Comper Chuangxiang DFMX1001 Comper Smart Doppler Fetal Monitor User Manual

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DFMX User Manual
Document Num:
History of Change:
User Manual JS02114DFMX V1.0
Issue Date:
Version:
Editor:
Reviewer:
Approver:
Date:xx-xx-xx
Date:xx-xx-xx
Date:xx-xx-xx
Product Name: COMPER SMART DOPPLER FETAL MONITOR
Product Model: DFMX
Content
Basic Function and Working Principle
Overview
Precautions, warnings and caution
Explanation of Symbol
Warnings and Cautions about Potential Electromagnetic
Interference
Warnings and cautions about chargeable lithium battery
Product disposal
The connection and remove of detachable components
Usage schematic diagram of Fetal Monitor
Charging tips
Fetal monitoring knowledge
Problems and Troubleshooting
Cleaning and maintenance
Storage and Shipping Condition
Basic Parameters and Specifications
The Registration Certificate Number and Production License
Number
Service Agencies and Information
Table for acoustic output level
Table for EMC
Dear customers,
Thank you for purchasing COMPER SMART DOPPLER
FETAL MONITOR. Please read the user manual to ensure
safe operation and accurate outcome before use. Keep this
manual readily available for reference.
Basic function of the product
Fetal Monitor is hand-held detection instrument, intended to be
used by health care professionals including obstetrician, nurse in
hospitals, clinics and pregnant women at home.
Application scope: monitor fetal heart sound and the range of
heart rate during antepartum.
Working principle
Adopting the principle of non-focused ultrasound
continuous wave Doppler, when in use, the ultrasonic
transducer generates an ultrasonic beam directing to the fetus. A
portion of the incoming ultrasonic beam will reach the surface of
fetal heart movement, due to the Doppler effect, the frequency
shift of the ultrasonic occurs, which can be detected by receiving
transducer. The low-frequency signal related to the fetal heart
can be separated by signal processing, and to be identified.
Overview
Manual
Parts list:
1. One Fetal Monitor
2. One pair of 3.5mm
earphone
Qualification
certificate
3. One USB charging cable
4. One manual
5. One qualification certificate
3
Instruction of parts:
1. Charging socket
2. Earphone socket
3. Status indicator lamp
4. Power key
5. FH reading lamp
6. Volume keys
7. Doppler ultrasound probe
Power switch
Volume down
Charging socket
Volume up
Earphone socket
Precautions, warnings and caution
All possible harms or damages caused by error operations have been
indicated in this manual, please read these instructions.
Please be aware and understanding that, for all human health and property
damage due to error operations specified in the Manual or deviating from the
designed purpose of the product, the Company shall not bear any
responsibility.
Prohibition
It represents absolutely not allowed
There may risk caused by operation that is out of the
performance of the product.
Warning
Represent matters that require special attention
May damage personal safety for the wrong purpose
Caution
Represent general considerations in using
If misused, it may cause personal injury or property damage
Explanation of Symbol
Consult instruction for use
Storage temperature limitation
Serial Number
Non-sterile
Do not use if package is
damaged
Atmospheric pressure
limitation
Caution, consult accompanying
document
Type BF applied part
non-ionizing radiation
Warning!
The device is intended for detecting Fetal Heart Rate not intended
for clinical treatment. If the result is distrustful, please use other
methods to check the fetal well-being immediately.
Environment conditions, operators and pregnant woman health
conditions vary during device use, synthetic judgment are
recommended in complex situation.
Clean ultrasonic probe before use, it is high recommended for
singe use to avoid cross - infection.
Keep out reach of infants and young children.
This product is ultrasonic product, and do not use it at the part other
than the abdomen.
Use the product matching earphone and charging cable. Using nonmatching accessories may lead to security risks of the product.
Use the product supporting medical ultrasonic coupling agent, or
similar products with a valid legal qualification of medical devices,
otherwise it may cause the risk of biohazard or performance
degradation.
Caution!
If the product breaks down during use, please shut down the power and turn to
contact customer service for trouble shooting.
Please inspect the bottom and surrounding of the ultrasonic probe before use and
make sure there is no obvious damage which may affect the patient safety and
instrument performance possibly.
Do not use the product close to strong electromagnetic fields, electromagnetic wave
and magnetic environment
* There is possibility of measurement errors or damage to the product
Avoid severe shock, falling from the height or stomping.
* There is possibility of causing damage to the product.
On the premise of clinical requirement, it is recommended that users should
minimize ultrasound exposure time.
Do not place the product into boiling water for sterilization
* There is possibility of product breakdown or product failure.
The product IP Rating is IPX4 (including ultrasound head) is a splash‐proof device, it
can immerse in saline and water, but please do not soak in hot water.
Except ultrasound head, other parts are designed of non‐anti‐soak, please do not
flush the product. Please wipe the product with a run‐out cloth to wipe the surface.
Please do not wipe the product with disinfectant or alcohol or other organic solvent.
Please wipe away the water with a dry cloth to keep maintenance.
Please do not conduct ultrasonic cleaning, or it may cause a failure.
Do not use a dryer, electric hair drier, otherwise it will cause a failure.
Warnings and Cautions about Potential Electromagnetic Interference
Warning!
In addition to the supporting earphone and charging cable, using
unspecified accessories and cables may cause the increase of
product radiation or the decline of immunity.
This product should not be used closely to or stacked with other
equipment, or if the close use or stacked use cannot be avoided,
should observe and verify whether the product can operate
normally in its configuration.
Caution!
Interference may occur in the vicinity of equipment
marked with the symbol
Warnings and cautions about chargeable lithium battery
The device is
built‐in rechargeable lithium battery, not removable,
please do not dismantle, damage the battery, heat the battery or throw it in fire.
There is possibility of a battery explosion.
Caution!
Please shut down the product after‐ use to avoid unnecessary
consumption of battery power.
If the product is not to be used for more than 3 months, please
store it in the environment of ‐10 ° C ‐ +40 ° C, otherwise there is a
risk of damage to the battery.
Product disposal
Caution!
Please clean the remaining coupling agent after
use, and wipe the product with cloth, twist dry
come not to drip the dishcloth of water
If the product becomes dirty, use a cloth or tissue
paper with a small amount of water to wipe it
clean.
At the end of product life, please deal with the
product according to the relevant local
environmental protection laws and regulations.
Caution!
Please conduct charging for at least 3 hours in the
initial use of the Fetal Monitor.
The product should be used with coupling agent.
The product is equipped with the function of
Bluetooth transmission
The connection and remove of detachable components
Insert the plug of earphone into the earphone socket of Fetal
Monitor;
In the process of charging, please insert the plug of USB
charging cable into the charging socket of Fetal Monitor;
Make sure that the plug is fully inserted when connecting
with the socket, and keep straight direction when removing.
Usage schematic diagram of fetal heart sound detector
Starting up
1. Long press the power
button, when the status
indicator lamp shows
white, indicating the
starting up.
2. A liberal
amount of
coupling
agent evenly
spread onto
abdomen.
Prompt:
A thin layer of coupling agent is appropriate, in the process of
searching fetal heart sound, if the coupling agent becomes
drying or coagulating, it can be appropriately added.
10
Usage schematic diagram of fetal heart sound detector
3. The schematic diagram of listening to the fetal heart sound: please
put on earphones, and then slowly move the Fetal Monitor to detect
fetal heart rate, and the continuous regular heartbeat indicates the
position of fetal heart, try to keep the unchanged position of Fetal
Monitor (volume keys can be used to adjust the sound volume).
11
Usage schematic diagram of fetal heart sound detector
4. After a period of continuous monitoring of fetal heart
sound, the different color of fetal heart sound reading
lamp indicates the range of fetal heart rate, blue indicates
the range of 120-160 beats/min, and orange indicates
other ranges.
Orange
<120 beats/min
>160 beats/min
Blue
120~160
beats/min
5. After measurement, press the power button for 3 seconds, and
extinction of light indicates power off.
3 seconds
12
6.Please wipe away the remaining coupling agent in
abdomen and Fetal Monitor probe.
13
Charging tips
Charging reminder
When start up the product,
the status indicator lamp
blinks orange light, right
after white light, alerting the
low power, and please
charge as soon as possible.
The charging cable is inserted
into the charging socket, and
the status indicator lamp
shows orange light, which
means the product enters into
the state of charging.
If device won’t turn on, please
charge as soon as possible.
After the charging is
completed, the status
indicator lamp shows blue
light.
14
Fetal monitoring knowledge
1. In general, fetal heart sound can be monitored after 12
weeks of pregnancy, but because of individual differences,
the gestational week that the fetal heart sound can be
monitored may be different.
2. In general, the fetal heart rate is in the range of 120 to 160
beats / min, when the fetal heart rate is less than 120 beats /
min or more than 160 beats / min, consult with your
physician depending on the individual situation.
3. When the pregnant woman finds that fetal heart sound
cannot be found in the original location, but fetal
movement can be felt, it indicates the fetal position may
change. Slowly move the probe in small extent to find the
fetal heart carefully. If you confirm that you cannot listen
to the fetal heart sound or the fetal movement is not
obvious, please go the hospital for consultation
immediately.
15
Problems and Troubleshooting
Problem/failure
Cannot hear sound
Noise is big
Can hear the sound but it is
relatively weak, and cannot
find the fetal heart position
Problem/failure
The power switch turns on,
but it is silent when rubbing
the probe
Noise is big
Can hear the sound but it is
relatively weak, and cannot
find the fetal heart position
Other failure
Possible reason
The volume is adjusted to the
weakest
Earphone is not inserted into the
device
•No coupling agent is applied on the
abdomen
•Noise is generated by the dragging
of probe on the abdominal wall
• Incorrect placement of probe
• No coupling agent is applied on the
abdomen
•Gestational age is short and fetal
heart sound is too weak
Possible reason
• Plug in your headphones and
increase the volume
• Apply the coupling agent to the
abdominal detection zone
• Find the fetal heart sound, lift up
the probe and avoid dragging, and try
to change the angle to get clear fetal
heart sound
• Apply the coupling agent to the
abdominal detection zone
• Use the product when the
gestational stage is a little longer
• Please contact with Comper
customer service
Problems and Troubleshooting
16
Cleaning and maintenance
Cleaning of Fetal Monitor
Wipe away the remaining coupling agent on the
ultrasonic probe. Be careful not to let the coupling agent,
BB oil or other liquid get into the interior in order to
avoid damage to the device.
If there is a lot of dirt on the ultrasonic detector probe,
please wipe the probe with a wringed cloth with neutral
detergent or water, and then use a soft cloth to wipe it
dry.
Please disinfect the ultrasound probe, wipe gently with
immersed medical cotton pad with 75% rubbing
alcohol.
Please comply with the following precautions to avoid breakdown or failure
Do not remove dirt by using volatile agents, diluent or
gasoline, etc.
Do not immerse the product into in water or wash it with
water.
Do not use hot water to conduct sterilization (over 50 ˚C).
Turn off the power before cleaning; please keep it dry
after cleaning
Do not store the product in the following environments, or otherwise it will
cause a breakdown or failure
Humid environment
High temperature, direct sunlight, dusty environment, or salt
environment
Environment with chemicals or corrosive gas
17
Storage and Shipping Condition
Storage environment
Temperature: -10°C to +40°C
Humidity: ≤85% RH
Ventilated room without corrosive gases
Transportation environment
Temperature: -40°C to + 55°C
Humidity: ≤90% RH
Atmospheric pressure: 50 to 101.3kPa
Method: air, sea, rail transport or coach transport
Basic Parameters and Specifications
Battery: Rechargeable lithium battery (3.7V)
Battery life: continuous use of 12 hours, more than 300 times of chargedischarge
Charging power supply: Micro USB (DC 5.0 V 160mA)
The charging power supply should be checked or replaced regularly.
