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September 2005

Product Comparison
Fetal Monitors

UMDNS information
This Product Comparison covers the following device terms and product codes as listed in ECRIs Universal Medical Device
Nomenclature System (UMDNS):
9 Monitors, Bedside, Fetal, Antepartum [18-339]
9 Monitors, Bedside, Fetal, Intrapartum [18-340]

Table of Contents
Scope of this Product Comparison ...............................................................................................................................3
Purpose..........................................................................................................................................................................3
Principles of operation..................................................................................................................................................4
FHR monitoring .......................................................................................................................................................4
UA monitoring .........................................................................................................................................................4
Pulse oximetry .........................................................................................................................................................5
Telemetry .................................................................................................................................................................5
Reported problems........................................................................................................................................................6
Purchase considerations...............................................................................................................................................7
ECRI recommendations...........................................................................................................................................7
Other considerations................................................................................................................................................7
Stage of development....................................................................................................................................................8
Bibliography..................................................................................................................................................................8
Standards and guidelines.............................................................................................................................................9
Citations from other ECRI publications ....................................................................................................................10
Supplier information ..................................................................................................................................................11
About the chart specifications....................................................................................................................................14
Product Comparison Chart ........................................................................................................................................16
Fetal Monitors

Policy Statement
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services research agency established in 1955. HPCS provides comprehensive information to help
healthcare professionals select and purchase diagnostic and therapeutic capital equipment more
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Fetal Monitors

September 2005
Fetal Monitors

Scope of this Product Comparison


This Product Comparison covers antepartum and intrapartum electronic fetal monitors that
detect, display, and print a record of fetal heart rate (FHR). Also covered are units with direct fetal
electrocardiography monitoring capabilities and external and internal uterine activity (UA)
monitoring. Some models also have telemetry capabilities. Fetal heart detectors (fetascopes),
ultrasonic stethoscopes, and home UA monitors are not included. For more information, see the
Product Comparison titled FETAL HEART DETECTORS, ULTRASONIC.
These units are also called: cardiotocographs, fetal electrocardiogram (ECG) monitors, fetal
heart rate monitors, ultrasonic fetal monitors.

Purpose
Electronic fetal monitoring provides graphic and
numeric information on FHR and maternal UA to
help clinical personnel assess fetal well-being.
During labor, the FHR often exhibits decelerations
and accelerations in response to uterine
contractions or fetal movements; certain patterns
are indicative of hypoxia. Examination of these
patterns, the baseline level, and variability
characteristics can indicate the need to alter the
course of labor with drugs or perform an operative
delivery (cesarean section or forceps delivery) if
corroborated by other clinical evidence. Fetal
monitors can also provide documentation of the
fetuss condition that could be useful in the event of
litigation.
Antepartum (before childbirth) monitors are used to monitor the fetuss development, movement,
and FHR patterns in utero. Antepartum monitors have only external monitoring capabilities, such as
ultrasound and external UA, and are typically used in the physicians office or clinic. They also are
often used in the hospital for high-risk mothers who are hospitalized before term for observation or
treatment not in conjunction with labor.
External FHR monitoring with an ultrasound transducer is often used in tests conducted long
before labor to assess fetal oxygenation levels and viability of the maternal-fetal exchange through
the placenta.
As labor begins, the smooth muscles of the uterus contract rhythmically, increasing the pressure
of the amniotic fluid and forcing the fetus against the cervix. By examining the frequency and
intensity of uterine contractions, the clinician can assess the progress of labor, monitor the effect of
labor-inducing or labor-inhibiting drugs, detect abnormal contraction patterns, and monitor FHR
response to decreased placental blood flow during contractions.
Intrapartum (during childbirth) monitors are used in the labor and delivery rooms and have
additional capabilities, which can include internal fetal ECG and hemoglobin saturation (SpO2),
internal uterine pressure, and maternal ECG, SpO2, and noninvasive blood pressure (NIBP)
monitoring. Many units now provide continuous monitoring of fetal oxygen, tissue perfusion, and
direct, noninvasive heart rate.

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Fetal Monitors

Principles of operation
Continuous electronic FHR monitoring can be performed indirectly, by applying an ultrasound
transducer to the mothers abdomen, or directly, by attaching an electrode assembly to the fetus
after rupture of the amniotic membranes. Uterine contractions can be recorded simultaneously by
placing a pressure transducer on the mothers abdomen or by directly measuring the change in
pressure within the uterus with a catheter.

FHR monitoring

Fetal monitors detect FHR externally by using an ultrasound transducer to transmit and receive
ultrasonic waves; the frequency (or Doppler) shift of the reflected signal is proportional to the
velocity of the reflecting structurein this case, the fetal heart. A transducer contains one or more
piezoelectric elements that convert an electrical signal into ultrasonic energy that can be transmitted
into tissues. When this ultrasonic energy is reflected back from the tissues, the transducer
reconverts it to an electrical signal that can be used to create a waveform for display and recording
and an audible FHR. However, this audible FHR is not the actual fetal heartbeat; it is the sound
that is created by the frequency shift of the ultrasonic signal.
Continuous-wave transducers transmit and receive the ultrasonic energy continuously. Pulsed-
wave transducers alternate the transmitting and receiving of the signal, possibly reducing the fetuss
exposure to ultrasonic energy. Some monitors use pulsed Doppler range-gating; the ultrasound
signal pulses in three dimensions until it locks onto the fetal heart target. A few monitors are also
capable of automatically recording gross (spine and trunk) fetal movements.
To consistently detect the fetal heart signal, the clinician positions the transducer and secures it
to the mothers abdomen with a strap. A special gel facilitates efficient acoustic coupling of the
transducer with the abdomen. As the fetus, mother, or transducer moves, the signal may weaken,
requiring that the transducer be repositioned or that additional gel be applied.
In the conventional method, the FHR is calculated by measuring the timing of the peaks in the
Doppler signal. Monitors now use autocorrelation, which builds a pattern from the received Doppler
signal. As a new FHR signal is received, it is compared to the previous signal, and the FHR display
and chart recorder are updated. If the received signal is artifact or noise, it will not correlate with
the previous FHR waveform. Therefore, autocorrelation processing reduces extraneous signal
artifact and thereby more accurately selects the reflected waves that represent FHR.
Intrapartum monitors have both internal and external means of monitoring FHR. Direct
(internal) ECG monitoring is performed by attaching a spiral electrode directly to the fetuss scalp
after rupture of the amniotic sac. The ECG signal is then amplified, and the interval between the R-
wave peaks is calculated and converted into beats per minute (bpm). This method reduces the
occurrence of movement artifacts experienced with indirect (external) methods, although it presents
risks for the mother and fetus that external methods do not (see Reported Problems).
Units are available that can simultaneously monitor twin heart rates noninvasively by using two
ultrasound transducers or by using one ultrasound transducer and a spiral ECG electrode. Also,
some newer models allow for simultaneous invasive monitoring of twins. Some units allow triplets to
be monitored using two ultrasound transducers and a spiral electrode. Some can detect when both
channels are receiving the same FHR signal and alert the user that the transducers need to be
repositioned. For simultaneous monitoring of FHR and maternal heart rate (MHR), the ultrasound
transducer detects the FHR, and a standard patient ECG cable obtains the MHR.

UA monitoring

UA can be monitored either externally by a transducer or internally by a catheter. External UA is


detected through a displacement transducer, or tocotransducer, that is strapped to the mothers
abdomen with a belt. As the uterus contracts, the shape and size of the abdomen change, which
depresses a small button in the transducer. The transducer registers this as a voltage change that is
proportional to the UA.

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Fetal Monitors

For internal UA monitoring, a pressure transducer is attached to a fluid-filled catheter that is


introduced through the vagina into the uterus after rupture of the amniotic sac. The transducer
records the pressure of the amniotic fluid trapped in the uterus, which reflects the increased
pressure during uterine contractions. Another type of catheter has a pressure sensor in its tip that is
calibrated before insertion into the uterus.
Fetal monitors can now be linked to allow the information from several patients to be viewed at a
central station. Many manufacturers have introduced obstetric data management systems (see the
report titled DATA MANAGEMENT SYSTEMS, OBSTETRICAL) to effectively capture and
preserve fetal monitoring records, which typically must be retained for 28 years after birth.

Pulse oximetry

Pulse oximetry is often used to monitor the mother during epidural administration. The
technology provides a spectrophotometric assessment of SpO2 by measuring light transmitted
through a capillary bed of a finger synchronized with the pulse. This system can alert medical
personnel to a serious condition, as a low oxygen reading often precedes other symptoms of distress.
With the development of noninvasive fetal probes, pulse oximetry has expanded into the delivery
room. It is hoped that this new technology will replace fetal blood sampling, the current method of
determining fetal SaO2 (arterial oxygen saturation). The theory of pulse oximetry (both obstetrical
and standard) is based on the optical properties of oxyhemoglobin versus those of deoxyhemoglobin.
With obstetrical technology, oxygenated hemoglobin reflects more red (R) light and less infrared (IR)
light than deoxyhemoglobin. Two light-emitting diodes (LEDs) flood the tissue with R and IR
wavelengths, while a photodetector measures the quantities of light not absorbed by the hemoglobin.
A microprocessor then calculates the oxygen saturation using the ratio of reflected red to infrared
light (R:IR).
Traditional probes utilize transmission oximetry, in which the light source and photodetector lie
on opposite sides of a tissue bed. However, intrapartum use does not provide a transversable body
region. A reflectance pulse oximeter probe, in which the light source and photodetector lie in the
same plane, is needed for intrapartum use. The probe is placed on the fetuss head and measures the
amount of light reflected from the underlying tissue. Fetal pulse oximeters that interface with
existing FHR monitors are currently available in Europe, North and South America, and the Pacific
Rim (except for Japan). Before clinical introduction into the United States, U.S. Food and Drug
Administration approval is required.

Telemetry

Some units have internal or external telemetry systems in which the FHR and UA signals are
transmitted by radio waves to a receiver at the fetal monitor. During continuous monitoring, the
mother wears a pocket-sized transmitter, allowing ambulation between contractions. FHR and UA
data can also be transmitted to a remote medical institution over telephone lines.
The UHF frequency bands used by wireless medical telemetry in the United States are congested.
More and more competitors are occupying those frequencies, putting medical telemetry at an ever-
greater risk for harmful interference. On June 12, 2000, the Federal Communications Commission
(FCC) released a report and order (FCC No. 00-211) making new frequencies available for medical
telemetry use on a primary basis. This will allow medical telemetry to be protected from other radio
transmissions within the same band.
The new frequency bands allocated by the FCC are called the Wireless Medical Telemetry Service
(WMTS). A key feature of this service is the designation of an organization as a frequency
coordinator to oversee a database of user information and avoid potential electromagnetic
interference. The new spectrum for medical telemetry includes three frequency bands: 608 to 614
MHz, 1,395 to 1,400 MHz, and 1,427 to 1,429.5 MHz. In these bands, the FCC permits both
unidirectional and bidirectional transmissions of patient data, plus some other types of
communication related to medical care (however, voice and video are prohibited).

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Fetal Monitors

Reported problems
There have been several reports of inaccurate FHRs recorded by fetal monitors. More common
errors include doubled or halved rates, masked fetal arrhythmias, and presentation of the MHR as
the FHR. Another particularly serious error is the report of false FHR decelerations during uterine
contractions due to ultrasonic signal-processing circuits holding the last FHR on occasional signal
peaks during noisy signals. These errors may lead to inaccurate diagnoses and inappropriate
intervention.
Reported complications of fetal scalp electrode application include fetal and maternal infection,
uterine perforation, herpes infections (some fatal), injury to the fetal eyes and scrotum, fetal
hemorrhage, cerebrospinal fluid leakage, skin lacerations, fetal scalp burns, and necrotizing fasciitis
of the fetal scalp (extensive necrosis secondary to severe anaerobic scalp infections). The most
frequently reported complication is scalp abscess. Most of these problems result from poor technique
and are rare with trained, experienced clinicians.
Problems resulting from intrauterine catheters include maternal infection and soft-tissue injury,
uterine perforation, umbilical cord compression and entanglement, and umbilical vessel damage.
These complications are rare.
Some investigators have expressed concern about the possible risks associated with fetal exposure
to ultrasound. Although these risks have not been clearly defined, it is important to note that most
fetal monitors emit far lower ultrasonic intensities than other ultrasonic medical devices, such as
ultrasonic scanners.
While the use of electronic fetal monitoring and the rate of cesarean section deliveries have both
increased in the past decade, the degree to which interpretation of fetal monitoring data has
influenced the cesarean section rate is uncertain.
Before pulse oximetry can become an integral part of fetal monitoring, several problems still need
to be addressed. One of the most pressing issues is how to interpret readings; it is not known what
SpO2 value indicates fetal distress. Studies have shown that many factors affect the accuracy of the
fetal pulse oximeter. The pressure of the probe on the skin, its placement on the fetal head, and
caput formation significantly change the SpO2 reading. The probes must be designed and calibrated
for a particular location on the fetal head. The oximeter must also be capable of detecting lower fetal
pulses and oxygen saturation levels.
Sensor positioning may be difficult, since the fetus is neither visible nor accessible to the clinician
during labor. In addition, the wet delivery environment is not conducive to sensor attachment.
Currently, probes that can be placed on the fetal cheek are being tested and made available by at
least one manufacturer. These probes are designed to be kept in place by pressure exerted by the
uterine wall. The accuracy and safety of these devices has been called into question due to blind
placement of the probes and the possible risk of injury to the fetus, the placenta, or the mother as
movement occurs throughout delivery. Several manufacturers are releasing units with the pulse
oximetry parameter to be used with the cheek probe.
One of the most common problems associated with telemetry is signal fading, during which the
signal is momentarily lost. This can result in inaccurate signals, false alarms, and loss of monitoring
data. No other equipment should operate on the frequency reserved for the telemetry systems, and
no outside sources of interference should impede the telemetry signals. Hospitals should inventory
and develop a management plan for all radio-frequency devices, such as two-way radios, which can
produce interference and crosstalk.
Because the patient wears the transmitter while ambulatory, it is possible for the transmitter to
be dropped on the floor or into a toilet or sink. Therefore, shock-resistant and waterproof or water-
resistant models are preferred. Users should conduct electrode preparation and attachment
appropriately. For more information on telemetry patient monitors, see the Product Comparison
titled PHYSIOLOGIC MONITORING SYSTEMS, TELEMETRIC; ECG MONITORS,
TELEMETRIC.

