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INVIVO Expression MRI Service Manual

1. LJ Section 2 Unpacking the System pages 3 4 Section 3 System Overview pages 5 11 Section 4 System Installation pages 13 21 Section 5 System Power Up page 23 L Section 6 Test and Inspection pages 25 40 Section 7 Removal and Replacement pages 41 61 Section 8 Service Parts pages 63 67 Section 9 List of Symbols pages 69 72 1 2 Text Conventions The manual uses the following conventions for Warnings Cautions and Notes CAUTION A Caution calls attention to a condition or possible situation that could damage or destroy the product or the user s work Note A Note calls attention to notable details or to conventions used within this text WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 1 of 82 Section 1 Introduction WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 2 of 82 2 UNPACKING THE SYSTEM This section provides instructions regarding the unpacking and inspection of the Expression MRI Patient Monitoring System Remove the system components from the shipping container s Verify the presence of all ordered items against the included packing list and purchase request Carefully examine all components for any damage that may have occurred d
2. Slide the batteries into their respective compartments and they will automatically latch into place If the battery does not latch automatically when fully inserted into the battery compartment then the battery is not positioned properly In this case reorient the battery then retry installation To install batteries in the PMC follow the steps below WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 7 of 82 Section 3 System Overview Battery Installation PMC Move the PMC away from the MR system outside of the 1 000 Gauss 0 1T field line as measured from the center line of the MR bore prior to installing batteries Remove the Battery Compartment Cover by lifting the latches 3 Slide the batteries into their respective holder until seated refer to the following figures Install the Battery Compartment Cover Assure that the Battery Compartment Cover is latched into place To remove batteries from the Cart and DCU press the battery eject button on the device and the battery will partially eject for easy removal To remove batteries from the PMC follow the steps below Move the PMC away from the MR system outside of the 1 000 Gauss 0 1T field line as measured from the center line of the MR bore prior to removing batteries Remove the Battery Compartment Cover by lifting t
3. 1 Invivo Exurecctolt MRI Patient Monitoring System Model 865214 EXPRESS SERVICE MANUAL NN 08 N Proprietary Information This document contains proprietary information which is protected by copyright Manufacturer Invivo Corporation 12501 Research Parkway Orlando FL 32826 407 275 3220 800 331 3220 www invivocorp com Warranty The information contained in this document is subject to change without notice Invivo Corporation makes no warranty of any kind with regard to this material including but not limited to the implied warranties or merchantability and fitness for a particular purpose Invivo Corporation 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 Limits of Liability Invivo has taken care to ensure the accuracy of this document However Invivo assumes no liability for errors or omissions and reserves the right to make changes without further notice to any products herein to improve reliability function or design Invivo may make improvements or changes in the product s or program s described in this document at any time Printing History New revisions of this document will incorporate all material updated since the previous revision Update packages may be issued between revisions and contain replacement and additional pages to be merged by a revision date at the bottom of the page The
4. 5 ft DCU power cable P N 453564109681 to the DC output of the power converter WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 19 of 82 Section 4 System Installation area near an approved AC outlet and then connect to that AC outlet back of the DCU control room or holding area Do not use the DCU Power Converter Kit P N 453564123631 inside the MR system room The device is magnetic and will be pulled into the MR system Never take the DCU Power Converter Kit into the MR system room The device is intended for use with the Display Control Unit only when used outside the MR system room WARNING None of the interconnection ports on the back of the DCU e g Communications AUX I O USB Keyboard Gating or Video are intended for direct patient connection An electric shock hazard can exist if the patient is electrically connected to any of these connections Do not dock the DCU to the Cart while the DCU is still connected to AC mains Damage to the DCU or power cable may result If the printer option is present in the DCU it may be CAUTION used in the MR system room at or outside the 1 000 Gauss 0 1T field line as measured from the center line of the MR bore of the MR system Do not move the DCU closer than the specified Gauss field line or damage to the printer failure to op
5. A VIOLATION OF LAW 48 of 82 Section 7 Removal and Replacement Channel Options Network A Network B Network C Network D Network E J Note Use RETURN to exit the SYSTEM CONFIG menu not ESC 7 1 3 2 Exchange Parameter Disabling If the exchange assembly contains options not purchased by the customer the options should be disabled Options connectors if not purchased will not be installed on the front of the Cart Ensure that a VGA display and a keyboard are connected to the Cart Enter the keyboard navigator by typing nav Press F4 to enter the SETUPS menu Select SERVICE BIO MED then SYSTEM CONFIG and finally select the non purchased parameter Enter the password to disable the parameter MNote Use RETURN to exit the SYSTEM CONFIG menu not the ESC Key and then cycle system power 7 2 The PMC WPU The instructions below detail removal and replacement of the WPU in the PMC 7 2 1 WPU Removal from the PMC 1 Lift the Latches then remove the Battery Compartment Cover P N 453564169211 from the PMC WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 49 of 82 Section 7 Removal and Replacement 2 Pull the latch holding the Battery in the Battery Tray and then using your other hand remove the Battery from the side opposite the connector Repeat the process
6. Control Unit DCU e One Wireless ECG WECG Module e One Wireless WSpO WSpO Module e Two Wireless Module Batteries e Four Cart DCU Batteries e One DCU Power Converter Kit e One Power Supply The DCU may be docked on the Cart or located remotely see the Expression IFU for details When docked on the Cart and with the Cart connected to AC mains power the DCU and Cart batteries are charged through the battery charger contained within the Cart For added flexibility the system can be configured with two additional DCUs The additional DCUs can be located in the MR system room MR control room or MR holding area Refer to the Expression IFU for warnings cautions and instructions regarding the DCU 3 2 Patient Management Configuration The Patient Management Configuration PMC consists of the following primary components e One Patient Management Configuration including the WPU e One DCU e One WECG module e One WSpO module e Two Wireless Module Batteries e Four PMC DCU Batteries e One DCU Power Converter Kit e Power Supply s one with dual DC Outputs or two with single DC Outputs Several options are available for the placement of the PMC including e Horizontal mounting to a patient examination table e Vertical mounting to a patient examination table e Mounting to an anesthesia cart and e Mounting to a stationary surface With the PMC connected to AC mains power the batteries within the PMC are charg
7. MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 13 of 82 Section 4 System Installation Input Output Configuration of Power Supply P N 989803169201 ci ES T 1 5 A 250 V VA AWAY PROM MAGNET AC Input A A C 369803169201 ADAPTER IS MAGNETIC AND WILL BE PULLED INTO THE MRI MAGNET MOUNT TO HORIZONTAL SURFACE USING VELCRO STRIPS AC INPUT i WARNING AA DC OUTPUT 10 FT 3M KEEP 10 FT 3 METERS DC Output AWAY FROM MAGNET l C 369803169201 ADAPTER IS MAGNETIC AND WILL BE PULLED INTO THE MRI MAGNET MOUNT TO HORIZONTAL SURFACE USING VELCRO STRIPS The ground terminal as designated by the 1 symbol on Power Supply P N 989803169201 allows Invivo authorized service personnel to connect a ground strap to prevent ESD discharge during servicing and for testing leakage currents CAUTION Performance of the Expression MRI Patient Monitoring System and any other devices within the room may be degraded if the ground terminal is used against Invivo s intended use as listed above WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 14 of 82 Section 4 System Installation 4 1 2 Part Number 989803168201 WARNING Ensure that the Power Supply P N 989803168201 10 FT 3M remains 10 feet 3 meters or more from the MR ES system mounted to a horizontal surface
