Freedom Instructions for Use Jan 2022

Contents 1. Introduction... 4 1.1 1.2 1.3 1.4

Indications of Use... 4 Contraindications... 4 Unpacking / Preliminary Checks... 5 Service Life... 5

2. Safety ... 6 2.1

WARNINGS... 7

3. Product Information... 9 3.1 3.2

3.3 3.4

System Overview... 9 The Receiver Unit... 10

3.2.1 3.2.2 3.2.3

Operation... 10 Front Panel Indicators... 11 Rear Panel controls and Indicators... 13

The Transducers... 14 Product Labelling... 16

4. Setup... 17 4.1 4.2

Receiver Connection... 17 Testing the Basic Functions... 17

5. Operation ... 19 5.1 5.2 5.3 5.4 5.5

Getting Started... 19 Application of the Transducers... 19 Ambulatory Monitoring... 21 Water Birth Monitoring... 21 Ending Monitoring / Switching Off... 22

6. Care and Cleaning... 23 6.1 6.2

General Care... 23 Cleaning and Disinfecting... 24

6.2.1 6.2.2

Transducers... 24 Receiver Unit... 26

7. Maintenance... 27 7.1 7.2 7.3 7.4 7.5

Mechanical Inspection ... 27 Corrective Maintenance... 27 Charging Transducer Batteries... 27 Transducer Battery Replacement... 27 Servicing... 27

EN

8. Trouble Shooting... 28 8.1 8.2 8.3

Manually Switching off the Transducers... 30 Re-enabling Transducers... 31 Changing the RF-channel... 32

9. Specifications ... 33 9.1 9.2 9.3 9.4 9.5 9.6 9.7

Equipment Classification ... 33 Receiver Unit (SF1-EUR / SF1-SL)... 33 US-Transducer (SF1-US)... 34 TOCO-Transducer (SF1-TOCO) ... 34 Environmental... 34 Directives and Standards Compliance*... 35 Recommended Consumables & Accessories* ... 35

10. Electromagnetic Compatibility... 36 11. Ultrasound Safety Considerations... 37 12. End of Life Disposal... 41 13. Warranty & Service... 42

Instructions For Use

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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.

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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

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.

1.4

Service Life

This has been defined as the minimum time period during which the device is expected to remain safe and suitable to meet its intended use, and all risk control measures remain effective. Huntleigh Healthcare Ltd’s commitment is that the expected service life for this Device has been defined as 7 years.

Instructions For Use

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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.

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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. 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.

Instructions For Use

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EN 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.

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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. "SF1EUR" 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.

Instructions For Use

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EN 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.

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3.2.2

Front Panel Indicators

Docking Transducers

A

B C 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.

Instructions For Use

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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.

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D - Transmission Indicators The transmission indicators are located on the upper right corner of the receiver (D). These indicators show the status of TOCO and US transducer transmission:

D

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

1

Connector for the Receiving Antenna

2

RF-Channel selector : ISM : 00 - 25 (26 channels) WMTS : 00-99 (100 channels)

3

Interface to Fetal Monitor

4

Mains Input, 100…240V, 50…60Hz, 10VA.

Instructions For Use

CTG

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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.

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SF1 TOCO - Sensor In the centre on the bottom of the TOCOtransducer is the sensor area, which measures uterine activity.

Sensor

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.

Instructions For Use

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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 symbol signifies that this product complies with the essential requirements of the Medical Device Directive (93/42/EEC) - Medical Device Regulation (EU/2017/745).

Manufactured By:

Huntleigh Healthcare Ltd. 35 Portmanmoor Road, Cardiff, CF24 5HN, United Kingdom T: +44 (0)29 20485885 [email protected] www.huntleigh-diagnostics.com

Legal Manufacturer in association with the CE mark in Europe ArjoHuntleigh AB Hans Michelsensgatan 10 211 20 Malmö, Sweden

YYYY-MM

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.

SN

Applied parts type CF

Alternating current (AC)

General Warning or Caution.

Refer to Instructions for Use

Serial Number

REF

Transducer Indicator (On / Off Symbol)

CTG

Antenna or Aerial connection point MD

Medical Device

US

Ultrasound Transducer

Product Number / Model Number Fetal monitor (CTG) connection point Battery Indicator

DI

Device Identifier

TOCO ContractionsTransducer

Transmission Symbol

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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 IEC606011:2005; 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)

Instructions For Use

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EN 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: • • • • • Note :

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 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 :

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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. Instructions For Use

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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.

Instructions For Use

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EN 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.

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