Mi Theta 600 and 500 User Manual

ENG

I - WARNINGS 1 - Counter-indications • Do not treat persons with implanted electronic equipment, such as pacemakers and intracardiac defillibrators. • Avoid electrode placement at the front and side areas of the neck. • Pregnant women should not be treated during the first trimester (12 weeks). • Do not use thoracic stimulation on patients with cardiac arrythmia. • Avoid lower limb stimulation in case of venous thrombosis or servere arterial obstruction (ischemia). • Avoid abdominal stimulation if you have abdominal or inguinal hernia. Important! • Read this manual and the accompanying Practical Guide carefully.

CefarCompex Mi Theta 600 / Theta 500 - USER MANUAL

2 - Safety measures

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Important points to take into account when using MiTheta 600/ Theta 500 and the system: • Do not use the stimulator or the

system in water or humid environments (saunas, hydrotherapy pools, etc.). • If pregnant, do not place electrodes directly over the uterus or connect pairs of electrodes across the abdomen. The reason is that, theoretically, the current could affect the foetus’s heart (although there are no reports of it being harmful). • Observe caution if treating patients with sensitivity problems or who are unable to let you know if they feel any discomfort, however slight. • Observe caution when stimulating in the immediate vicinity of cellular phones that are switched on, since this may affect the output power of the stimulator.

• Do not use the stimulator or system on a patient who is connected to a high-frequency surgical instrument as this could cause skin irritation or burns under the electrodes. • Do not use the stimulator or system within one metre of short wave or microwave devices as this could alter the currents generated by the stimulator. • Only use stimulation cables, rechargeable battery units and charger supplied by CefarCompex. • Always turn off the stimulator or make sure that the intensity for each channel is 0 before disconnecting cables from stimulator or electrodes. • Never connect the stimulation cables to an external power source due to risk of electric shock. • Do not use the MiTheta 600/Theta 500 stimulator, or charger if any of the elements are damaged (case, cables, etc.) or if the battery compartment is open. There is a risk of electric shock. • Unplug the charger immediately if your MiTheta 600/Theta 500 emits a continuous beeping sound or if you notice any abnormal heat, smell, or smoke from either the charger or the stimulator. • Never recharge the battery in a confined space (carrying case, etc.) as this could cause a fire or electric shock. • Keep MiTheta 600/Theta 500 and its accessories out of the reach of children. • Keep the stimulator, battery compartment and charger clean. • Sudden temperature changes can cause condensation to build up inside the stimulator. To prevent this, allow it to reach ambient temperature before use. • Do not use your MiTheta 600/Theta 500 while driving or operating machinery.

• Observe caution when using electrotherapy at the same time as the patient is connected to monitoring equipment with body worn electrodes. The stimulation might interfere with the signals to the monitoring equipment.

• When the electrodes loose their adhesiveness and do not stick properly to the skin, the stimulation can feel unpleasant. Be sure that the electrodes are in good condition, otherwise they have to be replaced.

ENG

• Clean and disinfect the tip of the motor point pen that comes in contact with the skin before each use.

Precautions when using the electrodes and the motor point pen: • Only use electrodes and pen supplied by CefarCompex. Other electrodes and pens may have electrical properties that are incompatible with the Mi Theta 600/Theta 500 stimulator. • Only place electrodes on healthy skin and never on skin lesions of any kind (wounds, swelling, burns, irritation, eczema, etc.). • Always turn off the stimulator or make sure that the intensity for each channel is 0 before moving or removing the electrodes.

• Do not apply solvents of any kind to the electrodes or pen. • Do not use electrodes with a surface < 18 cm2, as there will be a risk of suffering a burn injury. Caution should always be exercised with current densities > 2mA/cm2 • For optimal results, wash, clean and dry the skin before attaching the electrodes. • Attach the electrodes so the entire surface is in contact with the skin. • For hygiene reasons, each patient must have his own set of electrodes. Never use the same electrodes on different patients. • Some people with very sensitive skin may experience redness under the electrodes after a session. This redness is generally harmless and normally disappears within 10 to 20 minutes. Do not start another stimulation session in the same area, as long as the redness is still visible.

