SP 8.0 - Fitness Equipment COMPEX - Free user manual and instructions

USER MANUAL SP 8.0 COMPEX

It is strongly recommended to read these instructions and the contra-indications and safety measures carefully before using your stimulator.

1. Explanation of symbols 02

2. How does electrostimulation work? 03

3. How does MI technology work (Muscle Intelligence)? 05

Composition of kits and accessories 07 Device description 08 First use 10 Device function 11 Charging 25

Guarantee 33 Maintenance 33 Storage/transport and use 33 Disposal 33

MD medical device The stimulator is a category II device with built-in power supply and type BF applied parts.

SN Serial number Manufacturer’s name and address and date of manufacture UDI UDI Unique Device Identication Name and address of approved representative in the European Community Best used by This device must be separated from household waste and sent to special collection facilities for recycling and recovery Origin and date of manufacture The stand-by button is multi- functional Relative humidity Protect from sunlight Temperature Store in a dry place Atmospheric pressure IP22 on the unit IP 22 on the unit means the protection is eective against ingress of foreign solid objects (diameter greater than 12.5 mm) and against ingress of dripping water (when tilted up tp 15°). CE mark with notify body number LATEX Latex-free Reference number Batch number03

Electrostimulation involves stimulating nerve fibres by electrical impulses transmitted by electrodes. The electrical impulses produced by Compex stimulators are high-quality impulses that are safe, comfortable and effective and stimulate various types of nerve fibres:

1. Motor nerves to stimulate a muscle response referred to as electrical muscle stimulation (EMS).

2. Certain types of sensitive nerve fibres to obtain analgesic effects or pain relief.

1. STIMULATION OF MOTOR NERVES (EMS)

With voluntary activity, the brain orders muscles to contract and a command is then sent to nerve fibres in the form of an electrical signal. This signal is then sent to muscle fibres, which contract. The principle of electrostimulation correctly reproduces the process involved in a voluntary contraction. The stimulator sends an electrical impulse to nerve fibres to excite them. This excitation is then transmitted to muscle fibres and results in a mechanical response (= a twitch). This is the basic requirement for muscular contraction. The muscular response is to all intents and purposes identical to the muscular work controlled by the brain. In other words, the muscle does not distinguish between a command sent by the brain or the stimulator. Programme settings (number of impulses per second, duration of contraction, rest time, total programme duration) subject the muscle to various types of workout, depending on the muscle fibre. Various types of muscle fibres can be identified depending on their respective contraction speeds: slow, intermediate and rapid fibres. A sprinter clearly has more rapid fibres and a marathon runner has more slow fibres. With good knowledge of human physiology and perfect control of stimulation settings in the various programmes, muscular workout can be very accurately directed to achieve the desired objective (muscular strengthening, increased blood circulation, firming, etc.).04

2. STIMULATION OF SENSORY NERVES

Electrical impulses can also excite sensory nerve fibres to obtain analgesic effects or pain relief. Stimulating tactile sensory nerve fibres blocks pain being transmitted to the nervous system. Stimulating another type of sensory fibre increases the production of endorphins and therefore reduces pain. With pain relief programmes, electrostimulation can be used to treat acute or chronic localised pain and muscle pain. Note: Do not use pain relief programmes for an extended period without medical advice.

BENEFITS OF ELECTROSTIMULATION

Electrostimulation is a very effective method for making muscles work:

• with a significant improvement in various muscle qualities

• with no cardiovascular or mental fatigue

• with limited stress exercised on joints and tendons. Electrostimulation thereby enables more muscular workout than voluntary activity. For optimum results, Compex recommends supplementing your electrostimulation sessions with other exercise, such as:

