Temperature:-25°C ~ +70°C (-13ºF ~ +158ºF)
Humidity:15% RH ~ 95% RH (non-condensing)
Atmospheric Pressure:70 kPa ~106 kPa
Note: The time required for the Doppler to warm from the minimum storage temperature between uses
until it is ready for intended use is at least 2 hours; the time required for the Doppler to cool from the
maximum storage temperature between uses until it is ready for intended use is at least 2 hours
Performance Specifications
FHR (Essential Performance):
FHR Measuring Range: 50 bpm ~ 240 bpm
Accuracy: ±2 bpm
Note: FHR measurement result may not be accurate if the equipment is
measuring beyond its measuring range.
Power off when the Doppler receives no signal or operation for 2 minutes.
Transmission Range (Without Obstacles) :>5m (Indoor range depends on the
building’s structure and material.)
Effective Radiating Area: 490mm2 ± 15%
Battery Specifications
Two AA 1.5V alkaline batteries (AA, LR6, 1.5V)
Bluetooth Specifications
Occupied Channel Bandwidth:
Transmitter Unwanted Emissions:
Low Output Summary Table
(For systems whose global maximum value does not exceed 1.0)
System: SD1 Ultrasonic Pocket Doppler
Ordering Information
CAUTION
Only the parts supplied by the manufacturer should be used with the Doppler.
SD1 Doppler(Non-Bluetooth version)
SD1 Doppler(Bluetooth version)
Ultrasound Intensity and Safety
Ultrasound in Medicine
The use of diagnostic ultrasound has proved to be a valuable tool in medical practice. Given its known benefits for
non-invasive investigations and medical diagnosis, including investigation of the human fetus, the question of
clinical safety with regards to ultrasound intensity arises.
There is no easy answer to the question of safety surrounding the use of diagnostic ultrasound equipment.
Application of the ALARA (As Low As Reasonably Achievable) principle serves as a rule-of-thumb that will help
you to get reasonable results with the lowest possible ultrasonic output.
The American Institute of Ultrasound in Medicine (AIUM) states that given its track record of over 25 years of use
and no confirmed biological effects on patients or instrument operators, the benefits of the prudent use of
diagnostic ultrasound clearly outweigh any risks.
Ultrasound Safety and the ALARA Principle
Ultrasound waves dissipate energy in the form of heat and can therefore cause tissue warming. Although this effect
is extremely low with Doppler, it is important to know how to control and limit patient exposure. Major governing
bodies in ultrasound have issued statements to the effect that there are no known adverse effects from the use of
diagnostic ultrasound,however, exposure levels should always be limited to As Low As Reasonably Achievable
(the ALARA principle).
Explanation of MI/TI
MI (Mechanical Index)
Cavitations will be generated when ultrasound wave passes through and contacts tissues, resulting in instantaneous
local overheating. This phenomenon is determined by acoustic pressure, spectrum, focus, transmission mode, and
factors such as states and properties of the tissue and boundary. This mechanical bioeffect is a threshold
phenomenon that occurs when a certain level of ultrasound output is exceeded. The threshold is related to the type
of tissue. Although no confirmed adverse mechanical effects on patients or mammals caused by exposure at
intensities typical of present diagnostic ultrasound instruments have ever been reported, the threshold for
cavitation is still undetermined. Generally speaking, the higher the acoustic pressure, the greater the potential for
mechanical bioeffects; the lower the acoustic frequency, the greater the potential for mechanical bioeffects.
The AIUM and NEMA formulate mechanical index (MI) in order to indicate the potential for mechanical effects.
The MI is defined as the ratio of the peak-rarefactional acoustic pressure (should be calculated by tissue acoustic
attenuation coefficient 0.3 dB/cm/MHz) to the acoustic frequency.
MI = Pr, α
fawf ×CMI
CMI = 1 (MPa / MHz )
TI (Thermal Index)
Heating of tissues is caused by absorption of ultrasound when the ultrasound energy is applied. The temperature
rise is determined by the acoustic intensity, exposed area and thermo physical properties of the tissue.
