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- Page 1 INSTRUCTIONS FOR USE Sonicaid Team3 ® FTS-3 Fetal Telemetry System (Wireless Transducer System) 777866-2 06/2022...
- Page 2 About this Manual P/N: 777866 Version 2 Release Date: June 2022 © Copyright EDAN INSTRUMENTS, INC. 2020. All rights reserved. About this Manual This manual will help you understand the operation and maintenance of the product better. It is reminded that the product shall be used strictly complying with this manual. User’s operation failing to comply with this manual may result in malfunction or accident for which the manufacturer can not be held liable.
- Page 3 Terms Used in this Manual This guide is designed to give key concepts on safety precautions. WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death CAUTION A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure.
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Page 4: Table Of Contents
Contents 1. Safety Guide ..................6 Intended Use/Indications for Use ............6 Instruction for Safe Operation .............. 6 Ultrasound Safety Guide ............... 7 Safety Precautions................. 8 1.4.1 Warnings ........................ 8 1.4.2 Cautions ........................ 13 1.5 Definitions and Symbols ............... 15 2. Introducing the FTS-3 Fetal Telemetry System ........17 Brief Introduction ................... - Page 5 Appendix 1 Product Specifications ............40 A1.1 Environmental Specifications ............... 40 A1.2 Physical Specifications ................40 A1.3 Performance Specifications ..............41 A1.4 Rechargeable Lithium-ion Battery ............43 A1.5 Low Output Summary Table ..............44 Appendix 2 Troubleshooting ..............45 Appendix 3 Ultrasound Intensity and Safety .........46 A3.1 Ultrasound in Medicine ................46 A3.2 Ultrasound Safety and the ALARA Principle ........
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Page 6: Safety Guide
Safety Guide Caution: Federal (U.S.) Law restricts this device to sale by or on the order of a physician. NOTE: In order to ensure the operator and patient’s safety, read through this chapter before using this system. NOTE: This user manual is written to cover the maximum configuration. Therefore, your model may not have some of the parameters and functions described, depending on what you have ordered. -
Page 7: Ultrasound Safety Guide
• The protective degree against electric shock of the patient connections is : Ultrasound (FHR1, FHR2) Type BF External TOCO Direct Electrocardiography (DECG) Type CF Maternal Electrocardiography (MECG) Type CF with defibrillation protection The monitor described in this user manual is not protected against: a) The effects of high frequency currents b) The interference of electrosurgery equipment Ultrasound Safety Guide... -
Page 8: Safety Precautions
Safety Precautions WARNING and CAUTION messages must be observed. To avoid the possibility of injury, observe the following precautions during the operation of the instrument. 1.4.1 Warnings For using safely: FTS-3 is provided for the use of qualified physicians or personnel professionally trained. FTS-3 is not intended for use in intensive care units (ICU), operating rooms or for home use No modification of this system is allowed. - Page 9 SHOCK HAZARD - Do not attempt to connect or disconnect a power cord with wet hands. Make certain that your hands are clean and dry before touching a power cord. SHOCK HAZARD-To avoid the risk of electric shock, this equipment must only be connected to a mains supply with protective earth.
- Page 10 SHOCK HAZARD – Do not connect non-medical electrical equipment which has been supplied as a part of the system, directly to the wall outlet when the non-medical equipment is intended to be supplied by a multiple portable socket-outlet with an isolation transformer. If multiple instruments are connected to a patient, the sum of the leakage currents may exceed the limits given in the IEC/EN 60601-1 and may pose a safety hazard.
- Page 11 Make sure that the power is turned off and the power cord is disconnected from the AC socket before connecting or disconnecting equipment. Otherwise, the patient or operator may receive electrical shock or other injury. Parts and accessories used must meet the requirements of the applicable IEC 601 series safety standards, and/or the system configuration must meet the requirements of the IEC 60601-1 medical electrical systems standard.
- Page 12 Do not immerse, throw or wet the battery in water/ seawater. Do not destroy the battery: Do not pierce battery with a sharp object such as a needle. Do not hit with a hammer, step on or throw or drop to cause strong shock.
