RTM-01-RES

DIAGNOSTIC COMPUTER BASED

SYSTEM

PASSPORT

ÄÊÃÏ.942232.001

 



Contents

1.    General guidelines

2.    Utilization

3.    Technical Specifications

4.    Delivered set

5.    Device Structure and operation principles

6.    Safety measures

7.    Set up

8.    Measurement procedure

9.    Technical service

10.  Troubleshooting

11.  Packing and transporting

12.  Storage

13.  Service & Warranty

14.  Reclamations

15.  Acceptance protocol

16. Conservation and packaging

Warranty certificate


1.      General guidelines

1.1.      This Passport, including specifications, is a user’ manual for the RTM-01- RES integral internal temperature computer based system (hereafter referring to as a radiometer).

1.2.      Read this Passport before utilizing the radiometer.

2.      Utilization

2.1.      The RTM-01-RES medical microwave radiometer is intended for noninvasive measuring the averaged temperature of patients’ internal tissues as well as the skin temperature.

It is utilized in oncology, therapy, urology, endocrinology and other medicine fields for earlier detection of temperature-differentials related diseases; the monitoring of treatment as well as drugs and physiotherapy procedure effects.

The radiometer is designed basing on advanced achievement in radio reception and microwave technologies.

The device has a number of new diagnostic abilities.

Utilization of the device is absolutely harmless for both the patients with any disease and medical personnel. Therefore the measurement procedure can be performed repeatedly. If a PC is used the measurement results are processed by software.

2.2.      The radiometer is intended for performing examinations in health centers and clinics.

2.3.      The radiometer is designed in accordance with ÓÕË 4.2 climate conditions of national standards ÃÎÑÒ 15150, but shall be used at 19-25°C temperature, atmosphere pressure of 630-800 mm Hg and relative humidity shall be not more than 80%.

2.4.      Any electromagnetic noise must be eliminated.


3.      Technical Specifications

3.1.      The technical specifications of the RTM-01-RES are the following:

 

Power supply

220 ± 22 Volt, 1 phase, 50-60 Hz

Power consumption,   Watt ,  not more

20

Internal temperature range,  °C

32...38

Skin temperature range,  °C

25...45

Internal temperature measurement accuracy, when antenna VSWR is 1-1,8,  °C

±0.4

Skin temperature measurement accuracy, °C

±0,2

Maximum measurement time with the internal temperature sensor, when the measured temperature is 32 - 38°C, seconds

8

Maximum measurement time with the skin temperature sensor, when the measured temperature is 25 - 45°C, seconds

1

Dimensions:

 

Data Processing Unit (DPU),   mm

240õ260õ135

Internal temperature sensor (ITS),   mm

200õ60õ30

Skin temperature sensor (STS),   mm

40õ40õ140

The set weight excluding a PC and a printer,

kg, not more

4

Time of reliable work, hours,  not less

5000

Time of continuous running, hours,  not less

12

The device complies with the requirements of the national standards ÃÎÑÒ Ð 50276.0-92, class 1, type B.

4.      Delivered set

The device set consists of the following items:

Item

Document

Number, units

Data Processing Unit (DPU)

ÄÊÃÏ.943779.001

1

Internal temperature sensor (ITS)

ÄÊÃÏ.943429.001

1

Skin temperature sensor (STS)

-

1

0.25À Fuses

2

Passport

ÄÊÃÏ.942232.001ÏÑ

1

Checking method

ÄÊÃÏ.942232.001ÌÏ

1


Also the following items may be included in  the device set:

Tabl.  2

Item

Number, units

Comments

PC, packed by a manufacturer

1

SIEMENS NIXDORF SCENIC PRO D5(C5)

Color printer, À4, completed and packed by a manufacturer

1

-

Cable for DPB – PC connection

1

 

RTM-Diagnosis software

1

-

 

5.      Device Structure and operation principles

5.1.      The device set consists of the following items:

·     Internal temperature sensor with the antenna (ITS)

·     Skin temperature sensor (STS)

·     Data processing unit (DPU)

5.2.      According to physics laws, any object above zero emits radiation at all frequencies and, in particular, at microwave frequencies.

This feature of heated body is used for measuring averaged internal tissue temperature and detecting thermal abnormalities of internal tissues (higher or lower temperature of internal tissues).

The noise power received by the antenna contacted an evenly heated absorbing object is:

P=K*T*B, where

K - Boltzmann’s constant

B - System bandwidth (Hz),

T – Temperature of the biologic object

Therefore the power noise received by antenna is proportional to the tissue temperature.

When the object temperature is 309°K, i.e. 36°C the noise power received by the antenna is 3x10-13 Watt. This value corresponds with the noise generated by the antenna. Special methods are applied for receiving and processing signals.

Bioobjects that usually examined consist of several layers (e.g. skin – fat – muscle). The radiation power passes through all parts of tissues with different loses and different temperatures, so the temperature measured by the antenna is not equal to the physical temperature of the examined organ, but depends on the temperature of other body parties and loses in these parties. Also the antenna does not match the measured object absolutely. That leads to errors that are eliminated by the methods described later.

The techniques of diagnosing diseases is explained in Doctor’s Manual.

