2.

4 SAFETY TERMS AND CONDITIONS When disinfecting the case, use a non-oxidizing
The signal words shown below, left, identify the potential disinfectant, such as ammonium salts or
hazard categories. The definition of each category is as glutaraldehyde based cleaning solution, to avoid
follows: damage to the metal connectors.
User Manual
DANGER: This alert identifies hazards that will CAUTION: Environment of use
Fetal Doppler  cause serious personal injury or death. The product is designed for indoor use. Operator
must confirm that the environment of use meets
 
WARNING: This alert identifies hazards that may the required operating environmental
Model:JPD-100S+ cause serious personal injury or death. specifications before using.

Manual Ver.: 1.1 CAUTION: This alert identifies hazards that may CAUTION: Cold Environments
Issuing Date: May 2017 cause minor personal injury, product damage, or If the product is stored in an environment with a
temperature below the operating temperature, the
Thank you for purchasing the Fetal Doppler  
JPD-100S+ made by Jumper Medical Before using the
property damage.
unit should be allowed to warm up to the needed
operating temperature before using.
product, read this manual carefully and operate the product 2.5 SAFETY ALERT DESCRIPTIONS 3.1 PRODUCT STRUCTURE
2.6 SYMBOL DESCRIPTIONS
as specified in this manual. The following is a list of product safety alerts that appear in 3.1.1 Power on/off
this section and throughout this manual. You must read, The following symbols may appear in this manual, on the
understand, and pay heed to these safety alerts before product, or on its accessories. Some of the symbols Power on: Press and hold this button for about 2s and
SECTION 1: INTRODUCTION represent standards and compliances associated with the release this button, the power indicator is on, and the
attempting to operate the product. instrument is powered on.
1.1 PACKING LIST product and its use.
DANGER: Fire and Explosion Hazard Power off: When the instrument is in the power-on state,
Main unit X 1; Consult instructions for use of the press and hold this button for about 2s, the power indicator
USB charging cable X 1; Do not operate the Product in the presence product and/or its accessories. goes out, and the instrument is powered off.
Coupling agent X 1; of flammable gases to avoid possible explosion or
User manual X 1. fire hazard. Warning Information.
3.1.2 USB charging jack
WARNING: Use only Approved Equipment Authorized Representative in the Charging Requirements
1.2 PRODUCT DESCRIPTION Do not use batteries, gel, cables, or optional European Community.
CE Mark: The Product system conforms 1. Before using the instrument for the first time, if the
The product is mainly used to detect the sound of the fetal equipment other than those approved by Jumper power indicator blinks or the instrument is
Medical Equipment Co.,Ltd which may cause the to essential requirements of the Medical
heartbeat (SFH). Device Directive 93/42/EEC. automatically powered off due to a low battery level
In accordance with classification criteria in Annex IX on product to function improperly during a rescue. after the instrument is powered on, charge the
“Medical Device Directive 93/42/EEC”, the product is class instrument.
Date of manufacture. 2. Charge the instrument by using a mobile phone
IIa based on rule 10, “Devices for Direct Diagnosis or WARNING: Adjacent and/or Stacked Equipment charger or a computer USB jack.
Detection on physiological process”. The Product should not be used adjacent to or 3. Charge the instrument for about 2 to 4 hours.
stacked with other equipment. If adjacent or Manufacturer information.
stacked use is necessary, the Product should be
1.3 OPERATING PRINCIPLE 3.4 DESCRIPTIONS OF THE INDICATOR STATES
observed to verify normal operation in the
Based on the Doppler's principle, a 2.0MHz ultrasonic type BF applied part
configuration in which it will be used. Indicator type Indicator Instrument working
probe is used to capture fetal heart signals from the belly of state state
a pregnant woman. After signal processing of the backend CAUTION:Temperature/Humidity/Pressure Specifies serial number of the Product The instrument is
circuit, the fetal heart signals are output to the headset xtremes Steady
powered on/fully
socket, and audio signals are wirelessly sent by using the Exposing the Product to extreme environmental green
Batch code charged.
built-in Bluetooth module. A smartphone that has conditions outside of its operating parameters may Steady The instrument is
connected to the product receives the data and calculates compromise the ability of the Product to function Power orange charging.
and displays fetal heart rate information by using specified The environmental protection use period
properly. is 5 years. indicator/Fetal Blink orange The instrument is in a
mobile phone software. heart signal evenly low voltage state.
