User's Manual

Page 5 of 6
© Corventis 2010
For US distribution only IFU NUVANT 04-10
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Instructions on how to safely dispose of the PiiX
The PiiX has a Lithium-ion battery and must not be disposed of in a fire. If unable to properly dispose of the product or components in accordance with local and
federal regulations contact Corventis at 1-877-247-PiiX (7449) or 1 [phone].
Maintenance Instruction for zLink
For cleaning, gently wipe with a soft dry cloth. Please attempt to keep zLink dust free. zLink is not waterproof and should be kept dry. This device does not have
serviceable components. Please call Corventis Customer Service number if the device does not appear to be working properly. Do not disassemble, crush,
puncture, short external contacts or circuits, dispose of in fire or water, or expose a battery pack to temperatures higher than 60˚C. Please refer to Patient Guide for
zLink return instructions.
Specifications
The following performance specifications are for the PiiX and the zLink. All specifications are at 20°C (68°F) unless otherwise stated.
PiiX zLink Magnet
Shelf life 4 months N/A N/A
Battery Capacity 2300mAh 1800 mAh @ C/5 Rate @ 23° C N/A
Battery Charger Power Requirement N/A 100-240VAC, 50/60Hz, 15W N/A
Battery Life 7.5 days (180 hrs), non-
rechargeable
Provides 12 hrs of function before
recharging
N/A
Battery Voltage 3.0 Volts 3.7 Volts N/A
Operating Temperature 0
0
C to 41
0
C 0
0
C to 45
0
C 0
0
C to 45
0
C
Maximum Temperature of the Applied Part 44
0
C N/A N/A
Storage Temperature (power off) 0
0
C to 40
0
C 0
0
C to 40
0
C 0
0
C to 40
0
C
Operating Humidity 10% to 95% 10% to 95% 10% to 95%
Storage Humidity 5% to 95% 5% to 95% 5% to 95%
ECG
• Sampling Rate
• Digital Resolution
• Input Dynamic Range
• Input Offset Dynamic Range
• Timing Accuracy
200Hz
10bits
+/- 5mV
+/- 300mV
+/- 5 ms
N/A
N/A
N/A
N/A
N/A
N/A
Sampling Rate
• ECG
• Impedance
• Accelerometer
200 Hz (+/- 5%)
4 Hz
0.25 Hz (+/- 2%)
N/A
N/A
N/A
N/A
Measurement Ranges
• Heart Rate
• Impedance
• Respiration
• Posture
25 to 250 BPM
10 to 150 Ohms
4 to 60 Breaths per minute
+/- 2g range in x,y,z direction
N/A
N/A
N/A
N/A
N/A
Data Storage
• Capacity
• Type
7.5 days
Digital flash non-removable
7.5 days
Digital flash non-removable
N/A
Weight 50g / 1.8oz max 150g / 5.3oz max Portable
Communication Means RF Wireless between PiiX
and zLink
Cellular Phone between zLink and
Server
N/A
The heart rate 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, which are then aggregated into 5-minute and 24-hour averages for display. The pause algorithm monitors
the time between successive R-wave peaks. A timer is reset upon each R-wave peak detection, and a pause trigger is activated if the timer advances to 3 seconds
without an R-wave detection.
The arrhythmia detection algorithm of the NUVANT MCT System was tested according to ANSI/AAMI EC57 (Testing and reporting performance results of
cardiac rhythm and ST segment measurement algorithms) for ventricular tachycardia and ventricular fibrillation and determined to have an average sensitivity of
96.9% and an average positive predictive value (PPV) of 85.3%.
This equipment complies with International Standard IEC 60601-1-2 for electromagnetic compatibility for medical electrical equipments. 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) / 1 [phone], or at www.corventis.com
. Portable and mobile RF communication
equipments can affect nearby medical electrical equipment.
PiiX and zLink complies with Part 15 of the Federal Communications Commission (FCC) Rules – Radio Frequency Devices: Operation is subject to the condition
that (1) this device does not cause harmful interference. (2) this device must accept any interference received, including interference that may cause undesired
operation. Changes or modifications not expressly approved by Corventis could void the user's authority to operate the equipment. Note: This equipment has been
tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable
protection against harmful interference when the equipment is operated in a commercial
residential environment. This equipment generates, uses, and can radiate
radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications.