Ultrasound Technologies Freeplay FHRM User manual

Fetal Doppler/Monitor
Operating Manual
Issue 1.08
Freeplay FHRM

2
Freeplay FHRM Operating Instructions Copyright © UTL. 2018
CONTENTS
1. ABOUT THIS MANUAL 3
2. ABOUT THE FHRM 4
2.1 Intended Use 4
2.2 Accessories 4
2.3 AC Mains Adaptor 5
3. SAFETY 6
3.1 Prudent Use Statement 6
4. LABELLING 7
5. CONTROLS AND INDICATORS 8
6. CHARGING THE FHRM 10
7. OPERATING PROCEDURE 11
8. FETAL HEART DETECTION 12
9. FREQUENTLY ASKED QUESTIONS 13
10. PREVENTATIVE MAINTENANCE 14
10.1 Cleaning 14
10.2 General Maintenance 14
11. TROUBLESHOOTING 15
12. EQUIPMENT SPECIFICATION 16
12.1 FHRM Series Doppler Specifications 16
12.2 Environmental Requirements 16
12.3 Ultrasound Output Specification 17
12.4 FHR Display Performance 17
12.5 Electromagnetic Compatibility Tables 17
12.5.1 Manufacturers Declaration and Guidance : Emissions 17
12.5.2 Manufacturers Declaration and Guidance : Immunity 18
12.5.3 Manufacturers Declaration and Guidance : Separation Distances 19
13. WARRANTY 20
13.1 Terms and Conditions 20
NOTES 23

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Freeplay FHRM Operating Instructions Copyright © UTL. 2018
This user manual provides instructions for the operation of the Freeplay FHRM Fetal
Doppler/Monitor, hereafter refered to generically as the FHRM.
It is recommended that personnel study this manual before attempting to operate
the FHRM Fetal Doppler. The safe and effective use of this equipment requires
understanding of, and compliance with, all warnings, cautionary notices, and
instructions marked on the product, and included in this manual.
Typical users of FHRM Fetal Dopplers are trained medical professionals including,
but not limited to, Midwives, Clinicians and other health professionals.
If you have any queries regarding the operation of the FHRM Fetal Doppler or
understanding the information provided in this manual please contact your local
distributor or authorised Freeplay Representative
1. ABOUT THIS MANUAL

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Freeplay FHRM Operating Instructions Copyright © UTL. 2018
The Fetal Heart Rate Monitor (FHRM) is a portable hand-held, robust device with a
probe that uses Doppler ultrasound waves to detect the fetal heart rate.
The FHRM uses internal rechargable batteries to enable health professionals to
count the fetal heart rate in conditions where a reliable source of mains electricity
may not be available.
There are a number of options to recharge or power the device, with the wind- up/
self-powered being the most obvious.
The fetal heart can be “heard”on the loudspeaker while the fetal heart rate is shown
on the display screen.
2.1 Intended Use
The FHRM Fetal Doppler is intended for use in conventional Fetal Heart detection
and monitoring during antenatal and intrapartum care.
This device should only be used by trained medical personnel with a background in
obstetric care.
It should not be used for any other application or patient examination procedure.
If its use is in doubt, contact your local distributor or authorised Freeplay
Representative directly.
2.2 Accessories
The following accessories are supplied with every FHRM series Doppler:
AC Mains Adapter
Operating Manual
2. ABOUT THE FHRM

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Freeplay FHRM Operating Instructions Copyright © UTL. 2018
2. ABOUT THE FHRM
2.3 AC Mains Adaptor
The FHRM Fetal Doppler is supplied with a universal Mains AC to 12VDC mains
adaptor for charging the internal batteries of the FHRM Fetal Doppler.
The FHRM is disabled while charging and therefore can not be used on a Patient .
The AC Mains adaptor (A) is supplied with 2 plug heads , for UK (B) and EU (C) con-
nection types.
Select the appropriate plug head for your main connection. Align the plug head
connector with the mains adapter socket and slide together. Ensure that the plug
head clips into place and is securely attached before use.
WARNING: The device must only be used with the supplied power supply unit.
A B C

