User's Manual

ManualsBrandsMedtronic Monitoring ManualsElectronicsMobile Patient Management System

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

- 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.

Summary of content (5 pages)

PAGE 1
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.
PAGE 2
Step-by-step Operating Instructions – AVIVO Mobile Patient Management System No specific training is needed for the use of this system. zLink should be set-up first prior to PiiX application. zLink Set-up 1. Plug the zLink into a standard electrical outlet. 2. Dock zLink into the Base. The lights will automatically come on, confirming zLink is ON. Power Light: BLUE Light ON: Full charge confirmed AMBER Light ON: Low charge warning AMBER Light Flashing: Battery capacity less than 10%.
PAGE 3
5. 6. Handle the PiiX on the edges until the PiiX is placed on the skin. Place the PiiX in a diagonal position only, oriented with Corventis at the top. Noting the picture below, place the device in the chest region, to the left of the sternum and starting at the clavicle (or collarbone) referred to as the ‘left quadrant’. Left quadrant area 7. The PiiX must be in direct contact with the skin. Once applied, press the edges firmly against the skin.
PAGE 4
Transport and Storage Instructions Storage temperature: 0oC to 40oC Instructions on how to safely dispose of the PiiX and zLink Both PiiX and zLink have Lithium-ion batteries 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 (408) 790-9393.
PAGE 5
Specifications Shelf life Battery Capacity Battery Charger Power Requirement Battery Life Battery Voltage Operating Temperature Maximum Temperature of the Applied Part Storage Temperature (power off) Operating Humidity Storage Humidity ECG • Sampling Rate • Digital Resolution • Input Dynamic Range • Input Offset Dynamic Range • Timing Accuracy Sampling Rate • ECG • Impedance • Accelerometer Measurement Ranges • Heart Rate • Impedance • Respiration • Posture Data Storage • Capacity • Type Weight Communicati