Fluke Biomedical warrants this instrument against defects in materials and workmanship for one full year from the date of
original purchase. During the warranty period, we will repair or, at our option, replace at no charge a product that proves to
be defective, provided you return the product, shipping prepaid, to Fluke Biomedical. This warranty does not apply if the
product has been damaged by accident or misuse or as the result of service or modification by other than Fluke Biomedical.
IN NO EVENT SHALL FLUKE BIOMEDICAL BE LIABLE FOR CONSEQUENTIAL DAMAGES.
Only serialized products and their accessory items (those products and items bearing a distinct serial number tag) are covered under this one–year warranty. PHYSICAL DAMAGE CAUSED BY MISUSE OR PHYSICAL ABUSE IS NOT COVERED
UNDER THE WARRANTY. Items such as cables and nonserialized modules are not covered under this warranty.
Recalibration of instruments is not covered under the warranty.
This warranty gives you specific legal rights, and you may also have other rights which vary from state to state, province to
province, or country to country. This warranty is limited to repairing the instrument to Fluke Biomedical’s specifications.
Warranty Disclaimer
Should you elect to have your instrument serviced and/or calibrated by someone other than Fluke Biomedical, please be
advised that the original warranty covering your product becomes void when the tamper-resistant Quality Seal is removed or
broken without proper factory authorization. We strongly recommend, therefore, that you send your instrument to Fluke Biomedical for factory service and calibration, especially during the original warranty period.
Notices
All Rights Reserved
Copyright 2006, Fluke Biomedical. No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated into
any language without the written permission of Fluke Biomedical.
Copyright Release
Fluke Biomedical agrees to a limited copyright release that allows you to reproduce manuals and other printed materials for use in service training programs
and other technical publications. If you would like other reproductions or distributions, submit a written request to Fluke Biomedical.
Unpacking and Inspection
Follow standard receiving practices upon receipt of the instrument. Check the shipping carton for damage. If damage is found, stop unpacking the instrument.
Notify the carrier and ask for an agent to be present while the instrument is unpacked. There are no special unpacking instructions, but be careful not to damage the instrument when unpacking it. Inspect the instrument for physical damage such as bent or broken parts, dents, or scratches.
Technical Support
For application support or answers to technical questions, either email techservices@flukebiomedical.com or call 1-800- 648-7952 or 1-425-446-6945.
Claims
Our routine method of shipment is via common carrier, FOB origin. Upon delivery, if physical damage is found, retain all packing materials in their original
condition and contact the carrier immediately to file a claim. If the instrument is delivered in good physical condition but does not operate within specifications, or if there are any other problems not caused by shipping damage, please contact Fluke Biomedical or your local sales representative.
Standard Terms and Conditions
Refunds and Credits
Please note that only serialized products and their accessory items (i.e., products and items bearing a distinct serial number tag) are eligible for
partial refund and/or credit. Nonserialized parts and accessory items (e.g., cables, carrying cases, auxiliary modules, etc.) are not eligible for return or refund. Only products returned within 90 days from the date of original purchase are eligible for refund/credit. In order to receive a partial refund/credit of a product purchase price on a serialized product, the product must not have been damaged by the customer or by the carrier chosen by the customer to return the goods, and the product must be returned complete (meaning with all manuals, cables, accessories, etc.) and in “as new” and resalable condition. Products not returned within 90 days of purchase, or products which are not in “as new” and resalable condition, are not eligible for credit return and
will be returned to the customer. The Return Procedure (see below) must be followed to assure prompt refund/credit.
Restocking Charges
Products returned within 30 days of original purchase are subject to a minimum restocking fee of 15 %. Products returned in excess of 30 days after purchase, but prior to 90 days, are subject to a minimum restocking fee of 20 %. Additional charges for damage and/or missing parts and accessories will be applied to all returns.
Return Procedure
All items being returned (including all warranty-claim shipments) must be sent freight-prepaid to our factory location. When you return an instrument to
Fluke Biomedical, we recommend using United Parcel Service, Federal Express, or Air Parcel Post. We also recommend that you insure your shipment for its
actual replacement cost. Fluke Biomedical will not be responsible for lost shipments or instruments that are received in damaged condition due to improper
packaging or handling.
Use the original carton and packaging material for shipment. If they are not available, we recommend the following guide for repackaging:
Use a double–walled carton of sufficient strength for the weight being shipped.
Use heavy paper or cardboard to protect all instrument surfaces. Use nonabrasive material around all projecting parts.
