ShenZhen Jumper Medical Equipment JPD100SP Fetal Doppler User Manual
ShenZhen Jumper Medical Equipment Co.,Ltd Fetal Doppler Users Manual
User manual
User Manual
FetalDoppler
Model:JPD-100S+
Manual Ver.: 1.1
Issuing Date: May 2017
Thank you for purchasing the Fetal Doppler
JPD-100S+ 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;
USB charging cable X 1;
Coupling agent X 1;
User manual X 1.
1.2 PRODUCT DESCRIPTION
The product is mainly used to detect the sound of the fetal
heartbeat (SFH).
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
Based on the Doppler's principle, a 2.0MHz ultrasonic
probe is used to capture fetal heart signals from the belly of
a pregnant woman. After signal processing of the backend
circuit, the fetal heart signals are output to the headset
socket, and audio signals are wirelessly sent by using the
built-in Bluetooth module. A smartphone that has
connected to the product receives the data and calculates
and displays fetal heart rate information by using specified
mobile phone software.
SECTION 2: SAFETY GUIDANCE
2.1 INDICATIONS FOR USE
The product is normally applied to fetus above 20 weeks
growth, difference in pregnant mater.
● Listen to SFH: Operator can listen to the sound of
fetal heartbeat from the headset.
● Audio record: The sound of fetal heartbeat can be
recorded by a smartphone which is connected with the
product. CAUTION: It should not be used in life supporting
or life sustaining applications.
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
Do not operate the Product in the presence
of flammable gases to avoid possible explosion or
fire hazard.
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.
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: 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.
CAUTION: Systems Statement
Equipment connected to the product must be
certified to the respective IEC Standards ( IEC
60601-1 for medical equipment).
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 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.
Ipx4 Waterproofing grade 4
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
3.1.1 Power on/off
Power on: Press and hold this button for about 2s and
release this button, the power indicator is on, and the
instrument is powered on.
Power off: When the instrument is in the power-on state,
press and hold this button for about 2s, the power indicator
goes out, and the instrument is powered off.
3.1.2 USB charging jack
Charging Requirements
1. Before using the instrument for the first time, if the
power indicator blinks or the instrument is
automatically powered off due to a low battery level
after the instrument is powered on, charge the
instrument.
2. Charge the instrument by using a mobile phone
charger or a computer USB jack.
3. Charge the instrument for about 2 to 4 hours.
3.4 DESCRIPTIONS OF THE INDICATOR STATES
Indicator type
Indicator
state
Instrument working
state
Power
indicator/Fetal
heart signal
indicator
Steady
green
The instrument is
powered on/fully
charged.
Steady
orange
The instrument is
charging.
Blink orange
evenly
The instrument is in a
low voltage state.
Blink with the
fetal heart
signal
frequency
The instrument is in
the working state, and
the ultrasonic probe
captures a fetal heart
signal.
3.5 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
heartbeat. 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 fetus. Pls. 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.
3.6 CONNECTING THE INSTRUMENT TO THE
SMARTPHONE VIA BLUETOOTH
Software Downloading:
1. Download and install the mobile phone APP software
"AngelSounds" by scanning the QR code on the
packing box or searching for the APP in application
stores such as APP Store/Google Market.
2. This software supports iOS 7.0 and later versions, and
Android 4.3 and later versions. In addition, hardware
of the smartphone needs to support Bluetooth 4.0.
Bluetooth connection:
1. Start AngelSounds" on the smartphone, and enable
the Bluetooth function of the smartphone to search for
a Bluetooth device, find the Bluetooth name of the
Fetal doppler, and pair with the instrument.
Software Usage:
Detailed see software operation manual.
SECTION 4: MAINTENANCE & CLEANING AND
DISINFECTION
4.1 MAINTENANCE
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.
4.1.2 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.
4.1.3 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
● If the product is not been used for a long time, charge the
product once every three months.
● The product requires no calibration.
4.2 CLEANING PRODUCT AND ACCESSORIES
The following cleaning products may be used to clean the
exterior surfaces of the product.
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).
WARNING: Do not use abrasive cleaners or strong
solvents such as acetone or acetone-based cleaners.
WARNING: Do not use mixing disinfecting solutions (such
as bleach and ammonia) as hazardous gases may result.
WARNING:Do not use acid, alkaline, or corrosive
detergent.
WARNING: Do not clean electrical contacts or connectors
with bleach.
4.3 CLEANING INSTRUCTIONS
1. Before cleaning the product, turn off the product.
2. Before cleaning, remove all adherent soil (tissue, fluids,
etc.) and wipe thoroughly with a cloth dampened with
water before applying the cleaning solution.
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.
CAUTION: To prevent damage to the product, 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
product in liquids or pour cleaning liquids over, into or onto
the product.
4.4 DISINFECTION
Cleaning the unit surface and the transducer as the above
mentioned, then wipe the surface of transducer with 75%
ethanol or alcohol, clean the transducer surface with a dry,
soft cloth.
WARNING: Don’t use low temperature steam sterilization
or other way to sterilize.
WARNING:Don’t use high temperature sterilizing process.
SECTION 5: SPECIFICATIONS & TROUBLESHOOTING
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.
