EDAN SD2 User Manual

SD2 Ultrasonic Pocket Doppler User Manual
About this Manual
P/N: 01.54.459245
MPN: 01.54.459245010
Release Date:Mar. 2022
© Copyright EDAN INSTRUMENTS, INC. 2022. All rights reserved.
Statement
This manualwill 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 Edan Instruments, Inc. (hereinafter called
EDAN)cannot be held liable.
EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any materials
contained inthis manual shall not be photocopied, reproduced or translated intoother languages.
Materialsprotected by the copyright law, including but not limited to confidential information such as
technical information and patent informationare 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 intellectualproperties of EDAN.
EDAN holds the rights to modify, update, and ultimately explain this manual.
Responsibility of the Manufacturer
EDAN 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 EDAN, and
The electrical installation of the relevant room complies with national standards, and
The instrument is used in accordance with the instructions for use.
EDAN 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 EDAN as repairable by service personnel.
Product Information
Product Name:Ultrasonic Pocket Doppler
Model:SD2, SD2Pro, SD2 Plus, SD2 Lite, SD2 Basic
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 CAUTIONlabel 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 and patients on the order of a physician.
2 Before the SD2 is prescribed for home use, the user (patient) must be instructed/trained in
proper use of the equipment.
3 Home fetal heart rate detection has not been shown to prevent the onset of preterm labor nor
will it prevent the occurrence of preterm birth.
4 The Doppler is a tool to aid the user in hospitals, clinics or at home and should not be used in
place of normal fetal detection. It is not intended for treatment or use during labor and delivery.
5 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.
6 This device is not explosion-proof and cannot be used in the presence of flammable
anesthetics.
7 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.
8 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.
9 Do not use the device with HF surgical equipmentand do not use it in an MRI environment.
10 The device is not protected against defibrillation.
11 SHOCK HAZARD - Do not attempt to replace batteriesor connect or disconnect a power cord
with wet hands.
12 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.
13 Please ensure the light of SpO2 sensor is fully covered by the finger pulp. Please check the
application site every 0.5 to 1 hour. If the skin quality changes, please change another site
14 The medical electrical equipment needs to be installed and put into service according to the
EMC Information provided in this user manual.
15 Portable and mobile RF communications equipment can affect medical electrical equipment;
refer to section Recommended Separation Distances.
16 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 Only use SpO2 sensor approved by the manufacturer. Using other SpO2 sensors may
compromise device functionality.
5 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.
6 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. Refer to IEC61429 for standard disposal
when necessary.Do NOT dispose them together with house-hold garbage.
7 The loss of pulse signal may occur when the patient has poor peripheral perfusion, and the
screen will display "---". When there's measurement beyond range, invalid measurement or no
measurement value, it will display "---".
⚫ Introduction
Intended Use/Indications for Use
The SD2 detects fetal heart rate (FHR), maternal oxygen saturation (SpO2) and pulse rate (PR) for
pregnant women. The product is only intended for use in hospitals, clinics or at home by health care
professionals with relevant expertise and pregnant women who have been trained (by studying
instructional videos or product manuals) or have received professional guidance.
Features
You may not have all of these features, depending on the model purchased.
Model
SD2 SD2 Pro SD2 Plus
Function
√ √ √
Curve Display
√ √ √
FHR
√ √ √
PR
√
SpO2 O O
√ √
Bluetooth +APP O
√ √ √
Variable Frequency
√ √ √
AA Alkaline Batteries
Charging Function O O O
NOTE: √ = Standard O = Optional ╳ = Not Available
Interface：
There are three display modes. Double click the power touch key to switch the display modes. The
displayed results of SpO and PR are updatedevery second.
2
Numeric Display Interface FHR Curve Display Interface
Appearance（Above pictures are just for reference）
Power Touch Key
Loudspeaker
Power Touch Key
Battery
Volume Key
SpO2 Compartment
Sensor
Ultrasonic Transducer Head
Item Description
Indicates fetal heart beat and flickers to the fetal heart beat.