Use at least four inches of tightly packed, industry-approved, shock-absorbent material around the instrument.
Returns for partial refund/credit:
Every product returned for refund/credit must be accompanied by a Return Material Authorization (RMA) number, obtained from our Order Entry Group at
1-800-648-7952 or 1-425-446-6945.
Repair and calibration:
To find the nearest service center, goto www.flukebiomedical.com/service
In the U.S.A.:
Cleveland Calibration Lab
Tel: 1-800-850-4606
Email: globalcal@flukebiomedical.com
In Europe, Middle East, and Africa:
Eindhoven Calibration Lab
Tel: +31-402-675300
Email: ServiceDesk@fluke.com
In Asia:
Everett Calibration Lab
Tel: +425-446-6945
Email: service.international@fluke.com
or
Certification
This instrument was thoroughly tested and inspected. It was found to meet Fluke Biomedical’s manufacturing specifications when it was shipped from the
factory. Calibration measurements are traceable to the National Institute of Standards and Technology (NIST). Devices for which there are no NIST calibration standards are measured against in-house performance standards using accepted test procedures.
WARNING
Unauthorized user modifications or application beyond the published specifications may result in electrical shock hazards or improper operation. Fluke Biomedical will not be responsible for any injuries sustained due to unauthorized equipment modifications.
Restrictions and Liabilities
Information in this document is subject to change and does not represent a commitment by Fluke Biomedical. Changes made to the information in
this document will be incorporated in new editions of the publication. No responsibility is assumed by Fluke Biomedical for the use or reliability
of software or equipment that is not supplied by Fluke Biomedical, or by its affiliated dealers.
Manufacturing Location
The PS320 Fetal Simulator is manufactured by Fluke Biomedical, Everett WA.
The PS320 Fetal Simulator (hereafter called the
Simulator) is a compact, lightweight, high-performance
simulator for use by trained service technicians in fetal
monitor testing.
Cardiotocographs or Electronic Fetal Monitoring (EFM) is
a diagnostic tool used to identify a fetus at risk for
neurological injury or death. The trained clinician can then
carry out timely and appropriate intervention before the
underlying condition causes irreversible damage. The
goal of EFM is to detect fetal hypoxia at its earliest stage
and to attempt to prevent asphyxia resulting from
prolonged and severe hypoxia.
To gain a better overview of these clinical conditions,
please refer your available clinical references, or as a
suggested source, go to the Family Practice Notebook
website: http://www.fpnotebook.com. This website clearly
explains these clinical terms in Book: Obstetrics, Chapter:
Fetus, Page: Fetus Index.
The Simulator provides comprehensive simulation of fetal
and maternal ECG as well as uterine activity. It can
simulate several fetal parameters, including twins, via
such monitor modes as DECG and ultrasound. The
Simulator offers an easy user interface providing a 2 x 16character LCD display with adjustable contrast.
The Simulator runs on
line operated via a battery eliminator.
indication when the battery is low prior to shutting down. It
also supplies RS-232 two-way data communication to
control Simulator selections.
an internal 9-volt battery or is
It provides an
1
PS320
Users Manual
Safety
WXWarning. Read before using.
To avoid personal injury:
Do not use the Simulator in any
manner not specified in the Users
Manual. Otherwise, the protection
provided by this product may be
impaired.
•Always switch power Off and unplug
the battery eliminator before
cleaning.
•Inspect the product. If the Simulator
appears damaged or appears to
operate in a manner not specified in
the manual, DO NOT CONTINUE
USE. Return the product for service.
•Avoid spilling liquids on the
Simulator; fluid seepage into internal
components creates corrosion and a
potential shock hazard. Do not
operate if there is exposure of
internal components to fluid.
•Do not open this product. There are
no user replaceable parts.
WCaution
Calibrate the Simulator annually. Only
qualified technical personnel should perform
troubleshooting and service procedures on
the Simulator. Do not expose the Simulator
to temperature extremes. Ambient operating
temperatures should remain between 15 and
35 °C. Simulator performance may degrade if
temperatures fluctuate above or below this
range. Clean only with a damp, lint-free cloth,
using a mild detergent; wipe down gently.
Symbol Description
W
X
P
…
~
See Users Manual.
Caution risk of electric shock
Manufacturer’s declaration of product
compliance with applicable EU directives
Battery Eliminator Port
Do not dispose of this product as unsorted
municipal waste. Go to Fluke’s website for
recycling information.