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Fetal Monitors

Purchase considerations
ECRI recommendations

Included in the accompanying comparison chart are ECRIs recommendations for minimum
performance requirements for fetal monitors. These units are used to monitor antepartum and/or
intrapartum patients.
Fetal monitors should be capable of detecting, displaying, and printing a record of FHR and UA.
The unit should provide numeric values and graphical trends for FHR and UA. The units digital
display and recorder should indicate FHR over a minimum of 50 to 210 bpm. The display should also
show alarm limits and status for each monitored parameter. The ultrasound probe can be continuous
wave/Doppler or pulsed with a frequency of 1 to 2.5 MHz.
The monitor should provide user-adjustable alarm limits for high and low FHR, as well as for any
other monitored parameter (e.g., SpO2, ECG, maternal SpO2, maternal ECG). An audible and visual
indicator should be present for all alarm conditions.
The strip chart should be annotated with date, time, patient ID or bed number, alarm status, and
vital signs.
Users should consider the units ability to interface with other patient monitors and/or hospital
information systems/OB data management systems. ECRI prefers units that have an output
connector that allows data transmission to a data management system (i.e., for central monitoring
and archiving) or a central monitoring system.
The fetal monitor should have the capability to be optionally interfaced with other patient
monitors (e.g., pulse oximeters, NIBP monitors).
Some fetal monitors are capable of monitoring maternal ECG, pulse oximetry, and NIBP as an
integral part of the monitor. This may provide a cost savings if the hospital does not already have
the stand-alone maternal monitoring often used in conjunction with epidural administration.
Some units have internal or external telemetry systems in which the FHR and UA signals are
transmitted by radio waves to a receiver at the fetal monitor. The supplier should specify the
operating frequency band (e.g., 2.4 GHz ISM [Industrial, Scientific, and Medical]), channel allocation
and/or modulation technique (e.g., narrow-band, frequency-hopping spread-spectrum), and any
compliance with wireless communication standards (e.g., IEEE [Institute of Electrical and
Electronics Engineers] 802.11). Telemetric monitoring is optional and should be selected based on a
clinicians requirements

Other considerations

Prices for fetal monitors can range from $3,500 to $25,000, depending on the types of monitors
and accessories (e.g., transducers, carts, gel, paper, belts) purchased. Multiple-fetus monitors are
typically more expensive than single-fetus monitors. Telemetry capabilities also constitute a
significant added expense.
Purchasing issues include ease of use, reliability, and service support. A facility needs to
determine the maximum number of fetal monitors that are likely to be used and whether a unit that
can monitor two or three heart rates simultaneously would be beneficial. Hospitals should also
consider the rate of multiple births (e.g., twins, triplets).
Hospitals can purchase service contracts or service on a time-and-materials basis from the
supplier. Service may also be available from a third-party organization. A service contract can
ensure that preventive maintenance will be performed at regular intervals, thereby reducing the
possibility of unexpected maintenance costs. Also, many suppliers do not extend system performance
and uptime guarantees beyond the length of the original warranty unless the system is covered by a
service contract.
ECRI recommends that, to maximize bargaining leverage, hospitals negotiate pricing for service
contracts before the system is purchased. As a guideline, full-service contracts typically cost

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Fetal Monitors

approximately 8% of the monitors purchase price. Additional service contract discounts may be
negotiable for multiple-year agreements or for service contracts that are bundled with contracts on
other fetal monitors in the department or hospital.
Most fetal monitor manufacturers can network their devices with central stations and/or an
archiving (i.e., data management) system. If the fetal monitor is to be interfaced with a different
manufacturers system, the facility should ensure that all the capabilities of both devices will be
accessible. Some archival systems automatically record all patient data on optical disk, while others
require that the staff periodically download patient data onto the disk. Some units may allow data
that is collected from the cardiotocograph to be used for research, remote display, or further
processing using an RS232 connector; the fetal monitor acts as a slave monitor and operates by
commands from the host computer. Some manufacturers offer data-entry keyboards or bar coding for
entering nursing notes.

Stage of development
In the late 1960s, the first commercial fetal monitor using phonocardiography and tocography
became available. Fetal monitoring became more widely used in the early 1970s and is currently
used during labor in as many as 60% to 70% of deliveries in the United States. Although there is
some debate about the conditions under which these devices should be used, fetal monitors have
gradually gained sufficient acceptance among obstetricians and are often used during routine
deliveries.
In the 1980s, the second generation of fetal monitors, using autocorrelation, was introduced. More
recently, the third generation of monitors, using Doppler range-gating, became available.
A portable instrument to monitor FHR has been developed that allows for long-term monitoring in
the home. By placing a sensor on the maternal abdominal surface, the instrument records FHR
using parallel filtering of acoustic signals. The long-term records of data are stored in a high-
capacity, nonvolatile memory and can be read on a personal computer for analysis.
Maternal monitoring incorporated into fetal monitoring is a more recent development in childbirth
monitoring, as is the development of fetal pulse oximetry. Pulse oximetry promises to improve fetal
assessment in a noninvasive, relatively inexpensive fashion. Fetal movement recording may be
refined in the future to detect fetal breathing and to differentiate between gross and tone
movements. Recent studies have used ultrasonic waves to quantify the sinusoidal displacement of
the fetal diaphragm. Scientists believe that measurement of the fetal breathing movement may soon
become a valuable diagnostic technique.

Bibliography
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Br J Obstet Gynaecol 1997 Aug;104(8):910-6.
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Dildy GA. The physiologic and medical rationale for intrapartum fetal monitoring. Biomed Instrum
Technol 1999 Mar-Apr;33(2):143-51.
East CE, Colditz PB, Dunster KR, et al. Human fetal intrapartum oxygen saturation monitoring:
agreement between readings from two sensors on the same fetus. Am J Obstet Gynecol 1996
May;174(5):1594-8.
Freeman RK, Garite TJ, Nageotte MP. Fetal heart rate monitoring. 3rd ed. Baltimore: Lippincott
Williams & Wilkins; 2003.

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Institute for Clinical Excellence. The use of electronic fetal monitoring: clinical guidance [online].
2001 May [cited 2003 May 22]. Available from Internet: http://www.nice.org.uk.
Johnson N, McNamara H, Montague I, et al. Comparing fetal pulse oximetry with scalp pH. J
Reprod Med 1995 Oct;40(10):717-20.
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Standards and guidelines


Note: Although every effort is made to ensure that the following list is comprehensive, please note
that other applicable standards may exist.
American College of Obstetricians and Gynecologists. Antepartum fetal surveillance [technical
bulletin]. PB9. 1999 Oct.
Fetal heart rate patterns: monitoring, interpretation, and management [technical bulletin].
AT207. 1995 Jul.

Intrapartum fetal heart rate monitoring [technical bulletin]. 1995 Jul (revised 2005 May).
American National Standards Institute/Association for the Advancement of Medical
Instrumentation. Safe current limits for electromedical apparatus [standard]. 3rd ed. ANSI/AAMI
ES1-1993. 1985 (revised 1993).
Association of Womens Health, Obstetric, and Neonatal Nurses. Clinical competencies education
guide: antepartum and intrapartum fetal heart rate monitoring. 3rd ed. G13. 1998.
British Institute of Radiology. Clinical applications of ultrasonic fetal measurements [report]. 1991.
Institute for Clinical Systems Improvement. Intrapartum fetal heart rate management [guideline].
1994 Sep (revised 2003 Oct).
Institute of Electrical and Electronics Engineers. IEEE 802.11 handbook: a designers companion.
2nd ed. SP1136. 2005.

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Fetal Monitors

International Electrotechnical Commission. Medical electrical equipmentpart 1: general


requirements for safety [standard]. IEC 60601-1 (1988-12). 1988.
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Medical electrical equipmentpart 1: general requirements for safety. Amendment 2 [standard].


IEC 60601-1-am2 (1995-03). 1995.

Medical electrical equipmentpart 1-1: general requirements for safety. Collateral standard:
safety requirements for medical electrical systems. 2nd ed. IEC 60601-1-1 (2000-12). 1992
(revised 2000).

Medical electrical equipmentpart 1-2: general requirements for safety. Collateral standard:
electromagnetic compatibilityrequirements and tests. IEC 60601-1-2 (2001-09). 1993 (revised
2001).

Medical electrical equipmentpart 1-4: general requirements for safety. Collateral standard:
programmable electrical medical systems. IEC 60601-1-4 (2000-04). 1996 (revised 2000).

Medical electrical equipmentpart 2-37: particular requirements for the safety of ultrasonic
medical diagnostic and monitoring equipment. IEC 60601-2-37 (2001-07). 2001.

Methods of measuring the performance of ultrasonic pulse-echo diagnostic equipment [technology


information report]. IEC/TR 60854 (1986-10). 1986.

Ultrasonicscontinuous-wave Doppler systemstest procedures [technology information report].


IEC/TR2 61206 (1993-04). 1993.

Ultrasonicsfieldsguidance for the measurement and characterization of ultrasonic fields


generated by medical ultrasonic equipment using hydrophones in the frequency range 0.5 to 15
MHz [technology information report]. IEC/TR2 61220 (1993-05). 1993.
National Institute for Health and Clinical Excellence. Use of electronic fetal monitoring: the use and
interpretation of cardiotocography in intrapartum fetal surveillance [guideline]. 2001 May.
Ohio Nurses Association. Role of the registered nurse in electronic fetal monitoring [statement]. NP
43. 1983 (revised 1995).
Royal College of Obstetricians and Gynaecologists. Use of electronic fetal monitoring: the use and
interpretation of cardiotocography in intrapartum fetal surveillance [guideline]. 2001.
Society of Obstetricians and Gynaecologists of Canada. Fetal health surveillance in labour. J Obstet
Gynaecol Can 2002 Mar;24(3):250-62.
United States Preventive Services Task Force. Intrapartum electronic fetal monitoring
[recommendation]. 1989 (revised 1996).
U.S. Department of Health and Human Services. Food and Drug Administration. Performance
standards for sonic, infrasonic, and ultrasonic radiation-emitting products. 21 CFR Part 1050.
2004.

Citations from other ECRI publications


Health Devices
Electronic fetal monitors [evaluation]. 1987 Aug;16(8):259-86.

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Fetal Monitors

Electronic fetal monitors [evaluation update]. 1987 Dec;16(12):394-5.

Healthcare Risk Control


Fetal monitoring. 1996;4:Obstetrics and neonatal 3:1-17.
Technology overview: obstetrics and neonatal care. 1999;4:Obstetrics and neonatal 2:1-29.
Obstetrical liability: an overview. 2001;4:Obstetrics and neonatal 1:1-16.
Obstetrics. 2003;1:Self-assessment questionnaire 24:1-13.

Supplier information
Card Guard
Card Guard AG [352040]
Rheinweg 7-9
CH-8200 Schaffhausen
Switzerland
Phone: 41 (52) 6320050 Fax: 41 (52) 6320051
Internet: http://www.cardguard.com

Card Guard Japan [391868]


House Hongo Building 5/Fl Hongo 1-33-8 Bungko-ku
Tokyo 113-0033
Japan
Phone: 81 (3) 58039226 Fax: 81 (3) 58039227
Internet: http://www.cardguardjp.co.jp

Card Guard Scientific Survival Ltd [172261]


2 Pekeris Street Rabin Science Park
Rehovot IL-76100
Israel
Phone: 972 (8) 9484000 Fax: 972 (8) 9484004
Internet: http://www.cardguard.com
E-mail: users@cardguard.com

Instromedix, A Card Guard Co [102814]


6779 Mesa Ridge Rd Suite 200
San Diego, CA 92121
Phone: (858) 777-2200 (800) 633-3361 Fax: (858) 777-2374
Internet: http://www.instromedix.com
E-mail: webmaster@instromedix.com
CooperSurgical
CooperSurgical Inc [108594]
95 Corporate Dr
Trumbull, CT 06611
Phone: (800) 243-2974 Fax: (800) 262-0105
Internet: http://www.coopersurgical.com
E-mail: e-mail@coopersurgical.com
GE Healthcare
GE Healthcare Asia (Japan) [300443]
4-7-127 Asahigaoka Hino-shi
Tokyo 191-8503
Japan
Phone: 81 (3) 425826820 Fax: 81 (3) 425826830
Internet: http://www.gehealthcare.com.jp
E-mail: hisao.matsuka@gemsa.med.ge.com

ECRI. All Rights Reserved.