1 Fetal heart icon
2 Perfusion bar Indicates pulse beat
Displays fetal heart rate within the range from 30
FHR numeric
bpm to 240 bpm.
Displays pulse rate within the range from 30 bpm to
2
PR numeric
240 bpm
SpO2 numeric Displays SpO2 within the range from 70% to 100%
Volume
numeric
Battery
3
indicator
Fetal heart
4 signal quality
indicator
Volume
5 increase touch
key
Volume
6 decrease touch
key
Ultrasound
7
frequency
Power touch
8
key
⚫ Basic Operation
NOTE:
To ensure that the Doppler works properly, please read this chapter and ChapterSafety 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) 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.
Recommended Battery Type:
AA Alkaline battery（AA，LR6，1.5 V） ；AA Rechargeable NI-MH battery（AA, Ni-MH, 1.2 V）
Charging the NI-MH Batteries
When battery level is low,take the batteries out from the main unit, and charge them with a NI-MH battery
charger. The specifications of the provided battery charger are as below. You can also purchase a battery
charger that meets the following specifications:
Output：1.2V-500mA*4AA 500mA*2AAA
NOTE:
Ifrechargeable NI-MH battery is configured,
1 Please fully charge the battery after each use of the Doppler to ensure sufficient power during
subsequent use.
2 Please charge the battery after each transportation or storage.
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. SeeProduct Specificationsfor details about battery specifications.
3 If the batteries have been inserted incorrectly, the Doppler will not function or it will be
damaged.
4 Keep battery away from children. If swallowed, consult a physician at once.
5 Do not disassemble or short-circuit batteries.
6 Do not recharge alkaline batteries.
7 Do not dispose of batteries in fire or water.
8 Do not mix with used or other battery type (such as alkaline with carbon zinc).
9 Do not solder the batteries directly.
10 Do not over-discharge batteries.
11 Do not allow metal objects to contact the battery terminals.
12 To install or remove batteries, follow the equipment manufacturer's instructions.
13 Remove the battery and store it at a cool and dry environment if the Doppler is not used for a
long time.Do not keep batteries at temperature of 45°C or above, or at humidity of 75% or
above. For rechargeable NI-MH batteries, please charge them at least once every 3 months.
14 If rechargeable batteries are used, charge them fully before initial use by using the method
introduced in this manual.
15 The rechargeable NI-MH batteries should be charged by using the qualified dedicated
adapterthat conforms to requirements of IEC 60601-1.
16 If the time that the Doppler using rechargeable NI-MH batteries becomes much shorter than
usual, the battery life is at an end. Replace the batterieswith new ones.
Switching On
Touch the power touch key for about 1second when the Doppler is off, and the Doppler will display the
switching on interface
Switching Off
Touch the power 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 1minute, the Doppler will be switched off
automatically.
⚫ FHR Detection
SD2 is designed to detect the fetal heartbeat from the 10th week of gestation.
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.
Palpate the patient's abdomen gently to confirm the fetus's position.
c)
Place the Doppler on the patient's abdomen, and move it around the fetus's position
d)
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.
➢ At the end of the 12-week gestation, the uterus fundus is about 2-3 fingers' breadth (about 3-4.5
cm) above the symphysis pubis.
➢ At the end of the 16-week gestation, the uterus fundus is in the middle between the navel and
the symphysis pubis.
➢ At the end of the 20-week gestation, the uterus fundus is about 1 finger's breadth (about 1.5 cm)
SD2 Lite SD2 Basic
below the navel.
➢ At the end of the 24-week gestation, the uterus fundus is about 1 finger's breadth (about 1.5 cm)
above the navel.
O O ➢ At the end of the 28-week gestation, the uterus fundus is about 3 fingers' breadth (about 4.5 cm)
√ √
above the navel.
➢ At the end of the 32-week gestation, the uterus fundus is in the middle between the navel and
╳ √
the xiphisternum.
╳
O
➢ At the end of the 36-week gestation, the uterus fundus is about 2 fingers' breadth (about 3 cm)
╳
O
below the xiphisternum.
√ √
√ √
O O
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 probablyat the left sideand 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
SpO2 Wave Display Interface
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".
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 in 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 Whether the fetal heart sound can be obtained or not is related to the skill and qualification of
the operator.
6 If the fetal heart sound cannot be found for a long time, it is necessary make use of other
equipment.
7 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).
⚫ SOV Prompt
When detecting fetal heart rate, there are possibilities that maternal HR signal is mistaken for FHR signal.
The SOV function can reduce these possibilities.Detect FHR and PR at the same time. When FHR and
PR signals overlap, SD2 will issue a sound. At this time, examine the patient or reposition the probe until
Volume numeric is displayed in the center of the
screen, and ranges from level 0 to 7.
Displayed on the bottom left corner of the
screen and there are five degrees. When the
battery indicator is empty and keeps
flickering, it indicates that the battery level is
extremely low and battery needs to be
replaced or charged.
Displayed on the bottom right corner of the
screen and there are three
representing poor, acceptable and good
signal quality.
Touch the key to decrease volume.
Touch the key to increase volume.
Indicates the current ultrasound frequency. Touch the
volume increase and decrease touch keys simultaneously to
2MHz,
switch the frequency.
3MHz
2 MHz：used for more than 12-week gestation
3 MHz：used for more than 9-week gestation
Touch this key for a little while to switch it on or off;
Battery Capacity：500mAh~3000mAh
WARNING
before switching to display the test interface.
The coupling gel should not exceed this limit.
This area can be immerged in coupling gel
CAUTION
fetal heart signal is found.
⚫ SpO2 Detection
SpO2 Plethysmogram measurement is employed to determine the oxygen saturation of hemoglobin in
the arterial blood. The SpO2 numeric shows the percentage of hemoglobin molecules which have
combined with oxygen molecules to form oxyhemoglobin. The SpO2/PLETH parameter can also provide
a pulse rate signal and a plethysmogram wave.
NOTE:
1 The device is calibrated to display functional oxygen saturation.
levels,
2 The monitor does not have specific SpO2 calibration baselines.
3 SpO2 waveform is not proportional to the pulse volume.
4 A Functional tester or simulator cannot be used to assess the SpO
be used to test the accuracy of a particular calibration curve duplicated by the device, and it
turns out the calibration curve meetsthe accuracy.
Inaccurate measurements can be caused but not limited by:
● Incorrect device application
● high levels of ambient light sources, such as surgical lights (especially those with a xenon light
source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight
● failure to cover the sensor with fingerin high levels of ambient light conditions
● dysfunctional hemoglobins
● low peripheral perfusion
●
excessive or violent patient movement
●
venous pulsations
● intravascular dyes, such as indocyanine green or methylene blue
● externally applied coloring agents (nail polish, dye, pigmented cream)
● defibrillation
●
placement of the device on an extremity with a blood pressure cuff, arterial catheter, or intravascular
line
● electromagnetic interference
● Low perfusion
Lossofpulse signal can occur for the following reasons:
● a blood pressure cuff is inflated on the same extremity as the one with the device attached
● there is arterial occlusion proximal to the device
● low peripheral perfusion
⚫ Assessing the Validity of a SpO2 Reading
You can check the quality of the pleth wave and the stability of the SpO2 values to assess whether the
sensor functions properly and whether the SpO2 readings are valid. Always use these two indications
simultaneously to assess the validity of a SpO2 reading.
NOTE:
1 The SpO accuracy has been validated in human studies against arterial blood sample
2
reference measured with a CO-oximeter. Pulse oximeter measurements are statistically
distributed, only about two-thirds of the measurements can be expected to fall within the
specified accuracy compared to CO-oximeter measurements. The volunteer population in the
studies composed of local healthy men and women from age 19 to 37, with variations of skin
pigmentations. The SpO accuracy is as follows: ±2% for 90%-100% and ±4% for 70%-90%.