• regular physical exercise

• balanced and healthy diet

INTELLIGENCE)? N.B.: The activation/deactivation of MI functions is performed via the Settings menu MI-SCAN Just before starting a workout session, the MI-scan function probes the chosen muscle group and automatically adjusts the stimulator settings to the excitability of this area of the body, depending on your physiology. This function results in, at the start of the programme, a short test sequence during which measurements are taken. At the end of the test, intensities must be increased to start the programme. MI-TENS The MI-tens function limits unwanted muscle contractions in painful areas. With each intensity increase, a test phase occurs and if a muscular contraction is detected, the device automatically reduces the intensity of the stimulation. This function is only accessible in the TENS, Epicondylitis and Tendinitis programmes. MI-RANGE The MI-range function allows the user to select the ideal level of stimulation intensity for recovery, massage, capillarisation or even muscle pain programmes. At the beginning of the programme, the device prompts the user to increase stimulation intensity. During this increase, the device analyses the response of each stimulated muscle, and deduces their optimal level. As soon as a muscle reaches its optimal level, the related channel is automatically deselected and the stimulation intensity cannot be increased. To recover control, simply re-select the channel in question and raise or lower the stimulation intensities. MI-AUTORANGE The MI-autorange function pursues the same objective as MI-range except that in this case everything is done automatically. At the beginning of the programme, a single press of the up key of the multifunction pad allows the device to automatically increase the stimulation intensities until it detects the ideal level of intensity. Pressing the down key of the multifunction pad cancels the MI-autorange function. The device then goes into manual mode and intensities must be managed by the user.06 MI-ACTION The MI-action function allows you an electro-induced contraction to be initiated by means of a voluntary action. Thus the electro-induced contraction is perfectly controlled, the workout becomes more comfortable, more thorough and more complete. At the end of each active rest phase the remote control emits a beep. From this point the start of voluntary contraction is possible. If no voluntary contraction has occurred after a certain period of time, the device will automatically pause. This work mode is available only for programmes inducing powerful muscle contractions. N.B.: To function properly, the MI-action function needs good muscle twitches during the active rest phase. If they are not significant enough, the device emits beeps and a + sign appears on the channels. Similarly, in order to render these twitches possible, it is imperative that muscles be well relaxed during the rest phase. At the end of each contraction phase, it is necessary to ensure that you return to a position allowing for best muscle relaxation. The table below shows which functions are available with each device.

Only use this device with cables, electrodes, battery, power adaptor and accessories recommended by Compex.08 DEVICE DESCRIPTION REMOTE CONTROL A - On/Off button (press briefly to turn on, hold down for more than 2 sec. to turn off) B - 4 buttons for the selection/deselection of the stimulation channel C - Multifunction pad (up-down-left-right) to navigate the interface and increase or decrease the level of stimulation intensity of the selected channels D - Confirm button E - Plug for the USB cable or the docking station connector MODULE A - On/Off button (press briefly to turn on, press and hold down to turn off) Flashing green LED: Ready Flashing yellow LED: In stimulation B - Groove for winding the cable

SP 6.0 AND 8.0 DOCKING STATION

A - Remote control charging connector B - Notch to open the lid of the docking station C - Location for positioning the modules to be recharged D - Charger plug

FIT 5.0 DOCKING STATION

A - Remote control charging connector B - Location for positioning the modules C - Location for positioning the modules to be recharged D - Charger plug

C10 FIRST USE When using the device for the first time, the following steps must be followed:

2. Turn on all modules in order to pair them with the remote control.

Once a module is turned on and recognized by the remote control, a check appears on the module. When all modules are paired all check marks appear. N.B.: This pairing procedure is to be performed only once.11

The Favourites menu displays the last programmes done. You need only have one programme in the Favourites menu to become directly accessible after turning on the device. The programmes done will automatically be placed in the Favourites menu. The Favourites menu can contain up to 10 programmes. If new programmes are done, the old ones will automatically be removed from the list of favourites.

A Select the Favourites menu B Confirm your selection

A Select the desired electrode placement B Confirm your selection C Return to the previous step

A Select the desired favourite programme B Confirm your selection C Return to the previous step

DEVICE FUNCTION N.B.: The following screens are generic examples but they work in the same way regardless of the device that you have.12 The placement of electrodes selected during the programme appears. It is possible to scroll through other electrode placements.

3. CONNECT THE MODULES TO THE ELECTRODES

Stick the electrodes to your skin. The module is attached to the electrode from the side. Slide the module onto the electrode’s snap until it clips into place.

4. TURN ON THE MODULES

To launch the programme, see the section entitled “Start a stimulation programme.” A Return to the previous step B Confirm your selection BA13

For more information on programmes, connect to: www.compex.info The Programmes menu displays the programme categories.

