EDAN SD1 User manual

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文件名称：SD1，说明书_英文，EDAN2 (FDA版）
文件编号：01.54.458123
版本：1.1
产品型号：SD1
项目编码(Project Code)：2215A000
签批信息:
作者 : 周 睿 (zhourui) 2019-03-27 13:48:16
审核人 : 刘 小倩 (liuxiaoqian) 2019-03-27 14:15:17
审核人 : 余 俊煜 (yujunyu) 2019-03-28 08:43:36
审核人 : 马 家豪 (majiahao) 2019-03-27 14:20:56
审核人 : 陈 钰全 (chenyuquan) 2019-03-27 14:39:19
批准人 : 夏 欢欢 (xiahuanhuan) 2019-04-02 15:03:41
批准人 : 吴 明花 (wuminghua) 2019-04-02 13:22:08
版权©深圳市理邦精密仪器股份有限公司 (Copyright©Edan Instrument,Inc.)

SD1 Ultrasonic Pocket Doppler User Manual
About this Manual
P/N: 01.54.458123
MPN: 01.54.458123011
Release Date: Mar. 2019
Statement
This manual will help you understand the operation and maintenance of the product better. It is reminded that the
product shall be used strictly complying with this manual. User’s operation failing to comply with this manual
may result in malfunction or accident for which the manufacturer cannot be held liable.
The manufacturer owns the copyrights of this manual. Without prior written consent of the manufacturer, any
materials contained in this manual shall not be photocopied, reproduced or translated into other languages.
Materials protected by the copyright law, including but not limited to confidential information such as technical
information and patent information are contained in this manual, the user shall not disclose such information to
any irrelevant third party.
The user shall understand that nothing in this manual grants him, expressly or implicitly, any right or license to use
any of the intellectual properties of the manufacturer.
The manufacturer holds the rights to modify, update, and ultimately explain this manual.
Responsibility of the Manufacturer
The manufacturer only considers itself responsible for any effect on safety, reliability and performance of the
equipment if:
Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorized by
the manufacturer, and
The electrical installation of the relevant room complies with national standards, and
The instrument is used in accordance with the instructions for use.
The manufacturer will make available on request circuit diagrams, component part lists, descriptions, calibration
instructions, or other information that will assist service personnel to repair those parts of the equipment that are
designated by the manufacturer as repairable by service personnel.
Product Information
Product Name: Ultrasonic Pocket Doppler
Model:SD1
Terms Used in this Manual
This guide is designed to give key concepts on safety precautions.
WARNING
AWARNING label advises against certain actions or situations that could result in personal injury or death.
CAUTION
A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or
invalidate a procedure.
NOTE
A NOTE provides useful information regarding a function or a procedure.
Safety Precautions
CAUTION
Federal (U.S.) Law restricts this device to sale by or on the order of a physician.
NOTE:
This user manual is written to cover the maximum configuration. Therefore, your model may or may not have
some of the parameters and functions described, depending on what you have ordered.
This unit is internally powered equipment, and it is an IEC/EN 60601-1 Type BF applied part. Type BF
protection means that the connection between the equipment and personnel complies with permitted
leakage currents and dielectric strength of IEC/EN 60601-1.
WARNING and CAUTION messages must be observed. To avoid the possibility of injury, observe the
following precautions during the operation of the device.
WARNING
1 It is to be used by health care professionals on the order of a physician.
2 The Doppler is a tool to aid the healthcare professional in hospitals, clinics and should not be used in
place of normal fetal detection. It is not intended for treatment or use during labor and delivery.
3 Placement of the ultrasound transducer on the abdomen is critical to obtaining the fetal heart beat as
opposed to maternal heart beat or other abdominal noise. The user should be trained in proper
placement techniques either through acceptable Ob/Gyn training and individual state accreditation, or
as being prescribed by such a trained clinician and trained in device placement.
4 This device is not explosion-proof and cannot be used in the presence of flammable anesthetics.
5 Magnetic and electrical fields are capable of interfering with the proper performance of the device. For
this reason, make sure that all external devices operated in the vicinity of this device comply with the
relevant EMC requirements. X-ray equipment and magnetic resonance imaging (MRI) devices can
emit high levels of electromagnetic radiation.
