Globus PREMIUM 400 User Manual
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Globus PREMIUM 400 User Manual

Globus PREMIUM 400 User Manual

Electrostimulators
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Summary of Contents for Globus PREMIUM 400

  • Page 2 PREMIUM 400 DEAR CUSTOMER THANK YOU FOR CHOOSING A GLOBUS PRODUCT. WE REMAIN AT YOUR DISPOSAL FOR ANY ASSISTANCE OR ADVICE YOU MAY NEED DOMINO s.r.l. via Vittorio Veneto 52 31013 - Codognè - TV - Italy Tel. (+39) 0438.7933 Fax.

  • Page 3: Table Of Contents

    PREMIUM 400 Table of contents TECHNICAL FEATURES ....................5 Device ......................5 Use conditions ....................5 Technical features of the currents ..............5 Disposal of the device ..................6 Declaration of conformity .................. 6 INTENDED USE ......................7 EQUIPMENT ......................8 LABELLING AND SYMBOLS ..................
  • Page 4 PREMIUM 400 “Program List” menu ..................21 “Last 10” menu ....................23 “Favorites” menu .................... 23 “Treatments” menu ..................23 “Programming” menu ..................24 PROGRAM LIST ....................... 27 GENERAL NOTES ON ELECTRODE POSITIONING ............34 ELECTRODE POSITION ..................... 38 ELECTRODE POSITION (TENS) ................. 41 MICROCURRENT ELECTRODE POSITIONING ..............

  • Page 5: Technical Features

    PREMIUM 400 TECHNICAL FEATURES Device Size: 160x99x35.4 mm Weight: 404 g Case: in Food Grade ABS Protection level: IP20 + IP02 Storage and transport conditions Storage and transportation temperature: from -10°C to 45°C Max. relative humidity: 30% - 75% The values indicate the limits allowed if the product or its accessories are not in the original package.

  • Page 6: Disposal Of The Device

    PREMIUM 400 Min.frequency: Max.frequency: 200Hz Min. Intensity: 0 µA/1000 Ohm Step 10 µA Max. Intensity: 800 µA/1000 Ohm Amplitude value: included between 1 and 250 µseconds Ionophoresis: Channels available: Channel 1 Constant current: Min. Intensity: 0 mA/1000 Ohm Max. Intensity: 10 mA/1000 Ohm step 0.1 mA/1000 Ohm...

  • Page 7: Intended Use

    PREMIUM 400 2007/47 on medical devices, by the Notified Body Kiwa Cermet Italia, Via Cadriano 23, 40057 Granarolo Dell’Emilia (BO) Italy (n. 0476), in order to ensure product safety. INTENDED USE The after sales service is guaranteed for 5 years. We suggest having a check of the device every 2 years for the maintenance and to ensure the safety.

  • Page 8: Equipment

    PREMIUM 400 EQUIPMENT The electrostimulator is supplied complete of cables and electrodes to use: therefore, opening the package, it is necessary to check that the basic equipment is complete. If some elements should be missing, contact immediately the authorized retailer where you purchased the product.
  • Page 9 PREMIUM 400 Accessories that are not included in the equipment (to be purchased separately) The device can be used with the optional accessories listed below (it is possible to see their features in the website www.globuscorporation.com). In order to purchase these accessories, please contact your dealer.

  • Page 10: Labelling And Symbols

    PREMIUM 400 LABELLING AND SYMBOLS It refers to the manufacturer Warning The device emits current values over 10 mA or10V Keep the device dry This symbol indicates that the device complies with the directives on medical devices (93/42/EEC 47/2007/EEC). The number of the notified body is 0476.
  • Page 11 PREMIUM 400 Model It indicates the power supply model Input electric features of the power supply Output electric features of the power supply Nerve and Muscle It indicates the device type stimulator Input electric features of the device with external power Input power supply.

  • Page 12: Device

    PREMIUM 400 Device Model: DK7-088-0200-EU PRI: 100-240V 0V 50-60Hz 0.07A max SEC: 8.8V V 200mA Nerve and Muscle stimulator: Premium 400 Input power: 8.8V V 200mA IP20 Battery power: 7.2V V 1.4A Output: 120mA (1000Ω) A4R301900949 Internal battery: 7.2V NiMH 1800mAh...

  • Page 13: Panel And Keyboard

    PREMIUM 400 · Clean and degrease the skin. · Do not apply the electrode on wounds or injured skin. · Connect the cable connector to the electrode connector. · Remove the electrode. · Apply on the skin. · Start the program.

  • Page 14: Display And Interface

    PREMIUM 400 P+ Button It moves the selection upwards. It increases the intensity of the 4 channels simultaneously, while a program is running P- Button It moves the selection downwards. It increases the intensity of the 4 channels simultaneously, while a program is running RIGHT/USER button: It moves the selection to the right.

  • Page 15: Information Signals

    PREMIUM 400 INFORMATION SIGNALS Compliance Certifications: CE MDD certificate. The sound and acoustic signals are in compliance with the 60601-1-8 directive. Meaning of the signal "Electrode error" If one or more cables are not duly connected to the mains, or if cables for microcurrent are erroneously used to run an EMS program, the following signal will appear on the display: "Electrodes error".

  • Page 16: How To Connect The Cables

    PREMIUM 400 - The device is capable of delivering current values exceeding 10mArms. - Before each use always check the integrity of the device. This is a fundamental requirement for carrying out the therapy; do not use the device if the buttons or the cables are defective or malfunctioning.

  • Page 17: Connection Of The Electrodes

    PREMIUM 400 Connection of the electrodes Take the electrodes from the original packaging; all new electrodes have a sealed packaging. Ensure that the device is off. To start, connect the two plugs of the cables to the electrodes, then remove the electrodes from their place and put them on the skin. To place the electrodes correctly, see the images at the end of this manual.

  • Page 18: Safety Precautions

    - In the case of damaged cables, they must be replaced with original parts and not used anymore. - Only use Globus marked electrodes. - Great attention has to be paid when current densities exceed 2mA/cm² (effective value) for each electrode.
  • Page 19 PREMIUM 400 - Stimulation of the urogenital apparatus, in case of chronic urinary retention, in the upper urinary tract - Stimulation of the pelvic floor in presence of a complete peripheral denervation; - In case of actual or alleged tumor formation, consult the oncologist - Pains with unknown etiology.

  • Page 20: Side Effects

    PREMIUM 400 - Presence of ischemic tissues, wounds, skin or damaged or irritated mucosa, and/or in presence of infections. - Presence of contraceptive vaginal ring. - After an invasive or ablative surgical intervention, which has not been totally cured. - Patients subject to bleedings or using anticoagulants.

  • Page 21: Program List" Menu

    PREMIUM 400 “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 CURRENTS · MICROCURRENTS · PAIN-ANTALGIC · IONOPHORESIS · REHABILITATION - ACTION NOW...
  • Page 22 PREMIUM 400 To increase/decrease the intensity of all channels simultaneously, press the P+ or P- buttons of the keyboard. Runtime function (how to change the working phase parameters) Once a program has started, it is possible to modify: - time...

  • Page 23: Last 10" Menu

    PREMIUM 400 “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.

  • Page 24: Programming" Menu

    PREMIUM 400 This function is especially thought for the rent of the unit to inexpert users and/or to patients that have to carry out only some special programs that have been chosen by the specialist. Activation of the STIM LOCK function Press and hold the buttons fn and -->...
  • Page 25 PREMIUM 400 STEP 3. After setting the phase number of which the program is composed, different screens will appear where it is possible to select the desired parameters. Use P+ and P- to carry out the selection. The procedure executed until now is the same for every type of program you wish to create.
  • Page 26 PREMIUM 400 ** From the Program list” menu select the area and the desired program. Now select “Continue with 2+2” and select the second program. NOTE: During the Mode 2+2 the following screen will appear: ½ Firming ¾ Toning massage...

  • Page 27: Program List

    PREMIUM 400 “Contrast” function · It permits to modify with the P+ and P- buttons the contrast level in the display. “Auto shut off time” function · It permits to set with the P+ and P- buttons, a period of time (in minutes) after which the device, if not used, automatically turns off.
  • Page 28 PREMIUM 400 Special Sports program List Cross country skiing Running Martial arts Tennis Soccer Bike-riding TOTAL 44 NOTE: some programs are divided according to body areas. CE0476 does not refer to non-medical treatments. Fitness-Physical Shape Program List Firming Bio-Pulse firming...
  • Page 29 PREMIUM 400 Swollen arms Face capillaries Lifting effect Skin tone improvement Post-pregnancy drainage Post-pregnancy lipolysis Post-pregnancy firming Breast firming Breast sculpting TOTAL 36 NOTE: some programs are divided according to body areas. CE0476 does not refer to non-medical treatments. Medical currents – Microcurrents Program List...
  • Page 30 PREMIUM 400 Rotator cuff inflammation Tendon inflammation TOTAL 23 Because of the presence of clinical programs, this product is a medical 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.
  • Page 31 PREMIUM 400 Cervical pain Bursitis-tendinitis Osteoarthritis Knee pain Conventional antalgic Tens Total 12 Because of the presence of clinical programs, this product is a medical 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.
  • Page 32 PREMIUM 400 Because of the presence of clinical programs, this product is a medical 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. The home user can use ionophoresis treatments only after consulting a specialist who will prescribe treatment medicines and indications.
  • Page 33 PREMIUM 400 Program name Ramp-Up time Contraction time Action 0,2 - 1 s Action 0,5- 1s Action 1 - 1 s Action 2 - 1 s Action 3 - 2 s Action 4 - 2 s Action 2 - 6 s Total 7 programs CE0476 does not refer to non-medical treatments.

  • Page 34: General Notes On Electrode Positioning

    PREMIUM 400 "Delay time" refers to the delay seconds that the next pulse needs to start. CE0476 does not refer to non-medical treatments. GENERAL NOTES ON ELECTRODE POSITIONING Correct electrode positioning and size choice are fundamental to assure the effectiveness of electrostimulation.
  • Page 35 PREMIUM 400 MICRO – TENS CURRENT colored cables PAIN gray cables PAIN Indications for the treatment with incontinence programs The use of muscle stimulation programs referred to the treatment of urinary incontinence can be used exclusively for the treatment of urge, stress and mixed incontinence.
  • Page 36 PREMIUM 400 · Connect the cable to the device. · For the vaginal stimulation, lie flat supine with bended knee and opened legs. To use the anal probe, lie on one side in lateral decubitus position · Insert the probe in the vagina or anus using, if necessary, some water-based gel ·...
  • Page 37 PREMIUM 400 DENSITY = Current displayed in mA / Electrode area in cm² Indications for the application: The manufacturer declines the responsibility of the prescribing physician for the · choice of the drug to be used with ionophoresis. For this purpose, in this user manual the manufacturer provides the data for a correct definition of the protocol and the drug that has to be used.

  • Page 38: Electrode Position

    PREMIUM 400 ELECTRODE POSITION Biceps brachii Triceps brachii Flexor carpi Extensor carpi Deltoid Posterior deltoid Pectoral Pectoral Trapezius REV 4_26.4.22...
  • Page 39 PREMIUM 400 ELECTRODE POSITION Latissimus dorsi Infraspinatus Rhomboid Lumbar/Dorsal muscles Lumbar muscles Abdominals Rectus abdominis Rectus abdominis Gluteus REV 4_26.4.22...
  • Page 40 PREMIUM 400 ELECTRODE POSITION Gluteus Hamstrings Hamstrings Quadriceps Quadriceps Adductors Calf Calf Tibialis anterior REV 4_26.4.22...

  • Page 41: Electrode Position (Tens)

    PREMIUM 400 ELECTRODE POSITION (TENS) Anterior shoulder pain Shoulder pain Carpal tunnel Neck pain/Whiplash Chronic low back pain Sciatica Coxarthrosis Gonarthrosis/Knee pain Ankle joint arthrosis REV 4_26.4.22...

  • Page 42: Microcurrent Electrode Positioning

    PREMIUM 400 MICROCURRENT ELECTRODE POSITIONING Shoulder dislocation Brachialgia Carpal Tunnel Low Back Pain Sciatica Hip pain Knee Osteoarthritis Achilles Tendinopathy Sprained ankle REV 4_26.4.22...

  • Page 43: Action Principles

    PREMIUM 400 ACTION PRINCIPLES Muscular electrostimulation Electrostimulation is a technique that, by means of electric pulses that act on the muscle motor points (motoneurons), causes a muscular contraction similar to voluntary contraction. The majority of human muscles are striated or voluntary, with approximately 200 muscles on each side of the body (about 400 on the whole).

  • Page 44: Stimulation Intensity

    PREMIUM 400 muscles which only have type II fibers, like the orbicular muscle; however, the majority of human body muscles is composed of a combination of the two types. Studies on the distribution of fibers in the muscle have highlighted the close relationship between the (tonic or phasic) motoneuron and the functional features of the fibers it innervates;...
  • Page 45 PREMIUM 400 treatment description, recommended intensity levels indicated. N.B. Recommended current levels are just an indication. NOTE: It is not necessary to set the intensity value (in mA) in Microcurrent programs, since it has already been set for all the phases.

  • Page 46: Ionophoresis

    PREMIUM 400 Endorphin secretion When a nervous signal proceeds from the pain area to the brain, it spreads through a chain of connections joined together called synapses. The synapse can be seen as the space between the end of a nerve and the start of another. When an electric signal reaches the end of a nerve, it produces substances called neurotransmitters that pass through the synapse and activate the start of the next nerve.

  • Page 47: Maintenance And Cleaning

    PREMIUM 400 It is crucial to know if the active part of the medicine, after being dissociated in a ionic form, has positive or negative charge, with the aim of placing it correctly according to the direction of the electric flow.
  • Page 48 PREMIUM 400 Before placing the electrodes on the skin, we suggest to clean it accurately. After using the multi-purpose single patient and/or single-use electrodes, they must be stored using their plastic film and placed in a clean closed plastic bag.

  • Page 49: Warranty

    NOTE: Before returning the device for repairs, we recommend to read carefully the user instructions contained in the manual and visit Globus website. In case you need to return your product for assistance, contact your dealer or contact Globus Service.

  • Page 50: Frequently Asked Questions

    PREMIUM 400 Frequently Asked Questions What kind of electrodes should be used for electrostimulation? Use self-adhesive electrodes, which are practical and improve the quality of stimulation. If used with care, they will last for 25-30 applications. The electrodes should be replaced when they have no longer a good connection with the skin.
  • Page 51 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 suggested for toning; daily treatments are permitted for Lipolysis and Drainage programs.

  • Page 52: Emc Accompanying Documents

    PREMIUM 400 EMC accompanying documents Essential performance PERFORMANCE CONDITION RISK ACCEPTED EVENT Electrostimulation. External disturbance Display information no The machine must stop the stimulation. (Burst). longer readable. The machine must maintain the stimulation and accept the commands. Lack of internal...
  • Page 53 PREMIUM 400 In compliance with: EN 60601-1: 2006 + A1: 2013 EN 60601-1-2: 2015 EN 60601-2-10: 2015 EN 60601-1-11: 2015 Warning: radiofrequency communication devices (including accessories like antennas or antenna cables) must be used at least 3 meters away from every part (including cables and accessories) of the device.
  • Page 54 PREMIUM 400 REV 4_26.4.22...
  • Page 55 PREMIUM 400 REV 4_26.4.22...
  • Page 56 PREMIUM 400 REV 4_26.4.22...

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