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55

Rev. 1 del 24.10.2017

TABELLA 4

TABLE 4

GUIDA E DICHIARAZIONE DEL COSTRUTTORE – IMMUNITÀ ELETTROMAGNETICA – PER

GLI APPARECCHI ED I SISTEMI CHE NON SONO DI SOSTENTAMENTO DI FUNZIONI VITALI

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY –

FOR EQUIPMENT AND SYSTEMS THAT ARE NOT LIFE-SUPPORTING

Il THE CHAMPION è previsto per funzionare nell’ambiente elettromagnetico sotto specificato. Il

cliente o l’utilizzatore del THE CHAMPION deve garantire che esso venga usato in tale ambiente.

The THE CHAMPION is intended for use in the electromagnetic environment specified below. The

customer or the user of the THE CHAMPION should assure that it is used in such an environment.

Prova di immunità

Immunity Test

Livello di prova IEC

60601

IEC 60601 test level

Livello di

conformità

Compliance

level

Ambiente elettromagnetico – Guida

Electromagnetic environment -

Guidance

Gli apparecchi di comunicazione a RF

portatili e mobili non dovrebbero essere

usati più vicino a nessuna parte del

THE CHAMPION compresi i cavi, della

distanza di separazione raccomandata

calcolata con l’equazione applicabile

alla frequenza del trasmettitore

Portable and mobile RF

communications equipment should be
used no closet to any part of the THE

CHAMPION, including cables, than the

recommended separation distance

calculated from the equation applicable

to the frequency of the transmitter.

Distanza di separazione

raccomandata

Recommended separation distance

P

V

d

1

5

,

3

Summary of Contents for Champion GL4

Page 1: ...Rev 04 15 ...

Page 2: ...2 Rev 1 del 24 10 2017 ...

Page 3: ... s r l via Vittorio Veneto 52 31013 Codognè TV Italy Tel 39 0438 7933 Fax 39 0438 793363 E Mail info globuscorporation com www globuscorporation com This product has been manufactured according to the technical regulations in force and is certified according to Directive 93 42 EEC updated by 2007 47 directive for medical devices by KIWA CERMET ITALIA S P A Scrl authorization n 0476 in order to ens...

Page 4: ...ectrode application 10 Battery how to charge the batteries 11 LABELLING AND SYMBOLS 12 Device 13 PANEL AND KEYBOARD 15 Display and interface 16 ALARMS 16 Compliance 16 WARNINGS AND CONTRAINDICATIONS 17 Mandatory behavior 17 Warnings before use 17 Warnings during the use 18 Side effects 19 Contraindications 19 MAINTENANCE AND CLEANING 20 Device 20 Battery 20 Accessories 21 Disposal of the device 21...

Page 5: ...TIONS FOR USE 22 Program List menu 22 Last 10 menu 24 Favorites menu 25 Treatments menu 26 Programming menu 26 ACTION PRINCIPLES 30 Muscular electrostimulation 30 Tens 33 Microcurrents 34 Ionophoresis 34 PROGRAM LIST 35 WARRANTY 49 ...

Page 6: ...NS Channels available Channels 1 2 3 4 Constant current Yes Intensity 0 120 mA with 1000 Ohm load Wave form Rectangular biphasic symmetrical compensated Working frequency 0 3 150 Hz Recovery frequency 0 3 150 Hz Pulse amplitude 50 450 µs Working time from 1 to 30 seconds Recovery time from 0 to 1 minute Frequency mod range continuous variation from 1 to 150 Hz Min modulation time 3 seconds Amplitu...

Page 7: ...tant current Yes Min Intensity 0 mA 1000 Ohm Max Intensity 10 mA 1000 Ohm step 0 1 mA 1000 Ohm Min time 1 minute Max time 99 minutes Charger Brand FLO model DKT 088 0200 EU Input 100 240V 50 60Hz 0 2A Output 8 8 Vd c 0 2A Polarity Battery Battery pack Ni MH 7 2 V 1 8 Ah ...

Page 8: ...for MICROCURRENT and IONOFORESIS treatments C A bag containing 4 reusable self adhesive electrodes 50 x 50 mm Use these electrodes for small areas such as upper limbs calves cervical D A bag containing 4 reusable self adhesive electrodeS 50 x 90 mm Use these electrodes for big areas such as thighs abdomen and glutei E Charger See technical features F GL4 Unit G User manual and warranty Carrying ba...

Page 9: ... of the device every 2 years for the maintenance and to ensure the safety The numbers of treatments depend on the battery charge The duration of the battery is 6 months we suggest replacing it after that period The electrostimulators are designed to be used in the following operating environments domestic environment clinics physiotherapy centers rehabilitation centers general pain treatments beau...

Page 10: ... NOTE For EMS and TENS currents use indifferently the 4 channels with colored cables For microcurrents use only channels 1 and 3 For ionophoresis use only channel 1 Electrode application Take the electrodes from the original package all new electrodes have a seal on the package Be sure that the device is off To start connect the two cable plugs to the electrodes then disconnect the electrodes from...

Page 11: ...tteries when the battery indicator on the display indicates To charge the batteries turn off the electrostimulator and disconnect the electrodes then connect the elctrostimulator to the charger provided by inserting the plug in the appropriate inlet see picture above Do not use a different charger from the one provided with the device To replace the electrostimulator s batteries contact the author...

Page 12: ...old product Properly dispose of the product to help protect the environment For more information on recycling this product contact the local competent department the household waste management company or the store in which the product was purchased It indicates that the product has been produced respecting the directive 2011 65 CE It indicates the optimal temperatures for the storage and transport...

Page 13: ...e of the magnetic field emitted by the device it indicates the range of frequencies of the magnetic field emitted by the device Type It indicates the device type Power It indicates the power supply unit model of the device Battery It indicates the battery pack inside the device It refers to the expiry date It refers to the production lot It refers to the manufacturing date Polythene symbol Device ...

Page 14: ...nly Do not pull the electrode by grabbing the connector Do not apply the electrodes in such a way that they touch each other Do not apply electrodes on temples neck and transthoracic Do not leave the electrodes in the car Indicates the dimensions of the product Indicates the quantity of electrodes contained in the package Indicates the product code It refers to product certifications and indicates...

Page 15: ...nnels simultaneously P DEL Button To move the selection downwards While a program is running it decrements the 4 channels intensity simultaneously Right USER Button To move the selection to the right 3 While a program is running it goes to the next phase Button To start and stop the contraction during the execution of the Action Now programs in the devices that have these functions fn Runtime Pres...

Page 16: ...liance with directive 60601 1 8 Meaning of the Electrode error alarm If one or more cables are not connected to the mains or if microcurrents cables are used to an EMS program on the display the following alarm will appear Electrode error Program name Time indicators Battery indicator Time of the working phase and of the rest phase Stimulation intensity Type of currents and indicator of the phase ...

Page 17: ... maintain vital functions For a correct use of the Electromedical device refer to the tables attached If it is necessary to use the device near or together with other devices pay attention to its working It is recommended to read carefully the entire operating manual before using the device keep carefully this operating manual The device can emit current value above 10mArms Before each use always ...

Page 18: ...e device must be kept out of the reach of any pet that could damage it and contaminate electrodes and other accessories with parasites The cables of the electrostimulation should not be wrapped around people s neck to avoid any risk of strangulation and suffocation The mobile and fixed radio communications devices could influence the functioning of the electromedical device see the tables attached...

Page 19: ...ng cases Stimulation of the front part of the neck carotid sinus Pacemaker weavers Patients with tumor diseases see your oncologist Stimulation of the brain region Pains whose etiology is unknown Sores and dermatological diseases Severe traumas Stimulation on recent scars Pregnancy It is strictly forbidden to use the electrostimulator in the ocular area Near body areas with metallic implants or in...

Page 20: ... recommended to use the device in a clean room to avoid the contamination of the device with dust and dirt It is recommended to use the device in a ventilated space with regular air change Battery Battery info The device is equipped with a menu that can visualize the charge of the battery the values and the conditions of the end of the charge It is recommended to access to this menu only after a c...

Page 21: ... the surface with proper cleansers that respect the requirements described in the manual The electrodes must be stored in their bag and in an environment that respects the requirements described in the manual After the end of a treatment unplug the cables from the connectors and clean them carefully with proper cleansers that respect the requirements described in the manual After cleaning and dryi...

Page 22: ... alarm The unit name and software version appear on the lower right hand corner of the display Depending on the purchased model the entries of the main menu are shown Use the P and P buttons of the keyboard to move inside the menu Program List menu When selecting Program List the following areas according to the model are shown SPORT SPECIAL SPORTS FITNESS PHYSICAL SHAPE BEAUTY AESTETHICS MEDICAL ...

Page 23: ...channel intensity Increase decrease intensity To increase decrease the intensity of the single channel press the Up and Down buttons of the correspondent channels To increase decrease the intensity of all channels simultaneously press the P or P buttons of the keyboard Run Time functions Once a program has started it is possible to modify time frequency amplitude To modify the parameters of the ph...

Page 24: ... in progress press and hold the RIGHT button for 3 seconds To return to the previous phase press the left back button for 3 seconds Last 10 menu The electrostimulator stores the last 10 executed programs so that these are available for rapid and easy execution The storage occurs automatically at the end of each program When the memory is full older programs are automatically deleted When the devic...

Page 25: ... to exit AUTO STIM mode by pressing any increase button b Placing the cursor on Electrode placement a brief guide for correct electrode placement is displayed For further information on the electrode placement see the picture included in the end of this manual c Placing the cursor on Delete from the list the selected program will be no longer present in the Last 10 executed programs area The Last ...

Page 26: ... function is not activated Try to deactivate it If the problem persists contact the customer service Programming menu The Electrostimulator offers the possibility to create modify new programs This makes the device highly flexible and adaptable to all users requirements From the Programming menu it is possible to create new programs when the message EMPTY appears and to execute already personalize...

Page 27: ...delete NOTE it is not possible to set mixed multi phase programs e g EMS TENS program Advanced menu The advanced menu is composed of the following entries Mode 2 2 The device permits to execute two different programs Ems or Tens at the same time permitting the simultaneously treatment of two patients or two muscular groups How to set multiple treatments To execute simultaneously two different prog...

Page 28: ...er Only that specific user can use the programs stored in the Favorites memory NOTE Every time the device has been turned on the last user will be displayed Working time It indicates the total time the device has been used for stimulation treatments Setup By selecting setup the following screen will appear Backlight time function It permits to modify with the P and P buttons the duration of the ba...

Page 29: ...f time in minutes after which the device if not used automatically turns off Language selection function It permits to choose among 5 different languages for the navigation using the P and P buttons Confirm the selection with OK Service sounds function It permits to enable ON or disable OFF the acoustic tones emitted by the unit Battery info function see p 20 Turn off It permits to turn off the de...

Page 30: ...ic stimulation is not a direct source of energy but it works as a tool that causes a muscular contraction The same type of mechanism is activated when the muscular contraction is produced by the EMS they have the same function of a pulse naturally transmitted by the motor nervous system When the contraction is over the muscle relaxes and returns to its original state Isotonic and isometric contrac...

Page 31: ... same working session it will be necessary to regulate the intensity in order to obtain the same level of contraction because of the accommodation phenomena The current intensities recommended in the different phases are proposed as indicative values and each person should modify these levels according to his her personal needs Moderate intensity The muscle does not tire not even during prolonged ...

Page 32: ...nnected to the device and electrodes are not applied to the skin the electrostimulator brings immediately the intensity to 0 mA Therefore before starting a program make sure that the cables are connected to the device and that the electrodes are not worn as this could decrease their conduction capacity NOTE Use the Microcurrents programs only on channels 1 and 3 with the gray cables supplied If th...

Page 33: ...ned the gate related to the sensory signals is opened and the pain one is closed impeding in this way the passage of these signals to the brain Endorphin secretion When a nervous signal proceeds from the pain area to the brain it spreads through a chain of connections joined together called synapse The synapse can be seen as the space between the end of a nerve and the start of another When an ele...

Page 34: ...al therapy that can be used in many pathologies and the use of MENS together with other instrumental therapies such as for example laser and TENS can provide excellent clinic results that are usually difficulty to reach Ionophoresis Ionophoresis is an electrotherapy form that acts transmitting pharmacological substances inside the tissue thanks to a continuous electric current of unidirectional ty...