CefarCompex Mi Theta 600 / Theta 500 - USER MANUAL

• Do not place the electrodes or the pen in water.

5

ENG

II PRESENTATION 1 - Warranty This warranty is valid only if accompanied by proof of purchase. Your legal rights are not affected by this warranty. Your CefarCompex Mi Theta 600/Theta 500 stimulator is guaranteed for a period of 2 years from the date of purchase. The warranty covers the stimulator and the stimulation cables fitted with the system (material and workmanship) but not the battery unit, other cables, or charger. All defects arising from substandard material or workmanship are covered. The warranty does not cover damage resulting from impact, accident, improper use, insufficient protection against damp, immersion in water, or repair work conducted by unauthorized personnel.

CefarCompex Mi Theta 600 / Theta 500 - USER MANUAL

2 - Maintenance

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• Clean with a soft cloth and an alcohol-based, solvent-free cleaning product. Use only a minimum amount of liquid when cleaning the unit. • Do not disassemble the stimulator or charger as these all contain high-voltage components that could cause electric shock. This may only be done by persons or repair services authorized by CefarCompex. • Your stimulator does not require calibration. If your stimulator contains parts that seem worn or defective, please contact your nearest CefarCompex customer service centre regarding an upgrade. • Medical and health professionals are obliged to service the unit in compliance with relevant national laws and regulations. This involves testing performance and safety parameters at regular intervals.

3 - Storage and transportation conditions The CefarCompex Mi Theta 600/Theta 500 contains rechargeable batteries and so the storage and transportation conditions must not exceed the following figures: • Storage and transportation temperature: -20°C to 45°C • Maximum relative humidity: 75% • Atmospheric pressure: 700 hPa to 1060 hPa

4 - Usage conditions Temperature: 0°C to 40°C Relative humidity: 30% to 75% Atmospheric pressure: 700 hPa to 1060 hPa. Do not use in an explosion risk area.

5 - Elimination Batteries must be disposed in compliance with relevant national regulatory requirements. Any products bearing the WEEE marking (a crossed-out wheeled bin) must be separated from ordinary household waste and sent to special collection facilities for recycling and recovery.

6 - Standards

8 - Technical specifications

CefarCompex Mi Theta 600/Theta 500 is designed for use by health professionals and as such complies with relevant medical standards and regulatory requirements.

A) General information

CefarCompex Mi Theta 600/Theta 500 also complies with the IEC 60601-1 standard on general safety requirements for medical electrical devices, the IEC 60601-1-2 standard on electromagnetic compatibility, and the IEC 60601-2-10 standard on particular safety requirements for nerve and muscle stimulators. CefarCompex Mi Theta 600/Theta 500 also complies with Directive 2002/96/ EEC on waste electrical and electronic equipment (WEEE).

7 - Standardized symbols

Battery 941213: Nickel metal hydride (NiMH) rechargeable battery (4.8 V, 2000 mAh). Battery chargers: Only battery chargers bearing the following information can be used to recharge the batteries supplied with MiTheta 600/Theta 500 stimulators. Europe 683010 Type TR1509-06-E-133A03 Input 90-264 VAC /47-64 Hz/0.5 A max. Output 9 V/1.4 A/15 W UK 683012 Type TR1509-06-U-133A03 Input 90-264 VAC /47-64 Hz / 0.5 A max. Output 9 V/1.4 A /15 W

B) Neurostimulation All electrical specifications are given for an impedance of 500-1000 Ohm per channel. Channels: Four individually adjustable channels that are electrically isolated from each other and earthed.

Read the operating instructions before use.

Impulse shape: Constant rectangular current with pulse compensation to eliminate any direct current component to prevent residual polarization at skin level.

CefarCompex Mi Theta 600/Theta 500 is a class II device with internal electric power and type BF applied parts.

Maximum pulse intensity: 120 mA

Waste electrical and electronic equipment (WEEE) marking according to EN 50419 standard.

Pulse intensity increments: Manual adjustment of stimulation intensity: 0999 (energy units) – Minimum increment: 0.5 mA Pulse width: 30 to 400 microseconds Maximum electrical charge per pulse: 96 microcoulombs (2 x 48 μC, compensated) Standard pulse ramp-up time: 3 microseconds (20%-80% of maximum current) Pulse frequency: 1-150 Hz.

1250 In compliance with the requirements of the European Directive 93/42 EEC on medical devices.

CefarCompex Mi Theta 600 / Theta 500 - USER MANUAL

To guarantee your safety, CefarCompex Mi Theta 600/Theta 500 has been designed, manufactured, and distributed in compliance with the requirements of the European Directive 93/42/EEC on medical devices.

ENG

7

ENG

C) Information related to electromagnetic compatibility (EMC) The MiTheta600/Theta 500 is designed to be used in typical domestic or clinical environments and is approved according to the EMC safety standard of EN 60601-1-2. This device emits very low levels in the radio frequency (RF) interval and is therefore not likely to cause any interference with nearby electronic equipment (radios, computers telephones etc.). The MiTheta 600/Theta 500 is designed to withstand foreseeable disturbances originating from electrostatic discharges, mains supply magnetic fields or radio frequency transmitters. Despite this, it is not possible to guarantee that the stimulator is not affected by strong RF (radio frequency) fields emitting from for example mobile phones.

CefarCompex Mi Theta 600 / Theta 500 - USER MANUAL

More detailed information can be received upon request by contacting CefarCompex.

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III USAGE GUIDELINES For optimal results, use the electrode positions recommended by CefarCompex. For the placement of electrodes, refer to the electrode placement illustration. It is crucial to choose the right size of the electrodes and correctly position these on the muscle group you want to stimulate to ensure the efficacy of the treatment. To do this, always use the sizes and positions shown in the pictograms unless otherwise required by medical needs. Where necessary, look for the best possible position by slowly moving the electrode over the muscle until you find the point that will produce the best contraction (the motorpoint) or the most comfort for the patient. These recommended positions are also the optimal positions for the system, and as such should be followed closely.

CefarCompex disclaims all responsibility for consequences arising from electrodes placed in other positions.

2 - Body position

Refer to the pictures of the electrode placement to determine the stimulation position for your patient depending on the placement of the electrodes and the chosen program. This position will vary depending on the position of the electrodes, the muscle group you wish to stimulate, and the program you are using. For programmes that do not involve muscle contractions (Pain relief programmes, for example), make sure that the patient is as comfortable as possible.

3 - Adjusting stimulation energies The number of fibres recruited in a stimulated muscle depends on the stimulation energies used. It is therefore extremely important to use maximum stimulation energies where possible in order to recruit the maximum number of fibres. If the stimulation energy is too low, too few fibres will be obliged to work and the improvement in muscle quality will be negligible. It takes at least 3 sessions to reach this maximum energy level. The first few sessions serve to introduce progressive increments in stimulation energy (and muscle contraction) levels and to help the patient to become used to the method. After an initial warm-up period, which should produce very clear muscle twitches, increase the stimulation energies gradually, contraction by contraction, for the duration of the session.

4 - Level progression Generally speaking, it is not advisable to try to reach maximum stimulation levels too quickly. The different levels in each stimulation programme are designed to reeducate the muscle gradually. We recommend you to prioritize the stimulation energies at each level to recruit as many fibres as possible, before moving on to the next level. Also seek to progressively increase energy levels from session to session. For maintenance purposes, it is a good idea to hold one session per week with the energy level you used in the previous cycle.

CefarCompex Mi Theta 600 / Theta 500 - USER MANUAL

1 - Placement of electrodes

ENG

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ENG

IV

TECHNOLOGY

NOTE: Mi Theta 600: Two Mi-sensors are included in the kit and gives you the possibility to fully use the Mi-technology with , , and . Theta 500: This device is Mi-Ready. You can make an optional purchase of maximum one sensor cable, and take the advantage of the Mi-Technology with , and .

1 - Practical guidelines for using the system To access the functions, make sure that the stimulation cable fitted with the is connected to the stimulator before this is turned on.

CefarCompex Mi Theta 600 / Theta 500 - USER MANUAL

Do not connect the the stimulator is already on.

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cable if

The system may not work properly if restrained or subject to pressure in any way.

determines the chronaxy of the muscle in approximately 12 seconds and sends this data to the stimulator so that it can adapt the pulse width (duration) accordingly. Adapting the pulse width to the chronaxy of the muscle to be stimulated allows the same muscle response to be achieved with less energy. NOTE: The function is enabled only when a cable fitted with the system is connected to the stimulator. Maximum one sensor can be used for the THETA 500. As many as 2 different chronaxy measurements – corresponding to 2 different muscle groups – can be taken per session. The number of measurements depends on how many sensors are connected to the stimulator. Each channel that is connected to a standard cable receives the same data as a channel connected to a cable (see below).

The must be connected to an adhesive electrode at all times during a stimulation session.

This is a small sensor that links the stimulator to the electrodes. It performs a key function in that it measures certain physiological characteristics of the muscle to be stimulated and transfers this data to the stimulator, which, in turn, analyses the data and adapts its parameters accordingly. This tailoring of each programme to the changing condition of the muscle clearly enhances both patient comfort and therapeutic efficacy.

Before a programme is executed, the sensor scans the muscle briefly. During this time, a horizontal bar will move up and down the figure to the left on the screen.

Just before beginning a stimulation session, the analyses the excitability of the muscle to be stimulated. The

It is essential that the patient remains completely still and relaxed while these measurements are being taken. The system is very sensitive and the slightest contraction or movement could interfere with its results.

Note that certain people might feel an unpleasant tingling sensation during the test.

The mode is enabled only during work sequences (not during warm-up and relaxation sequences).

Once the test is complete, a symbol will appear on the screen indicating that the programme can be started.

The first muscle contraction in the work sequence is triggered automatically. This is followed by an active rest phase consisting of a series of muscle twitches.

is a work mode in which the patient triggers an electrically induced stimulation by voluntarily contracting one of his muscles. The stimulation contraction is therefore controlled by the patient.

For a patient to fully benefit from the training mode, his muscles must be well developed. Insufficiently developed muscles may, in some case, prevent the triggering of the electrically induced contraction. Programmes run in mode offer a number of distinct benefits: • They require the active participation of patients and encourage them to become fully involved in their treatment. • They allow patients to control their contractions, allowing them to feel more at ease with the system. • They optimize performance by combining voluntary and electrical stimulation exercises, which results in a more intensive recruitment of muscle fibres. • They help to retone the body and facilitate motor reeducation in patients with neuromuscular disorders.

A new contraction can only be triggered after a minimum rest time, which varies from programme to programme. The stimulator emits a signal to notify the patient when he can trigger another contraction. This signal can take different forms: • A series of short beeps with increasing frequency: voluntary contraction possible. • A continuous beep: ideal moment for voluntary contraction. • A series of short beeps with decreasing frequency: voluntary contraction still possible and work rate still satisfactory. • If no voluntary contractions are detected within a certain time (this varies from programme to programme), the stimulator will automatically enter Standby mode. NOTE: The system needs to record the muscle twitches in the active rest phase in order to offer optimal results. If the twitches are not sufficiently intense during this phase, the stimulator will emit a series of beeps and a sign will appear on the screen. Note that these muscle twitches will only occur if the muscles are sufficiently relaxed. Patients should therefore be encouraged to adopt a position in which they will be as relaxed as possible at the end of each contraction phase.

• They integrate the stimulation of stabilising muscles into a broader functional exercise plan. The mode is only available for certain programmes. Programmes run in always preceded by a

mode are test.

The function can be used to considerably reduce the number of unwanted muscular contractions, enhancing both user comfort and treatment efficacy.

CefarCompex Mi Theta 600 / Theta 500 - USER MANUAL

NOTE: Only available for MiTheta 600.

ENG

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ENG

It is available only for the TENS, Modulated TENS, Epicondylitis and Arthralgia programmes. When enabled, the function controls stimulation energies by keeping them at an effective level and reducing the number of unwanted contractions. It works by performing a series of short measurement tests (lasting 2 to 3 seconds) at regular intervals throughout the entire programme. A test is automatically launched whenever the stimulation energies are increased. The subject must remain perfectly still during the test to ensure optimal results. Depending on the results, the stimulator may automatically reduce the stimulation energies slightly.

