ShenZhen JPD300E User Manual

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.

No person or organization shall reproduce, modify or translate this specification without the written consent of

Jumper Company.

This Manual includes Technical Specifications and Instruction Manuel.

WARRANTIES

In the event that the following conditions are met, Jumper Company will be responsible for the safety, reliability

and 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 Jumper

Company.

（3）The storage environment, working environment and electrical environment of the product are in accordance

with the manual.

（4 ） The serial number tag or manufacturing mark of the product shall be clear and identifiable. It is verified

through the appraisal of Jumper Company that this product is manufactured by Jumper Company.

（5）Damage caused by non-human factors

The products that are under the warranty service regulations of Jumper Company shall enjoy free service. As for

the products that are beyond the warranty service regulations, Jumper Company shall charge for the service. If the

products are transported to Jumper Company for maintenance, the user shall bear the freight (including the customs

expenses).

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.com

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. If you hear no fetal heart sounds or feel no fetal

movements, verify whether the fetus is still alive by means of ultrasonic obstetrical examination. Then confirm that

the 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 and

deceleration phenomenon. Do not solely rely on the trend characteristics of the trace to identify the heart rate

source of the fetus.

 Only automatic fetal movement (AFM) markers on fetal traces do not consistently ensure that the fetus is still

alive. 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.

Contents

FCC Statement.....................................................................................................................................................................1

1. Introduction..................................................................................................................................................................... 2

1.1. Product Introduction.............................................................................................................................................2

1.2. Safety Guide......................................................................................................................................................... 3

1.3. Symbol and text description.................................................................................................................................6

2. Recommended clinical application................................................................................................................................. 6

3. Product Description......................................................................................................................................................... 7

3.1. Standard Configuration........................................................................................................................................ 7

3.2. Product Introduction.............................................................................................................................................8

3.3. Main interface (monitoring interface) description.............................................................................................11

3.4. Setting interface specification............................................................................................................................ 12

4. Setting of monitor..........................................................................................................................................................17

4.1. Disassembly and installation and list of accessories......................................................................................... 17

4.2. Connect the power supply Charge..................................................................................................................... 18

5. Operational Guidelines..................................................................................................................................................18

5.1. Preparation before Use.......................................................................................................................................18

5.2. FHR monitoring................................................................................................................................................. 18

5.3. TOCO monitoring.............................................................................................................................................. 19

5.4. Manual FM monitoring...................................................................................................................................... 19

5.5. Monitoring information update.......................................................................................................................... 19

5.6. Restore Factory Settings.....................................................................................................................................19

6. Maintenance and clean of Fetal Monitor...................................................................................................................... 20

6.1. Product Handling................................................................................................................................................20

6.2. Maintenance....................................................................................................................................................... 20

6.3. Cleaning and Disinfection..................................................................................................................................20

6.4. Gel...................................................................................................................................................................... 20

7. Packaging, transportation and storage...........................................................................................................................21

7.1. Packaging........................................................................................................................................................... 21

7.2. Transport.............................................................................................................................................................21

7.3. Storage................................................................................................................................................................21

8. Fault finding and eliminating........................................................................................................................................21

9. Warranty Period and Maintenance................................................................................................................................ 22

10. Technical Parameters...................................................................................................................................................23

AppendixⅠ—Electromagnetic Compatibility Declaration..............................................................................................27

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. These limits are designed to provide reasonable protection against harmful interference in a

residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and

used in accordance with the instructions,may cause harmful interference to radio communications.However, there is

no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful

interference to radio or television reception, which can be determined by turning the equipment off and on, the user is

encouraged 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 your

authority to operate this equipment.

1. Introduction

 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 no

 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 and

 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.

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. You don’t need to remember the pair relationship

between the host and the probe, it can be used as soon as you pick it up. The monitoring data is uploaded in real-time

through wireless WIFI, nurse central monitoring station can view the real-time monitoring information of the fetus and

keep abreast of the Fetal Monitoring situation.

This Fetal Monitor is applicable to external monitoring, it is equipped with an ultrasonic probe, a uterine

contraction 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:

longer worry about “checking the wrong number”.

clear fetal heart sound.