Page 35: ...aximum strength Speed endurance 3 levels Explosive strength Explosive strength CROSS COUNTRY SKIING Reactivity Speed endurance 2 levels Endurance strength 3 stages Shoulder prevention TRIATHLON Endurance 3 stages GOLF Aerobic exercise 3 levels RUNNING Specific strength 3 levels Endur strength 3 stages Aerobic 3 stages Shoulder strength 3 levels SAILING SWIMMING MARTIAL ARTS Endurance strength Endu...

Page 36: ...6 does not refer to non medical treatments Beauthy Aestethics Program List Drainage Bio pulse drainage Lipolysis Bio Pulse relaxing massage Toning massage Energizing massage Connective massage Swollen arms Face capillaries Definition Lifting effect Skin tone improvement Post pregnancy drainage Post pregnancy lipolysis Post pregnancy firming Breast firming Breast sculpting Figure TOTAL 60 NOTE some...

Page 37: ...re it is certified by the KIWA CERMET ITALIA S P A Body n 0476 according to 93 42 CEE directive for medical devices The certification covers clinical applications NOTES ON THE USE OF MICROCURRENT PROGRAMS This paragraph refers to the use of microcurrent programs The microcurrent programs differ from normal TENS and EMS programs as follows While conventional electrostimulation e g TENS uses current...

Page 38: ...am in 2 2 mode the electrostimulator will emit an error tone If according to your therapist you wish to modify the treatment protocol altering the intensity press and hold the UP and DOWN button for 3 seconds Medical currents Pain Antalgic Tens Program List The following programs are medical Menstrual pain Modulated antalgic Tens Scapulohumeral syndrome Endorphinic Tens Chronic pain Muscle pain Ch...

Page 39: ...dical device Therefore it is certified by the KIWA CERMET ITALIA S P A Body n 0476 according to 93 42 CEE directive for medical devices The certification covers clinical applications Type The urology programs require the use of specific endovaginal and endorectal electrode probes certified according to the Directive for Medical Devices 93 42 EEC These are bipolar probes with a 2 mm female adapter ...

Page 40: ...n s polarity the absorbent surface of the other electrode should be dampened with slightly salted water to promote conductivity To run the Ionophoresis programs use exclusively one special gray cable connected to the outlet of channel 1 Either the light gray or dark gray cable may be used The Ionophoresis programs cannot be run in the 2 2 mode with multiple treatments The IONOPHORESIS programs are...

Page 41: ...t contraction before contraction time is over it is enough to press again button In this case the program will cut the rest period and will place itself at the beginning of the ramp of the next stimulation waiting for the user to press button in order to start contraction The following programs are not medical Area Name Hz Ramp Up time Contraction time Upper limbs Action 0 2 1 s 30 0 2 1 Action 0 ...

Page 42: ...ion start between the channels will be noticed The following programs are not medical The 3S program list includes 54 parameter combinations Area Name Hz Delay time Upper limbs SerSeqStim 0 1 s 0 1 SerSeqStim 0 2 s 0 2 SerSeqStim 0 3 s 30 0 3 Lower limbs SerSeqStim 0 5 s 0 5 SerSeqStim 1 s 1 SerSeqStim 2 s 80 2 Trunk SerSeqStim 3 s 3 SerSeqStim 4 s 4 SerSeqStim serial 11 Total 54 Programs Delay ti...

Page 43: ...on during the stimulation The body position during the elctrostimulation session depends on the body part involved and on the program type that is being carried out During the treatment execution with high intensities we suggest blocking the limbs in order to work in isometry For instance if you want to treat the quadriceps with a strength program we suggest carrying out the treatment while sittin...

Page 44: ...v 1 del 24 10 2017 ELECTRODE PLACEMENT Biceps brachii muscle Triceps brachii muscle Flexor carpi muscle Extensor carpi muscle Deltoid muscle Pectoral muscle Pectoral muscle Trapezius muscle Trapezius muscle ...

Page 45: ... Rev 1 del 24 10 2017 ELECTRODE PLACEMENT Latissimus dorsi muscle Latissimus dorsi muscle Infraspinatus muscle Lumbar muscles Lumbar Dorsal muscles Abdominals Abdominals Abdominals Rectus abdominis muscle ...

