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GE HEALTHCARE PTE. LTD.
Class C medical device
GE Finland Oy
The MRI Monitor with L-CANE05 or L-CANE05A software, module options E-MRIPSN, E-MRICAiOV, E-MRICAiO, E-MRICO & accessories is indicated for monitoring of hemodynamic (comprising ECG (including heart rate, ST-segment and arrhythmia), NIBP, SpO2, & invasive blood pressure), respiratory (CO2, O2, N2O, anesthetic agents, anesthetic agent identification, & respiration rate), & ventilatory (comprising airway pressure, volume & flow) status of hosp patients during MR scanning. The NIBP measurement is indicated for patients who weigh 5kg & up. The MRI Monitor with L-CANE05 or L-CANE05A software is also indicated for documenting patient care related information. The MRI Monitor with L-CANE05 or L-CANE05A software, module options E-MRIPSN, E-MRICAiOV, E-MRICAiO, E-MRICO & accessories is indicated for use in the MR environment up to 300 Gauss with static magnets up to 3.0 Tesla. SpO2 and ECG monitoring is indicated only with accessories specifically designed for the MR environment.
Device System Info:[System or Procedure Pack], MRI monitor with L-CANES05 or L-CANE05A software, with other module options and acessories. As part of the S/5 product family, the S/5 MRI Monitor can be connected to the Datex-Ohmeda S/5 Network and Central for centraliseed viewing of vita patient data.; Models: S/5 8-Module frame (F-CU8-12-VG1) - M1138441, S/5 5-Module frame (F-CU5-01) - M1152119, S/5 5-Module frame (F-CU5P-01) - M1152117, S/5 Central Processor Unit for FCU5 (F-CPU-02) - M1138450, S/5 FCU5 power unit - N-AC-00, Cable between F-CU5 & F-CPU, 0,3 m/ 12 in - M1021337, Cable between F-CU5 & F-CPU, 3 m/ 10 ft - M1021338, Cable between F-CU5 & F-CPU, 10 m/ 33 in - M1021339, Cable between F-CPU & N-AC, 0,4 m/ 16 in - M1021340, Cable between F-CPU & N-AC, 2,7 m/ 9 ft - M1021341, S/5 Anesthesia Software License (L-ANE07-00) - M1119898, S/5 Anesthesia Software License with extended arrhythmia analysis (L-ANE07A-00) - M1119983, Display 12" LCD - L-LCC12A-01-EN, S/5 Command Bar - K-ANEB-00-EN, Frame Holder for S/5 Command Bar - 8001952, Table Holder for S/5 Command Bar - 8001953, S/5 Blank bar - K-BLANKB-00, S/5 Interface module - E-INT-00, S/5 Memory module - E-MEM-00-EN, S/5 Recorder Module - E-REC-00-EN, Extension Frame (F-EXT4-03-1) - E-EXT-00, deioRecorder for Anesthesia - L-ARK-00-EN, Display Controller (B-DISPX-01) - M1076677, Board - B-UPI4NET-02, S/5 F-CPU table holder - M1027910, Holder for S/5 Command bar - M1027908, Power Adapter Mount - M1035232, Adapter Plate for S/5 F-CU5(P) - M1027911, S/5 MRI Monitor - F-MRICM1-00, S/5 anesthesia software for MRI - L-CANE05, S/5 anesthesia software for MRI - L-CANE05A, Shield for S/5 MRI Monitor - N-MR12