Triomed UNIVERSAL User manual

ACTIVE MEDICAL DEVICE
FOR STIMULATION BY ELECTROMAGNETIC FIELD
USER MANUAL
TRIOMED UNIVERSAL
Version 3
Introduced on 20.03.2015
Tallinn 2015

The following signs have been used
in the Manual and for labelling the device:
2274
Manufacturer
2274
Non-ionising
radiation
Device serial number
2274
Not for general
(household) waste
Important informa-
tion about the device
or its operation
2274
Keep dry!
2274
Consult instructions
for use
2274
Fragile, handle
with care!
Caution, consult
accompanying docu-
ments
On/o
(press/press)
2274
Point of contact
with the body of the
patient
2274
Class II equipment

TABLE OF CONTENTS
1. PURPOSE 4
2. MECHANISMS OF THERAPEUTIC EFFECTS 5
2.1. General mechanisms of action 5
2.2. Mechanisms of specialised action of MM radiation 6
3. INDICATIONS AND CONTRAINDICATIONS FOR USE 8
3.1. Indications 8
3.2. Contraindications: 10
3.3. Recommendations for using external radiators 11
4. TECHNICAL AND OPERATIONAL CHARACTERISTICS 13
4.1. General technical characteristics 13
4.2. Structure and functioning 16
5. PACKAGE CONTENTS 19
6. LABELLING 19
7. PACKAGING 20
8. DISPOSAL 20
9. WARRANTY 20
10. PREPARING THE DEVICE FOR USE 21
10.1. Operating restrictions 21
10.2. Safety precautions 22
10.3. Preparing the device for use 22
10.4. List of possible faults and suggested remedies 24
10.5. Technical maintenance 25
11. PROCEDURE FOR USING THE DEVICE 26
11.1. Selecting the impact position 26
11.2. Local stimulation in the pathological focus 27
11.3. Use of device in Head zones 27
11.4. Stimulation of biologically active zones 29
11.6. Stimulation of reexogenic zones 31
11.7. Treatment description 31

TRIOMED UNIVERSAL. USER MANUAL4
1. PURPOSE
The TRIOMED UNIVERSAL device has been designed for
maintaining and strengthening the health of the elderly
as well as for treating and preventing various pathological
conditions by stimulating the skin with low intensity ( up to
10 μW/cm2) impulse electromagnetic radiation (EMR) in the
millimeter (MM) and ( up to 2 μW/cm2 ) infrared (IR) band.
The external radiators provide the EMR stimulation in the
frequency band between 40 and 75 GHz (wave length be-
tween 7,5 and 4,0 mm) as well as IR radiation.
The device is recommended for use primarily for restora-
tive treatment (rehabilitation) of patients with various socially
signicant dieases.
Restorative treatment (rehabilitation) is carried out irre-
spective of the duration of the disease and aims to eliminate
its consequences, prevent exacerbations and relapses, nor-
malise (maintain) disturbed physiological functions, restore
(optimise) physical capacity, increase the functional reserves
of the body and improve the quality of life in medical terms.
MM therapy can be used in comprehensive programmes
at early and later states of restorative treatment of diseases
and injuries, during rehabilitation and in the case of chronic
diseases during a non-acute period.
The device is easy to operate, safe, secure and lightweight
and can be used in-patient and out-patient settings (reha-
bilitation centres, rehabilitation departments), by outreach
teams and independently at home in consultation with
the treating physician.
In terms of its utilisation the device is classied
as a product of multiple cyclic use.

TRIOMED UNIVERSAL. USER MANUAL 5
2. MECHANISMS OF THERAPEUTIC EFFECTS
2.1. General mechanisms of action
Electromagnetic waves in the millimetre range have a
low capacity to penetrate biological tissues (0,2-0,6 mm), are
almost fully absorbed by the upper layers of the skin and by
the water, hydrated proteins and collagen bres contained
in them and do not have a thermal eect. At the cellular
level, electromagnetic waves in the MM range activate the
metabolism through calcium-dependent processes. The
response of the body is manifested in the skin and visceral
reexes as well in the general reaction aimed at strengthen-
ing the adaptation, adjustment and defence capacity. The
healing eects are achieved through the central and pe-
ripheral nervous system as well as through the protective
and regulatory systems of the body. Electromagnetic waves
in the MM range thus regulate the cellular biochemical ac-
tivity and physiological functions of the body in general.
The eects mentioned above are clinically manifested
in anti-inammatory, analgesic and anti-oedematous ac-
tion, improved tissue regeneration, increased non-specic
resistance of the body through stimulation of the immune
system, in enhanced systemic and regional hemodynamics,
normalised regulation of the autonomic nervous system
and in anti-stress action.
IR radiation of the band used penetrates 1 cm beneath
the skin and is absorbed by acceptor molecules and cellular
membranes.
The mechanisms of impact of IR radiation on biological
tissues comprise the totality of molecular and cellular eects
including the local activation of energy-binding processes