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Freeplay FHRM Operating Instructions Copyright © UTL. 2018
The FHRM Fetal Doppler is a screening tool to aid the healthcare professional and
should be used in conjunction with normal fetal monitoring. If there is doubt as to
the result obtained by using the unit, further investigations should be undertaken
immediately using alternative techniques.
We would recommend that to maintain the standard of performance of the FHRM,
whenever possible, the device is included in a scheduled maintenance scheme (see
section 10 for details).
Fluids should not be allowed to enter the device as this may result in damage to the
system.
Do not use the device if there is damage to either the probe or probe cable.
The FHRM contains no user servicable parts, all service requirements should be
referred to your local distributor or authorised Freeplay Representative.
The FHRM contains a rechargable NiMH battery pack that is not user replaceable.
Attempts to replace this battery pack could lead to damage to the unit,
environment and/or human health in incorrectly fitted, handled or disposed of
improperly.
The FHRM battery pack must only be replaced by your local distributor or
authorised Freeplay Representative.
WARNING: No modification of this equipment is allowed.
WARNING: FHRM Fetal Dopplers are not to be used in the presence of flammable
anaesthetics, flammable gases or in an oxygen rich environment.
WARNING: US Federal Law restricts this device for sale on or by order of a physician.
3.1 Prudent Use Statement
The FHRM has been designed to minimise the ultrasound exposure to the
patient. It is recommended that exposure to ultrasound should be kept As Low
As Reasonably Acheivable (ALARA guidelines). Avoid unnecessary prolonged
exposure. This is considered to be good practice and should be observed at all
times.
3. SAFETY

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Freeplay FHRM Operating Instructions Copyright © UTL. 2018
Symbol Definitions
The following symbols have been used on the front and rear labels of the FHRM and
are here defined according to EN60601-1.
Unit On/Off Control (Standby).
Type B Equipment Unit Classification.
Refer to operating manual
!
Attention, consult accompanying documents.
Associated with auxiliary connections, see operating manual.
This symbol on the product or on it’s packaging indicates that this
product must not be disposed of with your normal waste.
Battery Low.
Fetal Pulse Indicator
Product Manufacturer.
Direct Current
Connector Polarity (Tip Positive)
Product Serial Number
The product serial number can be found on the rear label of the product, beneath
the winding handle.
4. LABELLING

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Freeplay FHRM Operating Instructions Copyright © UTL. 2018
5. CONTROLS AND
INDICATORS
Battery Low Icon (B)
2MHz Fetal Probe (F)
Unit On / Off Control (A)
Fetal Heart Rate
Display (D)
DC Input Socket (C)
Fetal Pulse
Indicator (E)

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Freeplay FHRM Operating Instructions Copyright © UTL. 2018
The FHRM is powered from an internal battery, which can be charged using the
windup mechanism built into the unit or using the included AC power adapter.
To switch on the FHRM press the centre of the switch located on the front of the
unit (A).
The FHRM will stay on for approximately 2 minutes after the last FHR is detected or
until the on/off switch is pressed again.
The fetal heart signal is detected using the 2MHz ultrasound probe (F).
The FHRM displays battery condition on the LCD. A battery icon (B) is displayed
when the battery requires re-charging.
The fetal heart rate (D) is displayed on the LCD. The fetal pulse icon (E) flashes at
approximately the same rate as the detected fetal heart and the fetal heart sound is
presented from the built in loudspeaker.
On the rear of the unit there is the charging handle and a green LED that indicates
when the unit is charging.
The fetal probe (F) is permanently attached to the unit and no attempt must be
made to disconnect it.
5. CONTROLS AND
INDICATORS

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Freeplay FHRM Operating Instructions Copyright © UTL. 2018
6. CHARGING THE FHRM
This fetal heart rate monitor runs off rechargeable batteries that are inside the
device. The batteries may be recharged from three different power sources.
Mains electricity
The batteries can be charged from a mains electric power supply using a
power adaptor:
Plug the adaptor into a standard wall electricity plug and insert the cable
into the power socket of the fetal monitor. Switch on the wall plug. Check
that the green light on the fetal monitor is flashing. This means that the
batteries are now charging from the electric power supply.
It takes approximately 2 hours to fully charge the batteries. When they are
fully charged the green light on the fetal monitor will flash on and off slowly.
Now the fetal monitor will operate for approximately 7 hours continuously
before the batteries need recharging again.
Wind-up power
The batteries can also be recharged with power created by turning the wind-
up handle on the back of the fetal monitor:
Turn the wind-up handle fast in any direction. The green light next to the
power socket will come on brightly if you are winding the handle fast
enough to create power. If the light does not come on, you are winding the
handle too slowly and are not storing power in the batteries.
If you wind the device for 60 seconds, it will function and show a reading for
approximately 8 to 10 minutes, depending on the speed of winding.
The longer and faster you wind the longer the fetal monitor will function
without the need for further winding.
You can store wind-up power
by winding for any length
of time. All power created
by winding is stored in
the batteries.

