User's Manual
1
Table of Contents
1.0 Equipment Supplied ....................................................................................................... 2
2.0 General Description of Vpatch System .......................................................................... 2
3.0 Indications for Use ......................................................................................................... 2
3.1 Contraindications ....................................................................................................... 2
3.2 Warnings .................................................................................................................... 3
4.0 Vpatch System Equipment ............................................................................................ 3
4.1 REM Biosensor Array ................................................................................................ 3
4.2 Vpod and Vcell Devices ............................................................................................. 3
5.0 Conditions of Use .......................................................................................................... 4
6.0 System Operation .......................................................................................................... 5
6.1 Device Preparation and Charging ............................................................................. 5
6.2 Charging .................................................................................................................... 5
6.3 Cleaning ..................................................................................................................... 5
6.4 Skin Preparation ........................................................................................................ 5
6.5 Biosensor Array Application ...................................................................................... 6
6.6 Vcentral ...................................................................................................................... 7
6.7 Device Operation ....................................................................................................... 7
6.8 To Begin Monitoring ................................................................................................. 11
6.9 Frequently Used Functions During the Monitoring Period ....................................... 11
6.8.1 Pressing the Event Button ................................................................................... 11
6.9.2 Out of Range Indicators ....................................................................................... 11
6.9.3 Low Battery Alarms .............................................................................................. 11
6.9.4 Restarting the Vpod and Vcell ............................................................................. 12
6.10 Viewing the Patient’s ECG Data .............................................................................. 12
7.0 Transmission of Data ................................................................................................... 12
8.0 Specifications ............................................................................................................... 13
8.1 EMC Compliance ........................................................................................................... 15
8.2 FCC Compliance ............................................................................................................ 16
9.0 Storage and Transport Conditions ............................................................................... 17
9.1 Maintenance................................................................................................................... 17
10.0 Disposal ....................................................................................................................... 18
11.0 Explanation of Symbols Used on Vpatch System Documentation .............................. 19
11.1 Vpatch System Model/Serial Numbers .................................................................... 19
12.0 Start-Up Guide ............................................................................................................. 20
13.0 Indicator Guide ............................................................................................................ 21
14.0 Troubleshooting Guide ................................................................................................ 23
15.0 Standards .................................................................................................................... 25
16.0 Warranty ...................................................................................................................... 25
17.0 Distributor Details ........................................................................................................ 26
18.0 Manufacturer Details .................................................................................................... 26
19.0 Authorized Representative in the European Community ............................................ 26