8. MR bore Failure to properly place the Expression and its accessories in the MR system room will result in system or accessory failure and possible patient or user injury Always secure the Cart s wheel locks when the unit is placed within the MR system room WARNING If the Expression MRI Patient Monitoring System Cart rolls to the face of the MR system due to magnetically induced pull force DO NOT ATTEMPT TO DISLODGE THE EXPRESSION BY PULLING FROM THE DOCKED DCU OR GUIDE HANDLE AT THE TOP OF THE SYSTEM Dislodge the Expression by gently pulling from the base of the system at its lowest point This will prevent the base of the unit from experiencing higher MR pull forces in the vertical direction CAUTION Field strength variations in a particular MR system room which may be due to active shielding technology manufacturer variability future enhancements etc can make distinguishing the 5 000 Gauss level as measured from the center line of the MR bore difficult These variations may require moving the Cart away from the MR system if system abnormalities or malfunctions are observed Prior to clinical use ensure that the allowable distance of the Expression components from the MR system is maintained for proper operation WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 16 of 82 Section 4 Sys
9. PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 17 of 82 Section 4 System Installation Complete the following actions to install the PMC Mount the PMC Install the batteries into the PMC see Section 3 2 1 Locate the Power Supply and attach the AC Power Cord to the AC Input on the Power Supply see Section 4 1 Connect the male end of the 25 ft DC power cable P N AC517B to the DC Output on the Power Supply Position the Power Supply in the MR system room near an approved AC outlet at a distance of at least 10 feet 3 meters from the MR system see the warnings and cautions in Section 4 1 Plug the female end of the DC power cable into the Power Input on the PMC Plug the AC Power Cord into the AC outlet 4 4 Display Control Unit DCU The DCU may be used in the MR system room MR control room or in the MR holding area Warnings and cautions must be observed to ensure Safe use and system reliability The DCU can be docked to the Cart or can operate independently under battery or AC mains power If the DCU must be located in the MR system room it should be operated under battery power or docked to the Cart If the DCU must be located in the MR system room and connected to AC mains use the Power Supply P N 989803169201 or P N 989803168201 Additional power supplies may be purchased from your Invivo sales representative 4 4 1 Installed on the Cart The
10. REMOVING AG Mains POWER EEEO 23 Test ANG Inspection siii a O a 25 Bid When toT estaran ban 25 6 2 Test and Inspection Matrix CheckliSt cooooccccccnocononocononaronnonanonncnacononarononaronnonaoos 25 6 3 Performance Assurance Test Checklist ccccccccssssssseccecseesseccccsseeseeecceessauseeeeeeseaeees 26 6 4 Recommended Frequency Of Testing cccccsssccccssseceeeseceeeececeeeeeceueneceseaecesseeceseeaess 27 Es TEestProcess Descrip Ns 28 6 5 1 Test Equipment Requirements sscsssssssssssssssssssseeeeeeeeeeeeeeeeeeeseesesseeeeees 28 632 Initial POWE U Dana arandelas 28 oSA ETCOZ OOO mM ON Made 28 gt Operational Tests een re ne ne en Pn er ne ee ios 28 6 5 3 1 System Communication Verification ooocccoooccnonanonnnonononenanononanonos 29 ESA WWECG COMMUNICAMON liada 29 65 33 WHO COMMUNICIAO Nao 30 653 4 NIBP Vertice iaa cop cil dies 31 6 5 3 4 1 Pneumatic Leak Test High 1 row 0oooononcononncicinnnnnccns 31 6 5 3 4 2 Pneumatic Leak Test Low 229 Wir asa 31 6 5 3 4 3 NIBP Offset Verification ooccccccconoccnnnnnnonnncnnnnnnonnannnnos 31 6 5 3 4 4 Calibration Accuracy Check oocccccooncnccncnnnnonaconenaconenanos 32 6 532425 Overpressure AGU Eunice A 32 6 5 3 4 6 Overpressure Neonatal occccooccnconcnnnncnonononacononanonnononos 33 Bol AGUIT CUM TE lOs 33 6 5 3 4 8 Adult Dead Man Cuff occccccnnnccnnncccnnnnccnnnncnnnncan
11. documentation part number P N and revision indicate the current edition P N 989803162701 Rev D Copyright 2010 Invivo Corporation All rights reserved Printed in U S A Contents INtTOdUCION rica ia iii 1 LL ADQUETAIS Maa la sido 1 1 2 TeX COMV CMOS nenita uoisao 1 2 Unpacking the Syste Mica AA 3 SB 3VStem OVElVICW iia ia 5 3 1 Care Contisura ON 5 3 2 Patient Management Configuration saurer a a a a 5 32 1 Battery Operation Gar PMG and DCU aseeseen N nice 6 S21 Installation a a Removal ni aa 7 3 2 2 Battery Operation WECG and WSpO2 ModulesS ooo ccccnnoocncccnnnoanncncnonannnnconnnnss 8 23221 Installation ANG Removal usd idas 9 32 Sate Battery Usina ad 9 3 24 Battery Charging Instruction Sivsviinaii dai 10 3 2 5 Battery DiISOOSalIMSEFUCTIONS aiii cidcid 10 3 2 5 1 GUIdeines IN EUrope aaa 11 3 2 5 2 Guidelines in the United States c ooocccnnccccnncnnnnnnnncnnonnnncnnonnannnnnnnos 11 4 System installation nas 13 Alo PONTS Ds 13 ArT Part Number 9SIS0S II NAR 13 4 1 2 Part Number 989803168201 esun 15 AZ Cart COME Ua ON arado 16 4 3 Patient Management Configuration PMC cccccccssssccccccesececeeseceeeeeseceeseueeecessenes 17 4A Display CONTO LUN IDU A ean E teenie eet 18 441 WASTAGE onthe Carles arco a uaee as 18 44 2 Stand Alone Der dd 19 445 Additional Installation OPUS as 21 System POWE UD ini conguuceausonseseeneesessneurbeneoene 23 Dek
12. during procedures Degradation of system performance may result The manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications to the radios within this equipment Such modification could inhibit proper system communication WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 21 of 82 Section 4 System Installation WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 22 of 82 5 SYSTEM POWER UP Follow the steps below to perform system power up and operational verification Install batteries into the wireless ECG and SpO modules see Section 3 2 2 gt Turn ON the Cart or PMC using the power switch located to the left of the patient l connection area Turn ON the DCU using the power switch located on the front lower left corner of the DCU Verify proper communication between the WECG module WSpO module DCU and Cart or PMC by checking the power indicator LED on each component see Section 6 5 3 Verify proper operation of each patient parameter see Section 6 5 1 Removing AC Mains Power To remove the Expression MRI Patient Monitoring System Cart PMC or DCU from AC mains power use one of the following meth
13. following Replacement Exchange parts are available with a disposition defined by the Repair Strategy Service SE Replacement Exchange Part Description Part Number Repair Strategy WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 66 of 82 Section 8 Service Parts Service Number 453564194541 453564156991 453564194351 453564194361 453564194371 453564194381 453564194391 453564194401 453564194411 453564194421 453564194431 453564194441 Replacement Exchange Part Description Continued DCU W RECORDER SWEDISH Part Number 453564194541 453564156991 453564194351 453564194361 453564194371 453564194381 453564194391 453564194401 453564194411 453564194421 453564194431 453564194441 OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 67 of 82 Repair Strategy Whole Unit Exchange WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION Section 8 Service Parts WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 68 of 82 9 LIST OF SYMBOLS The symbols defined in the list below may be found in this document or located on the shipping containers the system and accessories of
14. hours when performing certain operations such as anesthetic agents monitoring printing charts and trends or running short automatic NIBP cycle times WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 6 of 82 Section 3 System Overview When the AC mains power is interrupted and batteries in the Cart PMC and DCU are inserted the Expression automatically switches to internal batteries J Note To prevent unintentional power interruption Invivo recommends keeping the batteries inserted in the equipment even when operating under AC mains power 3 2 1 1 Installation and Removal WARNING The batteries used within the Cart PMC and DCU contain some ferrous materials that are attracted to the MR magnetic field DO NOT install or remove the batteries from the devices when these units are closer than the 1 000 Gauss 0 1 T field line as measured from the center line of the MR bore The batteries will be attracted to the magnetic field possibly causing patient or user injury CAUTION Never force a battery into the battery compartment damage to the battery or the Expression MRI Patient Monitoring System will occur To install batteries into the Cart PMC and DCU the batteries must be oriented properly to latch into place in the battery compartments as the battery contours fit the device geometry
