• 6 second maternal ECG strip, with a choice of
real-time recording or “snapshot” together with
the fetal trace
• Maternal blood pressure and pulse oximetry
(optional)
Features
• Touchscreen for intuitive, easy operation
• Tilt and fold 6.5-inch TFT color display with a
wide viewing angle and large numerics
• Built-in 6-inch recorder for automatic printing of
fetal and maternal parameters on the trace
• Intelligent transducers are waterproof, light,
comfortable to wear and easy to clean
• Automatic channel management lets you connect
any fetal transducer, patient module or remote
The Philips Avalon FM30 fetal/maternal monitor
offers a state-of-the-art solution for all external and
internal fetal monitoring measurements in doctors’
practices, clinics and hospitals, during labor and
delivery and for antepartum monitoring of high-risk
patients.
With a cutting-edge feature set, including advanced
transducers, high quality signal processing, and a
touchscreen interface, the Avalon FM30 sets new
standards for performance, flexibility, convenience,
and ease of use.
Measurements
The Avalon FM30 lets you monitor and document:
• Up to three
ultrasound
• DECG via combined Toco/ECG “Toco
transducer (also can measure MECG)
• Uterine activity externally, or intrauterine pressure
• Maternal heart rate with ECG waveform display
1. Triplets monitoring is not currently available in the USA.
1
fetal heart rates externally using
+
”
event marker to any fetal sensor socket
• Cross-Channel Verification between all fetal and
maternal heart rates
• The blue transducer Finder LED lets you identify
at a glance which transducer is monitoring which
measurement
• Transmission of fetal and maternal parameters to
an obstetrical surveillance system
2
• Network connectivity to an OB TraceVue
via LAN connection using the optional system
interface, where OB TraceVue controls all patient
admit/discharge events
• Internal backup memory allows recovery of up to
one hour of trace data, either to paper or to an OB
Tr a c e V u e
• Cordless monitoring using the award-winning
Avalon CTS Cordless Fetal Transducer System
• Compact and light, with built-in carrying handle,
and stand for angled stance on any flat surface
• Comprehensive patient data presentation,
including at-a-glance patient identification, and
2. OB TraceVue Revision E.00.00 or later.
3. Requires Avalon CTS interface cable M2731-60001 (see Avalon
CTS data sheet for details), and monitor software revision D.00.00
or higher.
2
system over a LAN connection
system
3
the choice to add user-configurable notes
4
• Automatic screen layouts optimize size and
presentation of measurements
• Fetal Movement Profile (FMP) detects and
automatically records gross fetal body movements
for antepartum applications
• NST timer for antepartum applications
Description of Main Components
TFT Color Display
The monitor has an integrated, tiltable color TFT
display, with a wide viewing angle, providing high
resolution data presentation. Fetal and maternal
measurements are displayed as large, easy-to-read
numerics.
Information such as patient identification (including
the bed label when connected to a surveillance
system such as OB TraceVue), date and time, alarm
information, icons for recorder status, and prompt
and error messages are also clearly shown.
Touchscreen User Interface
•Fetal Movement
• Uterine Activity
The monitor prints the time, the date, trace
identification symbols, the monitoring mode and
the paper speed when first switched on, every ten
minutes after, and whenever the monitoring modes
change.
Maternal heart rate and the maternal pulse oximetry
value is printed every 5 minutes. In the case of
maternal noninvasive blood pressure measurement,
the annotation is made at the end of the
measurement.
Depending on the geography, there are two possible
paper scales:
•FHR Scale:
- Red paper: 30 to 240 bpm @ 30 bpm/cm
- Green paper: 50 to 210 bpm @ 20 bpm/cm
•Labor Scale:
- 0 to 100 units @ 25 units/cm
Alarms
When an alarm limit is exceeded, it is signalled 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
The monitor is operated using the touchscreen. All
user functions (apart from the On/Off switch) are
controlled directly from the screen, and the intuitive,
color, graphical user interface not only makes it
quick and easy to learn and use, but the lack of
mechanical controls also makes cleaning the Avalon
fetal monitor much quicker and simpler.
