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.
10 The 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.
11 The medical electrical equipment needs to be installed and put into service according to the EMC
Information provided in this user manual.
12 Portable and mobile RF communications equipment can affect medical electrical equipment; refer to
section Recommended Separation Distances.
13 Do 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
Switching off when no signal received for 2 Min
Sound volume adjustment
Bluetooth connection (Optional)
Appearance（Above pictures are just for reference）
LCD Display& Touch Keys
Indicates fetal heart beat and flickers to the fetal heart beat.
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.
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 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.
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.
Sound volume
increase touch
key
Touch the key for a little while to increase sound volume.
Sound volume
decrease touch
key
Touch the key for a little while to decrease sound volume.
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 AA alkaline batteries. Battery specification: LR6, AA, 1.5 V;
Note:
You can use AA alkaline 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:
Processor: dual-core Apple A6
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 SD1Care APP, and install and run it as prompted.
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.
Inspect the Doppler for any damage.
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
Ultrasonic Pocket Doppler
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:
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
Continuous running equipment
Physical Specifications
Length*Width* Height: (48±2) mm× (39±2) mm× (147±3) mm
◆Battery level
◆Signal intensity
Acoustic Impedance: 1.5x10
6
Pa.s/m ~1.7x10
6
Pa.s/m (35°C/95ºF )
Environment
Temperature:+5°C ~ +40°C ( +41ºF ~ +104ºF)
Humidity:15% RH ~ 95% RH(non-condensing)
Atmospheric Pressure:70kPa ~ 106 kPa
Ultrasonic Transducer Head
Battery Compartment Cover
The coupling gel should not
exceed this limit.
This area can
be immerged in
coupling gel
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