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Instructions For Use

Enclosure Leakage

Current (Limit)

N.C. S.F.C.

100µA 500µA

Patient Leakage

Current (Limit)

FHR1, FHR2, TOCO

N.C. S.F.C.

d.c. 10µA 50µA

a.c. 100µA 500µA

Patient Auxiliary

Current (Limit)

FHR1, FHR2, TOCO

N.C. S.F.C.

d.c. 10µA 50µA

a.c. 100µA 500µA

Patient Leakage

Current (Limit)

DECG, MHR(from MECG)

N.C. S.F.C.

d.c. 10µA 50µA

a.c. 10µA 50µA

Patient Auxiliary

Current (Limit)

DECG, MHR(from MECG

N.C. S.F.C.

d.c. 10µA 50µA

a.c. 10µA 50µA

Base Station
Weight

About1.8 kg

Size

310mm x 235mm x81mm

US-T Transducer
Weight

About 150 g

Size

Ø81 mm × 35 mm

TOCO-T Transducer & TOCO-E Transducer
Weight

About 150 g

Size

Ø81 mm × 35 mm

A1.3 Performance Specifications

Ultrasound
*FHR Measurement Range

50 bpm ~ 240 bpm

*Resolution

1 bpm

*Accuracy

±2 bpm

Technique

Ultrasound Pulse Doppler with autocorrelation

Pulse Repetition Rate

2 kHz

Pulse Duration

92 µs

Ultrasound Frequency

(1+10%) MHz

< 1 MPa

<10 mW/cm2

spta

<100 mW/cm2

Dielectric Strength

4000 Vrms

Содержание HUNTLEIGH FTS-3

Страница 1: ...FTS 3 Fetal Telemetry System Wireless Transducer System INSTRUCTIONS FOR USE Sonicaid Team3 777866 2 06 2022 ...

Страница 2: ...ight law including but not limited to confidential information such as technical information and patent information are contained in this manual the user shall not disclose such information to any irrelevant third party The user shall understand that nothing in this manual grants him expressly or implicitly any right or license to use any of the intellectual properties of the manufacturer The manu...

Страница 3: ... death CAUTION A CAUTION label advises against actions or situations that could damage equipment produce inaccurate data or invalidate a procedure NOTE A NOTE provides useful information regarding a function or a procedure Regulatory Approval Remarks MECG and DECG function ARE NOT available in the USA and Canada at the time of release of this user manual Consult your local representatives for the ...

Страница 4: ...guration 25 2 2 6 Connecting to the Monitor 26 2 2 7 Adjusting the Working Channel 26 2 3 Basic Operation 26 2 3 1 Charging the Transducers 26 2 3 2 Charge the Battery 26 2 3 3 General Application 28 2 3 4 Relocation of the Transducers 29 2 3 5 Ambulatory Monitoring 30 2 3 6 Underwater Monitoring 31 2 3 7 Basic Function Test 31 2 3 8 Performance Test 32 2 4 Ending Monitoring Switching Off 33 3 Mai...

Страница 5: ...Safety and the ALARA Principle 46 A3 3 Explanation of MI TI 46 A3 4 Prudent Use Statement 48 A3 5 References for Acoustic Output and Safety 48 A3 6 Transducer Acoustic Output Parameters List 48 A3 6 1 Test of Wireless Transducer FTS 3 48 Appendix 4 Abbreviations 51 Appendix 5 Ordering Information 52 Appendix 6 EMC Information 53 A6 1 Electromagnetic Emissions 53 A6 2 Recommended Separation Distanc...

Страница 6: ...eration NOTE In this manual System refers to FTS 3 The system is designed to comply with the international safety requirements IEC EN 60601 1 for medical electrical equipment It is class I equipment The system operates within specifications at ambient temperatures between 5 ºC 41 ºF and 40 ºC 104 ºF Ambient temperatures that exceed these limits could affect the accuracy of the instrument and cause...

Страница 7: ... rate monitoring during pregnancy and labour Clinical interpretation of fetal heart rate traces can diagnose fetal and or maternal problems and complications Instructions for Use in Minimizing Patient Exposure The acoustic output of the monitor is internally controlled and can not be varied by the operator in the course of the examination The duration of exposure is however fully under the control...

Страница 8: ...ospital grade outlet is required If the outlet has only two slots make sure that it is replaced with a three slot grounded outlet before attempting to operate FTS 3 The protective earth conductor is required for EMC purposes It has no protective function against electric shock Double and or reinforced insulation protects this device against electric shock Multiple portable socket outlets shall not...

