Introduction of Philips M2703A Flexible Fetal & Maternal Monitoring

The Avalon FM20/FM30 fetal monitor offers a reliable, cost-effective, high-performance solution for fetal monitoring needs in clinics and hospitals, doctors’ practices, and private households. This ranges from prenatal check-ups to antepartum monitoring of high-risk pregnancies, and monitoring during labor and delivery. With a cutting-edge feature set, including advanced transducers, triplets monitoring, high-quality signal processing, and a touchscreen interface, the Avalon FM20/FM30 sets new standards for performance, flexibility, convenience, and ease of use. The unique Smart Pulse measurement integrated into the Toco transducer simplifies monitoring. Without an additional sensor, the maternal pulse rate is monitored and continuously compared with the heart rate from the fetal sensor (cross-channel verification). In combination with an Avalon CL Transducer System, all fetal and maternal measurements can be monitored cablelessly, including twins, triplets, and Smart Pulse. The battery option gives monitoring flexibility for in-house transport, or bridging a mains power outage

Detailed Specifications (Key Features) 

The Philips Flexible Fetal & Maternal Monitoring system boasts several impressive specifications, including

• Dual-functional monitor for both fetal and maternal monitoring
• Wireless and lightweight design for ease of use and maneuverability 
• Advanced signal processing for clear and accurate data
• Integrated rechargeable battery with up to 6 hours of operation 
• Compatible with a variety of transducers and sensors 
• Secure data transmission to central stations
• User-friendly interface with customizable settings 
• Compliant with major medical standards, including IEC 60601-1 and FDA regulations

Description of Philips Flexible Fetal & Maternal Monitoring

The M2703A Flexible Fetal & Maternal Monitoring system is a state-of-the-art device designed for continuous and non-invasive monitoring of fetal and maternal heart rates and other vital signs. Its wireless and lightweight design allows for easy and comfortable use during labor and delivery, while its advanced signal processing technology ensures accurate and reliable data. The monitor is compatible with a wide range of transducers and sensors, making it a versatile tool for various medical applications. With its user-friendly interface and customizable settings, the M2703A Flexible Fetal & Maternal Monitoring  is an ideal choice for healthcare providers seeking a reliable and flexible monitoring solution.

Features

Transducers and Measurements

• The new generation of Avalon Smart transducers is waterproof, comfortable to wear, and easy to clean
• Ultrasound (US) fetal heart rate monitoring of singletons, twins, and even triplets
• Fetal Movement Profile (FMP) automatically detects fetal body movements for antepartum applications using an ultrasound transducer
• External uterine activity (Toco) monitoring
• Smart Pulse integrated into the Toco transducer detect the maternal pulse rate without the need for an additional sensor (SpO2 or MECG), confirming correct fetal heart rate monitoring
• Cross-Channel Verification (CCV) detects the coincidence between all fetal and maternal heart and pulse rates
• NST timer for antepartum applications
• Optional Non-Stress Test (NST) report software allows the interpretation of fetal heart rate and Toco traces. It generates automatically a printed report for an NST, based on NICHD guidelines from 2008 for electronic fetal heart rate monitoring, or based on the Dawes/Redman method (not available for USA, other FDA regulated territories, and Canada).
• Optional maternal noninvasive blood pressure (NBP) including pulse rate
• Heart rate with maternal ECG (MECG)
• Cableless monitoring with an Avalon CL Transducer System
• Beltless monitoring with the Avalon CL Fetal & Maternal Pod and Patch (not available for USA, other FDA regulated territories, and Canada)
• Extended wireless monitoring with the Avalon CL Wide Range Pod
• Optional monitoring of maternal temperature with the Tympanic Temperature Thermometer
• Entering of manually taken maternal temperature
• Direct fetal heart rate monitoring with fetal ECG (DECG) including waveform display (FM30 only)
• Intrauterine pressure monitoring (IUP) (FM30 only)
• Optional maternal pulse oximetry (SpO2) and continuous maternal pulse rate (FM30 only)
• Access of all screen-operable functions of the fetal monitor on a remote display through the support of the XDS Remote Display application in combination with IntelliSpace Perinatal

Monitor

• High-resolution color TFT touchscreen display with a wide viewing angle. Fetal and maternal measurements are displayed as large, easy-to-read numerics

  

