AngelSounds JPD-100S User manual

JPD-100S
Fetal Doppler
INSTRUCTION MANUAL
Manual Version: 1.1
Issuing Date: 2020.11

Product Information
Product Name: Fetal Doppler
Model: JPD-100S
Manufacturer: Shenzhen Jumper Medical Equipment Co., Ltd
Add: D Building, No. 71, Xintian Road, Fuyong Street, Baoan,Shenzhen,
Guangdong,China
Copyright
Copyright 2016.All rights reserved.
Statement
Shenzhen Jumper Medical Equipment Co., Ltd owns the copyright of this
non-public instruction manual.
Without authorization from Shenzhen Jumper Medical Equipment Co.,
Ltd, any individual or organization shall not copy, modify or translate this
manual.
All contents described in this manual are consistent with the actual
situation of the related product.
Shenzhen Jumper Medical Equipment Co., Ltd has right to revise all
contents of this manual if needed, without prior notice.
Shenzhen Jumper Medical Equipment Co., Ltd reserves the right of
final interpretation of this manual.
"JUMPER" and "ANGELSOUNDS" are the registered trademarks of
Shenzhen Jumper Medical Equipment Co., Ltd.
Please read the User Manual carefully to make sure safe and
proper use of this Fetal Doppler，Please read and fully understand the
Safety Precautions before use.

Table of Contents
SECTION 1: INTRODUCTION.......................................................................................... 2
1.1 OVERVIEW..................................................................................................................................... 2
1.2 PRODUCT DESCRIPTION........................................................................................................... 2
1.3 OPERATING PRINCIPLE............................................................................................................. 2
SECTION 2: SAFETY GUIDANCE...................................................................................3
2.1 INDICATIONS FOR USE.............................................................................................................. 3
2.2 CONTRAINDICATIONS FOR USE..............................................................................................3
2.3 NOTE FOR HOME USE................................................................................................................ 3
2.4 SAFETY TERMS AND CONDITIONS......................................................................................... 3
2.5 SAFETY ALERT DESCRIPTIONS...............................................................................................4
2.6 SYMBOL DESCRIPTIONS........................................................................................................... 5
SECTION 3: USING THE PRODUCT.............................................................................. 7
3.1 UNPACKING AND INSPECTING................................................................................................ 7
3.2 SETTING UP THE PRODUCT..................................................................................................... 8
3.3 BUILD IN BATTERY.......................................................................................................................8
3.4 OPERATE KNOB AND INDICATOR LIGHT...............................................................................9
3.4.1 POWER ON.........................................................................................................................9
3.4.2 POWER OFF.......................................................................................................................9
3.4.3 VOLUME ADJUSTMENT.................................................................................................. 9
3.4.4 AUDIO OUT.........................................................................................................................9
3.5 PREPARATION.............................................................................................................................. 9
3.6 USING PRODUCT TO DETECT................................................................................................10
SECTION 4: MAINTENANCE & AFTER-SALES SERVICE......................................10
4.1 MAINTENANCE............................................................................................................................10
4.2 RECOMMENDED MAINTENANCE AND CARE..................................................................... 11
4.3 VISUAL INSPECTION................................................................................................................. 11
4.4 CLEANING PRODUCT AND ACCESSORIES.........................................................................12
4.5 CLEANING INSTRUCTIONS......................................................................................................12
4.6 DISINFECTIONS.......................................................................................................................... 13
4.7 RECYCLING THE BATTERIES................................................................................................. 14
4.8 AUTHORIZED REPAIR SERVICE.............................................................................................14
4.9 CONTACT INFORMATION.........................................................................................................14
SECTION 5: SPECIFICATIONS AND SAFETY...........................................................15
5.1 SPECIFICATIONS....................................................................................................................... 15
5.2 MODE OF OPERATION..............................................................................................................15
5.3 PHYSICAL DIMENSIONS...........................................................................................................15
5.4 ENVIRONMENTAL REQUIREMENTS......................................................................................16
OPERATING CONDITIONS..............................................................................................................16
STORAGE AND SHIPPING CONDITIONS.................................................................................... 16
SECTION 6: ACCESSORIES......................................................................................... 16
6.1 OVERVIEW................................................................................................................................... 16
6.2 PRODUCT ACCESSORIES....................................................................................................... 16
SECTION 7 : TROUBLESHOOTING.......................................................................... 16
APPENDIX A: EMC INFORMATION-GUIDANCE AND MANUFACTURE’S
DECLARATION.................................................................................................................17

