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Related Manuals for Stimuli TECHNOLOGY tensi+
Summary of Contents for Stimuli TECHNOLOGY tensi+
- Page 1 FUI-PF0001-01/05-2024 2797...
- Page 3 DEVICE DESCRIPTION Tensi+ was designed to stimulate the poste- rior tibial nerve. 1. Positive electrode 2. Button (+) to increase the intensity of the stimulation 3. Charging port 4. Charge indicator 5. LEDs showing the stimulation intensity 6. Loop to insert the retention strap 7.
- Page 4 INSTRUCTION MANUAL Important safety instructions......................26 Purpose ................................26 Information about TENS technology ..................28 Technical description ..........................28 Using the Tensi+ device ........................29 Cleaning and maintenance ......................34 Environnemental conditions ......................35 Disposal of the device parts......................36 Warranty.................................36 10. Troubleshooting ............................36 Technical data ............................39 12.
- Page 5 Dear User, these instructions on the use of the Tensi+ device are intended for the patient or carer. 1. IMPORTANT SAFETY INSTRUCTIONS – Warnings ■ Read the manual carefully before using the device and always follow the treatment instructions. ■ Always use this device as intended and as described in this manual. Store the de- vice in a dry place and at room temperature (between -10°C (14°F) and 40°C (104°F)).
- Page 6 Precautions for use Tensi+ must only be used with the original acces- sories: charging cable (part no.: AC0203), retention strap, graphite silicone electrodes. Replacement accessories are available separately. The device must always be placed along the posterior tibial nerve on the inner side of the (right or left) ankle. The device must never be placed in another area.
- Page 7 3. INFORMATION ABOUT TENS TECHNOLOGY Transcutaneous Electrical Nerve Stimulation, more commonly known as TENS, is a non-medicinal, non-invasive technique. It uses electrodes on the skin to deliver electrical pulses close to an innervated area to affect nerve transmission. Tensi+ targets the posterior tibial nerve, part of which originates close to the nerve fibres controlling the bladder.
- Page 8 Pulse shape: Measured with an actual resistance (500 Ω and 1 kΩ). Time Intensity chosen by the user (0 to 50 mA) Measured using an ANSI/ AAMI-standard model. Time 5. USING THE TENSI+ DEVICE a. Precautions before each use ■ Take care not to damage the electrodes by bending them; ■...
- Page 9 b. Assembling the device One retention strap and 2 pre-assembled electrodes are provided with the device. To adjust the device at the ankle, pull on the long part of the retention strap. If the pre-assembled device is too loose, remove the short part of the strap and only use the long part.
- Page 10 c. Positioning the device Step 1: Clean your skin Always use the device on clean skin. Any oil, cream, lotion, dust or other substance on the skin could affect the electrical pulses. Clean the area to be treated (inner side of your ankle and Achilles tendon) with a damp cloth.
- Page 11 d. Operating the device Step 1: Switch the device on Press the on/off button for 1 second to turn on the device. You will hear a long, soft beep to indicate that the device is now on. Step 2: Initiate the treatment LED + Press the (+) button (short or long press) to LED 6...
- Page 12 Please note: ■ It is entirely possible to position Tensi+ on the ankle after turning it on. However, the intensity should only be regulated after positioning it on the ankle. ■ The device will tell you if you exceed 10 mA by emitting 2 short beeps. This is simply for information purposes.
- Page 13 6. CLEANING AND MAINTENANCE a. Installing and changing the electrodes To remove the electrodes, gently pull lengthwise while applying a little pressure. Insert the electrodes the other way to reinstall them. The electrodes should be inserted all the way in to the end of the groove. Ensure the electrodes are facing the right way (rounded tip pointing outwards).
- Page 14 c. Cleaning The device must be switched off and unplugged for maintenance and cleaning. Cleaning the electro-stimulator: Clean the device with a soft, smooth, dry cloth. Cleaning the electrodes: After each use, it is advisable to wipe the electrodes with a damp cloth to remove any remaining gel.
- Page 15 8. DISPOSAL OF THE DEVICE PARTS Dispose of the device in accordance with Directive 2012/19/EU on waste electrical and electronic equipment (WEEE). Contact your local waste disposal authorities if in doubt. Electrodes and straps: these parts are not hazardous waste and can be disposed of with household waste.
- Page 16 Situation Possible causes Solutions Switch off the device and remove The electrodes are not in the device from the skin. Add a direct contact with the drop of conductive gel to the elec- The treatment skin. trodes and reposition the device so that it is in contact with the skin.
- Page 17 Beeping sound and/or LED indicator(s) on: Situation Possible causes Solutions Reposition the device, add gel to LEDs 1 to 6 The electrodes are not in the electrodes if necessary, then flash + regular direct contact with the repeat the comfort level adjust- beeping.
- Page 18 IIa according to Regulation (EU) 2017/745 on Classification medical devices CE marking CE 2797 Stimuli Technology, 20 B rue Barthélémy Dan- Manufacturer jou, 92100 Boulogne-Billancourt, France Maximum intensity with resis- 50 mA (+/- 10%) tance (500 Ω and 1000 Ω)
- Page 19 Any serious incidents that occur in connection with the product must be reported by the patient and/or user to the manufacturer, Stimuli Techno- logy: service.client@stimuli-technology.com or Stimuli Technology, 20 bis rue Barthélémy Danjou, 92100 Boulogne-Billancourt, France and to the local...
- Page 20 Guidance and manufacturer’s declaration – electromagnetic emissions Tensi+ is intended for use in the electromagnetic environment specified below. The patient or user should ensure that it is used in such an environment. Com- Electromagnetic environment – Emissions test pliance comments Electromagnetic radiation Home healthcare environment disturbance...
- Page 21 Guidance and manufacturer’s declaration – electromagnetic immunity, radiofre- quencies Tensi+ is intended for use in the electromagnetic environment specified below. The patient or user should ensure that it is used in such an environment. WARNING: Portable RF communication equipment (including peripherals such as antenna leads and external antennas) should not be used within 30 cm (12 inches) of any part of the TESTED DEVICE, including leads specified by the manufacturer.
- Page 22 Key to symbols This manual contains information related to your safety. CE marking. This device meets the regulatory requirements of European regula- 2797 tion 2017/745 on medical devices. Device with type BF protection against electric shocks. Device serial number Year Month Series Part number...
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