Sonoline A/B Pocket Fetal Doppler
Contents
1. MEDIPREVENTIECENTRUM Webshop voor Fysiotherapie fitness en sport CE onz Sonoline A B Pocket Fetal Doppler User Manual CONTEC Medical Systems CO LTD www medipreventiecentrum nl www medipreventiecentrum nl Attention This user manual is written and compiled in accordance with the council directive MDD93 42 EEC for medical devices and harmonized standards In case of modifications and software upgrades the information contained in this document is subject to change without notice The manufacturer makes no warranty of any kind with regard to this material including but not limited to the 1mplied warranties of merchantability and fitness for a particular purpose The manufacturer assumes no responsibility for any errors that may appear in this document or for incidental or conseguential damage 1n connection with the furnishing performance or use of this material No part of this document may be photocopied reproduced or translated to another language without prior written consent of the manufacturer The information contained in this document is subject to change without notice Responsibility of the Manufacturer The manufacturer only considers itself responsible for any effects on safety reliability and performance of the equipment if Assembly operations repairs are carried out by persons authorized by the manufacturer and the device is used in accordance with the instructions for use A WARNINGA This device is2. Push down the button and hold 3 seconds to power off Sonoline B www medipreventiecentrum nl 3 2 2 Mode Button Sonoline B only Mode selection button Function mode selection press once to enter next working mode under working status For the Fetal Doppler has memory function when turning on the machine it will enter the mode selected before last power off automatically after self testing 3 2 3 Backlight Control Button Sonoline B Only Function Under mode 1 and mode 2 press the button to turn on off backlight Under mode 3 the button 1s for start stop operation please refer to 4 2 3 manual mode Mode 3 3 2 4 Volume Control Indicator ibm Volume adjusting direction indicator From left to right means that the sound level is from high to low 3 3 Introduction to Top Panel Headphone Socket a socket for audio output and can be connected with earphone or recorder with audio input to record 6 The socket terminal post or switch that connected with the A headphones Attention Refer to the accompanying documents Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards e g IEC 950 for data processing equipment and IEC 60601 1 for medical equipment Furthermore all configurations shall comply with the valid version of the system standard IEC60601 1 1 Everybody who connects additional equipment to the signal input connector or signal
3. output connector configures a medical system and is therefore responsible that the system complies with the requirements of the valid version of the system standard IEC60601 1 1 If in doubt consult our technical service department or your local distributor 3 3 1 Signal Interface www medipreventiecentrum nl Fig 3 8 Headphone Socket for Audio Output Headphone socket showed as Fig 3 8 the definition of pins showed as below Pin Definition 1 GND 2 Signal 3 Signal 4 Signal 5 Signal 10 www medipreventiecentrum nl Chapter 4 General Operation 4 1 FHR Inspection Power on by pressing the power button For Sonoline A indicator light will be on in green color For Sonoline B it will do self test when turning on the machine After self testing the LCD display is as Fig 3 4 Find the position of fetus At first please feel the position of the fetus by hand Find out the best direction for inspecting the fetal heart Apply a liberal amount of gel to the faceplate of probe place the faceplate of probe at the best position for detecting fetal heart Adjust the probe to obtain an optimum audio signal ideally by angling the probe around Adjust the volume according to requirements FHR Calculation For Sonoline A the method is to count the fetal heart beat times in one minute to get the FHR For Sonoline B the FHR result will be showed on LCD screen Turn off the machine For Sonoline A p
4. Fig 4 1 12 www medipreventiecentrum nl L ig Reese inlet cee MEETS AM Ie ee ue a uis h m WE a r sies ES bad gt Poy A 1 s gt 2 sS a 7 amp amp s i e Ac P Pj E Ee i id sh ZE Mau EE 5 ene e A E Ux en A Anna at hw YM bu Senn AM ME e e De Bees i hb Re CN e e 2 Bs EN EN og ef enone 22 MS ANS er OAN x EN A Me e E3 Sy al x eX e d Me k a SE AR Rer X s GEI hy s j Fi X Ff E Filii i 3 X iR CR ERKENS met ERR ERR Fig 4 1 Taking Out Probe Placing probe It is opposite to take out probe Hold the main unit with one hand and hold the top of the probe with another hand then push the probe into the probe holder 4 4 Inspection of Low Power For Sonoline A when it works normally the LED indicator light of the battery 1s green but when the power of the battery is low to the degree that it cannot support the Sonoline A to work normally the LED indicator light of the battery will flicker in green to remind the customer to change another new battery or charge the battery only the chargeable battery can be charged For Sonoline B when it works normally the LCD screen displays the status of the battery and the number of the grid in the status represents how much power is left when the power of the battery is low the power of the battery displays grid O to remind the customer to change another new battery or charge the battery o
