ShenZhen Jumper Medical Equipment JPD300EGS Fetal Monitor User Manual

ShenZhen Jumper Medical Equipment Co.,Ltd Fetal Monitor

User Manual

Model : JPD-300EFetal MonitorInstruction ManualVersion: V1.0Compile date: Sep. 2017Shenzhen Jumper Medical Equipment Co., Ltd.
StatementThis manual prepared fully in accordance with the “General Instructions for operating manual of GB/T9969industrial products” conforms to the national standards.The contents of this manual are completely consistent with the actual situation of this monitor.Shenzhen Jumper Medical Equipment Co., Ltd. (hereinafter referred to as Jumper Company) owns thisnon-public manual copyright.No person or organization shall reproduce, modify or translate this specification without the written consent ofJumper Company.This Manual includes Technical Specifications and Instruction Manuel.WARRANTIESIn the event that the following conditions are met, Jumper Company will be responsible for the safety, reliabilityand performance of the product:（1）Use this product in accordance with the Instruction Manuel/Technical Specifications.（2）The installation, maintenance and upgrade of the product shall be carried out by the personnel of JumperCompany.（3）The storage environment, working environment and electrical environment of the product are in accordancewith the manual.（4）The serial number tag or manufacturing mark of the product shall be clear and identifiable. It is verifiedthrough the appraisal of Jumper Company that this product is manufactured by Jumper Company.（5）Damage caused by non-human factorsThe products that are under the warranty service regulations of Jumper Company shall enjoy free service. As forthe products that are beyond the warranty service regulations, Jumper Company shall charge for the service. If theproducts are transported to Jumper Company for maintenance, the user shall bear the freight (including the customsexpenses).
After-sales Service UnitName: Shenzhen Jumper Medical Equipment Co., Ltd.Address: D Building, No. 71, Xintian Road, Fuyong Street, Baoan, Shenzhen, Guangdong, China.Tel: 0755-26696279/26692303Fax: 0755-26852025Postal Code: 518103Website: Http://www.jumper-medical.com
ForewordConfirm the fetus is alive before using the monitorCurrent Fetal Monitoring technology cannot always distinguish the fetal heart rate (FHR) signal source from thematernal heart rate signal (MHR) source under all circumstances. Therefore, you must use other methods to verify thatthe fetus is alive before using the Fetal Monitor, such as out-patient fetal movement, or using a fetal stethoscope, afetal heart meter, or a wooden earpiece for fetal heart sounds. If you hear no fetal heart sounds or feel no fetalmovements, verify whether the fetus is still alive by means of ultrasonic obstetrical examination. Then confirm thatthe fetus is the source of the FHR that you are monitoring.It is to be understood that:MHR traces can present features that are very similar to FHR traces, and even include acceleration anddeceleration phenomenon. Do not solely rely on the trend characteristics of the trace to identify the heart ratesource of the fetus.Only automatic fetal movement (AFM) markers on fetal traces do not consistently ensure that the fetus is stillalive. The dead fetus also moves and causes the monitor to mark the fetal movement.Here are a few examples of how MHR is mistakenly identified as FHR.When using ultrasonic sensors:△Can detect the mothers signal source, such as the mother’s heart, aorta or other large blood vessels beat.△When MHR is higher than normal values (especially over 100 bpm), false identification can occur.
ContentsFCC Statement.....................................................................................................................................................................11. Introduction..................................................................................................................................................................... 21.1. Product Introduction.............................................................................................................................................21.2. Safety Guide......................................................................................................................................................... 31.3. Symbol and text description.................................................................................................................................62. Recommended clinical application................................................................................................................................. 63. Product Description.........................................................................................................................................................73.1. Standard Configuration........................................................................................................................................ 73.2. Product Introduction.............................................................................................................................................83.3. Main interface (monitoring interface) description.............................................................................................113.4. Setting interface specification............................................................................................................................ 124. Setting of monitor..........................................................................................................................................................174.1. Disassembly and installation and list of accessories......................................................................................... 174.2. Connect the power supply Charge..................................................................................................................... 185. Operational Guidelines..................................................................................................................................................185.1. Preparation before Use....................................................................................................................................... 185.2. FHR monitoring................................................................................................................................................. 185.3. TOCO monitoring.............................................................................................................................................. 195.4. Manual FM monitoring...................................................................................................................................... 195.5. Monitoring information update.......................................................................................................................... 195.6. Restore Factory Settings.....................................................................................................................................196. Maintenance and clean of Fetal Monitor...................................................................................................................... 206.1. Product Handling................................................................................................................................................206.2. Maintenance....................................................................................................................................................... 206.3. Cleaning and Disinfection..................................................................................................................................206.4. Gel...................................................................................................................................................................... 207. Packaging, transportation and storage...........................................................................................................................217.1. Packaging........................................................................................................................................................... 217.2. Transport.............................................................................................................................................................217.3. Storage................................................................................................................................................................218. Fault finding and eliminating........................................................................................................................................ 219. Warranty Period and Maintenance................................................................................................................................ 2210. Technical Parameters...................................................................................................................................................23AppendixⅠ—Electromagnetic Compatibility Declaration..............................................................................................27
1FCC StatementThis device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:(1) This device may not cause harmful interference, and(2) This device must accept any interference received, including interference that may cause undesired operation.Notes:This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in aresidential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed andused in accordance with the instructions,may cause harmful interference to radio communications.However, there isno guarantee that interference will not occur in a particular installation. If this equipment does cause harmfulinterference to radio or television reception, which can be determined by turning the equipment off and on, the user isencouraged to try to correct the interference by one or more of the following measures:■ Reorient or relocate the receiving antenna.■ Increase the separation between the equipment and receiver.■ Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.■ Consult the dealer or an experienced radio/TV technician for help.Caution: Any changes or modifications to this device not explicitly approved by manufacturer could void yourauthority to operate this equipment.
21. Introduction1.1. Product IntroductionThank you for purchasing the Fetal Monitor. This product is a portable wireless Fetal Monitor. The data istransmitted to the host by Bluetooth technology instead of the traditional wired connection. The probe captures thefetal heart signal from the abdomen of the pregnant woman by using the principle of ultrasonic Doppler, its uniquemanufacturing technique makes the fetal heart sound clearer. You don’t need to remember the pair relationshipbetween the host and the probe, it can be used as soon as you pick it up. The monitoring data is uploaded in real-timethrough wireless WIFI, nurse central monitoring station can view the real-time monitoring information of the fetus andkeep abreast of the Fetal Monitoring situation.This Fetal Monitor is applicable to external monitoring, it is equipped with an ultrasonic probe, a uterinecontraction pressure probe and a fetal movement pen. Its performance conforms to the latest international standards.The whole machine design is simple, reliable and easy to use. The main features of this product are as follows:The portable Fetal Monitor can be used in the hospital or at home.The host and the probe can be freely paired. It is free to pair the probe. It can be used immediately after pairing.It can be placed freely, or hung on the wall. The probe will not fall down even if the host rotates 360°.The host will show the current pregnant woman’s name and the corresponding bed number so that the doctors nolonger worry about “checking the wrong number”.Data is real-time uploaded to the central station which can simultaneously connect to more than 30 beds.1MHz fetal heart probe of 9-chip wide beam uses the unique manufacturing technology, making small noise andclear fetal heart sound.The probe has built-in lithium battery, which can continuously work for more than 10 hours.Fetal heart probe will automatically shut down after 3 minutes without signal, which can save energy.It supports effective transmission within 10 meters between probe and host.Working PrinciplesFetal Monitor is the fetal heart rate detection through the noninvasive ultrasonic Doppler. We know that a certain
3frequency of ultrasonic wave will reflect when it encounters obstacles during the transmission. If the object isstationary, the reflected wave frequency is the same as the transmitted wave frequency. Once the object is moving, thereflection frequency will change, and the greater the movement rate of the object, the greater the change of thefrequency. So we put the ultrasonic probe on the abdomen surface of the pregnant woman. Since the fetal heart beathas movement relative to the ultrasonic probe, the reflected wave will cause frequency offset after the transmittingwave encounters the heart, so as to calculate the frequency of the fetal heart beat per minute (fetal heart rate), and soon. Uterine contraction pressure is to detect the uterine contraction pressure change of the pregnant woman throughuterine contraction probe sensor, and draw the curve. Fetal movement frequency is manually recorded by fetalmovement pen button according to the pregnant women feel their own fetal movement.Monitoring all stages after pregnancy.Fetal Monitor is not applicable to monitor water birth.Intended UsageIt is provided for medical institutions to monitor the fetal heart rate, the fetal movement and uterine contractionpressure.Product CompositionIt consists of the host and the ultrasonic probe.1.2. Safety GuideClassification according to anti-electric shock type and anti-electric shock degree:JPD-300E is class-II power supply BF type, a mobile ordinary equipment. Classification according to the degreeof protection against liquid inlet: a mobile ordinary equipment. The waterproof grade of the probe is IPX4.Application part to BF type.BF-type protection indicates that the patient connection should comply with the stipulation of IEC60601-1 toallowable leakage current and dielectric strength.Safe Operation InstructionsIn order to avoid possible injury, you are highly recommended to observe the following safety instructions whenoperating the device.
