Duo Sport - Fitness Equipment BLUETENS - Free user manual and instructions

USER MANUAL Duo Sport BLUETENS

Pre-requisites Box content The Duo Sport The Application First use Safety instructions Technical characteristics Customer Service Guarantee

We thank you for purchasing a Duo Sport device. Duo Sport is a medical device, to make best use of it, you will find all relevant informations included in this user manual. For any additional information or to simply give us your feedback, you can contact us at contact@bluetens.com. Thank you !

FRDuo Sport is the main unit that is inserted in Sport clip.The snap cables plugs to the Sport clip on one side and to the two S (small) electrodes on the other. Two sizes of cables are provided (15 & 25 cm)Duo Sport must be recharged via USB cable. While charging, the cable must be plugged, on one side, into the USB charger or computer, and on the other side into Duo Sport’s micro USB port.This user manual will allow you to get familiar with your Duo Sport in no time.Duo sport is delivered with a satchel, allowing you to carry it safely, together with its cables and electrodes, away from any liquid.For travelling, use the black protective hard case. Electrodes are included into the boxTip: for more details on your electrodes, read the instructions located in the plastic bag.

Getting started with Duo Sport is easy, here is some advice to let you benefit from it as quickly and safely as possible .

1. Please read the safety instructions as well as the contraindications at page 30.

2. Your Smartphone should support the minimum system requirements :

3. You will need to install the Bluetens App on your Smartphone.

Download and install the Bluetens App. If you need help to install a Smartphone Application, go on www.bluetens.com/app and follow the steps.Download and install Bluetens App

4. Your Bluetooth must be ON.

It is not necessary to pair your Duo Sport manually, your Smartphone will connect automatically as you will launch the program. This means that you will not need to fill in a PIN code or change your Bluetooth settings, Duo Sport is small, strong and clever too!Are all steps validated? So now we are ready to go through more serious things ;)iOS : iPhone 4s or above, iOS 8 or aboveAndroid : Bluetooth 4.0 compatible and Android 4.3 or above iOS Look for «Bluetens Get better» App on Appstore or scan this QR code and install the App. Android Look for «Bluetens Get better» App on Playstore or scan this QR code and install the App.

EN EN3. The Duo Sport ON/OFF Button: this button allows you to turn Duo Sport on and o.Intensity adjustment knob : allows you to increase or reduce the program’s intensity. To increase the intensity, turn the knob to the right, and to reduce it turn the knob to the left. Intensity increases in increments of 1 up to the level of 60. Turning the knob to the left you will reduce the intensity from 1 to the minimum level of 0.Program intensity indicators : the first indicator lights up when a program is launched . For all 15 intensity levels a blue indicator will light up, so you will see:Charge indicator : when your Duo Sport has less than 20% of battery remaining, charging light will blink. When you charge Duo Sport, the charge indicator will stop flashing and remain fixed until the battery is fully recharged then turns o.Power on indicator : with a simple touch of the ON/OFF button the light will turn green. A second press and the light will turn o .Slider : for safety reasons, you cannot recharge and use Duo Sport at the same time, drag the slider either to charge mode or usage mode.Sport clip plug : Sport clip entryMicro USB plug : USB cable entry.Reset button : this button will restore Duo Sport to factory settings.• 1 light from level 0 to 15• 2 lights from level 16 to 30• 3 lights from level 31 to 45• 4 lights from level 46 to 60

Electrodecable plug SPLIT Run a dierent program on each Duo Sport. Once first program is running, use the SPLIT option and select the second one. SKIP For «Tone» programs, you can now skip warm-up and recovery phase directly on the description page by clicking on warm-up or recovery icon. LINK/UNLINK Link or unlink your Duo Sport in the settings of the App. The Solo modo enables you to use one device at a time while Duo mode syncronizes your two devices. AUTOMATIC PAIRING Duo Sport will pair with your Smartphone automatically when you launch the program. It’s ‘Plug and Play’ , no manual intervention is necessary. FAVOURITES Get quick access to your favourites programs with Favourites option. On the program description page, click the star icon to create a shortcut in the «Favourites» menu. DOWNLOAD You can transfer the program of your choice to Duo Sport memory and enjoy it without using your Smartphone! Once you have downloaded the program, turn your Duo Sport on, slide the intensity wheel and the program will begin.To charge your Duo Sport :1. Unclip the Duo sport from the main electrode 2. Remove the device from the clip3. Push the slider to the right and connect the usb cable to charge the device

