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For US distribution only IFU NUVANT 04-10

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P00986-002 Rev A

NUVANT™ Mobile Cardiac Telemetry (MCT) System

INSTRUCTIONS FOR USE

Rx only

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. The NUVANT System model monitors, derives and

displays:

• ECG

• Heart Rate

The System may also monitor, derive and display:

• Activity

• Posture

• Respiration rate (including RR variability)

• Body fluid status

• Heart rate variability

Description of the System

The NUVANT System includes:

a) PiiX™ - an adherent patient-worn device containing multiple sensors used to track a suite of physiological parameters. The PiiX can also be

activated to associate patient symptoms with ECG data using a Patient Trigger Magnet. PiiX can collect approximately 500 ECG episodes.

However, PiiX must be replaced after 7.5 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 Charger – a charger 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 NUVANT System enables remote monitoring in ambulatory patients to:

a) Detect, store and transmit ECGs and other physiological data.

b) Assist physicians/health practitioners in the diagnosis and identification of various clinical conditions/events/trends through web services and

patient reports.

Based on the indications, the NUVANT System may be used for:

a) Patients who require monitoring for known, non-life threatening arrhythmias.

b) 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.

c) Patients with cardiac arrhythmia associated with co-morbid conditions.

d) Obtaining correlation of rhythm with symptoms when symptoms have unknown etiology.

e) Evaluating possible arrhythmias in a) patients recovering from cardiovascular or thoracic surgery; b) survivors of myocardial infarction; c) patients

with diagnosed sleep disorder breathing.

f) Evaluating benefits after initiating or discontinuation of anti-arrhythmic drug therapy.

g) Assessing the results of an ablation procedure for an arrhythmia.

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. PiiX should not be used on patients with implantable devices with active minute ventilation sensors.

2. Patient trigger magnet should not be used in patients who have implanted devices with active magnet features in the vicinity of the PiiX.

3. PiiX should be removed prior to external defibrillation or an MRI scan.

4. 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. PiiX is intended for single patient use.

6. PiiX should not be applied to broken, damaged or irritated skin.

Summary of content (6 pages)

PAGE 1
Page 1 of 6 P00986-002 Rev A NUVANT™ Mobile Cardiac Telemetry (MCT) System INSTRUCTIONS FOR USE Rx only 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.
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Page 2 of 6 7. PiiX is water resistant but not waterproof. It should not be submerged in water (showering is acceptable, but swimming and submersion bathing are prohibited). 8. PiiX should not be disassembled. 9. Replace the PiiX if it peels off; do not reapply the PiiX. 10. Replace the PiiX if it appears damaged. 11. No creams or lotions should be applied immediately prior to use of PiiX. 12. Store PiiX in a cool, dry location.
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Page 3 of 6 PiiX Application PiiX First device: 1. 2. 3. 4. 5. 6. Trim (rather than shave) hair in intended location. Use prep 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. Handle the PiiX on the edges until the PiiX is placed on the skin.
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Page 4 of 6 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: Enter your User Name and Password and click on Submit to proceed to the home page.
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Page 5 of 6 Instructions on how to safely dispose of the PiiX The PiiX has a Lithium-ion battery 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 1 (408) 790-9393. 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.
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Page 6 of 6 Exposure to radio frequency signals To maintain compliance with FCC RF exposure guidelines when you carry the zlink device on your body, use only 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. To reduce radio frequency (RF) exposure consider these safety guidelines: Use hands-free operation if it is available and keep the zlink device at least 0.98 in.