TRIOMED UNIVERSAL. USER MANUAL6
in pathological foci as well as the launching of a set of ad-
aptation and compensatory reactions arising in response
to the local stimulation at the cellular and molecular level.
The therapeutic eects include anti-inammatory,
lymph-draining and vasodilative action. The device acceler-
ates regression of inammatory processes and improves tis-
sue regeneration, local resistive capacity and anti-infection
defense.
2.2. Mechanisms
of specialised action of MM radiation
Responses of biological objects (tissues, organs, organ
systems) to EMR exposure in the MM band are specic. The
direction of the MM therapy depends on the method of use
(the location and duration of stimulation), the patient’s initial
condition and the characteristics of the MM stimulation.
An important role is played by the modulation of the
carrying MM radiation with the low-frequency signal corre-
sponding to the physiological rhythms of the organs, systems
and the body as a whole. Complex modulated signals dem-
onstrate a great harmonising potential and biological eect
and at the same time have a lower mean power.
Each therapeutic programme uses several low-frequency
modulations which have a positive directed impact on the
cells of various organs as well as on blood and lymphatic
vessels thus raising the eciency of treatment.
Clinical tests carried out over many years using the meth-
ods of molecular medicine at the Saint-Petersburg Institute of
Bioregulation and Gerontology in cooperation with the cen-
tre of International Association of Gerontology and Geriatrics
have shown that the use of the MM therapy through Triomed
devices in elderly and old patients with various socially

TRIOMED UNIVERSAL. USER MANUAL 7
signicant diseases helps normalise the oxidant, lipid, opioid
and glucocorticoid balance, reduce the number of exacerba-
tions, hospitalisations and admissions for emergency medi-
cal care as well as improve the emotional status and certain
parameters of the quality of life.
IR radiation of the band used penetrates 1 cm beneath
the skin and is absorbed by acceptor molecules and cellular
membranes.
The mechanisms of impact of IR radiation on biological
tissues comprise the totality of molecular and cellular eects
including the local activation of energy-binding processes
in pathological foci as well as the launching of a set of ad-
aptation and compensatory reactions arising in response
to the local stimulation at the cellular and molecular level.
The therapeutic eects include anti-inammatory, lymph-
draining and vasodilative action. The device accelerates re-
gression of inammatory processes and improves tissue re-
generation, local resistive capacity and anti-infection defence.

TRIOMED UNIVERSAL. USER MANUAL8
3. INDICATIONS AND CONTRAINDICATIONS
FOR USE
3.1. Indications
MM therapy can be indicated in the following cases:
• colds, influenza, acute respiratory infections, decrease
in general immunity during recovery and rehabilitation
after diseases: for non-specific stimulation of the immune
system, including to achieve a general invigorating effect;
• chronic heart failure (ischemic heart disease, stable
FC I-IV stenocardia; I-II degree arterial hypertension;
rhythm disturbance: rare ventricular arrhythmia, rare
supraventricular ectopy to increase the antioxidant ca-
pacity of the muscles, enhance the rheological proper-
ties of the blood, stabilise the processes of cholesterol
metabolism, reduce the intensity of immune inflamma-
tion, improve the endothelial function, normalise lung
ventilation during physical exertion, develop light pe-
ripheral vasodilatation, normalise the arterial blood
pressure and the heart rate variability;
• I-II degree arterial hypertension: to decrease high ar-
terial blood pressure by adjusting sympathetic-adrenal
and parasympathetic influences on the regulation of the
heart function, improve the overall health;
• organic diseases of the central nervous system (is-
chemic stroke, multiple sclerosis, internal brain injury,
traumatic encephalopathy): to improve the rheological
properties of the blood, normalise cognitive and motor
functions (increase the precision of simple and com-
plex sensory-motor actions, improve intellectual and
mnestic functions, enhance focusing), raise the endur-
ance of nervous processes and restoration of nervous
conductivity;