15. the 2 Screws P N 453564155961 from the supplied Screw Kit P N 453564185221 10 Test the functions see Section 6 WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 47 of 82 Section 7 Removal and Replacement 11 Replace the WPU Cover and then secure it using the previously removed Screw P N 453564155941 12 Install the Rear Base I O Cover onto the Cart and tighten the 2 Captivated Screws Configure the network see Section 7 1 3 7 1 3 Exchange Network Setup J Note The following VERY IMPORTANT steps must be performed following an exchange 7 1 3 1 Network Channel Options Obtain the system Network via the network label on the back of the Cart or by observing the network indicator at the bottom right of the DCU screen Ensure that a VGA display and a keyboard are connected to the Cart Enter the keyboard navigator by typing nav Press F4 to enter the SETUPS menu Select SERVICE BIO MED then SYSTEM CONFIG and finally NETWORK Enter the password the password is for Philips personnel only and can be attained by calling Technical Support to set the network option per the observed customer DCU network indicator WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS
16. the unit Attention Breathing Effort Non ionizing Consult Detected 0 Radiation Accompanying Documents Not MR Fuse Percent Compatible 0 Oxygen SpO e Saturation Product Part Earth Ground Alternating Number e Current Up Increment Device conforms Product Serial to the Medical Number Device Directive Down Attention Decrement Precautionary Alert Date of Latex Free Unlocked Manufacture Materials Used DANGER Antenna Direct Current High Voltage WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 69 of 82 Section 9 List of Symbols ih Non Invasive Universal Serial Blood Pressure Bus gt _ Oxygen Sensor ON AC Power Keyboard Access Here Defibrillator Weight Low Battery Proof Type CF J l Equipment IEC 60601 1 Protection Against Shock Dangerous Type CF Ai Patient Voltage Applied Part M Alarms Alarms Single Patient SOUND ON SOUND OFF Use Only DO NOT REUSE Alarms ON HOLD Alarms SILENCED Replace Fuses As Marked Heart Beat Attention Battery Detected Electrostatic Safety Device Observe Precautions e WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 70 of 82 Section 9 List of Symbols Tamne A ON Batt
17. using the pre applied Velcro strips and or secured to the floor or another immoveable surface with fasteners through the unit s mounting flange holes 989803168201 in order to prevent the Power Supply from being pulled into the MRI Magnet CAUTION If longer distances are required only use approved AC electrical extension cord P N 989803168221 avoid use of extension cords or multiple portable socket outlets which may create a safety hazard by compromising the grounding integrity of the MRI Patient Monitoring System Input Output Configuration of Power Supply P N 989803168201 Item Description O Power Supply 989803168201 AC Input Connector Strain Relief DC Output Connector 2 Mounting Flange Holes 4 Shield Cap LED Indicator Illuminated Power ON WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 15 of 82 Section 4 System Installation 4 2 Cart Configuration A Observe the following warnings cautions notes and instructions when installing setting up and using the Cart configuration for the Expression MRI Sa Patient Monitoring System a 4 The Expression MRI Patient Monitoring System Cart may be used inside the MR system room in a location at or outside the 5 000 5 000 or less Gauss 0 5T field line of the MR system as measured from the center line of the
18. 4mmHg Verify overpressure is displayed 146 154 INVASIVE PRESSURE VERIFICATION Verify Invasive Pressures P1 P2 at 0 50 100 150 200 1 1 49 PorF 240 1 51 99 101 148 152 198 202 238 242 WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 26 of 82 Section 6 Test and Inspection Assurance AGENT VERIFICATION Only if repairing Service Tesis number 453564099881 or 453564175761 Continued Verify Adult flow detection 200ml min 20ml min nik CO2 OCCLUSION message and flow drop 135 1 Verify Neo flow detection 150ml min 15ml min ein Performance 20 Verify left port flow rate is 35ml mint15ml min wicks Por F ml min 150 1 Verify right port flow rate is 165ml min 15ml min an 67 85 O i Apply 10 CO2 and verify 76mmHg 9mmHg mile PorF UN 02 Sensor Verification Pass or Fail PorF MA ETCO2 VERIFICATION Only if repairing Service number 453564155341 or 453564175791 Verify READJUSTING CO2 ZERO message Pass or Fail P or F Verify ETCO zero and flow value 80ml min 16ml min rie CO2 OCCLUSION message displayed within 30 seconds 7 Apply 10 CO2 and verify 76mmHg 9mmHg Ei RESPIRATION VERIFICATION A A Verify normal respiration rate TEMPERATURE VERIFICATION o Verify Ambient temperature within 2 0 C 6 4 Recommended Frequency of
19. D REPLACEMENT This section details removal and replacement techniques including the network changes required for exchange components WARNING Turn OFF and unplug AC mains power to the system and remove the batteries before performing service to avoid injury and equipment damage Before return shipment remove the antenna accessories and batteries from the Cart WPU PMC and DCU to avoid damaging the equipment 7 1 The Cart WPU The instructions below detail removal and replacement of the WPU on a Cart 7 1 1 WPU Removal from the Cart 1 Loosen the 2 Captivated Screws P N NS185N on the Rear Base I O Cover P N 453564088381 and then remove the cover from the Cart 2 Remove the Screw P N 453564155941 from the WPU Cover P N 453564099841 and then lift the WPU Cover off the Base Retain the Screw for reassembly WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 41 of 82 Section 7 Removal and Replacement 3 Remove the 2 Screws P N 453564155961 from the Cover P N 453564088191 by the Power Box 4 Label all the pneumatic hoses with a corresponding identifier and then disconnect the hoses from the ports on the WPU 5 Disconnect all Fiber Optic and Multifunction Cables from the WPU chassis WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT A
20. DCU contains some ferrous materials that are attracted to the MR magnetic field DO NOT install or remove the DCU from the Cart when the Expression MRI Patient Monitoring System is closer than the 1 000 Gauss 0 1 T field line as measured from the center line of the MR bore The DCU will be attracted to the magnetic field possibly causing patient or user injury WARNING Complete the following actions to install the DCU on the Cart WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 18 of 82 Section 4 System Installation While holding the DCU handle center the DCU over the Cart Mounting Shoe see illustration below bT Note Pressing the button on the back of the DCU is not necessary Tilt the DCU all the way back 2 With one hand press and hold the button on the back of the DCU see illustration above 3 With your other hand grasp the DCU handle and then lift upward while continuing to press the button until the DCU clears the Cart Mounting Shoe NS Lift the DCU off the Cart 4 4 2 Stand Alone Operation Observe the following instructions to operate the DCU using AC power Install batteries into the DCU see Section 3 2 1 2 Locate the DCU Power Converter Kit Attach the AC power cord to the AC input on the Power Converter P N 453563464761 3 Connect the male end of the
21. E CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 25 of 82 Section 6 Test and Inspection 6 3 Performance Assurance Test Checklist Performance Assurance Tests Verify that both Power Indicator LED s are illuminated Pass or Fail PorF GREEN on the DCU and on the WPU Verify communication COMM between the DCU Pass or Fail P or F WPU and the WECG and WSPO2 remotes Verify DCU WPU and WECG and WSPO2 Battery Icons Pass or Fail Por F displayed on DCU WECG COMM ao Verity Trace A is a Sequence of moving QRS pulses Dace Or Eai P or F without jittering Verify 60 1 BPM 59 61 BPM PorF WSPOZ COMM HS Enable amp turn ON SPO2 verify PROBE OFF when there Pass or Fail PorF is no finger inserted into the probe Verify smooth waveform w normal SPO2 reading PorF NIBP VERIFICATION lL Verify that the Pneumatic Leak Test High 1 row numbers have a difference between PEAK and FINAL of Pass or Fail PorF lt 10 Verify that the Pneumatic Leak Test Low 2nd row numbers have a difference between PEAK and FINAL of Pass or Fail PorF lt 10 NIBP OFFSET VERIFICATION 10 2 P or F Calibration Accuracy Check Verify 250 5mmHg on 245 255 Por F both sides NIBP Over Pressure Adult PRI 285 4mmHg SEC 295 281 289 Pork 4mmHg Verify overpressure is displayed 291 299 NIBP Over Pressure Neo PRI 156 4mmHg SEC 150 152 160 PorF
22. EASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 39 of 82 Section 6 Test and Inspection C Verification Verify that the message CO2 OCCLUSION is displayed within 30 seconds D Setup e With 10 percent 76mmHg CO2 applied to the unit and CO2 gas flowing for at least 2 minutes D Verification Verify that the unit detects CO2 and measures 76mmHg 9mmHg 6 5 3 8 Respiration Verification Setup e With REPSIRATION turned ON and a respiration bellows connected to the WSPO2 respiration port attach the bellows to the chest stomach region Verification Verify DCU respiration displays a rate consistent with the normal respiration rate typically 10 16BPM 6 5 3 9 Temperature Verification Setup e Set the PATIENT mode to ADULT the SETUPS PARAMETER SELECTION TEMP to ON and the 989803162531 body temp probe connected to the Temperature port Verification Verify that the reading is at the ambient temperature C within 2 C 6 5 4 Electrical Safety Testing The electrical safety of the system has been verified to meet IEC 60601 1 1 The service procedures have been specified so that it is not necessary to repeat electrical safety testing after completing repair WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 40 of 82 7 REMOVAL AN
23. ERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 60 of 82 Section 7 Removal and Replacement Channel Options MNote Use RETURN to exit the SYSTEM CONFIG menu not ESC 7 2 3 2 Exchange Parameter Disabling If the exchange assembly contains options not purchased by the customer the options should be disabled Options connectors if not purchased will not be installed on the PMC Ensure that a VGA display and a keyboard are connected to the PMC Enter the keyboard navigator by typing nav Press F4 to enter the SETUPS menu Select SERVICE BIO MED then SYSTEM CONFIG and finally select the non purchased parameter Enter the password the password is for Philips personnel only and can be attained by calling Technical Support to disable the parameter J Note Use RETURN selection to exit the SYSTEM CONFIG menu not the ESC Key and then cycle system power WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 61 of 82 Section 7 Removal and Replacement WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 62 of 82 8 SERVICE PARTS 8 1 Non Exchange Service Parts The following Non Exchange service parts are available Part Number ee E Non Exchange Service
24. ERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 36 of 82 Section 6 Test and Inspection B Setup e With P1 amp P2 turned ON in the SETUPS SERVICE SYSTEM CONFIG screen and P1 amp P2 turned ON in the SETUPS PARAMETERS SELECTION menu connect the IBP Simulator to the P2 Port B Verification Verify that the P2 menu on the DCU displays the pressures within the given tolerances as listed in Table 4 above 6 5 3 6 Agents Verification perform only if Agents is installed 6 5 3 6 1 Agents Flow Test A Setup e With AGENTS turned ON and PATIENT set to ADULT in the SETUPS PARAMETER SELECTION menu a sample line connected to the agents water trap and the Flowmeter connected to the end of the sample line open the exhaust port A Verification Verify that the flow is 200ml min 20ml min B Setup e With AGENTS turned ON and PATIENT set to ADULT in the SETUPS PARAMETER SELECTION menu a sample line connected to the agents water trap and with the sample line input blocked open the exhaust port B Verification Verify that the message CO2 OCCLUSION is displayed within 30 seconds C Setup e With AGENTS turned ON a sample line connected to the agents water trap and the Flowmeter connected to the end of the sample line block the exhaust port C Verification Verify that the flow drops to Oml min WARNING
25. HIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 59 of 82 Section 7 Removal and Replacement 17 After ensuring that no cables or hoses are pinched install the Cover P N 453564167621 over the Battery Tray PCU and WPU Secure the Cover using 4 Screws P N NS111N Configure the network see Section 7 2 3 AT Note Insome cases it may be necessary to temporarily remove the Water Trap to install the Cover 18 Replace the O2 Door Assembly P N 453564173991 on the Cover 7 2 3 Exchange Network Setup MNote The following VERY IMPORTANT steps must be performed following an exchange 7 2 3 1 Network Channel Options Obtain the system Network via the network label on the back of the PMC or obtain it by observing the network indicator at the bottom right of the DCU screen Ensure that a VGA display and a keyboard are connected to the PMC Enter the keyboard navigator by typing nav Press F4 to enter the SETUPS menu Select SERVICE BIO MED then SYSTEM CONFIG and finally NETWORK Enter the password the password is for Philips personnel only and can be attained by calling Technical Support to set the network option per the observed customer DCU network indicator WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MAT
26. MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 38 of 82 Section 6 Test and Inspection 6 5 3 6 2 02 Sensor Verification Setup e With the Artema O2 Sensor into sensor port at the back of the Cart select GAS CAL 02 INIT CAL in the SERVICE MENU Verification Verify that the 02 sensor is within its expiration date Verify an O2 value of 21 percent is displayed at ambient oxygen in the Agents box after calibration is completed Verify an O2 value of 21 percent is displayed at ambient air in Agents box after the calibration is completed f the sensor being tested does not give the appropriate results but a second sensor does operate properly lead troubleshooting procedures need to be undertaken 6 5 3 7 ETCO2 Flow Test Verification perform only if AB151 ETCO2 installed A Setup e With ETCO2 turned ON in the SETUPS PARAMETER SELECTION menu a sample line connected to the agents water trap the warm up period satisfied and ZERO CAL selected A Verification Verify that READJUSTING CO2 ZERO is displayed at the top center of the DCU screen B Setup e With a water trap installed a sample line connected to the water trap and the Flowmeter connected to the end of the sample line B Verification Verify that the flow is 80 ml min 16ml min C Setup e Block the sample line input WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY REL
27. Part Description 12NC CMS 453564067261 BATTERY MRI 14 8V 5 08 AH 453564178401 NUT HEX M10 X 1 5 8MM THICK SS 316 989803162961 TETHER KEY TOOL 989803152221 CAB POWER ADAPTER 5FT 3155 SER WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 63 of 82 Section 8 Service Parts Part Number 12NC CMS Non Exchange Service Part Description Continued WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 64 of 82 Section 8 Service Parts 8 2 Exchange Service Parts The following Exchange service parts are available Exchange P N 12NC CMS Exchange Service Part Description WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 65 of 82 Section 8 Service Parts 8 3 System Preventative Maintenance Parts The following Preventative Maintenance parts are available Invivo Part Number 12NC Preventative Maintenance Part Description Quantity Y 9003 4saseaos7261 BATTERY MAL 16 8V 508 HA A 5065 saaeoaiseger BATTERY 37v WRIS PAT MoE 3160 ANO 2 8 4 Service Numbers and Replacement Exchange Parts The
28. RE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 42 of 82 Section 7 Removal and Replacement 6 After ensuring that all loose parts are secure carefully tilt the Cart forward and while supporting the WPU remove the 4 Screws P N 453564157091 that secure the WPU to the Base Casting Discard the 4 Screws 7 Remove the 3 Screws P N 453564155961 that secure the Shield P N 453564088281 to the chassis and then remove the Shield Discard the Screws 8 Disconnect the Battery Cable from AS222 WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 43 of 82 Section 7 Removal and Replacement 9 Disconnect the Antenna from the WPU 10 Remove the WPU from the Cart Remove the Antenna Mast from the Antenna Bracket Place the WPU and the Antenna aside for return shipment WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 44 of 82 Section 7 Removal and Replacement 7 1 2 WPU Replacement into the Cart 1 Remove the replacement WPU from the shipping container along with the supplied accessories Insert the Antenna Mast into the Antenna Bracket 2 Secure the A