CAUTION: Battery Disposal Waterproofing grade 4 indicator The instrument is in
Recycle or dispose of the battery in accordance Ipx4 Blink with the
the working state, and
SECTION 2: SAFETY GUIDANCE It indicates that the equipment should fetal heart
with all federal, state and local laws. To avoid fire be sent to the special agencies the ultrasonic probe
signal
2.1 INDICATIONS FOR USE and explosion hazard, do not burn or incinerate according to local regulation for captures a fetal heart
frequency
the battery. separate collection after its useful life. signal.
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 CAUTION: Possible Radio Frequency (RF)
SECTION 3: USING THE PRODUCT
fetal heartbeat from the headset. Susceptibility 3.5 USING PRODUCT TO DETECT
RF susceptibility from cellular phones, CB radios This section provides the description for operation.
● Audio record: The sound of fetal heartbeat can be Locate the position of the fetus by hand touching, firstly to
recorded by a smartphone which is connected with the and FM 2-way radio may cause interference with find out the best direction to the fetal heart. Place the
product. the product. Do not operate wireless faceplate of probe at the best position for detecting fetal
radiotelephones in the vicinity of the Product – turn heartbeat. Adjust the transducer to obtain an optimum
CAUTION: It should not be used in life supporting audio signal ideally by angling the transducer around.
or life sustaining applications. power OFF to the radiotelephone and other like Generally, the site of heart of fetus is 1/3 below of navel line
equipment near the Product. at its earlier stage, it then moves upward with increasing of
gestational period, and the site of heart of fetus will be a
2.2 CONTRAINDICATIONS FOR USE CAUTION: Systems Statement little deviation to left or right with different fetus. Pls. make
Equipment connected to the product must be sure that the surface of the probe should be contacted fully
Normally none, as a particular case, please consult your with the skin. After the sound become clear, it is the proper
doctor. certified to the respective IEC Standards ( IEC functioning. If no coupling gel, water can be used.
60601-1 for medical equipment).
2.3 NOTE FOR HOME USE
Please consult your doctor. CAUTION: Case Cleaning Solutions
 a solution of soap and wipe dry with a clean cloth Possible Troubleshooting A 1.2 Electromagnetic Immunity
immediately.Wipe the transducer body with soft cloth Symptom cause
to remove any remaining coupling gel .Clean with The Fetal Doppler is intended for use in the
soap only. Power-on Low battery Charge the
Gestation failure level instrument electromagnetic environment specified below. The
Antepartum CAUTION: To prevent damage to the product, do not Low volume Increase the volume
clean any part of the Product or Accessories with No sound Insufficient Charge the customer or the user of the Fetal Doppler should assure
Parturition phenolic compounds. Do not use abrasive or power instrument that it is used in such an environment.
flammable cleaning agents. Do not steam, autoclave, Low volume Increase the volume
or gas-sterilize the Product or accessories. Fetal heart The coupling Coat the coupling IEC Compliance Electromagn
CAUTION: Cleaning liquids: do not submerge the cannot be agent is not agent or water
3.6 CONNECTING THE INSTRUMENT TO THE product in liquids or pour cleaning liquids over, into or onto found Immunity 60601 level etic
SMARTPHONE VIA BLUETOOTH coated
the product. Incorrect Adjust the probe test test environment
Software Downloading: 4.4 DISINFECTION probe location location
1. Download and install the mobile phone APP software Low The coupling Coat a proper level guidance
"AngelSounds" by scanning the QR code on the Cleaning the unit surface and the transducer as the above sensitivity agent is not amount of coupling
packing box or searching for the APP in application mentioned, then wipe the surface of transducer with 75% Floors should
coated agent
stores such as APP Store/Google Market. ethanol or alcohol, clean the transducer surface with a dry, be wood,