TRIOMED UNIVERSAL. USER MANUAL 9
• cerebralcirculatorydeficiencyandmildandmedium
discirculatory encephalopathy: to reduce headache,
dizziness and buzzing in the ears, lower high arterial
blood pressure, alleviate focal neurological symptoms
(pyramidal, cerebellar, Parkinson’s syndrome) and men-
tal disturbances. Has a particularly positive impact on
the sleep, emotions and the condition of higher cortical
functions;
• problems with vessels in the lower extremities
(chronic venous insufficiency, varicose vein disease,
post-thrombotic syndrome): to improve local microcir-
culation by increasing the permeability of blood capil-
laries, enhance the rheological properties of the blood
and intensify the regional lymph and blood flow;
• chronicinflammatorydiseasesoftherespiratorytract
(chronic bronchitis, chronic obstructive pulmonary
disease, asthma): to improve bronchial permeability,
normalise metabolic activity, stabilise the membranes
of phagocyteised neutrophils, lower the intensity of
peroxidation of lipids, lower the non-specific hyperac-
tivity of the bronchi, improve the functions of external
respiration, activate the discharge of bronchial mucus,
reduce the frequency of coughing fits;
• chronicdiseasesofthespineandjoints(degenerative
spine diseases, osteoarthrosis, spondylarthrosis): to
improve the mobility of the spine and joints, increase
the amplitude of active movements in the joints (loco-
motor functions), reduce oedemas and relieve the pain
syndrome;
• gastroduodenal ulcers: to relieve the pain syndrome
and dyspeptic complaints, accelerate the healing of the
ulcerous defect, alleviate psychoemotional problems;
• diabetic polyneuropathy: to reduce the severity of
the pain syndrome and the sensation of numbness
and burning, alleviate sensory disorders, improve

TRIOMED UNIVERSAL. USER MANUAL10
microcirculation, help with psychoemotional problems;
• climactericsyndrome: to reduce the frequency and in-
tensity of hot flashes, sweating, headaches and sleep dis-
orders, increase physical capacity, normalise the oxidative
status, arterial blood pressure and emotional condition;
• chronic prostatitis: to relieve pain, reduce inflamma-
tion, normalise urination, restore erection and copula-
tive function, alleviate psychoemotional problems;
• light depression: for mild sedative and anti-stress ef-
fect, to lower irritability and psycho-emotional distress,
to correct sleep disorders and raise spirits.
IR therapy can be indicated in the following cases:
• sluggishwoundsandulcers,
• chronic and subacute non-purulent inammatory
diseases of internal organs,
• burns and frostbites,
• diseases of the peripheral nervous system with
thepainsyndrome(myositis,neuralgia),
• consequences of musculoskeletal injuries,
• preparation of the skin zones for MM stimulation.
3.2. Contraindications:
• generalcontraindicationstophysicaltherapy;
• unknowndiagnosis;
• idiosyncrasytoelectromagneticmillimeter
stimulation;
• febrilestatesofunclearaetiology;
• patients having an implanted device with
autonomous power supply (in the area of the
device installation);
In the case of diseases which pose a serious threat
to life and health the device can be used only under the
supervision of a doctor.

TRIOMED UNIVERSAL. USER MANUAL 11
3.3. Recommendations
for using external radiators
Therapeutic stimulation TRIOMED UNIVERSAL device is
carried out using special external radiators exerting target-
ed impact on organs, tissues, organ systems and functional
systems of the human body.
Radiators in the MM band have been developed on the
basis of the generator of electromagnetic radiation in the
MM band (international patent No. EE 05541).
IR radiator is based on the serial IR diode.
External radiator 1(Universal) is designed to restore
optimal regulation which is the necessary condition for re-
covery of health. The stimulation of the hypothalamo-pitu-
itary-adrenal axis ensures restoration of tissue metabolism,
balancing of the sympathoadrenal and vagoinsular systems,
general invigorating and harmonising eect, increased ad-
aptation potential and anti-stress resistance of the body
as well as proper functioning of the organs by activating
the regulatory mechanisms.
The radiator is used for 1st and 2nd degree pathological
conditions accompanied by the disadaptation syndrome.
Recommended to be used as a treatment course.
Externalradiator5(IR)
Low-intensity IR stimulation allows to optimise the ener-
gy supply to the cells, normalise the system of intracellular
regulation and intensify biosynthetic processes. It facilitates
resonant absorption of energy by the cell helping improve
metabolic processes and increase the energy eciency
of the cell in situations of oxygen deciency.

