User's Manual

3
biosensor array. The presence of these magnetic studs may affect the performance of
the implanted device.
3.2 Warnings
 The device must be issued by health care professional. The issuing health care
professional must ensure that the person wearing the device, or their carer is capable
of and instructed in how to change the Vpod batteries and recharge the Vcell as per
the instructions outlined in Section 6.5, and Table 5 in Section 8.0
 Care should be taken to ensure that the Vpod and Vcell devices do not come into
contact with water or any other liquids. The Biosensor Array should not be
submerged in water, for example during a bath or while swimming.
 A biosensor array has a shelf-life of 28 days once it is removed from the sealed
plastic pouch.
 The Vpod should only be opened to replace discharged batteries or at the completion
of the monitoring period or if the batteries have discharged. DO NOT remove the coin
cell batteries from the Vpod during monitoring.
 The Vcell should be used in accordance with restrictions that apply to the use of
cellular mobile telephones.
 Care should be taken when changing the CR3032 coin cell batteries in the Vpod as
they may present a choking hazard.
 The CR3032 coin cell should be disposed of correctly as described in Section 10.0 on
page 18
 The Vpatch electronics should only be operated at temperatures between 0 °C and
40 °C (32 °F and 104 °F). Exceeding the recommended storage conditions and
conditions for use can result in impaired system performance.
4.0 Vpatch System Equipment
4.1 REM Biosensor Array
The REM Biosensor Array (BSA) provides quality ECG measurements to facilitate event
analysis, as well as being flexible and comfortable to wear.
4.2 Vpod and Vcell Devices
The Vpod and Vcell are shown below in Figure 1. The Vpod monitors ECG signals when
connected to the Biosensor Array on the patient’s body.
Figure 1: Vpod and Vcell Devices
A
Event Button/Pairin
g
Button
B Release Clips
C Char
g
in
g
Port
D On/Off Button
E LED
F Pairin
g
Button