Sonomed SONOMED DOPPLER MD4 User manual

ULTRASOUND
BLOOD - FLOW DETECTOR
SONOMED DOPPLER
Type MD4 and MD4-CW8
USER MANUAL
Ed. 6, Warszawa, 2017
Sonomed Ltd POLAND Warsaw 02-118 , Pruszkowska 4 d
Phone [phone], fax [phone]
www.sonomed.com.pl

Application
The pocket size Doppler blood flow detector is a simple device enabling a wide range of easy and reliable
diagnosis of blood flow in the vessels.
The Doppler probe is positioned over the examined vessel. The pencil type probe should be between 45 and
60 degree to the skin surface.
The Doppler signal detected in normal arteries generally contains easily differentiated flow phases; first,
louder with higher frequency (higher pitch) and next, with lower intensity and frequency (lower pitch). First
sound is like a strong whistle of wind, remaining two are like more silent noise. In a little narrower arteries
second phase disappear. In extremely narrow arteries (more than 50 %) there is heard only first phase suited to
systole. One-phase signal has usually high frequency and sounds like hiss. Under narrowing, sound has complex
character. It’s contained from high frequency suited to acceleration of flow with put, loud, booming tone which is
connected with disturbing flow from narrowing.
The Doppler signal from the stenosed vessels has higher frequency in the first, systolic phase. The successive
phases are considerably faded down or they disappear completely.
The Doppler diagnosis helps to investigate blood flow, localize the stenosis and occlusions. The unit is
applicable, helpful and it can successfully replace the stethoscope for measurements of blood pressure in patient
with difficult to hear Korotkoff sounds. This application is especially important in detecting of peak systolic
pressure (measured with cuffs and sphygmomanometer). The most common application is ABI (ankle brachial
index) calculation.
Operation
Sonomed Doppler is easy and handy to use. The unit design was though to simplify its use reducing to
minimum controls - volume up/down and on/off switches.
The front of the probe or patients skin should be covered with Ultrasound Gel in the way assuring good
acoustic coupling. It’s better to use more than less Ultrasound Gel. The automatic noise control reduces initial
noise and strong signals from probe movements. Despite of this during putting Ultrasound Gel at the probe it isn’t
advisable work with maximal volume. It is recommended to avoid use of an excessive force pressing probe on
patient’s body during examination by probe’s head as it could cause a pain. Sometimes Ultrasound Gel can also
breed skin’s allergy.
For shipment and transportation probe could be disconnected from main unit. Push-pull probe connectors are
marked and situated on side of the main unit. A pair of connectors is symmetrical, generally do not care
to the connecting order (with flat transducer, due the geometry, and only in difficulties it is worth to check both
positions). The self-latching mechanism of connectors protects of pulling out by the cable. To disconnect always
pull the metal part of the connector!
The basic version operates at ultrasonic frequency 5MHz that is the most common to cover wide range of
applications. 8MHz model is also offered. The pencil type transducers are offered as standard, other shapes like
flat one with “pre-set” Doppler angle are available.
To turn on the device – press button ON, to turn off - press OFF. To increase the volume - press to
decrease .
The continuous green LED light indicates that the unit is turned on. The pulsating green light shows that the
batteries should be recharged. When the unit is not used for a few minutes or batteries are low, it will be turned
off automatically.

To charge plug the chargers mini-jack to the main unit and connect to the mains. The red LED near
connector should shine. While charging the use of the device is excluded. If battery is completely discharged
turning on in correct way won’t be possible. It’s forbidden to continue work with pressing button ON. First of all
battery should be charge. The full battery charging time is 15 hours.
During charging the red light near headphone socket becomes weaker
and disappears.
Charging must be performed outside the patient area. A sample of
such area is shown on the drawing.
The integrated speaker allows listen to the signal of blood flow but the device also allows the doctor to listen
privately - plugging in the headphones automatically turns off the speaker. To connect the headphones there is the
same mini-jack socket as for the charger.
Maintenance
Sonomed Doppler should be operated within the range of environment temperature from 10oC to 45oC by
relative humidity not exceeding 85% and atmospheric pressure 70-106 kPa. Do not expose it neither to extreme
heat nor to extreme cold.
Special care is necessary for the probe. Mechanical shock is to be avoided, and special precautions are needed
with the ultrasonic probe since it can get damaged when hit by a hard surface. The probe can be cleaned by means
of a soft tissue, dampened with water or weak alcohol. Do not scratch. Do not use organic solvents. Only mild
cleaning and disinfecting liquids are recommended (with water or alcohol). Probe should be cleaned immediately
after use. Before examination working part of the probe should be disinfected by certificated liquid preparation
according to producer’s instruction (don’t soak cables and connectors). In case of risk that probe may contact with
hurt skin it’s advice to use a sterile cover on the probe.
Advices
When SONOMED DOPLER couldn’t be turned on it’s helpful to charge the battery.
When there isn’t any noise from speaker it must be checked if the headphones are not plugged.
When it’s difficult to obtain a Doppler signal it’ s important to check if correct probe is used and
Ultrasound Gel applied in satisfying quantity.
Repairs to the device
In case of damage or of any queries whatsoever, concerning the correct operation of the device, please contact
service. There are no user serviceable parts inside unit. Do not open it.
The service check of the device should be performed in third, fifth and seventh year since purchase. The intended
lifetime of the instrument is 10 years.
Attention: when charger is wet, poured a liquid over or with broken housing plugging to the mains is forbidden.
The proper operation of the charger is confirmed by shining diode. Battery can by charge only by charger which
is delivered by the Manufacturer. While device charging it’s use is forbidden.
The device has limited immunity to electromagnetic disturbance. Avoid operation near of their sources (for
example mobile phones) recommended protecting distances are mentioned in the tables.

Declaration of Conformity EC
no 08/2017/EN
Sonomed Sp. z o. o.
02-118 Warszawa
Ul. Pruszkowska 4 d
Poland
Tel. [phone]
Fax. [phone]
As a Manufacturer of the
SONOMED Doppler Blood Flow Detector
MD4, MD4-CW8
Declares that According rule 10 MDD 93/42 and Rozporządzenie Ministra
Zdrowia dated 5 11 2010; DZ U 215 poz. 1416 is a medical device class IIa
Device has been designed and manufactured in a way to conform Medical Devices Directive 93/42/EEC and to the
following European Union harmonized standards
PN-EN 60601-1: 2011 / A1:2014-02
PN-EN 60601-1-2: 2007 / AC:2010
PN-EN 60601-1-6: 2010
PN-EN 60601-2-37: 2008
PN-EN ISO 14971: 2012
PN-EN 62366-1:2015
PN-EN 980: 2010
PN-EN 1041: 2010
The assesment was done with Notified Body 2460
signed
Warszawa, 30 08 2017
President
Paweł Karłowicz

The device is offered in a dedicated plastic suitcase.
Standard package includes:
the Doppler unit, ultrasonic transducer CW5 (for MD4-CW8: CW8 option FCW8)
, battery charger, gel, user manual, headphones.
MDD Directive 93 / 43 EEC
Class IIa
Specification
Ultrasonic frequency
model MD-4 5 MHz
model MD4-CW8 8MHz
Audio output-loudspeaker >200mW
Frequency response 300 Hz-6 kHz
Ultrasound output P_<1MPa, Iob<20mW/cm2, Ispta<100mW/cm2
Rechargeable battery 3.6V, 1500mAh
Operating time (continuous) approx. 6 - 15h
Charging time 15 h
Dimensions 170x75x25mm.
Weight with battery 280 g
Headphone acoustic output mini jack 3.5
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