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Philips ePatch sensor Patient Manual
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Philips ePatch sensor Patient Manual

Philips ePatch sensor Patient Manual

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ePatch sensor
Patient guide
For assistance, please contact:
UK: 44 800 0260689

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Summary of Contents for Philips ePatch sensor

  • Page 1 Patient guide For assistance, please contact: UK: 44 800 0260689...

  • Page 2: Items Provided

    Items provided ePatch sensor Scrub pad Patient Symptom Return electrodes guide event diary envelope (sensor) (patches) (optional) NOTE: If the sensor was applied by a healthcare professional, please go to page 4. 1 Skin preparation Shave chest if needed before preparing skin.

  • Page 3: Patch Set-Up

    2 Patch set-up Remove the patch from its packaging. Place the sensor onto the blue plastic cradle of the patch. Press down firmly as shown to snap it securely in place. Ensure no gaps are visible between the blue cradle and the sensor. You will hear several clicks.
  • Page 4 Patch placement Carefully remove Place the patch in the centre of the clear plastic your chest and 3 fingers below liner from the patch. your collarbone, as shown in Avoid touching the pictures. Stretching your chest adhesive. may assist. NOTE: Avoid repositioning the patch after the first skin contact as this may decrease the quality of the recording.
  • Page 5 How to perform an Event Marker Your healthcare provider may ask you to perform an event marker (if enabled) when you feel symptoms such as shortness of breath, chest pain, dizziness or palpitations. Double tap the middle of the sensor rapidly (within 1 second) and a green light will appear on it for 1 second.
  • Page 6 After 5 days of wear or if the patch is loose, follow these steps. Patch replacement Remove patch and Remove sensor from patch: Press the blue tab down to snap sensor from chest by peeling the it open and then gently slide adhesive slowly.
  • Page 7 When the testing period is over. . . Remove patch and Remove the sensor from the sensor from chest patch. Dispose patch as guided by peeling the on page 5. adhesive slowly. Return sensor and symptom event diary to your prescribing physician or mail back items in a return envelope if provided by your physician.
  • Page 8 Important information You can continue to perform your normal daily activities. You can shower, but protect the sensor from direct spraying of water. The sensor is water-resistant, not waterproof. When the testing period is over, the sensor must be returned along with your symptom event diary.
  • Page 9 Important information Please visit www.Philips.com/ifu for other important information on the use of your ePatch sensor and patch. Refer to Instructions for Use. Limitations in use and contraindications: Not for use on patients with: • Severe allergies to adhesive materials or hydrogel.
  • Page 10 For assistance, please contact: UK: 44 800 0260689 ePatch is a Registered ©Philips 2023. All rights reserved Trademark of Braemar 02-02060 Rev A Date: 08/2023 Manufacturing, LLC...
  • Page 11 Precautions: • Avoid extreme physical activities or exposure to extreme environments. • The patch is single use only and can be worn for up to 5 days. • Do not use the patch if the package is tampered with, defective, opened or past its expiry date. •...

  • Page 12: Glossary Of Symbols

    Glossary of symbols Symbols for ePatch sensor Symbol Description CE mark indicates that the product conforms with standards for products sold within the European Union 2797 WEEE (Waste Electrical and Electronic Equipment) Directive (2002/96/EC) Type BF Applied Part Refer to instruction manual Protect from moisture Prescription use only (U.S.
  • Page 13 Symbols for patch Symbol Description Symbol Description Manufacturer CE mark indicates that the product conforms with standards for products sold within Quantity in package the European Union Do not use if package Medical Device is damaged Caution Use By Date Electronic instructions Batch Code for use...
  • Page 14 Incident reporting Any serious incident that has occurred in relation to the sensor or patch should be reported to Braemar, Philips Medical Systems Netherland B. V . and the competent authority of the Member State in which the user and/or...
  • Page 15 Intended use ePatch sensor is indicated for use on patients who may be asymptomatic or who may suffer from transient ePatch symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety.
  • Page 16 When wearing the sensor, avoid submersion in or direct spraying of liquids on sensor, as doing so may lead to device failure. If the sensor is not firmly connected to the patch, it is not splash proof. To avoid malfunction, make sure both parts are firmly connected with no gaps.
  • Page 17 After taking a shower, always check the adhesion of the patch to your skin. If no longer securely attached, replace patch. For full product details, please consult the IFU at www.philips.com/ifu Patch ECG Electrode Intended purpose/Indications for use/Target population The patch is indicated for use with a compatible ambulatory electrocardiogram (ECG) diagnostic device for recording of ECG from adolescents 18 - 21 years old and adults.
  • Page 18 Use or repeated use of patch may cause or increase skin irritation, discomfort or redness. Potential undesirable side effects Skin irritation, discomfort, redness from use or from repeated use of skin contacting patch electrode. For full product details, please consult the IFU at www.philips.com/ifu...