Medtronic Monitoring PIIX Mobile Patient Management System User Manual

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Document ID	1242855
Application ID	+6/ILMKj7N/Ct0GnHynlTQ==
Document Description	User Manual
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	15.53kB (194125 bits)
Date Submitted	2010-02-18 00:00:00
Date Available	2010-02-18 00:00:00
Creation Date	2010-02-01 11:22:50
Producing Software	Acrobat Distiller 6.0 (Windows)
Document Lastmod	2010-02-01 11:22:50
Document Title	Microsoft Word - AVIVO IFU US P00873-001_B SAM.docx
Document Creator	PScript5.dll Version 5.2
Document Author:	rmasline

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) zLinkTM - 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.
2.
PiiX should not be used on patients with implantable devices with active minute ventilation sensors.
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.
© Corventis 2010
For US distribution (01/10)
Page 1 of 5
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%. Full charge may take up to 4 hours
Cell Light:
BLUE: Adequate cell coverage
AMBER: No cell coverage. Move zLink to another location
Other lights on the zLink are utilized only if troubleshooting is necessary. Refer to these lights only if asked by a Corventis Customer
Service representative.
zLink may also be turned ON and OFF manually. To turn zLink ON when zLink is not docked in the Base, press the round Power button
located below the lights. All lights will come on, confirming zLink is ON. To turn zLink OFF, press the round Power button for several
seconds until all the lights turn off.
3.
To initiate use, charge the zLink for a minimum of 4 hours before removing it from the zLink Base
Keep your zLink in the Base overnight, every night. With a full charge, the zLink will remain charged for up to 12 hours. Preferably, the zLink
should be kept within 30 feet (9 meters) of the patient as much as possible to ensure data transmission.
PiiX Application
PiiX
First device:
1.
2.
3.
4.
Trim (rather than shave) hair in intended location. Avoid moles and pimples.
Use alcohol wipe provided with PiiX to clean the skin where the device is intended to be applied. Allow the skin to dry.
Remove the PiiX from the foil pouch by tearing at the notch and apply immediately.
Remove the covers from the underside of the PiiX.
© Corventis 2010
For US distribution (01/10)
Page 2 of 5
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.
Look for these indicators to appear on the PiiX display:
FILLED CIRCLE SYMBOL: Indicates the PiiX™ is
successfully activated. This symbol will appear
when skin contact is made and may blink during
duration of use.
CIRCLE MARK WITH LINE: Indicates it is necessary to
remove your PiiX™ and replace it with a new PiiX™
(unless your prescription has ended.)
PiiX Removal:
1.
2.
3.
Peel back the edge of the PiiX. Slowly and gently push the skin away from the PiiX as it is removed. Rapid removal can cause
skin irritation.
If the PiiX does not peel easily, soak the device with water to assist in softening the adhesive.
If skin irritation persists, leave the area exposed or under light clothing. Consult your healthcare provider for any topical
treatment options.
Physician Web Services
Go to www.corventis.com to login
First time login:
1.
Enter User Name and the Password provided and click Submit.
2.
Answer the Secret Question. Next, enter new password. Confirm new Password and click Submit. “Password has been changed”
notification will appear.
3.
Click on Login to proceed to the Home page.
Subsequent logins:
1.
Enter your User Name and Password and click on Submit to proceed to the home page.
© Corventis 2010
For US distribution (01/10)
Page 3 of 5
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.
User Assistance Information
If the AVIVO Mobile Patient Management System is not operating properly, please contact Corventis Customer Service at: +1-877-247-PiiX (7449), or (408) 7909393.
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.
Label Symbol Definition
Symbol and Definition
Symbol and Definition
Consult Instructions for Use
Do Not Reuse
Consult Instructions for Use (Mandatory)
Use‐by (Year‐month) or (year‐month‐date)
Caution: consult accompanying documents
Batch Number
Date of Manufacturer
Non‐Sterile
Temperature Limitations
Type BF applied part; Denotes device is not
in direct contact with cardiac muscle
IP34 ‐ Ingress protection
3 means protection against objects >=2.5mm in diameter (tools)
4 means protection against water splashing (shower)
Latex Free
Serial Number
Catalogue Number
Manufacturer’s Name and Address
Collection of electrical and electronic equipment
Wireless Transmission Symbol
Rx only ‐ Federal (USA) law restricts this product to sale by or on the order of a
physician.
Class II Equipment
© Corventis 2010
For US distribution (01/10)
Page 4 of 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
Communication Means
Adherent Device
4 month
2300mAh
N/A
7 days nonrechargable
3.0 Volts
00C to 410C
440C
00C to 400C
10% to 95%
5% to 95%
zLink
N/A
1800mAh @ C/5 Rate @ 23° C
100-240VAC, 50/60Hz, 15W
Provides 12 hrs of function before recharging
3.7 Volts
00C to 450C
N/A
00C to 400C
10% to 95%
5% to 95%
200Hz
10bits
+/5 mV
+/- 300mV
+/- 5 ms
N/A
N/A
N/A
N/A
N/A
200 Hz (+/- 5%)
4 Hz
0.25 Hz (+/- 2%)
N/A
N/A
N/A
25 to 250 BPM
10 to 150 Ohms
4 to 60 BrPM
+/- 2g range in x,y,z direction
N/A
N/A
N/A
N/A
7 days
Digital flash non-removable
50g / 1.8oz max
RF Wireless between PiiX and zLink
7 days
Digital flash non-removable
150g / 5.3oz max
Cellular Phone between zLink and Server
The heart rate algorithm of the AVIVO™ Mobile Patient Management System detects the peak of each R-wave and calculates the interval between successive Rwaves. 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 4 seconds without an R-wave detection.
The arrhythmia detection algorithm of the AVIVO™ Mobile Patient Management 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 (408) 790-9393, or at www.corventis.com. Portable and mobile RF communication
equipments can affect nearby medical electrical equipment. The zLink uses RF energy for its internal operations. The RF emission is very low and within IEC
60601-1-2 acceptable limits. It will not likely cause any interference with nearby equipment.
This device complies with Part 15 of the Federal Communications Commission (FCC) Rules – Radio Frequency Devices: Operation is subject to the condition that
this device does not cause harmful interference. 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 A 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 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.
User Assistance Number:
If the AVIVO System is not operating properly, please contact Corventis Customer Service:
1-877-247-PiiX (7449)
1 (408) 790-9393
Headquarters
Corventis, Inc.
2033 Gateway Place
Suite 100
San Jose, CA 95110
U. S. A.
R&D
Corventis, Inc.
1410 Energy Park Drive
Suite 1
St. Paul, MN 55108
U. S. A.
Patents pending
Corventis, AVIVO, PiiX and zLink are trademarks of Corventis, Inc.
© Corventis 2010
For US distribution (01/10)
Page 5 of 5

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