Compex Systems SP4.0: инструкция

Instruction for use

Mode d’emploi

Anweisungen

Istruzioni

Instrucciones

Instructies

Instruções

Инструкция

Bruksanvisning

Instruction for use

EN

TABLE OF CONTENTS

1. Explanation of symbols 02

2. How does electrostimulation work? 03

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

4. Device function 06

Contents of kits and accessories 06

Device description 07

Battery insertion 08

Connection 08

Preliminary settings 09

Choosing a category 09

Selecting a programme 10

MI-scan test 11

Adjusting stimulation intensities 11

Programme progression 12

End of a programme 13

Battery level and charging 13

5. Troubleshooting 15

6. Device maintenance 18

7. Technical specifications 19

8. EMC Table 21

It is strongly recommended to read these instructions and the contra-indications and safety

measures carefully before using your stimulator.

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EN

1. EXPLANATION OF SYMBOLS

See the instructions

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

Manufacturer’s name and address and date of manufacture

Name and address of approved representative in the European Union

This device must be separated from household waste and sent to special collection facilities for

recycling and recovery

The stand-by button is multi-functional

Protect from sunlight

Store in a dry place

This is an indication for protection against ingress of water and particulate matter. The mark IP20

IP20

on your unit means: your unit is protected against solid foreign objects of 12.5mm dia and greater.

on the unit

Not protected against water

IP02

IP02 on the carrying case means: Protected from the ingress of water droplets from a shower

on the case

of rain.

Latex-free

Reference number

Batch number

02

EN

2. HOW DOES ELECTROSTIMULATION WORK?

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 muscular 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 accurately 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 basic 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 work, depending on the muscle fibre. Various types

of muscle fibres can be identified according to their respective contraction speeds: slow, intermediate

and fast fibres. A sprinter clearly has more fast fibres and a marathon runner has more slow fibres. With

good knowledge of human physiology and full control of stimulation settings of the various programmes,

muscular work can be specifically pinpointed to achieve the desired objective (muscular strengthening,

increased blood circulation, firming, etc.).

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EN

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.

Caution: 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 muscular qualities

• With no cardiovascular or mental fatigue

• With limited stress exerted on joints and tendons. Electrostimulation thereby enables more muscular

work than voluntary activity.

For optimum results, Compex recommends supplementing your electrostimulation sessions with other

commitments, such as:

• Regular physical exercise

• A balanced and healthy diet

• A balanced lifestyle

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EN

3. HOW DOES MI (MUSCLE INTELLIGENCE)

TECHNOLOGY WORK?

To access MI functions the MI-sensor cable (not available on all devices) must be connected to the stimulator.

MI-SCAN

Just before starting a work 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 a short test sequence at the start of the programme, during which measurements

are taken.

At the end of the test, the intensity has to be increased to start the programme.

MI-TENS

The MI-tens function limits unwanted muscle contractions in painful areas.

With each intensity increase applied by the user, 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 indicates the ideal range for adjusting stimulation intensity, to be followed in the

following programmes: recovery, massage, capillarisation or even muscle pain.

When the device has detected the ideal intensity range, check mark will appear on the screen. For optimum

work, intensity should be kept within this range.

Not all devices have MI technology. The table below shows which functions are available with each device.

SP 2.0 SP 4.0 FIT 1.0 FIT 3.0

MI-SCAN

✓ ✓

-

✓

MI-TENS -

✓

-

-

MI-RANGE -

✓

-

-

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EN

4. DEVICE FUNCTION

CONTENTS OF KITS AND ACCESSORIES

SP 2.0 SP 4.0 FIT 1.0 FIT 3.0

REF QTY REF QTY REF QTY REF QTY

STIMULATOR 001096 1 001095 1 001098 1 001097 1

CHARGER 6830XX 1 6830XX 1 6830XX 1 6830XX 1

SET OF 4 SNAP CABLES 001119 1 001119 1 001119 1 001119 1

MI-SENSOR CABLE 601160 1 601160 1 N/A N/A 601160 1

BAG OF SMALL 5X5

42215 2 42215 2 42215 2 42215 2

ELECTRODES

BAG OF LARGE 5X10

42216 2 42216 2 42216 2 42216 2

ELECTRODES

INSTRUCTIONS ON

880053 1 880053 1 880053 1 880053 1

CD-ROM

QUICK START GUIDE 885624 1 885624 1 885624 1 885624 1

CARRY CASE 680029 1 680029 1 680029 1 680029 1

BATTERY PACK 94121X 1 94121X 1 94121X 1 94121X 1

Only use this device with cables, electrodes, battery, power adaptor and accessories

recommended by Compex.