11
Fetal Monitors

GE Medical Systems Information Technologies, Monitoring Div [393580]


8200 W Tower Ave
Milwaukee, WI 53223-3219
Phone: (414) 355-5000 (800) 558-5120 Fax: (414) 357-3456
Internet: http://www.gemedical.com

GE Medical Systems Information Technologies GmbH [401907]


Lerchenbergstrasse 15
D-89160 Dornstadt
Germany
Phone: 49 (7348) 986112 Fax: 49 (7348) 986155
Internet: http://www.gemedicalsystems.de
GIMA
GIMA SpA [345887]
via Monza 102
I-20060 Gessate MI
Italy
Phone: 39 (02) 953854209 Fax: 39 (02) 95380056
Internet: http://www.gimaitaly.com
E-mail: gima@gimaitaly.com
Huntleigh
Huntleigh Diagnostics Ltd, Div Huntleigh Healthcare Inc [333648]
35 Portmanmoor Road
Cardiff South Glamorgan CF24 5HN
Wales
Phone: 44 (29) 20485885 Fax: 44 (29) 20492520
Internet: http://www.huntleigh-diagnostics.com
E-mail: sales@huntleigh-diagnostics.co.uk

Huntleigh Healthcare Pty Ltd [202258]


63 Buckingham Drive PO Box 1116
Wangara WA 6947
Australia
Phone: 61 (8) 93093083 Fax: 61 (8) 93094582
Internet: http://www.huntleighhealthcare.com.au
E-mail: sales@huntleighhealthcare.com.au
Neoventa Medical
Neoventa Medical AB [418663]
Lilla Bommen 1
S-411 04 Goteborg
Sweden
Phone: 46 (31) 7583200 Fax: 46 (31) 7583299
Internet: http://www.neoventa.se
E-mail: info@neoventa.com
Nicolet Vascular/VIASYS
Nicolet Vascular VIASYS NeuroCare Group [359490]
5225 Verona Rd Bldg 2
Madison, WI 53711-4495
Phone: (608) 441-2266 (800) 525-2519 Fax: (608) 441-2232
Internet: http://www.viasyshealthcare.com
E-mail: info@nicoletvascular.com
Oxford Instruments
Oxford Instruments GmbH [287388]
Otto-von-Guericke-Ring 10

ECRI. All Rights Reserved.


12
Fetal Monitors

D-65205 Wiesbaden
Germany
Phone: 49 (6122) 9370 Fax: 49 (6122) 937100
Internet: http://www.oxford-instruments.com
E-mail: info@oxford.de

Oxford Instruments Medical [154924]


12 Skyline Dr Suite 230
Hawthorne, NY 10532-2133
Phone: (914) 593-7100 (800) 438-8322 Fax: (914) 593-7290
Internet: http://www.oxford-instruments.com
E-mail: info@ms.oxinst.com

Oxford Instruments Medical Limited [151096]


Manor Way
Old Woking Surrey GU22 9JU
England
Phone: 44 (1483) 770331 Fax: 44 (1483) 727193
Internet: http://www.oxford-instruments.com
E-mail: sales.medical@oxinst.co.uk

Oxford Instruments Private Ltd [365308]


371 Beach Road 02-07 Keypoint
Singapore 199597
Republic of Singapore
Phone: 65 63376848 Fax: 65 63376282
Internet: http://www.oxford-instruments.com
E-mail: oi.admin@oxford-instruments.com.sg
Philips
Philips Medical Systems, Cardiac & Monitoring Systems Div [397917]
3000 Minuteman Rd Mailstop 101
Andover, MA 01810
Phone: (978) 687-1501 (800) 934-7372 Fax: (800) 947-3299
Internet: http://www.medical.philips.com

Philips Medical Systems (Asia Pacific), Cardiac & Monitoring Systems Div [398048]
24/Fl Cityplaza One 1111 Kings Road
Taikoo Shing
Peoples Republic of China
Phone: 852 31977777 Fax: 852 25069261
Internet: http://www.medical.philips.com

Philips Medical Systems (Europe), Cardiac & Monitoring Systems Div [398047]
Herrenberger Strasse 124
D-71034 Boeblingen
Germany
Phone: 49 (7031) 4641552 Fax: 49 (7031) 4644096
Internet: http://www.medical.philips.com
E-mail: pmscc@philips.com

Philips Medical Systems Canada [397918]


281 Hillmount Rd
Markham, ON L6C 2S3
Canada
Phone: (905) 201-4100 Fax: (905) 201-4323
Internet: http://www.medical.philips.com
Spacelabs Medical
Spacelabs (Singapore) Pte Ltd, An OSI Systems Co [162905]

ECRI. All Rights Reserved.


13
Fetal Monitors

51 Changi Business ParkCentral 2 #08-02 The Signature


Singapore 486006
Republic of Singapore
Phone: 65 65877620
Internet: http://www.spacelabs.com

Spacelabs Medical Inc, An OSI Systems Co [101758]


5150 220th Ave SE PO Box 7018
Issaquah, WA 98027-7018
Phone: (425) 657-7200 (800) 522-7025 Fax: (425) 657-7212
Internet: http://www.spacelabs.com
E-mail: info@slmd.com

Spacelabs Medical Ltd (UK), An OSI Systems Co [360061]


Basepoint Business Centre Metcalf Way
Crawley RH11 7XX
England
Phone: 44 (7) 831162115
Internet: http://www.spacelabs.com
Toitu
HAH Medical [394364]
7747 Edgewater Ct
Lone Tree, CO 80124
Phone: (303) 792-2889 (800) 776-4043 Fax: (303) 799-3997
Internet: http://www.toituusa.com
E-mail: hahmedical@worldnet.att.net
North American distributor

Toitu Co Ltd [139325]


1-5-10 Ebisu Nishi Shibuya-ku
Tokyo 150-0021
Japan
Phone: 81 (3) 34961121 Fax: 81 (3) 34961376
Internet: http://www.toitu.co.jp
E-mail: international@toitu.co.jp
Ultrasound Technologies
Ultrasound Technologies Ltd [366254]
Lodge Way Portskewett
Caldicot Gwent NP26 5PS
Wales
Phone: 44 (1291) 425425 Fax: 44 (1291) 427093
Internet: http://www.doppler.co.uk
E-mail: sales@doppler.co.uk

About the chart specifications


The following terms are used in the chart:
Ultrasound intensity, mW/cm2: Manufacturers specified ultrasound intensity at the transducer-
skin interface, in milliwatts per square centimeter.
Integral signal simulation: Some units provide integral electrical simulation of direct and abdominal
ECG signals for the user to check that the monitoring system is functioning properly.
Computer interface: One or more computer interfaces for data collection and storage through a
central station, personal computer, and/or hospitalwide computer patient-data management system.
Event marker: A push-button recorder marker that allows the patient to indicate the timing of fetal

ECRI. All Rights Reserved.


14
Fetal Monitors

movement during antepartum testing. It also enables the nurse or physician to note the timing of
intrapartum events, such as fetal scalp blood sampling, position change, or drug administration.
Abbreviations
The following abbreviations are used in the chart:
BP Blood pressure IUPC Intrauterine pressure catheter
bpm Beats per minute LAN Local area network
CE Communaute Europeen LCD Liquid crystal display
CE mark Conformite Europeene mark LED Light-emitting diode
DECG Direct fetal electrocardiogram MDD Medical Devices Directive
DSP Digital signal processing MECG Maternal ECG
ECG Electrocardiogram MHR Maternal heart rate
EL Electroluminescent MSpO2 Maternal hemoglobin saturation
EN European Norm Ni-MH Nickel-metal hydride
FDA U.S. Food and Drug Administration NIBP Noninvasive blood pressure
FECG Fetal ECG NST Nonstress testing
FHR Fetal heart rate PC Personal computer
FM Fetal movement PCMCIA Personal Computer Memory Card
International Association
FMD Fetal movement detection
SN Serial number
FMP Fetal movement profile
SpO2 Hemoglobin saturation
FSpO2 Fetal hemoglobin saturation
TUV Technischer Ueberwachungs Verein
GSM Global System for Mobile
Communications UA Uterine activity
HR Heart rate UC Uterine contraction
IEC International Electrotechnical UL Underwriters Laboratories
Commission
US Ultrasound
IOB Output beam intensity
USB Universal Serial Bus
ISPTA Spatial peak, temporal average
VGA Video Graphics Array
intensity
WLAN Wireless local area network
IU Intrauterine

Note: The data in the charts derive from suppliers specifications and have not been verified
through independent testing by ECRI or any other agency. Because test methods vary, different
products specifications are not always comparable. Moreover, products and specifications are subject
to frequent changes. ECRI is not responsible for the quality or validity of the information presented
or for any adverse consequences of acting on such information.
When reading the charts, keep in mind that, unless otherwise noted, the list price does not reflect
supplier discounts. And although we try to indicate which features and characteristics are standard
and which are not, some may be optional, at additional cost.
For those models whose prices were supplied to us in currencies other than U.S. dollars, we have
also listed the conversion to U.S. dollars to facilitate comparison among models. However, keep in
mind that exchange rates change often.

ECRI. All Rights Reserved.


15
Fetal Monitors

Product Comparison Chart

MODEL ECRI-RECOMMENDED CARD GUARD COOPERSURGICAL GE HEALTHCARE


SPECIFICATIONS1
Basic Fetal Monitors CG-900P FETALGARDE Lite Corometrics 126 (Dual
US, FECG, Toco, IUP)
WHERE MARKETED Worldwide USA Worldwide
FDA CLEARANCE Yes Yes Yes
CE MARK (MDD) Yes Yes Yes
ANTEPARTUM/INTRAPARTUM Either or both Both External antepartum Both
Ultrasound
Type/frequency, MHz Continuous wave or Continuous Doppler/2.304 Pulsed Doppler with 9-crystal pulsed/1.151
pulsed/1-2.5 DSP/1.024
Intensity, mW/cm2 <20 <10 <5, typically 3-4
Special processing Not specified Autocorrelation Autocorrelation
FHR range, bpm 50-210 50-210 30-240 (USA), 50-210 50-210
(international)
Fetal ECG/SpO2 Optional/optional No/no No/no Yes/no
FHR range, bpm 50-210 50-210 NA 30-240
Uterine activity Yes Yes Yes Yes
External/internal Either; both preferred Yes/no Yes/no Yes/yes
Reference/zero controls Yes Autozero Push button with auto Push button with auto
rezero rezero
Twins or MHR/FHR Preferred No Both (US/US) Yes
Maternal ECG/NIBP/SpO2 Optional/optional/optional No/yes/yes No/no/no No/no/no
OUTPUT SIGNALS
Analog NA HR, UA FECG; optional FHR1,
FHR2, UA
Digital NIBP, temperature, HR (2), UA 3 x RS232
albumin, glucose, weight
Calibration, FHR/UA Preferred No/no Yes/yes Yes/yes
Integral signal simulation Optional No Yes FECG R-wave @ 120
bpm
Computer interface Ethernet, USB, RS232 RS232, modem RS232 Triple RS232
Telemetry features Optional None No FECG, US, toco or IUPC,
remote event marker,
headset
DISPLAY FEATURES
Digital FHR Yes Graphic LCD Yes FHR1 and FHR2
Number of displays By user preference 1 2 1 EL
Digital UA Optional, but preferred Graphic LCD Yes Yes
Alarms Yes Yes Yes Yes
High/low FHR Yes/yes Yes/yes Yes/yes Yes/yes
Other alarms No Loss of heart rate Optional Spectra Alerts

This is the first of two


pages covering the above
model(s). These
specifications continue
onto the next page.

ECRI. All Rights Reserved.