CefarCompex Mi Theta 600 / Theta 500 - USER MANUAL

NOTE: It is important to ensure that patients adopt the most comfortable position possible during stimulation, remain still, and do not contract any of the muscles in the stimulation area.

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The function is used in programmes which depend on the triggering of vigorous muscle twitches to indicate the optimal stimulation energy range. It is therefore only available in some of the programmes that use low stimulation frequencies (less than 10 Hz). When the function is enabled, the stimulator will check whether you are working in the optimal energy range. If the level is too low, it will prompt you to increase the level by displaying a series of signs on the screen. Once the stimulator has detected the ideal energy range, a square bracket will appear to the right of the bar graph corresponding to the stimulation channel the is connected to. The figures enclosed by this bracket indicate the range you must work in, in order to achieve optimal results.

If you set the energy level below this range, the stimulator will prompt you to increase it by flashing a series of signs on the screen.

V USING THE STIMULATOR

ENG

You are strongly advised to read the counter-indications and safety measures described at the beginning of this manual (chapter 1 “Warnings”) prior to using your stimulator.

A - On/Off button B - i button. This is used to: • Increase stimulation energies in several channels simultaneously. • Access the Top 5 menu (showing 5 most recently used programs. • Access the contraction info menu (showing number of contractions and total contraction time). • Access parameter info menu for personalised programmes. C - +/- buttons for 4 stimulation channels

D - Sockets for 4 stimulation cables E - Battery charger socket F - Stimulation cables Channel 1 = blue Channel 2 = green Channel 3 = yellow Channel 4 = red G - Stimulation cables fitted with system H - Stimulation cable fitted with snap connector I - Stimulation cable fitted with pin connector J - Rechargeable battery compartment K - Belt clip socket

CefarCompex Mi Theta 600 / Theta 500 - USER MANUAL

1 - Description of stimulator

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ENG

2 - Connections

Refer to the picture above to see how to connect the pen.

A) Connecting the cables

Connect the tip of the motor point (preferably to the red connector). The other snap connector must be connected to an electrode already on the muscle to be stimulated.

The stimulator cables plug into the 4 sockets on the base of the device. All 4 cables can be connected simultaneously. Both the +/- buttons and the cables are colour-coded to simplify use and facilitate identification of the different channels.

Mi Theta 600 Theta 500

The kit includes four snap-connector cables and four 2,1 mm pin-connector cables.

C) Charging The Mi Theta 600/Theta 500 is a portable muscle stimulator powered by a rechargeable battery unit. Recharging To recharge the Mi Theta 600/Theta 500, first disconnect the electrode cables from the device, then plug the charger to a wall socket and finally connect the stimulator to the charger.

CefarCompex Mi Theta 600 / Theta 500 - USER MANUAL

To connect a snap-connector cable to an electrode, simply insert the snap end of the cable into the electrode eyelet and twist it a quarter turn.

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In addition to these standard cables, Mi Theta 600 comes with 2 special cables fitted with the . These cables can be connected to any of the 4 sockets for the stimulation channels, on the base of the stimulator. Just like the standard cables, they must also be connected to 2 electrodes. NOTE: For Theta 500 you can make an optional purchase of maximum one sensor cable.

The charge menu illustrated below appears automatically.

B) Connecting the motor point pen Never use the motor point pen for any purposes other than locating the motor point of the muscle. Follow the instructions in this manual. Clean and disinfect the tip of the motor point pen that comes in contact with the skin before each use. Apply a small amount of gel to the skin when looking for the motor point to enhance patient comfort.

1a

1b

1a: The stimulator has been charged for 7 minutes and 27 seconds (a full charge may take 2-2,5 hours with the rapid charger delivered with your device). 1b: Charging is in progress. When charging is completed, total charge duration flashes and the battery symbol is completely full. The stimulator switches off automatically as soon as you disconnect the charger.

3 - Preliminary settings

ENG

A) Language, contrast, volume When you start the stimulator for the first time, you will need to choose the interface language you wish to use from the options screen. See below for instructions on how to proceed. There are a range of settings that you can adjust to suit your needs (interface language, display contrast, backlighting, volume). To change any of these settings, bring up the options screen by holding the On/Off button on the front of the stimulator for a few seconds.

