Model : JPD-300E Fetal Monitor Instruction Manual Version: V1.0 Compile date: Sep. 2017 Shenzhen Jumper Medical Equipment Co., Ltd.
Statement This manual prepared fully in accordance with the “General Instructions for operating manual of GB/T9969 industrial 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 this non-public manual copyright.
After-sales Service Unit Name: Shenzhen Jumper Medical Equipment Co., Ltd. Address: D Building, No. 71, Xintian Road, Fuyong Street, Baoan, Shenzhen, Guangdong, China. Tel: 0755-26696279/26692303 Fax: 0755-26852025 Postal Code: 518103 Website: Http://www.jumper-medical.
Foreword Confirm the fetus is alive before using the monitor Current Fetal Monitoring technology cannot always distinguish the fetal heart rate (FHR) signal source from the maternal heart rate signal (MHR) source under all circumstances. Therefore, you must use other methods to verify that the fetus is alive before using the Fetal Monitor, such as out-patient fetal movement, or using a fetal stethoscope, a fetal heart meter, or a wooden earpiece for fetal heart sounds.
Contents FCC Statement.....................................................................................................................................................................1 1. Introduction..................................................................................................................................................................... 2 1.1. Product Introduction...................................................................................................................
FCC Statement This 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 part 15 of the FCC Rules.
1. Introduction 1.1. Product Introduction Thank you for purchasing the Fetal Monitor. This product is a portable wireless Fetal Monitor. The data is transmitted to the host by Bluetooth technology instead of the traditional wired connection. The probe captures the fetal heart signal from the abdomen of the pregnant woman by using the principle of ultrasonic Doppler, its unique manufacturing technique makes the fetal heart sound clearer.
frequency of ultrasonic wave will reflect when it encounters obstacles during the transmission. If the object is stationary, the reflected wave frequency is the same as the transmitted wave frequency. Once the object is moving, the reflection frequency will change, and the greater the movement rate of the object, the greater the change of the frequency. So we put the ultrasonic probe on the abdomen surface of the pregnant woman.
Warning: Please do not completely rely on the alarm system of the monitor when the pregnant women being monitoring. Too low alarming setting or closing alarming voice may be harmful to patients. The most reliable 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 the same patient at the same time, the danger of leakage current may be greater.
and practical experience. Generally the safety check should be made every two years or according to the inspection regulations formulated by the public organization. Test according to the inspection rules designated 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.
the 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 from flowing into any liquid. Caution: Do not use a bad socket when plugged in.
The 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 hospitalization 3. Product Description 3.1. Standard Configuration The host The host has a liquid crystal display module (LCD) electronic circuit – microprocessor, signal processing system, audio system, display system and power supply.
3.2. Product Introduction 1 Indicator Lamp 2 Host switch button 3 Fetal movement recorder 11 View screen 4 Shuttle button 5 Uterine contraction back-to-zero button 6 Awaking button 10 Uterine contraction probe 7 Ultrasonic fetal heart probe 9 Uterine contraction probe switch 8 Ultrasonic fetal heart probe switch Figure 1 Product appearance 3.2.1 Indicator Lamp 1) Green on: indicates that the instrument is powered on normally. 2) Orange blinking: indicates low battery.
2) 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 or uterine contractions, the host will record the fetal movement. It records once only if it is repeatedly pressed within 15 seconds. 3.2.4. Shuttle button 1) Adjust the volume: in monitoring mode, select the shuttle button to adjust the volume. There are eight grades totally from 0 to 7.
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 will display 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.
3.2.9. Viewing screen 3.3. Main interface (monitoring interface) description FHR curve Fetal movement record Uterine contraction curve Fetal awaking records Figure 3 Schematic diagram of monitoring interface display Main Interface Description Device ID: display the device ID of the current device. The device ID can be set, with range of 00-99.
1. 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 station is required).
Figure 4 Setting Up the Interface Setting interface specification WiFi settings: access to WiFi settings, the searched or type in hotspot can be connected, and the password of WiFi 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.
Figure 5 Input Password Interface 3.4.2.
Figure 7 WiFi Configuration Interface Figure 8 Static IP Setting Interface 2) 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 default gateway. 3) IP and port number in the configuration process are IP address and port number connected with the central station.
3.4.3. Device ID Figure 9 Device ID Interface To distinguish different devices, set the number of the devices, select the different numbers by rotating the shuttle button, after the selection, pressing the button to confirm exit by pressing Back to set the number of the device, the settable range is 00 to 99. 3.4.4.
