Medtronic Monitoring PIIX2 Mobile Patient Management System User Manual Users manual
Medtronic Monitoring, Inc. Mobile Patient Management System Users manual
Users manual
NUVANT™
Mobile Cardiac Telemetry (MCT) System
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NUVANT™ MCT Instructions for Use
Instructions for Use
Rx Only
FOLLOW THESE INSTRUCTIONS CAREFULLY AND WATCH YOUR
INSTRUCTIONAL VIDEO BEFORE USING NUVANT MCT
Customer Service:
USA: 1-877-247-PIIX(7449)
The NUVANT Mobile Cardiac Telemetry (MCT) System is a wearable, wire-
less arrhythmia detection system that is used to aid clinicians in diagnosing
suspected cardiac arrhythmias. It consists primarily of the PiiX® wearable
monitoring device, the zLink® portable data transmission device and a Patient
Trigger Magnet to enable on-demand collection of ECGs (recordings of heart
rhythm). In combination with interpretation services provided by the Corventis
Monitoring Center, as well as secure online review of data (for prescribing phy-
sicians only), NUVANT MCT enables patient- and physician-friendly arrhythmia
detection for up to 30 days at a time.
How NUVANT MCT Works
Once activated, the wearable PiiX sensor continuously monitors the heart and
automatically collects ECGs when rhythm abnormalities are detected. Patients
can also drive collection of ECGs when they experience cardiac symptoms by
using the Patient Trigger Magnet. Data are automatically transmitted from the
PiiX to the zLink, which then automatically transmits the data to the Corventis
Monitoring Center. Certified cardiographic technicians at the Corventis
Monitoring Center review received data and document symptoms reported
by patients. Clinical reports, prepared by the Corventis Monitoring Center,
are delivered and made available at www.corventis.com to provide data to
prescribing physicians for the diagnosis and identification of various clinical
conditions, events and/or trends. Prescribing physicians may also be contacted
by the Corventis Monitoring Center directly when arrhythmias that meet pre-
defined criteria are detected.
IMPORTANT:
• The NUVANT MCT System is not intended to be an alarm or to
alert patients or physicians, and will not summon emergency
response in the event help is needed.
• The NUVANT MCT System is not intended to replace direct com-
munication with healthcare providers.
• Data provided by the system should be used by physicians along
with all other clinical findings and exams to come to a diagnosis.
• Patients should talk to their healthcare provider immediately if
there are any concerns or if their condition changes.
P01281-005 (05/13)
NUVANT™ MCT Instructions for Use
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Table of Contents
Getting Started .......................................................................................... 2
Using NUVANT MCT During the Monitoring Period .............................. 6
What to do at the End of Monitoring ..................................................... 8
Indications for Use, Contraindications, Warnings .................................. 9
Physician Services ...................................................................................... 10
Specifications, Compliance and Symbols ................................................ 11
Frequently Asked Questions .................................................................... 15
Contact Information .................................................................................. 16
Getting Started
Step 1: Locate the components of the NUVANT MCT System
PiiX is a wearable device that collects and
transmits physiological data. One or more
PiiX devices may be included in the package,
depending on the length of the prescription
power
linked
cell
send
zLink is a device that receives data from the
PiiX and transmits it to Corventis
Patient Trigger Magnet is used to collect a
record of your heart rhythm (ie, ECG) when
symptoms are felt
Link Holster is a wearable holder for the
zLink
zLink Charger is used to charge the zLink
Prep Wipes are used for cleaning skin
before applying the PiiX
Product Literature including these instructions, an instructional DVD, the
Notice of Privacy Practices and a NUVANT MCT patient travel card
NUVANT™ MCT Instructions for Use
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Step 2: Charge the zLink
• Connect the zLink Charger connector to the zLink and plug it into a
standard electrical outlet
• If the lights on the zLink do not turn on, push the round Power button
for at least 2 seconds
• Allow the zLink to charge for at least 6 hours
Step 3: Prepare for PiiX Application
• Trim as much hair as possible
from the intended location [for
men] on the upper left chest, as
seen in the diagram (for example,
using an electric razor or hair trim-
mer). Trim an area slightly larger
than the PiiX
• Using the Prep Wipe provided,
clean the skin where the PiiX will
be applied and allow time to dry
(clean an area slightly larger than
the PiiX)
• Do not use any creams or lotions
on your skin before application as
this will impact monitoring
IMPORTANT: Monitoring will be affected if hair is not trimmed or if
skin is not cleaned with the Prep Wipe. If this happens, you may be
required to use another PiiX.