A Select the desired programme category B Confirm your selection C Return to the previous step

A Select the desired programme B Confirm your selection C Return to the previous step

A Select the Programmes menu B Confirm your selection

Stick the electrodes to your skin. The module is attached to the electrode from the side. Slide the module onto the electrode’s snap until it clips into place.

5. TURN ON THE MODULES

To launch the programme, see the section entitled “Start a stimulation programme.” A Return to the previous step B Confirm your selection

A Select the desired electrode placement B Confirm your selection C Return to the previous step

HOW TO ACCESS OBJECTIVES

The Objectives menu displays the objectives downloaded from your personal account (see section entitled “Creating your personal account”). N.B.: The Objectives menu is only available for the SP 8.0 device. The progress bar under the objective shows the progress of the objective and what remains to be done. The bell indicates that there is an element of the objective to perform today.

1. SELECT AN OBJECTIVE

A Select the desired objective B Confirm your selection C Return to the previous step

A Select the Objectives menu B Confirm your selection

A Indicates an element of the objective to perform today B What remains to be done C What has already been accomplished: - What has been completed appears in green - What has not been completed appears in red16

2. SELECT AN ELEMENT TO DO

The element to do can be a programme or a task. The element to do is selected by default, but it is possible to select another. The next to a programme or a task signifies that it has been done.

3. SELECT ELECTRODE PLACEMENT

N.B.: In most cases a different electrode placement cannot be selected because it is directly linked to the objective.

4. CONNECT THE MODULES TO THE ELECTRODES

Stick the electrodes to your skin. The module is attached to the electrode from the side. Slide the module onto the electrode’s snap until it clips into place. A Select the desired element B Confirm your selection C Return to the previous step

A Select the desired electrode placement B Confirm your selection C Return to the previous step

To launch the programme, see the section entitled “Start a stimulation programme.” A Return to the previous step B Confirm your selection BA18

HOW TO ACCESS SETTINGS

The Settings menu enables certain elements to be configured such as backlighting, volume, language, etc. Some settings are not available in all devices.

Language: Allows you to change the device’s language MI-autorange: Turns the MI-autorange function on (ON) or off (OFF) MI-range: Turns the MI-range function on (ON) or off (OFF) MI-scan: Turns the MI-scan function on (ON) or off (OFF) MI-tens: Turns the MI-tens function on (ON) or off (OFF) MI-action: Turns the MI-action function on (ON) or off (OFF) N.B.: For an explanation of MI functions see the section entitled “3. How does MI technology work?”. A Select the Settings menu B Confirm your selection

A Select the desired setting B Confirm your selection C Return to the previous step

Cycles: Turns the Cycles function on (ON) or off (OFF) The Cycles function is for people who are already accustomed to electrostimulation and want to perform several training cycles. If the Cycles function is turned on (ON) an additional screen will appear for certain programmes (programmes inducing powerful muscle contractions) enabling the training cycle to be selected. The cycle logic refers to the workload performed by electrostimulation. And just like a normal workout, one has to to start with an amount of work then increase it over the course of the cycles. Thus, it is recommended starting with the 1st cycle and going on to the next level when the cycle is finished, normally after 4 to 6 weeks of stimulation based on 3 sessions per week. It is also important to have reached significant stimulation intensities in sessions before going on to another cycle. Power saving: Turns the Power saving function on (ON) or off (OFF). Decreases the intensity and the backlighting time. Sound: Turns the Sound function on (ON) or off (OFF). Contraction sound: Turns the contraction arrival warning sound on (ON) or off (OFF). Set time: Allows you to set the time on the device. Set date: Allows you to set the date on the device. Pair a new module: Enables a new module to be paired to the remote control. Reset the device: Enables the device to be re-set and return to the basic settings (Favourites deleted, Objectives cleared, Default settings). System info: Enables information related to the device to be viewed.20

START A STIMULATION PROGRAMME

Before beginning any stimulation programme, you must turn the modules on. To turn on the modules, press their respective On/Off button. As soon as the module is turned on, its battery level appears on the screen. Turn on the number of modules desired according to the electrode placement selected. As soon as a sufficient number of modules is turned on, a small arrow appears on the right of the screen. If the MI-scan function is activated, the programme starts with a short sequence during which measurements are taken. For the duration of the measurement test, it is important to stand still and be perfectly relaxed. Once the test is completed, the programme can start. Stimulation always starts at 000. A Return to the previous step B Confirm your selection and start the programme A B A Contraction phase B Warm up phase C Active rest phase D Relaxation phase E Number of contractions performed / Total number of contractions F Indication of the active MI function G Pop-up help indicating information or actions to be taken

Increase the stimulation intensities on the selected channels. By default, all of the channels are active at the beginning of the session. To deselect a channel, simply press the corresponding button. In this case only channel 1 is active. Any change of intensity will only be performed on channel 1.

