User's Manual

10
NUVANT
™
MCT Instructions for Use
ENGLISH
3. The PiiX should be removed prior to external defibrillation or an MRI scan.
4. The PiiX may cause mild discomfort, skin irritation, redness, itching, rash
or contact dermatitis in some individuals. The device should be removed
if any pain or discomfort occurs. If skin irritation or redness persists after
the device has been removed, a topical anti-inflammatory cream may be
applied to the area (in consultation with your health care provider).
5. The PiiX is intended for single patient use and should not be reapplied it if
peels off or is removed (ie, it is meant for one-time use).
6. The PiiX should not be applied to broken, damaged or irritated skin.
7. The PiiX is water resistant but not waterproof. It should not be sub-
merged in water (showering is acceptable, but swimming and submersion
bathing are prohibited).
8. The PiiX should not be disassembled.
9. Do not apply the PiiX if it appears damaged upon receipt.
10. No creams or lotions should be applied to the skin immediately prior to
the application of the PiiX
11. Store the PiiX in a cool, dry location. The device is designed to
withstand environmental temperature fluctuations between -20° to 65°C
(-4° to 149° F).
12. The system has not been fully evaluated for use with infants weighing less
than 22 lbs.
13. The system is not designed to detect pacemaker spikes.
Physician Services
Prescription Duration:
After registering with Corventis, physicians can prescribe NUVANT MCT for up
to 30 days at a time. As each PiiX is designed to last for up to 7.5 days (unless
the memory on PiiX becomes full beforehand), prescription lengths greater
than one week will be enabled through the use of more than one PiiX.
Clinical Reports:
Clinicians can receive clinical reports, including Episode, Daily and End of Use
Reports, directly from the Corventis Monitoring Center by fax and/or email.
Clinical data can also be securely reviewed online at www.corventis.com.
Upon clicking on the “LOGIN” link at the Corventis homepage, clinicians
will be prompted to input their personal Username and Password informa-
tion to access the application. Clinicians may download and/or print clinical
reports, review collected ECGs and also establish service preferences. For any
questions about online use, please contact Corventis Customer Service at
1-877-247-PiiX (7449).
Notifications:
The Corventis Monitoring Center may send Episode Reports and contact
prescribing physicians directly when arrhythmias that meet pre-defined criteria
are identified. Contact information and notification preferences will be
established upon registration and can be updated.
IMPORTANT: Patient data are updated for physician display upon
detection of a clinical event OR every two hours when no events
are detected, assuming a) PiiX is within 30 feet (9 meters) of zLink,
b) zLink has been appropriately installed and has sufficient power and
c) sufficient cellular coverage for data transmission exists. Analysis of
ECGs by the Corventis Monitoring Center may also affect the timing of
ECG display.