Information for users

 1. Device identification and manufacturer details 

  • Product name: TENA SmartCare Bladder Sensor

  • Classification: Class IIa under EU MDR 2017/745

  • UDI-DI: 08719326106298 (also provided on device label and packaging)

  • Article number: 10565 (also provided on device label and packaging)

  • Manufacturer: Novioscan B.V., Transistorweg 5, 6534 AT Nijmegen, The Netherlands 

  • Distributor / Brand owner: Essity Hygiene and Health AB, SE‑405 03 Göteborg, Sweden 

  • CE marking: CE 1639 

 

2. Intended purpose and indications 

The TENA SmartCare Bladder Sensor is a wearable ultrasound device that continuously monitors bladder fullness to help prevent incontinence in home and care settings. It provides real-time tracking, notifying users when it is time to visit the toilet. For more information, visit TENA.

 

Who it is for: 

Anyone experiencing urinary incontinence (day and/or night, specifically: 

  • Children aged 6 years and older

  • Adults with BMI 18.5–25 kg/m² 

 

Where to use it: 

  • At home

  • Professional healthcare settings (such as hospitals, nursing homes)  

 

3. Contraindications 

The device is not intended to be used: 

  • By pregnant or breastfeeding women

  • For individuals outside the specified BMI ranges

  • When bladder volumes fall below the device’s sensitivity threshold

  • For notification in children with a low night-time bladder capacity or bladder overactivity during the right (only use for monitoring purposes)

  • On non-intact skin

  • By individuals who use a wheelchair  

 

4. Precautionary information 

  • Read, understand and practice the precautionary and operating instructions.

  • Minors must be aided by an adult during the setup and use of the Bladder Sensor.

  • Only use the Bladder Sensor in combination with the TENA SmartCare Adhesive Patches, USB charger and ultrasound gel.

  • Handle the Bladder Sensor with care. Inappropriate handling of the Bladder Sensor may adversely affect its performance. 

  • Inspect the Bladder Sensor for cracks which may allow the ingress of conductive fluid before each use.  

  • DO NOT disassemble, modify or remodel the Bladder Sensor or its accessories. This may adversely affect its performance. 

  • DO NOT allow the Bladder Sensor to be heated above 45 °C during storage (113 °F).

  • DO NOT allow the Bladder Sensor to be heated above 40 °C during operation (104 °F).

  • DO NOT use in combination with X-ray or other ultrasound equipment.

  • The USB charger (with USB charger cable) must always be able to be removed from a wall outlet / socket without any obstruction.

  • The Bladder Sensor must not be immersed in water or other fluid.

  • The Bladder Sensor may only be repaired, and the battery may only be replaced by qualified personnel (trained by Novioscan).

  • The Bladder Sensor should not be used in an environment where Bluetooth Low Energy is not allowed.

  • Ensure that the environment in which the Bladder Sensor is used is not subject to any source of strong electromagnetic interference such as radio frequencies and magnetic fields. Potential electromagnetic or other interference could affect the Bladder Sensor or the other equipment. Try to minimize this interference: DO NOT use other equipment in conjunction with the Bladder Sensor.  

 

4.1. Additional precautionary information for the home environment: 

  • Do not lay the Bladder Sensor near the heater. 

  • Do not use the Bladder Sensor in the bathtub or under the shower. 

  • Do not soak the Bladder Sensor in water. 

  • Do not allow pets to chew or play with the Bladder Sensor or its accessories. 

  • Do not allow children to use the Bladder Sensor or its accessories for any other reasons than its intended use as described in section 4.1 

TO PREVENT ELECTRICAL SHOCK, DO NOT OPEN THE BLADDER SENSOR. THERE ARE HIGH VOLTAGE COMPONENTS. LEAVE MAINTENANCE TO QUALIFIED STAFF ONLY. 

 

5. Circumstances in which to consult a healthcare professional  

Consult a healthcare professional when use of the Bladder Sensor leads to: 

  • Skin irritation

  • Painful skin during or shortly after use

  • Damage to the skin

  • Signs of infection such as redness of the skin, swelling, or blistering 

 

6. Technical specifications 

TENA SmartCare Bladder Sensor 

  • Ultrasound frequency: 3.5 MHz 

  • Measuring range: 1–173 mm 

  • Battery: Li‑ion 3.7V, 300 mAh 

  • Connectivity: Bluetooth® Low Energy 5.x 

  • Water protection: IP65 

  • Dimensions: ~75 × 61 × 14 mm 

  • Weight: ~55 g 

  • Battery life: 7 days 

USB Charger: 

  • Charger (GTM46101-1005-USB) incl. USB-C cable  

  • Charges from 0% to 100% in 2 hours. 

  • Dimensions: 41.0 x 71.0 x 31.5  

  • Output Voltage: 5V 

  • Load: Min: 0A, Max: 0.3A 

  • Max. Output Power: 2A 

 

7. Operating environment 

  • Operating temperature: -10°C to +40°C 

  • Charging temperature: 0°C to +35°C 

  • Storage/transport: -10°C to +45°C 

  • Humidity: 15–75% (non-condensing) 

  • Pressure: 700–1060 hPa 

 

8. Service life 

  • Expected life-time: 2 years (i.e. battery-dependent) 

 

9. Availability of instructions and further information 

  • Printed Instructions for Use (IFU) are supplied with the product

  • Users must read the full documentation (IFU) prior to operating the device.  

 

10. Contact and Support