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STIWELL med4

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1. Deleting Custom Programs Indications Channel Plateau time seconds Pause time seconds Delay seconds Phases Treatment duration min Frequency Hz Pulse width us phase Rise time seconds Fall time seconds External Trigger Contraction 2 channel 1 User Settings Plateau pause seconds graphical visualization Treatment duration min Frequency Hz Pulse width us Rise and fall time Seconds External Trigger Warm up phase minutes Contraction 2 channel 1 Maximum intensity mA 94 For custom program design Plateau time 1 2 3 19 20 Pause time 1 2 3 19 20 Delay 1 2 3 19 20 10 15 20 25 30 35 40 60 90 120 1 2 3 138 139 140 50 100 150 350 400 0 0 5 1 3 5 4 YES NO 0 1 2 3 4 5 ON OFF 0 100 Indications Channel Plateau time seconds Pause time seconds Delay seconds Phases Treatment duration min Frequency Hz Pulse width us phase Rise time seconds Fall time seconds External Trigger Contraction 2 channel 1 User Settings Plateau pause seconds graphical visualization Treatment duration min Frequency Hz Pulse width us Rise and fall time Seconds External Trigger Warm up phase minutes Contraction 2 channel 1 Maximum intensity mA Program Overview Custom Programs For custom program design Plateau time 1 2 3 19 20 Pause time 1 2 3 19 20 Delay 1 2 3 19 20 10 15 20 25 30 35 40 60 90 1
2. Muscles Wrist Elbow flexors Deltoid Forearm extensors invertors Plateau time seconds 5 Delay seconds 1 Pause seconds 10 Treatment duration min Frequency Hz Pulse width us phase Rise time seconds Fall time seconds Therapy recommendation 2 3 x per day User Settings Treatment duration min 15 20 25 55 60 Frequency Hz 1 5 10 15 135 140 Pulse width us 50 100 150 350 400 Plateau pause seconds Plateau time 1 2 3 19 20 graphical visualization Pause time 1 2 3 19 20 Delay 1 2 3 19 20 Maximum intensity mA 0 100 Electrode Positioning Example 82 Indications Channels Muscles Plateau time seconds Delay seconds Treatment duration min Frequency Hz Pulse width us phase Rise time seconds Fall time seconds Pause after movement pattern seconds Therapy recommendation User Settings Treatment duration min Frequency Hz Pulse width us Plateau pause seconds graphical visualization Maximum intensity mA Program Overview Functional Programs Training movement patterns strength training 1 2 3 4 Wrist Elbow flexors Deltoid Forearm extensors invertors 7 5 0 1 2 3 x per day 15 20 25 55 60 1 5 10 15 135 140 50 100 150 350 400 Plateau time 1 2 3 19 20 Pause time 1 2 3 19 20 Delay 1 2 3 19 20 0 100 Wrist Extensors Channel 1 Ellbow Flexors Channel 2 Deltoideus Channel
3. Power endurance Sound on off WU 02 00 ule Program locked PC connected Time Treatment time pause time Pulse Types Ci 2OCCo Program active FUNCTIONS 9 Changing the treatment duration Changing settings Locking and unlocking the program Starting the program MENU NAVIGATION Use the control dial or the function keys A Y to move up or down select the parameters with Y AY confirm with vv ADDITIONAL DISPLAY SYMBOLS B 4 Confirm character for Save Program or Enter Password Delete character for Save Program or Enter Password Page down for Patient Treatment Data Cancel or go back Switch channels for the feedback programs Coordination Training and Myosymmetry Go back to the treatment overview when using a locked pro gram password required Retrieve patient treatment data only for locked programs There are no electrodes connected to this channel There is an electrode error on this channel EMG signals must be above the arrow Feedback Pro grams EMG signals must be below the arrow Feedback Pro grams Display of the current program phase Treatment duration cannot be set Language Selection Press the On Off key for at least 3 seconds the language selection menu appears Use the function key A Y to select the desired language and con firm with Y Program Selection Display Contrast Volu
4. Training recommendation User Settings Treatment duration min Training level Active pause Volume Feedback tone L Vaginal electrode Anal electrode Surface electrode Stress incontinence urge incontinence 1 2 Medium Active time 60 seconds pause time 0 seconds 5 x per week 2 minutes 2 4 Easy Tense to at least 60 of the calibrated value and relax to below 20 of the calibrated value Medium Tense to at least 70 of the calibrated value and relax to below 20 of the calibrated value Hard Tense to at least 80 of the calibrated value and relax to below 20 of the calibrated value Active time 10 20 30 40 50 60 seconds Pause time 0 0 5 1 29 5 30 seconds 0 100 1 x tone tune J The patient lies on her back relaxed and with the upper body slightly elevated The legs are upright and tilted slightly to the outside It is advisable to support the legs on the sides in order to improve relaxation 74 Program Overview Urology Indications Mixed Incontinence Phases Phase duration seconds Plateau time seconds Pause time seconds Frequency Hz Pulse width us phase Rise time seconds Fall time seconds Number of contractions 63 for 15 minutes of treatment Therapy recommendation 3 x per week 15 minutes User Settings Treatment duration min Number of contractions Maximum intensity mA Otto Bock Healthcare P
5. Serialnumber of the equipment ccc Sticker on the back side of the equipment Oo Bocki DLT Y FOR LIFE tle Bock Healticore Products GmbH Riabersinaie 23 1070 Wien Ausa Model STIWELL med4 Art 9001015 CE PE Designed in Austria CE conformity This product meets the requirements of the 93 42 EWG guidelines for medical products This product has been classified as a class lla product according to the classification criteria outlined in appendix IX of the gui delines The declaration of conformity was therefore created by Otto Bock according to appendix Il of the guidelines Definition of Terms Abbreviations D afinition of YMeETINITION Of Treatment duration Frequency Pulse width Rise time Plateau time Fall time Pause time Pause frequency Number of contractions Warm up phase Phase shift duration Pulse interval Automatic threshold adjustment 118 TAFE Ierms Total duration of the program Number of pulses within one second Length of an individual pulse for one pulse phase Specifies the time during which the current inten sity rises from zero to the established value Follows the rise time and describes the peak amplitude Specifies the time during which the current inten sity falls from the established value to zero No stimulation Specifies the frequency used for stimulation be tween the contractions during the pause time Number of contractions t
6. pt i i j aot f F Knee flexion Mm Ischiocrurales E E Foot flexion i M Triceps surae GS 24 Application Electrode positioning Hip and buttock muscles shoulder girdle muscles F Sideway raising of the arm Tad eM Supraspinatus mm i E Shoulder blade fixation ff Mm Romboidei B t Shoulder exterior rotation M Infraspinatus Shoulder extension M Latissimus dorsi f ff Raising the leg sideways B P E ENET l x PE _ Hip extension and rotation han vo M Glutaeus maximus j F Vee F Ly ala Otto Bock Healthcare Products GmbH Application Electrode positioning Torso muscles rear ia B Back extensor in the cervical vertebrae area F _ Mm Erector spinae cervicis eo Back extensor in the thoracic vertebrae area aa w g Mm Erector spinae thoracis ai HH A 4s Back extensor in the lumbar spine area 5 CA Mm Erector spinae lumborum ij id if H 26 Application Electrode positioning Arm and leg front are Elbow flexion M Biceps brachii Mm Digitores flexores l CF Finger and wrist flexion S Knee extension M Quadriceps femoris Ear F Raising the foot M Tibialis anterior Raising the outside edge of the foot Mm Peronaei Otto Bock Healthcare Products GmbH _ S 7 Muscle Strengthening Denervated Muscles Feedback Programs Feedback Game Display Fe
7. 80 mA Pulse width 2 1 ms 2 250 ms Pulse frequency 0 1 Hz 50 Hz Programs for enervated muscles Output current 100 mA at 1000 Ohm Pulse width 2 50 us 2 500 us Pulse frequency 1 Hz 140 Hz Mid frequency programs Output current 80 mA at 1000 Ohm Base frequency 3 kHz Amplitude modulation frequency 5 70 Hz 114 Appendix Charger Input voltage 90 264 VAC Input frequency 47 63 Hz Max output power 15 1 W Output 12 6 V 1 2 A Electrical safety EN 60950 EN 60601 1 EN 60335 2 29 UL 60601 1 Environmental conditions Operating conditions Operating temperature relative humidity 0 C to 40 C 10 90 Storage and transportation conditions Storage temperature relative humidity 20 C to 70 C 10 90 For the storage of STIWELL med4 accessories please consult the storage and operating conditions specified by the manufacturer Output current via load resistance Lood Rasistance ohm Otto Bock Healthcare Products GmbH Symbols for the sticker The meaning of the labels on the back side of the device is explained below Attention Please follow the instructions in the user manu al gt Type BF applied part gt Pa Do not dispose in household waste see chapter Dis posal Declaration of conformity according to the European Direc C tive for Medical Devices 93 42 EEC with the number of the oa specified authority 0297 SN 2005 32015
8. Hard Tense to at least 80 of the calibrated value and relax to below 20 of the calibrated value Active pause Active time 30 60 120 180 240 300 seconds 15 minutes Pause time 0 0 5 1 29 5 30 seconds The parameter Active Pause makes it possible to pause during the pro gram Parameter example Active time 1 minute pause time 20 seconds After one minute of alternately tensing and relaxing the program pauses for 20 seconds The electrode position illustrated here is an example for the use of 2 EMG channels The goal is to teach the patient to actively tense muscle group 1 channel 1 hand extensors while simultaneously relaxing muscle group 2 channel 3 hand flexors Subsequently muscle group 2 is tensed while muscle group 1 is relaxed Otto Bock Healthcare Products GmbH AA tl i Ny i da dia Ran a VImeuU m i ATJ Wi Y S y re Y i i te L Y 3 2 d For this program the orange EMG channel 1 green EMG channel 2 and white reference electrode electrode cables must be connected After the program is started the display shows two bars that represent the electromyograms of the two muscles Myosymmetry electrodes connected to channel 1 wf 09 51 and channel 3 100 pV 2 Now one of the muscles can be contracted while attempting to follow the resulting bar signal with the muscle of the contralateral affected side The muscle signal level can be adjusted by selecting the respectiv
9. If you want the language selection dialogue to be displayed every time the program starts select Language Selection under Settings The tone can also be deactivated or activated here Player General Balleron m Car Coordnaten training Control ballooncar with the difference of r the two muscle signals Difficulty high Language query after start he Background balloon game light blue car game bght grey Y Saund OFF r Mow player High graphic quality in the games 7 Edit This option has the following system requirements Pentum 1 2 Ghz 25ms response time for TFT flat screens Note Delete player This program is optimized for 16 bit color depth Dotantt valpe Slow TFT fat screen 7 TFT flat screen response time higher 25ms CB Program Overview Feedback PC Games WELL med4 connected to PC and switched on Select desired myo program on STIVVELL med4 and press START on STIVVELL med4 Status bar The status bar displays the current status as well as instructions e g Select the desired myoprogram on the STIWELL stimulation device and press START on the STIWELL stimulation device Otto Bock Healthcare Products GmbH 59 Game Menu Individual settings and configurations are possible for the various games strength activation endurance activation coordination muscle relaxation myosymmetry and EMG triggered stimulation Example Strength Activation ial L
10. be sent to an approved waste disposal facility or in case of doubt returned to the dealer You can help to protect the environment by separating your waste and properly recycling electrical and electronic equipment Proper recycling of electrical and electronic equipment enhances general health and protects the environment Appendix Accessories Self Adhesive Electrodes Item Number 4 self adhesive electrodes round 3 cm 9001S01 3 4 self adhesive electrodes 5x 5 cm 9001S01 5 4 self adhesive electrodes 5 x 9 cm 9001S01 5x9 2 self adhesive electrodes 8 x 13 cm 9001S01 8x13 Le Bay A A Rubber Electrodes Item Number Rubber electrode round 5 5 cm 9001S02 5 5 Rubber electrode round 7 5 cm 9001S02 7 5 Rubber electrodes 5 x 5cm 9001S05 5x5 Rubber electrodes 5 x 10 cm 9001S05 5x 10 Sponge pockets for 5 x 5 cm electrodes 9001S06 5x5 Sponge pockets for 5 x 10 cm electrodes 9001S06 5x 10 A Special Electrodes Item Number Vaginal electrode 9001S03 Anal electrode 9001S04 112 Appendix Other Items Item Number External Trigger 9001M01 Electrode gel for rubber electrodes 9001M02 Carrying clip 9001M03 Strap 30 cm 9001M04 Strap 70 cm 9001M05 Power cable EU version 9001C04 EU Power cable US version 9001C04 US Power cable GB version 9001C04 GB Power cable AUS version 9001C04 AUS S ATTENTION A Proper functionality and safety is only guaranteed with accessories recommended by the manufacturer The manufac