6 We recommend that exposure to ultrasound should be kept as low as reasonably achievable. This is
considered to be good practice and should be observed at all time.
7 Do not use the device with HF surgical equipment and do not use it in an MRI environment.
8 The device is not protected against defibrillation.
9 SHOCK HAZARD - Do not attempt to replace batteries with wet hands.
10The device should not be used adjacent to or stacked with other equipment and that if adjacent or
stacked use is necessary, the device should be observed to verify normal operation in the
configuration in which it will be used.
11The medical electrical equipment needs to be installed and put into service according to the EMC
Information provided in this user manual.
12Portable and mobile RF communications equipment can affect medical electrical equipment; refer to
section Recommended Separation Distances.
13Do not service or maintain the device or any accessory which is in use with a patient.
CAUTION
1 Refer servicing to qualified personnel.
2 Keep the device in a clean environment and avoid vibration during storage.
3 Do not sterilize the Doppler.
4 Electromagnetic Interference - Ensure that the environment in which the device is operated is not
subject to any source of strong electromagnetic emissions, such as radio transmitters, mobile
telephones, etc.
5 Prior to examination using the Doppler, check for visible damages of the main unit and the probe that
may endanger the patient/operator or machine performance. If the damage is found, replace them
with good ones at once.
6 The following safety checks should be performed once every two years or as specified in the
institution’s test and inspection protocol by a qualified person who has adequate training, knowledge,
and practical experience to perform these tests.
Inspect the equipment for mechanical and functional damage.
Inspect the safety relevant labels for legibility.
Inspect the equipment for mechanical and functional damage.
Inspect the safety relevant labels for legibility.
The leakage current should never exceed the limit. The data should be recorded in an equipment log.
If the device is not functioning properly or fails any of the above tests, the device has to be repaired.
7 The device and accessories are to be disposed of according to local regulations after their useful lives.
Alternatively, they can be returned to the dealer or the manufacturer for recycling or proper disposal.
Batteries are hazardous waste. Do NOT dispose them together with house-hold garbage.
Introduction
Intended Use/Indications for Use
The SD1 is a pocket Doppler device used for detecting the fetal heartbeat from the 10th week of gestation. It is
intended to be used by medical professionals only.
Features
FHR detection and display
FH signal intensity indicator
FH sound
FH icon
Switching off when no signal received for 2 Min
Battery indicator
Sound volume adjustment
Low battery warning
Bluetooth connection (Optional)
Sound volume levels
Appearance（Above pictures are just for reference）
LCD Display& Touch Keys
Item
Description
1
Fetal heart icon
Indicates fetal heart beat and flickers to the fetal heart beat.
2
Fetal heart signal
intensity
indicator
This indicator displays on the left side of the screen
and has three status: empty, half empty and full,
which respectively represents low, medium and high
fetal heart signal intensity.
3
FHR numeric
Displays fetal heart rate within the range from 50 bpm to
240 bpm. When fetal heart rate is out of the range, it
displays “---”.
Sound volume
numeric
Sound volume numeric is displayed in the center of the
screen, the same area as the FHR numeric. When you
adjust sound volume, the sound volume numeric will
display for 0.5 second before switching back to display
FHR numeric. Sound volume ranges from level 0 to 7.
4
Battery indicator
Battery indicator displays on the right side
of the screen. There are 5 battery levels,
represented by 0 to 4 panes in the icon.
When battery is empty, battery empty icon
will be displayed and flickering, and the
battery needs replacing.
5
Sound volume
increase touch
key
Touch the key for a little while to increase sound volume.
6
Sound volume
decrease touch
key
Touch the key for a little while to decrease sound volume.
7
On/Off touch
key
When the Doppler is off, touch this key for a little while to switch it
on;
When the Doppler is on, touch this key for a little while to switch it
off.
Battery
SD1 is powered by two AAalkaline batteries. Battery specification: LR6, AA, 1.5 V;
Note:
You can use AAalkaline batteries of the same specification purchased locally.
Basic Operation
NOTE:
To ensure that the Doppler works properly, please read this chapter and Chapter Safety Precautions before
operation; follow the steps when connecting all the components.
Opening the Package and Checking
Open the package; take out the Doppler and accessories carefully. Keep the package for possible future
transportation or storage. Check the components according to the packing list.
Check for any mechanical damage.
Check all the cables and accessories.
If there is any problem, contact us or your local distributor immediately.
Installing the Battery
a) Unscrew the screw with a cross screwdriver and remove the battery compartment cover.
b) Insert the battery into the compartment carefully. Ensure its anode and cathode terminals are aligned with the
anode and cathode marks on the compartment.
c) Install the compartment cover and secure it with the screw.
Removing/ Replacing the Battery
a) Unscrew the screw with a cross screwdriver and remove the battery compartment cover.
b) Take out the used battery. You can also replace it with a new one. Ensure the new battery’s terminals are placed
in the right direction as indicated by the anode and cathode marks.
c) Install the compartment cover and secure it with the screw.
WARNING
1 Turn off the Doppler before removing or replacing the battery.
2 Replace alkaline batteries with those of identical specifications provided by the manufacturer or
purchased locally. See Chapter Product Specifications for details about battery specifications.
3 If the batteries have been inserted incorrectly, the Doppler will not function or it will be damaged.
4 Do not disassemble or short-circuit batteries.
5 Do not recharge batteries.
6 Do not dispose of batteries in fire or water.
7 Do not allow metal objects to contact the battery terminals.
8 Do not mix with used or other battery type (such as alkaline with carbon zinc).
9 Do not solder the batteries directly. If soldering or welding connection to the battery is required,
consult our engineer for proper methods.
10 Do not over-discharge batteries.
11 To install or remove batteries, follow the equipment manufacturer’s instructions.
12 Keep battery away from small children. If swallowed, consult a physician at once.
13 Store the battery in cool, dry place before use. Do not keep batteries at temperature of 45°C or
above, or at humidity of 75% or above.
14 Dispose the battery according to the local regulations. Refer to IEC61429 for standard disposal
when necessary.
15 Remove the battery and store it at a cool and dry environment if the Doppler is not used for a long
time.
16 Batteries have life cycles. If the time that the Doppler using battery becomes much shorter than
usual, the battery life is at an end. Replace the battery with a new one of the same specification as
the one provided or recommended by the manufacturer.
Switching On
Touch the On/Off touch key for about 1second when the Doppler is off, and the Doppler will display the switching
on interface before switching to display the test interface .
Switching Off
Touch the On/Off touch key for about 1second when the Doppler is on, and the Doppler will be switched off.
If the Doppler is not in operation or no signal is received for 2 minutes, the Doppler will switch off automatically.
FHR Detection
Before applying the Doppler to inspect FHR, you should always check whether the Doppler is in good condition
and whether there is evident damage that might affect patient’s safety and the device’s function. If evident damage
is found, stop using it at once and replace it with a good one.
Procedures to Detect FHR:
a) Have the patient lie on her back.
b) Apply appropriate amount of coupling gel to the ultrasonic transducer head of the
Doppler and switch on the Doppler.
c) Palpate the patient’s abdomen gently to confirm the fetus’s position.
d) Place the Doppler on the patient’s abdomen, and move it around the fetus’s position or
tilt it until a clear and rhythmic heart sound is heard and FHR numeric is stably
displayed.
Note:
1 Do not mistake the maternal heart rate for fetal heart rate. The
fetal pulse should be different from the maternal pulse, which
can be measured at the wrist or neck.
2 Do not wear gloves to touch the keys. If there's water and
coupling gel on the fingers, please clean them first or the
touching effect will be influenced.
How to Find the Best FH Signal:
1) The easiest way: take the position the doctor last detected for FHR as a reference and move the Doppler around
the position slowly until the best FH signal is found.
2) The fetal heart position may change as the fetus moves inside the uterus. You can confirm the fetal position first
according to the position of the uterus fundus in different gestational weeks.
The clearest and loudest fetal heart sound is generally obtained when the Doppler is placed on the fetus’s back.
