Manual de Servicio Doppler Edan Sonotrax
Manual de Servicio Doppler Edan Sonotrax
Manual de Servicio Doppler Edan Sonotrax
SONOTRAX Series
EC Declaration of Conformity
Manufacturer: EDAN Instruments, Inc.
Addr: Energy Bldg., 2009 Nanhai Rd., Nanshan, Shenzhen, Guangdong province, 518054 P.
R. China
European Representative:Shanghai International Holding Corp. GmbH (Europe)
Addr: Eiffestrasse 80 D-20537 Hamburg Germany
Product: Ultrasonic Pocket Doppler
Model: SONOTRAX Lite, SONOTRAX Basic, SONOTRAX Basic A, SONOTRAX Pro,
SONOTRAX II, SONOTRAX II Pro
Classification (MDD, Annex IX): IIa
We herewith declare that the above mentioned product(s) meet the transposition into national
law, the provisions of Council Directive 93/42/EEC of 14 June 1993 concerning medical
devices - as amended by Directive 98/79/EC on in vitro diagnostic medical devices.
All supporting documentation is retained at the premises of the manufacturer.
DIRECTIVES
General Applicable Directives:
Medical Device Directive: COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning
medical devices (MDD 93/42/EEC).
Standards applied: EN ISO 9001, ISO13485, EN ISO14971, EN ISO10993-1, IEC 601-1, EN
60601-1-1, BS EN 60601-1-4, IEC 60601-1-2, EN 61157, EN 1041, EN 60417-2-2000,
IEC/TR 60878-2003, EN 980, EN 55011, ISO 1000, YY 0111-93, EN 61266, EN ISO 780 ,
GB/T 14740, GB/T 15464
Notified Body: TV SD Product Service GmbH, Ridlerstr 65, D-80339 Mnchen, Germany.
Identification number
Copyright
Copyright Edan Instruments, Inc. 2007. All rights reserved.
Attention
Edan Instruments, Inc. (hereinafter called EDAN) makes no warranty of any kind with regard
to this material, including, but not limited to the implied warranties of merchantability and
fitness for a particular purpose. EDAN assumes no responsibility for any error that may
appear in this document, or for incidental or consequential damage in connection with the
furnishing, performance or use of this material.
No part of this document may be photocopied, reproduced or translated to another language
without prior written consent of EDAN.
The information contained in this document is subject to change without notice.
for clinical use. If the FHR result is distrustful, please use other
methods such as stethoscope to verify immediately.
ii
Table of Contents
Chapter 1 Overview ................................................................................................................ 1
1.1 Appearance ...................................................................................................................................... 1
1.1.1 Display Panel ........................................................................................................................ 2
1.1.2 Buttons.................................................................................................................................. 2
1.1.3 Sockets.................................................................................................................................. 3
1.2 Technical Specifications .................................................................................................................. 3
1.2.1 Type of Instrument................................................................................................................ 3
1.2.2 Power Supply........................................................................................................................ 3
1.2.3 Normal Operating Environment............................................................................................ 4
1.2.4 Physical Characteristic.......................................................................................................... 4
1.2.5 LCD Display ......................................................................................................................... 4
1.2.6 Specification of Probes ......................................................................................................... 4
Chapter 5 Warranty.............................................................................................................. 22
iii
Chapter 1 Overview
SONOTRAX Series Ultrasonic Pocket Doppler is an advanced obstetrical unit, which can
meet routine examination requirements of obstetricians. They can also used for vascular
monitoring (optional).
There are six different models available: SONOTRAX Lite, SONOTRAX Basic,
SONOTRAX Basic A, SONOTRAX Pro, SONOTRAX II and SONOTRAX II Pro.
SONOTRAX Lite is for simple auscultation (intermittent listening). SONOTRAX Basic,
SONOTRAX Basic A, SONOTRAX Pro, SONOTRAX II and SONOTRAX II Pro are not
only used to listen in the fetal heart, they also display the fetal heart rate on a LCD screen.
