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General| Brand | AutoMedx |
|---|---|
| Model | SAVe II |
| Category | Medical Equipment |
| Language | English |
Details on trademarks, company contact, and document version.
Version information for the operation manual.
Details on FDA tracking requirements for ventilators.
Alerts to potentially hazardous situations that could cause death or serious injury.
Alerts to potentially hazardous situations that could cause equipment damage.
Warnings on proper use, environment, and handling to prevent harm.
Warnings regarding monitoring, damage, and contamination.
Cautions related to device security, fire hazards, and electrical safety.
Cautions on operating in wet environments, storage, and liquids.
Cautions for service, charging, battery, and sterilization procedures.
Overview of the SAVe II ventilator, its intended use, and core function.
Guidelines on when to use the device and in what conditions.
Key features, advantages, and risks associated with the SAVe II.
Description of the SAVe II's user interface, controls, and displays.
Visual identification of front panel controls and the alarm dashboard.
List of necessary consumables and accessories with their part numbers.
Steps for unpacking, verifying contents, and initial checks.
Instructions for attaching the breathing circuit and patient airway.
Guide to selecting patient height for initial setup.
Instructions for advanced users to adjust RR, TV, PIP, and PEEP.
How to connect the oxygen reservoir for higher FiO2 concentrations.
Using manual trigger, CPR mode, and responding to patient status.
Procedures for clearing debris from the breathing circuit.
Explanation of alarm levels, causes, and general responses.
Troubleshooting for Disconnect, PIP Reached, and Battery alarms.
Troubleshooting for Device, High PEEP, and MV High alarms.
Schedule for charging, cleaning, and verifying functionality.
Guidelines for cleaning the SAVe II unit and its accessories.
Instructions for replacing single-use components.
Recommendations for storing the SAVe II and its battery.
Recommendations for annual service and more frequent maintenance.
Detailed technical specs for parameters, power, and environment.
Declarations regarding electromagnetic emissions and immunity compliance.
Details on SAVe II and battery warranty, exclusions, and sole remedy.
List of part numbers for ordering accessories and manuals.
History of software releases and descriptions of changes made.
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