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Freeplay FHRM Operating Instructions Copyright © UTL. 2018
7. OPERATING PROCEDURE
First choose the power supply you will use to charge the batteries and make sure
you have enough power stored in the batteries to complete your examination.
Clean the ultrasound probe by wiping it with a cloth and disinfectant agent such as
chlorohexidene or sodium hypochlorite, NEVER use alcohol on the FHRM.
Switch the fetal monitor on by pressing the on/off button.
Put a gel, or water, on the ultrasound probe/or mother’s abdomen and place the
probe on the mother’s abdomen and move it around until the fetal heart is heard
well.
It is important NOT to use a mineral oil based gel (eg: KY jelly) between the probe
and the skin. An aqueous (water based) gel must be used, or water alone is quite
adequate. Mineral oil based gels can penetrate the plastic and cause damage to
the faceplate assembly. This will result in the device failing to function. Water
is adequate to create an air-free seal between the Doppler head and skin if an
aqueous gel is unavailable.
Keep the probe in that position when a good signal is heard.
The flashing heart symbol on the display screen indicates that a readable heart rate
is detected and the fetal heart rate per minute is shown on the screen.
The power source must be disconnected from the monitor before it can be used.
You will not be able to switch the monitor on if it is still attached to the power.

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Freeplay FHRM Operating Instructions Copyright © UTL. 2018
The FHRM can be used to detect the beating fetal heart from approximately the
10th week of gestation, though this will vary between patients.
Apply a liberal amount of coupling gel to the area just above the symphysis pubis
and position the probe face flat against the abdomen. Tilt the probe slowly until the
fetal heart is heard in the loudspeaker.
Later on in pregnancy the best signals are generally found higher up the abdomen.
Avoid sliding the probe over the abdomen as this results in an increase in the
background noise and makes it more difficult to detect the fetal heart sounds.
The FHRM may be used to locate the position of the placenta, thus aiding in
the early diagnosis of placenta praevia or eliminating placental site where
amniocentesis is to be performed.
The sound from the placenta is an indistinct swishing, caused by blood flow in
many vessels. There is no distinct beat pattern to the sound.
The vessels of the umbilical cord give rise to a higher pitched sound than the
normal fetal heart, with pulsations at the fetal rate.
8. FETAL HEART DETECTION

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Freeplay FHRM Operating Instructions Copyright © UTL. 2018
Q: What if the fetal monitor turns off unexpectedly?
A: There is no power left. Choose your power option and charge the batteries
before switching on the fetal monitor again.
Q: Can you damage the fetal monitor by turning the handle too fast?
A: No. The faster you turn the handle the more power you will store in the
batteries.
Q: What happens if you turn the handle in the wrong direction?
A: It does not matter in which direction you turn the handle. Either direction
will generate power.
Q: Is it safe to use the fetal monitor near other electrical equipment?
A: Yes. The fetal monitor will not affect or be affected by other electrical
equipment.
Q: Can the operator or patient receive an electric shock from the fetal
monitor?
A: No. It is specially designed so that it cannot give an electric shock.
Q: Will the device be damaged if it is dropped?
A: It may be damaged, especially if the probe is dropped. However it has been
designed to be robust and is not easily damaged.
Q: When do you know that the fetal heart rate reading on the display screen is
accurate?
A: The reading is only reliable if there is a heart icon shown and if the heart
rate does not change frequently on the display screen. If the icon is not
shown or the heart rate changes all the time, reposition the probe on the
mother’s abdomen and make sure that she remains still, as movement can
interfere with the reading. If the heart rate is less than 100, make sure you
are not measuring the mother’s pulse rate by comparing the reading on the
display screen with the mothers’wrist pulse rate.
A self-learning programme for professionals on fetal heart rate monitoring
during intrapartum care can be accessed free on:
http://bettercare.co.za/learning-programmes/intrapartum-care/
9. FREQUENTLY ASKED
QUESTIONS