• Intuitive user functionality via the touchscreen
• Quick and simple cleaning due to the absence of mechanical controls
• Optimized size and presentation of measurements with automatic screen layouts
• Displaying information such as Patient Identification (including the bed label when connected to a surveillance system such as IntelliSpace Perinatal), date and time, alarm information, recorder status, and prompt and error messages
• Fast access to functions, for example starting a recording or resetting the Toco baseline via configurable SmartKeys
• Adjustment of the heart rate and alarm volume with an indication of the current setting
• With the automatic channel management, all wired fetal transducers, patient modules, or remote event markers can be connected to any of the fetal sensor sockets at the left side of the monitor
• Identification of the relation between transducer and numeric through a transducer finder LED, with the position indication on the screen that shows to which fetal sensor socket a transducer is connected
• Comprehensive patient data presentation, including at-a-glance patient identification, and the choice to add user-configurable notes or individually typed notes
• Optional battery operation with a built-in Smart Battery  (M4605A) and an external AC/DC power supply (M8023A with option E25). The fetal monitor can operate using battery power for at least four hours.

Recorder

• Built-in six-inch high-resolution thermal array recorder with paper type detection and paper-out warning
• Trace output of fetal and maternal heart rates, fetal movements, and uterine activity, and annotation of time, date, trace identification symbols, patient information, and software versions
• Maternal heart and pulse rate are printed every five minutes
• SpO2 value is printed every five minutes (configurable to every 1 minute) (FM30 only)
• Maternal noninvasive blood pressure and temperature values are annotated at the end of the measurement
• Recording of six-second MECG and/or DECG wave snapshots with 25 mm/s scaling in parallel to, or separate from the fetal traces (FM30 only)
• Internal backup memory for at least 7 hours of trace data (>3.5 hours with previous hardware revision <A 00.18)
  • Stored data recording to print a specific patient episode from a selected patient at high speed, even multiple times
  • Bridge paper-out for printing the missing piece of trace after new paper has been loaded
  • Data recovery after an interruption of the online data transmission to an IntelliSpace Perinatal system over a LAN connection
• Paper Save Mode for maternal measurements

Alarms

When an alarm condition is fulfilled, it is signaled by the monitor in the following ways

• An alarm tone sounds
• An alarm message is shown on the screen
• The numeric of the alarming measurement flashes on the screen

Alarm categories

• Physiological Alarms: are triggered by fetal and maternal parameters (for example, to indicate vital sign alarm limit violations)
• Technical Alarms (INOPs): are triggered by signal quality problems, equipment malfunction, or equipment disconnection

Alarm modes

• All: patient alarms and INOPs are enabled, with audible and visual indications active (default setting)
• INOP only: INOPs are enabled, with audible and visual indications active

Alarm suspension

• Alarms Off/Pause Alarms function
• Alarm pause period: one, two, or three minutes, or indefinite

Alarm latching/non-latching

• Visual
• Audible
• Visual and audible

Standard Interfaces

Cableless monitoring with the Avalon CL Transducer System, that is connected to a fetal sensor socket.

Optional Interfaces

LAN/RS232 System Interface
The LAN/RS232 interface has two fully isolated ports

1. The LAN port is used to connect the monitor to an IntelliSpace Perinatal obstetrical information and surveillance system (revision E.0 or later) on a network. IntelliSpace Perinatal controls all patient admit/discharge events.
2. The RS232 port can be used for connecting the monitor to an obstetrical information and surveillance system, such as IntelliSpace Perinatal.

Dual system interface support: If an obstetrical information and surveillance system is connected via LAN, another information system (EMR) can be independently connected via RS232 in read-only mode.
Dual MIB/RS232 Interface
The dual MIB, Medical Information Bus (IEEE P1073), is a standard for interfacing medical devices, used for the Data Export functionality to export measurement values from the monitor to other devices or to connect the Tympanic Temperature Thermometer.
Flexible Nurse Call Interface

• Alarms generated on the monitor are signaled on an external device such as a nurse call system, a beeper, or a light
• Providing three general alarm relays
• Connection of the external device to the alarm relay of the monitor
• Configurable alarm criteria
• Active open and closed contacts and a user-definable delay time

Device Interface (USB Interfaces)
USB interfaces are used to connect USB devices (mouse, keyboard, or barcode reader) to the monitor.
Service Features

• The Configuration Mode is password-protected and allows trained users to customize the monitor configuration
• The Demo Mode is password-protected and is intended for training and educational purposes
• The Service Mode is password-protected and ensures that only trained staff can access service tests and tasks
• The Support Tool uses the LAN interface of the fetal monitor and helps technical personnel to:
  • carry out configuration, upgrades, and troubleshooting on an individual monitor
  • share configuration settings between monitors
  • back up the monitor settings

Related Products

Avalon CL Transducer System
The monitor is compatible with the Avalon CL Transducer System allowing expectant mothers to be continuously monitored without wires, whether in the bath or shower, in the bed, or while ambulating. Refer to the Avalon CL Technical Data Sheet for further information.

