User manual
Contents
1. 5 WARNINGS 1 e COUNLEHINGICACIONG 4 2 Safety TNC 4 PRESENTATION Warranty said 6 2 Mantenan e dans 6 3 Storage and transportation conditions 6 4 Usage conditions eden pete den 6 BUI EE 6 6 Standards 7 7 Standardized symbols ssssssesesesesesesescosososososososeseeseessesesesesose 7 8 gt Technical 2 7 USAGE GUIDELINES 1 Placement of 9 2 9 3 Adjusting stimulation 9 4 Level 9 IV USING THE STIMULATOR 1 Description of stimulator 10 2 Connections A Connecting the cables2. ssssesesesesesesessosssososososcscsrsrsserereeo 11 11 3 Preliminary settings Language contrast 2 52 11 4 Neurostimulation programmes A Choosing type of treatment 12 B Choosing programme category 12 C Choosing a programmMe sssssssssosososcscsssssseseeesesesesescseseseoe 12 D Personalizing a programme sssssssssesesesecsesesesesessssesosesesesesese 13 E Choosing the 2 2 function ssesesesesesseseseseseseseseososesesesesese 13 F Stimulation mode 14 5 Battery status and recharging Battery 15 Recharging 16 OTE GUDIESHOO 16 V LIST OF PROGRAMS 1 400 17 lt 5 4 LLI 94 2 te 8 4 gt lt Q ENG lt 5 4 192 Q 8 4 gt lt oO Q oO WARNINGS 1 Counter indications Do not treat persons with implanted electronic equipment such as pace makers and intracardiac defillibrators Avoid electr
3. 9 9b 9c 9 Ye Heat waves depicting the warm up sequence 9a Press the On Off button to return to the previous screen 9 b c de The unit will beep and the symbols for the 4 channels will alternate between and 000 The energy level for the 4 channels is at 0 To start the programme you will need to increase the energy levels in the channels you are going to use To do this use the cor responding buttons NOTE If you want to increase the energy levels in all 4 channels simultane ously press the i button Press it twice to increase the levels in the first 3 chan nels and 3 times to increase the levels in the first 2 channels Interdependent channels will be highlighted in white against a black background E Choosing the 2 2 function You now have the possibility to choose the 2 2 function which means that you can choose one program for the channel 1 and 2 then select one program from the 2 2 program list for channel 3 and 4 This means that you could treat two different body parts at the same time or combine two different programs on the same body part START 10a 10b 10c 10d 10e 10a Press the On Off button to return to the previous screen 10b Use the channel 1 button to choose the desired treatment area You can choose from 7 areas 10c Press the channel 2 to delete the warming up sequence by pressing the channel 2 the 2 2 mode is selected and the first pro
4. CefarCompex Rehab 400 also complies with the IEC 60601 1 standard on general safety requirements for medical electri cal devices the IEC 60601 1 2 standard on electromagnetic compatibility and the IEC 60601 2 10 standard on particu lar safety requirements for nerve and muscle stimulators CefarCompex Rehab 400 also complies with Directive 2002 96 EEC on waste electrical and electronic equipment WEEE 7 Standardized symbols A Read the operating instructions before use CefarCompex Rehab 400 is a class 11 device with internal electric power and type BF applied parts Waste electrical electronic equip ment WEEE marking according to EN 50419 standard 1250 In compliance with the requirements of the European Directive 93 42 EEC on medical devices 8 Technical specifications A General information Battery 941213 Nickel metal hydride NiMH rechargeable battery 4 8 V 2000 mAh Battery chargers Only battery chargers bearing the following information can be used to recharge the batteries supplied with Rehab 400 stimulators Europe 683010 Type TR1509 06 E 133A03 Input 90 264 VAC 47 64 Hz 0 5 A max Output 9 V 1 4 15 W UK 683012 Type TR1509 06 U 133A03 Input 90 264 VAC 47 64 Hz 0 5 A max Output 9 V 1 4A 15 W B Neurostimulation All electrical specifications are given for an impedance of 500 1000 Ohm per channel Channels Four individually adjustable
