AngelSounds MSLJB08 User manual

MSLJB08（mini）
Fetal Doppler
INSTRUCTION MANUAL

Product Information
Product Name: Fetal Doppler
Model: MSLJB08（mini）
Copyright
Copyright 2016. All rights reserved.
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.

Table of contents
SECTION 1: INSTRUCTION........................................... 3
1.1 INFORMATION..........................................................1
1.2 INDICATION FOR USE...............................................3
1.3 PRODUCT DESCRIPTION...........................................3
1.4 OPERATING PRINCIPLE............................................ 4
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
SECTION 4: CONTROLS AND INDICATORS..............9
4.1 APPEARANCE........................................................... 9
4.2 INDICATOR.............................................................10
4.3 KNOB.....................................................................10
4.4 SOCKET..................................................................10
4.5 BATTERY............................................................... 10
SECTION 5: OPERATION PROCEDURE.....................10
5.1 PREPARATION........................................................ 10
5.2 DETECTING............................................................ 12
5.3 RECORDING........................................................... 12
SECTION 6 PREVENTIVE MAINTENANCE.............. 12
6.1 MAINTENANCE...................................................... 13
6.2 VISUAL INSPECTION.............................................. 14

6.3 CLEANING PRODUCT AND ACCESSORIES...............14
6.4 DISINFECTIONS...................................................... 16
6.5 RECYCLE BATTERIES.............................................16
6.6 AUTHORIZED REPAIR SERVICE..............................16
SECTION 7: TECHNICAL SPECIFICATIONS.............16
SECTION 8 : TROUBLESHOOTING........................... 18
APPENDIX A EMC INFORMATION............................19

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 Information
This guide will show you how to use your Fetal Doppler to listen to the sound of
your baby's heartbeat.
1.2 Indication for Use
The AngelSounds Fetal Doppler MSLJB08 (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 heart rate when
listening. This device normally is applied to 16 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.
1.3 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”.
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 headset).
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 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.

Section 2: Safety Guidance
This product is internal powered equipment, and the degree of shock protection
is B applied part.
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 MSL 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
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 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 (i.e. IEC 60950 for data processing
equipment and IEC 60601-1 for medical equipment). Furthermore,
all configurations shall comply with the system standard IEC
60601-1-1. 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 60601-1-1. 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 a 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.

CAUTION: Product recycling or disposal
The product could be sent back to the manufacturer for recycling or
proper disposal after their useful lives.
2.2 Symbols
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
0482
CE Mark: The Product system conforms to
essential requirements of the Medical Device
Directive 93/42/EEC.
Date of manufacture.
Manufacturer information
Storage Temperature limit
Humidity limitation
Atmospheric Pressure limitation
0482

Upward
Specifies serial number of the Product
LOT Number
It indicates that the equipment should be sent to
the special agencies according to local regulation
for separate collection after its useful life.
Type B applied part
IPX4
Ingress Protection.
Section 3: Getting Started
This section presents information on unpacking the Product.
This section contains a list of parts for product. To place an order, contact your
representative or distributor.
3.1Unpacking an Inspecting
Every attempt is made to ensure your order is accurate and complete. However,
to be sure that your order is correct, verify 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 item is packing list:
No.
Item
Quantity
Packed or
Unpacked
1
Instruction Manual
1
√

2
Product
1
√
3
Recording Cable
1
√
4
Headset
1
√
5
Battery
1
√
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 setup the Product if
anything is damaged or defective. Contact MSL Ultrasonic Instrument
Customer Service immediately if anything is damaged or defective.
Section 4: Controls and indicators
This section provides the basic set up information. You need to read this section
in detail before operating the device.
4.1 Appearance
1. Power On/Off / Volume knob
2. Power indicator
3. Headset Socket
4.Transducer
5.Battery Compartment Cover
6.Audio output socket

4.2 Indicator
There is an indicating light on MSLJB08(mini).
Function: Power on indicate.
4.3 Knob
There is a knob on MSLJB08(mini).
Power on/off and volume knob
Function: Power on or off the device, change the volume of the speaker.
4.4 Socket
There are one headset socket and one USB interface used as audio out socket at
the device.
The headset socket can be connected with headset.
The USB interface is used to connect recording Cable (NOTE: please refer to
accessories).
4.5 Battery
This device is internal powered. The power of MSLJB08 (mini) comes from a
9V alkaline battery (IEC type No. 6F22 or equivalent).
Section 5: Operation procedure
This section provides the description for operation.
5.1 Preparation
Follow these recommendations to preparation for operation:
5.1.1 Install Battery

Open the battery cover, and install the 9V battery. Then, Install the battery
cover.
NOTE：You should push the battery cover backward like the figure upward.
Then you can open the battery cover.
Battery type: Alkaline battery 9V
CAUTION:
Remove the battery if the device is not likely to be used for some
time. And keep the battery in cool and dry environment.
WARNING: Irregular treatment of batteries may be result in
hazards to health and environment.
5.1.2 Connect headset
Before you practice the product, you should prepare an earphone or
a headset to hear the fetal heartbeat sound.
We will give you a headset as a present. It can help you to hear the
fetal heartbeat sound when you have not bought an earphone.
Insert the headset-plug into headset socket, and wire the handset.
5.1.3 Power on by turning the Power on/off and volume knob
5.1.4 Remove clothes from the pregnant maternal abdomen.