The device is a modulated null-radiometer with a slipping circuit for compensating reflection between the biological object and the antenna.

The functional scheme is illustrated in Fig. 1. When the temperature is measured, the antenna contacts the patient’s skin at the projection of the examined organ. The antenna receives microwave radiation from the examined organ as noise at microwave frequencies and the signal is amplified in ITS (2).

 
Functional scheme of RTM-01-RES

 

The signal amplified in ITS is transmitted to the DPU (data processing unit), where it is processed (3).

The voltage from the skin temperature sensor (STS) (4) is transmitted to the DPU too. The skin temperature sensor is non-contact infrared frequencies receiver.

The modes are switched by the buttons located on the front cover of the data processing unit. The internal and skin temperature values are displayed on the 3-digit temperature indicator as degrees Celsius with discreteness of 0.1.

Data processing unit produces serial digital signals for interfacing with PC.

On the front cover there are a temperature indicator, "ÐÀÄÈÎÄÀÒ×ÈÊ" (INTERNAL TEMPERATURE SENSOR) and "ÄÀÒ×ÈÊ ÒÅÌÏÅÐÀÒÓÐÛ ÊÎÆÈ" (SKIN TEMPERATURE SENSOR) button, and "ÑÅÒÜ" (POWER) power indicator. On the back cover of the DPU there are connectors for connecting with the internal temperature sensor (15-pin and coaxial connector), as well as a PC 9-pin connector, a coaxial connector for the internal and skin temperature sensors (analog signals that are on this connector has positive polarity with scale factor of 0.01 V/degree). Also the power switch and fuses are on the back cover.

6.      Safety measures

6.1.      The radiometer complies with the requirements of the national standards ÃÎÑÒ Ð 50276.0-92, class 1, type B.

6.2.      The safety measures for RTM-01-RES is similar to the general safety measures for any electronics.

6.3.      The radiometer is grounded by contacting solder pads that are in the two-pin plug.

6.4.       Devices connected to the RTM-01-RES must comply with the requirements of the national standards ÃÎÑÒ Ð 50276.0-92, class 1.

6.5.      When PC is used, a processing unit, a monitor and a printer must be located at 1.5 m distance and more from the patient.

6.6.      The radiometer and the PC must be connected to tripolar separated sockets.

7.      Set up

7.1.      The radiometer must be used indoors and all climatic requirements defined in Passport must be met.

7.2.      The radiometer is transported in the pasteboard box. The device must be unpacked indoors at room temperature.

7.3.      Open the box and take off the polyethylene cover from the units.

7.4.      Check to make sure that all items indicated in paragraph 4 are delivered.

7.5.      Connect the ITS with the data processing unit (coaxial and 15-pin connectors). Connect the STS with processing unit (9-pin connector). The connectors are on the back cover of the data processing unit.

7.6.      Insert a two-pin plug of the radiometer into 220 V sockets. Press the "Ñåòü" (Power) button located on the back cover of the DPU. The power indicator located above the "Ñåòü" button and the “Íàãðåâ” indicator located on the ITS will be on.

7.7.      The device must be heated for 30 minutes.

7.8.      Choose the skin temperature mode (mode 2): press the “ÄÀÒ×ÈÊ ÒÅÌÏÅÐÀÒÓÐÛ ÊÎÆÈ” (Skin temperature sensor) button. The below temperature indicator will be on.

7.9.      Connect the skin sensor surface with the skin of the palm near foundation of the thumb. Displayed temperature will be 30…35°C.

7.10.   Switch to the internal temperature mode (“ÐÀÄÈÎÄÀÒ×ÈÊ”). The indicator that is above will be on.

7.11.   Connect the antenna surface with the right or left neck side at the 5-cm high from the collarbone. Displayed temperature should be about 32…36°C. Checking device is complete.

7.12.   When a PC is used, connect PC units in accordance with User’s Manual. Plug the cable from DPU into the serial socket of the PC (Com1 or Com2).

7.13.   Turn on the radiometer and the PC. Install the RTM-Diagnosis software. Choose Settings/Device interface. Set COM 1 or COM 2 option according to 7.12 clause.

8.      Measurement procedure

8.1.      For measuring the internal temperature (mode 1) put the antenna on the body at the examined point. Substances for improving antenna contact with the skin are not required. The entire antenna surface must contact the skin.

8.2.      Read the temperature on the temperature indicator. When the mode 1 is used the temperature displayed on the indicator may vary about the average temperature at ± 0.1...0.2 °Ñ; therefore values displayed on the indicator must be averaged.

8.3.      The skin temperature is measured with the skin temperature sensor. Switch on the mode 2 (skin temperature sensor). The sensor must be perpendicular to the body surface and special facilities are used. The measurement time at one point is not more than 2 seconds. When the facilities for short distance are used the diameter of the investigated spot is 5 mm. For long distance it is 18 mm.

9.      Technical service

9.1.      Technical service shall be carried out in order to prevent damages.

9.2.      Read Safety Measures section of Passport before carrying out technical services.

9.3.      There are the following technical service types:

Day-to-day service performed by medical personnel according to section 7 herein;

Annual service performed by technical personnel once a year.

