 2 Insert the door into the recess with the snap tab between the spring and the inlet outlet ports Make sure that the tab snaps into place Figure 76 Replacing the CO Compartment Door Snap tab 167
110. d the NBP Service screen is displayed Run an Operational Check You must run an operational check after calibrating the NBP module in order for the calibration status to get updated See Operational Check on page 39 for instructions 22 w ai o a oconeccy Checking the CO Module CO These instructions describe how to test the CO module The CO tests are as follows CO Check Page Setup 23 Check the Status Display 24 Ambient Pressure 25 Leakage Check 26 Pump Check 27 Flow Rate Check 28 Noise Check 28 Calibration Check 29 CO Calibration 30 Run an Operational Check 31 Each of the tests assumes the device and the test equipment are still set up as they were at the end of the previous test If all results are as described the device passes that portion of the test Return to the Service Mode Main menu by pressing the Main Service soft key If there is any failure begin troubleshooting and repairing the device as needed See Troubleshooting on page 33 for more information Setup 1 Access the Service Mode Main menu as described in Accessing Service Mode on page 10 2 From the Service Mode Main menu select CO3 The pump starts when you access the CO Service screen 23 The CO Service screen is displayed as shown in Figure 12 Figure 12 CO Service Screen VAVEWAUKE CRY Ca DS Service coz CO2 Operating Hours 15 010 hours Replacement recommended Last Calibration 9 Jun 2002 Ambient
111. d with the Leakage check Ambient Pressure This menu enables you to adjust the ambient pressure setting of the monitor defibrillator 1 Ifthe ambient pressure is not within 12 mmHg of the reference value select Ambient Pressure from the CO Service menu 2 Use the Navigation buttons to enter the barometric pressure reference value The displayed ambient pressure is updated to the reference value 25 Leakage Check The leakage check consists of two parts 1 Check of the internal tubing between the pump outlet and the CO Outlet port on the monitor defibrillator device outlet This test is done by pressurizing the outlet line between the pump and the outlet port 2 Check of the internal tubing between the pump inlet and the FilterLine inlet This test is done by pulling a vacuum on the inlet line between the inlet fitting and the pump These procedures are described in the following sections Outlet leakage To perform Part 1 of the CO Leakage check 1 From the CO Service menu select Leakage Check 2 Set up the flowmeter and the MRx a Connect the FilterLine to the monitor defibrillator CO Inlet port b Connect tubing from the flowmeter outlet to the FilterLine Figure 13 CO Outlet Leakage Check Setup 3 Follow the instructions on the screen to perform Part 1 of the Leakage check 4 The reading on the flowmeter should decrease to between 0 and 4 ml min If this reading is correct proceed to the second part o
112. dures called out by the manufacturer of the safety analyzer in use e Only test the AC Mains line voltage used in the customer s facility there is no need to test both 120 VAC and 240 VAC e Test both Normal and Reverse Polarity line connections for each test and record the worst case value e Ifa chassis reference point is needed for the testing connect to the inside metal shaft on the ECG Out Sync jack This is not earth ground e The HeartStart MRx does not have an earth ground node that could be used for leakage testing purposes The only accessible earth ground node is at the AC inlet on the AC power module e Only perform the AC Mains test if the device has an AC power module AC Mains Leakage through earth ground wire of AC power cord 1 Normal Condition both AC line connections intact Should be lt 300 uA UL 120 VAC Should be lt 500 uA IEC 240 VAC Record as aaa 2 Single Fault Condition one AC line connection open Should be lt 1000 uA Record as bbbb Chassis Enclosure Leakage Use ECG Out Sync jack to measure enclosure leakage current This is not earth ground 1 Normal Condition Should be lt 100 uA lt 4 2 Record as ce 2 Single Fault condition Should be lt 300 uA UL Should be lt 500 uA IEC Record as dd 208 Patient Lead Leakage Leakage out of Source or into Sink patient connected inputs
113. e If the test fails run it without the Pads cable If the test passes replace the cable If the test fails Symptom Flat line no waveform no Pads Off message Replace Therapy port Replace Power PCA Poor ECG signal quality Radio frequency Relocate or turn off equipment that may noisy trace wandering baseline etc from signal acquired from paddles pads interference RFI is causing artifact Problem with internal cables Problem with Therapy port be causing RFI Be sure all internal cables are connected properly Check the cables from the Therapy port to the Therapy PCA and from the Therapy PCA to the Power PCA Run the Operational Check with the Pads cable If the test fails run it without the Pads cable If the test passes replace the cable If the test fails replace Power PCA Replace Therapy port Open circuit in internal Pads Off message even though pads cable has been Therapy port wiring or front end due to replaced and is properly connected Cable from Therapy port to Therapy PCA has bad connection Defective Therapy port or cable to Power PCA Problem with internal cable Defective Power PCA Reconnect cable properly Replace Therapy port Replace Therapy Power High Voltage cable Replace Power PCA 65 NBP Monitoring Problems Table 13 NBP Monitoring Problems Symptom Possible Causes Suggested Solution NBP Equip Malfunction NBP h
114. e configured to run real time or with a 10 second delay The strip prints the primary ECG lead with event annotations and measurements Auto Printing The printer can be configured to automatically print on Mark Events Charge Shock and Alarm When an alarm condition occurs the unit prints the Primary ECG wave and the alarming wave if configured Reports The following can be printed e Event Summary short medium and long e 12 Lead e Operational Check e Configuration Status Log e Device Information Speed 25 or 50 mm s with an accuracy of 5 Amplitude Accuracy 5 or 40 uV whichever is greater Paper Size e 50 mm W x 30 m 100 ft L e 75 mm W x 30 m 100 ft L Noninvasive Pacing Waveform Monophasic Truncated Exponential Current Pulse Amplitude 10 mA to 175 mA 5 mA resolution accuracy 10 or 5 mA whichever is greater Pulse Width 40 ms with 10 accuracy Rate 30 ppm to 180 ppm 10 ppm increments accuracy 1 5 Modes Demand or Fixed Rate Refractory Period 340 msec 30 to 80 ppm 240 msec 90 to 180 ppm 255 SpO Pulse Oximetry Range e SpO 0 100 e Pulse Rate 30 to 300 bpm Resolution 1 Display Update Period 1 sec typical numeric update rate SpO Accuracy with e M1191A sensor 1 standard deviation 70 to 100 2 5 e M1192A sensor 1 standard deviation 70 to 100 2 5 e M1193A sensor 1 standard deviation 70 to 100 2 5 e M1194A sensor 1 standard devia
115. e handle Line up the handle with the shaped posts on the cap plate 4 Replace the screws Replace the 2 T 15 screws and tighten 5 Replace the handle cover Line up the handle plate and snap into place After Repair Run Performance Verification and Safety testing as described in the Performance Verification chapter 101 Opening the case To open the sealed case safely perform the following steps in the order listed 1 Discharge the power supply capacitors see Discharge the Power Supply Capacitors below 2 Separate the case see Separate the Case below 3 Discharge the Therapy capacitor see Discharge the Therapy Capacitor on page 105 4 Disconnect the case halves see Disconnect the Case Halves on page 106 Each step is described in more detail in the following sections WARNING Remove all power sources AC battery DC before opening the device Failure to do so may allow the device to charge without warning and could result in serious injury or death Discharge the Power Supply Capacitors Always discharge the power supply capacitors before servicing the HeartStart MRx 1 Disconnect external power and remove all batteries The power supply capacitors are now discharging Wait at least 60 seconds before unplugging any internal connections Separate the Case Separate the front and back case from each other by performing the following steps WARNING Dangerous voltages may be
116. e no wires or cables are caught underneath the PCA Replace the large plastic shield Replace the screws Replace the 8 T 10 screws and tighten Connect the Power PCA Refer to Figure 65 and Table 26 The connections may be replaced in any order The order in Table 26 begins with the left edge of the Power PCA and then works around the rear case in a clockwise direction NOTE Be sure to loop the PCMCIA 2 wire bundle 6 in Figure 63 underneath the Therapy PCA 4 wire bundle 5 in Figure 63 Figure 65 Replacing the Power PCA After Repair Run Performance Verification and Safety testing as described in the Performance Verification chapter 151 NBP and CO Module Tray You need to remove the NBP and CO module tray for several of the rear case assembly replacement procedures Preparation 1 Open and separate the case See Opening the case on page 102 2 Position the rear case Lay the rear case on the work surface with the PCAs facing up and the Therapy port on the right 3 Remove the Therapy capacitor See Therapy Capacitor on page 146 Removal 1 Remove the 2 T 10 screws from the front of the tray TIP You may find it easier to stand the device up with the PCAs facing you for the following procedures 2 Disconnect the NBP 10 wire bundle from the Therapy PCA 1 3 Disconnect the CO ribbon cable from the Therapy PCA 2 4 Slide the tray out halfway 5 Disconnect the CO 3 wire
117. ears frozen when you turn the Therapy Ths These Kieb ee Monitor Knob to Monitor e Insert a battery or apply AC DC power module All settings have been set to factory default values Reconfigure the device to the user s settings See the Instructions for Use for details e Internal Memory Failure message with a beep e None Internal memory card is automatically reformatted All data on the card has been erased e Internal Memory Failure inop appears every time Run an Operational Check and check the status log If an the device is turned on Internal Memory error is listed replace the internal memory card 62 General Problems The following table discusses general problems that can occur Table 10 General Monitoring Problems Symptom Possible Causes Suggested Solution Replace Clock Battery The clock lithium battery Replace clock battery on Processor PCA message on the Processor PCA needs to be replaced One or more controls dont Bad connection between Run Controls test in Service Mode to respond e g select lead or keys and detection circuits confirm soft keys Check flex circuit connections between Display assembly and Processor PCA Failure in keypress detection Replace Processor PCA processing Failure in keys Replace Display assembly 63 ECG Monitoring Problems TIP When troubleshooting ECG problems always check the cable first by running an Operational Check When trou
118. ed CO value example 0 10 X 736 mmHg 73 6 mmHg 198 5 Calculate the allowable tolerance which is 7 of the expected reading Calculate as follows 0 07 X expected CO value tolerance mmHg example 0 07 X 73 6 mmHg 5 2 mmHg In this example the reading displayed with 10 cal gas must be 73 6 mmHg 5 2 mmHg or between 68 4 mmHg and 78 8 mmHg 6 Compare the displayed CO value to the allowable range of values If the displayed value falls within the allowable range the device has passed its accuracy test If the displayed value does not fall within the allowable range the CO measurement module needs to be calibrated Perform the steps under CO Calibration on page 30 then begin again at step 1 7 Return to the main CO Service screen by pressing the Done soft key 199 Functional Checks The functional checks exercise the basic functions of the monitor defibrillator They are intended as a broad check of the device s performance and are used in conjunction with the Service Mode and Safety tests to verify the performance of the device Functional checks are performed with the device in a normal clinical operating mode not in Service Mode If all elements of a test pass record that test as a PASS If there is any failure begin troubleshooting and repairing as needed Functional Check Page SpO2 Check 201 NBP Check 201 ECG Check 201 Defibrillator Measurement Test 202 Defibrill
119. ed to Monitor Mode 6 When a response is required use the Navigation buttons to select your answer and the Menu Select button to confirm your choice Table 4 on page 41 shows the tests in the order in which they are performed explains the prompts that may appear and describes the actions you should take if any Check the Status Log Select Status Log from the Service Mode Main menu The Status log includes entries for all errors logged during normal operating mode Automated tests Service tests and Configuration Mode and Operational Checks See Status Log Errors on page 55 for more information Remember to clear the Status log after a successful Operational Check Controls Test These instructions describe how to test the operation of the front panel controls If all results pass the device passes that portion of the test Return to the Service Mode Main screen by pressing the Main Service softkey If there is any failure begin troubleshooting and repairing the device as needed See Troubleshooting on page 33 Test the Buttons and Soft Keys 1 Select Controls from the Service Mode Main menu and press the Menu Select button A list of the front panel buttons soft keys and the Therapy Knob are displayed on the screen 2 Press each button and soft key and check the screen The screen shows Pass when each button and soft key press is detected Test Therapy Knob 3 Test the Therapy Knob Test t
120. ee Opening the case on page 102 4 Position the front case Lay the front case on the work surface with the display facing down and the printer in the lower left corner Removal 1 Unplug the ribbon cable from the Processor PCA 2 Remove the Therapy switch Replacement 1 Position the switch as shown in Figure 48 Orient the switch so the black stripe on the ribbon cable is on the edge closest to the fan Figure 48 Orientation of Therapy Switch 119 2 Connect the ribbon cable to the Processor PCA without twisting or kinking the cable 3 Replace the washer and nut Tighten the nut Do not overtighten 4 Check the orientation a Slide the Therapy Knob onto the shaft ensuring that the flat part of the knob recess aligns with the flat part of the shaft b Rotate the knob fully in both directions Check that the knob aligns properly with the panel markings 5 Close the case See Closing the case on page 176 After Repair Run Performance Verification and Safety testing as described in the Performance Verification chapter 120 Fan Assembly Preparation 1 Open and separate the case See Opening the case on page 102 2 Position the front case Lay the front case on the work surface with the display facing down and the printer in the lower left corner Removal 1 Unplug the braided fan cable from the Processor PCA 1 2 Remove the fan a Slowly bend the fan back and
121. el SpO Equip Malfunction The SpO hardware is e Unplug and replug the PCA faulty e If this does not clear the message replace SpO PCA No response no valueon Bad sensor e Try another sensor and cable screen no pleth bar as P e Bad internal connection Try flexing the SpO flex circuit to see if there is an intermittent failure that may self correct while other tests are being conducted e Carefully re seat the flex circuit between SpO port and SpO PCA Check that SpO PCA is properly seated on Processor PCA e SpO PCA failure e Replace SpO PCA Reads obviously wrong e Bad sensor e Try another sensor and cable Noisy intermittent signal e Bad sensor e Try another sensor and cable pee a 67 CO Monitoring Problems When troubleshooting CO problems it is recommended that you try replacing the CO module first If the problem persists then replace all of the CO internal tubing intake receptacle wires and tubing Table 15 CO Occlusion CO Calibration Overdue CO Service Required CO Overrange Failure to display CO measurement 68 CO Monitoring Problems Possible Causes Suggested Solution CO Equip Malfunction CO hardware malfunction A sample cannot be taken because the FilterLine is blocked The CO module should be calibrated once a year or after 4 000 operating hours The CO module has reached its end of life defined as 15 000 op
122. el This label is shipped as part of the Processor PCA kit It lists the product version and is affixed to battery compartment B 91 Removing and replacing labels Preparation 1 Turn the device off 2 Disconnect all external power and remove all batteries Removal 1 Start at one corner Using a sharp tool such as a utility knife pick up one corner of the label 2 Peel up the label Peel the label up by pulling slowly and evenly on the loosened corner Replacement 1 Clean the surface a Remove any adhesive residue by rubbing the dry surface with your finger and rolling up the adhesive residue Solvents are ineffective as is scraping with a tool b Clean the surface with isopropyl alcohol Allow it to dry 2 Peel off the backing Peel the backing off the new label Avoid touching the label adhesive as this can prevent the label from bonding properly 3 Apply the label a Align one edge of the label with the recess on the case then roll the label down slowly into position b Press firmly all over the label especially the edges to ensure it adheres to the case After Repair Visually inspect the device to ensure that you installed the labels correctly It is not necessary to run any Performance Verification and Safety testing 92 Printer Assembly The HeartStart MRx can have either the 50 mm printer or the 75 mm printer Follow the instructions for the printer installed in your device
123. ems 63 Display Problems 75 ECG Monitoring Problems 64 Audio Problems 75 NBP Monitoring Problems 66 Controls Problems 76 SpO Monitoring Problems 67 Internal Memory Problems 77 CO Monitoring Problems 68 External Data Card Problems Te 53 Audio Tones The HeartStart MRx emits tones to alert you to its status Table 5 Audio Tones Single beep Message tone Accompanies a new message on the display Informational such as switching to the other battery Charging tone Generated when the Charge button is pressed and continues until the device is fully charged Continuous tone lower pitch than charged tone Continuous tone Charged tone Generated when the selected defibrillation energy is reached and continues until the Shock button is pressed the Disarm soft key is pressed or the device disarmed automatically after the configured time had elapsed since pressing the Periodic chirp Tone repeated once a second Red alarm indicator message for applicable HR arrhythmia apnea and extreme desat alarms High pitched tone repeated five times followed by a pause Red alarm indicator message for applicable HR arrhythmia apnea and extreme desat alarms Tone repeated every two seconds lower pitch than red alarm tone Yellow alarm indicator message for applicable HR arrhythmia SpO NBP and EtCO alarms Lower pitched tone is repeated three times followed by a pause Yellow alarm indicator message for app
