Instrument for EHF-infrared therapy "Triomed". Operational manual (passport attached)

OKP 94 4420
Registration certificate Roszdravnadzor RF
№ FCP 2009/06554 from 28.12.2009.
The Certificate ROSS RU.ME01.B06576.

Instrument for EHF-infrared therapy "Triomed"
ТU 9444-014-61005106-2009
Operational manual
ТGКB 941.526.001 RE
(passport attached)

Saint-Petersburg, 2010

Operational manual was developed by OOO Triomed.
The document is not subject to copying or transferring to other organizations and persons without consent of the owner

Introduction

The present Manual is designed to train users on the correct operation of the instrument of extremely high frequency infrared (EHF and IR) therapy "Triomed" (hereinafter - the device).

Before using the device, study this Manual carefully!

During operation one should use the Manual on application of the instrument of EHF-IR therapy TGKB 941.526.001 PI and labels on radiators TGKB 943.139.001-005 ET.

Attention! EHF-effects should be avoided when:
• Diagnosis is uncertain;
• Individual hypersensitivity to the effect;
• Feverish conditions of unknown etiology;
• A patient having implanted devices with autonomous power supply (in the area of the device installation).

Patients with increased sensitivity to EHF radiation and contraindications, specified in the Manual, should consult with their physician prior to using the device.

It is prohibited to:
• Store the unit in places accessible to children and pets,
• Give radiators to children unattended.

1. Description and operation

1.1. Application
1.1.1. EHF-IR therapy “Triomed” device is a reflexological, physiotherapeutic and medical instrument for the treatment and prevention of various pathological conditions by exposure to low-intensity electromagnetic radiation of EHF and infrared ranges on human skin.

1.1.2. During 30 years, EHF-therapy demonstrated a multi-healing effect, the absence of non-favorable long-term results, side effects; there are no contraindications for use of the method.
EHF-therapy is most effective in treatment of diseases of peripheral and autonomic nervous systems, spine, musculoskeletal system, joints, otolaryngology, cardiovascular system, lungs and pleura, the digestive tract, skin and subcutaneous tissue, drug abuse treatment, gynecological diseases, allergic diseases; wound and burn treatment, and to relieve pain.
The inclusion of EHF therapy in complex treatment of many diseases allows to reduce drug dosage, potentiate drug action, to avoid using drugs in some cases, improve toleration of many drugs, reduce severity of side effects, achieve positive clinical results for drug-resistant patients

1.1.3. Recommendations on method and biologically active zones for EHF or IR-effects are given in the operational manual.

1.1.4. The device can be used by general medical, medical and preventive institutions as well as by an individual under the supervision of a physician in a hospital, outpatient and at home.

1.1.5. Operation of the device does not require special training.

1.1.6. Examples of the device name on the order or when referred to in other documentation:
«EHF-IR therapy "Triomed” device with radiator № 1, ТU 9444–014–61005106–2009»;
«EHF-IR therapy "Triomed” device with radiator № 5, ТU 9444–014–61005106–2009».

1.2. General technical parameters
1.2.1. The device complies to requirements of GOST Р 50444, ТU 9444–014–61005106–2009 and set of design documentation (КD) ТGКB 941.526.001.

1.2.2. The operational mode of the device classifies it as a product of multiple cyclic use.

1.2.3. The device is made resistant to mechanical impact in accordance with Group 2, according to GOST R 50444 at 4.2 climatic design UHL as per GOST 15150.
The device meets safety requirements of GOST R 50267.0 and it is designed as a product with the secure internal power supply, type B.
Potential risk of using the device classifies it as a class 2a under GOST R 51609.

1.2.4. Purchased parts and components comply with the requirements of normative documents approved in the prescribed manner and have certificates of manufacturers attached.

1.2.5. Dimensions of power supply are 105x54x33 mm.

1.2.6. Dimensions of radiator are 30x23x11 mm.

1.2.7. The cable length between the power supply and the radiator is no less than 1.0 or 1.8 m.

1.2.8. Power supply weight is 0.3 kg.

1.2.9. The radiator weight is no more than 0.05 kg.

1.2.10. The device operates from an internal power source: two elements LR06 (AA type) with a nominal DC voltage 3.0 V and consumes from a source no more than 0.033 A.