Page 46: ...46 Rev 1 del 24 10 2017 ELECTRODE PLACEMENT Gluteus Gluteus Biceps femoris muscle Adductors Rectus femoris muscle Quadriceps Gastrocnemius muscle Gastrocnemius muscle Tibialis anterior muscle ...

Page 47: ...47 Rev 1 del 24 10 2017 ELECTRODE PLACEMENT FOR TENS TREATMENTS Shoulder pain Elbow pain Cervical pain Lumbar pain Lumbar pain Sciatica Knee pain Knee pain Knee pain ...

Page 48: ... 24 10 2017 ELECTRODE PLACEMENT FOR MICROCURRENT TREATMENTS Shoulder pain Cervical pain Elbow pain Lumbar pain Sciatica Hip pain Muscle pain the electrodes should be placed on the painful area Knee pain Ankle pain ...

Page 49: ...essories to be repaired must be sent by and at the expenses of the customer in their original packages 2 The product s warranty is subject to the production of a fiscal document fiscal receipt receipted bill or sale invoice attesting the product s purchase date 3 The repair work shall have no effect on the original warranty expiry date and shall neither renew nor extend it 4 If during the repair w...

Page 50: ...stus lateralis of the quadriceps with one single channel They are not recommended for medical applications Does the power decrease by using Y cables The power intensity for each channel does not vary However when Y cables are used to split one single channel in two the current is distributed on a wider muscle area therefore contraction will be less pronounced Increase the intensity to obtain the s...

Page 51: ...eatment are necessary Results are obtained more quickly if treatments are combined with good physical activity and a correct life style How many sessions can I weekly perform For physical training consult the technical guide that is available on the Globus website For fitness and aesthetics programs the number of sessions depends on the type of treatment 3 4 sessions per week on alternate days are...

Page 52: ...ilizza energia RF solo per il suo funzionamento interno Perciò le sue emissioni RF sono molto basse e verosimilmente non causano nessuna interferenza negli apparecchi elettronici vicini The THE CHAMPION uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Emissioni RF RF emissions CISPR 11 ...

Page 53: ...I pavimenti devono essere in legno calcestruzzo o in ceramica Se i pavimenti sono ricoperti di materiale sintetico l umidità relativa dovrebbe essere almeno 30 Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Transitori treni elettrici veloci Electrical fast transient burst IEC 61000 4 4 2 kV per le linee di al...

Page 54: ...nto continuato anche durante l interruzione della tensione di rete si raccomanda di alimentare il THE CHAMPION con un gruppo di continuità UPS o con batterie Mains power quality should be that of a typical commercial or hospital environment If the user of the THE CHAMPION requires continued operation during power mains interruptions it is recommended that the THE CHAMPION be powered from an uninte...

Page 55: ...MPION should assure that it is used in such an environment Prova di immunità Immunity Test Livello di prova IEC 60601 IEC 60601 test level Livello di conformità Compliance level Ambiente elettromagnetico Guida Electromagnetic environment Guidance Gli apparecchi di comunicazione a RF portatili e mobili non dovrebbero essere usati più vicino a nessuna parte del THE CHAMPION compresi i cavi della dis...

Page 56: ... potenza massima nominale d uscita del trasmettitore in Watt W secondo il costruttore del trasmettitore e d è la distanza di separazione raccomandata in metri m Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Le intensità di campo dei trasmettitori a RF fissi come determinato...

Page 57: ...e teoricamente e con precisione Per valutare un ambiente elettromagnetico causato da trasmettitori RF fissi si dovrebbe considerare un indagine elettromagnetica del sito Se l intensità di campo misurata nel luogo in cui si usa un ACTIVA 500 PRO supera il livello di conformità applicabile di cui sopra si dovrebbe porre sotto osservazione il funzionamento normale del ACTIVA 500 PRO Se si notano pres...

Page 58: ...unicazione mobili e portatili a RF trasmettitori e il THE CHAMPION come sotto raccomandato in relazione alla potenza di uscita massima degli apparecchi di radiocomunicazione The THE CHAMPION is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the THE CHAMPION can help prevent electromagnetic interference by maintaining ...

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