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miha-bodytec II
Operating instructions

US

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Содержание BODYTEC II

Страница 1: ...miha bodytec II Operating instructions US...

Страница 2: ...ytec Inc 2171 Executive Drive Suite 200 Addison Illinois 60101 USA Telephone 1 833 367 6442 E mail usa miha bodytec com Internet www miha bodytec us This manual was created by kothes GmbH Internet www...

Страница 3: ...he prevention of acci dents and the general safety regulations for the location in which the device is used also apply The illustrations in this manual are provided for basic under standing and can be...

Страница 4: ...ers are used in this manual Identifier Explanation Step by step procedural instructions Results of procedural steps References to sections of this manual and to other applicable documents Lists withou...

Страница 5: ...EMC Warnings 45 5 Basic information on EMS training 47 5 1 Safety first 47 5 2 EMS training 47 5 3 Training frequency and regeneration 48 6 Understanding the device 51 6 1 Explanation of terms 51 6 2...

Страница 6: ...lans 87 11 5 Training 92 11 6 Transponder system 95 11 7 Training with synchronized start 99 12 After the training 100 12 1 Taking off electrodes 100 12 2 Cleaning and storage 101 12 2 1 Cleaning the...

Страница 7: ...bodytec II 1 Control unit Control unit top side on page 9 2 Power cable 3 On off switch 4 Connections and speaker 5 Column 6 Base plate 7 Guide rail 8 Clamping screw 9 Grab handle miha bodytec II Ove...

Страница 8: ...g which addresses all muscle groups is possible with up to 10 pairs of electrodes During conventional training electrical signals from the brain ini tiate contractions and thus movement of the muscles...

Страница 9: ...aining is very intense and thus short 10 20 minutes Fig 3 Control unit top side 1 Level controller for legs 2 Level controller for buttocks 3 Level controller for lower back 4 Level controller for upp...

Страница 10: ...ard is placed on the transponder card contact surface Fig 3 12 the settings stored on this card can be edited or loaded automatically Chapter 11 6 Transponder system on page 95 The multi function butt...

Страница 11: ...Fig 4 5 is located behind the perforations in the case The device uses the speaker to output acoustic signals that pro vide information on inputs and device status 1 2 Equipment Using equipment not o...

Страница 12: ...lectrode vest for applying electrodes to the upper body Table 1 Electrode sizes for each vest size Vest size Size 1 and size V1 Size 2 size 3 and size V2 in in 2 electrodes for abdomen 22 85 in 27 56...

Страница 13: ...e Size 1 pair 16 74 in each Size 2 pair 20 77 in each Size 3 pair 29 14 in each Buttocks electrode hereinafter referred to as i body belt for applying to the buttocks Table 3 Electrode sizes for each...

Страница 14: ...p spray bottle for moistening the electrodes The miha bodytec USB flash drive is delivered with the device and serves as a data carrier for performing updates as well as saving and transferring settin...

Страница 15: ...t our headquarters Address miha bodytec Inc 2171 Executive Drive Suite 200 Addison Illinois 60101 USA Telephone 1 833 367 6442 E mail usa miha bodytec com Website www miha bodytec us We are also alway...

Страница 16: ...isuse muscle atrophy The miha bodytec II electrical impulses allow the triggering of action potentials on motoneurons of motor nerves excitations These excitations of motoneurons are transmitted to th...

Страница 17: ...ly The intro duction of electrical current into the heart may cause car diac arrhythmias Stimulation must not be applied transcerebrally Stimulation must not be applied over swollen infected or inflam...

Страница 18: ...influence of alcohol drugs nar cotics and or painkillers In the event of doubts whether any contraindication is pre sent do not use the device In the event of doubts consult a doctor before the first...

Страница 19: ...ining session by the trainer Athletes patients must provide the trainer responsible for them with truthful information on current health restrictions e g fever Athletes patients make sure that none of...

Страница 20: ...the athletes patients and checks them so risks can be eliminated During a workout the trainer and the athletes patients must have unimpeded access to the device s control elements They must be able to...

Страница 21: ...mia that can be attributed to training with the device Since a theoretical residual risk remains strictly observe the instructions below Persons affected will lose consciousness after a brief period o...

Страница 22: ...enetrating the case Risk of fatal injury from improper exposure of the electrodes to moisture When moistening and putting on the electrodes ensure that there is a sufficient distance to the control un...

Страница 23: ...vice and the equipment used after training Before placing the device into intermediate storage mark the components with the date and name of the last trainer In the event of improper hygienic cleaning...

Страница 24: ...dy must be known Children are not allowed to train or play with the device or perform cleaning or maintenance tasks Handling the device without training instruction can result in dangerous situations...

Страница 25: ...Do not turn off the device during an update Wait for the update to finish and do not input anything The device can be permanently damaged if it is turned off during the update process or if the power...

Страница 26: ...complete the form Your health care provider is not required to report to the FDA In these situations you may complete the Online Reporting Form yourself You will receive an acknowledgement from FDA w...

Страница 27: ...h AMEND MENT 7 2016 Not for persons with pacemakers or implanted defibrillators The device must never be used by persons with cardiac pace makers or other active medical implants In this context also...

Страница 28: ...equipment Part 1 General require ments for basic safety and essential performance General warning sign General warning sign ES60601 1 2005 R 2012 And A1 2012 Table D 1 Symbol 20 Medical electrical eq...

Страница 29: ...uropean technical con formity n Mandatory sign IEC protection Class II n Mandatory sign RX only n Mandatory sign CAN ICES 3 B NMB 3 B Compliance with Canadian ICES 3 Rules n Mandatory sign FCC marking...

Страница 30: ...d Edition 2016 11 01 Clause 5 1 7 Medical Devices Symbols To Be Used With Medical Device Labels Labelling And Information To Be Supplied Part 1 General Require ments Serial number Indicates the manufa...

Страница 31: ...in accordance with Article 11 2 of Directive 2002 96 EC WEEE Recycle Elec tronic Equipment Waste of electrical and electronic equipment WEEE Electrical and electronic parts may contain toxic material...

Страница 32: ...ards Indicates the compli ance with the exemp tion from the routine evaluation limits in sec tion 2 5 of RSS 102 and with RSS 102 RF exposure for Class B digital devices 2 7 4 Cleaning symbols Symbol...

Страница 33: ...th environmental regulations from local municipal authorities or specialized disposal companies Environmental hazards can be caused by incorrect disposal The device must not be disposed of via domesti...

Страница 34: ...ytec II electrical impulses allow the triggering of action potentials on moto neurons of motor nerves excitations These excitations of motoneurons are trans mitted to the muscle fibers via the motor e...

Страница 35: ...500 ohm 300 mJ 50 mA 500 mJ Permissible ambient tem perature opera tion 40 F 105 F 5 C 40 C Time for warming up the device from the lowest storage tempera ture 13 F 25 C to the operating tem perature...

Страница 36: ...0 s 400 s in steps of 25 s Pulse rise setting 0 0 s 1 0 s in steps of 0 1 Frequency set ting 2 0 Hz 10 0 Hz in steps of 0 5 10 0 Hz 150 0 Hz in steps of 1 0 Pulse pause set ting 0 0 s 1 0 s in steps o...

Страница 37: ...an be formatted on the device Synchronized start 2 4 GHz M2M wireless mesh network Number of per sons training with synchronized start maximum 2 Cloud service 5 GHz Wi Fi Can only be used with an acce...

Страница 38: ...009 Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity n ISO 10993 10 2010 Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization Thi...

Страница 39: ...sition de RSS 102 rf utilisateurs peut obtenir l information canadienne sur l exposition et la conformit de rf L metteur r cepteur exempt de licence contenu dans le pr sent appareil est conforme aux C...

Страница 40: ...vant open source software license terms Any liability for the use of the open source software beyond the program cycle provided by us for the product as well as any liability for defects caused by cha...

Страница 41: ...tec II device is suit able for usage in any building including residential buildings and those connected directly to low voltage power supply networks installed for residential buildings Harmonic dist...

Страница 42: ...ipment IEC 61000 4 3 385 MHz 27 V m 450 MHz 28 V m 710 MHz 9 V m 745 MHz 9 V m 780 MHz 9 V m 810 MHz 28 V m 870 MHz 28 V m 930 MHz 28 V m 1720 MHz 28 V m 1845 MHz 28 V m 1970 MHz 28 V m 2450 MHz 28 V...

Страница 43: ...ith a maximum cable length of 3 meters or more Guidance and manufacturer s declaration electromagnetic immunity The miha bodytec II EMS training device has been designed for use in electromagnetic env...

Страница 44: ...separation dis tance d in m to a RF communications equip ment with a maximum power P in W can be cal culated using the equa tion in clause 8 10 of IEC 60601 1 2 d 6 E P Voltage dips IEC 61000 4 11 0...

Страница 45: ...dealers For replaceable parts available see Chapter 1 2 Equipment on page 11 Using other cables or equipment can void the authority to operate the equipment In the presence of an electromagnetic distu...

Страница 46: ...a cables and external antennas must be used no closer than 30 cm 12 inches to any part of the miha bodytec II EMS training device including cables specified by the manufacturer Otherwise degradation o...

Страница 47: ...s With EMS electrical pulses from outside acti vate the muscles It makes no difference to the muscle whether electrical stimulations are sent from the brain or from electrodes It reacts by contracting...

Страница 48: ...d active pulse rate muscle and tendon pains and also depression among other things The recommended training frequency is 1 2 times per week Do not train when feeling unwell in the event of severe musc...

Страница 49: ...carbohydrates This can be done by eating a meal high in carbohydrates but not heavy 2 3 hours before a workout The athlete s patient s body also requires adequate fluids The ath lete patient shall dr...

Страница 50: ...rotein energy drink such as a protein shake for better regeneration and for stimulation of muscle building Take a break after the workout and do not complete any further workouts to guarantee best pos...

Страница 51: ...can be automatically accessed on the transponder card during future workouts For this to work the Load level function must be active in the device settings In addition this option must also be set on...

Страница 52: ...raining To ensure that training with synchronized start is effective and safe a maximum of 2 persons training per trainer is recommended The brand code parameterization is used for selecting or adding...

Страница 53: ...he respective level controller Symbol Channels application area Channel 1 legs Channel 2 buttocks Channel 3 lower back Channel 4 upper back Channel 5 side back Channel 6 abdomen Channel 7 chest Channe...

Страница 54: ...tart navi gating the available options with the help of menu tabs After selecting a menu tab you will be shown the associated menus or secondary menu tabs 1 Turn the multi function button Fig 20 1 clo...

Страница 55: ...ings Fig 22 2 defined for the respective items in the menu The current settings are always displayed next to the associated menu items Menus are labelled with different colors The color of a menu item...

Страница 56: ...ubmenu associated with the menu item is selected 1 Open the desired menu item containing a submenu Selecting and opening menus on page 56 2 Press the multi function button Submenu has been selected Fi...

Страница 57: ...u see the Main menu menu item 4 Select the Main menu menu item The main menu is displayed 1 Press the multi function button The workout is cancelled or ended Training screen remains open 2 Press the m...

Страница 58: ...ent types of letters and upper and lower case letters n Briefly press the main controller Fig 29 12 to delete the last letter from the text box Pressing and holding the controller for longer will clea...

Страница 59: ...f the LED strip in the display and on the rear if a pause transition of more than 0 LEDs was selected n Pause transition Specifies how many LEDs are supposed to change color at the beginning of the pu...

Страница 60: ...nction button Display texts are shown in the language you have selected Every athlete patient can customize the language settings and store these personalized settings on the transponder card Selectin...

Страница 61: ...ied or deleted It can only be deactivated It will then only be displayed in the training plan memory settings and program memory settings The program can be activated again in these settings The Progr...

Страница 62: ...plans selection or in the favorites menu After storing the training plan you can change the exercises and the name but you cannot alter the program associated with the training plan If you select Paus...

Страница 63: ...te in the training with synchronized start session if it is set to the same program or same training plan as the master device Personnel n Trainer 1 Open the Setup menu tab The Setup menu tab opens 2...

Страница 64: ...ions can be stored on transponder cards When a transponder card is inserted an athlete patient can only choose from the set preselections 1 Open the Setup menu tab The Setup menu tab opens 2 Open the...

Страница 65: ...zed by the device and can therefore no longer be used The device settings the created workouts and the device statistics are saved to the miha bodytec USB flash drive as backup files 7 8 Restoring imp...

Страница 66: ...n start restoring the data stored on the miha bodytec USB flash drive Use the multi function button to select the Start process menu item and press the button to confirm your selection 9 All settings...

Страница 67: ...lt in material damage Do not disconnect it from the power source during an update Do not turn off the device during an update Wait for the update to finish and do not input anything The device can be...

Страница 68: ...lash drive is fully inserted A prompt appears asking if you want to perform an update 5 Answer the prompt with Yes The update process starts This can take several minutes 6 Wait for the update to comp...

Страница 69: ...ge 15 7 12 Displaying statistics 1 Open the Setup menu tab The Setup menu tab opens 2 Use the multi function button to select the Statistics summary menu item and press the button to confirm your sele...

Страница 70: ...ergarments Undergarments on page 14 Always pay attention to the correct size The undergarments must fit closely everywhere but must not cut into the skin or be too tight Pay attention that pants and s...

Страница 71: ...jury due to damaged cables Check the cables and electrodes for damage before every workout Never use the device if cables or electrodes are damaged Training with damaged cables or damaged electrodes c...

Страница 72: ...that they fit your arms and legs closely and do not cut in anywhere when closed The version information provides a guideline If i body straps flex never fit snugly when closed select a smaller size I...

Страница 73: ...is a sufficient distance to the control unit No water must penetrate the case There is a risk of fatal injury due to electrocution in the event of liquid penetrating the case of the control unit Do no...

Страница 74: ...rrect i body size on page 72 2 Spray the i body with water until a visible film of water has formed on the electrodes Fig 34 3 Put on the i body Close the fitting aid hook and loop in the area of the...

Страница 75: ...odes it can be pulled into place on the fabric in the front and rear However never pull on the silicone on the side to smooth out the i body Fig 36 Closing the i body Fig 37 Smoothing out the i body P...

Страница 76: ...flex must face outwards 8 Insert the hook into one of the loops Fig 40 Adjust the width so that it is comfortable for the athlete and at the same time provides enough contact pressure Fig 38 i body st...

Страница 77: ...the left arm 12 Connect both i body straps flex to the i body Fig 42 1 and 2 with the i body cable When connecting the i body straps flex always ensure that the corresponding cables medium length are...

Страница 78: ...the i body straps flex so that the pushbutton faces for wards Fig 46 17 If the i body straps flex does not fit properly select a dif ferent loop to make it tighter or wider If necessary select a diffe...

Страница 79: ...trodes to the cables then put on the i body belt 21 Connect both electrodes of the i body belt to the i body Fig 49 with the i body cable When connecting the i body belt always ensure that the corresp...

Страница 80: ...n nector of the i body Fig 52 1 Or Connect the i body connect wireless to the magnetic con nector of the i body Fig 52 2 See the i body connect wireless manual for further information All electrodes a...

Страница 81: ...dual components can be fatal There is a risk of fatal injury in the event of liquid penetrating the case Risk of injury from operating the device without column Only use the device if it is connected...

Страница 82: ...rol unit upside down on the cloth 3 Plug the connection cable into the control unit Fig 53 1 4 Connect the power supply to the control unit Fig 53 2 5 When connecting the power cable Fig 53 2 make sur...

Страница 83: ...conds after the device has been switched on before it is ready for use 7 Make sure that the main menu is displayed Main menu on page 54 You can now connect the electrodes to the device 9 3 Individual...

Страница 84: ...erial damage to the device this may result in injuries from a fall Personnel n Athlete Patient The height of the grab handle can be individually adjusted Pro ceed as follows to adjust the handle heigh...

Страница 85: ...e duration specifies the time in seconds s or milliseconds ms during which a current is output and the muscle is held in the shortened contracted condition The pulse frequency is displayed in Hertz Hz...

Страница 86: ...ce 20 min 7 Hz Continuous 0 s 0 s 350 s 5 Body relax 10 min 100 Hz 1 s 1 s 0 s 150 s 6 Test training 12 min 85 Hz 4 s 4 s 0 4 s 350 s The device uses bipolar pulses and supplies all channels equally d...

Страница 87: ...t training program has the identical parameters like the invigoration basic program The only difference is the length of the program and is therefore not to be regarded as another output mode It is id...

Страница 88: ...eft 12 3 Dynamic forward lunges right 12 4 Dynamic diagonal crunches left 12 5 Dynamic diagonal crunches right 12 6 Dynamic knee compression 12 7 Dynamic body rotation left 12 8 Dynamic body rotation...

Страница 89: ...verse diag onal left 12 3 Dynamic butterfly reverse diag onal right 12 4 Dynamic body rotation left 12 5 Dynamic body rotation right 12 6 Dynamic diagonal crunches left 12 7 Dynamic diagonal crunches...

Страница 90: ...ic forward lunges right 10 4 Dynamic side lunges left 10 5 Dynamic side lunges right 10 6 Dynamic knee compression 13 7 Dynamic diagonal crunches left 10 8 Dynamic diagonal crunches right 10 9 Dynamic...

Страница 91: ...ward lunges left 10 4 Dynamic forward lunges right 10 5 Dynamic side lunges left 10 6 Dynamic side lunges right 10 7 Dynamic diagonal crunches left 10 8 Dynamic diagonal crunches right 10 9 Dynamic cr...

Страница 92: ...ng Always check the program parameters Chapter 11 Over view of programs training plans on page 85 Selecting an incorrect program can result in injuries Safety first Stop a workout immediately if the a...

Страница 93: ...out at 30 40 and 50 for safety reasons Regardless of whether or not the Load level function is enabled an additional cut out is set for all programs and training plans when the device reaches a value...

Страница 94: ...upted unexpectedly during the workout the intensity of the channel drops to 0 and cannot be increased again afterwards The channel is shown in gray on the display The channel intensity can only be inc...

Страница 95: ...creasing light bar indicates the pause An active impulse is indicated by the shining LED knobs of all channels 10 If necessary adjust the pulse strength during the course of the training The pulses st...

Страница 96: ...contact surface 2 If the transponder card is still unformatted you are prompted to format the transponder card Confirm the prompt by selecting YES using the multi function button 3 If the transponder...

Страница 97: ...ice 2 Use the multi function button to select the Card management menu item 3 Place the transponder card on the designated contact sur face and change its settings as needed 4 Use the multi function b...

Страница 98: ...e Each athlete patient has the option of selecting an individual lan guage Once an individual language has been selected a custom ized language will automatically be used for all display texts as soon...

Страница 99: ...nder cards on the devices 2 Select a workout on the master device by pressing the multi function button once If Flexible training is activated the corresponding pro grams or training plans must be sel...

Страница 100: ...Detach the electrodes from the cables one after another 1 L WARNING Risk of injury if detaching the electrodes while the training program is running Make sure that no training program is active To do...

Страница 101: ...aning agents Solvents Chlorides Polishing agents Washing polishing agents Aerosol sprays Observe the cleaning symbols Chapter 2 7 4 Cleaning symbols on page 32 Do not dry clean the electrodes Do not e...

Страница 102: ...eed as follows Personnel n Trainer 1 Wash the i body by hand at a maximum water temperature of 105 F 40 C If a washer with a hand wash setting is available you can also wash the i body in the washer u...

Страница 103: ...e i body the i body straps flex and the i body belts regularly n Clean or replace accessories that are in inadequate hygienic condition 12 2 2 Cleaning the external cables Danger of material damage Di...

Страница 104: ...e The surface can become unsightly and the control unit can even be destroyed Only use a soft lightly moistened cloth for cleaning the foil key board and the case parts Never use abrasives or solvents...

Страница 105: ...o Be Supplied Part 1 General Require ments Fragile handle with care This symbol indicates that the package con tains fragile objects These packages must be transported carefully and protected against...

Страница 106: ...e packaging regularly If necessary renew or replace preserving agents Under certain circumstances storage instructions may be affixed to packages that extend beyond the requirements specified here Com...

Страница 107: ...disposed of via domestic waste The circuit board inside the control unit houses a CMOS battery which is used for storing the device settings when the device is unplugged The following type of battery...

Страница 108: ...e Fig 62 6 n i body i body on page 12 Replace damaged parts immediately with genuine replacement parts of the manufacturer Customer service on page 15 Do not use the device if there are signs of damag...

Страница 109: ...erator is located of all major incidents that occur in connection with the device Proceed as follows to fix the error 1 Remember or write down the error code 2 Switch off the device with the on off sw...

Страница 110: ...cables 103 Compliances 34 Computer viruses 67 Connecting electrodes Opening main menu 57 Contact data 15 Contraindications 18 Control unit Connecting 82 Connections 10 Mounting on the column 83 On of...

Страница 111: ...t 13 i body straps flex 13 Pump spray bottle 14 Transponder card 11 Undergarments 14 Error code in the status line 109 Error display 109 Error messages 109 Essential performance 45 Explanation of symb...

Страница 112: ...Maintenance Checking the mounting screws 108 Having the device checked 108 Sending in the device 108 Manufacturer 34 Medical implants 18 Memory card 34 Menu language Selecting 60 Menus Colors 55 Open...

Страница 113: ...habdomyolysis 18 Rotary switch 9 Symbolic assignment 53 S Scope of delivery 8 Service 15 Setting up a managed device 63 Setting up the master device 63 Settings 83 85 Resetting to factory settings 69...

Страница 114: ...rogramming 95 Selecting language settings for the athletes 98 Setting up synchronized start 97 Training plans 99 Using 97 Transport 106 Transporting the device 106 Tuberculosis 18 Tumor diseases 18 U...

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