Philips Avalon FM20 Instructions For Use Manual Download Page 164

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20 Printing the ECG Waveform

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Summary of Contents for Avalon FM20

Page 1: ...Instructions for Use Avalon Fetal Monitor FM20 30 FM40 50 Release G 0 with Software Revision G 02 xx Patient Monitoring ...

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Page 3: ...tion 19 Supported Measurements 19 Avalon FM20 and FM30 20 Avalon FM40 and FM50 21 Cordless Monitoring 22 Getting to Know Your Avalon FM20 FM30 23 Getting to Know Your Avalon FM40 FM50 24 Operating and Navigating 27 Operating Modes 32 Automatic Screen Layouts 33 Settings 33 Checking Your Monitor Revision 35 Preparing to Monitor 35 Starting Monitoring 53 Switching the Monitor to Standby 54 After Mon...

Page 4: ... OB TraceVue via RS232 85 8 Non Stress Test Timer 87 Setting NST Autostart Autostop 87 Viewing the NST Timer 87 Timer Expiry Notification 87 Accessing the NST Setup Pop up Keys 88 9 Non Stress Test Report 91 Setting Up an NST Report 91 NST Report Status Window 92 NST Reassurance Criteria 94 Non Reassuring Report 94 Non Reactive NST Test 94 10 Monitoring FHR and FMP Using Ultrasound 95 Technical De...

Page 5: ...tandard Separation Order 123 Classic Separation Order 123 When Trace Separation is Off 124 Troubleshooting 125 13 Fetal Heart Rate Alarms 127 Changing Alarm Settings 127 Changing Signal Loss Delay 128 14 Monitoring Uterine Activity Externally 129 What You Need 129 External Toco Monitoring 130 Toco Sensitivity 130 Troubleshooting 131 Testing Toco Transducers 132 15 Monitoring Uterine Activity Inter...

Page 6: ...ssing a Suspicious SpO2 Reading 152 Understanding SpO2 Alarms 152 Setting Up Tone Modulation 153 Setting the QRS Volume 153 19 Monitoring Maternal Heart Pulse Rate 155 Priority for Maternal Heart Pulse Rate 155 Cross Channel Verification 155 MHR from MECG Electrodes 156 Monitoring MECG Wave 158 Pulse Rate from SpO2 159 Pulse Rate from Toco MP 159 Adjusting the Heart Rate Pulse Alarm Limits 160 Ave...

Page 7: ... MECG Accessories 181 Noninvasive Blood Pressure Accessories 181 SpO2 Accessories 183 Recorder Paper 187 26 Specifications and Standards Compliance 189 Environmental Specifications 189 Physical Specifications 190 Performance Specifications 191 Recorder Specifications 201 Battery Specifications 203 Alarm Defaults 204 Compatible External Displays FM40 FM50 Only 204 Manufacturer s Information 205 Tra...

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Page 9: ...or may not have all of the features and options described in this guide The exact appearance of the monitor may differ slightly from that shown in the illustrations In this guide A warning alerts you to a potential serious outcome adverse event or safety hazard Failure to observe a warning may result in death or serious injury to the user or patient A caution alerts you to where special care is ne...

Page 10: ...nd transducer It is possible to pick up maternal signal sources such as the aorta or other large vessels Misidentification may occur when the MHR is higher than normal especially when it is over 100 bpm When using a fetal scalp electrode Electrical impulses from the maternal heart can sometimes be transmitted to the fetal monitor through a recently deceased fetus via the spiral scalp electrode cab...

Page 11: ...rding patient data and parameter values and for generating alarms from fetal and maternal parameters transmitting patient data and parameter values to a patient information and surveillance system use by trained health care professionals use in antepartum testing areas in labor and delivery rooms and during postpartum recovery in the hospital environment They are not intended for use in intensive ...

Page 12: ...he fetal heart rates of single fetuses twins and triplets in labor and delivery rooms in antepartum testing areas in private households and during transports in healthcare facilities Avalon Fetal Maternal Monitor FM40 Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity heart rate oxygen saturation non invas...

Page 13: ...ection of delivery unpack and check the shipment see Unpacking and Checking the Shipment on page 14 2 Mount the monitor as appropriate for your installation see Mounting the Monitor on page 15 3 Connect the fetal monitor to AC mains using the supplied power cord This configuration varies depending whether an external power supply battery option is used see External Power Supply M8023A on page 58 4...

Page 14: ...be charged and that the monitor can be powered by the battery 12 Test Transducers see Testing Ultrasound Transducers on page 112 and Testing Toco Transducers on page 132 Step Task Check Box when Task Done System Components Accessories and Supplies FM20 FM30 FM40 FM50 Toco Transducer with belt clip optional optional Toco MP Transducer with belt clip 1 1 1 1 US Transducer with belt clip 1 1 1 1 Pati...

Page 15: ...an advise you on alternatives Mounting the Monitor FM20 30 The monitor can be rested on a flat surface set at an angle using the built in stand or mounted on a wall on a cart or on a rollstand See the Service Guide for details FM40 50 The monitor can be rested on a flat surface or on a cart See your monitor s Service Guide for details Mounting the External Power Supply M8023A The external power su...

Page 16: ...g current power source of 100 V to 240 V 10 and 50 or 60 Hz 5 WARNING Always use the supplied power cord with the earthed mains plug to connect the monitor to an earthed AC mains socket Never adapt the mains plug from the power supply to fit an unearthed AC mains socket Check that the line frequency is correctly set for your institution 50 Hz or 60 Hz before putting the monitor into service FM20 F...

Page 17: ...9 for details Installation Preventive Maintenance Functionality Test FM20 30 with Battery Option E25 Only After power up touch the battery status indicator in the bottom right of the screen The battery status window should open Check to see if there is an exclamation mark flashing in the gauge Press the Main Screen key to close the window and return to the main screen Installation Preventive Maint...

Page 18: ... outlet is used the resulting system must be compliant with IEC EN 60601 1 1 Do not connect any devices that are not supported as part of a system Do not use a device in the patient vicinity if it does not comply with IEC EN 60601 1 The whole installation including devices outside of the patient vicinity must comply with IEC EN 60601 1 1 Any non medical device including a PC running an OB TraceVue...

Page 19: ...ew of alarms The remaining sections tell you how to perform individual measurements and how to care for and maintain the equipment Supported Measurements The following Fetal Measurements are supported Fetal Monitor or Model Fetal Heart Rate FHR via US including Twins Triple FHR via US Toco FHR via Direct ECG DECG Intrauterine Pressure IUP FM20 Standard Optional Standard FM30 Standard Optional Stan...

Page 20: ...isplayed on a 6 5 inch color display as numerics The display is a touchscreen and you operate the monitor using this touchscreen interface The integrated recorder documents fetal and maternal measurements as well as user defined annotations You can connect the monitor to an OB TraceVue system via the RS232 connection or over a LAN connection with OB TraceVue Revision E 00 00 and later Fetal Monito...

Page 21: ...cally uploaded to OB TraceVue after reconnecting to the system Trace printing during transport is also possible Avalon FM40 and FM50 This section outlines the capabilities of your monitor Avalon FM40 The Avalon FM40 fetal maternal monitor provides a solution for external fetal monitoring applications and non invasive maternal vital signs You can monitor fetal heart rates FHRs externally using ultr...

Page 22: ...r wired transducers When an Avalon CTS base station is connected via the appropriate interface cable to the fetal monitor and there are also wired transducers connected to the monitor the wired transducers are disabled whenever a cordless transducer is active To change back to using wired transducers dock the cordless transducers in the Avalon CTS base station or switch the base station to Standby...

Page 23: ...Avalon FM20 FM30 Overview Right Side with Battery Option 1 Touchscreen Display tilt and fold 2 Power LED 3 Paper Drawer 4 Paper Drawer release 5 Connectors see Left Side view 6 On Off Switch 7 Power Connector 8 On Standby Switch 9 MSL Connector ...

Page 24: ...Transducer System base station connected via the interface cable M2731 60001 or event marker 1 On Standby Switch 2 Power LED 3 Recorder Paper Table 4 Touchscreen Color Display 5 Transparent Paper Guide with tear off edge 6 Paper Eject Button Press to open paper drawer Press again and hold when removing paper 7 Fetal Sensor Sockets Connect any fetal sensor or patient module here including Avalon CT...

Page 25: ...tial Grounding Point 3 Power Cord Connector 4 Loudspeaker 5 Slot 01 for optional LAN RS232 system interface for connection to an obstetrical information and surveillance system 6 Slot 02 for optional interfaces Either dual PS 2 system interface A for mouse and keyboard connection Or MIB interface B for external touch screen connection 7 Slot 03 reserved for future use 8 Video Output VGA 9 Telemetr...

Page 26: ...is identical to the M2736A US transducer including all specifications Toco Transducer with ECG IUP capability M2735A 5 Connector for connecting ECG IUP adapter cables M2735A Toco transducer only 6 Butterfly Belt Clip shown fitted for use with belts without button holes 7 Close up of MECG adapter cable connected to Toco transducer 8 Close up of active Finder LED ...

Page 27: ... measurement numerics screen keys information fields status indicators alarms fields and menus FM40 50 If an optional external touch display with a MIB interface board are connected to the monitor you can operate the monitor using the external touch display Screen Elements Monitor Information Line 1 INOP and alarm status area shows active alert messages 2 LAN connection status indicator only RS232...

