User Manual
FetalDoppler
Model:JPD-200S
Thank you for purchasing the Fetal Doppler JPD-200S made by Jumper Medical. Before using the product,
read this manual carefully and operate the product as specified in this manual.
SECTION 1: INTRODUCTION
1.1 PACKING LIST
Main unit X 1;
Earphone X 1;
Audio cable for recording X 1;
User manual X 1.
1.2 PRODUCT DESCRIPTION
The product is a lightweight, portable detector. It is designed to meet your detecting and hearing needs by
providing advanced detecting functions and a full range of sound of the fetal heartbeat.
1.3 INTENDED USE
The product is mainly intended used to detect the sound of the fetal heartbeat (SFH).
The growth and development of a fetus can be found out through examination of these indices. It is
applicable for department of gynecology and obstetrics and clinic daily.
In accordance with classification criteria in Annex IX on "Medical Device Directive 93/42/EEC", the product is
class IIa based on rule 10, "Devices for Direct Diagnosis or Detection on physiological process".
The product is powered by an internal battery.
1.4 OPERATING PRINCIPLE
Fetal Doppler consists of probe (transmitter and receiver) and signal process unit.
Ultrasonic wave is transmitted from one piezoelectric ceramic at the front of the probe to the uterus of the
pregnant women. Echo is received by the other piezoelectric ceramic at the front of the probe when
ultrasonic wave reaches the fatal heart. Then it is converted into voltage. This Doppler signal is detected and
demodulated from the received signal. And the Doppler frequency is consistent with the rhythm of the fetal
systole and diastole. Once cardiac valves vibrate and a Doppler frequency excursion is formed. It is
transmitted an output signal of cardiac valves vibrating, and it is sent to the loudspeaker for getting a
rhythmical sound with the fetal heartbeat.
SECTION 2: SAFETY GUIDANCE
2.1 INDICATIONS FOR USE
The product is normally applied to fetus above 16 weeks growth, difference in pregnant mater.
● Listen to SFH: Operator can listen to the sound of fetal heartbeat from the loudspeaker or earphone.
● Audio record: The sound of fetal heartbeat can be recorded by a smartphone which is connected with
the product via audio cable.
2.2 CONTRAINDICATIONS FOR USE
Normally none, as a particular case, please consult your doctor.
2.3 NOTE FOR HOME USE
Please consult your doctor.
2.4 SAFETY TERMS AND CONDITIONS
The signal words shown below, left, identify the potential hazard categories. The definition of each category
is as follows:
DANGER: This alert identifies hazards that will cause serious personal injury or death.
WARNING: This alert identifies hazards that may cause serious personal injury or death.
CAUTION: This alert identifies hazards that may cause minor personal injury, product damage, or
property damage.
2.5 SAFETY ALERT DESCRIPTIONS
The following is a list of product safety alerts that appear in this section and throughout this manual. You
must read, understand, and pay heed to these safety alerts before attempting to operate the product.
Manual Ver.: 1.0
DANGER: The product should not be used in life supporting or life sustaining applications.
Issuing Date: November,2016
DANGER: Fire and Explosion Hazard
Do not operate the Product in the presence of flammable gases to avoid possible explosion or fire
hazard.
WARNING:Strangulation resulting from baby or child entanglement in monitoring cables.
WARNING: Do not modify this equipment without authorization of the manufacturer.
WARNING:Dust, light may affect the safety and performance of the instrument.
WARNING:Degraded sensors and electrodes, or loosened electrodes, that can degrade performance
or cause other problems.
WARNING:The effects caused by pets, pests or children
WARNING: Use only Approved accessories
Do not use other accessories that are not approved by the manufacturer.suck as batteries, gel,
cables, or optional equipment.Otherwise it will cause the product function is not normal.
WARNING: Adjacent and/or Stacked Equipment
The Product should not be used adjacent to or stacked with other equipment. If adjacent or
stacked use is necessary, the Product should be observed to verify normal operation in the
configuration in which it will be used.
CAUTION:Temperature/Humidity/Pressure xtremes
Exposing the Product to extreme environmental conditions outside of its operating parameters may
compromise the ability of the Product to function properly.
CAUTION: Battery Disposal
Recycle or dispose of the battery in accordance with all federal, state and local laws. To avoid fire
and explosion hazard, do not burn or incinerate the battery.
CAUTION: Radio Frequency (RF) Electromagnetic interference
RF susceptibility from cellular phones, CB radios and FM 2-way radio may cause interference with
the product. Do not operate radiotelephones in the vicinity of the Product – turn off the
radiotelephone and other wireless equipment near the Product.
CAUTION: Systems Statement
Equipment connected to the product must be certified to the respective IEC Standards (i.e. IEC
60950 for data processing equipment and IEC 60601-1 for medical equipment).
CAUTION: Cleaning Solutions
When disinfecting the case, use a non-oxidizing disinfectant, such as ammonium salts or
glutaraldehyde based cleaning solution, to avoid damage to the metal connectors.
CAUTION: Environment of use
The product is designed for indoor use. Operator must confirm that the environment of use meets
the required operating environmental specifications before using.
CAUTION: Cold Environments
If the product is stored in an environment with a temperature below the operating temperature, the
product should be allowed to warm up to the needed operating temperature before using.
2.6 SYMBOL DESCRIPTIONS
The following symbols may appear in this manual, on the product, or on its accessories. Some of the
symbols represent standards and compliances associated with the product and its use.
Consult instructions for use of the product and/or its accessories.
Warning Information
Authorized Representative in the European Community
CE Mark: The Product system conforms to essential requirements of the
Medical Device Directive 93/42/EEC.
Date of manufacture.
Manufacturer information.
Type BF applied part
Specifies serial number of the Product
Batch code
The environmental protection use period is 5 years.
Degree of protection against ingress of water and particulate matter.
IP22
It indicates that the equipment should be sent to the special agencies according
to local regulation for separate collection after its useful life.
SECTION 3: USING THE PRODUCT
This section provides the description for operation.
3.1 PRODUCT STRUCTURE
1.
Power on/off & Volume Knob
2.
Loudspeaker
3.
Working indicator light
4.
Transducer
5.
Battery compartment cover
6.
Earphone socket
7.
Recording socket