2. This software supports iOS 7.0 and later versions, and soft cloth.
Android 4.3 and later versions. In addition, hardware WARNING: Don’t use low temperature steam sterilization concrete or
of the smartphone needs to support Bluetooth 4.0. or other way to sterilize. EMC Information
WARNING:Don’t use high temperature sterilizing process. Electrostatic ±6 kV ±6 kV ceramic tile.
Bluetooth connection: discharge contact contact If floors are
1. Start AngelSounds" on the smartphone, and enable CAUTION:
the Bluetooth function of the smartphone to search for SECTION 5: SPECIFICATIONS & TROUBLESHOOTING (ESD) ±8 kV ±8 kV air covered with
a Bluetooth device, find the Bluetooth name of the This section presents the specifications and safety Fetal Doppler needs special precautions
Fetal doppler, and pair with the instrument. IEC air synthetic
standards of the Product. regarding EMC and needs to be installed and
61000-4-2 material, the
Software Usage: put into service according to the EMC
Detailed see software operation manual. 5.1 SPECIFICATIONS relative
NOTE: The following specifications are subject information provided for in the
humidity
to change and are only noted as a point of ACCOMPANYING DOCUMENTS.
reference. should be at
SECTION 4: MAINTENANCE & CLEANING AND
DISINFECTION Technical Specifications least 30 %.
CAUTION:
4.1 MAINTENANCE Acoustic working frequency: 2.0MHz±5% Power
4.1.1 The transducer acoustic surface is frangible and must Overall sensitivity : 96 dB Portable and mobile RF communications
Overall sensitivity at the distances 50,75,100 and 200 mm frequency
be handle with care .Gel must be wiped off from the equipment can affect Fetal Doppler.
transducer after use. These precautions will prolong the life from the face of the probe:95 dB、98 dB、96 dB、97 dB magnetic
of the unit. Doppler frequency and target velocity, used for the
4.1.2 The user must check that the equipment does not determination of b)(given to two significant Power fields
have visible evidence of damage that may affect patient figures):300Hz,12cm/s CAUTION:
frequency should be at
safety or product’s capability before use .The Spatial-peak temporal-peak acoustic pressure: 20.1kPa The Fetal Doppler should not be used adjacent
recommended inspection interval is once per month or less. Effective area of the ultrasonic transducer active (50/60 Hz) levels
If damage is evident, replacement is recommended before element: 4.8±0.3cm2 to or stacked with other equipment.
use. Output power: 7.9mW magnetic characteristic
4.1.3 To ensure the product is always functional when 3 A/m 3 A/m
Power working mode: Built-in rechargeable lithium battery field of
required, the following maintenance shall be performed. 7.4V A1.1 Electromagnetic Emissions
● Visual Inspection Working mode: Continuous working (greater than 6 lEC a typical
● Cleaning the product and its accessories hours) The Fetal Doppler is intended for use in the
● Check the battery fuel gauge 61000-4-8 location in a
● Testing product performance Battery capacity: 600mAh electromagnetic environment specified below. The
Charging limit: Input 5V 1A typical
● If the product is not been used for a long time, charge the customer or the user of the Fetal heart monitor should
product once every three months. Safety type: Internally powered equipment, type BF applied commercial
● The product requires no calibration. part assure that it is used in such an environment.