A Select the channels on which to act. When a channel is active the LED button emits a strong blue light. B Pause C Increase or decrease the stimulation intensities on the selected channels

A A C22 Depending on the programme, the diagram on the middle of the screen can change.

CONTRACTION/ACTIVE REST PROGRAMME

These programmes always begin with a warm-up phase. After this warm-up phase, a contraction cycles phase followed by active rest occurs (the number of cycles depends on the programme) and when all cycles are completed, the programme ends with a relaxation phase.

MASSAGE, RECOVERY TYPE PROGRAMME

These programmes consist of a single phase and have no contraction/active rest cycle. These are recovery, massage, capillarisation, or even pain type programmes. During this type of programme, frequency variations can occur. A Work phase

A Warm up phase B Active rest phase C Relaxation phase D Contraction phase E Work phase which consists of a contraction/active rest cycle

By pressing on the central button of the remote control or on the On/Off button of one of the modules during the stimulation, the device goes into pause. At this point it is possible to skip the current phase or exit the programme. Depending on the programme, maximum and average intensities statistics may appear. N.B.: The session restarts with intensities equal to 80% of those used prior to the interruption. A Skip the current phase or exit the programme B Resume the stimulation session C Skip the current phase or exit the programme CBA A Average stimulation intensity B Maximum stimulation intensity

At the end of the session a screen with a check mark appears. Pressing on any button returns you to the Favourites menu. To turn off the device, hold down the remote control’s On/Off button for 2 seconds. This will also result in turning off all modules. Depending on the programme, maximum and average intensities statistics may appear.25

Module battery levels appear just prior to launching the stimulation session. The remote control battery level is always visible in the top right corner.

CONNECT THE DOCKING STATION

Connect the AC adapter supplied with your device to the docking station and then plug it into a power outlet. It is strongly recommended that you fully charge the remote control batteries and modules before first use in order to improve its performance and life expectancy. A Module battery level B Remote control battery level

B26 CHARGE THE REMOTE CONTROL AND THE MODULES At the end of the stimulation session, it is strongly recommended that you store the remote control and modules in the docking station to charge the elements. SP 6.0, 8.0 FIT 5.0 In order to do so, place the remote control on its connector. Then place the modules in the slots provided for this purpose. To do so, place the pod without the On/Off button (the green one in the figure) in the location indicated in green and the other pod in the location indicated in blue. Do the same for the other modules.27

The pod without the On/Off button must fit on the small connectors. A magnet as well as the small vertical mark on the hull of the pod helps to position the pod correctly in its slot. When it is positioned correctly you should hear a click. N.B.: If the device is not used for an extended period, we recommend that you charge the batteries to 50% of their capacity every 3 months. A Remote control battery charging B Module charging C Module charged D No module present

A Remote control battery charging LED flashing: Module charging LED full: Module charged

When a module is placed on the docking station it appears on the remote control’s screen. As soon as the remote control and modules are fully charged, they go into standby mode. When a module is placed on the docking station, the green LED indicates the module’s status. As soon as the remote control and modules are fully charged, they go into standby mode. SP 6.0, 8.0 FIT 5.028

CREATE YOUR PERSONAL ACCOUNT

To take advantage of all of your device’s capabilities you must first create an account at the following address www.compexwireless.com and follow the instructions on the website. Functions associated with the SP 8.0

• Access a training schedule

• Download preset objectives directly into the device

• Create your own objectives and download them directly into the device

• Upload the device’s history (stimulation programmes done) to the website As soon as an objective is downloaded into the remote control, the first screen that appears when the device is switched on displays the daily tasks to be performed. Functions associated with the SP 6.0 and FIT 5.0

• Access a training schedule

• Upload the device’s history (stimulation programmes done) to the website29

ELECTRODE FAULT The remote control displays the symbol of an electrode and a disconnected module and an arrow flashes on the channel in question (in this case, channel 1).

• Ensure that the electrodes are properly connected to the module.

• Check to see if electrodes are old, worn and/or if contact is poor: try using new electrodes.

The remote control displays the out of range symbol and an arrow flashing on the channel where the problem was detected (in this case, channel 1).

• Check to make sure that the module and the remote control are less than 2 metres away from each other.

• Make sure you are not in an isolated area with no obstacle to reflect the signal from the remote control.

• Make sure you are in an area that enables the signal to be reflected from the remote control.30 SYNCHRONIZATION PROBLEM If the synchronization process was discontinued or cannot run successfully for any reason (remote control disconnected, power failure, etc.) the remote control may, in some cases, display this screen.

• Reconnect the remote control to the computer and restart the synchronization process.

BEHAVIOUR OF THE MODULE’S LED

The LED alternately flashes green and red: the module is out of range or not recognized by the remote control.

• Ensure the remote control is on.

• Ensure that the module and the remote control are less than 2 metres away from each other. The LED is still red.

• Ensure the module is charged.

• Try to restart the remote control and modules.

• If despite this the LED is still red, contact customer service provided and approved by Compex. The LED does not turn on.

• Ensure the module is charged.

• If despite this the LED still does not turn on, contact customer service provided and approved by Compex.31

MODULE UNCHARGED During the stimulation a module may be uncharged. In this case the symbol for an uncharged battery appears and an arrow flashing on the channel where the problem was detected (in this case, channel 1).

• Stop the stimulation and recharge the uncharged module.

• Abandon the uncharged module and continue the stimulation session without it. THE MODULE WILL NOT PAIR WITH THE REMOTE CONTROL At the time of first use, if the remote control is unable to pair all modules, an error message may appear.

• Ensure that the module is charged, and repeat the pairing step.

• If despite this the message returns, contact customer service provided and approved by Compex. STIMULATION DOES NOT PRODUCE THE USUAL SENSATION

• Check that all settings are right and check electrodes are properly positioned.

• Change the positioning of the electrodes slightly.

STIMULATION CAUSES DISCOMFORT

• Electrodes lose their adhesive capacity and no longer provide adequate contact with skin.

• Electrodes are worn and must be replaced.

• Change the positioning of the electrodes slightly.32

THE DEVICE IS NOT WORKING

• Ensure that the remote control and modules are charged.

• Try to restart the remote control and modules.

• If despite this the device still does not work, contact customer service provided and approved by Compex.33

GUARANTEE See the attached leaflet. MAINTENANCE Your stimulator does not require any calibration or periodic maintenance. Use a soft cloth and solvent-free alcohol-based detergent to clean your device. Use as little liquid as possible to clean the device. Do not dismantle the stimulator or the charger because they contain high voltage components which could cause electrocution. This must be carried out by Compex-approved technicians or repair services. If your stimulator contains parts that appear to be worn or faulty, please contact the closest Compex customer service centre.

TEMPERATURE -20° C to 45° C 0° C to 40° C

MAXIMUM RELATIVE HUMIDITY

75% 30% to 75% ATMOSPHERIC PRESSURE from 700 hPa to 1060 hPa from 700 hPa to 1060 hPa Do not use in areas at risk of explosion. DISPOSAL Batteries must be disposed of in accordance with national current regulations. Any product bearing the WEEE label (a bin crossed out with a cross) must be separated from household waste and sent to special recycling plants.34