5. graphs Active rest phase energies are shown by hatched bar graphs NOTE Active rest phase stimulation energies are automatically set at 50 of contraction intensities but can be modified during the rest phase Once modified they will be totally independ ent of the contraction intensities Pause mode 12a Press the On Off button to inter rupt the programme momentarily To restart it simply press the channel 4 button 12e The session will resume at 80 of the energy levels that were being used prior to the interruption NOTE If your Rehab 400 emits a beep ing sound and the symbols under the active channels begin to flash the stimulator is suggesting you to increase the level of the stimulation energies If you are working at the patient s maxi mum tolerance level simply ignore this message End of programme Different statistics are displayed depending on the programmes and op tions used It should be noted however that statistics are not available for all programmes 2 00 2 OOO At the end of each session small flag will be displayed on the screen and a short melody will be played NOTE Press the i button to access the contraction info screen To turn off the stimulator press the ON OFF button 5 Battery status and recharging Never recharge the stimulator with out first disconnecting the stimulation cables Never recharge the batte
6. Common Treatment or Conditioning 4e Press the channel 4 button to confirm your choice and access the pro gramme category selection screen Press the i button to access the Top 5 menu B Choosing a programme category TREATHENT REHABILITATION FAIN RELIEF a m m 5b 5e 5a Press the On Off button to return to the previous screen 5b Use the channel 1 button to choose a category 5e Press the channel 4 button to confirm your choice and access the programme selection screen Press the i button to access the Top 5 menu C Choosing a programme NOTE Consult our Practical Guide for help in choosing a programme Once you choose a category the screen will display a list of available programmes REHABILITATION a ee OF DISUSE ATROPHY REINFORCEMENT HEWRO SLON START 6b 6e 6a Press the On Off button to return to the previous screen 6b Use the channel 1 button to choose the programme you want 6e Press the channel 4 button to confirm your choice Certain pro grammes start right away while others allow you to specify additional options TOP 5 To access the Top 5 menu press the i button before selecting a programme The menu can be accessed from the type of treatment screen Figure 4 the programme category screen Figure 5 or the programme list screen Figur
7. radio frequency transmitters Despite this it is not possible to guarantee that the stimulator is not affected by strong RF radio frequency fields emitting from for example mobile phones More detailed information can be received upon request by contacting Il USAGE GUIDELINES 1 Placement of electrodes For optimal results use the electrode positions recommended by CefarCom pex For the placement of electrodes refer to the electrode placement il lustration It is crucial to choose the right size of the electrodes and correctly position these on the muscle group you want to stimulate to ensure the efficacy of the treatment To do this always use the sizes and positions shown in the pictograms unless otherwise required by medical needs Where necessary look for the best possible position by slowly moving the electrode over the muscle until you find the point that will produce the best contraction the motorpoint or the most comfort for the patient A CefarCompex disclaims all responsi bility for consequences arising from electrodes placed in other positions 2 Body position Refer to the pictures of the electrode placement to determine the stimulation position for your patient depending on the placement of the electrodes and the chosen program This position will vary depending on the position of the electrodes the muscle group you wish to stimulate and the program you ar
8. stimulator to the charger The charge menu shown below will automati cally appear on the screen 2 Oh The duration of the recharging operation is displayed on the screen The charger supplied with the stimulator fully recharges the stimulator within 2 2 5 hours The battery icon is animated while the battery is recharging When fully charged the icon will be full and the total time taken to recharge the battery will flash on the screen Simply discon nect the charger and the Rehab 400 will turn off automatically 6 Troubleshooting 2510 38 Electrode error The Rehab 400 will beep and alternately display a pair of electrodes and an ar row pointing to the channel where the problem was detected In the example above the stimulator has detected an error in channel 2 The electrode error message can mean that e there are no electrodes connected to this channel e the electrodes are old worn and or the contact is poor try using new electrodes e the electrode cable is faulty try con necting it to another channel If the problem persists replace the cable If for any reason yor device seems to present a malfunction other than those presented above please contact Cefar Compex customer service V LIST OF PROGRAMS Rehab 400 COMMON TREATMENT REHABILITATION DISUSE ATROPHY PREV OF DISUSE
9. A Precautions when using the elec trodes Only use electrodes supplied by Cefar Compex Other electrodes may have electrical properties that are incom patible with the Rehab 400 stimulator Only place electrodes on healthy skin and never on skin lesions of any kind wounds swelling burns irritation eczema etc Always turn off the stimulator or make sure that the intensity for each chan nel is 0 before moving or removing the electrodes Do not place the electrodes in water Do not apply solvents of any kind to the electrodes Do not use electrodes with a surface lt 18 as there will a risk of suffering a burn injury Caution should always be exercised with current densities gt 2 For optimal results wash clean and dry the skin before attaching the electrodes Attach the electrodes so the entire surface is in contact with the skin For hygiene reasons each patient must have his own set of electrodes Never use the same electrodes on dif ferent patients Some people with very sensitive skin may experience redness under the electrodes after a session This redness is generally harmless and normally disappears within 10 to 20 minutes Do not start another stimula tion session in the same area as long as the redness is still visible When the electrodes loose their adhe siveness and do not stick properly to the skin the stimulation can feel un pleasant Be sure that the
10. ATROPHY REINFORCEMENT NEURO REHAB Slow start BACK TRUNK STABILIZATION ATROPHY Mod Freq FORCE Mod Freq INCREASE CIRCULATION MUSCLE LESION PAIN RELIEF TENS 100Hz TENS 80Hz FREQ MODULATED TENS ENDORPHINIC DECONTRACTION PW MODULATED TENS BURST TENS MIXED TENS SPECIFIC TREATMENT PROGRAMS AESTHETIC TONING FIRMING SHAPING REFINEMENT ELASTICITY Optional 2 2 CONDITIONING X ACTIVE RECOVERY RECOVERY PLUS FITNESS MUSCLE BUILDING MUSCLE DEFINITION POWER MASSAGE TONING MASSAGE RELAXING MASSAGE TONING MASSAGE xo RELAXING MASSAGE 2 2 PROGRAMS FREQ MODULATED TENS PW MODULATED TENS BURST TENS ENDORPHINIC REINFORCEMENT SMALLER MUSCLE GROUPS REINFORCEMENT LARGER MUSCLE GROUPS DISUSE ATROPHY SMALLER MUSCLE GROUPS DISUSE ATROPHY LARGER MUSCLE GROUPS CefarCompex Rehab 400 USER MANUAL ENG N
11. CH ITALIANO ESFAROL MHECERLAMOS esa es ha 3a 3b 3c 3d 3e 3b Use the channel 1 button to choose the language you wish to use 3c Use the channel 2 button to adjust the contrast of the screen 3d Use the channel 3 button to adjust the volume 3e Use the channel 4 button to adjust the backlighting On Backlighting always on Off Backlighting always off Auto Backlighting activated whenever a button is pressed 3a Use the On Off button to confirm and save your choices The settings will be applied immediately ENG lt gt 5 4 LLI 94 te 8 4 gt lt Q ENG lt 5 4 192 T gt lt oO Q oO 5 N 4 Neurostimulation programmes To start the stimulator press the On Off button To choose a programme you must first choose a type of treatment and a programme category NOTE There is a table summarizing the different programmes and their func tions at the end of this manual A Choosing a type of treatment HEHU C COHHOH TREATMENT SFECIFIC 4 4 4e 4a Press the On Off button to turn off the unit 4b Use the channel 1 buttons to choose another type of treatment for ex
12. channels that are electrically isolated from each other and earthed Impulse shape Constant rectangular current with pulse compensation to eliminate any direct current component to prevent residual polarization at skin level Maximum pulse intensity 120 mA Pulse intensity increments Manual adjustment of stimulation intensity 0 999 energy units Minimum increment 0 5 mA Pulse width 30 to 400 microseconds Maximum electrical charge per pulse 96 microcoulombs 2 x 48 uC compensated Standard pulse ramp up time 3 micro seconds 20 80 of maximum current Pulse frequency 1 150 Hz ENG lt 5 4 LLI 94 8 4 gt lt 0 Q oO ENG lt 2 5 4 LLI 90 T 8 4 gt lt oO C Information related to electromag netic compatibility EMC The Rehab 400 is designed to be used in typical domestic or clinical environments and is approved according to the EMC safety standard of EN 60601 1 2 This device emits very low levels in the radio frequency RF interval and is therefore not likely to cause any inter ference with nearby electronic equip ment radios computers telephones etc The Rehab 400 is designed to withstand foreseeable disturbances originating from electrostatic discharges mains sup ply magnetic fields or
13. defective please contact your nearest Cefar Compex customer service centre regarding an upgrade Medical and health professionals are obliged to service the unit in compli ance with relevant national laws and regulations This involves testing performance and safety parameters at regular intervals 3 Storage and transporta tion conditions The Rehab 400 contains rechargeable batteries and so the storage and trans portation conditions must not exceed the following figures e Storage and transportation tempera ture 20 C to 45 C e Maximum relative humidity 75 e Atmospheric pressure 700 hPa to 1060 hPa 4 Usage conditions Temperature 0 C to 40 C Relative humidity 30 to 75 Atmospheric pressure 700 hPa to 1060 hPa Do not use in an explosion risk area 5 Elimination Batteries must be disposed in compli ance with relevant national regulatory requirements Any products bearing the WEEE mark ing a crossed out wheeled bin must be separated from ordinary household waste and sent to special collection facilities for recycling and recovery 6 Standards CefarCompex Rehab 400 is designed for use by health professionals and as such complies with relevant medical stand ards and regulatory requirements To guarantee your safety CefarCompex Rehab 400 has been designed manu factured and distributed in compliance with the requirements of the European Directive 93 42 EEC on medical devices
14. e 6 TOFS ACL MODULATED TENE 1 DISUSE ATROPHY 1 RESISTANCE 1 FRE OF DISUSE 1 Ale 7 7b 7d 7e 7a Press the On Off button to return to the previous screen 7b Use the channel 1 button to choose the programme you want 7d Use the channel 3 button to personalize the programme 7 Press the channel 4 button to start the programme Personalising a programme Not all programmes have an option screen In certain programmes you will need to choose the muscle group you want to stimulate The target area is shown in black on the figure above channel 1 Bl pesca EZ E 8a 8b 8c 8d 8e 8a Press the On Off button to return to the previous screen 8b Use the channel 1 button to choose the desired treatment area You can choose among 7 areas 8c Press the channel 2 button to delete the warming up sequence and to choose if you want to combine with any of the 2 2 programs on channel 3 and 4 8d Use the channel 3 button to choose the programme difficulty level 8e Use the channel 4 button to confirm your choices and launch the programme Adjusting stimulation energies When you start a programme you will be prompted to increase the stimulation energies This is the key to the success of any treatment Session duration in min 485555 25 10 gt 9
15. e using For programmes that do not involve muscle contractions Pain relief pro grammes for example make sure that the patient is as comfortable as possible 3 Adjusting stimulation energies The number of fibres recruited in a stimulated muscle depends on the stimulation energies used It is therefore extremely important to use maximum stimulation energies where possible in order to recruit the maximum number of fibres If the stimulation energy is too low too few fibres will be obliged to work and the improvement in muscle quality will be negligible It takes at least 3 sessions to reach this maximum energy level The first few sessions serve to introduce progres sive increments in stimulation energy and muscle contraction levels and to help the patient to become used to the method After an initial warm up period which should produce very clear muscle twitch es increase the stimulation energies gradually contraction by contraction for the duration of the session 4 Level progression Generally speaking it is not advisable to try to reach maximum stimulation levels too quickly The different levels in each stimulation programme are designed to reeducate the muscle gradually We recommend you to prioritize the stimulation energies at each level to recruit as many fibres as possible before moving on to the next level Also seek to progressively increase energy levels from session to session Fo
16. electrodes are in good condition otherwise they have to be replaced ENG lt 2 5 4 LLI Y 2 te T 8 4 gt lt Q oO ENG lt 5 4 192 Q 8 4 gt lt oO Q oO PRESENTATION 1 Warranty This warranty is valid only if accompa nied by proof of purchase Your legal rights are not affected by this warranty Your CefarCompex Rehab 400 stimula tor is guaranteed for a period of 2 years from the date of purchase The warranty covers the stimulator material and workmanship but not the battery unit cables or charger All defects arising from substandard material or workman ship are covered The warranty does not cover damage resulting from impact accident improper use insufficient protection against damp immersion in water or repair work conducted by unauthorized personnel 2 Maintenance e Clean with a soft cloth and an alcohol based solvent free cleaning product Use only a minimum amount of liquid when cleaning the unit Do not disassemble the stimulator or charger as these all contain high volt age components that could cause electric shock This may only be done by persons or repair services author ized CefarCompex e Your stimulator does not require calibration If your stimulator contains parts that seem worn or
17. gram in the list is displayed Press the channel 2 again in order to display the next program in the list 10d Use the channel 3 button to choose the program difficulty level 10e Use the channel 4 button to confirm your choices and launch the program ENG lt 5 4 LLI a T 8 4 gt lt Q oO OW ENG lt 5 4 192 Q T 8 4 gt lt oO Q 5 A NOTE The timer for ch 1 2 will control the total session time This means that the total time for ch 3 4 could not ex ceed the session time for ch 1 2 NOTE The program for ch 3 4 is always in one phase NOTE If a preset program uses more than two channels it s not avalable for the 2 2 mode E ATROPHY O00 O00 OOO The horizontal bars on top of the display shows the total duration and different phases of the programs Left bar for P1 and right bar for P2 P1 shows the program chosen for channel 1 and 2 P2 shows the program chosen for channel 3 and 4 F Stimulation mode 7 f OFS 0863 1083 107 12 12b 12c 12d 12e 12 b c 4 The different energies reached during the contraction phase are shown by a series of black bar
18. nd the cables are colour coded to simplify use and facilitate identification of the different channels The kit includes four 2 1 mm pin con nector cables B Charging The Rehab 400 is a portable muscle stimulator powered by a rechargeable battery unit Recharging To recharge the Rehab 400 first discon nect the electrode cables from the device then plug the charger to a wall socket and finally connect the stimulator to the charger The charge menu illustrated below ap pears automatically Oh 1a The stimulator has been charged for 7 minutes and 27 seconds a full charge may take 2 2 5 hours with the rapid charger delivered with your device 1b Charging is in progress When charg ing is completed total charge duration flashes and the battery symbol is com pletely full The stimulator switches off automatically as soon as you disconnect the charger 3 Preliminary settings A Language contrast volume When you start the stimulator for the first time you will need to choose the interface language you wish to use from the options screen See below for in structions on how to proceed There are a range of settings that you can adjust to suit your needs interface language display contrast backlighting volume To change any of these settings bring up the options screen by holding the On Off button on the front of the stimulator for a few seconds EMGLIEH FRANCAIS DEUTS
19. ode placement at the front and side areas of the neck Pregnant women should not be treated during the first trimester 12 weeks Do not use thoracic stimulation on patients with cardiac arrythmia Avoid lower limb stimulation in case of venous thrombosis or servere arte rial obstruction ischemia Avoid abdominal stimulation if you have abdominal or inguinal hernia Important Read this manual and the accompany ing Practical Guide carefully 2 Safety measures A Important points to take into account when using Rehab 400 Do not use the stimulator in water or humid environments saunas hydro therapy pools etc If pregnant do not place electrodes directly over the uterus or connect pairs of electrodes across the abdo men The reason is that theoretically the current could affect the foetus s heart although there are no reports of it being harmful Observe caution if treating patients with sensitivity problems or who are unable to let you know if they feel any discomfort however slight Observe caution when stimulating in the immediate vicinity of cellular phones that are switched on since this may affect the output power of the stimulator Do not use the stimulator on a patient who is connected to a high frequency surgical instrument as this could cause skin irritation or burns under the electrodes Do not use the stimulator within one metre of short wave or microwave de vices as
20. r maintenance purposes it is a good idea to hold one session per week with the energy level you used in the previous cycle ENG lt 5 4 LLI 94 T 4 4 gt lt Q ENG lt 5 4 LLI NY Q T gt lt oO Q 1 Description of stimulator CefarCompex On Off button 1 button This is used to Increase stimulation energies in several channels simultaneously Access the Top 5 menu showing 5 most recently used programs Access the contraction info menu showing number of contractions and total contraction time buttons for 4 stimulation chan nels Sockets for 4 stimulation cables Battery charger socket Rehab400 IV USING THE STIMULATOR A You are strongly advised to read the counter indications and safety measures described at the beginning of this manual chapter 1 Warnings prior to using your stimulator Stimulation cables Channel 1 blue Channel 2 green Channel 3 yel low Channel 4 red Stimulation cable fitted with pin connector Rechargeable battery compartment Belt clip socket 2 Connections A Connecting the cables The stimulator cables plug into the 4 sockets on the base of the device All 4 cables can be connected simultaneously Both the buttons a
21. ry with a charger other than that supplied by CefarCompex The Rehab 400 is powered by a recharge able battery unit The battery s duration varies according to the programmes and stimulation energies used We strongly recommend you to fully charge the bat tery before using it for the first time as this will extend battery duration and life time If you do not use your stimulator for long periods of time remember to recharge the battery regularly A Battery status The status of the battery is indicated by a battery icon on the screen If the battery icon contains just two lines this means that power is running low Stop the session and recharge the unit 444 25 fn OFF 2 ex Battery charge state icon If the START symbol normally displayed above the channel 4 button is not visible and the battery icon is flashing this means that the battery is complete ly discharged The stimulator can no longer be used Recharge immediately ENG lt 5 4 LLI 94 T 8 4 gt lt Q oO ENG lt 5 4 LLI 192 Q 8 4 gt lt oO Q oO Recharging Remove all stimulation cables from the stimulator before recharging it Connect the charger to the mains and then con nect the
22. this could alter the currents generated by the stimulator Only use stimulation cables recharge able battery units and charger sup plied by CefarCompex Always turn off the stimulator or make sure that the intensity for each chan nel is 0 before disconnecting cables from stimulator or electrodes Never connect the stimulation cables to an external power source due to risk of electric shock Do not use the Rehab 400 stimulator or charger if any of the elements are damaged case cables etc or if the battery compartment is open There is a risk of electric shock Unplug the charger immediately if your Rehab 400 emits a continuous beeping sound or if you notice any abnormal heat smell or smoke from either the charger or the stimulator Never recharge the battery in a confined space carrying case etc as this could cause a fire or electric shock Keep Rehab 400 and its accessories out of the reach of children Keep the stimulator battery compart ment and charger clean Sudden temperature changes can cause condensation to build up inside the stimulator To prevent this allow it to reach ambient temperature before use Do not use your Rehab 400 while driv ing or operating machinery Observe caution when using electro therapy at the same time as the patient is connected to monitoring equipment with body worn electrodes The stimu lation might interfere with the signals to the monitoring equipment
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