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FDA requirement for tracking defibrillator location and usage.
Customer responsibility for ensuring access to safety information.
Lists operating instructions and software versions for the device.
Defines terms used in the operating instructions.
Lists general safety warnings and cautions for device operation.
Explains symbols found on the device and in the manual.
Details ECG monitoring procedures, warnings, and troubleshooting.
Explains the process and considerations for acquiring a 12-lead ECG.
Covers SpO2 monitoring, indications, and procedures.
Describes NIBP monitoring, warnings, and procedures.
Explains EtCO2 monitoring, indications, and troubleshooting.
Details IP monitoring, indications, and procedures.
Discusses vital sign and ST segment monitoring.
Provides essential safety warnings before initiating therapy.
Guides on proper placement of electrodes and paddles for therapy.
Covers AED mode configuration, procedure, and troubleshooting.
Details manual defibrillation, warnings, and procedures.
Explains the steps for performing synchronized cardioversion.
Addresses common issues and solutions for defibrillation.
Outlines noninvasive pacing, warnings, and procedures.
Information about therapy electrodes, placement, and connection.
Specific details regarding pediatric paddles.
Information on internal handles with discharge control.
Introduces data storage and retrieval functions.
Provides an overview of the power adapter.
Details how to use the AC power adapter.
Covers maintenance procedures for the power adapter.
Information regarding the warranty for the device.
Lists available replacement parts and accessories.
Covers general maintenance and testing procedures for the equipment.
Details user-initiated tests for the device.
Provides instructions for cleaning the equipment.
Covers battery maintenance, charging, and storage.
Overview of available setup options for the device.
Guides on how to access and navigate the setup menus.
Details the general setup parameters and their configurations.
Configuration options for the manual defibrillation mode.
Setup options related to the pacing functionality.
Configuration settings for various monitoring parameters.
Setup options specific to the AED mode of operation.
Options for configuring input channels for monitoring.
Settings for managing waveform display configurations.
Configuration options for CO2 monitoring.
Configuration options for Noninvasive Blood Pressure monitoring.
Setup options for acquiring and displaying 12-lead ECG data.
Configuration settings for event logging and management.
Options for configuring alarm settings and limits.
Configuration options for the device's printer.
Settings for data transmission and communication.
Options for setting and adjusting the device's clock.
Options for resetting device settings to factory defaults.
General| Display | Color LCD |
|---|---|
| Defibrillator Waveform | biphasic |
| SpO2 Range | 0-100% |
| Pulse Oximetry | Yes |
| Operating Temperature | 0°C to 50°C (32°F to 122°F) |
| Storage Temperature | -20°C to 60°C (-4°F to 140°F) |
| Type | Defibrillator/Monitor |
| Power Source | AC power, rechargeable battery |
| ECG Monitoring | 3-lead ECG, 5-lead ECG, 12-lead ECG |
| Energy Selection | 1-360 Joules |
| Pacing Mode | Demand |
| Pacing Rate | 30 to 180 ppm |
| Recorder | Thermal printer |
| Capnography | Optional |
| Data Storage | Yes |
| Humidity | 15 to 95% non-condensing |
| Altitude | Up to 3, 048 meters (10, 000 feet) |
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