EDAN INSTRUMENTS SD6PEDAN Ultrasonic TableTop Doppler Probe User Manual
EDAN INSTRUMENTS, INC. Ultrasonic TableTop Doppler Probe
User manual
I
About this Manual
P/N: 01.54.456994
MPN: 01.54.456994011
Release Date: Oct. 2015
© Copyright EDAN INSTRUMENTS, INC. 2015. 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
II
injury or death.
CAUTION
A CAUTION label advises against actions or situations that could damage equipment, produce
inaccurate data, or invalidate a procedure.
NOTE
A NOTE provides useful information regarding a function or a procedure.
III
Table of Contents
Chapter 1 Safety Guide ................................................................................................................. 1
1.1 Intended Use/Indications for Use ........................................................................................ 1
1.2 Safety Precautions ............................................................................................................... 1
1.3 Symbols ............................................................................................................................... 4
Chapter 2 Introduction .................................................................................................................. 6
2.1 Main Unit ............................................................................................................................ 6
2.2 Probes .................................................................................................................................. 8
2.3 Control Keys ....................................................................................................................... 9
2.4 Indicators ........................................................................................................................... 10
2.5 LCD ................................................................................................................................... 11
Chapter 3 Basic Operation .......................................................................................................... 13
3.1 Opening Package and Checking........................................................................................ 13
3.2 Using Batteries .................................................................................................................. 13
3.2.1 Fitting Main Unit Battery ........................................................................................ 13
3.2.2 Fitting Wireless Probe Battery ................................................................................ 15
3.2.3 Charging Main Unit Battery.................................................................................... 16
3.2.4 Charging Wireless Probe Battery ............................................................................ 16
3.2.5 Care of Batteries ...................................................................................................... 17
3.3 Connecting the Power Cable ............................................................................................. 17
3.4 Using Wired Probe ............................................................................................................ 17
3.4.1 Probe Socket ........................................................................................................... 17
3.4.2 Connecting and Disconnecting a Wired Probe ....................................................... 18
3.5 Switching On ..................................................................................................................... 18
3.6 Switching Off .................................................................................................................... 19
3.7 Using Earphone ................................................................................................................. 20
3.8 Changing Doppler Settings ............................................................................................... 20
3.8.1 Switching Backlight On and Off ............................................................................. 20
3.8.2 Switching Key Sound On and Off .......................................................................... 20
3.8.3 Setting Auto-Shut-Off Time ................................................................................... 21
3.8.4 Choosing Language ................................................................................................. 21
3.8.5 Setting Date and Time ............................................................................................. 21
3.8.6 Setting Date Format ................................................................................................ 21
3.9 Replacing Fuses ................................................................................................................ 22
Chapter 4 FHR Examining ......................................................................................................... 23
Chapter 5 Recording and Playing .............................................................................................. 25
Chapter 6 Maintenance and Cleaning ....................................................................................... 26
IV
6.1 Inspection .......................................................................................................................... 26
6.2 Maintenance ...................................................................................................................... 26
6.3 Cleaning ............................................................................................................................ 27
6.4 Disinfection ....................................................................................................................... 27
6.5 Sterilization ....................................................................................................................... 28
Chapter 7 Warranty and Service ............................................................................................... 29
7.1 Warranty ............................................................................................................................ 29
7.2 Contact information .......................................................................................................... 29
Chapter 8 Product Specifications ............................................................................................... 30
8.1 Environmental Specifications ........................................................................................... 30
8.2 Physical Specifications ..................................................................................................... 30
8.3 Performance Specifications ............................................................................................... 31
8.4 Battery Specifications ....................................................................................................... 32
8.5 Low Output Summary Table ............................................................................................. 33
Appendix 1 Ordering Information ............................................................................................. 34
Appendix 2 EMC Information .................................................................................................... 35
A2.1 Electromagnetic Emissions ............................................................................................ 35
A2.2 Electromagnetic Immunity ............................................................................................. 36
A2.3 Electromagnetic Immunity ............................................................................................. 37
A2.4 Recommended Separation Distances ............................................................................. 38
Appendix 3 Ultrasound Intensity and Safety ............................................................................ 39
A3.1 Ultrasound in Medicine .................................................................................................. 39
A3.2 Ultrasound Safety and the ALARA Principle ................................................................ 39
A3.3 Explanation of MI/TI ..................................................................................................... 39
A3.3.1 MI (Mechanical Index) ........................................................................................ 39
A3.3.2 TI (Thermal Index) ............................................................................................... 40
A3.3.3 Measurement Uncertainties .................................................................................. 40
A3.4 Prudent Use Statement ................................................................................................... 40
A3.5 References for Acoustic Output and Safety ................................................................... 41
A3.6 Probe Acoustic Output Parameters List ......................................................................... 41
Appendix 4 Overall Sensitivity ................................................................................................... 43
A4.1 Overall Sensitivity of SD5 (2MHz Wired Probe) .......................................................... 43
A4.2 Overall Sensitivity of SD5 (3MHz Wired Probe) .......................................................... 44
A4.3 Overall Sensitivity of SD6 (2MHz Wireless Probe) ...................................................... 45
A4.4 Overall Sensitivity of SD6 (3MHz Wireless Probe) ...................................................... 46
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 Intended Use/Indications for 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.
1.2 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 SD5/SD6 Ultrasonic TableTop Doppler is a tool to aid healthcare professionals and
should not be used in place of normal fetal monitoring. It is not intended for
treatment.
2 This device is not explosion-proof and can not be used in the presence of flammable
anaesthetics.
3 SHOCK HAZARD – In order to protect the patient and the operator, the device case
should be grounded. The power receptacle must be a three-slot grounded outlet.
4 SHOCK HAZARD – Do not attempt to connect or disconnect a power cord with wet
hands. Make sure that your hands are clean and dry before touching a power cord.
5 Accessory equipment connected to the analog and digital interfaces must be
certified according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data
processing equipment and IEC/EN 60601-1 for medical equipment). Furthermore all
configurations shall comply with the valid version of the system standard IEC/EN
60601-1. Anybody who connects additional equipment to the signal input connector
or signal output connector to configure a medical system must ensure that the
system complies with the requirements of the valid version of the system standard
IEC/EN 60601-1. If in doubt, consult our technical service department or your local
distributor.
6 Exposure to ultrasound should be kept as low as reasonably achievable.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Safety Guide
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WARNING
7 Do not touch the signal input/output connector and the patient simultaneously.
8 Do not apply this device and other ultrasonic equipment simultaneously on the same
patient, in case of possible hazard caused by leakage current superposition.
9 Do not apply this device simultaneously with other PATIENT-connected equipment,
such as, a cardiac pacemaker or other electrical stimulators, on the same patient.
10 The device is not protected against defibrillation.
11 Do not use the device with HF surgical equipment.
12 Only use the probes provided by the manufacturer.
13 Before using the battery, make sure to read the user manual and safety precautions
thoroughly.
14 Do not heat or throw the battery into fire as this may cause explosion.
15 Do not solder the leading wire and the battery terminal directly.
16 Do not destroy the battery: Do not pierce the battery with a sharp object such as a
needle; do not hit with a hammer, step on or throw or drop to cause strong shock; do
not disassemble or modify the battery.
17 The battery should be charged, used or stored away from the static electricity.
18 Do not mix the battery with metal objects to avoid short-circuit.
19 The battery should be charged at least once a month to prevent overdischarge.
20 Replacement or charging of the battery shall be done at least 1.5 meters away from
patients.
21 The device shall only be used when the battery cover is closed.
22 If the device is not used for a long time, please remove the battery and store it as
required.
23 If the liquid leak from the battery spills onto your skin or clothes, wash well with fresh
water immediately.
24 If the liquid leak from the battery gets into eyes, do not rub the eyes. Wash them
well with clean water and see a doctor immediately.
25 Stop using the battery if abnormal heat, odor, discoloration, deformation or any other
abnormal condition is detected during use, charge, or storage. Please dispose it
according to the local regulations.
26 Do not immerse, throw, or wet the battery in water/seawater.
27 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.
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WARNING
28 Using accessories other than those specified by the manufacturer may result in
increased electromagnetic emissions or decreased electromagnetic immunity of the
device.
29 The appliance coupler or mains plug is used as isolation means from supply mains.
Position the device in a location where the operator can easily access the
disconnection device.
30 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.
31 The medical electrical equipment needs to be installed and put into service
according to the EMC Information provided in this user manual.
32 Portable and mobile RF communications equipment can affect medical electrical
equipment, refer to section A2.4 Recommended Separation Distances.
33 Do not service or maintain the device or any accessory which is in use with a
patient.
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 Do not sterilize the Doppler with autoclave or gas.
6 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.
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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Safety Guide
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1.3 Symbols
No. Symbol Definition
1
Headphones
2
Equipotential grounding
3
Alternating Current
4
Fuse
5 ON/OFF switch
6
Menu
7
Recording and play-back
8 Print control
9 Move the cursor downwards
10 Move the cursor upwards
11 Speaker
12 Decrease
13 Increase
14 Charge battery
15 Push right
16
Caution
17
Operating instructions
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18
TYPE BF APPLIED PART
19 CE marking
20
Disposal method
21 IPX4
The device is protected against splashing water. Water splashed
against the enclosure from any direction shall have no harmful
effects.
22 Part Number
23 SERIAL NUMBER
24
Date of manufacture
25
MANUFACTURER
26
AUTHORISED REPRESENTATIVE IN THE EUROPEAN
COMMUNITY
27
General symbol for recovery/recyclable
28
Caution: Federal (U.S.) law restricts this device to sale by or
on the order of a physician.
29
Refer to User Manual
(Background: Blue; Symbol: White)
30
Non-ionizing electromagnetic radiation
31* FCC ID:
SMQSD6PEDAN
Federal Communications Commission: FCC ID:
SMQSD6PEDAN
32* FCC ID:
SMQSD6MEDAN
Federal Communications Commission: FCC ID:
SMQSD6MEDAN
NOTE:
1 The user manual is printed in black and white.
2 * Applicable to SD6 only.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Introduction
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Chapter 2 Introduction
NOTE:
The pictures and interfaces in this manual are for reference only.
2.1 Main Unit
SD5:
SD6:
Figure 2-1 Overview
Figure 2-2 Top View of the Main Unit
1 Probe
2 Probe Cable
3 Main Unit
4 LCD
5 Speakers
6 Probe Socket
8
9
10
7 Probe Holder
8 Handle
9 Probe Sensor Socket
10 Main Unit Control Keys
1
2
3
4
5
6
5
3
4
5
5
7
1
SD5/SD6 Ultrasonic TableTop Doppler User Manual Introduction
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WARNING
Please do not touch the probe sensor socket and the patient simultaneously.
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
NOTE:
The main unit is not waterproof. Do not immerse it in any type of liquid.
18
17
16
20
19
16 Fuses
17 Power Socket
18 Equipotential Grounding
Terminal
19 Main Unit Label
20 Earphone Socket
21 Battery Compartment
21
11 12 13 14 15
11 Main Unit Indicator
12 On/OFF Key
13 Setup Key / Confirm Key
14 Up Key /
Record/Play Control Key
15 Down Key /
Print Control Key
SD5/SD6 Ultrasonic TableTop Doppler User Manual Introduction
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2.2 Probes
WARNING
Do not touch the charge sockets of the Doppler probe and the patient simultaneously.
CAUTION
1. Do not immerse the probe (and the probe cable) in any liquid.
2. Do not stretch the probe cable for more than three meters.
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 Probe Socket
4 Probe Cable
2
1
5 6 7 8
9 Probe Type Label
10 Probe Battery Compartment
11 Probe Charge Socket
9 10 11
4
3
1
2
5 Volume Decreasing Key
6 Volume Increasing Key
7 Power Key (only available
on wireless probe)
8 Probe Indicator
SD5/SD6 Ultrasonic TableTop Doppler User Manual Introduction
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Description:
The Doppler supports 2 MHz and 3 MHz 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
SD6 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 (SD6) has been tested and found to comply with the limits for a
Class B digital device, pursuant to part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates, uses and can radiate radio
frequency energy and, if not installed and used in accordance with the instructions,
may cause harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If this equipment
does cause harmful interference to radio or television reception, which can be
determined by turning the equipment off and on, the user is encouraged to try to
correct the interference by one or more of the following measures:
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
- Consult the dealer or an experienced radio/TV technician for help.
2.
Any changes or modifications to this unit not expressly approved by the party
responsible for compliance could void the user's authority to operate the equipment.
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 3.8.2 Switching the Key Sound On and Off for operation procedures.
(1) Power Key
SD5/SD6 Ultrasonic TableTop Doppler User Manual Introduction
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Function: Switch on/off the main unit or switch on the probe. Note that if the probe fails to
connect the main unit in two minutes, it will power off automatically.
(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).
Printing control (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 ( ).
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.
For SD6, the indicator lights up continuously in yellow – the probe battery is low; the
indicator flashes in green – the probe battery is being charged.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Introduction
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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.
5
Bluetooth Indicator
(Only available with
SD6)
The wireless probe is switched on and its communication
with the main unit is normal.
The wireless probe is switched off or its communication with
the main unit failed.
Probe Indicator
(Only available with
SD5)
The wired probe is well connected.
The wired probe is not connected.
6 Fetal heart signal intensity indicator
7 FHR numeric measurement value
8, 9 Date and Time
10 Heart Beat Indicator: When fetal heart signal is received, the heart shape flashes to
indicate the FHR refreshing frequency.
11 Volume Indicator
1
2
3
8
9
10
11
5
4
6 7
SD5/SD6 Ultrasonic TableTop Doppler User Manual Introduction
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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.
The LCD displays the battery charging icon when the main
unit is shut off and charging. During the charging process,
the battery charging icon changes as the battery level
increases.
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's authorized
personnel.
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 ① stays 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 100 V-240 V~ power supply.
Connecting the main unit to the AC power supply will charge the battery, no matter if it is on or
off. If the main unit is in the stand-by or switch off state, it takes no more than 5 hours to fully
charge the main unit battery. 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. Then connect the
main unit to the AC power supply.
If the probe is in the switch off state, it takes no more than 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 or charging 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 Do not expose the batteries to high temperature, heat them or dispose of them in
fire.
4 Do not disassemble the batteries.
5 Short circuit should be avoided.
CAUTION
1 If the Doppler is not used for an extended period, remove the batteries and 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:
100 V-240 V~, 50 Hz/60 Hz.
WARNING
If the protective grounding (protective earth) system is doubtful, 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 damage before switching on the main unit.
Modular Plug
Housing
1 Power
2 GND
3 Signal Wire
4 Signal Wire
SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation
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CAUTION
To avoid unwanted noise, do not take out or place the probe when the main unit is on.
Remember to take out the probe before switching on the main unit, and place the probe
after switching off the main unit.
To switch on the main unit:
Pick up the probe and then press the ON/OFF key on the main unit.
All the real-time examining menu elements light up in a few seconds. A start-up sound (if the key
sound is enabled) is heard. The Doppler performs a self test by displaying the FHR numerics in a
fast speed.
To switch on the wireless probe:
Press the Power key on the wireless probe. The probe indicator lights up in green.
NOTE:
1 For SD6, the Power keys of the wireless probe and the main unit need to be
pressed separately. After they are switched on, they will be connected with each
other automatically, and the LCD will display to indicate normal connection. If
you touch the acoustic faceplate of the probe gently with your hand, the Doppler will
give out sound.
2 For SD6, docking the probe when the main unit is powered on and is in normal
connection with the probe, the probe will turn off automatically and begin to charge.
If you take up the probe within 3 hours, it will power on automatically and be ready
for use.
3 For SD5, the wired probe is ready to use when the main unit is switched on.
3.6 Switching Off
When the examination is finished, switch off the main unit, wipe the remaining gel off the probe
with a clean soft cloth and then place the probe back into the holder.
To switch off the main unit, perform any one of these operations:
1) Press the ON/OFF key on the main unit.
2) Put the probe into the probe holder.
3) Auto shut off. If the main unit does not receive signal for a period of time, it will be
switched off automatically. The auto-shut-off time is preset in the setup menu. Refer to
section 3.8.3 Setting Auto-Shut-Off Time.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation
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To switch off the wireless probe:
NOTE:
1 If the probe is not to be used over a relatively long period of time, It is recommended
to switch off the main unit first, and then put the probe into the probe holder.
2 For SD6, if you switch off the main unit when it is in normal connection with the
probe, the probe will also be switched off.
3.7 Using Earphone
In a noisy environment, you are advised to use an earphone to hear fetal heart sound.
Insert the earphone plug into earphone socket on the back of the main unit (figure 2-4). The
speakers will be muted when the earphone is connected.
WARNING
Turn down the volume before using earphone to your ears.
CAUTION
Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing
equipment and IEC/EN 60601-1 for medical equipment). Furthermore all configurations
shall comply with the valid version of the system standard IEC/EN 60601-1. Anybody
who connects additional equipment to the signal input connector or signal output
connector to configure a medical system must ensure that the system complies with the
requirements of the valid version of the system standard IEC/EN 60601-1. If in doubt,
consult our technical service department or your local distributor.
3.8 Changing Doppler Settings
3.8.1 Switching Backlight On and Off
1 Press the Setup key for about 2 seconds to open setup menu.
2 Press the Setup key when the cursor stays at Backlight.
3 Press the Up/Down key to toggle between ON and OFF.
4 Press the Setup key.
3.8.2 Switching Key Sound On and Off
1 Press the Setup key for about 2 seconds to open setup menu.
2 Press the Up/Down key to move the cursor to Key Sound, press the Setup key.
3 Press the Up/Down key to toggle between ON and OFF.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation
- 21 -
4 Press the Setup key.
3.8.3 Setting Auto-Shut-Off Time
The Auto-Shut-Off feature facilitates the economical use of the Doppler. The main unit will
switch off automatically after no signal is received and no operation is performed for 1 minute，
3 minutes or infinite time.
1 Press the Setup key for about 2 seconds to open setup menu.
2 Press the Up/Down key to move the cursor to Auto Shut Off, press the Setup key.
3 Press the Up/Down key to move the cursor among options.
4 Press the Setup key.
3.8.4 Choosing Language
1 Press the Setup key for about 2 seconds to open setup menu.
2 Press the Up/Down key to move the cursor to Language, press the Setup key.
3 Press the Up/Down key to select the required language.
4 Press the Setup key.
3.8.5 Setting Date and Time
1 Press the Setup key for about 2 seconds to open setup menu.
2 Press the Up/Down key to move the cursor to Real Time Clock, press the Setup key.
3 Press the Setup key when the cursor stays at Hour.
4 Press the Up/Down key to choose a number from 00 to 23 and then press the Setup key to
confirm the choice.
5 In the same way, choose the Minute from 00 to 59. Choose the Year, Month and Day.
6 Move the cursor to EXIT and then press the Setup key.
3.8.6 Setting Date Format
You can choose to switch the date on or off. When it is on, the date format has three options:
DD/MM/YYYY, MM/DD/YYYY and YYYY/MM/DD.
To switch the date on and off or change date format:
1 Press the Setup key for about 2 seconds to open setup menu.
2 Press the Up/Down key to move the cursor to Date Format, press the Setup key.
3 Press the Up/Down key to toggle between ON and OFF. If you choose ON, the cursor
moves to the date format. Select a format.
4 Press the Setup key.
NOTE:
If no operation is performed in 30 seconds, the device will exit from the setup menu. The
SD5/SD6 Ultrasonic TableTop Doppler User Manual Basic Operation
- 22 -
setting changes will not be effective.
3.9 Replacing Fuses
WARNING
Switch off the main unit and unplug it before replacing the fuses.
Two fuses are located on the rear panel of the device, their specifications are:
Size: Ф5 mm*20 mm; Model: T400mAH250V.
