Patient monitor, multiparameter, transportable

Intended purpose

A portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre-hospital care applications. The device is indicated for: 3-, 4- and 5-lead ECG monitoring; 12 lead ECG recording with interpretation; real-time arrhythmia detection/alarming; QT measurement/alarming and ST measurements/alarming; impedance pneumography; noninvasive blood pressure (NIBP); end-tidal CO2 (ETCO2) and respiration rate; pulse oximetry (SpO2); contact temperature; and invasive pressure and extended pulse oximetry capability including; carboxy haemoglobin (SpCO), methemoglobin (SpMet), total haemoglobin (SpHb) and total oxygen content (SpOC) measurements. The monitor is intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere). The device is indicated for adults, paediatrics and neonates. The monitor can be used to display images from Interson 3.5 MHz General Purpose (GP) and 7.5 MHz Small Parts/Vascular (SR) USB ultrasound probes or a Karl Storz C-MAC S USB video laryngoscope. The device can also be used to display the following readings from a Masimo ISA OR+ gas module: end-tidal and fractionally inspired CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane, and Desflurane. These optional accessories are to be used in accordance with their indications for use.