Operating mode: continuous operation or hospital
4.2 CLEANING PRODUCT AND ACCESSORIES Emissions test Compliance
Electromagnetic compatibility: I group, B class environment
The following cleaning products may be used to clean the Waterproofing grade: IPX4
exterior surfaces of the product. Net weight of the main product: 99.5g±5g The Fetal Doppler uses RF
Dimension (diameter × thickness): 80mm×50mm RF Group 1 energy only for its internal A 1.3 Electromagnetic Immunity (not life-supporting)
 Isopropyl alcohol (70% solution in water)
 Mild soap and water Description of the acoustic coupling medium for normal emissions function. Therefore, its RF
 Sodium hypochlorite (chlorine bleach) (3% solution in use, together with its characteristic acoustic impedance: The Fetal Doppler is intended for use in the
water).  1.7×105g/cm2.s, fading  0.02dB/mm CISPR 11 emissions are very low and electromagnetic environment specified below. The
 Quaternary ammonium compounds (such as Lysol) The acoustic output parameter meets the provision freedom are not likely to cause any
(10% solution in water). from publication in IEC61157 Requirement for the customer or the user of the Fetal Doppler should assure
WARNING: Do not use abrasive cleaners or strong declaration of the acoustic output of medical diagnostic interference in nearby
solvents such as acetone or acetone-based cleaners. that it is used in such an environment.
ultrasonic equipment: P_<1MPa; Iob<20mW/cm2; electronic equipment.
WARNING: Do not use mixing disinfecting solutions (such Ispta<100mW/cm2 IEC Complian
as bleach and ammonia) as hazardous gases may result. The Fetal Doppler is suitable
WARNING:Do not use acid, alkaline, or corrosive Product service life: 5 years Immunity 60601 ce Electromagnetic
detergent. Production date: See the label for use in all establishments,
WARNING: Do not clean electrical contacts or connectors Operation conditions: Temperature: 5C to 40C; test test level environment –
with bleach. Humidity:≤80%RH; non-condensing RF Class B including domestic Level guidance
Atmospheric pressure:70kpa to 106kpa emissions establishments and those
4.3 CLEANING INSTRUCTIONS Transportation & Storage conditions: Portable and
Temperature: -20C to 55C; CISPR 11 directly connected to the
1. Before cleaning the product, turn off the product. Humidity:10%RH – 93%RH; non-condensing mobile RF
2. Before cleaning, remove all adherent soil (tissue, fluids, Atmospheric pressure:50kpa to 106kpa; indoor ventilated public low-voltage power
communication
etc.) and wipe thoroughly with a cloth dampened with place that has no corrosive gas supply network that supplies
water before applying the cleaning solution. s equipment
3. When cleaning, do not immerse. Keep the exterior 5.2 Troubleshooting buildings used for domestic
surface of the device clean and free of dust and dirt, should be used
clean exterior surface of the unit with a dry, soft Symptom Possible Troubleshooting purposes.
cause no closer to any
cloth .if necessary, clean it with a soft cloth soaked in
 part of the Fetal For transmitters rated at a maximum output power not listed - English:
Doppler above, the recommended separation distance d in metres This device complies with Industry Canada licence-exempt
including (m) can be estimated using the equation applicable to the RSS standard(s).
cables, than the frequency of the transmitter, where P is the maximum Operation is subject to the following two conditions: (1) This
recommended output power rating of the transmitter in watts (W) device may not cause interference, and (2) This device mu
NOTE 1 At 80 MHz and 800 MHz, the higher frequency
separation according to the transmitter manufacturer. st accept any interference, including interference that may c
range applies.
distance NOTE 1 At 80 MHz and 800 MHz, the separation distance ause undesired operation of the device.
NOTE 2 These guidelines may not apply in all situations.
calculated from for the higher frequency range applies.