SECTION 1: INTRODUCTION
1.1 OVERVIEW
Become familiar with the controls and how to use the product properly
before operating the product.
CAUTION: It should not be used in life supporting or life
sustaining applications.
CAUTION: It cannot replace the professional fetal monitor, when
the fetal heart rate is abnormal, or it can not find the fetal heart,
can not feel the fetal movement, pregnant woman should
immediately go to the hospital to seek the doctor's help.
Intended use
The Fetal Doppler JPD-100S is a hand-held, battery powered audio
Doppler device used for detecting fetal heartbeats.
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.
The product is mainly 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 II based on rule 10, “Devices
for Direct Diagnosis or Detection on physiological process”.
The product is powered by an internal battery.
1.3 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

3
wave reaches the fetal 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. The normal range of fetal heart rate:
110bpm-160bpm
Listen to SFH:
Operator can listen to the sound of fetal heartbeat from the
headset.
Audio record:
The sound of fetal heartbeats can be recorded by a recorder
which is connected with the product.
As a safety advisement that can only be connected with a
recorder complied with the safety requirements of IEC
60601-1.
2.2 CONTRAINDICATIONS FOR USE
Normally none, as a particular case, please consult your doctor.
2.3 NOTE FOR HOME USE
This device cannot replace a professional fetal monitor. If the fetal heart
rate is abnormal or cannot be located by using this monitor,the pregnant
woman should immediately go to the hospital to seek the doctor's help.If
fetal movement is not felt by the pregnant woman, immediately go to the
hospital to seek the doctor's help.
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:

4
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.
DANGER: Fire and Explosion Hazard
Do not operate the Product in the presence of flammable
gases to avoid possible explosion or fire hazard.
CAUTION: Temperature/Humidity/Pressure Extremes
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.
WARNING: Use only Approved Equipment
Do not use batteries, gel, cables, or optional equipment other
than those approved by Jumper Medical Equipment Co.,Ltd
which may cause the product to function improperly during a
rescue.
CAUTION: Possible Radio Frequency (RF) Susceptibility
RF susceptibility from cellular phones, CB radios and FM
2-way radio may cause interference with the product. Do not
operate wireless radiotelephones in the vicinity of the
Product – turn power OFF to the radiotelephone and other
like equipment near the Product.

5
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: Systems Statement
Equipment connected to the product must be certified
according to the respective IEC Standards (i.e. IEC 60950 for
data processing equipment and IEC 60601-1 for medical
equipment). Furthermore, all configurations shall comply with
the system standard IEC 60601-1-1. Anybody who connects
additional equipment to the signal input part or signal output
part configures a medical system, and is therefore,
responsible that the system complies with the requirements of
the system standard IEC 60601-1-1. The product service port
is only intended for use during maintenance by authorized
service personnel.
CAUTION: Case 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 unit 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
compliance associated with the product and its use.

6
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
Storage Temperature
Humidity
Atmospheric Pressure
Upward
Non-hook
Specifies serial number of the Product
Batch code
It indicates that the equipment should be sent
to the special agencies according to local
regulation for separate collection after its useful
life.
0482

7
SECTION 3: USING THE PRODUCT
This section provides the description for operation.
3.1 UNPACKING AND INSPECTING
Every attempt is made to ensure your accurate and complete order.
However, to be sure that your correct order, verifying the contents of the
box against your packing slip.
The product is designed for simplicity of operation and set-up and
requires minimal assembly. The following items are included in your
box:
1 (one) Product
1 (one) Headset
1 (one) Recording Cable
1 (one) Operator’s manual
1 (one) Battery (9V)
Carefully inspect each item as it is unpacked for any signs of damage
which may have occurred during shipment.
Check the components according to the packing list.
Check for any damage or defects. Do not attempt to assemble the
product if anything is damaged or defective. Contact Shenzhen
Jumper Medical Equipment Co., Ltd Customer Service immediately
if anything is damaged or defective.
Type B applied part
IPX4
Ingress Protection.

8
3.2 SETTING UP THE PRODUCT
Controls and indicators
1. Power On/Off/Volume Knob
2. Working Indicator Light
3. Headset Socket(two)
4. Transducer
5. Battery Compartment Cover
3.3 BUILD IN BATTERY
1. Open the battery cover. The rear panel is upturned. First, open the
cover (5) of battery compartment.
2. Install the battery. Take out the battery connector. Then plug the
battery to connector, after that put them into the battery compartment.
3. Close the battery cover. First, along the left of battery compartment
latch, put the cover at the right place. Then close the cover (5).
CAUTION:
Remove these batteries if the device is not likely to be used
for some time.
WARNING: Irregular treatment of batteries may be result in
hazards to health and environment.

