Philips M2925A, M2922A, M2926A User Manual

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M2922A, M2925A, M2926A

Philips FM-2 Portable Antepartum Fetal Monitor

Features

• Lightweight and portable, with carrying handle.

• Easy to read display for viewing of FHR and Toco traces and numerics.

• On-screen scrolling for viewing stored fetal traces.

• 15 BPM separated grid lines for easy viewing of fetal heart rate accelerations for NST assessment.

• Twins ultrasound monitoring capability.

• Configurable audib le and flashing fetal heart rate alarms.

• Uses watertight transdu cers compatible wit h entire Series 50 range of fetal moni tors.

• Event marker for easy documentation of events and kick counts.

• 12-hours memory for fetal traces.

• Internal battery pow er o r A C po w er f ro m e xternal power supply.

• 6-hours (approx.) battery back-up operation, rechargeable during normal monitoring.

• Download capability to transmit traces stored in its memory to a PC or a Philips OB TraceVue surveillance an d alerting system.

• Online transmission to a monitoring system such as OB TraceVue.

• Easily connects to off-the-shelf printer for documentation.

Description

FM-2 is a fetal monitor for non invasively measuring, and showing maternal uterine contractions and the fetal heart rate as a graphic display, and optionally on a strip chart recorder, printer or OB TraceVue system. The data is intended to aid in assessing the well being of the fetus during the final trimester of pregnancy nonstress test (NST).

This portable fetal monitor offers a solution for antepartum screening in the private doctor’s office, outpatient clinics, and for remote applications such as traveling nurses visiting patient’s homes, or for clinics in rural areas seeking remote consultation.

It is intended for use only by trained medical personnel located in hospitals, clinics, doctor’s offices and i n the p a tie n t ’s home or du r ing transport under the direction of a licensed practitioner.

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Alerting

connected continuously to the FM-2 monitor.

The FHR alarming has configurable upper, lower and delay time alarm limits. Enabled alerts are both visible and audible. Alerting can be switched off.

Transducers

It uses the same transducers originally designed fo r high acuity care settings. Reliable, durable, water tight, and easy to clean they inte rface to a ll Series 50 fetal monitors.

Chart-Ready Documentation Using a Printer

Connects to an HP DeskJet printer, u sing standard printer paper. This gives an economical, chart-ready printout that can be stored in the patient re cord. It can be faxed easily for remote consultations. See the Printer Specifications for a list of suppo rted printers .

Interface to OB TraceVue Surveillance and Alerting System

The monitor can transmit patient data vi a a mod em to an OB TraceVue sys tem. It can also connect directly to an OB TraceVue system for realtime, online monitoring.

Monitor Connectors and Interfaces

• RS232 serial port (9pin male) for modem, PC, cellular phone.

• Standard parallel printer port for connecting printer or recorder.

• Connector for remote event marker cable.

• 3 transducer sockets (2 US, 1 Toco).

• Power inlet for power supply.

Self Test

The monitor automatically performs a self test when the power is switched on.

Mounting

The monitor can be mounted on a wallstand or a rollstand.

Interface to PC

FM-2 viewer is an optional, cu stomer ins tallable, PC software utility running on an IBM-compatible PC. See theFM-2 Viewer Specificatio ns for system requirements.

Traditional Documentation Using the Recorder

Y ou can share the optional external recorder between several FM-2 monitors, to document stored fetal traces as traditional paper documentation. Also, the recorder has a real- time fetal trace ou tput when

It acts as a receiver and electronic storage medium. It accepts fetal traces downloaded from the monitor, either directly, or via a modem. It also offers the possibility to browse, annotate and print complete, or partial patient records. Data can be stored electronically on the PC or other st orage media.

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Monitoring Accessories

Standard Accessories and Supplies

These are included with the monitor

• 1 x Doppler Ultrasound FHR TransducerM1356A

• 1 x External TOCO Transducer - M1355A

• 1 x Remote Event Marker - 15249A

• 2 x Reusable Abdominal Belts - M1562A

• 1 pack of three transducer knob adapters -

M1356-43203

• M1913A - Paper Case of 40 packs thermal recorder paper, 0-100 mmHg IUP scale, 50-210 FHR scale, 1 min (3cm) highlighted lines. Green. Not available in Europe.

Associated Products

External Recorder (M2925A)

The recorder is an external device for printing stored fetal traces, or realtime fetal trace output. I t connects to the FM-2 via a standard (IEEE 1284 compliant)) printer cable.

• 1x 250ml ultrasound gel

• User’s Guide

• Pocket Guide to F etal M onitoring and Assessment

by Susan Martin Tucker (English language shipments only). ISBN 0-323-00884-4, 4th edition

• Service Guide

Additional Supplies and Accessories

These are not included with the moni tor, but can be purchased separately.

• M1356A - Second Doppler Ultrasound FHR Transducer for twins monitoring.

• M3919A - Canvas Tote Bag with room for monitor plus accessories.

• M1569A - Belt Fastening Button Pack of 10.