4Warning: Please do not completely rely on the alarm system of the monitor when the pregnant women beingmonitoring. Too low alarming setting or closing alarming voice may be harmful to patients. The mostreliable monitoring method is medical staff can monitor and operate the monitor closely and correctly.The alarm function of the monitor has to be regularly verified. When several devices are used on thesame patient at the same time, the danger of leakage current may be greater. It is suggested thatbefore connecting each other, the leakage testing should be conducted by qualified personnelprofessional to ensure the leakage current is within safety range, that is to say, it will not cause harmto the patient, the operator and the surroundings. The user should consult the manufacturer about thecorrect operating method if any further doubts. Before using this monitor, the operator must confirmthat the instrument is in normal working condition and operating environment. When using ahigh-frequency electrotome, the lead wires and guide wires for patient should be placed as far fromthe surgery as possible to keep the cables away from other devices, thereby reducing the risk of burnscaused by poor neutral connection of high-frequency electrotome. Regularly check whether therepeated use of accessories are damaged, whether the sensor is damaged, whether cable connectionsare reliable, replace if necessary, and properly handle the damaged accessories according to medicalwaste.Warning: Do not use in areas with flammable gases such as anesthetics, which has a danger of explosion.Warning: Never dispose of batteries into the fire because they may explode.Warning: Please do not touch the signal input or output connector and pregnant women at the same time.Caution: The repair of the device has to be conducted by the authorized qualified engineer.Caution: The design of the instrument is continuous working type. It is a closed anti-drop equipment, be watch out ofwetting.Caution: Keep the instrument clean and avoid oscillation.Caution: Do not make high temperature disinfection treatment or use electronic bean or radiation Y to sterilize.Caution: Electromagnetic interference --- ensure that the original use environment of the instrument is not affected bystrong electromagnetic interference sources, such as wireless transmitter or mobile phone.Caution: User must check if there is the damage that may affect the personal safety of patient or the performance ofdevice before use. The recommended inspection period is once a month or less. If no obvious damage isfound, it is recommended to change the damaged parts before use.Caution: The following safety checks must be executed by the person who has been trained, has certain knowledge
5and practical experience. Generally the safety check should be made every two years or according to theinspection regulations formulated by the public organization. Test according to the inspection rulesdesignated by public agency.Check if there is mechanical or functional damage;Check if the label related to the safety is legible.Check if the function is consistent with the description of the manual.Caution:The instrument is returned to the manufacturer for disposal in accordance with local regulations after theeffective life of the instrument.Caution: Dry batteries of fetal movement pen should be handled properly after use in accordance with localregulations.Caution: It must be stored in a cool and dry environment.Caution: Please do not mix metallic objects with batteries during storage to avoid accidental short circuit.Caution: We suggest that under the premise of meeting the clinical needs, the ultrasound irradiation time to pregnantwomen should be as short as possible.Caution: Do not use instrument immediately when it is transferred from a cold environment to a warm and humidplace.Caution: Keep the operating environment free from vibration, corrosion, flammable substances, and avoid too high ortoo low temperature and humidity.Caution: Stop the operation if the instrument is wet or has water condesation.Caution: Although the Fetal Monitor is designed to be firm, dropping and shaking resistant, and to meet complicatedclinical working needs, it should be handled carefully during its usage, especially, the ultrasonic probewafer is ceramic, shall not be dropped, bumped or surface scratched. But it should be careful when using.Caution: It is recommended to use water-based coupling agent. Oil-based coupling agent may damage the probesurface, which should be prohibited.Caution: After each use, wipe the couplant on the surface of the ultrasonic probe. The user can scrub the probe and
6the device by using a wet rag dipped with a neutral disinfectant or detergent.Caution: Wet a soft cloth with 1000ppm sodium hypochlorite solution to wipe and sterilize.Caution: The complete machine and probe parts cannot be sterilized by steam.Caution: The pressure probe is not waterproof and cannot use coupling agent. It must be absolutely prevented fromflowing into any liquid.Caution: Do not use a bad socket when plugged in.Caution: Please do not turn off speaker volume during monitoring, because fetal heart sound monitoring is veryimportant.Caution: The accuracy of the fetal heart rate is controlled by the device and cannot be adjusted by the user. If FHRresult is not accurate, please use other methods. For example, use a stethoscope to verify, or contact a localagent or manufacturer for assistance.1.3. Symbol and text descriptionSymbolDescriptionClass II equipmentType BF applied partNote! Please refer to this ManualNon-ionizing radiationIPX4Probe waterproof grading of 4When discarding the product, it must be taken to the separation and collection placefor recycling.WARNINGYou should know the information about how to avoid pregnant women and medicalpersonnel being injured.NOTESome important information that you should know2. Recommended clinical application
7The Fetal Monitor is suitable for external monitoring applications.Prenatal monitoring at all levels of the hospitalPrenatal monitoring at home or in communityExamination before hospitalization3. Product Description3.1. Standard ConfigurationThe hostThe host has a liquid crystal display module (LCD) electronic circuit – microprocessor, signal processing system,audio system, display system and power supply. Monitoring curve and monitoring state are displayed on the LCDscreen, selection and other functions can be conducted through the shuttle keys, including system parameter settings,freeze display, volume control and alarm control and so on.Ultrasound fetal heart probe USUltrasound (US) fetal heart probe is fixed on the abdomen of pregnant women by elastic bandage.Uterine contraction probe TOCOUterine contraction pressure (TOCO) probe is fixed on the abdomen of pregnant women by elastic bandage.Fetal movement pen FMPregnant women hold the fetal movement pen, and press the fetal movement pen button to record the fetal movementswhen pregnant women feel fetal movements or uterine contractions.AC AdapterInput: AC 100-240V，50/60Hz 0.8A Max.Output: DC 12V, 2.5A
83.2. Product IntroductionFigure 1 Product appearance3.2.1 Indicator Lamp1) Green on: indicates that the instrument is powered on normally.2) Orange blinking: indicates low battery. Please charge as soon as possible.3) Orange on: indicates that the instrument is charging.3.2.2. Host switch button1) In the power-off state, press switch button and hold it for 2 seconds to turn on the device.2) In the power-on state, press switch button and hold it for 2 seconds to turn off the device3) In power on state, each short press the switch button to update the monitoring.3.2.3. Fetal movement pen1) The fetal movement pen will automatically shut down when it is put into the side of the host.11 View screen9 Uterinecontraction probeswitch1 Indicator Lamp2 Host switch button3 Fetal movementrecorder4 Shuttle button5 Uterinecontractionback-to-zero button6 Awaking button10 Uterinecontraction probe7 Ultrasonic fetalheart probe8 Ultrasonic fetalheart probe switch