3b

3c

3d

3e

3b: Use the channel 1 +/- button to choose the language you wish to use. 3c: Use the channel 2 +/- button to adjust the contrast of the screen. 3d: Use the channel 3 +/- button to adjust the volume. 3e: Use the channel 4 +/- button to adjust the backlighting. On: Backlighting always on Off: Backlighting always off Auto: Backlighting activated whenever a button is pressed. 3a: Use the On/Off button to confirm and save your choices. The settings will be applied immediately.

CefarCompex Mi Theta 600 / Theta 500 - USER MANUAL

3a

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ENG

4 - Neurostimulation programmes

C) Choosing a programme

To start the stimulator, press the On/Off button. To choose a programme, you must first choose a type of treatment and a programme category.

NOTE: Consult our Practical Guide for help in choosing a programme. Once you choose a category, the screen will display a list of available programmes.

NOTE: There is a table summarizing the different programmes and their functions at the end of this manual. A) Choosing a type of treatment

6a

CefarCompex Mi Theta 600 / Theta 500 - USER MANUAL

4a

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4b

4e

4a: Press the On/Off button to turn off the unit. 4b: Use the channel 1 +/buttons to choose another type of treatment (for ex Specific Treatment or Conditioning). 4e: Press the channel 4 +/- button to confirm your choice and access the programme category selection screen. Press the i button to access the Top 5 menu.

6b

6e

6a: Press the On/Off button to return to the previous screen. 6b: Use the channel 1 +/- button to choose the programme you want. 6e: Press the channel 4 +/- button to confirm your choice. Certain programmes start right away while others allow you to specify additional options. TOP 5 To access the Top 5 menu, press the i button before selecting a programme. The menu can be accessed from the type of treatment screen (Figure 4), the programme category screen (Figure 5), or the programme list screen (Figure 6).

B) Choosing a programme category

7a 5a

5b

5e

5a: Press the On/Off button to return to the previous screen. 5b: Use the channel 1 +/- button to choose a category. 5e: Press the channel 4 +/- button to confirm your choice and access the programme selection screen. Press the i button to access the Top 5 menu.

7b

7d

7e

7a: Press the On/Off button to return to the previous screen. 7b: Use the channel 1 +/- button to choose the programme you want. 7d: Use the channel 3 +/- button to personalize the programme. 7e: Press the channel 4 +/- button to start the programme.

Not all programmes have an option screen. not connected In certain programmes, you will need to choose the muscle group you want to stimulate when there are no cables connected to the stimulator. The target area is shown in black on the figure above channel 1.

8a

8b

8c

8d

8e

8a: Press the On/Off button to return to the previous screen. 8b: Use the channel 1 +/- button to choose the desired treatment area. You can choose among 7 areas. 8c: Press the channel 2 +/- button to delete the warming-up sequence and to choose if you want to combine with any of the 2+2 programs on channel 3 and 4. 8d: Use the channel 3 +/- button to choose the programme difficulty level. 8e: Use the channel 4 +/- button to confirm your choices and launch the programme. connected The stimulator will automatically select the muscle group to be stimulated when a cable is connected to the unit. Reminder: The function will activate automatically in programmes that accommodate this function when at least one cable is connected to the stimulator.

9a: Press the On/Off button to return to the previous screen. 9b: NOTE: Only available in MiTheta 600. Use the channel 1 +/- button to enable the function. When the function is enabled, the screen will display the word ON or OFF. When in ON mode, it is the patient who triggers the stimulation. Reminder: Not all motor nerve stimulation programmes use the function. If the function is not available, there will be no symbol above channel 1. 9c: Press the channel 2 + button to delete the warming-up sequence. Press the channel 2 - button to choose if you want to combine with any of the 2+2 programs on channel 3 and 4. NOTE: When the 2+2 function is enabled, the cannot be activated and the corresponding symbol will disappear automatically from the screen. Use the channel 2 + button to delete the default warm-up period.

no warm-up sequence

warm-up sequence

9d: Use the channel 3 +/- button to choose the programme difficulty level. 9e: Use the channel 4 +/- button to confirm your choices and launch the programme. Preliminary

test

This test is launched only if a cable fitted with the system is already connected to the stimulator when this is turned on!

