Ultrasound Technologies PFM1 User manual

Operating Manual
PFM1
Fetal Monitor
Ultrasound Technologies Ltd Foresters House, Itton, Chepstow, Gwent. NP6 6BZ U.K.
Telephone [phone] Fax [phone]

Contents
PFM1OpManualIssue5
About This Manual.......................................................................................................... 1
Safety In Use ................................................................................................................... 2
Special Precautions...........................................................................................................................................2
Electrical Shock Hazard ..................................................................................................................................2
Explosion Hazard..............................................................................................................................................2
Handling the Delicate Transducers................................................................................................................3
Symbols Used....................................................................................................................................................3
Parts and Their Functions .............................................................................................. 4
PFM1 Front Panel Controls ............................................................................................................................4
Recorder On/Off.......................................................................................................................................4
Front Panel Event Mark...........................................................................................................................4
Volume Up.................................................................................................................................................4
Volume Down ...........................................................................................................................................4
US1 / US2 Transducer Select.................................................................................................................4
Toco Zero...................................................................................................................................................4
Indicators and Connectors...............................................................................................................................5
’Power On’ Indication..............................................................................................................................5
RS232 Output............................................................................................................................................5
Remote (Patient) Event Marker..............................................................................................................5
Probe Connection......................................................................................................................................5
Operating Procedures..................................................................................................... 6
User Configuration...........................................................................................................................................6
The Printer..........................................................................................................................................................8
Ultrasound Fetal Monitoring...........................................................................................................................9
Uterine Activity Monitoring.........................................................................................................................10
Fetal Activity...................................................................................................................................................10
Interpretation...................................................................................................................................................11
Troubleshooting ............................................................................................................12
No Display Information on LCD.................................................................................................................12
Keyboard Does Not Respond.......................................................................................................................12
No Sound From Loudspeakers.....................................................................................................................12
No FHR Information on Display or Recorder...........................................................................................12
No Chart Printed.............................................................................................................................................12
Maintenance ..................................................................................................................13
General..............................................................................................................................................................13
System Cabinet........................................................................................................................................13
Transducers..............................................................................................................................................13
Specification..................................................................................................................14

About This Manual
PFM1OpManualIssue5 Page 1
This booklet explains the operation and use of the PFM1 Antenatal Cardiotocograph. Care
has been taken during the design and manufacture of this product so that it satisfies all of the
current safety standards set down by BS EN60601
To achieve the best from this product read the following sections several times and if you
have any problems in the operation of a particular part of the product then contact your dealer
immediately or contact :
Ultrasound Technologies Ltd. German Office
Lodge Way, Portskewett Kleinenbroicher Str. 54a
GB-Caldicot NP26 5PS D-41352 Korschenbroich
Phone: [phone] / 425 425 +49 (0) 2161 / 677 194
Fax: [phone] / 427 093 +49 (0) 2161 / 677 195
Email: [email protected] [email protected]
Website: http://www.doppler.co.uk http://www.mydoppler.de
A service manual containing circuit descriptions, diagrams, parts and spares lists is available
for the PFM1 by contacting the address above.
To maintain the PFM1’s performance it is recommended that it be included in a periodic
maintenance program. The user preventative maintenance program is covered in this manual.
Maintenance outside the scope of the user should be undertaken on an annual basis by
trained service personnel; full details are available from your supplier, service centre or from
Ultrasound Technologies Ltd.
The PFM1 is supplied complete with the following: -
PFM1 Single Fetus Monitor PFM1 Twin Fetus Monitor
US1 Monitoring Transducer US1 Monitoring Transducer
External Toco Transducer US2 Monitoring Transducer
Patient Event Marker External Toco Transducer
Belt set (x1) Patient Event Marker
Paper spindle Belt set (x2)
Chart roll (x1) Paper spindle
Power Cord Chart roll (x1)
Operating instructions Power Cord
Doppler size Coupling gel Operating instructions
Doppler size Coupling gel

Safety In Use
PFM1OpManualIssue5 Page 2
Special Precautions
Your PFM1 Antenatal Cardiotocograph has been designed for
electrical safety. All the safety and operating instructions should be
read before operating the PFM1. Failure to do so could result in
injury to the user, patient, or damage to the system and accessories.
Electrical Shock Hazard
lDo not defeat the grounding integrity of this system. Protection against electrical shock,
in the event of failure of basic insulation, is provided by the connection of the chassis to
the safety ground. Safety grounding occurs only when the 3-wire cable and plug provided
with the system are connected to a properly grounded receptacle.
lDo not remove the system cover. The system should be serviced by trained and qualified
personnel only. Contacting the hazardous voltages within the system could cause
serious injury.
lDo not use the system if the power cord has any cuts or openings.
lDo not use the transducer if the cable has any cuts or openings.
lDo not use the transducer if the transducer face is cracked or chipped.
lDo not immerse the transducer cable connectors in any liquids.
lShould the electrical safety fuses have to be replaced, use only fuses of the same type
and rating.
Don not use this device at or close to water deliveries!
Explosion Hazard
Do not operate or use this system in the presence of flammable
anesthetics or gases as it could lead to explosion.

Safety In Use
PFM1OpManualIssue5 Page 3
Handling the Delicate Transducers
The transducers are delicate parts of the ultrasound system and
should be treated with care. The delicate crystals in the transducer
may crack and render the transducer unusable if the transducer is
subject to shock. Room temperature liquids should be used for
cleaning. Never use alcohol or mineral oil as an acoustic coupling
agent as transducer or cable damage could occur.
Symbols Used
The following symbols are used on the PFM1 and are in accordance
with BS EN60601-1-1990.
Where they are associated with the connection of external
equipment, that equipment must meet the relevant safety standards
in all cases.
Alternating current
Associated with power on indicator
Type B Equipment
Unit classification
Off (power: disconnection from the mains)
On (power: connection to the mains)
Attention, consult accompanying documents.
Associated with auxiliary connections see
operating instructions.
Dangerous voltage.
Associated with components internal to the PFM1.

Parts and Their Functions
PFM1OpManualIssue5 Page 4
PFM1 Front Panel Controls
The front panel control area contains 6 buttons used to control the operation
of the unit, they are all indicated by icons to aid language variations.
Recorder On/Off and Speed Change
This button is used to control the operation of the recorder. Press once and
the chart recorder will start, each consecutive short press will change the
speed . Pressing and holding the button down will stop the recording.
Event Mark 1
Places an event mark arrow at the top of the FHR scale .
Volume Up
This button is used to increase the audio volume level, or in configuration
mode to change user options.
Volume Down
This button is used to decrease the
audio volume level, or in configuration
mode to change user operations.
US1 / US1 Transducer Select and Twins trace mode.
Pressing this button changes the selected probe from US1 to US2 for volume
output. This is used when the unit is in twins mode with two US channels for
listening to either of the two fetuses. If this button is held the trace format will
change into two separate traces for twins monitoring, this mode is reset when
the units power is removed.
Toco Zero
This button zeros the Toco trace to the selected baseline.
Recorder On /
Off and speed
control
Event Mark 1.
Places arrow in
upper portion of
chart
Volume Up
Volume Down
Select ultrasound channel
for audio output and twins
split trace.
Toco Zero.
Sets Toco channel
to preset baseline
value.
Mains “ON”
indicator

Parts and Their Functions
PFM1OpManualIssue5 Page 5
Inputs / Outputs and Displays
’Power On’ Indication
The green LED associated with the above symbol indicates that power is
connected to the apparatus when illuminated.
RS232 Output
This output is for the connection of an external computer for data transfer.
The maximum voltage that can be applied to this output is 15VDC.
WARNING: Any external equipment connected to this output must meet the
relevant safety standard.
Remote Event Marker
Connection of an external event mark switch allows the patient to indicate
events by printing an arrow in the gap between the FHR and UA traces. The
maximum voltage that can be applied to this output is 15VDC.
Probe Connections US1, US2, Toco
This is for the connection of approved Doppler and Toco transducers. The
maximum voltage that can be applied to this output is 15VDC.