Page 28: ...ot connected to the interface cable disconnected from AC mains or is in Standby Avalon CTS interface cable is connected to the monitor Avalon CTS base station is connected powered on and cordless transducers are ready to use but no cordless transducers are currently active all are still docked in the base station Avalon CTS interface cable is connected to the monitor Avalon CTS base station is con...

Page 29: ...timer if configured default is Off Keys The monitor has three different types of keys Permanent Keys A permanent key is a graphical key that remains permanently on the screen giving you fast access to functions Good full acceptable medium Poor no signal Silence acknowledges all active alarms by switching off audible alarm indicators Main Screen closes all open menus and windows and returns to the ...

Page 30: ...ion is infinite this key is labeled Alarms Off Select again to immediately re enable alarm indicators Paper Advance advance the paper automatically to the next fold Start Recordng turn the trace recorder on Stop Recordng turn the trace recorder off Start ECG start printing the MECG DECG or both waves when both are available Stored Data Rec print trace data from the monitor s memory Admit Dischrge ...

Page 31: ...n Start Stop start stop manual noninvasive blood pressure measurement start auto series stop current automatic measurement within series Stop All stop all noninvasive blood pressure measurements Start NBP start manual noninvasive blood pressure measurement start auto series Stop NBP stop manual noninvasive blood pressure measurement stop current automatic measurement within series Repeat Time set ...

Page 32: ...sscode protected Monitoring Mode This is the normal mode for monitoring patients You can change elements such as alarm limits and so forth When you discharge the patient these elements return to their default values Changes can be stored permanently in Configuration Mode You may see items such as some menu options that are visible but grayed out so that you can neither select nor change them These...

Page 33: ...erates is controlled by its settings They determine screen content layout high and low alarm limits and so forth The active settings are the current settings the monitor uses including any adjustments made by the last user Active settings are not permanent but are retained after a loss of mains power There are also two preconfigured default settings User Default Factory Default User Default The Us...

Page 34: ...rement numeric select the measurement numeric on the screen to enter its setup menu For example to enter the Setup FHR1 menu select the FHR1 fetal heart rate 1 numeric via the Main Setup SmartKey if you want to setup a measurement when the measurement is switched off use the Main Setup SmartKey and select Measurements Then select the measurement name from the pop up list With this SmartKey you can...

Page 35: ...om the monitor s info line to enter the Date Time menu 2 Select in turn the Year Month Day Hour in 24 hour format and Minute as necessary 3 Select Store Date Time to change the date and time If connected to a Philips OB TraceVue system the monitor uses the OB TraceVue system date and time including daylight saving time changes WARNING Changing the date and time while the monitor is connected to an...

Page 36: ...t the monitor to AC mains The green LED comes on Press the On Standby switch The monitor performs a self test as it starts up Selftest OK the serial number and revisions for the software and firmware are printed on the fetal trace paper if recorder Auto Start is configured to On The monitor display comes on There is a start up tone from the loudspeaker Adjusting the Display Angle FM20 FM30 FM20 30...

Page 37: ... If you want to tilt the display further lift the display further forwards until you reach the desired angle To fold the display 1 Pull the display forwards as far as it will go 2 Then push it all the way back until it clicks shut If your monitor is wall mounted the display should be folded flat ...

Page 38: ...stened 2 Lie the patient on the bed and arrange the belt around her until it is tight but still comfortable 3 Fasten the belt by pushing the fixing button through the overlapping section of the belt Ensure that the fixing button and the loose ends of the belt are at the patient s side 4 When you have positioned a transducer satisfactorily you can attach it to the belt by pushing the belt button on...

Page 39: ...een the belt guides on the other side of the butterfly belt clip adjust for the correct tension then secure with the velcro fixing 1 Fasten one end with velcro fixing 2 Belt guides 3 Pull the other end through adjust for tension and secure with velcro fixing WARNING When connecting devices for acquiring measurements always position cables and NBP tubing carefully to avoid entanglement or potential...

Page 40: ...ernal non invasive blood pressure connect the cuff to the socket marked or NBP depending on geography For the FM40 and FM50 you can connect an Avalon CTS Cordless Fetal Transducer System interface cable M2732 60001 black connector to one of the two dedicated black sockets marked Tele at the rear of the monitor as an alternative to using one of the fetal sensor sockets at the front 1 SpO2 socket 2 ...

Page 41: ... triplets the first transducer you connect is automatically allocated a channel and the measurement is labeled FHR1 the second FHR2 and the third FHR3 See also chapters Monitoring Twin FHRs on page 113 and Monitoring Triple FHRs on page 121 When you touch a measurement numeric on the screen the setup menu for that measurement opens The fetal sensor socket to which the transducer for this measureme...

Page 42: ... recorder in the FM40 and FM50 features a transparent paper guide which facilitates correct alignment of the paper both during loading and while the recorder is running See Loading Paper FM40 FM50 on page 45 incorporates a tear off edge which not only allows you to tear off the trace paper where you like not necessarily at a fold but also helps to avoid paper misalignment while doing so see Tearin...

Page 43: ...3 Basic Operation 43 A Protrusion holds paper guide in closed position 3 Release the paper guide from one side of the holder 4 then remove the paper guide ...

Page 44: ...tKey or the Stop Recordng SmartKey to turn it off before loading a new pack of paper 2 Press the paper table release to unlock the paper drawer and then pull the table forward to open it fully 3 Lift out any remaining paper from the tray 4 Prepare to place the new pack of paper in the tray with the bottom side down The bottom side is indicated by the word STOP printed on the final page of the new ...

Page 45: ...amage the thermal line printhead This type of damage is not covered by warranty FM40 50 To load a pack of paper 1 If the recorder is on press the recorder Start Stop SmartKey or the Stop Recordng SmartKey to turn it off before loading a new pack of paper 2 Press the paper eject button to open the paper drawer 3 Lift out any remaining paper from the tray Press and hold the paper eject button to par...

Page 46: ...he bottom side down The bottom side is indicated by the word STOP printed on the final page of the new pack 6 Unfold the top page of the pack and position the uterine activity scale on the right 7 Slide the pack into the tray 8 Feed the paper evenly through the paper guide Do not close the paper guide yet 9 Close the paper drawer ...

Page 47: ...of the screen when there are five pages to go If you switch on the recorder or press the paper advance key when there are fewer than five pages remaining it may take two pages before the alert is activated Load a new pack in time If the recorder runs out of paper an audible paper out alert is sounded if so configured Fetal traces continue to be recorded into the monitor s backup memory and can be ...

Page 48: ...ed only visible in monitoring mode 4 Select the desired speed from the given choices 1 2 or 3 cm min Tearing Off the Paper FM20 FM30 CAUTION NEVER pull on the paper to advance it as this can cause misalignment of the paper ALWAYS tear off the paper along the perforation To tear off the trace paper after monitoring 1 If the recorder is running the recorder on status indicator is displayed turn off ...

Page 49: ...f the recorder is running the recorder on status indicator is displayed turn off the recorder by selecting the fetal recorder Start Stop SmartKey or the Stop Recordng SmartKey 2 Select the Paper Advance SmartKey This advances the paper automatically to the next perforation 3 When the paper stops advancing tear off the trace paper along the perforation Switching the Recorder On and Off Note that in...

Page 50: ...g Selftest OK confirmation that the monitor s self test completed successfully and that it is ready to use the software revision and firmware revision the serial number the time the date patient name and medical record number if entered the paper speed The current monitoring modes if any transducers are connected to the monitor are printed Whenever a transducer s mode is changed the following are ...

Page 51: ...cal trace header to be printed To switch the recorder off Either select Start Stop from the Fetal Recorder menu Or press one of the SmartKeys depending on configuration fetal recorder Start Stop or Stop Recordng If your recorder is configured with Confirmed Stop On a Configuration Mode setting you will need to confirm that you want to stop the recorder before it will stop When the recorder is off ...

Page 52: ...nter Notes SmartKey to open the Enter Note menu Scroll if necessary then select the note you wish to enter A confirmation dialog box opens Select Confirm to enter the note The note is then shown in the status line of the display and is annotated on the fetal trace if the fetal recorder is on By default notes are printed lengthwise in the direction of the trace in the space between the FHR grid and...

Page 53: ...al Quality During monitoring if the fetal heart rate signal quality fluctuates and becomes poor it does not necessarily mean that the transducer needs repositioning The fluctuation may be caused by fetal movement Allow time for the signal to stabilize before deciding whether to reposition the transducer ultrasound or apply a new electrode ECG For the best trace quality the signal quality indicator...

Page 54: ... the paper guide with the FM40 FM50 4 Switch off the monitor Disconnecting from Power FM20 30 To disconnect the monitor from AC power switch the monitor off using the On Off switch located on the right side of the device or unplug the power cord from the AC mains socket FM20 30 with Battery Option To disconnect from Battery power switch the monitor off using the On Standby switch located on the ri...

Page 55: ...30 only Paper misaligned due to drawer not being correctly shut Shut the drawer fully pushing evenly with both hands End of paper noted when pack not finished Bad paper feed or wrong paper Check paper feed and use recommended paper CHECK PAPER INOP is displayed See Patient Alarms and INOPs on page 73 FetRec EQUIP MALF INOP is displayed PAPER END INOP is displayed WRONG PAPER SCALE INOP is displaye...

Page 56: ...3 Basic Operation 56 ...

Page 57: ...Option You can switch between battery powered and mains powered AC operation without interrupting monitoring The monitor is connected to the AC mains power via the external power supply NOTE The Battery Option is not available for the FM40 FM50 ...

Page 58: ...vidual earth leakage currents so exceeding allowable limits Do not connect any devices that are not supported as part of a system Any non medical device placed and operated in the patient s vicinity must be powered via an approved isolation transformer that ensures mechanical fixing of the power cords and covering of any unused power outlets Battery Power Indicators The battery LED and battery sta...

Page 59: ... fluctuates depending on the system load the display brightness the recorder configuration and how many measurements you carry out Battery malfunction symbols Normal battery function is indicated by the battery power gauge together with the remaining operating time on the Main Screen You are informed of problems or changes in the status of the battery by the battery status malfunction indicator Th...

Page 60: ...s you approximately how long you can continue to use the monitor without an AC connection Note that this time fluctuates depending on the system load the display brightness and how many measurements you carry out and the remaining capacity of the battery TimeToFull is shown in place of TimeToEmpty if the monitor is connected to a power supply and tells you how much time is left until the battery i...

Page 61: ...the load by removing measurements reducing the screen brightness or stopping the recorder Internal temperature conditions could also cause the battery to not charge This is necessary to protect the battery from damage and does not indicate a malfunction Keep the monitor at room temperature and move it away from heat sources or out of direct sunlight The battery will resume charging when the temper...

Page 62: ...ere is no battery power left and the monitor switches itself off 3 Reconnect the monitor to mains power and charge the battery until it is full for use or charge to 50 for storage Battery Safety Information WARNING Use only Philips batteries part number M4605A Use of a different battery may present a risk of fire or explosion Do not open batteries or dispose of them in fire or cause them to short ...

Page 63: ...e may be a problem with the reliability of the data but that monitoring is not interrupted Alarms are indicated after the specified alarm delay time This is made up of the system delay time plus the trigger delay time for the individual measurement See the Specifications section for details If more than one alarm is active the alarm messages are shown in the alarm status area in succession An arro...

Page 64: ...currently set alarm limit and the first number shows the value at which that alarm limit was violated by the widest margin Flashing numeric The numeric of the measurement in alarm flashes Bright alarm limits If the alarm was triggered by an alarm limit violation the corresponding alarm limit on the monitor screen is shown more brightly Audible Alarm Indicators The audible alarm indicators configur...

Page 65: ...top right of the monitor screen gives you an indication of the current volume To change the volume 1 Select the volume symbol The volume scale pops up 2 Select the required volume from the volume scale When the alarm volume is set to zero Off the alarm volume symbol shows this If you switch the alarm volume off you will not get any audible indication of alarm conditions Power Loss Tone FM40 50 and...

Page 66: ...nected transducer switches off the associated measurement Pausing or Switching Off Alarms If you want to temporarily prevent alarms from sounding for example while you are moving a patient you can pause alarms Depending on your fetal monitor configuration alarms are paused for one two or three minutes or infinitely To view the alarm pause setting chosen for your unit 1 Select Main Setup Alarms Ala...

Page 67: ...es and seconds or alarms off symbol No alarms are sounded and no alarm messages are shown INOP messages are shown but no INOP tones are sounded The following INOPs are the only exceptions NBP CUFF OVERPRESS Batt EMPTY and Batt MALFUNCTION these INOPs are issued even if alarms are paused or off If a disconnect INOP is present and alarms are paused or switched off the measurement in question is swit...

Page 68: ...s Setup Menu select the alarm limit you want to change This calls up a list of available values for the alarm limit 2 Select a value from the list to adjust the alarm limit Reviewing Alarms To review the currently active alarms and INOPs select any of the alarm status areas on the fetal monitor screen The Alarm Messages window pops up All alarms and INOPs are erased from the monitor s alarm histor...

Page 69: ... acknowledge them When alarms are set to non latching their indicators end when the alarm condition ends Switching alarm latching on means that visual and or audible alarm indications are still displayed or announced by the monitor after the alarm condition ends The indication lasts until you acknowledge the alarm Viewing the Alarm Latching Settings To see the alarm latching setting for your monit...

Page 70: ...m has not been acknowledged Alarm condition still present Alarm tone on Alarm message Alarm tone on Alarm message Flashing numerics Alarm tone on Alarm message Flashing numerics Alarm condition no longer present All audible and visual alarm indicators automatically stop Alarm tone on Alarm message Flashing numerics Alarm message Flashing numerics Audible alarm indicators automatically stop Alarm h...

Page 71: ...ively see Changing Alarm Limits on page 127 4 Generate a fetal heart rate of approximately 180 bpm 3 beats per second for more that one minute 5 Verify the functioning of the visible and audible alarm Alarm Behavior at Power On Selecting AlarmsOffAtStart will cause alarms to be initially suspended or off the next time the monitor is switched on depending on the setting for Alarms Off The Alarms Of...

Page 72: ...5 Alarms 72 ...

Page 73: ... alarm tone DESAT DESAT xx yy SpO2 The SpO2 value has fallen below the desaturation alarm limit xx denotes the lowest measured value and yy is the desaturation limit Numeric flashes red alarm message alarm tone DFHR1 HIGH DFHR2 HIGH DFHR3 HIGH DFHR1 xxx yyy DFHR2 xxx yyy DFHR3 xxx yyy FHR DECG The fetal heart rate obtained from DECG has risen above the high alarm limit xxx denotes the highest meas...

Page 74: ...w alarm limit Numeric flashes and low limit is highlighted yellow alarm message alarm tone HR HIGH HR xxx yyy MECG The maternal heart rate obtained from the maternal ECG has risen above the high alarm limit xxx denotes the highest measured value and yyy is the high alarm limit Numeric flashes and high limit is highlighted yellow alarm message alarm tone HR LOW HR xxx yyy MECG The maternal heart ra...

Page 75: ...ion has exceeded the high alarm limit Numeric flashes and high limit is highlighted yellow alarm message alarm tone SpO LOW SpO2 The arterial oxygen saturation has fallen below the low alarm limit Numeric flashes and low limit is highlighted yellow alarm message alarm tone TACHY Pulse TACHY P xxx yy SpO2 The heart rate from the Pulse signal has exceeded the tachycardia limit xxx denotes the highes...

Page 76: ...onitor s hardware Contact your service personnel CHARGER MALFUNC INOP tone battery LED may flash Battery There is a problem with the battery charger in the monitor Connect the monitor to mains power and contact your service personnel CHECK BATT TEMP Battery The temperature of the battery is too high Check that the monitor is not exposed to heat Check Flex Texts INOP tone Monitor If this INOP appea...

Page 77: ...sure that all required leads are attached and no electrodes have been displaced Check all connections are sound and that the legplate attachment electrode is properly attached If the INOP persists try using another adapter cable or legplate attachment electrode If the INOP still persists contact your service personnel DFHR1 SIGNAL LOSS DFHR2 SIGNAL LOSS DFHR3 SIGNAL LOSS DECG The input signal qual...

Page 78: ...d off Noninvasive blood pressure The cuff pressure exceeds the overpressure safety limits Remove the cuff from the patient Make sure that the tubing is not kinked or twisted and that the correct patient category is selected Try restarting the measurement You can silence this INOP but the INOP message remains visible until the next measurement is started or the Stop All SmartKey is selected NBP EQU...

Page 79: ...ent There is a problem with the Toco MP transducer hardware Contact your service personnel Settings Malfunc INOP tone Monitor The monitor cannot use the predefined settings for monitoring Contact your service personnel Speaker Malfunct INOP tone Monitor Contact your service personnel to check the speaker and the connection to the speaker SpO EQUIP MALF INOP tone SpO2 There is a problem with the Sp...

Page 80: ...e pulsations of the SpO2 signal are outside the specified pulse rate range SpO SEARCHING Numeric unavailable SpO2 SpO2 is analyzing the patient signal to derive Pulse and SpO2 values Please wait until the search analysis is complete SpO SENSOR MALF Numeric is replaced by a INOP tone SpO2 The SpO2 sensor or adapter cable is faulty Try another adapter cable and sensor If the INOP persists contact yo...

Page 81: ...sists switch off the monitor and contact your service personnel User I F Malfunct INOP tone Monitor Perform a visual and functional check of all the monitor input devices Contact your service personnel WRONG PAPER SCALE INOP tone Recorder The grid scale of the paper in the monitor does not match the grid scale configured in the monitor Make sure that you use the correct paper and scale for your in...

Page 82: ...6 Patient Alarms and INOPs 82 ...

Page 83: ...dmit a patient 1 Select the patient name field or select the Admit Dischrge SmartKey to open the Patient Demographics window 2 Clear any previous patient data by selecting Dischrge Patient and then Confirm If you do not discharge the previous patient you will not be able to distinguish data from the previous and current patients for example on the recording 3 Select Admit Patient 4 Enter the patie...

Page 84: ...e field to display the Patient Demographics window and associated pop up keys 2 Select the pop up key for Dischrge Patient 3 Select Confirm to discharge the patient CAUTION In order to ensure that the settings are reset to user defaults for a new patient always discharge the previous patient from the fetal monitor NOTE In order to ensure a continuous record it is recommended to discharge the patie...

Page 85: ... and location related data that is visible on the monitor is set overwritten or updated by the OB TraceVue system See the OB TraceVue Instructions for Use for details OB TraceVue via RS232 In contrast to a LAN connection when the monitor is connected to an OB TraceVue system over an RS232 connection the OB TraceVue system has no control over the monitor s patient admission and discharge functions ...

