In stru ctio ns fo r Use Avalon Fetal Monitor FM20/30, FM40/50, Avalon CL R el e a s e J .3 . w i t h So f t w a re Re v i s io n J .3 0 .
1 Table of Contents 1 Introduction Who this Book is For Confirm Fetal Life Before Using the Monitor Introducing the Avalon Family of Fetal Monitors 2 What's New What's New in Release J.3 What's New in Release G.
Visual Alarm Indicators Audible Alarm Indicators Acknowledging Alarms Acknowledging Disconnect INOPs Alarm Reminder Pausing or Switching Off Alarms Alarm Limits Reviewing Alarms Latching Alarms Testing Alarms Alarm Behavior at Power On 6 Patient Alarms and INOPs Alarm Messages Technical Alarm Messages (INOPs) 7 Admitting and Discharging Admit/Discharge on the Monitor New Patient Check OB TraceVue/IntelliSpace Perinatal 110 111 114 114 114 115 117 118 118 120 121 123 123 126 137 137 139 139 8 Non-Stress
Cableless Monitoring - Important Considerations Preparing to Monitor Selecting Fetal Heart Sound Changing the Fetal Heart Sound Volume Fetal Movement Profile Troubleshooting Additional Information Testing Ultrasound Transducers 12 Monitoring Twin FHRs Important Considerations Monitoring Twins Externally Monitoring Twins Internally Separating FHR Traces Troubleshooting 13 Monitoring Triple FHRs Important Considerations Monitoring Triplets Separating FHR Traces "Standard" Separation Order "Classic" Separati
Making Connections Monitoring DECG Suppressing Artifacts Troubleshooting Testing DECG Mode 18 Monitoring Noninvasive Blood Pressure Introducing the Oscillometric Noninvasive Blood Pressure Measurement Preparing to Measure Noninvasive Blood Pressure Starting and Stopping Measurements Enabling Automatic Mode and Setting Repetition Time Enabling Sequence Mode and Setting Up The Sequence Choosing the Alarm Source Assisting Venous Puncture Calibrating NBP Troubleshooting 19 Monitoring Maternal Temperature 205
22 Printing the ECG Waveform 243 23 Paper Save Mode for Maternal Measurements 249 24 Recovering Data 251 Recovering Traces on Paper Recovering Traces on an OB TraceVue/IntelliSpace Perinatal System Recording Stored Data 25 Care and Cleaning General Points Cleaning and Disinfecting Cleaning and Disinfecting Monitoring Accessories Cleaning and Disinfecting the Tympanic Temperature Accessories Sterilizing 26 Maintenance Inspecting the Equipment and Accessories Inspecting the Cables and Cords Maintenanc
Monitoring After a Loss of Power ESU, MRI and Defibrillation Cardiac Pacemakers and Electrical Stimulators Fast Transients/Bursts Symbols on the System 307 307 307 307 308 29 Default Settings Appendix 311 Alarm and Measurement Default Settings Recorder Default Settings Index 8 311 314 317
1 1 Introduction Who this Book is For This book is for trained healthcare professionals using the Avalon FM20, FM30, FM40 and FM50 Fetal/Maternal monitors, and the cableless monitoring system Avalon CL. It describes how to set up and use the monitor and transducers. Familiarize yourself with all instructions including warnings and cautions before starting to monitor patients.
1 Introduction Avalon CTS Whenever one of these identifiers appear to the left of a heading or paragraph, it means that the Avalon CL information applies to that cableless monitoring system. Where the information applies to both systems, no distinction is made. Confirm Fetal Life Before Using the Monitor Fetal monitoring technology available today is not always able to differentiate a fetal heart rate (FHR) signal source from a maternal heart rate (MHR) source in all situations.
1 Introduction Introducing the Avalon Family of Fetal Monitors The Avalon family of fetal monitors consists of the Avalon FM20, FM30, FM40 and FM50. While the FM20/FM30 and the FM40/FM50 have different form factors, the method of operation is very similar for all monitors. The Avalon fetal monitors also share transducers, accessories, software, and are compatible with the Avalon CL, and Avalon CTS Cableless Fetal Transducer Systems.
1 Introduction Connecting the Monitor to AC Mains WARNING • Always use the supplied power cord with the earthed mains plug to connect to an earthed AC mains socket. Never adapt the mains plug from the fetal monitor to fit an unearthed AC mains socket. • Check that the line frequency is correctly configured in the Global Settings menu. • FM20/FM30 only: The protective earth conductor is required for EMC purposes. It has no protective function against electric shock.
1 Introduction WARNING The fetal/maternal monitors are not intended for: • use during defibrillation, electro-surgery, or magnetic resonance imaging (MRI). • ECG measurements on patients connected to electrical stimulator or with cardiac pacemakers.
1 Introduction WARNING Do not change the date and time setting, if the fetal monitor is connected to a Philips OB TraceVue/ IntelliSpace Perinatal system via a LAN -setup. The monitor uses the OB TraceVue/IntelliSpace Perinatal system date and time, including daylight saving time changes.
1 Introduction CAUTION Avoid the use of pulsating water jets in the bath or shower while monitoring, as these can be misinterpreted as an incorrect (or totally artificial) heart rate. Toco Baseline drift: The accuracy specified for baseline drift cannot be guaranteed for underwater usage. When using transducers under warm water the temperature increase causes a significant baseline change due to internal pressure increase.
1 Introduction 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 circuit. They may ignite, explode, leak or heat up, causing personal injury. If battery leakage should occur, avoid contact with skin. Refer to qualified and authorized service personnel. Dispose of used batteries promptly and in an environmentally-responsible manner.
1 Introduction WARNING Do not rely exclusively on the audible alarm system for fetal monitoring. Adjustment of alarm volume to a low level or off during monitoring may result in a dangerous situation. Remember that the most reliable method of fetal monitoring combines close personal surveillance with correct operation of monitoring equipment. WARNING Be aware that the monitors in your care area may each have different alarm settings, to suit different scenarios.
1 Introduction WARNING • Ensure that the conductive parts of the fetal scalp electrode and the maternal leg plate electrode do not contact other conductive parts, including earth. • Indication of the heart-rate may be adversely affected by the operation of cardiac pacemaker pulses or by cardiac arrhythmias. • During ambulant FHR monitoring, the chance of losing the signal or detecting the maternal heart rate is higher than during stationary monitoring.
1 Introduction WARNING Never attempt to connect the fetal scalp electrode to anything other than the correct DECG adapter cable. 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.
1 Introduction WARNING • Never apply the probe to the patient when the probe is not connected to the unit. • Always use a single-use probe cover to limit patient cross-contamination. • Measurement errors or inaccurate readings may result when: – probe covers other than the specified probe covers are used (see “Tympanic Temperature Accessories” on page 267) • Insert the probe slowly and carefully to avoid damage to the ear canal and the tympanic membrane.
1 Introduction WARNING • For fully conscious pediatric or adult patients, who have a normal function of perfusion and sensory perception at the measurement site: To ensure skin quality and correct optical alignment of the sensor, inspect the application site when the measurement results are suspicious or when the patient complains about pressure at the application site, but at least every 24 hours. Correct the sensor alignment if necessary. Move the sensor to another site, if the skin quality changes.
1 Introduction 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 used to verify the result of measures taken to resolve them (e.g., checking ECG cable connections).
1 Introduction WARNING • Do not operate the monitor if it is wet. If you spill liquid on the monitor, contact your service personnel or Philips service engineer. • Do not perform underwater monitoring (for example, in a bath or shower) using wired transducers. • Place the monitor where there is no chance of contact with, or falling into water or other liquid. • Do not dry equipment using heating devices such as heaters, ovens (including microwave ovens), hair dryers and heating lamps.
1 Introduction WARNING To avoid contaminating or infecting personnel, the environment or other equipment, make sure you disinfect and decontaminate the monitor appropriately before disposing of it in accordance with your country's laws for equipment containing electrical and electronic parts. For disposal of parts and accessories such as thermometers, where not otherwise specified, follow local regulations regarding disposal of hospital waste.
1 Introduction CAUTION • FM20/FM30 only: Although this is an electrical Class II device, it has a protective earth conductor which is needed for EMC purposes. • Always use the supplied power cord with the three-prong plug to connect the monitor to AC mains. Never adapt the three-prong plug from the power supply to fit a two-slot outlet.
1 Introduction WARNING • Leakage currents: 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. WARNING The fetal/maternal monitors are NOT intended for use during defibrillation, electro-surgery, or MRI.
1 Device Classification and Names within this Manual New cableless measurements for fetal and maternal monitoring supplement the Avalon fetal monitor family. The Avalon CL solution consists of the Avalon CL base station, the Avalon CL transducers, and the IntelliVue CL Pods. The IntelliVue CL Pods are only used for maternal measurements within the Avalon CL solution. To differentiate between the CL transducers and the CL Pods, the CL Pod are also referred to as maternal measurement Pods.
1 Introduction Avalon FM20/FM30 and FM40/ FM50 Wired Transducers Avalon CL Base Station Avalon CL Transducers IntelliVue CL Pods Toco/ Toco MP transducer Avalon CL US Transducer IntelliVue CL SpO2 Pod wired cableless cableless 865215 M2734A and M2734B 866076 Toco+ transducer with ECG/ IUP capability Avalon CL ECG/IUP Transducer cableless wired M2735A 866077 Patient Module for ECG/IUP M2738A 28
2 What's New 2 What's New This section lists the most important new features and improvements to the fetal monitors and their user interface introduced with Release J.3. You may not have all of these features, depending on the fetal monitor configuration purchased. What's New in Release J.3 Avalon CL Transducer System The Avalon CL system provides cableless monitoring with the Avalon FM20/FM30 and FM40/FM50 with the same functionality and performance as the wired measurement devices (e.g.
2 What's New Manually Entered Maternal Temperature Measurements Manually measured temperatures can be entered manually into the fetal monitor and stored in the database. They are also displayed as a numeric on screen, and are printed out on the recorder trace if required. New Design for the User Interface The user interface for the fetal monitors has been redesigned to bring the presented information into the foreground, letting the structural elements such as keys and frames retreat into the background.
2 What's New Data Export Support You can now export measurement values from the monitor to other devices via the LAN or RS232 interface. NBP Configurable Measurement Sequence Up to four measurement cycles can be set up which will run consecutively. For each cycle you can set the number of measurements and the interval between them. By setting the last cycle to run continuously you can have regular measurements continue after the sequence has run.
2 What's New • A bed hanger is available as a mounting option, especially for patient transport purposes within healthcare facilities. Maternal Pulse from Toco MP Transducer • The new Toco MP transducer can measure the maternal pulse rate, in addition to the other available sources; MECG, SpO2, and NBP.
2 • You can enter the NBP setup menu by touching the NBP numeric (on the screen) before the first measurement is taken. • Algorithm enhancements (more tolerant of movement artifacts). • There is an individual Alarm Tone Volume setting for Yellow, Red and Cyan alarms. • The new alarm settings available in Configuration Mode are: – AutoIncrease Vol and IncreaseVolDelay – AlarmsOffAtStart – ConfirmAlarmsOff Alarms For a detailed description of the settings see the Configuration Guide.
2 What's New 34
3 Basic Operation 3 Basic Operation This chapter gives you an overview of the monitor and its functions. It tells you how to perform tasks that are common to all measurements (such as entering data, switching a measurement on, changing some monitor settings, and setting up the recorder). The alarms section gives an overview of alarms. The remaining sections tell you how to perform individual measurements, and how to care for and maintain the equipment.
3 Basic Operation The following Maternal measurements are supported: Fetal Monitor or Model FM20 FM30 Maternal Heart Rate (MHR) via Maternal ECG Electrodes Maternal ECG (MECG) Wave FM50 Non-invasive Blood Pressure with Pulse Rate Pulse Oximetry (Maternal SpO2) with Pulse Rate - Standard - Standard Optional (built-in) Standard - Standard Optional (cableless) Optional (Interface cable and manual entry) - Standard Standard Optional (built-in) Optional (built-in) Optional (Interface cable a
3 Basic Operation Avalon FM20 The Avalon FM20 fetal/maternal monitor provides a solution for external fetal monitoring applications, and optional noninvasive maternal vital signs. You can monitor fetal heart rates (FHRs) externally using ultrasound, uterine activity and maternal pulse using an external Toco transducer, and the maternal heart rate (MHR) with maternal ECG electrodes, and optionally, noninvasive blood pressure and maternal oxygen saturation (SpO2). Measurements are displayed on a 6.
3 Basic Operation 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 noninvasive maternal vital signs. You can monitor fetal heart rates (FHRs) externally using ultrasound, uterine activity using an external Toco transducer, and the maternal heart rate (MHR) via maternal ECG electrodes, and non-invasive blood pressure and maternal oxygen saturation (SpO2).
