SCENAR-1-NT (version 01)
Contents
1. Fig 10 Fig 11 For detailed description of treatment in Diagnostics see recommen dations for treating in the individually dosed mode in the User s Manual provided with your device 6 11 Setting the Amplitude Modulation AM The amplitude modulation modes are the following continuous mode AM Off is indicated by a long beep mode AM 1 1 pause 1 sec pulses 1 sec the mode is indi cated by a short beep mode AM 2 1 pause 1 sec pulses 2 sec the mode is indi cated by two short beeps mode AM 3 1 pause 1 sec pulses 3 sec the mode is indi cated by three short beeps mode AM 4 1 pause 1 sec pulses 4 sec the mode is indi cated by four short beeps 15 Oper Manual 1 NT ver 01 doc Version 1 6 of February 15 2008 mode AM 5 1 pause 1 sec pulses 5 sec the mode is indi cated by five short beeps mode AM BEE generation of a single stimulus with the highest amplitude indicated by a dual tone beep 6 12 Setting 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 the mode is indi cated by a two tone beep In this mode the device ignores the settings of the F parameter swing 1 combined modulation mode FM Sw1 The mode is indicated by a low pitch beep At the same time the device forcedly sets the following2. 8 2 Other malfunctions shall be repaired only by the manufacturer 9 WARRANTY 9 1 The manufacturer guarantees that the device complies with this document when operated properly 9 2 Warranty period is 24 months from the date or purchase 19 Oper Manual 1 NT ver 01 doc Version 1 6 of February 15 2008 9 3 In case of malfunction during the warranty period the device with this Operating Manual shall be returned to the manufacturer 9 4 The warranty repair is not performed in case of device s Operat ing Manual absence or broken seals 9 5 The device is repaired at the expense of the owner in the follow ing cases the device was operated improperly the manufacturer s seals are broken mechanical damage to the device the warranty period expired 10 TRANSPORTATION AND STORAGE 10 1 The transportation of the devices to a customer is carried out by all kinds of covered vehicles except the plane compartments that have no heating at the air temperature from 50 to 50 C and 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 the transport container under normal climatic conditions for not less than 24 hours 10 3 The device shall be stored in the manufacturer s package in a heated room under the air temperature of 5 C to 40 C and relative hu midity not to exceed 80 at
3. SCENAR INT electrical neuro stimulator is intended for use in an electromag netic environment in which radiated RF disturbances are controlled The cus tomer or the user of SCENAR INT electrical neuro stimulator can help prevent electromagnetic interference by maintaining a minimum distance between port able and mobile RF communications equipment transmitters and the SCENAR INT electrical neuro stimulator as recommended below according to the maximum output power of the communications equipment Rated EE TO Separation distance to frequency of transmitter output power of d 1 2 P d 1 2 P d 2 3 P transmitter 150 KHZ to 80 80 MHz to 800 800 MHz to 2 5 NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher fre quency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people NOTE 3 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be deter mined using the equation applicable to the frequency of the transmit ter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer 25
4. neuro stimulator should assure that it is used in such an environment Immunity EN 60601 1 2 2002 Compliance Electromagnetic environ test test level level ment guidance Electro static dis charge ESD EN 61000 4 2 1995 Electrical fast tran sient burst EN 61000 4 4 2004 Surge EN 61000 4 5 1995 Al and A2 Voltage dips short interrup tions and voltage variations on power supply in put lines EN 61000 4 11 2004 4 kV contact 4 kV contact 8 kV air 2 kV for power supply lines Not applicable 1 kV for input output lines 1 kV differential mode Not applicable 2 kV common mode lt 5 Ur gt 95 dip in Ur for 0 5 cycle Not applicable 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5s Version 1 6 of February 15 2008 Floors should be wood con crete or ceramic tile If floors are covered with syn thetic material the relative humidity should be at least 30 SCENAR INT is internally powered equipment it has not AC mains terminals SCENAR INT is internally powered equipment it has not AC mains terminals SCENAR INT is internally powered equipment it has not AC mains terminals Oper Manual 1 NT ver 01 doc Version 1 6 of February 15 2008 Power fre Levels of the power fre guency quency magnetic field 50 60 Hz should be that of a typical magnetic com
