ShenZhen JPD100SP User Manual

2.4 SAFETY TERMS AND CONDITIONS

The signal words shown below, left, identify the potential hazard categories. The definition of each category is as

User Manual

FetalDoppler

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.



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

SECTION 3: USING THE PRODUCT

This section provides the description for operation.

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.

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

Power indicator/Fetal heart signal indicator

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.

state

Steady green

Steady orange Blink orange evenly

Blink with the fetal heart signal frequency

Instrument working state The instrument is powered on/fully charged. The instrument is charging. The instrument is in a low voltage state. The instrument is in the working state, and the ultrasonic probe captures a fetal heart signal.

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

Gestation Antepartum Parturition

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

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:

g/cm2.s, fading  0.02dB/mm

 1.7×10 The acoustic output parameter meets the provision freedom

from publication in IEC61157 Requirement f or t he

declaration of the acoustic output of medical diagnostic ultrasonic equipment: P_<1MPa; I I

spta

Product service life: 5 years Production date: See the label Operation conditions: Temperature: 5C to 40C;

Humidity:≤80%RH; non-condensing Atmospheric pressure:70kpa to 106kpa

Transportation & Storage conditions:

Temperature: -20C to 55C; Humidity:10%RH – 93%RH; non-condensing Atmospheric pressure:50kpa to 106kpa; indoor ventilated place that has no corrosive gas

<100mW/cm

5.2 Troubleshooting

Symptom

Possible cause

Symptom

Power-on

failure

No sound

Fetal heart

cannot be

found

Low

sensitivity

Possible cause

Low battery level

Low volume Insufficient

ower Low volume The coupling agent is not coated Incorrect probe location The coupling agent is not coated

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

Group 1

emissions

CISPR 11

<20mW/cm2;

Class B

emissions

CISPR 11

Troubleshooting

Charge the instrument

Increase the volume Charge the instrument Increase the volume Coat the coupling agent or water

djust the probe location Coat a proper amount of coupling a

ent

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.

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

Electrostatic

discharge

(ESD)

IEC

61000-4-2

IEC

60601

test

level

±6 kV

contact

±8 kV

air

Compliance

level

±6 kV

contact

±8 kV air

Electromagn

etic

environment

guidance

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

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

Complian

60601

test

level

Level

Electromagnetic

environment –

guidance

Portable and

mobile RF

communication

s equipment

should be used

no closer to any

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