Page 86: ...7 Admitting and Discharging 86 ...

Page 87: ... You can configure the timer notification symbol the NST label a progress bar and the elapsed time to be displayed in the top left hand corner of the screen By default the NST timer is not displayed on the screen Alternatively you can view the timer in the Timers window To open the Timers window Either a Press the Timer SmartKey Or b Access the NST pop up keys see Accessing the NST Setup Pop up Ke...

Page 88: ...using the SmartKey 2 Select NST to enter the Setup NST menu At the same time the pop up keys for controlling setting up the NST timer appear see Pop up Keys for NST Timer Setup on page 88 Via the NST Field Route 3 Select the NST field displayed in the top left hand corner of the screen when so configured The pop up keys for controlling setting up the NST timer appear see Pop up Keys for NST Timer ...

Page 89: ...et the run time you first need to enter the Setup NST menu 1 To enter the Setup NST menu Either a Enter the Main Setup menu using the SmartKey Then select NST Or b Access the NST pop up keys see Accessing the NST Setup Pop up Keys on page 88 and press the Setup NST key 2 Select Run Time ...

Page 90: ...8 Non Stress Test Timer 90 ...

Page 91: ...igns This test does not take into account any form of external fetal stimulation For every active ultrasound fetal heart rate measurement one NST report can reside in the monitor s memory The reports are cleared when you discharge a patient and when you start a new NST report When the NST Report option is available and the NST Report feature is on the NST status for all available ultrasound fetal ...

Page 92: ...has elapsed since the NST began Accelerations the number of FHR accelerations detected so far Baseline the average baseline value Variability the average variability value Short Term Variability the current short term variability STV value Decelerations the number of FHR decelerations detected so far FHR Availability current statistical FHR availability value Sinusoidal the current status of sinus...

Page 93: ...ime 11 34 12 06 Runtime 32 minutes Reporting Period 20 minutes Overall one line NST result summary NST Criteria not met Title Trace Interpretation Summary Result Accelerations Accelerations 2 at 11 59 12 02 Result Contractions Contractions 3 at 11 57 12 00 12 04 Result Baseline and Variability Baseline 125 bpm Range 118 bpm 129 bpm Variability 23 bpm Range 20 bpm 24 bpm Short Term Var 0 9 bpm 3 8 ...

Page 94: ... the reassuring criteria are met the first time in the current monitoring phase When performing NST with twins or triplets a separate NST Report is generated for each fetus In the printed report the average short term variability STV value is shown in bpm and ms This is not part of the reassurance criteria After the reassurance criteria have been met the clinician can print the NST Report and then...

Page 95: ...hrough which the fetal heart signal can be heard In parallel the Doppler echoes are processed through an autocorrelation algorithm to determine the fetal heart rate FHR The FHR is displayed on the monitor s numeric display and on the recorded trace Properly representing the fetal heart rate using a device that derives heartbeats from motion is a formidable task and the limitations of the technolog...

Page 96: ...fetal scalp electrode the ultrasound Doppler signal from a fetal heart consists of multiple components from atria diastole ventricles systole valves and pulsating arteries These components vary depending on fetal and transducer position and angle and are further modulated by factors such as fetal or maternal breathing These effects may produce what is called artifact Optimal transducer positioning...

Page 97: ... and individual differences in pulse signal quality on the abdominal skin via Toco MP What You Need Ultrasound transducer Ultrasound gel Transducer belt and optional butterfly belt clip if applicable Cordless Monitoring Important Considerations When using an Avalon CTS Cordless Fetal Transducer System M2720A with your monitor please note the following Refer to Cordless Monitoring on page 22 for ge...

Page 98: ...sducer CAUTION Using ultrasound gel not approved by Philips may reduce signal quality and may damage the transducer This type of damage is not covered by warranty Place the transducer on the abdomen if possible over the fetal back or below the level of the umbilicus in a full term pregnancy of cephalic presentation or above the level of the umbilicus in a full term pregnancy of breech presentation...

Page 99: ...al Heart Sound You can listen to the fetal heart sound from one ultrasound transducer at a time When the fetal heart sound is selected for a FHR channel you see the audio source symbol next to the FHR numeric label for that channel To select the audio source for a FHR channel Enter the Setup FHR1 menu for the channel you want to hear FHR1 used as an example Press Select Audio It may take a few sec...

Page 100: ...nsducer detects gross fetal body movements Eye movements are not detected and movement of the feet and hands may not be detected Positioning or repositioning of the transducer is recorded as fetal movement Maternal movement excessive fetal breathing or fetal hiccups may also be recorded as fetal movement You can mark these artifacts on the trace paper using either the remote event marker or the ev...

Page 101: ...FMP is printed on the paper The FMP detection activates after about half a minute of steady heart rate signals signal indicator half full or full to minimize transducer positioning artifact You will notice this deliberate delay When a new patient is admitted A patient discharge restarts the FMP statistics from zero When you connect an ultrasound transducer Switching FMP On and Off You can switch F...

Page 102: ...ing a fetal scalp electrode FM30 and FM50 only allows measurement of FHR down to 30 bpm Questionable FHR Recording MHR by mistake Reposition transducer Confirm fetal life Recording periodic signals when the transducer is not applied to the patient Disconnect all NON USED ultrasound transducers as continuous regular mechanical or electromagnetic influences can result in an artificial trace Recorded...

Page 103: ... baseline rate variability or pattern decelerations to accelerations especially in the second stage of labor When the baseline maternal heart rate is within about 15 bpm of the FHR When the user is unable to determine a baseline rate and variability occurs between consecutive contractions There are several ways to verify the source and or accuracy of the recorded fetal heart rate pattern These inc...

Page 104: ... Halving is accompanied by an abrupt switch of the trace to exactly half the prior baseline value This switch may simulate a FHR deceleration and be referred to by clinicians as a false deceleration Switching to maternal heart rate also referred to as Maternal Insertion The fetal heart can move partly or fully out of the ultrasound beam and the autocorrelation algorithm may then pick up and displa...

Page 105: ...und transducer first determine the fetal position using palpation Position the transducer over the strongest audible fetal heart sound from the monitor s speaker and wait at least six seconds after each transducer adjustment to verify a good signal quality displayed on the Signal Quality Indicator and a consistent FHR numeric display Having determined the position that provides a strong fetal sign...

Page 106: ...lon fetal monitor is indicated by a triangle on the touch screen that is displayed in one of three ways Avalon Fetal Monitor signal quality indicator display 1 Completely filled triangle indicating good signal quality good full 2 Half filled triangle indicating limited signal quality This condition may indicate a weak or ambiguous signal If this status persists reposition the transducer acceptable...

Page 107: ...d and averaged heart rate trace is printed Examples of Artifacts Following are recorded trace examples of complaints received regarding inaccurate output from the Avalon monitors Scaling is 3 cm min and 30 bpm cm 1 FHR1 2 Pulse 3 FHR1 Pulse Double Counting Baseline Rate 120 Baseline Variability Moderate Accelerations Present Decelerations Not apparent Contractions Excessive coupling hypertonus Art...

Page 108: ...minutes into the tracing may simulate a fetal deceleration but the abruptness and the lack of any compensatory changes when the normal rate returns suggests that this is half counting Insertion of the maternal heart rate see below may produce a similar pattern Note also very brief episodes of half counting maternal insertion and signal drop out Remediation Auscultation or the application of a dire...

Page 109: ...l to moderate variability The ability to assess fetal status is limited because about half of the tracing displays the maternal heart rate Remediation The application of a maternal transducer ECG or pulse oximeter will likely resolve any possible confusion with the tracing Repositioning the transducer may produce a more reliable tracing Consideration must also be given to applying a fetal scalp el...

Page 110: ...ment Reassuring tracing Note that there is episodic drop out of the signal with discontinuity of the fetal tracing Remediation Either improving the position of the transducer or the application of a fetal scalp electrode will reduce the amount of artifact in the tracing Noisy Erratic Signal and Dropout ...

Page 111: ...ems Table 3 The Ultrasound Transducer ___________________________________________________________ JOGC Journal of Obstetrics and Gynaecology Canada Volume 29 Number 9 September 2007 Chapter 2 Intrapartum Surveillance Page S35 Methods of Electronic Fetal Monitoring Among its disadvantages are the need for readjustment with maternal or fetal movements and the following the transducer may record the ...

Page 112: ...____________________________________ Testing Ultrasound Transducers If any of the following tests fail repeat the test using another transducer If the second transducer passes the tests confirming that the first transducer is defective contact your service personnel If the second transducer also fails the tests contact your Philips Service Engineer or Response Center To test an ultrasound transduc...

Page 113: ...e recording the same FHR If this happens check the trace and if necessary reposition an ultrasound transducer to detect the second FHR correctly Fetal heart rate measurements are labeled in the order in which you plug in the transducers for those measurements It does not matter which fetal sensor socket you use as the monitor allocates a channel automatically For instance the first transducer you ...

Page 114: ...ge 99 Monitor maternal pulse especially during later stages of labor to avoid mistaking maternal heart rate for FHR Make sure you are recording the best possible signals by referring to the signal quality indicators and repositioning the transducers if necessary Monitoring Twins Externally To monitor twin FHRs externally you need two ultrasound transducers Follow the procedures described in the Ch...