Electromagnetic propagation is affected by absorption and
the equation NOTE 2 These guidelines may not apply in all situations. - French:
reflection from structures, objects and people.
applicable to Electromagnetic propagation is affected by absorption and Le présent appareil est conforme aux CNR d'Industrie
a. Field strengths from fixed transmitters, such as base
the frequency of reflection from structures, objects and people. Canada applicables aux appareils radio exempts de licence.
stations for radio (cellular/cordless) telephones and land
Radiated 3 V/m 3 V/m the transmitter. L'exploitation est autorisée aux deux conditions suivantes:
mobile radios, amateur radio, AM and FM radio broadcast
RF 80 MHz Recommended SECTION 6: FCC/ISED CAUTION (1) l'appareil ne doit pas produire de brouillage, et
and TV broadcast cannot be predicted theoretically with
IEC to 2,5 separation This device complies with part 15 of the FCC Rules. (2) l'utilisateur de l'appareil doit accepter tout brouillage
accuracy. To assess the electromagnetic environment due
61000-4-3 GHz distance Operation is subject to the following two conditions: (1) This radioélectrique subi, même si le brouillage est susceptible
to fixed RF transmitters, an electromagnetic site survey
device may not cause harmful interference, and (2) this d'en compromettre le fonctionnement.
should be considered. If the measured field strength in the
device must accept any interference received, including
location in which the Fetal Doppler is used exceeds the
interference that may cause undesired operation.
a. Where P is applicable RF compliance level above, the Fetal Doppler SECTION 7: CONTACT INFORMATION
the maximum should be observed to verify normal operation. If abnormal 7.1 Manufacturer
Note: This equipment has been tested and found to comply
output power performance is observed, additional measures may be Shenzhen Jumper Medical Equipment Co., Ltd
with the limits for a Class B digital device, pursuant to part
rating of the necessary, such as re-orienting or relocating the Fetal Address: D Building, No. 71, Xintian Road, Fuyong Street,
15 of the FCC Rules. These limits are designed to provide Baoan,Shenzhen,Guangdong,China
transmitter in Doppler.
reasonable protection against harmful interference in a
watts (W) b Over the frequency range 150 kHz to 80 MHz, field 7.2 Authorized European Representative
residential installation. This equipment generates uses and
according to the strengths should be less than 3 V/m.
can radiate radio frequency energy and, if not installed and
transmitter A 1.4 Recommended Separation Distances
used in accordance with the instructions, may cause
manufacturer Recommended separation distances between portable and
harmful interference to radio communications. However,
and d is the mobile RF communications equipment and the Fetal
there is no guarantee that interference will not occur in a
recommended Doppler.
particular installation. If this equipment does cause harmful
separation The Fetal Doppler is intended for use in an
interference to radio or television reception, which can be
distance in electromagnetic environment in which radiated RF
determined by turning the equipment off and on, the user is
metres (m). disturbances are controlled. The customer or the user of
encouraged to try to correct the interference by one or more Shenzhen Jumper Medical Equipment Co., Ltd
Field strengths the Fetal Doppler can help prevent electromagnetic Address: D Building, No. 71, Xintian Road, Fuyong Street,
of the following measures: Baoan,Shenzhen,Guangdong,China
from fixed RF interference by maintaining a minimum distance between
-Reorient or relocate the receiving antenna. Tel: +86-755-26696279/26692192
transmitters, as portable and mobile RF communications equipment
-Increase the separation between the equipment and Fax: +86-755-26852025
determined by (transmitters) and the Fetal Doppler as recommended Website: www.jumper-medical.com
receiver.
an below, according to the maximum output power of the E-mail: info@jumper-medical.com
-Connect the equipment into an outlet on a circuit different
electromagnetic communications equipment.
from that to which the receiver is connected.
site survey, Rated Separation distance according to frequency
-Consult the dealer or an experienced radio/TV technician
should be less maximum of transmitter
for help.
than the output （m）
compliance power 150 kHz to 80 MHz to 800 MHz to
Any Changes or modifications not expressly approved by
level in each of 80 MHz 800 MHz 2.5 GHz
the party responsible for compliance could void the user's
frequency transmitter
authority to operate the equipment.
range. W
b. Interference
0.01 0.12 0.12 0.23 The device has been evaluated to meet general RF exposu
may occur in
0.1 0.38 0.38 0.73 re requirement. The device can be used in portable
the vicinity of
exposure condition without restriction.
equipment 1 1.2 1.2 2.3
marked with the
10 3.8 3.8 7.3
following
100 12 12 23
symbol: