I-Tech Mio-Sonic User manual

USER MANUAL
Ultrasound therapy
MIO-SONIC

IACER Srl i MNPG71-06
Index
INDEX I
TECHNICAL INFORMATION 2
MANUFACTURER 2
DECLARATION OF CONFORMITY 2
CLASSIFICATION 3
PURPOSE AND SCOPE 3
TECHNICAL FEATURES 3
DEVICE AND COMMANDS DESCRIPTION 5
LABELLING 5
Package content 6
HOW TO USE 7
INTRODUCTION TO THE TECHNOLOGY 7
CONTRAINDICATIONS 9
Side effects 9
WARNINGS 9
DEVICE USE 11
Antalgic and de-contracting treatments 14
Beauty treatments 15
DEVICE CARE 19
MAINTANCE 19
TROUBLESHOOTING 20
DISPOSAL 21
WARRANTY 21
Support 22
Spare part 23
ELECTROMAGNETIC INTERFERENCES AND ELECTROMAGNETIC COMPATIBILITY TABLES 23

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Technical Information
Manufacturer
I.A.C.E.R. S.r.l.
Via Enzo Ferrari, 2 • 30037 Scorzè (VE)
Tel. [phone] • Fax [phone]
IACER Srl. is an Italian manufacturer of medical devices (certified CE n°
0068/QCO-DM/235-2020 from the Notified Body n° 0068 MTIC InterCert
S.r.l.).
Declaration of conformity
I.A.C.E.R. S.r.l
Via Enzo Ferrari, 2 –30037 Scorzè (Ve), Italia
herewith declares under its own responsibility, that the product
MIO-SONIC
UMDNS Code: 11248
has been designed and manufactured according to the European Medical
Device Directive 93/4/EEC (transposed in Italy by the D.Lgs. 46/97), as
modified by the Directive 2007/47/EC (D.Lgs.37/2010) and further
modifications/integrations.
The product has been assigned to class IIa, according to Annex IX, rule 9 of
the Directive 93/42/EEC (and further modifications/integrations) and bears
the mark
Compliance of the concerned product with the Directive 93/42/EEC has been
assessed and certified by the Notified Body:
0068 –MTIC InterCert S.r.l.
Via G. Leopardi 14, Milano (MI) 20123
Certified number: 0068/QCO-DM/235-2020
following the certification procedure according to Annex II (excluding point 4)
of the Directive 93/42/EEC.
________________ _____________________
Place, date Legal Representative
MASSIMO MARCON
Scorzè, 31/01/2022

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Classification
The MIO-SONIC has the following classification:
•class IIa (Directive 93/42/EEC, Annex IX, rule 9, 10 and further
amendments);
•class II with BF type applied part (classification EN 60601-1);
•unprotected device, IPX0 protection degree based on penetration of
liquids and dust. Degree of protection IPX7 is for the treatment head.
DEVICE NOT SUITABLE FOR USE WITH IMMERSION;
•equipment and accessories not subject to sterilization;
•equipment unsuitable for use in presence of a flammable anesthetic
mixture containing air, oxygen and nitrous oxide;
•equipment suitable for continuous operation;
•equipment unsuitable for outdoors use.
Purpose and scope
Clinical intended use: Therapeutic and aesthetic
Environmental intended use: Ambulatory
The MIO-SONIC device for ultrasound therapy is ideal for the treatment of
muscular and nervous pathologies and for the recovery of traumas, in case of
both chronic and acute pathologies.
In fact, ultrasound therapy is indicated for antalgic treatments and relaxation
of contracted muscles, in the treatment of neuritis and sciatalgia, joint
calcifications, tendinitis, hematomas and contractures.
Very suitable also for applications in the aesthetic field, for the treatment of
cellulite, tissue regeneration, vascularization and lymphatic drainage. For
details, treatable pathologies, specific methods of application and use of the
programs, see the chapter dedicated to the use of the device.
The population of patients for electrotherapeutic treatment
using the MIO-SONIC device includes patients of both sexes, men and
women, adults (unless otherwise indicated). For more details, please refer to
Contraindications
Technical features
Characteristics
Specifications
Power supply
Medical power model GJ24WA-1500120V
Input: AC 100/240V, 50/60Hz
Output: DC 15V, 1.2A