• Remove the PiiX from the foil
pouch by tearing at the notch.
If you see any lights on the
PiiX before application, contact
Corventis Customer Service at
1-877-247-PIIX (7449)
• Grasp the top side of the PiiX as
seen in the diagram and turn it
over to view the underside
• Carefully pull each tab from the
underside of the PiiX to expose
the adhesive area
IMPORTANT: Take care not to touch the gel areas and not to fold the
fabric on to itself while you handle the PiiX.
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Step 4: Apply the PiiX to your Chest
• Bring the PiiX close to your upper left chest, taking care to hold it only as
described in Step 3
• As seen in the diagrams below, position the end of the PiiX with
“Corventis” just below the collarbone and angle the device towards the
nipple. To minimize skin irritation, do not place the PiiX over broken or
damaged skin
Sternum
Collarbone
MALE
Sternum
Collarbone
MALE
Sternum
Collarbone
FEMALE
• Petite patients can angle the PiiX slightly away from the nipple and
towards the left arm for a comfortable fit, as seen below
Sternum
Collarbone
• Once applied, use the palm of the hand to firmly apply pressure across
the surface of the PiiX. Then, use your fingers to press the edges of the
PiiX onto your skin
• Avoid strenuous motion, activity or showering for 30 minutes after PiiX
application
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EXAMPLES OF INCORRECT PIIX APPLICATION
Horizontal Upside Down
Applied over the nipple Applied under the arm
IMPORTANT: Monitoring will be affected if the PiiX device is not applied
correctly. If this happens, you may be required to use another PiiX.
Step 5: Confirm the PiiX has activated
• If you see a single blinking green
light within the circle symbol, it
means the PiiX is working properly
• If you DO NOT see this light within
15 minutes of application, please
call Corventis Customer Service at
1-877-247-PiiX (7449)
Key Things to Remember
• Wear the PiiX continuously until you see the following two symbols
( and ) appear on the PiiX display
• You can wear the PiiX while you shower (it is water resistant), but do NOT
submerge PiiX in water (for example, by swimming or sitting in a hot tub).
Avoid excessive rubbing of the PiiX while showering
• Once applied, do not remove and then reapply or reposition the PiiX. If
this happens, you may be required to use another PiiX (ie, it is meant for
one-time use)
• Keep the zLink close to you at all times (within 9 meters / 30 feet) and
charge it daily (for example, each night while you sleep)
• Carry the Patient Trigger Magnet with you at all times and use it when
you feel symptoms
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Using NUVANT MCT during the Monitoring Period
What to do when you feel cardiac symptoms
Use the Patient Trigger Magnet whenever you feel cardiac symptoms. It will
direct the PiiX to collect a record of your heart rhythm (ie, ECG), which will
then be automatically transmitted to your zLink and then automatically trans-
mitted to the Corventis Monitoring Center for review by Corventis technicians.
This information will then be provided to your physician.
• Position the Patient Trigger Magnet at one end of the PiiX and move it
lengthwise, once, across the surface and towards the opposite end (for
example, as seen in the diagram)
• The Patient Trigger Magnet can be used over light clothing (for example,
a shirt or light sweater)
• Carry the Patient Trigger Magnet with you at all times (taking care not to
come into contact with credit cards)
• •Do not place the Patient Trigger Magnet in a shirt pocket or on a neck-
lace, as that might cause unnecessary ECG collection
IMPORTANT: You may be contacted by a technician from the Corventis
Monitoring Center to discuss symptoms when the Patient Trigger Mag-
net is used. When you experience any symptoms, please make note of
the following to discuss with a technician:
• Type of symptoms
• Time of symptoms
• Duration of symptoms
• What you were doing
How to use the zLink
The zLink should be kept within 30 feet (9 meters) of you at all times to allow
transmission of data from the PiiX to the zLink
• During the day, carry the zLink with you using the zLink Holster
• At night, keep the zLink close to you while you sleep (for example, on a
nightstand)
The zLink should be kept ON at all times to allow transmission of data from
the PiiX to the zLink
• The zLink may be turned ON and OFF manually by pressing and holding
the Power button for several seconds. However, please keep the zLink
turned on at all times to ensure transmission
IMPORTANT: If you are out of range of the zLink or required to turn
it off (for example, when on an airplane or if asked by Corventis
Customer Service), you can continue to use the Patient Trigger Magnet
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to document symptoms and wear the PiiX. All of your data will be
stored on the PiiX and sent to the zLink when you are again within
range or when the zLink is turned back on.
