Safety Notes; Intended Use; Indications For Use; Contra-Indication - Schiller CARDIOVIT AT-1 G2 User Manual

CARDIOVIT AT-1 G2
F
User guide

1 Safety notes

1.1

Intended Use

 The CARDIOVIT AT-1 G2 is a 12-lead ECG device intended to be used by trained
medical professionals in healthcare facilities for cardiological diagnosis in adult
and paediatric patients.
 ECG analysis is complemented with algorithms that provide measurement
results, data, graphic presentation and interpretation for review by the user.
1.2

Indications for use

 The CARDIOVIT AT-1 G2 is a 12-lead ECG device intended to acquire ECG
signals from body surface electrodes and record, analyze, display and print
ECGs for cardiological diagnosis in adult and paediatric patients.
1.3

Contra-indication

 The unit is not intended for:
• sterile use.
• use in potentially explosive areas or in the presence of flammable gases such as
anaesthetic agents.
• direct cardiac application.
• use in an MRI suite.
1.4

Responsibility of the User

 The CARDIOVIT AT-1 G2 must only be used by qualified medical personnel.
 The numerical and graphical results and any interpretation given must be
examined with respect to the overall clinical condition of the patient and the
general recorded data quality.
 The responsibilities of the personnel for the operation and maintenance of the
device must be specified.
 Ensure that the personnel have read and understood this user guide. In particular
this section safety notes must be read and understood.
 Damaged or missing components must be replaced immediately.
 The safety, reliability and performance of the device can only be guaranteed
when the maintenance intervals as stated in the section
observed.
Safety notes 1
Intended Use 1.1
Maintenance are
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