11. 3 Forearm Pronators Channel 4 t 5 Otto Bock Healthcare Products GmbH 83 Program Overview Functional Programs Arm extension support Indications Training movement patterns strength training Channels 1 2 3 Muscles Wrist extensors Elbow extensors Spinal section of the deltoid Plateau time seconds 4 Delay seconds 0 2 Pause seconds 10 Treatment duration min Frequency Hz Pulse width phase Rise time seconds Fall time Seconds Therapy recommendation 2 3 x per day User Settings Treatment duration min 15 20 25 55 60 Frequency Hz 1 5 10 15 135 140 Pulse width us 50 100 150 350 400 Plateau pause seconds Plateau time 1 2 3 19 20 graphical visualization Pause time 1 2 3 19 20 Delay 1 2 3 19 20 Maximum intensity mA 0 100 Electrode Positioning Example 84 Program Overview Functional Programs Indications Training movement patterns strength training Channels 1 2 3 Muscles Wrist extensors Elbow extensors Spinal section of the deltoid Plateau time seconds 4 Delay seconds 0 2 Treatment duration min Frequency Hz Pulse width phase Rise time seconds Fall time Seconds Pause after movement pattern seconds Therapy recommendation 2 3 x per day User Settings Treatment duration min 15 20 25 55 60 Frequency Hz 1 5 10 15 135 140 Pulse width us 50 100 150 350 400 Plateau pause seconds Plateau tim
12. NOTE The unlocked program and the treatment data are deleted if you switch to the treatment overview after the unlocking process If a program with modified parameters will be used frequently it is useful to save it first see page 16 Retrieving Treatment Data The compliance data can be retrieved in the main menu under b lt 1 Press the function key gt to go to the detailed overview STATISTICS Atrophy Power endurance 2 Sessions Session Duration 60 min 2 Detail view Press the function key gt to page down Press X to return to the locked program 30 Min 2006 01 03 10 30 10 20 50 100 mA 30 Min 2006 01 02 10 30 10 20 50 100 mA Saving a program In the settings menu c select Save Program and press V Subsequently the Name Input window is displayed automatically Select a letter from the list using the control dial and confirm with the function key Letters can be deleted with the function key ag Select using Wheel JA B c DIE FIG H I J K L m IR S T U v w x y z 0 INJO P Q il2iata sje 7jsio The program is saved under Saved Programs with the selected name by pressing the V key If no name is entered the program name e g Program 1 suggested on the bottom line of the menu Is used automatically In order to avoid accidentally overwriting a previously saved program the question Overwrite program has to be confirmed with th
13. STIWELL med4 begins the day it is pur chased ND Cleaning Storage and Disposal Cleaning To clean the STIWELL med4 and the accessories use a slightly damp not wet soft cloth Always disconnect the charger from the outlet before cleaning it The following disinfectants are allowed isopropanol based disinfectants or strongly diluted bases Never immerse the STIWELL med4 or the accessories in water or other liquids The flexible straps and sponge pockets constitute the only exception and can be cleaned with mild soap and water maximum temperature 30 C To clean the vaginal and anal electrodes please follow the manufacturer s directions Storage The stimulation device and accessories should be stored in the case The case is designed so that the cables can remain connected to the device This protects the cables and the connectors If the STIWELL med4 will not be used for an extended period of time several months the device should be operated briefly every 2 3 months If the flashing battery symbol mar appears on the display the battery must be charged prior to further storage otherwise the battery life may be affected Disposal The STIWELL med4 stimulation device meets the requirements of guideline 2005 96 EG used electric and electronic devices WEEE The WEEE symbol on the product or in this user manual indicates that this product must not be disposed of with regular household waste The device must
14. muscle training and for muscle regeneration Introduction Contraindications Patients with pacemakers or other electronic emitters No stimulation in the proximity of metal implants Pregnancy Feverish or infectious diseases Skin disorders subject to inflammation or tumors in the stimulation area as well as thrombosis or phlebitis No transcerebral or transthoracic applications risk of heart rhythm disturbances No stimulation in the vicinity of the carotid artery or carotid gland No stimulation of the stomach muscles in case of abdominal wall or groin hernias No contralateral stimulation i e plus and minus pole of the same channel on opposite sides of the body Contraindications for the urological programs Patients with extra urethral incontinence fistula ectopic urethra Patients with overflow incontinence caused by evacuation disorders Patients with serious urine retention in the upper urethra Pregnancy Patients with total peripheral denervation of the pelvic floor Patients with intestinal clamps NOTE regarding the therapy recommendations in Chapter 2 The therapy times listed are recommendations and may deviate from the therapy times specified by your physician or therapist Please follow the instructions provided by your physician and therapist Otto Bock Healthcare Products GmbH Introduction Scope of Delivery Therapy base package in case Stimulation device as single device Charger Po
15. of 0 C to 40 C Higher or lower ambient temperatures can cause the stimulation device to malfunction or fail The device is intended for use in enclosed areas When using the device in conjunction with life support systems utmost caution is required it is possible that life support systems may be affected Please ensure that the electrodes are applied correctly see Program Description and Electrode Positioning and that the stimulation intensity is regulated properly Always keep the stimulation device out of reach of children Strong sources of electromagnetic radiation and high voltage for example television and radio transmitters mobile telephones metal detectors and conventional alarm systems in the direct vicinity of the STIWELL med4 stimulation device can affect the device especially the EMG measurements Proper functionality and safety is only guaranteed with accessories recommended by the manufacturer see accessory list Only vaginal and anal electrodes intended for electrostimulation and recommended by the manufacturer can be used with the electrostimulation device Worn electrodes can result in increased current densities therefore the condition of the electrodes should be checked before they are applied The stimulation device may only be opened and or repaired by service centers authorized by the manufacturer Appendix APPENDIX Troubleshooting and Maintenance Anyone who attempts
16. on the Rear Explanation of Terms Abbreviations 98 100 105 108 108 109 110 111 112 114 116 117 118 INTRODUCTION Intended Use The STIWELL med4 stimulation device is intended for the stimulation of muscles and nerves by using electric pulses in order to strengthen muscles promote circulation regenerate and relax muscles treat pain and help to reestablish movement patterns Physicians physiotherapists ergotherapists logopedicians sports scientists and patients use the STIWELL med4 in the following application areas Neu rology physical medicine and rehabilitation accident surgery orthopedics urology pain therapy dermatology general medicine sports medicine and sports training Symptom oriented biofeedback training enables playful training of central in nervation capacity maximum strength muscular endurance muscle relaxation and inter muscular coordination possible depending on the neurological symp toms EMG triggered electromyogram triggered stimulation is a combination of stimulation and biofeedback training The STIWELL med4 is intended for stationary use in a hospital as well as home use by the patient The physician therapist has the flexibility to adjust the programs and monitors the progress of the therapy Statistics regarding the completed treatments can be retrieved from the STIWELL med4 and from the PC Athletes can use neuromuscular electrostimulation to gain strength and muscular e
17. per day 10 15 20 25 30 35 40 0 1 0 2 0 5 1 250 Triangular rectangular trapezoidal 0 80 ATTENTION For this program using rubber electrodes with a sufficient amount of electrode gel is essential See pages 19 21 for application instructions NOTE By pressing any function key you can go directly to the settings menu and change the intensity for all channels To resume the program press the STOP rewind key 36 Program Overview Feedback Programs Feedback Programs Introduction Symptom oriented biofeedback train ing with cognitive re learning effects is an efficient type of therapy which supplements the therapeutic treat ment of neurological damage and can be used by the patient as controlled home therapy Depending on the neurological symptoms maximum strength muscular endurance intermuscular coordination and muscle relaxation can be trained The use of visual and audio feedback makes it possible for the patient to consciously recognize muscle tension and modulate the same ATTENTION The Myofeedback Applications should only be used after a neurological diagnosis with a precise neuro rehabilitative functional analysis and the specified therapy recommendations must be arranged with the treating physician Indications Disorders or injuries of the central nervous system for example spasticity or paresis after a stroke head brain trauma multiple sclerosis only after recommen
18. screen by clicking the Edit button next to the last name Make the required changes and then close the window by clicking the OK button If you want to create a new record for the patient search for the patient as described above and then open the patient data input screen Now change the record number The old values in the fields Date and Diagnosis Notes and the channel assignment are deleted and can be reentered Close the window by clicking the OK button 103 Protection of Data Privacy The first time the program is launched you are prompted to change the default password Leonardo Subsequently you can use the patient administration software Leonardo normally If you do not enter any data or move the mouse for more than 60 minutes default setting password protection is activated automatically In order to continue working you have to reenter the password you selected The length of time before password protection is activated automatically can be individually set under the menu item Extras User Management If you have forgotten your password back up the database and uninstall the program After reinstalling the program you will once again be able to access the database administrator rights are required Language The language set in the operating system is automatically used for the Leonardo user interface Should you wish to use a different language th
19. select External Trigger YES 3 Set the intensity as described on page 12 Electrode Array Attaching the electrodes correctly is vital for effective and safe treatment The electrode attachment points are determined by the physician or therapist The electrode size is selected according to the size of the muscle groups being stimulated When stimulating enervated muscles the electrodes should be attached in the vicinity of the motor points nerve muscle transition When stimulating denerved muscles the electrodes should be attached on a large area over the muscle Rubber electrodes with electrode gel can be attached with flexible straps or skin friendly adhesive bandages Do not leave the electrodes in the alcohol under any circumstances When using sponge pockets they must be slightly moistened with clean water prior to use The matching rubber electrodes are placed into the sponge pockets and attached with flexible straps Important Depending on the application the sponge pockets must be thoroughly washed with clean water ATTENTION The sponge pockets and corresponding rubber electrodes should definitely be used with the program Minor Atrophy With self adhesive electrodes the protective foil must first be removed in order to expose the adhesive layer Subsequently the electrode can be placed on the skin When using vaginal or anal electrodes follow the manufacturer s directions onnecting the
20. to record at least the last name of the patient After the treatment has been completed you can retrieve the data from the stimulation device The values are automatically assigned to the correct patient and are available for evaluation purposes Use the Details button to view the evaluation on the screen You also have the option of printing the values for documentation purposes e g for health insurance companies If you would like to supplement the recorded information an export function to Microsoft Word is also available EJ Patient Statistics User 1 Patient No fi Program Date Duration Intensity per Channel Atrophy Power endurance 06 06 2007 00 20 00 10 20 30 40 m Atrophy Power endurance 07 06 2007 00 20 00 20 15 20 15 m Circulation improvement 06 06 2007 00 10 00 20 20 20 20 m EMG triggered 1 EMG 08 06 2007 00 30 00 10 20 10 30 m Otto Bock Healthcare Products GmbH _ 101 Leonardo ew Patient Creating lt The following input screen is used to record patient information eq Patient Data Last Name First Name p Nn a Patient No Gender Male C Female Ins No Birthday o1 01 1960 Soc Insurance Agency Address Phone Number Country ZIP city AD E Mail Address Admission Number Diagnosis Remarks Date of Admission 06 06 2007 cone To open this screen either click the Edit button in an empty patient infor