Annual service includes examining radiometer units, and technical condition according to the method described in ÄÊÃÏ.942232.001 ÌÏ.

9.4.      The device is repaired by representatives of the manufacturer.

10.  Troubleshooting

10.1.   Possible problems are the following:

Problem

Possible cause

Solving

1. When you turn on the “Ñåòü” (Power) button the power indicator is not on.

One of the 0,25 À fuses of DPU is damaged. 

Replace a fuse

2. When the internal temperature sensor is checked in accordance with section 7, the temperature displayed on the temperature indicator is less than 30°C or more than 38°C.

The internal temperature sensor does not connect to DPU.

Connect the cable,

wear through 15-pin connector. 

3. When the internal temperature sensor is directed to the environment the temperature displayed on the temperature indicator is more than 40°C

There is powerful external noise.

Eliminate the source of this noise.

10.2.   When other problems occur, contact a manufacturer.

11.  Packing and transporting

11.1.   For delivery the radiometer is packed into a polyethylene film and box.

11.2.   The documentation is covered by paraffined paper, packed into polyethylene film and put into the box with the device.

11.3.   The radiometer can be transported by any flight transport excluding non-heated airplane sections, climatic conditions must correspond to the national standard ÃÎÑÒ 15150, group 5

12.  Storage

12.1.   For short term the radiometer must be stored indoors at 10…35°C temperature, and relative humidity must be 80 per cent at temperature of 25°C.

12.2.   For long term the radiometer must be stored at a warehouse of a manufacturer or customer in accordance with store conditions of the national standards ÃÎÑÒ 15.150.

13.  Service & Warranty

13.1.   The manufacturer guarantees that the radiometer corresponds to indicated specifications when all conditions and use, technical service, transporting and storing requirements indicated in the device documents are met.

13.2.   The warranty period is 12 months, it begins once the radiometer is set to be used.

13.3.   The warranty service is carried out by a manufacturer at no cost to the customer. If the radiometer is damaged as a result of wrong utilizing the device, the warranty service is carried out by a manufacturer at cost to the customer.


14.  Reclamations

14.1.   All reclamations must be filled in the following form:

Initial Exploitation Data

Problem appearance Data

Problem Brief Description

Comments
       

15.  Acceptance protocol

The RTM-01-RES Medical Radiometer, Factory #________ complies with the technical requirements and is serviceable.

Warranty period is 12 months, it begins once the device is set to be used.

Production data     “______” ________________ 199__ ã.

Director of RES, Ltd.                                              Vesnin S.G.                        

16. Conservation and packaging

The   RTM-01-RES   Medical,   factory   number   _______

is conservated and packed by RES, Ltd. in accordance with technical requirements.

Packing Data   “_________” ____________________ 199___ ã.

Packer  _______________     ___________________

                      (signature)                        (surname)

The packed device is accepted by      _______________     ___________________

                                                                    (signature)                        (surname)
RES, Ltd. 22, Bolshaya Pochtovaya, Moscow, 107082, Russia

tel.: +7 (095) 261-31-47

WARRANTY CERTIFICATE

for repairmen (change) within the warranty term


Medical device   -     RTM-01-RES Medical radiometer ÄÊÃÏ.942232.001ÒÓ
Number and production data________________________________________________
Purchased   _________________________________________________________________

                    (data, signature and stamp of sailor)
set in operation _______________________________________________________

                                                      (data, signature)
accepted for warranty __________________________________________

RES, Ltd. 22, Bolshaya Pochtovaya, Moscow, 107082, Russia

tel.: +7 (095) 261-31-47

WARRANTY CERTIFICATE

for repairmen (change) within the warranty term


Medical device   -     RTM-01-RES Medical radiometer ÄÊÃÏ.942232.001ÒÓ
Number and production data________________________________________________
Purchased   _________________________________________________________________

                    (data, signature and stamp of sailor)
set in operation _______________________________________________________

                                                      (data, signature)
accepted for warranty __________________________________________


-------------------------------------------------------------------------------------------------------


RES, Ltd. 22, Bolshaya Pochtovaya, Moscow, 107082, Russia

tel.: +7 (095) 261-31-47

WARRANTY CERTIFICATE

for repairmen (change) within the warranty term


Medical device   -     RTM-01-RES Medical radiometer ÄÊÃÏ.942232.001ÒÓ
Number and production data________________________________________________
Purchased   _________________________________________________________________

                    (data, signature and stamp of sailor)
set in operation _______________________________________________________

                                                      (data, signature)
accepted for warranty __________________________________________


-------------------------------------------------------------------------------------------------------

RES, Ltd. 22, Bolshaya Pochtovaya, Moscow, 107082, Russia

tel.: +7 (095) 261-31-47

WARRANTY CERTIFICATE

for repairmen (change) within the warranty term


Medical device   -     RTM-01-RES Medical radiometer ÄÊÃÏ.942232.001ÒÓ
Number and production data________________________________________________
Purchased   _________________________________________________________________

                    (data, signature and stamp of sailor)
set in operation _______________________________________________________

                                                      (data, signature)
accepted for warranty __________________________________________

 

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