9
3.4 OPERATE KNOB AND INDICATOR LIGHT
There has an 'Power on/off/volume knob (1)', it's easy to operate. And
working indicator light (2) shows working condition.
3.4.1 POWER ON
When the product is not in use, turn the 'Power on/off/volume knob (1)' to
right for switching on the product. Indicator light (2) is on.
3.4.2 POWER OFF
When in use, turn the 'Power on/off/volume knob (1)' to the end of left for
switching off the product. Indicator light (2) is off.
3.4.3 VOLUME ADJUSTMENT
Turn the 'Power on/off/volume knob (1)' to right; the sound volume will
increase. Contrary, Turn the 'Power on/off/volume knob (1)' to left, the
sound volume will decrease.
3.4.4 AUDIO OUT
A socket for audio output can only be connected with a recorder
complied with the requirements of IEC 60601-1.
3.5 PREPARATION
Follow these recommendations to prepare for operation:
Switching on by turning the 'Power on/off/volume knob (1)'.
Apply coupling gel to the faceplate of probe or abdomen.
Move the transducer slowly over the lower part of the abdomen.

10
3.6 USING PRODUCT TO DETECT
Locate the position of the fetus by hand touching, firstly to find out the
best direction to the fetal heart. Place the faceplate of probe at the best
position for detecting fetal heartbeats. Adjust the transducer to obtain an
optimum audio signal ideally by angling the transducer around. Generally,
the site of heart of fetus is 1/3 below of navel line at its earlier stage, it
then moves upward with increasing of gestational period, and the site of
heart of fetus will be a little deviation to left or right with different fetuses.
Please make sure that the surface of the probe should be contacted fully
with the skin. After the sound become clear, it is the proper functioning. If
no coupling gel, water can be used.
SECTION 4: MAINTENANCE & AFTER-SALES SERVICE
Proper maintenance of the product is very simple, yet it is an important
factor of its reliability. The section describes the maintenance and service
required for the product and its accessories.
4.1 MAINTENANCE
WARNING: Failure of the part of all responsible individuals,
hospitals or institutions, employing the use of product, to
implement the recommended maintenance schedule may cause
equipment failure and possible health hazards. The
manufacturer does not, in any manner, assume the responsibility
for performing the recommended maintenance schedule. The
sole responsibility rests with the individuals, hospitals, or
institutions utilizing the product.
4.1.1 The transducer acoustic surface is frangible and must be
handle with care .Gel must be wiped off from the transducer after
use. These precautions will prolong the life of the unit.
Gestation
Antepartum
Parturition

11
The user must check that the equipment does not have visible
evidence of damage which may affect patient’s safety or
product’s capability before use .The recommended inspection
interval is once per month or less. If damage is evident,
replacement is recommended before use.
4.1.2 To ensure the product is always functional when required, the
following maintenance shall be performed.
Visual Inspection
Cleaning the product and its accessories
Check the battery fuel gauge
Testing product performance
Correction: manually calculate the FHR with hearing fetal heartbeat
sound for qualification.
4.2 RECOMMENDED MAINTENANCE AND CARE
It is important that the product is stored at the operating temperature
range if it is expected to be used. Optimal battery life will be
obtained if stored and operated at room temperature. See Section 5
for temperature specifications.
The product requires no calibration.
4.3 VISUAL INSPECTION
The product and its accessories should be carefully inspected prior to
installation, once every 12 months thereafter and each time the
equipment is serviced.
Carefully inspect the equipment for physical damage
Inspect all external connections for loose connectors or frayed
cables.
Inspect the graphics display for marks, scratches, or other damage.
Verify that the safety label on back of the product is clearly legible
INSTRUCTION
INSPECT FOR
RECOMMENDED
REMEDY
Examine the
case
connectors and
accessories
Foreign substances
Clean the product and
its accessories as
described.

