EDAN SD5 User manual

I
About this Manual
P/N: 01.54.110755-13
Release Date: July 2012
© Copyright EDAN INSTRUMENTS, INC. 2009-2012. All rights reserved.
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 EDAN
INSTRUMENTS, INC. (hereinafter called EDAN) can not be held liable.
EDAN owns the copyrights of this manual. Without prior written consent of EDAN, 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 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.
Upon request, EDAN may provide, with compensation, necessary circuit diagrams, and other
information to help qualified technician to maintain and repair some parts, which EDAN may
define as user serviceable.
Terms Used in this Manual
This guide is designed to give key concepts on safety precautions.
WARNING
A WARNING label advises against certain actions or situations that could result in personal
injury or death.

II
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.

III
Table of Contents
Chapter 1 Safety Guide .................................................................................................................1
1.1 Safety Precautions...............................................................................................................1
1.2 Symbols...............................................................................................................................2
Chapter 2 Introduction..................................................................................................................4
2.1 Intended Use........................................................................................................................4
2.2 Major Parts..........................................................................................................................4
2.2.1 Main Unit ..................................................................................................................4
2.2.2 Probes........................................................................................................................6
2.2.3 Control Keys .............................................................................................................7
2.2.4 Indicators...................................................................................................................8
2.2.5 LCD...........................................................................................................................8
Chapter 3 Basic Operation..........................................................................................................10
3.1 Opening Package and Checking........................................................................................10
3.2 Using Batteries..................................................................................................................10
3.2.1 Fitting Main Unit Battery........................................................................................10
3.2.2 Fitting Wireless Probe Battery................................................................................12
3.2.3 Charging Main Unit Battery....................................................................................13
3.2.4 Charging Wireless Probe Battery............................................................................13
3.2.5 Care of Batteries......................................................................................................14
3.3 Connecting the Power Cable.............................................................................................14
3.4 Using Wired Probe............................................................................................................14
3.4.1 Probe Socket............................................................................................................14
3.4.2 Connecting and Disconnecting a Wired Probe .......................................................15
3.5 Switching On.....................................................................................................................15
3.6 Switching Off....................................................................................................................16
3.7 Using Earphone.................................................................................................................17
3.8 Using Security Lock..........................................................................................................17
3.9 Changing Doppler Settings ...............................................................................................19
3.9.1 Switching Backlight On and Off.............................................................................19
3.9.2 Switching Key Sound On and Off ..........................................................................19
3.9.3 Setting Auto-Shut-Off Time ...................................................................................19
3.9.4 Choosing Language.................................................................................................19
3.9.5 Setting Date and Time.............................................................................................19
3.9.6 Setting Date Format ................................................................................................20
3.10 Replacing Fuses ..............................................................................................................20
Chapter 4 Examining...................................................................................................................21
4.1 FHR Examining ................................................................................................................21

IV
4.2 Vascular Examining..........................................................................................................22
Chapter 5 Recording and Playing ..............................................................................................24
Chapter 6 Maintenance and Cleaning........................................................................................25
6.1 Inspection ..........................................................................................................................25
6.2 Maintenance ......................................................................................................................25
6.3 Cleaning ............................................................................................................................26
6.4 Disinfection.......................................................................................................................26
Chapter 7 Warranty and Service................................................................................................27
7.1 Warranty............................................................................................................................27
7.2 Contact information ..........................................................................................................27
Chapter 8 Product Specifications ...............................................................................................28
8.1 Environmental Specifications ...........................................................................................28
8.2 Physical Specifications......................................................................................................28
8.3 Performance Specifications...............................................................................................29
8.4 Battery Specifications .......................................................................................................30
8.5 Low Output Summary Table.............................................................................................31
Appendix 1 Ordering Information .............................................................................................32
Appendix 2 EMC Information – Guidance and Manufacture’s Declaration.........................33
A2.1 Electromagnetic Emissions- For all EQUIPMENT and SYSTEMS .............................33
A2.2 Electromagnetic Immunity – for all EQUIPMENT and SYSTEMS .............................34
A2.3 Electromagnetic Immunity – for EQUIPMENT and SYSTEMS that are not
LIFE-SUPPORTING ..............................................................................................................35
A2.4 Recommended separation distances between portable and mobile RF communication
equipment and the EQUIPMENT or SYSTEM- For EQUIPMENT or SYSTEM that are not
LIFE-SUPPORTING ..............................................................................................................36
Appendix 3 Overall Sensitivity ...................................................................................................37
A3.1 Overall Sensitivity of SD5 (2MHz Wired Probe) ..........................................................37
A3.2 Overall Sensitivity of SD5 (3MHz Wired Probe) ..........................................................38
A3.3 Overall Sensitivity of SD6 (2MHz Wireless Probe) ......................................................39
A3.4 Overall Sensitivity of SD6 (3MHz Wireless Probe) ......................................................40

SD5/SD6 Ultrasonic TableTop Doppler User Manual Safety Guide
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Chapter 1 Safety Guide
NOTE:
Familiarize yourself with this user manual before attempting to operate the Doppler.
Follow the operation and maintenance instructions to ensure proper use of it.
1.1 Safety Precautions
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 This device is not explosion-proof and can not be used in the presence of flammable
anaesthetics.
2 SD5/SD6 Ultrasonic TableTop Doppler is a tool to aid healthcare professionals and
should not be used in place of normal fetal monitoring.
3 This device is not intended for treatment.
4 Do not apply this device and other ultrasonic equipment simultaneously on a same
patient, in case of possible hazard caused by leakage current superposition.
5 Do not touch accessible parts of non-medical electrical equipment and the patient
simultaneously.
6 Do not apply this device simultaneously with other PATIENT-connected equipment,
such as, a cardiac pacemaker or other electrical stimulators, on a same patient.
7 The device is not protected against defibrillation. Do not use it with HF surgical
equipment.
CAUTION
1 Federal (U.S.) law restricts this device to sale by or on the order of a physician.
2 Refer servicing to qualified service personnel.
3 The main unit is designed for continuous operation and is ‘ordinary’. It is not
waterproof; do not immerse it in any liquid (i.e. not drip or splash-proof).
4 Keep the device clean. Avoid vibration.
5 Apply the SD5/SD6 in an environment with a temperature between +5 ºC (+41 ºF)
and +40 ºC (+104 ºF).
6 Electromagnetic Interference - Ensure that the environment in which the device is
operated is not subject to any source of strong electromagnetic interference, such
as radio transmitters, mobile telephones, etc..

SD5/SD6 Ultrasonic TableTop Doppler User Manual Safety Guide
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CAUTION
7 Check that the equipment does not have visible evidence of damage that may affect
personnel’s safety or examining capability before use. If damage is detected,
replacement is recommended.
8 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. At the end of their life hand
the batteries over to the applicable collection points for the recycling of waste
batteries. For more detailed information about recycling of this product or battery,
please contact your local Civic Office, or the shop where you purchased the product.
1.2 Symbols
Headphones
Equipotentiality
Alternating Current
Fuse
“ON”/“OFF” for a part of equipment
Menu
Recording and play back
Graphical recorder
Move the cursor downwards
Move the cursor upwards
speaker
Minus
Plus
Charge battery
Push right

SD5/SD6 Ultrasonic TableTop Doppler User Manual Safety Guide
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Caution. Refer to accompanying documents.
Consult Instructions for Use
Type B applied part. This symbol indicates the unit is internally powered
equipment, and the degree of protection against electrical shock is type B.
The symbol indicates that the device complies with the European Council
Directive 93/42/EEC concerning medical devices.
The symbol indicates that the device should be sent to the special agencies
according to local regulations for separate collection after its useful life.
IPX4 The device is protected against splashing water. Water splashed against the
enclosure from any direction shall have no harmful effects.
Part Number
Serial Number
Date Of Manufacture
Manufacturer
Authorized Representative in the European Community
General symbol for recovery/recyclable
Rx only (U.S.) Federal (U.S.) Law restricts this device to sale by or on the order of a
physician

SD5/SD6 Ultrasonic TableTop Doppler User Manual Introduction
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Chapter 2 Introduction
2.1 Intended Use
The SD5 Ultrasonic TableTop Doppler (hereinafter called “SD5”) and SD6 Ultrasonic TableTop
Doppler (hereinafter called “SD6”) are intended to be used by health care professionals including
registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by
prescription from licensed physicians in hospitals, clinics and private offices.
The 2 MHz and/or 3 MHz obstetrical probes are indicated for the detection of fetal heart rate
from early gestation thru delivery and as a general indication of fetal well being. They can also be
used to verify fetal heart viability following patient trauma.
The 4 MHz, 5 MHz and/or 8 MHz vascular probes are indicated for the detection of blood flow in
veins and arteries for assisting in the detection of peripheral vascular disease.
2.2 Major Parts
2.2.1 Main Unit
SD5:
SD6:
Figure 2-1 Overview
1 Probe
2 Probe Cable
3 Main Unit
4 LCD
5 Speakers
6 Probe Socket
7 Infrared Receivers
1
2
3
4
5
6
5
3
4
5
7
5
1

