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64000-00120 Rev 3
• gammaCore should not be applied across or through the head, directly on the eyes, covering the
mouth, on the chest or the upper back, or over the heart.
• The HCP must inform the patient using gammaCore to notify him/her of any change in health
status. The HCP must re-evaluate the patient’s suitability for treatment using gammaCore based
on the patient’s new health information.
The HCP must brief the patient on the following items:
• Do not use gammaCore:
o If the treatment location has an open wound, rash, infection, swelling, cancerous lesions, drug
patch, or abnormal anatomy
o If the patient’s skin is wet
o Concurrently with other therapeutic devices (e.g., TENS Unit, muscle stimulator)
• Caring for gammaCore
Patients should be instructed:
o To store gammaCore in a safe location out of reach of children.
o Not to use the device after its expiration date. The expiration date is indicated on the device
packaging.
o To contact electroCore Customer Service if the device is not working. They should not attempt
to open the case, replace the battery, or disassemble, repair or modify the device.
o That they should not submerge, splash, or expose gammaCore to water or other liquids,
including cleaning liquids. Moisture may damage the device.
o That exposure to extreme hot or cold temperatures outside the range of 0°C to 38°C (32°F to
100°F) may cause the device to not work properly.
o Not to mutilate, burn, or puncture the device.
o That gammaCore requires special precautions regarding electromagnetic compatibility
guidance (EMC) and needs to be handled according to the EMC information provided in
Section 20.
o That portable and mobile RF communications equipment can affect gammaCore (refer to
Section 20).
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