Fetal movement is usually the movement of fetal limbs. So, if frequent fetal movement occurs at the right side
of the abdomen, the fetus’s back is probably at the left side and vice versa. You can find the fetus’s back
according to fetal movement’s position.
If the fetus is in cephalic delivery position, the fetal heart is either on the right side or on the left side below the
navel; if the fetus is in breech delivery position, the fetal heart is either on the right side or on the left side above
the navel.
Steps to Find Fetal Heart:
Have the patient lie on back and relax >> confirm fetal position by hand >> apply coupling gel to the Doppler>>
place the Doppler on patient’s abdomen and start looking for the fetal heart >> the fetal heart is found when the
Doppler gives out a continuing thumping sound “boom-boom-boom”.
CAUTION
1 The Doppler’s degree of protection against harmful ingress of water is IP22. Do not immerse it in water.
2 The Doppler is delicate and sensitive. Please handle it with care and try to avoid dropping on to the
ground or any hard surfaces. Any damage caused by dropping is not covered by the warranty.
3 Keep the coupling gel away from children. If swallowed, consult a physician at once.
Note:
1 The best quality of fetal heart signal is obtained only when the Doppler is placed on the best detection position.
2 Do not place the Doppler near positions where placental sound or umbilical blood flow sound is loud.
3 If the fetus is in the cephalic position and the mother is supine, the clearest heart sound will normally be found
on the midline below the navel. During detection, the pregnant woman’s prolonged lying in the supine position
should be avoided to reduce the possibility of supine hypotension. Putting a pillow or cushion under the
patient’s head or feet can be of help.
4 It is not possible to obtain accurate FHR unless a clear fetal heart signal is detected. If the calculated FHR is
not in accordance with the beat of the fetal heart sound, the fetal heart sound auscultation result shall prevail.
5 When applied to the patient, the Doppler may warm slightly (less than 2°C (35.6°F) above ambient
temperature). When NOT applied, the Doppler may slightly (less than 5°C (41°F) above ambient temperature).
After Detection
1) Switch off the Doppler.
2) Wipe the remaining gel off the patient and the probe with a clean soft cloth or tissue.
Mobile Application Software (APP)
SD1 can connect to mobile phones with its Bluetooth function (optional). The SD1 Care APP has both Android
and iOS versions.
iOS APP operating environment:
Android APP operating environment:
A) hardware environment
A) hardware environment
Processor: dual-core Apple A6
CPU: frequency≥1.0GHz
RAM: ≥1GB
RAM: ≥1GB
B) software environment: iOS 8.0 and above operating
system
B)software environment: Android 4.3 and above
operating system
C)network environment: support Bluetooth
C)network environment: support Bluetooth
How to use SD1 Care APP
1. Download and install software
Scan either of the following QR codes to download the SD1CareAPP, and install and run it as prompted.
iOS Version
Android Version
Note:
1 Your mobile phone may prohibit the
installation of “applications from
unknown sources”. Enter Settings to
allow the installation first.
2 For normal functioning of the APP,
please give the APP function-related
permissions.
3 For how to use the APP, read the
instructions in the About sub-interface
under the Settings interface of the APP.
2. Activate the device
Open the APP and go to Settings>Activation and input SD1 activation code (14 numbers after 01).
3. Pair device
Open Bluetooth function of the mobile to automatically pair the SD1.
4. Start detection
Put the coupling gel on SD1 and position the probe to the optimal place of maternity's abdomen. And click the
"start" key. After pressing start, confirm that the data on the APP and the SD1 probe match. As with any
Bluetooth communication, it is important to make sure the connection is not compromised.
5. Adjust the fetal heart beat sound volume
When using mobile phone to play the fetal heart beat sound, you can adjust the volume with the volume keys of
the mobile phone. When using SD1 to play the heart beat sound, touch ‘volume+’ or ‘volume -’ to adjust the
volume.
6. Finish the detection
When the detection is finished, click ‘Stop’ touch key and the detection data will be saved automatically.
Note: Please make sure your mobile phone has enough battery power,and avoid killing the process directly or
switching to other applications during the fetal heart detection.
