to the SwissSTIM® FITNESS user manual.
Contents
1. 17 19 III Safety and Precautionary Guidelines A Special Warnings The SwisSs7y Fitness is intended for use by ADULTS and ONLY on healthy muscles NEVER use the SwiSSs7 Fitness on muscles that are Atrophied Painful Suffer spasms or On a limb with painful or otherwise afflicted joints The SwisSs77 Fitness is not intended for the treatment of any medical condition or disease nor is it intended for physiotherapy or muscle rehabilitation It is contraindicated for use on any muscle that is injured or diseased Do NOT attempt to use the SwiSSsym Fitness for Muscle reeducation To prevent muscle atrophy or spasms Improving range of motion Blood flow deficiencies venous thrombosis B Contraindications Do NOT use the SwiSSsym Fitness if you have any of the following medical conditions e An implanted cardiac pacemaker defibrillator or other implanted electronic or metallic devices e Pain syndromes VVarnings e Long term effects of chronic electrical stimulation are unknown e Apply electrodes ONLY to normal intact clean skin Do not apply electrodes over open wounds or over swollen infected or inflamed areas or skin eruptions e g phlebitis thrombophlebitis varicose veins etc e DO NOT APPLY STI MULATION Over frontal area of the neck near site of carotid sinus nerves o Over the neck or mouth Severe spasms of the laryngeal and pharyngeal muscles may occur with contractions strong enough to close the2. V A L M E D V User Manual SWISSs7 Fitness V 6 0 SS FI V60 EN V10 Phone 0041 27 2033 65 81 website www valmed ch Fax 0041 27 2003 65 87 email info valmed ch l Introduction The SwiSSsnm Fitness is manufactured distributed by VALMED SA Sion Switzerland The SwisSs77 Fitness is manufactured in accordance with the requirements of European Safety Standards EN 60601 1 EN 60601 2 10 and meets all requirements of the American Safety Standards for Transcutaneous Stimulators as set forth in ANS AAMI NS4 1985 it is approved by the United States Food and Drug Administration FDA K031611 The SwisSs7y Fitness is a Class II Medical Device and conforms to the requirements of European Directive CEE 93 42 and holds certificate number CE 0476 R BF device IAW IEC 601 1 External Placement on Body A Read this User Manual especially Safety and Indications and Contraindications before using the SwiSSsym Fitness Manufacturer is not liable for any damage caused by the improper use of the SwisS gt 7 Fitness neuromuscular stimulator 2 Valmed SA Switzerland il Table of Contents VI VII VIII Introduction Table of Contents Safety and Precautionary Guidelines Indications for Use SwiSSs77 Fitness Unit Components Operating Instructions Program Descriptions Useful Information SwiSSs77 Fitness Technical and Safety Data Electrode Placement 3 Valmed SA Switzerland 14 16
3. F Selecting a Stimulation Program Make sure your SWISSs77y Fitness is ON The LCD display will indicate the number of programs Scan the programs by using the scroll keys and select desired program Once a program is selected by using the S Select KEY the LCD display will show specific information about the program name total program time and program phases phase length The program will start with the first program phase unless a specific phase is selected and will complete ALL phases of the program unless the user selects only a specific program phase G Selecting a Phase of a Stimulation Program Selecting only a program phase is possible Once a program has been selected icons for the program phases will appear on the LCD display Use the 4 scroll keys to high light the desired phase and press the S Select KEY to select the phase H Automatic Program OFF Function If no scroll key is pressed within 60 seconds the SwiSSsym Fitness will automatically switch OFF to conserve battery life Selecting Program Intensity Once a program has been selected the ntensity controls on the SwisSs77 Fitness are activated There are 2 scroll keys a 48 and a for each right and left channel of the SwiSSsym Fitness Use the fe scroll key for each channel to sncrease Intensity and the scroll key to decrease the Intensity level The ntensity scale is a 100 step scale with 100 corresponding to the maximum ntensity level J
