Duo Sport 2 - Uncategorized BLUETENS - Free user manual and instructions

USER MANUAL Duo Sport 2 BLUETENS

59, rue Castellion 01100 Oyonnax FRANCE - regulation@s4m-europe.com Product model : DS2 Version : V1 .3 English 4 Français 23 Deutsch 42 Español 61 Other languages 87 Electrode placements 80 Description of currents output 82 Electromagnetic compatibility 84 2 3The Duo Sport 2 electro stimulator is a medically certified device that sends electrical impulses to muscles and nerves to relieve pain, relax or strengthen muscles, Read the instructions of use carefully to make sure you use the device correctly. Welcome ! BENEFITS OF ELECTROSTIMULATION:The device is made to relieve acute or chronic pain. Totally natural, it is an eective pain management solution. The Duo Sport 2 uses 2 modes of stimulation to relieve pain, one with an immediate eect, called «Gate Control», and a slower one, longer-lasting called «Burst». This method has been used for many years in pain centers, hospitals and physiotherapy practices.Electrostimulation is used in the medical and sports sectors, to act on muscles in order to relax or strengthen dierent body areas. Physical preparation, targeted muscle reinforcement, treatment and muscle recovery form a complete body workout to ensure good muscular health.This user manual is available by following the link:https://www.bluetens.com/en/content/48-user-manuals TENS EMS

11. Do not use this device if you have a pacemaker, implanted defibrillator, or any other implanted metallic or

electronic device. Such use could cause electric shock, burns, electrical interference, or death.

2. The device should not be used when cancerous or other lesions are present in the treatment area.

3. Stimulation should not be applied over open wounds, rashes, or swollen, red, infected, or inflamed areas

(e.g., phlebitis, thrombophlebitis, varicose veins, obliterative arteriosclerosis, etc.).

4. Electrode placements should be avoided in the carotid sinus region (front of the neck) or transcranially

5. Anxious users - the use of electrical stimulation requires user cooperation; therefore, the procedure

should not be attempted in users with communication disabilities or mental incapacity.

6. Users with cerebrovascular issues - individuals with a history of aneurysm, stroke, and transient ischemia

should not undergo electrical stimulation, as it stimulates peripheral blood flow, which could be fatal in such cases.

7. Epileptic users - Electrical stimulation impulses have the potential to trigger a seizure.

8. Cases of acute pain/pain of unknown origin - using an electrical stimulator in undiagnosed cases may

9. Acute inflammation and swelling of the genitourinary system, tumors, urinary stones, history of nervous

system diseases, and other illnesses.

10. Do not use during pregnancy, especially during the first trimester.

11. Presence of a severe systemic disease, such as scleroderma, diabetes mellitus with severe complications,

myopathy, multiple sclerosis, Parkinson’s disease, myelopathy, or serious diseases of the liver, lungs, kidneys, hematological system, or other comorbidities. CONTRAINDICATIONS The use of the device should be discontinued in the following circumstances:

1. If you feel unwell or uncomfortable, stop immediately. If there are any abnormalities in the skin or body,

consult your doctor and follow their instructions.

2. If you wish to move the electrode to other parts of the body during operation, please turn o the power

before moving it. Failure to do so may result in an electric shock.

3. Do not use this device while wearing other electronic devices.

This could cause malfunction of these devices (e.g., malfunction of an electronic watch). WARNINGS

• The electrode is treated as a BF-type applied part.

• Device name: Duo Sport 2

• Frequency: 1Hz to 1200Hz

• Output pulse: 24 to 400uS

• Output voltage: 0V to 120V (at 500Ω load)

• Output power: 10mW (r.m.s) MAX

• Operating environment: Temperature: 5°C to 35°C Humidity: 30%RH to 80%RH Atmospheric pressure: 700 to 1060hPa

• Storage environment: Storage temperature: 5°C to 25°C Humidity: 30%RH to 80%RH Atmospheric pressure: 700 to 1060hPa

• Product dimensions: 50.8mm X 51.5mm X 18mm

• Minimum lifespan: 5 years

• Safety: Biocompatibility of the G607 gel used in this product is compliant with ISO 10993-5, ISO 10993-10 standards