• M2208A - 100 Disposable Abdominal Belts

1.3m long, 50mm wide (52” lo ng, 2” wide). 1 bo x of 50 blue and 50 pink.

FM-2 Viewer Utility Software (M2926A)

The monitor can send data to an IBM-compatible PC running Microsoft NT4 or 98.

See the specifications section of this data sheet for system requirements.

Mounting (M3904A and M3909A)

• M3904A - GCX Wallmounting.

• M3909A - GCX Rollstand

• 40483A - Ultrasound Transmission Gel

12 x 250 ml bottles, shelf life 24 months maximum, 6 months minimum.

• 40483A - 5 Liter Refill Container shelf life 24 months maximum, 6 months minimum.

• M1910A - Paper Case of 40 packs thermal recorder paper, 0-100 mmHg IUP scale, 30-240 FHR scale, 1 min (3cm) highlights. Orange (USA).

• M1911A - Paper Case of 40 packs thermal recorder paper, 0-100 mmHg IUP scale, plus 0-13 kPa scale, 50-210 FHR scale, no highlighted 3 cm lines. Green (International).

1.The monitor has twins capability built in. To monitor

twins you require an additional ultrasound transducer. Purchase additional M1356A.

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Specifications

Monitor (M2922A)

Federal Law re stricts this device to use by or on the order of a physician.

Recharge without Maximum 8 hours to monitoring: full recharge when no

monitoring occurs (typical

4.75 hours).

Low power warning: Approximately 30 minutes

at 25

Standards Compliance

The FM-2 Portable Antepartum Fetal Monitor complies with the requirements of the Medical Device Directive 93/42/EEC and the following safety standards:

• EN60601-1/IEC60601-1, EN60601-1-1, EN60101-2-37

• IEC 1157

• IEC 60601-1

• UL2601-1

• CAN/CSA C22.2#601.1-M90

Class II equipment, double insulated Continuous operation

Parameter

Input

Connector

Resulting

Isolation

US BF BF Toco BF BF

Electromagnetic Compatibility

Complies with EN60601-1-2

Environmental

Operating Temp: -10oC to 45oC

F to 110oF)

(50

Storage Temp: -20

C to 60oC

(-29

F to 175oF)

Relative Humidity: 20% to 90% non

condensing

Altitude: 0-3048m (10,000 ft)

Dimensions

Power - External Power Supply

AC-powered 110-120V~, 50-60Hz,

0.15A or 220-240V~, 50-60Hz,

0.08A

Display

Backlight: Cold cathode fluorescent Active area: 3.78” x 2.83”

(320 x 240 dots) Resolution: 85 dots per inch Contrast: 10:1

Ultrasound

: < 4mW

sata

BPM range:

Paper scale: USA paper: 30-240 BPM,

International P aper: 50-210

BPM.

Ultrasound

processing range: 50-240 BPM. Accuracy: Leakage current:

±1% ±1 BPM. ≤10 µ A @ 264 VAC a pplied

to transducer.

Isolation: >4 kV RMS, Type BF

applied part.

Toco

Range: 0-100 relative units Resolution: 1 count Accuracy: Leakage:

±1% ±1 relative unit ≤10 µ A @ 264 VAC a pplied

to transducer

Isolation: >4 kV RMS, Type BF

applied part

Height: 15.24 cm (6.0 inches) Width: 26.4 cm (10.4 inches) Depth: 13.7 cm (5.4 inches) Weight: 2.27 kg (5lb)

Power - Battery

Type: Lead acid, rechargeable. Operation: minimum 2-hours fully

charged at 10

C, longer

at higher temperature.

Recharge during monitoring:

Maximum 14 hou rs full recharge during monitoring (typical 11 hours).

1.USA only

Transducers

Doppler Ultrasound FHR (M1356A)

Weight: 185 g (6.5 oz) Cable length: 2.5m (8ft 2in) Diameter: 75mm (2.95in) Latex free

External Toco (M1355A)

Transducer Weight: 180 g (6.3 oz) Cable length: 2.5m (8ft 2in) Diameter: 75mm (2.95in) Latex free

Remote Event Marker (15249A)

Length: 2.8m (9ft 2in)

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Weight 75g (2.65oz) Latex free

Reusable Abdominal Belt (M1562A)

Length: 1.3m (52in) Width: 50mm (2in)

With button holes, and pr e-attached buttons. Can be further cut. Contains latex.

FM-2 Viewer Utility Software (M2926A)

Windows operating system-based utility software. Supplied on CD-ROM, together with operating instructions, license and 3m PC connection cable.

System requireme nts :

• IBM-compatible PC (200MHz Pentium or equivalent)

• Standard VGA graphics adapter with 8MB memory

• CD-ROM drive

• 60 MB (minimum) available space on hard drive

• Windows 98, or NT (with service pack 6a)

operating system

Microsoft

®, and Windows® are either registered

trademarks or tradem arks of Microsoft Corporatio n in the United States and/o r other countries.