When any one of the fuses is blown, perform the following steps to replace it:
1. Using a flat-head screw driver, push the fuse in for about one millimeter and then rotate it
anticlockwise.
2. Remove the old fuse and replace it with a new fuse that is supplied by the manufacturer or of
the same specifications.
3. Push the new fuse into the socket for about one millimeter and then rotate it clockwise back
into position.
SD5/SD6 Ultrasonic TableTop Doppler User Manual FHR Examining
- 23 -
Chapter 4 FHR Examining
WARNING
1 Always check if the main unit and the probe are in good condition prior to use.
2 To avoid inaccurate diagnosis: (a) relocate the probe for the best FHR signal as the
fetal position changes; (b) when intrauterine fetal death is doubted by using this
examination method, try to verify it with other methods.
CAUTION
Handle the probe with care. Do not drop it on hard surfaces.
The 2 MHz and 3 MHz obstetrical probes are designed for FHR examining. The 2 MHz probe is
optimized for deep penetration and is widely used in the third trimester pregnancy. The 3 MHz
probe is a general purpose probe. It has better resolution and wider detection range than the 2
MHz probe, therefore is optimized for early fetal heart detection.
Follow these procedures to perform FHR examining:
1 Feel the position of the fetus by hand to find the best position to detect the fetal heart.
2 Switch on the Doppler and the probe.
3 Apply a small amount of coupling gel to the acoustic face of probe; place the probe face at the
best position for detecting fetal heart. Angle the probe to obtain an optimum audio signal.
Adjust the volume if required.
When an audible fetal heart signal is detected, a clear fetal heart sound will be heard from the
speakers/earphone, and numeric FHR value will be displayed on the LCD.
NOTE:
1 The best quality records will only be obtained if the probe is placed in the optimum
position.
2 Positions with strong placental sounds or umbilical blood flow sound should be
avoided.
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 umbilicus. During examining,
the pregnant woman’s prolonged lying in the supine position should be avoided
owing to the possibility of supine hypotension. Sitting up or lateral positions are
preferable and may be more comfortable.
4 It is not possible to obtain accurate FHR unless an audible 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual FHR Examining
- 24 -
5 When applied to the patient, the ultrasound transducer may warm slightly (less than
8°C (14.4°F) above ambient temperature). When NOT applied, the ultrasound
transducer may reach the highest temperature of 8°C (14.4ºF).
6 Maternal heart will be detected if the probe is strongly placed on maternal vessel.
7 For SD6, the effective transmission distance between the main unit and the wireless
probe is 5 meters. It is recommended that they are positioned within this distance in
photopic vision.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Recording and Playing
- 25 -
Chapter 5 Recording and Playing
The built-in recorder of the Doppler allows recording and playing fetal heart sound of 240
seconds (at most).
To record fetal heart sound:
Press and hold the Record/Play control key for two seconds. The character REC on the
LCD lights up. Recording starts.
Press the Record/Play control key again to stop recording and return to the real-time
examining mode.
To play the fetal heart sound:
Press the Record/Play control key in the real-time examining mode. The character PLA on
the LCD lights up. The Doppler plays the recorded fetal heart sound.
NOTE:
Observe the LCD, pay attention not to mistake the recorded fetal heart sound for the
real-time sound.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Maintenance and Cleaning
- 26 -
Chapter 6 Maintenance and Cleaning
6.1 Inspection
(1) Visual Inspection
Prior to using the device every time, do the following inspections:
Check the device and accessories to see if there is any visible evidence of damage that
may affect patient safety.
Check the power socket and power cables.
Check if the device functions properly to make sure it is in good condition.
If any damage is detected, stop using the device on the patient. Replace the damage part(s) or
contact the manufacturer for service before reusing it.
(2) Routine Inspection
The overall check of the device, including safety check and function check, should be performed
by qualified personnel every 6 to 12 months, and each time after service.
The equipment should undergo periodic safety testing to ensure proper patient isolation from live
parts. This should include leakage current measurement and insulation testing. The recommended
testing interval is once a year or as specified in the institution’s test and inspection protocol.
(3) Mechanical Inspection
Make sure all exposed screws are tight.
Check the external cables for splits, cracks or signs of twisting.
Replace any cable that shows serious damage.
Pay particular attention to the supply socket.
WARNING
Failure on the part of the responsible individual hospital or institution employing the use
of this equipment to implement a satisfactory maintenance schedule may cause undue
equipment failure and possible health hazards.
CAUTION
The maintenance must be performed by professional personnel.
6.2 Maintenance
Avoid scratching and damaging the LCD. The gathering of dew on the LCD may occur with
abrupt temperature or humidity changes. A table environment is recommended for the main unit.
Keep the exterior surface of the main unit clean, free of dust and dirt.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Maintenance and Cleaning
- 27 -
Handle the probe with care to avoid damaging the cover, piezoelectric crystals and mechanical
movement. Do not contact the probe with hard or sharp objects.
Do not excessively flex the probe cable.
Wipe the remaining gel off the probe after use.
Keep the probes in a dry environment, where the temperature should be lower than 45°C.
6.3 Cleaning
To clean the main unit:
Switch off the Doppler and unplug it from AC power supply. Clean the case 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. The recommended cycle is one week or when needed.
Clean the probe after each use to avoid cross infection and prolong its useful life.
To clean the probe:
Switch off the probe. Clean it using a soft cloth dampened with mild near neutral detergent,
ethanol (75%) or isopropanol (70%), and then wipe it dry with a dry cloth immediately.
CAUTION
1 Do not use strong solvent such as acetone.
2 Do not use an abrasive such as steel wool or metal polish.
3 Neither the main unit nor the probe is waterproof; do not immerse any part of them in
liquid. Entry of liquid into the Doppler may destroy the equipment.
4 Do not allow any liquid remain on the surface.
6.4 Disinfection
In normal use the main unit 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.
After each use, clean the probe 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.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Maintenance and Cleaning
- 28 -
6.5 Sterilization
Do not sterilize the Doppler, unless this is necessary according to your hospital regulation.
NOTE:
After cleaning or disinfection, check if the Doppler function well. If any problem is
detected, please contact the manufacturer for service before reusing them.
Checking Item
Checking Method
Visual Check Inspect the Doppler for any damage.
Function Check Check if the Doppler can be switched on or off properly (see 3.5 Switching On
and 3.6 Switching Off). When the Doppler is switched on, check if the LCD
works as described in 2.5 LCD; touch the probe faceplate gently with your hand
and check if the Doppler gives out sound normally.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Warranty and Service
- 29 -
Chapter 7 Warranty and Service
7.1 Warranty
EDAN warrants that EDAN’s products meet the labeled specifications of the products and will be
free from defects in materials and workmanship that occur within warranty period.
