© Corventis 2010
Page 1 of 5
For US distribution (01/10)
P00873-001 Rev. B
AVIVO™ Mobile Patient Management System
INSTRUCTIONS FOR USE
Rx only
Indications for Use
The AVIVO Mobile Patient
Management System is intended to continuously record, store, and periodically transmit physiological data. The System is indicated
for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias. The AVIVO Mobile Patient
Management System also monitors,
derives and displays:
•
ECG
•
Heart Rate (including HR variability)
•
Activity
•
Posture
•
Body Temperature
•
Respiration rate (including RR variability)
•
Body fluid status
Description of the Device
The AVIVO Mobile Patient Management System includes:
a)
PiiX™ - an adherent patient-worn device containing multiple sensors used to track a suite of physiological parameters. PiiX can collect up to 72
ECG episodes. However, PiiX must be replaced after 7 days of use or when the end of life indicator appears. An end of life indicator as shown
below, will light up when the PiiX needs to be replaced.
b)
zLink
TM
- a device that receives data from the PiiX and transmits to the Server.
c)
zLink Base – a charging station for the zLink.
d)
zLink Holster – a wearable holder for the zLink.
e)
Prep wipes – wipes used for cleaning the skin prior to applying the PiiX.
The AVIVO System enables remote monitoring of physiological parameters in ambulatory patients to:
a)
facilitate patient and medical management, and
b)
assist physicians/health practitioners in the diagnosis and identification of various clinical conditions/events/trends
.
Contraindications
1.
PiiX should not be used on patients with known allergies or hypersensitivities to adhesives or hydrogel.
Precautions
1.
PiiX should not be used on patients with implantable devices with active minute ventilation sensors.
2.
PiiX may cause mild discomfort, skin irritation, redness, itching, rash, 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).
3.
PiiX is intended for single patient use.
4.
PiiX should be removed prior to external defibrillation or an MRI scan.
5.
PiiX should not be applied to broken, damaged or irritated skin.
6.
PiiX is water resistant but not waterproof. It should not be submerged in water (showering is acceptable, but swimming and submersion bathing are
prohibited).
7.
PiiX should not be disassembled.
8.
Replace the PiiX if it peels off; do not reapply the PiiX.
9.
Replace the PiiX if it appears damaged.
10.
No creams or lotions should be applied immediately prior to use of PiiX.
11.
This product is recommended for adult use.
The AVIVO Patient Management System is not intended to replace direct communication with your healthcare provider. The system data should not be used
alone, but should be used along with all other clinical data and exams to come to a diagnosis. Additionally, it will not summon emergency response personnel in
the event you need help. Talk to your healthcare provider immediately if you have any concerns, or if your condition changes. The AVIVO System is not an
emergency response service. Seek medical advice if you experience any symptoms that concern you.
