User's Manual

1.0 Equipment Supplied

1 Vpod device

1 Vcell device

1 Mascot Type 2240 Li-Ion battery charger (4.2V)

1 Quick Start Guide

Note: The Vpatch Biosensor Array (BSA) is essential and supplied separately.

This User Manual is available electronically, for viewing or download, at

www.vpatchcardio.com.

2.0 General Description of Vpatch System

The Vpatch System is a Remote Event Monitoring (REM) system that records a patient’s

ECG signals and detects whether one of the following arrhythmias is present:

 Bradyarrhythmia

 Ventricular Tachycardia

 Supraventricular Tachycardia

 Ventricular Fibrillation

 Atrial Flutter

 Atrial Fibrillation

 First Degree Heart Block

 Second Degree Heart Block

 Third Degree Heart Block

This small battery operated portable system consists of the Vpod (a body-worn device), the

Vcell (a portable device) and the REM Biosensor Array (Biosensor). The Vpod is connected

to the REM Biosensor, which is worn by the patient.

The Vpod is pre-programmed to monitor ECG signals on a continuous basis using the

Biosensor Array. If an event is detected by the Vpod or triggered by the user (by pressing the

Event Button), the relevant ECG data is sent via a wireless link to the Vcell. Cellular

communication technology is used to send the data to a remote device/receiving station for

analysis by the patient’s clinician.

Note: This device is NOT a life saving device nor can it be used in any way to summon

first responders to administer first aid or emergency care. If there is a concern

regarding the health of the individual (i.e. chest pain or any other health concerns)

when wearing the device; the individual or nearest bystander should contact a medical

professional or emergency services IMMEDIATELY.

3.0 Indications for Use

The Vpatch System is intended for patients requiring ambulatory monitoring and is controlled

via a central point by a clinician. The system is suitable for patients experiencing

symptomatic or asymptomatic cardiac arrhythmias.

3.1 Contraindications

 The Biosensor Array (and therefore the Vpatch System) should not be applied to

patients with a skin disorder or patients with known sensitivities to hydrogels or

adhesives.

 The Vpatch System including the BSA has not been tested or approved for use to

during an MRI scan and therefore MUST be REMOVED from the patient prior to the

MRI procedure being performed.

 Patients fitted with an “active” implantable medical device such as a pacemaker or

ICD should not use the Vpatch System due to the presence of magnetic studs on the