21. too low Defective battery Send the device to an authorized service center for battery replace ment The EMG signal cannot 1 Main cable is not con Connect the main cable and refer be controlled nected properly ence cable properly 2 Reference cable is not con nected properly 108 Appendix Pulse Types The stimulation pulses of the STIWELL med4 are dual phase and direct current compensated Depending on the program constant current or constant voltage rectangular triangular or trapezoidal pulses can be selected For mid frequency programs the base frequency is 3 kHz rectangular The modulation frequency can be varied from 5 70 Hz Enervation programs i Rectangular pulse Denervation programs i Rectangular pulse ui ii e Triangular pulse T i Trapezoidal pulse Mid frequency i i Bees i Otto Bock Healthcare Products GmbH _ 1009 Warranty Our warranty periods follow legal regulations for warranty claims The STIWELL med4 stimulation device is warranted for two years unless legal regulations re quire a different warranty period The warranty period applies solely to defects of the STIWELL med4 stimulation device damage to the product caused by misuse or improper use of the accessories is excluded Opening the housing of the STIWELL med4 voids the warranty The electrode cables and wear parts are subject to natural wear during proper use for the intended purpose The warranty period for the
22. with and or with EMG t d 1 EMG the control dial and confirm with VW riggered Modifying the trigger threshold allows Ww l you to switch to the next higher or lower Sale aaa level of detail on the display W a Set the intensity using the control dial and confirm with STOP EMG triggered 1 EMG Nf After adjustment continue with lt W gt 4 The program now starts automatically The patient should tense as soon as the EMG triggered 1 EMG green LED is illuminated Try to reach the arrow by tensing the muscle Once NAN the arrow is reached stimulation takes Becoming arrow v place and the LED turns orange _ Hg e 44 Indications EMG channels Treatment goal Treatment duration min Frequency Hz Pulse width us Rise time seconds Plateau time seconds Pause time seconds Fall time seconds Automatic threshold adjustment Training recommendation User Settings Threshold threshold Treatment duration min Frequency Hz Pulse width us Rise time fall time seconds Plateau time seconds Pause time seconds Automatic threshold adjustment Volume Feedback tone Maximum intensity mA Program Overview Feedback Programs Muscular atrophy disorders injury of the central nervous system peripheral nerve lesions capab le of regeneration neuro orthopedic functional disorders 1 Coupling voluntary muscle innervation with EMG trig gered sti
23. 0 Promoting Circulation 300 Several times daily 50 100 150 350 400 0 100 33 Denervated Muscles Introduction In case of denerved muscles no stimulation is possible via the dam aged peripheral nerve The pre pro grammed automatic processes of the STIWELL med4 programs are based on a training session with natural muscle activity Triangular pulses are used to treat peripheral paralysis because they are able to stimulate peripherally paralyzed muscles with simultaneous minor stimulation of the sensitive nerve fibers of the surrounding tissue Medical Indications The variety of pulse width settings 1 250 ms also makes tetanic stimulation for the treatment of atrophy possible Alternatively trapezoidal pulses can also be used Rectangular pulses can also be used for the treatment of peripheral paralysis They represent the more effective type of current for the treatment of atrophy but cause significantly more pain Therefore this type of treatment Is only rec ommended for patients with reduced sensitivity Therapy Recommendation It is strongly recommended to use these programs only under professional supervision Training should take place several times a day under considera tion of the patient s resilience The intensity should be set so that the muscle contractions are as strong as possible without causing pain It is important to ensure that the therapy does not cause skin irritatio
24. 1 Calibration tense and relax the muscle according to the display Coordination Trainin takes place after pressing Gita 3 10 00 2 As soon as the green LED is illuminated the patient should try to reach the Coordination Training arrow by tensing muscle 1 right half Yy of the bar Reach the arrow NOTE Relax muscle 2 during this phase Then follow the arrow back to a relaxed position Repeat the same process with muscle 2 left half of the bar NOTE Relax muscle 1 during this phase The position of the arrow can be modified with and or with the control dial The muscles can be switched by pressing function key 3 52 Program Overview Feedback Programs Indications Training tonic muscle control neuro orthopedic coordination deficits muscular atrophy disorders injuries of the central nervous system peripheral nerve lesions muscle strength deficits EMG channels 2 Treatment goal The focus of training is coordination muscle tension and muscle relaxation Training level Easy Medium Hard Treatment duration min 7 10 15 Training recommenda 1 x per day tion User Settings Threshold threshold Increase decrease the threshold values Set while training Training level Easy Tense to at least 60 of the calibrated value and relax to below 20 of the calibrated value Medium Tense to at least 70 of the calibrated value and relax to below 20 of the calibrated value
25. 20 1 2 3 138 139 140 50 100 150 350 400 0 0 5 1 3 5 4 YES NO 0 1 2 3 4 5 ON OFF 0 100 Otto Bock Healthcare Products GmbH 95 Program Overview Custom Programs Indications Channel Plateau time seconds Pause time seconds Delay seconds Pulse width us phase Rise time seconds Fall time Seconds Phases Phase duration minutes Frequency Hz Contraction 2 channel 1 User Settings Plateau pause seconds graphical visualization Treatment duration min Frequency Hz Pulse width us Rise and fall time Seconds Warm up phase minutes Contraction 2 channel 1 Maximum intensity mA 96 For custom program design 2 21 2 10 30 10 OFF Plateau time 1 2 3 19 20 Pause time 1 2 3 19 20 Delay 1 2 3 19 20 10 15 20 25 30 35 40 60 90 120 1 2 3 138 139 140 50 100 150 350 400 0 0 5 3 3 5 4 0 1 2 3 4 5 ON OFF 0 100 Plateau Pause Setting 1 The Plateau Pause times can be modified under settings ome 2 Pressing the V key displays a graphic that represent the 4 stimulation channels starting with channel 1 Go Use the function A and Y to select the stimulation and delay times you want to modify 4 Change the time using the control dial 5 The pause time can only be modified for channel 1 the pause times for channel 2 4 are adjusted automatically 6 Press YW to return to the settings menu Setting a Second Contraction for Chan
26. 31 Program Overview Muscle Development Indications Muscle development training in case of atrophy for agonist antagonist Phases Channel Phase shift duration seconds Phase duration minutes Frequency Hz Pulse width us phase Rise time seconds Plateau time seconds Pause time seconds 16 Number of contractions 22 33 44 Fall time seconds 1 Therapy recommendation 1x daily User Settings Treatment duration min 30 40 50 Pulse width us 50 100 150 350 400 Warm up phase YES NO Maximum intensity mA 0 100 Electrode Positioning Example The illustration shows bipolar stimulation of two muscle groups with a total of four electrodes The flexor agonist and extensor antagonist can be alternately stimulated 32 Indications Phases Phase duration minutes Frequency Hz Pulse width us phase Rise time seconds Plateau time seconds Pause time seconds Pause frequency Hz Number of contractions Fall time seconds Therapy recommendation User Settings Pulse width us Warm up phase Maximum intensity mA Indications Phases Treatment duration min Frequency Hz Pulse width us phase Therapy recommendation User Settings Pulse width us Maximum intensity mA Otto Bock Healthcare Products GmbH Program Overview Muscle Development Muscle Development Training Maximum Strength Training 3 x per week 50 100 150 350 400 YES NO 0 10
27. Electrodes and Cables To connect the electrode cables the main cable is connected to receptacle A of the device Ensure that the label A on the cable matches the label A on the device Depending on the number of channels used the individual electrode cables are connected to the receptacles with the same color on the electrode connector The symbol ASindicates that no electrodes are connected to that channel One electrode is attached to the positive pole red plug and one to the negative pole black plug of each cable ATTENTION When connecting and disconnecting the electrode cables always grasp them by the plug never by the cord Electrode Durability e The durability of the electrodes is affected by several factors Including skin type frequency of use type of stimulation and storage play a role e The conductivity of the electrodes begins to diminish once they have been used repeatedly If contact with the electrodes is unpleasant a tingling feeling develops or the symbol appears frequently on the display the electrodes may be worn out e Depending on the design self adhesive electrodes can be used for ap proximately 10 30 applications carefully moistening the contact surface with water increases the conductivity and lifespan Self adhesive electrodes are designed for single patient use only Self adhesive electrodes should be placed back onto the protective foil after use e Follow the manufact
28. Fast abrupt movements should be avoided Completing several stimulation sessions in quick succession can cause metabolic disturbances in the patient and should therefore be avoided The stimulation of a single muscle can affect the patient s coordination since the respective antagonist is not stimulated Patients with a total partial prolapse of the uterus vagina must be stimulated with extreme caution applies to urological programs For patients with urethritis the disease must be treated before commencing electrostimulation with the urological programs of the electrostimulation device Parameter settings for amplitude frequency treatment duration etc outside the suggested limits for the respective programs can lead to skin irritation and or minor muscle damage and therefore require increased attentiveness Safety Instructions Product Specific Before operating the device ensure that all exterior components are intact and undamaged Handle the device carefully and use it solely for the intended purpose The stimulation device and the accessories must not be immersed in water or other liquids under any circumstances Follow the instructions for care and maintenance The device must not be stored or operated close to sources of radioactive radiation or X rays The stimulation device must not be exposed to direct solar radiation or sources of heat The device is designed to be operated at an ambient temperature
29. OPS iF Fs irs FS m FE er m F _ a REE AL LE eMo a Return to main menu first exit the game on the stimulation device Number of cars balloons on top of each other E Number of cars balloons below each other Number consecutive of cars balloons Number of cars balloons next to each other vertical coordination Level of difficulty for endurance activation Speed level at speed O a still picture is displayed L Switch between vertical horizontal orientation el Start from the left right side of the screen cy a Change the position of the cloud ao Change the position of the gas can The upper menu bar is used to display the following Program name and user Z 08 56 Remaining game time io Number of points earned Number of accidents 60 Program Overview Feedback PC Games For this program the orange EMG channel 1 and white reference electrode electrode cables must be connected ame The player has to raise the balloon above the threshold value bar using muscle strength in order to trigger stimulation The game is launched after calibration and after the thresh old value and intensity have been set see page 42 Muscle tension is displayed in the range of O 100 EHH EEFEEETEEET OSdUnent goq A i Amplifying a voluntary weak muscle contraction through EMG triggered stimu lation which leads to a visible noticeable muscle contraction muscle move ment Indic
30. Overview Sports 5 a Mir PS 7 Ate N e j Circulation improvement Indications To promote circulation Phases Treatment duration min Frequency Hz Pulse width us 300 Therapy recommendation Warm up training before sports exertion User Settings Pulse width us 50 100 150 350 400 Maximum intensity mA 0 100 Stimulation program Indications Warm up training and regeneration training Phases Phase duration minutes Frequency Hz Pulse width us Therapy recommendation Before in between and after training User Settings Pulse width us 50 100 150 350 400 Maximum intensity mA 0 100 Otto Bock Healthcare Products GmbH 91 Program Overview Mid Frequency Mid Frequency Introduction These programs are used for mus cle development a maximum of two muscle groups can be stimulated si multaneously MF 3 kHZ EMG triggered offers the additional option of EMG triggered stimulation The programs are suitable for the following indications e Muscular atrophy e Disorders or injuries of the central nervous system e Peripheral nerve lesions capable of regeneration e Neuro orthopedic functional disorders MF 3 kHz Indications Muscular atrophy disorders injury of the central nervous system peripheral nerve lesions capable of regeneration neuro orthopedic functional disorders Phases Treatment duration min Frequency kHz Modulation frequency Hz Ris
31. Wo Bock QUALITY FOR LIFE 3 oll cTANELL megi STIWELL med4 User Manual 0297 Otto Bock Healthcare Products GmbH 647G377 GB 07 07 50 Printed in Germany Table of Contents TABLE OF CONTENTS INTRODUCTION Intended Use Indications and Contraindications Scope of Delivery Product Description O N OD O Q Connecting the Stimulation Device to the PC te APPLICATION 9 Instructions for Use 9 Display Symbols 9 Language Selection 11 Program Selection Display Contrast Volume and Settings 11 Launching the Program and Setting the Intensity 12 Storing the Intensity 12 Changing the Treatment Duration 13 Changing Settings 13 Locking Program s for the Patient 14 Retrieving Treatment Data 15 Saving and Deleting Custom Programs 16 Overview for Therapeutic Use 17 Charging the Battery 18 Electrode Array 19 Pa PROGRAM OVERVIEW 28 Muscle Development 30 Denervated Muscles 34 Feedback Programs 37 Feedback Display Games 56 Feedback PC Games 57 Pain Therapy 68 Urology 70 Functional Programs 77 Sports 86 Mid Frequency 92 Custom Programs 94 Otto Bock Healthcare Products GmbH _ S Od Table of Contents ES PC SOFTWARE INSTALLATION MYOGAMES AND LEONARDO Patient Administration Software Leonardo 4 WARNINGS AND SAFETY INSTRUCTIONS 5 APPENDIX Troubleshooting and Maintenance Pulse Types Warranty Cleaning Storage and Disposal Accessories Technical Data Symbols Labels