In order to indicate the potential for temperature rise caused by thermal effects, the AIUM and NEMA formulate
thermal index (TI). It is defined as the ratio of the total acoustic power to the acoustic power required to raise the
tissue temperature by 1ºC (1.8°F).
According to different thermo physical properties of the tissue, TI is divided into three kinds: TIS, TIB and TIC.
TIS (Soft Tissue Thermal Index): It provides an estimate of potential temperature rise in soft or similar tissues.
TIB (Bone Thermal Index): It provides an estimate of potential temperature rise when the ultrasound beam passes
through soft tissue and a focal region is in the immediate vicinity of bone.
TIC (Cranial Bone Thermal Index): It provides an estimate of potential temperature rise in the cranial bones or
superficial bones.
Measurement Uncertainties
The uncertainties in the measurements were predominantly systematic in origin; the random uncertainties were
negligible in comparison. The overall systematic uncertainties were determined as follows:
1. Hydrophone Sensitivity: ± 12percent for intensity, ± 6 percent for pressure. Based on the hydrophone
calibration report by ONDA. The uncertainty was determined within ±1 dB in frequency range 1-15 MHz.
2. Digitizer: ±0.3 percent for intensity. ± 0.15 percent for pressure.
Based on the stated accuracy of the 8-bit resolution of the Agilent DSO6012 Digital Oscilloscope and the
signal-to-noise ratio of the measurement.
3. Temperature:±2.4 percent for intensity uncertainty, ±1.2 percent for pressure uncertainty.
Based on the temperature variation of the water bath of ± 1ºC (1.8°F).
4. Spatial Averaging: ± 3.5 percent for intensity, ± 1.75percent for pressure.
5. Non-linear Distortion: N/A.
No effects of nonlinear propagation were observed.
Since all the above error sources are independent, they may be added on an RMS basis, giving a total
uncertainty of ± 12.73 percent for all intensity values reported, ± 6.37 percent for all the pressure values,,± 12.6
percent for the Mechanical Index, uncertainty of ±12.73% percent for power,±0.15 percent for center frequency,
±6.87%for the MI.
Prudent Use Statement
Although no confirmed bioeffects on patients caused by exposure from present diagnostic ultrasound equipment
have ever been reported, the potential exists that such bioeffects may be identified in the future. Therefore, the
ultrasound should be used prudently. High levels of acoustic output and long exposure time should be avoided
while acquiring necessary clinical information.
Reference for Acoustic Output and Safety
1. “Bioeffects and Safety of Diagnostic Ultrasound” issued by AIUM in 1993
2. “Medical Ultrasound Safety” issued by AIUM in 1994
3. "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment,
Revision 3" issued by AIUM/NEMA in 2004
4. "Standard for real-time display of thermal and mechanical acoustic output indices on
diagnostic ultrasound equipment, Revision 2" issued by AIUM/NEMA in 2004
5. "Information for Manufacturers Seeking Marketing Clearance of Diagnostic
Ultrasound Systems and Transducers" issued in 2008.
6. “Medical electrical equipment—Part 2-37: Particular requirements for the basic safety and essential
performance of ultrasonic medical diagnostic and detection equipment" issued by IEC in 2007.
Acoustic Output Reporting Table for Track 1 Acoustic output reporting table for
IEC60601-2-37(IEC60601-2-37, Edition 2.1, 2015-0, table 201.103)
Transducer Model: SD1, Operating Mode: PW mode
Ispta.α at zPII.α
or
zSII.α(mW/cm2)
Ispta at zPII or
zSII (mW/cm2)
Operating control conditions
Acoustic Output Reporting Table for Track1(Non-autoscanning Mode)
Transducer Model: SD1 ,Operating Model: PW
Associated
Acoustic
Parameter
Operating
Control
Conditions
Standard Parameter Equal Contrast List
IEC60601-2-37 Standard Parameters
Attenuated Peak-rare-factional
Acoustic Pressure
Center Frequency, Acoustic Working
Frequency
Peak-rare-factional Acoustic
Pressure
-12dB Output Beam Dimensions
Depth for Soft Tissue Thermal
Index
Pulse Repetition Frequency
Attenuated Temporal-average
Intensity
Attenuated Pulse-average Intensity at
the point of Maximum MI
Depth for Bone Thermal Index
Attenuated Pulse-intensity
Integral
Soft Tissue Thermal Index
Equivalent Beam Diameter at
the point of Z
sp
Cranial-bone Thermal Index
EMC Information
Electromagnetic Emissions
Guidance and manufacturer’s declaration – electromagnetic emission
The SD1 Ultrasonic Pocket Doppler is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment.
