Huntleigh SONICAID FREEDOM SF1-EUR User manual

SF1-EUR

Contents
1. Introduction........................................................................4
1.1 Indications of Use..................................................................................4
1.2 Contraindications ..................................................................................4
1.3 Unpacking / Preliminary Checks..........................................................5
2. Safety .................................................................................6
2.1 WARNINGS.............................................................................................7
3. Product Information ...........................................................9
3.1 System Overview...................................................................................9
3.2 The Receiver Unit...................................................................................10
3.2.1 Operation................................................................................................................10
3.2.2 Front Panel Indicators............................................................................................11
3.2.3 Rear Panel controls and Indicators........................................................................13
3.3 The Transducers....................................................................................14
3.4 Product Labelling...................................................................................16
4. Setup...................................................................................17
4.1 Receiver Connection.............................................................................17
4.2 Testing the Basic Functions.................................................................17
5. Operation ...........................................................................19
5.1 Getting Started.......................................................................................19
5.2 Application of the Transducers............................................................19
5.3 Ambulatory Monitoring .........................................................................21
5.4 Water Birth Monitoring..........................................................................21
5.5 Ending Monitoring / Switching Off.......................................................22
6. Care and Cleaning ..............................................................23
6.1 General Care...........................................................................................23
6.2 Cleaning and Disinfecting.....................................................................24
6.2.1 Transducers ...........................................................................................................24
6.2.2 Receiver Unit..........................................................................................................26
7. Maintenance.......................................................................27
7.1 Mechanical Inspection ..........................................................................27
7.2 Corrective Maintenance ........................................................................27
7.3 Charging Transducer Batteries............................................................27
7.4 Transducer Battery Replacement.........................................................27
7.5 Servicing.................................................................................................27

3
Table of Contents
8. Trouble Shooting ................................................................28
8.1 Manually Switching off the Transducers.............................................30
8.2 Re-enabling Transducers......................................................................31
8.3 Changing the RF-channel .....................................................................32
9. Specifications ....................................................................33
9.1 Equipment Classification .....................................................................33
9.2 Receiver Unit (SF1-EUR / SF1-SL)........................................................33
9.3 US-Transducer (SF1-US).......................................................................34
9.4 TOCO-Transducer (SF1-TOCO) ...........................................................34
9.5 Environmental........................................................................................34
9.6 Directives and Standards Compliance*...............................................35
9.7 Recommended Consumables & Accessories* ..................................35
10. Electromagnetic Compatibility ........................................36
11. Ultrasound Safety Considerations ...................................37
12. End of Life Disposal..........................................................41
13. Warranty & Service ..........................................................42

4
Introduction
1. Introduction
1.1 Indications of Use
The Sonicaid™ Freedom (‘Freedom’) is a wireless fetal monitoring system
for the monitoring of fetal heart movement and maternal contractions
during intrapartum and antepartum periods of pregnancy.
It is an optional accessory for use with Huntleigh Healthcare Limited’s
approved Fetal Monitors such as Sonicaid FM820, FM830 Encore Fetal
Monitors (‘FM800E Monitors’) and Team Monitors (Excluding TeamIP) as
an alternative to their wired transducers. When connected to a suitably
approved Monitor, the system monitors:
• Uterine activity by using an external, pressure-sensitive TOCO
transducer, and
• Fetal heart rate (FHR) by pulsed Doppler ultrasound using an external
Ultrasound transducer.
Freedom is suitable for use in clinical and hospital facilities for use on
pregnant woman. The transducers are water tight allowing pregnant
women to be monitored while they are mobile, stationary or in a bath or
shower environment.
This system should only be used by, or under the supervision of, a
licensed physician or other health practitioner who is trained in the use of
FHR monitors.
1.2 Contraindications
Sonicaid™ Freedom is not intended for use with patients fitted
with cardiac pacemakers, during defibrillation, while undergoing
surgery, or while MRI scanning is taking place.
Sonicaid™ Freedom must not be used in intensive care units or
operating rooms.

5
Introduction
1.3 Unpacking / Preliminary Checks
Contents (supplied with each system)
Item Item Item
1 x Sonicaid™ Freedom
Receiver Unit
(WMTS: SF1-SL or
ISM: SF1-EUR)
1 x Instructions for
Use CD 1 x Receiving Antenna (Gainflex - GF430TNC)
1 x Ultrasound Transducer
(SF1-US) 1 x Interface Cable 2 x Transducer Clips
1 x TOCO Transducer
(SF1-TOCO) 1 x Mains Lead 1 x FM800E to Sonicaid™ Freedom
Fixing Kit
Delivery Inspection
Huntleigh takes every precaution to ensure that goods reach you in perfect
condition. However, accidental damage can occur in transit and storage.
For this reason we recommend that a thorough visual inspection is made
immediately the unit is received. Should any damage be evident or any parts
missing, ensure that Huntleigh or your distributor is informed at once.
Storage
Should the unit not be required for immediate use, it should be re-sealed into
its original packing after carrying out the initial delivery inspection, and stored
under covered conditions at a temperature between -10°C to +50°C, and
relative humidity of 10% to 93% non-condensing.

