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General| Device Type | Temperature Management System |
|---|---|
| Power Requirements | 100-240 VAC, 50/60 Hz |
| Patient Weight Range | No specific weight range; depends on catheter compatibility |
| Display | Color LCD Touchscreen |
| Indication | Maintain or control patient temperature |
| Cooling Capacity | Varies based on the catheter and patient needs |
| Heating Capacity | Varies based on the catheter and patient needs |
Provides essential safety information, including warnings, cautions, and notes for system operation.
Explains the meaning of symbols and labels used on the product and in the manual.
Details general safety measures and precautions for operating the system safely.
Guidelines for shipping, storage, ignition of anesthetics, and electrical safety.
Addresses probe failures, configuration changes, and safe priming of the saline circuit.
Ensuring tubing integrity, checking for air entry, and managing interference.
Introduces system operation, its states (SETUP, STANDBY, RUN), and the initial setup phase.
Details the system's self-test procedures for electronics, sensors, and cooling engine.
Explains system modes (STANDBY, RUN) and the user interface controls for operation.
Describes the operating screen and how to adjust target temperature and treatment modes.
Navigating the system menu and configuring settings like alarms and time.
Managing probe connections, handling alerts, and understanding system alarms.
Guides for setting up the system for the first patient and managing data after shutdowns.
Instructions for viewing and displaying patient temperature trend data graphs.
An overview of system alarms and the general approach to corrective actions.
Details specific alarms like air trap faults, coolant status, and their corrective actions.
Addresses alarms related to data download, log capacity, and patient temperature limits.
Covers alarms for probe disconnections, dislodgements, pump door status, and pump failure.
Provides an overview of troubleshooting procedures and important safety notes for qualified personnel.
A table listing system symptoms, probable causes, and recommended corrective actions.
Identifies critical events that require immediate discontinuation of use and service representative contact.
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