Sonotrax Lite
Sonotrax Lite
Sonotrax Lite
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.
Product Information
Product Name: Ultrasonic Pocket Doppler
Model: SONOTRAX Lite, SONOTRAX Basic, SONOTRAX Basic A, SONOTRAX Pro,
SONOTRAX II, SONOTRAX II Pro, SONOTRAX Vascular
II
III
IV
This unit is internally powered equipment, and it is an IEC/EN 60601-1 Type B applied
part. Type B protection means that the connection between the equipment and personnel
complies with permitted leakage currents and dielectric strength of IEC/EN 60601-1.
WARNING and CAUTION messages must be observed. To avoid the possibility of injury,
observe the following precautions during the operation of the device.
WARNING
1 The Doppler is a tool to aid the healthcare professional 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 Do not touch the signal input/output connector and the patient simultaneously.
4 We recommend that exposure to ultrasound should be kept as low as reasonably
achievable. This is considered to be good practice and should be observed at all
time.
5 Only use the probes provided by the manufacturer.
6 Do not throw batteries in fire as this may cause explosion.
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WARNING
7 Do not attempt to charge normal alkaline batteries. They may leak, catch fire or even
explode.
8 Remove the batteries and store it at a cool and dry environment if the monitor is not
used for a long time.
9 If the rechargeable batteries are stored alone and not used for a long time, we
recommend that the batteries should be charged at least once every 6 months to
prevent overdischarge.
10 The rechargeable NI-MH batteries and battery pack should be charged by using the
dedicated adapters supplied by the manufacturer.
11 SHOCK HAZARD - Do not attempt to connect or disconnect a power cord with wet
hands. Make certain that your hands are clean and dry before touching a power
cord.
12 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.
13 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
60601-1-1. 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 60601-1-1. If in doubt, consult our technical service department or
your local distributor.
14 Replacement or charging of the battery shall be done at least 1.5 meters away from
patients.
CAUTION
1 Federal (U.S.) law restricts this device to sale by or on the order of a physician.
2 Refer servicing to qualified personnel.
3 The main unit is designed for continuous operation and is ‘ordinary’. Do not immerse
it in any liquid (i.e. not drip or splash-proof).
4 Keep the device in a clean environment and avoid vibration during storage.
5 Do not disinfect or sterilize the Doppler.
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.
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CAUTION
7 Prior to examination using the Doppler, check for visible damages of the main unit
and the probe that may endanger the patient/operator or machine performance. If
the damage is found, replace them with good ones at once.
8 The following safety checks should be performed once every two years or as
specified in the institution’s test and inspection protocol by a qualified person who
has adequate training, knowledge, and practical experience to perform these tests.
Inspect the equipment for mechanical and functional damage.
Inspect the safety relevant labels for legibility.
Verify that the device functions properly as described in the instructions for use.
Test the the pregnant woman’s leakage current according to IEC 60601-1: Limit:
d.c 10 µA, a.c 100 µA.
The leakage current should never exceed the limit. The data should be recorded in
an equipment log. If the device is not functioning properly or fails any of the above
tests, the device has to be repaired.
9 When the battery is charged, used or stored, keep it away from objects or materials
with static electric charges.
10 If rechargeable batteries are used, charge them fully before initial use by using the
method introduced in this manual.
11 Do not short-circuit the batteries or install the batteries reversely.
12 Store the batteries in a cool and dry environment.
13 Do not mix the batteries with metal objects to avoid short-circuit.
14 The device shall only be used when the battery cover is closed.
15 Batteries have life cycles. The alkaline batteries are intended to be used once. If the
time that the Doppler using NI-MH battery becomes much shorter than usual, the
battery life is at an end. Replace them with a new same one provided or
recommended by the manufacturer.
16 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.
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1.3 Symbols
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 regulation for separate collection after its useful life.
Attention.
