Use Instructions

SpiroSphere
®
ECG Instructions for Use
Page 4/136
Version 02.02 • 04AUG2022
Table of Contents
Indications for Use ............................................................................................................................ 2
Contraindications .............................................................................................................................. 2
Notes on Safety in this Instruction Manual ....................................................................................... 6
Declaration of Conformity ................................................................................................................. 6
Graphical Symbols on the ECG amplier ......................................................................................... 7
Device Description............................................................................................................................ 8
Unpacking and Starting Operation ................................................................................................... 8
The SpiroSphere ............................................................................................................................. 9
Start-Up .......................................................................................................................................... 10
Shut down....................................................................................................................................... 11
LED Status SpiroSphere .......................................................................................................... 12
LED Status SpiroSphere Sensor .............................................................................................. 12
Troubleshooting .............................................................................................................................. 13
Sensor Insert and Remove ............................................................................................................. 15
Setup .............................................................................................................................................. 16
The Home Screen .......................................................................................................................... 19
Sensor Check ................................................................................................................................ 20
Calibration Check ........................................................................................................................... 20
Linearity Check ............................................................................................................................... 22
Add Patient ..................................................................................................................................... 23
Search Patient ................................................................................................................................ 25
Actions ........................................................................................................................................... 27
Preparing a Spirometry Measurement............................................................................................ 28
Perform a Forced Spirometry Measurement ............................................................................ 29
Perform a Slow Spirometry Measurement ............................................................................... 34
Medication Dosing Record ............................................................................................................. 37
Perform a Post Spirometry Measurement ................................................................................ 38
Adhoc Test ......................................................................................................................................40
Perform an Adhoc Test ............................................................................................................. 40
Assign Adhoc Test now ............................................................................................................ 41
Assign Adhoc Test later ............................................................................................................ 42
Show, Edit, Delete and Print Tests ................................................................................................. 43
Print Recorded Results................................................................................................................... 46
Settings and Tools .......................................................................................................................... 47
Resting ECG................................................................................................................................... 61
Information on ECG Recording ................................................................................................ 61
Performing an ECG Recording ................................................................................................ 66
ECG Results ............................................................................................................................ 72
ECG Evaluation ........................................................................................................................ 74
ECG Settings ........................................................................................................................... 75
Connecting an ECG Unit .......................................................................................................... 76
User Management .......................................................................................................................... 78
Backup & Recover ................................................................................................................... 88
Communication ........................................................................................................................ 90
Local IT Guide for Ethernet (LAN), WI-FI (WLAN) or optional 3G (Mobile Network) ............... 93
Report & Printing ...................................................................................................................... 95
Update ..................................................................................................................................... 97
About Device ............................................................................................................................ 98
Restore Default Settings .......................................................................................................... 98
Factory Reset ........................................................................................................................... 98