SweetieSong EZD-100S5 User manual

Table of Contents
SECTION 1: INTRODUCTION.............................................................................1
1.1 OVERVIEW.............................................................................................1
1.2 PRODUCT DESCRIPTION.......................................................................1
1.3 OPERATING PRINCIPLE.........................................................................1
SECTION 2: SAFETY GUIDANCE.......................................................................2
2.1 INDICATIONS FOR USE..........................................................................2
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 ............................................................3
2.6 SYMBOL DESCRIPTIONS.......................................................................6
SECTION 3: USING THE PRODUCT...................................................................7
3.1 UNPACKING AND INSPECTING..............................................................7
3.2 CONTROLS AND DISPLAY .....................................................................8
3.2.1 Structure and shape .......................................................................8
3.2.2 Specification...................................................................................9
3.3AUDIO OUT...........................................................................................10
3.4DIRECTIONFOR USING.......................................................................10
SECTION 4: MAINTENANCE & AFTER-SALES SERVICE................................12
4.1 MAINTENANCE ....................................................................................12
4.2 RECOMMENDEDMAINTENANCE AND CARE.......................................13
4.3 VISUAL INSPECTION............................................................................13
4.4 RECOMMENDEDCLEANING PRODUCTS............................................14

4.5 CLEANING INSTRUCTIONS..................................................................15
4.6 DISINFECTIONS...................................................................................16
4.7 RECYCLING THE BATTERIES ..............................................................16
4.8 AUTHORIZED REPAIR SERVICE..........................................................16
SECTION 5: SPECIFICATIONS AND SAFETY..................................................17
5.1 SPECIFICATIONS.................................................................................17
DISPLAY..............................................................................................17
ULTRASOUND.....................................................................................17
FHR PERFORMANCE..........................................................................18
BATTERY.............................................................................................18
5.2 MODEOF OPERATION.........................................................................18
5.3 PHYSICAL DIMENSIONS......................................................................18
5.4 ENVIRONMENTAL REQUIREMENTS....................................................18
OPERATING CONDITIONS ..................................................................18
STORAGE AND SHIPPING CONDITIONS ............................................18
SECTION 6: ACCESSORIES ............................................................................19
OVERVIEW ................................................................................................19
PRODUCTACCESSORIES.........................................................................19
APPENDIX A: EMC INFORMATION-GUIDANCE AND MANUFACTURE’S
DECLARATION ................................................................................................20
APPENDIX B: TROUBLESHOOTING................................................................23

1
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
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 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”.
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 wave reaches the fatal heart. Then it is converted into voltage.
This Doppler signal is detected and demodulated from the received

2
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. Simultaneously, it is sent to a
counter which calculate periods of heartbeat that is fetal heartbeat rate
(bpm=beat per minute).
SECTION 2: SAFETY GUIDANCE
2.1 INDICATIONS FOR USE
The product is normally applied to fetus above 9~12 weeks growth,
difference in pregnant mater.
Listen to SFH:
The sound of fetal heartbeat can be played through earphone or
speaker.
Record SFH:
When the device is connected to record devices with USB cable,it can
transmit the sound of the fetal heartbeat to record devices,such as
cellphone and computer, and save it into the record devices.
Playback SFH:
Operator can playback the sound of the fetal heartbeat saved in the
record devices which recorded with the device.
Transient FHR:
Automatically the instrument displays the value according to the fetal
heartbeat detected by the probe instantly.
Average FHR:

3
The detected fetal heartbeat signal will be calculate once every five
seconds for the average FHR and the value of the result will be
displayed.
Audio record:
The sound of fetal heartbeat 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
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.
DANGER: Fire and Explosion Hazard

4
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 Ultrasonic
Instrument 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.
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

5
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 requirements of the
system standard IEC 601-1-1. 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.

6
2.6 SYMBOL DESCRIPTIONS
The following symbols may appear in this manual, on the Product, or on
it’s 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 it’s
accessories.
Humidity
Warning Information
Atmospheric
Pressure
Authorized
Representative in the
European Community
Upward
CE Mark: The
Product system
conforms to essential
requirements of the
Medical Device
Directive 93/42/EEC.
Non-hook
Date of manufacture.
Specifies serial
number of the
Product
Manufacturer
LOT Number
Storage Temperature
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 presents information on unpacking and setting up the
product.
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) Main Uint
1 (one) Operator’s manual
1 (one) Lanyard
1 (one) Bag
1 (one) Audio Cable
1 (one) USB Cable
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., Limited Customer Service
immediately if anything is damaged or defective.

