Attention This user manual is written and compiled in
Contents
1. BadB Sw 1 58 A 45 7dB 2MHz hJ N A N e c c c ch oo T es T 20 4 8 B EN s e EU E x ba S ho w gt P s ao ON 172. The data should be recorded in an equipment log If the device 1s not functioning properly or fails any of the above tests the device has to be repaired OCAUTION The battery must be properly disposed according to local regulation after their use OCAUTION The battery must be taken out from the battery compartment if the device will not be used for a long time OCAUTION The device shall only be used if the battery cover is closed OCAUTION Battery must be stored in cool and dry place OCAUTION 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 A 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 A CAUTION This device can not be used with defibrillator or high frequency surgical unit OCAUTION Please choose the accessories authorized by our company or the device may be damaged OCAUTION Please keep the probe from edge tool CAUTION 9 Please use Pocket Fetal Doppler under the environment without strong electromagnetic field which may influence measure result When cleaning the machine CAUTION Don t
3. 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 1s controlled by the equipment and can not 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 amp CAUTION Don t use strong solvent for example acetone A CAUTION Never use an abrasive such an steel wool or metal polish amp CAUTION Do not allow any liquid to enter the product and do not immerse any parts of the device into any liquids OCAUTION Avoid pouring liquids on the device while cleaning amp CAUTION Don t remain any cleaning solution on the surface of the device Notes Wipe the surface of probe with 70
4. ethanol self air dry or clean with a clean dry cloth 6 3 Disinfecting 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 AWARNINGA Never try to sterilize the probe or equipment by low temperature steam or other method 14 Chapter 7 Solutions for Possible Problems If it appears below problems when you use the Pocket Fetal Doppler please solve them as below volume is too low adjust the volume louder No sound power is low change the battery volume is too low adjust the volume louder Weak sound power is low change the battery did not daub the gel daub the gel make the distance between the probe is too near from the main probe and the main unit a little unit gt further Noise TT lt disturbance from the outside signal keep far away from the outside power is low signal change the battery position of the probe is not correct adjust the position of the probe Low sensitivity did not daub the gel daub the gel 15 Appendix 1 Essentiality of Fetal Domestic Monitor Modern medicine think that FHR is an important gist to identify fetal health by recording FHR changes ca
5. service department or your local distributor 3 3 1 Signal Interface 2 L 3 Fig 3 6 Headphone Socket for Audio Output Headphone socket showed as figure 3 6 the definition of pins showed as below Pin Definition 1 GND 2 Signal 3 Signal 4 Signal 5 Signal Chapter 4 General Operation 4 1 FHR Inspection Error Reference source not found Power on by pressing the Power button It will do self test when turning on the machine After self testing the LCD display 1s as Fig 3 4 Error Reference source not found 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 Error Reference source not found FHR Calculation The FHR result will be showed on LCD screen Error Reference source not found Turn off the machine Keep pressing the power button 3 seconds to turn off V CAUTION 1 Put the probe on the best detecting position to get better detecting effect 2 Don t put the probe on the position where have strong Placental Blood Sound PBS or strong Umbilical Sound UMS 3Jf pregnant woman adopts horizontal position and the fetus position is n
6. uci east ia it tod te eov Ba Lacus qe dove M TA Ga eov sat NDE E ea Ld neos Do taeda Love a do dus 9 d I FR TANS OC CUNO IN ra 9 d A Mode Selec HO 8 Rar re rE Ree PALA TENAR A OP Re A TRGA rT ee RA A TRAB Mida 9 d FOODS O DEPA HO gas as aa Sa EN eie ern Gaii INA ok 9 A A Inspecao of LOV POWER sa sasana jana ga aaa ba kaa wie naa aa aaa ga eiae ova 10 2 5 Replace BARY aa aaa aan gga pa aa a a o aa 11 Chapter S Product SpecihcathoM 6 kanaka aa a a GA Aa HN AG ANAA AAN KAG NA Aa at 12 Chapter Mantenan a 14 6 KA PG Lan akin a a PAPAN 14 ONG NG sete ote tu a a a ag eee ne e E iat ae ces 14 GS e PING NT TOO TOUT 14 Chapter 7 Solutions for Possible Probl tns censier aa nada haha orava gga aaa oki 15 APPENA OA aaa aa a a A aaa aa TK E v 16 APPENA 2 jasa saa a aa AA aa ia aa aaa ia 17 II Chapter 1 Safety Guidance This unit is internally powered equipment the degree of shock protection is type B applied part A Type B applied part protection means that these patient connections will comply 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 AWARNINGA This device is not explosion proof and can not be used in the presence of flammable anaesthetics AWARNINGA Do not