Working Principles

Fetal Monitor is the fetal heart rate detection through the noninvasive ultrasonic Doppler. We know that a certain

frequency of ultrasonic wave will reflect when it encounters obstacles during the transmission. If the object is

 Monitoring all stages after pregnancy.

 Fetal Monitor is not applicable to monitor water birth.

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. Since the fetal heart beat

has movement relative to the ultrasonic probe, the reflected wave will cause frequency offset after the transmitting

wave encounters the heart, so as to calculate the frequency of the fetal heart beat per minute (fetal heart rate), and so

on. Uterine contraction pressure is to detect the uterine contraction pressure change of the pregnant woman through

uterine contraction probe sensor, and draw the curve. Fetal movement frequency is manually recorded by fetal

movement pen button according to the pregnant women feel their own fetal movement.

Intended Usage

It is provided for medical institutions to monitor the fetal heart rate, the fetal movement and uterine contraction

pressure.

Product Composition

It consists of the host and the ultrasonic probe.

1.2. Safety Guide

Classification 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 degree

of 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 to

allowable leakage current and dielectric strength.

Safe Operation Instructions

In order to avoid possible injury, you are highly recommended to observe the following safety instructions when

operating the device.

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. It is suggested that

before connecting each other, the leakage testing should be conducted by qualified personnel

professional to ensure the leakage current is within safety range, that is to say, it will not cause harm

to the patient, the operator and the surroundings. The user should consult the manufacturer about the

correct operating method if any further doubts. Before using this monitor, the operator must confirm

that the instrument is in normal working condition and operating environment. When using a

high-frequency electrotome, the lead wires and guide wires for patient should be placed as far from

the surgery as possible to keep the cables away from other devices, thereby reducing the risk of burns

caused by poor neutral connection of high-frequency electrotome. Regularly check whether the

repeated use of accessories are damaged, whether the sensor is damaged, whether cable connections

are reliable, replace if necessary, and properly handle the damaged accessories according to medical

waste.

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 of

wetting.

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 by

strong 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 of

device before use. The recommended inspection period is once a month or less. If no obvious damage is

found, 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

and practical experience. Generally the safety check should be made every two years or according to the



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.

inspection regulations formulated by the public organization. Test according to the inspection rules

designated by public agency.

Caution:The instrument is returned to the manufacturer for disposal in accordance with local regulations after the

effective life of the instrument.

Caution: Dry batteries of fetal movement pen should be handled properly after use in accordance with local

regulations.

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 pregnant

women should be as short as possible.

Caution: Do not use instrument immediately when it is transferred from a cold environment to a warm and humid

place.

Caution: Keep the operating environment free from vibration, corrosion, flammable substances, and avoid too high or

too 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 complicated

clinical working needs, it should be handled carefully during its usage, especially, the ultrasonic probe

wafer 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 probe

surface, 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

the device by using a wet rag dipped with a neutral disinfectant or detergent.

Symbol

Description

Class II equipment

Type BF applied part

Note! Please refer to this Manual

Non-ionizing radiation

IPX4

Probe waterproof grading of 4

When discarding the product, it must be taken to the separation and collection place

for recycling.

WARNING

You should know the information about how to avoid pregnant women and medical

personnel being injured.

NOTE

Some important information that you should know

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.

Caution: Please do not turn off speaker volume during monitoring, because fetal heart sound monitoring is very

important.

Caution: The accuracy of the fetal heart rate is controlled by the device and cannot be adjusted by the user. If FHR

result is not accurate, please use other methods. For example, use a stethoscope to verify, or contact a local

agent or manufacturer for assistance.

1.3. Symbol and text description

2. Recommended clinical application

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

 The host

 Ultrasound fetal heart probe US

 Uterine contraction probe TOCO

 Fetal movement pen FM

 AC Adapter

3. Product Description

3.1. Standard Configuration

The 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 LCD

screen, 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 (US) fetal heart probe is fixed on the abdomen of pregnant women by elastic bandage.

Uterine contraction pressure (TOCO) probe is fixed on the abdomen of pregnant women by elastic bandage.

Pregnant women hold the fetal movement pen, and press the fetal movement pen button to record the fetal movements

when pregnant women feel fetal movements or uterine contractions.

Input: AC 100-240V，50/60Hz 0.8A Max.

Output: DC 12V, 2.5A

+ 25 hidden pages