06

EN

DEVICE DESCRIPTION

H

A

DE

G

F

C

B

A Standby button

B Sockets for the 4 stimulation cables

C Stimulation cables

D +/- buttons for the 4 stimulation channels

E I-button, which allows:

• The intensities to be increased on several channels at the same time

• The last 5 programmes used to be accessed

F Charger socket (slide the red cover to the right to reveal the charger connector)

G Battery compartment

H Socket for belt clip

07

EN

The charging menu shown below appears automatically.

The charging duration is displayed on the screen. As soon as charging is complete, the battery flashes.

Disconnect the charger: the stimulator will switch off automatically.

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EN

5. TROUBLESHOOTING

ELECTRODE FAULT

The device emits a tone and alternately displays the pair of electrodes symbol and an arrow pointing towards

the channel on which a problem has been detected. In the above example, the stimulator has detected an

error on channel 1.

Check that the electrodes are connected to this channel.

If electrodes are old, worn and/or if the contact is poor: try using new electrodes.

Try using the stimulation cable on a different channel. If the cable is still faulty, replace it

(www.compexstore.com).

STIMULATION DOES NOT PRODUCE THE USUAL SENSATION

Check that all settings are correct and check electrodes are properly positioned.

Change the position of the electrodes slightly.

STIMULATION CAUSES DISCOMFORT

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

Electrodes are worn and must be replaced.

Change the position of the electrodes slightly.

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EN

THE STIMULATOR IS NOT WORKING

When an error screen is displayed during use, note the error number (in the example, the error number is

1/0/0) and contact the Compex-approved customer service centre.

THE BATTERY IS VERY FLAT

If the following screen appears, switch the device off and connect the charger.

If a battery is very flat, a recovery cycle will start, lasting 2 minutes.

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EN

When this has finished, if the battery is working properly, it will start charging; in this case, it is strongly

recommended to perform a charge/discharge cycle for the battery by pressing on the channel 4 button

to launch this cycle, which may take up to 12 hours. If, however, it proves to be faulty, the following screen

appears and the battery must be replaced.

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EN

6. DEVICE MAINTENANCE

GUARANTEE

See the attached leaflet.

MAINTENANCE

Your stimulator does not require neither calibration nor periodic maintenance. However when needed clean

with a soft cloth and solvent-free alcohol-based detergent. Use as little liquid as possible to clean the device.

Do not disassemble the stimulator or the charger as 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.

CONDITIONS FOR STORAGE/TRANSPORT AND USE

STORAGE AND TRANSPORT USE

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 regulatory requirements in force. Any product

bearing the WEEE label (a crossed-out wheeled bin) must be separated from household waste and sent to

special collection facilities for recycling and recovery.

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EN

7. TECHNICAL SPECIFICATIONS

GENERAL INFORMATION

94121x rechargeable Nickel-metal hydride (NiMH) battery (4.8 V / ≥ 1200 mA/h).

Battery chargers: only battery chargers with the part number 6830xx can be used to recharge the batteries

supplied with the stimulator.

Product and accessories expected service life: 5 years

Electrode shelf life: refer to electrodes bag

NEUROSTIMULATION

All the electrical specifications are supplied with an impedance from 500 to 1000 ohms per channel.

Channels: four independent and individually adjustable channels, electrically isolated from each other.

Impulsion form: constant rectangular current with pulse compensation to eliminate any direct current

component to prevent residual polarisation at skin level.

Maximum pulse intensity: 120 mA.

Pulse intensity increments: manual adjustment of stimulation intensity from 0 to 999 (energy) by minimum

increments of 0.5 mA.

Pulse amplitude: from 60 to 400 μs.

Maximum electrical charge per pulse: 96 microcoulombs (2 x 48 μC, compensated).

Standard pulse ramp-up time: 3 μs (20 %-80 % of maximum current).

Pulse frequency: 1 to 150 Hz.

INFORMATION ABOUT ELECTROMAGNETIC COMPATIBILITY (EMC)

The stimulator is designed to be used in typical domestic environments approved in accordance with the

safety standard EMC EN 60601-1-2.

This device emits very low levels in the radio frequency (RF) interval and is therefore not likely to cause

interference with nearby electronic equipment (radios, computers, telephones, etc.).

The stimulator is designed to withstand foreseeable disturbances originating from electrostatic discharge,

magnetic fields from the power supply or radio frequency emitters.

However, it is not possible to guarantee that the stimulator will not be affected by powerful RF (radio

frequency) fields originating, for example, from mobile phones.

For more detailed information about electromagnetic emissions and immunity, please contact Compex.

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EN

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 in force, 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 waste electrical and electronic

equipment (WEEE).

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EN

8. EMC TABLE

The Compex stimulator needs special precautions regarding EMC and needs to be installed and put into

service according to the EMC information provided.

Portable and mobile RF communications equipment can affect the Compex stimulator.

The use of Accessories, transducers, and cables other than those specified by the manufacturer, may result

in increased Emissions or decreased Immunity of the Compex stimulator.