5. Length x95 mm Width x35 mm Height Weight About 180 g including batteries Environment Working Temperature 5C 406 Humidity 80s Atmospheric Pressure 70 kPal06 kPa Transport and Storage Temperature 106 55 Humidity 93c Atmospheric Pressure 50 kPal06 kPa Display 45 mm x 25 mm LCD display Backlight The two statuses can be alternated turn off on the backlight FHR Performance Sonoline B model only FHR Measuring Range 50 BPM 240 BPM BPM beat per minute Resolution I BPM Accuracy 2 BPM Power Consumption lt 0 5 W Auto Shut OFF After 1 minute no signal power off automatically Sonoline B only Battery Type Recommended Two pieces of 1 5 V DC batteries SIZE AA LR6 2MHz Ultrasound Probe Standard Configuration Nominal Frequency 2 0 MHz Working Frequency 2 0 MHz 10 P 0 5 MPa 15 www medipreventiecentrum nl Ic lt 10 mW cm Loi lt 50 mW cm Ultrasonic Output Intensity 34 lt 5 mW cm Working Mode Continuous wave doppler Effective Radiating Area of Transducer 208 mm 15 Note In all working application modes mechanical index MI lt 1 thermal index TI lt 1 16 www medipreventiecentrum nl Chapter 6 Maintenance 6 1 Maintenance The probe acoustic surface is frangible and must be handled with care Gel must be wiped from the probe after use These precautions will prolong the life of the unit The user must check that the eguipment does not have visible e
6. adequate training knowledge and practical experience to perform these tests Inspect the equipment for mechanical and functional damage Inspect the safety relevant labels for legibility Verify that the device functions properly as described in the instructions for use Test the patient leakage current according to IEC 60601 1 1988 Limit 100 uA B The leakage current should never exceed the limit The data should be recorded in an equipment log If the device is not functioning properly or fails any of the above tests the device has to be repaired amp CAUTION The battery must be properly disposed according to local regulation after their use amp CAUTION The battery must be taken out from the battery compartment if the device will not be used for a long time CAUTION The device shall only be used if the battery cover is closed CAUTION Battery must be stored in cool and dry place VCAUTION If use rechargeable battery to insure capability and life please fully charge batteries before first use normally batteries must be continuously charged over 14 hours or charged according to the guidance displayed on the battery CAUTION Please don t set anode and cathode of the battery wrongly amp CAUTION The valid period of this product is five years amp CAUTION After the service life please return the products to the manufacture or disposal the products according to local regulations
7. not intended for treatment The intended use is for detecting Fetal Heart Rate If the FHR result is distrustful please use other methods such as stethoscope to verify 1mmediately Warranty The unit can not be repaired by users themselves All services must be done by the engineers approved by manufacturer We warrant that each product we sell you is free from defects in labor and materials and shall conform to its product specifications as defined in the user documentation If the product doesn t function as warranted during the warranty period we will repair or replace it without charge Misuse improper maintenance may void the warranty Using This Label Guide This guide is designed to give key concepts on safety precautions A WARNINGA A WARNING label advises against certain actions or situations that could result in personal injury or death OCAUTION 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 procedure C 0123 This item is compliant with Medical Device Directive 93 42 EEC of June 14 1993 a directive of the European Economic Community www medipreventiecentrum nl Chapter 1 Safety Guidance This unit 1s internally powered equipment the degree of shock protection is type B applied A Type B applied part protection means that these patient connections will comply
8. the Sonoline Pocket Fetal Doppler is used exceeds the applicable RF compliance level above the Sonoline Pocket Fetal Doppler should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Sonoline Pocket Fetal Doppler Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM for EQUIPMENT or SYSTEM that are not LIFE SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the Sonoline Pocket Fetal Doppler The Sonoline Pocket Fetal Doppler is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Sonoline Pocket Fetal Doppler can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Sonoline Pocket Fetal Doppler as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum output m power of transmitter 800 MHz to 2 5 GH a 80 MHz to 800 MHz GW a a d 3E 519 V4 P For transmitters rated at a maximum output power not listed above the recommended separation distance