7. use strong solvent for example acetone amp CAUTION Never use an abrasive such as steel wool or metal polish OCAUTION Do not allow any liquid to enter the product and do not immerse any parts of the device into any liquids OCAUTION Avoid pouring liquids on the device while cleaning amp CAUTION Don t remain any cleaning solution on the surface of the device When disinfecting the machine AWARNING Never try to sterilize the probe or equipment by low temperature steam or other methods AN Refer to accompanying documents 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 It contains components of ultrasonic signal transmitter and receiver analog signals processing unit FHR calculating unit LCD display control unit etc Pocket Fetal Doppler is a high performance model with fetal heart rate LCD digital display It has 3 work modes real time FHR display mode averaged FHR display mode and manual mode It has 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 2 2 Features Battery status indicator low power inspection of the battery Built in speaker Output for headphones The probe can be changeable Probe inspe
8. 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 implied 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 consequential damage in 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 1s used in accordance with the instructions for use AWARNINGA This device 1s not intended for treatment The intended use 1s for detecting Fetal Heart Rate If the FHR result is distrustful please use other methods such as stethoscope to verify immediately Warranty The unit can not be rep
9. aired 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 1s designed to give key concepts on safety precautions AWARNINGA 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 Table of Contents Chanter koe yO AICS sso 5 cess act IR RR NEM E note 1 Pal Safety Precautions sasada aaa aaa a Ta naa T Tem 1 Chapter 2 INF ce ON 5 6s ice apa NA Ne 4 2 LANGEN Wasesa toot t a ak t a nak t ee ror te 4 PASA CIS PEE NET RN v ov v v o ov a anan BAN p V 4 Chapter 3 Outlook and COont e uratiOD oorr n 5 SPI MI OTC AE ea T E E ET TS 6 32 P shBULtOD uite Ret nena sete a terse dra E ANG NA A ATE DUE Ste E E f TU Due Shed D E ADU DUE Spe seme Kg Aa kaa an 7 2 9 Inttod ction to TOp Paliel i anaa aaa kag a na aa haa eue cba t atria kk ens 7 Chapter 4 General ODerdtlOTin
10. authorized and gualified 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 OCAUTION Keep the device clean Avoid vibration OCAUTION Do not use high temperature sterilizing process and E beam or gamma radiation sterilization OCAUTION 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 1 transmitters mobile telephones etc Keep them far away CAUTION C 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 is once per month or less If damage 1s 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 adequate training knowledge and practical experience to perform these tests nspect 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
11. cing Probe There has been a probe connected to Pocket Fetal Doppler while packaged by the manufacturer If users need to replace it with another probe power off the Pocket Fetal Doppler at first then take out the probe from the parking of Pocket Fetal Doppler 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 Pocket Fetal Doppler is not used for a long time users are recommended to connect the plug of one probe to Pocket Fetal Doppler socket and put the probe in the parking Then pack the Pocket Fetal Doppler with the probe in the wrapping box 4 3 3 Taking out Probe and Placing Probe Error Reference source not found 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 Fig 4 1 a L i MARET KAN m m oa nd Be a7 Fat ah ana Fat ir amp 7a 7 8 9 TN PA ee 9 T a a a a oa Bug ming a 7 z AULUS EH Fig 4 1 Taking out Probe Error Reference source not found 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 When it works normally the LCD screen displays the status of the battery and
12. ction Backlight Auto shut off Two pieces of standard 1 5V alkaline battery available which can work no less than 10 hours Chapter 3 Outlook and Configuration LCD Panel Mode Button 1 Backlight Control Button Power Button Probe S 4 4 4 V OFFERS eee A A A BH etft1vTv7 r Loudspeaker u R3 7 Fig 3 1 Front Panel Battery Compartment Fig 3 2 Rear Panel Headphone A BN Attention Headphone Socket Fig 3 3 Top Panel 3 1 Front Panel 3 1 1 Display The LCD display for the Pocket Fetal Doppler is as follows Working Mode v c MHz Type of Probe Power Display Fig 3 4 LCD Display 3 1 2 Probe Socket Fig 3 5 Probe Socket FHR Display The probe socket is shown as Fig 3 5 above The definition of the jacks of the socket is as below m m TT on 0 mcm AWARNING 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 CONTROL and 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 and hold 3 seconds to power off 3 2 2 Mode Button Mode selection button Function mode selection press once to enter next working mode under working status For the Fetal Doppler has