The FM-2 viewer utilit y software complies with the requirements of the Medical Device Directive 93/ 42/EEC.

Federal Law restricts this device to use by or on the order of a physician.

Printers

Supported printers are:

• HP DeskJet 990Cxi

• HP DeskJet 980Cxi

• HP DeskJet 960c

• HP DeskJet 840c

• HP DeskJet 640c

• HP DeskJet 350

• HP Photosmart 1215

This list will be updated periodically. Contact Philips Medical sales for details ab out currently supported printers.

Recorder (M2925A)

Dimensions

Width: 23.4cm (9.2 inches) Depth: 26.2 cm (10.3 inches) Weight: 3.54 kg (7lb 13oz)

Standards Compliance

Safety

- Complies with EN60601-1, EN60601-1-1

- Class I equipment, requires 3-prong outlet with protecti ve earth

- Continuous operation

Electromagnetic Compatibility

Complies with EN60601-1-2

Power

AC-powered 110-120V~, 50-60Hz,

0.15A or 220-240V~, 50-60Hz,

0.08A

Consumption: 20 watts maximum at

normal supply voltage

Environmental

Operating Temp: -10oC to 45oC

F to 110oF)

(50

Storage Temp: -2 0

C to 60oC

(-29

F to 175oF) Relative Humidity: 20 to 90% non condensing Altitude: 0-3048m (10,000ft)

Recorder Paper (Thermal)

Style: Z-fold Pack size: 150 pages End-of-pack: Mark along paper edge,

stop sign on last page

Loading: Front door, drop-in, self

aligning

Paper detectors: Paper out, and recorder

loading door open

Paper speeds: Normal (1, 2, and 3 cm/

±1%) and batch print

min

(average 25 cm/min) Pape r tracking accuracy: accuracy) M1910A: 30-240 FHR range, orange (Canada and USA) grid, no kPa scale, 3cm

M1911A: 50-210 FHR range, green (International) grid, kPa scale, no

M1913A/J: 50-210 FHR range, green (Japan) grid, no kPa scale, 3 cm

±1% (exclusive of paper

highlighted lines.

Height: 12.5 cm (4.9 inches)

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Philips offers a wide range of fetal monitors for different envir onments a nd appl icatio ns. R eview the

capabilities of all fetal monitors to help you choose the monitor that is right for your needs.

Feature

Table legend:

• Standard

o Optional

− Unavailable

Designed for portability/transport Integrated fetal trace display On screen NST assessment ai d Battery operation and AC operation from power supply Off the shelf printer interface PC utility software External recorder Integrated recorder Fetal trace data storage (12 hours) Transmission to obstetrical surveillance system (for example

OB TraceVue) via phone line Twins heart rate separation

Direct system interface to obstetrical overview system such as OB TraceVue

Watertight, easy to cl ean transducers Indication when two channels record the same heart rate

(Cross Channel Verificatio n - CCV) Indication when you accide ntally record maternal SpO2 (Cross Channel Verification plus - CCV+) Performance PLUS! technology to ensure continuous,

accurate and high-quality ultrasound traces Precision signal track and hold to reduce artifacts and

increase sensitivity Interface to external fetal pulse oximeter (FSpO2)

Gross fetal body movement recording (fetal movement profile - FMP)

External fetal measurements Single US FHR

Twin US FHR Toco

Internal fetal measurements DECG

IUP/TTUIP Fetal SpO2 (FSpO2)

Integrated maternal measurements

Interface to external maternal monitor

a.Series 50 XMO not available in USA or Japan b. When maternal parameters are not already integrated in the Series 50 XM/XMO monitor (that is, you have not ordered option A03)

NIBP and SpO MECG

FM-2

(M2922A)

Series 50A

(M1351A)

Series 50 IP-2

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− oo

(M1353A)

(M1350B)

Series 50 XM

••

(M1350C)

Series 50 XMO

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Philips Medical Systems is part of Royal Philips Electronics

CORPORATE HEADQUARTERS:

Philips Medical Systems Nederland B.V. Postbus 10.000 5680 DA Best

Netherlands

UNITED STATES:

Philips Medical Systems Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01810 (800) 934-7372

CANADA:

Philips Medical Systems 2660 Matheson Blvd. E. Mississauga, Ontario L4W 5M2 (800) 291-6743

EUROPE, MIDDLE EAST AND AFRICA:

Philips Medizinsysteme Böblingen GmbH Cardiac and Monitoring Systems Hewlett-Packard Str. 2 71034 Böblingen Germany Fax: (+49) 7031 463 1552

LATIN AMERICA HEADQUARTERS:

Philips Medical Systems 5200 Blue Lagoon Drive 9th Floor Miami, FL 33126 (305) 267-4220

ASIA PACIFIC HEADQUARTERS:

Philips Medical Systems 24F Cityplaza One 1111 King's Road Taikoo Shing, Hong Kong (+852) 3197 7777

www.medical.philips.com

prohibited without the prior written consent of the copyright holder.

Published April, 2002 5990-0507EN