ZOLL CMCT Monitoring System Instructions For Use Manual page 7

3 WARNINGS AND PRECATIONS
• Do not use the CMCT System if you:
- Have allergies or skin sensitivities to electrode hydrogel and/or acrylic based
adhesives.
- Are pregnant (the CMCT System has not been tested on pregnant women).
- Have skin breakdown in areas where device (Patch + Sensor) placement is required.
• The CMCT System is not intended to be an alarm or to alert patients or physicians, and
will not summon emergency response in the event help is needed
• The CMCT System is not intended to replace direct communication with healthcare
providers.
• Data provided by the system should be used by physicians along with all other clinical
findings and exams to come to a diagnosis.
• Patients should talk to their healthcare provider immediately if there are any concerns
or if their condition changes.
• Remove the device (Patch + Sensor) from your body prior to an MRI scan, or any
emergency medical procedure. The CMCT System is not compatible for use with MRI
machines.
• If you have an implanted pacemaker or defibrillator, do not place the Sensor directly
on top of the implanted device. Consult with your physician about the correct
placement of the device for you.
• Sensor and Data Transmission Device must be turned OFF prior to boarding an
airplane. Remove Sensor from Patch and call ZOLL for further instructions.
• Do not wear the Patch for more than 5 days. Replace the Patch every 3 days, or more
frequently when needed. The Patch is designed for a maximum of 5 days use only.
• No creams of lotions should be applied to the skin immediately prior to the
application of the Patch.
• Do not re-use the Patch. Once the Patch is peeled off or removed, discard
immediately. The Patch is designed for single use. Re-using the Patch may result in
poor adhesion to the body and may affect measurements.
• Remove the device (Patch +Sensor) if any pain or discomfort occurs. If skin irritation,
discomfort, redness, itching or rash persists after the device is removed, a topical,
CMCT Monitoring System
Instructions for Use
Page 7 of 31