7. Real time detection mode and DEMO mode
We provide DEMO mode for users' reference. You can turn on DEMO key in Setup and enter fetal heart detection
interface to watch the DEMO. The word ‘DEMO’ is displayed in the interface to distinguish from real time
detection.
WARNING
SD1 complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
1) this device may not cause harmful interference, and
2) this device must accept any interference received, including interference that may cause undesired
operation.
NOTE:
1. This equipment (SD1) 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.
2. Any changes or modifications to this unit not expressly approved by the party responsible for compliance could
void the user's authority to operate the equipment.
Maintenance and Cleaning
Maintenance
Before each use, check if the equipment has visible evidence of damage that may affect the patient and the
operator’s safety or the Doppler’s functioning. If the damage is evident, contact the manufacturer for service or
replace it.
The overall check of the Doppler, including safety check and function check, should be performed by qualified
personnel every 12 months, and each time after service. And safety check must include current leakage test and
insulation test. Besides the above requirements, comply with local regulations on maintenance and measurement.
The accuracy of FHR is determined by the Doppler and cannot be adjusted by user. If you have doubt concerning
the accuracy of FHR, verify it with other methods such as using a stethoscope, or contact local distributor or the
manufacturer for help.
The Doppler is frangible and must be handled with care. Wipe the remaining gel off the Doppler after each use.
These measures can help prolong the Doppler’s life.
Replace the accessories such as the battery according to use. If any of the accessories are damaged, refer to chapter
Ordering Information for details and order new ones.
Please check the label for the date of manufacture, the service life is 5 years (The service life is limited to the
Doppler, not including the replaceable accessories. The only replaceable accessory of SD1 is battery. The
frequency of usage is 8 hours/day).
Cleaning
Before cleaning, switch off the Doppler.
Keep the exterior surface of the device clean and free of dust and dirt.
Clean the exterior surface of the Doppler with a dry, soft cloth. If necessary, clean it using a soft cloth dampened
with mild near neutral detergent, ethanol (75%) or isopropanol (70%), and then wipe it dry with a dry cloth
immediately.
CAUTION
1 Do not use strong solvent, such as acetone.
2 Never use an abrasive such as steel wool or metal polish.
3 The Doppler’s degree of protection against harmful ingress of water is IP22. Do not immerse it in
water.
4 Do not remain any solution on the surface after cleaning.
Disinfection
In normal use the Doppler does not need disinfection. In case of being soiled, clean the main unit case and then
disinfect it by wiping it with a soft cloth dampened with ethanol (75%) or isopropanol (70%). Then wipe it dry
with a dry cloth.
CAUTION
Do not immerse the Doppler into the disinfector.
Sterilization
Do not sterilize the Doppler.
NOTE:
After cleaning or disinfection, check if the Doppler functions well. If any problem is detected, please contact the
manufacturer for service before reusing it.
Checking Item
Method
Visual Check
Inspect the Doppler for any damage.
Functional Check
Check if the Doppler can be switched on and off normally (see Switching On and
Switching Off)When the Doppler is switched on, check if the display panel works as
described in LCD Display&Touch Keys; touch the ultrasonic transducer head gently
with your hand and check if the Doppler gives out sound normally.
Product Specifications
Product Information
Product Name
Ultrasonic Pocket Doppler
Model
SD1
Complied Standards
IEC 60601-1:2005/A1:2012, EN 60601-1:2006/A1:2013, IEC 60601-1-2:2014, IEC 60601-2-37:2015,IEC
61266:1994
Classification
Anti-electric Shock Type:
Internally powered equipment
Anti-electric Shock Degree:
Type BF equipment
Degree of Protection against Harmful Ingress of Water:
IP22. Protection against vertically falling water drops
when ENCLOSURE tilted up to 15°
Degree of Safety in Presence of Flammable Gases:
Equipment not suitable for use in presence of
flammable gases
Working System:
Continuous running equipment
EMC:
CISPR 11 Group 1 Class B
Physical Specifications
Size:
Length*Width* Height: (48±2) mm×(39±2) mm×(147±3) mm
Weight:
< 180g
LCD:
Size:
(24±2) mm×(13±2) mm
Display:
◆FHR
◆Battery level
◆Signal intensity
◆Sound volume level
◆FH icon
Coupling
Gel:
pH: 5.5~8.0
Acoustic Impedance: 1.5x106 Pa.s/m ~1.7x106Pa.s/m (35°C/95ºF )
Environment
Working:
Temperature:+5°C ~ +40°C ( +41ºF ~ +104ºF)
Humidity:15% RH ~ 95% RH(non-condensing)
Atmospheric Pressure:70kPa ~ 106 kPa
Ultrasonic Transducer Head
LCD Screen
Touch Keys
Loudspeaker
Screw
Battery Compartment Cover
The coupling gel should not
exceed this limit.