Direct current
Part Number
Serial Number
Date Of Manufacture
Manufacturer
Rx only (U.S.) Federal (U.S.) Law restricts this device to sale by or on the order of a physician
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2.1 Features
There are seven different models available: SONOTRAX Lite, SONOTRAX Basic,
SONOTRAX Basic A, SONOTRAX Pro, SONOTRAX II, SONOTRAX II Pro and
SONOTRAX Vascular.
SONOTRAX Lite and SONOTRAX Vascular are for simple auscultation (intermittent
listening). SONOTRAX Basic, SONOTRAX Basic A, SONOTRAX Pro, SONOTRAX II, and
SONOTRAX II Pro not only detect fetal heart sound; they also display the fetal heart rate on a
LCD screen.
The features of the Dopplers are listed in the following chart:
Model SONOTRAX SONOTRAX SONOTRAX SONOTRAX SONOTRAX SONOTRAX SONOTRAX
Function Vascular Lite Basic Basic A Pro II II Pro
LCD Display - - √ √ √ √ √
LCD Backlight - - - √ √ √ √
Probe Detecting √ √ √ √ √ √ √
Probe Identifying - - √ √ √ √ √
Audio Play √ √ √ √ √ √ √
Attached Earphone √ √ √ √ √ √ √
Volume Adjustable √ √ √ √ √ √ √
Modes Switching - - √ √ √ √ √
Audio Recording
- - - - √ - √
and Playing
Powered by Alkaline
√ √ √ √ √ - -
Batteries
Powered by
Rechargeable * * * * * - -
NI-MH Batteries
Powered by NI-MH
- - - - - √ √
Battery Pack
Low Battery
Detecting & √ √ √ √ √ √ √
indicating
Auto Shutdown - - √ √ √ √ √
Vascular Examining √ * * * * * *
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2.2.1 Appearance
5
2
7 8 9 10 11
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SONOTRAX Lite and SONOTRAX Vascular have a LED in the bottom left corner of its
display panel area. When powered on, the LED turns green. If the LED flashes in green, it
indicates that the probe is disconnected or poorly connected. If the LED flashes in orange, it
indicates that the battery is too low to support working. Change for a new battery or charge the
rechargeable battery in time.
For SONOTRAX Basic, SONOTRAX Basic A, SONOTRAX Pro, SONOTRAX II and
SONOTRAX II Pro, the LCD is shown as follows:
1 2 3 4
5 6 7
2 Working Mode
3 Playing Indicator
4 Recording Indicator
5 Battery Indicator
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6 Numeric FHR
7 Probe Type
2.2.3 Buttons
At most there are three push buttons (MODE, START/STOP and REC/PLAY) and a volume
control button on the main unit of the Doppler. Their primary functions are as follows:
Function: Start/ stop examining (Mode 3)/ setting (Mode 4 and Mode 5).
(3) REC/PLAY
(Only for SONOTRAX Pro/ SONOTRAX II Pro)
2.2.4 Socket
The two sockets are located on the top panel of the Doppler.
(1) Earphone socket : for outputting audio signals, the earphone or line-in cable connects to
the Doppler via this socket.
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(2) Charge socket : for charging the NI-MH battery pack, the dedicated charger connects
to the Doppler via this socket. (For SONOTRAX II and SONOTRAX II Pro only)
NOTE:
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 60601-1-1. 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 60601-1-1. If in doubt,
consult our technical service department or your local distributor.
Jack Definition
1 Power Supply
2 Signal
3 Probe Coding 1
4 Probe Coding 2
5 GND
6 (Shell) GND
CAUTION
1 Do not try to connect any other plug to the probe socket except the plug of the probes
mentioned above.
2 Do not stretch the probe cable for more than two meters long.
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2.2.6 Batteries
2.3 Probes
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Open the package; take out the Doppler and accessories carefully. Keep the package for possible
future transportation or storage. Check the components according to the packing list.
Check for any mechanical damage.
Check all the cables and accessories.
If there is any problem, contact us or your local distributor immediately.