3 Basic Operation Avalon CL Transducer System The Avalon CL Fetal Transducer System lets you monitor the patient continuously with cableless transducers during the antepartum period, labor, and delivery. You can monitor the fetal heart rate (FHR) using noninvasive CL Ultrasound transducers, or invasively using the CL ECG/IUP transducer with the direct electrocardiogram (DECG). The uterine activity can be monitored using an external CL Toco+ MP transducer.
3 Basic Operation Right Side with Battery Option 1 On/Off Switch 2 Power Connector 1 On/Standby Switch 2 MSL Connector Left Side 1 SpO2 Socket (optional) 2 Noninvasive Blood Pressure Socket (optional) 3 Fetal Sensor Sockets Each of the fetal sensor sockets accepts any fetal transducer, one Avalon CL or one Avalon CTS Cableless Fetal Transducer System base station, or an event marker.
3 Basic Operation Bottom There are five optional interfaces available for the Avalon FM20/30 monitor: • LAN/RS232 system interface • Dual PS/2 interface • MIB/RS232 interface • Flexible Nurse Call • USB port You can use two of the five optional interfaces at the same time.
3 Basic Operation Rear 1 Display Release 2 Carrying Handle 3 Built-in Stand Getting to Know Your Avalon FM40/FM50 Front 1 Touchscreen color display 2 Transparent paper guide with tear-off edge 3 Paper eject button 4 Power LED 5 On/Standby switch 6 Recorder paper table 7 Fetal sensor sockets 8 Noninvasive blood pressure socket 9 SpO2 socket Connect any fetal sensor or patient module at the fetal sensor sockets, including an Avalon CL or an Avalon CTS via interface cable (with red con
3 Basic Operation Rear 1 Reserved for future use: protective earth intended for use in system installations.
3 Basic Operation Transducers 1 Transducer finder LED - lights up on the transducer providing the measurement source 2 "MP" for M2734B "Toco MP" transducers (additionally capable of providing the maternal pulse measurement) 3 Belt Button 1 Cable - connects to any of the four fetal sensor sockets on the monitor Toco (M2734A) and Toco MP Transducer (M2734B) The M2736AA US transducer is identical to the M2736A US transducer, including all specifications Ultrasound Transducer (M2736A) 1 Toco+ Transd
3 Basic Operation 1 Butterfly belt clip (shown fitted; for use with belts without button holes) 2 Close-up of MECG adapter cable connected to Toco+ transducer 3 Close-up of active finder LED 1 Connector - for connecting ECG/ IUP adapter cables (same as for Toco+ transducer) 2 Cable - connects to any of the four fetal sensor sockets on the monitor Patient Module for ECG/IUP (M2738A) 45
3 Basic Operation Getting to Know Your Avalon CL Front 1 Transducer docking slots 2 On/Standby button with power LED 3 Device label 4 LED for optional cableless pods 5 Docking slots for cableless pods WARNING 46 • To avoid magnetic interference affecting the mode of the pacemaker, ensure that the Avalon CL base station does not come into close contact with implanted pacemakers.
3 Basic Operation Docking Slot for Cableless Transducers The Avalon CL base station has three docking slots to mechanically hold the CL transducers. The flexible electronic contacts identify the transducer type after docking. The transducers are charged while docked. The base station has a built-in radio interface with an integrated antenna to communicate with the transducers for assignment, configuration, and for transducer firmware updates.
3 Basic Operation Docking Slots for Cableless Measurement Pods The Avalon CL base station has one docking slot to mechanically hold an IntelliVue CL pod. The electronic contacts identify the CL pod type after docking. The CL pod is charged while docked. The LED under the docking slot indicates the battery status of the CL pod. The base station has a built-in short range radio interface with an integrated antenna to communicate with the CL pod for assignment and configuration.
3 Basic Operation Rear and Bottom 1 Name plate 1 Manufacturer label 2 Cable reel 49
3 Basic Operation Cableless Transducers The cableless Avalon CL transducers have a built-in radio interface with an on-board, integrated antenna. The fetal monitor connected to the Avalon CL base station can control the transducer using radio communication. The transducer transmits measured values, alarms, and status information to the fetal monitor. The cableless transducers are assigned by simply docking them at the Avalon CL base station.
3 Basic Operation CL ECG/IUP transducer Radio Range of CL Transducers The CL transducers have a operating range around the base station of at least 70 m in the line of sight. Obstructions as walls, metal doors, elevators and other environment structures can lead to signal loss. The Tele symbol indicator and the Tele Info window on the monitor's display (see “Screen Elements” on page 56 and “Tele Info Window” on page 92) provide information on the status of the signal strength.
3 Basic Operation Cableless Transducer LED Indication The cableless transducers have a multi-color LED that indicates the status of the transducer with specific colors. This LED remains visible when the transducer is correctly attached to the transducer belt (Philips standard belt). 1 LED LED Status Meaning White The LED lights up to identify the US transducer among other US transducers, and to easily verify the correct transducer assignment (transducer finder).
3 Basic Operation CL Transducer Battery Battery replacement is recommended after 500 charge/discharge cycles *2) or if the battery is older than 4 years whatever is reached first. If the battery of a cableless transducer has aged and an exchange of the battery is highly recommended, a prompt message is displayed at the fetal monitor for ca. 60 seconds. The prompt is repeated whenever the Tele Info window is opened until the battery is replaced.
3 Basic Operation CL Pods The two CL Pods provide measurement values for SpO2 and NBP on the built-in display, and communicate them to other system components using a wireless short range radio (SRR) interface. They are controlled with SRR from the Avalon CL base station and the connected fetal monitor. The maternal measurement pods are easily assigned by docking them at the Avalon CL base station.
3 Basic Operation Battery Status LED for CL Pods The CL Pods do not have their own battery status LED. On the Avalon CL base station the battery status LED for the CL Pods is located directly under the docking slot. 1 Battery status LED for CL Pods The battery status LED shows five different states: Status Meaning Green The docked CL Pod is fully charged. Yellow The docked CL Pod is charging. Yellow blinking The communication is established with the docked CL Pod.
3 Basic Operation FM40/50 If an optional external touch display is connected to the monitor, you can operate the monitor using the external touch display. 1 Monitor Information line 2 Measurement area 3 Key area 1 LAN connection status indicator only. RS232 system connection is not indicated. The train icon indicates if the fetal monitor is connected to OB TraceVue/IntelliSpace Perinatal, via a LAN cable or not.
3 Basic Operation Measurement Area 1 Antenna symbol (indicates a cableless measurement from a connected Avalon CL or Avalon CTS system).
3 Basic Operation Screen Details Icon Description The antenna symbol indicates a cableless measurement (Avalon CL or Avalon CTS). Indicates a short range radio measurement (IntelliVue CL Pods).
3 Basic Operation Icon Description The CL transducer is moved away from the base station approaching the limit of the area of reach. The US sound is replaced by an artificial QRS sound (like DECG). The DECG and MECG waves are no longer displayed.
3 Basic Operation SmartKeys SmartKeys are configurable graphical keys, located at the bottom of the main screen. They give you fast access to functions. The selection of SmartKeys available on your monitor depends on your monitor configuration, and on the options purchased. SmartKey Name Function Main Setup Enters main setup menu Pause Alarms Pauses alarm indicators. Pause duration depends on monitor configuration.
3 Basic Operation SmartKey Name Function Recorder Start/ Stop Turns the trace recorder on or off Paper Advance Advances the paper automatically to the next fold Stop Recordng Turns the trace recorder off Stored Data Rec Prints trace data from the monitor's memory Enter Notes Enters notes Timer Enters NST timer window Set Marker Marks an event Stop All Stops all noninvasive blood pressure measurements Stop NBP Stops manual noninvasive blood pressure measurement Stops current automatic me
3 Basic Operation Pop-Up Keys Pop-up keys are context-sensitive graphical keys that appear automatically on the monitor screen when required. E.g. the Confirm pop-up key appears when you need to confirm a change. Using the Touchscreen Select screen elements by pressing them directly on the monitor's screen. Disabling Touchscreen Operation 1 To temporarily disable the touchscreen operation of the monitor, press and hold the Main Screen permanent key for about three seconds.
3 Basic Operation Mode Description Password Protected Configuration Mode The Configuration Mode is for personnel trained in configuration tasks. You can change and store the default values and patient profiles permanently in the Configuration Mode. These tasks are described in the Configuration Guide. During installation, the fetal monitor is configured for use in your environment. This configuration defines the default settings you work with when you switch on the fetal monitor.
3 Basic Operation User Default The User Default is a complete configuration stored in the monitor's long-term memory. You can store the active settings, modified to your preference, in the User Default (in Configuration Mode). In monitoring mode, you can load the User Default settings to return to your preferred settings: 1 Select the Defaults SmartKey 2 Select Confirm in the dialog box to load the User Default. Factory Default The Factory Default is a complete configuration pre-defined at the factory.
3 Basic Operation Switching the Noninvasive Blood Pressure Measurement On and Off The noninvasive blood pressure measurement is the only measurement that you can manually switch on and off. To do this: 1 Enter the noninvasive blood pressure measurement's setup menu. 2 Select NBP to toggle between on and off. The screen display indicates the active setting. Changing Monitor Settings To change monitor settings such as brightness, or touch tone volume: 1 Enter the Main Setup menu.
3 Basic Operation WARNING Do not change the date and time setting, if the fetal monitor is connected to a Philips OB TraceVue/ IntelliSpace Perinatal system via a LAN -setup. The monitor uses the OB TraceVue/IntelliSpace Perinatal system date and time, including daylight saving time changes.
3 Basic Operation Switching On: FM20/FM30 FM20/30 1 Connect the monitor to AC mains and switch the monitor on. – The green power-on LED lights up. – 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.
3 Basic Operation 2 Lift the display forward. You will hear a click as the first position engages. If you want to tilt the display further, lift the display further forward until you reach the desired angle. 3 To fold the display, pull the display forwards as far as it will go 4 Then push the display all the way back until it clicks shut. If your monitor is wall-mounted, the display should be folded flat.
3 Basic Operation Fastening Belts and Transducers You can use more than one belt if, for example, you are monitoring uterine activity and FHR simultaneously. There are two basic ways to fasten belts and transducers: • Belts with button fixings. • Velcro belts together with the butterfly belt clip.
3 Basic Operation 70 4 When you have positioned a transducer satisfactorily, you can attach it to the belt by pushing the belt button on the transducer through one of the holes in the belt. 5 Alternatively, attach the butterfly belt clip to the transducer belt button and use this to attach the transducer to the belt. The clip allows you to slide the transducer for easy repositioning.
3 Basic Operation Using CL Transducers with a Belt Clip The Avalon CL transducers have their own belt clip. They can be optional ordered in a kit of 10 (989803184851). Avalon CL belt clip 1 Using Belt with Velcro Fixings Insert one end of the belt between the belt guides on one side of the butterfly belt clip, and secure with the velcro fixing.
3 Basic Operation Repositioning Transducers A patient possibly wears transducers for long periods without interruption. In rare cases, skin irritations may occur if a transducer is attached to one location for a longer period. To ensure there are no adverse effects on the patient's skin, inspect the transducer application site at least every three hours. If the skin quality changes, move the transducer to another site.
3 Basic Operation For the FM20 and FM30, you can connect an Avalon CL Cableless Fetal Transducer system interface cable (red connector) to one of the fetal sensor sockets at the left side of the monitor. For the FM40 and FM50, you can connect an Avalon CL or Avalon CTS Cableless Fetal Transducer System interface cable (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 (red connector) at the front.
3 Basic Operation The blue finder LED on a wired fetal transducer lights up when you touch the measurement on the screen, allowing you to identify the corresponding transducer. Finder LED 1 The white finder LED on a cableless fetal transducer lights up when you touch the measurement on the screen, allowing you to identify the corresponding transducer. 1 Finder LED cableless transducer The recorder prints an annotation showing the date, time, paper speed, and monitoring mode.
3 Basic Operation Paper Guide FM40/FM50 FM40/50 The 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 84. • 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 “Tearing Off the Paper” on page 80).
3 Basic Operation • the Recorder Speed 1 Fetal heart rate label 2 Uterine activity label The current monitoring modes (if any transducers are connected to the monitor) are printed.
3 Basic Operation time and date are locally adjusted, or if an OB system is connected that readjusts the time and date automatically. 1 Time stamp printed every ten minutes The trace records maternal parameters also. When measuring noninvasive blood pressure, the annotation is made at the end of the measurement. If the noninvasive blood pressure measurement repetition time is short, the noninvasive blood pressure numeric may not always be printed.