Upper 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 Version View the software version of the host. 3.4.6. Probe version View the software version of ultrasonic FHR probe. 3.4.7.
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 Conformity 4.2. Connect the power supply Charge 4.2.1. 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 Guidelines 5.1.
Move 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.
6. Maintenance and clean of Fetal Monitor 6.1. Product Handling Although the design of Fetal Monitor is strong enough to be used for clinical use, it is important to be careful in use and pay attention to maintenance, especially the wafer of ultrasonic probe is precise and cannot be rammed and fallen. 6.2. Maintenance In addition to cleaning, the Fetal Monitor does not require additional maintenance. Keep the outer surface of the device clean and free of dust.
probe is damaged because of using oil-based gel, the warranty of the device will be automatically terminated. 7. Packaging, transportation and storage 7.1. Packaging The monitor is sealed in a plastic bag and filled with sponge or foam, then packaged in the packaging box and sealed firmly. 7.2. Transport The monitor can be transported by usual transportation, such as airplane, train, and automobile, which should prevent violent collision and not be mixed with corrosive objects in transportation.
Probe damaged Change the probe The probe is not connected to the device well Abnormal uterine contraction pressure Readjust the probe position Incorrect probe position Process pressure reset No pressure reset Pregnant woman has no uterine contraction Press the pressure probe, the value of uterine contraction has no change Circuit drift in pressure probe Pressure probe damaged No response when press The FM pen is not successfully the FM pen matched with the host Speaker silence Too low volu
other products, please contact us, when you want to return this product, please follow the local disinfection process for disinfection and provide corresponding document to indicate the current state of the product. Please enclose the document in the product packing box. Note: Our company shall not assume responsibility for the incidental or consequential damages resulting from the errors in this manual or from the provision, actual performance and use of this manual.
Signal processing: special digital signal processing unit Measuring range: 60bpm to 210bpm Alarm Range: Upper limit: the adjustable range is 150bpm to 180bpm, the default is 160bpm Lower limit: the adjustable range is 90bpm to 120bpm, the default is 110bpm Maximum audio output power: 2W UC pressure Measuring range: 0-100mmHg Display The LCD screen shows the monitoring state of FHR curve, UC pressure curve, FM symbols, volume and so on, which can be frozen and replayed.
average sound intensity of space peak time shall not exceed 100mW/cm2. The sound intensity of the device type shall not exceed 5mW/cm2. Gel: viscous water-based compound is not irritative and allergic to skin.
Sound output report form Product model: JPD-300E Working mode of probe: pulse wave Probe Frequency: 1.0MHz TIS Index Name MI Maximum Index 0.02 Non-scanning P s of Aaprt > 1 cm2 ning - - 0.002 0.03 - - - 4 - P(zs) 0.46 zs 2.0 zbp 1.8 2.0 zb z at maximum Ipi 2.0 1.2 deq(zb) 1.0 fawf OthersInf ormation ControlC ondition - - 1.0 1.0 - Diameter X - - Φ1.2 Φ1.2 - of Aaprt Y - - Φ1.2 Φ1.2 - td 903.9 prr 1250 pr at maximum Ipi 0.018 deq at maximum Ipi Ipa.
AppendixⅠ—Electromagnetic Compatibility Declaration This device is capable of generating, using, and radiating RF energy. This equipment may cause the electromagnetic 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 of B-grade in first group, so as to provide corresponding protection measures for avoiding interference.
environment – guidance Group 1 The JPD-300E uses RF energy RF emissions only for its internal function. CISPR 11 Therefore, its RF emissions are very low and are to cause any not likely interference in nearby electronic equipment.
Surge IEC 61000-4-5 ±1 kV differential ±1 kV differential mode mode ±2 kV common ±2 mode kV hospital environment.
0.15MHz and the frequency of the transmitter. 80MHz） Conducted 10 V/m from the equation applicable to 10 V/m Recommended RF IEC 61000-4-3 separation distanced = 1.2 x P 80 MHz to 2,7 GHz P 80 MHz to 800 d = 1.2 x MHz d = 2.3 x P 800 MHz to 2.5GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).
(W) d 1.2 P d 1.2 P d 2.3 P 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Shenzhen Jumper Medical Equipment Co., Ltd. Address: D Building, No. 71, Xintian Road, Fuyong Street, Baoan, Shenzhen, Guangdong, China. Tel: +86-755-26692192, 26696279 Fax: +86-755-26852025 Website:www.jumper-medical.
