Patient Information
IFU 032
Please read this leaflet fully and carefully. It contains important information about wearing your Biosensor. Keep this leaflet; you may need to read it again. If you have any questions, ask your healthcare provider.
Shape of actual Biosensor may vary
Good to Know
- Limit activity after Biosensor has been applied to ensure good adherence.
- Carry out normal daily routine but limit activities that can cause excessive motion or sweating.
- Keep showers short with your back to the flow of water.
- If Biosensor accidentally gets wet, gently pat dry with a towel and minimize activity until fully dry.
- Press down Biosensor edges with your fingers at least twice a day, to maintain good adhesion.
- Avoid sleeping on your stomach, as this may interfere with Biosensor performance.
- Occasional skin itching and redness are normal around the Biosensor placement area.
- Travel is permitted when wearing Biosensor. If questioned during security screening, you may present this leaflet, or the Travel Notice, accessible via the UbiqVue Holter App menu.
Symptom Reporting
If asked by your healthcare provider to report symptoms such as dizziness, palpitations, or breathlessness, press the Biosensor button once.
You may also be asked to record symptoms using the UbiqVue Holter App.
Biosensor Application and Removal
- Follow the Patient Prep Kit instructions provided with the Biosensor.
Intended Use
- The UbiqVue Holter System is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of Electrocardiography (ECG) and Heart Rate (optional) at home and in healthcare settings. Patient physiological data is transmitted wirelessly from the UbiqVue wearable Biosensor to a Remote secure server for storage and analysis.
- The UbiqVue Holter System is intended for non-critical, adult population, who are 18 years of age or older.
Warnings
- DO NOT use Biosensor if you have a known allergic reaction to adhesives or electrode hydrogels.
- DO NOT use Biosensor if you have inflamed, irritated or broken skin in the Biosensor placement area.
- Remove Biosensor if skin irritation such as severe redness, itching or allergic symptoms develop. Seek medical attention if an allergic reaction persists.
- DO NOT wear Biosensor for more than the prescribed hours.
- Remove Biosensor immediately if your skin feels uncomfortably warm or if you experience a burning sensation.
Precautions
- DO NOT use on patients with active implantable medical devices including pacemakers, ICD and LVAD.
- Excessive motion or activity may adversely affect Biosensor performance and adhesion.
- Press down Biosensor edges and upper area with your fingers at least twice a day, to maintain adhesion.
- Avoid sleeping on your stomach, as this may interfere with your Biosensor performance.
- DO NOT use Biosensor if the package has been opened, appears damaged or has expired.
- Using certain skin barrier agents before applying the Biosensor may cause skin irritation or injury due to interaction with the hydrogel electrodes.
- If Biosensor becomes soiled (e.g. coffee spill), wipe clean with a damp cloth and pat dry.
- DO NOT immerse Biosensor in water.
- Keep showers short with your back to the flow of water. Gently pat dry with a towel and minimize activity until Biosensor is fully dry.
- DO NOT use creams or soap near Biosensor.
- DO NOT wear or use Biosensor during a magnetic resonance imaging (MRI) procedure or in a location where it will be exposed to strong electromagnetic fields.
- Keep Biosensor out of reach of children and pets.
- DO NOT reuse Biosensor, it is for single use only.
- Biosensor contains a battery. Dispose of the Biosensor in accordance with local laws and guidelines for routine non-hazardous electronic waste.