It is essential that the patient remains completely still and relaxed during the entire test. If the cable is connected, the test will begin as soon as you choose and personalise your programme.

9a

9b

9c

Session duration (in min.)

9d

9e

ENG

NOTE: The test is not launched if you choose a programme that does not require the pre-selection of a muscle group.

CefarCompex Mi Theta 600 / Theta 500 - USER MANUAL

D) Personalizing a programme

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Adjusting stimulation energies

ENG

When you start a programme, you will be prompted to increase the stimulation energies. This is the key to the success of any treatment. 10a

7b

7c

7d

10e

CefarCompex Mi Theta 600 / Theta 500 - USER MANUAL

10e: In this example the logo above channel 4 indicates that the cable is connected to the stimulator on channel 4. The figures in channel 4 will automatically change during the test as the sensor record different measurements.

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NOTE: When several sensors are connected simultaneously, the test is performed progressively, one connected channel after the other. The channel being scanned is easily identified by its changing numbers and the mi logo above the channel. The 4 +/- buttons will be disabled for the duration of the test. 10a: Press the On/Off button to interrupt the test at any moment. To relaunch the test from the start, press any of the 4 +/buttons. Press the On/Off button a second time to return to the list of programmes. Once the test is complete, you will automatically be taken to the default programme start screen and prompted to increase the stimulation energies.

Session duration (in min.)

11a

11b 11c 11d

11e

Heat waves depicting the warm-up sequence

11a: Press the On/Off button to return to the previous screen. 11 b c d e: The unit will beep and the symbols for the 4 channels will alternate between + and 000. The energy level for the 4 channels is at 0. To start the programme, you will need to increase the energy levels in the channels you are going to use. To do this, use the corresponding + buttons. NOTE: If you want to increase the energy levels in all 4 channels simultaneously, press the i button. Press it twice to increase the levels in the first 3 channels, and 3 times to increase the levels in the first 2 channels. Interdependent channels will be highlighted in white against a black background.

E) Choosing the 2+2 function

ENG

You now have the possibility to choose the 2+2 function which means that you can choose one program for the channel 1 and 2, then select one program from the 2+2 program list for channel 3 and 4.

12a

12b

12c

12d

12e

12a: Press the On/Off button to return to the previous screen. 12b: Use the channel 1 +/- button to choose the desired treatment area, You can choose from 7 areas. 12c: Press the channel 2 + to delete the warming up sequence, by pressing the channel 2 – the 2+2 mode is selected and the first program in the list is displayed. Press the channel 2 – again in order to display the next program in the list. 12d: Use the channel 3 +/- button to choose the program difficulty level 12e: Use the channel 4 +/- button to confirm your choices and launch the program. NOTE: The timer for ch 1+2 will control the total session time. This means that the total time for ch 3+4 could not exceed the session time for ch 1+2. NOTE: The program for ch 3+4 is always in one phase NOTE: If a preset program uses more than two channels, it’s not avalable for the 2+2 mode.

The horizontal bars on top of the display shows the total duration and different phases of the programs. Left bar for P1 and right bar for P2 P1 shows the program chosen for channel 1 and 2 P2 shows the program chosen for channel 3 and 4

F) Programming mode In the programming mode you could create a custom program and select your own parameters. Then name your program and save it in the custom programs category.

Go to the programming category.

CefarCompex Mi Theta 600 / Theta 500 - USER MANUAL

This means that you could treat two different body parts at the same time or combine two different programs on the same body part.

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ENG

Select NMES or TENS

18d: Use the channel 3 +/- button to maximize or minimize the space 18e: Use the channel 4 +/- button to save the program

Select the stimulation form In order to personalize the parameters:

NOTE: You can save maximum 10 custom programs. NOTE: Also the custom programs are possible to combine with a program from the 2+2 list by adding and selecting the 2+2 option. When you save this program will consist of one program on channel 1+2 (P1) and one program for channel 3+4 (P2) (Please see section “Choosing the 2+2 function”.)