6
Safety
2. Safety
Before using this equipment, please study this manual
carefully and familiarise yourself with the receiver,
transducers, the indicators and operation. Ensure that
each user fully understands the safety and operation of the
unit, as mis-use may cause harm to the user or patient, or
damage to the product.
Ultrasound monitoring should be performed in accordance
with current guidelines. The ALARA guideline (AIUM)
recommends that ultrasound exposure should be kept As
Low As Reasonably Achievable.
General Warning / Residual risks are those risks that require
a warning or caution to be entered into this manual. They are
identified by the proximity of this symbol.
This device may only be used in combination with one of
Huntleigh Heathcare Ltd's ('Huntleigh') Sonicaid™ FM800E or
Team fetal monitor range (excluding TeamIP). The FM800E
monitor range includes model numbers FM820E and FM830E.
Please keep these Instructions for Use to hand for future reference.
Refer to the appropriate Fetal Monitor Instructions for Use for details of
operation and handling.
Refer to Section 3.4 of this manual for definitions of all symbols used on
product labelling.

7
Safety
2.1 WARNINGS
The Sonicaid™ Freedom should only be used by personnel
familiar with the operation of electro-medical equipment,
especially for electronic monitoring of the fetal heart rate.
A possible explosion hazard exists if used in the presence of
flammable anaesthetics.
The Sonicaid™ Freedom should not be used at temperatures
lower than 10 or higher than 40 degrees centigrade.
Do not mount the unit directly above the patient. Locate the unit
so that it will not cause harm should it fall.
Do not operate the unit from the mains supply if the mains cable
is damaged.
Do not immerse any portion of the receiver unit in water or other
liquids. The transducers are watertight and may be used in water
(IPX8 - TRANSDUCERS ONLY).
If there is any damage to the transducer housings, do not use
the transducer under water. Refer the transducer to Huntleigh
Healthcare qualified service personnel for repair.
The transducers are protected from damage if dropped. Never
use the transducer without its protective bumper. It can be
removed for cleaning in accordance with the Cleaning and
Disinfection Procedure in Section 6.
If this product is connected to another item of electrical
equipment, it is important that the system is fully compliant with
EN60601-1.
The device is generating RF-radiation. It is designed for use in
hospitals and other clinical settings, also outside of shielded
areas. As in other medical electrical devices, fixed and mobile
RF-communication devices may disrupt the performance of the
Sonicaid™ Freedom.
The telemetry equipment is classified as IIb according to Medical
Devices Directive 93/42/EEC. The receiver unit is connected to
the AC line without a protective earth (Class 2). The line voltage
may be between 100 and 240V with 50 to 60Hz. The transducer
units are powered by safe current limited low voltage re-
chargeable batteries of 3.7V. Transducers are Class CF.

8
Safety
In case of a discharge of static electricity at the receiver,
the functions of the receiver may become disabled. Please
disconnect the mains lead for about 5 seconds.
To disconnect from the mains, the plug must be removed.
Always ensure that the plug is easily accessible.
The receiver unit should be plugged into the same mains supply
circuit as other equipment in use on the same patient.
Use only recommended accessories listed in this manual.
Do not modify this equipment without authorisation of the
manufacturer.

9
Product Information
3. Product Information
3.1 System Overview
Freedom consists of three components: the Ultrasound transducer (SF1-US),
the TOCO transducer (SF1-TOCO) and the Receiver (SF1-EUR or SF1-SL).
There are two receiver models operating at different radio frequencies for
different markets. "SF1-EUR" is for use in regions that use the ISM wireless
standard; "SF1-SL" is for use in regions that use the WMTS wireless standard.
When in use, the TOCO transducer sends signals to the US transducer, which
then transmits both signals to the Freedom receiver unit. The receiver converts
these signals into the required format for input to the attached Fetal Monitor
system. The system monitors two physiological parameters:
- Fetal Heart Rate
- Uterine activity
Key features:
• Transducers are small, light in weight and water tight
• Low voltage wireless transmission is safe for use in water
• No cables gives the patient greater freedom of movement in & out of bed
• The system is easy for the users to operate
• The transducers are powered by rechargeable Li-Ion batteries
• Batteries will automatically recharge when docked with the receiver
Transducers
The transducers contain radio frequency (RF) transmitters. Signals are
transmitted in an ISM or WMTS band according to location and local
regulations. The SF1-EUR (ISM) has 26 channels, and SF1-SL (WMTS) has
100 channels. The range depends on the local conditions. The exact range
of any telemetry system can only be determined by a field test. When the
US transducer is used under water the range will be reduced compared with
transmission in air.
During use the battery capacity of the transducers are monitored. The receiver
has a battery indicator for each transducer consisting of four green LEDs; four
LEDs indicating that the transducer is fully charged. When the battery becomes
discharged the transducer is automatically shut off.