5. see p 6 20 1 and 1f there is no contact with the skin for 30 seconds the device will automatically switch to the standby mode This will be accompanied by a beep text message and screen darkening To resume SCENAR operation press the Y button 6 20 The device has a Service menu Fig 13 To enter the Service menu press the buttons Y and simultaneously and a rising beep will sound The parameters of the Service menu are selected and set in the same way as in the main Menu to select a parameter use the buttons V and O and to set the required value use the buttons and When no buttons are pressed within 2 seconds the device switches to the previous state 17 Oper Manual 1 NT ver 01 doc Version 1 6 of February 15 2008 and the value of the highlighted parameter and this value solely is saved in the permanent mem at ory of the sei If the value has been changed Lght OFF Snd On then a descending beep will sound Cont 7 Ur i Le So within the same menu entering you Save Scr Read can change any number of parameters but only one parameter will be saved Fig 13 6 20 1 The AOff menu item enables or disables automatic turn off of SCENAR When the AOff is set to Off the automatic turn off is disabled At tention This may cause faster battery exhaustion when you leave the device switched on for a long time When the AOff is set to On then when no buttons are pressed and no contact with the skin has been detecte
6. Oper Manual 1 NT ver 01 doc Version 1 6 of February 15 2008 6 6 Apply the electrode on the skin on the Zone to be treated A short beep will sound indicating that the electrode is contacting the skin And the symbol will be displayed on the screen Make sure that patient isn t experiencing unpleasant sensations Press and hold down the button till the first signs like pricking light burning or vibrations appear They shall be sensed as comfortable and not painful but must be felt on the skin 6 7 To start therapy set the required mode Then put the electrode on the skin area to be treated see the User s Manual provided with your device 6 8 To treat auricular zones and acupuncture points connect your add on point probe to the appropriate jack Make sure of the contact by touching the skin with the probe Before every treatment of any acupunc ture point dip the end of the probe in water to wet the surface 6 9 In the B state the and buttons are used to control the en ergy strength within the range 1 to 250 units To control the energy strength you can either press the buttons step by step or press and hold the appropriate button this way is faster 16 steps per second When the energy strength reaches the value that cannot be further in creased decreased the device will indicate it with a long beep 6 10 Setting the Diagnostics When Diag Off is set which is indicated by a long beep the Diagnos tics is off
7. of the first measurement and so on 14 crt EJ LI Oh UM jek dT fin 6 al ld Le Ma 1 1 bat LJE t Lele el L1 a nan Fles ma ken m Cet hj i Lrdird tt Ft Hi Lr Oper Manual 1 NT ver 01 doc Version 1 6 of February 15 2008 For vertical display measurements are displayed in a column like in Diag 3 but the data of 16 measurements are displayed and they remain in their constant positions Diag 5 is intended for estimating the state of two meridians that make a pair In this case a special local electrode shall be used When Diag 5 is switched on the screen will display a matrix of 24 values in 4 columns 6 for the left hand 6 for the right hand 6 for the left foot and 6 for the right foot The columns are named respec tively 1H rH IF rF Fig 10 In this mode the picture on the screen can t be rotated To select a point to be measured use and buttons the selected point will be highlighted The measurement is made during 1 sec after the electrode contacts the skin and the measured value appears in the highlighted matrix entry To view the measurements as a graph Fig 11 press L button To return to the matrix press the button once again To quit Diag 5 press V button cole L i 444 NAW EH DEDEDEN TT OES Ki CO T LEKE cpg Fa ir E a gt EDE EDDIE ae ds Ee Fi Fe LoL ooo Low ooo ER T STS ee LES duldal m