EN5. First use > Select the Duo Sport product > Creation of a Duo Sport account. Click on «New user?» and create your account. Fill in the mandatory fields, read and accept the terms & conditions. Once you have created your account, you will receive an email with an activation link. Click on this link to validate your account. You can also use Duo Sport App without creating an account by clicking on «register later». > For your first use, a tutorial will be displayed. The tutorial picks up the various stages of Duo Sport operation to ensure a safe use, please take a few minutes to read it carefully. > The first step consists in defining the area and action you are looking for. Available body areas are : Upper back • Back • Lower back • Abdomen • Buttocks Thigh • knee • Calf • Ankle • Foot • Shoulder • Pectorals Upper arm • Elbow • Forearm • Wrist >Rotate the wheel to select the desired body area, then do the same for the desired action. Cure For physiotherapy care aiming to amplify rehabilitation or allow a rapid pain relief eect. Relax For a relaxing massage or to ease muscle tension, also very eective on improving quality and speed of recovery. Tone For a muscular work-out session. >Then press «GO». PROGRAM SELECTION

EN EN> Click on the program and access its description :

• Position advices All programs were created by our medical team composed by French physiotherapists, all State-certified, practicing in clinics and private practices. > Press «GO» and access to electrode placement’s advices.

> Place the electrodes as shown in the drawing. Make sure you have placed the 3 (or 6) electrodes on your skin, Duo Sport will not work unless all electrodes are connected. Caution: Make sure that Duo Sport is turned o during the electrode placement. Turn it on when prompted by the App. Tip: find all electrode usage instructions in the plastic bag. > Then press «GO». ELECTRODE PLACEMENT

EN EN> Turn DUO SPORT devices on by pressing «ON» when requested. Duo Sport will automatically connect to your smartphone and the program will start after a few seconds. > Adjust the program’s intensity turning Duo Sport wheel or using the App. To achieve greater eectiveness, follow our intensity advices.

> If you want to stop the program, press the «Stop» button. You will be redirected to the main menu. > If you are using Duo Sport in SOLO mode and you wish to start a dierent program on the second device, click on SPLIT icon to select a second program to run on your second Duo Sport device. > A message will indicate the end of the program. Turn Duo Sport o before removing the electrodes. Reposition the electrodes on the proper side of the plastic film and store them inside the sealed bag. PROGRAM TERMINATION

EN EN6. Safety instructions CONTRAINDICATIONS The use of Duo Sport is forbidden for people fitted with a pacemaker or epilepsy-prone. Duo Sport use is also not recommended for pregnant women , and people with a hernia or an incisional hernia. People suering from heart weakness must avoid areas around the heart. Don’t use Duo Sport if you have heart irregularities or heart diseases. IMPORTANT ! Do not use Duo Sport in water or in humid environements (sauna, balneotherapy and hammam, etc.). It is forbidden to place the electrodes on the sinocarotid region (in the front of the neck), on the transcranial region (through the head) or transthoraxale region (through the ribcage). To get it right, please follow the electrode placement’s advices, they have been prepared by health professionals and correspond to areas of the body where Duo Sport will be more eective. SAFETY PRECAUTIONS Do not use Duo Sport within a meter from shortwave medical devices or microwave equipment, which could modify the current generated by the device. Use only the cable provided by Bluetens. During sessions do not disconnect the electrode cable because power is on. The device must be turned o first. Never take o the electrodes when Duo Sport is powered on. Never connect the electrode cable to an external power source. That could cause electric shock. Do not use any damaged or defective electrode cable. Always use the USB cable provided by Bluetens to charge the device. Never use Duo Sport or the USB cable if damaged. Keep Duo Sport and its accessories out of reach of children. Prevent any foreign matter (soil, water, metal, etc.) from entering the device. Do not use Duo Sport while driving. Never recharge Duo Sport during its use; a sliding part (the slider) prevents the simultaneity of recharge and use as an extra protection. In case of doubt, do not hesitate to consult a doctor.