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Characteristics
Specifications
Isolation (EN 60601-1)
II
Applied part (EN 60601-1)
BF
Dimensions
(length x height x depth)
202x490x700mm
Weight
193g (power adapter not included)
Functioning
Continuous
Maximum power
6.4W ± 20% (modulation duty cycle at 100%)
Effective power
1.6W/cm² ± 20% (modulation duty cycle at
100%)
Frequency range
1MHz ± 10%
Frequency modulation
100Hz ± 10%
Waveform
Pulsed
Modulation duty cycle
L: 5%
M: 50%
H: 100%
Regolation intensity
Adjustable on 3 steps L-M-H
Ultrasound head
5 cm²
Effective radiant area
4 cm² ± 20%
Ultrasonic beam
Collimated
Head material
Alluminium
Conditions of use
Environmental
temperature
From +5° to +40°C
Relative humidity
From 30% to 75%
Atmospheric
pressure
From 800 to 1060hPa
Storage and transportation
conditions
Environmental
temperature
From -10° to +50°C
Relative humidity
From 20% to 93%
Atmospheric
pressure
From 700 to 1060hPa
Useful life of the device and its accessories: 2 years.

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Device and commands description
(1) Time indicator light
(2) Time button
(3) Power indicator light
(4) Intensity indicator light
(5) Mode button
(6) Power switch
(7) Ultrasound head
(8) AC/DC adapter connector
Labelling

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Symbols
Description
Manufacturer’s logo
Product CE certification released by Notified Body
n°0068.
Manufacturer
Manufacturing date (YYYY-MM)
Read instructions for use
WEEE Directive for the disposal of electronic waste
Applied part type BF
Class II device
IPX7
Degree of protection from temporary immersion under
water, up to 1m of depth and up to 30 minutes (only
for the ultrasound head).
Pay attention, Sign of danger
Package content
The MIO-SONIC package contains:
-n° 1 MIO-SONIC device;
-n° 1 medical power supply;
-n° 1 ultrasound gel;
-n° 1 transport bag;
-n° 1 user manual;
-n° 1 position manual.

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How to use
Introduction to the technology
The sound is given by a body vibration whose oscillation propagates in the air
with a certain frequency and reaches the human ear. The number of
oscillations (or pressure variations) per second is called sound frequency,
measurable in cycles per second, Hertz (Hz). For example, the human
auditory field goes from 20Hz up to 20,000Hz. The wavelength, on the other
hand, represents the space covered by the sound wave in a complete period
of oscillation.
Ultrasounds are mechanical sound waves, whose frequencies are higher than
those normally heard by a human ear. For years the mechanical waves of
ultrasounds, specially generated through piezoelectric materials, used in
various sectors of industry. In particular, the study of ultrasound wave
propagation in humans has allowed the construction of eco-diagnostic
medical instruments that have long been used in gynecology,
gastroenterology, angiology and cardiology; these technologies in fact exploit
the return echo deriving from an ultrasonic beam which propagates inside the
human body and which is slowed down in a different way depending on the
different anatomical structures it encounters.
Research has however shown that ultrasounds cause different biologic
effects, precisely because of the different impedance characteristic of the
various tissues. Among these effects, the thermal effect is the most known
and is the one who first has determined the use of ultrasounds in
orthopedics, physiatrist and sport medicine with pain relief function and in
aesthetic field for localized fat deposits and cellulite treatment.
The thermal effect consists in the
propagation of heat realized by the beam
of ultrasonic waves: by penetrating in the
biological tissues, the waves lose energy
and yield it to the system they pass
through; this energy transferred is
converted into heat with a significant
increase in local temperature, especially
at interface level between tissues with
different acoustic impedance (e.g.
bone/soft tissue), and with a
consequence increasing of the micro-

