Philips FM30 User Guide

PAD M2703A Software Revision D.0 Data Sheet

Avalon FM30

Fetal / Maternal Monitor

• 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.

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

• 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.

system over a LAN connection

system

the choice to add user-configurable notes

• 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

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.

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 Range Operating 0°C to 45°C (32°F to 113°F)

Storage

Humidity Range Operating <95% relative humidity @ 40°C/104°F

Storage

Altitude Range Operating -500 to 3000 m/-1640 to 9840 ft.

Storage

Transducers (M2734A/M2735A/M2736A/M2738A)

Temperature Range Operating 0°C to 40°C (32°F to 104°F)

Storage

Humidity Range Operating <95% relative humidity @ 40°C/104°F

Storage

Altitude Range Operating -500 to 3000 m/-1640 to 9840 ft.

Storage

SpO2 Sensors

Operating Temperature Range 0°C to 37°C (32°F to 98.6°F)

-20°C to 60°C (-4°F to 140°F)

<90% relative humidity @ 60°C/140°F

-500 to 13100 m/-1640 to 43000 ft.

-20°C to 60°C (-4°F to 140°F)

<90% relative humidity @ 60°C/140°F

-500 to 13100 m/-1640 to 43000 ft.

Physical Specifications

FM30 Monitor

Power Supply Voltages 100 VAC to 240 VAC ± 10%

Supply Frequency Range

Power consumption (maximum)

Dimensions and Weight Size mm/(in) ±1%: width x height x depth

Degree of Protection Against Electrical Shock

Electrical Class Class II equipment

Mode of Operation Continuous operation

Startup Time Time taken from switching on the monitor to

(without options)

Weight

Type CF

seeing the first parameter labels

Transducers (M2734A/M2735A/M2736A)

Shock Resistance Withstands ten 1m drops to concrete surface with possible cosmetic damage only

Water Ingress Protection Code M2734/35/36A IP 68 (immersion up to 1 m water depth for 5 hours)

M2738A IP 67 (immersion up to 0.5 m water depth for 30 minutes)

Dimensions and Weight M2734/35/36A Size (diameter) 83 mm/3.27 in

Weight (without cable)

M2738A Maximum size mm/(in):

width x height x depth

Cable length

Weight

Water Ingress Protection Code IP 68 (immersion up to 1m water depth of for 5 hours)

Degree of Protection Against Electrical Shock

Type CF

50 Hz to 60 Hz

60 VA

286 x 133 x 335 (11.3 x 5.2 x 13.2 in)

< 5.1 kg/11.2 lbs

< 30 seconds

< 220 g/7.8 oz.

50 x 28 x 135 (2.0 x 1.1 x 5.3 in)

2.5 m

< 150 g/5.3 oz.

Performance Specifications

Complies with EN/IEC EN 60601-2-37:2001+A1:2004. ECG measurement follows EN/IEC 60601-227:1994.

Fetal / Maternal

Fetal/Maternal Performance Specifications

Ultrasound Measurement Method Ultrasound Pulsed Doppler

Measurement Range US 50 to 240 bpm

Resolution Display 1 bpm

Printer 1/4 bpm

Jitter @ 200 bpm ≤ 3 bpm

Display Update Rate 1 / second

US Intensity Average output power P = (4.3 ± 0.4) mW

Peak-negative acoustic pressure p_ = (33.9 ± 3.6) kPa

Output beam intensity (Iob)

(= spatial average - temporal average intensity)

Spatial-peak temporal average intensity I

Effective radiating area @ -6 dB 1.81 cm

Signal Quality Indication

Beat to Beat Change (max.) for Ultrasound 28 bpm

US Frequency 1 MHz ± 100 Hz

US Signal range 3.5 μVpp to 350 μVpp @ 200 Hz

US Burst Repetition Rate 3.0 kHz

US LF Frequency Passband @ -3dB 100 to 500 Hz ± 20%

FMP Signal Range @ 33 Hz 200 μVpp to 40 mVpp

FMP Frequency Passband @ -3dB 10 to 100 Hz

Toco Measurement Method Strain Gauge Sensor Element

Sensitivity 1 unit = 2.5 g

Resolution Display 1 unit

Measurement Range 400 units

Signal Range 0 to 127 Units

Maximum Offset Range -300 units

Baseline Setting 20 units

Update Rate Display 1 / second

Auto Offset Correction 3 seconds after connecting the

Auto Zero Adjust TOCO value is set to zero following a

IUP Measurement Method Passive Resistive Strain Gauge Elements

Measurement Range -100 to +300 mmHg

Signal Range -99 to 127 mmHg

Resolution Display 1 mmHg

Sensitivity 5 μV/V/mmHg

Offset Compensation +100 to -200 mmHg

Baseline Setting 0 mmHg

Accuracy (not including sensor accuracy) ± 0.5% per 100 mmHg

Update Rate Display 1 / second

Auto Offset Correction 3 seconds after connecting the

Poor Empty

Acceptable Two-thirds full

Good Full

Duration ≤ 100 μs

Printer 1/4 unit

Printer ~4 / second

Printer 1/4 mmHg

Printer ~4 / second

(2.38 ± 0.75) mW/cm

sata =

= (10.3 ± 2.2) mW/cm

spta

transducer, the TOCO value is set to 20 units

negative measurement value for 5 seconds

transducer, the IUP value is set to 0 mmHg

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