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GE HEALTHCARE PTE. LTD.
Class C medical device
GE Healthcare Finland Oy
The CARESCAPE B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. It is indicated for monitoring of: • hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation and central venous oxygen saturation, and Surgical Pleth Index), • respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and • neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission). It is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. It is not intended for use in a controlled MR environment.
Models: CARESCAPE Monitor B650 - 2068487-001, Upgrade Program for Solar 8000 to B650 - M1197442, Upgrade Program for Anesthesia Monitor (AM) to B650 - M1197443, Upgrade Program for Critical Care Monitor (CCM) to B650 - M1197444, Remote-ON cable for Aisys and Avance - M1187043, E-PiCCO-00 - M1187062, PiCCO Injectate Sensor Cable, 0.9m - M1182448 , PiCCO Continuous Cardiac Output Cable, 4.1m - M1154585, BX50 ESP V2 UPGRADE ENGLISH INTL - 2068086-151, BX50 ESP V2 UPGRADE ENGLISH INTL - 2068086-251, Bx50 ESP V2 UPGRADE ENGLISH INTL - 2068086-451, Gas Sampling Line, disposable, PVC/PE, 2m/7ft - 2097307-001, Gas Sampling Line, disposable, PVC/PE, 3m/10ft - 2097307-002, Gas Sampling Line, disposable, PVC/PE, 6m/20ft - 2097307-003, CARESCAPE RAD - 2096726-001, E-EEGX - 2080993-004, N-EEGX - 2080994-004, Carescape B650 - 2095801-001