Category of product
Electric shock protection type: internal power supply
Electric shock protection type: BF product
Water proof level:
IPX4 (ultrasound probe)
IPX1 (for the other part of housing)
The degree of safety of combustible gas: not suitable for using in
environment with flammable gas
Operating mode: continuous operation
Size of product: 46 x 39 x 135 mm
Net weight: 150 g
Communication: Ultra-low-power consumption Bluetooth 4.0
Standard Compliance
AAMI / ANSI ES60601‐1:2005/(R)2012 and A1:2012,, c1:2009/(r)2012 and a2:2010/(r)2012
(consolidated text) medical electrical equipment ‐ part 1: general requirements for basic
safety and essential performance (iec 60601‐1:2005, mod). (General II (ES/EMC));
AAMI / ANSI / IEC 60601‐1‐2:2007/(R)2012, medical electrical equipment ‐ part 1‐2: general
requirements for basic safety and essential performance ‐ collateral standard:
electromagnetic compatibility ‐ requirements and tests (edition 3). (General II (ES/EMC));
IEC 60601‐1‐11 IEC 60601‐1‐11 Edition 1.0 2010‐04, medical electrical equipment ‐ part 1‐
11: general requirements for basic safety and essential performance ‐ collateral standard:
requirements for medical electrical equipment and medical electrical systems used in the
home healthcare environment [including: technical corrigendum 1 (2011)]. (General II
(ES/EMC))
IEC 60601‐2‐37‐2007Medical electrical equipment ‐ Part 2‐37: Particular requirements for
the basic safety and essential performance of ultrasonic medical diagnostic and monitoring
equipment
Basic Parameters and Specifications
Working environment
Temperature: + 15°C to + 35°C
Humidity: 30%~90%
Atmospheric pressure: 70 to 106 kPa
Product performance
Rated sound working frequency: 2.0 MHz ± 10%
Ultrasonic output power: <10 mW
Effective ultrasound emission area: <2.0 cm²
Comprehensive sensitivity: ≥ 90 dB
Fetal heart monitoring range: 65 ~210 beats / min
Fetal heart monitoring error: ≤ ±2 times / min
Continuous working time ≥ 2 hours
(Low battery or too large volume will shorten the
working hours)
Peak negative sound pressure: <0.2 MPa
Sound intensity of output beam: 20 mW / cm²
Spatial peak time average output sound intensity:
<100 mW / cm²
Service life: 3 years
Service Agencies and Information
Comper Chuangxiang
(Beijing)Technology Co.Ltd
Building 1, Floor 3 Unit 712, 713, No. 3
Yongchang North Road, Economic and
Technological Development Zone,
Beijing
US Agent Contact:
Name:
Contact number
Manual version: JS02114DFMX V1.0
19
Table for acoustic output level
COMPER
How the best is done
Copyright
Copyright is owned by Comper (Beijing) Technology Co., Ltd., the Company shall enjoy and reserve
all exclusive authority of copyright. No part of the Manual shall be increased or decreased, excerpted,
reproduced, altered or imitated without the prior written consent of the Company.
For the content of this Manual, the Company is not responsible for any explicit or implied warranty or
guarantee liability. The content change caused by product improvements and technology updates
could occur at any time without prior notice. The power of interpretation is vested by the Company.
Federal Communications Commission (FCC) Statement
15.21
You are cautioned that changes or modifications not
expressly approved by the part responsible for compliance
could void the user’s authority to operate the equipment.
15.105(b)
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.
This device complies with part 15 of the FCC Rules.
Operation is subject to the following two conditions:
1) this device may not cause interference and
2) this device must accept any interference, including
interference that may cause undesired operation of the device.
This equipment complies with FCC radiation exposure limits set
forth for an uncontrolled environment. End users must follow the
specific operating instructions for satisfying RF exposure
compliance. This transmitter must not be co-located or operating
in conjunction with any other antenna or transmitter.
The procedures necessary for safe operation shall be
provided, drawing attention to the safety hazards that may
occur as a result of an inadequate electrical installation when
the APPLIED PART of the ULTRASONIC DIAGNOSTIC
EQUIPMENT is a TYPE B APPLIED PART.
A notice shall be provided if the ULTRASONIC
DIAGNOSTIC EQUIPMENT or parts thereof are provided
with protective means against burns to the PATIENT when
used with high frequency(HF) surgical equipment. If no such
means are incorporated, notice shall be given in the
ACCOMPANYING DOCUMENTS and advice shall be
given regarding the location and use of the TRANSDUCER
ASSEMBLY to reduce the hazard of burns in the event of
defect in the HF surgical neutral electrode connection.
A recommendation calling the OPERATOR'S attention to the
need for regular testing and periodic maintenance including
inspection of the TRANSDUCER ASSEMBLY for cracks
that allow the ingress of conductive fluid shall be provided.
Instructions shall be provided regarding the avoidance of
unintended control settings and acoustic output levels.
Guidance and manufacturer’s declaration-electromagnetic emissions
The
DFMX is intended for use in the electromagnetic environment
specified below.
The customer or the user of the
DFMX should assure that it is used in
such an environment.
Emission test
Compliance
Electromagnetic environmentguidance
RF emissions
Group 1
The
DFMX uses RF energy
CISPR 11
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
Class B
The
DFMX is suitable for
CISPR 11
use in all establishments,
including domestic
Harmonic
Not applicable
establishments and those
emissions
directly connected to the public
IEC 61000-3-2
low-voltage power supply
Voltage
Not applicable
network that supplies buildings
fluctuations
used for domestic purposes.
/flicker emissions
IEC 61000-3-3
Guidance and manufacturer’s declaration‐electromagnetic immunity
The
(DFMX) is intended for use in the electromagnetic environment specified below.
The customer or the user of the
(DFMX)should assure that it is used in such an environment.
Immunity test
IEC 60601
Compliance level
test level
Electrostatic discharge(ESD) IEC 61000‐4‐2
+ 6 kV contact
+ 6 kV contact
+ 8 kV air
+ 8 kV air
Electrical fast transient/burst IEC 61000‐4‐4
Surge IEC 61000‐4‐5
Voltage Dips, short interruptions and voltage variations on
power supply input lines IEC 61000‐4‐11
+ 2kV for power
supply lines
+ 1kV for
input/output lines
+ 1kV line(s) to
line(s)
+ 2kV line(s) to
earth
<5% UT(>95% dip
in UT) for 0,5 cycle
40% UT(60% dip in
UT) for 5 cycles
70% UT(30% dip in
Not applicable
Not applicable
Electromagnetic 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%
Mains power quality should be
that of a typical commercial or
hospital environment.
Not applicable
Not applicable
Mains power quality should be
that of a typical commercial or
hospital environment.
Not applicable
Mains power quality should be
that of a typical commercial or
hospital environment. If the
user of the
(model)
requires continued operation
Not applicable
Not applicable
Power frequency(50/60 Hz) magnetic field IEC 61000‐4‐8
NOTE
UT) for 25 cycles
<5% UT(>95% dip
in UT) for 5 s
Not applicable
3 A/m
3 A/m
UT is the a.c. mains voltage prior to application of the test level.
during power mains
interruptions, it is
recommended that the
DFMX be powered from an
uninterruptible power supply
or a battery.
The DFMX power frequency
magnetic fields should be at
levels characteristic of a typical
location in a typical commercial
or hospital environment.
Guidance and manufacturer’s declaration‐electromagnetic immunity
The
(DFMX) is intended for use in the electromagnetic environment specified below.
The customer or the user of the
(DFMX) should assure that is used in such and environment.
Immunity test
IEC 60601 test level
Compliance level
Conducted RF
IEC 61000‐4‐6
3 Vrms
150 KHz to 80 MHz
Not applicable
Radiated RF
IEC 61000‐4‐3
3 V/m
80MHz to 2,5 GHz
3 V/m
Electromagnetic environment‐
guidance
Portable and mobile RF
communications
equipment should be used no
closer to any part of the
DFMX including cables, than the
recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
Recommended separation
distance:
d = 1,2 √P
d = 1,2 √P 80MHz to 800 MHz
d = 2,3 √P 800MHz to 2,5 GHz
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, a
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:
NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE2 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
exceeds the applicable RF compliance level above, the
DFMX is used
DFMX should be observed to verify normal operation. If abnormal performance is
observed, additional measures my be necessary, such as re‐orienting or relocating the
b Over the frequency range 150 kHz to 80 MHz, field strengths should be les than 3 V/m.
DFMX.
Recommended separation distance between
portable and mobile RF communications equipment and the
The
DFMX
DFMX is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the
DFMX can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the
DFMX as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of
transmitter
0,01
0,1
10
100
Separation distance according to frequency of transmitter
150 kHz to 80 MHz
d =1,2√P
N/A
N/A
N/A
N/A
N/A
80 MHz to 800 MHz
d =1,2√P
0,12
0,38
1,2
3,8
12
800 MHz to 2,5 GHz
d =2,3√P
0,23
0,73
2,3
7,3
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (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.
NOTE1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects
and people.

---

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