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Summary of Contents for Huntleigh SONICAID FREEDOM SF1-EUR
- Page 1 SF1-EUR...
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Page 2: Table Of Contents
Contents 1. Introduction ................ 4 Indications of Use .................. 4 Contraindications .................. 4 Unpacking / Preliminary Checks ............5 2. Safety ................. 6 WARNINGS ..................... 7 3. Product Information ............9 System Overview ................... 9 The Receiver Unit................... 10 3.2.1 Operation........................ - Page 3 8. Trouble Shooting ..............28 Manually Switching off the Transducers ..........30 Re-enabling Transducers ..............31 Changing the RF-channel ..............32 9. Specifi cations ..............33 Equipment Classifi cation ..............33 Receiver Unit (SF1-EUR / SF1-SL) ............33 US-Transducer (SF1-US) ............... 34 TOCO-Transducer (SF1-TOCO) ............
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Page 4: Introduction
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. -
Page 5: Unpacking / Preliminary Checks
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. -
Page 6: Safety
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. -
Page 7: Warnings
(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 qualifi ed service personnel for repair. The transducers are protected from damage if dropped. Never use the transducer without its protective bumper. - Page 8 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.
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Page 9: Product Information
Product Information 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;... -
Page 10: The Receiver Unit
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. -
Page 11: Front Panel Indicators
3.2.2 Front Panel Indicators Docking Transducers 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. - Page 12 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 fl ashing: Transducer not paired but charging.
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Page 13: Rear Panel Controls And Indicators
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: LED fl ickering amber: US Transducer off or out of range LED amber: Transducer docked or TOCO Transducer out of range... -
Page 14: The Transducers
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 fl ashes 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). - Page 15 SF1 TOCO - 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 sensor. Mechanical Protection The transducers are protected against damage by a silicone bumper. Never operate the transducer without this protective bumper.
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Page 16: Product Labelling
Product Labelling Attention, consult accompanying documents / Instructions for Use Sonicaid Freedom is Class II, double insulated according to the defi nitions in EN 60601-1:2006 Receiving Unit rating for protection against ingress of fl uids and IP30 particulate. Transducer rating for protection against ingress of fl uids and IPX8 particulate: The transducers are designed for operation under water. -
Page 17: Setup
4. Setup WARNING: These requirements must be met when Sonicaid™ Freedom is connected to any other electrical equipment. Medical equipment must comply with IEC60601-1/EN60601-1, or equivalent. The confi gured system must comply with the requirements of IEC60601-1:2005; clause 16. Receiver Connection The receiver unit should be plugged into the same mains supply circuit as other equipment in use on the same patient. - Page 18 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 fl ashing • US-transmission indicator LED turns green • US battery indicator LEDs indicate charge status •...
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Page 19: Operation
Operation 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. - Page 20 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.
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Page 21: Ambulatory Monitoring
Use little, or no gel if possible on the US-transducer. When the transducers are under water, this reduces the range. Positioning the receiver in line of sight of the transducers may improve reception. If you are in doubt, please contact Huntleigh or your distributor for assistance. -
Page 22: Ending Monitoring / Switching Off
Ending Monitoring / Switching Off Once monitoring is complete and the transducers and receiver have been cleaned (see Section 6.2), dock the transducers on the receiver, so they are easily located when you want to use the system again, and so the transducer batteries can be charged. -
Page 23: Care And Cleaning
Section 4.2. If there are any defects to the housing of a transducer do not use it in water. Contact Huntleigh or your distributor to get it repaired or to order a replacement. -
Page 24: Cleaning And Disinfecting
Cleaning and Disinfecting 6.2.1 Transducers Clean the two transducers before examining a patient using cleaning Method 1 below. Following patient examination clean and/or disinfect the transducers by the appropriate method based upon the risk of transferring an infection from one patient to another. - Page 25 Method 2 (Medium Risk) Remove the bumpers before cleaning. 1. Remove soiling and clean the transducers and the internal and external surfaces of bumpers with a mild detergent and then rinse in water. 2. Completely dry the transducers and the inside and external surfaces of the bumper.
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Page 26: Receiver Unit
6.2.2 Receiver Unit General Comments • Always keep the external surfaces clean and free of dirt and fl uids using a clean dry cloth to remove. • Clean the charging contacts regularly with a dry cloth. • Ensure that the charging contacts are completely dry following the cleaning and disinfecting procedure. -
Page 27: Maintenance
Look carefully for cracks which may allow the ingress of liquids or gels. Contact Huntleigh or your distributor for service or replacement of any broken or damaged cables, transducers or transducer protective bumpers If there is damage to the receiver, do not use and contact Huntleigh or your distributor. Corrective Maintenance All corrective maintenance must be performed by qualifi... -
Page 28: Trouble Shooting
Trouble Shooting This section gives some of the more common problems encountered during use together with possible causes. If the problem cannot be located after consulting the table below, the receiver should be disconnected from the mains power source and a qualifi ed technician should be consulted. Before attempting trouble-shooting, verify that all cables are properly connected to both the receiver, Fetal Monitor and the main power source. - Page 29 No TOCO signal on fetal monitor from telemetry. POSSIBLE CAUSE SOLUTION US-transducer not receiving Bring the transducers closer together signal from TOCO. until US receives signal from TOCO. TOCO not running (LED not Charge TOCO-transducer and try again. fl ashing). TOCO baseline zeroed before Wait for 20-30s after activating the wireless system has stabilised...