Страница 9: ... doubt consult our technical service department or your local distributor Connecting any accessory such as external printer or other device such as the computer to this system makes a medical system In that case additional safety measures should be taken during installation of the system and the system shall provide a Within the patient environment a level of safety comparable to that provided by ...

Страница 10: ...ously on a same patient in case of a possible hazard caused by leakage current superposition Do not apply this system simultaneously with other PATIENT connected equipment such as a cardiac pacemaker or other electrical stimulators on the same patient Do not place the TOCO transducer on oedematous or fragile tissue change the measuring site after half an hour FTS 3 must only be used on one patient...

Страница 11: ...ne with exposed electrical contacts Do not service or maintain FTS 3 or any accessory whilst in use with the patient Assembly of FTS 3 and modifications during actual service life shall be evaluated based on the requirements of IEC60601 1 The disposable ECG electrode must not be reused and must not be used if the packaging is damaged The instrument is precise Therefore to avoid instrument damage d...

Страница 12: ...y away from fire immediately when leakage or foul odor is detected Stop using the battery if abnormal heat odor discoloration deformation or abnormal condition is detected during use charging or storage Keep it away from FTS 3 Remove the battery and store it at a cool and dry environment if FTS 3 is not used for a long time Unplug FTS 3 before installing and removing the battery Do not connect the...

Страница 13: ...hould be replaced by service personnel authorised by the manufacturer If the transducer has been dropped or knocked please check whether the cover is airproof or damaged If you have any doubt please contact the manufacturer or local agent If the battery is removed from the base station and not used for a long time we recommend that the battery should be charged at least once every 6 months to prev...

Страница 14: ...ced by RF fields are subject to technological limitations To ensure that external electromagnetic fields do not cause erroneous measurements it is recommended to avoid the use of electrically radiating equipment in close proximity to these measurements Electromagnetic Interference FTS 3 should not be used adjacent to or stacked with other equipment refer to section A6 2 Recommended Separation Dist...

Страница 15: ...ended charging temperature for the battery is between 0 40 32 ºF 104 ºF Please do not exceed the temperature range 1 5 Definitions and Symbols Rx Only Federal U S Law restricts this device to sale by or on the order of a physician IPX1 Protected against vertically falling water drops IPX8 Protected against the effects of continuous immersion in water This product including its accessories and cons...

Страница 16: ...l for recovery recyclable Keep Dry This way up HANDLE WITH CARE DO NOT STEP ON STACKING LIMIT BY NUMBER Channel Adjustment Non ionizing electromagnetic radiation USB Connection Reserved Ethernet Port Reserved Wireless Transducer Working Indicator Importer Distributor ...

Страница 17: ... fetal maternal monitor and connects to the monitor by an interface cable supplied with the product The wireless transducers monitor the FHR and TOCO parameters up to 110 Metres line of sight and then the base station transfers the data to the monitor via the interface cable The monitor can display alarm print or review the parameters FTS 3 consists of the wireless US transducers US T transducers ...

Страница 18: ...or When the base station battery is charging the indicator is on When the battery level is low it is flashing 5 Wireless Connection Indicator When the transducer connects to the base station successfully the green light is on 6 Charging Point When you place the transducer in the docking slot you can charge the transducer by these contacts WARNING The charging contacts are specifically for charging...

Страница 19: ... station channel 4 USB port Reserved 5 Ethernet port Reserved 6 Communication Socket Fetal monitor interface Right Panel 1 Item Description 1 Power Switch Turn the base station on or off CAUTION This system is a normal medical device Do not switch the unit on and off repeatedly as damage could occur CAUTION Do not switch the unit off when the transducers are in use ...

Страница 20: ...20 Instructions For Use EN Base Panel 1 Item Description 1 Battery Compartment Battery location ...

Страница 21: ...ransducer Type Indicates the transducer type 3 System Working Channel Indicates the system working channel 4 Signal Indicator Indicates wireless signal strength 5 Battery Indicator Indicates battery level 6 TOCO E Display Display TOCO DECG when connected to DECG cable Display TOCO MECG when connected to MECG cable Display TOCO when not connected to DECG cable or MECG cable ...

Страница 22: ...g 2 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 1 3 2 Item 1 MECG Connector 2 MECG Fastener 3 Lead Wire ...

Страница 23: ...ables and accessories Should any damage be evident or any parts missing ensure that Huntleigh Healthcare Ltd is informed at once 2 2 2 Installing the Battery WARNING The Lithium battery pack should only be installed by suitably qualified personnel WARNING Switch off Sonicaid FTS 3 and unplug it before installing or removing the battery WARNING To disconnect from the mains the plug must be removed ...