10
Product Information
Receiver
The receiver has two docking areas for the TOCO and US transducers, three
sets of visual indicators (charging, battery level and transducer status) and the
antenna for receiving transmissions from the US transducer when in use. In
addition, the rear panel includes the receiving antenna, RF-Channel selector,
interface for connecting to the Fetal Monitor, and line voltage input for power.
The receiver and transducers have no buttons to operate. When identified
transducers are undocked, they are switched on automatically and the receiver
indicates the status of batteries and the quality of the incoming RF-signal. When
unidentified transducers are undocked, they are switched off.
To start monitoring, the transducers are undocked from the receiver and applied
to the patient. It is recommended that the US transducer be applied to the
patient first.
The TOCO-Transducer transmits its signal to the US-transducer. The US
transducer transmits both the US and TOCO signals to the receiver.
3.2 The Receiver Unit
3.2.1 Operation
The receiver does not have a mains switch. To turn on, connect the mains lead
from the rear mains input to mains supply. Always leave the receiver connected
to allow the transducers to be charged. If you want to switch off Freedom, dock
both transducers first, wait for charging indication, then disconnect the supply,
wait 10 seconds. All units are now switched off. All modules are turned on when
the receiver is powered again.
When power is applied with an ultrasound transducer docked in the charging
bay, it is automatically registered as belonging to this particular receiver
(referred to as "pairing" or "paired"). This ensures that, where multiple wireless
systems are being used in close proximity, there is no interference between
systems. Successful pairing is indicated by the charge position LED switching
on (not flashing).
To disconnect from the mains, the plug must be removed.
Always ensure that the plug is easily accessible.

11
Product Information
3.2.2 Front Panel Indicators
Docking Transducers
B
C
A
A - Docking/Charge Bays
Ensure there is no water or gel on the contact panels of the receiver or
transducer when charging, as this may prevent good contact.
Dock the transducers in position A when not in use. Place the transducers with
the golden charging rings facing the charging pins and snap into place.
The transducers are equipped with re-chargeable lithium polymer batteries.
When the transducer is docked the battery is charged automatically, provided
the receiver is connected to the mains supply.
Once a transducer has been positioned correctly for charging, a Green LED in
the corresponding holder (B) turns on.
It doesn’t matter in which of the two positions a transducer is docked. However,
to ensure the transducers are recognised without delay, the Ultrasound
transducer should be placed in the holder first. If the TOCO transducer is
inserted first, there may be a delay in the transducer being recognised.
Note: The gold plated contact rings MUST be clean & dry before the
transducer is docked. Failure to ensure this may cause
corrosion, poor contact and may invalidate the warranty.

12
Product Information
B - Charge Bay LEDs
The battery state during charging is indicated as follows:
- LED off: No transducer detected
- LED on: Transducer is being charged. The battery capacity is
displayed in the corresponding battery Indicator (C)
- LED flashing: Transducer not paired but charging. This allows
transducers to be charged on any receiver unit. Note,
however, that no battery charge indicator is displayed in this
mode.
If the LED flashes with a transducer which is correctly paired, remove the
transducer and re-dock it using a rapid snap-in action. Hesitation when docking
may result in the transducer not being recognised.
Note: Flashing LED - If the problem persists, rotating the transducer in
the docked position may clear the problem. A flashing LED may also
occur if the docking contacts, or the contact rings on the transducer, are
contaminated with fluids, gel, etc. Refer to the cleaning instructions for
cleaning these contacts.
C - Battery Indicators
C
Once a transducer has been identified by the
receiver, the corresponding battery indicator (C),
shows the battery level during operation and the
recharge level during charging. Each LED
represents about a quarter of the capacity. When
the battery is fully charged, all 4 LEDs are
continuously on. An operating time of about 16
hours is available on a full charge.
A complete charging process takes
approximately 2.5 hours.
If the transducer has fully discharged, a charging time of about 15 minutes
allows for an operation of more than 1 hour.
LED assignment: US - Ultrasound-transducer
TOCO - TOCO-transducer
It is recommended to leave the transducers docked on the receiver when not in
use.

