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SUBLIMED actiTENS User Manual

Device for transcutaneous electrical neurostimulation intended to treat pain in adults and intended for persons over 18 years of age with unimpaired intellectual abilities.
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The
is a connected medical device for transcutaneous electrical neurostimulation
actiTENS
intended to treat pain in adults and intended for persons over 18 years of age with unimpaired
intellectual abilities.
The
is fixed directly on to the body using a self-adhesive strip or textile accessory. It
actiTENS
adapts to the shape of your body with its flexible design. The
during your daily activities.
It is operated through a smartphone app that allows you to choose from a wide number of
stimulation programs and to save all the information recorded from the stimulation treatment
sessions.
To get the most out of your actiTENS, we recommend that a healthcare professional instruct you
how to correctly position the electrodes and to select an appropriate stimulation programme for
your specific needs.
is a medical device for hire or sale.
actiTENS
These instructions may be modified and you can consult the latest version through the
mobile app in the "Help" menu.
actiTENS
actiTENS
Programmes
Programmes
Programmes
SUMMARY
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app 59
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app 62
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USER GUIDE
actiTENS
Monitoring
Monitoring
Monitoring
can be used discreetly
actiTENS
Help
actiTENS
Help
actiTENS
Help
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Setti
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Setti
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Setti
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Summary of Contents for SUBLIMED actiTENS

  • Page 1: Table Of Contents

    It is operated through a smartphone app that allows you to choose from a wide number of stimulation programs and to save all the information recorded from the stimulation treatment sessions. To get the most out of your actiTENS, we recommend that a healthcare professional instruct you Programmes Monitoring...

  • Page 2: Intended Use And Patient Target Group

    1. INTENDED USE AND PATIENT TARGET GROUP is a connected medical device for transcutaneous electrical neurostimulation designed actiTENS to treat pain in adults. The intended patient population for medical device is adult patients actiTENS (persons over 18 years of age with unimpaired intellectual abilities) suffering from pain, and being mentally and physically capable of placing the electrodes and adjusting the intensity, or capable of expressing pain or wishes regarding treatment modifications or treatment termination.

  • Page 3: Precautions For Use

      ƒ For hygiene reasons, the electrodes must only be used by a single patient.   ƒ Do not attempt to open or modify the neurostimulator and the actiTENS actiCHARGE charging case - there is a risk of electric shock.

  • Page 4: Clinical Benefits

    • It is not recommended to use conducting gel with the electrodes.   ƒ Precautions for the use of the self-adhesive strip and textile accessories with the actiTENS: •  Do not place these accessories on damaged or irritated skin, and especially not on an open wound.

  • Page 5: Device Overview

    You should follow the advice given by a healthcare professional in choosing programmes, duration and intensity of stimulation and positioning of the electrodes of the neurostimulator. actiTENS 7.3. Controlling the intensity The stimulation intensity should be adjusted for a balance between a tolerable sensation with a decrease in pain.
  • Page 6 Channel 2 Channel 2 Indicator ON/OFF actiTENS actiTENS Channel 1 light button connector Self-adhesive strip Channel 1 Self-adhesive strip Channel 2 Standard size armband actiTENS Channel 1 Self-adhesive strip Self-adhesive strip Standard size armband actiTENS Standard size armband actiTENS Self-adhesive strip...

  • Page 7: Indicator Lights: Meaning

    Flashing red is updating. It is actiTENS Flashing blue important to complete the updating high frequency to be able to use actiTENS. For (2.8 times per second) more details see section 18. Flashing green turned on with no actiTENS low frequency session started or paused (0.8 times per second)

  • Page 8: Charging Your Actitens

    NB: as with all similar devices, the operating time of the battery will decrease with use. NB: to ensure the performance and safety of the machine, it is essential to use the AC charger provided with the actiTENS. Using other AC chargers invalidates the guarantee.

  • Page 9: Downloading The Actitens

    Programmes Monitoring actiTENS Help How to check how much charge your has left actiTENS The amount of charge can be checked via the app in the menu. actiTENS Programmes Monitoring actiTENS Help 11. DOWNLOADING THE actiTENS app is essential for starting and adjusting the settings for your stimulation actiTENS session.

  • Page 10: Placing The Device

    • Choose the number of electrodes based on the area to be stimulated: 2 or 4. • Use the same number of cables as electrodes. For two electrodes, only one channel on the will be active. With four electrodes, both actiTENS channels on the will be active. actiTENS...
  • Page 11   ƒ Step 3: attach the to the self-adhesive strip. actiTENS   ƒ Step 4: stick the self-adhesive strip attached to the near to the electrodes. actiTENS If you are using a textile accessory, place the accessory on the desired area of the body, then position the actiTENS directly on the textile accessory.

  • Page 12: How To Use The Actitens

    The user guide and contraindications can be found at all times in the "Help" menu.   ƒ Your telephone will communicate with the via Bluetooth to control the stimulation actiTENS programmes. You do not need to be connected to a mobile network or internet to use the actiTENS. Programmes Monitoring actiTENS...

  • Page 13: Launching A Programme

      ƒ Maintenance report 14. LAUNCHING A PROGRAMME   ƒ Select the “Programmes” menu from the navigation bar at the bottom of the screen. Programmes Settings Monitoring actiTENS Help   ƒ Recording a pain area (optional). Programmes Monitoring actiTENS Help...
  • Page 14 This information is saved under “Monitoring” and will be useful for your healthcare professional (see section 17 “Following up your treatment”). Programmes Monitoring This area is saved and can be modified at any time from the “Programmes” or "Settings" menus. My programmes Default programmes Gate Control 100 Hz...
  • Page 15 • 1 channel: Launching a programme Choice of channels Select the s mula on channels by touching them on the screen. Launching a programme Launching a programme Démarrage d'un programme You can select or both. CONTINUE Choice of channels Choice of channels Choix des canaux Wählen Sie die S mula onskanäle aus, Select the s mula on channels by...
  • Page 16 Place the device (if you have not already done so) following the chosen channel or channels, Con nue   ƒ Turn on the by pressing the ON/OFF button (if you have not already done so). actiTENS The indicator light will flash green. Android Launching a programme Launching a programme...
  • Page 17   ƒ Launch the automatic placement check. This step ensures that all the connections between the actiTENS, the cables, the electrodes and your body are working correctly and checks that there is good adhesion of the electrodes to the skin.
  • Page 18   ƒ  S etthedurationoftheprogramme.Theappallowsyoutochoosebetween10minutesand12 hours of stimulation. Each programme type is automatically set to a default duration, summarized in section 23“Description of the programmes”. Android Launching a programme Launching a programme Cancel Placing on the body Dura on STEP Start up Automa c check Dura on Set the dura on of the programme.
  • Page 19 You need to adjust the stimulation intensity. The stimulation intensity should be adjusted to balance a tolerable sensation with a decrease in pain. Gate Control 100 Hz Type of programme running Timer ACTITENS BATTERY Status RUNNING Intensity increase lock Pause Increase the intensity Channel 1...
  • Page 20 Remember During treatment, you can quit the actiTENS screen and use your telephone as usual. CONNECTED Programmes Monitoring actiTENS Help Settings Just press the icon actiTENS ) again to return to the app. Programmes Monitoring actiTENS Help Settings RUNNING To return to the control screen, touch the...

  • Page 21: Stopping The Stimulation Session

    •  You can also stop a session by pressing the ON/OFF button. This option is not actiTENS recommended because records of the session running will be incomplete. 16. REMOVING THE DEVICE Before removing the device, make sure that no session is running. The indicator light should be flashing green or off.

  • Page 22: Updating The Actitens

      ƒ Step 2: The app itself will tell you whether the can be updated. You can also update the actiTENS from the "Programmes" menus, "actiTENS" and "Settings". actiTENS   ƒ Step 3: Make sure that the and your telephone are sufficiently charged (at least 50%).
  • Page 23 Low back electrode 100 cm cable Low back electrode 100 cm cable 14 cm cable 14 cm cable armband size XL belt / bra accessory actiTENS actiTENS armband size XL belt / bra accessory actiTENS actiTENS armband size XS actiTENS...
  • Page 24 XL belt / bra accessory actiTENS actiTENS armband size XS actiTENS Electrode 50 mm x 90 mm Electrode 50 mm x 50 mm mixed actiTENS electrode Electrode connector 19.2 Using the low back electrode   ƒ First of all: prepare 4 cables. When using the low back electrode, it is preferable to have 4 short 14 cm cables (to order separately) Both channels are active.
  • Page 25   ƒ Step 2: clip the 4 cables on to the low back electrode and on to the actiTENS, making sure that the ends are compatible (narrow end on the electrode side, wide end on the side). actiTENS Remember The two ends of a cable are different. Make sure you clip the wide end to the and the narrow end to an electrode.

