Ultrasound Doppler System
Contents
1. Wiem TIS Soft tissue thermal index is a thermal index related to soft tissues TIS scan is the soft tissue thermal index in an auto scanning mode TIS non scan is the soft tissue thermal index in the non autoscanning mode TIB Bone thermal index is a thermal index for applications in which the ultrasound beam passes through soft tissue and a focal region is in the immediate vicinity of bone TIB non scan is the bone thermal index in the non autoscanning mode TIC Cranial bone thermal index is the thermal index for applications in which the ultrasound beam passes through bone near the beam entrance into the body Aaprt Area of the active aperture measured in cm Pra Derated peak rarefactional pressure associated with the transmit pattern giving rise to the value reported under MI Megapascals Wo Ultrasonic power except for TIS can in which case it is the ultrasonic power passing through a one centimeter window in units of milliwatts W 2 Derated ultrasonic power at axial distance z in units of milliwatts Isptaa Z1 Derated spatial peak temporal average intensity at axial distance z4 milliwatts per square centimeter Zs Axial distance corresponding to the location of maximum min W 3 z lraa z x 1 cm where z gt zbp in centimeters 7 1 69 Aapre in centimeters Zsp For MI it is the axial distance at which p 3 is measured For TIB it is the axial distance at which TIB is a global maximum for example Zsp Zp2. kV contact 6 kV contact Floor should be wood discharge ESD 8 kV air 8 kV air concrete or ceramic tile If IEC 61000 4 2 floors are covered with synthetic material the relative humidity should be at least 30 Electric fast 2 kV for 2 kV for Mains power quality should be transient burst power supply lines power supply that of a typical commercial IEC 61000 4 4 1 kV for lines and or hospital environment input output lines Surge 1 KV differential 1 KV differential Mains power quality should be IEC 61000 4 5 mode mode that of a typical commercial 2 kV 2 kV common mode common mode and or hospital environment 14 3 Immunity Test IEC 60601 Compliance Electromagnetic Test Level Level Environment Guidance Voltage dips lt 5 UT lt 5 UT Mains power quality should be short gt 95 dip in UT gt 95 dip in UT that of a typical commercial interruptions and for 0 5 cycle for 0 5 cycle and or hospital environment If voltage the user of the F10 image variations on 40 UT 40 UT intensifier requires continued power supply 60 dip in UT 60 dipin UT operation during power mains for 5 cycles for 5 cycles interruption IEC 61000 4 11 70 UT 70 UT it is recommended that the F10 30 dip in UT for 25 cycles for 25 cycles 30 dip in UT image intensifier be powered from an uninterruptible power supply or a battery lt 5 UT lt 5 UT 95 dip in UT 95 dip
3. 1 2000 A1 2003 Risk analysis managements medical devices TEC60601 1 1988 A1 1991 A2 1995 General requirements for Safety and Essential Performance IEC60601 1 1 2000 Safety requirements for medical electrical systems 1SO10993 1 2003 Biological evaluation of medical devices Part 1 Evaluation and testing Electrocardiograph 1EC60601 2 37 2005 Particular requirements for the safety of electrocardiographic monitoring equipment BS EN 61266 1995 IEC 61266 1994 Ultrasonics Hand held probe Doppler foetal heartbeat detectors Performance requirements and methods of measurement and reporting BS EN 61157 2007 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment Electromagnetic Compatibility TEC 60601 1 sub clause 36 IEC TEC60601 1 2 2001 A1 2004 Electromagnetic compatibility requirements amp test TEC61000 4 2 2001 Electrostatic Discharge Ed 1 2 TEC61000 4 3 2006 Radiated RF electromagnetic field Ed 2 1 TEC61000 4 8 2001 Power frequency 50 60Hz magnetic field Ed 1 1 CISPR 11 EN55011 RF Emissions Group 1 Class B Labeling EN1041 1998 Information supplied by the manufacturer with medical devices Marking TEC TR60878 2003 Graphical symbols for electrical equipment in medical practice EN980 2003 Graphical symbols for use in the labeling of medical devices 1S07000 2004 Graphical symbols for use on equipment index a
4. 80MHz and 800MHz the separation distance for the higher frequency range applies Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the F10 is used exceeds 3V m the F10 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the F10 or using a shielded location with a higher RF shielding effectiveness and filter attenuation 16 17