Страница 24: ...r 3 Take the battery out from package and put it into the compartment Make sure the battery connector is on the left and the battery label faces down WARNING Do not touch the battery terminals with fingers or metal materials This may cause a short circuit and be hazardous 4 Arrange the battery flat in the compartment and push the strip at the end of the battery into the gap 5 Shut the battery comp...

Страница 25: ...ower supply of the system complies with the following specification 100V 240V 50Hz 60Hz WARNING If the protective grounding protective earth system is in doubt the power of the system must be supplied by internal power supply only To disconnect from the mains the plug must be removed Always ensure that the power switch and plug are easily accessible NOTE If the mains supply is interrupted and a ba...

Страница 26: ...uttons on the rear panel of the base station to select the new channel number The channel range is 1 14 3 Restart the system when it enters the charging interface NOTE The working channel number used by a system cannot be duplicated with that used by a device of the same type 2 3 Basic Operation 2 3 1 Charging the Transducers Place the transducer in the docking slot and it displays the charging st...

Страница 27: ...utomatically when it is placed in the docking slot Keep the transducer free of water and coupling gel during charging When you charge the battery the screen will display as follows Full charging icon fully charged Increasing charging icon charging No charging icon the transducer is placed in the docking slot incorrectly If the screen displays ERROR it indicates that the transducer is not connected...

Страница 28: ... the transducer connects to the base station successfully the wireless connection indicator is always on and do not put back the inactivated transducer in the docking slot Place the transducer on the patient WARNING The MECG cable is defibrillation proof The DECG cable is not defibrillation proof NOTE Detailed operations please refer to the user manual of fetal maternal monitor NOTE If the working...

Страница 29: ...or the MECG cable be kept straight to avoid damage to the TOCO E transducer s interface caused by twisted cable 2 3 4 Relocation of the Transducers Transducers may be belted on the patient for a long time In rare cases this may lead to irritations to the patient skin To avoid skin irritations please inspect the application site at least every half an hour If the skin quality changes you should mov...

Страница 30: ...ce can be anticipated and others can be discovered by observing the signal Within the wireless range there may be dead spots where there is no signal due to building construction or interference from other sources The FHR may not be detected clearly when the patient moves in virtue of artificial interference The transducer is easy to shift underwater and it may lead to temporary signal loss No mat...

Страница 31: ... TOCO baseline in virtue of water temperature and depth or other reasons Please adjust the TOCO baseline until the pressure of the transducer in water is steady and keep checking it CAUTION A metal bath tub and underwater monitoring both reduce the operating range CAUTION DECG and MHR cannot be monitored underwater 2 3 7 Basic Function Test A functional test should be performed after initial insta...

Страница 32: ...harge the US T TOCO T or TOCO E transducers 2 3 8 Performance Test To test a US transducer 1 Connect the FTS 3 system to the monitor and switch it on 2 Take up a US T transducer and make sure it is successfully connected to the base station 3 Hold the transducer with one hand and gently touch the center of the transducer with the other hand in the frequency of 2 times per second 4 Check that the v...

Страница 33: ...e charged For charging the transducer batteries the system must be connected to the mains supply see Section 2 WARNING To disconnect from the mains the plug must be removed Always ensure that the plug is easily accessible Note After the fetus is delivered the monitor may pick up signals of the umbilical cord and display a trace numeric To avoid misinterpretation it is recommended to remove the tra...

Страница 34: ...pection The overall check of the base station and the accessories including safety check and function check should be performed by qualified personnel every 6 to 12 months and each time after service The equipment should undergo periodic safety testing to ensure proper patient isolation from leakage currents This should include leakage current measurement and insulation testing The recommended tes...

Страница 35: ...o clear away the oxide of coupling gel Charge and discharge the wireless transducer battery every 3 months 3 1 4 Battery Maintenance It is required to follow the instructions in this user manual during installation storage and maintenance of the battery When the battery is charged used or stored keep it away from objects or materials with static electric charges The recommended charge temperature ...

Страница 36: ...xample acetone CAUTION Never use an abrasive such as steel wool or metal polish CAUTION Do not allow any liquid to enter the product and do not immerse any part of the base station into any liquid CAUTION Avoid pouring liquids on the base station while cleaning CAUTION Do not allow any remaining solution on the surface of the base station NOTE The base station surface can be cleaned with hospital ...