32. am the orange EMG channel 1 and white reference electrode electrode cables must be connected Calibration tense and relax the muscle according to the display takes place after pressing GZ 10 00 2 As soon as the green LED is illumi nated the patient is prompted by the arrow to successively relax the muscle Relaxation training As soon as the EMG signal reaches W 09 49 the arrow it shifts further to the left AGEL oh arrow as a prompt to relax the muscle even 200 300 more The position of the arrow can be modified with and or with the control dial 50 Indications EMG channels Treatment goal Training level Treatment duration min Training recommendation User Settings Threshold threshold Set while training Volume Feedback tone Training level Program Overview Feedback Programs Excessive muscle tonus spastic paresis neuro orthopedic tension syndromes e g tension headaches vertebral pain syndromes 1 The focus of training is muscle relaxation Easy Medium Hard 7 10 15 Several times daily Increase decrease the threshold values 0 100 1 x tone tune Easy medium hard Electrode Positioning Example Otto Bock Healthcare Products GmbH ee E L ama Tu an a a m m F e AA Ari Ta FAILA ILA A oordination raining For this program the orange EMG channel 1 green EMG channel 2 and white reference electrode electrode cables must be connected
33. ations Muscular atrophy disorders injury of the central nervous system peripheral nerve lesions capable of regeneration neuro orthopedic functional disorders EMG channels 1 Treatment duration min 20 Frequency Hz Pulse width us Rise time seconds Plateau time seconds Pause time seconds Fall time seconds 35 0 5 3 6 0 5 Automatic threshold adjustment NO Training recommendation 2 3 x per day and muscle group User Settings Adjustment Height of the bar can also be set during play by using the control dial 15 20 30 40 50 1 5 10 15 135 140 50 100 150 350 400 1 2 3 19 20 0 0 5 1 2 5 3 2 3 4 39 40 YES NO Treatment duration min Frequency Hz Pulse width us Plateau time seconds Rise time fall time seconds Pause time seconds Automatic threshold adjustment Maximum intensity mA 0 100 Otto Bock Healthcare Products GmbH 61 Program Overview Feedback PC Games For this program the orange EMG channel 1 green EMG channel 2 and white reference electrode electrode cables must be connected The smaller balloon visualizes the muscle signal of the 2nd EMG channel In order to trigger stimulation the player has to use the muscle strength of the 1st EMG channel to raise the balloon above the threshold value bar and simultaneously keep the muscle signal of the 2nd EMG channel low The game is launched after calibration and after the threshold value and in
34. axation Treatment duration min 10 Feedback tone Tune Training recommendation 2 3 x per day User Settings Reduce speed Increase speed Increase number of cars to pass Decrease number of cars to pass Treatment duration min 10 20 30 Number of cars 1 6 Volume 0 100 56 Feedback Games PC Program Description The myofeedback software is used for symptom oriented biofeedback training on the PC The program is selected on the STIWELL stimulation device The parameters for the game game speed difficulty level are set and saved directly on the PC using the mouse Quick Reference Guide 1 Connect the STIWELL stimulation device to the PC USB cable and switch on the stimulation device see page 8 2 Select the PC user name or enter a new user on the PC in the Settings Menu 3 Select the desired Feedback Program on the STIWELL stimulation device press GG and carry out the calibration process for EMG triggered programs also set the Threshold and Intensity The PC program is launched automatically 1 DFA LJJa Eli m aaa El t ia O EO Bock Healthcare Products GmbH Program Overview Feedback PC Games NOTE The balloon game is launched by default The type of game can be selected on the PC Settings For EMG triggered stimulation the height of the threshold can be set with the control dial on the STIWELL stimulation device
35. ble For calibration refer to page 40 The game is launched after calibration recording the current level of muscle tension is complete Muscle tension is displayed in the range of O 100 Treatment goal The focus of training is muscle contraction maximum strength and quick muscle relaxation iit Cora sta Fs fies Fe Efe DPS Hri PFs ia ia Ig ay O Be ee cl Ee ee l Indications Muscular atrophy disorders injuries of the central nervous system peripheral nerve lesions capable of regeneration EMG channels 1 Treatment duration min 20 Training recommendation 1 2 x per day and muscle group User Settings Adjustment Balloons cars on top of each other Consecutive balloon cars Speed Position of the cloud gas can Horizontal vertical Start position left right Type of game Balloon car Otto Bock Healthcare Products GmbH 63 Program Overview Feedback PC Games Endurance training For this program the orange EMG channel 1 and white reference electrode electrode cables must be connected Game The player has to avoid the balloons cars by relaxing and tensing For calibration refer to page 40 The game is launched after calibration recording the current level of muscle tension is complete Muscle tension is displayed in the range of O 100 Treatment goal The focus of training is to increase muscular endurance and improve coordi na
36. conds Plateau time 1 2 3 19 20 graphical visualization Pause time 1 2 3 19 20 Delay 1 2 3 19 20 Maximum intensity mA 0 100 Electrode Positioning Example 78 Indications Channels Muscles Plateau time seconds Delay seconds Treatment duration min Frequency Hz Pulse width us phase Rise time seconds Fall time seconds Pause after movement pattern seconds Therapy recommendation User Settings Treatment duration min Frequency Hz Pulse width us Plateau pause seconds graphical visualization Maximum intensity mA Program Overview Functional Programs Training movement patterns strength training 1 2 3 Wrist extensor Finger flexors Thumb flexor 10 7 4 0 3 6 20 35 2 3 x per day 15 20 25 55 60 1 5 10 15 135 140 50 100 150 350 400 Plateau time 1 2 3 19 20 Pause time 1 2 3 19 20 Delay 1 2 3 19 20 0 100 Wrist Extensors Channel 1 Finger Flexors Channel 2 Thumb Flexor Channel 3 7 11 12 t s Otto Bock Healthcare Products GmbH 79 Program Overview Functional Programs Open and close Indications Training movement patterns strength training Channels 1 2 3 Muscles Thumb and finger Finger flexors Thumb flexor joint extensors Plateau time seconds 6 8 Delay seconds 0 8 Pause seconds 20 10 Treatment duration min 20 Frequency Hz Pulse width us phase Rise time seconds Fall tim
37. dation by a physician Disorders or injuries of the spinal cord for example incomplete paraple gia Peripheral nerve lesions capable of regeneration Neuro orthopedic functional disorders Treatment Goals Reduced spasticity Increased voluntary contractions Functional improvement of the paretic extremity facilitation of physiologi cal movement patterns Stimulation of central plasticity Otto Bock Healthcare Products GmbH _ 857 Therapy Recommendation Muscle contraction unaffected side If the patient is not yet able to generate muscle potentials on the affected side it is recommended to explain the therapy to the patient using the unaffected side Muscle development affected side In addition it may be helpful to stimulate the muscles with a muscle development program in order to make it clear to the patient Sensation and motor feedback which muscle groups should be activated in a targeted manner in the following therapy sessions Muscle contraction affected side Once the patient has learned to target the correct muscles he or she should attempt to increase EMG activity through repetitive training The display games or PC programs should be used to increase motivation where possible When exercises are carried out in comparison between the healthy and the affected side using the Myosymmetry program is recommended EMG triggered 1 channel Once muscular control has been reestablished to the extent
38. e 1 2 3 19 20 graphical visualization Pause time 1 2 3 19 20 Delay 1 2 3 19 20 Maximum intensity mA 0 100 Wrist Extensors Channel 1 Elbow Extensors Channel 2 Spinal Part of the Deltoideus Channel 3 Otto Bock Healthcare Products GmbH 85 Sports Introduction The sports programs for the STIWELL med4 were designed in consideration of training principles The following programs are available e Endurance e Strength e Power e Bodybuilding e Regeneration e Promoting Circulation Sports Training The STIWELL med4 program cycle is structured like physiological training It starts with a warm up phase and then initiates muscle training with gradually increasing contractions Just as with normal training contractions alternate with pauses there is a warm down phase at the end to obtain an optimal result without sore muscles This stimulation pattern promotes an aerobic muscular metabolism 86 Indications Phases Phase duration minutes Frequency Hz Rise time seconds Plateau time seconds Pause time seconds Pause frequency Hz Number of contractions Fall time seconds Pulse width us Therapy recommendation User Settings Treatment duration min Pulse width us Maximum intensity mA Indications Phases Phase duration minutes Frequency Hz Rise time seconds Plateau time seconds Pause time seco
39. e noticeable muscle contractions muscle movements 30 35 0 5 3 6 0 5 NO 2 3 x per day and muscle group Increase decrease the threshold values 15 20 25 55 60 1 5 10 15 135 140 50 100 150 350 400 0 0 5 1 2 5 3 1 2 3 19 20 2 3 4 39 40 YES NO 0 100 The electrode position illustrated here is an example that shows how two separate EMG channels chan nel 1 M deltoideus channel 2 M trapezius pars descendens can activate the target muscles upper arm abductors in isolation and simultaneously prevent evasive movements elevation in the shoulder girdle The goal is to teach the patient how to improve the functionality of glenohumeral abduction without elevat ing the shoulder As a reward the M deltoideus is simulated afer the mage threshold is reached Otto Bock Healthcare Products GmbH 47 For this program the orange EMG channel 1 and white reference electrode electrode cables must be connected Calibration tense and relax the muscle according to the display takes place after pressing GiGi 10 00 2 As soon as the green LED is illuminated the patient should try to reach the arrow by tensing the muscle Then follow the arrow back to a relaxed position The Ww a sid Reach the arrow position of the arrow can be modified with and or with the control dial l 300 48 Program Overview Feedback Programs Indications Muscular atrophy di
40. e seconds Therapy recommendation 2 3 x per day User Settings Treatment duration min 15 20 25 55 60 Frequency Hz 1 5 10 15 135 140 Pulse width us 50 100 150 350 400 Plateau pause seconds Plateau time 1 2 3 19 20 graphical visualization Pause time 1 2 3 19 20 Delay 1 2 3 19 20 Maximum intensity mA 0 100 Electrode Positioning Example 80 Indications Channels Muscles Plateau time seconds Delay seconds Treatment duration min Frequency Hz Pulse width phase Rise time seconds Fall time seconds Pause after movement pattern seconds Therapy recommendation User Settings Treatment duration min Frequency Hz Pulse width us Plateau pause seconds graphical visualization Maximum intensity mA Program Overview Functional Programs Training movement patterns strength training 1 2 3 Thumb and finger joint extensors 6 8 0 8 20 35 Finger flexors Thumb flexor 2 3 x per day 15 20 25 55 60 1 5 10 15 135 140 50 100 150 350 400 Plateau time 1 2 3 19 20 Pause time 1 2 3 19 20 Delay 1 2 3 19 20 0 100 Thumb and Finger Extensors Channel 1 Finger Flexors Channel 2 Thumb Flexor Channel 3 7 8 9 1011 17 18 t s Otto Bock Healthcare Products GmbH 81 Program Overview Functional Programs Hand to Mouth Indications Training movement patterns strength training Channels 1 2 3 4
41. e W key The function key X prevents overwriting and cancels the process of saving the program Deleting Saved Programs The NA program can be removed under settings Delete Program If you press V the program is deleted and you return to the treatment overview If you press X the program is not deleted and you return to the treatment overview 16 1 Delete Program Overview for Therapeutic Use Follow the steps below in the sequence they are presented 1 Attach the electrodes and connect the cables Switch on the stimulation device and select the program Modify settings if required Save the program if required Launch the program and set the intensity Lock the program se oO eS SP Launch the program again Activating and Deactivating the Access Lock When the stimulation device is turned off after locking a program the access lock is activated this means that after the device is restarted only the locked programs can be selected from the program overview and parameters can only be changed after entering a password Password protection can be deactivated see page 11 Locking Additional Programs By pressing the symbol additional programs can be selected from the treatment overview and locked after entering a password Thus any programs that are already locked do not have to be unlocked and the settings and or treatment data are not lost Unlocking a Program Select the program you want to unl
42. e channel with function key 1 or 3 and subsequently changing the amplification using the control dial NOTE The measurement range must be selected so that the current EMG value is in the range of 50 90 of the maximum display value 54 Indications EMG channels Treatment goal Treatment duration min Training recommendation User Settings Measurement range Program Overview Feedback Programs Training tonic muscle control neuro orthopedic coordination de ficits muscular atrophy disorders injuries of the central nervous system peripheral nerve lesions 2 The focus of training is muscular endurance and coordination 10 Individually determined by the therapist Electrode Positioning Example Otto Bock Healthcare Products GmbH 55 Program Overview Feedback Display Games Feedback Game Display as oe For this program the orange EMG channel 1 and white reference electrode electrode cables must be connected Calibration Tense and relax the muscle according to the display Game The player has to avoid the cars by tensing the muscle and then reach the gas can by relaxing as quickly as possible Press the STOP rewind key to return to the start menu Indications Muscular atrophy disorders injuries of the central nervous system peripheral nerve lesions capable of regeneration EMG channels 1 Treatment goal The focus of training is maximum strength and quick muscle rel
43. e electrode electrode cables must be connected Game The player has to avoid the balloons cars and reach the cloud gas can by tens ing and relaxing 2 muscles For calibration refer to page 40 The game is launched after the 2 muscle signals have been calibrated The muscle tension for both channels is displayed in the range of O 100 Treatment goal The focus of training is coordination muscle tension and muscle relaxation pypepagagad 9g gg ee egyy kx a E 1 d 5 Ba i a I H Indications Training tonic muscle control neuro orthopedic coordination deficits muscular atrophy disorders injuries of the central nervous system peripheral nerve lesions capable of regeneration muscle strength deficits EMG channels 2 Treatment duration min 20 Training recommendation 1 x per day User Settings Adjustment Number of cars balloons on top of each other from the top Number of cars balloons on top of each other from the bottom Speed Horizontal vertical Start position left right Type of game Balloon car 66 Program Overview Feedback PC Games Myosymmetry For this program the orange EMG channel 1 green EMG channel 2 and white reference electrode electrode cables must be connected Game The two balloons can be moved by tensing and relaxing 2 different muscles which allows muscle tension and relaxation to be compared The goal is to make the muscle signal of the aff
44. e frequency Hz Number of contractions Fall time seconds Pulse width us Therapy recommendation User Settings Pulse width us Maximum intensity mA Indications Phases Channel Phase shift duration seconds Phase duration minutes Frequency Hz Rise time seconds Plateau time seconds Pause time seconds Number of contractions Fall time seconds Pulse width us Therapy recommendation User Settings Pulse width us Maximum intensity mA Program Overview Sports Bodybuilding for experts 300 3 x per week 50 100 150 350 400 O 100 Agonist antagonist strength training 2 x per week 50 100 150 350 400 0 100 Otto Bock Healthcare Products GmbH 89 Program Overview Sports Indications Phases Channel Phase shift duration seconds Phase duration minutes Frequency Hz Rise time seconds Plateau time seconds Pause time seconds Number of contractions Fall time seconds Pulse width us Therapy recommendation 3 x per week User Settings Pulse width us 50 100 150 350 400 Maximum intensity mA 0 100 Indications For regeneration after sports exertion and to break down metabolic by products e g lactic acid lactate in the muscle Phases Treatment duration min Frequency Hz Pulse width us 300 Therapy recommendation After training User Settings Pulse width us 50 100 150 350 400 Maximum intensity mA O 100 90 Program
45. e time seconds Plateau time seconds Pause time seconds Fall time Seconds 0 5 Therapy recommendation 2 3 x per week User Settings Treatment duration min 10 15 20 35 40 Modulation frequency Hz 5 10 15 65 70 Plateau time seconds 1 20 Rise and fall time seconds 0 0 5 1 1 5 2 2 5 83 Pause time seconds 1 60 Maximum intensity mA 0 100 92 Program Overview Mid Frequency om FE r TUE L AT S LLI Ef N f m IZ 7 i i J WEE wy FAL TG be lV Indications Muscular atrophy disorders injury of the central nervous system peripheral nerve lesions capable of regeneration neuro orthopedic functional disorders EMG channels Treatment duration min Frequency kHz Modulation frequency Hz Rise time seconds Plateau time seconds Pause time Seconds Fall time seconds 0 5 Therapy recommendation 2 3 x per week User Settings Treatment duration min 10 15 20 35 40 Modulation frequency Hz 5 10 15 65 70 Plateau time seconds 1 20 Rise and fall time seconds 0 0 5 1 1 5 2 2 5 3 Pause time seconds 1 60 Maximum intensity mA 0 100 Otto Bock Healthcare Products GmbH 93 Program Overview Custom Programs Custom Programs This is where you have the option of creating custom programs All parameters can be individually adapted and saved under Saved Programs with a custom name for repeated use see page 16 Saving and
46. ected side come as close to the muscle signal of the healthy side as possible The muscle signal level can be adjusted by selecting the respective channel with function key 1 or 3 and subsequently changing the amplification using the control dial The muscle tension for both channels is displayed in the range of O 100 It is also possible to hide channel 1 or channel 2 Treatment goal The focus of training is muscular endurance and coordination iis Bi is Pre bis Timi ate ee 20 be i Indications Training tonic muscle control neuro orthopedic coordina tion deficits muscular atrophy disorders injuries of the central nervous system peripheral nerve lesions capable of regeneration EMG channels 2 Treatment duration min 20 Training recommendation Individually determined by the therapist Otto Bock Healthcare Products GmbH 67 Program Overview Pain Therapy Pain Therapy awe e IntroOaquCcTION Transcutaneous electrical nerve stimulation TENS is a symptomatic conservative treatment for pain It is based on the transcutaneus through the skin application of electric pulses The analgesic effect can be explained by the stimulation of sensitive nerve fibers which block pain transmission to the central nervous system on the spinal level gate control theory on the one hand and the increased release of the body s own analgesic substances endorphins on the other hand Various stimulati
47. edback Games PC Pain Therapy Urology 28 2 PROGRAM OVERVIEW Atrophy Power endurance Agonist Antagonist Maximum powertraining Circulation improvement Mild Atrophy Severe Atrophy EMG triggered 1 EMG EMG triggered 2 EMG Muscle tension Relaxation training Coordination training Myosymmetry Power training EMG triggered 1 EMG EMG triggered 2 EMG Power training Endurance training Relaxation training Coordination training Myosymmetry TENS conrentional TENS frequency modulated TENS Burst Urge Incontinence Stress Incontinence Mixed Incontinence EMG triggered 1 EMG EMG triggered 2 EMG Peak speed Feedback Continence anal EMG triggered anal FES Programs Sports MF Programs Individual Programs Saved Programs Grasp and release EMG grasp release Hand to mouth EMG hand to mouth Arm extension support EMG Arm extension support Open and close EMG open close Overall Endurance Power endurance Peak Speed Bodybuilding beginners Bodybuilding advanced Agonist Antagonist Power Agonist Antagonist Time Regeneration Circulation improvement Stimulation program MF 3kHz MF 3kHz EMG Single Phase Program Single Phase Program EMG Three Phase Program 29 Program Overview Muscle Development Muscle Strengthening Introduction Electro muscular stimulation EMS is a Conservative treatment method that causes the muscles to contract through electrically induced p
48. eek 15 minutes User Settings Treatment duration min 5 10 15 20 25 Frequency Hz 1 5 10 15 135 140 Pulse width us 50 100 150 350 400 Plateau time seconds 1 20 Rise and fall time Seconds 0 0 5 1 2 5 3 Pause time seconds 2 40 Automatic threshold adjustment YES NO Volume 0 100 Feedback tone 1 x tone tune Maximum intensity mA 0 100 72 Program Overview Urology For this program the orange EMG channel 1 vaginal electrode green EMG channel 2 and white reference electrode electrode cables must be connected Indications Stress incontinence mixed incontinence Treatment duration min Frequency Hz Pulse width us Rise time seconds Plateau time seconds Pause time seconds Fall time seconds Therapy recommendation 5 x per week 15 minutes User Settings Treatment duration min 5 10 15 20 25 Frequency Hz 1 5 10 15 135 140 Pulse width us 50 100 150 350 400 Plateau time seconds 1 20 Rise and fall time seconds 0 0 5 1 2 5 3 Pause time seconds 2 40 Maximum intensity mA 0 100 Otto Bock Healthcare Products GmbH _ 7B Program Overview Urology For this program the orange EMG channel 1 vaginal electrode and white reference electrode electrode cables must be connected After the end of the program the number of successfully completed contractions is displayed Indications EMG channels Treatment duration min Training level Active pause
49. elect Start Run and enter D Setup exe in the window that appears D represents your CD ROM drive If you assigned a different drive letter to your CD ROM drive then please use that letter instead Then click OK 98 Additional Installation Information Myogames Software Installation Language At the start of the installation process a language selection screen for the in stallation is displayed From that point forward all installation instructions are displayed in the selected language The selection dialogue can be deactivated Do not show this screen again The language selection can be modified in the settings menu Player General C Balloon Car Coordination training Control balloon car with the difference of the two muscle signals Difficulty high Language query after start iv Background balloon game light blue car game light grey 5 an YT Sound OFF E New player High graphic quality in the games v This option has the following system requirements Pentium 1 2 Ghz 25ms response time for TFT flat screens Note This program is optimized for 16 bit color depth Edit Delete player Slow TFT flat screen TFT flat screen response time higher 25ms Cancel Patient Administration Software Leonardo Installation Steps 1 The system environment for Leonardo is installed first Microsoft NET Framework Answer the displayed q
50. electromyogram is shown by the bars In order to trigger stimulation the electromyogram of EMG channel 1 must be above and that of EMG channel 2 must be below the respective threshold arrow 3 Press the Y key to set the amplitude Set the intensity using the control dial and confirm with the STOP rewind key 4 Now the program is launched As soon as the green LED is illuminated the patient should tense muscle 1 and simultaneously relax muscle 2 Try to exceed the arrow for the left hand bar by tensing the muscle while simultaneously remaining below the threshold for EMG channel 2 Once the arrow is passed stimulation takes place and the LED turns orange 46 Indications EMG channels Treatment goal Treatment duration min Frequency Hz Pulse width us Rise time seconds Plateau time seconds Pause time seconds Fall time seconds Automatic threshold adjustment Training recommendation User Settings Threshold threshold Treatment duration min Frequency Hz Pulse width us Rise time fall time seconds Plateau time seconds Pause time seconds Automatic threshold adjustment Maximum intensity mA Program Overview Feedback Programs Muscular atrophy disorders injury of the central nervous system peripheral nerve lesions capable of regeneration neuro orthopedic functional disorders 2 Coupling voluntary muscle innervation with EMG trig gered stimulation which results in visibl
51. iggered 1 EMG wf Amplitude Setting Continue w lt 5 5 Start program Try reaching the black arrow by contracting the muscle Once the arrow is reached stimulation takes place O If the muscle is not relaxed during the no stimulation period a white arrow will appear on the display at the threshold setting The black arrow will only re uw appear once the muscle is sufficiently Reach the arrow relaxed and remains under the white arrow threshold If the patient cannot remain under the white arrow the control dial to indivi dually adjust the threshold should be used INFORMATION e In order to induce a trigger when using the program EMG triggered 2 EMG the muscle of the 2nd EMG channel must also be relaxed so that the bar remains under the white arrow e During the PC games Spasm Control is accomplished by using a blue bar The balloon must stay below the blue bar during the no stimulation period Only then will the red bar that has to be reached in order to trigger a stimu lation appear You can adjust the bar level with the control dial on the STIWELL med4 de vice For this program the orange EMG channel 1 and white reference electrode electrode cables must be connected After pressing calibration tens Ing and relaxing muscles according to the display takes place as described EMG triggered 1 EMG on page 40 p Manually set the threshold to trigger the stimulation pulse