8. parameters Dmp Int Gap F After you activate the Sw1 mode you can change the settings of the Dmp parameter The settings that cannot be changed are marked with asterisk on the screen Fig 12 swing 2 combined modulation mode FM Sw2 The mee is in 0 36 OD Dnp Vor dicated by 2 low pitch beeps sn swing 3 combined modulation Di a9 i F KOEK mode FM Sw3 The mode is in AM Off Int x dicated by 3 low pitch beeps F swing 4 combined modulation FM Sud si mode FM Sw4 The mode is in Fig 12 dicated by 4 low pitch beeps 6 13 Setting the Damping mode Dmp The Damping modes are the following Damping Off Dmp Off is indicated by a long beep Damping 1 Dmp Sc1 is indicated by a short beep Damping 2 Dmp SC2 is indicated by 2 short beeps Damping 3 Dmp Sc3 is indicated by 3 short beeps Damping 4 Dmp Sc4 is indicated by 4 short beeps Variable damping Dmp Var is indicated by a two tone beep 6 14 Setting the Frequency F To control the frequency you can either press the buttons step by step or press and hold the appropriate button this way is faster Frequency can be controlled within the range 15 15 6 to 350 354 Hz step by step at a step of about 2 of the current frequency value 128 16 Oper Manual 1 NT ver O1 doc Version 1 6 of February 15 2008 steps in all When the maximum or minimum freguency is reached the device emits a long beep In addition reaching the freque
9. state that displays basic parameters here 1 16 o Dip Of f Diag OF 90 7 inafter called B state So the basic pa rameters of stimulation will be displayed Fig 2 AM DIT Int 1 The first line contains the timer indica FM off Gap 18 tor of the device s contact with the patient s skin contact no contact and a bat Fig 2 tery discharge indicator The timer is reset upon pressing any button and when Hd Al Or Unp Off automatic turn off is enabled the timer is reset on contacting the skin as well LE d F eli y f 5 4 Press the button V to switch to the H Of f nt 1 Menu state Fig 3 Press the button Y Jj at an interval of no longer than 2 seconds FM Off 18 to make sure that the highlighting switches Fig 3 cyclically Then wait until the device switches to the B state this will happen in 2 seconds after the latest pressing of the button Y then press the button once A long 1 sec beep will sound Press and hold the button The number in the right part of the top line will be changing from 1 to 250 and then a long beep will sound Oper Manual 1 NT ver 01 doc Version 1 6 of February 15 2008 If you performed all the operations mentioned above in this item and the device works as described the device is ready to be used for therapy Otherwise refer to the Chapter 8 Troubleshooting 5 5 Switch off the device using the switch button 6 USING THE DEVICE 6 1 When
10. thologies The device is intended to treat and rehabilitate people and can be used by medical professionals in medical prophylactic institutions hospi tals emergency care units as well as at home according to the doctor s prescription The device should be used under temperatures between 10 C and 35 C with relative humidity not to exceed 80 at a temperature of 25 C Potential risk from the device usage refers to Class Ila 2a DIRECTIVE 93 42 EEC GOST R 51609 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 equipment type BF which classifies it as a safe device for personal use 2 SPECIFICATIONS 2 1 Supply voltage from 3 0 up to 4 8 V three 1 5 V alkaline batteries 2 2 Maximum supply current not greater than 600 mA 2 3 SCENAR provides 2 3 1 two phase stimuli generated at a fixed frequency that can be controlled within 15 to 350 Hz 5 2 3 2 control of the stimulus 1 phase duration within 4 2 to 500 50 usec 2 3 3 Amplitude modulation with the following settings 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 Oper Manual 1 NT ver 01 doc Version 1 6 of February 15 2008 2 3 4 BEE mode generation of a single stimulus w
11. to 1460 100 usec 2 3 8 4 Sw4 with the following settings frequency modulation according to p 2 3 5 Oper Manual 1 NT ver 01 doc Version 1 6 of February 15 2008 variable damping according to p 2 3 6 intensity randomly changes from 1 to 4 gap continuously changes from 200 10 to 1600 100 usec and back 2 4 Device s weight not greater than 0 4 kg 2 5 Overall dimensions not greater than 190x70x40 mm 2 6 Average nonfailure operating time not less than 1000 hours 2 7 Average service life not less than 4 years 3 DELIVERY SET Each complete delivery set of the devices includes Table 1 Table 1 Article Quantity units l Portable transdermal electroneurostimulator with graphic display digital light and audible indications with a built in electrode for determining optimum zones time and therapeutic effect of stimulation SCENAR I NT version 01 Oper ine battery Add on probes Face probe Skull probe Point probe l Note Add on probes are optional at extra cost 4 DEVICE COMPONENTS AND CONTROLS 4 1 The device is illustrated in Fig 1 The device has an upper cover 1 with a screen 8 case with a built in electrode 9 and a battery cover 2 All components except for the batteries are located on the printed circuit board inside the device s case Oper Manual 1 NT ver O1 doc Version 1 6 of February 15 2008 4 2 The LCD screen 8 displays the results of measuring settings