92) The fetal movement pen will automatically turn on when it is removed from the side of the host.3) When used, pregnant women press the fetal movement pen button when they feel fetal movements oruterine contractions, the host will record the fetal movement. It records once only if it is repeatedly pressed within 15seconds.3.2.4. Shuttle button1) Adjust the volume: in monitoring mode, select the shuttle button to adjust the volume. There are eightgrades totally from 0 to 7. The corresponding system volume is from silent to the strongest, which can beadjusted by shuttle button, reducing sound through rotating to the left and increasing sound through rotatingto the right.2) Freeze playback: in monitoring mode, short press the shuttle button to enter the freeze playback function.The monitoring information can be played back by rotating the shuttle button (fetal heart sound does notsupport playback).3) Selection and confirmation: in setting mode, rotating shuttle button is the selection function. The cursor willmove when shuttle button rotates. Short press the shuttle button to confirm if enter the submenu or select aparameter.3.2.5. Uterine contraction back-to-zero button1) In monitoring mode, short press this button after the uterine contraction probe is fixed by bandage, thepressure display value is reset to 10.3.2.6. Awaking button1) Press once to awake fetal heart probe once, the awaking icon is displayed once on the pressedtime.3.2.7. Ultrasonic fetal heart probe1) When the host is in power on state, the ultrasonic fetal heart probe is taken out and turned on automatically.The probe will show the current electric quantity and it will disappear after 3 seconds, then the signal light is on.During the monitoring process, the signal light flashes with the signal strength of the ultrasonic fetal heart probe;2) The ultrasonic fetal heart probe is put into the host, making the metal contact of the fetal heart probe touchthe sub-contact of the host charging terminal. The probe will automatically pair with the host, all power indicatorlights are on, indicating the pairing is successful. The host will automatically charge for the probe;
103) The probe cannot be used during charging;4) The total electric quantity of the probe displays 3 grades. When it is in low power, only one grade willdisplay and flash continuously. Please charge as soon as possible at this time;5) Ultrasonic fetal heart probe will automatically shut down if there is no signal for 3 consecutive minutes;6) Long press ultrasonic fetal heart probe switch button for about 2 seconds to turn on / shut down.3.2.8. Uterine contraction probe1) The uterine contraction probe will automatically turn on when it is taken out, the probe displays the currentelectric quantity and it will disappear after 3 seconds;2) The uterine contraction probe is put into the host, making the metal contact of the uterine contraction probetouch the sub-contact of the host charging terminal. The probe will automatically pair with the host, allpower indicator lights are on, indicating the pairing is successful. The host will automatically charge for theprobe;3) The probe cannot be used during charging;4) The total electric quantity of the probe displays 3 grades. When it is in low power, only one grade willdisplay and flash continuously. Please charge as soon as possible at this time;5) Uterine contraction will automatically shut down if the uterine contraction keeps the same contraction valuefor 3 consecutive minutes;6) In turn-on state, long press the uterine contraction probe switch for about 2 seconds to shut down.Figure 2 Sub-contact schematic diagram of the host charging terminal.The metal contact of thefetal heart probeThe metal contact of theuterine contraction probe
113.2.9. Viewing screen3.3. Main interface (monitoring interface) descriptionFigure 3 Schematic diagram of monitoring interface displayMain Interface DescriptionDevice ID: display the device ID of the current device. The device ID can be set, with range of 00-99.Time: The current time, update time with the central station when connecting the central station, calculate the timefrom the starting up if there is no connection with central station.Volume: speaker volume indicator, eight grades display from 0 to 7. The corresponding system volume is from silentto the strongest, which can be adjusted by rotating the shuttle button, reducing sound through rotating to the left andincreasing sound through rotating to the right.Data: the state of the data that is currently connected to the central station. The icon is displayed when the connectionto the central station is successful and the data is being sent and received. Otherwise, the data is grayed out.WiFi: indicates the WiFi connection state of the device. When the connection between the device and the centralstation is successful, the indicator will be green. When the connection between the device and the router is successful,the indicator will be yellow. The indicator will be gray if WiFi is off.Electric quantity of the built-in power supply: indicates the current electric quantity and charging state of the built-inpower supply of the device.FHR curveFetalmovementrecordUterinecontractioncurveFetal awakingrecords
121. Normal work: display the current electric quantity;2. Low electric quantity tip: when the electric quantity is too low, it will flash continuously;3. Charging: it displays charging when access to the power adapter, the charging symbol flashes;Bed No.: displays the current bed number. the bed number is consistent with the device ID.Name: displays the name of the pregnant woman who is currently being monitored (connection to the central stationis required).Duration: the monitoring duration is started from pressing the start key.Fetal heart rate: displays the current fetal heart rate. The abnormal icon will light up if the current fetal heart rateexceeds the upper and lower limits of 15 seconds.Uterine contraction: displays the current uterine contraction value.Fetal movement: press a fetal movement mark to calculate the fetal movements. It records once only if it isrepeatedly pressed within 15 seconds.Fetal heart probe connection label: indicates the state label connected with the ultrasonic fetal heart probe. Whenthe host is paired with the ultrasonic fetal heart probe and the probe is on, the white background of the label will be onand the current electric quantity of the fetal heart probe will be displayed. When the fetal heart probe is taken out fromthe host box, the label will become green, indicating that automatic matching is complete. You can use the probe forfetal heart monitoring.Uterine contraction probe connection label: indicates the state label connected with the uterine contraction probe.When the host is paired with the uterine contraction probe and the probe is on, the white background of the label willbe on and the current electric quantity of the uterine contraction probe will be displayed. When the uterine contractionprobe is taken out from the host box, the label will become green, indicating that automatic matching is complete. Youcan use the probe for uterine contraction monitoring.Fetal movement record: indicates that the user presses the fetal movement pen at that time.Awaking record: indicates that the awaking function has been used once at that time.3.4. Setting interface specification
13Figure 4 Setting Up the InterfaceSetting interface specificationWiFi settings: access to WiFi settings, the searched or type in hotspot can be connected, and the password ofWiFi needs to be entered.Setting ID: access to set the Device ID of this device, the default ID is 00, and the optional range is 00 to 99.FHR Warning: warning settings include upper FHR limit, lower FHR limit, warning switch, etc.Host Version: View the current version of the host.Probe version: view the current version of ultrasonic FHR probe.Return: Return to the main interface.Reset Password: Reset the password that entered the setup interface.3.4.1. Access to Setup InterfaceLong press shuttle button for 2 seconds to access to setting interface after entering 4 numbers of password on thepassword entry screen (the default password is 1234), after the success of the password authentication, access tosetting interface from the main interface.