52. insulation must not be used Any modification of the original electrodes is prohibited Ensure that the electrodes are in good general condition ATTENTION A If skin irritation develops treatment must be discontinued immediately Ask your therapist or physician for advice before continuing treatment Utto Dock Meailtncare PI OQUCIS UOMDI Application Electrode positioning o ow Torso frontal flexion Mm Recti abdominis 22 Stomach muscles Note regarding electrode positioning The anode and cathode can also be attached opposite from the illustration Torso side flexion Torso side rotation Mm Obliqui boas fi b Si p i mi z amp jo Ll il ri A Application Electrode positioning Shoulder muscles leg muscles adductor muscle Raising the shoulder M Trapezius descendens Dp Rear Sideways raising of the arm i o Arm rotation l M Deltoideus f co to amp E j Retraction of the arm y 7 Interior shoulder rotation Shoulder blade fixation M Pectoralis major Shoulder blade exterior rotation he M Serratus anterior a Retraction of the leg Mm Adductores Otto Bock Healthcare Products GmbH _ S 8 Application Electrode positioning Arm and leg rear Ly j D Elbow extension M Triceps brachii wd Finger and wrist extension Mm Digitores extensores i Hip extension M Glutaeus max wl f z li
53. ion in the vicinity e g 1 m of a shortwave or microwave therapy device can cause the output values of the stimulation device to fluctuate Applying the electrodes in the vicinity of the chest can increase the risk of heart rhythm disturbances 106 Effective current densities above 2 mA cm2 require increased attentiveness of the user for all electrode surfaces for example this applies from 14mA for electrodes with a diameter of 3 cm and from 40mA for electrodes with a diameter of 5 cm The device must be turned off when attaching and removing the electrodes and the patient connection cables The long term effects of chronic electrostimulation are not known The neck and mouth should not be stimulated Doing so can result in severe spasms of the larynx and pharynx muscles the contractions can be severe enough to block the airway or to make breathing difficult If the treatment is ineffective or unpleasant it should be halted and the treating physician therapist should be contacted Some patients will need to adjust the stimulation intensity during the initial treatment phases in order to achieve a satisfactory therapeutic result For home therapy the therapist should diligently monitor the treatment through periodic checkups During functional electrostimulation the patient must not hold any pointed or sharp objects in his or her hand while practicing hand to mouth movements since this could result in facial injuries
54. is can be set under the menu item Extras Language 104 4 WARNINGS AND SAFETY INSTRUCTIONS Warnings User Specific Treatment in areas with sensitive skin requires additional attention For some patients electrical stimulation or the conductive medium can cause skin irritation or hypersensitivity This type of irritation can normally be reduced by using a different conductive medium or changing the placement of the electrodes The treatment of patients with cardiac disorders epilepsy multiple sclerosis hemophiliac tendencies or diabetes must be attended by a physician The STIWELL med4 must never be used while operating machinery or vehicles or during other activities where involuntary muscle contractions subject the user to an increased risk of injury The stimulation device must not be used if safe handling of the device cannot be guaranteed due to the influence of alcohol and or medications Care is required after acute trauma or fractures recent operations when muscle contractions may affect the healing process and in the vicinity of the uterus during menstruation In such cases the treatment must be attended by a physician The directions of the attending physician or therapist must be followed for electrode placement and the stimulation settings Simultaneously connecting the patient to a high frequency surgical device diathermy can result in burns underneath the stimulation electrodes Operat
55. lectrostimulation In case of incomplete paralysis the remaining functions can be improved In addition functional stimulation can help to relax a spastic muscle by reduc ing muscle tone All of the programs can also be used with EMG triggered stimulation In that case myo calibration is required before launching the program See page 40 Myo Calibration Muscle Tonus Adjustment For explanations regarding graphic visualization and or parameter settings for Plateau Pause see page 95 ATTENTION A In order to avoid overtiring the muscles the value for pause time delay time should be at least equal to the value for plateau time pause time delay time 2 plateau time Note regarding electrode positioning For EMG triggered programs the reference electrode must also be attached to the extremity that is the object of therapy lthcare Products Gmb 77 Program Overview Functional Programs Grasp and release Indications Training movement patterns strength training Channels 1 2 3 Muscles Wrist extensor Finger flexors Thumb flexor Plateau time seconds 10 7 4 Delay seconds O 3 6 Treatment duration min 20 Frequency Hz 35 Pulse width us phase Rise time seconds 1 Fall time seconds 1 Pause seconds 10 Therapy recommendation 2 3 x per day User Settings Treatment duration min 15 20 25 55 60 Frequency Hz 1 5 10 15 135 140 Pulse width us 50 100 150 350 400 Plateau pause se
56. mation screen or click New Entry in the list of patient names NOTE At a minimum you have to enter the last name for every patient All other values can be left blank However it is recommended to complete enough information so that confusion with another patient is not possible A multi line field is available to record the diagnosis If the record number is modified for an existing patient a new record is created Existing values for the current record date diagnosis notes muscle assignment are deleted from the fields The patient data do not need to be reentered In order to save the data you have entered or to save your changes exit the input screen by clicking OK If you exit the window by clicking Cancel all data and changes are discarded 102 Searching for a Patient The easiest way to search for a patient is to enter all or part of the last name After clicking the Search button all patients that match the search criteria are selected from the database and displayed in a list The desired entry can then be selected by clicking the corresponding line If you know the record number or the patient number you can find the patient and all corresponding data directly by entering the corresponding number The selection is confirmed with the Search button and the patient data are loaded Modifying Patient Data Search for a patient as described above Now you can open the patient data input
57. me and Settings Turn on the stimulation device using the On Off key The Treatment Overview appears on the display Use the function keys A and Y to select the desired treatment type and confirm with v Under e you can change the display 2 Denervated Muscles contrast volume date time and unlock 3 Feedback Programs function 4 Feedback Game Display 5 Feedback Games PC NOTE The unlock function is password protected In order to deactivate protection the password must be entered here see enclosed password card Now the Programs for the selected treat ment type are displayed Use the function a an ices pice SyS Zaun i o ae Avi e GESIE pro 2 Agonist Antagonist gram and confirm with V and the selected 3 Maximum power training program is displayed 4 Circulation improvement f i PO ee eee E YD rRAKAm Ans mattina tha lntanecit Launching the Program and Setting the Intensity Launch the program using To program the intensity press the function key that corresponds to the channel and set the intensity using the Atrophy Power endurance control dial A000 ili The setting is confirmed by pressing the function key a second time Press the STOP rewind key to exit the settings menu Atrophy Power endurance and launch the program When the pro YN 39 99 ele gram is running the intensity can only be changed during the plateau time If you do not wish to start the program e g t
58. mes daily at least 2 hour 10 20 30 40 50 O 100 Deep seated areas of pain myopathic pain chronic pain 1 20 80 200 100 400 1 2 x per day hour 10 20 30 40 0 100 69 Program Overview Urology Urology Biofeedback and electrostimulation as well as a combination of both are treatment methods that can be used to learn how to train and strengthen the pelvic floor voluntarily and in a controlled manner Intracorporal or surface mounted electrodes can register extremely minor levels of muscle activity which are normally not consciously perceived The patient can see the strength of the muscle contractions on the display of the device or hear them through audio feedback Electrostimulation is used to additionally strengthen muscles in particular it improves the endurance of muscles which is frequently insufficient and emphasizes the information the patient needs to learn It is a therapy option for the treatment of urinary and fecal incontinence and can result in sustained SUCCESS ATTENTION A The specified therapy recommendations have to be discussed with a specialist and must be individually adapted by him or her according to the patient s symptoms and condition Indications Urge Incontinence Phases Treatment duration min Frequency Hz Pulse width us phase Rise time seconds Plateau time seconds Pause time seconds Fall time seconds The
59. mulation which results in visible noticeable muscle contractions muscle movements 30 35 0 5 3 6 0 5 NO 2 3 x per day and muscle group Increase decrease the trigger threshold 15 20 25 30 35 40 45 50 55 60 1 5 10 15 135 140 50 100 150 350 400 0 0 5 1 1 2 2 5 3 1 2 3 19 20 2 3 4 39 40 YES NO 0 100 1 x tone tune 0 100 For EMG triggered electrostimulation at least three electrodes must be attached to the target muscles The proximal electrodes are initially used to record the remaining electromyographic activity the distal electrode is used as a reference If the patient is able to generate a signal with a sufficiently large amplitude the threshold value can be individually adjusted stimulation takes place via the proximal electrodes Otto Bock Healthcare Products GmbH 45 EMG triggered 2 EMG Function key 1 EMG channel 1 triggered muscle can also be stimulated Function key 3 EMG channel 2 triggered muscle cannot be stimulated For this program the orange EMG channel 1 green EMG channel 2 and white reference electrode electrode cables must be connected 1 After calibration relax and tense the muscle according to the display and EMG triggered 2 EMG before the program is launched the user can set the threshold values Ww arrow for initiating the stimulation pulse with the control dial after pressing function key 1 or 3 and can confirm with Y 2 The current
60. n 34 Indications Phases Treatment duration min Frequency Hz Pulse width ms phase Pulse interval period duration 2 pulse width ms Plateau pause seconds Pulse type Therapy recommendation User Settings Treatment duration min Frequency Hz Pulse width ms phase Plateau time seconds Pause time seconds Pulse type Maximum intensity V ATTENTION For this program using the sponge pockets and matching rubber electrodes is essential See page 19 for application in structions A Otto Bock Healthcare Products GmbH Program Overview Denervated Muscles Minor Atrophy From approx 1 3 weeks of immobility 20 20 10 30 3 6 Triangular 1 2 x per day 10 15 20 25 30 35 40 1 50 1 250 1 60 1 60 Triangular rectangular trapezoidal 0 80 Mild Atrophy N Attention correct electrodes see manual gt amp D 35 Program Overview Denervated Muscles eC a A Lau a ka ae Us ee I ro ARAL Cr f A ATTrHAHNY cS ALO o l y a ws rD V AN W Indications Phases Treatment duration min Frequency Hz Pulse width ms phase Pulse interval period duration 2 pulse width ms Pulse type Therapy recommendation User Settings Treatment duration min Frequency Hz Pulse width ms phase Pulse type Maximum intensity V Pronounced Atrophy From approx 1 2 years of immobility 1 15 0 1 200 9600 Trapezoidal 2 x
61. nds Pause frequency Hz Number of contractions Fall time Seconds Pulse width us Therapy recommendation User Settings Treatment duration min Pulse width us Maximum intensity mA Program Overview Sports General endurance training 2 10 20 30 22 44 67 1 300 1 x per day 20 30 40 50 100 150 350 400 0 100 Endurance training 2 3 10 15 20 10 15 20 40 60 2 2 8 8 16 16 3 3 22 33 44 22 33 44 1 1 3 x per week 30 40 50 50 100 150 350 400 0 100 Otto Bock Healthcare Products GmbH 87 Program Overview Sports Indications Phases Phase duration minutes Frequency Hz Rise time seconds Plateau time seconds Pause time seconds Pause frequency Hz Number of contractions Fall time seconds Pulse width us Therapy recommendation User Settings Pulse width us Maximum intensity mA Indications Phases Phase duration minutes Frequency Hz Rise time seconds Plateau time seconds Pause time seconds Pause frequency Hz Number of contractions Fall time seconds Pulse width us Therapy recommendation User Settings Pulse width us Maximum intensity mA 88 Power training 300 2 x per week 50 100 150 350 400 0 100 Bodybuilding for beginners 300 3 4 x per week 50 100 150 350 400 0 100 Indications Phases Phase duration minutes Frequency Hz Rise time seconds Plateau time seconds Pause time seconds Paus
