RITM OKB ZAO RITMSCENAR Super Pro v.2 Скачать руководство пользователя страница 33 | Manualshive

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RITM OKB ZAO RITMSCENAR Super Pro v.2 Скачать руководство пользователя страница 33

Operating Manual Version 7.3-03 of 28.07.20

33

ANNEX 1

Guidance and manufacturer's declaration –

electromagnetic compatibility (EMC)

Intended healthcare environment

–

Professional

Emissions

Classification

—

Standard

EN 55011

(idt CISPR

11)

Class A or B

B

—

Group 1 or 2

1

—

Conducted RF Emissions

N/A

NOTE 1

Radiated RF Emissions

PASS

Disturbance Power (if applicable)

N/A

NOTE 2

Harmonic Distortion per EN 61000-3-2
(Class A, B, C, D)

N/A

NOTE 1

Voltage Fluctuations and Flicker per
EN 61000-3-3

N/A

NOTE 1

Immunity

Electrostatic Discharges EN 61000-4-2

PASS

Radiated RF EM Fields and Proximity Wireless
fields EN 61000-4-3

PASS

Electrical Fast Transients and bursts
EN 61000-4-4

N/A

NOTE 3,4

Surges EN 61000-4-5

N/A

NOTE 3,5

Conducted Disturbances, induced by RF fields
EN 61000-4-6

N/A

NOTE 3,4

Voltage Dips and Interruptions EN 61000-4-11

N/A

NOTE 1

Rated Power-frequency Magnetic Field
EN 61000-4-8

PASS

Supplementary information:
NOTE 1) EUT is powered by internal batteries 6V DC
NOTE 2) If applicable Radiated RF Emissions, Disturbance Power is not neces-
sary
NOTE 3) The test is applicable to all d.c. power PORTS intended to be connect-
ed permanently to cables longer than 3 m.

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Содержание RITMSCENAR Super Pro v.2

Страница 1: ...ANUAL MANUFACTURER RITM OKB ZAO 99 Petrovskaya str Taganrog Russia 347900 Tel Fax 7 8634 62 31 79 www scenar com ru e mail medsc scenar com ru AUTHORIZED REPRESENTATIVE SCENAR Center Bulgaria ltd 9 V...

Страница 2: ...1 WARNING As the current densities for electrodes exceeds 2 mA r m s cm2 the device requires the special attention of the user WARNING The device should not be used adjacent to or stacked with other e...

Страница 3: ...on electrodes to chemical solvents or harsh cleaning fluids Follow cleaning instructions in this manual Clinical environment NOT suitable for use in the presence of flamma ble anaesthetic mixtures wi...

Страница 4: ...COMPLIES WITH THE ESSENTIAL REQUIREMENTS OF THE MEDICAL DEVICE DIRECTIVE Notified Body No 2265 3EC International a s Hrani n 18 Bratislava 82105 Slovakia APPLIED PARTS TYPE BF MANUFACTURER combined wi...

Страница 5: ...etting the Frequency F 24 6 2 6 Setting the Intensity Int 24 6 2 7 Setting the Stimulus Gap in a Burst Gap 24 6 2 8 Switching Off the Device 26 6 2 9 Switching the Device to the Standby Mode 26 6 3 SE...

Страница 6: ...from the device usage refers to Class IIa 2a DIRECTIVE 93 42 EEC GOST R 31508 The device complies with the standards EN 60601 1 GOST R 50267 0 and EN 60601 2 10 GOST R 50267 10 for internally powered...

Страница 7: ...33 F 10 R1 1 4W 11 k 5 R2 R3 1 4W 91 k 5 R4 1 4W 560 5 M1 M3 are measuring points Fig 1 1st Ph stimulus 1st phase duration 2d Ph stimulus 2nd phase duration Ua stimulus 2nd phase 1st pulse amplitude F...

Страница 8: ...gs pause time 1 0 0 5 sec stimulus burst time in the 1 1 mode 1 0 0 5 sec in the 2 1 mode 2 0 0 5 sec in the 3 1 mode 3 0 0 5 sec in the 4 1 mode 4 0 0 5 sec in the 5 1 mode 5 0 0 5 sec Umin minimum a...

Страница 9: ...6 Damping modes change of influencing stimulus initial shape Dmp Off no damping see Fig 8 Dmp Sc1 weak damping see Fig 9 Dmp Sc2 moderate damping see Fig 10 Dmp Sc3 strong damping see Fig 11 Dmp Sc4 m...

Страница 10: ...en stimuli in a burst between the end of the 1st phase of the current stimulus and the beginning of the 1st phase of the following stimulus called Gap from 200 10 to 1600 100 sec 2 3 8 Combined modula...

Страница 11: ...ng to p 2 3 5 variable damping according to p 2 3 6 intensity 3 gap randomly changes from 200 10 to 1460 100 sec 2 3 8 4 Sw4 with the following settings frequency modulation according to p 2 3 5 varia...