Operating Procedures
PFM1OpManualIssue5 Page 6
Operating the PFM1
In this section, information is supplied which will help you use the PFM1 for the fist time.
User Configuration
Firstly connect the AC supply cord.
It is necessary to set the operation of the PFM1 to meet your requirements.
Before turning the PFM1 on, press and hold down the Toco Zero button. Then, whilst
keeping the Toco Zero button pressed down, turn the PFM1 on by flicking the AC input on/off
switch which is located on the rear of the unit as part of the AC line input socket. When the
unit is on the front panel LED will be illuminated.
The PFM1 starts and then enters its User Configuration Mode, release the Toco
Zero button as soon as ‘Calibrate System’ is displayed .
You are then prompted to enter the date if different to that displayed.
To change the day and month press the Volume Up button. One press advances
the day by one, pressing the Volume Up button for longer advances the day by
10.
To change the year press the Volume Down button. One press advances the
year by one, pressing the Volume Down button for longer advances the year by
10.
When the correct date is displayed press the Toco Zero button once.
You are then prompted to enter the time if different to that displayed.
This works in a similar manner to the date with the Volume Up button advancing
the hours andthe Volume Down button advancing the minutes.
When the correct time is displayed press the Toco Zero button once.
You are then prompted to enter the Toco Base Line offset.
This sets an artificial zero line for the toco transducer above zero, it can be set
by pressing the Volume Up or Volume Down buttons for a value between 0 -20.
After setting this value the Toco will be set to this every time the Toco Zero
switch is pressed, and allows small negative Toco excursions to be seen on the
chart.
When the correct time is displayed press the Toco Zero button once.

Operating Procedures
PFM1OpManualIssue5 Page 7
You are then prompted to enter the Toco Filter Value.
This sets the filtering within the monitor to produce a smoother Toco trace if
required. ( The filter can remove some of the maternal breathing artifact). It is set
by pressing the Volume Up button for a value soothing value between 1sec and
2sec..
When the correct filter value is displayed press the Toco Zero button once.
You are then prompted to enter the Toco Range.
This sets the response of the Toco transducer to either a full scale of 100 or 200
on the chart print out. It is set by pressing the Volume Up button for a value
between 100 and 200..
When the correct range is displayed press the Toco Zero button once.
You are then prompted to enter the Chart recorder speed.
This sets the initial turn-on speed of the chart recorder. Then once the chart is
running the speed can be further changed to 1 ,2 or 3 cm/min. It is set by
pressing the Volume Up button for a value of 1, 2 or 3 cm/min..
When the correct speed is displayed press the Toco Zero button once.
You are then prompted to select the Data Block on or off.
The Data Block is printed at the start of each recording, this function can be
disabled by setting Data Block to off. It changes from on to off and back again by
pressing the Volume Up button..
When the Data Block is set to your requirements press the Toco Zero button
once.
You are then prompted to select the Tachycardia Alarm on or off.
The Tachycardia Alarm is triggered when the system detects a Tachycardia
above 170 bpm and an alarm tone sounds. The alarm is tone is stopped by
pressing the units volume button. Tachycardia Alarm can be set to on to off and
back again by pressing the Volume Up button..
When the Tachycardia Alarm is set to your requirements press the Toco Zero
button once.
You are then prompted to select the Bardycardia Alarm on or off.
The Bradycardia Alarm is triggered when the system detects a Bradycardia
below 100 bpm and an alarm tone sounds. The alarm is tone is stopped by
pressing the units volume button. Bradycardia Alarm can be set to on to off and
back again by pressing the Volume Up button..
When the Bradycardia Alarm is set to your requirements press the Toco Zero
button once.
The PFM1 will then restart and operate according to your settings.
The PFM1 is now operational, and the LCD screen will show US1 --- us2 ---
(if the unit is only a single fetus monitor it will only display US1 ---) and a Toco value.

Operating Procedures
PFM1OpManualIssue5 Page 8
The Printer
The PFM1 prints on plain thermal paper using a thermal array print head. Fetal heart
rate, uterine activity, and fetal movement are recorded together with date, time,
recorder speed and mode. The printer also prints a header block each time the
printer is turned on and the units chart scale.
To load the printer with paper, open the printer door by pressing firmly on the lid of
the printer. It will then release and can be lifted to a fully open position. Remove the
chart roll bar from inside the printer and place through the centre of the new chart roll.
(The chart roll must be removed from its protective plastic cover and the sticky tab
holding the roll together removed.) Insert the roll into the recorder so that the thermal
side of the paper is uppermost.
Pull the paper out of the front of the unit making sure it is positioned below the door
catches. Close the door and latch by pressing down firmly on it.
To operate the printer press the Recorder On/Off button (situated immediately to
the right of the printer door). The printer will start to run and the chart speed will be
shown in the LCD display. To turn the printer off press and hold the Recorder
On/Off button until the printer stops. (This only operates after the data block has been
printed). A small amount of paper will be fed out at high speed.
The printer will record at 1, 2 or 3 cm/min. To change the speed during recording
simply press the Recorder On/Off button momentarily. The PFM1 can be run at
the speed of your choice, and will always start at this pre-programmed speed every
time the printer is turned on. For details of how to change the pre-programmed
speed refer to ‘User Configuration’.
Thermal side
uppermost
Printer roller
Chart roll

Operating Procedures
PFM1OpManualIssue5 Page 9
Ultrasound Fetal Monitoring
The PFM1 ultrasound transducer is used to detect and monitor the fetal heart beat.
The PFM1 can monitor twins and if this option is chosen it is supplied with two
Ultrasound transducers. The primary Ultrasound Transducer (always supplied ) has a
yellow coded plug while the twin channel has a blue coded plug. Push the relevant
plug firmly into is colour coded front panel US socket and turn the unit on.
Locate a clear fetal heart sound using a Doppler Fetal Heart Detector and secure
the stretch belt in position, so that it passes over the transducer site, and clamp in
place by fastening the Velcro tabs back onto the surface of the belting after feeding
through the transducer.
Apply gel to the surface of the transducer locating it approximately in the position
determined by the Doppler detector. Position the transducer to obtain the clearest
fetal heart sound. The heart rate processor will start to calculate heart rate within
a few seconds and the heart rate can be observed on the LCD display. Correct
operation can be verified by observing that the pulse lamp is flashing at the heart
rate.
The heart shaped fetal pulse indicator is also used as a signal quality indicator.
When positioning the transducer observe the indicator, which should be solid under
the best signal conditions. If this indicator is only showing an outline heart then this
is an indication that the signal quality is not optimum. Improved recordings can
be obtained by repositioning the transducer so that this indicator always shows a
solid heart. In the absence of signals of adequate quality this indicator will be
permanently off.
The audio volume can be increased by pressing the volume up button marked with
the up arrow. Conversely to decrease audio volume press the button marked with
the down arrow. In twins mode the audio output is selected for either channel by
pressing the US 1/2 button. The selected channel is indicated on the LCD display by
the capital US letters. Once a clear fetal heart signal has been located set the
volume to the desired level using these controls.
Transducer position should be checked at least half-hourly during labour-monitoring
or prolonged NST. When repositioning the transducer, further coupling gel may
be required When repositioning the transducers always ensure that the fetal pulse
indicates the optimum signal conditions.
Results will vary from one patient to another, but in all cases good transducer
positioning is essential, and this may be aided by the use of a liberal amount of
coupling gel.
With the fetus in the vertex presentation, and the mother sitting or supine, the
clearest sound will normally be found on the midline below the umbilicus. In the
lateral position, clearer sounds may be found with the transducer displaced from the
centre line to the upper surface of the abdomen. The clearest signals in breach
presentation may be located higher and to one side.

