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Operating Manual Version 6.3-04 of 10.10.18

Guidance and manufacturer's declaration –

electromagnetic immunity

Immunity test

EN 60601-1-2

test level

Compliance

level

Electrostatic discharge (ESD)
EN 61000-4-2

± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air

PASS

Radiated RF EM fields EN
61000-4-3

3 V/m (

for Professional

Healthcare Facility Environ-
ment

)

80 MHz to 2.7 GHz
80 % Am at 1 kHz

10 V/m (

for Home Healthcare

Environment

)

80 MHz to 2.7 GHz
80 % Am at 1 kHz

PASS

Enclosure port immunity EN
61000-4-3

EN 60601-1-2:2015 Table 9

PASS

Power frequency (50/60 Hz)
magnetic field EN 61000-4-8

30 A/m

PASS

Содержание SCENAR Basic

Страница 1: ...TING MANUAL 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 lt...

Страница 2: ...WARNING As the current densities for electrodes exceed 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 equi...

Страница 3: ...cleaning liquid Allow to dry up thoroughly before use Clinical environment NOT suitable for use in the presence of flammable anaesthetic mixtures with air oxygen or nitrous oxides DO NOT REMOVE the up...

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: ...switched OFF the zones to be treated stimulation time for each zone and time of the whole session are determined by the therapist Energy is a parameter determining strength of every stimulus The Ener...

Страница 6: ...ENTS 11 4 SCENAR DEVICE OVERVIEW 12 4 1 SCENAR HOME 12 4 2 SCENAR SPORT 16 4 3 SCENAR BASIC 21 5 GETTING STARTED 23 5 1 SCENAR HOME 23 5 2 SCENAR SPORT 25 5 3 SCENAR BASIC 26 6 USING SCENAR DEVICE 27...

Страница 7: ...of combined therapy of different diseases The SCENAR device can be used by home users and in medical and prophylactic institutions to re move or reduce pain syndromes of various genesis swelling to s...

Страница 8: ...the skin impedance under the electrode see Fig 3 through 5 control of the stimulus 1st phase duration see Fig 2 within 4 2 to 500 50 sec meanwhile the amplitude of the first pulse of the stimulus 2nd...

Страница 9: ...Off load capacity 33 nF Fig 3 Load L1 S2 On load capacity 66 nF Fig 4 Load L2 load capacity 2 2 nF Fig 5 2 4 Fixed stimuli frequencies SCENAR Home 90 Hz 10 SCENAR Sport 14 60 90 340 Hz 10 SCENAR Basic...

Страница 10: ...tude value duration 1 0 0 3 sec Umin minimum amplitude Us set amplitude tp pause duration tb stimuli burst duration Fig 6 2 7 Time of dosed stimulation with L1 load SCENAR Home 20 to 40 sec SCENAR Spo...

Страница 11: ...one stimulation 9 V PP3 type battery 6F22KG 1604 1 Case 1 Consumer packaging 1 Operating Manual 1 Instruction for Use 1 Note 1 On the customer s request SCENAR devices can be completed with the follow...

Страница 12: ...5 Fm LED indicates the Frequency Modulation Fm mode preselecting 6 Am LED indicates the Amplitude Modulation Am mode preselecting 7 D LED indicates the Dosing mode preselecting The 4 Fm Am and D LEDs...

Страница 13: ...4 from minimal energy to 25 4 Fm from 26 to 50 4 Fm Am from 51 to 75 4 Fm Am D from 76 to 100 A long beep indicates the upper energy level limit The energy level decrease is accompanied by clicks at...

Страница 14: ...nd 4 light up While delivering the dose the D Am Fm and 4 LEDs light up sequentially by one or several together single beeps may sound depend ing on the dose delivery rate The greater the number of gl...

Страница 15: ...ng from 30 to 120 Hz and back The LED brightness is changing depending on the pulse frequency 4 1 9 Some modes may be used together D Am D Fm D Am Fm Am Fm For this purpose switch on the required mode...