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Freeplay FHRM Operating Instructions Copyright © UTL. 2018
To ensure continued accuracy and reliability from your FHRM you should regularly
perform the following routine maintenance tasks:-
10.1 Cleaning
• MaintainacleanenvironmentfortheFHRM.
• Removeallcouplinggel,blood,saline,etc.assoonaspossibleafteruse.
• Aftereachusecarefullywipeexcesscouplinggelfromtheprobewithasoft
tissue.
• NEVERcleanprobeswithalcoholoranyothersolventasthesemaycause
damage.
• Iftheprobeorunitrequiredisinfectionthenwipewithadampclothmoistened
with a mild dilution of Milton* or equivalent product. Recommended dilution
is 1 part Milton* 2% (20,000ppm of available chlorine) to 20 parts water.
• DONOTIMMERSEanyFHRMdeviceorprobeinanyliquid.
• NEVERAutoclavetheprobe.Theprobeshouldbecleanedwithasterilenon-
abrasive cloth dampened with an aqueous disinfectant. If, in extreme cases,
it is considered necessary to sterilize the probe this should be done using gas
sterilization methods at pressure and at elevated temperature in accordance
with hospital practice. Note that out-gassing periods should be adhered to.
10.2 General Maintenance
• Theprobefaceisverydelicateandmaybedamagedbydropping.Alwaysstore
the unit carefully and protect the probe.
• Regularlyinspecttheunitfordamage.Payparticularattentiontotheprobe
and probe cable.
• ReferdamagedunitstoyourlocaldistributororauthorisedFreeplay
Representative as soon as any damage is identified.
*Milton is a solution of 2% Sodium Hypochlorite.
10. PREVENTATIVE
MAINTENANCE

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Freeplay FHRM Operating Instructions Copyright © UTL. 2018
In the unlikely event of instrument failure, the following simple checks may
be made before contacting your local distributor or authorised Freeplay
Representative for further advice.
Functional Checks
• Turntheunitonandobservethedisplay,ifitdoesnotilluminate,chargethe
battery and try again.
• Ifthebatterylowindicatorremainson,thencallyourlocaldistributoror
authorised Freeplay Representative.
• Ifthebatterylowindicatorisoff(normaloperation)stroketheprobeface.
• Ifnoaudiosignalisheardintheloudspeaker,consultyourlocaldistributoror
authorised Freeplay Representative.
Operational Checks
• Makesurethattheprobearecorrectlypositioned.
• Observethatthefetalpulseiconflasheswitheachheartbeat.
If the FHRM does not perform as described above then contact your local
distributor or authorised Freeplay Representative.
NOTE: Be ready to provide the model, serial number and the nature of the problem.
The serial number can be found on the rear of the unit beneath the charging
handle.
There are no user serviceable parts inside the FHRM.
11. TROUBLESHOOTING

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Freeplay FHRM Operating Instructions Copyright © UTL. 2018
12. EQUIPMENT
SPECIFICATION
12.1 FHRM Series Doppler Specifications
Ultrasound
Frequency
Probe
Audio
Range
Power output
Indicators
Heart Rate Processing
2 MHz continuous wave.
2 crystal narrow beam.
Response 300Hz to 1KHz.
50 to 210 bpm.
<15m W/cm2SATA.
LCD heart rate and pulse indication.
Digital multipoint autocorrelator.
Controls and Indicators
Control
Indicators
Power on/off button.
3 digit FHR LCD display, FHR pulse icon, battery low icon, charge
indicator on rear
Power Supply
Hand Crank
Battery
Expected Battery Life
60 seconds of winding for 8 to 10 minutes of use
Rechargeable NiMH internal battery
>6 hours. (when fully charged)
Mains Battery Charger
Output Voltage DC
Input Voltage AC
Mains Frequency
Output Current
Input Power
12V
80 - 264 VAC
47 - 63Hz
1.25A
36W max
Enclosure
Material
Weight
Size
ABS.
590g typically, including probe.
180 x 90 mm.
Safety
FHRM Device Classification
Mains Charger Classification
Internally Powered ME Equipment - IEC 60601-1:2006.
Class II ME Equipment
12.2 Environmental Requirements
Operating
Ambient Temperature
Relative Humidity
Ambient Pressure
+10°C to +40°C.
30 – 70% non-condensing.
700 kPa to 1060 kPa.
Transit and Storage
Ambient Temperature
Relative Humidity
Ambient Pressure
-40°C to +70°C.
10% to 100%, including condensation.
500kPa to 1060kPa.

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Freeplay FHRM Operating Instructions Copyright © UTL. 2018
12. EQUIPMENT
SPECIFICATION
12.3 Ultrasound Output Specification
Maximum
Index Value
Index Component Values Acoustic Parameters
At Surface Below Surface P (mW) P1x1 (mW) zb (cm) fawf (MHz)
Obstetric 0.291 0.291 0.229 6.6 5.9 10 2.0
12.4 FHR Display Performance
Range Resolution Accuracy
50 - 210 bpm 1 bpm ± 1 bpm
12.5 Electromagnetic Compatibility Tables
As detailed in the Specifications, this product is classified as a Class A Group 1
type of product according to EN55011. This product is allowed in a domestic
establishment under the jurisdiction of a Healthcare professional.
The FHRM is designed to comply with EN60601-1, Medical Electrical Requirements
for Safety.
12.5.1 Manufacturers Declaration and Guidance : Emissions
Care has been taken through the design and manufacturing process to minimize
the electromagnetic (EM) emissions which 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 performed out of range of the
affected equipment.
Electromagnetic Emission
The FHRM is intended for use in the electromagnetic environment specified below.
The user of the FHRM should assure that it is used in such and environment.
Emission Test Compliance Electromagnetic Environment
RF Emissions CISPR II Group 1 The FHRM Fetal Doppler uses RF energy only for it’s
internal function. Therefore, it’s RF emissions are
very low and are not likely to cause any interference
in nearby electronic equipment.
RF Emissions CISPR II Class B The FHRM Fetal Doppler is suitable for use in all
establishments including domestic establishments
and those directly connected to the public
low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic Emissions
IEC 61000-3-4
Not Applicable
Voltage Fluctuations /
Flicker Emissions
IEC61000-3-3
Not Applicable