This area can
be immerged in
coupling gel

Transport and Storage:
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.
FHR Resolution:
1bpm
Audio Output:
Output Power: 2w
Background noise: <45dBA
Auto Power-off:
Power off when the Doppler receives no signal or operation for 2 minutes.
Bluetooth:
Transmission Range (Without Obstacles) :>5m (Indoor range depends on the
building’s structure and material.)
Ultrasound:
Nominal Frequency: 3MHz
Working Frequency: 3MHz
p_<1 MPa
Iob<10 mW/cm2
Ispta<100 mW/cm2
Isata<10 mW/cm2
Isppa.3<190 W/cm2
Ispta.3<94 mW/cm2
Effective Radiating Area: 490mm2 ±15%
Working Mode: pulse wave
Battery Specifications
Specification:
Two AA1.5V alkaline batteries (AA, LR6, 1.5V)
Working Duration:
◆≥6h
Bluetooth Specifications
FCC ID
SMQSD1MEDAN
Modulation:
GFSK π /4-DQPSK 8DPSK
Frequency:
2400-2483.5MHz
Tolerance Frequency:
≤ 20ppm
RF output power:
≤ 20dBm (EIRP)
Occupied Channel Bandwidth:
≤ 2MHz
Transmitter Unwanted Emissions:
≤﹣30dBm
Low Output Summary Table
(For systems whose global maximum value does not exceed 1.0)
System: SD1 Ultrasonic Pocket Doppler
Model (MHz)
Ispta.3
(mW/cm2)
TI Type
TI Value
MI
Isppa.3
(W/cm2)
SD1 CD3.0
5.69
TIS
0.05
0.01
0.02
TIB
0.01
Ordering Information
CAUTION
Only the parts supplied by the manufacturer should be used with the Doppler.
Parts
Part Number
Main Unit
SD1 Doppler(Non-Bluetooth version)
02.06.262535
SD1 Doppler(Bluetooth version)
02.06.262639
Accessories
AAAlkaline Battery
01.21.064086
Normal Carry Case
01.56.466428
Coupling Gel
01.57.078170
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 theALARA 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. SpatialAveraging: ±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 forAcoustic 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/NEMAin 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 1Acoustic 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
Index label
MI
TIS
TIB
TIC
At
Surface
Below
Surface
At
surface
Below
Surface
Maximum index value
0.01
0.05
0.01
N/A
Index component value
N/A
0.05
NA
0.01
Acoustic
Parameters
pr.αat zMI
(MPa)
0.02
P (mW)
7.35
7.35
N/A
P1x1 (mW)
N/A
N/A
zs(cm)
3.50
zb(cm)
3.70
zMI(cm)
3.70
zPII.α (cm).α
3.70
fawf (MHz)
3.00
3.00
3.00
N/A
Other
information
prr (Hz)
5000
srr(Hz)
N/A
npps
1
Ipa.α at zPII.α
(W/cm2)
0.02
Ispta.α at zPII.α
or
zSII.α(mW/cm2)
5.69
Ispta at zPII or
zSII (mW/cm2)
12.26
pr. at zPII
(MPa)
0.04
Operating control conditions
Fixed
Acoustic Output Reporting Table forTrack1(Non-autoscanning Mode)
Transducer Model: SD1 ,Operating Model: PW
Acoustic Output
MI
ISPTA.3
(mW/cm^2)
ISPPA.3
(W/cm^2)
Global Maximum Value
0.01
5.69
0.02
Associated
Acoustic
Parameter
Pr.3 (MPa)
0.02
W0 (mW)
7.35
8.97
fc (MHz)
3.00
3.00
3.00
Zsp (cm)
3.70
3.70
3.70
Beam dimensions
X-6
(cm)
2.50
2.50
Y-6
(cm)
2.50
2.50
PD (usec)
72.25
72.25
PRF (Hz)
5000
5000
EBD
Az.