9. CAUTION This device cannot be used with defibrillator or high frequency surgical unit CAUTION Please choose the accessories authorized by our company or the device may be damaged CAUTION Please keep the probe from edge tool VCAUTION Please use Sonoline under the environment without strong electromagnetic field which may influence measure result When cleaning the machine CAUTION Don t use strong solvent for example acetone amp 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 parts of the device into any liquids CAUTION Avoid pouring liquids on the device while cleaning www medipreventiecentrum nl VCAUTION Don t remain any cleaning solution on the surface of the device When disinfecting the machine NWARNINGYA Never try to sterilize the probe or equipment by low temperature steam or other methods N Refer to accompanying documents www medipreventiecentrum nl Chapter 2 Introduction 2 1 Overview Pocket Fetal Doppler is a hand held obstetrical unit which can be used in hospital clinic and home for daily self check by pregnant woman There are two different models available Sonoline A and Sonoline B Sonoline A model is for simple auscultation Sonoline B model is a high performance model with fetal heart rate LCD digital display It has 3 work modes real time FHR
10. IPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic immunity The Sonoline Pocket Fetal Doppler 1s intended for use in the electromagnetic environment specified below The customer or the user of Sonoline Pocket Fetal Doppler should assure that it is used in such an environment Electromagnetic environment Immunity test IEC 60601 test level Compliance level guidance Electrostatic r6 kV contact r8 r6 kV contact r Floors should be wood concrete or discharge ESD IEC kV air kV air ceramic tile If floor are covered 61000 4 2 with synthetic material the relative humidity should be at least 3090 Power frequency Power frequency magnetic fields 50Hz magnetic field should be at levels characteristic of a typical location in a typical IEC 61000 4 8 commercial or hospital environment 21 www medipreventiecentrum nl Guidance and manufacture s declaration electromagnetic immunity For EOUIPMENT and SYSTEMS that are not LIFE SUPPORTING Guidance and manufacture s declaration electromagnetic immunity The Sonoline Pocket Fetal Doppler is intended for use in the electromagnetic environment specified below The customer or the user of Sonoline Pocket Fetal Doppler should assure that it is used in such an environment Compliance Immunity test IEC 60601 test level level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any
11. ar Panel Headphone ra Pp a d P RS Attention Headphone Socket Fig 3 3 Top Panel Table 1 Model and Configuration www medipreventiecentrum nl Configuration Model Sonoline A Sonoline B 1 LCD Panel 2 Headphone Socket 3 Volume Control 4 Loudspeaker 5 Power Button 6 MODE Button 7 Backlight Control Button 8 Probe 9 Battery Compartment 10 Probe Socket Indicated the model has the configuration 3 1 Front Panel 3 1 1 Display Sonoline A model Indicator light will be green when turn on the machine When the power of the battery is low the LED indicator light of the battery will flicker in green color When the probe falls away from the Sonoline A the power indicator light turns into yellow and flicker While self testing the LCD display for Sonoline B is as follows Working Mode NF Power Display Fig 3 4 LCD Display 3 1 2 Probe y EN me dol c MHz FHR Display Type of Probe Sonoline A and Sonoline B includes four interchangeable probes 2MHz normal ultrasound probe 2MHz water proof probe 3 MHz normal ultrasound probe 3MHz water proof probe 2MHz Normal Ultrasound Probe The 2MHz normal ultrasound probe is standard configuration for the pocket fetal doppler www medipreventiecentrum nl n hj c20 a N Gs i N ao sl AX ey Ss NN yd ee UC CN ARR 2 it A M AL Fig 3 5 2M Hz Normal Ultrasound Probe The mean
12. asure FHR again press the backlight control button to start Repress it it will stop calculating This rate value is retained until the measurement is repeated or the mode is changed 4 3 Probe Operation 4 3 1 Inspecting Probe When the probe falls away from the Sonoline for Sonoline A the power indicator light turns into yellow and flicker For Sonoline B the LCD screen displays the flickering and the probe frequency indication data disappeared At this moment the probe needs to be reconnected After connected well LCD screen will stop flickering and display the probe freguency data 4 3 2 Replacing Probe There has been a probe connected to Sonoline while packaged by the manufacturer If users need to replace it with another probe power off the Sonoline at first then take out the probe from the parking of Sonoline And then pull out the plug of the probe from its socket Then connect the plug of the probe which needs to be displaced with the socket Note Place the temporarily unused probe carefully and avoid falling off stress etc When the Sonoline is not used for a long time users are recommended to connect the plug of one probe to Sonoline socket and put the probe in the parking Then pack the Sonoline with the probe in the wrapping box 4 3 3 Taking out Probe and Placing Probe Taking out the probe Hold the main unit with one hand and hold the handle of the probe with another hand to take out the probe See