• Program control by Bluetooth 4.0 (BLE) compatible smartphone

• Compatible with Android 4.3 and above, iPhone 4s, iOS8 and above

• Powered by a rechargeable built-in lithium-ion battery

• Intensity adjustment on the device

• Medical certified device

• Electrode and USB cables included

• Reusable electrodes included

• Output Current : Maximum 120mA (peak), average of 20 mA

• Output voltage : Maximum 100 V (without load), 65V (with load)

• Automatic shut-o after each program : yes

• Ignition safety : 100%

• Classified as type BF

• CE regulations concerning Medical Devices (Directive 93/42/EEC)

• ROHS : devices built without materials that can have a harmful impact on the environment

• Protection against electric shock class 2

• Device in contact with the patient excluded heart area

• Read the user manual carefully RECOMMENDATIONS (storage and transport) Temperature : 10°C / 45°C - Humidity level : 25% / 80% Information on waste management At the end of the product life, make sure to discard it properly, following the relevant national rules. We thank you, in advance, for dropping the product in a place provided for this purpose in order to ensure a safe disposal in the respect of the environment. Duo Sport must be used only in accordance with the proposed programs. Bluetens Limited cannot be held responsible for any misuse or manipulation of Duo Sport. Handle electrodes only when Duo Sport is turned o. Duo Sport is a class IIA medical device certified by TÜV, do not leave it near children. Hereby, Bluetens limited, declares that Bluetens is in compliance with the essential requirements and other relevant provisions of 1999/5/EC directive and 3/42/EEC directive 9. A copy of the Declaration of conformity is available on request to Bluetens Ltd, 2003 20/F Tower 5, China Hong Kong City, 33 Canton Road, TST, Hong-Kong or Bluetens France, 5 passage Saint Bernard, 75011 Paris, France and on www.bluetens.com/doc

7. Technical characteristics

EN ENWe manage all after-sale questions directly.If you need assistance after the purchase of your Duo Sport from one of our distributors, do notreturn the product to the physical store, please contact us directly at contact@bluetens.com or visit the troubleshooting page on www.bluetens.com Our agents will get back to you within 24 hours with a quick solution.Duo Sport is guaranteed for two years, this warranty does not cover damages caused by improper maintenance or usage not compliant with the related documentation, accidents (shock, fire,liquid), modifi cations, repairs, misuse or normal wear and tear. This guarantee covers material or manufacturing defects. This guarantee covers products purchased directly from Bluetens or from aBluetens authorized dealer only.GUARANTEE PERIODYour product is guaranteed two years from the date of purchase, the battery has a six month guarantee.NOT COVERED BY THE GUARANTEEElectrodes, clip, satchel, as well as cables and accessories included in the box do not benefi t fromthis guarantee.BLUETENS AT YOUR SERVICEIn the event of a defect covered by the guarantee, Bluetens team will send you a return slip and will be responsible for the repairs or exchange of your device as well as of its return to you.HOW TO GET CUSTOMER SUPPORT?You can reach our Customer Service at any time at the following address:contact@bluetens.com, a member of our team will be dedicated to find a solution to your request.

PROGRAMMA BEËINDIGING

User instructions for TENS CAUTIONDo not use while sleeping.Do not use while driving.Do not continuously keep electrodes on body.Do not use metal to touch the electrode.Use this product with high frequency surgery devices might cause those device to become unstable. MAIN DEVICE MAINTENANCE• Clear regularly.• Take o cables from the device and electrode after power o.• Use soft cloth to clean if the device is dirty.• Use wet cloth with neutral detergent or spirit to clean if necessary.• Do not use spirit on theLED panel.• Do not use other detergent.• Keep water or liquids away from the device.OPERATION INSTRUCTIONSThe device needs to be used together with the water proof carrying case in order to prevent any damage caused by water. Please put the device into the carrying bag during use .Then use the App to realize all settings and controlling of the device.