5. Contact us Mediana Co Ltd Wonju Medical Industry Park 1650 1 Donghwa ri Munmak eup Wonju si Gangwon do Korea Tel 82 2 542 3375 82 33 742 5400 Fax 82 2 542 7447 82 33 742 5483 Web http www mediana co kr EU representative TECNOMED 2000 S L Valencia 25 28012 Madrid Spain MEDIANA Mediana Co Ltd A7153 0 0609 P N OPM F10 EN 2009 08 17 Medical Device MEDIANA Ultrasound Doppler System PERATOR MANUAL Table of Contents Section 1 Safety ea eae ao ee ee eae ee ae ee eae eee T 1 1 1 Safe Operation settee teeters 1 1 2 Warings 100s eerie eee eee e 4 3 O has E EEEE E dh cee Gea de Sees 2 Section 2 F10 62st ees eee etsy ieee eine e eee 4 OA FIO LE E TEE ances R eee 4 2 2 Configuration sees creer eee eee 4 2 3 Composition 0206 e ieee eee eee eee 4 Section 3 How to use your F10 gt 6 2 1 Operational Requirements gt 6 XF HOW tO USE eee sccree dare wate aceon cat eneeaie 6 2 3 Simple Clinic Information gt 7 Section 4 Maintenance and Cleaning 7 General Information ccecce seee 8 Product Guarantee cette ee 9 Specifications 06006 e eee cece eee 10 Copyright Mediana Corporation 2009 All rights reserved Printed in Korea Section 1 Safety 1 1 Safe Operation p gt Examine the monitor and any accessories periodical
6. Warranty Period 1 Year off 1 minute later the sound will be muted automatically In this Date of Purchase case a single beep sound will be heard 5 minutes later the Customer Hospital system will go to sleep mode In this case two beep sounds will be heard The display will be turned off In this mode power very Aadrass little power is consumed lf you want to wake up the device from sleep mode first of all turn the power off and then 1 second later turn the switch on by turning the switch counterclockwise p gt 1 5V x 2 AA Type Batteries are used for the system power Do not use any other type of battery Use of the wrong battery type may damage the equipment p gt Federal law restricts this device to sale by or on the order of a Name Telephone Sales Agency Manufacturer Mediana Co Ltd physician p gt Do not open the device cover or disassemble the device Refer servicing to qualified personnel of Mediana Co Ltd x Thank you for purchasing F10 gt Definition of Symbols x This product is manufactured and has passed through strict quality control and inspection This symbol identifies a safety note Be sure to understand x Compensation standard concerning repair replacement refund the function of this control before using it Control function is of the product complies with Consumer protection law described in the operation manual IEC60601 1 Type BF Equipment IEC60601 1 P IPX7 1met
7. ch the F10 is used exceeds the applicable RF compliance level above the F10 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the FM20 Over the frequency range 150 kHz to 80MHz field strengths should be less than V1 V m Immunity Test IEC 60601 Compliance Electromagnetic Test Level Level Environment Guidance The F10 is intended for use in the electromagnetic environment specified below The customer or the user of the F10 should assure that it is used in such an environment Recommended separation distances between portable and mobile RF communications equipment and the FM20 Recommended separation distance between portable and mobile RF communications equipment and the FM20 The F10 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of he F10 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the F10 as recommended below according to the maximum output power of the communications equipment Rated Maximum Separation distance according to frequency of transmitter m Output Power of 150 kHz to MHz 80 MHz to 800 MHz 800 MHz to 2 5GHz Transmitter W d 3 5 ViJy p d 3 5 EJ 4p d 7 Eq Jp 0 01 0 12 0 11 0 23 The F10 mu
