Use Instructions

SpiroSphere
®
ECG Instructions for Use
Page 74/136
Version 02.02 • 04AUG2022
ECG Evaluation
The printed report will show the 12-lead ECG tracing, as well as information
pertaining to the patient details, system calculated Interval Duration
Measurements, Interpretation. These are provided as a guide only. Final clinical
decision lies with the Physician.
Interpretation according to HES
®
SpiroSphere with ECG provides the Hannover ECG System HES
®
, which has
been developed together with leading cardiologists all over the world.
Today, the HES
®
algorithm is considered as quasi standard for ECG recording
and interpretation.
Automatic interpretation of the ECG is not possible for pediatric subjects
with an age below 16 years and for pacemaker subjects.
A qualied physician has to reassess all SpiroSphere ECG measurements.
An interpretation by SpiroSphere with ECG is only signicant when
considered together with other clinical ndings. ECG interpretation
statements made by SpiroSphere with ECG represent partial qualitative
and quantitative information on the subject‘s cardiovascular condition
and no therapy or drugs can be administered solely on the interpretation
statements.
It is possible to print with: Gain: 10mm/mV or 5mm/mV | Speed: 25mm/s or
50mm/s (depending on the congured on-screen display).