  • Page 26: Storing, Cleaning And Scrapping

    They may cause serious damage to the equipment. •  To remove dirt, use a damp cloth and mild detergent (e.g. washing up liquid), to clean the actiTENS, the cables, the AC charger and the charging case. You can also use...

  • Page 27: Devices Lifetime

    21. DEVICES LIFETIME COMPONENT LIFETIME neurostimulator 5 years actiTENS Charging case 5 years Cables 6 months 2 weeks of treatment Electrodes See the precautions for use and storage 1 week of treatment Self-adhesive strip See the precautions for use and storage...
  • Page 28 •  Once the programme is launched, disconnection does not affect the running of the actiTENS. The Bluetooth signal range may be affected by the charge level of your telephone or your actiTENS. Some telephones are designed to cut the connection more quickly to save the battery.

  • Page 29: Description Of The Programmes

      ƒ The neurostimulator and its components are guaranteed under normal conditions of use. COMPONENT DURATION OF THE GUARANTEE neurostimulator 2 years actiTENS charging case actiCHARGE 2 years and AC charger Cables Not guaranteed Electrodes, self-adhesive strip, Consumables not guaranteed: see the precautions for use...
  • Page 30 P1 GATE CONTROL 100 HZ Frequency: 100 Hz Technical specifications Pulse width: 200 µs Default duration: 30 min Mode of action Inhibition of pain signal Intensity (mA) Intensity (mA) Intensity (mA) Intensity (mA) Pulse width Pulse width Time Time P2 GATE CONTROL 80 HZ Intensity (mA) Intensity (mA) Frequency: 80 Hz...
  • Page 31 P4 MIXED Intensity (mA) Intensity (mA) Intensity (mA) Intensity (mA)   ƒ Channel 1: Gate Control Frequency: 100 Hz Pulse width: 200 µs Pulse width Pulse width Technical specifications   ƒ Channel 2: Endorphinic Frequency: 2 Hz Pulse width: 200 µs  ...
  • Page 32 Frequency (Hz) Frequency (Hz) Sequence 1 Sequence 1 Sequence 2 Sequence 2 Time Time (minutes) (minutes) Frequency (Hz) Frequency (Hz) P6 HAN STIMULATION Frequency (Hz) Frequency (Hz)   ƒ 1 sequence (duration: 3 s): Gate control Sequence 1 Sequence 1 Frequency: 100 Hz Pulse width: 150 µs Sequence 1...
  • Page 33 P7 2 HZ BURST Frequency (Hz) Frequency (Hz) Frequency (Hz) Frequency (Hz)   ƒ 1 sequence (duration: 0.25 s): Gate Control Frequency: 100 Hz Sequence 1 Sequence 1 Pulse width: 150 µs Technical specifications   ƒ 2 sequence (duration: 0.25 s): No pulse  ...
  • Page 34 Frequency (Hz) Frequency (Hz) Frequency (Hz) Frequency (Hz) Sequence 1 Sequence 1 Sequence 1 Sequence 1 Sequence 2 Sequence 2 Time Time (seconds) (seconds) P9 MUSCLE STIMULATION Frequency: 50 Hz Intensity (mA) Intensity (mA) Frequency (Hz) Frequency (Hz) Pulse width: 250 µs  ...
  • Page 35 P10 MASSAGE Frequency: 80 Hz Pulse width: 150 µs Intensity (mA) Intensity (mA)   ƒ Channel 1: •  1 sequence (1 s): Increasing intensity from 0 mA to the value set •  2 sequence (1 s): Decreasing intensity from the value set to 0 mA Technical specifications  ...
  • Page 36 P11 FRICTION Frequency: 80 Hz Pulse width 150 µs   ƒ Channel 1: •  1 sequence (0.2 s): Increasing intensity from 0 mA to the value set •  2 sequence (0.2 s): Decreasing intensity: value set to 0 mA Technical specifications  ...
  • Page 37 P13 NAUSEA Frequency: 10 Hz Technical specifications Pulse width: 180 µs Default duration: 30 min Stimulation of endorphin secretion for a general analgesic Mode of action effect P14 TIBIAL NERVE STIMULATION Frequency: 10 Hz Technical specifications Pulse width: 180 µs Default duration: 30 min Stimulation of endorphin secretion for a general analgesic Mode of action...