124. entration you are using typically 5 0 and the ambient pressure Calculate as follows concentration of cal gas X ambient pressure expected CO value For example 0 05 X 736 mmHg 36 8 mmHg 7 Calculate the allowable tolerance which is 5 of the expected reading Calculate as follows 0 05 X expected CO value tolerance mmHg example 0 05 X 36 8 mmHg 1 8 mmHg In this example the reading displayed with 5 cal gas must be 36 8 mmHg 1 8 mmHg or between 35 0 mmHg and 38 6 mmHg 8 Compare the displayed CO value to the allowable range of values If the displayed value falls within the allowable range proceed to the 10 Calibration Check section below If the displayed value does not fall within the allowable range the CO measurement module needs to be calibrated Perform the steps under CO Calibration on page 30 then begin again at step 1 29 10 Calibration Check 1 2 3 Disconnect the 5 gas and regulator if needed and connect the 10 gas Turn on the gas Wait until the displayed CO value is stable Calculate the expected CO reading which depends on both the gas concentration you are using typically 10 0 and the ambient pressure Calculate as follows concentration of cal gas X ambient pressure expected CO value example 0 10 X 736 mmHg 73 6 mmHg Calculate the allowable tolerance which is 7 of the expected reading Calculate as follows 0 07 X
125. er using a straight blade screwdriver 5 Figure 47 Removing the Measurement Module Panel 117 4 Remove the measurement module panel Lift the module straight up out of its groove in the front case Replacement 1 Place the measurement module panel into position Align its gasket with the groove in the case and lower the module into position Be careful not to cut pinch or crush the soft gasket NOTE Make sure that you carefully seat the measurement module panel without skewing it or crushing the gasket 2 Replace the washer and standoff 3 Loop the SpO flex circuit through the plastic shield 4 Connect the measurement module panel a Connect the ECG connector cable to the Processor PCA Be sure that the connector is properly centered and both latches are locked b Connect the SpO flex circuit to the SpO PCA c Connect the ECG Out jack wire to the Processor PCA d Connect the modem wire if present to the measurement module panel 5 Replace the plastic shield over the SpO PCA Replace and tighten the two screws 6 Close the case See Closing the case on page 176 After Repair Run Performance Verification and Safety testing as described in the Performance Verification chapter 118 Therapy Switch Preparation 1 Remove the Therapy Knob See Therapy Knob on page 90 2 Remove the nut and washer Loosen and remove the nut 9 16 inch and washer 3 Open and separate the case S
126. erating hours The CO value is higher than the measurement range Problem with internal tubing connections CO module failure CO module failure Internal tubing broken or damaged Processor PCA failure Therapy PCA failure Make sure that you have the correct module in the device See Other Electrical Assemblies on page 216 for information on ordering the CO module Replace the CO module Check that the FilterLine is not kinked and is free of any blockages Disconnect and reconnect the FilterLine to reset the module If necessary replace the FilterLine If the message still appears replace the CO internal tubing and intake receptacle wires and tubing Replace CO module Calibrate the CO module See Checking the CO Module on page 23 Replace CO module all CO internal tubing and intake receptacle wires and tubing Check accuracy as described in Checking the CO Module on page 23 Calibrate if needed Check internal tubing Reconnect replace internal tubing and intake receptacle wires and tubing as needed Replace COymodule Replace the FilterLine Re seat both ends of the wire between the intake receptacle and the CO module Replace case interconnect ribbon cable Replace CO module Replace the CO internal tubing and intake receptacle wires and tubing Replace Processor PCA Replace Therapy PCA Table 15 Symptom Reading inaccurate CO Check Exhau
127. ering replacement 216 AC Power test 203 Accessory pouches installing 87 AED Mode 2 Audio functional description 246 troubleshooting 75 Audio tones troubleshooting 54 Automated tests critical functions 35 daily 36 description 36 Fail BF 38 Fail CF 38 Fail NC 38 hourly 36 non critical functions 35 RFU indicator 36 summary 36 summary results 38 weekly 36 B Battery functional description 241 key component tracking 231 M3538A lithium ion battery 9 testing 203 Battery Connector PCA functional description 240 key component tracking 229 ordering replacement 215 repair 169 Bedrail hook mount ordering replacement 220 removal and replacement 89 C Cable placement 83 Calibration CO module 28 NBP module 21 Case closing 176 disconnecting the halves 106 opening 102 Clock battery functional description 247 ordering replacement 216 repair 132 Closing the case 176 CO door ordering replacement 220 repair 167 CO module calibration 23 197 functional description 248 ordering replacement 216 repair 162 troubleshooting 68 Controls test 193 troubleshooting 76 D Daily tests 36 Data card See external data card Data storage functional description 247 Defibrillation functional description 244 troubleshooting 70 Defibrillator AC Power test 203 battery test 203 disarm test 204 Defibrillator discharge tool part number 85 using 105 Device info entering serial number and enabling
128. ert the buttons into the case Line up the notches on the buttons with the slots in the case and push into place 3 Replace the Processor PCA See Processor PCA on page 123 4 Close the case See Closing the case on page 176 After Repair Run Performance Verification and Safety testing as described in the Performance Verification chapter 140 Front Case Assembly The front case replacement involves moving existing parts from the old case to the new and replacing the labels Preparation 1 Remove the printer See Printer Assembly on page 93 2 Remove the Therapy Knob See Therapy Knob on page 90 3 Open and separate the case See Opening the case on page 102 4 Position the front case Lay the front case on the work surface with the display facing down and the printer in the lower left corner Removal 1 Remove the speaker microphone assembly See Speaker and Microphone Assembly on page 111 2 Remove the Printer PCA See Printer Connector PCA on page 133 3 Remove the measurement module panel See Measurement Module Panel on page 117 4 Remove the Processor PCA and SpO PCA together Leave the SpO2 PCA in place on the Processor PCA then remove the Processor PCA from the Front Case See Processor PCA on page 123 5 Remove the Display assembly See Display Assembly on page 135 6 Remove the Therapy switch See Therapy Switch on page
129. es e Storage Trapezoidal waveform acceleration gt 30 g velocity change 742 cm s 10 on all six faces Vibration e Operating Random vibration 0 30 Grms 5 500 Hz for gt 10 minutes axis PSD 0 0002 g Hz from 5 to 350 Hz 6 dB octave slope from 350 to 500 Hz e Storage Random vibration 2 41 Grms 5 500 Hz for gt 10 minutes axis PSD 0 02 g Hz from 5 to 100 Hz 6 dB octave slope from 100 to 137 Hz 0 dB octave slope from 137 to 350 Hz 6 dB octave slope from 350 to 500 Hz Swept sine vibration 0 75 g 0 to peak 5 to 500 H2 resonant search 1 octave minute sweep rate 5 minute resonant dwell at 4 resonances per axis Water Solids Resistance e Water Resistance Meets EN60601 2 4 Water testing performed with cables connected to the device e Solids Resistance IP2X EMC Complies with the requirements of standard EN 60601 1 2 2001 Safety Complies with the requirements of applicable safety standards Other Considerations e The HeartStart MRx is not suitable for use in the presence of concentrated oxygen or a flammable anesthetic mixture with air oxygen or nitrous oxide e Hazards arising from software errors were minimized by the product s compliance with the software requirements contained in EN 60601 1 4 1996 Mode of Operation Continuous AC Line Powered 100 240 VAC 50 60 Hz 1 0 46 A Class 1 Battery Powered 14 8 V Rechargeable Lithium Ion DC Powered Input 11 32 VDC 11 A e Outp
130. ew holes in the white plastic cover 3 Replace the paper and close the door See the label on the inside of the printer door or the Instructions for Use for additional instructions After Repair Perform Performance Verification and Safety testing as described in the Performance Verification chapter Paddle Tray There is a 50 ohm load resistor pre assembled inside the tray which is used to test the paddles Preparation 1 Turn the device off 2 Disconnect all external power and remove all batteries Removal 1 Remove the paddles from the tray Disconnect the paddles from the Therapy port Snap both paddles out of the paddle tray and lay them aside 2 Remove the screws from the tray plates Loosen and remove the 4 T 15 screws Gently lift the paddle tray to gain access to the wires 4 Pull the spade connectors straight off of the tabs being careful not to bend the tabs 5 Remove the paddle tray Figure 31 Removing the Paddle Tray 95 Replacement 1 Install the tray plates into the tray a Hold the paddle tray so that the connections are facing towards you and the handle is on top b Holding the tray plate at an angle place one plate into the left tray inserting the tab through the hole c While holding the plate at an angle connect the spade connector from the black wire to the tab 1 d Holding the tray plate at an angle place the other plate into the right tray inserting the tab through
131. ey Components 229 211 Parts and Accessories Notes The tables in this chapter list two part numbers one is the 12NC number and the other is the 5x5 number Use the 12NC number when ordering replacement parts and kits Use the 5x5 part identifier number when calling the Response Center The following notes contain some important information relating to replacement parts Ordering Replacement Parts To order replacement parts e In the US call 888 561 5018 e Outside the US contact your local Philips Medical Systems office Ordering Supplies and Accessories To order accessories and supplies e Visit our Medical Systems website at www medical philips com cms and follow the links to Supplies e In the US call 800 225 0230 e Outside the US contact your local Philips Medical Systems Sales Office or your authorized Philips Medical Systems Dealer or Distributor Key Component Tracking Replacement assemblies marked with an asterisk contain one or more Key Components Key Components require detailed tracking by recording the Key Component part number and either the Key Component s date code or its serial number This data must be recorded for both the failed assembly and the replacement assembly Philips Medical Systems service personnel must record this information on the Customer Service Order CSO The Key Components that are part of the replacement assemblies are listed in Table 40 on page 229 212 Replacement
132. f the leakage test the Inlet Leakage by pressing the Proceed soft key If this reading is incorrect gt 4 ml min flow it indicates a leak in the line between the pump outlet and the CO Outlet port Begin troubleshooting and repairing the device as needed See Troubleshooting on page 33 26 Inlet leakage To perform Part 2 of the CO Leakage check 1 Set up the flowmeter and the MRx a Leave the FilterLine connected to the monitor defibrillator CO Inlet port b Disconnect the FilterLine from the flowmeter outlet c Connect the tubing from the flowmeter inlet to the monitor defibrillator CO Outlet port Figure 14 CO Inlet Leakage Check Setup 2 Follow the instructions on the screen to perform Part 2 of the Leakage check 3 The reading on the flowmeter should decrease to between 0 and 4 ml min If this reading is incorrect gt 4 ml min flow it indicates a leak in the line between the FilterLine inlet and the pump inlet Begin troubleshooting and repairing the device as needed See Troubleshooting on page 33 Pump Check This test checks the strength of the pump by occluding the inlet and measuring how deep a vacuum the pump can pull NOTE Itis important these tests be conducted in this order For example if you perform the Pump check and there s a leak you haven t found because you didn t perform the leak tests it may appear that the device has a faulty pump when in fact it s a lo
133. for Use for more information After Repair Run Performance Verification and Safety testing as described in the Performance Verification chapter 114 The SpO PCA can be removed without removing any other front case assemblies Preparation 1 Open and separate the case See Opening the case on page 102 2 Position the front case Lay the front case on the work surface with the display facing down and the printer in the lower left corner Removal 1 Move the plastic shield a Loosen and remove the two T 10 screws b Lift up the plastic shield 2 Disconnect the SpO flex circuit from the SpO PCA a Grasp the connector and pull sideways 1 Figure 45 Disconnecting the SpO PCA 3 Remove the screw Loosen and remove the J 10 screw 115 4 Lift the SpO PCA As you lift the SpO PCA it will disconnect from the Processor PCA The connector may lift up with the SpO PCA or it may stay secured to the Processor PCA In either case keep the connector as you will need it for the replacement procedure Figure 46 Removing the SpO PCA Connector Sg U N J AN ir EN Replacement 1 Place the SpO PCA in position a Ifthe connector is secured to the Processor PCA leave it in place If not secure the connector to the Processor PCA b Line up the pins on the SpO PCA with the connector on the Processor PCA c Line up the screw holes on the SpO PCA w
134. fore proceeding to the next test to avoid the safety timeout 21 Test the linearity 1 Pressurize the expansion chamber to increase pressure to approximately 150 mmHg 2 When the pressure is stabilized compare the displayed pressure reading to the pressure indicated by the manometer If the difference between the manometer and the displayed pressure is gt 2mmHg perform the steps in Calibrate the NBP Measurement Then repeat this linearity test Calibrate the NBP Measurement NOTE Ifthe error message Calibration failed Check that the pressure applied is correct Please restart calibration appears after entering either calibration point re start the calibration Pressing the Calibrate soft key starts the calibration process You must complete the calibration process within three minutes or the NBP module times out and will be out of calibration 1 Press the Calibrate soft key The message Apply 0 mmHg Select Next when ready is displayed 2 Release all of the pressure in the expansion chamber so that the manometer reads 0 mmHg 3 Press the Next soft key The message Apply 250 mmHg Select Next when ready is displayed 4 Increase the pressure so that the manometer reads 250 mmHg 5 Press the Next soft key If the calibration is successful the message Calibration complete Please perform the accuracy and leakage tests to check the results is displayed After several seconds the message clears an
135. forth to loosen it being careful not to damage the sheet metal 2 b When the fan is loose lift it off of the adhesive Figure 49 Replacing the Fan w 3 Peel the adhesive off of the sheet metal Make sure that all of the adhesive is removed Replacement 1 Clean the fan and the PCMCIA aluminum plate Wipe both the fan and the PCMCIA aluminum plate with 70 isopropyl alcohol and let them dry Do not touch the surfaces once you have cleaned them 2 Remove one side of the adhesive backing and secure it to the fan 121 3 Position the fan Position the fan so that the label on the fan s hub is facing the external data card guide and the 2 wire bundle is closest to the speaker microphone assembly The bottom of the fan contains the molded CE mark 4 Peel off the adhesives backing and install the fan between the 2 tabs on the PCMCIA sheet metal Press and hold the fan in place for 10 to 20 seconds to secure it to the PCMCIA aluminum plate Connect the fan cable to the Processor PCA 6 Close the device See Closing the case on page 176 After Repair Run Performance Verification and Safety testing as described in the Performance Verification chapter 122 Processor PCA The Processor PCA contains the device s operating software All Processor PCAs are American English part number 12NC 453563478461 5x5 M3535 68101 When you install a new Processor PCA you must also e Enter the device s seria
136. from the system power supply to high voltage alternating current The Backlight Inverter PCA is part of the Display assembly 241 Indicators The External Power LED is controlled by the Power PCA via a driver located on the Processor PCA The External Power LED is part of the Display assembly and is connected into the Processor PCA via flex circuits The Shock button backlight LEDs are mounted on the Processor PCA directly behind the Shock button and are controlled by the Processor PCA The Shock button backlight illuminates only when that button is active When using pads or switchless internal paddles the Shock button is active and lit when the device is charged and ready to deliver a shock When using external or switched internal paddles the Shock button is disabled and not lit the Shock buttons on the paddles are active instead RFU Indicator Displays the status of the device with an hourglass indicating the device is ready for use and a solid red X indicating a critical failure This indicator is visible even when the device is off Front Panel Buttons The Charge Shock Print and Sync buttons are mounted in the front case They operate by actuating four small switches mounted on the Processor PCA directly behind each button All of the buttons around the display Navigation Menu Select etc and the soft keys are part of a membrane keypad They are connected to the Processor PCA by flex circuits Presses from all
