I-Tech PHYSIO 4 User manual

USER MANUAL
I-TECH PHYSIO 4
I-TECH PHYSIO EMG

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INDEX
INDEX ........................................................................................................I
TECHNICAL INFORMATION .......................................................................1
MANUFACTURER ........................................................................................... 1
DECLARATION OF CONFORMITY ........................................................................ 1
CLASSIFICATION............................................................................................. 1
PURPOSE AND SCOPE...................................................................................... 2
TECHNICAL FEATURES ..................................................................................... 3
DEVICE AND COMMAND DESCRIPTION ................................................................ 5
LABELS......................................................................................................... 6
Packaging content ................................................................................ 7
PURPOSE ..................................................................................................8
INTRODUCTION TO THE TECHNOLOGY................................................................. 8
CONTRAINDICATIONS...................................................................................... 9
Side effects.......................................................................................... 10
WARNINGS................................................................................................. 10
PATIENT PREPARATION.................................................................................. 13
DEVICE USE ................................................................................................ 14
Instructions on use for a single patient............................................... 14
Instructions on use for two patients ................................................... 16
INDICATIONS FOR USE OF ELECTROTHERAPY....................................................... 16
Wave programs .................................................................................. 16
REHAB programs................................................................................. 33
EMS Programs..................................................................................... 46
Programmable memories ................................................................... 62
Surface electromyography instructions for use (sEMG)...................... 69
DEVICE’S CARE........................................................................................ 73
MAINTENANCE............................................................................................ 73
TROUBLESHOOTING...................................................................................... 74
Battery charging ................................................................................. 75
DISPOSAL ................................................................................................... 75
WARRANTY ................................................................................................ 76

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Support ............................................................................................... 77
Spare part ........................................................................................... 77
ELECTROMAGNETIC INTERFERENCES AND ELECTROMAGNETIC COMPATIBILITY TABLES. 78

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Technical information
Manufacturer
I.A.C.E.R. S.r.l.
Via S. Pertini, 24/a • 30030 Martellago (VE)
Tel. [phone] • Fax [phone]
IACER S.r.l. is an Italian manufacturer of medical devices (certified CE n°
0068/QCO-DM/234-2020 from the Notified Body n°0068 MTIC InterCert
S.r.l.)
Declaration of conformity
I.A.C.E.R. S.r.l
Via S.Pertini 24/A – 30030 Martellago (Ve), Italy
declares under its own responsibility that the product
I-TECH PHYSIO 4
I-TECH PHYSIO EMG
UMDNS Code: 11503 e 11474 (respectively)
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
Certificate no.: 0068/QCO-DM/234-2020
following the certification procedure according to Annex II (excluding point
4) of the Directive 93/42/EEC.
______________________ _____________________
Place, date Legal Representative
Martellago, 03/08/2020
MASSIMO MARCON

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Classification
The I-TECH PHYSIO 4/EMG has the following classification:
•Class IIa (Directive 93/42/CEE, Annex IX, rule 9, 10 and further
amendments);
•Class II with BF type applied part (Classification EN 60601-1);
•Equipment protection level IP20, against solid bodies greater than
12.5mm in diameter and liquids penetration.
•Equipment unsuitable for use in presence of a flammable
anesthetic mixture with air or oxygen or with nitrous oxide;
•Equipment suitable for continuous operation;
•Equipment unsuitable for outdoors use.
Purpose and scope
Clinical intended use: Therapeutic
Environmental intended use: Ambulatory and hospital
The I-TECH PHYSIO electrotherapy medical device is available in 2 versions:
I-TECH PHYSIO 4 and I-TECH PHYSIO EMG. The two devices differ only for
the presence of the electromyographic module in the EMG version, by
which it is possible to obtain an indication of the pre, during and post
therapy of muscular activity. The EMG module should not be intended as a
medical device with diagnostic evaluations.
Both devices are equipped with medical programs suitable for muscle
rehabilitation in general, pain therapy (analgesic and muscular atrophy
programs) and functional recovery of muscles after trauma or an accident,
specific programs for ionophoresis, incontinence and the treatment of
denervated muscles, as well as non-medical programs for muscle cool-
down, muscle strengthening, beauty treatments (firming and drainage). It
is possible, therefore, to treat a wide range of both chronic and acute
pathologies.
Due to the number of pathologies, these devices are intended for use by a
professional therapist, a fitness coach at a public / private center or clinic,
or professional operators in general.
The patient population intended for electrotherapy treatment using the I-
TECH PHYSIO EMG and / or I-TECH PHYSIO 4 devices includes patients of
both sexes, men and women, of age unless otherwise indicated by medical
doctors. For further details, please refer to the Contraindications section.