12
Damage or cracks
Contact Our Customer
Service
Examine
accessory
cables
Foreign substances
Clean the cables as
described in the
Section 5
Broken parts, cracks,
damage, or extreme wear,
broken or bent connectors
and pins, after bending and
flexing the cable
Replace cable if any
abnormalities are
found.
Examine
disposable
accessories
Expired product or Product
pads
Replace any products
approaching or past
their expiration dates.
WARNING: After the visual inspection, if the product and/or its
accessories are damaged please contact our Customer Service.
The product will need to be returned back to us for repair. The
accessories should be disposed of appropriately and
replacement parts shall be ordered.
4.4 CLEANING PRODUCT AND ACCESSORIES
The following cleaning products may be used to clean the exterior
surfaces of the product as well as the batteries.
Isopropyl alcohol (70% solution in water)
Mild soap and water
Sodium hypochlorite (chlorine bleach) (3% solution in water).
Quaternary ammonium compounds (such as Lysol) (10% solution
in water).
Do not use abrasive cleaners or strong solvents such as acetone or
acetone-based cleaners.
Do not use mixing disinfecting solutions (such as bleach and
ammonia) as hazardous gases may result.
Do not clean electrical contacts or connectors with bleach.
4.5 CLEANING INSTRUCTIONS
4.5.1 Before cleaning the product, turn the device off and disconnect the
power cord.

13
4.5.2 Before cleaning, remove all adherent soil (tissue, fluids, etc.) and
wipe thoroughly with a cloth dampened with water before applying
the cleaning solution.
4.5.3 When cleaning, do not immerse. Keep the exterior surface of the
device clean and free from dust and dirt, clean exterior surface of
the unit with a dry, soft cloth .if necessary, clean it with a soft cloth
soaked in a solution of soap and wipe dry with a clean cloth
immediately.
Wipe the transducer body with soft cloth to remove any remaining
coupling gel .Clean with soap only.
4.5.4 Wring any excess moisture from the cloth before cleaning.
4.5.5 Avoid pouring fluids on the device, and do not allow fluids to
penetrate the exterior surfaces of the device.
4.5.6 To prevent scratching the display, the use of a soft cloth is
recommended.
CAUTION: To prevent damage to equipment, do not clean any
part of the Product or Accessories with phenolic compounds. Do
not use abrasive or flammable cleaning agents. Do not steam,
autoclave, or gas-sterilize the Product or accessories.
CAUTION: Cleaning liquids: do not submerge the device in
liquids or pour cleaning liquids over, into or onto the device.
.
* Don’t use strong solvent, for example, Acetone.
* Never use an abrasive such as steel wool or metal polish.
* Do not allow any liquid to enter the product, and do not immerse any
parts of the device into and liquids.
* Avoid pouring liquids on the device while cleaning.
* Don’t remain any cleaning solution on the surface of the device.
Wipe the surface of sensor of transducer with 70% ethanol or alcohol,
self-air dry or clean with a clean, dry cloth.
4.6 DISINFECTIONS
Cleaning the unit surface and the transducer as the above mentioned,
then wipe the surface of transducer with 70% ethanol or alcohol, clean
the transducer surface with a dry, soft cloth.
* Don’t use low temperature steam sterilization or other way to sterilize.
* Don’t use high temperature sterilizing process.

14
4.7 RECYCLING THE BATTERIES
The batteries are recyclable. Remove the old battery from the Product
and follow your local recycling guidelines or Refer to local regulations.
WARNING: Irregular treatment of batteries may be result in
hazards to health and environment.
4.8 AUTHORIZED REPAIR SERVICE
The Product has no user-serviceable internal components. Try to resolve
any maintenance issues with the Product by using the Troubleshooting
Table presented in this chapter. If you are unable to resolve the problem,
contact Jumper Medical Equipment Co., Ltd Service department.
NOTE: The warranty will be void upon unauthorized disassembly
or service of the product.
4.9 CONTACT INFORMATION
Product is manufactured by:
Authorized European Representative:
MedPath GmbH
Mies-van-der-Rohe-Strasse 8, 80807 Munich, Germany
Order Entry:
To order additional Ultrasonic Instrument or accessories:
Website: http://www.jumper-medical.com
Shenzhen Jumper Medical Equipment Co., Limited
D Building, No. 71, Xintian Road, Fuyong Street,
Baoan,Shenzhen, Guangdong,China
Tel:[phone] Fax:[phone]
E-mail: [e-mail]
Website: http://www.jumper-medical.com