2
2 The pulse rate accuracy is obtained by comparison to the pulse rate generated with an arterial
oxygen simulator (also an electronic pulse simulator).
3 Generally, the quality of the SpO2 pleth wave reflects the quality of the light signals obtained by
the sensor. A wave of poor quality manifests a decline of the signal validity. On the other hand,
the stability of the SpO2 values also reflects the signal quality. Different from varying SpO2
readings caused by physiological factors, unstable SpO2 readings are resulted from the sensor's
receiving signals with interference. The problems mentioned above may be caused by patient
movement, wrong sensor placement or sensor malfunction. To obtain valid SpO2 readings, try to
limit patient movement, check the placement of the sensor, measure another site or replace the
sensor.
⚫ SpO2 Detection
1. Hold the device with one hand and press the thumb on the SpO2 sensor continuously.
2. Movement is not recommended during measurement.
3. When the signals are stable, read corresponding data from screen.
NOTE:Avoid external light sources such as radiated rays or ultrared rays.
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)
SD2 can connect to mobile phones with its Bluetooth function (optional). The SD2 APP has both Android
and iOS versions.
iOS APP operating environment:
A) hardware environment
Processor: dual-core Apple A6
RAM: ≥2GB
B) software environment: iOS 13.5.1 and above
operating system
C)network environment: support Bluetooth
Scan either of the following QR codes to download the SD2APP, and install and run it as prompted.
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
iOS Version
Android Version
About sub-interface under the Settings interface of
the APP.
WARNING
This device 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.
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.
Radiation Exposure Statement
This device complies with RF radiation exposure limits set forth for an uncontrolled environment.
This transmitter must not be co-located or operating in conjunction with any other antenna or
transmitter.
NOTE:
1.This equipment (SD2) 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.
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
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 Dopplerafter 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 SD2 is battery.
The frequency of usage is 8 hours/day).
Cleaning
Before cleaning, switch off the Doppler.Clean the exterior surface of the Doppler with a soft,cleancloth
dampened withethanol (75%) or mild near neutral detergent thoroughly until no visible contaminants
remain. After cleaning, wipe off the cleaning solution with a fresh cloth or paper towel dampened with tap
water until no visible cleaning agent remains.Dry the monitor in a ventilated and cool place.
CAUTION
1 Do not use strong solvent, such as acetone.
2 Never use an abrasive such as steel wool or metal polish.
3 Do not remain any solution on the surface after cleaning.
Disinfection
Before disinfection, switch off the Doppler.
Wipe the exterior surface of the Doppler with a soft, clean cloth dampened with ethanol (75%) or mild
near neutral detergent.Wipe off the disinfectant solution with a dry cloth after disinfection if necessary.Dry
the Doppler for at least 30 minutes in a ventilated and cool place.
CAUTION
Do not immerse the Doppler into the disinfector or water.
⚫ Product Specifications
Product Information
Product Name Ultrasonic Pocket Doppler
Model
SD2、 SD2 Basic、 SD2 Lite、 SD2 Plus、 SD2 Pro
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 60601-1-11:2015, IEC 61266:1994
Classification
Anti-electric Shock Type:
Anti-electric Shock Degree:
Degree of Protection against Harmful Ingress of
Water:
Degree of Safety in Presenceof Flammable
Gases:
Working System:
EMC:
Physical Specifications
accuracy. However, it can
2
Android APP operating environment:
A) hardware environment
CPU: frequency≥1.0GHz
RAM: ≥4GB
B)software environment: Android 8.0 and above
operating system
C)network environment: support Bluetooth
Internally powered equipment
Type BF equipment
IP22 Protection against vertically falling water
drops when ENCLOSURE tilted up to 15°
Equipment not suitable for use in presence of
flammable gases
Continuous running equipment
CISPR 11 Group 1 Class B