The warranty is void in cases of:
a) damage caused by mishandling during shipping.
b) subsequent damage caused by improper use or maintenance.
c) damage caused by alteration or repair by anyone not authorized by EDAN.
d) damage caused by accidents.
e) replacement or removal of serial number label and manufacture label.
If a product covered by this warranty is determined to be defective because of defective materials,
components, or workmanship, and the warranty claim is made within the warranty period, EDAN
will, at its discretion, repair or replace the defective part(s) free of charge. EDAN will not provide
a substitute product for use when the defective product is being repaired.
7.2 Contact information
If you have any question about maintenance, technical specifications or malfunctions of devices,
contact your local distributor.
Alternatively, you can send an email to EDAN service department at: support@edan.com.cn.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Product Specifications
- 30 -
Chapter 8 Product Specifications
8.1 Environmental Specifications
Working
Temperature: 0ºC ~ + 40ºC ( +32ºF ~ +104ºF)
Relative Humidity: 15% RH ~ 95% RH (non-condensing)
Atmospheric Pressure: 86 kPa ~ 106 kPa
Transport and Storage
Temperature: -20ºC ~ +55ºC (-4ºF ~ +131ºF)
Relative Humidity: 15% RH ~ 95% RH (non-condensing)
Atmospheric Pressure: 70 kPa ~ 106 kPa
8.2 Physical Specifications
Dimensions and
Weight
Dimensions:
Main Unit: 265 mm x 155 mm x 180 mm
Probes: 140 mm x 40 mm x 32 mm
Weight:
Main Unit: 1.7 kg (with battery and probe)
Wireless Probe: <140 g (with battery)
Wired Probe: <100 g
Power Supply
Main unit
Operating Voltage: 100 V-240 V~
Operating Frequency:
50 Hz/60 Hz
Input Power: 35 VA
Battery: 7.2 V/2000 mAh (Ni-MH Battery)
Probe
Battery: 3.7 V/800 mAh (Lithium Battery)
Standards
Compliance
IEC 60601-1:2005, EN 60601-1:2006, IEC 60601-1-2:2007,
EN 60601-1-2:2007, IEC/EN 60601-2-37
Anti-electric Shock Type Class I equipment with internal power supply
Anti-electric Shock Degree Type BF applied parts
SD5/SD6 Ultrasonic TableTop Doppler User Manual Product Specifications
- 31 -
Degree of Protection against
Harmful Ingress of Water
Main Unit: Ordinary equipment (Sealed equipment
without liquid proof)
Probe: IPX4
Degree of Safety in Presence of
Flammable Gases
Equipment not suitable for use in presence of
flammable gases
Disinfection/Sterilizing Method Refer to this user manual for details
EMC CISPR 11 Group1 Class A
Earth Leakage Current (Limit): N.C. S.F.C.
500 µA 1000 µA
Enclosure Leakage Current (Limit):
N.C. S.F.C.
100 µA 500 µA
Patient Leakage Current (Limit):
N.C. S.F.C.
d.c. 10 µA 50 µA
a.c. 10 µA 50 µA
Patient Auxiliary Current (Limit):
N.C. S.F.C.
d.c. 10 µA 50 µA
a.c. 10 µA 50 µA
Display:
Effective display area: 62.0 mm (W) x 44.0 mm (H)
Number of characters: 128*64 Dots
Dot size: 0.39 mm (W) x 0.55 mm (H)
Dot pitch: 0.44 mm (W) x 0.60 mm (H)
Ultrasonic Gel:
pH: 5.5~8.0
Acoustic Impedance: 1.5x10
6
Pa.s/m ~1.7x10
6
Pa.s/m
(in 35°C(95ºF))
8.3 Performance Specifications
FHR Performance (Essential
Performance):
FHR Measurement Range: 50 bpm ~ 240 bpm
Accuracy: ± 2 bpm
FHR Resolution: 1 bpm
Recording and Playing:
Audio Sampling Frequency: 4 kHz
Recording Length: 240 seconds
White Back Light: Two Brightness Adjustable: OFF, ON
SD5/SD6 Ultrasonic TableTop Doppler User Manual Product Specifications
- 32 -
Audio Output Power: 3 W
Auto Shut off: 1-minute/3-minute no signal and no operation
Bluetooth Transmission Distance: Photopic vision: >5 m (the indoor distance depends on
the building structure and material)
Ultrasound:
Nominal Frequency:
2 MHz Wired /Wireless Probes: 2 MHz
3 MHz Wired /Wireless Probes: 3 MHz
Working Frequency:
2 MHz Wired /Wireless Probes: (2.0 ± 10%) MHz
3 MHz Wired /Wireless Probes: (3.0 ± 10%) MHz
2 MHz Wired/wireless probe: I
ob
< 20 mW/cm
2
3 MHz Wired/wireless probe:
p-
< 1 MPa
I
spta
< 100 mW/cm
2
I
sata
< 20 mW/cm
2
W0 < 50mW
Working Mode: Continuous wave Doppler
Effective Radiating Area of Probe:
2 MHz /3 MHz Wired /Wireless probes:
(245±15%) mm
2
8.4 Battery Specifications
For main unit For probe
Type: Ni-MH Battery Lithium Battery
Nominal Capacity: 2000 mAh 800 mAh
Nominal Voltage: 7.2 V 3.7 V
Necessary Charge Time:
≤5 hours (the main unit is in
the stand-by or switch off
state)
≤5 hours (the probe is in the
switch off state)
Expected Battery Life:
≥8 hours (the new battery is
fully charged before
use, and
the fetal heart sound at 1 meter
right ahead of the main unit
speaker is higher than 80 dB)
≥3 hours (the new battery is
fully charged before use)
SD5/SD6 Ultrasonic TableTop Doppler User Manual Product Specifications
- 33 -
Circle Life: ≥300 times
(after 300 circles, only 90% of the capacity can be restored.)
Storage Temperature: -20°C ∼ +60°C (-4 ºF ~ +140 ºF) (1 month) or
-20°C ∼ +40°C (-4 ºF ~ +104 ºF) (3 months)
8.5 Low Output Summary Table
Low Output Summary Table
(for systems with no transducers having global maximum index values exceeding 1.0)
System: Ultrasonic TableTop Doppler
Transducer Model
(MHz)
I
spta.3
(mW/cm
2
) TI Type TI Value MI I
sppa.3
(W/cm
2
)
CW 2.0 (SD5) 1.774 TIS 0.0159 0.00628 0.001774
TIB 0.0301
CW 3.0 (SD5) 5.867 TIS 0.0969 0.00813 0.005867
TIB 0.1113
CW 2.0 (SD6) 3.484 TIS 0.0203 0.00785 0.003484
TIB 0.0531
CW 3.0 (SD6) 5.307 TIS 0.1132 0.00763 0.005307
TIB 0.1141
SD5/SD6 Ultrasonic TableTop Doppler User Manual Ordering Information
- 34 -
Appendix 1 Ordering Information
CAUTION
Only the parts supplied by the manufacturer should be used with the Doppler.
