Triomed COMPACT User manual

ENERGY AND INFORMATION DEVICE
USER MANUAL
TRIOMED COMPACT
Version 4
Introduced on 20.03.2015
Tallinn 2015

EC DECLARATION OF CONFORMITY
MANUFACTURER:
Name of the company: Triomed EU OU (Ltd)
ID-code: No. 12146269
Address: Maealuse 4, EE-12618 Tallinn, Estonia
Telephone: +(372)56888978
E-mail: triomed-eu.eu
Triomed EU OU (Ltd) does hereby declare that we are solely responsi-
ble for the following product:
Energy and information device “TRIOMED COMPACT“ (with inte-
grated emitters, options: 40-43 GHz)
It is in conformity with the provisions of the following EC Directives, including any
amendments, and with national legislation implementing these Directives:
Directive 2004/108/EC - Electromagnetic compatibility directive (EMC)
Directive 2001/95/EC - General Product Safety Directive (GPSD)
The following harmonized standards have been applied:
- EN 55011:2009+A1:2010 “Industrial, scientic and medical equipment –
Radiofrequency disturbance characteristics - Limits and methods of
measurement”.
- EN 61000-6-3:2007 + EN 61000-6-3:2007/A1:2011+ EN 61000-6-3:2007/AC:2012
“Electromagnetic compatibility (EMC) - Part 6-3: Generic standards – Emission
standard for residential, commercial and light-industrial environments”.
- EN60065:2014 “Audio, video and similar electronic apparatus – Safety
requirements”
On the basis of Directive 2004/108/EC the device and its packaging will bear the
CE- mark.
Sergey Pichchev
COO Triomed EU OU
(Ltd)
Date and place of
issue:
21 June 2015
Tallinn, Estonia
2274

TRIOMED COMPACT. USER MANUAL 3
Dear Consumer!
This manual on how to use the TRIOMED COMPACT device
is meant for users and medical sta.
The device is supplied ready for use and can be implemented
only for its intended purpose in strict compliance with the operation instruc-
tions, safety measures and rules of therapeutic application.
Please read this Manual carefully before using the device and follow all the
instructions! Please take notice of the contraindications for use and prohibi-
tions. You will be able to achieve high therapeutic eciency, avoid possible
risks and increase the longevity of the device.
In the event of improper use of the device the right to make claims shall be
forfeited and the risk of possible dangers shall be exclusively with the owner.
This Manual is an integral part of the device. To have the information
at hand, always keep the Manual together with the device.
If you have any questions concerning the use of the device, please refer to the
information provided on the manufacturer’s website at www.triomed-eu.eu
or contact your seller.
After its manufacture, the device is carefully examined to ensure its nor-
mal operation as well as cleaned and disinfected using Aerodesin® 2000
disinfection agent.
The use of the device does not eliminate the need for the patient to remain
under medical supervision.
The document cannot be amended without prior negotiation with
TRIOMED EU Ltd.
Last updated on 20.03.2015.
2274

TRIOMED COMPACT. USER MANUAL
4
THE FOLLOWING SIGNS HAVE BEEN USED
IN THE MANUAL AND FOR LABELLING
THE DEVICE:
CE labelling
2274
Non-ionising
electromagnetic
radiation
Device serial number
2274
Not for general
(household) waste
Important
information about
the device or its
operation
2274
Keep dry!
2274
Consult instructions
for use
2274
Fragile,
handle with care!
Caution,
consult
accompanying
documents
On/o (press/press)
2274
Point of contact
with the body
of the patient
2274

TABLE OF CONTENTS
1. PURPOSE 6
2. MECHANISMS OF THERAPEUTIC EFFECTS 8
2.1. General mechanisms of action 8
2.2. Mechanisms of specialised action of MM radiation 9
3. INDICATIONS AND CONTRAINDICATIONS FOR USE 11
3.1. Indications 11
3.2. Contraindications for using MM radiation: 15
4. TECHNICAL AND OPERATIONAL CHARACTERISTICS 16
4.1. General technical characteristics 16
4.2. Structure and functioning 18
4.3. Use of the device 20
5. PACKAGE CONTENTS 22
6. LABELLING 22
7. PACKAGING 23
8. DISPOSAL 23
9. WARRANTY 23
10. PREPARING THE DEVICE FOR USE 24
10.1. Operating restrictions 24
10.2. Safety precautions 25
10.3. Preparing the device for use 25
10.4. List of possible faults and suggested remedies 26
10.5. Technical maintenance 27
11. PROCEDURE FOR USING THE DEVICE 28
11.1. Programme description 29
11.2. Selecting the impact position 37
11.4. Use of device in Head zones 38
11.5. Stimulation of biologically active zones 40
11.6. Stimulation of reexogenic zones 43
11.7. Treatment description 43