13
Product Information
D - Transmission Indicators
DThe transmission indicators are located on the
upper right corner of the receiver (D). These
indicators show the status of TOCO and US
transducer transmission:
LED flickering amber:
US Transducer off or out of range
LED amber:
Transducer docked or TOCO Transducer out
of range
LED green:
Transducer in range and good signal quality
LED flickering green/amber:
Transducer near range limit, or disturbance by
another RF-transmitter.
If known to be in range, refer to Section 8.3 to change the channel of the
Freedom unit.
3.2.3 Rear Panel controls and Indicators
1 2 3
4
1Connector for the Receiving Antenna
2
RF-Channel selector :
ISM : 00 - 25 (26 channels)
WMTS : 00-99 (100 channels)
3Interface to Fetal Monitor CTG
4Mains Input, 100…240V, 50…60Hz, 10VA.

14
Product Information
3.3 The Transducers
Indicator
On the top of each transducer is a green indicator LED.
Once the transducer is undocked, the LED is switched ON and flashes to
indicate normal operation.
Note that unpaired transducers will switch off when undocked.
If the LED on a paired transducer stays off, refer to the troubleshooting guide
(section 8).
Connections
Contacting Plate On the top surface of the transducer
is a contact plate. The two connecting
rings connect to the charging pins
on the receiver when the transducer
is docked for charging. All rings
are internally disconnected during
operation.

15
Product Information
SF1 TOCO - Sensor
Sensor
In the centre on the bottom of the TOCO-
transducer is the sensor area, which
measures uterine activity.
Avoid applying excess pressure to the
sensor.
Mechanical Protection
The transducers are protected against damage by a silicone bumper. Never
operate the transducer without this protective bumper. It can be removed for
cleaning if required. Refer to Section 6.2 for instructions.
Transducer Application
The transducers are applied
using the belt clips supplied,
together with the same belts as
for the wired transducers.
Replacement belts & clips are
available.
Refer to section 9.7 for
Recommended Consumables
and Accessories.
The belt clips should be
clipped over the top face of
the transducer, over the gold
contact plate, as shown.

16
Product Information
3.4 Product Labelling
Attention, consult accompanying documents / Instructions for Use
Sonicaid Freedom is Class II, double insulated according to the
definitions in EN 60601-1:2006
IP30 Receiving Unit rating for protection against ingress of fluids and
particulate.
IPX8 Transducer rating for protection against ingress of fluids and
particulate: The transducers are designed for operation under
water. (1M for 16 hours)
This product complies with the essential requirements of the
Medical Devices Directive 93/42/EEC as amended by 2007/47/EC
General Warning or Caution.
This product, including its accessories and consumables, is
subject to the WEEE (Waste Electrical and Electronic Equipment)
regulations and should be disposed of responsibly in accordance
with local procedures.
Applied parts type CF Alternating current (AC)
SN: Serial Number PN: Product Number / Model
Number
Refer to Instructions for
Use CTG Fetal monitor (CTG) connection point
Antenna or Aerial
connection point Battery Indicator
Transducer Indicator
(On / Off Symbol) REF Product Code
Transmission Symbol TOCO ContractionsTransducer
US Ultrasound Transducer Manufacturer

17
Setup
4. Setup
WARNING: These requirements must be met when Sonicaid™
Freedom is connected to any other electrical equipment.
1 Medical equipment must comply with IEC60601-1/EN60601-1, or
equivalent.
2 The configured system must comply with the requirements of
IEC60601-1:2005; clause 16.
4.1 Receiver Connection
The receiver unit should be plugged into the same mains supply
circuit as other equipment in use on the same patient. Do not
make any modifications to the power supply of the receiver and
transducer units.
• Connect the interface cable which is clearly identified, from output of the
receiver unit to the interface input of the fetal monitor.
• Connect the receiving antenna and select RF channel (See Section 8.3)
• Dock the transducers with the receiver powered off.
• Connect the mains supply lead from the receiver unit to mains supply. This
will pair the receiver and transducers.
• Charge the transducer batteries
• Switch on the Fetal Monitor (refer to its Instructions for Use)
The system is ready for monitoring.
4.2 Testing the Basic Functions
A functional test should be performed after initial installation, following each step
below:
1. Remove TOCO-transducer, while the US-transducer is charging:
• charge bay LED and battery indicator LEDs turn off
• LED in TOCO-transducer starts flashing
• no further action (no signal transmission, because the US-transducer is not
running)