137. g remove speaker clean and replace speaker e Tighten hardware as needed e Replace speaker microphone assembly e Replace Processor PCA e Reload the language e Replace Processor PCA Voice prompt present but no Processor PCA failure e Replace Processor PCA tones Controls Problems Table 21 Controls Problems Possible Causes Suggested Solution One or more of the buttons near the Therapy Knob doesn t respond correctly Print Sync Charge or Shock One or more of the buttons around the display doesn t respond correctly softkeys Event Summary Mark Event Lead Select Alarm Pause Navigation Menu Select The Therapy switch doesn t respond correctly Processor PCA failure Failure in Display assembly Processor PCA failure Therapy switch defective Processor PCA failure e Run Controls test in Service Mode to confirm Check button pieces for mechanical operation Replace Processor PCA Run Controls test in Service Mode to confirm Check connections to Display assembly Replace Display assembly Replace Processor PCA Replace Therapy switch Replace Processor PCA Internal Memory Problems Table 22 Internal Memory Problems Possible Causes Suggested Solution Internal Memory Failure Patient data cannot be stored None Internal memory card is automatically message with a beep in internal memory because reformatted All data on the card is erased the
138. hanical Parts Front panel buttons 453563476711 M3535 69111 Theap Knob 453563476791 M3535 69116 External Data Card holder 453563476851 M3535 69119 Plastic shields 453563496431 M3535 69177 contains plastic shields for SpO PCA ribbon cable Power PCA rear case 221 6 Parts and Accessories Labels Labels There are 4 groups of labels that are available to order for the HeartStart MRx the Instruction label set the Hazardous Shock Warning label set the Branding label set and Speaker label The Connector label set the Product Version label and the Primary label are only available as part of field replacement kits Each set of labels is one sheet containing all the labels in that set Instruction Label Sets There is one Instruction Label set for each language This set includes labels for e AC power compartment e Battery compartments e DC In port e Network port e Therapy port e Therapy Knob e Service Warning e Warning labels for Paddle tray top of device e Instruction labels 1 and 2 for each side of the Paddle tray e Color ID labels for Paddle tray NOTE Fach Instruction label set includes a label for devices with pacing and a label for devices without pacing You must ensure that you place the correct label on the device Table 38 Instruction Label Sets Traditional Chinese M3535 69173 222 Hazardous Shock Warning Label Set The Hazardous Shock Warning Label set 12NC 453563492751 5x5 M3535 691
139. harges up to the new lower level At a higher energy setting the Therapy PCA charges the capacitor until the new level is reached If the requested charge is not used within the configured timeframe 30 60 or 90 seconds the Processor PCA automatically directs the Therapy PCA to disarm the capacitor as a safety precaution Delivering a shock The discharging cycle delivering a shock is initiated by any of the following three events e Pressing the front panel Shock button when using pads or switchless internal paddles The button is disabled when using external paddles or switched internal paddles This button press is then detected and processed by the Processor PCA e Simultaneously pressing the Shock buttons on both the external Sternum and Apex paddles These button presses are transferred from the buttons to the Therapy PCA via the paddles cable The Therapy PCA transfers the button press to the Processor PCA via a large ribbon cable The button press is then detected and processed by the Processor PCA e Pressing the Shock button on the switched internal paddles This button press is transferred from the button to the Therapy PCA via the paddles cable The Therapy PCA transfers the button press to the Processor PCA via a large ribbon cable The button press is then detected and processed by the Processor PCA In any case the Processor PCA directs the Therapy PCA to deliver the shock Patient resistance is derived from the curren
140. he ECG cable paddles audio and display functionality along with replicating the Weekly test Operational Checks also notify you if the battery NBP module or CO module need calibration At completion of the Operational Check the message Operational Check Passed is displayed if all of gt CC the tests pass If any test fails the message Non Critical Failure Critical Failure or Battery Failure is displayed depending upon the severity of the failed functionality You must fix the problem and successfully run the Operational Check to clear the failure Keep in mind the following points about the Operational Check e The Operational Check runs the Defib test on battery power to reflect optimal operating conditions for defibrillation The device automatically disconnects AC DC power e Perform the Defib Test for each type of patient Therapy cable used on the device multifunction defib pads external or internal paddles At the conclusion of the Defib Test you can attach another Therapy cable and repeat the test e The message In Progress is displayed as each test is run The test result pass or fail is displayed at the completion of each test See Table 4 on page 41 for a full explanation of each test e Use the test results to troubleshoot and repair the device e Clear the Status log after all errors have been addressed and the Operational Check passes See Status Log Errors on page 55 for
141. he Therapy Knob by turning it to each of the available settings and verifying that the value next to Therapy Knob on the display matches the knob position Turning the Therapy Knob to Off turns the device off Figure 83 Controls Test Service Screen 02 Mar 2003 10 52 A__ e SEVICE contRots test Mark Event Lead Select Soft Key 2 Soft Key 3 Soft Key 4 Alarm Pause Event Summary Up Arrow Down Arrow Menu Select Sync Therapy Knob Charge Shock Print Main Service 2 Softkey Pass Pass Pass Not Tested Not Tested Not Tested Not Tested Not Tested Not Tested Not Tested Pass Monitor Pass Pass Not Tested Softkey 3 Softkey 4 193 Printer Test The printer test checks printer parameters and prints test patterns to check the print head and the paper drive mechanism Perform the printer test at the configured speed of either 25 mm sec or 50 mm sec Start the Printer Test 1 Select Printer from the Service Mode Main menu and press the Menu Select button The printer prints a series of test patterns 2 Stop the printout Once the patterns have printed press the Print button to stop the printout Inspect the Test Patterns 3 Check the print quality Verify that the test patterns on the strip are as indicated in Figure 84 a Area A contains printouts of all characters and symbols Verify that they are readable b Check Area B for stray marks or lines c Chec
142. he test a Access the Service Mode Main menu as described in Accessing Service Mode on page 10 b Select NBP from the Service Mode Main menu Check 3 Pressurize the expansion chamber to approximately 280 mmHg 4 When the pressure stabilizes compare the displayed pressure reading to the pressure indicated by the manometer 5 Ifthe difference between the manometer and the displayed pressure is gt 2mmHg perform the steps in Calibrate the NBP Measurement on page 22 196 CO Calibration Check This check only needs to be performed if CO is installed The monitor defibrillator must be operating for at least 20 minutes prior to starting this test with the FilterLine connected to the CO Inlet port See Maintenance Tools and Equipment on page 18 for information on equipment needed to run the test Setup 1 Set up the calibration gas as shown in Figure 86 a Connect the 5 calibration gas to the CO Inlet port b Turn on the gas Figure 86 CO Noise and Calibration Check Setup M2267A M1920A 15210 64020 DN 10 N 15210 64010 5 End open to atmosphere 13907A 2 Start the test a Access the Service Mode Main menu as described in Accessing Service Mode on page 10 b Select CO from the Service Mode Main menu c From the CO Service menu select Calibration Check Check This tests the accuracy of the CO measurement and if needed adjusts the measurement to meet specificat
143. heck the device s repair history Step 11 11 Examine the device s repair history Some intermittent problems cannot be reproduced If the device was returned before for the same problem replace the most likely subassembly 12 Run the Service tests if needed Use the tests available in Service Mode to focus in on possible causes See Service Mode Tests on page 192 for more information 13 Repair any problems found Follow the procedures in the Repair chapter to replace defective parts or subassemblies When the repair is complete continue with Step 14 14 Verify the device s performance Use the procedures found in the Performance Verification chapter to verify that the device is operating properly Be sure the testing you perform is appropriate for the level of repair The requirements for testing are described in Required Testing Levels on page 180 46 Troubleshooting Flowcharts Figure 19 shows the parts of the device that are tested in each mode Use this chart to troubleshoot the device based on failures in some tests and not in others Figure 20 through Figure 24 show the troubleshooting steps for each state of the RFU Indicator Figure 19 Test Coverage Controls Software Firmware SW FW Analog A U Printer S 3 3 Q Q ze z 3 Nn aqqe9 uned User SW FW T E k T Electromechanical Display Module PCA Self Test n Speaker Automated Tests peo soL
144. ibration status to get updated See Operational Check on page 39 for instructions 31 3 Troubleshooting This chapter describes how to troubleshoot the HeartStart MRx monitor defibrillator Overview Here are the topics covered in this chapter Topic Page Troubleshooting Tools and Equipment 34 Obtaining Replacement Parts 34 Ready For Use Indicator 35 Automated Tests 36 Operational Check 39 Service Mode Tests 44 Troubleshooting Methodology 45 Troubleshooting Flowcharts 47 Troubleshooting Tables 53 33 Troubleshooting Tools and Equipment You need the following tools and equipment e Defibrillator Discharge Tool M2475 69573 Used to discharge the defibrillator capacitor e 50 ohm defibrillator test load grey plug connector M3725A e 50 ohm defibrillator test load white barrel connector M1781A Obtaining Replacement Parts See Parts and Accessories on page 211 for details on replacement parts 34 Oo ei Ready For Use Indicator The Ready For Use RFU indicator located on the upper right corner of the device reports the status of critical functions of the device as determined by the Automated tests These Automated tests run periodically while the device is turned off but has a power source and check the following critical functions of the device e defibrillation and cardioversion e pacing e pads paddles ECG e 3 lead 5 lead 12 lead ECG e battery The RFU indicator also reports failu
145. ied in the tables below The customer or the user of the HeartStart MRx should assure that it is used in such an environment 271 Ziz Table 44 Electromagnetic Emissions For devices with serial numbers USO01XXXXX RF emissions Group 1 The HeartStart MRx uses RF energy only for its CISPR 11 internal function Therefore its RF emissions are very low and not likely to cause interference in nearby electronic equipment RF emissions Class A CISPR 11 Harmonic Class A The HeartStart MRx is suitable for use in all emissions establishments other than domestic establishments IEC 61000 3 2 or those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes It may be used in domestic establishments if it is under the supervision of healthcare professional Voltage Complies fluctuations flicker emissions IEC 61000 3 3 l International standard IEC 60601 1 2 dated April 1993 allows for equipment to be operated in domestic locations if it is under the supervision of a healthcare professional Note that national authorities may apply whatever measures they consider necessary to protect radio communications This allowance will no longer apply to medical equipment being sold or put into service after 1 November 2004 For devices with serial numbers USOO2XXXXX RF emissions Group 1 The HeartStart MRx uses RF energy only for its CISPR 11 internal function Therefore it
146. if an ECG is displayed If the device recognizes the Therapy cable but still doesn t charge there may be a break in the Therapy cable Replace Therapy cable Run Controls test in Service Mode to confirm Replace Display assembly if needed Replace Therapy PCA Replace Processor PCA Replace Power PCA Replace Processor PCA Confirm by rotating Therapy Knob back and forth to check travel and alignment Run Controls test in Service Mode to test Therapy Knob Reinstall Therapy Knob if necessary Replace Therapy switch Replace Therapy PCA Replace Processor PCA 71 Table 16 Defibrillation Problems Continued Symptom Possible Cause Suggested Solution Charges too slowly e The device is being e Install a fully charged battery operated with AC DC power no battery or the battery power is low Battery not fully charged Install a fully charged battery or defective e Therapy PCA defective Replace Therapy PCA Won t Shock in Manual e Faulty paddles Confirm paddles problem by connecting Defib mode using Shock Pads and attempting to discharge device buttons on paddles using Shock button on the MRx Replace paddles if needed Problem with internal Check restore connections between connections Therapy port and Therapy PCA and between Therapy PCA and Processor PCA Therapy port defective Replace Therapy port Therapy PCA defective Replace Therapy PCA Failure on Processor PCA Replace P
147. iled e 8 digit error code for software errors for factory use e optional additional information about the error e device operating mode at the time of the error The status log can contain up to 50 entries with 25 being displayed on a single screen NOTE Clear the Status log after a successful Operational Check by pressing the Menu Select button from the Status log menu and selecting Clear Log To view the Status log 1 Access Service Mode See Accessing Service Mode on page 10 2 From the Service Mode Main menu select Status Log and press the Menu Select button 55 56 3 Press the Print Log soft key if you want to print the report Figure 25 Status Log Screen eK CS SEVICE status Loc 25 Apr 2003 10 50 Selftest NBP Module autotest 24 Apr 2003 15 15 Disconnect Failed 12LXmit Device 23 Apr 2003 8 15 Internal Fan Failure Fan Assembly service 22 Mar 2003 5 20 Communication NBP Module autotest 21 Mar 2003 11 00 Processor 5V Power PCA opcheck 20 Feb 2003 13 20 ECG Gain Accuracy Processor PCA service 19 Feb 2003 7 45 ECG Bias Processor PCA opcheck 18 Jan 2003 15 15 Main Software 0x00A00151 runtime 17 Jan 2003 2 25 No response 12LXmit Device 16 Jan 2003 2 24 Communication S p02 Module autotest 15 Dec 2002 18 18 Communication Sp02 Module autotest 14 Dec 2002 18 18 Communication Printer Assembly opcheck 13 Dec 2002 3 30 Communication Printer Assembly opcheck 12 Nov 2002 17 05 Main S
148. ing signals measuring observing behavior and recording results Safety tests which consist of connecting the MRx to a safety analyzer and measuring results The Performance Tests are sequenced to check more basic functions first and then build on that to check more complex functions We recommend you perform these tests in this sequence Topic Page Visual Inspection 191 Service Mode Tests 192 Functional Checks 200 Safety Tests 208 190 Visual Inspection A thorough visual inspection of the device should include at least the checks described below Check Cables Supplies and Accessories l Are they the right ones Sometimes a problem can be resolved simply by using the cables and supplies with which the device was designed to operate Are they the correct Philips models recommended for use with the HeartStart MRx or are they some other brand Are they all present The device should have An undamaged fully charged Philips battery A new dry roll of Philips printer paper Printer paper may jam if paper is wet Also the printer may be damaged if wet paper is allowed to dry while in contact with the printhead elements Cables and sensors which are approved by Philips and known to be good Also make sure that all external cables are fully inserted in their receptacles A new empty Philips data card 3 Are the consumables fresh Check the ECG electrodes and multifunction electrode pads for freshness d
149. ing the Operational Check are written to the Status log Use these messages to isolate the problem The Automated Test summary lists the results of past hourly daily and weekly tests and provides you with information on the device s history If no further troubleshooting is needed proceed to Step 13 to repair the device Otherwise continue with Step 8 45 8 Use the Troubleshooting tables to identify the problem Use the Troubleshooting tables to find information on messages and common troubleshooting issues If no further troubleshooting is needed proceed to Step 13 to repair the device Otherwise continue with Step 9 9 Interview the user Gather the external components If possible talk directly with the user who reported the problem Identify what they were doing when the problem occurred and exactly what happened What was on the display Were any sounds noticed Were there operational problems If possible obtain the cables paddles battery etc that were in use when the problem occurred and use them in your evaluation If no further troubleshooting is needed proceed to Step 13 to repair the device Otherwise continue with Step 10 10 Try to reproduce the problem Try to reproduce the problem using the Troubleshooting tables to identify the symptoms and possible solutions and perform any repairs indicated as in Step 13 If the problem cannot be reproduced an intermittent condition or operator error is likely C
150. ion tubing High Voltage Pads Cable Analog ECG 2 wires Pads Paddles Analog ECG Sensing Defib Pads a wirs Paddles joueg UOl4 ECG Cable Leads LED Ext lt ECG Signal Flow Power Keys Softkeys Menu Select mounted on Display Assembly mounted on Display Assembly Up Down Info Alarm Suspend Lead Select Therapy Switch j Buttons CHARGE SHOCK SYNC PRINT SHOCK Microphone Speaker RFU Indicator mounted on Processor PCA Backlight mounted on Processor PCA 4 wires ribbon cable PCMCIA card slot ECG Out 2 wires m flex circuit Analog ECG flex PMS a Control Data Power 50 pin ribbon cable Data Card slot Therapy Capacitor Battery PCA Y 0S g 0IS Video Data flex circuit Keys LED 2 flex 9 wires circuits Data Control o o Paddle g Tray Ld AC Power Module Li lon Battery Pack Functional Descriptions The following sections provide descriptions of the functions handled by each component Processor PCA The Processor PCA performs the following functions e Overall system control e High