Parts Part Number
Probe
2 MHz Wired Probe 02.01.212045
3 MHz Wired Probe 02.01.212046
Probe Cable 01.13.036108
2 MHz Wireless Probe 02.01.212047
3 MHz Wireless Probe 02.01.212048
Accessory
Ni-MH Battery for Main Unit 01.21.064220
Lithium Battery for Wireless Probe 01.21.064125
Carry Bag 01.56.465630
Power Cord (European Standard) 01.13.036638
Power Cord (American Standard) 21.13.036384
SD5/SD6 Ultrasonic TableTop Doppler User Manual EMC Information
- 35 -
Appendix 2 EMC Information
A2.1 Electromagnetic Emissions
Guidance and manufacture’s declaration- electromagnetic emission
The SD5/SD6 is intended for use in the electromagnetic environment specified below. The customer
or the user of the SD5/SD6 should assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment-guidance
RF emissions
CISPR 11 Group 1
The SD5/SD6 uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11 Class A
The SD5/SD6 is suitable for use in all establishments,
other than domestic and those directly connected to the
public low-voltage power supply network that supplies
building used for domestic purposes.
Harmonic emissions
IEC 61000-3-2 Class A
Voltage
fluctuations/flicker
emissions
IEC61000-3-3
Complies
SD5/SD6 Ultrasonic TableTop Doppler User Manual EMC Information
- 36 -
A2.2 Electromagnetic Immunity
Guidance and manufacture’s declaration – electromagnetic immunity
The SD5/SD6 is intended for use in the electromagnetic environment specified below. The customer or
the user of SD5/SD6 should assure that it is used in such an environment.
Immunity test IEC 60601 test level
Compliance level Electromagnetic
environment -guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood,
concrete or ceramic tile. If
floor are covered with
synthetic material, the relative
humidity should be at least
30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±2 kV for power
supply lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±1 kV line(s) to line(s)
±2 kV line(s) to earth
±1 kV line(s) to line(s)
±2 kV line(s) to earth
Mains power quality should be
that of a typical commercial or
hospital environment.
Power frequency
(50 Hz/60 Hz)
magnetic field
IEC61000-4-8
3 A/m 3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT (60% dip in
UT) for 5 cycles
70% UT (30% dip in
UT) for 25 cycles
<5% UT (>95% dip in
UT) for 5s
<5% UT
(>95% dip in UT) for
0.5 cycle
40% UT (60% dip in
UT) for 5 cycles
70% UT (30% dip in
UT) for 25 cycles
<5% UT (>95% dip in
UT) for 5s
Mains power quality should be
that of a typical commercial or
hospital environment. If the
user of the SD5/SD6 requires
continued operation during
power mains interruptions, it is
recommended that the
SD5/SD6 be powered from an
uninterruptible power supply
or a battery.
NOTE UT is the a.c. mains voltage prior to application of the test level.
SD5/SD6 Ultrasonic TableTop Doppler User Manual EMC Information
- 37 -
A2.3 Electromagnetic Immunity
Guidance and manufacture’s declaration – electromagnetic immunity
The SD5/SD6 is intended for use in the electromagnetic environment specified below. The customer or
the user of SD5/SD6 should assure that it is used in such an environment.
Immunity
test
IEC 60601 test
level Compliance level Electromagnetic environment
-guidance
Portable and mobile RF communications
equipment should be used no closer to
any part of the SD5/SD6 , including
cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended separation distance
Conducted
RF
IEC
61000-4-6
3 Vrms
150 z to 80 MHz
3Vrms
0.1 Vrms
1.995MHz~2.010MHz
2.985MHz~3.015MHz
d=1.2
P
d=35
P
1.995 MHz to 2.010 MHz
d=35
P
2.985 MHz to 3.015 MHz
Radiated RF
IEC
61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m d=1.2
P
80 MHz to 800 MHz
d=2.3
P
800 MHz to 2.5 GHz
Where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the recommended
separation distance in metres (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,
a
should be
less than the compliance level in each
frequency range.
b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
SD5/SD6 Ultrasonic TableTop Doppler User Manual EMC Information
- 38 -
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the SD5/SD6 is used exceeds the applicable RF compliance level
above, the SD5/SD6 should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the SD5/SD6
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
A2.4 Recommended Separation Distances
Recommended separation distances between portable and mobile RF communications
equipment and the SD5/SD6
The SD5/SD6 is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the SD5/SD6 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the SD5/SD6 as recommended below, according to
the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter
(W)
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
d=1.2
P
(d=35
P
1.995 MHz to 2.010 MHz
2.985 MHz to 3.015 MHz)
80 MHz to 800 MHz
D=1.2
P
800 MHz to 2.5 GHz
D=2.3
P
0.01 0.12(3.5) 0.12 0.23
0.1 0.38(11.1) 0.38 0.73
1 1.2(35) 1.2 2.3
10 3.8(111) 3.8 7.3
100 12(350) 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Ultrasound Intensity and Safety
- 39 -
Appendix 3 Ultrasound Intensity and Safety
A3.1 Ultrasound in Medicine
The use of diagnostic ultrasound has proved to be a valuable tool in medical practice. Given its
known benefits for non-invasive investigations and medical diagnosis, including investigation of
the human fetus, the question of clinical safety with regards to ultrasound intensity arises.
There is no easy answer to the question of safety surrounding the use of diagnostic ultrasound
equipment. Application of the ALARA (As Low As Reasonably Achievable) principle serves as a
rule-of-thumb that will help you to get reasonable results with the lowest possible ultrasonic
output.
The American Institute of Ultrasound in Medicine (AIUM) states that given its track record of
over 25 years of use and no confirmed biological effects on patients or instrument operators, the
benefits of the prudent use of diagnostic ultrasound clearly outweigh any risks.
A3.2 Ultrasound Safety and the ALARA Principle
Ultrasound waves dissipate energy in the form of heat and can therefore cause tissue warming.
Although this effect is extremely low with Doppler, it is important to know how to control and
limit patient exposure. Major governing bodies in ultrasound have issued statements to the effect
that there are no known adverse effects from the use of diagnostic ultrasound, however, exposure
levels should always be limited to As Low As Reasonably Achievable (the ALARA principle).
A3.3 Explanation of MI/TI
A3.3.1 MI (Mechanical Index)
Cavitations will be generated when ultrasound wave passes through and contacts tissues,
resulting in instantaneous local overheating. This phenomenon is determined by acoustic pressure,
spectrum, focus, transmission mode, and factors such as states and properties of the tissue and
boundary. This mechanical bioeffect is a threshold phenomenon that occurs when a certain level
of ultrasound output is exceeded. The threshold is related to the type of tissue. Although no
confirmed adverse mechanical effects on patients or mammals caused by exposure at intensities
typical of present diagnostic ultrasound instruments have ever been reported, the threshold for
cavitation is still undetermined. Generally speaking, the higher the acoustic pressure, the greater
the potential for mechanical bioeffects; the lower the acoustic frequency, the greater the potential
for mechanical bioeffects.
The AIUM and NEMA formulate mechanical index (MI) in order to indicate the potential for
mechanical effects. The MI is defined as the ratio of the peak-rarefactional acoustic pressure
(should be calculated by tissue acoustic attenuation coefficient 0.3dB/cm/MHz) to the acoustic
frequency.
SD5/SD6 Ultrasonic TableTop Doppler User Manual Ultrasound Intensity and Safety
- 40 -
MI = P
r, α
f
awf
× C
MI
C
MI
= 1 (MPa / MHz )
A3.3.2 TI (Thermal Index)
Heating of tissues is caused by absorption of ultrasound when the ultrasound energy is applied.
The temperature rise is determined by the acoustic intensity, exposed area and thermophysical
properties of the tissue.
In order to indicate the potential for temperature rise caused by thermal effects, the AIUM and
NEMA formulate thermal index (TI). It is defined as the ratio of the total acoustic power to the
acoustic power required to raise the tissue temperature by 1ºC.
According to different thermophysical properties of the tissue, TI is divided into three kinds: TIS,
TIB and TIC.
TIS (Soft Tissue Thermal Index): It provides an estimate of potential temperature rise in soft or
similar tissues.
TIB (Bone Thermal Index): It provides an estimate of potential temperature rise when the
ultrasound beam passes through soft tissue and a focal region is in the immediate vicinity of
bone.
TIC (Cranial Bone Thermal Index): It provides an estimate of potential temperature rise in the
cranial bones or superficial bones.
A3.3.3 Measurement Uncertainties
The uncertainties in the measurements were predominantly systematic in origin; the random
uncertainties were negligible in comparison. The overall systematic uncertainties were
determined as follows:
1. Hydrophone Sensitivity: ± 23 percent for intensity, ± 11.5 percent for pressure. Based on
the hydrophone calibration report by ONDA. The uncertainty was determined within ±1dB
in frequency range 1-15MHz.
2. Digitizer: ±3 percent for intensity. ± 1.5 percent for pressure.
Based on the stated accuracy of the 8-bit resolution of the Agilent DSO6012 Digital
Oscilloscope and the signal-to-noise ratio of the measurement.
3. Temperature: ± 1 percent
Based on the temperature variation of the water bath of ± 1 ºC.
4. Spatial Averaging: ± 10 percent for intensity, ± 5 percent for pressure.
5. Non-linear Distortion: N/A.
No effects of nonlinear propagation were observed.
Since all the above error sources are independent, they may be added on an RMS basis, giving a
total uncertainty of ± 25.1 percent for all intensity values reported, ± 12.7 percent for all the
pressure values and ± 12.6 percent for the Mechanical Index.
A3.4 Prudent Use Statement
Although no confirmed bioeffects on patients caused by exposure from present diagnostic
SD5/SD6 Ultrasonic TableTop Doppler User Manual Ultrasound Intensity and Safety
- 41 -
ultrasound equipment have ever been reported, the potential exists that such bioeffects may be
identified in the future. Therefore, the ultrasound should be used prudently. High levels of
acoustic output and long exposure time should be avoided while acquiring necessary clinical
information.
A3.5 References for Acoustic Output and Safety
1. “Bioeffects and Safety of Diagnostic Ultrasound” issued by AIUM in 1993
2. “Medical Ultrasound Safety” issued by AIUM in 1994
3. "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment,
Revision 3" issued by AIUM/NEMA in 2004
4. "Standard for real-time display of thermal and mechanical acoustic output indices on
diagnostic ultrasound equipment, Revision 2" issued by AIUM/NEMA in 2004
5. "Information for Manufacturers Seeking Marketing Clearance of Diagnostic
Ultrasound Systems and Transducers" issued in 2008.
6. “Medical electrical equipment—Part 2-37: Particular requirements for the basic safety and
essential performance of ultrasonic medical diagnostic and monitoring equipment" issued by
IEC in 2007.
A3.6 Probe Acoustic Output Parameters List
Acoustic Output Reporting Table for Track 1
Non-autoscanning
Mode
Operating Mode: CW mode
Transducer: CD2.0
Working Frequency: 2.0MHz
Acoustic Output MI I
SPTA.3
(mW/cm^2)
I
SPPA.3
(W/cm^2)
Global Maximum Value 0.02154 30.52 0.03052
Associated Acoustic
Parameter
P
r.3
(MPa) 0.03047
W
0
(mW) 32.09 32.09
f
c
(MHz) 2.00 2.00 2.00
Z
sp
(cm) 3.78 3.78 3.78
Beam dimensions
X
-
6
(cm) 2.449 2.449
Y
-
6
(cm) 0.1658 0.1658
PD (usec) N/A N/A
PRF (Hz) N/A N/A
EBD
Az.
(cm) Φ1.7678
Ele.
(cm) Φ1.7678
Operating Control
Conditions Fixed
SD5/SD6 Ultrasonic TableTop Doppler User Manual Ultrasound Intensity and Safety
- 42 -
Acoustic Output Reporting Table for Track 1
Non-autoscanning
Mode
Operating Mode: CW mode
Transducer: CD3.0
Working Frequency: 3.0MHz
Acoustic Output MI I
SPTA.3
(mW/cm^2)
I
SPPA.3
(W/cm^2)
Global Maximum Value 0.01342 17.45 0.01745
Associated Acoustic
Parameter
P
r.3
(MPa) 0.02325
W
0
(mW) 43.90 43.90
f
c
(MHz) 3.00 3.00 3.00
Z
sp
(cm) 5.20 5.20 5.20
Beam dimensions
X
-
6
(cm) 0.6228 0.6228
Y
-
6
(cm) 1.372 1.372
PD (usec) N/A N/A
PRF (Hz) N/A N/A
EBD
Az.
(cm) Φ1.7678
Ele.
(cm) Φ1.7678
Operating Control
Conditions Fixed
SD5/SD6 Ultrasonic TableTop Doppler User Manual Overall Sensitivity
- 43 -
Appendix 4 Overall Sensitivity
A4.1 Overall Sensitivity of SD5 (2MHz Wired Probe)
Diameter of
Target
Reflector
(mm)
Distance
(d)(mm)
Reflection
Loss A(d)
Two-way Attenuation
B=∑B
a
+B
w
VS(r.m.s)
mV
Vn(r.m.s)
mV
(
)
( )
=...
