Shezhan Jumper JPD-100S User manual

JPD-100S（mini）

Fetal Doppler

INSTRUCTION MANUAL

Manual Version: V1.1
Issuing Date: 2012.11.2

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Product Information

Product Name: Fetal Doppler

Model: JPD-100S（mini）

Manufacturer: Shenzhen Jumper Medical Equipment Co., Ltd
Address: 5th Floor Building No. 34, Baoyuan Industrial Zone,
Xixiang Street, Baoan District, Shenzhen 518102 ,P.R. China

Copyright

Copyright2010. All rights reserved.

Statement

Shenzhen Jumper Medical Equipment Co., Ltd owns the
copyright of this non-public instruction book.
Without written authorization from Shenzhen Jumper Medical
Equipment Co., Ltd, any individual or organization shall not
copy, modify or translate this book.
All contents described in this book are consistent with the actual
situation of the related product.
Shenzhen Jumper Medical Equipment Co., Ltd has right to
revise all contents of this book if needed, without prior notice.
Shenzhen Jumper Medical Equipment Co., Ltd reserves the
right of final interpretation of this book.
"ANGELSOUNDS" is the registered trademark of Shenzhen
Jumper Medical Equipment Co., Ltd.

Precaution Labels Definition

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.

NOTE: The label indicates what you should attention.

Fetal Doppler

Table of contents

SECTION 1: INSTRUCTION ....................................................1

1.1 CONTACT INFORMATION ..................................................1

1.2 INDICATION FOR USE .......................................................2

1.3 PRODUCT DESCRIPTION ..................................................3

1.4 OPERATING PRINCIPLE ....................................................3

1.5 CONTRAINDICATIONS FOR USE .........................................4

1.6 ADVERSE EFFECTS..........................................................4

SECTION 2: SAFETY GUIDANCE ..........................................5

2.1 SAFETY ALERT DESCRIPTIONS ..........................................5

2.2 SYMBOLS .......................................................................7

SECTION 3: GETTING STARTED ...........................................8

3.1UNPACKING AN INSPECTING ..............................................8

3.2ACCESSORIES .................................................................9

SECTION 4: CONTROLS AND INDICATORS .......................10

4.1 APPEARANCE ...............................................................10

4.2 INDICATOR ...................................................................11

4.3 KNOB ..........................................................................11

4.4 SOCKET .......................................................................11

4.5 BATTERY .....................................................................11

SECTION 5: OPERATION PROCEDURE ..............................12

5.1 PREPARATION ..............................................................12

5.2 DETECTING ..................................................................14

5.3 RECORDING .................................................................16

SECTION 6 PREVENTIVE MAINTENANCE ..........................16

6.1 MAINTENANCE ..............................................................16

6.2 VISUAL INSPECTION ......................................................18

6.3 CLEANING PRODUCT AND ACCESSORIES .........................19

6.4 DISINFECTIONS .............................................................21

6.5 RECYCLE BATTERIES ....................................................21

6.6 AUTHORIZED REPAIR SERVICE .......................................21

SECTION 7: TECHNICAL SPECIFICATIONS .......................21

APPENDIX A EMC INFORMATION.......................................25

Section 1: Instruction

Become familiar with the controls and how to use the PRODUCT
properly before operating the product.

CAUTION: Federal law restricts this device to be sold by or on
the order of a physician or practitioner licensed by state law in
which he/she practices to use or order the use of the device.

CAUTION: It should not be used in life supporting or life
sustaining applications

1.1 Contact Information

Manufacturer: Shenzhen Jumper Medical Equipment Co., Limited;
Manufacturer Address: 5th Floor Building No. 34, Baoyuan Industrial
Zone, Xixiang Street, Baoan District, Shenzhen 518102 ,P.R. China
Telephone Number: [phone]
F a x: [phone]
Web site: http://www.jumper-medical.com

Manufacturing:

Authorized European Representative:

Shenzhen Jumper Medical Equipment Co., Limited;
5th Floor Building No. 34, Baoyuan Industrial Zone,
Xixiang Street, Baoan District, Shenzhen 518102 ,P.R.
China

Wellkang Ltd
Suite B, 29Harley Street ,
LONDON,W1G9QR,u.k.

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US Agent:

Tingting Yan
CHINESE LEGAL CONSULTANT, LLC.
2836 rainview dr. san jose, CA 95133
Phone: [phone]
Fax: [phone]
Email: [e-mail]

Order Entry:

To order additional Ultrasonic Instrument or accessories:
Worldwide
Web site: http://www.jumper-medical.com

Customer Service:

To receive customer support:
U.S. and Canada Outside U.S. and Canada
408-729-3833 + 86 755 26696279
408-729-3844 (Fax) + 86 755 26852025 (Fax)
Email: [e-mail] Email: [e-mail]

1.2 Indication for Use

The AngelSounds Fetal Doppler JPD-100S (mini) is a prescription from
licensed physician in hospitals, clinics and private offices. It is intended
to be used by care professionals including practical nurses, midwives,
relative technicians, and physician assistants.
This device can detect the Fetal Heart Rate. Connect the headset allows
for hearing the sound of the fetal heartbeat. You can count the fetal
heartbeat rate when listening. This device normally is applied to 12
weeks gestation or later, difference in pregnant mater.
The device detects fetal life from early gestation thru delivery, and it can
be a general indication of fetal well being. It can also be used to verify
fetal heart viability following patient trauma.

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1.3 Product Description

The product is a lightweight, portable detector. It is designed to m eet
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 fetal heartbeat rate (FHR) and
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
gynaecology 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 a 9V internal battery.

1.4 Operating Principle

Fetal Doppler consists of transmitter unit, receiver unit, signal process
unit, and signal output unit (such as speaker, headset, display screen
etc).

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

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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 signal demodulate unit to get
the Doppler frequency signal, and process the signal become the signal
that can be heard by human using headset.

1.5 Contraindications for Use

Normally none, as a particular case, please consult your doctor.

1.6 Adverse effects

No adverse effect.

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Section 2: Safety Guidance

This product is internal powered equipment, and the degree of shock
protection is BF.

It means that these person connections will comply with permitted
leakage currents, dielectric strengths of IEC/EN60601.

2.1 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 heed
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.

WARNING: Use only Approved Equipments
Do not use batteries, gel, cables, or optional equipment other
than those approved by Jumper Medical Ultrasonic
Instrument Co., Ltd. which may cause the Product to function
improperly during a rescue.

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.

WARNING: Practice the ALARA principle

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We recommend that exposure to ultrasound should be kept
as low as reasonably achievable principle. This is considered
to be good practice and should be observed at all time.

WARNING: Aid healthcare professional tool
The product should not be used in place of normal fetal
monitoring. It is a tool to aid the healthcare professional.

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.

CAUTION: Possible Radio Frequency (RF) Susceptibility
RF susceptibility from cellular phones, CB radios and FM 2­way 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.

CAUTION: Systems Statement
Equipment connected to the Product must be certified to the
respective IEC Standards (i.e. IEC 950 for data processing
equipment and IEC 601-1 for medical
equipment). Furthermore, all configurations shall comply
with the system standard IEC 601-1-1. 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

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