8
3.2 CONTROLS AND DISPLAY
3.2.1 Structure and shape
Main body
①Switch/Volume
②Earphone Jack
③USB Socket
④LCD
⑤Probe
⑥Battery Cover Lock
⑦Label
⑧Battery Cover
⑨Indicator Holder
⑩USB Speaker Socket

9
3.2.2 Specification
①Switch/Volume
Function: Turn on or off the device, change the volume.
②Earphone Jack
Function: Connect to the earphone to play fetal heartbeat or connect to
the record devices, such as computer or cellphone , to record heartbeat
sound and save it on the record devices .
③USB Socket
Functions: Play the heartbeat sound through the speaker when the USB
speaker sockets on both main body and base are connected with an
USB cable.
④LCD
Function: Display heartbeat rate on it.
⑤Probe
Functions: Detect fetal heartbeat.
⑥Battery Cover Lock
Function: Lock the Battery Cover.
⑦Battery Cover
Function: Hold the battery.
⑧Label
Function: Information about model, manufacturer, agent and so on.
⑨Indicator
Function: Indicate that the USB Speaker Socket is connected to USB
Socket with an USB cable.
⑩USB Speaker Socket

10
Function: It’s used to connect to USB socket in Main body with USB
cable, then the heartbeat sound can be played through the speaker in
Base.
CAUTION:
Remove the battery 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.
3.3 AUDIO OUT
The ‘Earphone Jack’ socket can be connected to headset or recorder.
A socket for audio output can only be connected with a recorder
complied with the requirements of IEC 60601-1
3.4 DIRECTION FOR USING
1.Revolve the Battery Cover Locker⑥in the proper direct before using
it for the first time ,take off Batter Cover⑦,put in 9V battery.
2.Plug earphone into Earphone Jack②(Using unmatched earphone
maybe affect the hearing effect)
3.Revolve Switch/Volume to power on the device ,the LCD ④displays
“- - -”at this moment. Put on the earphone, adjust the volume to proper
level.
4. 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 ⑤at the
best position for detecting fetal heartbeat. Adjust the probe to obtain an
optimum audio signal ideally by angling the probe around. Generally,

11
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 fetus.
Pls. make sure that the surface of probe should be contacted fully with
the skin. After the sound become clear and stays stable for a few
seconds, the FHR value will appear on the LCD in real time. If no
coupling gel, water can be used.
5.plug one end of the record cable into Earphone Jack ②,the other
end into record device, like computer, then it is capable to record the
fetal heart beat .Move the probe ⑤to gravida’s left breast to record
her heart beat, replaying it can calm down the baby after the fetus is
born.
6. Rotate the Switch/Volume to power off the device
7.Connect the USB socket③in main body to USB Speaker Socket⑩in
the Base with an USB cable if you want to use the speak in Base, then
the Indicator⑨is on after you power on the device.
Note: abnormal value of FHR may appear during the searching of fetal
heart.
Gestation
Ante partum
Parturition

12
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 on 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.
The user must check that the equipment does not have visible
evidence of damage that may affect patient 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

13
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 7 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
INSTRUCTIO
N
INSPECT FOR
RECOMMENDED
REMEDY
Examine the
case
connectors
and
accessories
Foreign substances
Clean the Product and its
accessories as described.
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
Replace cable if any
abnormalities are found.

14
wear, broken or bent
connectors and pins,
after bending and
flexing the cable
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 RECOMMENDED CLEANING PRODUCTS
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.

15
4.5 CLEANING INSTRUCTIONS
4.5.1 Before cleaning the product, turn the device off and disconnect the
power cord.
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 of 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 phenol 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.

16
* 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
4.7 RECYCLING THE BATTERIES
The battery is 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 cause
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 Shenzhen Jumper Medical Equipment Co.,
Limited Service.

17
NOTE: The warranty will be void upon unauthorized
disassembly or service of the product.
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.
DISPLAY
LCD Size
34mm X 16mm
ULTRASOUND
Ultrasonic emitting frequency:
2.5MHz±3%
Overall sensitivity at the distances
200mm from the face of the probe
（Doppler
frequency:300±50Hz,Targe velocity:
10cm/s~40cm/s）
≥90dB
Spatial-peak temporal-peak acoustic
pressure
<8.6kPa
Output power
＜20mW
Effective area of the ultrasonic
transducer active element
1.57cm2
The acoustic coupling medium for
normal use:
ph: 5.5~8, Acoustic
impedance:
≤1.7×105g/cm2.s