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Page 13: Cautions
If the battery is stored inside FTS-3 for a long time without AC power connection, it will discharge over time and the battery indicator for "remaining capacity" will become less accurate. High internal temperature may prevent the battery from charging. Keep FTS-3 at room temperature and move it away from heat sources or out of direct sunlight. - Page 14 Switch off the system power before cleaning. Cleaning consists of removing all dust from the exterior surface of the equipment with a soft brush or cloth. Only the sensor and cable of US/TOCO transducers are watertight. Pay attention not let any liquid enter the transducer plug. The materials with which the patient or any other person can come into contact conform to the standard of EN ISO 10993-1.
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Page 15: Definitions And Symbols
The wireless transducers are IPX8 waterproof, but the base station should be kept non-soaked and non-condensing. The system may be condensing during transportation in high humidity or low temperature. The use of accessories and cables other than those specified may result in increased electromagnetic emissions or decreased electromagnetic immunity of the system. This equipment generates, uses and radiates radio-frequency energy, and if it is not installed and used in accordance with its accompanying documentation, it may cause interference to radio communications. - Page 16 General symbol for recovery/ Fragile , handle with care recyclable Keep Dry This way up HANDLE WITH CARE DO NOT STEP ON STACKING LIMIT BY Channel Adjustment NUMBER Non-ionizing USB Connection (Reserved) electromagnetic radiation Wireless Transducer Working Ethernet Port (Reserved) Indicator Importer Distributor...
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Page 17: Introducing The Fts-3 Fetal Telemetry System
Introducing the FTS-3 Fetal Telemetry System Brief Introduction FTS-3 Fetal Telemetry System (hereinafter called FTS-3) provides monitoring for FHR, DECG MHR, AFM and TOCO for pregnant women. When connected to a compatible fetal monitor, FTS-3 provides wireless patient monitoring in the antepartum period and during labor and delivery. -
Page 18: Base Station
2.1.1 Base Station Top Panel Item Description Docking Slot Locate and charge the transducer. Power Indicator When you turn the power supply, the indicator is on. AC Indicator When AC power is supplied, the indicator is on. When the base station battery is charging, the indicator Battery Indicator is on. - Page 19 Rear Panel Item Description AC Outlet Mains supply Cooling Fan Air ventilation Channel Adjustment Button Adjust the base station channel USB port Reserved Ethernet port Reserved Communication Socket Fetal monitor interface Right Panel Item Description Power Switch Turn the base station on or off. CAUTION.
- Page 20 Base Panel Item Description Battery Compartment Battery location Instructions For Use...
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Page 21: The Transducers
2.1.2 The Transducers US-T Transducer TOCO-T Transducer TOCO-E Transducer Item Description Transducer Apply to the pregnant women. Transducer Type Indicates the transducer type. System Working Indicates the system working channel. Channel Signal Indicator Indicates wireless signal strength. Battery Indicator Indicates battery level. Display “TOCO/DECG”... -
Page 22: Accessories
2.1.3 Accessories FTS-3 DECG Cable Item DECG Cable Plug DECG Cable Connector WARNING. connecting the fetal spiral electrode to the DECG cable, make sure that you have chosen the correct connector for the fetal spiral electrode according to the marking on the DECG cable. FTS-3 MECG Cable Item MECG Connector... -
Page 23: Installation Guide
Installation Guide WARNING. Warning: Installation must be carried out by qualified personnel authorised by the manufacturer. 2.2.1 Opening the Package and Checking Visually examine the package prior to unpacking. If any signs of mishandling or damage are detected, contact the carrier to claim for damage. Open the package; take out the base station and accessories carefully. Keep the package for possible future transportation or storage. - Page 24 If the system is provided with a rechargeable lithium-ion battery, follow these steps to install the battery: 1. Place Sonicaid FTS-3 upside down on a flat surface covered with cloth or another type of protecting pad. 2. Remove the screws of the battery compartment using a cross-head screw driver.
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Page 25: Installing The System
2.2.3 Installing the System FTS-3 should be placed on a flat surface. It should be away from any device with strong radiation and avoid being in a shielded room. More than 2 similar systems should be kept at a distance of over 1.5m. Alternatively, it can be installed on a wall or a trolley approved by Huntleigh. -
Page 26: Connecting To The Monitor
NOTE. The TOCO-T transducer and the TOCO-E transducer cannot be used simultaneously. 2.2.6 Connecting to the Monitor Use the interface cable supplied to connect the FTS-3 system to the monitor. Switch on the monitor and the FTS-3 system. 2.2.7 Adjusting the Working Channel Wireless transmission can be interrupted by other transmitters operating on the same frequency. - Page 27 CAUTION. When the transducer indicates the power is low, replace the transducer with a fully charged one or the monitoring will be interrupted. CAUTION. When docking the transducer into the docking slot for charging, check that the transducer is well placed and whether it is charging. Battery indicator Status Battery is fully charged.