8. emperature of 10 C 40 C and humidity of 30 8 gt Handle with care gt Avoid dust or flammable materials p gt Make sure the batteries are inserted correctly p gt When detaching the probe from the main body slide the probe upwards to prevent damage 3 2 How to use p gt Turn the power and volume switch counterclockwise to turn the device on and adjust the volume level gt Apply a liberal amount of ultrasound gel to the face of transducer end of the probe p gt Place the transducer directly against the abdomen just above the point where the pelvic bones meet in early pregnancy gt Search for the fetal heart by slowly moving the probe around until the fetal heart sounds are heard gt Search for the position which can get the clearest heart sound p gt When the input signal is good and stable FHR will appear the screen and heart rhythm indicator will flash as shown in figure F10 Ultrasound Doppler System Heart Rhythm gt When the input signal is not stable outer shape of heart rhythm indicator will flicker gt Ifthe voltage level of battery is lower than the required level the battery low message bat Lo will appear as shown in Figure In this case the unit will not functional correctly and the batteries should be replaced gt If the user wants to use external speaker connect the audio cable with audio connection on top of the F10 3 3 Simple Clinic Information gt Accele
9. er in watts W according to he transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as deter mined by an electromagnetic site survey should 15 4 Immunity Test IEC 60601 Compliance Electromagnetic environment Test level level guidance Immunity and Compliance Level be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with he following symbol i Immunity Test IEC 60601 Actual Compliance Level Test Level Immunity Level Conducted RF 150 kHz to 80 MHz 3 Vrms 3 Vrms IEC 61000 4 6 Radiated RF 80 MHz to 2 5 GHz 3V m 3V m IEC 61000 4 3 Note At 80 MHz and 800 MHz the higher frequency range applies Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 6 Guidance and manufacturer s declaration Electromagnetic Immunity Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in whi
10. er of water for up to 30minutes IEC60529 Specifications 10 p gt Specifications Ultrasound Center Frequency 2MHz Intensity lt 10mW cm2 Sensitivity 10 12 Weeks Onward Heart Rate Counting Range 50 240bpm FHR Accuracy 2 of range Battery Type 1 5V x 2 LR6 battery AA Type Power consumption 3VA maximum Battery Life About 360min Continuously use PC Interface Sound Card using by BCM220 S W Waterproof Probe IPX7 p gt Physical Main Body L 75mm x 128mm x D 26mm Probe L 25mm X H 131mm x D 25mm Weight Main Body and Probe 200g with batteries p gt Environmental Operating Temperature 10 C 50 F to 40 104 F Operating Humidity 30 85 non condensing Operating Atmospheric Pressure 70kr 106 Kr Storage Temperature 10 14 F to 60 C 131 F Storage Humidity 20 95 non condensing Storage Atmospheric Pressure 70k 106xr Specifications p gt Acoustic Ouput Terms and Definitions Term Definition Isptas Derated spatial peak temporal average intensity in units of milliwatts em TI type Applicable thermal index for the transducer imaging mode and exam type TI value Thermal index value for the transducer imaging mode and exam type MI Mechanical index Ipas MImax Derated pulse average intensity at the maximum MI in units of
11. in UT for 5 sec for 5 sec Power 3 A m 3 A m It may be necessary to position frequency the F10 further from the 50 60 Hz sources of power frequency magnetic field IEC 61000 4 8 magnetic fields or to install magnetic shielding The power frequency magnetic field should be measured in the intended installation location to assure that it is sufficiently low Note Ur is the a c mains voltage prior to application of the test level Guidance and manufacturer s declaration Electromagnetic Immunity IEC 60601 Test level Immunity Test Compliance level Electromagnetic environment guidance The F10 is intended for use in the customer or the user of the F10 should electromagnetic environment specified below The assure that it is used in such an environment Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz Radiated RF 3 V m IEC 61000 4 3 80 MHz to 800 MHz 3 Vim 800 MHz to 2 5 GHz 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz 3 V m Portable and mobile RF communications equipment should be used no closer to any part of the FM20 including cables than the recommended separation distance calculated from the equation appropriate to the frequency of the transmitter Recommend separation distance d 3 5 V Jp d 3 5 E1 Jp 80 MHz to 800 MHz d 7 E Jp 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitt
12. in centimeters deq z Equivalent beam diameter as a function of axial distance z and is equal to 4 0 Wo Mira 2 where ITA z is the temporal average intensity as a function of z in centimeters fe Center frequency in MHz Dim of Aapr Active aperture dimensions for the azimuthal x and elevational y planes in centimeters PD Pulse duration microseconds associated with the transmit pattern giving rise to the reported value of MI PRF Pulse repetition frequency associated with the transmit pattern giving rise to the reported value of MI in Hertz Pr Pllmax Peak rarefactional pressure at the point where the free field spatial peak pulse intensity integral is a maximum in Megapascals deqg Pllmax Equivalent beam diameter at the point where the free field spatial peak pulse intensity integral is a maximum in centimeters FL Focal length or azimuthal x and elevational y lengths if different measured in centimeters 11 Specifications p gt Acoustic Ouput Table This table indicates the acoustic output for the systzem and transducer combinations with a thermal index or mechanical transducer model and imaging mode Transducer Model F10 Operating Mode CW Doppler index equal to or greater than one This table is organized by TIS TIB Index Label MI Sean Non scan B TIC Aapn 1 Aapr gt 1 Global Maxim
13. ly to ensure that the cables line cords transducers and instruments do not have visible evidence of damage that may affect patient safety or monitoring performance The recommended inspection terval is once per week or less Do not use the F10 if there is any isible sign of damage Do not attempt to service th F10 Only qualified service person should attempt any needed internal servicing Perform periodic safety testing to insure proper patient safety This should include leakage current measurement and insulation testing The commended testing interval is once per year The F10 is not specified or intended for operation in conjunction with any other type of monitoring equipment except the specific devices that have been identified for use in this Operator s Manual 1 2 Warings WARNING Be informed that it may cause serious injury or death to the patient property damage material losses against the Warning sign WARNING EXPLOSION HAZARD Do not use the F10 in a flammable atmosphere where concentrations of flammable anesthetics or other materials may ocuur 1 3 Cautions CAUTION Be informed that it may cause no harm in life but lead to injury against the Caution sign CAUTION The relevant law restricts this device to sale by or on the order of a physician CAUTION Keep the operating environment free of dust vibrations corrosive or flammable materials and extremes of temperature and humidity The
14. nd synopsis 13 Manufacture s Declaration A WARNING For best product performance and measurement accuracy use only accessories supplied or recommended by Mediana Use accessories according to the manufacturer s directions for use and your facility s standards The use of accessories transducers and cables other than those specified may result in increased emission and or decreased immunity of the FM20 The F10 is intended for use in the electromagnetic environment specified below The customer or user of the F10 should assure that it is used in such an environment 1 Guidance and manufacturer s declaration Electromagnetic Emissions a Electromagnetic Environment Emission Test Compliance guidance RF emission Group 1 The F10 uses RF energy only for its internal CISPR 11 function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B CISPR 11 Harmonic emissions Class A IEC 61000 3 2 Voltage fluctuations flicker Complies emission IEC 61000 3 3 2 Guidance and manufacturer s declaration Electromagnetic Immunity Immunity Test IEC 60601 Compliance Electromagnetic Test Level Level Environment Guidance The F10 is intended for use in the electromagnetic environment specified below The customer or the user of the F10 should assure that it is used in such an environment Electrostatic 6