4. airway and or cause difficulty in breathing Stimulation over the neck could also have a adverse effects on the heart rhythm or blood pressure Transcerebrally o Over swollen infected or inflamed areas of skin eruptions e g phlebitis thrombophlebitis varicose veins etc o Across the chest because the introduction of electrical current into the chest may cause rhythm disturbances to the heart which could be fatal Consult with your physician before using this device because it maybe possible to cause lethal rhythm disturbances to the heart in susceptible individuals Over or in proximity to cancerous lesions o If you are epileptic o After experiencing acute trauma or fracture 4 Valmed SA Switzerland o Following recent surgery o If you have a hernia abdominal or lingual o To the frontal laryngeal and temporal regions of the neck Never use the SwisSs77 Fitness while driving operating machinery or during activities in which involuntary muscle contractions may endanger the user or others The effects of stimulation of the brain are unknown Therefore do not apply stimulation across the head and do not place electrodes opposite sides of the head Do not use the SwiSSsym Fitness in the bath or shower Persons with suspected heart problems or epilepsy should obtain appropriate medical advice Never use the SwisSs77 Fitness while sleeping NEVER immerse the SwiSSsym Fitness unit in any liquid Precautions The safety o
5. trauma or surgical procedure in the past six 6 months Have cardiac problems or cardiac disease Have epilepsy Have painful and or atrophied muscles Have abdominal or inguinal hernia Have limited range of motion in skeletal joints Have blood circulatory problems 5 Valmed SA Switzerland F Electrode Guidelines The PalsFlex electrodes that are supplied as a standard accessory with your SwiSSsym Fitness mold easily to your body contours and are reusable The specific instructions for electrode use are indicated on the factory sealed storage pouch The recommended sizes are oval 3 by 5 electrodes for large areas e g leg muscles and round 3 electrodes for smaller areas such as forearm muscles e Use only skin pads electrodes supplied by manufacturer Other electrodes may not stimulate correctly and may render the treatment ineffective e Apply electrodes only to clean intact normal skin e Do not apply electrodes over open wounds inflamed swollen or infected skin area or over any skin eruptions such as varicose veins phlebitis etc e Do not share electrodes with other users Multiple users may result in adverse skin reactions e Replace self adhesive electrodes when they do not adhere stick firmly to the skin G Potential Adverse Reactions Skin irritation and burns beneath the electrodes has been reported from use of some neuromuscular stimulators 6 Valmed SA Switzerland IV Indications for Use The Swisss
6. 4 Strength This program imposes high power work on the muscle fibers and is intended to develop the maximum contractile force in a muscle The program consists of warm up and workout periods Stimulation is subtetanic twitch and continuous during the warm up phase and alternates between strong tetanic and weak twitch contractions during the workout phase Intensity of stimulation during the continuous twitch periods is automatically reduced in order to provide some rest between strong tetanic contractions There are no silent pauses during the workout phase Recommended frequency is not less than twice weekly 14 Valmed SA Switzerland Program 5 Explosive Strength This program increases the speed at which maximum muscle force is achieved This program consists of warm up and workout phases During warm up the stimulation is continuous at subtetanic twitch frequency while during the workout phase the stimulation alternates between short and strong tetanic and long periods of twitch contractions There is no pause during these phases Recommended frequency is as frequently as desired Program 6 Active Recovery This program consists of low frequency muscle twitches that simulate a massage and induce increased blood flow The program is one continuous no pause low frequency subtetanic stimulation The frequency of impulses and the impulse phase duration are constant during the entire program Recommended frequency is after each st