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Page 28: General Application
It takes about 3.5 hours to charge the battery. It is recommended to place the transducer in the docking slot when the transducer is not used for a long time. Install the transducer in the base station and the transducer icon will be displayed on the screen. -
Page 29: Relocation Of The Transducers
NOTE. Please apply coupling gel to the US-T transducer before use and move the transducer to get the desired fetal heart and belt it to the belly. Underwater monitoring requires less coupling gel or no coupling gel. The TOCO-T transducer and TOCO-E transducer can be applied to the belly directly without coupling gel. -
Page 30: Ambulatory Monitoring
2.3.5 Ambulatory Monitoring IMPORTANT: Apply the transducers while the patient is standing for ambulatory monitoring. For ambulatory monitoring of a patient, undock the transducers from the base station and apply them to the patient as described in Section 5.2. During monitoring take care that: •... -
Page 31: Underwater Monitoring
2.3.6 Underwater Monitoring IMPORTANT: Apply the transducers when the patient is in the water for monitoring under water. Use little, or no gel if possible on the US-transducer. Most wireless signal can be absorbed by water. Wireless transmission distances are shorter when monitoring under water. If you have any questions, contact the manufacturer or the local agent. -
Page 32: Performance Test
Remove the TOCO-T or TOCO-E transducer and test the following function: • The TOCO-T or TOCO-E transducer screen displays the standard start interface. • The TOCO-T or TOCO-E transducer indicator is green. • The monitor screen displays TOCO. Touch the measuring area of the TOCO-T or TOCO-E transducer gently: •... -
Page 33: Ending Monitoring / Switching Off
2.4 Ending Monitoring / Switching Off Once monitoring is complete and the transducers and base station have been cleaned, dock the transducers on the base station, so that they are easily located when you want to use the system again, and the transducer batteries can be charged. For charging the transducer batteries, the system must be connected to the mains supply (see Section 2). -
Page 34: Maintenance And Cleaning
Maintenance and Cleaning Maintenance WARNING. All corrective maintenance must be performed by qualified engineers, approved by Huntleigh. The Sonicaid FTS-3 Service manual (PN 777882) is designed as an aid to engineers in maintenance and service of repairable parts. 3.1.1 Maintaining Inspection 1. Visual Inspection Prior to using FTS-3, do the following inspections: •... -
Page 35: Base Station Maintenance
3.1.2 Base Station Maintenance Keep the exterior surface of the monitor and the base station clean, free of dust and dirt. Stop using the base station and contact the service personnel immediately if accidental wetting occurs. 3.1.3 Transducer Maintenance WARNING. The transducers must be cleaned before docking in the base station after each use. -
Page 36: Cleaning And Disinfecting
Cleaning and Disinfecting WARNING. Unplug the base station from the AC power source and detach all accessories before cleaning. Do not immerse the unit in water or allow liquids to enter the case. WARNING. If liquid is splashed on or into the main unit inadvertently, or enters the conduit, stop using the system and contact the manufacturer for service immediately. -
Page 37: Cleaning The Base Station
CAUTION. Please do not light the TOCO transducer with ultraviolet light for a long time. NOTE. The manufacturer has no responsibility for the effectiveness of controlling infectious disease using these chemical agents. Please contact infectious disease experts in your hospital for details. In order to avoid infection, clean and disinfect the base station and accessories after each use. -
Page 38: Sterilising
Cleaning the Leads To disinfect the leads, follow these steps: 1) Wipe them with a soft cloth dampened in the recommended cleaning solution. 2) Wipe them clean with a soft cloth dampened in water. 3) Air-dry them or wipe the remaining moisture with a soft dry cloth. Sterilising Do not sterilise the base station or the accessories, unless this is necessary according to your hospital regulation. -
