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SUBLIMED actiTENS Instructions For Use Manual

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INSTRUCTIONS FOR USE
The actiTENS device is a transcutaneous electrical nerve
stimulator to be used to ease pain in people ages 22
and older. The stimulator is set on a self-adhesive strip,
directly on the body. Thanks to the flexible design, it fits
your body shape and can be discreetly used 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, a healthcare
professional will instruct you how to correctly position
the electrodes and to select an appropriate stimulation
program for your specific needs.
SBM1AL011 - Notice_US_202306_v6
actiTENS
1

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  • Page 1 To get the most out of your actiTENS, a healthcare professional will instruct you how to correctly position the electrodes and to select an appropriate stimulation program for your specific needs.
  • Page 2 SBM1AL011 - Notice_US_202306_v6...

  • Page 3: Table Of Contents

    6. INDICATOR LIGHT: MEANING 7. CHARGING YOUR actiTENS 8. DOWNLOADING THE actiTENS APP 9. PLACING THE DEVICE GETTING TO KNOW THE actiTENS APP 11. LAUNCHING A PROGRAM 12. STOPPING A STIMULATION SESSION 13. TAKING OFF THE DEVICE 14. FOLLOWING-UP YOUR TREATMENT 15.
  • Page 4 SBM1AL011 - Notice_US_202306_v6...

  • Page 5: Intended Use / Indications For Use

    1. INTENDED USE / INDICATIONS FOR USE actiTENS is intended to be used as:  Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications: Symptomatic relief and management of chronic, intractable pain Adjunctive treatment for post-surgical and post- trauma acute pain...

  • Page 6: Warnings And Precautions For Use

    • For hygiene reasons, the electrodes must only be used by a single patient. • Do not attempt to open or modify the actiTENS neurostimulator and the charging case - there is a risk of electric shock. • Do not use the actiTENS neurostimulator and the charging case in the immediate vicinity (e.g.
  • Page 7 • Do not use the device in a flammable environment (ex: gas station). • Do not use the actiTENS device in emergency medical services. • We recommend that you do not use the actiTENS neurostimulator while driving a vehicle or handling dangerous equipment (saw, lawnmower...) because of...
  • Page 8 Do not use the stimulator during physical activities that may involve collision or impact. • If you drop the actiTENS or the charging case, check the condition of the device before use. If the device is damaged, there is a risk of electric shock during use.

  • Page 9: Therapy

    • Keep your applications and devices up to date. • Do not store the actiTENS neurostimulator for a long time without using it to avoid deep discharge of the batteries. • We recommend that the phone is locked (manually or...

  • Page 10: Device Overview

    1 AC charger • 1 instruction for use • 1 Quick-start guide Remember: the two ends of the cable are different. Make sure you clip the wide end to the actiTENS and the narrow end to an electrode. SBM1AL011 - Notice_US_202306_v6...
  • Page 11 Indicator Electrodes 50 mm X 50 mm Electrode connector For charging the device SBM1AL011 - Notice_US_202306_v6...

  • Page 12: Indicator Light: Meaning

    For more details (2.8 times per second) see chapter 15 All of this information, plus the actiTENS stimulator battery level indicator are also available via the app in the actiTENS menu actiTENS at the bottom of the screen. SBM1AL011 - Notice_US_202306_v6...

  • Page 13: Charging Your Actitens

    (type of program and intensity), the skin resistance of the patient and the surroundings. NB: to ensure the performance and safety of the machine, the AC charger (SBM1AF211) provided with the actiTENS must be used at all times. Using other AC charger invalidates the actiTENS guarantee.

  • Page 14: Downloading The Actitens App

    (battery charging) to permanent green (battery charged), unplug the AC charger and disconnect the micro-USB from the charging case. How to check how much charge your actiTENS stimulator has? The charge level of charge can be checked via the app, in the actiTENS actiTENS menu.

  • Page 15: Placing The Device

    This incompatibility may be temporary and can sometimes be resolved by updating your phone and/or the actiTENS app. 9. PLACING THE DEVICE • Preliminary step: Choose the number of electrodes based on the area to be stimulated: 2 or 4.
  • Page 16 Step 3: attach the actiTENS stimulator to the self-adhesive strip. • Step 4: stick the self- adhesive strip attached to the actiTENS near to the electrodes. Example using two electrodes • Step 5: clip the cables (wide end) to the actiTENS stimulator. SBM1AL011 - Notice_US_202306_v6...