16
Fetal Monitors

Product Comparison Chart


MODEL ECRI-RECOMMENDED CARD GUARD COOPERSURGICAL GE HEALTHCARE
SPECIFICATIONS1
Basic Fetal Monitors CG-900P FETALGARDE Lite Corometrics 126 (Dual
US, FECG, Toco, IUP)
RECORDER Any Receiving center Thermal array Integral thermal array, Z-
fold paper
Channels 2 NA 2 (plus alphanumerics) 8 (plus alphanumerics)
Paper speed, cm/min No preference NA 1, 2, 3 1, 2, 3
Vertical scale, bpm/cm No preference 7 30 30 (30-240 range), 20 (50-
210 range)
Record height
FHR trace, cm No preference 7 7 7 or 8
UA trace, cm No preference 4 4 4
Event marker Yes Yes Yes Yes
Annotations Date, time, patient ID or Physician summary notes Time, date, mode, paper Time, date, speed, mode,
bed number, alarm status, speed, optional annotation UA reference, parameter
vital signs inoperable, maternal vital
signs, keyboard notes
Remote recording Optional Yes Yes No
Record storage
Number of hr Optional 0.5 (1 full recording) 12 8 @ 3 cm/min
H x W x D, cm (in) 8 x 23.1 x 16 (3.1 x 9.1 x 11.5 x 24.2 x 20.4 (4.5 x 17 x 41.9 x 43.9 (6.7 x
6.3) 9.5 x 8) 16.5 x 17.3)
WEIGHT, kg (lb) 1.5 (3.3) with battery 3.4 (7.5) 10.9 (24)
LINE POWER, VAC Standard 100-120, 220-240 100-120, 220-240 100, 120, 220, 230, 240
BATTERY, TYPE Any common type 6V Lead acid None
Operating time, hr 1 Not specified 4 @ room temp NA
Rechargeable Optional Yes Yes NA
Recharge time, hr Not specified 14; 8 with monitor off NA
Low-battery notice Yes Yes 30 minutes NA
PLANNING &
PURCHASE
List price $3,000 $3,000-6,000 $12,310-18,520
Year first sold Not specified 2000 1997
Warranty 1 year 2 years; 1 year, 1 year
transducers
Fiscal year Not specified November to October January to December
OTHER None specified. US signal indicator; NST ChartLight; large EL
SPECIFICATIONS indicator; cable display; independent
management. volume controls; song
player; upgradable design;
9-crystal ultrasound;
remote event marker;
heart rate offset; fetal
movement detection;
same-loop or button-top
transducers for bedside,
telemetry, and
hydrotherapy; Spectra
Alerts; QwikConnect spiral
electrodes; Saflex IUPC.
1
Supplier Footnotes These recommendations
are the opinions of ECRI's
technology experts. ECRI
assumes no liability for
decisions made based on
this data.
Model Footnotes
Data Footnotes

ECRI. All Rights Reserved.


17
Fetal Monitors

Product Comparison Chart


MODEL GE HEALTHCARE GE HEALTHCARE GE HEALTHCARE GE HEALTHCARE
Corometrics 128 (Dual Corometrics 129 (Dual Corometrics 171 (US, Corometrics 172 (Dual
US, FECG, Toco, IUP, US, FECG, Toco, IUP, Toco) US, Toco)
MBP, MSpO2) MBP, MSpO2, MECG)
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide
FDA CLEARANCE Yes Yes Yes Yes
CE MARK (MDD) Yes Yes Yes Yes
ANTEPARTUM/INTRAPARTUM Both Both Both Both
Ultrasound
Type/frequency, MHz 9-crystal pulsed/1.151 9-crystal pulsed/1.151 9-crystal pulsed/1.151 9-crystal pulsed/1.151
Intensity, mW/cm2 <5, typically 3-4 <5, typically 3-4 <5 <5
Special processing Autocorrelation Autocorrelation Autocorrelation Autocorrelation
FHR range, bpm 50-210 50-210 50-210 50-210
Fetal ECG/SpO2 Yes/no Yes/no No/no No/no
FHR range, bpm 30-240 30-240 30-240 30-240
Uterine activity Yes Yes Yes Yes
External/internal Yes/yes Yes/yes Yes/no Yes/no
Reference/zero controls Push button with auto Push button with auto Push button with auto Push button with auto
rezero rezero rezero rezero
Twins or MHR/FHR Yes Yes No Twins; dual external
Maternal ECG/NIBP/SpO2 Yes/DINAMAP/Nellcor or Yes/DINAMAP/Nellcor or No/no/no No/no/no
Masimo SET Masimo SET
OUTPUT SIGNALS
Analog FECG; optional FHR1, FECG and MECG; FHR1, FHR2, UA FHR1, FHR2, UA
FHR2, UA optional FHR1, FHR2, UA
Digital 3 x RS232 3 x RS232 2 x RS232 2 x RS232
Calibration, FHR/UA Yes/yes Yes/yes Yes/yes Yes/yes
Integral signal simulation FECG R-wave @ 120 FECG R-wave @ 120 No No
bpm bpm
Computer interface Triple RS232 Triple RS232 Dual RS232 Dual RS232
Telemetry features FECG, US, toco or IUPC, FECG or MECG, US, toco US, toco, remote event US, toco, remote event
remote event marker, or IUPC, remote event marker, headset marker, headset
headset marker, headset
DISPLAY FEATURES
Digital FHR FHR1 and FHR2 FHR1 and FHR2 Yes FHR1 and FHR2
Number of displays 1 EL 1 EL 3 (LED) 3 (LED)
Digital UA Yes Yes Yes Yes
Alarms Yes Yes Yes Yes
High/low FHR Yes/yes Yes/yes Yes/yes Yes/yes
Other alarms Maternal BP and SpO2, Maternal BP, SpO2, and None None
optional Spectra Alerts ECG, optional Spectra
Alerts

This is the first of two


pages covering the above
model(s). These
specifications continue
onto the next page.

ECRI. All Rights Reserved.


18
Fetal Monitors

Product Comparison Chart


MODEL GE HEALTHCARE GE HEALTHCARE GE HEALTHCARE GE HEALTHCARE
Corometrics 128 (Dual Corometrics 129 (Dual Corometrics 171 (US, Corometrics 172 (Dual
US, FECG, Toco, IUP, US, FECG, Toco, IUP, Toco) US, Toco)
MBP, MSpO2) MBP, MSpO2, MECG)
RECORDER Integral thermal array, Z- Integral thermal array, Z- Integral thermal array, Z- Integral thermal array, Z-
fold paper fold paper fold paper fold paper
Channels 8 (plus alphanumerics) 8 (plus alphanumerics) 3 (4 alphanumeric) 3 (4 alphanumeric)
Paper speed, cm/min 1, 2, 3, and maternal-only 1, 2, 3, and maternal-only 1, 2, 3 1, 2, 3
Vertical scale, bpm/cm 30 (30-240), 20 (50-210) 30 (30-240), 20 (50-210) 30 (30-240), 20 (50-210) 30 (30-240), 20 (50-210)
Record height
FHR trace, cm 7 or 8 7 or 8 7 or 8 7 or 8
UA trace, cm 4 4 4 4
Event marker Yes Yes Yes Yes
Annotations Time, date, speed, mode, Time, date, speed, mode, Time, date, speed, Time, date, speed,
UA reference, parameter UA reference, parameter mode(s), UA reference, mode(s), UA reference,
inoperable, maternal vital inoperable, maternal vital parameter inoperable parameter inoperable
signs, keyboard notes signs, keyboard notes
Remote recording No No No No
Record storage
Number of hr 8 @ 3 cm/min 8 @ 3 cm/min 8 @ 3 cm/min 8 @ 3 cm/min
H x W x D, cm (in) 17 x 41.9 x 43.9 (6.7 x 17 x 41.9 x 43.9 (6.7 x 14.6 x 42.5 x 25.4 (5.8 x 14.6 x 42.5 x 25.4 (5.8 x
16.5 x 17.3) 16.5 x 17.3) 16.8 x 10) 16.8 x 10)
WEIGHT, kg (lb) 10.9 (24) 10.9 (24) 3.6 (8) 3.6 (8)
LINE POWER, VAC 100, 120, 220, 230, 240 100, 120, 220, 230, 240 100-230 100-230
BATTERY, TYPE None None None None
Operating time, hr NA NA NA NA
Rechargeable NA NA NA NA
Recharge time, hr NA NA NA NA
Low-battery notice NA NA NA NA
PLANNING &
PURCHASE
List price $12,310-18,520 $12,310-18,520 $4,390-9,750 $4,390-9,750
Year first sold 1997 1997 1999 1999
Warranty 1 year 1 year 1 year 1 year
Fiscal year January to December January to December January to December January to December
OTHER Smart BP with DINAMAP; Smart BP with DINAMAP; Large LED displays; 9- Large LED displays;
SPECIFICATIONS ChartLight; large EL ChartLight; large EL crystal ultrasound; remote independent volume
display; independent display; independent event marker; heart rate controls; 9-crystal
volume controls; MSpO2 volume controls; MSpO2 offset; same-loop or ultrasound; remote event
choice; song player; choice; song player; button-top transducers for marker; heart rate offset;
upgradable design; 9- upgradable design; 9- bedside, telemetry, and same-loop or button-top
crystal ultrasound; remote crystal ultrasound; remote hydrotherapy; optional transducers for bedside,
event marker; heart rate event marker; heart rate fetal acoustic stimulator; telemetry, and
offset; fetal movement offset; fetal movement optional fetal movement hydrotherapy; optional
detection; same-loop or detection; same-loop or detection. fetal acoustic stimulator;
button-top transducers for button-top transducers for optional fetal movement
bedside, telemetry, and bedside, telemetry, and detection.
hydrotherapy; Spectra hydrotherapy; selectable-
Alerts; vital signs history lead MECG; Spectra
and recovery mode; Alerts; vital signs history
QwikConnect spiral and recovery mode;
electrodes; Saflex IUPC. QwikConnect spiral
electrodes; Saflex IUPC.
Supplier Footnotes
Model Footnotes
Data Footnotes

ECRI. All Rights Reserved.


19
Fetal Monitors

Product Comparison Chart


MODEL GE HEALTHCARE GE HEALTHCARE GE HEALTHCARE GE HEALTHCARE
Corometrics 173 (US, Corometrics 174 (Dual Corometrics 256 (Dual Corometrics 259 (Dual US,
FECG, Toco, IUP) US, FECG, Toco, IUP) US, FECG, Toco, IUP) FECG, Toco, IUP, MBP,
MSpO2, MECG)
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide
FDA CLEARANCE Yes Yes Yes Yes
CE MARK (MDD) Yes Yes Yes Yes
ANTEPARTUM/INTRAPARTUM Both Both Both Both
Ultrasound
Type/frequency, MHz 9-crystal pulsed/1.151 9-crystal pulsed/1.151 9-crystal pulsed/1.151 9-crystal pulsed/1.151
Intensity, mW/cm2 <5 <5 <5, typically 3-4 <5, typically 3-4
Special processing Autocorrelation Autocorrelation Autocorrelation Autocorrelation
FHR range, bpm 50-210 50-210 50-210 50-210
Fetal ECG/SpO2 Yes/no Yes/no Yes/no Yes/no
FHR range, bpm 30-240 30-240 30-240 30-240
Uterine activity Yes Yes Yes Yes
External/internal Yes/yes Yes/yes Yes/yes Yes/yes
Reference/zero controls Push button with auto Push button with auto Push button with auto Push button with auto rezero
rezero rezero rezero
Twins or MHR/FHR Twins, dual external Twins, dual external Yes Yes
Maternal ECG/NIBP/SpO2 No/no/no No/no/no No/no/no Marquette/DINAMAP/Nellcor,
Masimo SET, GE Ohmeda
OUTPUT SIGNALS
Analog FHR1, FHR2, UA FHR1, FHR2, UA FECG; optional FHR1, FECG and MECG; optional
FHR2, UA FHR1, FHR2, UA
Digital 2 x RS232 2 x RS232 3 x RS232 3 x RS232
Calibration, FHR/UA Yes/yes Yes/yes Yes/yes Yes/yes
Integral signal simulation No No FECG R-wave @ 120 FECG R-wave @ 120 bpm
bpm
Computer interface Dual RS232 Dual RS232 Triple RS232 Triple RS232
Telemetry features FECG or MECG, US, FECG or MECG, US, toco FECG, US, toco or IUPC, FECG or MECG, US, toco or
toco, IUP, remote event or IUPC, remote event remote event marker, IUPC, remote event marker,
marker, headset marker, headset headset headset
DISPLAY FEATURES
Digital FHR FHR1 and FHR2 FHR1 and FHR2 FHR1 and FHR2 FHR1 and FHR2
Number of displays 3 (LED) 3 (LED) 1 (VGA) 1 (VGA)
Digital UA Yes Yes Yes Yes
Alarms Yes Yes Yes Yes
High/low FHR Yes/yes Yes/yes Yes/yes Yes/yes
Other alarms None None Optional Spectra Alerts Maternal BP, SpO2, and
ECG; optional Spectra Alerts

This is the first of two pages


covering the above model(s).
These specifications
continue onto the next page.

ECRI. All Rights Reserved.