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CAUTION
The direction of the batteries should comply with the polar mark on the cover. Reversed
connection is forbidden.
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CAUTION
1 If the Doppler is not used for an extended period, take the alkaline/NI-MH batteries
out and store them in a cool and dry environment.
2 Do not remove the NI-MH battery pack frequently after initial installation.
3 If the Doppler is not used for an extended period, charge the NI-MH batteries or the
NI-MH battery pack at least every three months.
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CAUTION
Do not take out or place the probe when the Doppler is on. Remember to take out the
probe before switching on the Doppler, and place the probe after switching off the
Doppler.
CAUTION
Do not pull the probe cable directly.
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3.4 Switching on
Press the POWER button on the front panel to switch on the Doppler.
If the probe is not connected or poorly connected, the LCD display a flashing “--- MHz” sign.
You should reconnect the probe properly.
When the probe is well connected, the LCD stops flashing and shows the probe
frequency in the bottom right corner.
Press the button on the left panel, the doppler work mode switches
among these modes, and the work mode is shown in the top left corner of LCD.
When the doppler is swiched on, it enters mode 1 automatically.
Keep pressing the button until the working mode on LCD displays 4. Press the
button. The backlight is enabled when the LCD reads “ON”, and it is disabled when the LCD
reads “OFF”.
The setting in this mode is saved automatically after the mode is changed or normal power-off.
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The panes disappear gradually with the energy consumption. When the energy is low, the empty
battery symbol flashes and the Doppler gives sharp alarm sounds (NOTE: SONOTRAX Basic
does not give alarm sound). Approximately five minutes later, the Doppler shuts down
automatically.
You should replace the batteries or charge the rechargeable batteries.
CAUTION
Make sure the Doppler is shut down before charging the battery or opening the battery
compartment.
When the alkaline batteries are low in energy, they should be removed from the main unit, by
using the procedures described in section 3.2 Installing/Replacing Battery. Dispose of them
according to local regulations.
New alkaline batteries with identical specifications are required. Install them to the Doppler as
introduced in section 3.2.
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WARNING
DO NOT CHARGE THE ALKALINE BATTERY.
WARNING
1. Make sure the batteries are not connected reversely before plugging the charger into
the power socket.
2. The battery charger meets the requirements of Standard IEC60950, and it should be
placed outside the patient environment when it's working (1.5m away from the
patient).
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WARNING
The AC-DC power adapter meets the requirements of Standard IEC60950, and it should
be placed outside the patient environment when it's working (1.5m away from the
patient). The Doppler is not available for examining during charging.
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Chapter 4 Examining
4.1 FH Examining
Before applying the Doppler for fetal heart (FH) examining, a proper probe should be chosen.
The 2.0 MHz obstetrical probe is optimized for deep penetration and late pregnancy. The 3.0
MHz obstetrical probe has higher sensitivity and is optimized for early pregnancy (after 10 weeks
gestation).
NOTE:
In some cases, fetal heart beats at 10 weeks gestation can not be detected due to the
maternal physical difference and the operator’s technique.
If the Doppler works in mode 1, the numeric is the real-time heart rate, it changes continuously.
If the Doppler works in mode 2, the numeric is the average of every 8 heart beats, it changes
slowly.
If the Doppler works in mode 3, press the button once and start counting immediately,
viz. count one at the moment when the button is pressed. The LCD shows a flashing heart shape
symbol and “---”. Press the button again on the 10th count (after nine beat intervals). The
Doppler calculates and displays the average FHR over the 10 beats. This rate value will not
disappear until another measurement starts or the mode is changed.
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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 impossible to examine FHR unless a fetal heart sound is present. The fetal pulse
can be distinguished from the maternal pulse by feeling the mother’s pulse during
the examination.
Recording:
In mode 1, 2 or 3, press and hold the button for three seconds, the machine starts recording,
and the LCD reads .
The longest record time is 240 seconds. When the time is up or the button is pressed again,
the Doppler stops recording and returns to the real-time status.