3 Basic Operation Recording Elements The trace paper of the recorder has much information printed on it. Here is an exemplary trace with the most common print outs and their meaning. Each trace header contains the last name and first name, the patient ID, patient date of birth, the current date and time, patient's bed label, and the gestational age of the pregnancy.
3 Basic Operation Choosing Paper Speed You can choose a Recorder Speed of 1, 2, or 3 centimeters per minute (cm/min). The default setting is 3 cm/min. The ACOG technical bulletin on FHR monitoring states that "accurate pattern recognition is difficult if not impossible at 1 cm/min and that 1 cm/min is only recommended for more economic screening. When FHR abnormalities arise, the faster paper speeds will enhance FHR pattern recognition".
3 Basic Operation This reflects exactly when the marker button was first pressed; keeping the button pressed has no influence on the annotation. Tearing Off the Paper 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. FM40/FM50 The recorder's paper guide incorporates a tear-off edge, allowing you to tear off the trace paper cleanly where you like (not necessarily at a fold).
3 Basic Operation 2 Tear off the paper as shown in the picture. To ensure a clean tear, always tear in an upwards motion, as indicated by the arrows. You can start tearing from the left or right (right-handed user shown). You may want to use both hands to guarantee that the paper is not misaligned during the tear off. 3 If you wish to tear off the paper at a fold, select the Paper Advance SmartKey, wait for the paper to stop, then tear it off. FM20/FM30 The FM20/FM30 does not have a paper guide.
3 Basic Operation Loading Paper FM20/FM30 CAUTION Using recorder paper that is not approved by Philips can result in accelerated paper fading and can damage the thermal line printhead. This type of damage is not covered by warranty. FM20/FM30 To load a pack of paper: 82 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.
3 Basic Operation 4 Unfold the top page of the pack and position the uterine activity scale on the right. 5 Slide the pack into the tray.
3 Basic Operation 6 Push the paper drawer back until it "clicks" closed. 7 Press the recorder Start/ Stop SmartKey or the Start Recordng SmartKey to switch on the recorder. Annotations of trace information are printed on the trace paper (see “Switching the Recorder On and Off ” on page 75 for details). Loading Paper FM40/FM50 CAUTION Using recorder paper that is not approved by Philips can result in accelerated paper fading and can damage the thermal line printhead.
3 Basic Operation 2 Press the paper eject button to open the paper drawer. 3 Lift out any remaining paper from the tray. 4 Press and hold the paper eject button to partially eject the paper, thus making it easier to remove. 5 Hinge the transparent paper guide forward. It is held in the closed position by a small protrusion on each side of the holder.
3 Basic Operation 86 6 A - Protrusion holds paper guide in closed position. 7 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 pack. 8 Unfold the top page of the pack and position the uterine activity scale on the right. 9 Slide the pack into the tray.
3 Basic Operation 10 Feed the paper evenly through the paper guide. Do not close the paper guide yet. 11 Close the paper drawer. 12 Now close the paper guide.
3 Basic Operation 13 Press the recorder Start/ Stop SmartKey or the Start Recordng SmartKey to switch on the recorder. Annotations of trace information are printed on the trace paper (see “Switching the Recorder On and Off ” on page 75 for details). Entering Notes Your monitor has a set of 15 factory pre-configured notes (see below). The maximum length of one single note is 30 characters. It is possible to edit the notes in Configuration mode (see the Configuration Guide).
3 Basic Operation 4 By default, notes are printed lengthwise in the direction of the trace, in the space between the FHR grid and the uterine activity grid. If you prefer, you can configure the recorder to print across the trace. 5 You can change this in Configuration Mode by changing the Notes Recording setting in the Fetal Recorder menu from Along (default) to Across (notes print width wise across the trace).
3 Basic Operation Cableless Monitoring Basics of Cableless Systems The fetal monitors FM20/FM30 and FM40/FM50 are compatible with the Avalon CL and Avalon CTS Cableless Fetal Transducer system. Regard the following points for cableless monitoring: • You can connect one Avalon CL with a red connector to a FM20/FM30 or a FM40/FM50 (fetal socket). • You can connect up to two Avalon CLs with a black connector to a FM40/FM50 (Tele socket).
3 Basic Operation Activating Cableless Transducers The CL transducers of the Avalon CL are activated by picking them up from the base station. If the CL transducer is activated, an antenna symbol is displayed on the fetal monitor screen next to the numeric of the measurement. See the Avalon CTS Instruction for Use for the activation of the cableless transducers of this system.
3 Basic Operation Tele Info Window The Tele Info window of the fetal monitors allows you to manage the Avalon CL system. Below is an exemplary view of the Tele Info window. Your window may differ depending on the status of the connected system. To open the Tele Info window you can: 1 Configure a Tele Info SmartKey to open the window, 2 click on the TELE icon on the main screen, or 3 select the Main Setup and then Tele Info.
3 Basic Operation Telemetry When the monitor recognizes a connected Avalon CL or Avalon CTS interface cable (red or black connector), it confirms the recognition with the following status indicators displayed in the lower right-hand corner of the screen: Indicator Avalon CTS Avalon CL Avalon CTS interface cable is connected to A base station is connected to the monitor, but the the monitor, but the Avalon CTS base station base station is in Standby mode.
3 Basic Operation • With the Avalon CL Transducer system you can now monitor twins and triplets with CL transducers. The Avalon CTS System does not have this option. About RF Signal Quality Signal transmission can be disturbed if: • the patient is out of range of the receiving area. • there is interference from another, possibly stronger, RF signal (a broadcasting station, for instance).
3 Basic Operation Three CL transducers can be docked and charged at the Avalon CL base station at the time. If a fourth transducer should be assigned to the Avalon CL base station: 1 Remove first the three already docked CL transducers from the base station and place them on the patient. 2 Then dock the remaining fourth transducer at the base station and wait until the LED of the fourth transducer signals that it has communication with the base station.
3 Basic Operation 3 A confirmation window opens with the prompt Please Confirm and Device will be removed. 4 Press the pop-up key Confirm. A prompt states then clDev has been removed. or Unassign the cableless Pods via it's user interface. See the Cableless Measurement Instruction for Use. or Dock the cableless Pod at another base station or charger and therefore assigning it to the new device.
3 Switching the Monitor to Standby To switch the monitor to Standby: Either 1 Select the Monitor Standby SmartKey. Or 1 Enter the Main Setup menu using the SmartKey. 2 Select Monitor Standby. 3 Pressing any key or selecting any field on the screen will resume monitoring. Note If a Avalon CL base station is connected to your FM 20/30 monitor, do not turn off the monitor if you need to recharge the batteries of the CL transducers. They can only be recharged if the FM20/30 monitor is on.
3 Basic Operation 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. FM40/FM50 and FM20/ FM30 with Battery Option The On/Standby button does not disconnect the monitor from the AC power source. To disconnect, unplug the power cord from the AC mains socket.
3 Basic Operation Troubleshooting Problem Possible Causes Solutions Light or no trace. Wrong paper. Use recommended paper. Dirty printhead. Clean printhead. See “Cleaning the Print Head” on page 255. FM20/30 only: Paper misaligned due Shut the drawer fully, pushing evenly with to drawer not being correctly shut. both hands. End of paper noted when pack not Bad paper feed or wrong paper. finished. Check paper feed and use recommended paper. Check Paper INOP is displayed.
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4 FM20/30 Battery Option 4 FM20/30 Battery 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. External Power Supply M8023A The external power supply M8023A (option #E25) allows you to operate the fetal monitor from an AC (alternating current) power source of 100 V to 240 V (± 10%) and 50/60 Hz (± 5%).
4 FM20/30 Battery Option WARNING • Always use the supplied power cord with the earthed mains plug to connect the external power supply M8023A (option #E25) to an earthed AC mains socket. Never adapt the mains plug from the power supply to fit an unearthed AC mains socket. • Do not use AC mains extension cords or multiple portable socket-outlets.
4 FM20/30 Battery Option Battery LED Colors If the monitor is connected to mains power, this means Green Battery power is > 90% Yellow Battery charging (battery power < 90%) Less than 10 minutes power remaining Red, flashing Red, flashes intermittently If the monitor is running on battery power, this means Battery or charger malfunction Battery malfunction Battery Status on the Main Screen Battery status information is permanently displayed on all screens.
4 FM20/30 Battery Option Battery Status Window 1 To access the Battery Status window and its associated pop-up keys, select the battery status information on the screen, or select Main Setup, Battery. – – – – Capacity, remaining tells you how much power is left in the battery. Capacity, fullCharge tells you how much power the battery can hold when fully charged. TimeToEmpty tells you approximately how long you can continue to use the monitor without an AC connection.
4 Checking Battery Charge To check the charge status of a battery, refer to the battery power gauge on the screen, or open the Battery Status window. When Battery Lifetime is Expired When the battery is aged, either after 3 years from manufacturing date or after 500 charge/discharge cycles, it is recommended to replace the battery. To remind you of this, a message will appear in the Battery Status window.
4 FM20/30 Battery Option Conditioning the Battery You must condition the battery when the "battery requires maintenance" symbol shows on the screen. Do not interrupt the charge or discharge cycle during conditioning. CAUTION Condition the battery with a monitor not currently in use. The monitor switches off automatically when there is no battery power left. To condition the battery, 1 Charge the battery until it is completely full.
4 FM20/30 Battery Option 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 circuit. They may ignite, explode, leak or heat up, causing personal injury. If battery leakage should occur, avoid contact with skin. Refer to qualified and authorized service personnel.
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5 Alarms 5 Alarms The alarm information here applies to all measurements. Measurement-specific alarm information is contained in the sections on individual measurements. The fetal monitor has two different types of alarm: patient alarms and INOPs. Patient Alarms Red and yellow alarms are patient alarms. A red alarm indicates high priority, such as a potentially life threatening situation (for example, SpO2 below the desaturation alarm limit).
5 Alarms WARNING Alarm systems of the monitor and those of the connected OB system are independent and not synchronized. Alarm Mode You can configure the alarm mode for your fetal monitor. There are two possible modes: • All: alarms and INOPs are enabled, with all audible and visual indicators active. • INOP only: only INOPs are enabled, with audible and visual indication active. This is the default alarm mode. WARNING In INOP only mode, no fetal/maternal patient alarms are enabled or indicated.
5 Alarms Audible Alarm Indicators The audible alarm indicators configured for your fetal monitor depend on which alarm standard applies in your hospital. Audible alarm indicator patterns are repeated until you acknowledge the alarm by switching it off or pausing it, or until the alarm condition ceases (if audible alarm indication is set to non-latching). WARNING Do not rely exclusively on the audible alarm system for fetal monitoring.
5 Alarms Changing the Alarm Tone Volume The alarm volume symbol at the top right of the monitor screen gives you an indication of the current volume. To change the volume: 1 Select the volume symbol. 2 The volume scale pops up. Alarm Volume 3 Select the required volume from the volume scale. When the alarm volume is set to zero (Off), the alarm volume symbol shows this symbol: If you switch the alarm volume off, you will not get any audible indication of alarm conditions.
5 Alarms Power Loss Tone FM20/30 When power is lost - no power is available from the AC power source or from the battery - a beeper with will sound. The tone can be silenced by pressing the On/Standby button. Battery Option, FM40/50 Acknowledging Alarms To acknowledge all active alarms and INOPs, select the Silence key This switches off the audible alarm indicators. A check mark beside the alarm message indicates that the alarm has been acknowledged.
5 Alarms 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, Alarm Settings. 2 Check the Alarms Off setting. This setting can be changed in Configuration Mode.
5 Alarms 3 Select Alarms Off. To Switch Individual Measurement Alarms On or Off This applies to alarm mode All. 1 Select the measurement numeric to enter its setup menu. 2 Select Alarms to toggle between On and Off. The alarms off symbol is shown beside the measurement numeric. While Alarms are Paused or Off When red alarms are paused or off: The red Alarms Paused lamp on the monitor front panel is lit. In the alarm field, the monitor displays the message Al.
5 Alarms Extending the Alarm Pause Time If your monitor has the function extended alarm pause enabled, you can extend the alarm pause time. Use this to prevent alarms being indicated, for example, while you are washing a patient or carrying out a procedure. Only extend the alarm pause time when you are sure that clinical personnel are available to monitor the patient's condition closely. To extend the alarm pause time to five or 10 minutes, 1 Select one of the alarm fields.
5 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 history when you discharge a patient, or if you enter Demonstration Mode. Alarm Messages Window The Alarm Messages window shows all the currently active alarms and INOPs in chronological order, beginning at the top with the most recent.
5 Alarms Latching Alarms The alarm latching setting for your monitor defines how the alarm indicators behave when you do not 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.