14Figure 5 Input Password Interface3.4.2. WiFi settings1) Access to the WiFi configuration interface, automatically search the nearby WiFi, rotate the shuttle button to selectthe hotspot to connect, enter the password, and select OK to connectFigure 6 WiFi Search Interface
15Figure 7 WiFi Configuration InterfaceFigure 8 Static IP Setting Interface2) After selecting the dynamic IP by default, the local area network will be automatically distributed IP to the device.Select static IP, it will skip to the setting static IP interface, then could set fixed IP, subnet mask and defaultgateway.3) IP and port number in the configuration process are IP address and port number connected with the centralstation.4) Select type in, enter SSID and the corresponding password through virtual keyboard.5) If there is no WiFi hotspot can be searched, select Re-Scan or exit the list.6) Select “Back” to return back to the main interface (monitoring interface).
163.4.3. Device IDFigure 9 Device ID InterfaceTo distinguish different devices, set the number of the devices, select the different numbers by rotating the shuttlebutton, after the selection, pressing the button to confirm exit by pressing Back to set the number of the device, thesettable range is 00 to 99.3.4.4. FHR WarningFigure 10 FHR Warning InterfaceFHR Warning selects on, when the rate of FHR is abnormal for 15 seconds consecutively, exceeding the upperlimit and lower limit range of setting, the system makes warning sound, select off, and close the warning.
17Upper FHR limit: the adjustable range is 150bpm to 180bpm, and the default is 160bpm.Lower FHR limit: the adjustable range is 90bpm to 120bpm, and the default is 110bpm.Return: Return to the setup interface.3.4.5. Host VersionView the software version of the host.3.4.6. Probe versionView the software version of ultrasonic FHR probe.3.4.7. Reset PasswordAccess to setting interface, select Reset password, enter the new password, the new password allows themaximum number of characters to be entered in 10 bits, click OK after the completion of entry to complete passwordreset.4. Setting of monitorThis section tells you how toDisassembly and InstallationConnection to Power Supply4.1. Disassembly and installation and list of accessories4.1.1. Carefully remove the host and accessories from the packing box.4.1.2. Check to see if there is any loss or damage in the packing box according to the following table.Fetal Monitor host X 1FHR ultrasonic probe X 1TOCO pressure probe X 1
18FM pen X 1Probe bandage X 2Power adapter X 1Gel X 1Instruction ManualWarranty Card (included in this specification)Certificate of Conformity4.2. Connect the power supply Charge4.2.1. Insert the DC plug of the power adapter into the power socket behind the device.4.2.2. Insert the AC plug of the power cable into the power socket of Extranet.4.2.3. The screen displays charging and this device can be used in charge.5. Operational Guidelines5.1. Preparation before UseLong press the switch button for 2 seconds, the screen enters the main monitoring interface, remove theultrasonic probe, the TOCO probe and the FM pen from the host, if the FHR probe connection identifier and TOCOprobe connection identifier of the screen light up, it indicates the success of matching with the probe (if the match fails,please rematch the probe back to the contact point).5.2. FHR monitoring5.2.1. Pregnant women should maintain an easy-to-monitor position, usually in a semi-supine position.5.2.2. Pass the strap down the waist (two straps are required to monitor fetal heart rate and uterine pressure).5.2.3. Apply proper amount of couplant on the surface of the ultrasonic probe, put the probe on the abdomen of thepregnant woman, and make sure the probe and the abdomen of the pregnant woman are in good contact.
19Move the probe slowly to find the best position. The fetal heart sound in the speaker is strongest at this time,and the fetal heart rate is shown continuously on the screen.5.2.4. After finding the best position, the probe is fixed at the position and the strap is fixed. If the probe moves,adjust the probe’s position again to seek for the best signal.5.2.5. During monitoring, please do not turn off the speaker's volume; when the fetal heart rate signal is very weak,you can hardly hear the fetal heart sound from the speaker. Note that the digital fetal heart rate displayed onthe screen now might be meaningless.5.2.6. After fixing the ultrasonic probe, rotate the shuttle to adjust the volume to the appropriate volume.5.3. TOCO monitoring5.3.1. Pass the strap through the back of the pressure probe, place the sensor at the pregnant woman's uterine fundus,fix the strap, adjust the position; the tightness of the strap should be appropriate.5.3.2. Press the uterine contraction pressure reset button on the host, at which point the uterine contraction positionshows the uterine contraction pressure reset value 10.5.4. Manual FM monitoringRemove the FM pen from the host, when use, press the button of the FM pen when the pregnant womanfeels FM, the host will record the FM, repeatedly press in 15 seconds, only recorded once, place back the FM pento the side of the host after use, and the FM pen will be automatically turned off.If the FM icon of the interface turns gray, place the FM pen to the side again for re-adsorption, then removethe FM pen out again, if the icon lights up, the match is successful.5.5. Monitoring information updateDuring the monitoring process, short press the switch button, refresh the monitoring information, and restartthe monitoring.5.6. Restore Factory SettingsSimultaneously press the awakening button and the UC zeroing button on the main interface for one secondto restore the factory setting.
206. Maintenance and clean of Fetal Monitor6.1. Product HandlingAlthough the design of Fetal Monitor is strong enough to be used for clinical use, it is important to be careful inuse and pay attention to maintenance, especially the wafer of ultrasonic probe is precise and cannot be rammed andfallen.6.2. MaintenanceIn addition to cleaning, the Fetal Monitor does not require additional maintenance. Keep the outer surface of thedevice clean and free of dust. Clean the outer surface of enclosure (including LCD display) with a dry and soft cloth.If necessary, clean the enclosure with only soft rag soaked with soap water. Use a soft cloth to wipe off the excess gelon probe. Use only soap and water to clean probe.Caution: Do not use acetone and other strong solvents.Caution: Do not use wearable material (such as steel wool or silver polishing agent).Caution: Do not allow any liquid to enter the enclosure or immerse any part of the instrument into the liquid.Caution: Do not pour the cleaning liquid into the instrument.Caution: Do not make cleaning liquid leave on the surface of instrument.Note: The surface of the probe can be wiped with 70% alcohol or isopropanol, naturally dried or cleaned with cleanand dry cloth.6.3. Cleaning and DisinfectionClean the outer surface of the device and the probe according to the above method, then wipe the surface of theprobe with 70% alcohol or isopropanol. Wipe the probe with a dry, soft cloth to remove the liquid on the surface.Caution: Do not sterilize the device or probe with low temperature steam or other methods.6.4. GelIt is recommended to use random-carrying water-based gel. It is absolutely prohibited to use oil-based gel, if the
21probe is damaged because of using oil-based gel, the warranty of the device will be automatically terminated.7. Packaging, transportation and storage7.1. PackagingThe monitor is sealed in a plastic bag and filled with sponge or foam, then packaged in the packaging box andsealed firmly.7.2. TransportThe monitor can be transported by usual transportation, such as airplane, train, and automobile, which shouldprevent violent collision and not be mixed with corrosive objects in transportation. Transportation, climate andenvironment should be in accordance with:a) Ambient temperature range: -20 ℃~ + 55 ℃;b) Relative humidity range: ≤95%;c) Atmospheric pressure range: 50kPa ~ 106kPa.7.3. StoragePacked monitors must be stored in well ventilated room with temperature of -20℃~+55℃, relative humidity nomore than 80％, and without corrosive gas.8. Fault finding and eliminatingThe quality and reliability of antenatal monitor are high. If you have any problems, please find the problems andeliminate the faults according to the table below.SymptomPossible causeTroubleshooting methodNo display at boot timeThe host is powered off.Connect the power adapter for charge.Abnormal FHRThe probe is not connected to thedevice wellThe location of the probe is incorrect,the fetal heart is not foundNo couplant or too little couplantReconnectReadjust the probe positionReadjust the probe position after signalrestorationAdd couplant
22Probe damagedChange the probeAbnormal uterinecontraction pressureThe probe is not connected to thedevice wellIncorrect probe positionNo pressure resetPregnant woman has no uterinecontractionReconnectReadjust the probe positionProcess pressure resetWait for pregnant woman’s uterinecontractionPress the pressure probe,the value of uterinecontraction has no changeor little change.Circuit drift in pressure probePressure probe damagedContact the manufacturer formaintenance or Change the pressureprobeNo response when pressthe FM penThe FM pen is not successfullymatched with the hostPlace the FM pen in the side of thedevice for re-adsorption, and then takeout the FM pen againSpeaker silenceToo low volume adjustmentVolume upWiFi icon shows grayTurn off WiFi functionDisconnect from the routerAccess to setting interface, open theWiFi function and configure WiFiCheck the routerThe screen displays theprobe icon in grayUnpairedThe probe is chargingRetake the probe and align to thecontact point for matching.Normal phenomenon9. Warranty Period and MaintenanceWe provide the one-year warranty and lifelong maintenance for this product. If the device fault occurs to devicefails to work, the manufacturer shall be contacted in time, any form of maintenance or other disposal of thedevice is prohibited.The service life of this device is five years.Please contact the manufacturer for repair or replacement if any problem occurs in the followingaccessories:Probe: When the probe line appears to be damaged, broken or in bad contact, please contact the manufacturer intime to consult for maintenance or replacement.Power line: When the power line appears to be damaged, broken or in bad contact, please immediately stop touse, and consult the manufacturer to undertake timely replacement.About after-sales service, maintenance and any other involved problem or any problems involving the company's
