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, scientic 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 eciency, 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 reexogenic 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 signicant 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.
Intermsofitsutilisationthedeviceisclassiedasaproduct
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 eect. 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
reexes as well in the general reaction aimed at strengthen-
ing the adaptation, adjustment and defence capacity. The
healing eects 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 eects mentioned above are clinically manifested
in anti-inammatory, analgesic and anti-oedematous ac-
tion, improved tissue regeneration, increased non-specic
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 eects include anti-inammatory,
lymph-draining and vasodilative action. The device acceler-
ates regression of inammatory 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 specic. 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
eect 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 eciency of treatment.
Table of contents
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