Страница 37: ...rs the connector After cleaning no remaining cleanser is allowed on the surface Clean the charging point periodically or it will not be charged 3 2 1 Cleaning the Base Station Regular cleaning of the base station enclosure is strongly recommended The solutions recommended for system cleaning are mild near neutral detergent ethanol 75 and isopropanol 70 Clean the base station enclosure with a soft ...

Страница 38: ...tion 3 4 Before Use NOTE Check if the base station cables and accessories function well If any problem is detected please contact the manufacturer for service before reusing them Visual Inspect the base station and cables etc for any damage Power On Power on the system Does it boot up successfully without errors Functionality Test When the monitor is connected to FTS 3 after power up check whether...

Страница 39: ...S document HSG 93 26 UK only Huntleigh Healthcare Ltd reserve the right to return product that does not contain a decontamination certificate Customer Care Department Huntleigh Healthcare Ltd Diagnostic Products Division 35 Portmanmoor Rd Cardiff CF24 5HN United Kingdom Tel 44 0 29 20496793 Service 24hr answer machine Tel 44 0 29 20485885 Fax 44 0 29 20492520 Email sales huntleigh diagnostics co u...

Страница 40: ...EN 60601 2 37 IEC 60601 2 27 EN 62479 2010 ETSI EN 301 489 1 ETSI EN 301 489 3 ETSI EN 300 220 1 ETSI EN 300 220 2 Anti electric Shock Type Class I equipment with internal power supply Anti electric Shock Degree FHR1 FHR2 TOCO BF DECG CF MHR from MECG CF with defib protection Degree of Protection against Harmful Ingress of Water Base station IPX1 protected against vertically falling water drops Tr...

Страница 41: ...nt Limit DECG MHR from MECG N C S F C d c 10µA 50µA a c 10µA 50µA Base Station Weight About1 8 kg Size 310mm x 235mm x81mm US T Transducer Weight About 150 g Size Ø81 mm 35 mm TOCO T Transducer TOCO E Transducer Weight About 150 g Size Ø81 mm 35 mm A1 3 Performance Specifications Ultrasound FHR Measurement Range 50 bpm 240 bpm Resolution 1 bpm Accuracy 2 bpm Technique Ultrasound Pulse Doppler with...

Страница 42: ...when performing underwater monitoring using US T and TOCO T transducers keep the transducer at a distance 30cm from the water surface and a distance 8m from the base station Modem Mode GFSK Transmission Rate About 25kbps Channel Range 1 14 Transducer Antenna FM antenna Base Station Antenna Internal antenna DECG Technique Peak peak detection technique DFHR Measurement Range 30bpm 240bpm Resolution ...

Страница 43: ...00 nA Accuracy and Response to Irregular Rhythm Not Supported Response time to Change in MHR MHR range 80bpm 120bpm Range 7s 11s average 9s MHR range 80bpm 40bpm Range 8s 12s average 10s Tall T wave Rejection Exceeds ANSI AAMI EC13 2002 Sect 3 1 2 1 C maximum recommended 1 5mV T Wave amplitude AFM Display Range 0 999 FM Mode Automatic AFM Mode Trace default or Black Mark Technique Pulsed Doppler u...

Страница 44: ... in transducer 12h full new battery used in TOCO E transducer connected with DECG or MECG cable Cycle Life 500 times A1 5 Low Output Summary Table For systems with no transducers having global maximum index values exceeding 1 0 System Fetal Telemetry System Transducer 12 Crystal Wafer Transducer Model ISPTA 3 mW cm2 TI Type TI Value MI Ipa 3 MImax W cm2 PW1 0MHz 1 66 TIS 0 0079 017 0 0092 TIB 0 06...

Страница 45: ...transducers for best signal Transducer is sliding on the skin Reposition and fasten securely Use less gel on the US transducer Excessive movement Ask the patient to restrict movement RF interference or patient at the end of range Instruct patient to stay inside the area where reception is good Charging indicator is off even though the transducer is docked for charging POSSIBLE CAUSE SOLUTION Trans...

Страница 46: ...ed statements to the effect that there are no known adverse effects from the use of diagnostic ultrasound however exposure levels should always be limited to As Low As Reasonably Achievable the ALARA principle A3 3 Explanation of MI TI MI Mechanical Index Cavitations will be generated when ultrasound wave passes through and contacts tissues resulting in instantaneous local overheating This phenome...

Страница 47: ... rise in the cranial bones or superficial bones Measurement Uncertainty The uncertainties in the measurements were predominantly systematic in origin the random uncertainties were negligible in comparison The overall systematic uncertainties were determined as follows 1 Hydrophone Sensitivity Based on the HNP 0400 hydrophone calibration certificate the hydrophone measurement uncertainty for 1 15MH...