(cm)
2.50
Ele.
(cm)
2.50
Operating
Control
Conditions
Fixed
Standard Parameter Equal Contrast List
IEC60601-2-37 Standard Parameters
Parameter
Note
Parameter
Note
pr.α
Attenuated Peak-rare-factional
Acoustic Pressure
fawf
Center Frequency, Acoustic Working
Frequency
pr
Peak-rare-factional Acoustic
Pressure
X
-12dB Output Beam Dimensions
P
Output Power
Y
zs
Depth for Soft Tissue Thermal
Index
td
Pulse Duration
Pα(Zs)
Attenuated Output Power
prr
Pulse Repetition Frequency
(Pulse Repetition Rate)
Ita.α(Zs)
Attenuated Temporal-average
Intensity
deq
Equivalent Beam Diameter
zbp
Break-point Depth
Ipi.α at max
MI
Attenuated Pulse-average Intensity at
the point of Maximum MI
zb
Depth for Bone Thermal Index
Aaprt
-12dB Output BeamArea
Ipi.α
Attenuated Pulse-intensity
Integral
MI
Mechanical Index
Ipi
Pulse-intensity Integral
TIS
Soft Tissue Thermal Index
deq(Zb)
Equivalent Beam Diameter at
the point of Zsp
TIB
Bone Thermal Index
TIC
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.
Emission test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
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.
RF emission
CISPR 11
Class B
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.
Harmonic emissions
IEC/EN61000-3-2
Not applicable
Voltage fluctuations
/flicker emissions
IEC/EN61000-3-3
Not applicable
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.
Immunity test
IEC 60601 test level
Compliance
level
Electromagnetic
environment-guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
8kV contact
15kV air
8kV contact
15kV air
Floors should be wood,
concrete or ceramic tile. If
floor are covered with
synthetic material, the
relative humidity should be
at least 30%.
Electrical Fast
Transient/Burst
IEC/EN61000-4-4
±2kV for power supply lines
±1kV for input/output lines
Not applicable
Not applicable
Surge
IEC/EN61000-4-5
±1 kV line(s) to line(s)
±2 kV line(s) to earth
Not applicable
Not applicable
Voltage dips, short
interruptions, and
voltage variations
on power supply
input lines
IEC/EN61000-4-11
<5%UT(>95% dip inUT)
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
Not applicable
Not applicable
Power frequency
(50Hz/60Hz)
magnetic field
IEC61000-4-8
30 A/m
30 A/m
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.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic environment-guidance
Conducted RF
IEC61000-4-6
Radiated RF
IEC61000-4-3
3 Vrms
150 kHz ~ 80
MHz
6Vrmsc)in ISM
bands between
0,15 MHz
and80 MHz
10V/m
80 MHz ~ 2.7
GHz
Not Applicable
10 V/m
80 MHz to 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:
d = 0.35 P
80 MHz to 800 MHz
d = 0.7 P
800 MHz to 2.7 GHz
E/6 Pd 
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 Pis the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and dis 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.