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The CE0068 marking on the device applies exclusively to medical programs
(see the following paragraphs concerning the detailed description of the
programs).
Technical features
Characteristics
Specifications
Power supply
Rechargeable batteries NiMH 7.2V, 2000mAh
(dimensions 6xAA)
Battery charger
Model EA1018G-12V
100-240VAC, 50-60Hz, 1.0A input
12VDC, 2.0A output
Not replaceable 250VAC, 2A fuse
Max. absorbed current
1.6 A
Absorption
DC 12V, 1.5A
Output power
120mA (with 1000 Ohm rated load)
Isolation class (EN
60601-1)
II
Applied part (EN 60601-
1)
BF
Dimensions (mm)
(length x width x height)
180x110x50
Protection level IP
IP20
Conditions of use
Environmental
temperature
From +10 to +40°C
Relative humidity
From 15 to 93%
Atmospheric pressure
From 500 to 1060hPa
Storage and
transportation
conditions
Environmental
temperature
From +5 to +40°C
Relative humidity
From 15 to 93%
Atmospheric pressure
From 500 to 1060hPa
Electrotherapy (models 4 and EMG)
Number of programs
A total of 86 programs divided as follows:
-n. 26 prog.
TENS/ANALGESIC/IONOPHORESIS
(diadynamic, faradic, Kotz and interferential
currents).
-n. 25 prog. REHAB (denervated muscles,

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Characteristics
Specifications
incontinence, pains).
-n. 17 prog. EMS (strengthening, heating,
muscular cool-down and beauty
treatments).
-n. 18 prog. Customisable.
Max out
160Vpp with a load of 1000 Ohm
Frequency
Between 0.5 and 40kHz
Impulse
Between 20 microseconds and 400 milliseconds
Duration of therapy
Preset programs, free memories of up to 60
minutes
Electromyography (only EMG model)
Dynamic input
0 ÷ 4.16mVpp
Bandwidth
16 ÷ 402Hz
Input level of noise
< 3V
RMS
Gain
794V/V
Input impedance
> 100GΩover the whole band
CMRR
>100dB
Dynamic output
0 ÷ 3.3V
Resolution
10bit
Sampling frequency
1024Hz
ATTENTION: the device has an output current over 10mA.
Expected useful life of the device is set in 10 years.

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Device and command description
Channel intensity
increase/decrease buttons
Program and parameter
selection/confirmation
Patient 1 selection button
Patient 2 selection button
4/EMG input
Channel 1/2
USB input
Channel 3/4
Battery charger
ON/OFF

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Labels
Label on the back of the device
Model I-TECH PHSYIO EMG Model I-TECH PHYSIO 4
Simbolo
Significato
Manufacturer’s logo.
Product CE certification released by Notified Body
N° 0068.
Manufacturer.
Manufacturing date (YYYY-MM).
Read instructions for use.
RAEE directive for the disposal of electronic waste.
Classe II device according to IEC 60601-1.
Applied part type BF according to IEC 60601-1.
Temperature humidity (temperature of the storage
environment, on the package).
Limits of relative humidity (relative humidity of the
storage environment, on the package)

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Simbolo
Significato
Not protected against the infiltration
of liquids,
keep dry.
Device able to supply current at above 10mA with a
load of 1KOhm.
Packaging content
The I-TECH PHSYIO 4 and I-TECH PHSYIO EMG pack contains:
•N° 1 mainframe (I-TECH PHSYIO 4 or I-TECH PHSYIO EMG);
•N° 1 battery charger model EA1018G-1E;
•N° 2 electrotherapy connection cables with 2 mm female
connector, length about 2.5m;
•N° 2 iontophoresis connection cables with 2mm female
connector, length about 2.5m;
•N° 1 EMS electrotherapy connection cable with 2mm female
connector, length about 2.5m (for the prg. Co1 continuous
current);
•N° 2 set of rectangular single-patient electrotherapy electrodes;
•N° 2 set of square single patient electrotherapy electrodes;
•N° 1 set of round single-patient EMG electrodes (only for I-TECH
PHYSIO EMG);
•N°1 set of square button single patient electrotherapy
electrodes;
•N°1 iontophoresis kit (elastic band, 2 rubber electrodes and 2
sponges);
•N°1 PEN-EL nib with tip for EMS stimulation;
•N°1 PHYSIOAMP EMG amplifier module (only for I-TECH PHYSIO
EMG version);
•N°1 user manual;
•N°1 user manual of the electrodes’ positions;
•N°1 bag for the transportation.
Additional iontophoresis kits are available as accessories on request.