Страница 12: ...ttery AAA type 4 Cover 1 Operating Manual 1 Instruction for Use 1 Note 1 On the customer s request the electroneurostimulators can be completed with the following add on electrodes Face electrode Comb...

Страница 13: ...settings and device s state Fig 14 4 3 The device has the following controls on the upper side 1 of its case button 3 is used to decrease the energy strength or value of a selected parameter button 4...

Страница 14: ...witches to the state that displays basic parameters hereinafter called B state So the basic parameters of stimulation will be displayed Fig 16 Fig 15 The first line contains the timer indica tor of th...

Страница 15: ...rated in the Fig 18 dotted lines mean that the Dose is on Fig 18 After being switched on the device is always in the B state In the B state the device will stimulate at the settings displayed on the s...

Страница 16: ...ape modes Fig 19a and 2 portrait modes Fig 19b To change the screen orienta tion press the button in the B state or in the Dose state a b Fig 19 6 1 4 There is a battery indicator in the top line of t...

Страница 17: ...ones and acupuncture points connect your add on point electrode to the appropriate jack Make sure of the contact by touching the skin with the electrode Before every treatment of any acupuncture point...

Страница 18: ...ing mode for searching the optimal treatment places Dose 4 indicated by 4 short beeps is similar to Dose 3 but the data are displayed in the circle when the screen image is horizontal Optional Dose 3...

Страница 19: ...way until either Dose or Zero is achieved Timer Initial reaction Initial shape factor Dose Current shape factor Reaction rate Reaction and shape rate chart Zero Dose Zero Current reaction Fig 21 In D...

Страница 20: ...nergy strength will decrease to the minimal level and the device will be waiting for the electrode to be taken off from the skin Once the electrode is taken off the previously set value of the energy...

Страница 21: ...ose 3 and or Dose 4 modes can represent the labile screening mode data for searching skin areas with maximal reaction in a labile mode current reaction to the initial reaction ratio in the audio visua...

Страница 22: ...for the right hand 6 for the left foot and 6 for the right foot The columns are named respectively lH rH lF rF Fig 25 In this mode the picture on the screen cannot be rotated To select a point to be...

Страница 23: ...tting the Frequency Modulation FM The frequency modulation modes are the following fixed frequency mode FM Off Activating the mode is indi cated by a long beep variable frequency mode FM On Activating...

Страница 24: ...by 1 2 3 4 and 5 short beeps respectively While the beeps sound the frequency cannot be changed This makes it easier to set the required frequency 6 2 6 Setting the Intensity Int The intensity the num...

Страница 25: ...2381 2273 2174 1786 1316 1042 862 735 641 568 50 3333 3125 2941 2778 2632 2500 2000 1429 1111 909 769 667 588 30 3846 3571 3333 3125 2941 2778 2174 1515 1163 943 794 685 602 20 4167 3846 3571 3333 31...

Страница 26: ...o the standby mode press simultaneously the buttons and To resume operation press the button 6 3 SERVICE MENU The device has a Service menu state Fig 28 To enter the Service menu press the buttons and...

Страница 27: ...mode SCENAR will switch to the standby mode in 5 10 or 20 minutes even if there was a contact with the skin This mode is intended to treat one point for a specified time Attention In the AOff Off and...

Страница 28: ...te that the settings have been saved 6 3 8 Reading the Settings Read The Read menu item allows to read the earlier saved sets of parame ters from the non volatile memory see p 6 3 7 Select the number...

Страница 29: ...t on again Check whether the require ments of p 5 4 are fulfilled If the problem persists contact the manufacturer The SCENAR device emits 5 short beeps from time to time The picture on the LCD disapp...

Страница 30: ...s supplied by the manufacturer of the SCENAR device There is no energy both on the add on and built in electrodes when the add on electrode is con nected but the energy on the built in electrode is fe...

Страница 31: ...6 Customer claims are rejected if the product has been subjected to any mechanical damage re sulting from an accident fire acts of nature or acts of God the manufacturing serial numbers labels seals...

Страница 32: ...d relative humidity not to exceed 100 at a temperature of 25 C with a protection from a direct atmospheric precipitation 10 2 After transportation at negative temperatures the device should be kept in...

Страница 33: ...NOTE 1 Immunity Electrostatic Discharges EN 61000 4 2 PASS Radiated RF EM Fields and Proximity Wireless fields EN 61000 4 3 PASS Electrical Fast Transients and bursts EN 61000 4 4 N A NOTE 3 4 Surges...

Страница 34: ...d to connect directly to outdoor cables Guidance and manufacturer s declaration electromagnetic immunity Immunity test EN 60601 1 2 test level Compliance level Electrostatic discharge ESD EN 61000 4 2...

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