151. ions 5 Calibration Check 1 Wait until the displayed CO value is stable 197 2 Calculate the expected CO reading which will depend on both the gas concentration you are using typically 5 0 and the ambient pressure Calculate as follows concentration of cal gas X ambient pressure expected CO value For example 0 05 X 736 mmHg 36 8 mmHg 3 Calculate the allowable tolerance which is 5 of the expected reading Calculate as follows 0 05 X expected CO value tolerance mmHg example 0 05 X 36 8 mmHg 1 8 mmHg In this example the reading displayed with 5 cal gas must be 36 8 mmHg 1 8 mmHg or between 35 0 mmHg and 38 6 mmHg 4 Compare the displayed CO value to the allowable range of values If the displayed value falls within the allowable range proceed to the 10 Calibration Check section below If the displayed value does not fall within the allowable range the CO measurement module needs to be calibrated Perform the steps under CO Calibration on page 30 then begin again at step 1 10 Calibration Check 1 Disconnect the 5 gas and regulator if needed and connect the 10 gas 2 Turn on the gas 3 Wait until the displayed CO value is stable 4 Calculate the expected CO reading which will depend on both the gas concentration you are using typically 10 0 and the ambient pressure Calculate as follows concentration of cal gas X ambient pressure expect
152. is organized into the following sections Topic Page Required Testing Levels 180 Verification Test Equipment 182 Test and Inspection Matrix 184 Performance Verification Procedures 190 179 Required Testing Levels The Performance Verification and Safety Tests in this chapter are intended to verify proper operation of the HeartStart MRx following repair The level of testing required corresponds to the type of repair performed and is divided into 3 categories e External repairs replacements e Printer replacement e Internal repairs External Repairs Replacements External repairs replacements are those involving the repair or replacement of one or more of the following items The key point is that the case has not been opened e Accessory pouches e Internal paddles and or adapter cable e Pads adapter cable e ECG cable e SpO cable e NBP cuff or interconnect tubing e AC or DC power modules e AC power cord e Therapy Knob e Paddle tray e Paddle tray 50 ohm load resistor The following tests are required after an External Repair or Replacement when the case has not been opened e Perform the Visual Inspection Visual Inspection on page 191 e Run the Operational Check Operational Check on page 192 e Print and Verify the Status log Service Mode Tests on page 192 e Therapy Knob only Run the Controls test see Controls Test on page 193 e Paddle tray and Paddle tray 50 ohm load resistor on
153. isconnect all external power and remove all batteries The primary and secondary labels which contain the model number serial number and options key are now visible 3 Record the model number serial number and options key s from the labels on the back case 128 Insert the AC power module or the battery charged to at least 20 and turn the Therapy Knob to Monitor The device powers up into Service Mode From the Service Mode Main menu select Device Info From the Device Info menu select Model Number Select the model number From the Device Info menu select Edit S N An alphanumeric menu is displayed Figure 53 Entering Serial Number 02 Mar 2003 10 52 A__ e Service pevice nro Model Number M3535A Serial Number Options Language American English Serial Number US00100_ Main Service Enter the serial number using the Navigation buttons to scroll through the letters and numbers Press the Menu Select button to complete each selection Select Cancel or backspace to cancel a selection Scroll through the list and select Done when you have finished entering the serial number 129 130 NOTE 10 From the Device Info menu select Options Key An alphanumeric menu is displayed Figure 54 Enabling Options 02 Mar 2003 10 52 A__ e Service pevice nro Model Number M3535A Serial Number US00100320 Options Sp0O2 CO2 NBP Language American English Options Key 1234567_
154. ith the standoffs on the Processor PCA As you push gently down the pins on the SpO PCA will connect to the Processor PCA 2 Replace the one T 10 screw in the left corner of the PCA 3 Connect the SpO PCA Connect the SpO flex circuit to the SpO PCA Make sure it slides in all of the way 4 Place the plastic shield over the SpO PCA and secure Replace and tighten the two I 10 screws 5 Close the case See Closing the case on page 176 After Repair Run Performance Verification and Safety testing as described in the Performance Verification chapter 116 Measurement Module Panel There are different measurement module panels depending on the options in the device Preparation 1 Open and separate the case See Opening the case on page 102 2 Position the front case Lay the front case on the work surface with the display facing down and the printer in the lower left corner Removal 1 Move the plastic shield from the SpO PCA a Loosen and remove the two T 10 screws b Lift up the plastic shield 2 Disconnect the measurement module panel a Disconnect the ECG connector cable from the Processor PCA by releasing the latches at the edges of the connectors 1 b Disconnect the SpO flex circuit from the SpO PCA 2 c Disconnect the modem wire if present from the measurement module panel 3 d Disconnect the ECG Out jack wire from the Processor PCA 4 3 Remove the standoff and wash
155. itor defibrillator is not connected to a patient when performing any function in Service Mode NOTE Make sure that you insert a battery charged to at least 20 into the device or connect external power when you are performing functions in Service Mode To access Service Mode l 2 3 Turn the Therapy Knob to Monitor Press the Menu Select button to display the Main menu Select Other From the Other menu select Service The message Leaving Normal Operating Mode Patient Monitoring is Off To return to Normal Operating Mode press the Exit Softkey appears Press the Menu Select button to acknowledge the message You are prompted to enter a password Enter the password 27689 by scrolling through the list until the desired number is highlighted Press the Menu Select button to activate each selection Select Done when you have entered all of the numbers The Service Mode Main menu is displayed as shown in Figure 6 Figure 6 Service Mode Main Menu 02 Mar 2003 10 52 A__ e ServICe man Service Operational Check Status Log m Service Software Upgrade Navigating in Service Mode Service Mode uses the same navigation controls as normal operating mode e To select a menu item use the Navigation buttons to highlight your choice then select that choice by pressing the Menu Select button e To exit Service Mode and return to clinical mode press the Exit Service soft key e To return to the Ser
156. ivity gt 90 for adult defibrillation Shockable Rhythm 300 Meets AAMI DF39 requirement and AHA Ventricular Tachycardia recommendation sensitivity gt 75 for adult defibrillation Non shockable Rhythm 250 Meets AAMI DF39 requirement specificity gt 95 and Normal Sinus Rhythm AHA recommendation specificity gt 99 for adult defibrillation Non shockable Rhythm 500 Meets AAMI DF39 requirements and AHA Asystole recommendation specificity gt 95 for adult defibrillation Non shockable Rhythm 600 Meets AAMI DF39 requirements and AHA All other non shockable recommendation specificity gt 95 for adult defibrillation rhythms a From Philips Medical Systems ECG rhythm databases b American Heart Association AHA AED Task Force Subcommittee on AED Safety amp Efficacy Automatic External Defibrillators for Public Access Use Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance Incorporation of New Waveforms and Enhancing Safety American Heart Association AHA AED Task Force Subcommittee on AED Safety amp Efficacy Circulation 1997 95 1677 1682 ECG and Arrhythmia Monitoring Inputs Up to four 4 ECG waves may be viewed on display and up to two 2 waves printed simultaneously Lead I II or III is obtained through the 3 wire ECG cable and separate monitoring electrodes With a 5 lead ECG cable leads aVR aVL aVF and V can also be obtained Pads ECG is obtained through
157. k for white lines printhead elements stuck off or black lines printhead elements stuck on Measure the Print Speed 4 Verify the print speed Measure between the long tick marks area C to verify paper speed Distance should be 25mm 5 1 25 mm if print speed is configured for 25 mm sec 50 mm 5 2 5 mm if print speed is configured for 5 0mm sec 194 Figure 84 Printer Test Output MAAMA A AAAA AAAA TAAA AAAA 195 NBP Calibration Check This check only needs to be performed if NBP is installed See Maintenance Tools and Equipment on page 18 for information on equipment needed to run the test NBP Safety Timeout Do not keep the cuff pressurized for more than 3 minutes The NBP module times out if the pressure is greater than 5mmHg for 180 seconds The valve opens and the pressure drops To reset the module exit Service Mode and press the Start NBP soft key The inop Cuff not deflated is displayed Access the NBP Service screen again to start the calibration Setup 1 Connect the NBP tubing to the NBP port on the monitor defibrillator and connect the test manometer and expansion chamber to the tubing Figure 85 NBP Test Setup Expansion Chamber Tubing To NBP port Manometer 2 Start t
158. l number and enable options using the Service Mode menus e Set the device s language if other than American English using the appropriate Software Support tool See Table 30 on page 214 for part numbers Removing the Processor PCA involves disconnecting many cables and removing many screws Take your time and be methodical Preparation 1 Save the configuration settings to a data card If possible save the customer s configuration settings to a data card so the configuration can be restored after the repair is complete See the ustructions for Use for information 2 Remove the data card tray 3 Open and separate the case See Opening the case on page 102 4 Position the front case Lay the front case on the work surface with the display facing down and the printer in the lower left corner Removal 1 Remove the SpO PCA See SpO PCA on page 115 2 Remove the measurement module panel See Measurement Module Panel on page 117 3 Disconnect all cables See Figure 50 on page 124 and Table 25 on page 125 The order in Table 25 begins with the left edge of the Processor PCA and then works around the front case in a clockwise direction 123 124 Figure 50 Processor PCA Connections Table 25 Processor PCA Connections No No RFU indicator Push out latch slide out flex ribbon cable Therapy switch Push on latch pull straight up 2 wire black twisted cable if RJ 11 telephone ja
159. lace Processor PCA ECG Cable Failure ECG Bias Replace ECG cable Pads Cable Failure Replace Pads cable Paddles Cable Failure Replace Pads cable Pads ECG Equip Failure NBP Equip Malfunction Pads Gain Pads Noise Pads 5V Pads PCI Paddles in Pockets Pads Impedance Pads Bias Replace Power PCA Replace Power PCA Replace Power PCA Replace Pads cable Power PCA Replace Pads cable Power PCA Replace Pads cable Power PCA Replace Power PCA Self test Replace NBP module SpO Equip Malfunction Self test Replace SpO module eee lenin apap wane 57 Table 6 Status Log Errors Continued Inop Status Log Error Status Log Error Error Suggested Solution CO Equip Malfunction Self test Replace CO module ee Gimin tasm OOO Printer Malfunction Selftest Replace printer AM miin O aae OOOO Incompatible Printer Unsupported language Printer The 50mm printer is in the device and the software is Assembly looking for the 75 mm printer Install the 75 mm printer in the device SW Watchdog Fail If recurring reload software and contact Response Center The following table lists additional actions to try if the suggested solution in Table 6 does not fix the problem Table 7 Additional Solutions nop Status Log Error Suggested Solution NBP Equip Malfunction Communication e Replace NBP module cable e Replace case interconnect ribbon cable e Replace Processor PCA SpO Equip Malfunction C
160. lace the NBP and CO module tray See NBP and CO2 Module Tray on page 152 160 NOTE You connect the NBP tubing when you put the case halves together See Internal Assemblies Front Case on page 107 4 Replace the Therapy capacitor See Therapy Capacitor on page 146 5 Close the case See Closing the case on page 176 After Repair Run Performance Verification and Safety testing as described in the Performance Verification chapter 161 CO Module NOTE There are two CO module kits Make sure that you order and install the correct module for your device Check the product version label under battery compartment B or print the device info to determine the device s product version See Rear case labels on page 15 or Printing the Device Information on p pag g page 16 for information on determining the devices s product version The NBP and CO modules are mounted onto a tray To replace either module you need to remove the tray first then replace the individual module If you are replacing the CO3 module only start with Preparation continue with Removing the CO Module on page 164 and Replacing the CO Module on page 166 and finish with After Repair If you are replacing the CO module and intake receptacle and internal tubing start with Preparation and follow the instructions all the way through to the end Preparation 1 Open and separate
161. layed Run Operational Check with ECG cable Acknowledge failure Yes message shock or pacing functions Run Operational Check Check Status log Yes Replace ECG cable Troubleshoot device using tables if necessary i Run ECG test without ECG cable ECG test passes Operational Check passes Yes Run Performance Verification tests Place device back in service 51 Figure 24 RFU Indicator Solid X No Chirp Solid X no chirp Check power source RFU displa Yes Hourglass no inops No No Device turns on Replace Processor PCA Device turns on Yes Run Operational Check Check Status log No Call Response Center Yes Troubleshoot device using tables if necessary Repair if necessary Run Performance Verification tests Place device back in service 52 Troubleshooting Tables The Troubleshooting tables provide information on messages and common troubleshooting issues NOTE Before replacing any components always run an Operational Check and check the Status log for errors Before replacing any parts check to see if all the cables and flex circuits are properly connected See Repair Notes on page 82 This section is organized into the following tables Topic Page Topic Page Audio Tones 54 Defibrillation Problems 70 Status Log Errors 55 Pacing Problems 70 Startup Errors 62 Printing Problems 74 General Probl
162. le the flex with bent tip needle nose pliers whose jaws are covered with a soft material such as plastic tubing or tape Internal Connections Whenever troubleshooting indicates a particular PCA may be at fault it is always good practice to check all the connections to that PCA and retest before replacing the PCA Cable and Assembly Placement How the wires and cables are routed and dressed inside the chassis plays an important role in two areas in preventing long term wear problems and in reducing electromagnetic and radio frequency interference emitted by the monitor defibrillator e When you disassemble any part of the device pay special attention to how cables and wires are routed e When you reassemble the device be sure to route and dress all cables and wires as they were originally e Return all components to their original position within the case Device Reassembly If you do not reassemble the device correctly it may no longer be properly sealed This could result in water damage to the device Be sure to maintain the water resistant seal by e Replacing all gaskets in their proper locations e Correctly assembling all parts that mate with gaskets making sure the gaskets are not wrinkled or pinched e Replacing all screws e Making sure that screws are not cross threaded and that they are firmly tightened e Tightening M3 screws to 6 inch pounds and M4 screws to 10 inch pounds 83 Disposal Prior to disp
163. lect No once all cables have been tested If prompted calibrate the battery See the Instructions for Use for details SpO gt Checks the internal SpO PCA None None The SpO cable is not tested NB CO Checks to see if the CO module is functioning determines if it is due for calibration P Checks to see if the NBP module is functioning determines if it is due for calibration None None None None Operational Check Report The Operational Check takes only a short time to complete When it is done a report is printed as shown in Figure 18 The first part of the report lists test results The second part lists checks to be performed by the user Figure 18 Operational Check Report Operational Check Report Current Test Results Model Number M3535A Display Test Pass NBP Test Pass Serial Number USD00123456 General System Test Pass CO2 Test Pass Options 12 Lead NBP SpO2 EtCO2 Pacer Audio Test Pass Printer Test Pass Ver B 03 00 Leads ECG Test Pass ECG Cable Pads Paddles ECG Test Pass Pads Current Operational Check Pacer Test Pass DD Mon YYYY HH MM SS Defib Test Pass External Paddles Battery Compartment A Test Pass Last Operational Check Battery Compartment B Test Pass DD Mon YYYY HH MM SS Pass Fail SpO2 Test Pass Qty Check List _ Defibrillator Inspection ___ CO2 FilterLine Comments ___ Cables Connectors ____ Paddles Pads ____ Monitoring Electrodes ____ Charged Batteries
164. licable HR arrhythmia SpO NBP and EtCO alarms Tone repeated every two seconds lower pitch then yellow alarm tone Cyan indicator message Lower pitched tone is repeated twice followed by a pause Cyan indicator message Tone occurring synchronously with QRS tone each heart beat 54 Charge button ic chirp Low battery or RFU failure Repeated periodically while the condition exists Continuous tone alternating pitch Device will shut down in one minute Philips Red Alarm Tone Generated while at least one red alarm is occurring 80 5 dB IEC Red Alarm Tone Generated while at least one red alarm is occurring 76 5 dB Philips Yellow Alarm Tone Generated while at least one yellow alarm is occurring 67 4 dB IEC Yellow Alarm Tone Generated while at least one yellow alarm is occurring 73 4 dB Philips Inop Tone Generated while at least one inop condition is occurring IEC Inop Tone Generated while at least one inop condition is occurring Status Log Errors The Status log includes entries for all errors logged during normal operating mode Automated tests Service and Configuration Mode and Operational Checks In some cases an inop also appears on the screen when in normal operating mode Non critical conditions such as low battery and calibration due are not listed in the Status log Each entry includes the e date and time of the error e most likely module or PCA that fa
165. lock connector M301A 05 10200 HeartStart Pads Adapter barrel connector Connects to M3507A pads connector cable Defibrillation Pads Pads Cables Adapters and Test Load gray flat connector Hands free Pads Cable plug style M3725A 50 ohm defibrillator test load plug connector M3508A 22 a Table 39 Supplies Continued External Paddles Standard External Paddles Water Resistant External Paddles Sterilizable External Paddles Internal Reusable Switched Paddles 7 5 cm Switched Internal Paddles 6 0 cm Switched Internal Paddles 4 5 cm Switched Internal Paddles 2 8 cm Switched Internal Paddles Internal Reusable Switchless Paddles 7 5 cm Switchless Internal Paddles e WN Q Oo NTP A on NNN AW ao dS gt gt gt M4743A lt Ziz aN HX oy N NIN N Hr oy aN NI gt gt gt X X 6 0 cm Switchless Internal Paddles 4 5 cm Switchless Internal Paddles 2 8 cm Switchless Internal Paddles Internal Paddles Adapter Cable Internal Disposable Switched Paddles Large Disposable Switched Internal Paddles 989803127131 Medium Disposable Switched Internal Paddles 989803127141 Small Disposable Switched Internal Paddles Internal Disposable Switchless Paddles JHBBE NINININI N ALAIA AIA Ooi BR OO NI gt gt gt S gt X X X X 9 OO 9 OO Oo pi NO N d NO i Large Disposable Switchless Internal Paddles 989803127161 9898031271
166. lty separating the halves remove the data card tray Place one hand with your fingers in the data card slot and grasp the therapy port with the other hand Pull the case halves apart while applying steady pressure until the seal starts to break This can sometimes take up to one minute Figure 38 Clamshell Open Case 104 Discharge the Therapy Capacitor WARNING Use extreme caution in the following steps Dangerous voltages may be present on components and connections Do not touch any components or connections until you are sure the capacitor is discharged 1 Position the rear case Stand the rear case up on its base with the large blue Therapy capacitor facing you 2 Using the Defibrillator discharge tool clip the hooked end onto the resistor that looks like a large staple on the Therapy PCA 1 3 Touch the other end of the discharge tool to the metal portion of the Therapy capacitor s red spade connector and hold in place for at least 5 seconds 2 Figure 39 Using the Discharge Tool 4 Once you make contact for at least 5 seconds the Therapy capacitor is now discharged NOTE The Therapy PCA prevents dangerous voltages from existing on the Therapy capacitor after the device is turned off If there are sparks or any other evidence of significant electrical current when you apply the discharge tool replace the Therapy PCA 105 Disconnect the Case Halves 1 Disconnect the case halves a Disconnec
167. ly Run the Paddle Safety Check see Paddles Safety Check on page 207 180 Printer Replacement The printer is accessible for replacement from the exterior of the device without opening the case If the printer was replaced and the case was not opened the following tests are required e Perform the Visual Inspection see Visual Inspection on page 191 e Run the Operational Check see Operational Check on page 192 e Run the Printer Test see Printer Test on page 194 e Print and Verify the Status Log see Service Mode Tests on page 192 Internal Repairs If the case was opened regardless of what else the repair involved all of the Performance Verification and Safety tests must be performed e Run the Performance Verification and Safety tests see Test and Inspection Matrix on page 184 and Performance Verification Procedures on page 190 181 Verification Test Equipment Table 28 lists the equipment needed to perform the Performance Verification and Safety tests and provides specifications for commercially available analyzers and simulators Test equipment is called out within each test procedure when needed Table 28 Verification Test Equipment ECG Simulator Leads Leads simulated 3 5 or 10 if 12 lead option installed Amplitude accuracy 2 Rate accuracy 2 ECG Simulator Pads Paddles Amplitude accuracy 2 Rate accuracy 2 Defibrillator Analyzer Waveform c
168. m Expiration Period 2 years Pressure 144 PSIG Volume 10L 12 Lead ECG Inputs With a 10 lead cable leads I II IHI aVR aVL aVF V C1 V C6 can be obtained All 12 Lead ECG waves can be viewed on the display simultaneously All 12 leads can be printed on the strip chart printer in 3x4 format Patient Data Storage Internal Event Summary The internal Event Summary stores up to 8 hours of continuous ECG waveforms and events per Event Summary with a maximum capacity of 60 Event Summaries or 62 megabytes of patient data whichever comes first Data Card Event Summary The Data Card stores up to 8 hours of continuous ECG waveforms and events per Event Summary with a maximum capacity of 60 Event Summaries or 62 megabytes of patient data whichever comes first Environmental M3535A Temperature 0 C to 45 C operating 20 to 70 C storage e Charging the battery at temperatures above 45 C may degrade battery life e Storing the battery for extended periods at temperatures above 40 C will reduce battery capacity and degrade battery life Humidity Up to 95 Relative Humidity e Printer paper may jam if paper is wet e Thermal Printer may be damaged if wet paper is allowed to dry while in contact with printer elements Altitude e Operating 0 to 15 000 ft 0 to 4 500 m e Storage 0 to 15 000 ft 0 to 4 500 m 259 Shock e Operating Half sine waveform duration lt 3 ms acceleration gt 145 g 1 time on all six fac
169. moving the Therapy PCA 4 Remove the Therapy PCA Grasp the Therapy PCA by the black square relays and lift the Therapy PCA straight up out of the rear case Replacement 1 Place the Therapy PCA into position a Position the PCA in the rear case lining the PCA up on the Therapy port side first b Line up the PCA holes with the threaded case posts Make sure there are no wires or cables caught underneath the PCA 2 Replace the screws Replace the 3 T 10 screws and tighten 156 3 Replace the standoffs Replace the 8 standoffs and tighten Note that on each standoff the two ends are different the end with the groove should be up 4 Replace the NBP and CO module tray See NBP and CO2 Module Tray on page 152 5 Connect the Therapy PCA Refer to Figure 67 on page 155 and Table 27 on page 155 The connections may be replaced in any order The order in Table 27 begins with the left edge of the Therapy PCA and then works around the Rear Case in a clockwise direction 6 Replace the Therapy capacitor See Therapy Capacitor on page 146 7 Replace the Power PCA See Power PCA on page 148 Figure 69 Replacing the Therapy PCA 8 Close the case See Closing the case on page 176 After Repair Run Performance Verification and Safety testing as described in the Performance Verification chapter 157 Therapy Port Preparation 1 Open and separate the c
170. n Discharge yourself to a conductive metal surface which is connected to earth ground before making connections or touching the marked connector All staff using the HeartStart MRx should be instructed on these precautionary measures in order to avoid damage to this sensitive medical equipment The EMC standards state that manufacturers of patient coupled equipment must specify immunity levels for their systems See Tables 44 through 47 for this detailed immunity information See Table 48 for recommended minimum separation distances between portable and mobile communications equipment and the HeartStart MRx Immunity is defined in the standard as the ability of a system to perform without degradation in the presence of an electromagnetic disturbance Degradation in ECG quality is a qualitative assessment which can be subjective Caution should therefore be taken in comparing immunity levels of different devices The criteria used for degradation is not specified by the standard and may vary with the manufacturer For additional information about compliance with the EMC standards and the Declaration of Conformity Statement please see the Philips Medical web site at http powerstation medical philips com Select the Business Data Viewer Tab and then select the Declaration of Conformity link listed under Regulatory Guidance and Manufacturer s Declaration The HeartStart MRx is intended for use in the electromagnetic environment specif
171. n page 146 9 Close the case See Closing the case on page 176 After Repair Run Performance Verification and Safety testing as described in the Performance Verification chapter 153 Therapy PCA Preparation 1 Open and separate the case See Opening the case on page 102 2 Position the rear case Lay the rear case on the work surface with the PCAs facing up and the Therapy port on the right 3 Remove the Power PCA See Power PCA on page 148 4 Remove the Therapy capacitor See Therapy Capacitor on page 146 5 Remove the NBP and CO module tray See NBP and CO2 Module Tray on page 152 NOTE If the device does not have the NBP or CO modules simply unscrew the tray and slide it out Removal 1 Disconnect all cables See Figure 67 and Table 27 on page 155 The connections may be removed in any order The order in Table 27 begins with the top of the left edge of the Therapy PCA and then works around the Rear Case in a clockwise direction 154 Figure 67 Therapy PCA Connections 4 Ge Q a 7 K3 G TMZ Ribbon cable Processor PCA Release latches at edges of connector pull plastic shield Close latches to remove plastic shield 10 wire bundle NBP module Push on latch to release pull wiggle 155 2 Remove the screws Loosen and remove the 3 T 10 screws 3 Remove the standoffs Loosen and remove the 8 5 16 inch hex standoffs Figure 68 Re
172. n printhead according to procedures in the Instructions for Use Operating temperature is Wait until temperature is back in beyond specified range Operating range to continue printing Printer failure Replace printer Paper moves but print Dirty printhead Clean printhead according to procedures quality poor or some dots in the Instructions for Use missing Printer failure Replace printer Waveforms or text distorted Printer failure Replace printer even though they look OK on display Black line running along Dots printhead elements paper stuck on due to Printer failure Replace printer White line running along Dirt on printhead e Clean printhead paper Dots printhead elements stuck off due to e Printer failure Replace printer Fails Printer Test in Service Printer failure Replace printer Mode other than symptoms above Processor PCA failure Replace Processor PCA Incompatible Printer The 50mm printer is in Ensure that the 75 mm printer is installed the device and the in the device software is looking for the 75 mm printer 74 Display Problems Table 19 Display Problems Symptom Possible Causes Suggested Solution Display completely dim No Failure of backlight e Check cable between Processor PCA and response all light or all inverter dark Check display and backlight connections Display failure Replace Display assembly No power supply or Replace Power PCA o
173. n test includes low energy internal discharges If a 3 5 or 10 lead ECG cable is attached the cable is tested as well Weekly Sunday between 11 00 Performs a Daily Test plus delivers a high energy internal PM and 1 00 AM discharge to exercise the entire defibrillation circuitry Automated tests do not test the therapy cables paddles buttons audio or the display An ECG cable is tested if connected at the time of the test Automated Test Summary 36 An Automated Test Summary ATS showing the results of recent tests may be viewed or printed as evidence that the HeartStart MRx is tested regularly To run the ATS 1 Turn the Therapy Knob to Monitor 2 Press the Menu Select button 3 Using the Navigation buttons select Other and press the Menu Select button 4 Select Operational Check and press the Menu Select button The message Leaving Normal Operating Mode appears to let you know that you are exiting from clinical functionality of the device 5 Using the Navigation buttons select Auto Test Summary and press the Menu Select button The Automated Test Summary is displayed 6 Press the Print soft key to print the report A io Bile R Mor mS En ass IND Ea The report shows the results of the most recent hourly test the daily tests that have run since the last weekly test and the last 53 weekly tests Test results are reported as described in Table 3 Figure 16 Automated Test Summary S
174. ndary power source and for continual battery charging The HeartStart MRx performs Automated Tests on a regular basis The status of the device s critical functions are reported to the Ready For Use RFU indicator Prominently displayed the RFU indicator communicates the status of your device letting you know if it is operating correctly needs attention or is unable to deliver therapy In addition performing the specified Operational Check ensures that the HeartStart MRx is functioning properly The HeartStart MRx automatically stores critical event data in its internal memory such as Event Summaries and 12 Lead Reports The HeartStart MRx also enables you to copy data and event information on an optional external data card for downloading to Philips data management solution HeartStart Event Review Pro The HeartStart MRx is highly configurable to better meet the needs of diverse users Be sure to familiarize yourself with the device s configuration before using the HeartStart MRx Tour of the Device This section gives an overview of the outside of the device Figure 1 Front view External Power Indicator Synchronized Cardioversion Sync button a ee A Ready For Use RFU Tp a Ss B Indicator X e V n J N Hie Mark Event g a Therapy Knob Lead Select CHARGE button button SHOCK button Display Printer Printer door Printer door latch Print button DOO a 2O
175. nect the four wire connector to the Processor PCA 5 Close the case See Closing the case on page 176 After Repair Run Performance Verification and Safety testing as described in the Performance Verification chapter 112 Internal Memory Card The internal memory card resides in the PCMCIA slot on the Processor PCA The internal memory card can be removed without removing any other front case assemblies Preparation 1 Open and separate the case See Opening the case on page 102 2 Position the front case Lay the front case on the work surface with the display facing down and the printer in the lower left corner Removal 1 Remove the shoulder screw 1 Loosen and remove the T 10 shoulder screw on the Processor PCA 2 Stand the front case up with the display facing away from you 3 Remove the internal memory card a Press the black eject button 2 b Pull the card out Figure 44 Removing the Internal Memory Card IID NN Replacement 1 Insert the internal memory card into the PCMCIA slot closest to the Processor PCA a Align the card so that the CE label is facing the Processor PCA b Push the card into the slot as far as it can go 2 Replace the shoulder screw 113 3 Close the device See Closing the case on page 176 NOTE Make sure that you set the device s configuration values to the institution s settings See the Configuration chapter in the Instructions
176. ng the device as needed See Troubleshooting on page 33 Setup 1 Insert a battery charged to at least 20 and disconnect the AC power cord 2 Connect the Pads cable to the MRx 3 Connect the defibrillator analyzer to the Pads cable 4 Turn the Therapy Knob on the MRx to Pacer 5 Set Pacer mode to Fixed Test Pacing 1 Generate a fixed pacing waveform on the MRx for 70 ppm 30mA c Pressthe Pacer Rate soft key and use the Navigation buttons to set the rate to 70 ppm d Pressthe Pacer Output soft key and use the Navigation buttons to set the rate to 30mA e Pressthe Start Pacing soft key 2 Check the default output on the defibrillator analyzer a The output should read 70 ppm and 30mA 5mA 3 Test the maximum output by generating a fixed pacing waveform on the MRx for 180 ppm 160 mA a Press the Pacer Rate soft key and use the Navigation buttons to increase the rate to 180 ppm b Press the Pacer Output soft key and use the Navigation buttons to increase the output to 160 mA 4 Check the output on the defibrillator analyzer The output should read 180 ppm and 160 mA 16 mA 205 Synchronized Cardioversion Test This section describes how to check the synchronized cardioversion function WARNING Whenever possible we recommend that clinicians perform synchronized cardioversion procedures while directly monitoring the patient through the HeartStart MRx s electrodes or lead inputs If
177. nly if display is all power supply failure dark Processor PCA failure Replace Processor PCA Left or right half of display is Backlight cable Reseat the connector dim or display is not disconnected from uniformly bright inverter PCA Backlight bulb failure Replace Display assembly Fails Display Test in Display failure Replace Display assembly Operational Check Display Processor PCA failure Replace Processor PCA problem other then symptoms above Audio Problems Table 20 Audio Problems Symptom Possible Causes Suggested Solution No audio at all e Speaker failure e Check speaker connections e Replace speaker microphone assembly Processor PCA failure e Replace Processor PCA Audio is distorted Damage to speaker cover Replace speaker label Speaker damage or e Replace speaker microphone assembly failure Processor PCA failure e Replace Processor PCA 75 Table 20 Symptom Buzzing noise when audio active Tones present but no voice prompt in AED Mode Audio Problems Continued Possible Causes Suggested Solution e Damage to speaker label Debris between speaker and speaker label Speaker hardware loose Speaker failure Processor PCA failure Software error or failed localization upgrade Processor PCA failure e Replace speaker label e Remove speaker label clean out debris install new speaker label If debris is behind plastic housin
178. nsmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the HeartStart MRx is used exceeds the applicable RF compliance level above the HeartStart MRx should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the HeartStart MRx d Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 27 276 Table 47 Electromagnetic Immunity Nonlife Supporting Functions Portable and mobile RF communications equipment should be used no closer to any part of the HeartStart MRx including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation Distance Conducted RF 3 Vrms IEC 61000 4 6 150 kHz to 80 MHz d l 24 P Radiated RF 3 V m IEC 61000 4 3 80 MHz to 2 5 GHz d 1 2 P 80 MHz to 800 MH a 2 34 P 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter s specified output power and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following sym
179. nt tracking 230 Internal repairs required testing levels 181 K Key components tracking 85 tracking table 229 L Labels ordering replacement 222 removing and replacing 91 M Manual Defib Mode 2 Measurement module panel ordering replacement 217 repair 117 Menus how to display 8 Model number entering 129 Monitor Mode 2 N NBP and CO module tray repair 152 NBP module calibration 19 disconnecting tubing 106 functional description 247 ordering replacement 216 repair 160 troubleshooting 66 O Opening the case 102 Operational Check report 43 running 39 summary 44 tests 41 Options enabling 128 key 130 P Pacer Mode 2 Pacer test 205 Pacing functional description 246 troubleshooting 73 Paddle tray ordering replacement 220 repair 95 Paddles functional description 242 key component tracking 230 ordering replacement 219 safety check 207 Pads cables key components tracking 231 Passwords Configuration Mode 8 Service Mode 8 Patient impedance functional description 244 PCAs ordering replacements 215 PCMCIA hole plug ordering replacement 216 repair 109 Performance Verification Functional Checks 200 safety tests 208 Test and Inspection matrix 184 test equipment 182 Visual Inspection 191 Plastic shields ordering replacement 221 Power PCA functional description 240 key component tracking 229 ordering replacement 215 repair 148 Power supply capacitors discharging 102
180. ntinued Pads Cable page 209 Source Normal Condition hhh Source Single Fault Condition open earth open neutral iii With Mains on applied part lt 5000 uA Single Fault condition jjj then Patient Lead Leakage Safety test passes Note When recording test results separate results within a test by slashes separate tests by a semicolon and use no empty spaces For example V x OC x SL x C x Prix NC x CO x Sp x E x NM xP x SC x DA x DB x D x Pa x S1 p aaa bbbb S2 p cc dd S3 p eee ftt gge hhh 1ii jjj V p OC p SL p C p Pr p NC p CO p Sp p E p NM pP p SC p DA p DB p D p Pa p S1 p 125 800 S2 p 99 299 S3 p 9 49 49 100 500 5000 189 Performance Verification Procedures This section gives instructions for performing inspections and running Performance Verification and Safety tests on the HeartStart MRx If desired you can make copies of the Test and Inspection Matrix page 184 and use it to record results The Performance Verification procedures are divided into two levels e Visual Inspection examining for damage wear contamination e Performance Verification and Safety tests consist of the following tests and checks Service Mode tests including Operational Check which consist of running the device in Service Mode applying signals measuring observing behavior and recording results Functional checks which consist of running the device in its normal operating mode apply
181. ode also allows you to view and print the status log check and enter device information such as serial number and options and upgrade the software and set the device s language CAUTION Be sure that the monitor defibrillator is not connected to a patient when performing any functions in Service Mode Operational Check 192 NOTE TIP Operational Checks should be performed at regular intervals to supplement the hourly daily and weekly Automated Tests executed by the MRx Automated Tests provide adequate assurance that the device is in a functional state of readiness Operational Checks supplement the Automated Tests by verifying therapy cables the ECG cable paddles audio and display functionality along with replicating the Weekly test Operational Checks also notify you if the battery NBP module or CO module need calibration Always run an Operational Check and check the Status log after a repair Run the Operational Check 1 Attach a Pads or Paddles therapy cable 2 Attach an ECG cable 3 Insert a battery charged to at least 20 4 Access Service Mode see Accessing Service Mode on page 10 5 From the Service Mode Main menu select Operational Check and press the Menu Select button You can run Operational Check from the Other menu in Monitor Mode or from the Service Mode Main menu the Operational Check is the same in both modes When you exit the Operational Check from Service Mode you are return
182. oftware 0x00C 00082 runtime 11 Oct 2002 11 11 ECG 5V Processor PCA autotest 10 Oct 2002 7 25 Configure Failed 12LXmit Device 9 Oct 2002 5 23 Main Software 0x00C00082 runtime 8 Oct 2002 4 23 Selftest NBP Module autotest 7 Oct 2002 4 23 Communication Sp02 Module autotest 6 Oct 2002 4 23 Selftest Printer Assembly autotest 5 Oct 2002 5 23 Pads Noise Processor PCA autotest 4 Oct 2002 5 15 DSP Communication Processor PCA autotest 3 Oct 2002 3 25 Pads Noise Processor PCA autotest 2 Sep 2002 1 20 Selftest CO2 Module opcheggg OVE PI COMAOA SEN Status Log Main Prev Next Print Clear Log Service Page Page ZE xit Table 6 Status Log Errors Status Log Error Suggested Solution Internal Fan Failure Replace Fan assembly Inop Power Supply Failure Processor 5V Therapy 5V Therapy 5V V Standby 12V Supply 3V Supply 3V Standby Ground Voltage Replace Processor PCA Replace Therapy PCA Replace Power PCA Replace AC DC power module Replace Power PCA Replace Power PCA Replace Power PCA Replace Processor PCA Replace Processor PCA Shock Equip Malfunction Charge Shock Failure Replace Therapy PCA Pacing Failure Replace Therapy PCA Pacer Equip Malfunction Pacing Failure Replace Therapy PCA ECG Equip Malfunction ECG Gain ECG Noise ECG 5V ECG Front End Failure ECG Bias Replace Processor PCA Replace Processor PCA Replace Processor PCA Replace Processor PCA Rep
183. ommunication e Replace measurement module panel e Replace Processor PCA Selftest e Replace Processor PCA CO Equip Malfunction Communication e Replace CO module ribbon cable e Replace case interconnect ribbon cable e Replace Processor PCA Printer Malfunction Communication e Replace printer data cable e Replace Processor PCA The following table lists the messages and corresponding 12 lead transmission errors that can appear in the status log For additional information on 12 lead transmission implementation see the 12 Lead Transmission Implementation Guide M3536 90900 58 Error Message Transmission Settings Have Not Been Configured No transmission devices detected Transmission Failed Error configuring transmission device No Dial tone Table 8 12 Lead Transmission Status Log Errors Status Log Error Possible Causes Suggested Solutions Missing settings The Hub information Modify the Hub Configuration settings on the 12LXmit Config settings are not correct MRx as needed No response 12LXmit Device The cell phone is not Check that the phone is connected to the serial cable and that the serial cable is connected to the RS232 port on the MRx For some phones it may be necessary to disconnect the cable and reconnect it before each transmission connected properly The cell phone s RS232 port is not configured correctly Work with your cell phone provider to enable the RS232
184. ompatibility Meets all specs below using biphasic truncated exponential waveform Masi ene Energy measurement accuracy lt 20 J s 0 4 joules gt 20 J lt 2 of reading Cardioversion measurement range 150 to 150 ms Test Load es Load resistance 50 Q 1 non inductive Pacer tester Load impedance lt 400 Q Current measurement accuracy 10 mA 50 mA lt 2 mA 50 mA 200 mA lt 4 Rate measurement accuracy 30 180 ppm lt 0 5 Waveform duration measurement 30 180 ppm 1ms accuracy NBP Tester Pressure range gt 280 mmHg Pressure measurement accuracy ImmHg 182 Table 28 Verification Test Equipment Continued CO Tester ee Flowmeter 0 1 ml min 5 calibration gas 5 CO 0000001 balance N 10 calibration gas 10 CO 0000001 balance N Pressure regulator Safety Tester Leakage current measurement range 0 5000 uA Leakage current measurement 1 accuracy 183 Test and Inspection Matrix Table 29 summarizes Performance Verification tests and inspections for the HeartStart MRx Table 29 Test and Inspection Matrix Visual Inspection V Inspect the device accessories cables etc for signs of wear damage corrosion or missing items as described on page 191 Service Mode Tests Operational Check OC Run the Operational Check page 192 Status log SL Check the status log after the Operational Check page DD Run test to check buttons
185. ons equipment Table 48 Recommended Separation Distances Rated Maximum Output 150 kHZ to 800 MHz 800 MHz to 2 5 GHz Power of Transmitter W d 1 2VP d 2 34 P For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined 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 s manufacturer At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 277 Waveforms 200 Biphasic Waveform into 25 Ohms Voltage Vv in pom Lom en 3 0 Time ms 200 Biphasic Waveform into 50 Ohms Voltage v in cc mm 5 0 Time ms 278 200 Biphasic Waveform into 75 Ohms u H 200J Biphasic Waveform into 100 Ohms Voltage v 279 200J Biphasic Waveform into 125 Ohms u H 200 Biphasic Waveform into 150 Ohms Voltage v 280 200J Biphasic Waveform into 175 Ohms S S00 175mA4 Pacing Pulse into 100 Ohm Load pot E a PA ft ty if tt l pf 281 50 ohm load resistor ordering replacement 216 repair 98 A AC Power module functional description 240 key component tracking 231 ord
186. osal remove the batteries Then dispose of the device in accordance with your country s regulations for equipment containing electronic parts WARNING Properly dispose of or recycle depleted batteries according to local regulations Do not puncture disassemble or incinerate batteries Be careful not to short the battery terminals because this could result in a fire hazard WARNING Disposal of the device with the battery inserted presents a potential shock hazard WARNING To avoid contaminating or infecting personnel the environment or other equipment make sure you disinfect and decontaminate the monitor defibrillator appropriately prior to disposal Disposing of Empty Calibration Gas Cylinders To dispose of empty calibration gas cylinders 1 Empty the cylinder completely by pushing the pin of the regulator valve or by pulling out the pin of the fill wave using a tire valve stem wrench or a pair of needle nose pliers 2 When the cylinder is empty either remove the valve stem from the fill or regulator hole or drill a hole in the cylinder 3 Write Empty on the cylinder and dispose of it appropriately for scrap metal WARNING Ensure that the cylinder is completely empty before trying to remove the valve stem or drill the tank Repair Tools and Equipment The following tools are needed to perform the procedures in this chapter e Torx T10 and T15 drivers or Torx driver kit part number 5181 1933 T
187. ose tubing connection 1 From the CO Service menu select Pump Check 2 Follow the instructions on the screen to perform the Pump check 3 The difference between the cell pressure displayed and the ambient pressure should be more than 120 mmHg If the pressure reading is correct difference gt 120 mmHg the device passes the pump test If the pressure reading is incorrect it indicates the pump is defective regardless of the number of hours it has run and the CO module must be replaced See CO Module on page 162 27 Flow Rate Check 1 From the CO Service menu select Flow Rate Check 2 Follow the instructions on the screen to perform the Flow Rate check NOTE Be sure there are no kinks pinches or obstructions in any of the tubing this can create a restriction that will diminish the flow rate and cause a false failure of this test 3 If the flow rate is within the tolerance limit 50 ml min 7 5 ml min the test passes If the flow rate is not within the tolerance limit proceed to Step 4 to calibrate the flow rate 4 Use the Navigation buttons to increase and decrease the flow until it is as close as possible to 50 ml per minute as indicated on the flowmeter gauge 5 When you are satisfied that the flow is set as close as possible to 50 ml press the Store Flow soft key to confirm the setting If the adjusted flow is not stored within 60 seconds of the adjustment the old flow setting is restored NOTE Ifthe fl
188. ow cannot be adjusted to within tolerance the CO module must be replaced See CO Module on page 162 Noise Check This test looks for noise on the CO signal due to deterioration of the IR source 1 From the CO Service menu select Noise Check 2 Set up the calibration gas as shown in Figure 15 a Connect the 5 calibration gas to the CO Inlet port b Turn on the gas Figure 15 CO Noise and Calibration Check Setup M2267A M1920A 15210 64020 an 10 N 15210 64010 5 End open to atmosphere 13907A 3 Follow the instructions on the screen to perform the Noise check 4 Wait until the displayed CO value is stable Check the noise index reading 28 5 If the noise index exceeds 3 mmHg the CO module must be replaced See CO Module on page 162 Calibration Check This tests the accuracy of the CO measurement and if needed adjusts the measurement to meet specifications 1 The monitor defibrillator must be operating for at least 20 minutes prior to starting this test with the FilterLine connected to the CO Inlet port 2 From the CO Service menu select Calibration Check 3 The CO Calibration screen is displayed 5 Calibration Check 4 Set up the calibration gas as shown in Figure 15 a Connect the 5 calibration gas to the CO Inlet port b Turn on the gas 5 Wait until the displayed CO value is stable 6 Calculate the expected CO reading which depends on both the gas conc
189. ower PCA and then works around the rear case in a clockwise direction Figure 653 Power PCA Connections G amp LLLOLYL Table 26 Power PCA Connections pase K 6 wire bundle Therapy PCA Push on latch to release pull wiggle 8 wire bundle Battery Connector PCA Gently pull wiggle Note Be careful not to break off the tabs N 1 Blt nee a a vire bunde DC Power Connector Push on hatch ese pal B__ Avinehunde rheng PCA Paskon ack oree pal 8 evire bunde PCMCIA holeplug Push on ach kee pal C ribbon cable Processor PCA Release latches at edges of connector pull plastic shield Close latches to remove plastic shield 9 wire bundle Therapy PCA Push on latch to release pull Remove the large plastic shield ef o 2 Remove the 5 screws and plastic shield and place to the side You will need to replace this when you install the new Power PCA 3 Remove the screws Loosen and remove the 3 remaining T 10 screws 149 4 Remove the Power PCA Lift the Power PCA straight up out of the rear case Figure 64 Removing the Power PCA p N rt E E ET OSE NY NEE fN oe A Sa YY Replacement TIP It may be easier to connect cables 8 and 7 with the accompanying plastic shield before the Power PCA is placed in the case 1 150 Place the Power PCA into position Position the PCA in the rear case lining up its holes with the threaded standofts Make sur
190. per motor accordingly It senses when the paper is out or the door is left open Printing The Printer Connector PCA provides e Printhead power from the Power PCA e Serial communications and logic power from the Processor PCA to the printer module The Printer Connector PCA is an interconnection PCA only and has no active circuitry All printing of data is handled by the Processor PCA Waveforms graphics numeric values and messages are all generated and formatted by the Processor PCA using either data it has or data it receives from other parts of the device This data is then passed to the Printer Connector PCA in serial digital messages via al0 wire bundle and then on to the printer Contrast The printing contrast is controlled automatically by the printer itself The printer module senses printhead supply voltage temperature and impedance and adjusts drive voltage to the printhead and thus contrast based on these readings Out of Paper Door Open The printer also incorporates an optical sensor that detects when there is no paper left or when the printer door is open The information is passed to the Processor PCA in serial digital messages via the Printer Connector PCA and the10 wire bundle and the Processor PCA generates the appropriate screen message and tones to alert the user ECG Monitoring Functions Leads ECG There are two separate ECG front ends one for signals coming in on the paddles or pads cable and one
191. power and d is the recommended separation distance in meters m gt Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol o At 80 MHz and 800 MHz the higher frequency range applies These guidelines my not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz and 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz gt The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in these frequency ranges 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 tra
192. r waveform for all Leads and Pads 2 Check the Heart Rate HR Verify that the Heart Rate HR displayed is correct 3 Check the alarms a Verify that the heart rate alarm is sounding assuming that 30 bpm is below the configured lower limit b Set the simulator to 60 bpm c Verify that the heart rate alarm stops 201 4 Check Leads Off a Using the Lead Select button select Pads or Paddles b Disconnect the ECG simulator from the Therapy cable and verify that the display shows a dashed line in place of the waveform and that the device sounds an alert and displays the Pads Off message c Ifyou are testing a 3 lead cable use the Lead Select button to select Lead II NOTE Ifyou are testing anything other than a 3 lead ECG cable make sure an ECG waveform appears in Wave Sectors 1 and 2 d Ifyou are testing a 5 lead cable select the V or V C lead depending on the electrode configuration e Disconnect each of the ECG electrodes from the simulator one at a time and verify that the display shows a dashed line in place of the waveform when that electrode is disconnected Verify that the device sounds an alert and displays the Leads Off message 5 Repeat the above test setting the simulator for normal sinus rhythm NSR 1mV amplitude at 200 bpm 6 Verify that the heart rate alarm sounds assuming that 200 bpm is above the configured upper limit Check ECG printing 1 Reconnect the simulator Connect
193. rd Problems Th 4 Repair 79 Overview 79 Who Should Perform Repairs 80 Repair Philosophy 80 Calling for Service 81 Repair Notes 82 Safety Precautions 82 Flex Circuit Connections 82 Flex Circuit Handling 83 Internal Connections 83 Cable and Assembly Placement 83 Device Reassembly 83 Disposal 84 Disposing of Empty Calibration Gas Cylinders 84 Repair Tools and Equipment 85 Key Components 85 External Assemblies 86 Accessory Pouches 87 Bedrail Hook Mount 89 Therapy Knob 90 Labels 91 Printer Assembly 93 Paddle Tray 95 Paddle Tray 50 ohm Load Resistor 98 Handle and Cap Plate 100 Opening the case 102 Discharge the Power Supply Capacitors 102 Separate the Case 102 Discharge the Therapy Capacitor 105 Disconnect the Case Halves 106 Internal Assemblies Front Case 107 Overview of Front Case 108 PCMCIA Hole Plug 109 Speaker and Microphone Assembly 111 Internal Memory Card 113 SpO PCA 115 Measurement Module Panel 117 Therapy Switch 119 Fan Assembly 121 Processor PCA 123 Clock Battery 132 Printer Connector PCA 133 Display Assembly 135 Ready For Use Indicator 138 Front Panel Buttons 140 Front Case Assembly 141 Internal Assemblies Rear Case 144 Overview of Rear Case 145 Therapy Capacitor 146 Power PCA 148 NBP and CO2 Module Tray 152 Therapy PCA 154 Therapy Port 158 NBP Module 160 CO Module 162 CO2 Compartment Door 167 Battery Connector PCA 169 Rear Case Assembly 174 Closing the case 176 5 Performance Verification 1