Page 115: ...ource coincide at any time that is if the same heart rate is being monitored by more than one transducer this is detected via the monitor s cross channel verification feature and appears on the screen and is repeatedly printed on the trace paper after about 30 seconds If the suspended coincidence persists for more than one minute without interruption then the INOP COINCIDENCE will additionally app...

Page 116: ...e Main Setup menu Determining the Separation Order In Configuration Mode you can choose between two different ways for dealing with the trace offsets on the recording the order in which they are separated when Trace Separation is On 1 Enter the Main Setup menu by pressing the Main Setup SmartKey 2 Select Fetal Recorder 3 Select Separation Order to toggle between Standard and Classic Standard the F...

Page 117: ... FHR trace is labeled every 5cm The label for FHR2 is annotated with The following trace shows trace separation switched on Only the FHR2 trace is offset The numerical FHR value displayed on the monitor remains unchanged Subtract 20 from the recorded trace for FHR2 to obtain the true FHR2 value For example if the recorded trace shows 160 then the true FHR is 140 Classic Separation Order To make di...

Page 118: ...witching Trace Separation On and Off on page 116 for details of how to switch trace separation on or off When Trace Separation is On When trace separation is turned on the recorder prints a dotted line labeled with the three FHRs at the top and at the bottom Examples of the two methods Standard Classic for determining the trace separation order are provided here When Trace Separation is Off To ind...

Page 119: ...g DECG on page 137 for common problems you might encounter when monitoring FHR directly The following problem may occur when monitoring twins For more information see Additional Information on page 103 Problem Possible Cause Solution is printed repeatedly and appears on the screen Both transducers are recording the same FHR or one fetal transducer is recording the MHR Reposition an ultrasound tran...

Page 120: ...11 Monitoring Twin FHRs 120 ...

Page 121: ...onitoring single or twin FHRs The nature of the application increases the likelihood that a fetal heart rate is monitored by more than one transducer Make sure that you are recording three different fetal heart rates Pay particular attention to any coincidence of heart rates detected by the monitor s cross channel verification feature The cross channel verification feature alerts you by showing a ...

Page 122: ... and repositioning the transducers if necessary Monitoring Triplets To monitor triple FHRs you need three ultrasound transducers Follow the procedures described in Monitoring FHR and FMP Using Ultrasound on page 95 and in Monitoring Twin FHRs on page 113 The blue transducer Finder LED lets you identify at a glance which transducer is monitoring which heart rate channel Cross Channel Verification I...

Page 123: ...el for FHR2 is annotated with and the FHR3 label is annotated with The following trace shows triplets with Trace Separation on and using Standard separation order The traces for FHR2 and FHR3 are offset The numerical FHR values displayed on the monitor remain unchanged Subtract 20 from the recorded trace for FHR2 to obtain the true FHR2 For example if the recorded trace shows 160 then the true FHR...

Page 124: ...played on the monitor remain unchanged Subtract 20 from the recorded trace for FHR1 to obtain the true FHR1 For example if the recorded trace shows 160 then the true FHR is 140 Similarly add 20 to the recorded trace for FHR3 to obtain the true FHR3 When Trace Separation is Off To indicate that trace separation is switched off a dotted line labeled prints across the FHR scale 1 Standard trace separ...

Page 125: ...rasound on page 95 The following problem may occur when monitoring triplets For more information see Additional Information on page 103 Problem Possible Cause Solution is printed repeatedly More than one transducer is recording the same FHR or a fetal transducer records the same heart rate as the MHR Reposition one or more ultrasound transducer as appropriate ...

Page 126: ...12 Monitoring Triple FHRs 126 ...

Page 127: ...elay The monitor retains these settings even when switched off The alarm limits are printed on the trace every few pages if alarms are on Turning Alarms On or Off 1 Connect either an ultrasound or a DECG transducer to a free socket on the monitor 2 Enter the Setup Menu for a connected FHR measurement 3 Select Alarms to toggle between On and Off Changing Alarm Limits 1 Connect either an ultrasound ...

Page 128: ...n seconds from the pop up list 4 To change the low alarm limit delay time in seconds select Low Delay and select the delay time in seconds from the pop up list Changing Signal Loss Delay The signal loss delay is the configurable delay before an INOP You can change the delay in Configuration mode 1 Connect either an ultrasound or a DECG transducer to a free socket on the monitor 2 Enter the Setup M...

Page 129: ...ey also have wider ECG IUP and Pulse capabilities The external Toco transducer measures the frequency duration and relative strength of contractions but not their absolute intensity Amplitude and sensitivity depend on various factors such as the position of the transducer the belt tension and the size of the patient What You Need Toco Toco MP or Toco Transducer Abdominal Belt disposable shown ...

Page 130: ... optimum recording of uterine activity Reset the Toco baseline as necessary see Resetting the Toco Baseline on page 130 but not during a contraction The following example trace shows two contractions Resetting the Toco Baseline Press the Toco Baseline SmartKey This resets the Toco baseline to 20 on the display and trace Automatic Baseline Adjustment If the Toco value is negative for more that five...

Page 131: ...ove 100 units Toco trace is exceeding the paper scale Physical transmission of pressure from the uterus to the sensor is much higher than the average value The belt must be tight enough to ensure good contact between the patient s skin and the entire surface of the transducer without causing discomfort Ensure you are using the correct belt Adjust it as necessary Ensure a good contact between the p...

Page 132: ... transducer is defective contact your service personnel If the second transducer also fails the tests contact your Philips Service Engineer or Response Center To test a Toco transducer 1 Switch on the monitor and the recorder 2 Connect the transducer to the fetal monitor 3 Gently apply pressure to the pick up button 4 Check that after a few seconds the value on the display and paper shows this cha...

Page 133: ...lated What You Need Illustration 1 shows the complete connection chain from the IUP catheter to the fetal monitor using the patient module A Disposable Koala IUP Catheter B Reusable Koala IUP Adapter Cable 9898 031 43931 C Patient Module M2738A Illustration 2 shows the complete connection chain from the IUP catheter to the fetal monitor using the Toco transducer A Reusable Koala IUP Adapter Cable ...

Page 134: ... monitor The monitor is automatically zeroed The IUP display shows 0 IUP indicating internal measurement is printed at intervals on the trace Zero the monitor see Zeroing the Monitor on page 134 If you suspect the catheter is not responding appropriately flush as directed in the catheter s instructions for use A pressure spike appears on the trace if you flush after connecting the transducer to th...

Page 135: ...en baseline not visible Zero adjustment is incorrect Zero the system Trace is a straight line Transducer is defective Remove and touch the catheter If the trace does not show up and down movements use a new transducer Catheter blocked Please refer to catheter Instructions for Use Trace is superimposed with noise End of catheter is in the uterine wall Please refer to catheter Instructions for Use I...

Page 136: ...15 Monitoring Uterine Activity Internally 136 ...

Page 137: ...here the MHR can be misidentified as the FHR when using a fetal scalp electrode Electrical impulses from the maternal heart can sometimes be transmitted to the fetal monitor through a recently deceased fetus via the spiral scalp electrode appearing to be a fetal signal source The recorded MHR and any artifact can be misinterpreted as a FHR especially when it is over 100 bpm To reduce the possibili...

Page 138: ...Europe only not for USA 9898 031 37641 C DECG Adapter Cable 9898 031 37651 D Pre gelled Attachment Electrode 9898 031 39771 E Toco Transducer M2735A Illustration 2 shows the equivalent chain using the patient module A Fetal Scalp Electrode single spiral 9898 031 37631 B Fetal Scalp Electrode double spiral Europe only not for USA 9898 031 37641 C DECG Adapter Cable 9898 031 37651 D Pre gelled Attac...

Page 139: ...re now ready to begin monitoring DECG WARNING The fetal maternal monitor is not a diagnostic ECG device In particular the display of fetal maternal ECG is intended only for evaluating signal quality for fetal maternal heart rate as derived from the ECG waveform When in doubt it can be used to identify sources of compromised signal quality such as noise or muscle artifacts It can subsequently be us...

Page 140: ...t rate changes of 28 bpm or more however caused are not recorded Fetal arrhythmia will also be suppressed If you suspect fetal arrhythmia switch artifact suppression off When artifact suppression is off all recorded fetal heartbeats within the specified range are shown The default setting is On artifacts are suppressed To change the setting 1 Enter the Setup DFHR1 menu 2 Select ArtifactSuppress to...

Page 141: ...ble Reconnect the fetal scalp electrode Check all connections Disconnect and reconnect the connector several times Check all connections Disconnect and reconnect the connector several times If problem persists use a new fetal scalp electrode Erratic trace Erratic display No ECG signal Poor contact between the reference electrode and the mother Check for fetal demise Use a new fetal scalp electrode...

Page 142: ...16 Monitoring FHR Using DECG 142 Testing DECG Mode Refer to the monitor s Service Guide ...

Page 143: ... from above systolic pressure The amplitude suddenly increases as the pulse breaks through the occlusion in the artery As the cuff pressure decreases further the pulsations increase in amplitude reach a maximum which approximates to the mean pressure and then diminish Studies show that especially in critical cases arrhythmia vasoconstriction hypertension shock oscillometric devices are more accura...

Page 144: ...ment on demand Results are displayed for up to one hour Auto continually repeated measurements between one and 120 minute adjustable interval You can make a manual measurement between two measurements in Auto mode Reference Method The measurement reference method can be Auscultatory manual cuff or Invasive intra arterial For further information see the Application Note supplied on the monitor docu...