Electromagnetic environment - guidance
The SD1Ultrasonic Pocket 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 SD1 Ultrasonic Pocket 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.
/flicker emissions
IEC/EN61000-3-3
Electromagnetic Immunity
Guidance and manufacture’s declaration–electromagnetic immunity
The SD1 Ultrasonic Pocket Doppler is intended for use in the electromagnetic environment specified below. The
customer or the user of the device should assure that it is used in such an environment.
Electromagnetic
environment-guidance
Electrostatic discharge
(ESD)
Floors should be wood,
concrete or ceramic tile. If
floor are covered with
synthetic material, the
relative humidity should be
at least 30%.
Transient/Burst
IEC/EN61000-4-4
±2kV for power supply lines
±1kV for input/output lines
± 1 kV line(s) to line(s)
interruptions, and
voltage variations
on power supply
input lines
IEC/EN61000-4-11
for 0.5cycle
40%UT(60%dip in UT)
for5 cycles
70%UT(30%dip in UT)
for25 cycles
<5%UT(>95% dip inUT)
for 5s
(50Hz/60Hz)
magnetic field
IEC61000-4-8
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Electromagnetic Immunity
Guidance and manufacture’s declaration – electromagnetic immunity
The SD1 Ultrasonic Pocket Doppler is intended for use in the electromagnetic environment specified below. The
customer or the user of the device should assure that it is used in such an environment.
Electromagnetic environment-guidance
IEC61000-4-6
Radiated RF
IEC61000-4-3
150 kHz ~ 80
MHz
6Vrmsc)in ISM
bands between
0,15 MHz
and80 MHz
10V/m
80 MHz ~ 2.7
GHz
Portable and mobile RF communications
equipment should be used no closer to any part of
the SD1 Ultrasonic Pocket Doppler, including
cables, than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance:
at RF wireless communications
equipment bands (Portable RF communications
equipment (including peripherals such as antenna
cables and external antennas) should be used no
closer than 30 cm (12 inches) to any part of the
SD1 Ultrasonic Pocket Doppler, including cables
specified by the manufacturer).
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 meters (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 SD1 Ultrasonic Pocket
Doppler is used exceeds the applicable RF compliance level above, the SD1Ultrasonic Pocket Doppler should
be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the SD1 Ultrasonic Pocket Doppler.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
c
The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to6,795 MHz;
13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur radio
bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7
MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz,21,0 MHz to 21,4
MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.
Table-Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment
IMMUNITY
TEST
LEVEL
(V/m)
±5 kHz
deviation
1kHz sine
Pulse
modulation
b)
217 Hz
GSM
800/900,TETRA
800,iDEN 820,
CDMA 850,
LTE Band 5
GSM 1800;
CDMA 1900;
GSM 1900;
DECT; LTE
Band 1, 3,
4,25;UMTS
Pulse
modulation
b)
217 Hz
Bluetooth,
WLAN,802.11
b/g/n, RFID
2450, LTE
Brand 7
Pulse
modulation
b)
217 Hz
Pulse
modulation
b)
217 Hz
Note: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and
the ME EQUIPMENT or ME SYSTEM maybe reduce to 1m. The 1 m test distance is permitted by IEC
61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50% duty cycle square wave signal.
c) As an alternative FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not
represent actual modulation, it would be worst case
Recommended Separation Distances
Recommended separation distances between portable and mobile RF communications equipment
and the SD1 Ultrasonic Pocket Doppler
The SD1 Ultrasonic Pocket Doppler is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of theSD1 Ultrasonic Pocket Doppler can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the SD1 Ultrasonic Pocket Doppler as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter
Separation distance according to frequency of transmitter (m)
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.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
Overall Sensitivity
Velocity of Target
(cm/s)
S：Overall Sensitivity (S=A+B+C)dB
C:Signal to Noise Ratio (dB)
...
