Miha BODYTEC II Operating Instructions Manual Download Page 28

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2.7.2 Symbols on the back

Fig. 15: Symbols on the back of the miha bodytec II

Symbol

Standard Reference

Standard Title

Symbol Title

Explanatory Text

ES60601-1:2005/

(R)2012 And A1:2012,

Table D.2, Symbol 2

Medical electrical

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

equipment – Part 1:

General require-

ments for basic

safety and essential

performance.

Type BF applied

part

Identifies a type BF

applied part complying

with IEC 60601-1.

Safety

2021-07-28

miha-bodytec II EMS training device

Summary of Contents for BODYTEC II

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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