12. B state to control the energy value the device will return to the Diag nostics state if no buttons are pressed within 2 seconds To switch the device to the Menu state use the button Y 6 3 The device can display information on the screen in 3 possible directions horizontal Fig 5a vertical for the right hand and vertical for the left hand Fig 5b To rotate the image on the screen press the L button in the B state or in the Diagnostics state 1 16 Dmp Off Diag 8 F 90 7 AM Off Int 1 FH Off Gap 10 Fig 5a 6 4 There is a battery indicator in the top line of the screen The de gree of its infill shows the battery s charge If the indicator is blank re move all 3 batteries and install 3 new ones 6 5 When switching on the device the following parameters are set the energy strength of stimulus is set to the minimum setting 1 diagnostics is switched off Off amplitude modulation is switched off Off frequency modulation is switched off Off damping is switched off Off intensity is set to the minimum setting 1 gap between stimuli in a burst is set to the minimal value 10 stimulus frequency is set to 90 7 Hz A Attention To avoid painful sensations when treating the most sen sitive areas on the patient s body it is recommended that the energy strength is decreased to minimum before the treatment by pressing and holding the button until a long beep sounds 11
13. Diag 1 indicated by a short beep activates the individually dosed mode hereinafter IDM with the adaptive integral criterion of deliv ered stimulation Dose and integral criterion of achieving the null rela tive dynamics Zero Diag 2 indicated by 2 short beeps activates IDM with the differential criterion of achieving the null dynamics Differential Dose Diag 3 indicated by 3 short beeps activates the Screening mode search of optimal treatment sites Diag 4 indicated by 4 short beeps is similar to Diag 3 but the data are displayed in the circle when the screen image is horizontal Diag 5 indicated by a dual tone beep is used to carry out electro punctural diagnostics in 24 points 6 points on each extremity with a point probe When switching between diagnostics modes damping switches off automatically After Diag 1 or Diag 2 has been selected if no buttons are pressed within 2 seconds the device will switch to the Diagnostics state Fig 6 12 Oper Manual 1 NT ver 01 doc Version 1 6 of February 15 2008 Once the device detects that the elec trode is contacting the skin the device will give a short low pitch signal will change to in the top line and in a second it will give a short high pitch signal and the screen will display both digitally and graphically the results measured over the first second the diagram will show current ongoing Fig 6 reaction change with time After 1 second more m
14. EMC and needs to be in stalled and put into service according to the EMC information provided in Annex 1 WARNING As the current densities for electrodes exceeds 2 mA r m s cm the device requires the special attention of the user WARNING The device should not be used adjacent to or stacked with other equipment This appliance is marked according to the European directive 2002 96 EC on Waste Electrical and Electronic Equipment WEEE By ensuring this product is disposed of cor rectly you will help prevent potential negative consequences for the environment and hu man health which could otherwise be caused by inappropriate waste handling of this product The symbol Ky on the documents accompanying the product indicates that this ap pliance may not be treated as household waste Instead it shall be handed over to the ap plicable collection point for the recycling of electrical and electronic equipment Disposal must be carried out in accordance with local environmental regulations for waste disposal For more detailed information about treatment recovery and recycling of this prod uct please contact your local city office your household waste disposal service or the shop where you purchased the product Oper Manual 1 NT ver 01 doc Version 1 6 of February 15 2008 Origin RITM OKB ZAO 99 Petrovskaya Taganrog 347900 Russia Model SCENAR 1 NT version 01 Classification Type of protection against electric shock In