How to charge the zLink
• Charge the zLink daily, (for example, every night while you sleep)
• The zLink may take up to 6 hours to fully charge
• With an adequate charge, the zLink can be used for up to 12 hours
before needing to be recharged
• The Linked, Cell and Send lights on the zLink are utilized by Corventis
Customer Service for troubleshooting. Refer to these lights only if asked
by a Corventis Customer Service representative
IMPORTANT: If the battery on the zLink runs out, you can continue to
use the Patient Trigger Magnet to document symptoms and wear the
PiiX. All of your data will be stored on the PiiX and transmitted once
the zLink is charged.
When to remove or replace the PiiX
Each PiiX device is designed to operate with normal wear and tear over the
course of use for up to 7.5 days. The PiiX is also water resistant. You can
keep wearing the PiiX while you shower, but do not submerge it in water (for
example, in a bath or hot tub).
Depending on the length of your prescription, you may need to wear more
than one PiiX. As seen in the diagram below, the PiiX display will let you
know when it should be removed.
• If you see a single blinking green
light within the filled circle symbol,
this means the PiiX is working
properly. You should continue to
wear the device.
• If you also see two red lights
within the circle with a crossed
line symbol, you should remove
and replace the device with a
new PiiX (unless your monitoring
period is over).
IMPORTANT: Each PiiX device should be worn continuously until the
two red lights behind the circle with the crossed line are seen.
This may take up to 7.5 days, but could be less. Once it has been
removed, do not reapply the PiiX as this will affect monitoring (ie, it is
meant for one-time use only). Please call Corventis Customer Service
at 1-877-247-PIIX (7449) if you have any questions about when to
remove the PiiX.
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How to remove the PiiX
• Grasp an edge of the PiiX with one hand and begin to peel it away from
your skin
• Using the other hand, slowly and gently push the skin away from the PiiX
as it is removed
IMPORTANT: Rapid removal can cause skin irritation. If irritation
persists after PiiX removal, consult your healthcare provider for topical
treatment options.
How and when to dispose of the PiiX
The PiiX has a Lithium battery and must not be disposed of in a fire. Please
dispose of your PiiX devices in accordance with local and federal regulations.
IMPORTANT: Please do not dispose your PiiX devices until the end of
the monitoring period. This helps to ensure that all of your data are
transmitted.
What to do at the End of Monitoring
How to return your zLink
When your prescription is complete, it will be necessary to return the zLink,
the zLink Charger, and the Patient Trigger Magnet to avoid being billed for
the value of the system. You do NOT need to return used PiiX devices. Follow
the steps below to return the materials to Corventis:
• Remove the postal envelope provided in the original packaging.
• Place the zLink, the zLink Charger, and the Patient Trigger Magnet back
into the original box.
• Place the box into the postal envelope and seal.
• Place the envelope in the mail. No additional postage is required.
IMPORTANT: Please return your materials only when your prescription
is complete. Call Corventis Customer Service at 1-877-247-PiiX (7449) if
you need information about the status of your prescription.
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Indications for Use, Contraindications
and Precautions
Indications for Use
The NUVANT Mobile Cardiac Telemetry (MCT) System is intended to continu-
ously measure, record and periodically transmit physiological data. The System
is indicated for those patients who require monitoring for the detection of
non-lethal cardiac arrhythmias such as, but not limited to, supraventricular
tachycardias (e.g. atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular
ectopy, bradyarrhythmias and conduction disorders. The NUVANT MCT System
monitors, derives and displays: ECG, Heart Rate
Description of the System
The NUVANT MCT System consists primarily of the PiiX monitoring device,
the zLink data transmission device and a Patient Trigger Magnet (to enable
on-demand collection of ECGs). Once activated, the wearable PiiX sensor
continuously monitors the heart and automatically collects ECGs when rhythm
abnormalities are detected. Patients can also drive collection of ECGs when
they experience cardiac symptoms by using the Patient Trigger Magnet.