Page 145: ...rements immediately Check more frequently when making automatic or stat measurements Correcting the Measurement if Limb is not at Heart Level To correct the measurement if the limb is not at heart level to the displayed value Understanding the Numerics Depending on the numeric size not all elements may be visible Your monitor may be configured to display only the systolic and diastolic values Alar...

Page 146: ... systolic value gives you a preliminary indication of the systolic blood pressure during measurement Starting and Stopping Measurements Use the Setup menu or the SmartKeys to start and stop measurements Enabling Automatic Mode and Setting Repetition Time 1 In the Setup NBP menu select Mode 2 Toggle between Auto and Manual if necessary to pick the measurement method 3 If making an automatic measure...

Page 147: ... Dia selected but the fetal monitor can only derive a mean value mean alarms will nevertheless be announced using the most recent mean alarm limits Check that the mean alarm limits are appropriate for the patient even when not using mean as the alarm source When no value can be derived an NBP MEASURE FAILED INOP will be displayed Assisting Venous Puncture You can use the cuff to cause sub diastoli...

Page 148: ...ff not at heart level Check cuff size level and position Noninvasive blood pressure reference method set incorrectly Check the reference method configured auscultatory or intra arterial and correct if necessary in Configuration Mode Displays zeros for systolic and diastolic values Measurement automatically repeats Severe vasoconstriction at cuff site Move cuff to another limb check for shock or ve...

Page 149: ...ors and the patient population and application sites for which they are appropriate Familiarize yourself with the instructions for use supplied with your sensor before using it CAUTION Do not use OxiCliq disposable sensors in a high humidity environment such as in neonatal incubators or in the presence of fluids which may contaminate sensor and electrical connections causing unreliable or intermit...

Page 150: ...ient Temperature At elevated ambient temperatures be careful with measurement sites that are not well perfused because this can cause severe burns after prolonged application All listed sensors operate without risk of exceeding 41 C on the skin if the initial skin temperature does not exceed 35 C Extremities to Avoid Avoid placing the sensor on extremities with an arterial catheter an NBP cuff or ...

Page 151: ...correct optical alignment Correct the sensor alignment if necessary If the skin quality changes move the sensor to another site Change the application site at least every four hours Injected dyes such as methylene blue or intravascular dyshemoglobins such as methemoglobin and carboxyhemoglobin may lead to inaccurate measurements Inaccurate measurements may result when the application site for the ...

Page 152: ...ia is present the SpO2 pulse rate may differ from the heart rate calculated from ECG but this does not indicate an inaccurate SpO2 value WARNING With pulse oximetry sensor movement ambient light especially strobe lights or flashing lights or electromagnetic interference can give unexpected intermittent readings when the sensor is not attached Especially bandage type sensor designs are sensitive to...

Page 153: ...eneral system alarm signal delay time Adjusting the SpO2 Alarm Limits In the Setup SpO menu Select High Limit then choose the upper alarm limit Select Low Limit then choose the lower alarm limit Adjusting the Desat Limit Alarm The Desat alarm is a high priority red alarm notifying you of potentially life threatening drops in oxygen saturation 1 In the Setup SpO menu select Desat Limit 2 Adjust the...

Page 154: ...18 Monitoring SpO2 154 ...

Page 155: ...e that when higher priority measurements are connected but temporarily not providing valid numerics lower priority numerics may be displayed and recorded instead Cross Channel Verification It is recommended that you monitor both the maternal pulse rate heart rate and the fetal heart rates to reduce the risk of misinterpreting the maternal heart rate for the fetal heart rate See Confirm Fetal Life ...

Page 156: ...chain from the foam electrodes applied to the patient to the fetal monitor using the patient module A Pre gelled Foam Electrodes 40493A B C D E B MECG Adapter Cable M1363A C Patient Module M2738A Illustration 2 shows the equivalent chain using the Toco transducer A Pre gelled Foam Electrodes 40493A B C D E B MECG Adapter Cable M1363A C Toco Transducer M2735A To simultaneously measure DECG and MHR ...

Page 157: ...mine the sequence of actions Depending on the equipment you are using ensure that either the Patient Module or the Toco transducer is connected to the fetal monitor Connect a pre gelled Foam Electrode to each of the two leads on the MECG Adapter Cable Apply the Foam Electrodes to the patient following the instructions supplied with the Foam Electrodes Depending on the equipment you are using conne...

Page 158: ...T segments for evaluation of fetal maternal cardiac status during labor have not been evaluated FM30 50 When measuring MECG with the Avalon FM30 or FM50 the MECG waveform along with the heart rate numeric is displayed on the screen when using a Toco transducer or a patient module WARNING The fetal maternal monitor is NOT intended for use during defibrillation electro surgery or MRI Remove all tran...

Page 159: ...e heart rate calculated from MECG Due to motion artifacts arrhythmia or individual differences in pulse signal quality on the abdominal skin it may become necessary to choose the MECG measurement to derive a maternal heart rate WARNING No alarm is possible when Toco MP is the source of the pulse rate No QRS tone is audible when Toco MP is the source of the pulse rate NOTE In rare cases it is possi...

Page 160: ...P is being measured The value is displayed on the screen and printed on the trace It is not the actual pulse value but an average pulse rate taken during the most recent noninvasive blood pressure measurement The value is updated after each successive measurement If you need a continuous measurement you should monitor using MECG SpO2 or pulse from Toco MP Troubleshooting Testing MECG Mode Refer to...

Page 161: ...rived from the ECG waveform When in doubt it can be used to identify sources of compromised signal quality such as noise or muscle artifacts It can subsequently be used to verify the result of measures taken to resolve them e g checking ECG cable connections or adapting the fetal ArtifactSuppress configuration The safety and effectiveness of the displayed fetal maternal ECG waveform i e P QRS and ...

Page 162: ...rupted while the ECG strip prints A new trace header is printed out to mark where the real time fetal trace resumes The following trace shows the MECG waveform Overlap This recording mode gives you a delayed six second snapshot of the maternal and or direct fetal ECG for documentation on the fetal strip but without interrupting the fetal trace It takes 5 minutes to print this six second snapshot a...

Page 163: ...order to enter the Fetal Recorder menu 3 Select ECG Wave to toggle between Separate and Overlap To print the ECG wave s Either Select the Start ECG SmartKey Or 1 Enter the Main Setup menu by selecting the SmartKey 2 Select Fetal Recorder to enter the Fetal Recorder menu 3 Select Start ECG Wave Or 1 Select the ECG Wave 2 Select Start ECG Wave in the ECG wave menu 1 Paper speed 2 Date ...

Page 164: ...20 Printing the ECG Waveform 164 ...

Page 165: ...er is printed first before the measurements are recorded A new header is also printed when there is a date change at midnight Each NBP measurement is recorded The time when the measurement ended is recorded Other maternal parameters SpO2 maternal heart rate or Pulse are recorded every five minutes The rules described in the section Priority for Maternal Heart Pulse Rate on page 155 apply Paper Sav...

Page 166: ...21 Paper Save Mode for Maternal Measurements 166 ...

Page 167: ... drawer is open the exact time when this happens is annotated in the backup memory If the Bridge Paperout setting is set to On default when new paper is loaded and the recorder is started a trace recovery printout of the data recovered from the backup memory is automatically printed out at high speed up to 20 mm s starting from the time noted in the backup memory This ensures that no data is lost ...

Page 168: ...ystem the following applies The trace data in the monitor s internal memory must relate to a specific patient in the OB TraceVue system In other words there were no discharge events made on the monitor that would change the patient context The patient must have an open episode No data will be uploaded if the patient is not admitted to OB TraceVue For this reason it is not possible to use the monit...

Page 169: ...elected entry or select one of the choices on the other pop up keys to print only a specified portion of the entry for example Last 15 min for the last 15 minutes of trace data The current patient s entry is at the top of the list The oldest entry at the bottom of the list has no start time specified as part of the data originally stored may have been over written by the current patient s data The...

Page 170: ...22 Recovering Data 170 ...

Page 171: ... country General Points The transducers and patient modules are sensitive instruments Handle them with care Keep your monitor transducers patient modules cables and accessories free of dust and dirt After cleaning and disinfection check the equipment carefully Do not use if you see signs of deterioration or damage If you need to return any equipment to Philips always decontaminate it first before ...

Page 172: ...nd ammonia as hazardous gasses may result Skin contact To reduce the risk of skin irritations do not allow a cleaning or disinfecting agent to leave residues on any of the equipment surfaces wipe it off with a cloth dampened with water after allowing the appropriate time for the agent to work or before applying to a patient Hospital policy Disinfect the product as determined by your hospital s pol...

Page 173: ... liquid Isopropanol 80 Bacillol AF liquid spray 100 g concentrate contains Propan 1 ol 45 0 g Propan 2 ol 25 0 g Ethanol 4 7 g Bacillol 25 liquid Ethanol 100 mg g Propan 2 ol 2 Propanol 90 mg g Propan 1 ol 1 Propanol 60 mg g Meliseptol spray 50 1 Propanol Accel TB RTU liquid 0 5 accelerated hydrogen peroxide Oxivir Tb Cleaner Disinfectant spray 0 5 accelerated hydrogen peroxide Oxivir Tb Wipes wip...

Page 174: ...23 Care and Cleaning 174 ...