A number of SmartKeys at the bottom of the main
screen allow fast access to functions, for starting a
recording, or resetting a Toco baseline, for instance.
Heart rate and alarm volume adjustment, with an
indication of the current setting, are always available
at the top of the screen.
Integrated Recorder
The Avalon fetal monitor has an integrated, high
resolution thermal array recorder, with paper-out/end detection.
Traces are recorded at either 1, 2 or 3 cm/min.
Continuous traces are made for:
• Fetal Heart Rate(s)
• Maternal Heart Rate
4. Using standard Roman-8 character sets.
Alarm categories:
• Physiological Alarms for fetal and maternal
parameters (to indicate vital sign alarm limit
violations, for instance)
• Tec h nic a l Al a r m s ( I NO PS)
are triggered by signal
quality problems, equipment malfunction or
equipment disconnect.
Alarm modes:
• INOP only: only INOPs are enabled, with audible
and visual indication active. This is the default.
• All: patient alarms and INOPs are enabled, with
audible and visual indicators active.
Alarm suspension:
• Alarms Off/Pause Alarms function
• Alarm pause period: indefinite, or one, two, or
three minutes.
Alarm latching/non-latching:
•Visual
•Audible
• Visual and audible
Interfaces
LAN/RS-232 System Interface
The monitor has an optional LAN/RS-232 interface
board with two fully-isolated ports:
- The LAN connection is for connecting the
monitor to an OB TraceVue obstetrical
2
information and surveillance system on a
network, or to a PC for configuration or
upgrade using the Support Tool
- The RS232 connection can be used for
connecting the monitor to an obstetrical
information and surveillance system, such as OB
Tr a c e V u e
Input Device Interface (Dual PS/2 Interface)
This optional interface provides two PS/2 ports to
enable the monitor to be connected to off-the-shelf,
“plug-and-play” input devices:
- Mouse: any specified PS/2 mouse or trackball
may be used for navigation and data entry.
- Computer keyboard: a PS/2 computer keyboard
can be used for data entry instead of the onscreen pop-up keyboard.
Service Features
• The Support Tool helps technical personnel to
– carry out configuration, upgrades and
troubleshooting on an individual monitor.
– share configuration settings between monitors.
– back up the monitor settings.
• The Service Mode is password-protected and
ensures that only trained staff can access service
tests and tasks.
• 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.
Related Products
The monitor is in conformity with the essential
requirements of the European Medical Devices
Directive 93/42/EEC and the following major
international standards:
Safety, Performance
• EN 60601-1:1990+A1:1993+A2:1995/IEC
60601-1:1988+A1:1991+A2:1995
• EN 60601-1-1:2001/IEC 60601-1-1:2000
• EN/IEC 60601-2-27:1994
• EN/ISO 9919:2005
• EN 60601-2-30:2000/IEC 60601-2-30:1999
• EN/IEC 60601-2-37:2001+A1:2004
• EN 60601-2-49:2001/IEC 60601-2-49:2001
• UL 60601-1:2003
• CAN/CSA C22.2#601.1-M90
• AS/NZS 3200.1.0-1998
The possibility of hazards arising from hardware and
software errors was minimized in compliance with
ISO 14971:2000+A1:2003, EN60601-14:1996+A1:1999 and IEC 60601-14:1996+A1:1999.
Alarm sounds are compliant with the draft ISO/
IEC 9703-2 Standard.
Electromagnetic Compatibility
• EN/IEC 60601-1-2:2001+A1:2004
• ICES-001:1988
The Avalon fetal monitor is classified as
electromagnetic emissions Class B, except whenever
used with the IUP/ECG patient module M2738A,
when it is classified as Class A.
This ISM device complies with Canadian ICES-
001. Cet appareil ISM est conforme a la norme
NMB-001 du Canada.