• Lifespan: sealed storage for 3 years, to be stored at room or cool temperature (5°C to 25°C) and protected from direct sunlight. MAIN DEVICE: ELECTRODES: SAFETY WARNINGSSPECIFICATIONS EN EN 6 7THE DEVICE Intensity decrease Button Intensity increase Button Intensity Indicator Lights (each quarter represents 15 levels): Quarter 1: intensity from 1 to 15 Quarter 2: intensity from 16 to 30 Quarter 3: intensity from 31 to 45 Quarter 4: intensity from 46 to 60 The Duo Sport 2 turns on and o by pressing the blue button in the center of the device. Here is an explanation of the inputs, outputs, and buttons of the device. Output for charging cable and electrode cable

4. As subcutaneous use presents a high risk to humans or other devices, the use of this device is prohibited.

5. Use under supervision mandatory for children (over 7 years old) and disabled persons. Risk of accident

6. Do not use this appliance in a bathroom or a place with high humidity. Do not use while bathing or

showering. Strong electric shock could occur.

7. Do not use while sleeping. This could damage the product, and the displacement of the electrode could

8. Do not use while driving. It could cause an accident due to the strong stimulation.

9. Do not keep the electrodes on your body all the time. This could cause skin irritation.

10. Do not use metal to touch the electrode. This could cause an electric shock.

11. Application near the thoracic region could cause cardiac discomfort. Seek the advice of a doctor

13. Discontinue use and do not increase the intensity level if you experience discomfort during use.

14. The electrode cable must not encircle your neck to avoid strangulation.

15. Do not modify the equipment. Please use original accessories, it will cause an unusable eect if you use

third party accessories on the market.

16. Keep out of reach of children to avoid inhalation or ingestion of small parts.

1. If you have a skin allergy, you should stop using it immediately.

2. Stimulation must not be applied through or over the head, directly to the eyes, covering the mouth or on

the front of the neck (especially the carotid sinus).

1. Users may experience skin irritation and a burning sensation under the stimulation electrodes applied to

2. Users may experience pain or discomfort during or after application.

Note: Users should stop using the device and consult their doctor if they experience any adverse reactions.

The Duo Sport 2 is charged using the USB-C cable included in the box. Charging time is approximately 1 hour. When the battery is below 20%, the charge indicator light flashes orange. This indicator light will remain orange during the charging time and will go out once the battery is full. We recommend charging the device with its USB-C cable connected to a computer. If you wish to use a mains adapter, please ensure that the power is compatible. The battery recharges on average once a month, if the device is used once every 2 days. Note:

• This device cannot be used while charging.

• The mains adapter must comply with standard IEC62368-1, respect at least 2 MOOP and have an output of 5V/1A.

CHARGING THE BATTERY

Power adapter EN EN 10 11> Launch the Application and select your device from the available options. > Log in using the options provided or create an account. > A tutorial will introduce you to the Application and its features. FIRST USE The Bluetens Application is available on Google Play and Appstore. The Application is compatible with Smartphones and Tablets: iPhone : iOS 13 and above Android : Android 10 and above (Modified Android versions may make the Application incompatible) Download and install the Application according to your Smartphone. Notes: Bluetooth must be activated to use the Application. Android smartphones must also authorise access to the location service, to the Application. The Bluetens Application does not have access to any data. This condition is required by Android versions to stabilise Bluetooth. Available on Available on

DOWNLOAD AND INSTALLATION

THE APPLICATION EN EN 12 13CURE Dierent programmes to relieve all types of pain. RELAX Muscle massage programmes and post- physical exertion recovery. TONE Physical preparation and muscle strengthening programmes. > Select the action and the body part SINGLE SESSION:

Choose the body parts according to your needs. > Press «GO» to access the list of programmes. SPLIT FUNCTION Activate the Split function to run two dierent programs simultaneously. > Choose from the main functions on the home page:

SIMPLE ELECTROSTIMULATION SESSION

TREATMENTS: generic treatments for common pathologies MY PROGRAMS: recommended programmes to achieve the goals you have set.

PRESENTATION AND USE

EN EN 14 15The default intensity is 1, press + or - to change it. The maximum intensity is 60. The intensity can also be set directly on the device. Note: Once your session is over, make sure you switch o the device before handling the electrodes. Replace them on the plastic (indicated side) and store them in a cool, dry place.

RUNNING PROGRAM PROGRAM DESCRIPTION ELECTRODES PLACEMENT TURN YOUR DEVICE ON The connection between the Application and the device is established automatically at this stage. Do not pair manually! EN EN 16 17• Remove the cables from the device after use.

• Use a soft cloth to clean dirt on the device

• Use a damp cloth with a neutral detergent or alcohol to clean if necessary.

• Do not use thinner or petrol to clean.

• Do not use alcohol on the back of the device

• Do not use any other detergents.

• Keep water or liquids away from the device

• Keep out of direct sunlight, heat, damp and dusty places. MAIN DEVICE

• Do not use extra gel with the electrodes.

• Always replace and store the electrodes on the correct side of the plastic provided.

• Use a little water to clean the electrode if necessary.

• Do not wipe the electrode with a cloth or paper.

• The lifespan of the electrodes varies between 30 and 50 uses depending on the quality of the skin, hairiness, perspiration and the care taken.

• Electrodes are consumables; when they no longer adhere to the skin, it’s a sign that they need changing.

• Do not stack or bend the electrodes.

• Do not touch the gel with your fingers.

• Apply to clean, dry skin, without cream or oil. ELECTRODES

PERSONALISED SUPPORT TO HELP YOU REACH

YOUR SPORT OR HEALTH OBJECTIVES

> Select or describe your problem, then fill in your profile and proceed to payment. Within 48 hours you will receive your personalised treatment to follow for a minimum of 4 weeks (electrostimulation and physical exercises) and follow the prescriptions to get better quickly. The healthcare professional will make sure that your exercises are carried out properly and that you feel good. PREMIUM FUNCTION CARE INSTRUCTIONS EN EN 18 19The product must not be disposed of with household waste. Consumers are legally obliged to dispose of electrical equipment at a collection point in their town. Contact your local council for more information or a retailer.

Essential informations for a correct use is indicated by the corresponding symbols. The following symbols can be seen on the device and on the labelling. SYMBOL TITLE IP22 IP code of the device: the degree of protection of this device against the intrusion of solid foreign objects -- ≤ 12.5 mm in diameter (and against access to dangerous parts with a finger); the degree of impermeability is of the drip type (inclination of 150). Disposal in compliance with directive 2002/96/EC (WEEE) This side up Date of manufacture Batch code CE mark, Certificate issued by TUV SUD. Manufacturer Type BF applied part

Warning: to avoid the risk of injury, read the manufacturer’s instructions

carefully. Symbol for «AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY» Fragile, handle with care Store the product in a dry place. Protect from water and rain. Product packaging is recyclable Importer Medical device

Electrodes, cables and accessories included in the box are not covered by this warranty. WARRANTY DISCLAIMER Bluetens has not authorised any agency to repair its products. If you experience any problems with your device, please contact us. Bluetens will not be responsible for the results of any repair. The intervention of a third party on our products will void the 2-year warranty. The use of third-party electrodes or accessories could cause the device to malfunction and will void the warranty. The user should not attempt to repair the device or its accessories by himself. Each device has been inspected through systematic validation. The performance is stable and does not require calibration or validation. If your product does not achieve the expected performance and the basic function changes during normal use, please contact us. Please note that Bluetens will not be responsible for quality issues caused by improper use.

INTRODUCTIONTROUBLESHOOTING AND WARRANTY

• Dimensiones: 50.8mm X 51.5mm X 18mm

Decontracting massage Frequency: 1Hz - Impulse: 150µs - Treatment time: 30minutes