1.1 Appearance
Take example for 2.0MHz waterproof probe.
Figure 1-1 Front Panel
-1-
Playing
FHR Refresh
Frequency
Recording
FHR Display
Battery Indicator
Probe Type
1.1.2 Buttons
At most there are four push buttons (Power, MODE, START/STOP and REC/PLAY) and a
volume control button on the SONOTRAX Series Ultrasonic Pocket Doppler. Their primary
functions are as follows:
(1) Power Button
Function: Switch on or off the Doppler.
Function: Start/ stop monitoring (Mode 3)/ setting (Mode 4 and Mode 5).
(4) REC/PLAY
(Only for SONOTRAX Pro/ SONOTRAX II Pro)
Function: Adjust volume. Rotate the volume gear clockwise to turn up the volume, while
rotate it anti-clockwise to turn down the volume.
1.1.3 Sockets
The two sockets are located on the top panel of the Doppler.
(1) Earphone socket
GND
Signal
Signal
Signal
Signal
4
5
2
1
Monitor Type: This product belongs to type B portable ordinary device classified by medical
electric equipment safety standard.
This product is a kind of ordinary equipment without ability of preventing liquids from
entering.
-3-
Weight:
3bpm
-4-
Chapter 2 Principle
2.1 Principle of Probe
The sine wave signal generated by an oscillator is amplified and matched in impedance by
FEFT and transformer, then be sent to the transmitting crystal of probe. The ultrasound
emitted from the crystal reflects when meeting an obstacle. The receiving crystal receives the
echo signal, after a process of demodulating, filtering and amplifying, this signal can be used
by the mainboard.
Signal envelope
and compare
-5-
FHR
LCD
display
on
-6-
-7-
1: TDO
3: TMS
5: GND
7: 3.3V
2: TDI
4: TCK
6: RST
8: NC
2) Feel the fetal heart position with hand, apply some gel on the acoustic surface of the probe
and put the probe on the position. Move the probe slowly until clear audio signal is heard.
Thus it can be seen that the probe plays an important role in FHR monitoring, the probes
veracity has a direct bearing on the FHR accuracy. Inspect the probe with the following
procedure:
1) Install the battery, press the POWER button to turn on the Doppler;
2) Adjust the volume to make the sound be heard clearly;
3) Hold the probe with one hand, knock the acoustic surface gently with a flat-bottom pencil
or similar objects. Listen to the sound, change for a new probe if the sound isnt normal.
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Chapter 3 Service
3.1 Disassemble the Doppler
3.1.1 Remove the Probe
Place the probe in the following steps: (Take example for 2.0MHz waterproof probe.)
1) Hold the main unit with one hand, and hold the top of the probe with another hand (Figure
3-1).
2) Take out the top of the probe (Figure 3-2).
3) Take out the whole probe from the frame (Figure 3-3).
4) Pull out the plug of the probe from its socket (figure 3-4).
Figure 3-1
Figure 3-2
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Figure 3-3
2) Press down the stripe symbols (that without arrowhead) with one thumb, at the same time
slide the battery cover out along the direction of arrowhead with the other thumb (Figure
3-6);
Figure 3-5
Figure 3-6
3) Take out the battery out from the compartment a little and disconnect the battery from the
connector (Figure 3-7);
For SONOTRAX Basic, SONOTRAX Basic A, SONOTRAX Pro SONOTRAX II and
SONOTRAX II Pro Ultrasonic Pocket Doppler, hold the battery connector cables and pull
the plug out from the socket inside the case (figure 3-8).
Figure 3-7
Figure 3-8
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Information
Label
Buttons
Label
4) Disjoin the case, the Doppler unit consists of five parts: front panel, rear panel, speaker,
LCD and PCB.