NOTE:
Only the last set of recorded fetal heart sounds is saved in the Doppler. It is cleared
when new sounds are recorded.
Playing:
When the machine is not recording in mode 1, 2 or 3, press the button once, the machine
plays the recorded sound, and the LCD reads .
When the recorded sound comes to the end or the button is pressed again, the Doppler
stops playing and returns to the real-time status.
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NOTE:
Observe the LCD, pay attention not to mistake the recorded fetal heart sound for the
real-time sound.
(the socket with the symbol “ ”) of the PC, refer to figure 4-1. If the PC has no audio input
socket, insert the plug into the microphone socket (the socket with the symbol “ ”).
Turn on PC and run the sound recorder (Click on Start > Programs > Accessories >
Entertainment > Sound Recorder). Refer to figure 4-2.
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Perform FHR examination with the method described in section 4.1. When the ideal signal is
detected, unplug the earphone (if it’s connected) and insert the other plug of the audio cable into
the earphone socket on the Doppler.
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c) If the line in or/and microphone volume control is/are not shown in the Volume Control
menu, click on Options > Properties, tick Line In and Microphone as shown in figure 4-6,
click on OK:
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WARNING
The Doppler is not intended for ophthalmic use. Do not use it for examining ophthalmic
vessels, or any other procedures which may cause the ultrasound beam to pass through
the eye.
4MHz, 5MHz or 8MHz vascular probes are to be connected to the Doppler to perform vascular
examination.
Choose the appropriate probe as required. The probe with how frequency has a deeper
penetration depth, while the probe with high frequency has better resolution and wider detecting
range. The 4MHz vascular probe is optimized for examining blood vessels; the 5MHz vascular
probe is optimized for examining deeper vessels, and the 8MHz vascular probe is optimized for
examining surface vessels.
Apply a liberal amount of gel on the site to be examined. Place the probe at a 45º angle on the skin
over the vessel to be examined. Adjust the position of the probe to obtain the loudest blood flow
sound. Refer to figure 4-8 for the probe sites:
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Vascular examination only provides audio signals of arteries and veins. The figure displayed on
the LCD screen is null.
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Safety:
Complies with: IEC/EN 60601-1, IEC/EN 60601-1-2, IEC/EN 61266
Classification:
Anti-electric Shock Type: Internally powered equipment
Main Unit
Size: 34 mm × 89 mm × 141 mm (Depth×Width×Height, ±1mm)
Weight: <300 g (including the battery)
Probe
Weight: 100g
Cable Length: 2.5m
Size: 88mm (diameter)×35mm (thickness)
Environment:
Working:
Temperature: +5°C ~ +40°C ( +41 ºF ~ +104 ºF)
Humidity: 25% ~ 80% (non-condensing)
Atmospheric Pressure: 860hPa ~ 1060hPa
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Display:
45mm*25mm LCD display
FHR Performance:
Sensitivity: 10 weeks gestation (3MHz)
FHR Measuring Range: 50bpm ~ 210bpm
Resolution: 1bpm
Accuracy: ±3bpm
White Backlight:
Two Brightness Adjustable: OFF, ON
Ultrasonic Gel:
Weight: 60g
Acoustic Impedance: 1.533 106Pa . s/m
SONOTRAX Basic 9 hr 8 hr /
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SONOTRAX Basic A 9 hr 8 hr /
SONOTRAX II / / 8 hr
SONOTRAX Pro 9 hr 8 hr /
SONOTRAX II Pro / / 8 hr
Ultrasound
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Chapter 6 Maintenance
6.1 Maintenance
You must check that the equipment does not have visible evidence of damage that may affect the
patient and the operator’s safety or the Doppler’s capability before each use. Pay special attention
to the cracks on the probe and the cable before immersing them into conductive fluid. If the
damage is evident, replacement is recommended.
The probe is frangible and must be handled with care.
Wipe the remaining gel after use to prolong the probe life.