15. ration The pattern restored after FHR increasing more than 15 bpm for more than 15 sec from baseline Baseline FHR value in the section of no pains p gt Deceleration The pattern restored after FHR decreasing more than 15 bpm for more than 15 sec from baseline p gt Normal FHR The pattem that FHR is formed between 120 and 160 p gt Reactive The case that Acceleration happens more than 2 times for 10 minutes Healthy p gt Non Reactive The case that Acceleration happens less than 2 times for 10 minutes Section 4 Maintenance and Cleaning To keep the device clean apply alcohol on a soft cloth and wipe the body and the probe once a month Do not use lacquer thinner ethylene or an oxidizing agent If you use material that is not approved it may cause damage to the product In this case the product will not be guaranteed within the warranty period Keep the probes clean from dust or grime Wipe the cable with a damp and with clinical alcohol once a week Do not immerse the main body or the probe in any liquid or detergent Keep the main unit and the probe away from any liquid General Information Product Guarantee p gt F10 is classified as listed below Type BF Model Name F10 Internal powered equipment according to IEC EN 60601 1 Approval No This equipment conforms to Level B according to IEC EN Approval Date poetic Serial No gt Turn the power off after use If you do not turn the power switch
16. st be used only in Conducted RF 3 Vrms 3 Vrms a shielded location with a IEC 61000 4 6 150 kHz to 80 MHz 150 kHz to 80 minimum RF shielding MHz effectiveness and for each cable that enters the shielded location with a minimum RF shielding effectiveness and for each cable that enters the shielded location Radiated RF 3 V m 3 V m Field strengths outside the IEC 61000 4 3 80 MHz to 800 80 MHz to 2 5 shielded location from fixed RF MHz GHz transmitters as determined by an electromagnetic site survey 3 Vim 3 V m should be less than 3 V m 800 MHz to 2 5 GHz Interference may occur in the vicinity of equipment marked with he following symbol in 0 1 0 37 0 36 0 73 1 1 17 1 16 2 33 10 3 69 3 68 7 37 Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Note It is essential that the actual shielding effectiveness and filter attenuation of the shielded location be verified to assure that they meet the minimum specification 100 11 66 11 66 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note At
17. um Index Value a a 0 727 b Pra MPa 0 00236 Wo mw 6 2 min of Wa Z1 Ira s Z1 _ mW H ES Z cm ee 2 2p cm 2S ze cm 1 4 1 4 3 dea Zsp cm 1 414 lt fe MHz 200 2 00 Dim of Aaprt X cm 0 898 Y cm 0 65 PD psec 10 5 PRF Hz 99968 g Pr Pllmax MPa 2 deg Pllmax cm 5 Focal Length FL cm FLy cm lpa3 Mlmax W cm gt 2 Control 1 Exam Type 3 5 Control 2 Sample Volume 3 S Control 3 PRF Os O O Control 4 Sample Volume Position 12 a This index is not required for this operating mode value is lt 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this operating condition since the global maximum index value is not reported for the reason listed Reference Global Maximum Index Value line Data are not applicable for this transducer mode Specifications p gt Compliance Item Compliant with Classification Internally powered Type of protection Type BF Applied part Mode of operation Short time operation Degree of protection Class IPX7 DOP Probe General 93 42 EEC Directives for medical devices 1S09001 2000 Quality Management Systems Requirements 1S013485 2003 Quality Systems Medical Devices Particular requirements for the application of IS09001 1S01497
18. unit should be kept clean and free of transducer gel and other substances CAUTION Do not operate the unit if it is damp or wet because of condensation or spills Avoid using the equipment immediately after moving it from a cold environment to a warm humid location CAUTION The equipment conforms to Class A according to IEC EN 60601 1 Safety of Electric Medical Equipment This equipment conforms to Level B according to IEC EN 60601 1 2 Electromagnetic Compatibility Requirements CAUTION Equipment containing primary batteries shall contain a warning to remove these batteries if Equipment is not likely to be used for some time Operator manual Rev 00 F10 F10 Operator manual Rev 00 Section 2 F10 gt Main Body Rear View 2 1 F10 F10 is a pocket sized fetal doppler that measures the fetal heart Battery Cover rate and outputs the fetal heart sound through a built in speaker Measuring the fetal heart rate FHR gives an indication of fetal well being 2 2 Configuration F10 Main Body 1EA Ultrasound Gel 1EA Carrying Case 1EA 1 5V Battery 2EA User Manual 1EA 2 3 Composition p gt Main Body Front Top and Left side View Groove Joint Sensor Power and Volume Switch Ear Phone Jack Probe Holder LCD Window Speaker Section 3 How to use your F10 3 1 Operational Requirements gt F10 has to be used under surrounding t
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