20
Fetal Monitors

Product Comparison Chart


MODEL GE HEALTHCARE GE HEALTHCARE GE HEALTHCARE GE HEALTHCARE
Corometrics 173 (US, Corometrics 174 (Dual Corometrics 256 (Dual Corometrics 259 (Dual
FECG, Toco, IUP) US, FECG, Toco, IUP) US, FECG, Toco, IUP) US, FECG, Toco, IUP,
MBP, MSpO2, MECG)
RECORDER Integral thermal array, Z- Integral thermal array, Z- Integral thermal array, Z- Integral thermal array, Z-
fold paper fold paper fold paper fold paper
Channels 3 (4 alphanumeric) 3 (4 alphanumeric) 8 (plus alphanumerics) 8 (plus alphanumerics)
Paper speed, cm/min 1, 2, 3 1, 2, 3 1, 2, 3 1, 2, 3, and maternal-only
Vertical scale, bpm/cm 30 (30-240 range), 20 (50- 30 (30-240), 20 (50-210) 30 (30-240 range), 20 (50- 30 (30-240 range), 20 (50-
210 range) 210 range) 210 range)
Record height
FHR trace, cm 7 or 8 7 or 8 7 or 8 7 or 8
UA trace, cm 4 4 4 4
Event marker Yes Yes Yes Yes
Annotations Time, date, speed, Time, date, speed, Time, date, speed, mode, Time, date, speed, mode,
mode(s), UA reference, mode(s), UA reference, UA reference, parameter UA reference, parameter
parameter inoperable parameter inoperable inop, maternal vital signs, inoperable, maternal vital
keyboard notes signs, keyboard notes
Remote recording No No No No
Record storage
Number of hr 8 @ 3 cm/min 8 @ 3 cm/min 8 @ 3 cm/min 8 @ 3 cm/min
H x W x D, cm (in) 14.6 x 42.5 x 25.4 (5.8 x 14.6 x 42.5 x 25.4 (5.8 x 17 x 41.9 x 43.9 (6.7 x 17 x 41.9 x 43.9 (6.7 x
16.8 x 10) 16.8 x 10) 16.5 x 17.3) 16.5 x 17.3)
WEIGHT, kg (lb) 3.6 (8) 3.6 (8) 10.9 (24) 10.9 (24)
LINE POWER, VAC 100-230 100-230 100, 120, 220, 230, 240 100, 120, 220, 230, 240
BATTERY, TYPE None None None None
Operating time, hr NA NA NA NA
Rechargeable NA NA NA NA
Recharge time, hr NA NA NA NA
Low-battery notice NA NA NA NA
PLANNING &
PURCHASE
List price $4,390-9,750 $4,390-9,750 $12,900-14,700 $16,900-18,700
Year first sold 1999 1999 2005 2005
Warranty 1 year 1 year 1 year 1 year
Fiscal year January to December January to December January to December January to December
OTHER Large LED displays; Large LED displays; ChartLight with backlit Smart BP with DINAMAP
SPECIFICATIONS independent volume independent volume keys; large, dimmable SuperSTAT; ChartLight
controls; 9-crystal controls; 9-crystal VGA display; independent with backlit keys; maternal
ultrasound; remote event ultrasound; remote event volume controls; song alarm lockout; large,
marker; same-loop or marker; heart rate offset; player; upgradable design; dimmable VGA display;
button-top transducers for same-loop or button-top 9-crystal ultrasound; independent volume
bedside, telemetry, and transducers for bedside, remote event marker; controls; MSpO2 choice;
hydrotherapy; telemetry, and heart rate offset; fetal song player; upgradable
QwikConnect spiral hydrotherapy; movement detection; design; 9-crystal
electrodes; Saflex IUPC; QwikConnect spiral same-loop or button-top ultrasound; remote event
optional fetal acoustic electrodes; Saflex IUPC; transducers for bedside, marker; heart rate offset;
stimulator; optional fetal optional fetal acoustic telemetry, and fetal movement detection;
movement detection. stimulator; optional fetal hydrotherapy; Spectra same-loop or button-top
movement detection. Alerts; QwikConnect spiral transducers for bedside,
electrodes; Saflex IUPC. telemetry, and
hydrotherapy; selectable-
lead MECG; Spectra
Alerts; vital signs history
and recovery mode;
QwikConnect spiral
electrodes; Saflex IUPC.
Supplier Footnotes
Model Footnotes
Data Footnotes

ECRI. All Rights Reserved.


21
Fetal Monitors

Product Comparison Chart


MODEL GIMA GIMA HUNTLEIGH HUNTLEIGH
29520 29540 Baby Dopplex BD3000 Baby Dopplex BD3002
WHERE MARKETED Worldwide Worldwide USA USA
FDA CLEARANCE Yes No Yes Yes
CE MARK (MDD) Yes Yes Yes Yes
ANTEPARTUM/INTRAPARTUM Antepartum Intrapartum Antepartum Antepartum
Ultrasound
Type/frequency, MHz Pulsed Doppler/not Pulsed Doppler/not Pulsed Doppler/1.5 Pulsed Doppler/1.5
specified specified
Intensity, mW/cm2 <10 <10 <10 <10
Special processing Autocorrelation Autocorrelation Autocorrelation Autocorrelation
FHR range, bpm 50-210 50-210 30-240 or 50-210, 30-240 or 50-210,
selectable selectable
Fetal ECG/SpO2 Optional/no Optional/no No/no No/no
FHR range, bpm 50-240 50-210 30-240 or 50-210 30-240 or 50-210
Uterine activity Yes Yes Yes Yes
External/internal Yes/yes Yes/yes Yes/no Yes/no
Reference/zero controls Not specified Not specified Push button/yes Push button/yes
Twins or MHR/FHR Single only Twins No/no Single or twins FHR
Maternal ECG/NIBP/SpO2 No/no/no No/no/no Not specified Not specified
OUTPUT SIGNALS
Analog HR/UA HR/UA/fetal ECG Doppler audio Doppler audio
Digital No Not specified NA NA
Calibration, FHR/UA Yes/yes Yes/yes NA NA
Integral signal simulation Yes Yes NA NA
Computer interface LAN LAN NA NA
Telemetry features No LAN No No
DISPLAY FEATURES
Digital FHR Yes Yes Yes Yes
Number of displays 2 1 3-digit LED 2 (3-digit LED)
Digital UA Yes Not specified 2-digit LED 2-digit LED
Alarms Yes Yes No No
High/low FHR Yes Not specified NA NA
Other alarms None None specified NA NA

This is the first of two


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model(s). These
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ECRI. All Rights Reserved.


22
Fetal Monitors

Product Comparison Chart


MODEL GIMA GIMA HUNTLEIGH HUNTLEIGH
29520 29540 Baby Dopplex BD3000 Baby Dopplex BD3002
RECORDER Thermal array Thermal array Thermal array Thermal array
Channels 1 Not specified 2, plus alphanumeric 3, plus alphanumeric
Paper speed, cm/min 1, 2, 3 1, 2, 3 1, 2, 3; selectable 1, 2, 3; selectable
Vertical scale, bpm/cm Yes Not specified 20/30, selectable 20/30, selectable
Record height
FHR trace, cm Not specified Not specified 7 or 8 7 or 8 (2)
UA trace, cm Not specified Not specified 4.5 4.5
Event marker Yes Yes Patient and clinical Patient and clinical
Annotations Yes Yes Time, date, mode, paper Time, date, mode, paper
speed, FMD, annotations, speed, FMD, annotations,
events events
Remote recording No Optional No No
Record storage
Number of hr None Not specified NA NA
H x W x D, cm (in) 29 x 30 x 9 (11.4 x 11.8 x 40 x 40 x 20 (15.7 x 15.7 x 9.3 x 38 x 25 (3.7 x 15 x 9.3 x 38 x 25 (3.7 x 15 x
3.5) 7.9) 9.8) 9.8)
WEIGHT, kg (lb) 2.9 (6.4) 9 (19.8) 3.5 (7.7) 3.5 (7.7)
LINE POWER, VAC 100-240 Not specified 120 (USA) 120 (USA)
BATTERY, TYPE Optional 13 V Not specified None None
Operating time, hr Not specified Not specified NA NA
Rechargeable Not specified Not specified NA NA
Recharge time, hr Not specified Not specified NA NA
Low-battery notice Yes Not specified NA NA
PLANNING &
PURCHASE
List price $2,700 Not specified Not specified Not specified
Year first sold 2004 2002 1995 2001
Warranty 1 year 1 year 2 years; 1 year, 2 years; 1 year,
transducers transducers
Fiscal year Not specified Not specified January to December January to December
OTHER None specified. None specified. Designed for community Designed for community
SPECIFICATIONS and hospital use; choice and hospital use; choice
of carrying case, mobile of carrying case, mobile
cart, or wall-mount cart, or wall-mount
bracket; trace bracket; trace
annotation/clinical event annotation/clinical event
marker allows marker allows
documentation of clinical documentation of clinical
action. Meets action. Meets
requirements of CE, EN requirements of CE, EN
60601-1, FDA, and TUV. 60601-1, FDA, and TUV.
Supplier Footnotes
Model Footnotes
Data Footnotes

ECRI. All Rights Reserved.


23
Fetal Monitors

Product Comparison Chart


MODEL HUNTLEIGH HUNTLEIGH HUNTLEIGH NEOVENTA MEDICAL
Baby Dopplex BD4000 Baby Dopplex BD4002 Fetal Assist STAN S31
WHERE MARKETED Worldwide Worldwide Worldwide Europe
FDA CLEARANCE Yes Yes Yes Submitted
CE MARK (MDD) Yes Yes Yes Yes
ANTEPARTUM/INTRAPARTUM Both Both Antepartum Intrapartum
Ultrasound
Type/frequency, MHz Pulsed Doppler/1.5 Pulsed Doppler/1.5 Pulsed Doppler/1.5 Pulsed Doppler/1.0, 1.5
Intensity, mW/cm2 <10 <10 <10 <20
Special processing Autocorrelation Autocorrelation Autocorrelation Autocorrelation
FHR range, bpm 30-240 or 50-210, 30-240 or 50-210, 30-240 or 50-210, 50-240
selectable selectable selectable
Fetal ECG/SpO2 Optional/interface option Optional/interface option No/no With ST waveform
analysis/no
FHR range, bpm 30-240 or 50-210 30-240 or 50-210 30-240 or 50-210 30-240, 50-210
Uterine activity Yes Yes Yes Yes
External/internal Yes/optional Yes/optional Yes/no Yes/yes
Reference/zero controls Push button/yes Push button/yes Push button with auto Push button with auto
zero rezero
Twins or MHR/FHR Twins (US/US, US/ECG) Twins (US/US, US/ECG), NA Both (US/US, US/ECG,
using 2 units single unit external MHR)
Maternal ECG/NIBP/SpO2 External interface External interface NA No/yes/yes (external
device)
OUTPUT SIGNALS
Analog NA NA NA No
Digital HR, UA, date, time, fetal HR, UA, date, time, fetal Same as BD4002 plus 2 HR, UA, ECG data
movement, system movement, system remote system upgrade
parameters, event, service parameters, event, service capability
data data
Calibration, FHR/UA NA NA NA No/no
Integral signal simulation NA NA NA No
Computer interface RS232 x 2 RS232 x 2 RS232, PCMCIA USB, RS232, Ethernet
Telemetry features Yes Yes GSM, WLAN, or landline No
DISPLAY FEATURES
Digital FHR Yes Yes Yes Yes
Number of displays 3-digit LED 2 (3-digit LED) 1 color graphic 1 (LCD 800 x 600)
Digital UA 2-digit LED 1 (2-digit LED) NA Yes
Alarms Yes Yes Yes No
High/low FHR Yes/yes Yes/yes Yes/yes NA
Other alarms Loss of contact Loss of contact None specified NA

This is the first of two


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model(s). These
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24
Fetal Monitors

Product Comparison Chart


MODEL HUNTLEIGH HUNTLEIGH HUNTLEIGH NEOVENTA MEDICAL
Baby Dopplex BD4000 Baby Dopplex BD4002 Fetal Assist STAN S31
RECORDER Thermal array Thermal array Optional Thermal array or laser
printer
Channels 2, plus alphanumeric 3, plus alphanumeric NA NA/digital interface
Paper speed, cm/min 1, 2, 3; selectable 1, 2, 3; selectable NA 1, 2, 3
Vertical scale, bpm/cm 20/30, selectable 20/30, selectable 20/30, selectable 20/30
Record height
FHR trace, cm 7 or 8 2 x 7 or 2 x 8 4 7 or 8
UA trace, cm 4.5 4.5 1.1 2
Event marker Patient and clinical Patient and clinical Patient and clinical Yes
Annotations Time, date, mode, paper Time, date, mode, paper Time, date, mode, paper Time, date, mode, user
speed, alarm status, speed, alarm status, speed, alarm status, annotations, system
events, FMD, annotations events, FMD, annotations events, FMD, annotations events, ECG events
Remote recording No No GSM, WLAN, or landline Yes
Record storage
Number of hr NA NA 500 with 30 min integral >200
storage
H x W x D, cm (in) 9.3 x 38 x 25 (3.7 x 15 x 9.3 x 38 x 25 (3.7 x 15 x 23.5 x 15 x 5 (9.2 x 5.9 x 33 x 42 x 14 (13 x 16.5 x
9.8) 9.8) 2) 5.5)
WEIGHT, kg (lb) 4.5 (9.9) 4.5 (9.9) 1.2 (2.6) 9 (19.8)
LINE POWER, VAC 120 (USA) 120 (USA) 120 (USA) 100-240, 50/60 Hz
BATTERY, TYPE None None Yes Not specified
Operating time, hr NA NA 4 Not specified
Rechargeable NA NA Yes Not specified
Recharge time, hr NA NA 1.5 Not specified
Low-battery notice NA NA Yes Not specified
PLANNING &
PURCHASE
List price Not specified Not specified Not specified Not specified
Year first sold 1997 1999 1999 2004
Warranty 2 years; 1 year, 2 years; 1 year, 2 years; 1 year, 2 years
transducers transducers transducers
Fiscal year January to December January to December January to December January to December
OTHER User plug-in upgrade User plug-in upgrade 4 hr use with integral Monitor with ST waveform
SPECIFICATIONS capability allows user to capability allows user to battery pack; color analysis of the fetal ECG.
upgrade from antepartum upgrade from antepartum graphical display with
to intrapartum operation; to intrapartum operation; touchscreen to display
connecting 2 units allows wide-printout option; dual FHR and UA in real time;
the system to monitor 2 signal-quality indicators chart scale options; plug-
FHRs; wide-printout (US); automatic fetal and-play transducer
option for twin HR movement detection and connectivity allows user to
monitoring; signal-quality trace annotation. Meets connect any transducer;
indicator (US); automatic requirements of CE, EN PCMCIA allows
fetal movement detection 60601-1, FDA, and TUV. connection to modem,
and trace annotation. memory, or network
Meets requirements of modules. Meets
CE, EN 60601-1, FDA, requirements of CE, EN
and TUV. 60601-1, and TUV.
Supplier Footnotes
Model Footnotes
Data Footnotes

ECRI. All Rights Reserved.