Operating Procedures
PFM1OpManualIssue5 Page 10
Transducer position which results in sounds with a strong placental or cord
signal should be avoided, as these frequently render traces with artifacts.
It is important that a distinct fetal heart sound is present during monitoring for
correct function of the unit . Any doubt about fetal variability should be checked by
listening to the audible signal, or by an alternative diagnostic technique.
A simple check of the ultrasonic system can be made by holding the transducer
against the palm of the hand and stroking the back of the hand at a fixed rate, for
example, twice per second. A clear audible signal should be heard and the digital
display should show a rate after approximately five seconds. With the printer
running this rate will be recorded on the chart.
Uterine Activity Monitoring
The Toco transducer is used to monitor uterine activity. The transducer plug is
colour coded grey for ease of identification. To monitor uterine activity plug the
Toco transducer into the grey UA input socket.
The Toco transducer is sealed to prevent the ingress of fluids. NO coupling gel is
required for this transducer to operate correctly.
Place the transducer on the centre line over the fundus in a position where the
uterus is firm, and secure in place with the stretch belting. Attach belt in the same
fashion as with the ultrasound transducer.
Once the transducer is in position, push the Toco Zero button on the front panel to
zero the recording. The position of the zero baseline can be set to suit individual
preferences. For details of how to change the pre-programmed baseline refer to
‘User Configuration’.
Fetal Activity
Fetal activity may be recorded with the assistance of the patient. A hand-held
marker switch is provided for this purpose and this is plugged into the socket
immediately to the right of the UA input on the front of the unit.
If the patient feels movement of the fetus she may press the switch and this will
mark the paper with an arrow in the gap between the HR and UA traces.
Alternatively this marker may be used by the midwife to indicate any changes made
during the procedure, such as repositioning of the transducers or movement of the
patient.
A front panel event marker is also provided, and this marks the trace on the top edge
of the HR scale. This can be used where two types of indication are required.

Operating Procedures
PFM1OpManualIssue5 Page 11
Interpretation
The following is intended only as a brief guide. For a fuller explanation of the
interpretation of chart records, refer to suitable reference books.
During the antepartum period the Non Stress Test (NST) is an accurate means of
predicting fetal well-being. The criteria proposed by Schifrin et al for the
interpretation of the NST is summarised.
Reactive -accelerations of 15 BPM or more which last for 15 seconds or longer
twice in any 10 minute period. These may be accompanied by fetal activity.
Non-reactive -evidence of fetal movement during a forty minute period, but without
the reactivity indicated above.
Unsatisfactory -recording quality too poor to determine the above criteria.
Stimulation of the fetus, or repositioning of the transducers may result in an improved
recording.
Results from the NST may indicate the requirements to perform other diagnostic
checks such as the Contractions Stress Test (CST).

Troubleshooting
PFM1OpManualIssue5 Page 12
The information in this section will help you to check and correct common operation and
system problems. Refer to the troubleshooting hints which deal with your problem. Perform
the suggested steps. If the problem is not solved, check once again to make sure that you
have used all of the suggested steps to resolve the problem.
Electronic failures and service procedures are not included in this manual, as all servicing of
the system must be performed by a qualified service technician. Valuable time however can
be saved by documenting the problem .
In general, when you have a problem, check your control settings to be sure that they are in
proper operating position. Consult the appropriate section in this manual for specific
information on particular controls or operating modes.
WARNING: Disconnect system from the power source before checking fuses and
connections.
Check all connections and fuses. For replacement fuses consult the technical specifications
for specific ratings required.
No display information on LCD
·Verify the system is on and that the fuses are intact.:
Keyboard does not respond
·Reset system by turning off then back on.
·Verify the system is on and that the fuses are intact.
No sound from loudspeaker.
·Verify the system is on and that the fuses are intact.
·Check volume control is set high.
·Check that the correct transducer has been selected.
·Check connection of the transducer.
No FHR information on display or FH trace printed on recorder.
·Check that the correct transducer has been selected and connected
to the patient.
·Check connection of the transducer.
·Check for audio FH complex and reposition transducer until clearly
heard.
No chart printed .
·Verify the system is on and that the fuses are intact.
·Check that the recorder is turned on.
·Check paper is inserted into the recorder correctly.
·Check recorder door is correctly closed
·Check that paper moves out of the recorder at the correct rate.