23other products, please contact us, when you want to return this product, please follow the local disinfection process fordisinfection and provide corresponding document to indicate the current state of the product. Please enclose thedocument in the product packing box.Note: Our company shall not assume responsibility for the incidental or consequential damages resulting from theerrors in this manual or from the provision, actual performance and use of this manual.This manual contains the proprietary information which is protected by copyright law. All rights reserved, no oneis allowed to photocopy or duplicate any part of this manual or translate it into any other language without the priorwritten consent of our company.The content in this manual may be subject to change without further notice.Warning: The intended use of this device is clinical and cannot be used for treatment. If the FHR result is not reliable,please use other methods immediately, such as using a stethoscope.Annotation notes of this manual are as follows:Warning: You should know the information about how to avoid pregnant women and medical personnel beinginjured.Caution: You should know the information about how to avoid being hurt by the device.Note: Important information you should know.:Refer to accompanying documents.10. Technical ParametersProduct Name: Fetal MonitorProduct Model: JPD-300EFetal Heart Rate (FHR)Probe: multi-chip, wide beam, pulse working mode, high sensitivity.Ultrasonic intensity: less than 5mW/cm2Working frequency: 1.0MHz±5%
24Signal processing: special digital signal processing unitMeasuring range: 60bpm to 210bpmAlarm Range:Upper limit: the adjustable range is 150bpm to 180bpm, the default is 160bpmLower limit: the adjustable range is 90bpm to 120bpm, the default is 110bpmMaximum audio output power: 2WUC pressureMeasuring range: 0-100mmHgDisplayThe LCD screen shows the monitoring state of FHR curve, UC pressure curve, FM symbols, volume and so on,which can be frozen and replayed.Power supply: AC 100-240V 50/60Hz, internal battery: lithium battery3.7V 3000mAhInput Power: 20VAWork mode: continuous working for more than 10 hours after full power supplySize: 89.2mm (length)*202mm(width)*75.9mm (height)Net weight: 882.5g (power adapter and accessories are not included)EnvironmentWorking environment: temperature: +5℃to +40℃humidity: ≤80% atmospheric pressure: 86KPa to 106KPaTransportation and storage environment: temperature: -20 ℃to +55 ℃humidity: ≤95% atmospheric pressure:50KPa to 106KPaProbe sound output: According to the regulations of international standard IEC 61157, the peak negative acousticpressure shall not exceed 1 MPa, and the output beam sound intensity shall not exceed 20mW/cm2. The
25average sound intensity of space peak time shall not exceed 100mW/cm2. The sound intensity of thedevice type shall not exceed 5mW/cm2.Gel: viscous water-based compound is not irritative and allergic to skin.
26Sound output report formProduct model: JPD-300EWorking mode of probe: pulse waveProbe Frequency: 1.0MHzIndex NameMITISTIBTICScanningNon-scanningNon-scanningAaprt 1 cm2Aaprt > 1 cm2Maximum Index0.02--0.0020.03-Parameterspr.a0.017P--4-Minimum of P(zs)and Ita,(zs)0.46zs2.0zbp1.8zb2.0z at maximum Ipi2.0deq(zb)1.2fawf1.0--1.01.0-Diameterof AaprtX--Φ1.2Φ1.2-Y--Φ1.2Φ1.2-OthersInformationtd903.9prr1250prat maximum Ipi0.018deq at maximum Ipi1.2Ipa.3 at maximum MI0.00OperationControlConditionControl 1××××××Control 2××××××Control 3××××××…………………Note 1: For the maximum number of TIS not produced in this mode, no information about TIS formula isrequired.Note 2: For any transducer component that is not used in the head of a transcranial or newborn baby, noinformation about TIC is required.Note 3: If the device satisfies the exemption clauses of both 51.2aa) and 51.2dd), no information about MI and TIis required.
27AppendixⅠ—Electromagnetic Compatibility DeclarationThis device is capable of generating, using, and radiating RF energy. This equipment may cause theelectromagnetic interference between other medical devices or non-medical devices, as well as radio communications.According to the statement of IEC 60601-1-2, this product belongs to the medical device with the emission limit ofB-grade in first group, so as to provide corresponding protection measures for avoiding interference. Nevertheless, itcannot be fully guaranteed that the electromagnetic interference will not occur under specific installation conditions.When it is discovered that this equipment causes an interference phenomenon, (it needs to be confirmed by theswitch-on and switch-off of the equipment), the operators (or the maintenance personnel) can eliminate theinterferences based on the following measures:Adjust or reposition the affected device;Increase the distance between the device and the affected device;Use another power supply to provide power for the device;Consult maintenance engineers for more advice.Note: Before using this device, please make sure that all of the requirements for EMC in this section are met.Note: This Chapter shall list the contents described in IEC 60601-1-2, and the users are obliged to ensure thatthis equipment and its nearby equipment conform to the RF interference parameters as indicated in thegeneral safety requirements.Note: Near this device, do not using the devices that purposely transmit RF signals (mobile phones, radioreceiver and transmitter or radio controlled products), for this may cause operation to exceed thespecified values. When it is near this device, please switch off such types of the device. The operatorshall have the responsibility to prompt the patient or other personnel near the device to comply fullywith the above requirements.Note: The manufacturer will not be responsible for any interference caused by the use of non-recommendedinternal connecting cables or any unauthorized changes or modifications to this equipment.Guidance and manufacturer’s declaration – electromagnetic emissionsThe JPD-300E is intended for use in the electromagnetic environment specified below. Thecustomer or the user of the JPD-300E should assure that it is used in such an environment.Emissions testComplianceElectromagnetic