Страница 48: ...output indices on diagnostic ultrasound equipment Revision 2 issued by AIUM NEMA in 2004 5 Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers issued in 2008 6 Medical electrical equipment Part 2 37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment issued by IEC in ...

Страница 49: ... 1 66 0 0092 Associated Acoustic Parameters Pr 3 MPa 0 017 Wo total mW 9 69 9 69 fc MHz 1 00 1 00 1 00 Zsp cm 6 55 6 55 6 55 Beam Dimensions x 6 cm 0 48 0 48 y 6 cm 0 56 0 56 PD µS 90 07 90 07 PRF Hz 2000 00 2000 00 Overall EBD cm Az cm Φ3 46 Elev cm Φ3 46 Operating Control Conditions Focus mm Fixed Depth mm Fixed Frequency MHz 1 00 IEC60601 2 37 standard parameter equal contrast list IEC60601 2 3...

Страница 50: ...se average Intensity at the point of Maximum MI Aaprt 12dB Output Beam Area MI Mechanical Index TIS Soft Tissue Thermal Index TIB Bone Thermal Index TIC Cranial bone Thermal Index parameter specified in TRACK1 of FDA Guidance TRACK1 parameter NOTE pr 3 Derated Peak rare factional Acoustic Pressure W0 Output Power zsp zsp zB 3 Depth for Bone Thermal Index fc Center Frequency Acoustic x 6 6dB Beamwi...

Страница 51: ...tor MHR Maternal Heart Rate ICU Intensive Care Unit ID Identity IUP Intra Uterine Pressure IUPC Intra Uterine Pressure Catheter LCD Liquid Crystal Display MAP Mean Artery Blood Pressure MECG Maternal ECG MFM Manual Fetal Movement Detection MRI Magnetic Resonance Imaging NIBP Non Invasive Blood Pressure NST Non Stress Test PR Pulse Rate RF Radio Frequency SOV Signals Overlap Verification SpO2 Pulse...

Страница 52: ...98 TOCO T Wireless TOCO Transducer USA ACC OBS 099 Wireless TOCO E Transducer ACC OBS 100 2 lead ECG Cable Snap Style AHA ACC OBS 101 2 lead ECG Cable Snap Style IEC ACC OBS 102 DECG Cable Reusable Cable for Tyco FSE The accessories employed by the manufacturer such as the rechargeable battery are products having passed the authentication of CE and they have the characteristics specified by their ...

Страница 53: ...etal Telemetry System The FTS 3 Fetal Telemetry System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the FTS 3 Fetal Telemetry System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the FTS 3 Fetal Telemetry Sy...

Страница 54: ... line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 0 UT 0 5 cycle At 0 45 90 135 180 225 270 and 315 0 UT 1 cycle and 70 UT 25 30 cycles Single phase at 0 0 UT 50 300 cycle 0 UT 0 5 cycle At 0 45 90 135 180 22...

Страница 55: ...gnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80MHz and 800MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Fie...

Страница 56: ... 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation b 217 Hz 2 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation b 217 Hz 2 28 5240 5100 5800 WLAN 802 11 a n Pulse modulation b 217 Hz 0 2 9 5500 5785 Note If necessary to achieve the IMMUNITY TEST LEVEL the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM maybe reduce to 1m The 1...

Страница 57: ...uces a stream of sound waves which penetrate into the maternal abdomen and bounce off the fetal heart Then the transducer receives the echoes and transfers them to the monitor which turns the signal into fetal heart beating sound and fetal heart rate trace Therefore placement of the transducer is critical to ultrasound fetal heart monitoring A7 2 Artifacts in Fetal Heart Monitoring 1 How does arti...

Страница 58: ...le 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 The clinicians may interpret it as a deceleration However the heart beat sound from the monitor speaker is still reliable even when doubling or halving is occurring ...

Страница 59: ...moves partially out of the ultrasound wave path the transducer receives mixed or weak signals and thereby the monitor presents erratic traces When the fetal heart moves fully out of the path inadequate consecutive and periodic signals are received and no trace is represented Erratic traces and transitory episodes of drop out are common especially when the fetus or and mother move s If they exist f...

Страница 60: ...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 Huntleigh Healthcare Ltd 35 Portmanmoor Road Cardiff CF24 5HN United Kingdom T 44 0 29 20485885 sales huntleigh diagnostics co uk www huntleigh diagnostics com www huntleigh diagnostics com ...

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