Content
1 Intended Use, Indications and Operation ....................................................... 5
1.1 Intended Use .......................................................................................... 5
1.2 Indications .............................................................................................. 5
1.3 Mode of Operation ................................................................................. 6
2 Regulatory Compliance and Labeling .............................................................. 7
2.1 Regulatory Compliance ........................................................................... 7
2.2 Information on the Device Labels ........................................................... 9
2.3 Symbols on the Packaging Label ........................................................... 11
3 Safety and Reliability .................................................................................... 12
3.1 Definitions ............................................................................................ 12
3.2 General Warnings ................................................................................. 13
3.3 General Cautions .................................................................................. 14
3.4 Safety and Reliability Only with Proper Maintenance ........................... 16
3.5 Cleaning the Recorder and Accessories ................................................ 17
3.6 Disposing of the Device, Batteries, and Accessories ............................. 18
3.7 Established Medical Practices ............................................................... 18
3.8 Manufacturer Responsibility ................................................................. 18
4 Control Elements, Putting into Operation ..................................................... 19
4.1 Control Elements .................................................................................. 19
4.2 Putting into Operation, Fully Charging the Battery ............................... 20
5 Recording and sending an ECG ..................................................................... 25
5.1 How and where you apply the device ................................................... 25
5.2 Recording an ECG ................................................................................. 26
5.3 Sending an ECG Recording .................................................................... 28
5.4 Switching off the Device ....................................................................... 30
6 The System of PhysioMem and ReSTA .......................................................... 31
6.1 Overview .............................................................................................. 31
6.2 ECG Report ........................................................................................... 32
7 Meaning of Display Symbols and Audible Notifications ................................ 35
7.1 Display Symbols .................................................................................... 35
7.2 Audible Notifications ............................................................................ 37