18
Setup
2. Dock TOCO-transducer for charging again:
• charge bay LED and battery indicator LEDs turn on
3. Remove US-transducer (US):
• charge bay LED turns off
• LED in US-transducer starts flashing
• US-transmission indicator LED turns green
• US battery indicator LEDs indicate charge status
• US channel becomes active: US is indicated on fetal monitor
4. Simulate audio signal:
• Stroke bottom face of transducer at approximately 2 strokes per second to
simulate a fetal heart signal.
• fetal monitor shows heart rate, after a short delay.
5. Remove the TOCO-transducer:
• charge bay LED turns off
• LED in TOCO-transducer starts flashing
• TOCO-transmission indicator LED turns green
• TOCO battery indicator LED's indicate charge status
• TOCO channel becomes active: TOCO is indicated on fetal monitor
Note : The TOCO transducer must be in operating range of the US
transducer (Maximum range 30cm).
6. Press gently on the sensor area of the transducer:
• fetal monitor shows adequate TOCO values
7. Dock US-transducer for charging
• US and TOCO-transmission indicator LEDs turn Amber
• charge bay LED turns on
• US battery bay LEDs indicate charge status
• Fetal monitor returns to normal operating mode with wired transducers.
8. Dock TOCO transducer for charging
• charge bay LED turns on
• TOCO battery indicator LEDs indicate charge status
9. Wait until both Battery Indicators show all 4 LEDs on (battery fully
charged). A complete charge cycle takes approximately 2.5 hours.
Note : It is recommended that the serial numbers from installed and
matched receiver and transducer units are recorded for future
use if required. This may be important if several telemetry
systems are used within a ward or confined area.

19
Operation
5. Operation
5.1 Getting Started
• Charge the transducer batteries
• Switch on the Fetal Monitor (refer to its Instructions for Use)
• Apply transducers to the patient (Refer to Section 5.2).
When the US-transducer is undocked from the charging bay, the unit is
automatically switched on and is ready to use.
The system is ready for monitoring if the transmission indicator LED and battery
indicator LEDs are illuminated green.
5.2 Application of the Transducers
Ultrasound transducer
Fix the transducer to the belt clip. Apply ultrasound gel to the surface of the
transducer.
Note: Use recommended gel only. Do not use oil based gels.
Use the minimum amount of gel required, to prevent it from sliding too easily on
the skin.
• When the transducer is to be used in water, use only a little gel, or no gel if
possible.
• Position the transducer. Adjust for best, clear, fetal heart sounds. Refer to
the Fetal Monitor instructions for use for further information.
• Secure firmly with the belt. For optimum performance during periods of
mobility, ensure that the belt is tight enough to prevent the transducer
slipping. Avoid patient discomfort through excessive tightening.

20
Operation
TOCO transducer
• Position the TOCO transducer over the fundus of the uterus (refer to the
Fetal Monitor instructions for use for further application information), and
fasten it securely.
• Allow the system to stabilise for 20-30 seconds while communication is fully
established with the fetal monitor.
• Adjust the TOCO baseline using the toco zero button on the Fetal Monitor,
once the system has stabilised.
• After any drop-out in the wireless link, it will be necessary to re-zero the
toco channel when communication is re-established. Allow the system to
stabilise as above before re-zeroing.
Note: The TOCO-transducer transmits its signals to the US-transducer. The
distance between them should not exceed 30cm. If this range is exceeded, toco
data will be lost. When it comes back in range, the stabilisation period & re-
zeroing as detailed above will need to be repeated.
False recording of FHR
When monitoring FHR using Doppler ultrasound, the heart
rate may be falsely reported. This can be caused by a number
of effects including double-rating or half rating, and is
characteristic of ultrasound fetal monitoring. Another cause may
be detection of maternal signals, (particularly in the absence of
fetal signals). Doubling of the maternal rate can result in a trace
looking very like a normal fetal trace. For further information on
this, refer to the Fetal Monitor instructions for use.
If the fetal heart signal has large variations in rate, is weak, or is in the presence
of large maternal signals, noise or artefact, it is possible for the system to
double count or half rate for short periods of time. This is characteristic of
monitoring fetal heart rates with ultrasound.
To minimise the chances of double rating, half rating or other
types of artefact occurring, always palpate the abdomen and
listen to the fetal heart with a hand-held Doppler unit before
applying the ultrasound transducers. This helps to verify the
fetal heart and to locate the area where best signal quality can
be expected. For further information on this refer to the Fetal
Monitor instructions for use.