15. MANUFACTURER RITM RU SERIAL NUMBER CAUTION CONSULT ACCOMPANYING DOCUMENTS DATE OF MANUFACTURE KAAR EC REP AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY Oper Manual 1 NT ver 01 doc Version 1 6 of February 15 2008 CONTENTS N PUR POSE OE EE EE EE EE EE 5 2 SFE IEIG A PIONS ie ee ES GE De OR Ge Ee ed De Ge ee 5 S DELIVERY SET nee Ee n ie Ee ee Ge ee ek Ge Ge ie ee eg 7 4 DEVICE COMPONENTS AND CONTROLS ee 7 5 PREPARING DEVICE FOR OPERATION eeeeeoeoe000000000000000000 9 6 USING THE DEVIC Eana a 10 7 MAINTENANCE SER VICE spisccassesncicsssacceascacacssusciaceassaskebsedsescoasenees 18 8 TROUBLESHOOTING esse ses sesse sesse des seekos sees es see Does besede obees se esse 19 9 WARRANTY isiin aa od eed ede Hok oi ds ed ss es die 19 10 TRANSPORTATION AND STORAGE cccccccccscscccccceeeeees 20 ANNE N Usissncosasscusnsesisnssstsseunsteacansesseuseseseseussdunsouaseesusvevascessesevecsvsviecesssss 21 Oper Manual 1 NT ver 01 doc Version 1 6 of February 15 2008 1 PURPOSE SCENAR I NT version 01 portable transdermal electroneu rostimulator with graphic display digital light and audible indications with a built in electrode for determining optimum zones time and thera peutic effect of stimulation hereinafter the device is intended for delivering general therapeutic non invasive treatment to the physiological systems of the body via human skin areas in order to treat various pa
16. RITM OKB ZAO SCENAR 1 NT version 01 Portable Transdermal Electroneurostimulator with Graphic Display Digital Light and Audible Indications with a Built In Electrode for Determining Optimum Zones Time and Therapeutic Effect of Stimulation CE 0120 OPERATING MANUAL MANUFACTURER RITM OKB ZAO Petrovskaya 99 Taganrog 347900 RUSSIA tel fax 7 8634 623179 www scenar com ru e mail medsc scenar com ru AUTHORIZED REPRESENTATIVE KOSMED INTERNATIONAL BV Chopinlaan 129 4384KX Vlissingen The Netherlands tel 31 0 118479180 fax 31 0 118479157 www ritmedic com e mail intermed1 zeelandnet nl Oper Manual 1 NT ver 01 doc Version 1 6 of February 15 2008 IMPORTANT INFORMATION PLEASE READ THIS PAGE CAREFULLY WARNING This device should NOT be used on an individual who has a heart pace maker or other electrically powered implant fitted WARNING Application of electrodes near the thorax may increase the risk of cardiac fibrillation WARNING Simultaneous connection of a patient to a h f surgical equipment may result in burns at the site of the stimulator electrodes and possible damage to the stimulator WARNING Operation in close proximity e g 1 m to a shortwave or microwave therapy equipment and mobile communicators may produce instability in the stimulator output WARNING Aged people children and people with disabilities may not use the stimulator WARNING The device needs special precautions regarding
17. a temperature of 25 C 20 Oper Manual 1 NT ver 01 doc Version 1 6 of February 15 2008 ANNEX 1 Guidance and manufacturer s declaration electromagnetic emissions SCENAR INT electrical neuro stimulator is intended for use in the electromag netic environment specified below The customer or the user of SCENAR INT electrical neuro stimulator should assure that it is used in such an environment Emissions test RF emissions EN 55011 1998 Aland A2 RF emissions EN 55011 1998 Aland A2 Harmonic emis sions IEC 61000 3 2 2000 Voltage fluctuati ons flicker emissions EN 61000 3 3 2001 Al Group Class B Not applicable Not applicable Electromagnetic environment guid Compliance Pe SCENAR INT electrical neuro stimulator uses RF energy only for its internal func tion Therefore its RF emissions are very low and are not likely to cause any inter ference in nearby electronic equipment SCENAR INT electrical neuro stimulator is suitable for use in all establishments including domestic establishments Notel SCENAR INT is internally pow ered equipment it has not AC mains ter minals 21 Oper Manual 1 NT ver 01 doc Guidance and manufacturer s declaration electromagnetic immunity SCENAR INT electrical neuro stimulator is intended for use in the electromagnetic environment specified below The customer or the user of SCENAR INT electrical
18. and device s state 4 3 The device has the following controls on the upper side 1 of its case button 5 is used to decrease the energy strength or value of a selected parameter button 6 VY is used to select parameters and exit the standby mode button 7 is used to increase the energy strength or value of a selected parameter button 11 _J is used to rotate the picture on the screen switch button 10 is used to switch on off the device F 1 10 Fig 1 4 4 On the lateral surface of the case there is a jack 3 for connecting add on probes and jack 4 for connecting test equipment ATTENTION Jack 4 shall not be used during the device s op eration It is closed with blank plugs 4 5 The device is powered from 3 alkaline batteries Oper Manual 1 NT ver 01 doc Version 1 6 of February 15 2008 5 PREPARING DEVICE FOR OPERATION 5 1 Before every procedure disinfect the device s electrode with a cotton wad wetted in a 3 hydrogen peroxide solution with the addition of 0 5 solution of an approved cleaning liquid Allow to dry up thor oughly before use 5 2 Open the battery compartment cover and install the batteries Switch the device on using the switch button on the front panel A mes sage containing the information about the device s name version and its software release date e g will be displayed for 2 seconds and a beep will sound 5 3 Then the device switches to the a
