Use Instructions
SpiroSphere
®
ECG Instructions for Use
Page 5/136
Version 02.02 • 04AUG2022
Cleaning/Hygiene Spirometry ......................................................................................................... 99
Hygiene ECG................................................................................................................................ 102
Functional Check ECG ................................................................................................................. 103
Troubleshooting Guide ECG ........................................................................................................ 103
Return of Goods in Medical Institutions ........................................................................................ 105
General Safety Precautions.......................................................................................................... 109
Safety Precautions ECG............................................................................................................... 114
General Cautions and Warnings ............................................................................................ 114
Operation Cautions and Warnings ......................................................................................... 115
Graphical Symbols ....................................................................................................................... 118
UDI ......................................................................................................................................... 118
MD .......................................................................................................................................... 118
SN .......................................................................................................................................... 118
REF ........................................................................................................................................ 118
Electromagnetic Emission and Immunity SpiroSphere ECG ........................................................ 122
Bluetooth
®
Wireless Communication ...................................................................................... 127
Technical Data Spirometry............................................................................................................ 128
Technical Data Flow Sensor ................................................................................................... 129
Technical Data ECG ..................................................................................................................... 130
Item Numbers of Disposables and Accessories ........................................................................... 132