13. d in oO d E V4P metres m can be estimated using the equation applicable to the frequency of the transmitter where P 1s the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation 1s affected by absorption and reflection from structures objects and people 25 Appendix 3 Overall Sensitivity 1 58 A 45 7dB G 2MHz Doppler Freguency Hz www medipreventiecentrum nl Overall Sensitivity Two Mr Attenuation Mr B B fias E dB Time LLAES B 40 DIE KEN ENES B 40 B B oo oo M us us P P P P P tJ 57 6 V r m s Overall Sensitivity V r ms S A dH B C dB 24
14. display mode averaged FHR display mode and manual mode They are all availabe for user replaceable batteries The user interface includes power button mode button volume control single speaker headphone Jack and LCD display for heart rate battery and working mode probe type Both of the two models have audio output and can be connected with earphone or recorder with audio input They use standard 1 5 V DC alkaline battery 2 pieces Rechargeable battery and charger can be optionally configured Sonoline A and Sonoline B includes four interchangeable probes 2MHz normal ultrasound probe 2MHz water proof probe 3MHz normal ultrasound probe 3MHz water proof probe 2 2 Features Battery LED indicator Sonoline A only Battery status indicator Sonoline B only Low power inspection of the battery Built in speaker Output for headphones 2 MHz 3 MHz probe can be connected Probe inspection Backlight Sonoline B only Auto shut off Sonoline B only Two pieces of standard 1 5V alkaline battery available which can work no less than 10 hours www medipreventiecentrum nl Chapter 3 Outlook and Configuration LCD Panel Mode Button o6 X Backlight Control Button Power Button Probe d a N s 2 eee FETA IA e e H H s 41 27 _ Loudspeaker I i E a a Fig 3 1 Front Panel Sonoline B as Example Battery Compartment Fig 3 2 Re
15. eep far away from the outside signal Power is low J Change the battery JPosition of the probe is not correct Y Adjust the position of the probe 3 Did not daub the gel JDaub the gel Low sensitivity 19 www medipreventiecentrum nl Appendix 1 Essentiality of Fetal Domestic Monitor Modern medicines think that FHR is an important gist to identify fetal health by recording FHR changes can observe fetal hypoxia fetal distress and the umbilical cord around the neck and other symptoms Fetal domestic monitor test FHR rate changes by listening to fetal heart sound mainly fetal domestic monitor is a powerful guarantee to improve generational safety Fetal heart rate changes most obviously in the following three periods 1 Within 30 minutes after pregnant women get up 2 Within 60 minutes after pregnant women finish lunch 3 Within 30 minutes before pregnant women go to bed For the above three periods because of the change of the body status of pregnant women the activity of food digesting needs the body to provide more oxygen relatively the oxygen for fetus becomes less It is easy to arose symptoms such as fetus anoxia Testing the FHR at this time can display the healthy status for the fetus best The above three periods can only be tested at home by pregnant women themselves so FHR domestic monitor is very important This Sonoline can hear the fetal heart sound for fetus above twelve weeks and calculate the FHR with heart fetal heart
16. ings of CD2 0 on the label are as follows C The work mode for the probe is continuous wave D The structure form for the probe is cell type 2 0 The freguency of the probe is 2 MHz 3MHz Normal Ultrasound Probe The 3MHz normal ultrasound probe is optional configuration for the pocket fetal doppler Fig 3 6 3MHz Normal Ultrasound Probe The meanings of CD3 0 on the label are as follows C The work mode for the probe is continuous wave D The structure form for the probe is cell type 3 0 The freguency of the probe is 3 MHz www medipreventiecentrum nl Serious Statement c amp The above are descriptions of 2MHz and 3MHz normal ultrasound probe they are applicable for USA market and European market amp 2MHz water proof probe and 3MHz water proof probe are only applicable for USA market 3 1 3 Probe Socket east Fig 3 7 Probe Socket The probe socket is shown as Fig 3 7 above The definition of the jacks of the socket is as below Probe Coding 2 Probe Coding 3 Shell GND WARNING Do not attempt to connect the probes which are not manufactured by our company with the machine 3 2 Push Button There are three push buttons POWER MODE and BACKLIGHT CONTROLvand a volume control button on Pocket Fetal Doppler The primary functions are as follows 3 2 1 Power Button Function Power on off Power on Push the button once Power off Push down the button until the machine is off Sonoline A