Страница 16: ...a two tone descending ascending beep If the SCENAR device switches off automatically the keyboard will be unlocked when the SCENAR device is switched on next time 4 1 12 To switch the SCENAR device o...

Страница 17: ...button activates the preselected mode or increases the energy level stimulus strength 11 button deactivates the preselected mode or decreases the energy level stimulus strength 4 2 4 On the left side...

Страница 18: ...the D LED during 2 seconds Optional Also while the D LED is blinking the D2 mode can be selected by pressing the button sequence of single taps The activa tion of the D2 mode is indicated by two short...

Страница 19: ...the Am LED is blinking press the button to switch the mode on and press the button to switch the mode off The mode switching on is accompanied by an ascend ing two tone beep the switching off by a des...

Страница 20: ...of pulses in a batch and the gap between the pulses are controlled automatically at the 90 Hz frequency While any Preset is ON the switching to another mode by pressing the button will be locked and...

Страница 21: ...ck side of the casing 1 there is a built in electrode 2 and a battery cover 12 4 3 2 On the upper side of the casing there are following indicators 3 LED indicates the energy level stimulus strength 4...

Страница 22: ...cks at the adjustment rate the increase of the LED brightness and the 5 F1 and F2 LEDs light ing up one after another A long beep indicates the upper energy level limit The energy level decrease is ac...

Страница 23: ...buttons simultaneously no sounds 4 3 8 Optional To lock unlock a keyboard press and hold the and buttons for about 2 sec until the SCENAR device emits a two tone descending ascending beep If the SCEN...

Страница 24: ...Use the or button to adjust the stimuli energy This is accompanied by the LEDs flashing on indicating the energy level 4 from minimal energy to 25 4 Fm from 26 to 50 4 Fm Am from 51 to 75 4 Fm Am D fr...

Страница 25: ...he default settings press and hold the and but tons simultaneously for about 2 sec until the intermittent audio signal sounds The reset to the default settings occurs irrespective of whether the SCENA...

Страница 26: ...larity If the battery is installed correctly a beep sounds and the LED lights up Otherwise reset the SCENAR device refer to item 5 3 2 ATTENTION DO NOT use any power adapters to power the SCENAR devic...

Страница 27: ...the addition of 0 5 solution of an approved cleaning liquid Allow to dry up thoroughly before use 6 USING SCENAR DEVICE 6 1 SCENAR HOME 6 1 1 The Instruction for Use is the main document to be consul...

Страница 28: ...nsations Press and hold the button until the first pricking sensation vibration or for mication at the comfortable level ATTENTION To avoid uncomfortable and painful sensations of a patient it is reco...

Страница 29: ...ing the button until the intermittent audio signal sounds before the start of procedure or when going to treat the most sensitive skin areas 6 3 4 When the treatment is over it is recommended to reset...

Страница 30: ...n tact the manufacturer The SCENAR device emits short beeps twice a sec when there is no skin contact Low battery Replace the battery If the problem persists after the bat tery is replaced contact the...

Страница 31: ...SCENAR device jack Use only the add on electrodes 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 elec trode is connect...

Страница 32: ...nufacturer s seals are broken there is mechanical damage to the SCENAR device the warranty period has expired 9 6 Customer claims shall be rejected if the product has been subjected to any mechanical...

Страница 33: ...rature from 50 C to 50 C and relative humidity 100 at a temperature of 25 C with a protection from a direct atmospheric precipitation 10 2After transportation at negative temperatures the SCENAR de vi...

Страница 34: ...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...

Страница 35: ...EN 61000 4 2 8 kV contact 2 kV 4 kV 8 kV 15 kV air PASS Radiated RF EM fields EN 61000 4 3 3 V m for Professional Healthcare Facility Environ ment 80 MHz to 2 7 GHz 80 Am at 1 kHz 10 V m for Home Heal...

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