Page 175: ...ke sure that the housings are not cracked or broken that everything is present that there are no spilled liquids that may have entered the housing and that there are no signs of abuse 2 Inspect all accessories transducers sensors and cables and so forth Do not use a damaged accessory 3 Switch the monitor on and make sure the display is bright enough If the brightness is not adequate contact your s...

Page 176: ...dity exceeds 60 Avoid intensive light UV light as this may cause the paper to turn gray or the thermal print to fade Avoid storing the thermal paper in combination with the following conditions Papers that contain organic solvents This includes papers with tributyl and or dibutyl phosphates for example recycled paper Carbon paper and carbonless copy paper Products containing polyvinyl chlorides or...

Page 177: ...ermal printhead 1 Switch off the monitor 2 Open the paper drawer and remove the paper if necessary to gain access to the thermal printhead 3 Gently clean the thermal printhead with a cotton swab or soft cloth soaked in isopropyl alcohol Disposing of the Monitor WARNING To avoid contaminating or infecting personnel the service environment or other equipment make sure the equipment has been appropri...

Page 178: ...cle the paper Instructions for Use FM20 30 with Battery Option E25 Only The Lithium Ion battery should be removed and recycled according to local laws and regulations Transducer The transducer housing is a two component molding of polycarbonate white and polyurethane yellow and has one brass thread insert molded in All labeling on the transducer has been done by laser so no separation is necessary...

Page 179: ...s approved accessories Packaging Do not use a sterilized accessory if its packaging is damaged Protection against electric shocks The transducers and accessories listed in this chapter are NOT defibrillator proof Electro Surgery Defibrillation and MRI The fetal maternal monitors are NOT intended for use during defibrillation electro surgery or MRI Remove all transducers sensors and accessories bef...

Page 180: ...of 6 989803143401 DECG Accessories New Philips DECG Solution NOT compatible with QwikConnect Plus Solution accessories DECG reusable legplate adapter cable with flushing port 989803137651 DECG leg attachment electrode for DECG legplate adapter cable 989803139771 DECG fetal scalp electrode single spiral worldwide availability 989803137631 DECG fetal scalp electrode double spiral Europe only Not for...

Page 181: ...T mix accessories from the New Philips DECG Solution marked with those from the QwikConnect Plus Solution marked MECG Accessories Noninvasive Blood Pressure Accessories The following accessories are approved for use with the fetal monitor Accessory Part Number MECG reusable adapter cable M1363A Foam ECG electrodes snap fit for MECG Adapter Cable disposable 40493D E ...

Page 182: ...t Category color Limb Circumference Bladder Width Part No Tubing Adult Thigh grey 45 0 56 5 cm 21 0 cm M4559A M1598B 1 5 m or M1599B 3 0 m Large Adult X Long burgundy 35 5 46 0 cm 17 0 cm M4558A Large Adult burgundy 35 5 46 0 cm 17 0 cm M4557A Adult X Long navy blue 27 5 36 5 cm 13 5 cm M4556A Adult navy blue 27 5 36 5 cm 13 5 cm M4555A Small Adult royal blue 20 5 28 5 cm 10 6 cm M4554A Maternal P...

Page 183: ...les directly from Tyco Healthcare Some sensors may not be available in all countries Do not use more than one extension cable with any sensors or adapter cables Do not use an extension cable with Philips reusable sensors or adapter cables with part numbers ending in L indicates Long version All listed sensors operate without risk of exceeding 41 C on the skin if ambient temperature is below 37 C M...

Page 184: ...cable M1192T Small adult pediatric sensor 0 45 m cable for patients between 15 kg and 50 kg Any finger except thumb Use only on adult patients with FM30 40 50 M1196T Adult clip sensor 0 9 m cable for patients over 40 kg Any finger except thumb M1191ANL Special Edition SE Adult sensor 3 m cable for patients over 50 kg Any finger except thumb No adapter cable required SE sensors work with FM30 40 50...

Page 185: ...0 kg Requires M1943A 1 0 m or M1943AL 3 0 m adapter cable OxiMax MAX AL OxiMax MAX A with long cable OxiMax MAX P Pediatric foot hand sensor patient size 10 50 kg Use only on adult patients with FM30 40 50 OxiMax MAX N Adult finger or neonatal foot hand sensor patient size 40 kg or 3 kg Use only on adult patients with FM30 40 50 Oxisensor II D 25 Adult sensor patient size 30 kg Requires M1943A 1 0...

Page 186: ...ith FM30 40 50 989803148291 LNCS TC I Ear Sensor 30 kg Use only on adult patients with FM30 40 50 989803148301 MASIMO LNOP disposable adhesive sensors LNOP Adt Adult Sensor 30 kg 989803140231 LNOP Adtx Adult Sensor 30 kg n a LNOP Pdt Pediatric Sensor 10 50 kg Use only on adult patients with FM30 40 50 989803140261 LNOP Pdtx Pediatric Sensor 10 50 kg Use only on adult patients with FM30 40 50 n a L...

Page 187: ...pter cable for Philips Nellcor disposable sensors M1943AL Adapter cable 3 m cable OC 3 Adapter Cable for OxiCliq sensors Available from Nellcor LNOP MP12 LNOP MP Series Patient Cable 3 6 m Adapter Cable for Masimo LNOP sensors Available from MASIMO LNC MP10 LNCS MP Series Patient Cable 3 0 m Adapter Cable for Masimo LNCS sensors Product Number Geography FHR Scale Grid Color Scale Units Highlighted...

Page 188: ...25 Accessories and Supplies 188 ...

Page 189: ... 32 F to 113 F with battery option charging 0 C to 35 C 32 F to 95 F with battery option fully charged 0 C to 40 C 32 F to 104 F Storage 20 C to 60 C 4 F to 140 F Humidity Range Operating 95 relative humidity 40 C 104 F Storage 90 relative humidity 60 C 140 F Altitude Range Operating 500 to 3000 m 1640 to 9840 ft Storage 500 to 13100 m 1640 to 43000 ft Transducers M2734A M2734B M2735A M2736A M2738...

Page 190: ...ight x depth 286 x 133 x 335 1 11 3 x 5 2 x 13 2 in 1 420 x 172 x 370 5 16 5 x 6 8 x 14 6 in 5 Weight 5 1 kg 11 2 lbs 9 0 kg 19 8 lbs Degree of Protection Against Electrical Shock Type CF Electrical Class Class II equipment Class I equipment Mode of Operation Continuous operation Water Ingress Protection Code IP X1 provided recorder drawer is shut Global Speed 6 25 mm sec 12 5 mm sec 25 mm sec 50 ...

Page 191: ...28 x 135 2 0 x 1 1 x 5 3 in Cable length 2 5 m Weight 150 g 5 3 oz Degree of Protection Against Electrical Shock Type CF Transducer Identification Optical Signal Element Finder LED Not M2738A Transducers M2734A M2734B M2735A M2736A M2738A Interface Cable for Avalon CTS M2731 60001 and M2732 60001 Shock Resistance Withstands a 1m drop to concrete surface with possible cosmetic damage only Water Ing...

Page 192: ...with new fully charged battery Basic monitoring configuration 2 hours Display Brightness 70 Recorder On at 3cm min NBP Auto Mode at 15min 2 US Transducers 1 Toco with MECG 1 Patient Module with DECG Charge Time When monitor is off approx 6 hours When monitor is in use more than 10 hours depending on monitor configuration ...

Page 193: ...0 3 2 mW cm2 Effective radiating area 12 dB 3 11 0 74 cm2 Signal Quality Indication Poor Quality Empty Acceptable Quality Half full Good Quality Full Beat to Beat Change max for Ultrasound 28 bpm US Frequency 1 MHz 100 Hz US Signal range 3 5 µVpp to 350 µVpp 200 Hz US Burst Repetition Rate 3 0 kHz Duration 100 µs US LF Frequency Passband 3dB 100 to 500 Hz 20 FMP Signal Range 33 Hz 200 µVpp to 40 µ...

Page 194: ...mHg Signal Range 99 to 127 mmHg Resolution Display 1 mmHg Printer 1 4 mmHg Sensitivity 5 µV V mmHg Offset Compensation 100 to 200 mmHg Accuracy not including sensor accuracy 0 5 per 100 mmHg Update Rate Display 1 second Printer 4 seconds Auto Offset Correction 3 seconds after connecting the transducer the IUP value is set to 0 mmHg ECG Type DECG Single Lead ECG derived from Fetal Scalp Electrode M...

Page 195: ...rm i e P QRS and T segments for evaluation of fetal maternal cardiac status during labor have not been evaluated Filter Bandwidth 0 8 to 80 Hz Inop Auxiliary Current Leads Off Detection 100 µA Input Signal Range DECG 20 µVpp to 6 mVpp MECG 150 µVpp to 6 mVpp Dielectric Strength 1500 Vrms Defibrillator Protection None ESU Protection None Performance Specifications Fetal Heart Rate Ultrasound DECG A...

Page 196: ...ave amplitude a 8 0 mm Heart Rate Averaging Method Three different methods are used Normally heart rate is computed by averaging the 12 most recent RR intervals For runs of PVCs up to 8 RR intervals are averaged to compute the HR If each of 3 consecutive RR intervals is greater than 1200 ms that is rate less than 50 bpm then the 4 most recent RR intervals are averaged to compute the HR Display Upd...