194. res in critical functions detected at run time during an Operational Check and during Service Mode tests Always check the RFU indicator when troubleshooting the device Automated test failures of non critical components such as the NBP SpO CO3 and printer modules are not reflected in the RFU indicator but are reported through inops when the device is turned on The RFU indicator displays the status of the device using the following definitions Table 1 RFU Indicator Status Blinking black hourglass Shock pacing and ECG functions are ready for use and sufficient battery power is available Blinking red X with or Low battery or no battery The device Charge the battery as soon as possible and or without a periodic chirp can be used but run time is limited replace the battery with a charged battery Chirping indicates the battery is not Charging may be done in the HeartStart MRx being charged No chirping indicates the by connecting to AC DC power or in a battery is being charged Philips approved battery support system Solid red X and a A failure has been detected that prevents Turn the Therapy Knob to Monitor A message periodic chirp the delivery of a shock pacing or ECG__ describing the failure is displayed Begin acquisition troubleshooting as described in Troubleshooting Methodology on page 45 Note The device displays the message for the first critical failure that is detected To
195. rocessor PCA Won t Shock in Manual Failure of front panel Run Controls test in Service Mode to see if Defib mode using Shock button button is operating Replace Display button on MRx assembly if needed Therapy PCA defective Replace Therapy PCA Failure on Processor PCA Replace Processor PCA Wont Shock in AED mode Failure of front panel Run Controls test in Service Mode to when Shock button pressed button confirm Therapy PCA defective Replace Therapy PCA Failure on Processor PCA Replace Processor PCA Doesn t deliver correct Therapy PCA defective Replace Therapy PCA energy into defibrillator analyzer or delivers no energy at all Shock Equip Malfunction error is displayed Failure on Processor PCA Replace Processor PCA 72 Table 16 Defibrillation Problems Continued Symptom Possible Cause Suggested Solution Discharges only partially Therapy PCA defective Replace Therapy PCA some energy remains after discharge e Failure on Processor PCA Replace Processor PCA Charges OK but disarms Patient impedance sensed as Replace paddles or pads and pads cable as when press Shock or paddle too high or too low during needed buttons energy delivery due to Pads paddles losing contact with patient Pads paddles failure Pads cable failure Therapy PCA defective Replace Therapy PCA Failure on Processor PCA Replace Processor PCA Device sensed Pads
196. ry or death WARNING Use only 3 wire AC power cords with 3 pronged grounded plugs WARNING Never operate the HeartStart MRx MRx in standing water Do not immerse or pour fluids on any portion of the HeartStart MRx MRx WARNING Do not use the HeartStart MRx MRx in a flammable or oxygen rich atmosphere This can cause an explosion hazard WARNING Operating the HeartStart MRx MR x or its accessories in conditions outside the environmental specifications can result in device or accessory malfunction The HeartStart MRx should be allowed to stabilize within the operating temperature range for 30 minutes prior to operation WARNING Electric shock hazards exist internally Do not remove assembly screws Refer servicing to qualified personnel WARNING Where the integrity of the external protective earth conductor is in doubt the device shall be operated from its internal power source 266 WARNING To break connection with main power remove plug from wall outlet CAUTION Do not discharge the defibrillator with the paddles shorted together CAUTION Conductive parts of electrodes and associated connectors for applied parts including the neutral electrode should not contact other conductive parts including earth CAUTION Following electrosurgery interference the equipment returns to the previous operating mode within 10 seconds without loss of stored data Measurement accuracy may be
197. s Repairs that involve replacing components on a PCA are not supported CAUTION Individual component replacement should not be attempted Component level repair is inadvisable due to the extensive use of surface mount technology and the high parts density on the circuit boards Unauthorized component replacement can impair performance of the HeartStart MRx WARNING Remove all power sources AC battery DC before opening the device Failure to do so may allow the device to charge without warning and could result in serious injury or death Batteries The M3538A Lithium Ion battery is rechargeable The battery periodically requires a calibration At the end of the battery s useful life it should be discarded and replaced Refer to the Instructions for Use for additional information For information on ordering replacements see Ordering Supplies and Accessories on page 212 WARNING Never crush penetrate or attempt to open lithium ion batteries Never incinerate lithium ion batteries High case temperatures resulting from abuse of the battery could cause physical injury The electrolyte is highly flammable Rupture of the battery pack may cause venting and flame CAUTION Due to their high energy density lithium ion batteries can deliver significant power Use care when working with or testing lithium ion batteries Do not short circuit the terminals Accessing Service Mode CAUTION Be sure that the mon
198. s RF emissions are very low and not likely to cause interference in nearby electronic equipment RF emissions Class B CISPR 11 Harmonic Class A The HeartStart MRx is suitable for use in all emissions establishments including domestic establishments or IEC 61000 3 2 those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Voltage Complies fluctuations flicker emissions IEC 61000 3 3 Table 45 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 Ur is the AC mains voltage prior to application of the test level 6kV contact 8kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2kV common mode lt 5 Uy gt 95 dip in Ur for 0 5 cycle 40 Uy 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec Electromagnetic Immunity General 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 Uy gt 95 dip in Ur for 0 5 cycle 40 U 60 dip in Ur for 5 cycles 70 Ur for 25
199. se 2 Check the Ready for Use RFU indicator See Ready For Use Indicator on page 35 3 Perform a visual inspection Thoroughly examine the device and its cables and accessories Refer to Visual Inspection on page 191 If no further troubleshooting is needed proceed to Step 13 to repair the device Otherwise continue with Step 4 4 Turn on the device Failures and messages appear on the display when you turn on the monitor defibrillator Continue with Step 5 5 Check the status log The Status log includes entries for all errors logged during normal operating mode Automated tests Service Mode tests and Operational Checks The error indicates the most likely module or PCA that failed See Status Log Errors on page 55 for more information Continue with Step 6 6 Run the Operational Check The Operational Check tests the functionality of all PCAs and modules present on the device For example if the HeartStart MRx is equipped with the Noninvasive Blood Pressure measurement the Operational Check performs a self test on that module and includes the results both on the screen and on the printed report The Operational Check results indicate the area of the device that is experiencing problems Use this information to troubleshoot and repair the device See Operational Check on page 39 for detailed instructions Continue with Step 7 7 Check the Status log and the Automated Test summary Any errors that occur dur
200. setting the defibrillator disarms automatically Additionally when the MRx is fully charged you can disarm it any time by turning the Therapy Knob to the Off position e Make sure that you disconnect all power before opening the device e Make sure you discharge the device before working with it e Make sure you work in a static safe environment Use a static control wrist band in conjunction with an antistatic pad which is grounded per the manufacturer s instructions e Special cleaning technologies are used during the manufacturing of the PCAs Be careful not to touch the surface areas of the PCAs with bare hands Additionally oil from hands can affect product performance Flex Circuit Connections In order for flex circuit connections to function properly they must be disconnected and reconnected as follows e Always unlatch the PCA mounted connector before removing the flex circuit and hold the latch open while reinserting the flex circuit into the connector e When reconnecting align the flex circuit carefully in its receptacle Make sure it is both centered from side to side in the connector and oriented at 90 degrees to the connector e Be sure the flex circuit is fully seated in the connector and the connector is properly latched 82 Flex Circuit Handling The flex circuits are delicate and can be damaged by improper handling e Do not bend sharply e Do not scrape the contact surface against other parts e Hand
201. sist in training the Service Training video M3535 89300 NTSC M3535 89310 PAL is available Overview In this chapter you ll find general information that you should know before servicing the HeartStart MRx Detailed information regarding controls operation and capabilities of the device can be found in the nstructions for Use that was shipped with the product The Instructions for Use also provides information on setting up the device and regular maintenance procedures such as performing operational checks and battery maintenance We recommend you review the Instructions for Use before servicing this device This Service Manual assumes you are familiar with the controls and with basic operations This chapter is organized into the following sections Topic Page Features and Capabilities 2 Tour of the Device 3 General Service Information 8 Accessing Service Mode 10 Other Resources 16 Features and Capabilities The HeartStart MRx is a lightweight portable monitor defibrillator It provides four modes of operation Monitor Manual Defib AED and Pacer optional In Monitor Mode you can monitor up to four ECG waveforms acquired through a 3 5 or 10 lead ECG set or multifunction electrode pads Optional monitoring of pulse oximetry SpO noninvasive blood pressure NBP and carbon dioxide EtCO3 are also available Measurements from these parameters are presented on the display and alarms are available to alert you to
202. st The CO module does not start when the FilterLine is connected to the MRx There is no CO waveform on the display CO Monitoring Problems Continued Possible Causes Suggested Solution FilterLine is blocked or damaged CO module needs calibration CO module failure Problem with internal tubing connections When CO is turned on the exhaust tube or outlet port is blocked to the extent that a measurement sample cannot be taken Note If the exhaust tube becomes blocked during monitoring the CO waveform will be a flat line and if alarms are on an apnea alarm will be annunciated e FilterLine is damaged e Intake receptacle failure e CO module failure or sensor failure e Replace FilterLine Check accuracy as described in Checking the CO Module on page 23 Calibrate if needed Replace COjmodule Check internal tubing and intake receptacle wires and tubing Reconnect replace as needed Replace FilterLine Make sure the exhaust tubing is not kinked and is free of blockages If necessary replace the internal tubing and intake receptacle wires and tubing Replace CO module Replace FilterLine Run an Operational Check If the CO test fails replace the CO module If the CO test passes examine the sensor for dirt or foreign objects clean if necessary If problem persists replace the CO internal tubing intake receptacle wires and tubing Replacement
203. strip with the correct information on it waveform text shock d Verify on the defibrillator analyzer that the delay between the peak of the QRS and the delivered shock was lt 30 ms Paddles Safety Check This section describes how to test the paddles to ensure they are connected correctly This test checks the PCI Patient Contact Indicator function of the paddles The PCI measurement is used to detect Pads Off and Paddles Off and to illuminate the PCI LEDs on PCl equipped paddle sets If all results are as described the device passes that portion of the test 1 Connect a set of external paddles to the device a Make sure the metal surfaces of the paddles are clean and dry Also make sure the slide on adult paddle adapters are clean shiny and making good contact to the paddle surface b Put the paddles in the paddle tray 2 Turn the Therapy Knob to Monitor 3 Verify that the PCI is not lit 4 Take one paddle out of the paddle tray 5 Verify that one red LED of the PCI flashes 6 Take both paddles from the paddle tray and hold them firmly together face to face metal to metal Be sure the paddles are clean and are making good contact with one another 7 Verify that all LEDs on the PCI are lit 207 Safety Tests This section discusses tests of the MRx s electrical safety The Philips Safety test designation for each test is provided for reference of Philips service personnel Test Notes e Use the proce
204. t and voltage delivered during the initial portions of the waveform and the biphasic waveform timing is then adjusted as needed to deliver the correct energy The Therapy PCA aborts delivery of the shock if any of the followings situation occur e During the impedance measurement the impedance is outside of operating limits too high or too low e At any time during delivery of the shock it detects an open circuit voltage too high for that point in the waveform or a short circuit current too high for that point in the waveform Should any of these conditions be detected the Therapy PCA terminates delivery of the waveform and disarms the capacitor The problem is reported to the Processor PCA which displays and or prints the appropriate messages Another safety feature is the presence of an identification resistor in the pads and paddles cables If the device does not sense that resistance it gives a Cable Off message and does not charge the capacitor 245 Delivering synchronized cardioversion Synchronized cardioversion operates the same as delivering a shock except that the shock must be synchronized to the R wave of the ECG The Processor PCA is responsible for detecting the R wave and placing markers on the printed strip and on the display to indicate the timing of the proposed cardioversion shock A synchronized shock can be delivered in either of two ways e First when using pads by pressing and holding the Shock bu
205. t the NBP tubing from the measurement module panel 1 b Disconnect the two ribbon cables from the Processor PCA by releasing their latches and pulling straight out 2 3 c Disconnect the two wire printer power cable from the Power PCA by releasing the latch and pulling straight down toward the bottom of the case 4 Figure 40 Disconnecting the Case Halves 2 Pull the halves of the case apart Separate the halves of the case and set them on the work surface 106 Internal Assemblies Front Case This section is organized into the following topics Topic Page Topic Page Overview of Front Case 108 Fan Assembly 121 PCMCIA Hole Plug 109 Processor PCA 123 Speaker and Microphone Assembly 111 Clock Battery 132 Internal Memory Card 113 Printer Connector PCA 133 SpO PCA 115 Display Assembly 135 Measurement Module Panel 117 Ready For Use Indicator 138 Therapy Switch 119 Front Panel Buttons 140 Front Case Assembly 141 107 108 Overview of Front Case Refer to Figure 41 to identify assemblies in the front case Figure 41 Front case overview Therapy switch Modem cable and clip Modem card Internal Memory card PCMCIA Hole Plug if aaa if present Plastic shield Measurement module panel SpO PCA Printer PCA ee E ERN NoN eye AT A peers NE ee a oa ee HK Aik i ees g Speaker microphone Clock battery Processor PCA Display PCMCIA Hole Plug Prepar
206. ted inside the pouch pockets Figure 27 Accessory Pouch Assembly After Repair Run Performance Verification and Safety testing as described in the Performance Verification chapter Bedrail Hook Mount Preparation 1 Turn the device off 2 Position the rear case Lay the rear case on the work surface with the display facing down and the printer in the lower left corner Removal 1 Loosen and remove the 2 T 15 screws 2 Remove the bedrail hook mount Replacement 1 Secure the bedrail hook mount to the back of the device using the two screws After Repair Visually inspect the device to ensure that you installed the bedrail hook mount correctly It is not necessary to run any Performance Verification and Safety testing 89 Therapy Knob Preparation 1 Turn the device off 2 Disconnect all external power and remove all batteries Removal 1 Turn the knob to AED 2 Pull the knob off its shaft Grasp the knob and pull straight out from the front of the device Use pliers if necessary Figure 28 Therapy Knob Replacement Replacement 1 Push the knob onto the shaft a Align the flat side of the clip inside the knob with the flat surface on the shaft and press the knob into place Be sure the knob is pressed fully into place b Check to be sure it rotates freely and that it points to the correct markings on the front panel After Repair Run Performance Verification and Safety testing as
207. temporarily decreased while performing electrosurgery or defibrillation This does not affect patient or equipment safety Do not expose the equipment to x ray or strong magnetic fields MRI CAUTION Be aware of patient cables including ECG monitoring equipment when used with high frequency surgical equipment NOTE This device and its accessories are not intended for home use NOTE The HeartStart MRx can be operated with only AC DC power only 14V M3538A Lithium Ion Battery or AC DC power and M3538A battery simultaneously NOTE For operation in the U S the AC power cord must have the proper NEMA type plug NOTE The HeartStart MRx MRx does not require the practice of any special ElectroStatic Discharge ESD precautionary procedures 267 Defibrillation WARNING _ Keep hands and feet clear of paddle electrode edges Use your thumbs to depress the shock buttons on the paddle handle WARNING Do not allow multifunction electrode pads to touch each other or to touch other ECG monitoring electrodes lead wires dressings etc Contact with metal objects may cause electrical arcing and patient skin burns during defibrillation and may divert current away from the heart Battery WARNING Properly dispose of or recycle depleted batteries according to local regulations Do not puncture disassemble or incinerate batteries WARNING Built in safety circuits can not protect against handling abuse Adhere to all