7. TI ON I NDI CATOR minutes ra mir Phase 0 PROGRAM PHASE NUMBER INDICATOR 9 Valmed SA Switzerland ven h dimn OSmin d mir iit WARM UP PHASE AND DURATION INDICATOR Indicate that warm up phase is selected dark background and lasts eleven minutes 05 mitt SPECIFIC WORK PHASE NDI CATOR AND DURATION Indicate the specific work phase and five minutes duration rin d mir EMAL COOL DOWN PHASE INDICATOR AND DURATION Indicate the winding down phase and four minutes duration l BATTERY CHARGE INDICATOR Example 0 EEE n a STIMULATION INTENSITY INDICATORS ON EACH CHANNEL saa Indicate stimulation ntensity level independently set on the two channels Example PS FINISH FINISH END OF PROGRAM I NDI CATOR The session is over Switch the unit OFF by pressing one of the two keys with a downward pointing arrow 10 Valmed SA Switzerland SMART CARD ABSENT INDICATOR The smart card on which the programs are recorded is not in place or is not properly inserted Switch unit OFF open the back battery slot and insert the smart card or check that card is correctly positioned SMART CARD INVALID INDICATOR The smart card inserted in the back slot is not valid Switch unit OFF open the back battery slot and insert a valid smart card INFORMATION ON FUNCTIONS DURING TREATMENT ode during treatment STOP Enables user to stop the program before pre set time RESUME Enables use
8. Using Pause Function Any SWISSs77y Fitness program can be paused by pressing the S Select KEY once When this is done the following choices can be made STOP Stops program RESUME Program resumes from point it was stopped 12 Valmed SA Switzerland CHANGE PHASE Returns user to program phase menu and allows user to repeat a phase skip to next phase or repeat the entire program K Switching Your Swissgsz w Fitness OFF During Treatment Press both scroll keys until the ntensity level falls to 0 press one of the scroll keys again and the unit will beep and switch OFF L Connections Please refer as needed to the control schematic of the SwisSs7 y Fitness page 8 1 2 3 4 Ensure that the unit is OFF Connect the skin pads electrodes to each output cable Position the skin pads electrodes on the motor points of the muscles to be treated refer to page 19 in this manual for proper positions Connect the output cables to the output socket of the Swisssz w Fitness unit The two 2 cables can be connected to either output socket on the SwissS7 M Fitness the SwissS77 M Fitness unit will function properly M Automatic Switch OFF The SwisSs77 Fitness will automatically switch OFF three 3 minutes after completion of a program To turn the unit OFF immediately press one of the scroll keys N Troubleshooting If your Swisssz Fitness unit is not working please check the foll
9. commended frequency is before all neuromuscular stimulation training sessions and also before any physical exercise or activity Program 2 Endurance Impulse sequences in this program are designed to improve the body s resistance to fatigue improved endurance and consist of warm up and workout periods During the warm up period the stimulation is continuous and muscle contractions are twitch like In the work period stimulation is intermittent and consists of ON and OFF periods During the ON period contractions are subtetanic while during the OFF period there is a pause with no stimulation and no muscle contractions Recommended frequency is two to three times weekly on major muscle groups Program 3 Resistance The impulse sequences in this program are intended to increase the time a muscle is able to maintain high power work over short time periods The intensive contractions of stimulated muscles may induce an exhaustion state in these muscle fibers without psychological fatigue and little cardiovascular stress The Resistance Program activates the anaerobic metabolism and induces the production of lactic acid This program consists of warm up and workout periods During the warm up period the stimulation is continuous no pauses During the workout periods it alternates between tetanic and twitch contractions There are no pauses during the workout phase Recommended frequency is three times weekly on target muscle groups Program
10. f neuromuscular stimulation during pregnancy has not been established Use caution when if o User has skin areas that lack normal sensation o Following surgical procedures if muscle contractions might impede the healing process o Over a menstruating or pregnant uterus o There is a tendency to bleed internally following acute trauma or fracture Place electrodes in accordance with illustrations in this User Manual Users should ensure that extremities are isometrically fixed braced during treatment sessions to prevent movement that results from stimulation This unit should not be used while driving operating machinery or during any activity in which involuntary muscle contractions may place the user at undue risk of injury Some users may experience skin irritation or hypersensitivity due to the electrical stimulation or the conductive medium Keep the SwisSs7 Fitness neuromuscular stimulator out of the reach of children Application of moderate heat thermal wrap to muscles as well as moistening skin prior to treatment improves treatment efficacy use of cold packs on treated muscles after treatment is likewise recommended This unit should only be used with the leads electrodes and accessories provided by the manufacturer DO NOT use the SwisSs7 Fitness IF YOU Have an implanted cardiac pacemaker defibrillator or other implanted electronic or metallic devices Have been diagnosed with cancer Are pregnant Have suffered acute
11. imulation and physical exercise results in the most positive fitness gains B Scheduling Neuromuscular stimulation works by inducing specific contractions at varied user selected intensity levels When starting neuromuscular training it is not unusual to experience some aching These aches are similar to aches that one experiences after eccentric work such as long downhill walks or intense jumping Scheduling of specific muscle groups is recommended avoid intensive stimulation of the same muscle groups on consecutive days Intensive stimulation tires the muscles and adequate recovery time is essential to attain improved muscle performance this phenomenon is known as overcompensation Taking the following steps will help minimize aching e Increase intensity levels workload gradually e Saunas and hot baths accelerate recovery after heavy exercise due to increased blood Supply to muscles 7 Valmed SA Switzerland C Training Complements Optimal muscle strength improvement is obtained when you combine different methods of muscle exercise Neuromuscular stimulation in conjunction with regular moderately intense exercise is especially effective in attaining maximum strength gains and is recommended for the serious athlete or physical fitness focused individual Recreational athletes should combine neuromuscular stimulations with other dynamic exercises these exercises can include endurance sports team sports sport training e
12. imulation training session The timing sequences and frequencies for the Swisssz Fitness programs are provided in this table Stimulus frequency maximum with tetanic contractions Max Impulse duration Program time total 15 Valmed SA Switzerland VIII Useful I nformation A Inserting or Replacing Batteries The battery charge indicator will indicate when the battery weakens and requires replacement If the battery is not replaced your SwiSSsym Fitness will cease to operate within one 1 hour Remove slide the cover of the unit Remove old battery and insert a fresh 9 volt lithium alkaline or rechargeable NiCd NiMh battery recharger and batteries provided in some countries Ensure proper battery polarity your SwisSs7 Fitness will not operate if polarity is reversed B Warnings Concerning Battery Handling Always read and follow the specific instructions provided by battery manufacturers Note the following Ensure that battery polarity is correct Do not expose batteries to temperatures exceeding manufacturer s specifications Do not store and or ship this unit with batteries inserted Do not attempt to recharge alkaline or lithium batteries Do not dispose of any battery in fire Note that batteries may present burn or fire hazard if short circuited Improper battery handling may result in explosion leakage or flames C Handling Cleaning the SWiSSsnm Fitness Unit Use soft brush or soft cloth to clean
13. oltage lt 5 V volts 10 Peak open circuit voltage during treatment 90mA milliamperes 10 Power Supply One 9 Volt lithium alkaline or NiCd NiMh rechargeable battery Battery charge lasts approximally 10 hours according to stimulation intensity The output and program timing parameters are stable 2 throughout the life of the battery Standard Accessories Four skin pads nonpolar self adhesive reusable electrodes One alkaline 9 Volt battery One 9 volt battery charger Two 9 volt rechargeable batteries 2 cables Carrying case and User Manual Size Unit size is approximately 12 5 8 1 2 6 cm Weight is 200 grams or approximately 7 oz Cleaning Maintenance Use soft brush or soft cloth to clean unit case do not use liquid cleansers Use same procedure with electrical leads Your Swisssz wm Fitness is designed to be maintenance free 17 Valmed SA Switzerland B Safety The SwiSSsym Fitness meets the requirements of ANSI AAMI NS4 1985 American Standard and the EC 601 2 10 European Safety Standard Specific Safety Features and Measures to Prevent Misuse The SwisSs77 Fitness is inherently designed so that improper or accidental application of this unit cannot produce cardiac rhythm disturbances This does not include individuals with implanted cardiac pacemakers This inherent safety is due to the minimal electric charge of all stimulating impulses in the SwiSSsynm Fitness n all programs of stimulation
