GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission(NMT) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 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. The CARESCAPE Monitor B650 is not intended for use during MRI. K092027 CARESCAPE Monitor B850 The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation), Airway Gases (Fi/Et C02, 02, N20 and Anesthetic Agent), Spirometry, Gas Exchange (02 Consumption (VO2), C02 production (VCO2), energy expenditure (BE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. The CARESCAPE Monitor B850 provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for bed to bed viewing and to data management software devices via a network. The CARESCAPE Monitor B850 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. In addition to the healthcare practitioner, the CARESCAPE Monitor B850 is designed to provide configuration and troubleshooting capabilities to qualified service personnel. The CARESCAPE Monitor B850 is not intended for use during MRI. K131414 CARESCAPE MONITOR B850 The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Thermodilution and pulse contour), Temperature, Mixed Venous Oxygen Saturation, and Central Venous Oxygen Saturation). Respiratory [Impedance Respiration, Airway Gases (C02, 02, N20 and Anesthetic Agents), Spirometry, Gas Exchange] and N

Detalles del retiro

Fabricante

GE Healthcare, LLC

Distribuidor

Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CZECH REPUBLIC, FINLAND, FRANCE GERMANY, GREECE, ITALY, LITHUANIA, POLAND, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM.

Lote

Mfg Lot or Serial # SEW13380452HA SEW13380454HA SEW13380455HA SEW13380500HA SEW13380501HA SEW13380502HA SEW13380503HA SEW13380504HA SEW13380505HA SEW13380506HA SEW13380507HA SEW13380508HA SEW13380509HA SEW13380512HA SEW13380520HA SEW13380524HA SEW13380525HA SEW13380526HA SEW13380534HA SEW13380535HA SEW13380536HA SKA13130068GA SKA13130071GA SKA13130075GA SKA13130077GA SKA13130078GA SKA13130082GA SKA13130085GA SKA13140118GA SKA13370167GA SKA13370211GA SKA13370214GA SKA13370215GA SKA13370216GA SKA13370217GA SKA13370218GA SKA13370219GA SKA13370220GA SKA13370221GA SKA13370222GA SKA13370223GA SKA13370224GA SKA13370225GA SKA13370226GA SKA13370227GA SKA13370228GA SKA13370229GA SKA13370230GA SKA13370231GA SKA13370232GA SKA13370233GA SKA13370234GA SKA13370235GA SKA13370236GA SKA13370237GA SKA13370238GA SKA13370239GA SKA13370240GA SKA13370241GA SKA13370242GA SKA13370263GA SKA13370265GA SKA13370267GA SKA13370268GA SKA13370269GA SKA13370270GA SKA13370271GA SKA13370272GA SEW13380133HA SEW13380155HA SEW13380256HA SEW13380258HA SEW13380259HA SEW13380260HA SEW13380264HA SEW13380265HA SEW13380266HA SEW13380267HA SEW13380268HA SEW13380269HA SEW13380271HA SEW13380305HA SEW13380319HA SEW13380371HA SEW13380375HA SEW13380377HA SEW13380400HA SEW13380413HA SEW13380415HA SEW13380422HA SEW13380423HA SEW13380424HA SEW13380425HA SEW13380426HA SEW13380427HA SEW13380429HA SEW13380432HA SEW13380433HA SEW13380434HA SEW13380435HA SEW13380436HA SEW13380437HA SEW13380438HA SEW13380439HA SEW13380440HA SEW13380441HA SEW13380442HA SEW13380443HA SEW13380444HA SEW13380445HA SEW13380446HA SEW13380447HA SEW13380453HA SEW13380459HA SEW13380461HA SEW13380463HA SEW13380464HA SEW13380465HA SEW13380497HA SEW13380498HA SEW13380499HA SKA13130089GA SKA13130101GA SED13017065GA SED13017067GA SED13027233GA SED13027251GA SED13027253GA SED13027259GA SED13027261GA SED13027263GA SED13027265GA SED13027266GA SED13027267GA SED13027268GA SED13027269GA SED13027270GA SED13027271GA SED13027272GA SED13027273GA SED13027274GA SED13027275GA SED13027276GA SED13027277GA SED13027278GA SED13027412GA SED13027413GA SED13027415GA SEW13379826HA SEW13379860HA SEW13379863HA SEW13380254HA SEW13380306HA SEW13380313HA SEW13380399HA SEW13380402HA SKA13370170GA SED10353754GA SED10353755GA SED10353756GA SED10353757GA SED10353758GA SED10353759GA SED10353760GA SED10353761GA SED10373970GA SED10373971GA SED10373972GA SED10373973GA SED10373974GA SED10373975GA SED10373977GA SED10373980GA SED10373981GA SED10373983GA SED10373988GA SED10374003GA SED10384049GA SED10384064GA SED10384085GA SED10384087GA SED10384092GA SED10384100GA SED10384102GA SED10384107GA SED10384109GA SED10384112GA SED10384117GA SED10384119GA SED10384120GA SED10384121GA SED10384122GA SED10384123GA SED10384124GA SED10384125GA SED10384126GA SED10384127GA SED10384128GA SED10384129GA SED10384131GA SED10384132GA SED10384143GA SED10384149GA SED10394174GA SED10404188GA SED10485073GA SED10536439GA SED10536442GA SED10536443GA SED10536444GA SED10536447GA SED10536457GA SED10536459GA SED10536473GA SED11026570GA SED11036588GA SED11036609GA SED11036610GA SED11036618GA SED11036619GA SED11036620GA SED11036622GA SED11036658GA SED11036660GA SED11036662GA SED11036668GA SED11036675GA SED11036686GA SED11057067GA SEW10334205HA SEW10334221HA SEW10334222HA SEW10334244HA SEW10334255HA SEW10385224HA SEW10385242HA SEW10385273HA SEW10385281HA SEW10466987HA SEW10466989HA SEW10466990HA SEW10466991HA SEW10466992HA SEW10466993HA SEW10466995HA SEW10466997HA SEW10466999HA SEW10467002HA SEW10467006HA SEW10467007HA SEW10467087HA SEW10467088HA SEW10467089HA SEW10467092HA SEW10467093HA SEW10467094HA SEW10467096HA SEW10467358HA SEW10467370HA SEW11141062HA SEW11151201HA SEW11151278HA SEW1117

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States