5.1.5 Applying couple gel to the faceplate ( ) of probe
or abdomen of pregnant woman.
5.2 Detecting
5.2.1 Find the fetal heart and listen the fetal heartbeat sound
Locate the position of the fetus by hand touching, firstly to find out the best
direction to the fetal heart. The position of the fetal heart in abdomen of
pregnant woman you can contrast the figure below. 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.
5.2.2 Calculate the fetal heartbeat rate
Count the fetal heartbeat sound in one minute, the number you counted is the
fetal heartbeat rate. Repeat count at least 3 times, you will get the range of fetal
heartbeat rate.
5.3 Recording
When you hear the fetal heartbeat sound, you can connect one socket with a
headset, and another can connect with computer. You can replay the recorded
sound files anytime, and you can send them whoever you want.
Section 6 Preventive maintenance
Gestation
Antepartum
Parturition

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.
6.1 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.
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.
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
Correction: manually calculate the FHR with hearing fetal heartbeat sound for
qualification.
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.

6.2 Visual Inspection
The product and its accessories should be carefully inspected prior to
installation, once every 16 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.
Verify that the Safety label on back of the product is clearly legible
INSTRUCTION
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
wear, broken or bent
connectors and pins,
after bending and
flexing the cable
Replace cable if any
abnormalities are found.
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.
6.3 Cleaning Product and Accessories
Listed below are recommendations for cleaning the Product and its accessories.

Recommended cleaning product:
The following cleaning products may be used to clean the exterior surfaces of
the Product as well as the batteries.
Do not use abrasive cleaners or strong solvents such as acetone or
acetone-based cleaners.
Do not mix disinfecting solutions (such as bleach and ammonia) as
hazardous gases may result.
Do not clean electrical contacts or connectors with bleach.
Cleaning instructions:
1. Before cleaning the Product, turn off the device and disconnect the power
cord.
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
4. Wring any excess moisture from the cloth before cleaning.
5. Avoid pouring fluids on the device, and do not allow fluids to penetrate
the exterior surfaces of the device.
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 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 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.
* 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.
6.4 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
6.5 Recycle 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 result in
hazards to health and environment.
6.6 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 MSL
Service.
NOTE: The warranty will be void upon unauthorized disassembly or service of
the product.
Section 7: Technical specifications
This section presents the specifications and safety standards of the product.
NOTE: The following specifications are subject to change and are only noted
as a point of reference.

Product name: Fetal Doppler
Mode: MSLJB08(mini)
Safety: Complies with IEC 60601- 1, EN 60601- 1, EN60601-1-2, IEC 61266
Classification:
Anti-electric shock type: Internal powered equipment
Anti-electric shock degree: Type B applied part.
Classification of protection against harmful ingress of water: Ordinary
protection IPX4(probe)
Methods of sterilization or disinfection: No sterilization required the
equipment
Degree of Safety in Presence of Flammable Gases: Equipment not suitable
for use in the presence of flammable gases
Mode of operation: Continuous operation
EMC: Group I Class B
Technical parameters:
Ultrasound:
Ultrasonic emitting frequency: 3MHz
Overall sensitivity at the distances 200mm from the face of the probe (Doppler
frequency: 500±50Hz, Target velocity: 10cm/s~40cm/s): ≥90dB
Spatial-peak temporal-peak acoustic pressure: ≤1MPa
Output power: <20mW
Effective area of the ultrasonic transducer active element:2.65cm2±0.3cm2
The acoustic coupling medium for normal use: ph: 5.5~8, Acoustic impedance:
≤1.7*105g /cm2·s
Working mode: Continuous wave Doppler
Audio output:
Audio output power: <0.5 W
Audio out Socket: Φ3.5mm/USB interface
Recommended battery type:
9V DC alkaline battery (IEC Type No. 6F22 or equivalent)
Stand-by Time: >4hours

Suitable gestation: 16 gestational weeks or later, difference in pregnant mater.
Physical Characteristic:
Size: 104.5mm(length) * 50mm(width) * 70mm(height)
Weight: 69.5g (only main unit, not including battery)
Environmental Requirements:
Operating Conditions:
Temperature: 5C to 40C
Humidity: 0 to 80% RH, non-condensing
Atmospheric pressure: 86kPa to 106kPa
Storage and Shipping Conditions:
Temperature: - 20C to 55C（-4℉-131℉）
Humidity: 10 to 93% RH, non-condensing
Atmospheric pressure: 50kPa to 106kPa
Section 8 : Troubleshooting
What appearance to be a malfunction may not always serious, if your product
should not perform as expected, consult the table below to see if the problems
can be corrected before seeking help from your dealer or service representative.
Symptom
Cause
Remedy
Audio scream
Audio volume too
high
Too much gel on the
probe surface
Battery is exhausted
Turn down the
volume
Use less gel
Replace the
batteries
Weak sound output
Audio volume too
low
Insufficient gel
Battery is exhausted
Turn up the
volume
Add gel
Replace the