Maintenance
PFM1OpManualIssue5 Page 13
The following are the user preventative maintenance tasks. It is recommended that these be
performed on a regular basis at a frequency determined by the usage of the equipment, but
not less than once every month.
WARNING: Before undertaking any of these tasks disconnect the unit from the
mains.
General
Check all cables, connectors and transducers for damage and repair
or replace where necessary. The repair may involve your local
service centre, supplier or Ultrasound Technologies Ltd. For advise
on any damaged part contact them immediately.
Cleaning -Enclosure
Clean the exterior of the system with a soft dry cloth. In the event of
stubborn spots, disconnect the system from the power source. Use a
soft cloth that has been dampened -not soaked -in a mild detergent
solution or isopropyl alcohol. Be sure to keep excess moisture from
entering the cabinet via any openings that may be present.
Cleaning -Transducers
Use a cloth dampened in a mild detergent solution or isopropyl
alcohol to clean the transducer and cable. Remove all traces of the
detergent or alcohol by wiping with a cloth dampened in clear water.
Never soak the transducer cable or connector.
WARNING: Transducers must never be exposed to gas or heat sterilisation.

Specification
PFM1OpManualIssue5 Page 14
Specification
Ultrasound
Frequency 1.8 and 2.1 MHz continuous wave
Transducer Multi element wide angle
Audio Response 300 -1 Khz
Range 50 -210 bpm
Power Output Within European standard
Indicators LCD heart rate and pulse indication
Toco
Transducer Differential external pressure transducer
Response 0 -5 Hz
Scale 0 -100
Indicators LCD Toco level indication
Data Presentation
Strip chart recorder and alphanumeric display module.
Printhead 4 inch thermal solid state printhead
Resolution 8 dots / mm
Speeds 1,2,3,cm/min
Paper Roll or Z fold
Paper type Plain black thermal
Display 32 character by 2 line LCD display module
Controls 6 control buttons (for Paper Start /Stop,
Volume Up, Volume Down, US½, Toco
Zero and Event Mark)
Indicators Green power on/ off
Power Supply
AC input voltage 200 -260 VAC or 100 -130 VAC (User
selected)
Frequency 46 -64 Hz
Power 60VA
Enclosure
Material Steel.
Safety
Unit Designed to BS EN60601-1-1990
Electrical Designation Class 1 Type B

Specification
PFM1OpManualIssue5 Page 15
Computer interface
Transfer 3 wire RS232
Data Rate 9600 baud
Data Standard 8 bits no parity 1 stop bit
Data Format UltraTec Comms Standard
The following Consumables are available for use with the PFM1
Belt set (5 per pack)
Paper spindle
Chart roll (10 rolls per pack))
Power Cord
Doppler size Coupling gel
This Equipment complies with the essential requirements of the European Council
Directive. 93/42/EEC
0120
Guidelines for Identifying and resolving adverse EMC conditions
Emissions
Care has been taken through the design and manufacturing processes to
minimise the EM emissions that may be produced by this equipment.
However, in the unlikely event that the unit causes an EM disturbance to
adjacent equipment, we suggest that the procedure is carried out 'out of
range' of the affected equipment.
Immunity
If the user has any doubt regarding the unit's EM immunity during routine
operation, we suggest that the source of EM disturbance is identified and its
emissions reduced.
If the user has any doubt regarding the identification and resolution of
adverse EM conditions, they may contact Ultrasound Technologies Ltd to
seek advice