Fetal Monitors
Fetal Monitors
Fetal Monitors
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
The Healthcare Product Comparison System (HPCS) is published by ECRI, a nonprofit health
services research agency established in 1955. HPCS provides comprehensive information to help
healthcare professionals select and purchase diagnostic and therapeutic capital equipment more
effectively in support of improved patient care.
The information in Product Comparisons comes from a number of sources: medical and biomedical
engineering literature, correspondence and discussion with manufacturers and distributors,
specifications from product literature, and ECRIs Problem Reporting System. While these data are
reviewed by qualified health professionals, they have not been tested by ECRIs clinical and
engineering personnel and are largely unconfirmed. The Healthcare Product Comparison System and
ECRI are not responsible for the quality or validity of information derived from outside sources or for
any adverse consequences of acting on such information.
The appearance or listing of any item, or the use of a photograph thereof, in the Healthcare
Product Comparison System does not constitute the endorsement or approval of the products
quality, performance, or value, or of claims made for it by the manufacturer. The information and
photographs published in Product Comparisons appear at no charge to manufacturers.
Many of the words or model descriptions appearing in the Healthcare Product Comparison System
are proprietary names (e.g., trademarks), even though no reference to this fact may be made. The
appearance of any name without designation as proprietary should not be regarded as a
representation that is not the subject of proprietary rights.
ECRI respects and is impartial to all ethical medical device companies and practices. The
Healthcare Product Comparison System accepts no advertising and has no obligations to any
commercial interests. ECRI and its employees accept no royalties, gifts, finders fees, or commissions
from the medical device industry, nor do they own stock in medical device companies. Employees
engage in no private consulting work for the medical device industry.
About ECRI
ECRI (formerly the Emergency Care Research Institute) is a nonprofit health services research
agency. Its mission is to improve the safety, quality, and cost-effectiveness of healthcare. It is widely
recognized as one of the worlds leading independent organizations committed to advancing the
quality of healthcare.
ECRIs focus is healthcare technology, healthcare risk and quality management, and healthcare
environmental management. It provides information services and technical assistance to more than
5,000 hospitals, healthcare organizations, ministries of health, government and planning agencies,
voluntary-sector organizations, associations, and accrediting agencies worldwide. Its more than 30
databases, publications, information services, and technical assistance services set the standard for
the healthcare community.
ECRIs services alert readers to technology-related hazards; disseminate the results of medical
product evaluations and technology assessments; provide expert advice on technology acquisitions,
staffing, and management; report on hazardous materials management policy and practices; and
supply authoritative information on risk control in healthcare facilities and clinical practice
guidelines and standards.
September 2005
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.
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
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).
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.
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
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
Bozki Z. Instruments & methods: digital communication with fetal monitors. Obstet Gynecol 1997
Nov;90(5):837-9.
Dassel AC, Graaff R, Aardema M, et al. Effect of location of the sensor on reflectance pulse oximetry.
Br J Obstet Gynaecol 1997 Aug;104(8):910-6.
Devoe L, Boehm F, Paul R, et al. Clinical experience with the Hewlett-Packard M-1350A fetal
monitor: correlation of Doppler-detected fetal body movements with fetal heart rate parameters and
perinatal outcome. Am J Obstet Gynecol 1994 Feb;170(2):650-5.
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.
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.
Kovcs F, Trk M. An instrument using parallel filtering of acoustic signals to record fetal heart
rate. Biomed Instrum Technol 1995 May-Jun:29(3):213-9.
Liston R, Crane J, Hughes O, et al. Fetal health surveillance in labour. J Obstet Gynaecol Can 2002
Apr;24(4):342-55.
Lurie S, Weissman A, Blumberg G, et al. Fetal oximetry monitoring: a new wonder or another
mirage? Obstet Gynecol Surv 1996 Aug;51(8):498-502.
Mannheimer PD, Casciani JR, Fein ME, et al. Wavelength selection for low-saturation pulse
oximetry. IEEE Trans Biomed Eng 1997 Mar;44(3):148-58.
Mannheimer PD, Fein ME, Casciani JR. Physio-optical considerations in the design of fetal pulse
oximetry sensors. Eur J Obstet Gynecol Reprod Biol 1997 Mar;72(Suppl):S9-19.
Miesnik SR, Stringer M. Technology in the birthing room. Nurs Clin North Am 2002 Dec;37(4):781-
93.
Nijland R, Nierlich S, Jongsma HW, et al. Validation of reflectance pulse oximetry: an evaluation of
a new sensor in piglets. J Clin Monit 1997 Jan;13(1):43-9.
Simpson KR. Monitoring the preterm fetus during labor. MCN Am J Matern Child Nurs 2004 Nov-
Dec;29(6):380-8.
Yamakoshi Y, Shimizu T, Shinozuka N, et al. Automated fetal breathing movement detection from
internal small displacement measurement. Biomed Tech (Berl) 1996 Sep;41(9):242-7.
Zottoli EK, Wood C. The fundamentals of electronic fetal monitoring. Biomed Instrum Technol 2003
Sep-Oct;37(5):353-8.
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.
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.
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
D-65205 Wiesbaden
Germany
Phone: 49 (6122) 9370 Fax: 49 (6122) 937100
Internet: http://www.oxford-instruments.com
E-mail: info@oxford.de
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
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.