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
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