208. teries in Compartments A and B Defib Tests defibrillation circuitry and Depending on the cable delivers a shock through e pads into a test load and or external paddles into the MRx and or e internal paddles into a load connected as follows e Ifthe Pads cable is attached you are prompted to Verify Test Load is Attached and Press the Charge Button If external paddles are attached you are prompted to Verify Paddles are in Holders and Press the Charge Button If internal paddles are attached you are prompted to Apply Paddles to Load and Press the Charge Button If no cable is attached you are prompted to Connect Therapy Cable Once charged the Shock button lights and you are prompted to Press Shock or Press Shock buttons on paddles After the test completes using one Therapy cable you are prompted to Run defib test again with a different therapy cable Yes No Cal Recommended if battery calibration is required Respond to the prompt as follows e Check the test load is attached and press the Charge button Make sure the paddles are seated in their pockets and press the Charge button Apply the paddles to the load and press the Charge button e Connect a Therapy cable Press the Shock button Use the Navigation and Menu Select buttons to respond Change the cable and select Yes to repeat the test for another cable You should repeat the test for each cable used Se
209. the simulator to the device as described in the Setup section 2 Print a strip a Press the Print button to print a strip b Verify that it shows a normal ECG with a clean baseline c Verify that the date time and configuration information printed at the top of the strip is correct d Press the Print button again to stop printing Defibrillator Measurement Test These instructions describe how to test the defibrillation functions The test sequence causes the MRx to e Charge and deliver a shock when powered by AC power alone e Charge and deliver a shock when powered by battery alone e Charge and disarm when the Disarm softkey is pressed If all results are as described the device passes that portion of the test If there is any failure begin troubleshooting and repairing the device as needed See Troubleshooting on page 33 202 Defibrillator Test AC Power At 200 J These instructions describe how to test the defibrillation function when powered only by AC power no battery installed Setup 1 Turn the MRx off and remove the batteries 2 Install the AC power module and plug its mains power cord into an outlet 3 Connect the Pads cable to the MRx 4 Connect the defibrillator analyzer to the Pads cable 5 Set the analyzer to measure delivered energy Test the Charge Shock Functions 1 Charge and Deliver a 200J shock a Turn the MRx s Therapy Knob to 200J b Press the Charge but
210. these procedures This section is organized into the following topics Topic Page Accessory Pouches 87 Bedrail Hook Mount 89 Therapy Knob 90 Labels 91 Topic Printer Assembly Paddle Tray Paddle Tray 50 ohm Load Resistor Handle and Cap Plate Page J3 95 98 100 Accessory Pouches Preparation Disconnect all external power and remove all batteries Installation 1 Lower the device into the sleeve of the carry case The rear base of the device fits in the sleeve socket Figure 26 Accessory Pouch Assembly 2 Lift up the paddle tray if present a If paddles are connected disconnect them from the Therapy port and remove them from the paddle tray b Remove the 4 T 15 screws from the tray plates c Gently lift the paddle tray up leaving all wires connected 3 Lift up the handle and cap plate if present a Remove the handle cover by lifting up the notch with your fingernail or a screwdriver and pushing in on either side of the handle cover and lifting up b Remove the 2 T 15 screws c Remove the handle d Gently lift the cap plate up 87 88 4 Fold the two sleeve flaps over the top of the device positioning them so that the screw holes are exposed 5 Replace the paddle tray or cap plate as appropriate so that the molded openings fit over the sleeve flaps 6 Secure the front and rear cinch straps using the metal rings provided 7 Attach the side pouches using the snaps loca
211. ting as described in the Performance Verification chapter 143 Internal Assemblies Rear Case This section is organized into the following topics Topic Page Topic Page Overview of Rear Case 145 NBP Module 160 Therapy Capacitor 146 CO Module 162 Power PCA 148 CO2 Compartment Door 167 NBP and CO2 Module Tray 152 Battery Connector PCA 169 Therapy PCA 154 Rear Case Assembly 174 Therapy Port 158 144 Overview of Rear Case Refer to Figure 61 to identify assemblies in the rear case Figure 61 Rear case overview Battery Connector PCA behind Therapy PCA CO Compartment WZ m PCMCIA 2 wire Door i Y LYS Vl ea a bundle VY jG lt gal ivirtd a Therapy port g Power PCA lastic shield Therapy PCA NBP module behind Therapy capacitor O module Therapy capacitor Module tray 145 Therapy Capacitor Preparation 1 Open and separate the case See Opening the case on page 102 2 Position the rear case Lay the rear case on the work surface with the PCAs facing up and the Therapy port on the right WARNING Be sure the Therapy capacitor has been discharged before performing the following steps See Discharge the Therapy Capacitor on page 105 146 Removal 1 Disconnect the Therapy capacitor a Remove the white wire from the clip 1 b Disconnect the white wire from the Therapy PCA using pliers if necessary 2 c Disconnect the red wire from the Therapy
212. tion 70 to 100 4 0 e M1195A sensor 1 standard deviation 70 to 100 4 0 e NELLCOR sensors 1 standard deviation 80 to 100 3 0 Pulse Rate Accuracy 2 or 1 bpm whichever is greater Alarm Range e Low Limit 50 to 99 Adult Pediatric e High Limit 51 to 100 Adult Pediatric Alarm Delay 10 seconds NBP Pressure Range e Systolic 40 260 mmHg e Diastolic 20 200 mmHg Initial Pressure 160 mmHg Adult 120 mmHg Pediatric Maximum Pressure 280 mmHg Overpressure Safety Limits Maximum of 300 mmHg Cuff Inflation Time 50 second maximum pediatric or adult Accuracy 3mmHg 256 Alarm Range e Systolic high limit 35 270 Adult 35 180 Pediatric e Systolic low limit 30 265 Adult 30 175 Pediatric e Diastolic high limit 15 245 Adult 15 150 Pediatric e Diastolic low limit 10 240 Adult 10 145 Pediatric e Mean high limit 25 255 Adult 25 160 Pediatric e Mean low limit 20 250 Adult 20 155 Pediatric Rated Life 50 000 measurement cycles 36 day for 2 3 years Auto Mode Repetition Time 1 2 5 5 10 15 30 60 or 120 minutes Measurement Time Auto manual mode 30 seconds average HR gt 60 bpm 170 seconds maximum Interconnect Tube Length e M1598B Connect tubing 1 5 m e M1599B Connect tubing 3 0 m EtCO Range 0 to 99 mmHg Resolution 1 mmHg 0 1kPa Accuracy For values between 0 and 38 mmHg 2 mmHg For values between 39 and 99 mmHg 5 of reading 0 08
213. ton to charge the MRx c Press the Shock button to deliver the shock to the defibrillator analyzer d If the device is not configured to print on the Charge command press the Print button 2 Check the analyzer readings The delivered energy should be 200J 30J 3 Check the printed strip from the MRx The selected energy should be 200J The delivered energy should be 200J 30J and will be printed on the strip if the device is configured to print on shock 4 Repeat the test using paddles pressing the Shock button on the paddles in Step Ic Defibrillator Test Battery Power At 200 J These instructions describe how to test the defibrillation function when powered only by a battery charged to at least 20 with no AC power connected Setup 1 Insert a battery charged to at least 20 and disconnect the AC Power cord 2 Connect the defibrillator analyzer to the Pads cable 3 Connect the Pads cable to the MRx 4 Connect the defibrillator analyzer to the Pads cable 5 Set the analyzer to measure delivered energy 203 Test the Charge Shock Functions 1 Charge and deliver a 200J shock a Turn the monitor defibrillator s Therapy Knob to 200J b Press the Charge button to charge the MRx c Press the Shock button to deliver the shock to the defibrillator analyzer d Ifthe device is not configured to print on the Charge command press the Print button 2 Check the analyzer readings The delivered energy should
214. tteries and no AC supply or with one battery and one AC supply The device transitions between power sources as sources are added and removed without interrupting any operation as long as at least one source of power is always present AC Power Module Assembly The AC power module has a standard power connector and operates between 100 240VAC at 50 or 60 Hz The AC power module plugs into battery compartment B and can power the device and charge the battery that is in battery compartment A 240 Battery The batteries used in the HeartStart MRx utilize lithium ion chemistry Lithium ion batteries feature very high energy density allowing the use of smaller and lighter batteries to achieve the same power levels as in nickel cadmium batteries In addition lithium ion batteries are more environmentally friendly than nickel cadmium or lead acid batteries and do not suffer from the memory effect that plagues nickel cadmium chemistries Each battery pack includes built in protective circuitry to prevent damage from overcharging excessive discharge current and other types of electrical abuse It contains circuitry to monitor the amount of charge available in the battery This information is communicated to the Processor PCA via the Battery Connector PCA and the Power PCA which provides battery status information on the display In addition each battery pack has on board temperature sensing which is monitored by the Power PCA for battery ch
215. tton until the next time an R wave is detected e Second by simultaneously pressing and holding the Shock buttons on both the Sternum and Apex paddles until the next time an R wave is detected When both events occur either type of button press and detection of an R wave the Processor PCA directs the Therapy PCA to deliver the shock Transcutaneous Pacing Pacing is initiated and controlled by pressing front panel buttons These button presses are transferred from the buttons to the Processor PCA via a flex circuit The button presses are detected and processed by the Processor PCA The Processor PCA directs the Therapy PCA to deliver the pacing pulses at the rate and output current selected by the user The Therapy PCA controls the output current and the wave shape and the Processor PCA controls when each pace pulse occurs depending on the selected rate and the demand mode setting The pacing pulses are delivered via the pads cable to the multifunction electrode pads The pacing current delivered is reported back to the Processor PCA which sends the information to the display and activates any printouts or screen messages as needed Audio The HeartStart MRx has two types of audio output tones and voice prompts Both are generated and controlled by the Processor PCA which also amplifies the signals and passes them directly to the speaker via a wire pair Audio input is routed from the microphone to the Processor PCA over a separate
216. ut 18 V 5 A 90 W 260 Environmental M3536A Temperature 0 C to 45 C operating 20 to 70 C storage e Charging the battery at temperatures above 45 C may degrade battery life e Storing the battery for extended periods at temperatures above 40 C will reduce battery capacity and degrade battery life Humidity Up to 95 Relative Humidity e Printer paper may jam if paper is wet e Thermal Printer may be damaged if wet paper is allowed to dry while in contact with printer elements Altitude e Operating 0 to 15 000 ft 0 to 4 500 m e Storage 0 to 15 000 ft 0 to 4 500 m Shock e Operating Half sine waveform duration lt 3 ms acceleration gt 145 g 1 time on all six faces e Non operating Shipping Trapezoidal waveform acceleration gt 30 g velocity change 742 cm s 10 on all six faces e Bump EN60068 2 29 Bump Half sine 40 g peak 6 msec duration 1 000 bumps x 3 axes e Free Fall IEC 68 2 32 Free Fall Drops on all faces onto a steel surface excluding bed rail hook 30 in 76 2 cm with carrying case 16 in 40 6 cm without carrying case Vibration e Operating MIL STD 810E 514 4 Category 6 Helicopter General Storage UH60 e Non Operating IEC 68 2 6 Vibration sinusoidal 10 57 Hz 0 15mm 58 150 Hz 2g 20 sweeps x 3 axes IEC 68 2 64 Vibration broad band random 10 20 Hz 0 05 g Hz 20 150 Hz 3 dB octave 150 Hz 0 0065 9 Hz 1 5 hours x 3 axes Solids Water Resistance IP24 W
217. vice Mode Main menu from any service screen press the Main Service soft key NOTE The device s default configuration settings are restored when you return to clinical mode after exiting Service Mode 11 Service Mode Functions You can perform a variety of service related activities from Service Mode as follows e Run an Operational Check See Operational Check on page 39 e View print and clear the Status log See Status Log Errors on page 55 e Perform maintenance on the NBP module See Checking the NBP Module on page 19 e Perform maintenance on the CO module See Checking the CO Module on page 23 e Run the Controls test See Controls Test on page 193 e Run the Printer test See Printer Test on page 194 e View information about the device such as model number serial number options enabled on the device and the device s language See Device Info on page 13 You also use the Device Info menu to enter the serial number and to enable options on the device after a Processor PCA repair See Entering the Serial Number and Enabling Options on page 128 for more information NOTE You can print detailed information on board and module levels through the Print Device Info option available in normal operating mode See Printing the Device Information on page 16 e Install software and change the device s language using the Software Support Tool See Software Support Tool
218. warnings and cautions in handing and using lithium ion batteries WARNING Do not expose batteries to temperatures greater than 60 C 140 F Excess temperatures may result in battery damage WARNING Keep batteries away from flame and other heat sources WARNING Do not short circuit the battery Avoid placing batteries around metal objects that may short circuit the battery WARNING Avoid getting batteries wet or using batteries in high humidity environments WARNING Do not crush dent or allow any deformation of the batteries WARNING Do not disassemble or open batteries Do no attempt to alter or bypass the safety circuit 268 WARNING Do not use or connect the battery to batteries of other chemistries WARNING Avoid extreme shock and vibration to the battery WARNING Avoid electrostatic discharge to the battery WARNING Avoid extreme shock and vibration to the battery WARNING Do not use or connect the battery to batteries of other chemistries 269 Electromagnetic Compatibility When using the HeartStart MRx electromagnetic compatibility with surrounding devices should be assessed A medical device can either generate or receive electromagnetic interference Testing for electromagnetic compatibility EMC with and without the appropriate accessories has been performed according to the international standard for EMC for medical devices IEC 60601 1 2 This IEC stand
219. wire pair in the same connector as the speaker wires The audio is filtered digitized and processed on the Processor PCA 246 Data Storage The HeartStart MRx has the capability of storing the following information e Patient data acquired during an event e Configuration data set up by the user to define specific settings related to the behavior of the device e Support data generated by the device to support the maintenance and service of the device e Device data set up by the manufacturer to define installed options serial numbers etc External Data Card In addition to storing data in internal memory the HeartStart MRx supports an external Compact Flash data card You can copy patient data such as ECG waveform and shock advisories from internal memory to the external data card The data card is read by the HearStart Event Review Pro for post event analysis or by a compatible Compact Flash card reader Clock Backup Battery The Clock Backup Battery lithium battery located on the Processor PCA provides standby power to maintain the system time and date during times when the main battery is either absent or discharged and no external power is supplied NBP Module The NBP module handles the following functions e Inflation and deflation of the NBP cuff e Measurement of pressure in cuff e Detection of pressure waveform and extraction of the systolic and diastolic values from that waveform e Calculation
220. x complies with the requirements of the Medical Device Directive 93 42 EEC and carries the C 0123 mark accordingly Manufacturer Philips Medical Systems 3000 Minuteman Road Andover MA USA 01810 1099 978 687 1501 Authorized EU representative Philips Medizin Systeme B blingen GmbH Hewlett Packard Str 2 71034 Boblingen Germany Canada EMC ICES 001 Warning Radio frequency RF interference from nearby transmitting devices may degrade the performance of the HeartStart MRx Electromagnetic compatibility with surrounding devices should be assessed prior to using the monitor defibrillator c Conventions Used in This Manual This Service Manual contains the following conventions WARNING Warning statements describe conditions or actions that can result in personal injury or loss of life CAUTION Caution statements describe conditions or actions that can result in damage to the equipment or loss of data NOTE Notes contain additional information on usage TIP Tips provide hands on insight into servicing this product TEXT represents messages that appear on the screen Softkey represents softkey labels that appear on the screen above or below the button to which they correspond On line viewing only Hypertext represents hypertext links which will display as blue click on the blue link to go to that destination then click on the blue destination to return Abbreviations Name Abbreviation HeartStart
221. y Size 128 mm x 171 mm Type TFT Color LCD Resolution 640 x 480 pixels VGA Sweep Speed 25mm s nominal stationary trace sweeping erase bar for ECG and SpO 6 25 mm sec for CO Wave Viewing Time 5 seconds ECG Battery Type 6 0 Ah 14 8 V rechargeable Lithium Ion Dimensions 165 mm H x 95 mm W x 42 mm D 6 5 in x 3 8 in x 1 6 in Weight Less than 1 6 lb 0 73 kg Charge Time with instrument off Approximately 3 hours to 100 Approximately 2 hours to 80 indicated by indicator Charging the battery at temperatures above 45 C may degrade battery life Capacity At least 5 hours of monitoring with ECG SpO and CO monitored continuously and NBP measured every 15 minutes or at least 50 full energy discharges with a new fully charged battery operating at room temperature 25 C Battery Indicators Battery gauge on battery capacity indicator on display flashing RFU indicator chirp and LOW BATTERY message appears on display for low battery condition When LOW BATTERY message first appears there is still enough energy remaining for at least 10 minutes of monitoring time and six maximum energy discharges with a new battery at room temperature 25 C Battery Storage Storing the battery for extended periods at temperatures above 40 C will reduce battery capacity and degrade battery life 254 Thermal Array Printer Continuous ECG Strip The Print key starts and stops the strip The printer can b

HEARTSTART MRx - Frank`s Hospital Workshop

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