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Purpose
Introduction to the technology
Electrostimulation consists of the electric micro-impulses from I-TECH
PHYSIO 4/EMG to the human, conducted through the electrodes applied to
the body by means of connection cables.
The fields of application of electrostimulation are pain therapy, muscular
rehabilitation, recovery of muscle trophism after injury or a surgical
operation, athletic preparation and beauty treatments.
Specific electric impulses are used for every one of these applications.
The stimulation intensity is shown for each channel, on a scale of 0 to
120mA, on the I-TECH PHYSIO 4/EMG. For Sport and Beauty programs, the
intensity differs according to the type of muscle or the program in use. The
following description helps the user to choose the correct intensity
according to impulse.
The type of impulses can be classified as follows:
1. Tense impulse: for TENS programs, the intensity should be
adjusted to a level between the thresholds of perception and
pain. The maximum limit is reached when the muscles
surrounding the treating area begin to contract. It is best to stay
below that limit.
2. Microcurrent pulse: the maximum adjustable intensity is 12, so
very low. It can be set between 6 and 12 and may be barely
perceivable: this is not a fault, but quite normal for the program.
3. Ionophoresis pulse: the intensity must be strong enough to
produce a relevant perception, near pain, till the muscles
surrounding the area treated begin to contract. Maximum
adjustable intensity: 50.
4. EMS impulse: in this case the intensity is raised a little at a time to
stimulate and gradually increase the metabolism of the treated
muscle. A comparison could be drawn with a car: the engine
needs to warm up before it can be run at maximum speed.
5. Toning, training, atrophy contraction impulse: the muscle treated
must visibly contract during a training impulse. The fact that the
muscle tends to stiffen and increase in volume will be visible to
the naked eye. Intensity should be increased gradually (in the first
contraction) to enable you to identify the right level of stimulation
comfort. Intensity can be increased up to the personal tolerance

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threshold during the second training contraction; this operation is
then repeated during each contraction until the workload reaches
the level of intensity recommended in the description of the
single programs. We recommend that you record the level of
intensity reached in order to try to improve the level of
stimulation and consequently your performance.
6. Massage, winding down, active recovery impulse: the intensity
must be adjusted gradually to massage the treated muscle. The
level of intensity should be sufficient to obtain a comfortable
massage. Bear in mind that there is no need to endure high levels
of intensity in this case as it is meant to be a massage, meaning
that intensity can be increased gradually and not to an excessive
degree.
7. Capillarisation impulse: increase the intensity gradually to
produce constant, visible stimulation of the area treated; a
medium stimulation threshold is recommended, always below the
pain threshold.
8. Lipolysis/drainage impulse: the “pump” effect is produced by
sequential tonic contractions. The intensity must be sufficient to
produce these contractions: the greater the contraction, the
greater the induced pump effect. There is no benefit to be gained
from enduring intensity high enough to cause pain. The first
electrostimulation sessions should be carried out at a low
intensity to allow the organism to get used to new sensations. In
this way intensity can be increased gradually without causing any
trauma.
9. Other impulse: see program description.
Contraindications
Do not use the device when there are cancerous lesions in the area of
treatment. Stimulation must not be carried out in areas that are infected,
swollen or inflamed, or when there are skin eruptions (phlebitis,
thrombophlebitis, etc.).
It is forbidden to use I-TECH PHYSIO4 and PHYSIO EMG if the patient has a
pacemaker, is cardiopathic, suffers from epilepsy, is a pregnant woman, is an
anxious person, has severe disease, has inguinal or abdominal hernias. Do not
use the device if the source of the pain is unknown or not diagnosed. Use the
device ONLY after having a diagnosis. In the event of injury, muscle stress or