14. owing 1 2 3 4 Is the battery correctly inserted Are the cable connectors properly inserted into the Swisssz Fitness unit Are the skin pads electrodes connected to the cables Are the skin pads electrodes adhering to the skin If not wet the pad surfaces sparingly with water With incorrect non symmetrical stimulation feeling please check the following eS S JC Ji Electrodes may be dry or greasy Electrodes not positioned correctly Battery almost empty Non symmetrical positioning of the electrodes See Section X Intensity on the two channels are set differently 13 Valmed SA Switzerland VII PROGRAM DESCRIPTIONS The SwiSSsym Fitness has six muscle stimulation programs Each program addresses a specific stimulation application for skeletal muscles Always stimulate muscles isometrically make sure that the limb in which a muscle is being stimulated is firmly secured to prevent the movement of the limb resulting from muscle contraction The SwiSSsym Fitness programs are defined as follows Program 1 Potentiation The Potentiation Program prepares muscles to work faster and easier at the very beginning of training This program features two continuous no pause stimulation patterns Muscle contractions are tetanic or subtetanic in the first pattern and the frequency of impulses is variable Contractions in the second pattern are twitch like The two patterns are alternatively repeated ten times Re
15. r to quit PAUSE mode and resume treatment from where it was stopped CHANGE PHASE OPTION Enables the user to return to the phase menu and repeat or lengthen one particular phase or skip to the following phase C Inserting New Batteries Slide back cover until battery compartment Is open Insert new battery use ONLY a 9 volt alkaline lithium high quality or rechargeable battery and ensure proper polarity D Inserting or Replacing Smart Card The Smart Card contains the specific program information for your SwisSs77jy Fitness f the card needs to be installed do so ONLY when your SwisSs77 Fitness is OFF Open battery compartment and insert the Smart Card into its slot making sure that the card is properly positioned LOGO on the card facing up 11 Valmed SA Switzerland E Turning Your SwiSSsym Fitness ON Press one of the scroll keys marked to turn the Swisssz a Fitness ON This activates the LCD screen and sound but not the ntensity function This function is only activated after a program selection has been made If the SwisSs7y Fitness log does not appear or if the display indicates low battery strength your SwiSSsynm Fitness will not function properly If the message SWITCH OFF NOW AND INSERT CARD appears turn the SwisSs7 Fitness OFF by pressing one of the scroll keys Insert Smart Card If the message INVALID CARD CHANGE CARD appears an invalid card has been inserted
16. tc THE BOTTOM LI NE The SwisSs77 Fitness is a truly valuable adjunct for training various muscle groups V Swisss Unit Components Connectors for electrode cables Display Menu navigation keys TT Backside cover battery compartment 8 Valmed SA Switzerland VI Operating Instructions A Key Symbols and Functions S Select Key Use this KEY to select a program select a program phase and to START a selected program Once a program has started use this KEY to make further selections in the program A Multiple Function Scroll Keys Use either key to turn the SwisSs7 Fitness ON When the SwiSSsym Fitness is ON use these keys to scroll through the programs Once a stimulation program has started use these keys to s ncrease the stimulation ntensity one key for each channel Y Multiple Function Scroll Keys When the SwisSs7j Fitness is ON use these keys to scroll through the programs Once a stimulation program has started use these keys to decrease the stimulation ntensity one key for each channel After stimulation program is completed use either key to turn the SwiSSsym Fitness OFF B Display LCD Screen I ndications SwiSS sym Fitness START SCREEN FITHESS FDA VWERSIOH LI 5 EHGLISH FPrOSr ams Example Program Screen 24 miki Phase os lt MENU NAVIGATION KEY SCROLL INDICATORS PROGRAM NUMBER I NDI CATOR P ACTIVE RECOVERY PROGRAM NAME INDICATOR PROGRAM DURA