* Contact your local Fluke Biomedical Sales Agent for further details
2462114
Fetal ECG
Primary fetal cardiac activity is presented simultaneously
in both direct/internal scalp-electrode-derived and
indirect/external, ultrasound-derived (US-1) signal
formats. Another indirect/external, ultrasound-derived
(US-2) signal provides secondary fetal cardiac activity for
The US-1 channel also provides the electrical drive signal
to operate the Mechanical Fetal Heart (MFH-1). The
MFH-1 mimics the physical movement of the fetal heart
and tests the indirect/external ultrasound transducer and
the electronic fetal monitor.
either independent "normal" or "twins" simulation.
US-1 .................................................................... Tracks the primary direct fetal activity
US-2 .................................................................... Secondary fetal cardiac activity for either independent “normal” or “twins” simulation.
4
Fetal SimulatorSpecifications
Fetal Patterns
The dynamic fetal ECG patterns listed in Table 1 are
interactive with uterine activities described in Table 2 and
represent a wide range of clinical conditions encountered
during the labor and delivery process. These selections
illustrate the fetal response to the uterine pressure. To
gain a better overview of these clinical conditions, please
refer to your available clinical references, or as a
suggested source, go to the Family Practice Notebook
website: http://www.fpnotebook.com
. This website clearly
explains these clinical terms in Book: Obstetrics, Chapter:
Fetus, Page: Fetus Index.
Table 1. Fetal ECG Patterns
Pattern Description
TREND#1 – TWIN FETAL PATTERNS
NORMAL Normal pattern
TACHYCARDIA Tachycardia pattern
BRADYCARDIA Bradycardia pattern
ARRHYTHMIAS Arrhythmia pattern
LATE DECELERATION Late deceleration
EARLY DECELERATION Early deceleration
MODERATE DECELER. Moderate variable deceleration
ACCELERATION #1 Acceleration wave #1
ACCELERATION #2 Acceleration wave #2
SINUSOIDAL (HIGH) Sinusoidal pattern, large change
SINUSOIDAL (LOW) Sinusoidal pattern, small change
SEVERE VAR. DEC. #1 Severe deceleration wave #1
SEVERE VAR. DEC. #2 Severe deceleration wave #2
PROLONGED DECELER. Prolonged deceleration
BIPHASIC DECELERAT. Biphasic deceleration
5
PS320
Users Manual
Table -1. Fetal ECG Patterns (cont.)
Pattern Description
EXAGGERATED DECELE. Exaggerated deceleration
NON_UNIFORM DECELE. Non-uniform deceleration (2 different shapes)
VAR. DECELERATION (U) Variable deceleration “U” shaped
VAR. DECELER. TACH Variable deceleration with high rate BPM
VAR. DECELER (V) Variable deceleration “V” shaped
VAR. DECEL. (POST) Variable deceleration post exaggerated
VAR. DECELERATION Variable deceleration
DECELER. (POSITION) Variable deceleration with position changes
Refer to Figure 1 and Table 3 for views and descriptions
of Simulator
features.
8
1
Top Panel
Batt. elim.
9V DC
US 2 US 1Toco RS-232
2
OffOn
Left Panel
6
Right Panel
9
78
Figure 1. Controls, Indicators, and Connectors
Front Panel
FETAL SIMULATOR
PS320
MAINSUBSCROLLVIEW
DISPLAY
FETAL
FETAL
MATERNAL
TOCO
5 µV40 µV
AMPL.
ENTER
FETAL
MAT.AMPL.MAT.
TOCO
LCDLCD
3
4
5
4
ebv001f.eps
Fetal SimulatorControls, Indicators, and Connectors
Table 3. Controls, Indicators, and Connectors
Item Name Description
A Battery Eliminator
Connection
For use in operating the Simulator from any standard electrical outlet. To ensure safe
operation, use only the Fluke Biomedical Battery Eliminator (PN 2647372).
WXWarning
Caution risk of electric shock, use only the battery eliminator specified
in this manual or the protection provided may be impaired.
B Power Switch Switches the power On and Off.
C LCD Display 15 mm x 60 mm (0.58 in. x 2.37 in.) window displaying up to two lines of 20-point font.
D
9
Control Keys
ENTER Enters the selected code line value into memory.
MAIN Selects the main headings or groupings.
SUB Selects the functions within the main menu.
SCROLL Scrolls selections back whether within the main menu or sub menu.