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circulation, which allows the dissipation of one part of the heat produced.
After that there are also non thermal effects related to the propagation of
ultrasonic waves: the mechanical effects are due to the strength applied by
the sound waves on the cells that thus undergo micro-displacements towards
areas with less pressure, getting into torsion and rotation phenomes, with
consequent formation of small vortices in the interstitial fluids (streaming).
These pressure variations generate biochemical and biological effects, that
occur like possible alterations of the permeability of cellular membranes and,
in the case of adipose cells, like the liberation of complex molecules such as
the fats contained in them, beyond which are then placed into the circulatory
system and largely disposed of through the lymphatic system and
microcirculation.
Finally, closely related to the biochemical effect is phonophoresis, which
consists of the ability of ultrasounds to introduce a drug into tissues.
Another non thermal phenomena is that of cavitation. Cavitation is a physical
phenomenon which consists into formation of steam zones within the fluid.
The dissolved gasses within the fluid they aggregate as a result of the
lowering of pressure realized by the ultrasound, forming bubbles or cavity
containing vapor and subsequently they implode for the displacement in
zones with a greater pressure. The energy which is then free produced
reactions in the surrounding zones.
In therapeutic field ultrasounds are obtained in an artificial way using the
proprieties of dilatation and compression of some mineral crystal when they
are subject to the action of an electric field. So the ultrasonic irradiation
generate vibrations and a consequent micro-massage of remarkable intensity,
acting in depth into tissues. The heat is therefore generated by this micro-
massage, whom consists in the impact and friction of the cellular and
intracellular structures affected by the beam of ultrasonic waves.
The ultrasonic therapy is particullary
indicated for all the patologies of the
locomotor system in which is desired an
antalgic effect, i.e. in general in the sciatalgia
and neuritis, in the periarticular calcifications,
in the Duplay disease, in the Dupuyten
disease, organized hematomas and scar
tissues, tendinitis, muscle contractures.
The ultrasounds can also been used efficacy
in the treatment of imperfections caused by

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the cellulite, reactivated the local circulation and reducing the “orange peel”
effect. They facilitate the absorption of active substance like essential oils,
fat-soluble vitamins (e.g. A and E vitamin) and water-soluble agents through
the epidemic layers, relaxing the tissue with appreciable results in the
relaxation of the wrinkles.
Finally, considerable results occur in activation of anti-inflammatory
processes that regenerate tissues in case of acne and furunculosis, in the fat
mobilization with the restoration of the tropism of cellulitic tissue and the
tissue balance, with positive impact on the lymphatic vascularization and
drainage.
Contraindications
It is absolutely prohibited the use of MIO-SONIC in patients with severe
arrythmia or has a pacemaker, with heart disease or severe cardiovascular
problems, suffers from epilepsy, phlebitis in place, thrombophlebitis, in
feverish state, anxiety or serious illnesses, vein thrombosis, severe
osteoporosis, inflammation, arteriopathies (except in case of medical
prescription). For treatment of children under 18 years of age, a medical
prescription is required and in any case consult your doctor.
Side effects
By the use of ultrasound may arise momentary inflammations in the treated
area, momentary increase of the pain, overdose injuries, reactions of the
nervous system or blood clotting. If such symptoms persist suspend the
therapy and consult your doctor.
Warnings
It is recommended:
•to use the device by keeping a distance of at least 3 meters from
televisions, monitor, mobile telephones or any other elettronic device
even if the devise doesn’t generate and receive any electromagnetic
interference by other devices.
•to avoid the use of the device by persons who did not read carefully this
manual.
•not to wear metal objects during treatment;
•to use ONLY accessories supplied by device manufacturer.
It is forbidden:

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•to use the device in the presence of patient monitoring equipment, of
electrosurgical or shortwave or microwave therapy equipment or other
equipment that sends electrical impulses into the body and in general in
combination to other medical devices, since it could cause problems to
the device;
•to use the device by persons known to be unsound-minded, or suffering
from sensibility disorders, permanently or temporarily disabled unless
assisted by qualified personnel (e.g. a doctor or therapist); by persons
younger than 12 years old or not adequately educated about the device
use by an adult person;
•to use the device in presence of signs of deterioration of the device
itself, cables and/or ultrasound head: please contact the dealer or the
manufacturer following the instructions given in the paragraph Support.
Control carefully the integrity of the device before each use;
•to use the device close to flammable substances/gas/explosives, in
environments with high concentrations of oxygen, with aerosol-therapy
devices or in wet environments (use of the device is prohibited in
bathroom or shower areas or while showering/bathing);
•to use the device while driving or during the operation and control of
equipment/machinery;
•the use of the device in hyposensitive areas, on the carotid sinuses
(carotid), genitals, near the uterus and abdomen, in the area of the body
in which glands are present. Also avoid using the device on the neck and
mouth. Finally, avoid treatment with direct exposure of the eye to the
ultrasonic beam;
•maintain the ultrasound head stationary on one point during the
therapy;
•to use pointed or sharp objects on the device keyboard.
Warning:
•pay attention to use connection cables with children/young people:
strangulation danger;
•do not mix connection cables up with earphones or other devices and do
not connect the cable to other equipment.
•The device is not intended for outdoor use.
The manufacturer considers himself responsible for the performances,
reliability, safety and security of the device only if:
•any addition, modification and/or repair are carried out by
authorized personnel;

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•the environmental electrical installation to which MIO-SONIC is
connected is compliant to the national laws;
•the instructions for use contained in this manual are strictly
followed.
Should any foreign materials penetrate the device contact the retailer or
manufacturer immediately. If dropped down, check that the housing is not
cracked or damaged in any way; if so, contact the retailer or manufacturer.
Should you notice any changes in the device’s performance during treatment,
interrupt the treatment immediately and consult the retailer or
manufacturer.
Consult a doctor before using MIO-SONIC with metallic
osteosynthesis devices.
IF YOU HAVE ANY DOUBTS REGARDING THE DEVICE USE CONSULT YOUR
DOCTOR.
Device use
Clean and disinfect the ultrasound head with a disinfectant solution before
and after the use.
To utilize MIO-SONIC:
1. connect the power supply to the device.
2. Move the switch to the ON position: the power
indicator (under the written POWER) will
illuminate, while the other six will begin to light
up alternatively and the head will start to
vibrate reporting that the device has
automatically preheating mode. When the
preset temperature is reached (after about 3
minutes) the six lights will flash 5 times, so the

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device will enter in standby mode. If the warming feature is not
needed, press both the MODE button and the TIME button
simultaneously, in this way the device will go back to standby mode.
When the device is in standby mode, the modulation duty cycle is
defaulted at 5% and the (L) indicator light will be illuminated.
DO NOT APPLY THE ULTRASOUND HEAD TO THE SKIN OF
THE PATIENT during the warming period! The device will
automatically exit the head warming feature if any load is
detected in the preheating process.
To restart the warming feature, you will have to power off the device
and turn it back on again.
3. Wash the area to be treated so that it is free
of oil and dirt. Apply a generous layer of
ultrasound transmission gel on the treatment
area. The gel is fundamental to ensure a
correct fit between the treated area and the
ultrasound head and so the efficiency of the therapy.
4. Press several times the MODE button to
select the modulation duty cycle. The mode
button has three levels, Low (L, preset),
Medium (M) and High (H).
5. Press several times the TIME button: the lights
will light up in seuqnce related to the 5-10-15
minutes of therapy and the device will start
working. Set the time, the device will start
automatically the treatment.
6. Place the ultrasound head on treatment area: is
important perform therapy moving
continuously and uniformly the ultrasound
head around the treatment area, with slow
and circular or vertical movements of at least
7-8 cm. PROHIBITED MAINTAIN THE

