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General| Operating Principle | Turbine |
|---|---|
| Ventilation Modes | CPAP |
| Respiratory Rate Range | 5 to 60 breaths per minute |
| FiO2 Range | 21% to 100% |
| Alarms | High pressure, Low pressure, High minute volume, Low minute volume, Apnea, High respiratory rate, Low respiratory rate, High FiO2, Low FiO2, Disconnection, Power failure, Battery low |
| Power Supply | 100-240 V AC, 50/60 Hz |
| Display | Color touchscreen |
Defines WARNING statements providing important information about potentially hazardous situations.
Defines CAUTION statements providing important information about hazardous situations.
Defines NOTE statements providing additional operational information.
Describes responsibilities and requirements for the operating organization.
Specifies requirements for the user group to operate the device.
Specifies requirements for personnel involved in reprocessing.
Specifies requirements for service personnel.
Specifies requirements for specialized service personnel.
Lists common abbreviations and symbols used in the manual.
Provides broad safety guidelines and warnings for device usage.
Safety precautions and warnings specific to the Carina device.
Emphasizes the critical importance of adhering to the manual's guidelines.
Information on device upkeep, servicing, and compatible accessories.
Restrictions on device use in explosion-risk areas and with connected devices.
General patient safety measures and the importance of monitoring.
Device safety features and electromagnetic compatibility guidelines.
Guidelines for installing accessories and storing the manual.
Safety precautions for handling disposable and sterile items.
Specific warnings regarding patient injury, fire, and malfunctions.
Safety related to ventilation parameters, overheating, and toppling.
Safety for electric connections and importance of monitoring ventilation.
Steps for performing backup ventilation with an independent device.
Defines the intended purpose and scope of the Carina ventilator.
Explains the meaning and characteristics of sub-acute care.
Description of the main unit's components and features.
Information about the device trolley and bed/wall mounting options.
Overview of the device's operational capabilities and features.
Provides lists of abbreviations and symbols used in the manual.
Description of the device's control panel and display interface.
Details of the screen structure, status lines, and display elements.
Explanation of the color coding used in the device interface.
Instructions on how to open and navigate through device menus.
Procedure for selecting and setting ventilation modes.
How to adjust specific ventilation settings and parameters.
Safety precautions to be taken before assembling and preparing the device.
Steps for initial setup, including filter installation and positioning.
Instructions for attaching the device to the trolley and its accessories.
Detailed steps for connecting breathing circuits with leakage or expiratory valves.
Procedures for connecting and preparing the breathing gas humidifier.
Instructions for connecting the device to mains and battery power sources.
Steps for connecting the device to gas supplies, including oxygen.
Connecting the nurse call system and using MEDIBUS/MEDIBUS.X protocols.
Safety guidelines and procedures for transporting patients with the device.
Safety information and prerequisites before starting the device.
Steps for powering on the device and its self-test procedure.
Procedures to check if the device is ready for patient use.
Instructions for connecting a test lung for device verification.
A checklist to guide the user through device verification steps.
How to choose between Non-Invasive (NIV) and Invasive (Tube) ventilation.
Steps to set up the oxygen supply mode (HPO or LPO).
Procedure for initiating ventilation for the patient.
Safety precautions and warnings related to ventilation operations.
Instructions for configuring ventilation modes and specific parameters.
Detailed guide on using the device for non-invasive ventilation.
How to activate and use the apnea ventilation feature.
Explanation and activation of the AutoAdapt feature for pressure adjustment.
How to display and interpret device settings and measured values.
How to lock device keys to prevent accidental activation.
Information and safety guidelines for using low-pressure oxygen sources.
Steps for activating and managing the device's standby mode.
Procedures for safely ending device operation and shutting it down.
How to improve the accuracy of the internal battery charge state display.
How alarms are displayed visually and acoustically based on priority.
Procedure for adjusting alarm limits to ensure patient safety.
How to temporarily mute acoustic alarms and nurse call signals.
Summary of settings available within the configuration menu.
Steps to access the service menu for advanced settings and info.
How to set the audible volume for device alarms.
Options for selecting screen display types (Curves, Measured Values).
Choosing between NIV and Tube ventilation application modes.
Setting the oxygen supply source (HPO or LPO).
How to activate and configure the device's night mode.
Steps to resolve issues related to power supply failure.
Steps to resolve issues related to gas supply failure.
A comprehensive guide to identify alarm causes and apply remedies.
Instructions for operating the device in emergency ventilation mode.
Steps for safely dismantling the device and its accessories.
General information and safety guidelines for reprocessing the device.
Classification of devices and components based on reprocessing requirements.
Details on tested and validated procedures for component reprocessing.
Specific steps for reprocessing non-critical parts of the device.
Specific steps for reprocessing semi-critical parts of the device.
Introduction to maintenance and definitions of key concepts.
Procedures for regular inspections and safety verification.
Information on scheduled preventive maintenance tasks and intervals.
Guidelines and recommendations for device repair.
Step-by-step instructions for replacing the device's inlet filter.
Instructions on how to charge the device's internal battery.
Safety precautions required before disposing of the device and its components.
Guidelines for the proper disposal of packaging waste.
Instructions and regulations for the disposal of device batteries.
Procedures for the final disposal of the medical device.
Specifies temperature, pressure, and humidity ranges for operation and storage.
Lists all configurable parameters and their ranges.
Data on device performance, resistance, and flow rates.
Details on the values displayed on the device screen and their accuracy.
Information on parameters monitored by the device and alarm limits.
Electrical, physical, and software specifications of the device.
Default ventilation settings for different modes.
Dimensions, weight, and load capacity of the device trolley.
Description of the alarm system's functionality and compliance.
Information on electromagnetic compatibility, emissions, and immunity.
Guidelines and prerequisites for connecting the device to IT networks.
Explanation of the device's pneumatic system and functional units.
Factors affecting volume measurement accuracy and manual correction.
Detailed explanations of the different ventilation modes (VC-SIMV, NIV, etc.).
Advanced settings like Apnea ventilation, Trigger, and AutoAdapt.
Overview of Non-Invasive and Invasive ventilation therapy types.
Description of extra features like Flow Reduction and SyncPlus.
How the device measures and displays tidal and minute volumes.
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