The Compex stimulator should not be used adjacent to or stacked with other equipment and if adjacent

or stacked use is necessary, the Compex stimulator should be observed to verify normal operation in the

configuration in which it will be used.

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS

The Compex stimulator is intended for use in the electromagnetic environment specified below. The customer or the user of

the Compex stimulator should assure that it is used in such an environment.

ELECTROMAGNETIC ENVIRONMENT

EMISSION TESTS COMPLIANCE

– GUIDANCE

The Compex uses RF energy only for

Radiated Emissions CISPR 11 Group 1

its internal function. Therefore, its RF

emissions are very low and are not

likely to cause any interference in

Conducted Emissions CISPR 11 Class B

nearby electronic equipment.

The Compex is suitable for use in all

Harmonic emissions IEC 61000-3-2 Class A

establishments, including domestic

establishments and those directly

connected to the public low-voltage

Voltage fluctuations IEC 61000-3-3 Complies

power supply network that supplies

buildings used for domestic purposes.

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EN

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY

The Compex stimulator is intended for use in the electromagnetic environment specified below. The customer or the user of

the Compex stimulator should assure that it is used in such an environment.

IEC 60601

ELECTROMAGNETIC ENVIRONMENT -

IMMUNITY TEST

COMPLIANCE LEVEL

TEST LEVEL

GUIDANCE

Floors should be wood, concrete or ceramic

±6kV contact

±6kV contact

Electrostatic discharge

tile. If floors are covered with synthetic

(ESD) IEC 61000-4-2

material, the relative humidity should be at

±8kV air

±8kV air

least 30%.

±2kV for power supply

±2kV (power lines)

Electrical fast

lines

Mains power quality should be that of a

transient/burst

Not Applicable

typical commercial or hospital environment.

IEC 61000-4-4

±1kV for input/output

(I/O lines)

lines

±1kV Line to Line (or

±1kV Line to Line

Surge

Neutral)

Mains power quality should be that of a

IEC 61000-4-5

Not Applicable

typical commercial or hospital environment.

±2kV line(s) to earth

(Line to Earth)

<5% UT

<5% UT

(>95% dip in UT) for

(>95% dip in UT) for

0,5 cycle

0,5 cycle

40% UT

40% UT

Mains power quality should be that of a

Voltage dips, short

(60% dip in UT) for 5

(60% dip in UT) for 5

typical commercial or hospital environment.

interruptions and

cycles

cycles

If the user of the Compex stimulator requires

voltage variations on

continued operation during power mains

power supply

70% UT

70% UT

interruptions, it is recommended that the

input lines

(30% dip in UT) for 25

(30% dip in UT) for 25

Compex stimulator be powered from an

IEC 61000-4-11 a

cycles

cycles

uninterrupted power supply or a battery.

<5% UT

<5% UT

(>95% dip in UT) for

(>95% dip in UT)

5 sec

for 5 sec

Power frequency

Power frequency magnetic fields should be at

(50/60Hz) magnetic

3 A/m 3 A/m

levels characteristic of a typical location in a

field IEC 61000-4-8

typical commercial or hospital environment.

a UT is the a.c mains voltage prior to application of the test level.

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EN

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY

The Compex stimulator is intended for use in the electromagnetic environment specified below. The customer or the user of

the Compex stimulator should assure that it is used in such an environment.

IEC 60601

ELECTROMAGNETIC ENVIRONMENT -

IMMUNITY TEST

COMPLIANCE LEVEL

TEST LEVEL

GUIDANCE

Portable and mobile RF communications

equipment should be used no closer to any

part of the Compex stimulator, including

cables, than the recommended separation

distance calculated from the equation

applicable to the frequency of the transmitter.

Recommended separation distance

d = 1.2 √P

d = 1.2 √P 80 MHz to 800 MHz

3 Vrms

d = 2.3 √P 800 MHz to 2,5 GHz

Conducted RF

150 kHz to 80 MHz

3Vrms

IEC 61000-4-6

where P is the maximum output power rating

3 V/m

3V/m

of the transmitter in watts (W) according to

1.4 GHz to 2,7 GHz

the transmitter manufacturer and d is the

Radiated RF

recommended separation distance

IEC 61000-4-3

10 V/m

10V/m

in metres (m).

26MHz to 1GHz

Field strengths from fixed RF transmitters,

as determined by an electromagnetic site

surveya, should be less than the compliance

level in each frequency rangeb.

Interference may occur in the vicinity of

equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection

from structures, objects and people.

a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,

amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess

the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the

measured field strength in the location in which the Compex stimulator is used exceeds the applicable RF compliance level

above, the Compex stimulator should be observed to verify normal operation. If abnormal performance is observed, additional

measures may be necessary, such as reorienting or relocating the Compex stimulator.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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