1.2.11. The device depends on the connected transmitter provides output characteristics, which must comply with those in Table 1.

Table 1

Type of transmitter	Carrying frequency	Wave length	Modulating frequency if carrying frequency, Hz	Duration of radiation, s	Average power of EHF-radiation or power flow of Infrared radiation, mW
№ 1	40 - 43 GHz	7.5 - 6.98 mm	10 ± 0,5	1 : 600	0.001 – 0.01
№ 2	52 - 57 GHz	5.77 – 5.26 mm	10 ± 0,5	1 : 600	0.001 – 0.01
№ 3	57 - 63 GHz	5.26 – 4.76 mm	10 ± 0,5	1 : 600	0.001 – 0.01
№ 4	50 - 75 GHz	6.0 – 4.0 mm	10 ± 0,5	1 : 600	0.001 – 0.01
№ 5	250 - 375 GHz	1.2 – 0.8 micron	-	600	0.001 – 0.01

Comments:

Type transmitter is denoted by color markings on it: № 1 - red, № 2 - green, № 3 - blue, № 4 - yellow, № 5 - white.
Transmitters ## 1, 2, 3, 4 can be programmed to operate in modes with modulation frequency parameters from 1 to 100 Hz and exposure time from 1 to 600, at that the carrier frequency of the transmitter does not change.
New parameters are specified on the transmitter’s label.

1.2.12. The device has light and sound indications of the following statuses:
• power is turned on;
• discharge of batteries;
• start and end of treatment;
• disruption of the system and transmitters.

1.2.13. Build-up time to operating mode is no more than 5 sec.

1.2.14. The device provides for normal continuous operation for 10 hours with characteristics that were consistent with those in the Table 1.

1.2.15. The device has a built-in timer, which provides the shut down of mechanism after (10 ± 1) after the end of the procedure.

1.2.16. Cases of transmitters and of the device are made out of non-toxically plastic material.

1.2.17. The outer surface of the device is resistant to disinfection by MU 287-113 3% hydrogen peroxide solution according to GOST 177 with the addition of 0,5% solution of detergent in accordance with GOST 25644.

1.2.18. The device when operating is stable to:
• climate conditions in accordance to GOST 15150 with UHL 4.2: nominal temperature parameters are: +35°С - +10°С; relative humidity is 80% at 25°С;
• mechanical stress with parameters of GOST R 50444 for the group of products 2: vibratory loads in the frequency range 10-55 Hz with the amplitude of displacement of 0.15 mm

1.2.19. The device in transport packaging is stable to:
• climate conditions in accordance to GOST 15150 for storage conditions 5;
• mechanical stress with parameters of GOST R 50444 for transport conditions.

1.2.20. Average operational time before disruption is no less than 1500 hours. Non-working condition is characterized by failure of the device to comply with the requirements of item 1.2.11.

1.2.21. An average operational lifetime of the device till the write-off is at least 5 years. The criteria for bordering state when the device is considered inoperable are when its restoration is technically or economically impractical.

1.3. Technical characteristics of a transmitter
1.3.1. The transmitter is an integral part of the EHF-IR therapy "Triomed” device.

1.3.2. The transmitter is designed to generate electrical impulses of EHF or infrared range of radiation, and also to control the power supply.

1.3.3. Structurally the transmitter consists of a generator, transmitter and control unit.

1.3.4. When the transmitter is connected with a cable to the power supply, the transmitter control unit emits the signal, which provides automatic switch on of the power supply, chooses an operational mode and displays the mode number on the screen.

1.3.5. Radiation is switched on after pressing control button on the power supply.

1.3.6. When manufactured, each transmitter is configured to generate radiation on one of the fixed frequency: 40 : 43 GHz, 52 : 57 GHz, 57 : 63 GHz, 50 : 75 GHz (EHF-range) and 250 : 375 THz (IR range). Type of transmitter is marked in a table with serial number by the color corresponding to the carrier frequency (red, green, blue, yellow, white).

1.3.7. When manufactured, control unit of the radiator is configured in a way that the power supply of the device generated set forth characteristics of low-frequency modulation of the carrier frequency. At product shipping (if the customer does not indicate otherwise), the modulation frequency is 10 ± 0,5 Hz.