29. S COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 52 of 82 Section 7 Removal and Replacement 11 Label and then disconnect all the pneumatic hoses from the WPU ports 12 Remove the 4 Screws P N 453564157171 and the 4 Spacers P N 453564168171 that secure the PCU to the WPU Then remove the PCU from the WPU and set the PCU aside WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 53 of 82 Section 7 Removal and Replacement 13 Carefully flip the WPU over and remove the 4 Screws that secure the WPU to the Mounting Plate Place the WPU aside for shipment 7 2 2 WPU Replacement into the PMC 1 Remove the replacement WPU from the shipping container along with the supplied accessories Secure the WPU to the Mounting Plate P N 453564166021 using 4 Screws NN D A A P N 453564168691 CAUTION Torque the Mounting Plate Screws to 40 lb ft 1 Ib ft WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 54 of 82 Section 7 Removal and Replacement 2 Carefully flip the assembly over and place the PCU atop the WPU 3 Connect th
30. Servico Partida diana 63 3 1 Nom Exchange Service PS a a REE 63 22 EX Nane c Serce PAINS arnar E E te 65 8 3 System Preventative Maintenance Palts cccccssccssccssccseccsecesecescceeccesceeeceeeeeeceseenaes 66 8 4 Service Numbers and Replacement Exchange Parts cccccccccsssssssssssseseseeeeeecccseeseeeees 66 Listof SYMDO l is id S AA AAAAA 69 1 INTRODUCTION This Express Service manual is intended for use by qualified service personnel for the repair and maintenance of the Expression MRI Patient Monitoring System This manual contains information regarding the installation intended use accessories and troubleshooting of a fully equipped Expression MRI Patient Monitoring System The terms Cart and Patient Management Configuration PMC are used throughout this document to refer to the configurations of the Expression MRI Patient Monitoring System Specific differences between available configurations where applicable are noted in the text Some information in this manual may depict monitoring features that your system does not contain For information on features and enhancements that are not included in your system contact Invivo Corporation at 800 331 3220 or your Invivo sales representative For additional information about your accessories please consult the documentation that accompanied the accessory 1 1 About this Manual This manual contains the following sections LJ Section 1 Introduction page 1
31. THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 37 of 82 Section 6 Test and Inspection D Setup e With AGENTS turned ON and PATIENT set to NEO in the SETUPS PARAMETER SELECTION menu a sample line connected to the agents water trap and the Flowmeter connected to the end of the sample line open the exhaust port D Verification Verify that the flow is 150ml min 15ml min E Setup e With the water trap removed the Flowmeter connected to the left port of the water trap receptacle as viewed when facing the monitor and the right port of the water trap receptacle left open E Verification Verify that the flow is 35ml min 15ml min F Setup e With the water trap removed the Flowmeter connected to the right port of the water trap receptacle as viewed when facing the monitor and the left port of the water trap receptacle left open F Verification Verify that the flow is 165ml min 15ml min G Setup e With 10 76mmHg CO2 applied to the unit allow CO2 gas to flow for at least 2 minutes G Verification Verify that the unit detects CO2 and measures 76mmHg 9mmHg Also verify the respiration count does not exceed 0 while gas is flowing WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS
32. Testing Recommended Frequency of Testing Recommended once a year or as specified Performance Assurance by local laws and after any type of repair of the unit Regular Preventative Maintenance Recommended once a year or after repair WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 27 of 82 Section 6 Test and Inspection 6 5 Test Process Description The system under test must be handled in compliance with ESD procedures and as detailed below 6 5 1 Test Equipment Requirements The following equipment is required when testing the Expression Patient Monitoring System 6 5 2 453564185591 Wireless WECG Module with AC599 ECG leads 453564185581 Wireless SP02 Module Gen 2 with a 452213305371 SpO2 Fiber Optic Sensor 989803169201 Power Adapter MRI with cable AC517A AC517B plus AC power cord HE02 DCU Cart rechargeable battery P N 9093 453564067261 or 989803169491 partially discharged WSPO2 WECG rechargeable battery P N 9065 A standard computer keyboard and VGA computer monitor w video port cable Adult NIBP cuff IRI 9070E Neonatal NIBP cuff IRI ANO1A Class II Patient Simulator medSim 300 model or equivalent Pressure IBP Simulator Body Temp Probe 989803162531 OMEGA FL 211 Flowmeter or equivalent and sample line Manometer Baumanometer or equivalent C
33. Thus hazardous waste of spent cells and batteries can be disposed after they are first neutralized through an approved secondary treatment prior to disposal as required by U S Land Ban Restriction of the Hazardous and Solid Waste Amendments of 1984 Disposal of spent batteries must be performed by authorized professional disposal company which has the knowledge in the requirements of the Federal the State and the Local authorities regarding hazardous materials transportation and waste disposal Confirm proper disposal requirements with your healthcare facility distributor and or local EPA office WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 11 of 82 Section 3 System Overview WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 12 of 82 4 SYSTEM INSTALLATION This section provides instructions regarding the installation of the Expression MRI Patient Monitoring System Observe the following warnings cautions and notes when installing setting up and using the Expression MRI Patient Monitoring System WARNING Do not use the Expression MRI Patient Monitoring System in the presence of flammable anesthetics Always verify proper communication of the Expression with the c
34. WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 30 of 82 Section 6 Test and Inspection 6 5 3 4 NIBP Verification 6 5 3 4 1 Pneumatic Leak Test High 1 row Setup e With the patient setup as ADULT connect an Adult cuff IRI 9070E and hose to the NIBP ports Tightly wrap the cuff around a fixed object Verification Verify that at the end of each leak test cycle a minimum of two cycles the difference between PEAK and FINAL is lt 10 6 5 3 4 2 Pneumatic Leak Test Low 2 row Setup e With the patient setup as ADULT connect an Adult cuff IRI 9070E and hose to the NIBP ports Tightly wrap the cuff around a fixed object Verification Verify that at the end of each leak test cycle a minimum of two cycles the difference between PEAK and FINAL is lt 10 6 5 3 4 3 NIBP Offset Verification Setup e Apply no pressure Verification Verify in the SETUPS SERVICE BIO MED NIBP TEST CALIBRATE menu that the offset reading on the primary PRI port is 10 2 WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 31 of 82 Section 6 Test and Inspection 6 5 3 4 4 Calibration Accuracy Check A Setup e PATIENT mode set to ADULT and 250m
35. d in a dry place at a temperature between 0 C to 40 C The Expression MRI Patient Monitoring System uses rechargeable batteries that contain hazardous material These batteries must be recycled or disposed of properly Refer to disposal guidelines listed below Do not disassemble or incinerate the battery WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 10 of 82 Section 3 System Overview 3 2 5 1 Guidelines in Europe The European Community EC has issued two directives regarding battery disposal 91 157 EEC and 93 86 EEC Each member country implements these independently Thus in each country the manufacturers importers and users are responsible for the proper disposal or recycling of batteries Confirm proper disposal requirements with your healthcare facility or distributor ix 3 2 5 2 Guidelines in the United States The U S Federal Environmental Protection Agency EPA hazardous waste regulations as conveyed by the Resources Conservation and Recovery Act RCRA neither specifically list nor exempt lithium batteries The only metal of possible concern in the battery is the lithium metal that is not listed or characterized as a toxic hazardous waste Significant amount of spent cells and batteries that are untreated and not fully discharged are considered as reactive hazardous waste
36. e Battery Cable to AS222 Then while ensuring that the Antenna Mast extends into the bracket aperture secure the Antenna to the connector on the WPU 4 Secure the Battery Cable Ground Lugs to AS222 using the 2 Screws P N 453564109901 WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 55 of 82 Section 7 Removal and Replacement 5 Position the Shield P N 453564165251 over AS222 and then secure it to the WPU using 3 Screws P N 453564155961 MNote It may be necessary to manipulate the Battery Cable to allow the Shield to properly seat 6 Install a Cable Tie P N HC19 through the clamp and around the Battery Cable Pull the Cable Tie snug then trim the excess length 7 Secure the Multifunction Cable P N 453564163331 to the PCU DCU Connector on the WPU chassis WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 56 of 82 Section 7 Removal and Replacement 8 Position the Multifunction Cable to provide a small service loop at the connector and then install 2 Cable Ties P N HCO4 Pull the Cable Ties snug then trim the excess length 9 Connect the LED TEMP and IBP cables to the respective connectors on the WPU 10 Route a