17. nly the chargeable battery can be charged 4 5 Replacing Battery 4 5 1 Taking out Battery The rear panel is upturned First open the battery compartment then take out the battery from the battery compartment see Fig 4 2 13 www medipreventiecentrum nl Fig 4 2 Replacing Battery 4 5 2 Replacing Battery First put two AA size batteries into the battery compartment as for the direction of battery please refer to the instruction inside the battery compartment at last close the battery compartment VCAUTION amp The battery must be taken out from the battery compartment if the device will not be used for a long time 14 www medipreventiecentrum nl Chapter 5 Product Specification Product Name Sonoline Pocket Fetal Doppler Model No Sonoline A and Sonoline B Safety Complies with IEC 60601 1 1988 A1 1991 A2 1995 Classification Anti electroshock Type Internally powered eguipment Anti electroshock Degree Type B applied part R Harmful Liguid Proof Degree Main unit Ordinary eguipment sealed eguipment without liguid proof Probe Prevent from water splashing degree of protection IPX4 Degree of Safety in Presence of Flammable Gases Equipment not suitable for use in presence of flammable gases Working System Continuous running eguipment EMC Group I Class B Suitable Using Range Suitable for use after the 12th week of pregnancy Physical Characteristic Size 135 mm
18. ny liquids CAUTION amp Avoid pouring liquids on the device while cleaning CAUTION Don t remain any cleaning solution on the surface of the device Notes Wipe the surface of probe with 70 ethanol self air dry or clean with a clean dry cloth 6 3 Disinfecting and Sterilization Clean the equipment case probe etc as above and then wipe the probe with an alcohol impregnated wipe 70 ethanol Wipe the probe with a clean dry cloth to remove any remaining moisture 17 www medipreventiecentrum nl NOTE 1 The recommended periods of cleaning sterilization and disinfecting are once per month 2 After cleaning sterilization and disinfecting users must inspect whether have any obvious damage which may affect the patient safety and instrument performance possibly NWARNINGYA Never try to sterilize the probe or equipment by low temperature steam or other method 18 www medipreventiecentrum nl Chapter7 Solutions for Possible Problems If it appears below problems when you use the Sonoline please solve them as below Y Volume is too low 9Power is Y Adjust the volume louder No sound low J Change the battery Y Volume is too low Y Adjust the volume louder Weak sound JPower is low Change the battery Did not daub the gel Daub the gel amp Probe is too near from the main unit Make the distance between the probe and the main unit a little Noise mE further 3 Disturbance from the outside signal 9 K
19. part of the Sonoline Pocket Fetal Doppler including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance q gio Ya P 80 MHz to 800 MHz Radiated RF 3 V m IEC 61000 4 3 80 MHz to 2 5 GHz a d ERO y P S00MHzto25 GHz ca Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d 1s the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Co NOTE 1 At 80 MHz and 800 MHz 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 22 www medipreventiecentrum nl Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and PM 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
20. ress power button to turn off the machine directly For Sonoline B keep pressing the power button 3 seconds to turn off CAUTION k Put the probe on the best detecting position to get better detecting effect k Don t put the probe on the position where have strong Placental Blood Sound PBS or strong Umbilical Sound UMS L If pregnant woman adopts horizontal position and the fetus position is normal put the probe on the position of lower navel midline to get the clearest FHR sound Do not measure FHR unless audible fetal sound has been heard 4 2 Mode Selection 4 2 1 Real time FHR Display Mode Mode 1 This mode is only for Sonoline B At the moment of detecting FHR signal the LCD will display the flashing heart symbol and display real time FHR simultaneously 4 2 2 Averaged FHR Display Mode Mode 2 This mode is only for Sonoline B 11 www medipreventiecentrum nl It is used to obtain more stable heart rate readings In this mode FHR is averaged 8 beats The LCD displays the flashing heart symbol when displaying FHR 4 2 3 Manual Mode Mode 3 This mode is only for Sonoline B When entering into mode 3 the system will automatically counts the audible beats FHR will be showed in Format and the LCD flashes heart symbol Press the backlight control button to stop calculating The unit will automatically calculate the derived FHR averaged over the caculating time and display the result If me