aField 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.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
cThe 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
Test
Frequency
(MHz)
Brand a)
(MHz)
Service a)
Modulation
b)
Maximum
Power(W)
Distance
(m)
IMMUNITY
TEST
LEVEL
(V/m)
385
380-390
TETRA 400
Pulse
modulationb)
18Hz
1.8
0.3
27
450
430-470
GMRS 460,
FRS 460
FM C)
±5 kHz
deviation
1kHz sine
2
0.3
28
710
704-787
LTE Brand 13,
17
Pulse
modulationb)
217 Hz
0.2
0.3
9
745
780
810
800-960
GSM
800/900,TETRA
800,iDEN 820,
CDMA850,
LTE Band 5
Pulse
modulationb)
18 Hz
2
0.3
28
870
930
1720
1700-1990
GSM 1800;
CDMA1900;
GSM 1900;
DECT; LTE
Band 1, 3,
4,25;UMTS
Pulse
modulationb)
217 Hz
2
0.3
28
1845
1970
2450
2400-2570
Bluetooth,
WLAN,802.11
b/g/n, RFID
2450, LTE
Brand 7
Pulse
modulationb)
217 Hz
2
0.3
28
5240
5100-5800
WLAN 802.11
a/n
Pulse
modulationb)
217 Hz
0.2
0.3
9
5500
5785
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
(W)
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
Pd 2.1
80 MHz to 800 MHz
d = 0.35 P
800 MHz to
2.7GHz
d = 0.7 P
0.01
/
0.035
0.07
0.1
/
0.11
0.22
1
/
0.35
0.7
10
/
1.11
2.21
100
/
3.5
7
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
D
d
A
B
VS
Vn
C
S
∑Ba
Bw
B
1.58
3MHz
50
40.9
T
5#4#
0
77.0
140
75
5.42
123.32
Ba
77.0
75
44.4
T
5#3#
0
68.4
80
40
6.02
118.82
Ba
68.4
100
46.9
T
5#3#
0
69.6
180
90
6.02
122.52
Ba
69.6
200
52.9
T
5#3#
0
68.4
83
42
5.92
127.22
Ba
75.1
2.38
3MHz
50
39.0
T
5#4#
0
77.0
130
69
5.50
121.50
Ba
77.0
75
42.5
T
5#4#
0
77.0
115
55
6.41
125.91
Ba
77.0
100
45.0
T
5#3#
0
68.4
130
65
6.02
119.42
Ba
68.4
200
51.0
T
5#4#
0
77.0
78
43
5.17
133.17
Ba
75.1
Doppler Frequency (Hz)
505
Velocity of Target
(cm/s)
10
Note
D: Diameter of Target
Reflector(mm)
A: Attenuation A(dB))
S：Overall Sensitivity (S=A+B+C)dB
d: Distance (d)(mm)
VS: Signal RMS (mV)
C:Signal to Noise Ratio (dB)
 
 








... ... log20 10 smrV smrV C
n
s
B:Two-wayAttenuation(dB)
B=∑Ba+Bw
Vn: Noise RMS (mV)
Troubleshooting
Problem
Possible Cause
Solution
Fail to power on, or
shut down shortly after
switching on
Battery level is very low.
Replace the battery.
Battery is not installed properly.
Re-install the battery.
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.
EDAN INSTRUMENTS, INC.
Address: #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, PingshanDistric, 518122
Shenzhen, P.R. China
Email: [e-mail]
Tel: [phone]
Fax: [phone]
www.edan.com.cn
EC REPRESENTATIVE
Shanghai International Holding Corp. GmbH
Eiffestrasse 80, 20537 Hamburg Germany
Tel. : [phone]
E-mail: [e-mail]
Definition of Symbols
No.
Symbol
Definition
No.
Symbol
Definition
1
CE marking
10
Authorized
Representative in the
European Community
2
Disposal method
11
General symbol for
recovery/recyclable
3
Operating
instructions
12
Refer to User Manual
(Background: Blue;
Symbol: White)
4
Caution
13
MR Unsafe–Keep
away from magnetic
resonance imaging
(MRI) equipment
5
Type BF applied
part
14
Non-ionizing
electromagnetic
radiation
6
Part Number
15
IP22 Protected against
solid foreign objects of
12,5 mm ∅and
greater ，Protection
against vertically
falling water drops
when ENCLOSURE
tilted up to 15°
7
Serial Number
(Start with H on
battery
compartment
cover)
16
Federal (U.S.) law
restricts this device to
sale by or on the order
of a physician.
8
Date of
Manufacture
17
FCC ID:
SMQSD1MEDAN
Federal
Communications
Commission: FCC ID:
SMQSD1MEDAN
9
Manufacturer