5 Alarms Alarm Latching Behavior Alarm Condition Red and Yellow Measurement Alarms Acknowledgment Presence Non-latching alarms Visual and audible latching Visual latching, audible non-latching Alarm 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 All audible and visual condition no alarm indicators longer present automatically stop Alarm tone on Alarm message Fla
5 Alarms Alarm Behavior at Power On If the monitor is switched off for longer than one minute and then switched on again, or after a loss of power lasting longer than one minute, the monitor can be configured to restore either the alarm settings from the monitor's User Defaults, or the most recently used alarm settings. When a patient is discharged, the User Defaults of the monitor are always restored independent of the setting.
6 Patient Alarms and INOPs 6 Patient Alarms and INOPs This chapter lists alarms and technical alarms (INOPs) for the fetal monitors irrespective of their priority. Alarm Messages Fetal alarms are identified by either "FHR" or "DFHR". All other alarms without these identifiers refer to maternal parameters. Alarm Message From Condition *** Brady (Pulse) SpO2 The heart rate from the Pulse signal Numeric flashes and alarm has fallen below the bradycardia limit is highlighted, red alarm limit.
6 Patient Alarms and INOPs Alarm Message From Condition *** Extreme Tachy MECG The maternal heart rate obtained Numeric flashes, red alarm from the maternal ECG has risen message, alarm tone. above the extreme tachycardia limit. xxx denotes the highest measured value, and yy is the extreme tachycardia limit.
6 Patient Alarms and INOPs Alarm Message From Condition Indication ** SpO₂ High SpO2 The arterial oxygen saturation has exceeded the high alarm limit. Numeric flashes and high limit is highlighted, yellow alarm message, alarm tone. ** SpO₂ 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.
6 Patient Alarms and INOPs Technical Alarm Messages (INOPs) Monitor INOPs INOP Message Indication What to do Bus Master Malfunc Monitor: INOP tone There is a problem with the monitor's hardware. Contact your service personnel. Bus Master Incomp Monitor: INOP tone The Bus Master board or firmware is incompatible and cannot be used with this monitor software revision. Contact your service personnel.
6 Patient Alarms and INOPs INOP Message Indication What to do Settings Malfunct Monitor: INOP tone The monitor cannot use the predefined settings for monitoring. Contact your service personnel. Speaker Malfunct Monitor: INOP tone Contact your service personnel to check the speaker and the connection to the speaker. SRR Incompatible Monitor: INOP tone The connected SRR (Short Range Radio) board or FW cannot be used with this base station SW revision. Contact your service personnel.
6 Patient Alarms and INOPs FM20/FM30 Battery INOPs INOP Message Indication Batt Empty Monitor: INOP tone Batt Incompat Monitor: INOP tone The battery cannot be used with this monitor. Replace it with the correct battery. Batt Low Monitor: INOP tone The estimated battery-powered operating time remaining is less than 20 minutes. Batt Malfunction Monitor: INOP tone Batt Missing Monitor: INOP tone No battery found in FM20/30. Contact your service personnel.
6 Patient Alarms and INOPs INOP Message Indication What to do Wrong Paper Scale Monitor: INOP tone 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 institution: pre-printed: 30-240 in US and Canada, 50-210 in other geographies.
6 Patient Alarms and INOPs Cableless Transducer INOPs INOP Message Indication cl US Disconnect Monitor: INOP tone cl Toco Disconnect cl ECG/IUP Disconn cl US Malfunction cl Toco Malf The cableless transducer has lost the connection to the CL transducer: tone and cyan monitor for more than 5 sec.
6 Patient Alarms and INOPs DECG and MECG INOPs INOP Message Indication What to do DFHR1 Equip Malf Monitor: INOP tone There is a problem with the DECG hardware. Contact your service personnel. DFHR1 Leads Off Monitor: INOP tone DFHR2 Leads Off Numeric is replaced by a -?- One or more DECG lead is not attached. Make 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.
6 Patient Alarms and INOPs INOP Message Indication NBP Cuff Overpress Monitor: INOP tone (severe The cuff pressure exceeds the overpressure safety limits. yellow/red INOP tone) Remove the cuff from the patient. Ensure that the tubing Numeric is replaced by a -?- is not kinked or twisted and that the correct patient category is selected. During this INOP, alarms cannot be paused or switched Try restarting the measurement. You can silence this INOP, but the INOP message remains visible until the off.
6 CL NBP Pod INOPs INOP Message Indication What to do cl NBP Disconnect Monitor: INOP tone The CL NBP Pod has lost the SRR connection to the monitor.
6 Patient Alarms and INOPs SpO2 INOPs INOP Message Indication What to do SpO₂ Equip Malf Monitor: INOP tone There is a problem with the SpO2 hardware. Contact your service personnel. SpO₂ Erratic Monitor: INOP tone Check the sensor placement. Try another adapter cable and sensor. If the INOP persists, contact your service personnel. Numeric is replaced by a -?SpO₂ Extd.
6 Patient Alarms and INOPs INOP Message Indication What to do SpO₂ Upgrade Monitor: display only The SpO2 measurement is currently in UPGRADE mode. Monitoring is not possible in this mode. Numeric unavailable CL SpO2 Pod INOPs INOP Message Indication What to do cl SpO₂ Batt Empty Monitor: INOP tone !!cl SpO₂ BatEmpty CL SpO2 Pod: display message The remaining battery time of the CL SpO2 Pod is below 30 minutes. Charge the battery.
6 Patient Alarms and INOPs Tympanic Temperature INOPs INOP Message Indication What to do Malfunction Monitor: INOP tone The thermometer or the interface board are defective. Check module on another monitor. Connect another module to this monitor and replace the interface board. If the problem persists, contact your service personnel. Incompat.
7 7 Admitting and Discharging The fetal monitor can store basic patient demographic information used to identify patients. Admit/Discharge on the Monitor This section describes how you admit and discharge patients when using the monitor as a stand-alone device (that is, when not used with an obstetrical information and surveillance system such as OB TraceVue/IntelliSpace Perinatal). Admitting a Patient The fetal monitor displays physiological data as soon as a patient is connected.
7 Admitting and Discharging 5 Select Confirm. The patient status changes to admitted. If the recorder is running, the recorder stops and immediately restarts to annotate the new patient data. Quick Admitting a Patient Use Quick Admit to quickly admit a patient using only a limited set of demographic data. 1 Select the Quick Admit SmartKey. 2 Enter the required data (ID fields or last name depending on configuration) with the keyboard or a barcode scanner. 3 Select Enter.
7 Admitting and Discharging NOTE In order to ensure a continuous record, it is recommended to discharge the patient at the monitor before performing a new patient admission in OB TraceVue/IntelliSpace Perinatal. New Patient Check The fetal monitor can be configured to ask you in certain situations: • after a specified power-off period • after a specified standby period whether a new patient is now being monitored.
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8 8 Non-Stress Test Timer The non-stress test (NST) timer shows the elapsed time for the non-stress test. The timer counts up to the time you set for the NST. Setting NST Autostart/Autostop You can set the recorder so that it starts automatically (NST Autostart) when the NST timer is started, and stops automatically (NST Autostop) when the NST is complete (when the set run time has elapsed). As default, NST Autostart is On, and NST Autostop is Off.
8 Non-Stress Test Timer Timer Expiry Notification When the timer expires, the color changes from blue to green, you hear a single tone, and a message appears in the status line on the main screen. The volume of the tone can be set in Configuration Mode.
8 Non-Stress Test Timer Pop-up Keys for NST Timer Setup Pop-Up Keys Selecting this pop-up key lets you.... Comments Start Start the timer. Stop Stop the timer, allowing either restarting after a pause (Start) or clearing (Clear key). Setup NST Enter the Setup NST menu. From here you can set the This pop-up key is not available with run time. Route 2, as the Setup NST menu is already open. Timer Return to the Timers window.
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9 Non-Stress Test Report 9 Non-Stress Test Report It is generally accepted that a non stress test (NST) allows you to assess fetal well-being. The monitor's NST report process uses fetal ultrasound (but not DECG) heart rate traces and the Maternal Toco trace, generating a printed report when criteria are met and it is an indication of the fetal well-being. The American term Non Stress Test (NST) is used for antepartum testing.
9 Non-Stress Test Report NST Report Status Window The NST Report window displays a detailed overview of the current NST status for any available ultrasound fetal heart rate measurement. You can see: • NST Status - whether it is ready, ongoing, or the time and date at which it was stopped, or at which it finished. • Elapsed time - the time that has elapsed since the NST began. • Accelerations - the number of FHR accelerations detected so far. • Baseline - the average baseline value.
9 Example NST Report Field Field Content Report Title, with FHR label and date NST Report for FHR1 on 12 Oct. 2009 Product Information Product DE53102345 G.01.70, OB A.04.24, Toco DE52401090, FHR1 DE00002345 A.05.
9 Non-Stress Test Report Field Field Content Result: Sinusoidal: No Sinusoidal Rhythm detected Result: Decelerations Events before Reporting Period: before Reporting Period Decelerations: 1 at: 11:38 severe prolonged This field is enabled if there were decelerations between the start of NST and the start of the reporting period.
9 Non-Stress Test Report An NST Report is generated when 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.
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10 Cross-Channel Verification (CCV) Cross-Channel Verification (CCV) 10 Misidentification of Heart Rates FHR detection by the monitor may not always indicate that the fetus is alive. Confirm fetal life before monitoring, and continue to confirm that the fetus is the signal source for the recorded fetal heart rate (see “Confirm Fetal Life Before Using the Monitor” on page 10).
10 Cross-Channel Verification (CCV) Cross-Channel Verification Functionality The cross-channel verification functionality (CCV) of the fetal monitors compares all monitored heart rates (maternal and fetal), and indicates automatically whether any two channels are picking up the same signal, or monitoring similar values. If the fetal monitor detects that any channels have the same or similar values the Coincidence INOP is issued with an INOP tone that can have a configurable delay.
10 FHR1 (US) FHR2 (US) FHR3 (US) DFHR (DECG) DFHR (DECG) Maternal Pulse (Toco MP) Maternal Pulse (SpO2) Maternal HR (MECG) 151
10 Coincidence Examples Coincidence of Maternal Pulse and FHR When the maternal pulse and FHR are being monitored, and the measured values are very similar or the same, the coincidence question mark is displayed on the monitor’s screen above both of the corresponding numerics (in this case maternal pulse and FHR). Often the signal loss or coincidence happens because the fetal or maternal movement displaced the ultrasound transducer, and a repositioning of the transducer is necessary.
10 Cross-Channel Verification (CCV) The coincidence question mark is also printed on the trace paper next to the corresponding FHR and maternal pulse. 1 Printed coincidence question mark on trace 2 FHR1 and pulse traces Coincidence of Twins/Triplets FHRs When both FHR1 and FHR2 are being monitored, and the measured values are very similar or the same, the coincidence question mark is displayed on the monitor’s screen above both of the corresponding numerics (in this case FHR1 and FHR2).
10 Cross-Channel Verification (CCV) The coincidence question mark is also printed on the trace paper next to the corresponding FHR1 and FHR2. 1 Printed coincidence question mark on trace 2 FHR1 and FHR2 traces Recommended Actions for INOP Coincidence 154 1 Confirm fetal life by palpation of fetal movement or auscultation of fetal heart sounds using a fetoscope, stethoscope, or Pinard stethoscope.
11 Monitoring FHR and FMP Using Ultrasound Monitoring FHR and FMP Using Ultrasound 11 To monitor a single FHR externally, you use an ultrasound transducer attached to a belt around the mother's abdomen. The ultrasound transducer directs a low-energy ultrasound beam towards the fetal heart and detects the reflected signal. Your monitor can also detect fetal movements and print the fetal movement profile (FMP) on the trace.
11 Monitoring FHR and FMP Using Ultrasound trouble tracking the abrupt changes, and may misrepresent the true FHR pattern. Signals such as those from moving fetal limbs are usually very strong, thereby masking the fetal heart signal. During prolonged movements where the fetal heart signal is masked, the FHR appears blank on the numeric display and as a gap on the recorded trace.
11 Monitoring FHR and FMP Using Ultrasound • With the Avalon CL Transducer System you can now monitor twins and triplets with cableless transducers. The Avalon CTS System does not have this option. The wireless symbol appears next to the measurement label, indicating that the measurement is being made by a cableless transducer.
11 Monitoring FHR and FMP Using Ultrasound Preparing to Monitor Prepare for ultrasound monitoring using the list below. The standard procedures in use in your facility determine the sequence of actions. 1 Determine fetal position. 2 Fasten the belt around the patient. 3 Switch on the monitor and the recorder. 4 Connect the transducer to a free socket. The signal quality indicator for the heart rate initially displays an invalid signal.