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ULTRASOUND HEAD STATIONARY IN ONE POINT DURING THE
THERAPY.
7. At the end of the therapy all the time lights
indicator will shut off. Move the switch on the
OFF button and unplug the device from its
power supply.
8. Clean the ultrasound head from the gel before
storing the device and its accessories in the bag. DO
NOT IMMERSE THE DEVICE IN WATER!
N.B. before storing the device and its accessories in the bag, disconnect the
cables. If this does not do, the cables may take excessive folds near the
connectors, that can cause a damage of the cables.
ATTENTION: it is recommended to use the ultrasound with the
intensity set on M. for H intensity is recommended maximum
attention in maintaining in continuous moving the ultrasound head.
The intensity L corresponds approx. to 0,08W/cm², the intensity M
approx. to 0,80W/cm² and intensity H approx. to 1,6W/cm².
ATTENTION: to ensure the safety of the patient, the device is
equipped with a recognition system of correct coupling between the
ultrasound head and the patient skin. In case of non-correct
coupling or inadequate contact, the light related to the period of
therapy will start light up.
ATTENTION: to ensure the safety of the patient, the device is also
equipped of a system for regulating the temperarure. In the case the
ultrasound head excees 42°C, the device will stop the treatment
and time indicator light will flash two times; it will not be possible
continue the treatment program until the temperature is below
40°C.

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Antalgic and de-contracting treatments
For the details and suggestions about the treatable pathologies with
ultrasound please refer to 1-2-3 pages of the PAIN ZONE AND TREATMENTS
POINT card included in the manual. In the figures of the table are indicated in
red color the pain areas, with blue color the treatment points (trigger points).
The pain areas may not match with the treatment points, as it is evidenced in
some illustrations.
It is recommended to execute a daily cycle of therapy, with an average
duration of 10 minutes each, for a maximum period of 21 days. In case the
pain persists, stop for 7 days the treatment and eventually restart another
therapy cycle of 21 days.
Pathology
Intensity
Frequency
Headache
L
Daily
Face pain
L
Daily
Mononeuropathy
L-M
Daily
Muscle pain
M-H
Daily
Cervical Rizopathy
L-M
Daily
Neuralgia
M-H
Daily
Sciatalgy
M-H
Daily
Knee pain
M-H
Daily
Trapezium pain
M-H
Daily
Lumbalgy
M-H
Daily
Thigh pain
M-H
Daily
Neck pain
L-M
Daily
Shoulder pain
L-M
Daily
Elbow pain
L-M
Daily
Rheumatic pains
L-M
Daily
Intercostal pains
L-M
Daily
Mestrual pains
L
Daily
Phantom limb pain
L-M
Daily
Hip pain
M-H
Daily
Knee osteoarthritis pain
M
Daily

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Beauty treatments
Cavitation and aesthetics
In medical field, for dermatological diagnosis and applications, is used sound
waves frequencies between 1 and 16MHz for both thermal antalgic effect
who can produce, for both controlled cavitation to use to remove the kidney
stone (shock wave lithotripsy), which are crushed right through the formation
of micro-bubbles which imploding erode solid formations inside the kidneys.
Furthermore, cavitation is also used in aesthetic medicine to eliminate or
reduce adiposities, a technique that has been called non-surgical liposuction.
In particular the cellulite is a disturb that affects the ipoderm, a tissue which
is found under the derm and that has a mainly adipose nature; the
conseguence is the increase of the volume of the adipose cells, of the water
retention and of the stasis of liquids in the intercellular spaces.
The cellulite can be divided:
•Compact: it creates an edema that is an accumulation of liquids and it
is present in the adipose tissue, especially arround the ankles, the
calves and it affects subjects with a good health and with a tonic
musculature.
•Flaccid: is manifested in middle-age people, with a ipotonic
musculature.
•Edematous: is the evolution of the compact cellulite and is manifested
in presence of circulation pathologies.
The cavitation used in aesthetic field consists inth eapplication of particula
low frequencies sound waves (0,03-3MHz) which generate inside the adipose
tissue vapour bubbles that implodes, releasing energy that disintegrates the
adipose cells and so transforms the local fat in an easly eliminable form with
the help of a correct dreinage of the lymphatic system and of the urinary
tract.
If from many years the application of ultrasound was used with 3MHz
frequencies, more recently the development of knowledge induced the
producers of ultrasounds and cavitation equipments to reduce the
frequencies of employment, because the ability of ultrasounds to penetrate
in depth is inversely proportional at the beam of ultrasound frequency;
consequently today 3MHz, 1Mhz, up to 0.03MHz devices are commercially
available.