...
log20
10
smrV
smrV
C
n
s
dB
Overall Sensitivity
(S=A(d)+B+C)
dB
∑B (T: ultrasonic attenuation
phantom No. B
a
:dB)
Bw
(dB)
B
(dB)
1.58
A=45.7dB@
2MHz
50 39.8 T
6#6#6#1# 0 78.3 70.06 31.43 6.96 125.06
B
a
78.3
75 43.3 T
6#6#6# 0 74.6 69.39 29.83 7.33 125.23
B
a
74.6
100 45.8 T
6#6#5#4# 0 72.6 69.72 29.66 7.42 125.82
B
a
72.6
200 51.8 T
6#6#4#3# 0 67.6 54.04 29.35 5.30 124.70
B
a
67.6
2.38
A=43.2dB@
2MHz
50 37.2 T
6#6#6#2# 0 80.0 60.47 31.09 5.78 122.98
B
a
80.0
75 40.7 T
6#6#6#1# 0 78.3 58.64 30.32 5.73 124.73
B
a
78.3
100 43.2 T
6#6#6#1# 0 78.3 63.61 30.74 6.32 127.82
B
a
78.3
200 49.2 T
6#6#4#3# 0 67.6 52.58 29.31 5.08 121.88
B
a
67.6
Doppler Frequency (Hz) 200 Velocity of Target
(cm/s) 10
SD5/SD6 Ultrasonic TableTop Doppler User Manual Overall Sensitivity
- 44 -
A4.2 Overall Sensitivity of SD5 (3MHz Wired Probe)
Diameter of
Target
Reflector
(mm)
Distance
(d)(mm)
Reflection
Loss A(d)
Two-way Attenuation
B=∑B
a
+B
w
VS(r.m.
s)
mV
Vn(r.m.
s)
mV
(
)
( )
=...
...
log20
10
smrV
smrV
C
n
s
dB
Overall Sensitivity
(S=A(d)+B+C)
dB
∑B (T: ultrasonic attenuation
phantom No. B
a
:dB)
Bw
(dB)
B
(dB)
1.58
A=44.5dB@
3MHz
50 40.9 T
6#5#3# 0 79.4 64.45 31.07 6.34 126.64
B
a
79.4
75 44.4 T
6#5#3# 0 79.4 60.2 29.59 6.17 129.97
B
a
79.4
100 46.9 T
6#4#1#2# 0 77.7 69.53 29.58 7.42 132.02
B
a
77.7
200 52.9 T
6#4#1# 0 68.1 59.84 29.52 6.14 127.14
B
a
68.1
2.38
A=42.0dB@
3MHz
50 39.0 T
6#5#2#1# 0 82.0 61.84 30.32 6.19 127.19
B
a
82.0
75 42.5 T
6#4#3#1# 0 81.6 60.0 30.4 6.01 130.11
B
a
81.6
100 45.0 T
6#4#3# 0 75.1 69.53 30.75 7.09 127.19
B
a
75.1
200 51.0 T
6#4#1# 0 68.1 57.63 29.56 5.80 124.90
B
a
68.1
Doppler Frequency (Hz) 380 Velocity of
Target (cm/s) 10
SD5/SD6 Ultrasonic TableTop Doppler User Manual Overall Sensitivity
- 45 -
A4.3 Overall Sensitivity of SD6 (2MHz Wireless Probe)
Diameter of
Target
Reflector
(mm)
Distance
(d)(mm)
Reflection
Loss A(d)
Two-way Attenuation
B=∑B
a
+B
w
VS(r.m.s)
mV
Vn(r.m.s)
mV
(
)
( )
=...
...
log20
10
smrV
smrV
C
n
s
dB
Overall
Sensitivity
(S=A(d)+B+C
)
dB
∑B (T: ultrasonic attenuation
phantom No. Ba:dB)
Bw
(dB)
B
(dB)
1.58
A=45.7dB@
2MHz
50 39.8 T
6#6#6#2# 0 80.0 35.80 16.43 6.76 126.56
B
a
80.0
75 43.3 T
6#6#6#1# 0 78.3 36.47 16.04 7.13 128.73
B
a
78.3
100 45.8 T
6#6#5#4# 0 72.6 39.12 18.43 6.54 124.94
B
a
72.6
200 51.8 T
6#6#4#2# 0 65.4 42.0 19.45 6.69 123.89
B
a
65.4
2.38
A=43.2dB@
2MHz
50 37.2 T
6#6#6#2# 0 80.0 46.71 16.37 9.12 126.32
B
a
80.0
75 40.7 T
6#6#6#2# 0 80.0 41.77 17.60 7.51 128.21
B
a
80.0
100 43.2 T
6#6#6#1# 0 78.3 39.95 18.23 6.81 128.31
B
a
78.3
200 49.2 T
6#6#5#4# 0 72.6 40.84 20.54 5.97 127.77
B
a
72.6
Doppler Frequency (Hz) 218 Velocity of Target
(cm/s) 10
SD5/SD6 Ultrasonic TableTop Doppler User Manual Overall Sensitivity
- 46 -
A4.4 Overall Sensitivity of SD6 (3MHz Wireless Probe)
Diameter of
Target
Reflector
(mm)
Distance
(d)(mm)
Reflection
Loss A(d)
Two-way Attenuation
B=∑B
a
+B
w
VS(r.m.s)
mV
Vn(r.m.s)
mV
(
)
( )
=...
...
log20
10
smrV
smrV
C
n
s
dB
Overall Sensitivity
(S=A(d)+B+C)
dB
∑B (T: ultrasonic attenuation
phantom No. B
a
:dB)
Bw
(dB)
B
(dB)
1.58
A=44.5dB@
3MHz
50 40.9 T
6#5#4#1# 0 90.3 39.57 18.31 6.69 137.89
B
a
90.3
75 44.4 T
6#5#3#1# 0 86.0 38.4 18.59 6.30 136.70
B
a
86.0
100 46.9 T
6#4#3# 0 75.1 45.32 19.96 7.12 129.12
B
a
75.1
200 52.9 T
6#4#3# 0 79.4 40.2 19.36 6.35 138.65
B
a
75.1
2.38
A=42.0dB@
3MHz
50 39.0 T
6#5#4#1# 0 90.3 40.48 18.43 6.83 136.13
B
a
90.3
75 42.5 T
6#5#4# 0 83.8 38.1 19.26 5.93 132.23
B
a
83.8
100 45.0 T
6#4#3# 0 75.1 45.61 18.74 7.73 127.83
B
a
75.1
200 51.0 T
6#4#3# 0 75.1 47.56 19.47 7.76 133.86
B
a
75.1
Doppler Frequency (Hz) 377 Velocity of Target
(cm/s) 10