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Figure 2-2 Top View of the Main Unit
Figure 2-3 Main Unit Control Keys
Figure 2-4 Back View of the Main Unit
Figure 2-5 Right View of the Main Unit
9
10
11
8 Probe Holder
9 Handle
10 Probe Sensor Socket
11 Main Unit Control Keys
19
18
17
22
20
21
17 Fuses
18 Power Socket
19 Equipotential Grounding
Terminal
20 Main Unit Label
21 Security Slot
22 Earphone Socket
23 Battery Compartment
23
12 13 14 15 16
8
12 Main Unit Indicator
13 On/OFF Key
14 Setup Key / Confirm Key
15 Up Key /
Record/Play Control Key
16 Down Key /
Print Control Key

SD5/SD6 Ultrasonic TableTop Doppler User Manual Introduction
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NOTE:
The main unit is not waterproof. Do not immerse it in any type of liquid.
2.2.2 Probes
Wireless Probe:
Wired Probe:
Figure 2-6 Top View of the Probe
Figure 2-7 Probe Control Keys
Figure 2-8 Bottom View of the Probe
1 Acoustic Face
2 Probe Control Keys
3 Infrared Sender
4 Probe Socket
5 Probe Cable
2 3
1
6 7 8 9
10 Probe Type Label
11 Probe Battery Compartment
12 Probe Charge Socket
10 11 12
5
4
1
2
6 Volume Decreasing Key
7 Volume Increasing Key
8 ON/Off Key (only available
on wireless probe)
9 Probe Indicator

SD5/SD6 Ultrasonic TableTop Doppler User Manual Introduction
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Description:
The Doppler supports 2MHz, 3MHz, 4MHz, 5MHz and 8MHz probes supplied by the
manufacturer. The probe nominal frequency is disclosed on the probe type label.
Probes of SD5 are wired, while probes of SD6 are wireless.
WARNING
1 Do not touch the charge sockets of the Wireless Doppler probe and the patient at the
same time.
2 Do not immerse the probes or the probe cable in any liquid.
CAUTION
Do not stretch the probe cable for more than three meters.
2.2.3 Control Keys
Control keys are provided to switch on or off the device, perform the functions and change the
settings.
A beep sound will be heard when you press a key of the main unit. Or you can switch off the
sound. Refer to section 3.9.2 Switching the Key Sound On and Off for operation procedures.
(1) ON/OFF key
Function: Switch on/off the main unit or the probe.
(2) Up Key / Record/Play Control Key
Function: Move the cursor upwards / to the previous item (in the setting mode).
Recording and playing control (in the real-time examining mode).
(3) Down Key / Print Control Key
Function: Move the cursor downwards / to the next item (in the setting mode).
Printingcontrol(reserved).
(4) Setup Key / Confirm Key
Function: Enter setup menu (in the real-time examining mode).
Confirm selection (in the setting mode).
(5) Volume Control Keys
Function: Decrease the FHR volume ( ). Increase the FHR volume ( ).

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2.2.4 Indicators
(1) Main unit indicator
The indicator of the main unit indicates the connection status of the main unit and AC power:
The indicator lights up in green – the AC power is connected.
The indicator flashes in green – the main unit is charging the main unit battery.
The indicator goes off – the AC power is not connected.
(2) Probe indicator
The indicator of the probe indicates the status of the probe:
The indicator lights up in green – the probe is switched on.
The indicator flashes in yellow when the volume control key is pressed – the volume has
been decreased/increased to its minimum/maximum.
The indicator lights up continuously in yellow – the probe battery is low.
The indicator flashes in green – the probe battery is being charged.
2.2.5 LCD
The Doppler has four modes: examining mode, recording mode, playing mode and setting mode.
In the former three modes, the LCD displays as follows:
Item Description
1 Battery Indicator
The battery is installed and the battery energy is full.
The main unit battery is low.
The main unit battery is not installed.
2 Recording Indicator: The Doppler is recording fetal heart sound. (Only in the recording
mode)
3 Playing Indicator: The Doppler is playing the recorded fetal heart sound. (Only in the
playing mode)
4 AC Indicator AC power is connected.
1
2
3
4
5
6
7
8
9

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Infrared Indicator
(Only available with
SD6)
Infrared signal is received.
Infrared signal is not received, indicating that poor quality
signal is received.
5
Probe Indicator
(Only available with
SD5)
The probe is well connected.
The probe is not connected.
6, 7 Date and Time
8 Heart Beat Indicator: When fetal heart signal is received, the heart shape flashes to
indicate the FHR refreshing frequency.
9 FHR numeric measurement value
In the setting mode, the LCD displays as the right figure
shows.
The rectangular mark that moves up and down is called the
“cursor”. Press the Up key or the Down key to move it
back or forth.

SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation
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Chapter 3 Basic Operation
3.1 Opening Package and Checking
Open the package; take out the Doppler and accessories carefully. Place them on a flat, clean
surface.
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.
3.2 Using Batteries
CAUTION
The fitting of the batteries should be carried out by the manufacturer authorized
personnel. Do not remove them afterwards.
3.2.1 Fitting Main Unit Battery
The main unit is powered either by alternating current or a Ni-MH battery.
It is recommended to power the main unit solo by a battery during operation. Therefore, charge
the battery fully before use to ensure enough power. Connecting to mains power supply will
charge the battery no matter if the main unit is on or off.
WARNING
Switch off the Doppler and remove the power cord before fitting the main unit battery.
To fit the battery for the main unit:
1 Follow the arrow direction to open the battery compartment cover. The battery connecting
cable & connector and the metal insert show up.

SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation
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2 Tilt the battery sideways and put its bottom left corner into the battery compartment from the
left end of the compartment to the right. Make sure connector ①stays out of the compartment.
3 Keep pushing the battery into the compartment until the metal insert springs back to lock the
battery.
Battery Connecting
Cable & Connector
Metal Insert
Battery Connector ①
Battery Connector ②

SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation
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4 Connect the two connectors (①&②) and then put them into the compartment.
5 Close the battery compartment cover.
3.2.2 Fitting Wireless Probe Battery
The wireless probe is powered by a lithium battery.
To fit the battery for the probe:
1 Remove the screw on the battery compartment cover with a screw driver and then take the
cover away with your hand.

SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation
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2 Fit the battery. Make sure the polarities correspond with the battery compartment diagram.
3 Close the battery compartment cover and fix it with the screw.
3.2.3 Charging Main Unit Battery
Observe the battery indicator on the LCD, the panes in it indicate the main unit battery electric
energy. They go off gradually with the consumption of the battery. When the battery indicator
turns into “ ”, the battery power is low. You need to switch to outer AC power and charge the
battery in time.
To charge the main unit battery, you need to connect the Doppler to 100V-240V~ power supply.
Connecting the main unit to power supply for approximately 3 hours will charge the battery fully,
no matter if it is on or off. During this period, the main unit indicator flashes in green, and the
panes in the battery indicator increase gradually. When the battery is fully charged, the indicator
has four panes.
3.2.4 Charging Wireless Probe Battery
When the wireless probe battery is low, the probe power indicator turns into yellow. You need to
switch off the probe and charge the battery in time.
To charge the probe battery, you need to place the probe in the probe holder. Connecting the
main unit to alternating current is recommended.
It takes 4 to 5 hours to fully charge the probe battery. During this period, both the main unit
indicator and the probe indicator will flash in green.

SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation
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3.2.5 Care of Batteries
WARNING
1 Replacement of batteries shall be done at least 1.5 meters away from the patient.
2 Close the battery compartment before using the main unit or the probe.
3 Charge the battery with specified charger only.
4 Do not expose the batteries to high temperatures, heat them or dispose of them in
fire.
5 Do not disassemble the batteries.
6 Short circuit should be avoided.
CAUTION
1 Keep the batteries in a cool and dry environment. The environment temperature
must not exceed the range of -20°C ~ +40°C (-4°F ~ +104°F).
2 If the Doppler is not used for an extended period, charge the batteries at least once
a month.
3 The batteries must be properly disposed according to local regulations after their
useful life.
3.3 Connecting the Power Cable
Apply the power cable provided with the Doppler. Put the connector of the power cord to the
power socket on the Doppler (figure 2-4). Put the plug of the power cord into a grounded 3-slot
power output special for hospital usage.
NOTE:
Make sure the AC power supply of the Doppler complies with the following specification:
100V-240V~, 50Hz/60Hz.
WARNING
If the protective grounding (protective earth) system is doubtful, the power of the
Doppler must be supplied only by inner power.
3.4 Using Wired Probe
3.4.1 Probe Socket
SD5 adopts wired probes. The probe cable is a telephone cable with a standard RJ11 plug on each
terminal.

SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation
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RJ11 Interface:
3.4.2 Connecting and Disconnecting a Wired Probe
To connect the wired probe to the main unit,
1 Take out the probe cable from package. Insert one modular plug of the cable into the probe
socket of the main unit.
2 Insert the other modular plug into the probe socket of the probe.
To disconnect the probe, press the housing of the modular plug and then pull it out.
3.5 Switching On
WARNING
Make sure all the metal parts are linked to the protective earth cord and the power cord
is free of defect before switching on the main unit.
Modular Plug
Housing
1 Power VCC +5V
2 GND
3 Signal Wire
4 Signal Wire