7. TECHNICAL SPECIFICATIONS

GENERAL INFORMATION Remote control battery: Rechargeable 3.7[V] / ≥ 1,500[mAh] lithium polymer (LiPo) battery. Module battery: Rechargeable 3.7[V] / ≥ 450[mAh] lithium polymer (LiPo) battery. SP 6.0, 8.0, FIT 5.0 AC power adapter: Only 5[V] / 3.5 [A] AC power adapters bearing reference number 64902X can be used to recharge your device. Product and accessories expected service life: 5 years Electrode shelf life: refer to electrodes bag NEUROSTIMULATION All the electrical specifications are supplied for an impedance from 500 to 1000 ohms per channel. Outputs: four independent and individually adjustable channels, electrically insulated from one another. Impulsion form: constant rectangular current with compensated impulses to eliminate any direct element of continuous current to avoid any residual polarisation from the skin. Maximum impulse intensity: 120 mA. Impulse intensity increments: manual adjustment of stimulation intensity from 0 to 999 (energy) by minimum increments of 0.25 mA. Duration of impulses: from 50 to 400 μs. Maximum quantity of electricity per impulse: 96 microcoulombs (2 x 48 μC, compensated). Typical impulse rise time: 3 μs (20%-80% of maximum current). Frequency of impulses: 1 to 150 Hz.35

RF DATA Transmission frequency band: 2.4[GHz] ISM The characteristics of the type and frequency of modulation: GFSK, +/-320[kHz] deviation Effective emission power: 4.4 [dBm] STANDARDS To ensure your safety, the stimulator has been designed, manufactured and distributed in accordance with the requirements of the amended European Directive 93/42/CEE covering medical devices. The stimulator also complies with the CEI 60601-1 standard covering general safety requirements for electromedical devices, with the CEI 60601-1-2 standard covering electromagnetic compatibility and the CEI 60601-2-10 standard covering special safety requirements for nerve and muscle stimulators In accordance with current international standards, a warning must be given about applying electrodes to the thorax (increased risk of cardiac fibrillation). The stimulator also complies with Directive 2002/96/CEE covering electrical equipment and electronic waste (WEEE). INFORMATION ABOUT ELECTROMAGNETIC COMPATIBILITY (EMC) The Compex is designed to be used in typical domestic approved environments in accordance with the safety standard EMC EN 60601-1-2. This device emits very low levels in the radiofrequency interval (RF) and is therefore not likely to cause interference with electronic equipment nearby (radios, computers, telephones, etc.). The Compex is designed to support anticipated disturbance originating from electrostatic discharge, magnetic fields for the power supply or radiofrequency emitters. However, it is not possible to guarantee that the stimulator will not be affected by powerful RF fields (radiofrequency) originating from other sources. For more information about electromagnetic emission and immunity, please contact Compex.36

The Compex Stimulator requires special precautions regarding EMC and needs to be installed and put into service according to the information provided on the EMC in this manual. All RF wireless transmission devices can affect the Compex Stimulator. The use of accessories, sensors, and cables other than those specified by the manufacturer, may result in greater emissions or reduce the immunity of the Compex Stimulator. The Compex Stimulator should not be used beside or stacked on other equipment, if adjacent or stacked use is necessary, one must check the correct functioning of the Compex Stimulator within the context of the configuration used.

The Compex Stimulator is intended for use in the electromagnetic environment specied below. The customer or user of the Compex Stimulator should ensure that it is used in this environment

EMISSIONS TEST COMPLIANCE

ELECTROMAGNETIC ENVIRONMENT - GUIDE RF emissions CISPR 11 Group 1 The Compex Stimulator uses RF energy only for its internal operation. Consequently, its RF emissions are unlikely to interfere with any adjacent electrical device (radios, computers, telephones etc.). RF emissions CISPR 11 Class B Compex Stimulator is suitable for use in any establishment, other than a private dwelling or a place connected directly to the low voltage mains supply which powers residential buildings. Harmonic emissions

Class A Voltage uctuations/ emission oscillations

RECOMMENDATIONS AND DECLARATION BY THE MANUFACTURER CONCERNING ELECTROMAGNETIC IMMUNITY Compex Stimulator is designed for use in the electromagnetic environment stipulated below. The buyer or user of the Compex Stimulator must ensure it is used in this recommended environment. IMMUNITY TEST TEST LEVEL IEC 60601 OBSERVANCE LEVEL ELECTROMAGNETIC ENVIRONMENT - RECOMMENDATIONS Electrostatic discharge (DES)

±6 kV at the contact ±8 kV in air ±6 kV at the contact ±8 kV in air Floors must be wood, concrete or ceramic tile. If oors are covered with synthetic material the relative humidity must be maintained at a minimum of 30%. Fast transient electrical bursts

±2 kV for power supply lines ±1 kV for input/output lines ±2 kV for power supply lines Not Applicable for input/ output lines The quality of the electrical power supply should be that of a typical commercial or hospital environment. Surge