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any other health problem consult your doctor before using the device and
only use it under medical supervision.
Side effects
No significant side effects are known. In some cases of particularly
sensitive people, skin redness occurs at the electrodes after treatment: the
redness normally disappears few minutes after treatment. If the redness
persists, consult a doctor.
In some rare cases evening stimulation causes some difficulties in falling
asleep. In this case, suspend the treatment and consult a doctor.
Warnings
Treatment efficacy depends on the patients’ selection by qualified persons.
The long term effects of a chronic stimulation are unknown.
The device has been designed and manufactured to be operated
exclusively with the internal rechargeable batteries and the charger
present in the kit.
It is recommended:
•to control position and meaning of all the labels on the
equipment;
•not to damage the connection cables to the electrodes and to
avoid winding the cables around the device;
•to avoid the use of the device by persons who did not read
carefully this manual. Keep the device away from children;
•not to wear metal objects during treatment;
•to use the electrodes on clean and dry skin. When using the
electrodes, follow the instructions given in the manual and on the
package of the electrodes. Use only single-patient electrodes,
supplied exclusively by the manufacturer, and take care to avoid
the exchange of electrodes between different users. I-TECH
PHYSIO4 and I-TECH PHYSIO EMG has been tested and guaranteed
for the use only with the electrodes supplied by the
manufacturer;
•to use ONLY accessories supplied by device manufacturer. Only
use battery chargers supplied by the manufacturer; the use of
battery chargers not supplied by the manufacturer will free the

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same from any responsibility related to damage to the equipment
or user and will expose the user to risks such as short circuits and
fire.
It is forbidden:
•to use the device in the presence of patient monitoring
equipment, of electrosurgical (possible bruises and burns) 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 stimulator;
•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; the use by people
with low IQ;
•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 in presence of signs of deterioration of the
device itself, cables and/or electrodes: 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 while driving or during the operation and
control of equipment/machinery.
•to position the electrodes in such a way that the current crosses
the heart area (e.g. a black electrode on the chest and a red
electrode on the shoulder blade); however, electrodes can be
positioned along the muscular fascia of the heart area, as used for
pectoral strengthening. Danger of heart arrythmia;
•to position the electrodes close to the eyes; make sure that the
current delivered does not cross the eyeball (one electrode
diametrically opposite to the other in relation to the eye); keep a
distance of at least 3 cm from the eyeball;
•to position the electrodes on the carotid sinuses (carotid), in
particular in patient with a well known sensibility on reflection

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of the carotid sinuses; to position the electrodes near genitals
and in those areas that have poor sensibility;
•to simulate the thyroid or apply stimulation on the neck and
mouth, as this stimulation could case important muscle spasms
that can obstruct the airways, creating difficulty in breathing
and problems with the heart rhythm and blood pressure;
•to use pointed or sharp objects on the device keyboard.
Attenzione:
•keep right distance between electrodes: the contact between
electrodes could cause wrong stimulations or irritations/burns;
•do not use damaged electrodes even if they well adhere to the
skin;
•to the integrity of the plug and the casing of the battery charger. If
any signs of deterioration appear in any of these parts, stop using
the battery charger immediately and contact the retailer or
manufacturer;
•care should be taken for use in patients with suspected heart
problems;
•stimulation intensity and electrodes position should be
suggested by the prescriber doctor;
•be sure that the electrodes well adhere to the skin. Cases of skin
irritation persistent even hours after treatment may occur in the
area of application of the electrodes after prolonged use of the
same;
•do not mix connection cables up with earphones or other devices
and do not connect the cable to other equipment;
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
autorized personnel;
•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.

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Should you notice any changes in the device’s performance during
treatment, interrupt the treatment immediately and consult the retailer or
manufacturer.
If the stimulation is uncomfortable decrease intensity. If the
problem persists consult a doctor.
Some patients could suffer from skin irritation or oversensitivity
due to stimulation or gel. If the problem persists, suspend the
stimulation and consult a doctor.
Consult a doctor before using I-TECH PHYSIO4/EMG with metallic
osteosynthesis devices.
IF YOU HAVE ANY DOUBTS REGARDING THE DEVICE USE CONSULT YOUR
DOCTOR.
Patient preparation
Before using I-TECH PHYSIO 4/EMG clean the skin of the area to be treated;
with the cable disconnected from I-TECH PHYSIO 4/EMG, connect the
electrostimulation cable jacks to the self-adhesive electrodes; position the
self-adhesive electrodes on the skin (see photos of electrode positions in the
Positions manual); connect both cables to the relative jacks CH1/CH2 or
CH3/CH4 (the software, for safety, requires the connection of all therapy
cables) for each program selected the display will show the active channels
and the type of cable to be inserted (refer to the table below).
Type of cable
Program
TYPE 1
From W01 to W26
From R01 to R25
From E01 to E17
From M01 to M18
TYPE 2
W27
TYPE 3
C01
The type of cable is screen-printed on each cable connector as shown in the
photo:
Figure 1 – Cable type.

