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The TeslaGuard® Patient Monitor is capable of monitoring: - SpO2 (Arterial Oxygen Saturation) - ECG (3-Lead) - IBP (Invasive Blood Pressure) - NIBP (Non-invasive Blood Pressure) - CO2 and Anesthetic Agents (with optional multi-gas module) This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. With the optional multi-gas module installed, sampled breathing gases from adults and pediatrics can be displayed. The multi-gas module continuously measures the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture, and communicates real time and derived gas information to the TeslaGuard Patient Monitor. The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, no physicians or technicians, trained on the use of the device, who will determine when to rely on the information provided by the device based upon their professional assessment of the patient's medical condition. The device is intended for use in the Adult, Pediatric and Neonatal populations.

The TeslaGuard design allows monitoring of intensive care patients while in an MRI-scanner. During use, the unit must be positioned in a way that the maximum field strength is not higher than 20 mT, and the distance to the magnet core is at least 1.5m. This 510(k) has been filed to establish substantial equivalence for an optional multi-gas module. With the multi-gas module installed, sampled breathing gases from adults and pediatrics can be displayed. The multi-gas module continuously measures the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture, and communicates real time and derived gas information to the TeslaGuard Patient Monitor.

The Testa"Be® monitor is an automatic oscillometric measuring system designed to take non-invasive blood pressure measurements. It measures systolic pressure, diastolic pressure, mean arterial pressure and heart rate. The Testa "BP® monitor is intended to be used on neonate, pediatric and adult populations during MR-examinations at a maximum magnetic field strength of 20mT.

The Testa"(820) Blood Pressure Monitor is an automatic non-invasive blood pressure (NIBP) measurement system that is intended for use in an MR-environment at a maximum magnetic field strength of 20mT. The completed system meets the requirements of AAMI standard SP10:2003+A1:2003. The Testal Pro design makes it possible to position the system within an RF-shielded MRI-room. The Testa VBP® measures and displays: 1. Systolic Pressure 2. Diastolic Pressure 3. Heart Rate (BPM) 4. Mean Arterial Pressure (MAP) MIPM will distribute pressure cuffs for use with the Testa" that are manufactured by other medical device manufacturing companies, and which are already cleared by FDA for sale in the USA.