Avalon CL Transducer System  
Avalon CL Fetal & Maternal Pod and Patch

The CL F&M Pod provides measurement values for fetal and maternal heart rate and uterine activity. It is controlled via short-range radio from the Avalon CL base station and the connected fetal monitor. The operating range is in-room, unless the CL F&M Pod is used in connection with the CL Wide Range Pod. The CL F&M Pod is assigned by docking it at the Avalon  CL base station. For monitoring, the CL F&M Pod is placed on a CL F&M Patch and held in place by integrated magnets. Monitoring with the CL F&M Pod and Patch can continue when the patient takes a shower. The CL F&M Pod is not intended for underwater monitoring, for example in a bathtub.

Avalon CL Wide Range Pod
The Avalon CL Wide Range Pod is an extension of the  Avalon CL solution. The Avalon CL Wide Range Pod extends the signal range of the cableless and beltless measurements. It transmits the cableless and beltless measurement signals via the hospital WLAN to the fetal monitors. Wearing the Avalon CL Wide Range Pod, the patient can walk freely within the hospital’s WLAN range during monitoring. Prior to use, the Avalon CL Wide Range Pod is charged with and assigned to the Avalon CL base station.

Tympanic Temperature Thermometer
The monitor is compatible with the Tympanic Temperature Thermometer which measures the maternal temperature in the ear. The value of this measurement can be automatically adjusted to correspond to a different body reference site. The measured value is shown on the display of the thermometer and transmitted to the monitor. Refer to the Tympanic Temperature Thermometer Technical Data Sheet for further information.

Regulatory and Standards Compliance

The monitor complies with the requirements of the European Medical Devices Directive 93/42/EEC and the following major international standards.
Safety Specifications
The fetal monitors comply with the following major international safety and performance standards

• IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+A1:2013
• IEC 60601-1-6:2010-A1:2013 / EN 60601-1-6:2010+A1:2015
• IEC 60601-1-8:2006+A1:2012 / EN 60601-1-8:2007+A1:2013
• IEC 60601-2-49:2011 / EN 60601-2-49:2015
• ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010/2012
• CAN/CSA C22.2#60601-1-14
• JIS T 1303 2005

The possibility of hazards arising from hardware and software errors was minimized in compliance with ISO 14971:2007 / EN ISO 14971:2012  and  IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+A1:2013.
Alarm sounds are compliant with Standard  
IEC 60601-1-8:2006+A1:2012 / EN 60601-1-8:2007+A1:2013
Electromagnetic Compatibility

• IEC 60601-1-2:2014 / EN 60601-1-2:2015
• ICES-003:2012

The monitor is classified as electromagnetic emissions Class B, except when used with the IUP/ECG patient module M2738A, then it is classified as Class A.
This ISM device complies with Canadian ICES-003. Cet appareil ISM est conforme à la norme NMB-001 du Canada.
Environmental Specifications
The monitor may not meet the given performance 
specifications if it is stored and used outside the specified temperature and humidity ranges.
FM20/FM30 Monitor

Physical Specifications

Performance Specifications
Complies with 
IEC 60601-2-37:2007 +A1:2015/ EN 60601-2-37:2008. ECG measurement follows 
IEC 60601-2-27:2011 +AC:2012/ EN 60601-2-27:2014 except clauses listed below

• 201.6.2, 201.8.5.5
• 201.12.1.101
• 202.6.2.101

Alarm Specifications

Pros & Cons of Flexible Fetal & Maternal Monitoring

Pros

• Wireless and lightweight design for ease of use and maneuverability
• Advanced signal processing for clear and accurate data
• Compatible with a variety of transducers and sensors 
• User-friendly interface with customizable settings 
• Secure data transmission to central stations 

Cons

• Higher price point compared to some competing products 
• Battery life may not be sufficient for long procedures 
• May require additional training for optimal use

Customer Reviews of Philips M2703A 

The Philips Flexible Fetal & Maternal Monitoring system has received positive reviews from customers, with many praising its ease of use, accuracy, and versatility. However, some customers have noted issues with the battery life and the need for additional training for optimal use. Overall, the Philips M2703A is a highly regarded monitoring solution for healthcare providers seeking a reliable and flexible tool for fetal and maternal monitoring.