  • Page 38: Positioning The Electrodes

    24. POSITIONING THE ELECTRODES The electrodes can be positioned according to the painful area to be stimulated, using either 2 electrodes or 4 electrodes. We remind you that it is strongly recommended to consult a health professional to test the positioning of the electrodes for the best possible pain relief. During this test, to find the optimum position for you we recommend that you choose an initial position of the electrodes and launch a programme.

  • Page 39: Catalogue References

    25. CATALOGUE REFERENCES standard Kit ................... SBM1AA007 actiTENS   ƒ 1 (neurostimulator) ................SBM1AA100 actiTENS   ƒ 2 self-adhesive strips ............... SBM1AB001 actiTENS   ƒ 1 Standard size armband ..............SBM1AG301 actiTENS   ƒ 2 packs of 2 x 40 cm cables ..............

  • Page 40: Technical Data Sheet

    Frequency of supply network 50-60 Hz Input and output voltage and intensity of 5VDC–1A charging case actiCHARGE Conditions of use of the actiTENS, the From 10°C to 40°C with relative humidity from 15% charging case and the AC to 93% actiCHARGE charger...

  • Page 41: App

    Cooling time of the device when it has been stored at 45°C 10 minutes minimum for it to be ready for use at ambient temperature (20°C) dimensions 108 mm x 53.5 mm x 17 mm actiTENS Weight of ~ 65 g actiTENS charging case dimensions 133.8 mm x 79 mm x 34 mm...

  • Page 42: Description Of The Symbols Used

    Device with a degree of protection against electric shocks in compliance with standard IEC 60601-1 The entire envelope is a type BF actiTENS applied part. Designed solely for use INDOORS. This is only applies when the device is connected to the mains.
  • Page 43 DESCRIPTION OF THE SYMBOLS USED Symbol of the ON/OFF button for switching the neurostimulator actiTENS on and off. Humidity range to which the device may be exposed during storage. Minimum and maximum temperatures to which the medical device may be exposed during storage.

  • Page 44: Electromagnetic Compatibility

      ƒ Portable radio frequency communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the actiTENS, including its cables. Otherwise, degradation of the performance of the actiTENS these devices could result.
  • Page 45 180°, 225°, 270°, 225°, 270°, 315° Voltagedips, typical commercial or hospital 315° brief cut-offs and environment. If the actiTENS 0% Ut for a voltage variations user requires continuous 0% Ut for a duration duration of 1 cycle, on electrical running during power cuts,...
  • Page 46 IPortable and mobile RF communication equipment must 3Vrmsfrom not be used closer to any part 3Vrmsfrom 150 kHz to of the actiTENS, including 150 kHz to 80 MHz Conducted RF 80 MHz cables, than the recommended Disturbances 6VinISMbands separation distance, from the...
  • Page 47 If abnormal performance is observed, extra measures may be required such as reorienting or repositioning the actiTENS. Over the reference range of frequencies from 150 kHz to 80 MHz, field intensities should be lowerthan3V/mand6V/mfortheISMbands....
  • Page 48 Table 3: Recommended separation distances between portable and mobile RF communications equipment and the actiTENS MAXIMUM RATED SEPARATION DISTANCE ACCORDING TO EMITTER FEQUENCY M OUTPUT POWER OF THE EMITTER W FROM 150 KHZ FROM 80 MHZ FROM 800 MHZ TO 80 MHZ TO 800 MHZ TO 2.7 GHZ...
  • Page 50 Via Giorgio Ribotta 5, IT - 00144 Roma, Vigilance on Medical DevicesHead of Unit 5 E-mail : dgfdm@postacert.sanita.it, vigilance@sanita.it, l.lispi@sanita.itMDD Premier marquage obtenu en janvier 2018 actiTENS First marking obtained in 2018 CE-Kennzeichnung erstmals im Januar 2018 erhalten Primo marchio ricevuto in gennaio 2018 SBM1AL001...

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