37. ed through the internal battery charger The accompanying DCU can be located in the MR system room MR control room or MR holding area For added flexibility the system can also be configured with two WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 5 of 82 Section 3 System Overview additional DCUs Refer to the Expression IFU manual for warnings cautions and instructions regarding the DCU 3 2 1 Battery Operation Cart PMC and DCU The Cart PMC and DCU batteries are interchangeable Depending upon your equipment type the number and location of the batteries P N 989803169491 will differ e The Cart has two batteries located on the underside of the unit e The DCU has two batteries located on the left and right sides of the unit e The PMC has two batteries located beneath the latched top cover on the unit The lower portion of the DCU contains the System Status area dedicated to displaying the battery and wireless communication status see Section 6 5 3 Refer to Expression IFU manual for a full explanation of the Battery Status Display Maximum operation time of the Cart PMC and DCU batteries is approximately 8 hours when anesthetic agents and CO are turned off and NIBP ECG and SpO parameters are running at 5 minute intervals Battery operation time will be reduced by up to 2
38. erate may result If operation of the DCU is necessary in close proximity to the 1 000 Gauss 0 1T field line position the DCU so that the printer is on the opposite side of the gurney If the printer option is not present the DCU may be used at or outside the 5 000 Gauss 0 5T field line as measured from the center line of the MR bore WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 20 of 82 Section 4 System Installation 4 5 Additional Installation Options Additional installation options such as those listed below may increase operator ease of use as the Expression DCU Cart and PMC are configured with input output ports that permit connections to external equipment e Connection to an external projector e Connection to an external monitor e Connection to facility information systems CAUTION When using the input output connections on the back of the DCU Cart or PMC verify that the final installation complies with IEC EN 60601 1 1 General Requirements for the Safety of Medical Electrical Systems to assure operator and patient safety Always check the summation of leakage currents when the Expression MRI Patient Monitoring System is connected to additional external equipment Do not remove the input output door or leave the input output port uncovered while in the MR system room
39. ery _ Remote Display Power Potential Serial Fiber Optic restrictions for Communications Temperature equipment Port including radios may apply within one or more European EU member states End Tidal CO Warning Shock Pneumatic O Anesthetic Hazard Respiration Agents Do Not Adjust Radio Network Hardwire Link Without Wireless Referring Modules To Service Manual Network A Waste Gas Cardiac ECG Output Gating Output Network B End Tidal CO MR Conditional O Anesthetic A Agents Input Network C Wheel Brake Device E conforms to 097 the R amp TTE Directive fir Radio amp Telecom munications Terminal Equipment WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 71 of 82 Section 9 List of Symbols Network D Underwriters Radio Network ple Laboratories UL Expression cus Classified Mark WPU Base to UL 60601 1 for the United DCU NF UN States and Patient Monitoring System Canada Network E Dispose of in accordance with Rotate your country s Counter requirements l NF clockwise to OPEN Ensure power Ensure power supply P N supply P N 989803169201 Eta n 989803168201 O Rotate 10 FT 7 3M 7 remains 10 feet remains 10 feet Clockwise to 3 meters or 3 meters or CLOSE more from the more from t
40. for the remaining Battery 3 Remove the O2 Door Assembly P N 453564173991 from the PMC Cover 4 Remove the Water Trap from the Water Trap Receptacle WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 50 of 82 Section 7 Removal and Replacement 5 Remove the 4 Screws P N NS111N that secure the PMC Cover P N 453564167621 to the Base and then carefully lift the Cover off the Base It may be necessary to push slightly on the Battery Tray 6 Disconnect all Fiber Optic and Multifunction Cables from the WPU chassis 7 Cut the Cable Ties that secure the Multifunction Cable to the WPU chassis WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 51 of 82 Section 7 Removal and Replacement 8 Cut the Cable Tie that secures the Battery Cable to the chassis Also remove the Antenna then place it aside for shipment 9 Remove the 3 Screws P N 453564155961 from the Shield P N 453564165251 and then remove the Shield from the WPU 10 Remove the 2 Screws that secure the Battery Cable Ground Lugs to the WPU chassis Then disconnect the Battery Cable from AS222 and move the assembly aside WARNING THIS PAGE CONTAIN
41. he C oes 69201 989803168201 MR system MR system DO NOT Move DO NOT Move DO NOT Move Expression DCU Expression Expression Cart with Printer Patient Configuration Inside 1 000 Management Inside 5 000 Gauss Line as Configuration Gauss Line as measured from Inside 2 000 measured from the center line of Gauss Line as the center line the bore off measured from of the bore the center line of lt 2000 G the bore Federal Communications Commission WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 72 of 82 Section 9 List of Symbols PHILIPS WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 73 of 82
42. he latches Pull the latch holding the battery with one hand Using your other hand pull the battery out from the side opposite the connector of the PMC 3 2 2 Battery Operation WECG and WSpO2 Modules The WSpO and WECG modules have interchangeable batteries P N 9065 These batteries slide and latch into the battery slots in the WECG and WSpO modules WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 8 of 82 Section 3 System Overview 3 2 2 1 Installation and Removal CAUTION The 9065 Battery and wireless module should not be placed in the Field of View to minimize the chance of image artifact MiNote The WECG and WSpO module batteries are non magnetic and can be removed and replaced from the modules while in the MR magnetic field To install batteries into the WSpO and WECG modules slide a battery into the battery slot in the module until the battery latches on each side into place To remove batteries from the WSpO or WECG modules simultaneously press the latches on both sides of the battery then slide the battery out of the module 3 2 3 Safe Battery Use The following warnings cautions and notes shall be observed to ensure the safety of operators and patients WARNING Stop using any battery that exhibits abnormal heat odor color deformation or is in an abnormal c
43. ires Colors Scheme WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 29 of 82 Section 6 Test and Inspection Table 2 Table 3 Pati i Patient Si lat ECG Lead Color ASE Imu Do ECG Lead s ore ie al Terminals Lead Wires GREEN R S WHITE BLACK WHITE RA f I WHITE RED BLACK lAa f m BLACK RED e Set the Patient Simulator to output a 1 0mV QRS pulse at 6O0BPM NORMAL SINUS mode e Power up the WECG remote by inserting a rechargeable battery e LEAD 1 1 0mV Within the EC menu of the simulator set TRACE A LEAD to SCALE of 10 mm mV HR TONE SOURCE and select QRS Verification DCU TRACE A shows a waveform sequence of moving QRS pulses without jitter The ECG numeric shows a count of 60 1BPM The QRS Heart Rate Tone is present with NO double tones 6 5 3 3 WSpO2 Communication Perform the following test to verify WSPO2 Communication with the DCU Setup e Inthe SETUPS PARAMETER SELECTION enable SpO2 e Connect a SpO2 probe to the WSPO2 sensor and power up with a battery Verification With the no finger placed inside the probe verify that PROBE OFF is displayed With a finger tip placed inside the probe verify an SPO2 pulse waveform With a finger tip placed inside the probe verify that a reasonable SPO2 number 95 100 is displayed
