Safety Notes; Intended Use; Indication For Use; Optional Use - Schiller CARDIOVIT CS-104 User Manual

CARDIOVIT CS-104
User Guide

1 Safety Notes

1.1

Intended Use

 The CARDIOVIT CS-104 is a 12-lead ECG and Spirometry (option) system
intended to be used by trained medical professionals in healthcare facilities for
cardiological diagnosis in adult and paediatric patients.
 Analysis of the ECG and Spirometry is accomplished with algorithms that provide
measurements, data presentations, graphical presentations, and interpretations
for review by the user.
1.2

Indication for Use

 The CARDIOVIT CS-104 is a 12-lead ECG device intended to acquire ECG
signals from body surface electrodes, and record, analyse and display ECGs for
cardiological diagnosis in adult and paediatric patients.
 Using the optional spirometry module and the associated accessories, the
CARDIOVIT CS-104 is intended to record, analyse, display and print measures
and waveforms of pulmonary function tests for the diagnosis of lung diseases in
adult and pediatric patients able to understand the test instructions.
1.3

Optional Use

 The following options can be sold with the CARDIOVIT CS-104:
– Exercise ECG (standard in some configurations)
– Arrhythmia detection: detection of arrhythmias during exercise tests and rest-
ing rhythm acquisition.
– Vector ECG: provides a 3-dimensional view on the electrical activity, and adds
value to the diagnostic of the hearts backside
– Spirometry Test: Indicated to assess patient's pulmonary health status and
evaluate symptoms, signs, or abnormal laboratory test results. The spirometry
module analyses flow/volume and volume/time waveforms recorded during
pulmonary function tests. (standard in some configurations)
1.4

Characterisation of Users

 The CARDIOVIT CS-104 is intended to be used by trained medical professionals
or under direct supervision of a licensed health care practitioner, in hospitals,
clinics, physician offices and outreach centres.
1.5

Characterisation of Patients

 The CARDIOVIT CS-104 is intended to be used for adult and paediatric patients.
 The CARDIOVIT CS-104 is intended to be used as a spirometry system for adult
and paediatric patients able to understand test instructions
Safety Notes 1
Intended Use 1.1
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