  • Page 17: Getting To Know The Actitens App

    You will need to accept these conditions to be able to use the actiTENS. The user guide and contraindications can be found at all times in the "Help" menu.
  • Page 18 The actiTENS mobile app offers you to create a user account. This user account is optional for the use of your actiTENS but will give you access to more functionalities related to your health monitoring. A user account is necessary to keep your data in case you change phone or uninstall the app.

  • Page 19: Launching A Program

    Medical questionnaires and monitoring the impact of pain on your daily life actiTENS: If the stimulator is not connected: connection button If the stimulator is connected: actiTENS battery level actiTENS If a program is running: access to the remote control...
  • Page 20 • Choose a program from suggested list. (the list of programs and their descriptions available in section 17 of these instructions for use) • Choose the channel or channels that you want to use. Remember: 2 electrodes = 2 cables Channel 1 or Channel 2 4 electrodes = 4 cables Channel 1 and Channel 2...
  • Page 21 o 1 channel: o 2 channels: • Place the device on your body (if you have not already done so). For help, go to the “Placing the device” section (section 9). SBM1AL011 - Notice_US_202306_v6...
  • Page 22 • Turn on the stimulator by pressing the ON/OFF button (if you have not already done so). The indicator light will blink green. SBM1AL011 - Notice_US_202306_v6...
  • Page 23 • Launch the automatic placement check. This step ensures that all the connections between the actiTENS stimulator, the cables, the electrodes and your body are working correctly. NB: if there is an error, manually check the connections, cables and electrodes and repeat the automatic check.
  • Page 24 • Define the program length. The app allows you to choose between 10 minutes and 12 hours of stimulation. Each program type is automatically set to a default length, summarized in section 18 “Program overview”. SBM1AL011 - Notice_US_202306_v6...
  • Page 25 • Enter your pain level (an option that can be deactivated via the “My Account” menu) before your stimulation session. Historical data can be accessed via the “My Health” menu (see section 14.2. “Pain level history”). NB: at the end of a session, you will be asked your pain level again.
  • Page 26 • The actiTENS control screen is displayed. The timer automatically starts when you start adjusting the intensity. You need to adjust the stimulation intensity. The stimulation intensity should be adjusted to reach a balance between a tolerable sensation and pain relief.
  • Page 27 To return to the app, touch the actiTENS icon. To return to the control screen, touch the actiTENS icon, then the program running. actiTENS • How to adjust the position of the electrodes...

  • Page 28: Stopping A Stimulation Session

    12. STOPPING A STIMULATION SESSION • Stopping at the end of a session: the stimulation session stops automatically at the end of the time set. A notification appears to confirm the end of the session. • Stopping during a session: A session can be stopped temporarily or permanently while it is running.

  • Page 29: Following-Up Your Treatment

    Carefully unstick the electrodes and the self- adhesive strip and put them back on their plastic film before placing them in their bag. The cables can be detached from the actiTENS stimulator electrodes carefully unpluggging the connectors (do not pull on the cables).

  • Page 30: Actitens Updates

    IMPORTANT: While the actiTENS indicator light blinks blue, you will not be able to switch it ON nor OFF. If the actiTENS battery is emptied, it first has to be charged to resume the update. SBM1AL011 - Notice_US_202306_v6...

  • Page 31: Storage Conditions And Cleaning

    Your self-adhesive strips should be changed every week. For replacing your electrodes by new ones, contact the supplier who supplied you the actiTENS Standard kit. Please only use electrodes supply by Sublimed with references mentioned in the section 21. •...

  • Page 32: Customer Support

    Customer Care Department. NB: If you use the actiTENS stimulator at the maximum setting for several hours, the device may overheat and display an error as a safety precaution. If this is the case, wait for the machine to fully cool down.
  • Page 33 The actiTENS has disconnected Once a program has been launched, dis- connection does not affect the operation of the actiTENS. The strength of the Bluetooth signal can vary affected depending on how much charge your phone or the actiTENS features.
  • Page 34 • Do not attempt to modify the device, as this invalidates the guarantee. • Under normal conditions of use, actiTENS stimulator is designed for a service life of at least 5 years. • Contact your reseller or SUBLIMED: ▪...

  • Page 35: Program Overview

    18. PROGRAM OVERVIEW Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12 and P13 correspond to TENS mode. Program P9 corresponds to EMS mode. P1 100Hz Technical Frequency: 100 Hz information Pulse width: 200 µs Default duration: 30 minutes Mode of action Inhibits pain signals SBM1AL011 - Notice_US_202306_v6...
  • Page 36 P2 80Hz Technical Frequency: 80 Hz information Pulse width: 150 µs Default duration: 30 minutes Mode of action Inhibits pain signals P3 2Hz Technical Frequency: 2 Hz information Pulse width: 250 µs Default duration: 30 minutes Mode of action Stimulates the muscles for a general pain-relieving effect SBM1AL011 - Notice_US_202306_v6...
  • Page 37 P4 Mixed Technical Channel 1: 100Hz Frequency: 100 Hz information Pulse width: 200 µs Channel 2: 2Hz Frequency: 2 Hz Pulse width: 200 µs Default duration: 30 minutes Mode of action Combined action: Inhibits pain signals Stimulates the muscles for a general pain-relieving effect SBM1AL011 - Notice_US_202306_v6...
  • Page 38 P5 Sequential Technical sequence (1/3 of the time, so by information default: 10 minutes): Program 100Hz Frequency: 100 Hz Pulse width: 150 µs sequence (2/3 of the time, so by default: 20 minutes): Program 2Hz Frequency: 2 Hz Pulse width: 200 µs Default duration: 30 minutes Mode of action Combined action:...
  • Page 39 P6 HAN Stimulation Technical sequence (duration: 3 seconds): information Program 100Hz Frequency: 100 Hz Pulse width: 150 µs sequence (duration: 3 seconds): Program 2Hz Frequency: 2 Hz Pulse width: 200 µs These sequences alternate every 3 seconds Default duration: 30 minutes Mode of action Combined action: Inhibits pain signals Stimulates the muscles for a general...
  • Page 40 P7 Burst 2 Hz Technical sequence (duration: 0.25 information seconds): Program 100Hz Frequency: 100 Hz Pulse width: 150 µs sequence (duration: 0.25 seconds): no pulse These sequences alternate every 0.25 seconds Default duration: 30 minutes Mode of action Combined action: Inhibits pain signals Stimulates the muscles for a general pain-relieving effect...
  • Page 41 P8 Frequency modulation Technical sequence (duration: 7.5 information seconds): Increasing frequency: 2 Hz to 80 Decreasing pulse width: 200 µs to 100 µs sequence (duration: 7.5 seconds): Decreasing frequency: 80 Hz to 2 Increasing pulse width: 100 µs to 200 µs These sequences alternate every 7.5 seconds Default duration: 30 minutes...
  • Page 42 P9 Muscle Stimulation Technical Frequency: 50 Hz information Pulse width: 250 µs sequence (2 seconds): Increasing intensity: 0mA to desired intensity sequence (5 seconds): Constant intensity (desired intensity) sequence (1 second): Decreasing intensity: desired intensity to 0mA sequence (12 seconds): No pulse These sequences alternate...
  • Page 43 P10 Massage Technical Frequency: 80 Hz information Pulse width: 150 µs Channel 1: 1st sequence (1 second): Increasing intensity from 0mA to the desired value sequence (1 second): Decreasing intensity from the desired value to 0 mA Channel 2: sequence (1 second): Decreasing intensity from the desired value to 0 mA sequence (1 second): Increasing...
  • Page 44 P11 Rubbing Technical Frequency: 80 Hz Pulse width: 150 µs information Channel 1: sequence (0.2 seconds): Increasing intensity from 0 mA to the desired value sequence (0.2 seconds): Decreasing intensity from the desired value to 0 mA Channel 2: sequence (0.2 seconds): Decreasing intensity from the desired value to 0 mA sequence (0.2 seconds):...
  • Page 45 P13 Nausea Technical Frequency: 10 Hz information Pulse width: 180 µs Default duration: 30 minutes Mode of action Stimulates the muscles for a general pain-relieving effect Treatment type and choice of program to be determined with your doctor based on your disease. SBM1AL011 - Notice_US_202306_v6...