Prevention muscle loss 1 Frequency variable - Impulse: 200µs 15Hz~80Hz Inc 2.2 seconds - 80Hz Hold 10 seconds 80Hz~15Hz Dec 1.3 second - 15Hz Hold 8 Seconds Phase time est: 21.5 second - Loop for: 30 minutes 82 83ELECTROMAGNETIC COMPATIBILITY The device has been thoroughly tested and inspected to assure proper performance and operation. The EMC Test Report Number of TUV: 68.730.20.0074.01 Model: CL2, CL2M, CL2P, DS2 Mode Description Charging The EUT’s USB-C port is connected to a single-port USB-C cable (length: 80 cm) and is charged by an AC / DC adapter. EMS + Lien BT The EUT is powered by a rechargeable 3.7VDC lithium battery. Its USB-C port is connected to a double electrode cable (4 ends, length: 110 cm), and the electrode cable terminals are connected to electrode pads (Size: 50 x 100 mm). The part of the electrode cable 40 cm away from the EUT is immersed in 0.9% saline solution. The EUT is connec- ted to the APP via Bluetooth, and its treatment functions are controlled by the APP or by the EUT itself. Next, the EUT is set to Nev.1 Acute Pain mode (Pain) and set to maximum power for the operation. TENS + Lien BT The EUT is powered by a rechargeable 3.7VDC lithium battery. Its USB-C port is connec- ted to a dual-electrode cable (4 ends, length: 110 cm), and the electrode cable terminals are connected to electrode pads (Size: 50 x 100 mm). The part of the electrode cable that is 40 cm away from the EUT is placed in 0.9% saline solution. The EUT is connected to the APP via Bluetooth, and its processing functions are controlled by the APP or by itself. Next, the EUT is set to TENS mode and adjusted to maximum power for operation. MODES OF OPERATION: Configuration Description AC Powered 230VAC/50Hz AC Powered 100VAC/50Hz & 240VAC/50Hz (Only for Voltage dips and Voltage interruptions) Output Frequency 1Hz 10Hz 50Hz 100Hz 200Hz 500Hz 1KHz 1,2KHz Output Pulse 400uS 300uS 100uS 100uS 50uS 50uS 34uS 24uS Output Voltage Vpp 0-120V 0-120V 0-110V 0-85V 0-85V 0-57V 0-57V 0-57V TEST CONFIGURATION OUTPUT PARAMETERS Test Condition: Group1, Class B Test Result Radiated Emission 30MHz to 1000MHz Pass Conducted Emission on AC 150kHz to 30MHz Pass Harmonic Class A Pass Flicker Pass EMISSION TESTS EN 60601-1-2:2015, IEC 60601-1-2:2014 84 85Test Condition: Group1, Class B Test Result Electrostatic Discharge (IEC 61000-4-2) ±2kV ±4kV ±6kV ±8kV ±15kV Contact: ±8kV Air: ±2kV ±4kV ±8kV ±15kV Radiated Immunity (IEC 61000-4-3) 80MHz to 2700MHz 10V/m 385MHz 27V/m 450MHz 28V/m 710MHz, 745MHz, 780MHz 9V/m 810MHz, 870MHz, 930MHz 28V/m 1720MHz, 1845MHz, 1970MHz 28V/m 2450MHz 28V/m 5240MHz, 5500MHz, 5785MHz 9V/m 10V/m, 80% Am at 1kHz 27V/m PM at 18Hz 28V/m FM ± 5 kHz deviation at 1kHz sine 9V/m PM at 217 Hz 28V/m PM at 18Hz 28V/m PM at 217 Hz 28V/m PM at 217 Hz 9V/m PM at 217 Hz Electrical Fast Transient (IEC 61000-4-4) For AC Power port: ±2kV, 100 kHz repetition frequency For signal input/output port: ±1kV, 100 kHz repetition frequency For AC port: Power supply lines: ±2kV Surge (IEC 61000-4-5) For AC Power port: ±0.5kV, ±1kV (Line to line) ±0.5kV, ±1kV, ±2kV (Line to Ground) For signal input/output port: ±2kV (Line to Ground) For AC port: (L-N): ±0.5kV ±1kV Conducted Immunity (IEC 61000-4-6) For AC Power port, patient coupling port and signal input/output port: 150KHz to 80MHz 3V (80% Am at 1kHz) ISM and amateur radio bands between 150KHz to 80MHz 6V (80% Am at 1kHz) For AC port and patient coupling port: 150KHz to 80MHz 3V (80% Am at 1kHz) ISM and ama- teur radio bands between 150KHz to 80MHz 6V (80% Am at 1kHz) Voltage Dips and Interruption (IEC 61000- 4-11) 0%, 70%, 0% of UT For AC power port: 0% for 0.5 cycle (at 0°, 45°, 90°, 135°,180°, 225°, 270° and 315°), 0% for 1 cycle (at 0°), 70% for 25 cycles (at 0°), 0% for 250 cycles Power Frequency Magnetic Field (IEC 61000- 4-8) 50Hz, 60Hz 30A/m 50Hz: 30A/m 60Hz: 30A/m IMMUNITY TESTS EN 60601-1-2:2015, IEC 60601-1-2:2014 THIS USER MANUAL IS AVAILABLE IN OTHER LANGUAGES AT THE FOLLOWING LINK: https://www.bluetens.com/en/content/48-user-manuals OTHER LANGUAGES