Data are automatically transmitted from the PiiX to the zLink, which then
automatically transmits the data to the Corventis Monitoring Center. Certified
cardiographic technicians at the Corventis Monitoring Center review received
data and document symptoms reported by patients. Clinical reports, prepared
by the Corventis Monitoring Center, are delivered and made available at
www.corventis.com to provide data to prescribing physicians for the diagnosis
and identification of various clinical conditions, events and/or trends.
Based on the indications, the NUVANT System may be used for:
1. Patients who require monitoring for suspected or known, non-life threat-
ening arrhythmias
2. Patients with symptoms such as chest pain, syncope, lightheadedness
or near syncope, vertigo, dizziness, fall, palpitations, transient ischemic
episodes, dyspnea (shortness of breath) that might be due to cardiac
arrhythmias.
3. Patients with cardiac arrhythmias associated with co-morbid conditions.
4. Obtaining correlation of rhythm with symptoms when symptoms have
unknown etiology.
5. Evaluating possible arrhythmias in a) patients recovering from cardiovas-
cular or thoracic surgery; b) survivors of myocardial infarction; c) patients
with diagnosed sleep disorder breathing.
6. Evaluating benefits after initiating or discontinuation of pharmacological
therapy (e.g., anti-arrhythmic, beta-blocker, anti-coagulation therapies).
7. Assessing the results of an ablation procedure for an arrhythmia.
8. Providing data to guide treatment decisions (e.g. pharmacological or
procedural/device-based treatments) and assessing treatment results in
patients with non-life threatening arrhythmias
Contraindications
1. Patients with known allergies or hypersensitivities to adhesives or hydrogel.
2. Patients with potentially life-threatening arrhythmias, or who require
inpatient / hospital monitoring.
Precautions
1. Minute ventilation sensing on implantable devices should be disabled for
the duration of PiiX usage
2. The Patient Trigger Magnet should not be used when PiiX are applied in
the vicinity of implanted devices with active magnet features.
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3. The PiiX should be removed prior to external defibrillation or an MRI scan.
4. The PiiX may cause mild discomfort, skin irritation, redness, itching, rash
or 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).
5. The PiiX is intended for single patient use and should not be reapplied it if
peels off or is removed (ie, it is meant for one-time use).
6. The PiiX should not be applied to broken, damaged or irritated skin.
7. The PiiX is water resistant but not waterproof. It should not be sub-
merged in water (showering is acceptable, but swimming and submersion
bathing are prohibited).
8. The PiiX should not be disassembled.
9. Do not apply the PiiX if it appears damaged upon receipt.
10. No creams or lotions should be applied to the skin immediately prior to
the application of the PiiX
11. Store the PiiX in a cool, dry location. The device is designed to
withstand environmental temperature fluctuations between -20° to 65°C
(-4° to 149° F).
12. The system has not been fully evaluated for use with infants weighing less
than 22 lbs.
13. The system is not designed to detect pacemaker spikes.
Physician Services
Prescription Duration:
After registering with Corventis, physicians can prescribe NUVANT MCT for up
to 30 days at a time. As each PiiX is designed to last for up to 7.5 days (unless
the memory on PiiX becomes full beforehand), prescription lengths greater
than one week will be enabled through the use of more than one PiiX.
Clinical Reports:
Clinicians can receive clinical reports, including Episode, Daily and End of Use
Reports, directly from the Corventis Monitoring Center by fax and/or email.
Clinical data can also be securely reviewed online at www.corventis.com.
Upon clicking on the “LOGIN” link at the Corventis homepage, clinicians
will be prompted to input their personal Username and Password informa-
tion to access the application. Clinicians may download and/or print clinical
reports, review collected ECGs and also establish service preferences. For any
questions about online use, please contact Corventis Customer Service at
1-877-247-PiiX (7449).
Notifications:
The Corventis Monitoring Center may send Episode Reports and contact
prescribing physicians directly when arrhythmias that meet pre-defined criteria
are identified. Contact information and notification preferences will be
established upon registration and can be updated.
IMPORTANT: Patient data are updated for physician display upon
detection of a clinical event OR every two hours when no events
are detected, assuming a) PiiX is within 30 feet (9 meters) of zLink,
b) zLink has been appropriately installed and has sufficient power and
c) sufficient cellular coverage for data transmission exists. Analysis of
ECGs by the Corventis Monitoring Center may also affect the timing of
ECG display.