TRIOMED UNIVERSAL. USER MANUAL12
The main indications for using infra-red radiation are:
preparation of zones for MM stimulation, cicatricial changes
in tissues, subacute and chronic non-purulent inammatory
diseases of internal organs, sluggish wounds and trophic
ulcers, diseases of the peripheral nervous system with the
pain syndrome, residual eects of burns and frostbites, au-
tonomic dysfunctions, complications of diabetes.
The contraindications for using infra-red radiation
are: benign and malignant neoplasms, active forms of
tuberculosis, III degree hypertension, bleeding and II-
III degree circulatory deciency. Stimulation of the eyes
is not recommended.
Stimulation should be carried out locally in the patho-
logical focus (wounded surfaces, trophic ulcers, non-
purulent inammatory diseases, cicatricial changes),
at the edge of the popliteal fold when the knee joint
is bent on the inside , in the zone of the outer third
of the subclavian area and in area between the 7th
cervical vertebra and the 1st thoracic vertabra.

TRIOMED UNIVERSAL. USER MANUAL 13
4. TECHNICAL AND OPERATIONAL
CHARACTERISTICS
4.1. General technical characteristics
The device and radiators are produced without using
any harmful chemical substances in compliance with the
TRIOMED EU Ltd technical documents and meet the re-
quirements of Directives 93/42/EEC and 2007/47/EC.
As far as potential risks of use are concerned, the device
is classied as Class IIa equipment according to Directive
93/42/EEC and has been designed as a product with internal
safe power supply.
The device consists of three parts (Fig 1):
• low-frequency electronic TRIOMED generator (power unit);
• external radiators 1 and 5 (other MM EMR radiators as
well as the IR radiator can be purchased separately);
• standard cable (USB А – miniUSB B 5 pin).
1– radiator
2– mini USB В 5
pin connector
3– cable
4–USB A
connector
5–power supply
unit
Figure1.
Generalviewoftheradiatorandthecable

TRIOMED UNIVERSAL. USER MANUAL14
The radiators are connected to the power unit using
the USB cable.
The software allows to automatically control all the
functions of the device.
The external surfaces of the power unit and the external
radiators are disinfected using a 3% solution of hydrogen
peroxide or a 1% water solution of chlorhexidine.
The device includes two LR06 batteries (АА type).
No conservation during the life cycle is required. If the
device is not used for a long time, it is recommended to take
the batteries out and keep them separately.
No special safety measures are required.
The main technical characteristics of the TRIOMED
UNIVERSAL device are given in Table 1 below.
Table 1
No Characteristics Description
1 Start–up time no more than 5 sec
2 Type of work with speci-
ed characteristics
continuous, uninter-
rupted
3 Automatic shutdown
function
in 10±1 sec after the
end of the programme
4 Mean time between fail-
ures
no less than 1500 hours
5 Life cycle no less than 5 years
6 Material of the bodies
of the power unit and
radiators
ABC plastic
7 Ambient temperature
during use
between
+ 10 and + 35 °С

TRIOMED UNIVERSAL. USER MANUAL 15
8 Rated air humidity (com-
bination of relative hu-
midity and temperature)
80 % at 25 °С
9 Rated direct voltage 3,0 V
10 Consumption current no more than 80 mA
Depending on the radiator used, the device should ensure
the output characteristics meeting those given in Table 2.
Table 2
ICarrier
frequency
Wave length Label
colour
Duration,
sec:
Power flow
density,
μW/cm2)
1 40 - 43 GHz 7,5 - 6,98 mm red 1÷1800 0,0001 - 0,6
2 52 - 57 GHz 5,77 - 5,26 mm green 1÷1800 0,0001 - 0,6
3 57 - 63 GHz 5,26 - 4,76 mm blue 1÷1800 0,0001 - 0,6
4 50 - 75 GHz 6,0 - 4,0 mm yellow 1÷1800 0,0001 - 0,6
5250-375 THz 1,2 - 0.8 µm white 1÷1800 0,0015 - 0,2
Millimeter electromagnetic radiation is modulated by
a simple low-frequency or complexly modulated signal.
The frequency, duration and form of modulating signals
are changed by the software during the treatment ses-
sion. The programme number according to the Unied
Programme Register of the Manufacturer is shown in the
identication number of the radiator. The carrier frequency
is not changed.
Exampleofdesignation.
Radiator 1:
- radiator type – Identication color - red,
- programme number according to the Unied
Programme Register of the Manufacturer – “1”.