62. ndurance and to support muscle regeneration Electrostimulation is intended as a supplement to conventional training The STIWELL med4 is battery powered It has four stimulation channels and two EMG measurement channels Information The STIWELL med4 is not approved for sale in the USA Indications Neuromuscular electrostimulation NMES can be prescribed by a physician in the following cases Prevention and delay of muscular atrophy caused by immobilization e g cast Strengthening muscles during a rehabilitation phase Maintaining and or improving joint mobility Muscle relaxation decubitus pressure sore prevention Treatment of aconuresis strengthening the pelvic floor muscles Maintaining the trophicity and muscle mass of peripherally denerved muscle groups in the neuromotoric rehabilitation phase Functional rehabilitation of the locomotor system Treatment of paresis and movement training after nerve reconstruction Transcutaneous electrical nerve stimulation TENS Indications for EMG triggered EMG controlled muscle stimulation and or biofeedback training Disorders or injuries of the central nervous system e g spasticity or paresis after a stroke disorders after head brain trauma Disorders or injuries of the spinal cord e g incomplete paraplegia Peripheral nerve lesions capable of regeneration Neuro orthopedic functional disorders In sports neuromuscular electrostimulation can be used for additional
63. nel 1 1 For secondary stimulation on channel 1 after stimulation on channel 2 4 is complete select Contraction 2 channel 1 under settings and press the Y key 2 Set Contraction 2 channel 1 to ON and confirm with V Plateau time Contraction 2 channel 1 2 seconds Pause time 1 second fr lt 22 seconds N Plateau time Delay time 10 seconds Plateau time Delay time 7 seconds Plateau time Delay time 3 seconds 7 seconds S N NOTE The settings for the 2 contraction of channel 1 and the rise and fall times are also displayed in the graphic Therefore it is recommended to establish these settings before the Plateau Pause times 97 PC Software Installation PC SOFTWARE INSTALLATION MYOGAMES AND LEONARDO Installing Myogames Software Patient Administration Software Leonardo Windows 2000 XP Windows 2000 XP Pentium Il 450 MHz and up Pentium II 450 MHz and up 64 MB RAM or more 64 MB RAM or more CD ROM drive CD ROM drive USB 1 1 and USB 2 0 USB 1 1 and USB 2 0 Administrator rights to your PC are required to install the software Connect the STIWELL med4 device to your PC using the USB cable included in the delivery Close all open programs and insert the supplied CD into your CD ROM drive The installation screen is displayed automatically O Setup STAWELL med al Select the desired program If the installation screen is not displayed automatically s
64. ng to the electrode skin impedance Derivation of electrical muscle activity Resistance of the electrodes To keep from exceeding a desirable degree or level Through the head through the chest Sideways movement away from the body at the shoulder joint AL nea at ARme A ppreviations ed EMG EMS LED NMES TENS USB ZNS 120 Electromyogram Electromyostimulation Light Emitting Diode Neuromuscular Electrostimulation Transcutaneous Electrical Nerve Stimulation Universal Serial Bus Central Nervous System For information on software installation and operation see the STIWELL med4 User Manual Chapter PC Software Otto Bock Healthcare Products GmbH Kaiserstra e 39 1070 Wien Austria Tel 43 1 526 95 48 Fax 526 79 85 vertrieb austria ottobock com www ottobock at Otto Bock has been certified by the German Society for the Certification of Quality Assurance Systems DQS in accordance with DIN EN ISO 13485 2003 Management System
65. o change some parameters first then by keeping the STOP Rewind key pressed for gt 1 5 sec you will get back into the setting menu ATTENTION A You can pause the program at any time by pressing the STOP rewind key You can modify the intensity using the settings menu before the program resumes If the program is not resumed within 10 minutes the stimulation device shuts off automatically Storing the Intensity If the intensity for the patient was established before the program was locked then the intensity is stored Upon resuming after locking the program the intensity automatically regulates itself up to the stored value 70 of the stored value if the frequency lt 1 Hz 12 Ad pei Va IAA 4 x l CAAT aaas a fa Chan ging the Treatment Rat gp a Duration Under Treatment Duration you can select the duration of the treatment program To confirm the settings and return to the selected program press YW ea la Pa ya p IA Fn l ay ded F a A Changing Setting ny gt Now you can change certain settings and specified parameters under lt depending on the program Press Y to enter the selected settings menu e g turning off the warm up phase pulse width saving the program Press the cancel key X to return to the settings menu Atrophy Power endurance 40 00 lr gt Program Duration y am A Atrophy Power endurance A000 aa GD 1 Pul
66. ock from the program overview and press the Unlock symbol The message Enter password to unlock is displayed As soon as you confirm with the key VY awindowis displayed to enter the password also see page 16 Enter Password to unlock Charging the Battery The STIWELL med4 must only be charged using the supplied charger The STIWELL med4 cannot be operated during the charging process The current charging state is shown on the display m If the battery symbol is flashing the battery must be charged using the supplied charger However the treatment already in progress can normally be completed If the battery is fully discharged the charging process takes approximately 170 minutes Connect the battery cable to the stimulation device receptacle B and then connect the charger to an outlet Ensure that the label B on the cable matches the label B on the device The LED on the charger is illuminated in red during the charging process As soon as the charging process is complete a green light is displayed The charger must be disconnected from the outlet and from the STIWELL med4 ATTENTION A The battery must not be charged at ambient temperatures below 0 C since this can lead to battery damage To disconnect the charger do not pull on the cord always grasp the plug External Trigger 1 Connect the External Trigger accessory manual switch to receptacle B on the stimulation device 2 Under
67. on parameters make it possible to treat acute and chronic pain the only thing the patient feels is a slight tingling or slight muscle contractions underneath the electrode The treatment can be easily integrated into daily life and in the best cases can contribute to reducing the dosage of pain medications NOTE By pressing any function key you can go directly to the settings menu and change the intensity for all channels To resume the program press the STOP rewind key TENS Conventional Indications Phantom pain scar pain post operative pain lumbalgy acute pain Phases 1 Treatment duration min 30 Frequency Hz 80 Pulse width us phase 150 Therapy recommendation Several times daily at least 1 hour User settings Treatment duration min 30 60 90 120 Maximum intensity mA 0 100 A 0s frequency modulated Indications Phases Frequency Hz Plateau time seconds Treatment duration min Pulse width us Therapy recommendation User Settings Treatment duration min Maximum intensity mA Indications Phases Treatment duration min Frequency Hz Pulse width us phase Plateau time ms Phase duration ms Therapy recommendation User Settings Treatment duration min Maximum intensity mA m p Otto Bock Healthcare Products GmbH Program Overview Pain Therapy Phantom pain scar pain post operative pain lumbalgy Several ti
68. onfirm the with Y Calibration of two muscle signals 2 EMG channels 2 muscle signals are calibrated first relax and tighten Muscle 1 and then Muscle 2 40 Error sources incorrect calibration e Tension in the relaxation phase e Relaxation in the tension phase e Defective electrodes e Cable connected incorrectly e Defective cable Calibration error Launch program Recalibration during therapy If recalibration is required during therapy press the STOP rewind key followed by the START key and then recalibrate as described above The program resumes at the point where it was interrupted If the patient cannot relax the muscle during the pause following the stimulation you can draw the patient s attention to do so by using Spasm Control which helps the patient to actively relax Spasm control can be implemented in all EMG triggered programs except Urology Select Spasm Control from the menu exec and confirm with V eeeealiine 05s 7 Autom Threshold OFF 8 Spasm control OFF 9 Volume 10 10 Feedback signal beep 2 Set Spasm Control to ON and con firm with Vv X will get you back into the program After pressing Ztp er takes oe as described under Myo Calibration Use the control dial to adjust the threshold a ager stimulation and confirm with EMG triggered 1 EMG Ww Set Threshold 42 4 Adjust intensity with the control dial EMG tr
69. rapy recommendation 5 x per week 20 minutes User Settings Treatment duration min 5 10 15 20 25 Maximum intensity mA 0 100 70 Indications Training levels Plateau time seconds Pause time seconds Treatment duration min Frequency Hz Pulse width us Rise time seconds Fall time seconds Therapy recommendation User Settings Treatment duration min Maximum intensity mA Training levels Indications Phases Phase duration seconds Plateau time seconds Pause time seconds Frequency Hz Pulse width us phase Rise time seconds Fall time seconds Number of contractions Therapy recommendation User Settings Treatment duration min Number of contractions Maximum intensity mA Otto Bock Healthcare Products GmbH Program Overview Urology Stress Incontinence Medium 8 9 15 5 x per week 15 minutes 5 10 15 20 25 0 100 Easy medium hard Mixed Incontinence 500 450 400 350 350 350 2 1 63 for 15 minutes of treatment 5 x per week 15 minutes 71 Program Overview Urology For this program the orange EMG channel 1 and white reference electrode electrode cables must be connected Indications Stress incontinence mixed incontinence Treatment duration min Frequency Hz Pulse width us phase Rise time seconds Plateau time seconds Pause time seconds Fall time seconds Automatic threshold adjustment NO Therapy recommendation 5 x per w
70. riggered during the re spective contraction phase Phase with a frequency that does not trigger any tetanic muscle contractions prepares the muscles for the therapy that follows The interval in seconds until a second program phase starts offset against the first program phase Calculated from the period duration minus 2 pulse width If the patient reaches the established threshold and stimulation is triggered the established threshold is automatically adjusted upwards if the threshold is not reached several times It is automatically adjusted downwards Delay Modulation frequency Reference electrode Constant current Constant voltage Electromyogram Electrode impedance Inhibiting Transcerebral transthoracic Glenohumeral abduction The interval in seconds between the start of stimulation on the first channel and the start of stimulation on the following channel Frequency at which the stimulation amplitude varies program mid frequency The reference electrode is required when the bipolar derivation technique is used The purpose of this method is improved signal quality since noise suppression is improved This means that the pulse current as described in the user manual is rectangular pulse shaped and the voltage is correspondingly consistent according to the electrode skin impedance This means that the pulse voltage is rectangular and the current is correspondingly consistent accordi
71. roducts GmbH Program Overview Urology For this program the orange EMG channel 1 and white reference electrode electrode cables must be connected Indications Stress incontinence mixed incontinence Treatment duration min Frequency Hz Pulse width us phase Rise time seconds Plateau time seconds Pause time seconds Fall time seconds Automatic threshold adjustment NO Therapy recommendation 3 x per week 15 minutes User Settings Treatment duration min 5 10 15 20 25 Frequency Hz 1 5 10 15 135 140 Pulse width us 50 100 150 350 400 Plateau time seconds 1 20 Rise and fall time seconds 0 0 5 1 4 5 5 Pause time seconds 2 40 Automatic threshold adjustment YES NO Volume 0 100 Feedback tone 1 x tone tune Maximum intensity mA 0 100 76 Functional Programs Introduction In case of muscle weakness or loss of use caused by the central nervous system it is possible to support mus cle function through electric pulses Functional electrostimulation with the help of these electric pulses attempts to reestablish or compensate for movement functions the body has lost due to injury or illness partially or to a limited extent Since it can initialize and control muscle movements in a targeted manner functional stimulation combined with physiotherapy treatment methods can contribute to a noticeably better therapy result Centrally paralyzed muscles can be trained using e
72. se width 400 us 2 Max Intensity OFF 3 Warm up Yes 4 Save program ATTENTION For safety related reasons the setting options for the frequency pulse width and ON OFF times are restricted by the device The physician therapist can select and lock one or more programs for a pa tient and also establish patient specific parameters for these programs The locking function is intended for home therapy and also for inpatient treatment The patient automatically starts off with the last program that was locked If several programs were locked maximum 20 they can be selected from the program overview Select a program and if required modify lt parameters under settings e g pulse width frequency set the intensity Atrophy Power endurance if desired and then press the Lock sully symbol The modified values are stored Confirm the locking process with v Lock Program The next time the device is switched on only the locked program Is visible Atrophy Power endurance The treatment data can be retrieved 40 00 r under function key 1 b lt The maximum storage capacity is 270 treatments per locked program To return to the overview of all locked programs press the STOP rewind key 14 Anwendung 4 To return to the treatment overview please press the unlock key and confirm with Y If the unlock function is password protected the password Unlock Program must be entered