  • Page 46: Positioning The Electrodes

    19. POSITIONING THE ELECTRODES The electrodes can be positioned depending on the area of pain to be stimulated, by either using 2 or 4 electrodes. It is highly recommended that you make an appointment to see a healthcare professional to test the positioning of the electrodes, to get the best pain relief from your device.

  • Page 47: Technical Data Sheet

    1 mA to 60 mA ± 10% with a 0.5 mA step Battery Li-Ion Output voltage and max 60 mA ± 10% (1000 Ω) intensity of the actiTENS / max 60 V ± 10% stimulator Does not deliver a current Essential performance > 60 mA ± 10% of actiTENS stimulator or a voltage >...
  • Page 48 From 5°C to 27°C (41°F to Storage conditions for 81°F) with a relative the actiTENS standard humidity from 5% to 93% Temperature between 15°C and 25°C (59°F and 77°F) are best suited to preserve the battery’s capacity From -10°C to 45°C (14°F to 113°F), with a...
  • Page 49 IP22: protection from touch by fingers and IP classification of the objects greater than 12.5 actiTENS stimulator mm, protection from water spray up to 15° from vertical IP21: protection from touch by fingers and IP classification for the objects greater than 12.5...
  • Page 50 Device with a degree of protection against electric shocks, conform to the standard IEC 60601-1. Any shell for the actiTENS is a BF type applied part. Design for INTERIOR use only. This is only valuable when the actiTENS is charging (connected to the main) Manufacturer’s address.
  • Page 51 The actiTENS stimulator ON/OFF button symbol for turning the stimulator on and off. Humidity range the device can be exposed Minimum and maximum temperatures the medical device can be exposed to. ℞ Prescription-only device actiTENS is MR Unsafe SBM1AL011 - Notice_US_202306_v6...

  • Page 52: Catalogue References

    21. CATALOGUE REFERENCES actiTENS Standard Kit SBM1AA017:  actiTENS (stimulator) SBM1AA110  1 Pack of 2 Self-Adhesive strips SBM1AB011  2 Packs of 2 medium 40 cm cables SBM1AE001  1 Pack of 4 UltraStim® snap Electrodes 50 x 50 mm SN2020 (Manufactured by Axelgaard Co.,...

  • Page 53: Electromagnetic Compatibility

    The actiTENS is intended for clinical use and home use. The actiTENS is intended to be used in the electromagnetic environment specified below. The user of the actiTENS must ensure that it is used in such an environment. WARNINGS •...
  • Page 54 CISPR 11 RF Emissions Class B The actiTENS is suitable for use in all premises, including domestic premises and those connected directly to the IEC 61000-3-2 Class A...
  • Page 55 0% Ut for a lines duration of 1 power the actiTENS using duration of 1 energy source that does not cycle, 70% cycle, 70% experience cuts or a battery. for a...
  • Page 56 Immunity test IEC 60601-1-2 Test level Level of conformity Directives IEC 610004-3 The equipment must The equipment must The actiTENS has not be used within not be used within Proximity fields been tested and 30cm of other 30cm of other...
  • Page 57 If the intensity of the field, measures at the place where the actiTENS is used, exceeds the level of RF conformity applicable above, the actiTENS should be observed to verify that it is working normally.

  • Page 58: Fcc Compliance Statement

    23. FCC COMPLIANCE STATEMENT This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation.
  • Page 59 INFORMATION: MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, product use errors with human medical products, including drugs, biologic products, medical devices, dietary supplements, infant formula, and cosmetics. If you think you or someone in your family has experienced a serious reaction to a medical product, you are encouraged to take the reporting form to your doctor.
  • Page 60 Submitting Adverse Event Reports to FDA Use one of the methods below to submit voluntary adverse event reports to the FDA: Report Online at www.accessdata.fda.gov/scripts/medwatch/index.cfm? action=reporting.home Consumer Reporting Form FDA 3500B. Follow the instructions on the form to either fax or mail it in for submission.
  • Page 61 SBM1AL011 - Notice_US_202306_v6...
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  • Page 63 SBM1AL011 - Notice_US_202306_v6...
  • Page 64 +33(0)4 76 37 17 58 137, rue de Mayoussard 38430 Moirans FRANCE contact@subli-med.com ℞ Caution: Federal law restricts this device to sale by or on the order of a physician. SBM1AL011 - Notice_US_202306_v6...

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