ITEM STANDARD Conductivity After 100 skin application, peel the gel o from the carbon film in the water and dry it. The impedance is <200ohms between any two points A.C. impedance for gel-to-metal by LCR meter: <100ohms at 100Hz; <80ohms at1,000Hz <70ohms at10,000Hz; <65ohms at100,000Hz Lead wire Adaptable to male pin from 1.95~2.10m Strength between leadwire and connector is min. 4kg pulling force Strength between leadwire and electrode pad is min.3.kg pulling force Adhesive force Gel is strongly attached to the carbon film, hard to peel it o Protective liner 110X110mm, 0.075mm transparent release liner, no gel residue when peel the electrode o Printing Lot number & expiry date: firm and legible Safety Biocompatibility of the gel G607 used for this product conforms to

Package 120±5mmX185±5mm, transparent eco-friendly PE re-sealable bag Applicable humidity Humidity: 15%~70% Temperature: 0°C~30°C Shelf life 2-year sealed storage under 30°C, gel color and adhesion remain unchanged ITEM STANDARD Size 49.5±0.5 mm Thickness 1.6 + 0.4 mm Appearance No stain, no gel spillover at the edges Backing material White non-woven cloth Gel adhesion Under normal humidity (60%), skin application is above 100 times after 72 hour unprotected storing Under high humidity (80%), skin application is above 30 times after 72-hour unprotected storing Under low humidity (20%), skin application is above 10 times after 72-hour unprotected storing Dried completely at 100°C for 1.5 hours, skin application is above 5 times For un-pretreated or sweaty skin, skin application is above 10 times. Comfortable cutaneous sensation No edge lift after 2-hour skin application under any condition Skin adhesion reaction time: No need to press or press for less than 3 secondsTable 202 GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY The BLT15DS is intended for use in the electromagnetic environment specified below. The customer or the user of the BLT15DS should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance Electrostatic discharge (ESD)

± (2, 4, 6) kV contact ± (2, 4, 8) kV air ± (2, 4, 6) kV contact ± (2, 4, 8) kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Electrical fast transient/burst

±2 kV for power supply lines ±1 kV for input/output lines Not applicable Mains power quality should be that of a typical commercial or hospital environment. Surge

±1 kV dierential mode ±2 kV common mode Not applicable Mains power quality should be that of a typical commercial or hospital environment. Voltage dips, short interrup- tions and vol- tage variations <5 % UT (>95 % dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT) Not applicable Mains power quality should be that of a typical commercial or hospital environment. If the user of the BLT15DS requires continued operation during power mains interruptions, it is recommended that the BLT15DS be powered from an uninterruptible power supply or a battery. on power supply input lines

for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec Power frequency (50/60 Hz) magnetic field

3 A/m 3A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE UT is the a.c. mains voltage prior to application of the test level

ELECTROMAGNETIC COMPATIBILITY DESCRIPTIONS

The EMC declaration according to the requirement of EN 60601-1-2 CAUTIONS User must regard EMC, please install and put in service BLT15DS according to the EMC information provided in the accompanying documents. Portable and mobile RF communications equipment can aect medical electrical equipment. The performance of the EQUIPMENT and SYSTEM that was determined to be essential performance. Table 201-Guidance and manufacturer’s declaration-electromagnetic emissions for BLT15DS, as following table. Table 202-Guidance and manufacturer’s declaration-electromagnetic immunity for BLT15DS, as following table. Table 204 -Guidance and manufacturer’s declaration-electromagnetic immunity for BLT15DS, as following table. Table 206 Recommended separation distances between portable and mobile RF communications equipment and BLT15DS, as following table. Table 201 Table 204 GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY The BLT15DS is intended for use in the electromagnetic environment specified below. The customer or the user of the BLT15DS should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance Conducted RF

3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2,5 GHz Not applicable 3 V/m Portable and mobile RF communications equipment should be used no closer to any part of the BLT15DS, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance 80 MHz to 800 MHz 800 MHz to 2,5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as deter- mined by an electromagnetic site survey, a should be less than the compliance level in each frequency range’s Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic envi- ronment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the BLT15DS is used exceeds the applicable RF compliance level above, the BLT15DS should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the BLT15DS. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

ELECTROMAGNETIC EMISSIONS The BLT15DS is intended for use in the electromagnetic environment specified below. The customer or the user of the BLT15DS should assure that it is used in such an environment. Immunity test Compliance Electromagnetic environment – guidance RF emissions CISPR 11 Group 1 The BLT15DS uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interfe- rence in nearby electronic equipment. RF emissions CISPR 11 Class B The BLT15DS is suitable for use in all establishments, including domestic establishments. Harmonic emissions

PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE BLT15DS The BLT15DS is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the BLT15DS can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the BLT15DS as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in me- ters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reflection from structures, objects and people.236 contact@bluetens.com www.bluetens.com