VIEW Pressing VIEW scrolls through the currently active functions.
LCD / LCD Changes the contrast of the display.
PS320
Users Manual
Table 3. Controls, Indicators, and Connectors (cont.)
Item Name Description
E
Soft Keys These keys provide one-step selection of Simulator functions.
FETAL / FETAL Scrolls through available fetal heart rate parameters.
MAT. / MAT. Scrolls through available maternal heart rate parameters.
AMPL Scrolls through available amplitude parameters.
TOCO Scrolls through available TOCO parameters.
5 μV Selects sensitivity of 5 μV.
40 μV Selects sensitivity of 40 μV.
F ECG Connectors
10
Five snap and multi-banana connectors for ECG output, allowing for connection to
any ECG. These labeled terminals and on the left side panel. Labels and their
definitions are as follows:
Label Definition
Fetal Fetal ECG signal
Fet/Mat Fetal and Maternal ECG signal. Fetal signal is approximately ½ of the
maternal amplitude selected.
Fetal SimulatorPowering the Simulator
Table 3. Controls, Indicators, and Connectors (cont.)
Item Name Description
Maternal Maternal ECG signal F ECG Connectors
Reference Ground reference lead
G RS-232 6-pin mini-DIN plug connector for the serial connection.
H Toco 6-pin mini-DIN connector for the Toco signal cable.
I US 1 & US 2 8-pin mini-DIN plug connector for ultrasound cable plugs.
Powering the Simulator
The Simulator uses a 9-V alkaline battery. When it
detects less than about 5.6 volts, it goes into a shutdown
mode, sounds a continuous tone alarm, and displays the
following message:
The battery resides in the base of the instrument. Use a
9-volt alkaline battery (Duracell
Do not use mercury, air, or carbon-zinc batteries.
®
MN1604 or equivalent).
W Warning
The 9-volt alkaline battery provided with the
Simulator may explode or leak if recharged,
inserted improperly, or disposed of in a fire.
Dispose of the battery in accordance with
any applicable state or local regulations.
11
PS320
Users Manual
As an alternative to a battery, you can power the
Simulator with the supplied battery eliminator. Use only
the Fluke Biomedical Battery Eliminator (PN 2647372) to
ensure safe operation.
WXWarning
Caution risk of electric shock, use only the
battery eliminator specified in this manual or
the protection provided may be impaired.
Note
Remove the 9-V battery and disconnect the
Battery Eliminator if you do not intend to use the
Simulator for an extended period.
You must use the Battery Eliminator when using the
Mechanical Fetal Heart (MFH-1).
Operating the Simulator
Connect the Simulator to the device-under-test. First,
connect the ECG leads. The active lead goes on the
Fetal, Fet/Mat, or Maternal points as appropriate. The
reference lead connects to the reference point.
1. Switch the Simulator On. The LCD window displays
the program version for about two seconds. The
window then displays the default code entry display.
2. Use the keypad to increase or decrease fetal ECG
rate and amplitude, increase or decrease maternal
ECG rate and amplitude, select TOCO level and
amplitude, and adjust display contrast. Then press
ENTER.
3. To select a simulation, repeatedly press MAIN to
select FETAL ECG, MATERNAL ECG, UTERINE
ACTIVITY, FETAL PATTERNS, or AUXILIARY. Then
press SUB to access the next level of available
selections. Press SCROLL to move through these
selections. Press ENTER to activate the selection.
4. At any point, you can view the Simulator’s current
parameter settings by pressing VIEW. Repeatedly
press VIEW to scroll through all of the settings.
Note
Only use the ENTER key when scrolling through
the current settings. Using a menu scroll or
change key interrupts the scrolling operation.
12
Fetal SimulatorOperating the MFH-1
5. The first parameter setting is “TOCO=00 5µV”.
Thereafter, each time you press VIEW, current
settings appear in the following sequence:
TOCO=00 5µV
MAT SENS. @ 1mV
FET SENS. @ 1mV
US1=150 US2=NORM
FETHR=150 STATIC
MATERNAL HR=100
Operating the MFH-1
The Mechanical Fetal Heart (MFH-1) is an accessory to
the Simulator. Connect the MFH-1 to the US 1 port on the
Simulator via the cable supplied with the MFH-1. Set the
rate and rhythm of the mechanical heart by adjusting the
US 1 output on the Simulator. For the MFH-1 to function,
you must power the Simulator through the Battery
Eliminator. The MFH-1 will not function on battery power.