TRIOMED COMPACT. USER MANUAL
6
1. PURPOSE
The TRIOMED COMPACT 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 W/cm2) pulsed electromagnetic radiation (EMR) in the mil-
limeter (MM) and (up to 2 W/cm2) infrared (IR) band. Built-in
radiators provide the EMR stimulation in the frequency band
between 40 and 43 GHz (wavelength between 7,5 and 6,9 mm)
and between 250 and 375 GHz
(wavelength between 1,2 and
0,8 µm).
The device is recommend-
ed for use primarily for restor-
ative treatment (rehabilita-
tion) of patients with various
socially signicant diseases.
Restorative treatment
(rehabilitation) can be per-
formed irrespective of the du-
ration of the disease and aims
to eliminate its consequences,
prevent exacerbations and
relapses, normalise (main-
tain) disturbed physiological

TRIOMED COMPACT. USER MANUAL 7
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 compre-
hensive 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 set-
tings (rehabilitation centres, rehabilitation departments), by
outreach teams and independently at home in consultation
with the treating physician.
Intermsofitsutilisationthedeviceisclassiedasaproduct
of multiple cyclic use.

TRIOMED COMPACT. USER MANUAL
8
2. MECHANISMS OF THERAPEUTIC EFFECTS
2.1. General mechanisms of action
Electromagnetic waves in the millimeter (MM) 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 con-
tained in them and do not have a thermal eect. At the cel-
lular 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 periph-
eral 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 activity
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 hemodynam-
ics, normalised regulation of the autonomic nervous system
and in anti-stress action.

TRIOMED COMPACT. USER MANUAL 9
IR radiation is absorbed by acceptor molecules and cel-
lular membranes.
The mechanisms of impact of IR radiation on biological
tissues comprise the totality of molecular and cellular ef-
fects including the local activation of energy-binding proc-
esses in pathological foci as well as the launching of a set of
adaptation 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
defence.
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 ini-
tial 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 cor-
responding to the physiological rhythms of the organs, sys-
tems and the body as a whole. Complex modulated signals

TRIOMED COMPACT. USER MANUAL
10
demonstrate a great harmonising potential and biological
eect and at the same time have a lower mean power.
Each therapeutic programme uses several low-frequen-
cy 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.

TRIOMED COMPACT. USER MANUAL 11
3. INDICATIONS AND CONTRAINDICATIONS
FOR USE
MM therapy can be used in prevention programmes, in
comprehensive treatment of acute diseases and exacerba-
tions of chronic illnesses as well as in restorative treatment
(rehabilitation) programmes, including follow-up treatment.
3.1. Indications
MM therapy can be indicated in the following cases:
• colds, influenza, acute respiratory infections, decrease
in general immunity during recovery and rehabilita-
tion after diseases: for non-specific stimulation of the
immune system, including to achieve a general invigor-
ating effect;
•
chronic heart failure (ischemic heart disease, stable FC
I-IV stenocardia; I-II degree of arterial hypertension;
rhythm disturbance: rare ventricular arrhythmia, rare su-
praventricular ectopy): to increase the antioxidant capac-
ity of the muscles, enhance the rheological properties
of the blood, stabilise the processes of cholesterol me-
tabolism, reduce the intensity of immune inflammation,
improve the endothelial function, normalise lung venti-
lation during physical exertion, develop light peripheral
vasodilatation, normalise the arterial blood pressure and
the heart rate variability;

TRIOMED COMPACT. USER MANUAL
12
•I-II degree arterial hypertension: to lower high arterial
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;
•
cerebral circulatory deficiency and mild and medium
discirculatory encephalopathy: to reduce headache, diz-
ziness and buzzing in the ears, lower high arterial blood
pressure, alleviate focal neurological symptoms (pyramidal,
cerebellar, Parkinson's syndrome) and mental disturbances.
It 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 capillar-
ies, enhance the rheological properties of the blood and
intensify the regional lymph and blood flow;

TRIOMED COMPACT. USER MANUAL 13
• 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 per-
oxidation of lipids, lower the non-specific hyperactivity
of the bronchi, improve the functions of external respi-
ration, 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 (locomotor
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 microcircu-
lation, help with psychoemotional problems;
• climactericsyndrome: to reduce the frequency and in-
tensity of hot flashes, sweating, headaches and sleep
disorders, increase physical capacity, normalise th
e
oxidative status, arterial blood pressure and emotional
condition;

TRIOMED COMPACT. USER MANUAL
14
• chronicprostatitis: to relieve pain, reduce inflammation,
normalise urination, restore erection and copulative
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.