44. lass II DMM or equivalent Chest Pneumograph sensor bellows PN 94023 Initial AC Power Up With the Power Supply P N 989803169201 or P N 989803168201 connected to the AC mains power verify that the Power Indicator LEDs on the DCU and Cart or PMC are illuminated GREEN 6 5 3 6 5 2 1 ETCO2 Option Only Verify that the ETCO2 parameter is turned ON in the SERVICE SYSTEM CONFIG menu Operational Tests Use the tests in this section to verify system operations WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 28 of 82 Section 6 Test and Inspection 6 5 3 1 System Communication Verification With the DCU and Cart or PMC powered up and booted verify communication COMM between the DCU Cart and the WECG and WSPO2 remotes Verify that for all Conditions Tested the icons for the DCU WPU WECG and WSPO2 remotes are present on the DCU as depicted in Table 1 below Table 1 Conditions DCU System Icons Tested DC Power batteries only AC Power with batteries installed AC Power without batteries installed No COMM 6 5 3 2 WECG Communication Perform the following test to verify WECG Communication with the system Setup e Attach the leads of the WECG remote to the medSim Patient Simulator as indicated in Table 2 below Table 3 illustrates the ECG Leads to Lead W
45. ll Fiber Optic cables behind the Antenna PCB as shown WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 57 of 82 Section 7 Removal and Replacement 11 Except for the ZERO hose reconnect the pneumatic hoses to the respective ports on the WPU 12 If equipped with Agents proceed to Step 13 otherwise cut Hose P N HP115 to 15 inches 6 cm then connect one end to the ZERO port on the WPU and connect the other end to the Zero Port Filter Install a Cable Tie P N HC19 through the clamp then loosely around the ZERO Hose Trim any excess Cable Tie length 13 Install the Water Trap P N HP168 for Agents or P N HP174 for ETCO2 on the Water Trap Receptacle on PCU WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 58 of 82 Section 7 Removal and Replacement 14 Install the 4 Spacers P N 453564168171 and then secure the PCU using the 4 Screws P N 453564157171 CAUTION Position the PCU so that the Screws are positioned at the back of the slots also ensure that the Antenna Mast remains captured 15 Dress the cables and hoses through the cable clamp then close the clamp 16 Test the functions see Section 6 WARNING T
46. muHg pressure applied to NIBP Pump right port A Verification Verify that the PRESS READING of the SEC transducer in the NIBP CAL window indicates 250 t5mmHg B Setup e PATIENT mode set to ADULT and 250mmuHg pressure applied to NIBP Pump right port B Verification Verify that the PRESS READING of the PRI transducer in the NIBP CAL window indicates 250 t5mmHg 6 5 3 4 5 Overpressure Adult A Setup e Set the pressure applied by the NIBP right port to 295 4mmHg A Verification Verify that over pressure bleed down occurs and that OVER PRES is displayed B Setup e Set the pressure applied by the NIBP right port to 285 4mmHg B Verification Verify that OVER PRES is displayed WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 32 of 82 Section 6 Test and Inspection 6 5 3 4 6 Overpressure Neonatal A Setup e With PATIENT mode set to NEO set the pressure applied by the NIBP right port to 150 4mmHg A Verification Verify that over pressure bleed down occurs and OVER PRES is displayed B Setup e With PATIENT mode set to NEO set the pressure applied by the NIBP right port to gt 142 but lt 150 mmHg B Verification Verify that the OVER PRES alarm activates within 15 seconds C Setup e With PATIENT m
47. nocccanininons 34 6 5 3 4 9 Neo Natal BP ocu cid 34 6 5 3 4 10 Neo Natal Dead Man Cuff ooocccnnccccnnccnnnnnnnonnnnnnncnnonanonss 35 6 0 3 4 11 Leak MME OUT Adalid 35 6 5 3 4 12 Leak Time Out Neo Natal c ooccoccnccnccnnccnncnnccnccnnconconoso 35 E Cali Date EV FOR ara TE AA AAAA 36 6 5 3 5 Invasive Pressure VerifiCatiOn cccccscscsccscsccececscscaccececscaceecscaeens 36 SaO Agents Verica ON csi 37 ESOL ABN FIOW Testo criada 37 6 5 3 6 2 02 Sensor Verification oooccoccccconccnnnnnnononcnnnnnncnnannnoss 39 6 5 3 7 ETCO2 Flow Test Verificati Ninnie a a e 39 ESS RESDIFAtION V CLITICALION eier a T S 40 603 Temperature Verica ON sisas 40 654 Electrical Saret Tes nr nee TANA 40 Removal and Replacements a 41 EL Te Cat Write 41 7 1 1 WPU Removal from the CafFt oo ccooccccnococccoccncooonncnnonnnconnnnnononnnononnnnnnnnncononnnonnnnnonnnnnnns 41 71 2 WP0O Replacementinto ne Callas 45 7 13 Exchange Network SCUUD static lili 48 FLL NETWORK Channel Opos aa a aa 48 7123 2 Exchange Parameter DISAQNING is 49 12 TEPME WP U sua iii iia o eae 49 TZ WPU Removal Irom tie PIMC cess seria sates ces Rete tea e eee 49 7 2 2 WPU Replacement into the PMC iiiscictetissaneinitecicaititiseiainatines nia 54 72 5 Exchange Network SetUDiasiiia dai dla delia 60 7 2 3 1 Network Channel OptONS siii tia 60 7 2 3 2 Exchange Parameter Disabling ooocoooorocoooorenononononocncnonorennonoress 61
48. ntenna to the Antenna Connector on the WPU 3 Carefully place the WPU into the Cart Ensure that the WPU is not pinching the Battery Cable then connect the cable to AS222 WARNING Use care when connecting the Battery Cable as sharp edges can cause damage to the wiring WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 45 of 82 Section 7 Removal and Replacement 4 Attach the Shield to the WPU using the 3 Screws P N 453564185231 from the supplied Screw Kit P N 453564185221 5 Connect the Multifunction Cable to the PCU DCU Connector on the WPU and then tighten the Connector Retaining Screws 6 Connect the LED TEMP and IBP cables to the respective connectors on the WPU WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 46 of 82 Section 7 Removal and Replacement 7 Verify again that the Battery Cable is not pinched Start 4 Screws P N 453564157091 from the supplied Screw Kit P N 453564185231 through the Base Casting and into the WPU Then carefully tilt the Cart forward and tighten the 4 Screws 8 Reconnect all the pneumatic hoses to the respective ports on the WPU 9 Replace the Cover by the Power Box using
49. o the NIBP ports the cuff placed around a finger that is held above shoulder height to insure blood pressure is below 100mmHg start the NIBP function Verification m Verify that the cuff inflates to approximately 130mmHg and that the cuff deflates when a blood pressure determination has been reached m Verify that systolic mean and diastolic pressure numerics are present in the NIBP menu and that the values are normal for the operator s neo finger pressure WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 34 of 82 Section 6 Test and Inspection 6 5 3 4 10 Neo Natal Dead Man Cuff Setup e With the PATIENT mode set to NEO a neonatal cuff IRI ANO1A connected to the NIBP ports and the cuff placed around a fixed object with an approximate diameter of 1 inch start the NIBP function Verification Verify that the unit displays a zero reading at the end of the NIBP cycle 6 5 3 4 11 Leak Time Out Adult Setup e With the PATIENT mode set to ADULT all cuff connections removed and all NIBP ports open start the NIBP function Verification Verify that the pump shuts off within 6 seconds 1 5 seconds and that the error message NOT INFLATING is displayed in the NIBP menu 6 5 3 4 12 Leak Time Out Neo Natal Setup e With the PATIENT mode set to NEO all cuff connection
50. ode set to NEO set the pressure applied by the NIBP right port to 156 4mmHg C Verification Verify OVER PRES is displayed A Note The pressure will not fall during this test step D Setup e With PATIENT mode set to NEO set the pressure applied by the NIBP right port to gt 142 but lt 150 mmHg D Verification Verify that the OVER PRES alarm activates within 15 seconds 6 5 3 4 7 Adult Cuff Test Setup e With an adult cuff IRI 9070E connected to the NIBP ports and the cuff placed around an arm start the NIBP function WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 33 of 82 Section 6 Test and Inspection Verification Verify that the cuff inflates to approximately 170mmHg and that the cuff deflates when a blood pressure determination has been reached Verify that those systolic mean and diastolic pressure numerics are present in the NIBP menu 6 5 3 4 8 Adult Dead Man Cuff Setup e With an adult cuff IRI 9070E connected to the NIBP ports and the cuff placed around a fixed object with an approximate diameter of 1 inch start the NIBP function Verification Verify that the unit displays a zero reading at the end of the NIBP cycle 6 5 3 4 9 Neo Natal BP Setup e With the PATIENT mode set to NEO a neonatal cuff IRI ANO1A connected t