Place the ultrasound transducer face up on your work
surface and coat it with an appropriate ultrasound
conductive gel. The MFH-1 outputs the mechanical signal
via the simulation window. Place this window over each
transducer crystal in turn to verify each crystal’s function.
See Figure 2.
THIS SIDE UP
MFH-1
FOR USE WITH PS320
MECHANICAL
FETAL HEART
PROBE
SIMULATION POINT
Ultrasound Transducer
Connected to US 1
output on PS320
Gel applied between
transducer and
mechanical heart
ebv002f.eps
Figure 2. Mechanical Fetal Heart (MFH-1)
When you are finished, clean the MFH-1 with normal
soap and water, and then dry.
13
PS320
Users Manual
Simulating Functions
Refer to Table 4 for a list of simulating functions. An
arrow indicates a main menu grouping of selections. An
asterisk (*) indicates a sub menu selection.
Table 4. Simulating Functions
Main Menu Sub Menu Function
→FETAL ECG
14
∗FETAL RATE +30 Increases fetal rate up by 30 bpm
*FETAL RATE -30 Decreases fetal rate up by 30 bpm
*FET SEN. 50μV Sets fetal ECG amplitude to 50 μV
*FET SEN. 100μV Sets fetal ECG amplitude to 100 μV
*FET SEN. 200μV Sets fetal ECG amplitude to 200 μV
*FET SEN. 0.5mV Sets fetal ECG amplitude to 0.5 mV
*FET SEN. 1 mV Sets fetal ECG amplitude to 1 mV
*FET SEN. 2 mV Sets fetal ECG amplitude to 2 mV
Fetal SimulatorSimulating Functions
Table 4. Simulating Functions (cont.)
Main Menu Sub Menu Function
→MATERNAL ECG
→UTERINE ACTIVITY
*MAT SEN. 0.5mV Sets maternal ECG amplitude to 0.5 mV
*MAT SEN. 1 mV Sets maternal ECG amplitude to 1 mV
*MAT SEN. 2 mV Sets maternal ECG amplitude to 2 mV
*MAT RATE +20 Increases maternal rate by 20 bpm
*MAT RATE –20 Decreases maternal rate by 20 bpm
*SENS @ 5μV mmHg Sets pressure sensitivity to 5 μV
*SENS @40μV mmHg Sets pressure sensitivity to 40 μV
*UTERINE LVL =0 Sets uterine level to 0 (zero)
*ANALOG TO +1 V Sets analog uterine output from 0 to +1V. 1V=100 mmHg
*ANALOG TO –1V Sets analog uterine output from 0 to –1V. -1V = 100 mmHg
*UTERINE STATIC Sets uterine output in steps of 20 mmHg
*EXECUTE TOCO WA Starts a TOCO wave, not valid during trend selection
*UTERINE WVF OFF Stops TOCO wave, not valid during trend selection
*UTERINE WV 0-25 Sets standard TOCO wave from 0 to 25 units
15
PS320
Users Manual
Main Menu Sub Menu Function
Table 4. Simulating Functions (cont.)
→UTERINE ACTIVITY
→FETAL PATTERNS
16
*UTERINE WV 0-50 Sets standard TOCO wave from 0 to 50 units
*UTERINE WV 0-100 Sets standard TOCO wave from 0 to 100 units
*SHORT DURATION Selects short duration TOCO waveform, not valid during trend
*NORMAL DURATION Selects norm duration TOCO waveform, not valid during trend
*INCREASED DURAT Selects long duration TOCO waveform, not valid during trend
*TRIPLING Selects tripling TOCO waveform, not valid during trend
*INCR. REST TONE Selects TOCO waveform with increased baseline level, not valid
during trend
*COUPLING Selects coupling TOCO waveform, not valid during trend
*TRIPLING Selects tripling TOCO waveform, not valid during trend
*TREND #1 Selects real patient trend of fetal heart rate and TOCO, other
TOCO selections not valid during this selection
*NORMAL Selects normal pattern
*BRADYCARDIA Selects bradycardia pattern
*TACHYCARDIA Selects tachycardia pattern
Fetal SimulatorSimulating Functions
Table 4. Simulating Functions (cont.)
Main Menu Sub Menu Function
→FETAL PATTERNS
*ARRHYTHMIAS Selects arrhythmia pattern
*LATE DECELERATI Selects late deceleration pattern
*EARLY DECELERAT Selects early deceleration pattern