G) Stimulation mode

CefarCompex Mi Theta 600 / Theta 500 - USER MANUAL

17a

20

17b

17c

17d

17e

17a: Press the On/Off button to return to the previous screen 17b: Use the channel 1 +/- button to move the cursor between the different settings 17c: Use the channel 2 +/- button to increase or decrease the setting values 17d: Use the channel 3 +/- button to show further parameters possible to adjust 17e: Use the channel 4 +/- button to save the program Saving programme 18a: Press the On/Off button to return to the previous screen

18a

18b

18c

18d

18e

18b: Use the channel 1 +/- button to move the cursor in the program name 18c: Use the channel 2 +/- button to write letters and figures

19a

19b

19c

19d

19e

19 b c d e: The different energies reached during the contraction phase are shown by a series of black bar graphs. Active rest phase energies are shown by hatched bar graphs. NOTE: Active rest phase stimulation energies are automatically set at 50% of contraction intensities but can be modified during the rest phase. Once modified, they will be totally independent of the contraction intensities. Pause mode 19a: Press the On/Off button to interrupt the programme momentarily. To restart it, simply press the channel 4 +/– button (19e). The session will resume at 80% of the energy levels that were being used prior to the interruption. NOTE: If your MiTheta 600/Theta 500 emits a beeping sound and the + symbols under the active channels begin to flash, the stimulator is suggesting you to increase the level of the stimulation energies. If you are working at the patient’s maximum tolerance level, simply ignore this message.

To access the screen, simply hold down the i button.

Skip function NOTE: The Skip function is not available for THETA 500. In certain programmes, the skip function allows you to end the current programme phase and move on to the next one. For skip function to work, the unit must be in Pause mode.

21a

21d

Statistics NOTE: The Statistics function is not available for THETA 500. The Mi Theta 600/Theta 500 stimulator includes a statistics menu containing important programme information that can be consulted in real time. To access the statistics screen, you must place the stimulator in pause mode or wait for the programme to end.

13a

13b

13d

22e

In neuromuscular electrostimulation (NMES) programmes, MAX indicates the maximum stimulation energy level reached per channel during the contraction phase. AVG indicates the average stimulation energy level used by the different channels during the contraction phase.

21e 13a

21a: Press the On/Off button to return to the list of programmes in the category you are working with. 21d: Use the channel 3 +/- button to skip a particular sequence of a programme. When you do this, the unit will beep and the cursor under the progress bar will move to the beginning of the next sequence. 21e: Use the channel 4 +/- button to resume the programme at the chosen sequence. NOTE: The skip function is not available for all programmes. It should also be noted that this function can reduce the effectiveness of a programme if used to shorten the work sequence excessively.

ENG

13b

13d

23e

In low frequency programmes, the function figure enclosed by a single square bracket shows what percentage of stimulation time was spent in the optimal energy range. 22-23e: Press the channel 4 +/- button to resume the programme at the point where it was interrupted.

CefarCompex Mi Theta 600 / Theta 500 - USER MANUAL

Contraction information When working with a muscle contraction programme, you can access the contraction info screen at any time to consult the number of contractions and total contraction time.

21

ENG

End of programme Different statistics are displayed depending on the programmes and options used (see Figures 22 and 23). It should be noted, however, that statistics are not available for all programmes.

At the end of each session, a small flag will be displayed on the screen and a short melody will be played. NOTE: Press the i button to access the contraction info screen.

CefarCompex Mi Theta 600 / Theta 500 - USER MANUAL

To turn off the stimulator, press the ON/ OFF button.

22

5 - Battery status and recharging Never recharge the stimulator without first disconnecting the stimulation cables. Never recharge the battery with a charger other than that supplied by CefarCompex. The Mi Theta 600/Theta 500 is powered by a rechargeable battery unit. The battery’s duration varies according to the programmes and stimulation energies used. We strongly recommend you to fully charge the battery before using it for the first time as this will extend battery duration and life time. If you do not use your stimulator for long periods of time, remember to recharge the battery regularly. A) Battery status The status of the battery is indicated by a battery icon on the screen. If the battery icon contains just two lines, this means that power is running low. Stop the session and recharge the unit.

Battery charge state icon

fig. 25

If the START symbol normally displayed above the channel 4 +/– button is not visible and the battery icon is flashing, this means that the battery is completely discharged. The stimulator can no longer be used. Recharge immediately.