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Specifications, Compliance and Symbols
Specifications
The following performance specifications are at 20°C (68°F) unless otherwise stated
PiiX zLink Patient
Trigger
Magnet
Shelf life Refer to PiiX
pouch label
N/A N/A
Battery Charger
Power Requirement
N/A 100-240VAC,
50/60Hz
N/A
Battery Life 7.5 days (180
hrs), non-
rechargeable
Provides 12 hrs of
function before
recharging
N/A
Operating
Temperature
0˚C to 41˚C
(32˚F to 105.8˚F)
0˚C to 45˚C
(32˚F to 113˚F)
N/A
Maximum
Temperature of the
Applied Part
44˚C (111.2˚F) N/A N/A
Storage Temperature
(power off)
-20˚C to 65˚C
(-4˚F to 149˚F)
-20˚C to 65˚C
(-4˚F to 149˚F)
N/A
Operating Humidity 10% to 95% 10% to 95% N/A
Storage Humidity 5% to 95% 5% to 95% N/A
ECG
Sampling Rate
Digital Resolution
Input Dynamic Range
Input Offset
Dynamic Range
200Hz (+/-5%)
10bits
+/- 5mV
+/- 300mV
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Impedance
Measurements
Peak current injection
RMS current injection
40 uA
29 uA
N/A
N/A
N/A
N/A
Measurement
Ranges, Heart Rate
25 to 250 BPM N/A N/A
Data Storage
Capacity
7.5 days N/A N/A
Weight 50g / 1.8oz max 150g / 5.3oz max Portable
Communication
Means
Bluetooth
between PiiX and
zLink
Cellular Phone
between zLink and
Server
N/A
Arrhythmia Detection Algorithms and Automatic ECG Collection
In addition to patient-driven collection of ECGs using the Patient Trigger Mag-
net, the NUVANT MCT system also uses proprietary algorithms based on rate,
rhythm and morphology to continuously analyze rhythm abnormalities and
to initiate automatic ECG collection. ECGs are automatically collected upon
detection of the following conditions:
• Heart Rate >= 130 bpm
• Heart Rate <= 40 bpm
• Pause >= 3 seconds
• Atrial Fibrillation
• Ventricular Tachycardia/Ventricular Fibrillation
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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.
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FCC Compliance
PiiX and zLink devices comply 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 and (2)
this device must accept any interference received, including interference that
may cause undesired operation. Changes or modifications not expressly ap-
proved 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 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.
Exposure to radio frequency signals
To maintain compliance with FCC RF exposure guidelines when you carry the
zlink device on your body, use only the holster equipped with an integrated
belt clip that is supplied by Corventis. Use of accessories that are not expressly
approved by Corventis might violate FCC RF exposure guidelines.
Specific absorption rate data
The zlink device meets the US Government requirements for exposure to radio
waves when used as directed in this section.
The zlink is a radio transmitter and receiver. It is designed and manufactured
not to exceed the emission limits for exposure to radio frequency (RF) energy
set by the Federal Communications Commission (FCC) of the U.S. Govern-
ment when used as directed in the previous section. These limits are part of
comprehensive guidelines and establish permitted levels of RF energy for the
general population. The exposure standard for wireless devices employs a unit
of measurement known as the Specific Absorption Rate, or SAR. The SAR limit
set by the FCC is 1.6W/kg. Tests for SAR are conducted using standard operat-
ing positions specified by the FCC. Before a wireless device model is available
for sale to the public, it must be tested and certified to the FCC that it does
not exceed the limit established by the government-adopted requirement for
safe exposure under the recommendations of the International Commission
on Non-Ionizing Radiation Protection (ICNIRP).
The FCC has granted an Equipment Authorization for this wireless device
model with all reported SAR levels evaluated is in compliance with the FCC RF
emission guidelines when the zlink is used as directed in this section.
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Label Symbol Definitions
Consult Instructions for Use Do Not Reuse
Follow Instructions for Use Use-by (Year-month) or
(year-month-date)
Caution: consult
accompanying documents
Latex Free
Batch Number Serial Number
Date of Manufacture Catalogue Number
Non-Sterile Manufacturer’s Name and
Address
Temperature Limitations Collection of electrical and
electronic equipment
Type BF applied part; Denotes
device is not in direct contact
with cardiac muscle
Wireless Transmission Symbol
IP 35 Ingress Protection
3 means protection against
objects >= 2.5mm in
diameter (tools)
5 means protection against
water jets (shower)
Federal (USA) law restricts
this product to sale by or on
the order of a physician.
Class II Equipment
0086
Conformite Europeenne
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Frequently Asked Questions
What is a PiiX?
A PiiX is a patient-worn medical device designed to comfortably adhere to the
skin. The device contains sensors that collect your ECG waveform (a tool for
analyzing the activity of your heart).
How long will my PiiX last?
Each PiiX device is designed to last up to 7.5 days (unless the memory fills up
beforehand). However, inappropriate PiiX application, or removal and reappli-
cation of the PiiX during use, will affect monitoring. If this happens, you may
be required to use another PiiX.
What information is transmitted to my physician?
Your heart activity is monitored 24 hours a day, 7 days a week. Any unusual
heart activity is recorded, and transmitted for review to your physician.
What do I do when I feel symptoms?
Whenever symptoms occur, trigger the PiiX to record your heart activity by us-
ing the Patient Trigger Magnet (provided). Swipe the magnet along the entire
length of the PiiX, once, at a uniform rate. An ECG will be collected by the
PiiX, transmitted to the zLink and then transmitted to the Corventis Monitor-
ing Center for review and delivery to your physician.
How can I report my symptoms?
Technicians from Corventis will occasionally call you to discuss your symptoms.
Please make note of the type of symptoms, the duration of symptoms, when
they happened and what you were doing so it can be discussed with a techni-
cian.
Should I keep the Patient Trigger Magnet with me at all times?
Yes, you should always carry the Patient Trigger Magnet with you. Please keep
the Patient Trigger Magnet away from your credit cards or identity cards as
the magnet may erase them. Also, please do not place the Patient Trigger
Magnet in a shirt pocket or on a necklace, as that might cause unnecessary
ECG collection.
Can I take a shower while wearing my PiiX?
Yes, the PiiX is water resistant so you can shower while wearing it. However,
do NOT submerge PiiX in water by swimming or sitting in a hot tub. In addi-
tion, avoid excessive rubbing of the PiiX during showering.
Should I carry the zLink with me when I travel?
Yes, take zLink with you at all times. zLink will remain charged for up to 12
hours. If you plan to be away for longer than 12 hours, take the zLink charger
with you.
Will I need to change the battery in the zLink or the PiiX?
Battery replacement is not required for the PiiX and the zLink. However, we
recommend that you charge the zLink every night.
How close must I be to zLink to ensure that the data collected by my
PiiX are transmitted?
Remain within 30 feet (9 meters) of zLink for successful data transmission.
How often do I need to change the PiiX device?
When both of the following two symbols and appear on the PiiX
display, you should remove PiiX. Please apply a new PiiX if your monitoring
period has not ended.
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NUVANT™ MCT Instructions for Use
ENGLISH
What if PiiX causes my skin to itch?
If you experience skin irritation while wearing PiiX, speak with your physician.
Will I need to notify airline security screeners about my PiiX?
Although PiiX and zLink devices may trigger airport detectors, they will not be
damaged. Carry the NUVANT MCT patient travel card provided as part of your
NUVANT MCT System when traveling or entering high security areas. Simply
notify airport personnel that you are wearing a PiiX medical device and show
them your patient card.
Can I wear a PiiX through a shoplifting detector in a store?
Yes, the PiiX will not set off store detectors and will not be damaged by them.
Can I use microwave ovens or TV remotes while wearing a PiiX?
Yes, it is safe to operate these devices as they will not affect performance of
the PiiX.
Can I be close to wireless phones, WiFi, or other electromagnetic
devices?
Yes, although some sources of Electromagnetic Interference (EMI) may
temporarily disrupt data transmission.
Can I carry my cellphone while wearing PiiX?
Yes, but do not place your cellphone in a pocket directly over PiiX. Some
cellphones have magnets that can lead to unintended ECG collection.
Will hot or cold environments affect PiiX performance?
PiiX provides accurate and reliable performance in a temperature range of
32˚ F to 105.8˚ F (0˚ C to 41˚ C).
Are my medical data protected during transmission?
Your data are transmitted securely to the Corventis Monitoring Center and
securely stored.
Contact Information
Corventis Customer Service
1-877-247-PiiX (7449)
Corventis, Inc.
1410 Energy Park Drive
St. Paul, MN 55108
© Corventis, Inc. 2013
Patents pending
Corventis, the Corventis Logo, PiiX, zLink and NUVANT are trademarks of Corventis, Inc.
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