TRIOMED COMPACT. USER MANUAL 15
3.2. Contraindications
for using MM radiation:
• 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).
Contraindications for using IR radiation:
• benignormalignantneoplasms,
• activeformsoftuberculosis,
• III-degreehypertension,bleedingandII-III
degree circulatory deciency.
Stimulation of the eyes should be avoided.
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 COMPACT. USER MANUAL
16
4. TECHNICAL AND OPERATIONAL
CHARACTERISTICS
4.1. General technical characteristics
The device is produced without using any harmful chemi-
cal substances in compliance with the TRIOMED EU Ltd tech-
nical documents and meets the requirements 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 TRIOMED COMPACT device has in-built generator
of millimeter electromagnetic radiation (carrier frequency
between 40 and 43 GHz, wave length between 7,5 and
6,98 mm) and generator no.5 of IR radiation (wave length
between 1,2 and 0,8 µm).
The software allows to generate MM and IR radiation with
various modulation and distribution of stimulation during
the treatment session. The device features 8 programmes
(31-38) described in Section 11.
The number "1, 5" following the name refers to the type
of generator installed and the number in brackets "(31-38)"
refers to one of the eight treatment programmes (according
to the unied register of the manufacturer).

TRIOMED COMPACT. USER MANUAL 17
For ease of use of the device and better memorisation
of the programme numbers, the treatment programmes in
this user manual are marked with numbers 1-8 correspond-
ing to the programmes numbered 31-38 in accordance with
the unied register of the manufacturer.
The main technical characteristics of the TRIOMED
COMPACT device are given in Table 1 below.
Table 1
No Characteristics Description
1Start–up time no more than 5 sec
2Type of work with specied
characteristics
continuous, uninterrupted
3 Automatic shutdown function after the end of the programme
4Overall dimensions no more than 75×45×13 mm
5Weight no more than 0.1 kg
6Mean time between failures no less than 1500 hours
7 Life cycle no less than 8 years
8Body material polycarbonate plastic
9Ambient temperature during
use
between + 10 and + 35С
10 Rated air humidity (combina-
tion of relative humidity and
temperature)
80 % at 25 °С
11 Rated direct voltage 3,0 V
12 Consumption current no more than 30 mA
13 Power consumption no more than 100 mVA
The device comes with a CR2032 battery.

TRIOMED COMPACT. USER MANUAL
18
Millimeter electromagnetic radiation is modulated by a
simple low-frequency or complexly modulated signal. The
frequency, duration and form of modulating signals are
changed during the treatment session according to original
programmes labelled by identication numbers. The mod-
ulation of millimeter radiation in accordance with various
programmes ensures multimodality of exposure enhancing
the therapeutic eect.
The external surfaces of the device are disinfected using
a 3% solution of hydrogen peroxide or a 1% water solution
of chlorhexidine.
No special safety measures are required.
4.2. Structure and functioning
The device is a monoblock unit.
The top panel of the body of the device (g 1) houses the
control button.
The following can be found under the top panel: a bat-
tery holder, 4 LEDs indicating the switched-on state and the
stimulation programmes and a speaker.
The bottom panel of the body (g 2) houses the IR radia-
tor (IR diode) and two screws.
The generator of the MM EMR is located under the bot-
tom panel.
The side panels (g 1) house a hanging loop and a bridge
for fastening a strap.

TRIOMED COMPACT. USER MANUAL 19
Figure1.Generalview
1 – light indicators
2 – control button
3 – hanging loop
4 – battery holder
5 – strap fastening
6 – speaker
Figure 2. Bottom panel
1 – IR radiator
2 – location of the MM EMR
generator
3 – screws of the bottom panel
When the control button is pressed, the device switches
on and programme no.1 is selected. When the button is
held in the pressed position, the device keeps changing
the programmes as indicated by the LEDs switching on
briey (for approx. 2 seconds) in various combinations (g
3-10). If the control button is not released, the programme
switching cycle is repeated. When the button is released
during the indication of a particular programme, the device
activates it turning the radiation on.

TRIOMED COMPACT. USER MANUAL
20
To conrm that the device is working in accordance with
the programme selected, the corresponding LEDs (g 3-10)
are switched on and a sound signal is produced briey
at certain intervals (3-4 sec).
To use the device without sound, enter again the pro-
gramme selection mode by pressing and holding the con-
trol button. Wait for the LED combination selected earlier
and release the control button. The device is programmed
to switch on the sound in every other programme selection
cycle.
The device memorises and activates at the next start-up
the programme used in the previous session. A brief press
on the control button switches the device on and activates
the programme that has been memorised skipping the se-
lection mode. The programme currently in use is indicated.
Having nished its operation according to the pro-
gramme selected the device switches o automatically.
The device can be switched o at any time by pressing
the control button.
4.3. Use of the device
Decide on the suitable treatment programme (Section 11.1).
Find out the LED combination which indicates it (Fig. 3-10).
Switch on the device and select the programme.
The device will activate the programme and start gener-
ating radiation after you release the control button.