25
Fetal Monitors

Product Comparison Chart


MODEL NICOLET NICOLET OXFORD INSTRUMENTS OXFORD INSTRUMENTS
VASCULAR/VIASYS VASCULAR/VIASYS
VersaLab APM VersaLab APM2 Sonicaid FM820 Labour Sonicaid FM830 Maternal
Antepartum Monitor Antepartum (Twins) and Delivery Vital Signs
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide
FDA CLEARANCE Yes Yes Yes Yes
CE MARK (MDD) Yes Yes Yes Yes
ANTEPARTUM/INTRAPARTUM Antepartum Antepartum Intrapartum Intrapartum
Ultrasound
Type/frequency, MHz Continuous wave/2.0 Continuous wave/1.8, Pulsed, directional/1.5, 2.0 Pulsed, directional/1.5, 2.0
continuous wave/2.0
Intensity, mW/cm2 <10 <10 <20 IOB, <100 ISPTA <20 IOB, <100 ISPTA
Special processing Autocorrelation Autocorrelation Cross-correlation with Cross-correlation with
directional diastolic directional diastolic
detection (DDD) detection (DDD)
FHR range, bpm 50-250 50-250 30-240 or 50-210, 30-240 or 50-210,
selectable selectable
Fetal ECG/SpO2 No/no No/not specified Direct/no Direct/no
FHR range, bpm NA NA 30-240 or 50-210 (direct 30-240 or 50-210 (direct
FECG) FECG)
Uterine activity Yes Yes Yes Yes
External/internal 0-100%/no 0-100%/no 0-100%/0-100 mm Hg; 0-100%/0-100 mm Hg;
optional 1-15 kPa optional 1-15 kPa
Reference/zero controls Automatic and manual Automatic and manual Automatic and manual Automatic and manual
Twins or MHR/FHR No/no Yes/yes Yes/yes Yes/yes
Maternal ECG/NIBP/SpO2 No/no/no No/no/no MHR (optional)/no/no MHR/yes/yes
OUTPUT SIGNALS
Analog NA NA No No
Digital NA NA RS232/RS485 RS232/RS485
Calibration, FHR/UA NA NA Not specified Not specified
Integral signal simulation No No Not specified Not specified
Computer interface No No RS232 RS232
Telemetry features No No Optional Optional
DISPLAY FEATURES
Digital FHR Yes Yes Graphic display Graphic display
Number of displays 2, numeric or graphic 2, numeric or graphic 1 1
Digital UA Yes Yes Yes Yes
Alarms Yes Yes Yes Yes
High/low FHR Yes/yes Yes/yes Yes/yes Yes/yes
Other alarms No NA Signal-loss alarm, MHR, Signal-loss alarm, MHR,
NIBP, SpO2 NIBP, SpO2

This is the first of two


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onto the next page.

ECRI. All Rights Reserved.


26
Fetal Monitors

Product Comparison Chart


MODEL NICOLET NICOLET OXFORD INSTRUMENTS OXFORD INSTRUMENTS
VASCULAR/VIASYS VASCULAR/VIASYS
VersaLab APM VersaLab APM2 Sonicaid FM820 Labour Sonicaid FM830 Maternal
Antepartum Monitor Antepartum (Twins) and Delivery Vital Signs
RECORDER Thermal printer Thermal printer Thermal-array printhead Thermal-array printhead
Channels 2 2 Flexible format Flexible format
Paper speed, cm/min 1, 2, 3 1, 2, 3 1, 2, 3 1, 2, 3
Vertical scale, bpm/cm 50 50 20 or 30 20 or 30
Record height
FHR trace, cm 7 7 8 8
UA trace, cm 3.25 3.25 3.4 3.4
Event marker Yes Yes Yes Yes
Annotations Patient name, number, Patient name, number, Automatic time/date Automatic time/date
examiner, start and end examiner, start and end mode, user name, patient mode, user name, patient
times, print speed, times, print speed, name, ID number, name, ID number,
elapsed exam time elapsed exam time gestation gestation
Remote recording No No No No
Record storage No No Yes Yes
Number of hr NA NA 10 then auto paper out 10 then auto paper out
H x W x D, cm (in) 31 x 23 x 7.3 (12.2 x 9.1 x 31 x 23 x 7.3 (12.2 x 9.1 x 18.6 x 35.3 x 35.8 (7.3 x 18.6 x 35.3 x 35.8 (7.3 x
2.9) 2.9) 13.9 x 14.1) 13.9 x 14.1)
WEIGHT, kg (lb) 1.9 (4.2) 1.9 (4.2) 9.5 (21) 9.5 (21)
LINE POWER, VAC 100-250 100-250 Not specified Not specified
BATTERY, TYPE 7.2 V Ni-MH 7.2 V Ni-MH Not specified Not specified
Operating time, hr 3 3 Not specified Not specified
Rechargeable Yes Yes Not specified Not specified
Recharge time, hr 3 3 Not specified Not specified
Low-battery notice Yes Yes Not specified Not specified
PLANNING &
PURCHASE
List price $3,995 $4,995 Not specified Not specified
Year first sold 2002 2002 2000 2000
Warranty 1 year 1 year 2 years 2 years
Fiscal year January to December January to December April to March April to March
OTHER Built-in printer. Built-in printer. Care option antepartum Care option antepartum
SPECIFICATIONS FHR analysis; EasiNotes FHR analysis; EasiNotes
clinical annotations; clinical annotations;
separate channels for separate channels for
twins printout; integration twins printout; integration
into major obstetrics into major obstetrics
management systems. management systems.
Supplier Footnotes
Model Footnotes
Data Footnotes

ECRI. All Rights Reserved.


27
Fetal Monitors

Product Comparison Chart


MODEL OXFORD INSTRUMENTS OXFORD INSTRUMENTS OXFORD INSTRUMENTS OXFORD INSTRUMENTS
Sonicaid TEAM CARE Sonicaid TEAM DM Sonicaid TEAM IP Sonicaid TEAM
with FHR Analysis Antepartum1 Intrapartum Single/Duo Antepartum
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide
FDA CLEARANCE Submitted Yes Yes Yes
CE MARK (MDD) Yes Yes Yes Yes
ANTEPARTUM/INTRAPARTUM Not specified Antepartum Intrapartum Antepartum
Ultrasound
Type/frequency, MHz Pulsed, directional/1.5; opt Pulsed, directional/1.5 Pulsed, directional/1.5, 2.0 Pulsed, directional/1.5 and
2 (twins) 2.0 (twins); TEAM Duo
Antepartum monitor has a
2 MHz frequency
Intensity, mW/cm2 <20 IOB, <100 ISPTA <20 IOB, <100 ISPTA <20 IOB, <100 ISPTA <20 IOB, <100 ISPTA
Special processing Cross-correlation with Cross-correlation with Cross-correlation with Cross-correlation with
directional diastolic directional diastolic directional diastolic directional diastolic
detection (DDD) detection (DDD) detection (DDD) detection (DDD)
FHR range, bpm 30-240 or 50-210, 30-240 or 50-210, 30-240 or 50-210, 30-240 or 50-210,
selectable selectable selectable selectable
Fetal ECG/SpO2 No/no No/no Yes/no No/no
FHR range, bpm NA NA 30-240 or 50-210 NA
Uterine activity Yes Yes Yes Yes
External/internal 0-100%/no 0-100%/no Yes/yes, 0-100%, 0-10 0-100%/no
mm Hg, 0-15 kPa
Reference/zero controls Automatic and manual Automatic and manual Automatic and manual Automatic and manual
Twins or MHR/FHR Optional/yes No/no Twins (US/US or Optional twins/no
US/FECG)
Maternal ECG/NIBP/SpO2 No/no/no No/no/no MECG (except for No/no/no
USA)/no/no
OUTPUT SIGNALS
Analog No No No No
Digital RS232/RS485 RS232/RS485 RS232/RS485 RS232/RS485
Calibration, FHR/UA No/yes No/yes No/yes No/yes
Integral signal simulation No No No No
Computer interface RS232 RS232 RS232 RS232
Telemetry features Optional Optional Optional Optional
DISPLAY FEATURES
Digital FHR Yes/graphic trace Yes/graphic trace Yes/graphic trace Yes/graphic trace
Number of displays 1 1 1 1
Digital UA Yes Yes Yes Yes
Alarms Yes Yes Yes Yes
High/low FHR Yes/yes Yes/yes Yes/yes Yes/yes
Other alarms Signal-loss alarm, MHR, Signal-loss alarm, MHR, Signal-loss alarm, MHR, Signal-loss alarm, MHR,
NIBP, SpO2 NIBP, SpO2 NIBP, SpO2 NIBP, SpO2

This is the first of two


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model(s). These
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ECRI. All Rights Reserved.


28
Fetal Monitors

Product Comparison Chart


MODEL OXFORD INSTRUMENTS OXFORD INSTRUMENTS OXFORD INSTRUMENTS OXFORD INSTRUMENTS
Sonicaid TEAM CARE Sonicaid TEAM DM Sonicaid TEAM IP Sonicaid TEAM
with FHR Analysis Antepartum1 Intrapartum Single/Duo Antepartum
RECORDER Thermal-array printhead Optional thermal-array Thermal-array printhead Thermal-array printhead
printhead
Channels Flexible format Flexible format Flexible format Flexible format
Paper speed, cm/min 1, 2, 3 1, 2, 3 1, 2, 3 1, 2, 3
Vertical scale, bpm/cm 20 or 30 20 or 30 20 or 30 20 or 30
Record height
FHR trace, cm 8 8 (optional with printer) 8 8
UA trace, cm 3.4 3.4 (optional with printer) 3.4 3.4
Event marker Yes Yes Yes Yes
Annotations Automatic time/date Automatic time/date Automatic time/date Automatic time/date
mode, user name, patient mode, user name, patient mode, user name, patient mode, user name, patient
name, ID number, name, ID number, name, ID number, name, ID number,
gestation gestation gestation gestation
Remote recording No (optional TEAM DM) Yes No No (optional TEAM DM)
Record storage Yes Yes Yes Yes
Number of hr 6 6 6 6
H x W x D, cm (in) 16.3 x 27.4 x 27.4 (6.3 x 16.3 x 27.4 x 27.4 (6.3 x 16.3 x 27.4 x 27.4 (6.3 x 16.3 x 27.4 x 27.4 (6.3 x
10.8 x 10.8) 10.8 x 10.8) 10.8 x 10.8) 10.8 x 10.8)
WEIGHT, kg (lb) 5 (11.1) 5 (11.1) 5 (11.1) 5 (11.1)
LINE POWER, VAC Not specified Not specified Not specified Not specified
BATTERY, TYPE Not specified Not specified Not specified Not specified
Operating time, hr Not specified Not specified Not specified Not specified
Rechargeable Not specified Not specified Not specified Not specified
Recharge time, hr Not specified Not specified Not specified Not specified
Low-battery notice Not specified Not specified Not specified Not specified
PLANNING &
PURCHASE
List price Not specified Not specified $7,581 Not specified
Year first sold 1991 1991 1991 1991
Warranty 1 year 1 year 1 year 1 year
Fiscal year April to March April to March April to March April to March
OTHER 20-character user name; 20-character user name; 20-character user name; 20-character user name;
SPECIFICATIONS watertight ultrasound watertight ultrasound watertight ultrasound watertight ultrasound
transducers; maternally transducers; maternally transducers; maternally transducers; maternally
sensed event marker; sensed event marker; sensed event marker; sensed event marker;
user language selection; user language selection; user language selection; user language selection;
English (noncoded) English (noncoded) English (noncoded) English (noncoded)
system messages; system messages; system messages; system messages;
alphanumeric or actual alphanumeric or actual alphanumeric or actual alphanumeric or actual
FHR/UA strip; drop-in FHR/UA strip; drop-in FHR/UA strip; drop-in FHR/UA strip; drop-in
paper load with low-paper paper load with low-paper paper load with low-paper paper load with low-paper
alert; auto time/date alert; auto time/date alert; auto time/date alert; auto time/date
notation; toco transducer. notation; toco transducer. notation; toco transducer. notation; toco transducer.
Supplier Footnotes
1
Model Footnotes For distance monitoring.
Data Footnotes

ECRI. All Rights Reserved.