TRIOMED UNIVERSAL. USER MANUAL16
4.2. Structure and functioning
Thepowerunitincludes(Fig2and3):
• indicatoroftheprogrammenumberoftheattached
radiator and the remaining time of stimulation;
• USBconnectorforthecable(USBA–miniUSBB5pin);
• buttontoswitchonthedeviceandactivatethe
programme of the radiator as well as to switch o the
device;
• beeperforsoundindicationofthefunctioningofthe
device;
• batterycompartment.
USB A connector for the cable
Indicator
Control button
Figure2.Frontview.
Generalviewofthefrontpanel
Beeper
The lid of the battery compart-
ment with the label
Figure3.Backwiev

TRIOMED UNIVERSAL. USER MANUAL 17
Theradiatorincludes(Fig4):
• LEDtoindicatethefunctioningofthedevice;
• miniUSB5pinconnectorforthecable(USBA–miniUSB
B 5pin);
• MMEMRgeneratororIR-diode(dependingofthe
radiator type)
Light indicator
Identication
number
Factory number
miniUSB B 5pin
connector
Figure 4.
Externalradiator.Topview Working surface
The device with the batteries in is always on standby.
Figure5
Figure 6

TRIOMED UNIVERSAL. USER MANUAL18
When the radiator is attached to the power unit
through the USB cable (Fig 5), the device is switched
on automatically and the indicator shows the num-
ber of the programme (Fig 6) of the attached
radiator (001 for radiator 1 and 005 for radiator 5).
Upon pressing the control button the radiation is
switched on and the indicator shows the duration of the
session in seconds. The countdown will begin, the beeper
located on the power unit will produce sound and the LED
is periodically on and o on the radiator.
If the control button is not pressed within 10 seconds
after the radiator has been attached, the device enters the
standby mode and the indicator is switched o. To switch
the device on, press the control button. The indicator will
show the number of the programme of the radiator at-
tached. To switch radiation on, press the control button
again. The countdown begins, the beeper will produce
sound and the LED will be switched on the radiator.
At the end of the session the indicator will show three
zeros (000). If the control button is not pressed again within
10 seconds, the device will be switched o automatically
and the numbers on the indicator will be turned o.
You can switch o radiation any time during the ses-
sion by pressing the control button. The programme
will be stopped.

TRIOMED UNIVERSAL. USER MANUAL 19
5. PACKAGE CONTENTS
The package contents of the TRIOMED UNIVERSAL de-
vicearelistedonthepackage(box)andinclude:
• low-frequencyelectronicTRIOMEDgenerator
(power unit);
• externalradiatorNo.1;
• externalradiatorNo.5;
• standardcable(USBА–miniUSBB5pin);
• 2LR06batteries;
• usermanual;
• consumerpackaging;
• warranty.
Additional radiators can be purchased separately.
6. LABELLING
The marking is shown on the label placed on the lid
of the power unit.
The label specifies:
• name of the device,
• factory number (se-
rial number/year of
manufacture)
• handling symbols,
TRIOMED EU
EU-0034/13
Legal address of the manufacturer, power consump-
tion, the type and amount of nutrients and other necessary
information is given in this manual.
The marking of the radiator is shown on the colour label
located under the glass (Fig 4). The label colour corresponds

TRIOMED UNIVERSAL. USER MANUAL20
with the carrier frequency of radiation (Table 2). The label
shows the identication number, the serial factory number
and the trademark.
7. PACKAGING
The packaging protects the device from weather and
mechanical damage. The packaging (box) provides all the
required information in English and the language of the sell-
er’s country about the product, package contents, manufac-
turer. It also contains handling symbols and data concerning
the certication in the European Union.
The device is placed into the storage bag and put into
the box.
8. DISPOSAL
2274
The device is produced in accordance with the EU
requirements for the content of harmful chemical
substances. The device should be disposed of into
a special container for radioelectronic
equipment.
9. WARRANTY
The warranty is provided on a separate sheet which can
be found in the box.