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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)

Summary of content (16 pages)

PAGE 1
ENGLISH NUVANT ™ Mobile Cardiac Telemetry (MCT) System 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, wireless arrhythmia detection system that is used to aid clinicians in diagnosing suspected cardiac arrhythmias.
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ENGLISH 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.......................................................................................
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ENGLISH 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 trimmer).
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ENGLISH 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.
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ENGLISH 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.
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ENGLISH 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 transmitted to the Corventis Monitoring Center for review by Corventis technicians. This information will then be provided to your physician.
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ENGLISH 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.
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ENGLISH 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.
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ENGLISH Indications for Use, Contraindications and Precautions Indications for Use The NUVANT Mobile Cardiac Telemetry (MCT) System is intended to continuously 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.
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ENGLISH 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.
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ENGLISH 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), nonrechargeable Provides 12 hrs of function before recharging N/A Operating Temperature 0˚C to 41˚C (32˚F to 105.
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ENGLISH 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 successive R-wave peaks.
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ENGLISH 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 approved by Corventis could void the user’s authority to operate the equipment.
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ENGLISH Label Symbol Definitions IP 35 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
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ENGLISH 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 reapplication of the PiiX during use, will affect monitoring.
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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.