Triomed UNIVERSAL User Manual

Triomed UNIVERSAL User Manual

Active medical device for stimulation by electromagnetic field

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A C T I V E M E D I C A L D E V I C E
FOR STIMULATION BY ELECTROMAGNETIC FIELD
USER MANUAL
TRIOMED UNIVERSAL
Version 3
Introduced on 20.03.2015
Tallinn 2015

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Summary of Contents for Triomed UNIVERSAL

  • Page 1 A C T I V E M E D I C A L D E V I C E FOR STIMULATION BY ELECTROMAGNETIC FIELD USER MANUAL TRIOMED UNIVERSAL Version 3 Introduced on 20.03.2015 Tallinn 2015...
  • Page 2 The following signs have been used in the Manual and for labelling the device: 2274 Manufacturer Non-ionising radiation Device serial number Not for general (household) waste Important informa- tion about the device Keep dry! or its operation Consult instructions Fragile, handle 2274 for use with care!
  • Page 3: Table Of Contents

    TABLE OF CONTENTS 1. PURPOSE 2. MECHANISMS OF THERAPEUTIC EFFECTS 2.1. General mechanisms of action 2.2. Mechanisms of specialised action of MM radiation 3. INDICATIONS AND CONTRAINDICATIONS FOR USE 3.1. Indications 3.2. Contraindications: 3.3. Recommendations for using external radiators 4. TECHNICAL AND OPERATIONAL CHARACTERISTICS 4.1.
  • Page 4: Purpose

    TRIOMED UNIVERSAL. USER MANUAL 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/cm...
  • Page 5: Mechanisms Of Therapeutic Effects

    TRIOMED UNIVERSAL. USER MANUAL 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 fibres contained in them and do not have a thermal effect.
  • Page 6: Mechanisms Of Specialised Action Of Mm Radiation

    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...
  • Page 7 TRIOMED UNIVERSAL. USER MANUAL significant 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.
  • Page 8: Indications And Contraindications For Use

    TRIOMED UNIVERSAL. USER MANUAL 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;...
  • Page 9 TRIOMED UNIVERSAL. USER MANUAL • 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;...
  • Page 10: Contraindications

    TRIOMED UNIVERSAL. USER MANUAL 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;...
  • Page 11: Recommendations For Using External Radiators

    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-...
  • Page 12 TRIOMED UNIVERSAL. USER MANUAL The main indications for using infra-red radiation are: preparation of zones for MM stimulation, cicatricial changes in tissues, subacute and chronic non-purulent inflammatory diseases of internal organs, sluggish wounds and trophic ulcers, diseases of the peripheral nervous system with the pain syndrome, residual effects of burns and frostbites, au- tonomic dysfunctions, complications of diabetes.
  • Page 13: Technical And Operational 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...
  • Page 14 No special safety measures are required. The main technical characteristics of the TRIOMED UNIVERSAL device are given in Table 1 below. Table 1 Characteristics Description Start–up time...
  • Page 15 TRIOMED UNIVERSAL. USER MANUAL Rated air humidity (com- 80 % at 25 °С bination of relative hu- midity and temperature) Rated direct voltage 3,0 V 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.
  • Page 16: Structure And Functioning

    TRIOMED UNIVERSAL. USER MANUAL 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 off the device; • beeper for sound indication of the functioning of the device; • battery compartment. USB A connector for the cable...
  • Page 17 TRIOMED UNIVERSAL. USER MANUAL 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 Identification 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.
  • Page 18 TRIOMED UNIVERSAL. USER MANUAL 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).
  • Page 19: Package Contents

    TRIOMED UNIVERSAL. USER MANUAL 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.
  • Page 20: Packaging

    TRIOMED UNIVERSAL. USER MANUAL with the carrier frequency of radiation (Table 2). The label shows the identification 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-...
  • Page 21: Preparing The Device For Use

    TRIOMED UNIVERSAL. USER MANUAL 10. PREPARING THE DEVICE FOR USE 10.1. Operating restrictions The device can be used only after reading the User Manual. IT IS FORBIDDEN: • to use the device without reading the User Manual; • to use the faulty or damaged device;...
  • Page 22: Safety Precautions

    TRIOMED UNIVERSAL. USER MANUAL IT IS NOT RECOMMENDED • to use R06 saline batteries. Such batter- ies serve only a short period of time and have limited resource whereupon they deteriorate contaminating and damaging the device. It is recommended to use LR06 batteries.
  • Page 23 TRIOMED UNIVERSAL. USER MANUAL To replace the batteries slide the lid to the side at the back of the power unit, take the lid off, extract the old bat- teries and insert the new ones observing the polarity in accordance with the marking on the body of the devices and on the batteries.
  • Page 24: List Of Possible Faults And Suggested Remedies

    TRIOMED UNIVERSAL. USER MANUAL 10.4. List of possible faults and suggested remedies Possible faults and suggested remedies are listed in Table 2. Table 2 No Signs of a fault Likely reason Remedy the number of The batteries are replace the bat-...
  • Page 25: Technical Maintenance

    TRIOMED UNIVERSAL. USER MANUAL when the control button is pressed, electric circuit send the device the beeper makes failure to be repaired no sound, the in- dicator does not show duration of the session, the countdown does not begin, the...
  • Page 26: Procedure For Using The Device

    This User Manual regulates the therapeutic use of the device. By exposing the body surface to a millimeter electro- magnetic field using the TRIOMED UNVERSAL device, you can exert a positive effect on the internal organs, trophic processes, metabolic processes, secretory activity and other vital functions of the organism.
  • Page 27: Local Stimulation In The Pathological Focus

    TRIOMED UNIVERSAL. USER MANUAL The systemic effects of the therapy are of a prolonged character. Stimulation only produces an initial positive ef- fect which builds up in the next 2-3 weeks after a course of stimulation. That is why a pause of 3 to 8 weeks (depend- ing on the patient’s state of health) is necessary between...
  • Page 28 TRIOMED UNIVERSAL. USER MANUAL The figure shows the zones of increased skin sensitivity (hy- peresthesia) which are called the Head’s projection zones. In these areas of the skin, any normally painless irritation in the form of pressure, touch, heat or cold causes pain or discomfort.
  • Page 29: Stimulation Of Biologically Active Zones

    TRIOMED UNIVERSAL. USER MANUAL (1 treatment session per day). After the body has adapted to the stimulation, the intensity of the treatment is increased to 2-3 treatment sessions per day. If necessary, the course of treatment can be repeated in 2-6 weeks.
  • Page 30 TRIOMED UNIVERSAL. USER MANUAL Stimulation of the lum- bosacral area improves the blood circulation and the trophism of the tissues in the zone of stimulation, in the lower extremities as well as in the pelvic organs. It is indicated in the case of vas-...
  • Page 31: Stimulation Of Reflexogenic Zones

    TRIOMED UNIVERSAL. USER MANUAL under the xiphoid process. The course of treatment consists of 10-15 sessions 1-2 times per day. Clinical research has shown a connection between the skin in the lower part of the anterior abdominal wall and the internal genitourinary organs. Stimulation of the ante- rior abdominal wall allows to actively influence the state of these organs.
  • Page 32 TRIOMED UNIVERSAL. USER MANUAL Figure 8. Ways of attaching the radiator • If the placing took more than 10 seconds, the device will enter the standby mode. Press the control button to return the device to the ready mode. • To switch on the radiation and begin the treatment ses- sion, the control button needs to be pressed.

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