User's Manual
12
NUVANT
™
MCT Instructions for Use
ENGLISH
For example, the detection algorithm of the NUVANT MCT System detects the
peak of each R-wave and calculates the interval between successive R-waves.
The RR intervals are then used to calculate beat-to-beat heart rate values and
to initiate collection of ECGs. RR intervals are also aggregated into 5-minute
and 24-hour averages to summarize patient heart rate over the monitoring
period. For Pause detection, the algorithm monitors the time between succes-
sive R-wave peaks. A pause trigger is activated if an internal timer advances to
3 seconds without R-wave detection.
In order to provide relevant, exception-based arrhythmia reporting, the NUVANT
MCT System’s proprietary ECG analysis algorithms proactively manage redundant
reporting of ECGs for a select set of arrhythmias when persistently detected:
• Tachycardias with heart rate >= 130bpm and < 165bpm
• Bradycardias with heart rate >= 30bpm and < 40bpm
• Atrial Fibrillation
• Ventricular Tachycardia < 165bpm
For these arrhythmias, the PiiX algorithm detection sensitivity and positive
predictive value results, which are obtained from the respective databases in
strict accordance with EC-57* and with 0% downtime, are as follows:
Test Rhythm Name
Sensitivity
(%)*
Positive
Predictive
Value (%)*
QRS Detection (average)
Including all Tachycardias with heart
rate >= 130bpm and < 165bpm,
Bradycardias with heart rate >=30bpm
and <40bpm
AHA: 98.87
MIT-BIH:
99.77
AHA: 99.61
MIT-BIH:
99.82
AF Duration (gross) MIT-BIH: 88 MIT-BIH: 82
* as measured by EC-57 standards testing on 10/25/2011
Redundant reporting of ECGs for this select set of arrhythmias is managed
as follows:
• The PiiX will report no more than two (2) ECGs for each of these
arrhythmias each hour
• The PiiX will wait ten (10) minutes before allowing a subsequent ECG to
be reported for each of these arrhythmias
Note: a) ECGs are reported for all Tachycardias with heart rate >= 165bpm,
all Bradycardias with heart rate < 30bpm and all Pauses >= 3 seconds; b)
The PiiX keeps a complete count of all arrhythmias that are detected; c)
Supplemental ECGs are also reported i) every six (6) hours for prolonged Atrial
Fibrillation episodes and ii) every twenty-four (24) hours, irrespective of the
presence of an arrhythmia
zLink Maintenance
Please attempt to keep zLink dust free. If necessary, gently wipe the zLink
with a soft dry cloth to clean the surface. The zLink is not waterproof and
should be kept dry. This device does not have user serviceable components in-
side. Do not disassemble, crush, puncture, short external contacts or circuits,
dispose of in fire or water, or expose the battery pack to temperatures higher
than 65˚C (149˚F).
Electromagnetic Interference
This equipment complies with International Standard IEC 60601-1-2 for elec-
tromagnetic compatibility for medical electrical equipment. Medical electrical
equipment needs special precautions regarding EMC, and all equipment must be
installed and put into service according to the EMC information provided upon
request by calling Corventis Customer Service at 1-877-247-PiiX (7449). Portable
and mobile RF communication equipment can affect nearby medical electrical
equipment.