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Application
The ultrasound head must evenly act on the treated zone, so as to evitate
that in the untreated area remain substantial and unsightly adipose
formations.
IT MUST ALSO BE MAINTAINED IN A CONTINUOUS MOVEMENT TO
PREVENT THE OVERHEATING OF THE TREATED AREA.
The ultrasound head it must be maintained in a continuous contact with the
treated area with the use of a conductive gel, better if the gel has an active
substance.
Always act on an area of up to 20x20cm for about 10 minutes for then pass in
nearly area, until have treated all the affected area (a complete thigh
treatment depends of the thigh dimentions and will vary from 20 to 30
minutes). This job can be performed at intervals of hours or days between an
area and the adjacent one or in rapid sequence.
The use of lotions or gel containing active principles, promotes the action of
the ultrasound.
One of the peculiarities of ultrasound is to favor the penetration of
substances and active substances under the skin (phonophoresis). If
therefore a specific active principle is used, the effect of the ultrasound will
be amplified.
The purpose of cavitation is therefore to transform the fat cells (fat) into a
form easily eliminated by the organism that can expel it thanks to the
lymphatic system. It is recommended, after the cavitation session, carry out
as desired:
•hard walking for 30/40 minutes;
•a pressotherapy session for 20/30 minutes;
3MHz beam, typically more collimated
but with less tissue penetration.

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•swimming for 20/30 minutes,
in order to favorite the disposal of fat “became liquid”.
Thanks to the effects that the product (thermal, chemical, mechanical,
cavitation), ultrasounds are useful for their ability to:
•stimolation of the local circulation system,
•improvement of skin trophism,
•cellular oxygenation.
Treatment
The major areas indicated fot the draining/anticellulite treatment with the
ultrasounds are:
•thighs;
•calfs;
•hips (pads);
•ankles;
•knee;
•gluteus;
•arms;
•abdomen (with maximum ultrasound intensity at M).
Programs
Area
Intensity
N° app.
tot
Frequency
Thighs drainage
M-H
20
Daily
Thighs compact cellulite
M-H
30
Daily
Thighs flaccid cellulite
M-H
40
Daily
Thighs edematous cellulite
H
40
Daily
Calfs drainage
M-H
20
Daily
Calfs compact cellulite
M-H
25
Daily
Calfs flaccid cellulite
M-H
30
Daily
Calfs edematous cellulite
H
30
Daily
Pads drainage
M
20
Daily
Pads compact cellulite
M
25
Daily
Pads flaccid cellulite
M
30
Daily
Pads edematous cellulite
M-H
30
Daily
Ankles and knees drainage
L-H
15
Daily
Ankles and knees compact
cellulite
L-H
20
Daily
Ankles and knees flacid cellulite
L-H
25
Daily

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Area
Intensity
N° app.
tot
Frequency
Ankles and knees edematous
cellulite
L-H
30
Daily
Gluteus drainage
M-H
20
Daily
Gluteus compact cellulite
M-H
25
Daily
Gluteus flaccid cellulite
M-H
30
Daily
Gluteus edematous cellulite
H
30
Daily
Arms drainage
L-M
15
Daily
Arms compact cellulite
L-M
20
Daily
Arms flaccid cellulite
L-M
20
Daily
Arms edematous cellulite
L-M
20
Daily
Abdomen drainage
L-M
20
Daily
Abdomen compact cellulite
L-M
25
Daily
Abdomen flaccid cellulite
L-M
30
Daily
Abdomen edematous cellulite
M-H
30
Daily
Acne / Pimples
L
10/20
Daily
REMEMBER:
•keep always in movement ultrasound head;
•use a good amount of gel to ensure contact;
•in 10 minutes act on an area of 20x20cm;
•if the area to be treated is more than 20x20cm, divide it into 2 or
more parts and treat it in succession;;
•act with uniformity on the treated area.