28environment –guidanceRF emissionsCISPR 11Group 1The JPD-300E uses RF energyonly for its internal function.Therefore, its RF emissions arevery low and are not likelyto cause any interferencein nearby electronic equipment.RF emissionsCISPR 11Class BThe JPD-300E is suitablefor use in allestablishments, includingdomestic establishments andthose directly connected tothe public low-voltage powersupply network thatsupplies buildings used fordomestic purposes.Harmonic emissionsIEC 61000-3-2CompliesVoltage fluctuation/ flickeremissionsIEC 61000-3-3CompliesGuidance and manufacturer’s declaration – electromagnetic immunityThe JPD-300E is intended for use in the electromagnetic environment specified below. The customer orthe user of the JPD-300E should assure that it is used in such an environment.Immunity TestIEC 60601 Test LevelCompliance levelElectromagneticEnvironment -GuidanceElectrostatic discharges(ESD)IEC 61000-4-2±8 kV contact±15 kV air±8kV Contact±15kV AirFloors should be wood,concrete or ceramic tile.If floors are coveredwith synthetic material,the relative humidityshould be at least 30 %.If ESD interfere withthe operation ofequipment,countermeasurementssuch as wrist strap,grounding shall beconsidered.Electrical fast transient(EFT)IEC 61000-4-4±2 kV for powersupply lines±2 kV for powersupply linesMains power qualityshould be that of atypical commercial or
29hospital environment.SurgeIEC 61000-4-5±1 kV differentialmode±2 kV commonmode±1 kV differentialmode±2 kV commonmodeVoltage dips,shortInterruptions andvoltage variationson power supplyinput linesIEC 61000-4-110 % UT(100 % dip in UT)for 0,5 cycle0 % UT(100 % dip in UT)for 1 cycles70 % UT(30 % dip in UT)for 25/30cycles0 % UT(100 % dip in UT)for 250/300 cycles0 % UT(100 % dip in UT)for 0,5 cycle0 % UT(100 % dip in UT)for 1 cycles70 % UT(30 % dip in UT)for 25/30cycles0 % UT(100 % dip in UT)for 250/300 cyclesMains power qualityshould be that of atypical commercial orhospital environment.If the user of theJPD-300E requirescontinued operationduring power mainsinterruptions, it isrecommended that theJPD-300E be poweredfrom an uninterruptiblepower supply or abattery.Power frequencymagnetic field(50/60 Hz)IEC 61000-4-83 A/m3 A/mPower frequencymagnetic fields shouldbe at levels haracteristicof a typical locationin a typicalcommercial or hospitalenvironment.Note: UTmeans AC network voltage before applied with test voltage.Guidance and manufacturer ’s declaration –electromagnetic immunity –for EQUIPMENT andSYSTEMS that are not LIFE-SUPPORTINGGuidance and manufacturer’s declaration – electromagnetic immunityThe JPD-300E is intended for use in the electromagnetic environment specified below. The customer orthe user of the JPD-300E should assure that it is used in such an environment.Immunity TestIEC 60601 Test levelCompliancelevelElectromagnetic Environment- GuidanceConductedRFIEC 61000-4-63 Vrms 150 kHz to80 MHz （6V in ISMand amateur radiobands between0.15MHz and 80MHz）3 Vrms 150kHz to80 MHz（6V inISM andamateur radiobands betweenPortable and mobile RFcommunications equipmentshould be used no closer to anypart of the JPD-300E, includingcables, than the recommendedseparation distance calculated
300.15MHz and80MHz）from the equation applicable tothe frequency of the transmitter.Recommended separationdistanced = 1.2 xPd = 1.2 xP80 MHz to 800MHzd = 2.3 xP800 MHz to2.5GHzwhere P is the maximum outputpower rating of the transmitterinwatts (W) according to thetransmitter manufacturer and dis the recommended separationdistance in metres (m).Field strengths from fixed RFtransmitters, as determined byan electromagnetic site survey,should be less than thecompliance level in eachfrequency range. Interferencemay occur in the vicinityof equipment marked with thefollowing symbol:ConductedRFIEC 61000-4-310 V/m80 MHz to2,7 GHz10 V/mRecommended separation distances between portable and mobile RF communications equipment and theEQUIPMENT or SYSTEM –For EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTINGRecommended separation distances between Portable and mobile RF communications equipmentand the JPD-300EThe JPD-300E is intended for use in an electromagnetic environment in which radiated RF disturbancesare controlled. The customer or the user of the JPD-300E can help prevent electromagnetic interferenceby maintaining a minimum distance between portable and mobile RF communications equipment(transmitters) and the JPD-300E as recommended below, according to the maximum output power of thecommunications equipment.Ratings of thetransmitterMax. Output PowerSeparation distance according to frequency of transmitterm150kHz -80MHz80MHz -800MHz800MHz -2.5GHz
31(W)Pd 2.1Pd 2.1Pd 3.20.010.120.120.230.10.380.380.7311.21.22.3103.83.87.3100121223For transmitters rated at a maximum output power not listed above, the recommended separationdistance d in meters (m) can be estimated using the equation applicable to the frequency of thetransmitter, where P is the maximum output power rating of the transmitter in watts (W) according to thetransmitter 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 is affected byabsorption and reflection from structures, objects and people.
Shenzhen Jumper Medical Equipment Co., Ltd.Address: D Building, No. 71, Xintian Road, Fuyong Street, Baoan, Shenzhen,Guangdong, China.Tel: +86-755-26692192, 26696279Fax: +86-755-26852025Website:www.jumper-medical.comPostal Code: 518103

Navigation menu