EDAN INSTRUMENTS SD1MEDAN User Manual

SD1 Ultrasonic Pocket Doppler User Manual

 FHR monitoring 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

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 indicatordisplays
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 keyfor 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.

Ultrasonic Transducer Head

LCD Screen

Touch Keys

Loudspeaker

Screw

Battery Compartment Cover

About this Manual

P/N: 01.54.457985
MPN: 01.54.457985010
Release Date: Apr. 2018
© Copyright EDAN INSTRUMENTS, INC. 2018. 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: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 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

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.

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 or at home and should not be used in place of normal fetal
monitoring. 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 equipmentand do not use it in

an MRI environment.

CAUTION

WARNING

8 The device is not protected against defibrillation.
9 SHOCK HAZARD - Do not attempt to replace batteries with wet

hands.

10 Do not connect any equipment or accessories that are not approved by

the manufacturer or that are not IEC 60601-1 approved to the device.
The operation or use of non-approved equipment or accessories with
the device is not tested or supported, and device operation and safety
are not guaranteed.

11 Using accessories other than those specified by the manufacturer may

result in increased electromagnetic emissions or decreased
electromagnetic immunity of the device.

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 The medical electrical equipment needs to be installed and put into

service according to the EMC Information provided in this user manual.

14 Portable and mobile RF communications equipment can affect medical

electrical equipment; refer to section Recommended Separation
Distances.

15 Do not service or maintain the device or any accessory which is in use

with a patient.

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.

WARNING

CAUTION

 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

Appearance（Above pictures are just for reference）

LCD Display& Touch Keys

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
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) 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.

1 Turn off the Doppler before removing or replacing the battery.

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

TBC

TBC

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.

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 Name

Ultrasonic Pocket Doppler

Model

SD1

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

Anti-electric Shock Type:

Internally powered equipment
Anti-electric Shock Degree:

Type BF equipment

Degree of Protection against
Harmful Ingress of Water:

IP22. Do not immerse it in water.
Degree of Safety in Presenceof

Equipment not suitable for use in

The coupling gel
should not exceed

this limit.

This area can
be immerged in
coupling gel

2 Replace alkaline batteries with those of identical specifications

provided by the manufacturer or purchased
locally.SeeChapterProduct Specificationsfor 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.

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.

WARNING

 FHR Monitoring

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 a ffect 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 Monitor 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.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 monitored 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
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 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 t he 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 on the best monitoring 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 monitoring, t he 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 pa tient‘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 Monitoring

1) Switch off the Doppler.

2) Wipe the remaining gel off the patient and the probe with a clean soft

cloth or tissue.

CAUTION

 Mobile Application Software (APP)

SD1 can connect to mobile phones with its Bluetooth function (optional).
The SD1 APP has both Android and iOS versions.

How to use SD1 Medical APP

1.Download and install software
Scan either of the following QR codes to download the SD1Medical APP,
and install and run it as prompted.

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 monitoring

When the monitoring 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 monitoring.

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 monitoring interface to watch the DEMO.
The word ‗DEMO‘ is displayed in the interface to distinguish from real
time detection.

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.

WARNING

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
correctthe 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 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 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.

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 theDoppler 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.

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.

CAUTION

CAUTION

 Product Specifications

Product Information

Complied Standards

Classification