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Page 30: Manually Switching Off The Transducers
No battery indicator LEDs illuminated POSSIBLE CAUSE SOLUTION RF Interference Occasionally, the battery indicator LEDs may show absence of charge. As long as the transducers have been properly docked, with the charge bay LEDs showing that charging is in progress for a minimum of 15 minutes, the transducers should operate normally. -
Page 31: Re-Enabling Transducers
Switching Off Hold the transducer at the right hand side of the receiver as shown on the pictures below. Position the letters so that the “TOCO” or “US” are as shown. By moving the transducers along the right hand side of the receiver wall the transducers will switch off and reset accordingly The process will take approximately 2-3 seconds. -
Page 32: Changing The Rf-Channel
Changing the RF-channel Wireless transmission can be disturbed by other transmitters running on the same frequency. If there are several Freedom units in one ward, all receivers must be set to different channel numbers. The operating channel is set using the controls located on the rear panel of the Freedom receiver. This is performed as follows: 1. -
Page 33: Specifi Cations
Specifi cations Equipment Classifi cation Type of protection The receiver unit is connected to the AC line against electric shock. without a protective earth (class 2). Degree of protection Transducer - SF1-US : Class CF applied parts against electric shock Transducer - SF1-TOCO : Class CF applied parts Mode of operation. -
Page 34: Us-Transducer (Sf1-Us)
US-Transducer (SF1-US) Measurement External Fetal Heart Rate by Pulsed Doppler Ultrasound Ultrasound Complies with IEC 60601-2-37 parameter Transmission Cordless to receiver (SF1-EUR / SF1-SL) Range Up to 30m, from under-water up to 8m (subject to local environment) Modulation Digital, FSK Antenna Helix RF-Transmitter According to receiver: SF1-EUR (ISM), SF1-SL (WMTS) -
Page 35: Directives And Standards Compliance
Directives and Standards Compliance* European Directives: The Sonicaid™ Freedom complies with the essential requirements of the Medical Devices Directive (93/42/EEC) with amendments by 2007/42/EC and the Radio and Telecommunications Terminal Equipment Directive (1999/5EU). Standards: Safety IEC/UL/CSA/EN 60601-1 (Second Edition) IEC/ANSI/AAMI/CSA/EN 60601-1 (Third Edition) EN60601-1-6:2010, IEC 60601-2-37:2007 Electromagnetic EN60601-1-2:2007... -
Page 36: 10. Electromagnetic Compatibility
10. Electromagnetic Compatibility Make sure the environment in which the Sonicaid™ Freedom is installed is not subject to strong sources of electromagnetic interference (e.g. radio transmitters, mobile phones). This equipment generates and uses radio frequency energy. If not installed and used properly, in strict accordance with the manufacturer’s instructions, it may cause or be subject to interference. -
Page 37: 11. Ultrasound Safety Considerations
Acoustic output data for the transducers is summarized in the following tables. Acoustic Output The Sonicaid Freedom’s ultrasound transducer, which is used with Huntleigh's approved fetal monitors, has a single mode of operation, with fi xed acoustic output parameters that are not user adjustable. Refer to Table 1 for the Acoustic... - Page 38 Table 1 Acoustic Output Reporting Table for Track 1 – Non-Auto-scanning Mode Sonicaid Freedom Wireless Fetal Monitoring System Operating Mode: PWD Application(s): Fetal Monitoring Acoustic Output SPTA.3 SPPA.3 (mW/cm (mW/cm Global Maximum Value* 0.0261 4.64 17.5 (MPa)* 0.0258 total (mW)* 27.5 27.5 (MHz)
- Page 39 Defi nition of Terms The derated spatial peak temporal average intensity SPTA.3 The derated spatial peak pulse average intensity SPPA.3 The spatial average temporal average intensity SATA The mechanical index The derated peak rarefactional pressure The ultrasonic power The acoustic center frequency The axial distance at which the reported parameter is measured respectively the in-plane (azimuthal) and out-of-plane (elevational) -6dB dimensions in the x-y plane where z...
- Page 40 * Note: Values for reference only as these values are not used to defi ne output limits for pulsed Doppler fetal heart rate monitors. Measurement Uncertainty Table 4 contains the measurement uncertainty of the acoustic output parameters stated in tables 1, 2 and 3 above. Table 4: Measurement Uncertainty of Acoustic Output Parameters Parameter Measurement Uncertainty...
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Page 41: 12. End Of Life Disposal
12. End of Life Disposal This symbol signifi es that 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. -
Page 42: 13. Warranty & Service
• Mark the package ‘Service Department ‘ For further details, refer to NHS document HSG(93)26 (UK only). Huntleigh Healthcare Ltd reserve the right to return product that does not contain a decontamination certifi cate. Customer Care Department. Huntleigh Healthcare Ltd, Diagnostic Products Division, 35, Portmanmoor Rd.,... - Page 43 Manufactured in the UK by Huntleigh Healthcare Ltd. As part of the ongoing development programme the company reserves the right to modify specifi cations and materials without notice. Sonicaid and Huntleigh are registered trademarks of Huntleigh Technology Ltd. 2013. © Huntleigh Healthcare Ltd. 2013...
- Page 44 Bedfordshire, LU5 5XF © Huntleigh Healthcare Limited 2013 COMPANY, MEMBER OF THE GETINGE GROUP ® and ™ are trademarks of Huntleigh Technology Limited As our policy is one of continuous improvement, we reserve the right to modify 778332-EN-6 designs without prior notice.
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