11 Monitoring FHR and FMP Using Ultrasound 1 FHR1 2 Audio source symbol To select the audio source for an FHR channel: 1 Enter the Setup FHR1 menu for the channel you want to hear (FHR1 used as an example). 2 Press Select Audio. It may take a few seconds for the audio source symbol to appear. Changing the Fetal Heart Sound Volume The FHR volume symbol at the top right of the Fetal Heart Sound Volume window gives you an indication of the current volume.
11 Monitoring FHR and FMP Using Ultrasound Fetal Movement Profile The Fetal Movement Profile (FMP) parameter detects fetal movements via an ultrasound transducer connected to the monitor. Only the fetus monitored on the FHR1 channel is monitored for FMP. Once you have enabled FMP (see “Switching FMP On and Off” on page 161), it is triggered automatically whenever: • You connect an ultrasound transducer. • A patient is discharged.
11 Monitoring FHR and FMP Using Ultrasound 2 FMP started here A Indication of current fetal movement. B The FMP statistics are presented as two percentage figures: The first figure shows the percentage of detected fetal movements in the previous ten minutes. C The second figure shows the percentage of detected fetal movements since the start of recording. To mark the start of the FMP statistic, FMP is printed on the paper with an arrow.
11 Monitoring FHR and FMP Using Ultrasound Troubleshooting Problem Possible Causes Solutions Erratic trace Fetal arrhythmia Erratic display Obese patient Consider monitoring FHR using DECG after the rupture of membranes. Transducer position not optimal Reposition transducer until signal quality indicator shows a good signal (at least half-full).
11 Monitoring FHR and FMP Using Ultrasound Additional Information Artifact in Fetal Heart Rate Measurement How to detect it and reduce its occurrence using the Avalon Fetal Monitor The ultrasound derived FHR measurement technique in Avalon fetal monitors, like all other ultrasound fetal monitors’ FHR measurement techniques, has limitations that can lead to misrepresentation of the fetal heart rate pattern and potential misinterpretation of the fetal condition.
11 Monitoring FHR and FMP Using Ultrasound Doubling: The auto correlation algorithm can display a doubled fetal or maternal heart rate if the duration of diastole and systole are similar to each other, and if the heart rate is below 120 bpm. Doubling, usually brief, is accompanied by an abrupt switch of the trace to double the baseline value.
11 Monitoring FHR and FMP Using Ultrasound Multiple Fetuses With multiple fetuses, the potential to experience these artifacts is increased. Positioning of the transducer is even more critical. Ultrasound scanning should be used to help with positioning of individual transducers. See also “Monitoring Twin FHRs” on page 171 and “Monitoring Triple FHRs” on page 179. Obtaining a Good Heart Signal To successfully position the ultrasound transducer, first determine the fetal position using palpation.
11 Monitoring FHR and FMP Using Ultrasound Signal Quality Indicator Avalon compared with its predecessor, the Series 50 Signal quality indicator on Avalon fetal monitors: Instead of a traffic light-like design (red – yellow – green) used on the Series 50, the signal quality on the Avalon 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 (goo
11 Monitoring FHR and FMP Using Ultrasound Double-Counting Contractions Excessive, coupling, hypertonus Artifact Double-Counting Comment Reassuring tracing. The excessive uterine activity should prompt discontinuation of any oxytocic agent. Remediation The true fetal rate can be confirmed by auscultation or by fetal scalp electrode.
11 Monitoring FHR and FMP Using Ultrasound Maternal-Switching (Maternal Insertion) Baseline Rate 170 - Tachycardia Baseline Variability Moderate Accelerations Unable to determine Decelerations Absent Contractions Absent Artifact Maternal insertion, noise Comment The fetus has an elevated baseline rate of about 170 bpm with minimal to moderate variability. The ability to assess fetal status is limited because about half of the tracing displays the maternal heart rate.
11 Signal ambiguity resulting in unexpected outcome with external fetal heart rate monitoring By Duncan R. Neilson Jr, MD; Roger K. Freeman, MD; Shelora Mangan, RNC, MSN, CNS American Journal of Obstetrics & Gynecology, June 2008: ___________________________________________________________ Antepartal and Intrapartal Fetal Monitoring, 3rd Edition (2007) By Michelle L.
11 Monitoring FHR and FMP Using Ultrasound By Donald Gibb, S. Arulkumaran Butterworth-Heinemann, ISBN 0-7506-3432-2 Page 65, “False or erroneous baseline because of double counting of low baseline FHR” Page 66, “Bradycardia: fetal or maternal” ___________________________________________________________ Role of Maternal Artifact in Fetal Heart Rate Pattern Interpretation Klapholz, Henry M, MD; Schifrin, Barry S.
12 Monitoring Twin FHRs 12 Monitoring Twin FHRs The FHRs of twins are externally monitored using two ultrasound transducers. The Avalon CL Transducer system provides the option to monitor twins with cableless transducers. The Avalon CTS system does not have this option. FM30/50 Twin FHRs are monitored throughout labor and delivery. After rupture of the membranes, you can monitor one twin externally using ultrasound, and the other internally using DECG.
12 Monitoring Twin FHRs • The trace recorded for FHR1 is thicker (darker) than that recorded for FHR2. This ensures that the two heart rates are easily distinguishable. The thickness of the recorded trace can be changed in Configuration Mode. • Remember that only one fetal heartbeat can be heard from the loudspeaker at any time. • The audio source symbol shows you which fetus you are listening to.
12 Monitoring Twin FHRs Monitoring Twins Internally FM30/50 Monitor one twin using the procedures described in “Monitoring FHR and FMP Using Ultrasound” on page 155. Monitor the second twin using the procedures described in “Monitoring FHR Using DECG” on page 195.
12 Monitoring Twin FHRs Separation Order Type In Configuration Mode, you can choose between two different ways, Standard and Classic, for dealing with the trace offsets on the recording (the order in which they are separated) when Trace Separation is On. • Standard: the FHR2 trace is shifted up by 20 bpm (it is recorded 20 bpm higher than it really is). No offset is ever applied to the FHR1 trace - it stays where it is. (In case of a third FHR, this is shifted down by 20 bpm.
12 Monitoring Twin FHRs 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 differentiating the traces easier, the trace from the ultrasound transducer connected to the FHR1 channel is separated from that of FHR2 by 20 bpm.
12 Monitoring Twin FHRs When Trace Separation is Off To indicate that trace separation is switched off, a dotted line labeled +0 prints across the FHR scale.
12 Troubleshooting Common problems that may occur when monitoring FHR using ultrasound are listed in “Monitoring FHR and FMP Using Ultrasound” on page 155. See also “Monitoring FHR Using DECG” on page 195 for common problems you might encounter when monitoring FHR directly. The following problem may occur when monitoring twins. Problem The question mark is printed repeatedly, and appears on the screen and the INOP Coincidence is issued.
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13 Monitoring Triple FHRs 13 Monitoring Triple FHRs If your monitor is equipped with the triplets option, it carries the label. You can monitor triple FHRs externally using three ultrasound transducers. With the Avalon CL Transducer system you can now monitor triplets with cableless transducers. The Avalon CTS system does not have this option. Refer to the appropriate preceding chapters for contraindications, and more information about the available measurement methods.
13 Monitoring Triple FHRs • The fetal sensor socket to which a transducer is connected, is identified by the transducer position indicator in the blue setup menu header: FM20/FM30 FM40/FM50 • The trace recorded for the FHR3 is thicker (darker) than that recorded for FHR1, which is thicker than that for FHR2. This ensures that the three heart rates are easily distinguishable. The thickness of the recorded trace can be changed in Configuration Mode.
13 Monitoring Triple FHRs The recorder prints a dotted line labeled -20 across the FHR scale, to identify the trace for FHR3. The FHR trace is labeled every 5 cm. The label for FHR2 is annotated with +20 and the FHR3 label is annotated with 20. 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.
13 Monitoring Triple FHRs The FHR trace is labeled every 5 cm. The label for FHR1 is annotated with +20 and the FHR3 label is annotated with 20. The following trace shows triplets with Trace Separation on, and using Classic separation order. The traces for FHR1 and FHR3 are offset. The numerical FHR values displayed 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.
13 When Trace Separation is Off To indicate that trace separation is switched off, a dotted line labeled +0 prints across the FHR scale.
13 Monitoring Triple FHRs 2 Classic trace separation switched off here Troubleshooting Common problems that may occur when monitoring FHR using ultrasound are listed in “Monitoring FHR and FMP Using Ultrasound” on page 155. The following problem may occur when monitoring triplets. Problem The question mark is printed repeatedly, and appears on the screen and the INOP Coincidence is issued.
14 14 Fetal Heart Rate Alarms Fetal heart rate (FHR) alarms can give both audible and visual warning of a non-reassuring fetal condition. Your monitor must be configured to alarm mode All to enable the FHR alarms (see “Alarms” on page 109). Changing Alarm Settings When you do any of the following actions for any FHR measurement channel, this applies for all active FHR measurements, both ultrasound and DECG: • Turning FHR alarms on or off. • Changing alarm limits. • Changing alarm delays.
14 Fetal Heart Rate Alarms 3 To change the high alarm limit delay time, select High Delay and select the delay time (in 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 a Signal Loss INOP is issued.
15 Monitoring Uterine Activity Externally Monitoring Uterine Activity Externally 15 You can measure uterine activity externally using a Toco transducer. You can also use a Toco+, Toco MP, or a CL Toco+ MP transducer for the same purpose, although they also have more (ECG/ IUP and Pulse) capabilities. The external Toco transducer measures the frequency, duration and relative strength of contractions, but not their absolute intensity.
15 Monitoring Uterine Activity Externally Abdominal Belt (disposable shown) External Toco Monitoring Prepare for Toco monitoring using the list below. The standard procedures in use in your facility determine the sequence of actions. 1 Fasten the abdominal transducer belt around the patient. 2 Connect the Toco transducer to a free socket on the monitor. The Toco baseline is automatically reset. The Toco display shows 20.
15 Troubleshooting External Toco Monitoring Problem Possible Causes Solutions Quality of the trace deteriorates or the Toco baseline varies The belt is incorrectly fastened and is The belt must be tight enough to ensure too slack or too tight, or the belt has lost good contact between the patient's skin its elasticity. and the entire surface of the transducer without causing discomfort. Ensure you are using the correct belt. Adjust it as necessary.
15 Monitoring Uterine Activity Externally If the second transducer also fails the tests, contact your service personnel. 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 pickup button. 4 Check if after a few seconds the values on the display and paper show this change in pressure. You can test all Toco transducers, including the cableless ones, as described above.
16 Monitoring Uterine Activity Internally Monitoring Uterine Activity Internally 16 FM30/50 You can monitor intrauterine pressure (IUP) using an intrauterine catheter together with a patient module, Toco+, or the CL ECG/IUP transducer, after rupture of the membranes and the cervix is sufficiently dilated.
16 Monitoring Uterine Activity Internally Illustration 2 shows the complete connection chain from the IUP catheter to the fetal monitor using the Toco+ transducer: 1 Disposable Koala IUP Catheter (M1333A) 2 Reusable Koala IUP Adapter Cable (9898 031 43931) 3 Toco+ transducer (M2735A) Illustration 3 shows the complete connection chain from the IUP catheter to the fetal monitor using the CL ECG/IUP transducer: 192 1 Disposable Koala IUP Catheter (M1333A) 2 Reusable Koala IUP Adapter Cable (9898 0
16 Internal (IUP) Monitoring Read the instructions that accompany the intrauterine catheter and the adapter cable before you start monitoring. Zero the monitor when instructed. WARNING Do not catheterize if placenta previa is diagnosed, or if uterine bleeding from an undetermined source is present. Prepare for IUP monitoring using the list below. The standard procedures in use in your facility determine the sequence of actions. 1 Perform a complete clinical evaluation.
16 Monitoring Uterine Activity Internally Troubleshooting Internal (IUP) Monitoring Problem Possible Causes Solutions No change in pressure during Dry environment or possible extracontraction. ovular placement of sensor tip. Refer to catheter Instructions for Use. Only pressure peaks can be seen (baseline not visible). Zero adjustment is incorrect. Zero the system. Trace is a straight line. Transducer is defective. Remove and touch the catheter.
17 Monitoring FHR Using DECG 17 Monitoring FHR Using DECG FM30/50 This chapter describes how to monitor a single fetal heart rate via direct ECG (DECG), using a spiral fetal scalp electrode in the intrapartum period. Read and adhere to the instructions that accompany the fetal scalp electrode, the DECG adapter cable, and the attachment electrode. Pay attention to all the contraindications, warnings, and for the DECG adapter cable, the cleaning and disinfection procedures.