Page 197: ...olic 10 to 245 mmHg 1 5 to 32 kPa Mean 20 to 255 mmHg 2 5 to 34 kPa Accuracy Max Std Deviation 8 mmHg 1 1 kPa Max Mean Error 5 mmHg 0 7 kPa Pulse Rate Range 40 to 300 bpm Accuracy average over noninvasive blood pressure measurement cycle 40 to 100 bpm 5 bpm 101 to 200 bpm 5 of reading 201 to 300 bpm 10 of reading Measurement Time Typical at HR 60bpm Auto manual 30 seconds adult Maximum time 180 se...

Page 198: ... Korotkoff sound was used to determine the diastolic pressure Alarm Specifications Range Adjustment Systolic Adult 30 to 270 mmHg 4 to 36 kPa 10 to 30 mmHg 2 mmHg 0 5 kPa 30 mmHg 5 mmHg 1 kPa Diastolic Adult 10 to 245 mmHg 1 5 to 32 kPa Mean Adult 20 to 255 mmHg 2 5 to 34 kPa Overpressure Settings Adjustment 300 mmHg 40 kPa 2 sec not user adjustable Factory Default Settings Mode Manual Repetition ...

Page 199: ...100 Accuracy Philips Reusable Sensors M1191A B M1191AL BL M1191ANL M1192A M1192AN 2 70 to 100 M1191T M1192T M1194A M1194AN M1196A M1196T 3 70 to 100 Philips Disposable Sensors with M1943A L M1131A M1901B M1903B M1904B 3 70 to 100 M1133A M1134A 2 70 to 100 NellcorPB Sensors with M1943A L MAX A MAX AL MAX P MAX N D 25 D 20 N 25 OxiCliq A P N 3 70 to 100 Masimo Reusable Sensors with LNOP MP12 or LNC ...

Page 200: ...ce to low limit 0 to 50 bpm 5 bpm steps max 14 seconds Clamping at 30 to 100 bpm 5 bpm steps SpO2 Factory Default Settings Desat Alarm Limit 80 Low Alarm Limit 90 High Alarm Limit 100 Desat Alarm Limit Delay 20 seconds Low Alarm Limit Delay 10 seconds High Alarm Limit Delay 10 seconds Averaging Time 10 seconds NBP Alarm Suppression On Parameter Alarms On Off On Color Cyan Pulse Settings Pulse Alar...

Page 201: ...r black page marks Accuracy 3 cm min 2 cm min 1 cm min 5 mm page Usable Print Width 128 mm Resolution 8 dots mm 200 dpi Time Delay to see trace on paper 30s 1 cm min Trace Separation Offset for FHR Ultrasound and DECG Twin Standard FHR2 20 bpm Classic FHR1 20 bpm Triplet Standard FHR2 20 bpm FHR3 20 bpm Classic FHR1 20 bpm FHR3 20 bpm Recorder Default Settings Setting Choice Default Recorder Speed...

Page 202: ...sity 1 5 n a Recorder Symbols Symbol Description Alarm is on printed next to measurement label Upper and lower alarm limit printed next to measurement label FMP detection is on Beginning of the date time annotation Warning INOP Measurement from a cordless transducer printed next to measurement label Pulse from SpO2 Pulse from Toco MP Pulse from NBP Trace separation 20 bpm in label Recorder Default...

Page 203: ...example fast printout of MECG wave on FM30 Recorder Symbols Symbol Description M4605A Battery Specifications Physical Specifications W x D x H 149 mm 5 866 in x 89 mm 3 504 in x 19 8 mm 0 78 in Weight 490 g 1 08 lb per battery Performance Specifications Nominal Voltage 10 8 Volt Rated Capacity at discharge C 5 6000 mAh Continuous Discharge Capability 6 5 A Environmental Specifications Temperature ...

Page 204: ... and EN 61000 3 2 Communication Standard complies with the SMBus specification v 1 1 M4605A Battery Specifications Alarm Setting Choice Default Alarm Mode INOP only All INOP only Alarm Volume 0 10 5 Alarms Off 1 min 2 min 3 min Infinite 3 min Alarm Text Standard Extended Standard Visual Latching Red YellowRed Off Off Audible Latching Red Only Off Off Alarm Sounds Traditional ISO Traditional Alarm ...

Page 205: ... of the European Medical Devices Directive 93 42 EEC and the following major international standards Safety and Performance The monitor complies with the following major international safety and performance standards EN 60601 1 1990 A1 1993 A2 1995 IEC 60601 1 1988 A1 1991 A2 1995 EN 60601 1 1 2001 IEC 60601 1 1 2000 EN 60601 1 6 2004 IEC 60601 1 6 2004 EN IEC 60601 2 27 2006 EN ISO 9919 2005 EN 6...

Page 206: ...ng plug to connect the monitor to AC mains Never adapt the three prong plug from the power supply to fit a two slot outlet CAUTION The use of accessories transducers and cables other than those specified may result in increased electromagnetic emissions or decreased electromagnetic immunity of the device WARNING Do NOT use cordless mobile phones or any other portable RF communication system within...

Page 207: ...Once the source is located there are a number of things that can be done to mitigate the problem 1 Eliminating the source Turn off or move possible sources of EMI to reduce their strength 2 Attenuating the coupling If the coupling path is through the patient leads the interference may be reduced by moving and or rearranging the leads If the coupling is through the power cord connecting the system ...

Page 208: ...me use Table 1 Guidance and Manufacturer s Declaration Electromagnetic Emissions Emissions Test Compliance Avoiding Electromagnetic Interference Radio Frequency RF emissions Group 1 The device uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Harmonic emissions IEC 61000 3 2 Class A Volt...

Page 209: ...ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typical commercial and or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV comm...

Page 210: ... VRMS according to IEC 60601 1 2 over the specified test frequency range Over the frequency range 150 kHz to 80 MHz the recommended separation distance in meters d is found by the following equation For a compliance level of 3 0 VRMS d 1 2 P Table 4 Guidance and Manufacturer s Declaration Electromagnetic Immunity Radiated RF Immunity Test EN IEC 61000 4 3 IEC 60601 1 2 Test Level over 80 MHz to 2 ...

Page 211: ...nt The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment and the device as recommended below according to the maximum output power of the communications equipment Note T...

Page 212: ...If several items of equipment used to monitor a patient are interconnected the resulting leakage current may exceed allowable limits ECG electrodes NEVER allow ECG electrodes to contact other electrical conductive parts including earth Monitoring After a Loss of Power If the monitor is without power for less than one minute monitoring will resume with all active settings unchanged If the monitor i...

Page 213: ...re NOT intended for use during defibrillation electro surgery or MRI Remove all transducers sensors and accessories before performing electro surgery defibrillation or MRI otherwise harm to the patient or the user can result Cardiac Pacemakers and Electrical Stimulators WARNING The fetal maternal monitors are NOT intended for use for ECG measurements on patients connected to electrical stimulators...

Page 214: ...30 with Battery Option Power On LED Electrical Class II equipment in which the protection against electric shock relies on double or reinforced insulation FM20 FM30 Fetal Sensor Socket symbol SpO2 Socket symbol Noninvasive Blood Pressure Socket symbol Symbol indicating the monitor has the triplets option Symbol indicating the monitor is capable of intrapartum monitoring Button to open paper drawer...

Page 215: ... Protection code according to IEC 60529 All transducers excluding M2738A are rated IP 68 protection against dust access to hazardous parts and the effects of continuous immersion in water to a depth of 1 0 meter for five hours IP X1 Ingress Protection code according to IEC 60529 The monitors and interface cable for the Avalon CTS M2731 60001 M2732 60001 are rated IP X1 protection against water dri...

Page 216: ...26 Specifications and Standards Compliance 216 ...

Page 217: ... cleaning 177 configuration mode 32 configuring alarm tone 64 confirming fetal life 10 96 113 121 confirming fetal life and FHR 96 connecting power 16 cross channel verification 10 97 113 115 121 122 155 CCV and triplets 121 CCV and twins 113 comparing FHR with MHR 97 D damage claims 15 data recovery 167 date from OB TraceVue 35 date setting 35 DECG 139 141 142 193 DECG INOPs 141 DECG specificatio...

Page 218: ...nal heart rate and cross channel verification 155 maternal heart rate and priorities 155 maternal heart rate from MECG 156 sources of maternal heart rate 155 measurement settings 34 changing measurement settings 34 entering setup menu 34 measurements 33 34 191 setting up measurements 34 switching on and off measurements 33 MECG 140 156 157 158 159 160 161 181 193 accessories 181 alarm limits 193 c...

Page 219: ...nitoring 53 signal quality of SpO2 152 silencing alarms 66 specifications 189 190 191 193 201 built in recorder specifications 201 DECG specifications 193 ECG specifications 193 environmental specifications 189 monitor 189 SpO2 sensors 189 transducers 189 IUP specifications 193 measurement specifications 191 MECG specifications 193 performance specifications 191 193 Toco specifications 193 transdu...

Page 220: ...rnal monitoring 114 importance of monitoring MHR 113 invasive monitoring 115 monitoring FHR 113 monitoring twins 113 offsetting baselines 116 twins and FMP 100 U ultrasound 95 98 112 193 applying gel 98 testing a transducer 112 ultrasound display specifications 193 ultrasound monitoring 95 ultrasound specifications 193 understanding screens 33 using the adapter cable 139 uterine activity 129 130 1...

Page 221: ...Part Number 453564290161 Printed in Germany 08 11 453564290161 ...

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