Instructions for Use
Ergostik
Serial no.: xx|8|201|yyy and 2201xxxxx
Version: 7 | Release date: 02. August 2021
Page 13
2
Conditions of Use
Any other use of Ergostik which is not described in this IFU is
deemed improper use. The responsible organisation of
Ergostik alone is liable for any direct or indirect damage
resulting from not adhering to these conditions.
They are then solely responsible for the fulfillment of the basic
requirements of the medical device and assumes complete
product liability for the whole system.
2.1
Intended Purpose
The medical device Ergostik is a PC-based measuring device
used to determine physical ability by measuring gas exchange.
The examination involves an analysis of the interplay between a
patient’s heart, circulatory system, breathing and metabolism
whilst their body is being put under a defined load. The test
subject is put under load whilst on an ergometer. Their heart
rate, breathing rate, respiratory minute volume, oxygen intake
and carbon dioxide output is continually recorded throughout the
process.
The Ergostik consists of a case with integrated electronics used
to determine ventilation, as well as to analyze oxygen and
carbon dioxide levels. It is connected to a computer via an
integrated USB interface. A 12 V power supply is used. The tried
and tested Ergoflow flow sensor is used to measure flow.
The measurement device is supplied with BLUE CHERRY®
software. The standard version contains CPET, spirometry and
flow / volume measurements, as well as pre / post examinations
and trend analysis. The software contains a database for patient
information and measurement results. The modular design of
both software and hardware allows additional measurement
options to be incorporated, such as MVV or SPO2.