51. ods e Remove the AC power cord from the AC mains outlet or e Remove the DC power cord from the rear input port of the device WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 23 of 82 Section 5 System Power Up WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 24 of 82 6 TEST AND INSPECTION This section details Test and Inspection instructions intended to verify system operations 6 1 When to Test When to Perform Tests Installation Perform Visual Inspection and Power ON i Perform Visual Inspection Power ON and Preventative Maintenance Assurance Tests A Perform Visual Inspection Power ON and All Repairs Assurance Tests Perform Visual Inspection Power ON and Upgrade Assurance Test Perform Visual Inspection Power ON and All other service events Assurance Test 6 2 Test and Inspection Matrix Checklist Test and Inspection Matrix AA a AR Inspect the unit and cables for If Yes Visual test Visual PorF a laia is passed Power PowerON Verify normal power up PassorFail or PassorFail Performance A daa Pass or Fail PorF described in the assurance block No saf hi system WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT AR
52. ondition If a battery is punctured or liquid leaks onto your skin or clothing wash skin and clothing with fresh water immediately If liquid leaks from a battery and gets into your eyes do not rub your eyes Wash eyes well with clean water and consult a doctor immediately CAUTION Ifthe battery terminals become dirty wipe them with a clean dry cloth before use Keep the battery terminals away from metal objects MNote Batteries have life cycles If the time that the battery is powering the equipment becomes much shorter than usual the battery life is at an end Remove a battery with an expired life cycle from the equipment immediately Replace the battery with a new Invivo specified battery Refer to Section 8 for part numbers WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 9 of 82 Section 3 System Overview 3 2 4 Battery Charging Instructions Charge the batteries before use When installing the system for the first time all batteries must be charged at least 12 hours with AC power to the Expression turned off so that the batteries are fully charged and conditioned for operation The Cart PMC and DCU batteries are charged by integrated intelligent battery chargers These intelligent charging devices automatically provide the appropriate profile needed to efficiently charge and condition
53. orresponding DCU prior to patient use CAUTION Avoid the use of cellular phones or other radio frequency transmitters in the proximity of an operating Expression MRI Patient Monitoring System Where the integrity of the external protective conductor in the installation or its arrangement is in doubt the system shall be operated from batteries bT Note Do not use two Expression MRI Patient Monitoring Systems in the same MR room as this will lead to communication errors A minor but noticeable degradation in the Wireless ECG and Wireless SpO gt radio communications will occur in the presence of high powered radios 4 1 Power Supply Depending upon the equipped Power Supply observe the following warnings cautions and notes when installing setting up and using the Expression MRI Patient Monitoring System 4 1 1 Part Number 989803169201 WARNING Ensure that the Power Supply P N 989803169201 10 FT 3M remains 10 feet 3 meters or more from the MR per system Mount the Power Supply to a horizontal surface using the pre applied Velcro strips on the O bottom of the supply 989803169201 CAUTION Avoid use of electrical extension cords or Multiple Portable Socket Outlets which may create a safety hazard by compromising the grounding integrity of the Expression MRI Patient Monitoring System WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS
54. s removed and all NIBP ports open start the NIBP function Verification Verify that the pump shuts off within 6 seconds 1 5 seconds and that the error message NOT INFLATING is displayed in the NIBP menu WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 35 of 82 Section 6 Test and Inspection 6 5 3 4 13 Calibrate Error Setup e With the unit NOT in STANDBY mode and 15mmHg pressure applied push the NIBP START STOP key Verification Verify that the pump does not start and that the CALIB message appears within 30 seconds 6 5 3 5 Invasive Pressure Verification A Setup e With P1 amp P2 turned ON in the SETUPS SERVICE SYSTEM CONFIG screen and P1 amp P2 turned ON in the SETUPS PARAMETERS SELECTION menu connect the IBP Simulator to the P1 Port A Verification Verify that the P1 menu on the DCU displays the pressures within the given tolerances as listed in Table 4 below Table 4 Pressure Transducer Simulator Trace P1 Ez Numeric Display AT Note The systolic diastolic and mean values should read within 1mmHg of one another If any readings are out of tolerance change the simulator and cable then repeat the test If the test fails a total of 3 times after 3 unique simulators and cables the IBP module is faulty WARNING THIS PAGE CONTAINS COPYRIGHTED MAT
55. tem Installation Complete the following actions to install the Cart configuration Install the batteries into the Cart see Section 3 2 1 2 Locate the Power Supply and attach the AC Power Cord to the AC Input of the Power Supply see Section 4 1 3 Connect the male end of the 25 ft DC power cable P N AC517B to the DC Output of the Power Supply Position the Power Supply in the MR system room near an approved AC outlet at a distance of at least 10 feet 3 meters from the MR system Plug the female end of the DC power cable into the Power Input of the Cart Position the Cart within the parameters specified in the warnings and cautions above and then lock the wheels Plug the AC Power Cord into the AC outlet 4 3 Patient Management Configuration PMC Observe the following warnings and instructions when installing setting up and using the PMC for the Expression MRI Patient aa Monitoring System The Patient Management Configuration PMC may be used inside the MR system room at or outside the 2 000 Gauss 0 2T field line as measured from the center line of the MR bore Always ensure that no portion of the PMC is closer than 2 000 Gauss 0 2T field line and that the PMC is securely fastened to the mounting surface System failure or patient injury may result if the PMC is brought closer than 2 000 Gauss 0 2T field line WARNING WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR
56. the batteries When the Cart PMC and DCU are plugged into AC power and turned off the battery charger is functional and will automatically charge the batteries When the Cart PMC and DCU are turned ON they operate from AC power and charge the batteries simultaneously When the Cart PMC and DCU batteries are removed from the system the user can determine battery capacity by pressing the battery s Power Level button then observing the LEDs The LEDs indicate the battery capacity in 20 percent increments from 20 100 percent Indications of battery capacity are also available via the DCU see the Expression IFU manual The minimum battery voltage value for normal operation is 14 8V The Wireless ECG and SpO module batteries must be charged by the stand alone Invivo battery charger P N 9023 Refer to the instructions and cautions provided with the battery charger for more information Indications of battery capacity are also available via the DCU see the Expression IFU manual The minimum battery voltage value for normal operation is 3 4V 3 2 5 Battery Disposal Instructions The Expression MRI Patient Monitoring System uses lithium polymer and lithium ion batteries that are subject to strict disposal regulations for user and environmental safety CAUTION Never heat or throw the battery into a fire Heating the battery will damage the safety circuitry which can cause rupture or ignition of the battery Batteries must be store
57. uring shipment Save the packing materials and related shipping documents as these will be required to process a claim with the carrier if damage during shipment occurred To resolve any issues or concerns with your order or product or to report shipping damage contact Invivo Customer Service see Warranty CAUTION The Expression MRI Patient Monitoring System must be used and stored according to the environmental specifications in Appendix A of the Instructions for Use IFU manual Failure to follow these specifications can affect the accuracy of the Expression MRI Patient Monitoring System 1 Open the 4 Snaps that secure the lid to the crate Remove the lid and Foam Insert C from the crate WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 3 of 82 Section 2 Unpacking the System 2 Remove the Accessories Box and Foam Insert B WARNING THIS PAGE CONTAINS COPYRIGHTED MATERIALS THAT ARE CONFIDENTIAL AND OR PROPRIETARY ANY RELEASE OR DISTRIBUTION OF THIS MATERIAL WITHOUT PERMISSION IS A VIOLATION OF LAW 4 of 82 3 SYSTEM OVERVIEW Depending on the system the Expression MRI Patient Monitor has several possible configurations 3 1 Cart Configuration The Cart configuration consists of the following primary components e One Cart including the Wireless Processing Unit WPU e One Display

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