1.3.8. Transmitters of EHF range can be reprogrammed to different parameters of the modulation frequency from 1 to 100 Hz and exposure time from 1 to 600, with a carrier frequency of the transmitter remaining the same. New transmitter parameters are specified in the relevant section of the label on a transmitter.

1.3.9. In the outer case of each transmitter, a Light Emitting Diode, that signals on transmitter’s performance, is installed, and a mini USB 5 pin connector for the cable.

1.3.10. The transmitter is packaged along with the apparatus or separately in polyethylene in accordance with GOST 10354.

1.4. The unit components, design and performance

1.4.1. The unit consists of:
• low-frequency electronic generator "Triomed" TU 6349-005-61005106-2009 (hereinafter "power supply")
• remote transmitters (from number 1 to number 5) TGKB 941.526.001-005,
• standard cable USB А – mini USB 5 pin,
• two batteries LR06 (AA) with a nominal DC voltage 3.0 V.

1.4.2. The unit design and performance are described in the operational manual and.

1.5. Completeness
The set of delivery must meet the list specified in the table 2.

Table 2

№	Name	Catalogue number	Number of units
1.	The device of EHF-IR therapy “Triomed”:	ТGКB 941.526.001	1
1.1.	• low-frequency electronic generator "Triomed"	ТU 6349.005.61005106.2009	1
1.2.	• remote transmitter № 1.	ТGКB 943.139.001	1
2.	The device of EHF-IR therapy “Triomed”:	ТGКB 941.526.001	1
2.1.	• low-frequency electronic generator "Triomed",	ТU 6349.005.61005106.2009	1
2.2.	• remote transmitter № 2.	ТGКB 943.139.002	1
3.	The device of EHF-IR therapy “Triomed”:	ТGКB 941.526.001	1
3.1.	• low-frequency electronic generator "Triomed",	ТU 6349.005.61005106.2009	1
3.2.	• remote transmitter № 3.	ТGКB 943.139.003	1
4.	The device of EHF-IR therapy “Triomed”:	ТGКB 941.526.001	1
4.1.	• low-frequency electronic generator "Triomed",	ТU 6349.005.61005106.2009	1
4.2.	• remote transmitter № 4.	ТGКB 943.139.004	1
5.	The device of EHF-IR therapy “Triomed”:	ТGКB 941.526.001	1
5.1.	• low-frequency electronic generator "Triomed",	ТU 6349.005.61005106.2009	1
5.2.	• remote transmitter № 5.	ТGКB 943.139.005	1
6.	standard cable USB А – mini USB 5 pin	USB 2,0-M 5P-1AM/M5З-1M	1
7.	Operation documentation:
7.1.	• operational manual	ТGКB 941.526.001 RE	1
7.2.	• application manual	ТGКB 943.139.001 IP	1
7.3.	• transmitter label	ТGКB 943.139.001 ET ТGКB 943.139.002 ET ТGКB 943.139.003 ET ТGКB 943.139.004 ET ТGКB 943.139.005 ET	1

Comments:

The shipping of the device can include any combination of the items 1, 2, 3, 4, 5.
At the request of the customer the shipping may be composed of a generator and several transmitters. Content of delivery is specified on the label on the device.

1.6. Labeling
1.6.1. Labeling of the device complies with GOST R 50444 and set of design documentation.

1.6.2. Each transmitter has a color plate attached in accordance with GOST 12969, where the color denotes the type of transmitter and a serial number.
Transmitter label contains:
• Trade mark or manufacturer name ("LLC Triomed");
• unit name (transmitter EHF-IR therapy "Trio-Med");
• serial number;
• manufacture date (year, month);
• identification of technical specifications (TU 9444-014-61005106-2009).
The label is included in the packaging of the transmitter.

1.6.3. Labeling is made in a manner ensuring its accuracy and safety during the period of transportation, storage and operation.

1.6.4. Labeling consumer packaging complies with GOST 14192 and the set of design documentation.

1.6.5. Packaging label contains the following data:
• trade mark of the manufacturer;
• unit name,
• unit serial number;
• packaging date.
Additional inscriptions describing packaging may be included.

