EDAN INSTRUMENTS INC. SD1MEDAN 用户手册
SD1 Ultrasonic Pocket Doppler User Manual
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
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
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,
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.
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.
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.
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.
should be observed at all time.
7 Do not use the device with HF surgical equipmentand do not use it in
an MRI environment.
WARNING
8 The device is not protected against defibrillation.
9 SHOCK HAZARD - Do not attempt to replace batteries with wet
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.
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.
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.
Distances.
15 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 monitoring and display
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
Appearance(Above pictures are just for reference)
LCD Display& Touch Keys
Item
Description
1
Fetal
heart
icon
heart
icon
Indicates fetal heart beat and flickers to the
fetal heart beat.
2
Fetal
heart
signal
intensity
indicator
heart
signal
intensity
indicator
This indicator displays on the
left side of the screen and has
three
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.
medium and high fetal heart
signal intensity.
3
FHR
numeric
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 ―---‖.
within the range from 50 bpm
to 240 bpm. When fetal heart
rate is out of the range, it
displays ―---‖.
Sound
volume
numeric
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.
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
indicator
Battery indicatordisplays
on the right side of the
screen.
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
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.
needs replacing.
5
Sound
volume
increase
touch
key
volume
increase
touch
key
Touch the keyfor a little while to increase
sound volume.
6
Sound
volume
decrease
touch
key
volume
decrease
touch
key
Touch the key for a little while to decrease
sound volume.
7
On/Off
touch
key
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.
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
ChapterSafety Precautions before operation; follow the steps when
connecting all the components.
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.
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
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.
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
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.
indicated by the anode and cathode marks.
c) Install the compartment cover and secure it with the screw.
Ultrasonic Transducer Head
LCD Screen
Touch Keys
Loudspeaker
Screw
Battery Compartment Cover