Seca CT8000P-2 - Safety Notes; Intended Use; Indications for Use; Contra-Indication

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Art. no.: 2.511407 Rev.: a
Safety notes 1
User guide Intended Use 1.1
CT8000P-2
1 Safety notes
1.1 Intended Use
1.2 Indications for use
1.3 Contra-indication
 The CT8000P-2 is a 12-lead ECG and spirometry (optional) device intended to
be used by trained medical professionals in healthcare facilities for cardiological
diagnosis in adult and paediatric patients.
 ECG and spirometry analysis is complemented with algorithms that provide
measurement results, data, graphic presentation and interpretation for review by
the user.
 Patient data is exchanged between the CT8000P-2 and a data management
system by means of USB stick, LAN or WLAN.
 The CT8000P-2 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.
 The optional spirometry module of the CT8000P-2 incl. accessories is intended
for the recording, analysis, display and printout of pulmonary function test
measurements and curves for the diagnosis of diseases in adult and paediatric
patients who are able to understand the test instructions.
Note: The spirometry option is not available for version 1.1.x.
 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.