User's Manual

5.0 Conditions of Use

The patient should adhere to the following conditions while using the Vpatch System:

 The Vpatch System is to be operated under the restrictions which apply to the use of

cellular/mobile telephones.

 Only use a genuine Biosensor that is supplied with the device or sourced from an

approved agent.

 The Biosensor should be within its shelf life.

 Biosensors are single-use only and should not be used if they are damaged.

 The use of damaged or unsuitable Biosensors may lead to poor results or

unnecessary skin irritation.

 Excessive exercise and perspiration may decrease the length of time that the

Biosensor Array can be worn.

 Avoid touching or rubbing the Biosensor Array once it has been applied.

 Apply a new Biosensor Array if reduced adhesion is observed.

 A slight reddening of the skin or minor irritation underneath and/or immediately

adjacent to the Biosensor Array border is normal. If this is uncomfortable for the

person wearing the device, it is recommended they contact the issuing Healthcare

professional for consideration of discontinuation, replacement or re-positioning of the

BSA.

 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.

 The Biosensor (BSA) is not defibrillation-proof and therefore MUST be REMOVED

prior to the use of a cardiac defibrillator on the patient.

 The Biosensor Array can be worn in the shower (excluding power showers) with the

Vpod device disconnected. The Biosensor Array should be gently dabbed dry with a

lint free cloth and the Vpod device cleaned and reconnected as soon as possible

thereafter.

 The Vpod device can be worn during sleep.

 The Vpatch devices and accessories should be kept out of the reach of children and

pets.

 The Vpatch Devices are designed to be resistant to normal environmental conditions

such as lint, dust and light including sunlight. All care should be taken to minimise

exposure. If required cleaning instructions are included in section 6.3 Cleaning of

these Instructions for Use.

 There are no user serviceable parts.