15
SECTION 5: SPECIFICATIONS AND SAFETY
This section presents the specifications and safety standards of the
Product.
5.1 SPECIFICATIONS
NOTE: The following specifications are subject to change and
are only noted as a point of reference.
ULTRASOUND
Ultrasonic emitting frequency:
3MHz
Overall sensitivity at the distances
200mm from the face of the transducer
（Doppler frequency:300±50Hz,Targe
velocity: 10cm/s~40cm/s）
≥90dB
Spatial-peak temporal-peak acoustic
pressure:
<1MPa
Output power:
<20mW
Effective area of the ultrasonic
transducer active element:
4.92cm2
The acoustic coupling medium for
normal use:
ph :5.5~8, Acoustic
impedance:
1.5*106~1.7*106Pa·s/m
AUDIO OUTPUT
Audio Output Power:
<0.2 W
Audio out socket:
Φ3.5mm
BATTERY
Battery Voltage:
9V
Type:
IEC6F22 9V alkaline
5.2 MODE OF OPERATION
Continuous operating
5.3 PHYSICAL DIMENSIONS
104mm (W) x 120mm (D) x 61mm (H), Wt: 0.14kg (including battery)

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W –4.1 in, D –4.7in, H –2.4 in, Wt: 31lbs (including battery)
5.4 ENVIRONMENTAL REQUIREMENTS
OPERATING CONDITIONS
Temperature: 5C to 40C
Humidity: <80% RH, non-condensing
Atmospheric pressure: 86kPa to 106kPa
STORAGE AND SHIPPING CONDITIONS
Temperature: - 20C to 55C
Humidity: 10% - 93% RH, non-condensing
Atmospheric pressure: 50kPa to 106kPa
SECTION 6: ACCESSORIES
6.1 OVERVIEW
This section contains a list of parts and software accessories for Product.
To place an order, contact your representative or distributor.
6.2 PRODUCT ACCESSORIES
Product is available in more than twenty languages, with others being
added on a regular basis. For a complete list of those available, contact
your sales representative or Shenzhen Jumper Medical Equipment Co.,
Ltd Customer Service.
Section 7 : Troubleshooting
What appears to be a malfunction may not always serious, if your
product does not perform as expected, consult the table below to see if
ACCESSORIES
Part Number
Description
JP100S-HS13B
Headset Φ3.5mm
JP100S-RC1.2M
Recording cable Φ3.5mm

17
the problems can be corrected before seeking help from your dealer or
service representative.
Symptom
Cause
Remedy
Audio scream
Audio volume too
high
Too much gel on
the probe surface
Battery is
exhausted
Turn down the
volume
Use less gel
Replace the
batteries
Weak sound output
Audio volume too
low
Insufficient gel
Battery is
exhausted
Turn up the
volume
Add gel
Replace the
battery
Low sensitivity
Incorrect probe
position
Insufficient gel
Locate the correct
position
Add gel
Appendix A: EMC Information-Guidance and Manufacture’s
Declaration
CAUTION:
Fetal Doppler needs special precautions regarding EMC and
needs to be installed and put into service according to the EMC
information provided for in the ACCOMPANYING
DOCUMENTS.
CAUTION:
Portable and mobile RF communications equipment can affect
Fetal Doppler.
CAUTION:
The Fetal Doppler should not be used adjacent to or stacked
with other equipment.
A1.1 Electromagnetic Emissions

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The Fetal Doppler is intended for use in the electromagnetic
environment specified below. The customer or the user of the Fetal heart
monitor should assure that it is used in such an environment.
Emissions
test
Compliance
RF
emissions
CISPR 11
Group 1
The Fetal Doppler uses RF energy only for
its internal function. Therefore, its RF
emissions are very low, and are not likely to
cause any interference in nearby electronic
equipment.
RF
emissions
CISPR 11
Class B
The Fetal Doppler is suitable for use in all
establishments, including domestic
establishments and those directly
connected to the public low-voltage power
supply network that supplies buildings used
for domestic purposes.
A 1.2 Electromagnetic Immunity
The Fetal Doppler is intended for use in the electromagnetic
environment specified below. The customer or the user of the Fetal
Doppler should assure that it is used in such an environment.
Immunity test
IEC
60601
test level
Compliance
level
Electromagnetic
environment guidance
Electrostatic
discharge
(ESD)
IEC
61000-4-2
±6 kV
contact
±8 kV air
±6 kV
contact
±8 kV air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30 %.
Power
frequency
(50/60 Hz)
magnetic field
lEC
61000-4-8
3 A/m
3 A/m
Power frequency magnetic
fields
should be at levels
characteristic of
a typical location in a
typical
commercial or hospital
environment.
A 1.3 Electromagnetic Immunity (not life-supporting)
The Fetal Doppler is intended for use in the electromagnetic environment