±1 kV dierential mode N/A ±1 kV dierential mode ±2 kV joint mode The quality of the power supply should be that of a typical commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply lines

<5 % VT (dips >95 % de UT) for 0.5 cycle <40 % VT (dips >60 % de UT) for 5 cycles <70 % VT (dips >30 % de UT) for 25 cycles <5 % VT (dips >95 % de UT) for 5 seconds <5 % VT (dips >95 % de UT) for 0.5 cycle <40 % VT (dips >60 % de UT) for 5 cycles <70 % VT (dips >30 % de UT) for 25 cycles <5 % VT (dips >95 % de UT) for 5 seconds The quality of the power supply should be that of a typical commercial or hospital environment. If the Compex Stimulator user requires continuous operation during mains power cuts, it is recommend that the Compex Stimulator is powered by a UPS or a battery. Magnetic eld at grid frequency (50/60 Hz)

3 A/m 3 A/m Magnetic elds at the mains frequency should be at a level characteristic of a typical location in a typical commercial or hospital environment. NOTE :VT is the AC supply voltage before application of the test level.38

Compex Stimulator is designed for use in the electromagnetic environment stipulated below. The buyer or user of the Compex Stimulator must ensure it is used in this recommended environment. IMMUNITY TEST

OBSERVANCE LEVEL ELECTROMAGNETIC ENVIRONMENT - RECOMMENDATIONS Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz 3 Vrms 3 V/m Portable and mobile RF communication devices must only be used relative to the Compex Stimulator and its wiring at a distance which is not less than the spacing recommended and calculated using the appropriate equation for the transmitter’s frequency. Recommended spacing d = 1.2 √P d = 1.2 √P 80 MHz to 800 MHz d = 2.3 √P 800 MHz to 2.5 GHz where P is the maximum output power of the transmitter in watts (W) set by the manufacturer’s specications and where d is the recommended spacing in metres (m). The eld intensity of RF xed transmitters, as determined by an electromagnetic survey a must be less than the observance level to be found in each frequency rangeb. Interference may occur close to any appliance identied by the following symbol: NOTE 1 At 80 MHz and at 800 MHz ,the high frequency amplitude is applied NOTE 2 These guidelines may not be appropriate for some situations. Electromagnetic wave propagation is modied by absorption and reection due to buildings, objects and persons. a The eld intensity from xed transmitters, such as radio telephone base stations (cellular/wireless) and a mobile radio, amateur radios, AM and FM radio transmissions and TV transmissions cannot be predicted with any accuracy. It may therefore be necessary to consider an analysis of the electromagnetic environment of the site to calculate the electromagnetic environment coming from xed RF transmitters. If the eld intensity measured in the environment where the Compex Stimulator is located exceeds the appropriate RF observance level above, the Compex Stimulator should be monitored to ensure it is operating properly. In the event of abnormal operation, new measures may then be imposed, such as realignment or movement of the Compex Stimulator. b Above the frequency amplitude from 150 kHz to 80 MHz, the eld intensity must be < 3 V/m. 20xx LATEX FREE REF39

The Compex Stimulator is designed for use in an electromagnetic environment in which radiated RF waves are controlled. The buyer or user of the Compex Stimulator can contribute to preventing electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication devices (transmitters) and the Compex Stimulator according to the table of recommendations below and according to the maximum output power of the telecommunication device.

In the case of transmitters whose maximum output power is not shown in the table above, the recommended spacing of d in metres (m) can be calculated using the appropriate equation for the transmitter frequency, where P is the maximum output power of the transmitter in watts (W) as set by the transmitter manufacturer NOTE 1 At 80 MHz and at 800 MHz ,the spacing for high frequency amplitude is applied. NOTE 2 These guidelines may not be appropriate for some situations. Electromagnetic wave propagation is modied by absorption and reection due to buildings, objects and persons.40

ESSAI D’ÉMISSIONS CONFORMITÉ

4. ACCENSIONE DEI MODULI

5. ACCENSIONE DEI MODULI

5. ACCENSIONE DEI MODULI

GUASTO AGLI ELETTRODI

5. PROBLEEMOPLOSSING

INNEHÅLLSFÖRTECKNING