Technical Specifications
Acoustic working frequency: 2.0MHz±5%
Overall sensitivity : 96 dB
Overall sensitivity at the distances 50,75,100 and 200 mm
from the face of the probe:95 dB、98 dB、96 dB、97 dB
Doppler frequency and target velocity, used for the
determination of b)(given to two significant
figures):300Hz,12cm/s
Spatial-peak temporal-peak acoustic pressure: 20.1kPa
Effective area of the ultrasonic transducer active
element: 4.8±0.3cm2
Output power: 7.9mW
Power working mode: Built-in rechargeable lithium battery
7.4V
Working mode: Continuous working (greater than 6
hours)
Battery capacity: 600mAh
Charging limit: Input 5V 1A
Safety type: Internally powered equipment, type BF applied
part
Operating mode: continuous operation
Electromagnetic compatibility: I group, B class
Waterproofing grade: IPX4
Net weight of the main product: 99.5g±5g
Dimension (diameter × thickness): 80mm×50mm
Description of the acoustic coupling medium for normal
use, together with its characteristic acoustic impedance:
1.7×105g/cm2.s, fading 0.02dB/mm
The acoustic output parameter meets the provision freedom
from publication in IEC61157 Requirement for the
declaration of the acoustic output of medical diagnostic
ultrasonic equipment: P_<1MPa; Iob<20mW/cm2;
Ispta<100mW/cm2
Product service life: 5 years
Production date: See the label
Operation conditions: Temperature: 5C to 40C;
Humidity:≤80%RH; non-condensing
Atmospheric pressure:70kpa to 106kpa
Transportation & Storage conditions:
Temperature: -20C to 55C;
Humidity:10%RH – 93%RH; non-condensing
Atmospheric pressure:50kpa to 106kpa; indoor ventilated
place that has no corrosive gas
5.2 Troubleshooting
Symptom Possible
cause
Troubleshooting
Symptom Possible
cause
Troubleshooting
Power-on
failure Low battery
level Charge the
instrument
No sound Low volume
Insufficient
p
ower
Increase the volume
Charge the
instrument
Fetal heart
cannot be
found
Low volume
The coupling
agent is not
coated
Increase the volume
Coat the coupling
agent or water
Low
sensitivity
Incorrect
probe location
The coupling
agent is not
coated
A
djust the probe
location
Coat a proper
amount of coupling
a
g
ent
EMC Information
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
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
Electromagn
etic
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 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
Complian
ce
level
Electromagnetic
environment –
guidance
Portable and
mobile RF
communication
s equipment
should be used
no closer to any
Gestation
Antepartum
Parturition
Radiated
RF
IEC
61000-4-3
3 V/m
80 MHz
to 2,5
GHz
3 V/m
part of the Fetal
Doppler
including
cables, than the
recommended
separation
distance
calculated from
the equation
applicable to
the frequency of
the transmitter.
Recommended
separation
distance
a. Where P is
the maximum
output power
rating of the
transmitter in
watts (W)
according to the
transmitter
manufacturer
and d is the
recommended
separation
distance in
metres (m).
Field strengths
from fixed RF
transmitters, as
determined by
an
electromagnetic
site survey,
should be less
than the
compliance
level in each
frequency
range.
b. Interference
may occur in
the vicinity of
equipment
marked with the
following
symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency
range applies.
NOTE 2 These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a. Field strengths from fixed transmitters, such as base
stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast
and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the
location in which the Fetal Doppler is used exceeds the
applicable RF compliance level above, the Fetal Doppler
should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be
necessary, such as re-orienting or relocating the Fetal
Doppler.
b Over the frequency range 150 kHz to 80 MHz, field
strengths should be less than 3 V/m.
A 1.4 Recommended Separation Distances
Recommended separation distances between portable and
mobile RF communications equipment and the Fetal
Doppler.
The Fetal Doppler is intended for use in an
electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of
the Fetal Doppler can help prevent electromagnetic
interference by maintaining a minimum distance between
portable and mobile RF communications equipment
(transmitters) and the Fetal Doppler as recommended
below, according to the maximum output power of the
communications equipment.
Rated
maximum
output
power
of
transmitter
W
Separation distance according to frequency
of transmitter
（m）
150 kHz to
80 MHz
80 MHz to
800 MHz
800 MHz to
2.5 GHz
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed
above, the recommended separation distance d in metres
(m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum
output power rating of the transmitter in watts (W)
according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance
for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
SECTION 6: FCC/ISED CAUTION
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.
Note: 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.
Any Changes or modifications not expressly approved by
the party responsible for compliance could void the user's
authority to operate the equipment.
The device has been evaluated to meet general RF exposu
re requirement. The device can be used in portable
exposure condition without restriction.
- English:
This device complies with Industry Canada licence-exempt
RSS standard(s).
Operation is subject to the following two conditions: (1) This
device may not cause interference, and (2) This device mu
st accept any interference, including interference that may c
ause undesired operation of the device.
- French:
Le présent appareil est conforme aux CNR d'Industrie
Canada applicables aux appareils radio exempts de licence.
L'exploitation est autorisée aux deux conditions suivantes:
(1) l'appareil ne doit pas produire de brouillage, et
(2) l'utilisateur de l'appareil doit accepter tout brouillage
radioélectrique subi, même si le brouillage est susceptible
d'en compromettre le fonctionnement.
SECTION 7: CONTACT INFORMATION
7.1 Manufacturer
Shenzhen Jumper Medical Equipment Co., Ltd
Address: D Building, No. 71, Xintian Road, Fuyong Street,
Baoan,Shenzhen,Guangdong,China
7.2 Authorized European Representative
Shenzhen Jumper Medical Equipment Co., Ltd
Address: D Building, No. 71, Xintian Road, Fuyong Street,
Baoan,Shenzhen,Guangdong,China
Tel: +86-755-26696279/26692192
Fax: +86-755-26852025
Website: www.jumper-medical.com
E-mail: info@jumper-medical.com