29
Fetal Monitors

Product Comparison Chart


MODEL PHILIPS PHILIPS PHILIPS PHILIPS
M 1351A Antepartum M 1353A Intrapartum M 2922A Antepartum FM- M1350B Intrapartum
Series 50 A Series 50 IP-2 2 portable Series 50 XM
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide
FDA CLEARANCE Yes Yes Yes Yes
CE MARK (MDD) Yes Yes Yes Yes
ANTEPARTUM/INTRAPARTUM Antepartum Intrapartum Antepartum Intrapartum
Ultrasound
Type/frequency, MHz Pulsed Doppler/0.9984 Pulsed Doppler/0.9984 Pulsed Doppler/1.024 Pulsed Doppler/0.9984
Intensity, mW/cm2 <1.5/0.25-0.5 <1.5/0.25-0.5 <4 <1.5/0.25-0.5
Special processing Autocorrelation with Autocorrelation with Not specified Autocorrelation with
precision track-and-hold precision track-and-hold precision track-and-hold
FHR range, bpm 30-240, beat-to-beat 30-240, beat-to-beat 30-240 30-240, beat-to-beat
Fetal ECG/SpO2 No/no Yes/Nellcor N400 No/no Yes/Nellcor N400
interface interface
FHR range, bpm 30-240 (internally up to 30-240 (internally up to NA 30-240 (internally up to
300) 300) 300)
Uterine activity Yes Yes Yes Yes
External/internal Yes/no Yes/yes Yes/no Yes/yes
Reference/zero controls Push button Push button Push button (configurable) Push button
Twins or MHR/FHR Optional twins with dual Invasive or noninvasive Dual US for twins/no MHR Invasive or noninvasive
US combination
Maternal ECG/NIBP/SpO2 No/yes via external Yes/yes via external No/no/no Yes/yes/yes, integrated
monitor/no monitor/no
OUTPUT SIGNALS
Analog All FHR, UA All FHR, MHR, UA No All FHR, MHR, UA
Digital All FHR, UA, FMP, NIBP, All FHR, MHR, UA, FMP, 2 FHR, toco date/time, All FHR, MHR, UA, FMP,
annotations, FSpO2 NIBP, maternal FSpO2 patient ID to recorder, NIBP, maternal SpO2,
(Nellcor OxiFirst N400) (Nellcor OxiFirst N400) printer, OB system, FM-2 annotations
software utility
Calibration, FHR/UA Yes/yes Yes/yes Yes/yes Yes/yes
Integral signal simulation Yes Yes Yes (demo mode) Yes, test mode
Computer interface Optional Optional RS232 Standard RS232; optional
analog/RS232/RS422 analog/RS232/RS422 RS422, analog
Telemetry features FHR (external/internal), FHR (external/internal), None FHR (external/internal),
UA (external/internal), UA (external/internal), UA (external/internal),
FMP, marker, nurse call FMP, marker, nurse call FMP, marker, nurse call1
DISPLAY FEATURES
Digital FHR Dual optional Dual FHR1 and FHR2 Dual
Number of displays 1 (2) 2 One 5.1" LCD 2
Digital UA Yes Yes Yes Yes
Alarms Yes Yes Yes Yes
High/low FHR Yes/yes, adjustable delay Yes/yes, adjustable delay Yes/yes Yes/yes, adjustable delay
Other alarms Yes Yes Yes Yes

This is the first of two


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model(s). These
specifications continue
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ECRI. All Rights Reserved.


30
Fetal Monitors

Product Comparison Chart


MODEL PHILIPS PHILIPS PHILIPS PHILIPS
M 1351A Antepartum M 1353A Intrapartum M 2922A Antepartum FM- M1350B Intrapartum
Series 50 A Series 50 IP-2 2 portable Series 50 XM
RECORDER Not specified Not specified M2925A external recorder Not specified
Channels 5 (FHR1/2, UA, FMP, 5 (FHR1, FHR2/MHR, UA, 3 (FHR1/2, UA) 8 (FHR1/2, MHR, UA,
external FSpO2) FMP, external FSpO2) FMP, FSpO2, external)
Paper speed, cm/min 1, 2, 3, selectable 1, 2, 3, selectable 1, 2, 3, selectable 1, 2, 3, selectable; paper
save with NIBP
Vertical scale, bpm/cm 30, optional 20 30, optional 20 30 or 20 30, optional 20
Record height
FHR trace, cm 7 or 8 7 or 8 7 or 8 7 or 8
UA trace, cm 4 4 4 4
Event marker Yes Yes Internal and external Yes
Annotations Time, date, speed, mode, Time, date, speed, mode, Time, date, speed, mode, Time, date, speed, mode,
maternal NIBP, notes maternal NIBP, notes patient ID (monitor SN maternal NIBP, maternal
and software revision) SpO2, notes
Remote recording No No Yes No
Record storage No No Yes No
Number of hr NA NA 12, nonvolatile memory NA
H x W x D, cm (in) 12.7 x 35.6 x 30.5 (5 x 14 12.7 x 35.6 x 30.5 (5 x 14 15.2 x 26.4 x 13.7 (6 x 15.2 x 43.2 x 38.1 (6 x 17
x 12) x 12) 10.4 x 5.4) x 15)
WEIGHT, kg (lb) 5.9 (13) 5.9 (13) 2.27 (5.4) 12.7 (28)
LINE POWER, VAC 110/120, 220/240 110/120, 220/240 110/120, 220/240V via 110-240
external supply
BATTERY, TYPE Not specified Not specified Not specified NA
Operating time, hr Not specified Not specified 2 minimum with fully Not specified
charged battery
Rechargeable Not specified Not specified Yes Not specified
Recharge time, hr Not specified Not specified 14 maximum Not specified
Low-battery notice Not specified Not specified Yes, charge indicator and Not specified
tone
PLANNING &
PURCHASE
List price $4,310; $5,450 $7,400-7,950 $4,100-4,550 $12,560-15,150
Year first sold 1992 2002 2001 1995
Warranty 5 years (monitor) 1 year 1 year 1 year
Fiscal year January to December January to December January to December January to December
OTHER Watertight transducers; Watertight transducers; 5.1" LCD for onscreen Watertight transducers;
SPECIFICATIONS Fetal Movement Profile Fetal Movement Profile fetal trace viewing; 15 Fetal Movement Profile
auto detects fetal auto detects fetal bpm separated grid lines auto detects fetal
movements; Performance movements; Performance for NST assessment; movements; Performance
PLUS US signal PLUS US signal connects to off-the-shelf PLUS US signal
processing; cross-channel processing; cross-channel Hewlett Packard InkJet processing; cross-channel
verification avoids picking verification avoids picking printer; watertight verification avoids picking
up 1 FHR with both US up 1 FHR with both US transducers; AC and up 1 FHR with both US
transducers or the MHR transducers; selectable battery operated; transducers or the MHR
with the US transducer; offset on twin FHR; transmits stored traces to with the US transducer;
selectable offset on twin optional bar-code reader, a stand-alone Windows selectable offset on twin
FHR; optional bar-code interface to GE DINAMAP PC or surveillance FHR; Nellcor interface to
reader, interface to GE NIBP, and Colin BP; system, either directly or FSpO2; optional bar-code
DINAMAP NIBP, and optional bar-code reader, via modem. reader, interface to other
Colin BP; optional bar- interface to other monitors, and BP and
code reader, interface to monitors, and BP and MSpO2.
other monitors, and BP MSpO2.
and MSpO2.
Supplier Footnotes
Model Footnotes
1
Data Footnotes Avalon CTS Cordless
Fetal Transducer System
for cordless monitoring of
FHR and UA

ECRI. All Rights Reserved.


31
Fetal Monitors

Product Comparison Chart


MODEL PHILIPS SPACELABS MEDICAL SPACELABS MEDICAL SPACELABS MEDICAL
M1350C Intrapartum AMS-02-6701/02 AMS-02-7700 MOM (Maternal
Series 50 XMO Obstetrical Monitor)
WHERE MARKETED Worldwide, except Japan Worldwide Worldwide, except USA Worldwide
and USA
FDA CLEARANCE No Yes Yes Yes
CE MARK (MDD) Yes Yes Yes Yes
ANTEPARTUM/INTRAPARTUM Intrapartum Antepartum Intrapartum Both
Ultrasound
Type/frequency, MHz Pulsed Doppler/0.9984 Pulsed Doppler/1.024 Pulsed Doppler/1.024 Pulsed Doppler/1.024
(FHR1), 1.068 (FHR2) (FHR1), 1.068 (FHR2) (FHR1), 1.068 (FHR2)
Intensity, mW/cm2 <1.5/0.25-0.5 <15 (peak) <15 (peak) <7 (peak), 2 average
Special processing Autocorrelation with Autocorrelation Autocorrelation Autocorrelation
precision track-and-hold
FHR range, bpm 30-240, beat-to-beat 50-216 50-216 50-210
Fetal ECG/SpO2 Yes/yes, integrated No/no Yes/yes Yes/yes
FSpO2 parameter
FHR range, bpm 30-240 (internally up to NA 30-300, heart rate to 300 30-300, heart rate to 300
300) bpm on digital display, bpm on digital display,
paper changes to half rate paper changes to half rate
with indicator with indicator
Uterine activity Yes Yes Yes Yes
External/internal Yes/yes Yes/no Yes/yes Yes/yes
Reference/zero controls Push button Push button with auto Push button with auto Touch panel with auto
rezero (external only) rezero (external only) rezero (external only)
Twins or MHR/FHR Invasive or noninvasive Optional twins (US/US) Twins (US/US, ECG, Twins (US/US, ECG,
combination ECG/US) ECG/US)
Maternal ECG/NIBP/SpO2 Yes/yes/yes, integrated No/yes/yes Yes/yes/yes Yes/yes/yes
OUTPUT SIGNALS
Analog All FHR, MHR, UA Yes (FHR1, FHR2, UA Yes (FHR1, FHR2, UA, Yes (FHR1, FHR2, UA)
optional) ECG optional)
Digital All FHR, MHR, UA, FMP, Optional Yes Optional (FHR1, FHR2,
NIBP, maternal SpO2, US)
FSpO2, annotations
Calibration, FHR/UA Yes/yes Yes/yes Yes/yes Yes/yes
Integral signal simulation Yes, test mode No No Yes
Computer interface Standard RS232; optional RS485, optional RS232 RS485, optional RS232 RS485, RS232
RS422, analog
Telemetry features FHR (external/internal), None None None
UA (external/internal),
FMP, marker, nurse call
DISPLAY FEATURES
Digital FHR Dual Yes (FHR1, FHR2) Yes (FHR1, FHR2) Yes (FHR1, FHR2)
Number of displays 2 2 2 2
Digital UA Yes Yes Yes Yes
Alarms Yes Yes Yes Yes
High/low FHR Yes/yes, adjustable delay Yes/yes, high-FHR alarm Yes/yes, high-FHR alarm Yes/yes, high-FHR alarm
preset at 170 bpm, low- preset at 170 bpm, low- preset at 170 bpm, low-
FHR alarm is adjustable FHR alarm is adjustable FHR alarm is adjustable
with pattern recognition with pattern recognition with pattern recognition
and only activates when and only activates when and only activates when
the FHR deviates from a the FHR deviates from a the FHR deviates from a
certain pattern certain pattern certain pattern
Other alarms Yes None None Maternal HR, SPO2, NIBP

This is the first of two


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model(s). These
specifications continue
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32
Fetal Monitors