73. sorders injuries of the central nervous system peripheral nerve lesions capable of regeneration EMG channels 1 Treatment goal The focus of training is maximum strength and quick muscle relaxation Training level Easy Medium Hard Treatment duration min 7 10 15 Training recommendation 1 2 x per day and muscle group User Settings Threshold threshold Increase decrease the threshold values Set while training Training level Easy Tense to at least 60 of the calibrated value and relax to below 20 of the calibrated value Medium Tense to at least 70 of the calibrated value and relax to below 20 of the calibrated value Hard Tense to at least 80 of the calibrated value and relax to below 20 of the calibrated value Active pause Active time 30 60 120 180 240 300 seconds 15 minutes Pause time 0 0 5 1 29 5 30 seconds Volume 0 100 Feedback tone 1 x tone tune The parameter Active Pause makes it possible to pause during the pro gram Parameter example Active time 1 minute pause time 20 seconds After one minute of alternately tensing and relaxing the program pauses for 20 seconds For selective biofeedback training three electrodes must be attached over the weakened muscle The focus of training can be varied and or adapted to the individual training condition of the muscle by using various training levels Otto Bock Healthcare Products GmbH _ 4 For this progr
74. tensity have been set see page 42 The muscle tension for both channels is displayed in the range of O 100 TELUH HEHHE ireatment godi Amplifying a voluntary weak muscle contraction through EMG triggered stimulation which leads to a visible noticeable muscle contraction muscle movement Indications Muscular atrophy disorders injury of the central nervous system peripheral nerve lesions capable of regeneration neuro orthopedic functional disorders EMG channels 2 Treatment duration min 20 Frequency Hz 35 Pulse width us Rise time seconds 0 5 Plateau time seconds 3 Pause time seconds 6 Fall time seconds 0 5 Automatic threshold adjustment NO Training recommendation 2 3 x per day and muscle group User Settings Adjustment Height of the bar can also be set during play by using the control dial Treatment duration min 15 20 30 40 50 Frequency Hz 1 5 10 15 135 140 Pulse width us 50 100 150 350 400 Plateau time seconds 1 2 3 19 20 Rise time fall time seconds 0 0 5 1 2 5 3 Pause time seconds 2 3 4 39 40 Automatic threshold adjustment YES NO Maximum intensity mA 0 100 62 Program Overview Feedback PC Games Power training For this program the orange EMG channel 1 and white reference electrode electrode cables must be connected Game The player has to avoid the balloons cars by tensing and reach the clouds gas can by relaxing as quickly as possi
75. that the patient can reach an EMG threshold value in a reproducible manner with voluntary activity triggered stimulation can support the movement initiated by the patient and increase the force of the contraction EMG triggered 2 channel lf associated spastic reactions are observed in neighboring muscle groups during therapy a second EMG channel can be used in this program to avoid stimulation in presence of this undesirable activity 38 Muscle Relaxation If the focus of the therapy Is relaxation and or tonus reduction of spastic muscles use of the program Muscle Relaxation is recommended once again display or PC games can also be used as a useful tool to increase motivation Coordination The synergetic interaction of several muscle groups within a function also see Functional Stimulation as well as the reestablishment of antagonistic functions can only be achieved if more complex movement patterns are practiced 39 Myo Calibration Muscle Tonus Adjustment After selecting a feedback program and pressing the START key within the program calibration of the EMG channel is initiated Calibration of a muscle signal 1 EMG channel First relax the muscle and confirm the tonus while at rest relaxation value with W Muscle tension Wf CAUTION Please relax 100 l Muscle tension VW Muscle Contract maximally maximum tension value contraction value r m Now contract the muscle and c
76. tion Bee Ese ee Indications Muscular atrophy disorders injuries of the central nervous system peripheral nerve lesions EMG channels 1 Treatment duration min 20 Training recommendation 2 3 x per day User Settings Adjustment Level of difficulty Consecutive balloons cars Speed Horizontal vertical Start position left right Type of game Balloon car 64 Program Overview Feedback PC Games For this program the orange EMG channel 1 and white reference electrode electrode cables must be connected The player has to avoid the balloons cars by tensing and then has to relax as quickly as possible For calibration refer to page 40 The game is launched after calibration recording the current level of muscle tension is complete Muscle tension is displayed in the range of O 100 Ireatment goal The focus of training is muscle relaxation Indications Excessive muscle tonus spastic paresis neuro orthopedic tension syndromes e g tension headaches vertebral pain syndromes EMG channels 1 Treatment duration min 20 Training recommendation 2 3 x per day Indications Adjustment Balloons cars on top of each other Speed Horizontal vertical Start position left right Type of game Balloon car Otto Bock Healthcare Products GmbH Program Overview Feedback PC Games Coordination Training For this program the orange EMG channel 1 green EMG channel 2 and white referenc
77. to repair and or modify the STIWELL med4 and or its accessories risks damaging the STIWELL med4 and or the accessories Therefore any steps not described in the troubleshooting guide are prohibited Improper use voids all warranty claims NOTE In case of repeated problems please have the device repaired by an authorized dealer Error description Cause Correction solution or message Error message on the Incorrect data structure or Turn the device off and on again display System Error hardware defect The stimulation device 1 Poor skin contact The 1 Attach the electrodes correctly has recognized an elec electrodes are not attached with proper skin contact Care trode error properly fully moisten the contact surface e g on channel 2 with water Poor skin contact due to 2 Replace the electrodes worn electrodes Defective cable 3 Replace the cable Unpleasant tingling feel Intensity is too low to cause 1 Increase the intensity ing during stimulation contractions and no contractions Poor electrode conductivity 2 Carefully moisten the contact surface with water Replace the electrodes 3 Electrodes not attached 3 Ensure the electrodes are attached correctly correctly The device cannot be Battery is discharged Charge the battery switched on The device suddenly Battery is discharged Charge the battery turns itself off during the self test or during stimu lation at high intensity Operating time is
78. turer s application and safety instructions must be followed in all cases Additional equipment connected to the analog and digital interfaces of the device must be proven to correspond to the respective EN specifications e g EN 60950 for data processing devices and EN 60601 for electronic medical devices Furthermore all configurations must conform to the system standard EN 60601 1 1 Anyone who connects additional devices to the signal input or signal output interfaces is a system configurator and is therefore responsible for ensuring compliance with the system standard 60601 1 1 For questions please contact your local specialist dealer or technical service Otto Bock Healthcare Products GmbH Technical data General Technical Data The STIWELL med4 is a class BF medical device with internal power supply Li lon battery It must only be used in enclosed areas at room temperature Stimulation device Stimulation channels A maximum of 4 depending on the program EMG measurement channels 2 Types of current Low frequency dual phase and direct current free rectangular triangular and trapezoidal pulses Power supply Li lon battery 1950 mAh 11 1 V Battery charge time Max 170 minutes PC interface USB 1 1 and USB 2 0 compatible Dimensions H x W x D 175 x 95 x 30 mm Weight 440g EMG measurement range 1 pV 2000 uV Programs Programs for denervated muscles Output voltage 80 V at 1000 Ohm Output current Max
79. uestion with Yes If this component already exists on your system this step is skipped and the installation of Leonardo starts immediately 2 In all other cases you have to launch setup again after the first step is complete To do so open and close the CD ROM drive or select Start Run type D Setup exe see above and then click OK Microsoft and Windows are registered trademarks of Microsoft Corporation Pentium is a registered trademark of Intel Corporation 99 Leonardo Patient Administration Software Leonardo Program Description The software is used to record patient data and save treatment data transfered into the program database by the stimulation device The treatment information can be printed at any time for documentation purposes Connecting the Stimulation Device to the PC Connect the stimulation device to the PC as described on page 8 Main Menu File Data Import Tools Help m Patient Data g E Enter New Patient Delete Patient Last Name es 5 a Patient No E A First Name ST Diagnosis Remarks Gender Male Female Soc No Birthday Admission Number EE e AI Date of Admission Statistics Import Data from Stimulator Details in between 04 08 2006 and 04 09 2006 Program Name Number of Therapies Program Name Number of Therapies 100 Leonardo In order to use the statistic function you first have
80. ulses A decrease of muscle strength during immobilization e g post operative im mobilization is avoided and the development of muscular dysbalance can be prevented The prevention and therapy of muscular atrophy using EMS can help to prevent secondary orthopedic problems and to shorten the duration of stationary treatment 30 Program Overview Muscle Development A Li m h y r E can ma Yap ATrONN KHO WU s ar A n fall i fine a ATrODNnY rower enaurance a ww Indications Muscle development training in case of atrophy especially to improve muscular endurance Phases Phase duration min Frequency Hz Pulse width us phase Rise time seconds Plateau time seconds Pause time seconds 16 16 Pause frequency Hz Number of contractions 22 33 44 22 33 44 Fall time seconds 1 1 Therapy recommendation 2 3 x per week and muscle group User Settings Phase duration min 20 30 40 50 Pulse width us 50 100 150 350 400 Warm up phase YES NO Maximum intensity mA 0 100 E Af gt t FA el PN pP ro H ee oe ee geg E YANA P Electrode Positionin 9g cxampie The bipolar positioning example shown in the illustration two electrodes per muscle group is a typical application for the rehabilitation of atrophied or weakened muscles EMS is a valuable supplement to conventional therapy and can contribute to accelerated treatment SUCCESS Otto Bock Healthcare Products GmbH
81. urer s recommendations for the lifespan of rubber electrodes e When an electrode is worn out or no longer adheres properly it must be replaced immediately since the effectiveness comfort and safety of the treatment can otherwise be affected NOTE When removing self adhesive electrodes from the protective foil or from the skin do not grasp the connecting cables 20 Skin Protection and Electrode Wear Skin irritation at and around the electrode contact site is a possible side effect of electrostimulation This reaction is usually caused by poor electrode skin contact or mechanical irritation due to the repeated use of adhesive bandages to attach the electrodes Use hypoallergenic self adhesive electrodes when required Follow the steps below as well as those described in the chapter Warnings and Safety Instructions 1 The electrodes must have good skin contact in order to ensure a good electrical connection and to minimize the risk of skin irritation To improve conductivity a suitable conductive gel must be used with rubber electrodes 2 Ensure that the contact surfaces of the electrodes are clean The contact surfaces must be washed with mild soap and water rinsed with warm water and dried carefully in between applications 3 Prior removal of heavy body hair improves the contact of the electrodes to the skin If a razor irritates the skin trim the hair carefully using scissors 4 Electrodes with damaged cable
82. wer cable country specific version Main cable with plug Stimulation electrode cable Reference electrode cable USB cable 3 packages of self adhesive electrodes 5x5 cm Instructions for use CD Case 900101 country ID e g 900101 D for Germany 900101S country ID 9001P01 9001C04 country ID See accessory list 9001C01 Yellow 9001C02 4 Lilac 9001C02 11 Orange 9001C02 2 3 Green 9001C02 3 9001C03 9001C05 9001S01 5 647G377 country ID e g 647G377 D for Germany 646C 130 Vx x 642V16 Introduction Product Description LED display Display Function keys to operate the device Intensity controller STOP rewind key 6 6 G00 ON OFF key Q Electrode cable connection A Charging connection B Type plate USB connection Otto Bock Healthcare Products GmbH Introduction Ov Main cable Electrode cables Connecting the Stimulation Device to the PC When using the Feedback PC Games program or the patient administration software Leonardo the stimulation device is connected to the PC using the USB cable see illustration FUNCTION KEY ASSIGNMENT Stimulation channel 1 EMG measurement channel 1 Stimulation channel 2 Stimulation channel 3 EMG measurement channel 2 Stimulation channel 4 cn APPLICATION Instructions for Use Display Symbols G4 2 3 6 STATUS BAR Battery capacity Atrophy

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