21
ePatch
®
ADDENDUM TO THE PATIENT EDUCATION GUIDE
Indications for use
ePatch is indicated for use on patients who may be asymptomatic or who may suffer from
transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-
syncope, syncope, fatigue, chest pain and/or anxiety.
ePatch is intended for use by adolescents 18-21 and adults.
Contraindications
The sensor is not intended for use on:
•Patients with implanted pacemakers.
The compatible ECG patch is not intended for use in the following cases:
•The compatible ECG patch is not intended for use on patients with known allergies to adhesive
materials or hydrogel.
•The compatible ECG patch should not be placed on broken, damaged, or irritated skin.
RX only
Caution: Federal law restricts this device to sale by or on the order of a physician.
Precautions
Avoid contact with the eyes or mucus membranes of gels, alcohol, acetone, or any substance
used in the placement or removal of the patch. This can damage the eyes or mucus membranes
of the patient.
Do not use an obviously broken sensor. This can cause electric discharge or decrease the quality
of the acquired signals.
Do not touch the terminals at the backside of the sensor or let them touch other conductive parts
or earth. This may damage the sensor.
Minimize the number of devices connected to the patient. Otherwise, there is a risk of
accumulation of leakage current.
Store and use the sensor within temperature, pressure, and humidity ranges specified in Section
8.1.4. Avoid exposing any part of the sensor to heat sources, heat radiators and fireplaces,
direct exposure to sunlight, nebulizers, or electrical steam kettles. Temperature changes
cause condensation and moisture that can lead to malfunction of the sensor. Before using the
sensor, allow the sensor to acclimate to ambient temperature. For reference, if the temperature
difference between the sensor and the environment is above 10ºC, a 20 minutes wait time in an
intermediate temperature is recommended.
The sensor is only splash proof (Protection level IPX4) when it is correctly connected to a
compatible patch. Otherwise, it is not splash proof. This implies that the sensor should not be
exposed to any kind of liquid when it is not connected to a compatible patch. Even when the
sensor is correctly connected to a compatible patch, it should never be exposed to a direct jet of
water or any other liquid material. This might cause electrical short circuiting of the sensor.
Do not expose the internal parts of the sensor, the provided Micro USB cable, or the provided USB
power adapter to any liquids. Do not submerge the sensor, the provided Micro USB cable, or the
USB power adapter in any liquid. This may cause electric short circuiting or electrical discharge.
Mobile phones, transmitters, and similar equipment generating radio frequency (RF) emissions
should not be used or placed next to the sensor during recordings. This can affect the sensor.
Follow the recommendations regarding the separation distance specified in the manufacturer’s
declaration for EMC in this Instruction Manual, see Annex 1.
Warnings
Do not use the sensor in an X-ray, computed tomography (CT), or magnetic resonance imaging
(MRI) environment. This may affect the scanning results, it can lead to malfunction of the sensor,
and it may result in injuries to the patient.
Do not attempt to open, adjust, or modify the sensor, the provided Micro USB cable, or the
provided USB power adapter. This can lead to electrocution, burns, and malfunction.
Always use the sensor together with compatible accessories (patches, Micro USB cable, and
USB power adaptor) that are supplied by the manufacturer. Use of other equipment may result in
increased emissions or decreased immunity of the sensor and can cause damage to the device
or decrease the quality of the acquired signals. Use of other equipment or un- approved patches
might also lead to skin irritations, allergy, electrical shock, and malfunction of the sensor. Use of
other chargers may damage the device and/or the accessories.
Do not connect the sensor to other equipment than specified in this Instruction Manual. This can
lead to previously unidentified risks.
Keep the sensor, the patches, the provided Micro USB cable, and the USB power adapter out of
reach of children, pests, and pets. There is a danger of strangulation if the provided Micro USB
Cable is misused. There is a danger of choking if the sensor and/or the accessories are swallowed.
Do not use a defibrillator on a patient wearing the sensor. The sensor is not protected against
defibrillation shocks. Use of a defibrillator can lead to injuries to the patient and malfunction of
the sensor. Remove patch and sensor prior to defibrillation.