Figure 3-10 Main Parts of the Unit
LCD
Front Panel
PCB
Speaker
Rear Panel
5) Hold the two edges of LCD and unplug it from its socket on the PCB (figure 3-11).
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6) Unplug the speaker connector from the socket on the PCB; Apply a few drops of alcohol
to the heat-melting adhesive that sticks the speaker to the front panel (figure 3-12), take
out the speaker after the glue is melted.
Figure 3-12 Heat-Melting Adhesive on the Speaker and the Speaker Connector
Speaker Connector
Heat-melting Adhesive
7) Unplug the battery plug of SONOTRAX Lite from its socket on the PCB (figure 3-13).
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Battery Plug
8) Remove the three screws shown in figure 3-14 to take the PCB off from the rear panel.
Figure 3-14 The screws that fix the PCB
PCB screws
- 15 -
3.2 Troubleshooting
3.2.1 Operation failure
Phenomenon
Possible Cause
The battery has run down.
The
volume
control
damaged.
The PCB is damaged.
button
Solution
Renew or charge the battery.
is Renew a POWER button.
Renew a PCB.
is Renew a volume control.
Renew a PCB.
is Renew a POWER button.
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Possible Cause
Solution
Renew the LED/LCD.
Renew the PCB.
Renew a probe.
Renew a PCB.
Renew a LCD.
System error.
The probe is damaged.
Renew a PCB.
Strongly
interfered
electromagnetic field.
Sound with noise
No output from
earphone.
The LED/LCD is dim,
the speaker volume is
down.
Renew a speaker.
Renew a socket.
Renew a PCB.
3-11).
5) Line up the front panel Line three posts of the front panel and their corresponding holes
on the rear panel (figure 3-15), join the two panels together tightly.
Figure 3-15 Posts and Holes
6) Fix the case with two 3x6 screws and three 3x10 screws (figure 3-16).
Figure 3-16 Fixing screws
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4.2 Cleaning
Before cleaning, switch off the power and take out the batteries.
Keep the exterior surface of the device clean and free of dust and dirt, clean exterior surface
(display screen included) of the unit with a dry, soft cloth. If necessary, clean it with a soft
cloth soaked in a solution of soap, or water and wipe dry with a clean cloth immediately.
Wipe the probe with soft cloth to remove any remaining coupling gel. Clean with soap and
water only.
CAUTION
CAUTION
CAUTION
CAUTION
CAUTION
NOTE: Wipe the surface of probe with 70% ethanol or isopropranol alcohol,
self-air dry, or clean with a clean, dry cloth.
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4.3 Disinfecting
Clean the equipment exterior surface, probe, etc. as above. For the disinfecting of 2.0 MHz
waterproof monitoring probe/ 2.0MHz waterproof probe/ 3.0MHz waterproof probe, immerse
the probe into the solutions of Benzalkonium Bromide, 0.5% Chlorhexidine, 2%
Glutaraldehyde or 75% ethanol to disinfect. Wipe the probe with a clean, dry cloth to remove
any remaining moisture.
NOTE: Please pay attention to the height when the probe is immersed in order
to prevent the sterilant from entering the probe socket.
CAUTION
Part Number
MS2-14019
MS3-14214
MS3-14320
MS3-14321
MS3-14346
MS3-14347
M21-64048
M21R-64083
M21R-64082
Earphone
M13-36041
Carry Bag
MS1-14268
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Chapter 5 Warranty
EDAN warrants that the SONOTRAX series ultrasonic pocket Doppler we sell is free from
defects in material and workmanship. In the status of normal operation and maintenance, if
EDAN receives notice of such defects during the warranty period ( 12 months starts from the
date of purchase), EDAN shall, at its option, either repair or replace hardware products which
prove to be defective.
This unit has no parts that can be repaired by the users. The equipment must be serviced only
by authorized and qualified personnel.
If the product doesnt function as warranted during the warranty period, EDAN will repair or
replace it without charge. Contact us if needed.
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