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Make sure that I-TECH PHYSIO4/EMG is switched off before
disconnecting the electrodes at the end of the treatment.
Device use
Instructions on use for a single patient
1. Turn on I-TECH PHYSIO 4/EMG by pressing ON/OFF button on the
small rear panel of the device.
2. Select single mode and press the OK key to confirm.
3. Select the program group: Wave, Rehab, EMS or MEM, using the
right and / or left arrow keys.
4. Select the program using the up/down arrow buttons (e.g.E03 basic
strength).
5. Select male or female with the right / left arrow keys (when
applicable).
Select
male
Select
female
6. Select the muscle group with the up/down buttons.
arms
male
trunk
male
Legs
male
arms
female
trunk
female
legs
female
7. Press the OK key to start stimulation and the relative text appears on
the screen; place the electrodes on the skin, connect the cables, and
increase the intensity; the type of cable required for the selected
type of treatment also appears on the screen. To start the work
session, press the Up arrow key of at least one of the channels used
for electrostimulation, and increase the intensity of the output
current; the I-TECH PHYSIO 4/EMG opens the work screen
automatically, displaying the name of the selected program.
8. Press the up arrow button for each channel in use to increase
current intensity until the personal tolerance level is reached
(stimulation comfort).

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A bar indicating the start and end of a contraction will appear on the
display while the electronic stimulator is working. The periods of
muscular contraction (bold bar) and the periods of recovery (dotted
or striped bar) are graphically visualized under the bar with a cursor.
This enables the user to know exactly when a contraction starts.
9. At the end of the first phase, I-TECH PHYSIO 4/EMG At the end of the
first phase, the I-TECH PHYSIO 4/EMG cancels the previously
selected intensity, and warns the user with an intermittent signal; to
continue with the program, increase the intensity again. Three
sound signals will advise of the end of the program. At the end of the
program, switch off the I-TECH PHYSIO 4/EMG and remove the
cables. Attach the electrodes to the transparent films and put them
in their original packaging
Option to simultaneously increase the intensity on all 4 channels
Select the desired program as instructed above.
Increase the intensity of all the channels up to at least 1 by pressing the
relative keys, and then press the Up arrow keys to increase the intensity
for all 4 channels. To decrease the intensity, press the Down arrow keys.
Skip phase control
Press the right arrow button during normal program operation to skip to
the next phase.
Pause / stop program control
During normal program operation, press the OK button once to
momentarily pause the normal work cycle. Press the OK button again to
restart the program.

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Press the OK button twice consecutively to stop the program.
Instructions on use for two patients
1. Turn on I-TECH PHYSIO 4/EMG by pressing the ON/OFF button on
the small rear panel of the device.
2. Select the two patient mode and press the OK key to confirm.
3. Next, select the program required for patient 1 following the
instructions above.
4. Press key 2 to set the program and make the relative adjustments
for patient 2.
During therapy, it is possible to switch between patient 1 and patient 2 at any
time by pressing key 1 or 2 on the keyboard.
ATTENTION: In this mode, the cable recognition by software does
not take place, be particularly careful when using the correct cables
for each type of program (see Figure 1 - Cable type).
Indications for use of electrotherapy
Wave programs
ATTENTION! It must be remembered that an electronic stimulator
is a very effective analgesic instrument and that pain can indicate
various types of medical condition. Most of the programs
described in this section are analgesic. You are advised to read the
ENTIRE manual carefully before using I-TECH PHYSIO 4/EMG.
TENS, an acronym standing for Transcutaneous Electrical Nerve
Stimulation, is a therapeutic technique mainly used for analgesic purposes
to counter the effects (usually pain) of a wide variety of medical
conditions. For this purpose, it finds application in treating everyday
ailments troubling mankind: neck pain, arthrosis, myalgia, neuritis, back
pain, periarthritis, heaviness in legs, muscle weakness, just to mention a
few.
On an academic level, TENS can be divided into various categories
according to the mechanism used to reduce the pain. The main types are:
conventional TENS (or fast analgesic), training TENS (or delayed analgesic),
which is similar to the effect of the electro acupuncture, TENS scan where
the stimulation parameters are changed during the treatment, TENS at
maximum values with antidromic action and consequently an immediate