Product Comparison Chart


MODEL PHILIPS SPACELABS MEDICAL SPACELABS MEDICAL SPACELABS MEDICAL
M1350C Intrapartum AMS-02-6701/02 AMS-02-7700 MOM (Maternal
Series 50 XMO Obstetrical Monitor)
RECORDER Not specified Thermal array Thermal array Thermal array
Channels 8 (FHR1/2, MHR, UA, 4, plus alphanumeric 6, plus alphanumeric Multiple, plus
FMP, FSpO2, external) alphanumeric
Paper speed, cm/min 1, 2, 3, selectable; paper 1, 2, 3 1, 2, 3 1, 2, 3
save with NIBP
Vertical scale, bpm/cm 30, optional 20 20 or 30 20 or 30 30 and/or 20
Record height
FHR trace, cm 7 or 8 7 7 7
UA trace, cm 4 4 4 4
Event marker Yes Yes Yes Yes
Annotations Time, date, speed, mode, Time, date, mode, paper Time, date, mode, paper Time, date, mode, paper
maternal NIBP, maternal speed, optional annotation speed, optional speed, optional
SpO2, notes annotation, variability plot parameters depending on
user selection
Remote recording No No No Optional
Record storage No Yes Yes Yes
Number of hr NA 1 1 1
H x W x D, cm (in) 15.2 x 43.2 x 38.1 (6 x 17 19.7 x 36.8 x 31.1 (7.8 x 19.7 x 36.8 x 31.1 (7.8 x 29.5 x 30.2 x 23.6 (11.6 x
x 15) 14.5 x 12.3) 14.5 x 12.3) 11.9 x 9.3)
WEIGHT, kg (lb) 13 (28.7) 6.1 (13.5) 6.1 (13.5) 10.5 (23.3)
LINE POWER, VAC 110/120, 220/240 100-120, 220-240 100-120, 220-240 100-120, 220-240
BATTERY, TYPE Not specified None None None
Operating time, hr Not specified NA NA NA
Rechargeable Not specified NA NA NA
Recharge time, hr Not specified NA NA NA
Low-battery notice Not specified NA NA NA
PLANNING &
PURCHASE
List price $18,600-23,000 Not specified Not specified Not specified
Year first sold 1998 Not specified Not specified 2000
Warranty 1 year 1 year 1 year 1 year
Fiscal year January to December January to December January to December January to December
OTHER Integrated FSpO2 Chart paper annotation Chart paper annotation Fetal monitor network plus
SPECIFICATIONS parameter licensed by from clinical information from clinical information Mermaid wireless
Nellcor; watertight system; computer system; computer communication; SpO2
transducers; Fetal interface to all central interface to all central interfaces; maternal vital
Movement Profile auto surveillance and OB surveillance and OB signs recorder; interactive
detects fetal movements; management systems; management systems; network functions (remote
Performance PLUS US paper-out memory (60 paper-out memory (60 view, alarm watch); data
signal processing; cross- min) for FHR1, FHR2, and min) for FHR1, FHR2, and shuttle; up to 5 waveforms
channel verification avoids UA; optional interface to UA; SpO2 interfaces on display.
picking up 1 FHR with physiologic monitors, dual (graphic plot); optional
both US transducers or US frequencies, Mermaid interface to physiologic
the MHR with the US wireless communication, monitors, dual US
transducer; selectable and maternal NIBP and frequencies, Mermaid
offset on twin FHR; SpO2; adjustable toco wireless communication,
Nellcor maternal SpO2; sensitivity. maternal
optional bar-code reader, NIBP/SpO2/ECG, and
interface to other ECG/HR variability plots.
monitors, and BP and
MSpO2.
Supplier Footnotes
Model Footnotes
Data Footnotes

ECRI. All Rights Reserved.


33
Fetal Monitors

Product Comparison Chart


MODEL TOITU TOITU TOITU TOITU
Multiple Fetus Antepartum Multiple Fetus Antepartum Multiple Fetus Intrapartum Single Fetus Antepartum
MT-430A MT-516 MT-430 MT-325
WHERE MARKETED North America Worldwide Worldwide Worldwide
FDA CLEARANCE Yes Yes Yes Yes
CE MARK (MDD) Not specified Not specified Not specified Not specified
ANTEPARTUM/INTRAPARTUM Antepartum Antepartum Intrapartum Antepartum
Ultrasound
Type/frequency, MHz Pulsed Doppler/1.1 Pulsed Doppler/1.1 Pulsed Doppler/1.1 Pulsed Doppler/1.1
Intensity, mW/cm2 <1.5 <1.5 <1.5 <1.5
Special processing Autocorrelation Autocorrelation Autocorrelation Autocorrelation
FHR range, bpm 50-212 50-210 50-212 50-210
Fetal ECG/SpO2 No/not specified No/not specified Autocorrelation/not No/not specified
specified
FHR range, bpm 50-210 50-210 50-210 50-210
Uterine activity Yes Yes Yes Yes
External/internal Yes/no Yes/no Yes/yes Yes/no
Reference/zero controls Push button Push button Push button Push button
Twins or MHR/FHR Dual noninvasive Dual noninvasive US/US, US/DECG, triplets No/no
(2 US, 1 ECG),
US/MECG, US/US/MECG
Maternal ECG/NIBP/SpO2 No/no/no No/no/no No/no/no No/no/no
OUTPUT SIGNALS
Analog ECG, FHR, UA, Doppler ECG, FHR, UA, Doppler FHR1/2, UA, ECG, FM1/2 ECG, FHR, UA, Doppler
sound, fetal movement sound, fetal movement sound, fetal movement
spike spike spike
Digital Alarm Alarm Alarm Alarm
Calibration, FHR/UA Yes/yes Yes/yes, automatic Yes/yes Yes/yes, automatic
Integral signal simulation No No No No
Computer interface Optional RS232 Optional RS232 Optional RS232 Optional RS232
Telemetry features None Outside USA None None
DISPLAY FEATURES
Digital FHR Yes Yes Yes Yes
Number of displays 2 2 2 1
Digital UA Bar graph Digital reading Bar graph No
Alarms Yes Yes Yes Yes
High/low FHR Dual Yes/yes Dual Yes/yes
Other alarms Paper Paper Paper Paper

This is the first of two


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model(s). These
specifications continue
onto the next page.

ECRI. All Rights Reserved.


34
Fetal Monitors

Product Comparison Chart


MODEL TOITU TOITU TOITU TOITU
Multiple Fetus Antepartum Multiple Fetus Antepartum Multiple Fetus Intrapartum Single Fetus Antepartum
MT-430A MT-516 MT-430 MT-325
RECORDER Linear thermal array Thermal printer by line Linear thermal array Thermal pen
thermal head
Channels 6 6 6 2
Paper speed, cm/min 1, 2, 3 1, 2, 3 1, 2, 3 1, 2, 3
Vertical scale, bpm/cm 30 (20 optional) 30 (20 optional) 30 (20 optional) 30 (20 optional)
Record height
FHR trace, cm 7; 8 optional 7; 8 optional 7; 8 optional 7; 8 optional
UA trace, cm 4 4 4 4
Event marker Dual Dual Dual Yes
Annotations Paper speed, date, time, Paper speed, date, time, Paper speed, date, time, Paper speed, date, time,
mode, institution, dual FM mode, calibration, FM dot mode, institution, dual FM mode, calibration, FM dot
dot mark, UC adjust/high- mark, UC adjust, minute dot mark, UC adjust/high- mark, UC adjust, minute
low, minute mark mark low, minute mark mark
Remote recording Via rear connector Via rear connector Via rear connector Via rear connector
Record storage
Number of hr No No NA NA
H x W x D, cm (in) 20.3 x 24.1 x 35.6 (8 x 9.5 24 x 25 x 20 (9.4 x 9.8 x 20.3 x 24.1 x 35.6 (8 x 9.5 21.6 x 20.3 x 24.1 (8.5 x 8
x 14) 7.9) x 14) x 9.5)
WEIGHT, kg (lb) 9.1 (20) 4.5 (9.9) 9.1 (20) 4.5 (10)
LINE POWER, VAC 100-120, 220-240 100-120, 220-240 100-120, 220-240 100-120, 220-240
BATTERY, TYPE None None None None
Operating time, hr NA NA NA NA
Rechargeable NA NA NA NA
Recharge time, hr NA NA NA NA
Low-battery notice NA NA NA NA
PLANNING &
PURCHASE
List price $8,500, includes all $6,500, includes all $11,475, includes all $5,400, includes all
transducers and transducers and transducers and transducers and
accessories accessories accessories accessories
Year first sold Not specified 2003 Not specified Not specified
Warranty 1 year, includes all 1 year, includes all 1 year, includes all 1 year, includes all
transducers transducers transducers transducers
Fiscal year January to December January to December January to December January to December
OTHER Fetal movement detection; Fetal movement detection; Fetal movement detection; Fetal movement detection;
SPECIFICATIONS recording in spike recording in spike recording in spike recording in spike
waveform for both fetuses waveform for both fetuses waveform for both fetuses waveform. Meets
concurrent with dual FHR; concurrent with dual FHR; concurrent with dual FHR; requirements of IEC 601-
double Doppler; single- double Doppler; single- double Doppler; single- 1.
fetus mode; selectably- fetus mode; selectably- fetus mode; selectably-
sensitive toco transducer. sensitive toco transducer. sensitive toco transducer.
Meets requirements of Meets requirements of Meets requirements of
IEC 601-1. IEC 601-1. IEC 601-1.
Supplier Footnotes
Model Footnotes
Data Footnotes

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35
Fetal Monitors

Product Comparison Chart


MODEL TOITU ULTRASOUND ULTRASOUND ULTRASOUND
TECHNOLOGIES TECHNOLOGIES TECHNOLOGIES
Single Fetus Antepartum FETATRACK 310 FETATRACK 360 PFM1
MT-332
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide
FDA CLEARANCE Yes Not specified Not specified Not specified
CE MARK (MDD) Not specified Yes Yes Yes
ANTEPARTUM/INTRAPARTUM Antepartum Antepartum Both Antepartum
Ultrasound
Type/frequency, MHz Pulsed Doppler/1.1 Continuous/2.1 and 1.8 Continuous/2.1 and 1.8 Continuous/2.1 and 1.8
Intensity, mW/cm2 <1.5 <20 <20 <20
Special processing Autocorrelation Autocorrelation Autocorrelation Autocorrelation
FHR range, bpm 50-212 50-240 30-240 50-240
Fetal ECG/SpO2 Autocorrelation/not No/not specified Yes/not specified No/no
specified
FHR range, bpm 50-212 NA 30-240 NA
Uterine activity Yes Yes Yes Yes
External/internal Yes/yes Yes/no Yes/yes Yes/no
Reference/zero controls Push button Push button with auto Push button with auto Push button with auto
rezero rezero (external only) rezero
Twins or MHR/FHR No/no Yes/no Yes/yes Yes/no
Maternal ECG/NIBP/SpO2 No/no/no No/no/no Yes/no/yes No/no/no
OUTPUT SIGNALS
Analog FHR, UA, ECG, fetal US, UA US, UA US, UA
movement spike, Doppler
sound
Digital Alarm US, UA US, UA, ECG, IU US, UA
Calibration, FHR/UA Yes/yes Yes/yes Yes/yes Yes/yes
Integral signal simulation No No No No
Computer interface Optional RS232 RS232 RS232 RS232
Telemetry features Outside USA None None None
DISPLAY FEATURES
Digital FHR Yes Yes Yes Yes
Number of displays 1 2 2 2
Digital UA Bar graph Yes Yes Yes
Alarms Yes Yes Yes Yes
High/low FHR Yes/yes Yes/yes Yes/yes Yes/yes
Other alarms Paper Bradycardia, tachycardia Bradycardia, tachycardia Bradycardia, tachycardia

This is the first of two


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model(s). These
specifications continue
onto the next page.

ECRI. All Rights Reserved.


36
Fetal Monitors

Product Comparison Chart


MODEL TOITU ULTRASOUND ULTRASOUND ULTRASOUND
TECHNOLOGIES TECHNOLOGIES TECHNOLOGIES
Single Fetus Antepartum FETATRACK 310 FETATRACK 360 PFM1
MT-332
RECORDER Optional thermal array Thermal array Thermal array Thermal array
Channels 2 3 4 3
Paper speed, cm/min 1, 2, 3 1, 2, 3 1, 2, 3 1, 2, 3
Vertical scale, bpm/cm 30 (20 optional) 20, 30 20, 30 20, 30
Record height
FHR trace, cm 7; 8 optional 7.5 8 7.5
UA trace, cm 4 2 3.5 2
Event marker Yes Yes Yes Yes
Annotations Paper speed, date, time, Time, date, FHR mode, Time, date, FHR mode, Time, date, FHR mode,
mode, institution, FM dot transducers, paper speed, transducers, paper speed, transducers, paper speed,
mark, UC adjust/high-low, alarm state alarm state alarm state
minute mark
Remote recording Via rear connector No No No
Record storage
Number of hr No Not specified 2, memory backup Not specified
H x W x D, cm (in) 20.3 x 24.1 x 35.6 (8 x 9.5 18 x 23 x 27 (7 x 9 x 10.6) 14 x 34 x 39 (5.5 x 13.4 x 12 x 27 x 33 (4.7 x 10.6 x
x 14) 15.4) 13)
WEIGHT, kg (lb) 9.1 (20) 5 (11) 7 (15.4) 6 (13.2)
LINE POWER, VAC 100-120, 220-240 Not specified Not specified 100-130, 200-260
BATTERY, TYPE None Not specified Not specified None
Operating time, hr NA Not specified Not specified NA
Rechargeable NA Not specified Not specified NA
Recharge time, hr NA Not specified Not specified NA
Low-battery notice NA Not specified Not specified NA
PLANNING &
PURCHASE
List price $6,975, includes all $3,800 $7,400 $4,235
transducers and
accessories
Year first sold Not specified 2004 2004 1996
Warranty 1 year, includes all 3 years 3 years 3 years
transducers
Fiscal year January to December January to December January to December January to December
OTHER Fetal movement detection; Complies with IEC 601-1 Complies with IEC 601-1 Complies with IEC 601-1
SPECIFICATIONS recording in spike Class 1 Type B. Class 1 Type B. Class 1 Type B.
waveform. Meets
requirements of IEC 601-
1.
Supplier Footnotes
Model Footnotes
Data Footnotes

ECRI. All Rights Reserved.


37