19. anual 1 NT ver O1 doc Version 1 6 of February 15 2008 6 20 7 The Write menu item allows to save up to 5 sets of parame ters Diag AM FM Dmp F Int and Gap To save the sets of pa rameters in one of 5 cells select the cell number and wait until the device exits the Service menu A descending beep will indicate that the settings have been saved 6 20 8 The Read menu item allows to read the earlier saved sets of parameters of the basic modes of stimulation from the permanent mem ory see p 6 20 7 Select the number 1 5 of the cell that contains your presettings saved earlier and wait until the device exits the Service menu A descending beep will sound and the settings will be applied And the energy strength will be automatically set to minimum 7 MAINTENANCE SERVICE 7 1 The device shall be serviced and repaired only by the manufacturer 8 TROUBLESHOOTING 8 1 If the device is not operating properly identify the problem and refer to the following trouble shooting chart for suggested solutions as indicated in the following Table 2 Table 2 Some adjustments don t Processor Switch off the device and work or after the battery islmalfunction in 5 10 sec switch it on replaced the requirements Check if the requirements of 5 4 are not fulfilled of p 5 4 are fulfilled After the device is switched The battery is Replace the batteries on the picture on the LCD discharged periodically disappears or is distorted
20. d within 30 sec SCENAR will switch to the standby mode see p 6 19 If AOff is set to 5m 10m or 20m then when no buttons pressed and no contact with the skin has been detected within 30 sec SCENAR will also switch to the standby mode Moreover in the Diag O 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 Pressing any button as well as taking the electrode up from the skin or a new contact resets the timer 6 20 2 The Lght menu item is the time of screen backlighting for the following events pressing any button reaching the Dose or Zero ex piration of the first second of measuring in the Diagnostics state or expiration of every 30 seconds 6 20 3 The Cont menu item allows to control the picture contrast 6 20 4 The Save Scr menu item allows to save the current direction of the picture on the screen as default 6 20 5 The Lng menu item allows to select a language two lan guages are available Russian and English 6 20 6 The Snd menu item is for volume control When Snd O is set all sounds except for clicks while controlling the energy strength will be disabled and in the B state a corresponding indication Fig 14 will be displayed in the top line of the screen Snd 1 is for minimum sound volume Snd 2 for medium vol Fig 14 ume and Snd 3 for maximum volume 18 Oper M
21. easurement results for the 2 second will be displayed on the screen Then current results of measuring time reac tion rate of reaction change shape factor illustrated in the Fig 7 will be updated every second and the diagram will be completed It will continue this way until either Dose or Zero is achieved Timer Initial shape factor Initial reaction Current shape factor Current reaction Reaction diagram Rate of reaction change Dose symbol Zero symbol Fig 7 The device will notify that the Dose is achieved by two simultane ous indications 2 second two tone audible signal will be played symbol will be displayed on the screen and will stop displaying digital data for 3 sec The device will notify that the Zero is achieved by two other simul taneous indications series of low pitch sounds will be played for 2 seconds symbol will be displayed on the screen and will stop displaying digital data for 3 sec If after the Dose or Zero is reached the current reaction has changed then a corresponding symbol will be blinking on the screen To avoid change of these parameters make sure to take the device up from the skin within 3 sec 13 Oper Manual 1 NT ver 01 doc Version 1 6 of February 15 2008 Once you take the device up from the skin will change to in the top line and all other information will stay the same on the screen In the Diagnostics state pressing a
22. hould be less than the compliance level in each frequency range Interference may occur in the vi cinity of equipment marked with the following symbol We 1 Field strengths from fixed transmitters such as base stations for radio cellu lar cordless telephones and land mobile radios amateur radio AM and FM ra dio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an elec tromagnetic site survey should be considered If the measured field strength in the location in which SCENAR INT electrical neuro stimulator 1s used exceeds the applicable RF compliance level above the SCENAR INT electrical neuro stimulator should be observed to verify normal operation If abnormal perform ance is observed additional measures may be necessary such as re orienting or relocating the SCENAR INT electrical neuro stimulator 2 Over the frequency range 150 kHz to 80 MHz field strengths should be less than 1 V m NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propaga tion is affected by absorption and reflection from structures objects and people 24 Oper Manual 1 NT ver 01 doc Version 1 6 of February 15 2008 Recommended separation distances between portable and mobile RF communications equipment and the SCENAR INT electrical neuro stimulator
23. ith the first pulse of the 2 phase having the highest amplitude 2 3 5 Frequency modulation variable frequency with the follow ing settings variation range 30 to 120 Hz 45 variation period 7 2 sec 2 3 6 Damping modes change of influencing stimulus initial shape Dmp Off no damping Dmp Sci weak damping Dmp Sc2 moderate damping Dmp Sc3 strong damping Dmp Sc4 maximum damping Dmp Var variable damping with the following settings damping variation range from Dmp Off to Dmp Sc4 and back period of damping variation 7 5 2 0 sec 2 3 7 Generation of stimulus bursts The number of stimuli in a burst intensity is controlled within to 8 at a step of 1 and the pause be tween stimuli in a burst gap from 200 10 to 1600 100 usec 2 3 8 Combined modulation swing modes 2 3 8 1 Swi with the following settings frequency modulation according to p 2 3 5 variable damping according to p 2 3 6 intensity 3 gap continuously changes from 200 10 to 1600 100 usec and back 2 3 8 2 Sw2 with the following settings frequency modulation according to p 2 3 5 variable damping according to p 2 3 6 intensity 3 gap randomly changes from 200 10 to 500 25 usec 2 3 8 3 Sw3 with the following settings frequency modulation according to p 2 3 5 variable damping according to p 2 3 6 intensity 3 gap randomly changes from 200 10
24. manipulating the device observe the indications on the screen and beeping 6 2 A chart of the device s basic states is illustrated in the Fig 4 dot ted lines mean that the Diagnostics is ON 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 screen Use the and buttons to control the energy strength of stimulation Use the VY button to switch the device to the Menu state Energy setting B state no buttons pressed within 2 s button Y Se eS ee N RE no buttons pressed buttons within 2 s i ge Menu button Y i Pa no buttons pressed MANE _ within 2s Diagnostics lt Fig 4 In the Menu state you can set all parameters except for the energy strength For detailed description of these parameters see the items 6 10 6 16 A current parameter is highlighted inversely Use the and but tons to change the current parameter s value Use the Y button to move down the menu use the L button to move up the menu If no buttons are 10 Oper Manual 1 NT ver 01 doc Version 1 6 of February 15 2008 pressed within 2 seconds the device will switch to the B state or if any diagnostics is on the device will switch to the Diagnostics state To activate the Diagnostics set the Diag parameter to 1 2 3 4 or 5 in the menu In this state pressing the and buttons switches the device to the
25. mercial or hospital envi field ronment EN 61000 4 8 2003 Al NOTE Uris the a c mains voltage prior to application of the test level Guidance and manufacturer s declaration electromagnetic immunity SCENAR INT electrical neuro stimulator is intended for use in the electromagnetic environment specified below The customer or the user of SCENAR INT electrical neuro stimulator should assure that it is used in such an environment EN 60601 1 Immunity test 2 2002 test level Electromagnetic environment guidance Portable and mobile RF communi cations equipment should be used no closer to any part of the SCENAR INT electrical neuro stimulator including cables than the recommended separation dis tance calculated from the equation applicable to the frequency of the transmitter Recommended separation dis tance d 1 2V4P Conducted RF 3 Vrms EN 61000 4 150 kHz to 80 MHz 6 2003 outside ISM bands A1 IS1 2004 d 1 2 VP 80 MHz to 800 MHz d 2 3VP 800 MHz to 2 5 GHz Radiated RF 3 V m 23 Oper Manual 1 NT ver 01 doc EN 61000 4 80 MHz to 2 5 3 2001 AVIS1 2004 Version 1 6 of February 15 2008 Where P is the maximum output power rating of the transmitter in watts W according to the transmit ter manufacturer and d is the rec ommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey s
26. ncies of 30 5 59 6 90 7 119 and 181 Hz is indicated by 1 2 3 4 and 5 short beeps respectively While the beeps sound the frequency cannot be controlled This makes it easier to set the required frequency 6 15 Setting the Intensity Int The intensity the number of stim uli in a burst can be controlled within the range of 1 to 8 but the maximal intensity value depends on frequency gap and energy strength The greater the frequency gap and energy strength are the smaller maximal intensity you can set For example at a maximal frequency 354 Hz the intensity cannot be greater than 2 With increased frequency gap or en ergy strength the intensity is automatically decreased when needed 6 16 Setting the Stimulus Gap in a Burst Gap To control the gap you can either press the buttons step by step or press and hold the appropriate button this way is faster At intensity 1 the Gap parameter has no sense though it can still be controlled and then when you will be increasing the intensity the device will use the set value of the gap 6 17 To switch off the device use the switch button on the front panel The settings are NOT SAVED after switching off but you can save your 5 sets of parameters in the permanent memory of the device see p 6 20 6 6 18 To switch the device to the standby mode press simultane ously the buttons Y and DO To resume operation press the button v 6 19 If the automatic turn off is enabled
27. ny button resets the timer and measurements Moreover touching the skin with the electrode also resets the timer When switching on Diag 3 Diag 4 and Diag 5 all modulations and damping are switched off forcedly Data displayed on the screen at Diag 3 are shown in Fig 8 and those for Diag 4 are illustrated in Fig 9 In these modes after 1 second stimulation a short beep will sound too and the energy strength will de crease to the minimal level and the device will be waiting for the elec trode to be taken off from the skin Once the electrode is taken off the previously set value of the energy is restored Successively applying the device on the points to be treated you can get up to 8 results of initial measurements on the screen Initial reaction Initial shape factors Fig 8 Every next measuring its results are dis played in the next line For Diag 3 the re sults of the 8 measuring will be displayed in the 8 line and those of the 9 measuring will be displayed again in the in the 8 line So all previous lines will as if move one line upwards So in the Diag 3 screening the screen displays the results of initial measure ments for the latest 8 points Fig 9 In Diag 4 horizontal and vertical data display are different For horizontal display measurements are displayed in a circle clockwise beginning from the upper position 10 positions in all The results of the 11 measurement will be displayed in the position
28. ternally powered equipment 3 bat teries each of 1 5V Applied parts Type BF Waterproofing No special protection against liquid ingress provided IPXO0 Cleaning amp Disinfecting Wipe electrode area with a cotton swab dampened with 3 hydrogen peroxide solution with the addition of 0 5 solution of an approved cleaning liquid Allow to dry up thoroughly before use Clean casing with a damp not soaking cloth and mild soap solution Allow to dry before use Clinical environment NOT suitable for use in the presence of flammable anaesthetic mixtures with air oxygen or nitrous oxides Add on probes Only insert extension probes supplied by the manufacturer that are suitably suppressed from electromagnetic radiation Only insert extension probes in the socket provided DO NOT REMOVE the upper casing this access is for the use of service personnel only Batteries Remove battery from device if not in use for an extended period Connect correctly DO NOT TRY TO RECHARGE disposable batteries Dispose of used batteries responsibly Use good quality within date long life 1 5V ALKALINE Type LR6 AA batteries NOTE Total battery removal should be used during storage and transportation to avoid battery drain The device should NOT be operated with the battery cover removed as this exposes the operator to live battery circuits in contravention of the Safety Regulations Marks and symbols on the device case APPLIED PARTS TYPE BF
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