Invivo Xper Flex Cardio Physiomonitoring System

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

PHILIPS ELECTRONICS SINGAPORE PTE LTD

Class:

Class C medical device

Manufactured by:

INVIVO, a division of Philips Medical Systems

Therapeutic area:

General Hospital

Therapeutic indications:

The physiomonitoring system is intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring. The system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, pulse oximetry (SpO2), end tidal CO2 (ETCO2), fractional flow reserve (FFR), non-invasive blood pressure (NIBP), surface body temperature and thermal cardiac output. The system also provides for clinical data acquisition, medical image/data processing, and analytical assessment. The system is indicated for use in the following areas: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology and other areas where cardiac monitoring may be required. Use of the system is not intended where unattended patient monitoring is desired, or in situations where arrhythmia detection is required. The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or internet, or may f

Product summary:

Device System Info:[System or Procedure Pack], Monitoring system with software (version 2.3); Models: Xper Information Management System - 830230, 4 lead Set Grabber, IEC, 16 lead Hemo ECG Leadwire - 989803174241, 4 lead Set Grabber, AAMI, 16 lead Hemo ECG Leadwire - 989803174231, Xper Flex Cardio Physiomonitoring System - FC2010, Xper Flex Cardio Physiomonitoring System - FC2020

Authorization date:

2013-08-19