Monitors with software revision D.00.00 (or higher)
are compatible with the Avalon CTS Cordless Fetal
Transducer System (M2720A), allowing expectant
mothers to be continuously monitored without
wires, whether in the bath or shower, in the bed, or
while ambulating. Monitors with earlier software
revisions can be upgraded to the lastest software
version (see “Upgrade Options” on page 14). Refer
to the Avalon CTS Data Sheet for the required
Avalon CTS interface cable (M2731-60001) and
further information.
Standards Compliance
US Federal Law restricts this device to sale by or on
the order of a physician.
3
Environmental Specifications
The monitor may not meet the given performance specifications if stored and used outside the specified
temperature and humidity ranges.
FM30 Monitor
Temperature RangeOperating0°C to 45°C (32°F to 113°F)
Default: 170 bpm
10 to 300 seconds in steps of 10 s
Default: 240 s
10 to 300 seconds
in steps of 10 s
Default: 300 s
in steps of 10 s
MECG Alarm
RangeAdjustment
Specifications
MECG Alarm LimitsHigh Range: 31 to 240
Default: 120 bpm
Low Range: 30 to 235
Default: 50 bpm
TachycardiaDifference to high limit: 0 to 50 bpm
Default: 20 bpm
Clamping at: 150 to 240 bpm
Default: 200 bpm
BradycardiaDifference to low limit: 0 to 50 bpm
Default: 20 bpm
Clamping at: 30 to 100 bpm
Default: 40 bpm
1 bpm steps (30 to 40 bpm)
5 bpm steps (40 to 240 bpm)
5 bpm steps
5 bpm steps
5 bpm steps
5 bpm steps
Noninvasive Blood Pressure
Measurement Validation: In adult mode, the blood pressure measurements determined with this device comply with the American National
Standard for Electronic or Automated Sphygmomanometers (ANSI/AAMI SP10 - 1992) in relation to mean error and standard deviation,
when compared to intra-arterial or auscultatory measurements (depending on the configuration) in a representative patient population. For the
auscultatory reference the 5th Korotkoff sound was used to determine the diastolic pressure.
Complies with IEC 60601-2-30:1999/EN60601-2-30:2000.
Measurement RangesSystolic30 to 270 mmHg (4 to 36 kPa)
Diastolic
Mean
AccuracyMax. Std. Deviation: 8 mmHg (1.1 kPa)
Pulse RateRange40 to 300 bpm
Accuracy
(average over
noninvasive blood
pressure measurement
cycle)
Measurement TimeTypical at HR > 60bpm
Cuff Inflation TimeTypical for normal adult cuff: Less than 10 seconds
Initial Cuff Inflation Pressure165 ±15 mmHg
Auto Mode Repetition Times1, 2, 2.5, 3, 5, 10, 15, 20, 30, 45, 60 or 120 minutes
Venipuncture Mode Inflation
Inflation Pressure20 to 120 mmHg (3 to 16 kPa)
Automatic deflation after170 seconds
10 to 245 mmHg (1.5 to 32 kPa)
20 to 255 mmHg (2.5 to 34 kPa)
Max. Mean Error: ±5 mmHg (±0.7 kPa)
40 to 100 bpm: ±5 bpm
101 to 200 bpm: ±5% of reading
201 to 300 bpm: ±10% of reading
Auto/manual: 30 seconds (adult)
Maximum time: 180 seconds (adult)
Alarm SpecificationsRangeAdjustment
SystolicAdult: 30 to 270 mmHg (4 to 36 kPa)10 to 30 mmHg: 2 mmHg (0.5 kPa)
DiastolicAdult: 10 to 245 mmHg (1.5 to 32 kPa)
MeanAdult: 20 to 255 mmHg (2.5 to 34 kPa)
> 30 mmHg: 5 mmHg (1kPa)
Overpressure SettingsAdjustment
> 300 mmHg (40 kPa) > 2 secnot user adjustable
SpO
2
Maternal pulse oximetry provides numerics and pulse trace for oxygen saturation (SpO2) of functional
maternal arterial hemoglobin. Heart rate is measures from maternal ECG electrodes (if connected).