...
log20
10
smrV
smrV
C
n
s
B:Two-wayAttenuation(dB)
B=∑Ba+Bw
Troubleshooting
Fail to power on, or
shut down shortly after
switching on
Battery level is very low.
Battery is not installed properly.
Fail to switch on the Doppler as
instructed.
Touch the On/Off touch key for a
while to power on the Doppler.
The Doppler has malfunctions.
Contact service personnel.
Loudspeaker does not
work.
Sound volume has been turned down to
the lowest level.
Adjust sound volume to appropriate
level.
If the Doppler is configured with
Bluetooth, fetal heart sound can be played
by mobile phone.
Set to play fetal heart sound by
mobile phone or the Doppler on the
APP.
The Doppler has malfunctions.
Contact service personnel.
FHR cannot be
displayed stably.
There is strong interference source such as
high frequency machines and mobile
phones nearby.
Use the Doppler away from strong
interference sources.
The fetal heart position has changed
because of fetal movement.
Relocate the Doppler to the best fetal
heart rate detection position.
Friction between the Doppler and patient’s
abdomen causes false displaying.
Find the best fetal heart rate detection
position.
Sensitivity is low and
noise is too much.
There is strong interference source such as
high frequency machines and mobile
phones nearby.
Use the Doppler away from strong
interference sources.
The Doppler is not applied with coupling
gel.
Apply coupling gel to the Doppler.
The Doppler is not placed at the best
detection position.
Relocate the Doppler to the best fetal
heart rate detection position.
The Doppler has malfunctions.
Contact service personnel.
Doppler cannot be
connected to mobile
phone.
The Bluetooth of mobile is not open.
Open the Bluetooth of mobile.
The Doppler used is not configured with
Bluetooth function.
Use the Doppler with Bluetooth
function.
The Bluetooth function of Doppler has
malfunctions.
Use the FHR and sound detected and
displayed on the SD1 itself, and
contact service personnel.
Warranty and Service
Warranty
The manufacturer warrants that the manufacturer’s products meet the labeled specifications of the products and
will be free from defects in materials and workmanship that occur within warranty period.
The warranty is void in cases of:
A. damage caused by mishandling during shipping.
B. subsequent damage caused by improper use or maintenance.
C. damage caused by alteration or repair by anyone not authorized by the manufacturer.
D. damage caused by accidents.
E. replacement or removal of serial number label and manufacture label.
If a product covered by this warranty is determined to be defective because of defective materials, components, or
workmanship, and the warranty claim is made within the warranty period, the manufacturer will, at its discretion,
repair or replace the defective part(s) free of charge. the manufacturer will not provide a substitute product for use
when the defective product is being repaired.
Contact Information
If you have any question about maintenance, technical specifications or malfunctions of devices, contact your
local distributor.
Address: #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, PingshanDistric, 518122
Shenzhen, P.R. China
Email: info@edan.com.cn
Tel: +86-755-2689 8326
Fax: +86-755-2689 8330
www.edan.com.cn
Shanghai International Holding Corp. GmbH
Eiffestrasse 80, 20537 Hamburg Germany
Tel. : +49-40-2513175
E-mail: shholding@hotmail.com
Definition of Symbols
Authorized
Representative in the
European Community
General symbol for
recovery/recyclable
(Background: Blue;
Symbol: White)
MR Unsafe–Keep
away from magnetic
resonance imaging
(MRI) equipment
Non-ionizing
electromagnetic
radiation
IP22 Protected against
solid foreign objects of
12,5 mm ∅ and
greater ， Protection
against vertically
falling water drops
when ENCLOSURE
tilted up to 15°
Serial Number
(Start with H on
battery
compartment
cover)
Federal (U.S.) law
restricts this device to
sale by or on the order
of a physician.
Federal
Communications
Commission: FCC ID:
SMQSD1MEDAN
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