Page 39: Warranty & Service
Warranty & Service Huntleigh Healthcare Diagnostic Products Division standard terms and conditions apply to all sales. A copy is available on request. These contain full details of warranty terms and do not limit the statutory rights of the consumer. Service Returns If for any reason the Sonicaid FTS-3 has to be returned, please: •... -
Page 40: Appendix 1 Product Specifications
Appendix 1 Product Specifications A1.1 Environmental Specifications Operating Storage Temperature range +5 ºC ~ +40 ºC -20 ºC ~ +55 ºC (+41ºF ~ +104ºF) (-4ºF ~ +131 ºF) 15% to 93% (non Relative Humidity 15% to 93% (non condensing) condensing) 86 kPa to 106 kPa Pressure 70 kPa to 106 kPa A1.2 Physical Specifications... -
Page 41: A1.3 Performance Specifications
Enclosure Leakage N.C. S.F.C. Current (Limit) 100µA 500µA Patient Leakage N.C. S.F.C. Current (Limit) d.c. 10µA 50µA FHR1, FHR2, TOCO a.c. 100µA 500µA Patient Auxiliary N.C. S.F.C. Current (Limit) d.c. 10µA 50µA FHR1, FHR2, TOCO a.c. 100µA 500µA Patient Leakage N.C. - Page 42 TOCO *TOCO Range 0~ 100 *Non-linear Error ±1 0% *Resolution Baseline Drift due to 1 unit/min/°C (free air) Temperature Changes 5 units/min/°C (underwater) Zero Mode Automatic/ Manual Dielectric Strength 4000 Vrms RF Index Transmission Power Wireless transducer:< 1mW e.r.p Base station:< 10mW e.r.p Frequency Range (Area 433.050MHz~434.790MHz Conforms to CE)
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Page 43: A1.4 Rechargeable Lithium-Ion Battery
* MHR Alarm Limits 30 bpm ~ 240 bpm *Anti-electric Shock Type Defibrillating-proof ECG falls off Detect automatically Patient Leakage Current N.C. S.F.C. (Limit) d.c. 10µA 50µA a.c. 10µA 50µA Patient Auxiliary Current N.C. S.F.C. (Limit) d.c. 10µA 50µA a.c. 10µA 50µA Differential Input Impedance... -
Page 44: A1.5 Low Output Summary Table
Transducer Battery Nominal Capacity 1600 mAh Charge Current (Standard) 700 mA Nominal Voltage 3.7 V Charge Voltage (Standard) (4.2±0.1) V >17h (full new battery used in transducer) Operating time >12h (full new battery used in TOCO-E transducer connected with DECG or MECG cable) Cycle Life ≥... -
Page 45: Appendix 2 Troubleshooting
Appendix 2 Troubleshooting US-transducer is removed but no power POSSIBLE CAUSE SOLUTION Transducer battery discharged. Charge transducer Base station and transducer are Replace the transducer then remove again. working on different RF-channels. Restart the Base station No signal on Fetal Monitor even though the indicators on base station are green. POSSIBLE CAUSE SOLUTION Interface cable to Fetal Monitor is... -
Page 46: Appendix 3 Ultrasound Intensity And Safety
Appendix 3 Ultrasound Intensity and Safety A3.1 Ultrasound in Medicine The use of diagnostic ultrasound has proved to be a valuable tool in medical practice. Given its known benefits for non-invasive investigations and medical diagnosis, including investigation of the human fetus, the question of clinical safety with regards to ultrasound intensity arises. - Page 47 TI (Thermal Index) Heating of tissues is caused by absorption of ultrasound when the ultrasound energy is applied.nThe temperature rise is determined by the acoustic intensity, exposed area and thermophysicalbproperties of the tissue. In order to indicate the potential for temperature rise caused by thermal effects, the AIUM andNEMA formulate thermal index (TI).
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Page 48: A3.4 Prudent Use Statement
A3.4 Prudent Use Statement Although no confirmed bioeffects on patients caused by exposure from present diagnostic ultrasound equipment have ever been reported, the potential exists that such bioeffects may be identified in the future. Therefore, the ultrasound should be used prudently. High levels of acoustic output and long exposure time should be avoided while acquiring necessary clinical information. - Page 49 (Hz) 2000.00 (Hz) npps α at z α (W/cm 0.0092 PII. Other α at z α mW/cm 1.66 spta. PII. or z α SII. at z mW/cm 4.34 spta pr. at z (MPa) 0.023 Focus(mm) Fixed Operating Control Depth(mm) Fixed Conditions Frequency(MHz) 1.00 Operating Mode: PW mode Working Frequency: 1.0MHz Acoustic Output SPTA.3...
- Page 50 Ita.α(Zs) Attenuated Temporal-average Intensity Break-point Depth Depth for Bone Thermal Index Ipi.α Attenuated Pulse-intensity Integral Pulse-intensity Integral deq(Zb) Equivalent Beam Diameter at the point of Zsp fawf Center Frequency, Acoustic Working Frequency -12dB Output Beam Dimensions Pulse Duration Pulse Repetition Frequency (Pulse Repetition Rate) Equivalent Beam Diameter Focal Length Ipi.α...
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Page 51: Appendix 4 Abbreviations
Appendix 4 Abbreviations Abbreviation Full Name Alternative Current Automatic Fetal Movement [Detection] Beat(s) Per Minute Cardiotocography Direct Current DECG Direct ECG DFHR Direct FHR Diastolic Blood Pressure Electrocardiogram Fetal Heart Fetal Heart Rate Fetal Movement Fetal Stimulator Maternal Heart Rate Intensive Care Unit Identity Intra-Uterine Pressure... -
Page 52: Appendix 5 Ordering Information
Appendix 5 Ordering Information Accessories (standard and optional configuration) supplied or approved by the manufacturer can be used with the system. See the following table for details. Part Number Accessory ACC-OBS-093 Team3 Interface Cable ACC-OBS-094 Rechargeable Lithium-Ion Battery (14.8V, 5000mAh) ACC-OBS-095 Wireless Ultrasound Transducer (European Standard) ACC-OBS-096... -
Page 53: Appendix 6 Emc Information
Appendix 6 EMC Information A6.1 Electromagnetic Emissions Guidance and Manufacturer’s declaration - electromagnetic emissions FTS-3 Fetal Telemetry System is intended for use in the electromagnetic environment specified below. The customer of the user of FTS-3 should assure that it is used in such and environment. Emissions Test Compliance Electromagnetic Environment - guidance... -
Page 54: A6.3 Electromagnetic Immunity
A6.3 Electromagnetic Immunity Guidance and Manufacturer’s declaration - electromagnetic immunity FTS-3 is intended for use in the electromagnetic environment specified below. The customer or the user of FTS-3 should assure that it is used in such an environment. IEC 60601 test Electromagnetic Environment - Immunity Test Compliance level... - Page 55 Guidance and Manufacturer’s declaration - electromagnetic immunity The FTS-3 Fetal Telemetry System is intended for use in the electromagnetic environment specified below. The customer or the user of FTS-3 Fetal Telemetry System should assure that it is used in such an environment. Immunity Compliance IEC 60601 test level...
- Page 56 Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test IMMUNITY Band Maximum Frequency Service Modulation TEST LEVEL (MHz) Power(W) (MHz) (V/m) Pulse modulation 380-390 TETRA 400 18Hz GMRS 460, FRS ±5 kHz deviation 30-470 1kHz sine Pulse modulation 704-787 LTE Brand 13, 17 217 Hz 800/900,TETRA Pulse modulation 800-960...
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Page 57: Appendix 7 Limitations Of Ultrasonic Monitoring
Appendix 7 Limitations of Ultrasonic Monitoring A7.1 How Does Ultrasound Work When the ultrasound waves strike an object, they bounce back and create an echo. If the object moves toward the sound source, the frequency of the echo increases. If the object moves away from the sound source, the frequency of the echo decreases. - Page 58 Halving: When the FHR increases to 180 bpm or higher, it is possible for the monitor to mistake the two separate hearbeats for the diastole and systole of a single heartbeat. As a result, a heart rate trace that is half the actual heart rate is produced. This often happens during tachycardia, representing an abrupt switch of the trace to half the actual heart rate.
- Page 59 Stethoscopy should be applied when sudden changes in baseline are detected. If the amniotic membrane rupture and cervical dilatation are sufficient, consider using a spiral electrode to obtain precise FHR with direct fetal ECG as the signal source. (4) Erratic Traces / Drop out When the fetal heart moves partially out of the ultrasound wave path, the transducer receives mixed or weak signals, and thereby the monitor presents erratic traces.
- Page 60 If a serious incident occurs in relation to this medical device, affecting the user, or the patient then the user or patient should report the serious incident to the medical device manufacturer or the distributor. In the European Union, the user should also report the serious incident to the Competent Authority in the member state where they are located.
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