Otherwise, the pulse rate is derived from pulse oximetry.
Complies with EN/ISO 9919:2005 (except alarm system; alarm system complies with IEC 60601-249:2001).
Measurement Validation: The SpO2 accuracy has been validated in human studies against arterial blood sample reference measured with a
CO-oximeter. Pulse oximeter measurements are statistically distributed, only about two-thirds of the measurements can be expected to fall
within the specified accuracy compared to CO-oximeter measurements. Display Update Period: Typical: 2 seconds, Maximum: 30 seconds.
Max. with noninvasive blood pressure INOP suppression on: 60 seconds.
SpO2 Performance Specifications
SpO
2
The specified accuracy is
the root-mean-square
(RMS) difference
between the measured
values and the reference
values
PulseRange30 to 300 bpm
Range
Accuracy
Resolution
Accuracy
Resolution
0 to 100%
Philips Reusable Sensors:
M1191A, M1191AL, M1191ANL, M1192A, M1192AN= 2% (70% to 100%)
M1191T, M1192T, M1194A, M1194AN = 3% (70% to 100%)
Philips Disposable Sensors with M1943A(L):
M1131A, M1901B, M1903B, M1904B = 3% (70% to 100%)
®
NellcorPB
MAX-A, MAX-AL, MAX-P, MAX-N, D-25, D-20, N-25, OxiCliq A, P, N = 3% (70% to
100%)
1%
±2% or 1 bpm, whichever is greater
1 bpm
Sensors with M1943A(L):
7
SpO2 Performance Specifications
SensorsWavelength range500 to 1000 nm.
Emitted Light Energy
Pulse Oximeter Calibration Range70% - 100%
Information about the wavelength range can be especially useful to clinicians (for
instance, when photodynamic therapy is performed).
≤ 15mW
SpO2 Alarm
RangeAdjustmentDelay
Specifications
SpO
2
Desat50 to low alarm limit1% steps
Pulse 30 to 300 bpm1 bpm steps (30 to 40 bpm)
TachycardiaDifference to high limit 0 to 50 bpm5 bpm stepsmax. 14 seconds
BradycardiaDifference to low limit 0 to 50 bpm5 bpm stepsmax. 14 seconds
50 to 100%1% steps(0, 1, 2, 3,... 30) + 4
5 bpm steps (40 to 300 bpm)
Clamping at 150 to 300 bpm
Clamping at 30 to 100 bpm
5 bpm steps
5 bpm steps
seconds
max. 14 seconds
Recorder Specifications
Built-in Thermal Array Fetal Trace Recorder
MechanismThermal Array Recorder
Paper & PrintingTypeStandard Z-fold paper
Standard Speeds (real-time traces)3 cm/min, 2 cm/min, 1cm/min
ECG Wave Recording
(not real-time)
Paper AdvanceUp to 20 mm/s
SensingOptical Reflex Sensor for black page marks
Accuracy
@ 3 cm/min, 2 cm/min, 1 cm/min
Usable Print Width128 mm
Resolution8 dots/mm (200 dpi)
Time Delay to see trace on paper <30s @ 1 cm/min
Trace Separation Offset for FHR
(Ultrasound and DECG)
±5 mm/page
TwinFHR2 +20 bpm
TripletFHR2 +20 bpm
Emulated 25 mm/s
Print speed is variable up to 20 mm/s and
depends on the print load
FHR3 -20 bpm
Ordering Guide and Accessory Options
You can order the Avalon FM30 fetal monitor under the product number M2703A. To order, precede the
required option number with M2703A (for example, M2703A #B71 adds the noninvasive blood pressure
measurement). “K” options let you modify your order. Below you will find tables giving you a quick overview
of the monitor’s standard capablities, and what is available as options. Refer to “Standard Accessories
Included” on page 10 for a list of items shipped as part of the standard configuration. Start-up quantities of
fetal supplies are available in five convenient kits.