17. the typical impulse is below 10 micro coulombs and the maximum possible impulse is 20 micro coulombs zero net current Moreover this maximum charge of 20 micro coulombs is significantly below the cardiac rhythm disturbance Safety margin of 25 micro coulombs per pulse the standard as established by the Association for Advancement of Medical Instrumentation AAMI in AAMI ANSI standard NS4 1985 and acknowledged by the U S Food and Drug Administration FDA Specific safety features in your SwiSSsym Fitness include 1 Impossible for users to modify the embedded programs users can only modify the intensity of stimulation 2 All programs begin with minimal electrical ntensity the user must increase the ntensity to the desired training level 3 Maximum possible electrical impulse is 20 micro coulombs 4 Cable design prevent the possibility of accidental connection to a power source such as an AC power outlet 5 Automatic control of stimulation current density precludes excessive current density at the electrode skin interface and ensures skin safety 18 Valmed SA Switzerland Electrode Placement Leg Electrode Placements Quadriceps Thighs Femoral Biceps Arms Electrode Placements Forearm Triceps Abdominals 19 Valmed SA Switzerland Femoral Biceps
18. unit case do not use liquid cleansers Use same procedure with electrical leads Your SwiSSsym Fitness is designed to be maintenance free D Storage Conditions The SwiSSsym Fitness may be stored for prolonged periods with no degradation ENSURE that the battery is removed when the unit is not used on a regular basis E Battery Disposal Always dispose of batteries in accordance with battery manufacturer instructions F Warranty Free replacement for two 2 years except for accessories incl batteries and shipping charges Free replacement will be made if defect is in manufacture of unit free replacement does not apply when damages are related to improper use or abuse of unit 16 Valmed SA Switzerland IX Swissszw Fitness Technical and Safety Data A Unit Technical Characteristics Stimulation Channels Two independent isolated channels Separate ntensity control levels for each channel Adjustments 5 keys control all stimulation functions and ntensity levels Display The graphical LCD 100 X 30 pixels 46x16 mm signals all stimulation functions stimulation intensity per channel length of program battery charge status etc Output Current waveform during training Asymmetrical biphasic with fast rise and zero net current Voltage waveform open circuit Low voltage rectangular compensated monophasic impulse Peak open circuit voltage during each impulse 45 Vp 10 Maximum Output at 500 Load RMS v
19. zw Fitness is intended for stimulation of healthy muscles in order to enhance and facilitate improved muscle performance The SwisSs7y Fitness is therefore properly considered as a technique or means for muscle training The SWISSs7 y Fitness is NOT intended for use in any therapy or for treatment of any medical conditions or diseases The SwisSs77 Fitness training programs are not designed or optimized for injured or otherwise impaired muscles and use of the SwisSs77j Fitness on such muscles is contraindicated SwiSSs77 Fitness provides six muscle stimulation training programs Each program is for specific application indication and stimulation of skeletal muscles as follows Potentiation training Program Endurance training Program Resistance training Program Strength training Program Explosive Strength training Program Active Recoverytraining Program ee Ad JE A Guidance for Effective Training with the SWiSSsnm Fitness Muscles gain strength when exposed to resistance loads that exceed approximately seventy 70 percent of maximal voluntary contraction MVC force The Swisssz nw Fitness achieves this level of MVC forces and in fact produces forces that range from 70 100 percent of your MVC optimal training results occur when muscles are stimulated ssometrically that is the arm s or leg s that is being stimulated is firmly secured to prevent movement of that limb which may result from muscle contractions Neuromuscular st
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