1.7. Packaging
1.7.1. Packaging of the device provides protection from climatic and environmental factors and is carried out according to GOST R 50444.

1.7.2. Packaging is made in accordance with the requirements of design documentation of the manufacturer and secures the device safety during transportation and storage.

1.7.3. The device is packaged in a blister made out of thermoplastic material, or in polyethylene in accordance with GOST 10354 and in a cardboard box.

2. Use of purpose

Device use of purpose is specified in the operational manual.
Safety measures
In case of performance failure, or under any emergency conditions with urgent evacuation of medical personnel, special security measures are not required when handling the device.

3. Technical maitenance

3.1. Technical maintenance of the device (test performance and characteristics of EHF and infrared radiation) is conducted once a year at repair and warranty service offices.

3.2. Device functional tests are conducted based on the information on the indicator, the presence of an alarm and a light signal on the transmitter during operation.

3.3. Testing of EHF and infrared radiation is performed using special equipment.

4. Transportation and storage

4.1. The device is transported by all kinds of transport in accordance with the requirements of GOST R 50444 and the rules of carriage of goods applied to each kind of transport.

4.2. Terms of device transportation must meet the conditions of transporting 5 according to GOST 15150.

4.3. Conditions of storage of the device in the manufacturer’s packaging in warehouses of either a manufacturer or a customer must meet the conditions of storage 2 according to GOST 15150.

5. Acceptance certificate

The device EHF-IR therapy “Triomed”
Serial number __________ complies with TU 6349–005–61005106–2009 found fit for use.
Manufacturing date «___» _____________20___.

Stamp
QC ___________________ ______________(signature)

6. Packaging certificate

The device EHF-IR therapy “Triomed” serial number __________
Packaged in accordance with the requirements set forth in design documentation.

Packaging date «____» _____________ 20___ .
Packaged by ________________

7. Manufacturer warranty

7.1. The manufacturer guarantees compliance with the requirements of the technical and design documentation providing the consumer complies with the conditions of operating, transportation and storage.

7.2. Warranty period of the device operation is 12 months from the date of sale.

7.3. Guaranteed shelf life is 6 months from the date of shipment.

7.4. Average time before the failure is no less than 1500 hours.

7.5. The average lifetime of the devise before the write-off is at least 5 years. On expiry of the term the device should be recycled.

7.6. In case the device is put in operation during its warranty period of storage, the latter is terminated. Manufacturer's warranty shall be terminated on the expiry of the warranty period of storage.

7.7. Factory defects are eliminated free of charge during the warranty period.

7.8. If you have more than three warranty cases during a warranty period, defective device is replaced with a new one.

7.9. The warranty rights cannot be transferred to a third party; they do not cover:
• product defects related to neglect or violation of the rules of operation, storage and transportation;
• when a product undergone design changes made by an unauthorized party;
• a product with deleted, changed or unclear serial number and (or) warranty seal;
• product subjected to disassembly or opening of the case, undergone maintenance or repair by persons or organizations not authorized by the manufacturer;
• damage due to reasons beyond manufacturer’s control, such as natural phenomena, natural disasters, fires, actions of domestic and wild animals, insects (ants, cockroaches), ingestion of foreign objects or liquids inside a product, and other similar reasons;
• in case of the presence of external and internal stains, deep scratches, cracks, dents, scuffs and other mechanical damage, appeared in the process of careless exploitation and violation of rules of transportation;
• in the absence of duly executed warranty card.

7.10. Warranty and post-warranty repairs are performed by OOO "Triomed" or by its official representatives.

7.11. If the fault of the product is not relevant to the warranty case, the repair is performed on a contractual basis.

7.12. Information about complaints.
In case of the device failure during the warranty period, the owner must deliver the unit or send it by mail COD to the manufacturer’s address or to the address of the company, [performing warranty repair. The device must have the following documents attached:
• Application for repair with the owner’s address and phone number; Description of the defect (repair list);
• Warranty card (Annex A).

8. Recycling

Device shall be disposed of in the container specially designed for radio-electronic equipment.

9. Manufacturer’s information

Manufacturing Company: OOO "Triomed”,
Russia, 192289, Saint-Petersburg, Malaya Balkanskaya street, d. 59a,

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