17 Monitoring FHR Using DECG What You Need You can measure fetal DECG using the equipment combinations shown in the following illustrations. WARNING Never attempt to connect the fetal scalp electrode to anything other than the correct DECG adapter cable. Illustration 1 shows the complete connection chain from the fetal scalp electrode to the fetal monitor using the Toco+ transducer.
17 Monitoring FHR Using DECG Illustration 2 shows the equivalent chain using the CL Toco+ MP or CL ECG/IUP transducer.
17 Monitoring FHR Using DECG Illustration 3 shows the equivalent chain using the patient module. 1 Fetal Scalp Electrode, single spiral, (9898 031 37631) 2 Fetal Scalp Electrode, double spiral, Europe only, not for USA (9898 031 37641) 3 DECG Adapter Cable (9898 031 37651) with Pre-gelled Attachment Electrode (9898 031 39771) 4 Patient Module (M2738A) Making Connections WARNING Follow the instructions supplied with each of the monitoring accessories you are using.
17 Monitoring FHR Using DECG You are 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 used to verify the result of measures taken to resolve them (e.g.
17 Monitoring FHR Using DECG 3 Check the artifact suppression setting and change it if necessary (see “Suppressing Artifacts” on page 201).
17 WARNING Periodically compare the mother's pulse with the signal coming from the monitor's loudspeaker to ensure that you are monitoring fetal heart rate. If the MHR coincides with the FHR, do not misinterpret the MHR as the FHR (see also “Confirm Fetal Life Before Using the Monitor” on page 10 and “Cross-Channel Verification (CCV)” on page 149. Suppressing Artifacts When the monitor's artifact suppression is on, instantaneous heart rate changes of 28 bpm or more, however caused, are not recorded.
17 Monitoring FHR Using DECG Troubleshooting Problem Possible Cause Solutions DFHR1 Equip Malf DFHR2 Equip Malf DFHR3 Equip Malf Malfunctioning equipment See “Patient Alarms and INOPs” on page 121.
18 Monitoring Noninvasive Blood Pressure Monitoring Noninvasive Blood Pressure 18 This fetal monitor uses the oscillometric method for the noninvasive blood pressure measurement.
18 Monitoring Noninvasive Blood Pressure • with rapid blood pressure changes • with severe shock or hypothermia that reduces blood flow to the peripheries • with obesity, where a thick layer of fat surrounding a limb dampens the oscillations coming from the artery • on an edematous extremity. Measurement Methods There are three measurement methods: • Manual - measurement on demand. Results are displayed for up to one hour.
18 Monitoring Noninvasive Blood Pressure 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 Add 0.75 mmHg (0.10 kPa) for each centimeter higher or Deduct 0.75 mmHg (0.10 kPa) for each centimeter lower or Add 1.9 mmHg (0.25 kPa) for each inch higher. Deduct 1.9 mmHg (0.25 kPa) for each inch lower.
18 Monitoring Noninvasive Blood Pressure NBP Measurement Timestamp Depending on your configuration, the time shown beside the NBP numeric can be: – – • the time of the most recent NBP measurement, also known as the "timestamp", or the time until the next measurement in an automatic series, displayed with a graphic representation of the remaining time, as shown here. The NBP timestamp will normally show the completion time of the NBP measurement.
18 Monitoring Noninvasive Blood Pressure 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 measurement, select Repeat Time or press the Repeat Time SmartKey and set the time interval between two measurements.
18 Monitoring Noninvasive Blood Pressure Choosing the Alarm Source You can monitor for alarm conditions in systolic, diastolic, and mean pressure, either singly or in parallel. Only one alarm is given, with the priority of mean, systolic, diastolic. Menu option Pressure value monitored Sys. systolic Dia.
18 Troubleshooting Problem Possible Causes Cuff will not inflate Monitor is in Service or Configuration Mode High or low values measured (against clinical expectations) Solutions Technical defect Call service Cuff tubing not connected Connect cuff tubing Contraction occurring Wait until contraction has finished Patient talking before or during measurement Allow patient to rest quietly, then try again after three to five minutes Incorrect cuff size or cuff not at heart level Check cuff size, l
18 Monitoring Noninvasive Blood Pressure 210
19 Monitoring Maternal Temperature Monitoring Maternal Temperature 19 Measuring Tympanic Temperature The tympanic thermometer measures the patient's temperature in the ear using infrared technology. The result of this measurement can be automatically adjusted to correspond to a different body reference site. The result is displayed on the screen of the thermometer and transmitted to the monitor. The thermometer is used with single-use probe covers for infection control during measurement.
19 Monitoring Maternal Temperature Thermometer Display and Controls The tympanic thermometer has a liquid crystal display. The display shows the patient's temperature in numerics and guides you with symbols through the measurement process. Functional Keys 1 Eject key 2 Change unit key: °Celsius / °Fahrenheit 3 Start measurement key 4 Pulse timer key Description of Use Press the eject key to eject the probe cover.
19 Monitoring Maternal Temperature Status Screens The thermometer performs an internal test at every start-up to verify that the system components are functioning properly. It measures the ambient temperature. During start-up and measurement, the thermometer screens communicate the current status. Images Description Ambient Temperature above specified range Ambient Temperature below specified range System errors System error 12 - there is a problem with the settings.
19 Monitoring Maternal Temperature 4 Pick up a new probe from the probe container on the base station. 5 Inspect the probe cover to make sure it is fully seated (no space between cover and tip base) and there are no holes, tears, or wrinkles in the plastic film. 6 Place the thermometer with the probe in the ear canal, sealing the opening with the probe tip. For consistent results, ensure that the probe shaft is aligned with the ear canal. 7 Press and release the start-up key gently.
19 WARNING • Never apply the probe to the patient when the probe is not connected to the unit. • Always use a single-use probe cover to limit patient cross-contamination. • Measurement errors or inaccurate readings may result when probe covers other than the specified probe covers are used (see “Tympanic Temperature Accessories” on page 267) • Insert the probe slowly and carefully to avoid damage to the ear canal and the tympanic membrane.
19 Monitoring Maternal Temperature Entering Temperature Manually A temperature measurement can be entered manually. 1 Press the SmartKey Enter Temp. 2 A numeric pad opens. 3 Enter the temperature values. 4 Press the Enter key. The aging time (time the entered value is valid) can be configured in the Configuration Mode.
20 Monitoring SpO2 20 Monitoring SpO2 FM30/40/50 The pulse oximetry measurement (SpO2) is intended for use with maternal patients. Philips pulse oximetry uses a motion-tolerant signal processing algorithm, based on Fourier Artifact Suppression Technology (FAST). It provides two measurements: • Oxygen saturation of arterial blood (SpO2) - percentage of oxygenated hemoglobin in relation to the sum of oxyhemoglobin and deoxyhemoglobin (functional arterial oxygen saturation).
20 Monitoring SpO2 WARNING Proper Sensor Fit: If a sensor is too loose, it might compromise the optical alignment or fall off. If it is too tight, for example because the application site is too large or becomes too large due to edema, excessive pressure may be applied. This can result in venous congestion distal from the application site, leading to interstitial edema, hypoxemia and tissue malnutrition.
20 Monitoring SpO2 WARNING • For fully conscious maternal patients, who have a normal function of perfusion and sensory perception at the measurement site: To ensure skin quality and correct optical alignment of the sensor, inspect the application site when the measurement results are suspicious or when the patient complains about pressure at the application site, but at least every 24 hours. Correct the sensor alignment if necessary. Move the sensor to another site, if the skin quality changes.
20 Monitoring SpO2 Assessing a Suspicious SpO2 Reading Traditionally, pulse rate from SpO2 was compared with heart rate from ECG to confirm the validity of the SpO2 reading. With newer algorithms, such as FAST-SpO2, this is no longer a valid criteria because the correct calculation of SpO2 is not directly linked to the correct detection of each pulse.
20 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 SpO₂ menu, select Desat Limit. 2 Adjust the limit. Adjusting the Pulse Alarm Limits See “Adjusting the Heart Rate / Pulse Alarm Limits” on page 230. Setting Up Tone Modulation If tone modulation is on, the QRS tone pitch lowers when the SpO2 level drops.
20 Monitoring SpO2 222
21 Monitoring Maternal Heart / Pulse Rate Monitoring Maternal Heart / Pulse Rate 21 You can monitor the maternal heart/pulse rate using one of four sources: • Maternal pulse from Toco MP or CL Toco+ MP transducer (pulse rate) • SpO2 (pulse rate) • Maternal heart rate (MHR) via MECG electrodes • NBP (pulse rate) Maternal heart / pulse rates derived from Toco MP or CL Toco+ MP, SpO2 and MECG are continuous measurements, and are compared against the FHR for cross-channel verification.
21 Monitoring Maternal Heart / Pulse Rate MHR from MECG Electrodes You can measure MHR using the equipment combinations shown in the following illustrations. Illustration 1 shows the complete connection chain from the foam electrodes applied to the patient to the fetal monitor using the patient module. 1 Patient Module (M2738A) 2 MECG Adapter Cable (M1363A) 3 Pre-gelled Foam Electrodes (40493A/B/C/D/E) Illustration 2 shows the equivalent chain using the Toco+ transducer.
21 Monitoring Maternal Heart / Pulse Rate Illustration 3 shows the equivalent chain using a CL Toco+ MP transducer or a CL ECG/IUP transducer. 1 Avalon CL base station (866074) 2 CL Toco+ MP or CL ECG/IUP transducer (866075 or 866077) 3 MECG Adapter Cable (M1363A) 4 Pre-gelled Foam Electrodes (40493A/B/C/D/E) To simultaneously measure DECG and MECG, you can use a Toco+, a CL Toco+ MP, or a CL ECG/IUP transducer for MECG.
21 Monitoring Maternal Heart / Pulse Rate Applying Electrodes To derive the MHR (when you do not want to view the MECG waveform), you can place the electrodes just below the outer end of the clavicle near each shoulder. 1 MECG Electrodes Making Connections WARNING Follow the instructions supplied with each of the monitoring accessories you are using. Prepare for monitoring MHR using the list below. The standard procedures in use in your facility determine the sequence of actions.
21 Monitoring Maternal Heart / Pulse Rate Monitoring MECG Wave 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 used to verify the result of measures taken to resolve them (e.g.
21 Monitoring Maternal Heart / Pulse Rate Viewing the Waveform on the Screen 1 Measurement label (FHR1) 2 Measurement label (Toco) 3 Measurement label (DFHR3) 4 Measurement label (FHR1) 5 Measurement label (SpO2) 6 Measurement label (HR) 7 1mV scale bar 8 MECG wave with maternal label 9 DECG wave with fetal label 10 Measurement label (Temp) maternal temperature 11 Measurement label NBP NOTE The 1mV scale bar for the DECG and MECG wave is not displayed on the screen if you monitor DECG
21 Troubleshooting Problem Possible Causes Solutions MECG Leads Off displayed. One or more MECG leads is not attached.
21 Monitoring Maternal Heart / Pulse Rate WARNING • No alarm is possible when Toco MP or CL Toco+ MP transducer is the source of the pulse rate. • No QRS tone is audible when Toco MP or CL Toco+ MP transducer is the source of the pulse rate. • The Toco MP or CL Toco+ MP transducer signal is significantly less reliable if the patient is up and moving about, or is pushing during the second stage of labor. NOTE In rare cases it is possible to pick up a fetal signal source.
21 Monitoring Maternal Heart / Pulse Rate Average Pulse Rate from Noninvasive Blood Pressure WARNING No alarm is possible when noninvasive blood pressure is the source of the pulse rate. When you are measuring noninvasive blood pressure, the monitor can also calculate the average pulse rate. This occurs in either manual or automatic mode, when neither MECG, SpO2 nor pulse from Toco MP or CL Toco+ MP transducer are measured. The value is displayed on the screen, and printed on the trace.
21 Monitoring Maternal Heart / Pulse Rate 232
22 Printing the ECG Waveform 22 Printing the ECG Waveform FM30/50 You can print the ECG wave onto the trace paper. If you are monitoring both DECG and MECG, both waves will be printed. The start of the wave recording is annotated above the wave with MECG for Maternal ECG, with DECG for Direct fetal ECG, and with 25 mm/sec below the wave. WARNING The fetal/maternal monitor is not a diagnostic ECG device.
22 Printing the ECG Waveform MECG waveform on its own 1 MECG 2 Paper speed DECG and MECG waveforms 1 DECG 2 Paper speed When the recorder is on, there are two choices for printing the ECG wave: • Separate: This recording mode gives you a six-second ECG strip on the fetal trace paper in fast printout mode.
22 prints. A new trace header is printed out to mark where the MECG print-out starts and another FHR header mark signals when the fetal trace resumes. The following trace shows the MECG waveform: 1 FHR1 trace interrupted 2 MECG header 3 Paper speed 4 FHR1 trace resume • 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.
22 Printing the ECG Waveform The following trace shows both the DECG and MECG waveforms: 1 FHR1 and FHR2 2 DECG header 3 MECG header 4 Paper speed To make your choice: 1 Enter the Main Setup menu. 2 Select Fetal Recorder 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 Record ECG Wave SmartKey. Or 236 1 Enter the Main Setup menu by selecting the SmartKey.
22 Or 1 Select the ECG Wave. 2 Select Record ECG Wave in the ECG wave menu.
22 Printing the ECG Waveform 238
23 Paper Save Mode for Maternal Measurements Paper Save Mode for Maternal Measurements 23 Your monitor's recorder features a Paper Save Mode, where maternal vital signs are recorded using less paper than during a normal trace recording. When Paper Save Mode is enabled, and if the recorder is stopped, it will start automatically to print data from maternal measurements as they occur, and then stop again to save paper. You enable Paper Save Mode in Configuration Mode (default is off).
23 Paper Save Mode for Maternal Measurements 240
24 24 Recovering Data The monitor stores trace data, including annotations, in its internal backup memory. This allows the monitor to recover trace data that would otherwise be lost under certain circumstances. This trace recovery data can be automatically retrieved and printed in the event of the paper running out, or automatically transmitted to an OB TraceVue/IntelliSpace Perinatal system (LAN connection only), allowing continuity of data.
24 Recovering Data • The change back to a real-time recording from a trace recovery printout prompts the recording to restart. A new vertical trace header annotation consisting of the time, date and paper speed is printed, letting you see where the trace recovery printout ends, and where the real-time trace continues. • There can be a gap of up to 30 seconds between the trace recovery printout and the beginning of the real-time trace.
24 Recovering Data Traces are not available for periods the monitor was switched off, in Service mode, in Standby, or if the trace period was shorter than one minute. To delete all stored trace periods press the Erase All key. The speed of the printout depends on the configured recorder speed and on the amount of trace data available. The fetal trace printed from the trace data contains all data from the real-time trace, with the exception of the maternal heart rate, the pulse numeric and the ECG wave.
24 Recovering Data It may be that you only see one entry (the current patient’s data) in the Stored Data Recording window if that patient was monitored for a period long enough to erase any earlier entries. If you make a stored data recording for an old entry (that is, not for the current patient), the recorder performs a fast trace printout of the stored data, advances the paper to the next paper fold, then stops.
25 25 Care and Cleaning Use only the Philips-approved substances and methods listed in this chapter to clean or disinfect your equipment. Warranty does not cover damage caused by using unapproved substances or methods. Philips makes no claims regarding the efficacy of the listed chemicals or methods as a means for controlling infection. Consult your hospital’s Infection Control Officer or Epidemiologist.
25 Care and Cleaning WARNING • Do not operate the monitor if it is wet. If you spill liquid on the monitor, contact your service personnel or Philips service engineer. • Do not perform underwater monitoring (for example, in a bath or shower) using wired transducers. • Place the monitor where there is no chance of contact with, or falling into water or other liquid. • Do not dry equipment using heating devices such as heaters, ovens (including microwave ovens), hair dryers and heating lamps.
25 Care and Cleaning Recommended Disinfectants We recommend that you use one of the following disinfectants: Product Name Product Type Ingredients Isopropanol 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 (= 1Propanol) 60 mg/g Meliseptol® spray 50% 1-Propanol Accel TB RTU liquid 0.
25 Care and Cleaning Cleaning and Disinfecting the Tympanic Temperature Accessories Probe and Thermometer Body 1 Wipe the thermometer body clean with a damp cloth. The water temperature should not exceed 55°C (130°F). Do not soak, rinse, or submerge the thermometer under water. You may add a mild detergent to the water. 2 Clean the probe tip with a lint free swab. If the probe tip is soiled, clean it with a dampened swab.
26 Maintenance 26 Maintenance WARNING Schedule: Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards. In case of problems: If you discover a problem with any of the equipment, contact your service personnel, Philips, or your authorized supplier. Electric shock hazard: Do not open the monitor housing.
26 Maintenance Maintenance Task and Test Schedule The following tasks are for Philips-qualified service professionals. All maintenance tasks and performance tests are documented in detail in the service documentation supplied on the monitor's documentation DVD. Ensure that these tasks are carried out as indicated by the monitor's maintenance schedule, or as specified by local laws, whichever comes sooner. Contact a Philips-qualified service professionals if your monitor needs a safety or performance test.
26 Maintenance To remove the paper guide: 1 Press the paper eject button to open the paper drawer. 2 Hinge the transparent paper guide forward.
26 Maintenance 252 A Protrusion holds paper guide in closed position. 3 Release the paper guide from one side of the holder.
26 4 Then remove the paper guide. Refitting is a reversal of the removal procedure.
26 Maintenance Storing Recorder Paper Recorder paper is not intended for long-term archival storage. Another medium should be considered if this is required. Dyes contained in thermal papers tend to react with solvents and other chemical compounds that are being used in adhesives. If these compounds come into contact with the thermal print, the print may be destroyed over time. You can take the following precautionary measures to help avoid this effect: • Store the paper in a cool, dry and dark place.
26 Maintenance Cleaning the Print Head To clean the recorder's thermal print-head: 1 Switch off the monitor. 2 Open the paper drawer, and remove the paper if necessary, to gain access to the thermal print head. 3 Gently clean the thermal print head with a cotton swab or soft cloth soaked in isopropyl alcohol.
26 Maintenance Disposing of the Monitor WARNING To avoid contaminating or infecting personnel, the environment or other equipment, make sure you disinfect and decontaminate the monitor appropriately before disposing of it in accordance with your country's laws for equipment containing electrical and electronic parts. For disposal of parts and accessories such as thermometers, where not otherwise specified, follow local regulations regarding disposal of hospital waste.
27 Accessories and Supplies 27 Accessories and Supplies All accessories listed for the fetal monitor may not be available in all geographies. You can order parts, accessories and supplies from Philips supplies at www.healthcare.philips.com or consult your local Philips representative for details. All accessories and supplies listed here are reusable, unless indicated otherwise.
27 Accessories and Supplies Avalon CL Base Station CL Base Station Part Number Avalon CL Base Station can either be ordered with the option K30 866074 (red connector) or K40 (black connector) Transducers Transducer Part Number Avalon Toco Transducer M2734A Avalon Toco+ Transducer for Toco, DECG, MECG or IUP monitoring M2735A Avalon Toco MP Transducer for Toco and Maternal Pulse M2734B Avalon Ultrasound Transducer M2736A Avalon Ultrasound Transducer USA M2736AA ECG/IUP Patient Module (for D
27 Accessories and Supplies Accessory Description Part Number Belt (reusable, brown, contains latex) 32 mm wide, 15 m roll 1500-06281 50 mm wide, 5 belts M1562A 60 mm wide, 5 belts 1500-0642 60 mm wide, 15 m roll 1500-0643 Belt (disposable, yellow, water resistant) 60 mm wide, pack of 100 M2208A Ultrasound gel 12 Bottles 40483A 5 liter refill (with dispenser) for 40483A Shelf life: 24 months max.
27 Accessories and Supplies DECG Accessories: Component Compatibility Use the following pictorial guide to check component compatibility for DECG accessories. CAUTION Do not mix accessories from the New Philips DECG Solution (marked 1) with those from the QwikConnect Plus Solution (marked 2).
27 Accessories and Supplies Adult Multi-Patient Comfort Cuffs and Disposable Cuffs Maternal Patient Limb Circumference Category Bladder Width Disposable cuff Part No. Reusable cuff Part No. Tubing Adult (Thigh) 42.0 - 54.0 cm 20.0 cm M1879A M1576A Large Adult 34.0 - 43.0 cm 16.0 cm M1878A M1575A Adult 27.0 - 35.0 cm 13.0 cm M1877A M1574A M1598B (1.5 m) or M1599B (3.0 m) Small Adult 20.5 - 28.0 cm 10.
27 Accessories and Supplies Adult Single Patient Soft Cuffs Maternal Patient Category Limb Circumference Bladder Width Part No. Tubing Adult (Thigh) 45.0 - 56.5 cm 20.4 cm M4579B Large Adult X-Long 35.5 - 46.0 cm 16.4 cm M4578B Large Adult 35.5 - 46.0 cm 16.4 cm M4577B M1598B (1.5 m) or M1599B (3.0 m) Adult X-Long 27.5 - 36.5 cm 13.1 cm M4576B Adult 27.5 - 36.5 cm 13.1 cm M4575B Small Adult 20.5 - 28.5 cm 10.
27 Accessories and Supplies SpO2 Accessories Some Nellcor sensors contain natural rubber latex which may cause allergic reactions. See the Instructions for Use supplied with the sensors for more information. M1901B, M1903B and M1904B are not available in USA from Philips. Purchase Nellcor OxiCliq sensors and adapter cables 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.
27 Accessories and Supplies Description Comments Product Number Special Edition (SE) No adapter cable required. M1191ANL Adult sensor (3 m cable), for patients over 50 kg. Any finger except thumb. SE sensors work with FM30/40/50, as well as with OxiMax-compatible M1192AN SpO2 versions of other Philips Small adult, pediatric sensor (1.5 m cable) for patients between 15 kg and 50 kg. Any finger except monitors. thumb. Special Edition (SE) Use only on adult patients with FM30/40/50.
27 Accessories and Supplies Nellcor SpO2 Accessories Product Number Description Comments NELLCOR disposable sensors (must be ordered from Nellcor) OxiMax MAX-A Adult finger sensor (patient size > 30 kg) OxiMax MAX-AL OxiMax MAX-A with long cable OxiMax MAX-P Pediatric foot/hand sensor (patient size 10-50 kg) Requires M1943A (1.0 m) or M1943AL (3.0 m) adapter cable. Use only on adult patients with FM30/40/50.
27 Accessories and Supplies Product Number Description Philips Part Number LNOP Adtx Adult Sensor (> 30 kg) n/a LNOP Pdt Pediatric Sensor (10 - 50 kg) 989803140261 Use only on adult patients with FM30/40/50 LNOP Pdtx Pediatric Sensor (10 - 50 kg) n/a Use only on adult patients with FM30/40/50 LNOP Neo-L Neonatal Sensor (< 3kg) or Adult adhesive Sensor (> 40 kg) 989803140291 Use only on adult patients with FM30/40/50 MASIMO LNCS disposable adhesive sensors (No adapter cable required) LNCS Adt
27 Extension / Adapter Cables Description Comments Product No. Extension cable (2 m) For use with Philips reusable sensors and adapter cables. M1941A Adapter cable (1.1 m cable) Adapter cable for Philips/Nellcor disposable sensors. M1943A Adapter cable (3 m cable) M1943AL Adapter Cable for OxiCliq sensors Available from Nellcor. OC 3 LNOP MP12 LNOP MP Series Patient Cable (3.6 m) Adapter Cable for Masimo LNOP sensors M1020-61102 LNC MP10 LNCS MP Series Patient Cable (3.
27 Accessories and Supplies Batteries Description Comment Product No. Smart Battery 10.8 V, 6000 mAh, Lithium Ion For Avalon FM20 or Avalon FM30 with battery option #E25 M4605A Avalon CL Cableless Smart transducer Battery Replacement Kit Consists of one Philips Lithium Ion Battery 989803184861 (Part No. 453564107871), a tool to open and close the cableless transducer for battery replacement and two replacement O-ring seals.
28 Specifications and Standards Compliance Specifications and Standards Compliance 28 The monitors are intended to monitor a mother and her fetus(es), which from an electrical safety point of view, are one person. Environmental Specifications The monitor may not meet the given performance specifications if stored and used outside the specified temperature and humidity ranges.
28 Specifications and Standards Compliance Transducers (M2734A/M2734B/M2735A/M2736A/M2738A) Altitude Range Operating -500 to 3000 m/-1640 to 9840 ft. Storage/Transportation -500 to 13100 m/-1640 to 43000 ft.
28 Specifications and Standards Compliance Physical Specifications Avalon CL Base Station Dimension and Weight Size mm/(in): 349 x 74 x 183 mm (349 mm-5% max. width 350 mm) width x height x depth (13.7 x 2.9 x 7.2 in 13.7 in -5% max. width 13.8 in) Weight 0.985 kg /2.2 lbs Electrical Class When connected to M2702A/ M2703A/M2704A/M2705A Class II equipment using a red connector at the fetal sockets. When connected to M2704A/M2705A Class I equipment using a black connector in the telemetry socket.
28 Specifications and Standards Compliance Monitor Physical Specifications M2702A/M2703A Global Speed 6.25 mm/sec, 12.
28 Specifications and Standards Compliance 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 Ingress Protection Code IP X1 Dimensions and Weight Maximum size mm/(in): width x height x depth 55 x 28 x 50 (2.2 x 1.1 x 2.0 in) Cable length 2.5 m Weight < 200 g/7.0 oz. M8023A (Option #E25) External Power Supply Weight and Dimensions Maximum Weight 700 g ±10% (1.
28 Specifications and Standards Compliance Interface Specifications Flexible Nurse Call Relay1 Connectors 20 pin MDR (Mini D-Ribbon), active open and closed contacts Contact <=100 mA, <=24 V DC Isolation Basic insulation (reference voltage: 250 V; test voltage: 1500 V) Delay <[Configured Latency +0.5] sec 1 The power loss indication functionality of the Nurse Call Relay board is not supported with fetal monitors.
28 Specifications and Standards Compliance Performance Specifications Battery Specifications Performance Specifications Avalon FM20/30 Battery Option #E25 Operating Time Basic monitoring configuration: >2 hours (with new, fully charged battery) (Display Brightness: 70%, Recorder: "On" at 3cm/min, Charge Time When monitor is off: approx. 6 hours When monitor is in use: more than 10 hours (depending on monitor configuration).
28 Specifications and Standards Compliance Performance Specifications US Intensity CL (866076) Average output power P = (12.4 ± 0.4) mW Peak-negative acoustic pressure p_ = (49.1 ± 5.2) kPa Output beam intensity (Iob) Isata = (2.77 ± 0.56) mW/cm2 (= spatial average - temporal average intensity) Spatial-peak temporal average intensity Ispta = (21.1 ± 5.1) mW/cm2 Effective radiating area @ -12 dB A-12dB = (4.47 ± 0.89) cm2 Thermal index (TI) and mechanical index (MI) are always below 1.0.
28 Specifications and Standards Compliance Performance Specifications Wavelength Range 780 to 1100 nm Range 40 to 240 bpm Resolution 1 bpm Display Update Rate 1/s Accuracy ± 2% or 1 bpm, whichever is greater Update Rate every 4 seconds Performance Specifications IUP Measurement Method Passive Resistive Strain Gauge Elements Measurement Range -100 to +300 mmHg Signal Range -99 to 127 mmHg or -13.2 to 16.
28 Specifications and Standards Compliance Performance Specifications Electrode Offset Potential Tolerance ± 400 mV 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 Pace pulse detection None WARNING The fetal/maternal monitor is not a diagnostic ECG device.
28 Specifications and Standards Compliance MECG Alarm Specifications Range Adjustment MECG Alarm Limits 1 bpm steps (30 to 40 bpm) 5 bpm steps (40 to 240 bpm) High Range: 31 to 240 Default: 120 bpm Low Range: 30 to 235 Default: 50 bpm Tachycardia Difference to high limit: 0 to 50 bpm 5 bpm steps Default: 20 bpm Clamping at: 150 to 240 bpm 5 bpm steps Default: 200 bpm Bradycardia Difference to low limit: 0 to 50 bpm 5 bpm steps Default: 20 bpm Clamping at: 30 to 100 bpm 5 bpm steps Default: 4
28 Specifications and Standards Compliance Performance Specifications Cuff Inflation Time Typical for normal adult cuff: Less than 10 seconds Initial Cuff Inflation Pressure 165 ±15 mmHg Auto Mode Repetition Times 1, 2, 2.
28 Specifications and Standards Compliance Display Update Period: Typical: 2 seconds, Maximum: 30 seconds. Max. with noninvasive blood pressure INOP suppression on: 60 seconds.
28 Specifications and Standards Compliance SpO2 Alarm Specifications Range Adjustment Delay Tachycardia Difference to high limit 0 to 50 bpm 5 bpm steps max. 14 seconds Clamping at 150 to 300 bpm 5 bpm steps Bradycardia Difference to low limit 0 to 50 bpm 5 bpm steps Clamping at 30 to 100 bpm max.
28 Specifications and Standards Compliance Displayed Temperature Measurement Range Mode Range °C Range °F Ear 33.0 to 42.0 91.4 to 107.6 Oral (ear + 0.6. °C) 33.6 to 42.0 92.5 to 107.6 Core (ear + 1.04 °C) 34.0 to 42.0 93.2 to 107.6 Rectal (ear + 1.16 °C) 34.2 to 42.0 93.6 to 107.6 Caution: ASTM E1965-98 specifies 34.4°C to 42.2°C (94°F to 108°F) Ambient Temperature Range Mode Range °C Range °F Operating 10 to 95% RH, noncondensing 16 to 33 60.8 to 91.
28 Specifications and Standards Compliance Recorder Specifications Built-in Thermal Array Fetal Trace Recorder Mechanism Thermal Array Recorder Paper & Printing Type Standard Z-fold paper Standard Speeds (real-time traces) 3 cm/min, 2 cm/min, 1cm/min Fast Print Speed (stored traces) Max.
28 Specifications and Standards Compliance Recorder Symbols Symbol Description FMP detection is on Beginning of the date/time annotation Warning (INOP) Measurement from a cableless transducer (printed next to measurement label) Measurement from a cableless maternal measurement Pod (SpO2 or NBP) Pulse from SpO2 Pulse from Toco MP Pulse from NBP Trace separation +20 bpm (in label) Trace separation -20 bpm (in label) Trace separation Off (in trace) Trace separation +20 bpm (in trace) Trace separation -2
28 Specifications and Standards Compliance Recorder Symbols Symbol Description Coincidence of heart rates is detected Marker Special wave, with different speed and scale (for example, fast printout of MECG wave on FM30) Compatible External Displays: FM40/FM50 Only External displays can be connected with a maximum cable run of 10 m.
28 Specifications and Standards Compliance Regulatory and Standards Compliance The monitor is in conformity with the requirements of the European Medical Devices Directive 93/ 42/EEC and bears the CE marking: The monitor is classified into Class IIb to Annex IX rule 10.
28 Specifications and Standards Compliance Safety Tests Fetal Monitor All the safety tests and procedures required after an installation or an exchange of system components are described in your monitor's Service Guide. These safety tests are derived from international standards but may not be sufficient to meet local requirements. WARNING • Do not use additional AC mains extension cords or multiple portable socket-outlets.
28 Specifications and Standards Compliance 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 the patient vicinity, or within a 1.0 m radius of any part of the fetal monitoring system.
28 Specifications and Standards Compliance Reducing Electromagnetic Interference CAUTION The device should not be used adjacent to, or stacked with, other equipment unless otherwise specified. The product and associated accessories can be susceptible to interference from continuous, repetitive, power line bursts, and other RF energy sources, even if the other equipment is compliant with EN 60601-1-2 emission requirements.
28 Specifications and Standards Compliance Electromagnetic Emissions and Immunity The EMC standards state that manufacturers of patient-coupled equipment must specify immunity levels for their systems. See Tables 1 to 4 for this detailed immunity information. See Table 5 for recommended minimum separation distances between portable and mobile communications equipment and the product.
28 Specifications and Standards Compliance Table 2 - Guidance and Manufacturer's Declaration: Electromagnetic Immunity Immunity Test IEC 60601-1-2 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharge (ESD) IEC 61000-4-2 ± 6 kV contact ± 8kV air ± 6 kV contact ± 8kV air Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
28 Specifications and Standards Compliance Radio Compliance Notice Avalon CL with WMTS Operation of this equipment requires the prior coordination with a frequency coordinator designated by the FCC for the Wireless Medical Telemetry Service. This device complies with Part 15 of the FCC Rules and RSS-210 of Industry Canada.
28 Specifications and Standards Compliance Finding Recommended Separation Distances In the following table, P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer, and d is the recommended separation distance in meters (m).
28 Specifications and Standards Compliance Table 4 - Guidance and Manufacturer's Declaration: Electromagnetic Immunity Radiated RF Immunity Test EN/IEC 61000-4-3 Electromagnetic Environment Guidance: IEC 60601-1-2 Test Level over 80 MHz to 2.
28 Specifications and Standards Compliance Recommended Separation Distances from Other RF Equipment 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.
28 Specifications and Standards Compliance 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 is without power for more than one minute, the behavior depends on your configuration. If Automat. Default is set to Yes, the User Defaults will be loaded when power is restored. If Automat. Default is set to No, all active settings are retained, if power is restored within 48 hours. The Automat.
28 Specifications and Standards Compliance Symbols on the System This caution/warning symbol indicates that you should consult the Instructions for Use (this document), and particularly any warning messages. Connection direction indicator This symbol indicates that you should consult the Instructions for Use (this document).
28 SpO2 Socket symbol. IP 68 Ingress 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). Noninvasive Blood Pressure Socket symbol. IP X1 Ingress Protection code according to IEC 60529.
28 Specifications and Standards Compliance FCC ID Socket for connecting Avalon CTS interface cable M2732-60001 or Avalon CL interface cable (with black connector, FM40/FM50) Identifies the year and month of manufacture. Symbol indication for nonionizing radiation. Symbol indicating separate collection for waste electrical and electronic equipment.
29 Default Settings Appendix 29 Default Settings Appendix This appendix documents the most important default settings of your fetal monitor and the Avalon CL Base Station with the cableless transducers as they are delivered from the factory. For a comprehensive list and explanation of default settings see the Configuration Guide supplied with your fetal monitor. The monitor's default settings can be permanently changed in Configuration Mode.
29 Default Settings Appendix Coincidence Default Settings Coincidence Default Settings Coincidence Tone immediately NBP Default Settings Factory Default Settings Mode Manual Repeat Time 15 min Alarms from Sys.
29 Default Settings Appendix SpO2 Default Settings SpO2 Factory Default Settings Desat Limit 80 Low Limit 90 Low Limit 100 High Limit 20 seconds Desat Delay 10 seconds Low Alarm Delay 10 seconds High Alarm Delay 10 seconds NBP Alarm Suppr.
29 Default Settings Appendix Tympanic Temperature Default Settings pTemp Settings Factory defaults H10/H20/H40 H30 (deviations from H10/H20/H40) Adult Adult Low Limit 36°C (96.8°F) High Limit 39°C (102.
29 Default Settings Appendix Setting Choice Default Intensity 4 (medium) n/a Cal.
29 Default Settings Appendix 306
1 A accessories 267, 268, 270, 271, 272, 273, 277 cl NBP pod accessories 272 cl SpO2 pod accessories 276 fetal accessories 268 fetal recorder accessories 277 latex information 267 MECG accessories 270 noninvasive blood pressure accessories 270, 271, 272 adult cuffs 272 multi-patient comfort cuff kits 271 reusable cuffs 271 single-hose disposable cuffs 272 SpO2 accessories 273 Philips sensors (disposable) 273 Philips sensors (reusable) 273 transducer accessories 268 ACOG technical bulletin 80 actions after
F factory defaults 289, 290, 294 noninvasive blood pressure factory defaults 289 recorder factory defaults 294 SpO2 factory defaults 290 FAST 227 Fourier Artifact Suppression Technology 227 fetal accessories 268 fetal arrhythmia 208 fetal demise 10 fetal display specifications 285 IUP - fetal display specifications 285 Toco - fetal display specifications 285 US - fetal display specifications 285 fetal heart rate alerting. See FHR 191 fetal heart rate. See FHR 157 fetal movement 163 fetal movement profile.
oscillometric measurement method 211 P Paging Patient 97 paper 80, 81, 82, 83, 85, 264, 277 default paper speed 80 loading paper 83, 85 paper out INOP 82 paper speed 80 changing 80 default 80 defaults 80 setting 80 paper, when to reload 82 recorder paper 277 removing paper 83, 85 storing paper 264 tearing off a trace 81 Paper Advance key 61 Paper-Out indication 82 passcode protection 63 patient alarms 123 Patient Demographics window 137 patient module 205, 235 paused alarms 115, 116 restarting paused alarm
281 connecting transducer to monitor 73 fixing transducer to belt 70 repositioning transducers 73 Toco transducer 193 Toco+ transducer 193 transducer belt clip 70 transducer specifications 281 transducer testing 173, 195 Toco 195 ultrasound 173 triplets 183, 184, 185, 188 cross-channel verification 183 external monitoring 184 importance of monitoring MHR 183 monitoring triplets 183 offsetting baselines 184 troubleshooting 100, 165, 181, 188, 195, 199, 209, 217, 240 DECG 209 FHR 165 IUP 199 MECG 240 trouble
Part Number xxxxxxxxxxx Printed in Germany 06/13 *453564405521*