13. l Characteristic Size 135mm Length x95mm Width x35 Height mm Weight About 180g including batteries Environment Working Temperature 5 C 40 C Humidity lt 80 Atmospheric Pressure 70 kPa 106kPa Transport and Storage Temperature 10 C 55 C Humidity x93 Atmospheric Pressure 50 kPa 106kPa Display 45mmx25mm LCD display Backlight The two statuses can be alternated turn off on the backlight FHR Performance FHR Measuring Range 50 240BPM BPM beat per minute Resolution IBPM Accuracy 2BPM Power consumption lt 0 8W Auto Shut OFF After 1 minute no signal power off automatically Battery Type Recommended Two pieces of 1 5 V DC battery SIZE AA LR6 12 Probe Nominal Frequency 2 0MHz Working Frequency 2 0MHz 10 P 0 5MPa Iob 10 mW cm Ispta 50mW cnY Ultrasonic Output Intensity Isata lt 5 mW cnY Working Mode Continuous wave Doppler Effective Radiating Area of Transducer 208mm 15 13 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 equipment does not have visible evidence 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
14. 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 O Function Error Reference source not found Under mode 1 and mode 2 press the button to turn on off backlight Error Reference source not found Under mode 3 the button is for start stop operation please refer to 4 2 3 manual mode Mode 3 3 2 4 Volume Control Indicator E 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 Q The socket terminal post or switch that connected with the headphones A 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 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
15. n observe fetal hypoxia fetal distress and the umbilical cord around the neck and other symptoms Fetal domestic monitor test FHR 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 become 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 Pocket Fetal Doppler can hear the fetal heart sound for fetus above twelve weeks and calculate the FHR with check the LCD display 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 16 Appendix 2 Overall Sensitivity Overall Sensitivity Two way Attenuation V rms Va r m s C dio on Overall Sensitivity B XB B m m Bv P rans S A d B C dB gt B T mm
16. ormal put the probe on the position of lower navel midline to get the clearest FHR sound 4Do not measure FHR unless audible fetal sound has been heard 4 2 Mode Selection 4 2 1 Real time FHR Display Mode Mode 1 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 It 1s used to obtain more stable heart rate readings In this mode FHR 1s averaged 8 beats The LCD displays the flashing heart symbol when displaying FHR 4 2 3 Manual Mode Mode 3 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 measure FHR again press the Backlight Control button to start Repress it it will stop calculating This rate value 1s retained until the measurement 1s repeated or the mode is changed 4 3 Probe Operation 4 3 1 Inspecting Probe When the probe falls away from the Pocket Fetal Doppler the LCD screen displays the flickering 66 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 frequency data 4 3 2 Repla
17. the number of the grid in the status represents how much power 1s left when the power of the battery 1s low the power of the battery displays grid 0 to remind the customer to change another new battery or charge the battery only the chargeable battery can be charged 10 4 5 Replacing Battery 4 5 1Taking out Battery The rear panel is upturned First open the battery compartment then take out the battery from the battery compartment see Figure 4 2 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 CAUTION The battery must be taken out from the battery compartment if the device will not be used for a long time 11 Chapter 5 Product Specification Product Name Pocket Fetal Doppler Safety Complies with IEC 60601 1 1988 A1 1991 A2 1995 Classification Anti electroshock Type Internally powered equipment Anti electroshock Degree Type B applied part A Harmful Liquid Proof Degree Ordinary equipment sealed equipment without liquid proof Degree of Safety in Presence of Flammable Gases Equipment not suitable for use in presence of flammable gases Working System Continuous running equipment EMC Group I Class B Suitable Using Range Suitable for use after the 12th week of pregnancy Physica
18. throw batteries in fire as this may cause them to explode AWARNING Do not attempt to recharge normal dry cell batteries they may leak and may cause a fire or even explode AWARNING Don t touch signal input or output connector and the patient simultaneously AWARNINGA 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 AWARNING Pocket Fetal Doppler is a tool to aid the healthcare professional and should not be used in place of normal fetal monitoring AWARNING A Replacing battery shall only be done outside the patient environment 1 5m away from the patient A WARNINGA Please use the Pocket Fetal Doppler probe provided by the manufacturer AWARNINGA Do not pull the line of probe longer than 2 meters or else the probe may break away from the connector of the Pocket Fetal Doppler OCAUTION The device must be serviced only by
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