The overall check of the Doppler, including safety check and function check, should be
performed by qualified personnel every 12 months, and each time after service. Besides the above
requirements, comply with local regulations on maintenance and measurement.
6.2 Cleaning
Before cleaning, switch off the Doppler.
Keep the exterior surface of the device clean and free of dust and dirt.
Clean the exterior surface (display screen included) of the main unit with a dry, soft cloth. If
necessary, clean it with a soft cloth soaked in soap water and then wipe it dry with a dry cloth
immediately.
Wipe the remaining coupling gel off the probe. Clean it with a soft cloth dampened in solution
(soap water, 70% ethanol or isopropranol alcohol) and then air-dry it or wipe the moisture with a
soft dry cloth.
CAUTION
1 Clean the main unit with soap and water only. Avoid strong solvent, such as acetone.
2 Never use an abrasive such as steel wool or metal polish.
3 The main unit is not waterproof. Do not immerse any part of it into liquid.
4 Avoid pouring liquids on the main unit while cleaning.
5 Do not remain any solution on the surface after cleaning.
6 Only the body and cable of the probe are waterproof. Do not immerse the probe
socket into any liquid.
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CAUTION
1 Pay attention not to immerse the probe socket into the disinfector.
2 The main unit is not waterproof, do not disinfection it.
3 Never try to sterilize the probe or the main unit.
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CAUTION
Only the parts supplied by the manufacturer should be used with the Doppler.
Accessory
Earphone 01.14.104751
Consumable
- 36 -
The SONOTRAX Series Ultrasonic Pocket Doppler is intended for use in the electromagnetic
environment specified below. The customer or the user of the device should assure that it is used in such
an environment.
The SONOTRAX Series Ultrasonic Pocket Doppler is intended for use in the electromagnetic
environment specified below. The customer or the user of the device should assure that it is used in such
an environment.
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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.
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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 SONOTRAX Series Ultrasonic Pocket Doppler is used exceeds the
applicable RF compliance level above, the SONOTRAX Series Ultrasonic Pocket Doppler should be
observed to verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as reorienting or relocating the SONOTRAX Series Ultrasonic Pocket Doppler.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
The SONOTRAX Series Ultrasonic Pocket Doppler is intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the SONOTRAX Series Ultrasonic Pocket Doppler as
recommended below, according to the maximum output power of the communications equipment.
For transmitters rated at a maximum output power not listed above, the recommended separation distances
in metres (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.
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T 20 4.8 4.0 -
50 45.7 0 57.6 186 94 5.93 109.2
Ba 40 9.6 8.0 -
T 20 4.8 3.4 -
75 45.7 0 56.4 175 90 5.78 107.8
1.58 Ba 40 9.6 6.8 -
A=45.7dB@
2MHz T 20 4.8 3.4 -
100 45.7 0 56.4 174 89 5.82 107.9
Ba 40 9.6 6.8 -
T 20 4.8 - -
200 45.7 0 49.6 173 90 5.68 100.9
Ba 40 9.6 - -
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1.58 T 10 4 - -
A=44.5dB@ 50 0 61.5 179 90 5.97 111.9
3MHz Ba 43.6 17.9 - -
T 10 3 - -
75 0 57.2 186 94 5.93 107.63
Ba 43.6 13.5 - -
T 10 3 - -
100 0 57.2 173 88 5.87 107.5
Ba 43.6 13.5 - -
T 10 1 - -
200 0 50.2 171 89 5.67 100.3
Ba 43.6 6.5 - -
2.38 T 10 4 - -
A=42.0dB@ 50 0 61.5 194 88 6.73 110.2
3MHz Ba 43.6 17.9 - -
T 10 3 - -
75 0 57.2 172 87 5.92 105.1
Ba 43.6 13.5 - -
T 10 2 - -
100 0 53.2 165 85 5.76 100.9
Ba 43.6 9.6 - -
T 10 1 - -
200 0 50.2 160 84 5.59 97.8
Ba 43.6 6.5 - -
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