Corventis NUVANT Manuel utilisateur

NUVANT™

Mobile Cardiac Telemetry (MCT) System

ENGLISH

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.

NUVANT™MCT Instructions for Use

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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

NUVANT™MCT Instructions for Use

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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

NUVANT™MCT Instructions for Use

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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

NUVANT™MCT Instructions for Use

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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.

NUVANT™MCT Instructions for Use

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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.

NUVANT™MCT Instructions for Use

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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.

NUVANT™MCT Instructions for Use

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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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