All features listed as options can be added at a later time (see “Upgrade Options” on page 14).
8
Standard Measurements
TypeDescription
Standard Fetal
Measurements:
Standard Maternal
Measurements:
*We recommend to switch off FMP during labor.
**You can measure MECG using the “Toco
Accessories” on page 11).
Fetal Heart Rate (FHR) via ultrasound-
Twins monitoring via ultrasoundK02
Fetal Movement Profile* (FMP)-
Toco-
FHR via Direct ECG (DECG)-
Intrauterine Pressure (IUP)K03
Maternal ECG** and Heart Rate via MECG electrodes, including MECG
waveform
+
” transducer if you are not already using it to measure DECG. Order M1363A separately (see “MECG
Optional Measurements
TypeDescriptionRequired Option
Optional Fetal
Measurements:
Optional Maternal
Measurements:
Triple FHR via ultrasound
(Not currently available in USA)
Noninvasive Blood Pressure (NIBP) with
Pulse Rate
Pulse Oximetry (maternal SpO2) together
with NIBP with Pulse Rate
C73K02
B71K31
B73K31 + K91
Recommended
Accessory Option
(See “Accessory Options” on
page 9)
K03
Recommended
Accessory Option(s)
(See “Accessory Options” on
page 9)
Optional Interfaces
DescriptionRequired Option
Dual PS/2 Interface
for keyboard and mouse connection
System Interface
(1 x RS232 port and 1 x LAN port)
J22M8024A #A01)
J70-
Accessory Options
Option NumberDescription
K01
K02
K03
K04
K31
K91
The Avalon FM30 comes with one ultrasound transducer. To add a second M2736A ultrasound transducer,
order option K01.
The Avalon FM30 comes with one ultrasound transducer. To add two additional M2736A ultrasound
transducers, order option K02 (only in conjunction with C73).
Order ECG/IUP Patient Module M2738A (includes MECG adapter cable M1363A), using option K03.
Order the Remote Event Marker (9898 031 43411) using option K04.
Order Antimicrobial NIBP Cuff assortment kit with 3 m (10 ft) connection tubing (M1599B) using option
K31:
small adult - M4554A; adult - M4555A; large adult - M4557A
Order reusable Adult Finger SpO2 sensor (M1191AL), cable length 3 m (10 ft), using option K91.
Recommended
Accessory Option
(See “Input Devices” on
page 13)
Paper Scaling Options
Option NumberDescription
P01
P02
50-210 bpm paper scaling
30-240 bpm paper scaling
9
Fetal Supplies Starter Kits
Kit NumberDescriptionContents
862214
862215
862216
862217
862218
Standard Antepartum Kit (North America)Paper (30-240), belts, gel, belts buttons, belt
clips
Standard Antepartum Kit (Europe, Latin America, Asia)Paper (50-210), belts, gel, belts buttons, belt
Standard Antepartum Kit (Japan)Paper (50-210), belts, gel, belts buttons, belt
Intrapartum DECG Kit (single spiral)Fetal scalp electrodes, fetal adhesive pad
Intrapartum DECG Kit (double spiral).
Europe only. Not for USA
clips
clips
electrodes
Fetal scalp electrodes, fetal adhesive pad
electrodes
Standard Accessories Included
DescriptionQuantity
“Toco+” transducer for Toco, DECG, MECG or IUP monitoring1
Ultrasound transducer1
Butterfly Belt Kit2
Fetal paper pack (country-specific, installed)1
Power cable1
DECG adapter cable 9898 031 376511
Instructions for Use1
Documentation CD-ROM (includes Service Guide and Instructions for Use)1
Transducers
Transducer Part Number
Ultrasound transducerM2736A
Toco transducer for monitoring external TocoM2734A
“Toco+” transducer for monitoring Toco, DECG, MECG or IUPM2735A
ECG Patient Module for monitoring maternal heart rate or IUPM2738A