21. s not intended for fetal use AWARNING Replacing battery shall only be done outside the patient environment 1 5m away from the patient AWARNING Please use the Sonoline probe provided by the manufacturer AWARNING Do not pull the line of probe longer than 2 meters or else the probe may break away from the connector of the Sonoline CAUTION The device must be serviced only by authorized and qualified personnel CAUTION The device is designed for continuous operation and is ordinary Do not immerse in any liquid 1 e not drip or splash proof CAUTION Keep the device clean Avoid vibration CAUTION Do not use high temperature sterilizing process and E beam or gamma radiation sterilization CAUTION Electromagnetic Interference Ensure that the environment in which the device is operated is not subject to any sources of strong electromagnetic interference such as radio transmitters mobile telephones etc Keep them far away www medipreventiecentrum nl VCAUTION The user must check that the equipment does not have visible evidence of damage that may affect patient safety or monitoring capability before use The recommended inspection interval 1s once per month or less If damage is evident replacement is recommended before use CAUTION The following safety checks should be performed once every two years or as specified in the institution s test and inspection protocol by a qualified person who has
22. sound for Sonoline A or check the LCD display for Sonoline B You can listen to the fetal heart sound for 1 2 minutes every time Pregnant women can take down the record data which can be a reference for doctors to insure the health of the fetus Appendix 2 Guidance and manufacture s declaration electromagnetic emissions For all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic emission The Sonoline Pocket Fetal Doppler 1s intended for use in the electromagnetic environment specified below The customer of the user of the Sonoline Pocket Fetal Doppler should assure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance RF emissions The Sonoline Pocket Fetal Doppler uses RF energy CISPR 11 only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic eguipment RF emission The Sonoline Pocket Fetal Doppler 1s suitable for use CISPR 11 Class B in all establishments including domestic 20 www medipreventiecentrum nl Harmonic emissions establishments and those directly connected to the IEC 61000 3 2 Not applicable public low voltage power supply network that supplies buildings used for domestic purposes Voltage fluctuations flicker emissions Not applicable IEC 61000 3 3 Guidance and manufacture s declaration electromagnetic immunity for all EQU
23. vidence of damage that may affect patient safety or Pocket Fetal Doppler capability before use The recommended inspection interval is once per month or less If damage is evident replacement is recommended before use The equipment should undergo periodic safety testing to insure proper patient isolation from leakage currents This should include leakage current measurement The recommended testing interval is once every two years or as specified in the institution s test and inspection protocol The accuracy of FHR is controlled by the equipment and cannot be adjusted by user If the FHR result is distrustful please use other method such as stethoscope to verify immediately or contact local distributor or manufacture to get help 6 2 Cleaning Before cleaning switch off and take out the batteries Keep the outside surface of the device clean and free of dust and dirt clean exterior surface display screen included of the chassis with a dry soft cloth If necessary clean the chassis with a soft cloth soaked in a solution of soap or water and wipe dry with a clean cloth immediately Wipe the probe with soft cloth to remove any remaining ultrasound coupling gel Clean with soap and water only D CAUTION Don t use strong solvent for example acetone D CAUTION Never use an abrasive such an steel wool or metal polish D CAUTION Do not allow any liquid to enter the product and do not immerse any parts of the device into a
24. with permitted leakage currents dielectric strengths of IEC 60601 1 1 1 Safety Precautions WARNING and CAUTION messages must be observed To avoid the possibility of injury observe the following precautions during the operation of the device NWARNINGYA This device is not explosion proof and cannot be used in the presence of flammable anaesthetics AW ARNING Do not throw batteries in fire as this may cause them to explode NWARNINGYA Do not attempt to recharge normal dry cell batteries they may leak and may cause a fire or even explode NWARNINGYA Don t touch signal input or output connector and the patient simultaneously NWARNINGA Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards e g IEC 950 for data processing equipment and IEC60601 1 for medical equipment Furthermore all configurations shall comply with the valid version of the system standard IEC60601 1 1 Everybody who connects additional equipment to the signal input connector or signal output connector configures a medical system and is therefore responsible that the system complies with the requirements of the valid version of the system standard IEC 60601 1 1 If in doubt consult our technical service department or your local distributor NWARNINGA Sonoline Pocket Fetal Doppler is a tool to aid the healthcare professional and should not be used in place of normal fetal monitoring This i
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