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Freeplay FHRM Operating Instructions Copyright © UTL. 2018
12.5.2 Manufacturers Declaration and Guidance : 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.
Electromagnetic Immunity
The FHRM is intended for use in the electromagnetic environment specified below.
The user of the FHRM should assure that it is used in such and environment.
Immunity test IEC60601 test
level
Compliance
level
Electromagnetic environment - guidance
Electrostatic
Discharge (ESD)
IEC61000-4-2
±6KV contact
±8KV air
±6KV contact
±8KV air
Floors should be wood, concrete or ceramic
tile. If the floor is covered in synthetic material
the relative humidity should be at least 30%.
Portable and mobile RF communications
equipment should be used no closer to any
part of the FHRM including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.
Radiated RF IEC
61000-4-3
3V/m 80MHz
to 2.5GHz
3V/m d=1.2√P (80MHz to 800MHz)
d=2.3√P (800MHz to 2.5GHz)
Where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in meters
(m). Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey (a), should be less than the compliance
level in each frequency range (b).
Interference may occur in the vicinity of
equipment marked with the following
symbol:
Note 1: At 80MHz and 800MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and/or people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the FHRM device is used exceeds the applicable RF compliance
level above, the FHRM device should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating
the device.
b. Over the frequency range 150kHz to 80MHz, field strengths should be less than 3 V/m.
12. EQUIPMENT
SPECIFICATION

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Freeplay FHRM Operating Instructions Copyright © UTL. 2018
12.5.3 Manufacturers Declaration and Guidance : Separation Distances
Recommended separation distances between portable and mobile communications
equipment and a FHRM
The FHRM is intended for use in an electromagnetic environment in which RF disturbances are
controlled. The user of the FHRM can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications equipment (transmitters) and
the FHRM as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum
output power of
transmitter (W)
Separation distance according to frequency of transmitter (m)
150KHz to 80MHz
d=1.2√P
80MHz to 800MHz
d=1.2√P
800MHz to 2.5GHz
d=2.3√P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where (P) is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
Note 1: At 80MHz and 800MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and/or people.
This equipment complies with the essential requirements of the European Council Directive
93/42/EEC + 2007/47/EC relating to Medical Devices.
12. EQUIPMENT
SPECIFICATION

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Freeplay FHRM Operating Instructions Copyright © UTL. 2018
13. WARRANTY
13.1 Terms and Conditions
1. The Warranty
Ultrasound Technologies Ltd. warrants the product, when new, to be free of
defects in material and workmanship and to perform in accordance with the
manufacturer’s specification for a minimum period of three years from the date of
purchase from Ultrasound Technologies Ltd.
2. Replacement of Product or Components
Ultrasound Technologies Ltd. will repair or replace any components found to be
defective or at variance from manufacturer’s specification at no cost during the
warranty period.
3. Return of a Faulty Product
It shall be the purchaser’s responsibility to return the product, at their cost, directly
to Ultrasound Technologies Ltd. or to an authorized Ultrasound Technologies Ltd.
distributor, agent or service representative.
4. Procedure for Return
In order to return the product directly to Ultrasound Technologies Ltd. the
purchaser must first obtain a return authorization from Ultrasound Technologies
Ltd.’s Service Centre.
5. Condition of Products for Return
All products must be returned in a clean, decontaminated condition and with
a decontamination certificate. Ultrasound Technologies Ltd. reserves the right
to refuse to service equipment returned without a suitable decontamination
certificate or in a contaminated condition. Ultrasound Technologies Ltd. will not be
responsible for units damaged during return due to poor packing.
6. Exclusion from the Warranty
This warranty does not include breakage or failure due to tampering, misuse,
neglect, accident or shipping, nor the effects of normal wear and tear.