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ACUTRONIC fabian Therapy evolution User Manual

ACUTRONIC fabian Therapy evolution
106 pages
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fabian Therapy evolution | SW 5.1.x
Ref: 121003.EN / Date 2020-01-22
Warning
Carefully read the instructions of use
before using the ventilator to
familiarise yourself with the function of
the equipment
Ventilation Beyond Limits
fabian Therapy evolution
and Auxiliary Systems
Instructions for Use, Software Version 5.1.x

Table of Contents

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ACUTRONIC fabian Therapy evolution Specifications

General IconGeneral
BrandACUTRONIC
Modelfabian Therapy evolution
CategoryMedical Equipment
LanguageEnglish

Summary

Introduction to the fabian Therapy evolution

Working with the Instructions

Guidance on how to use the manual and familiarize with the ventilator.

Notices and Warnings

Explanation of the different categories of notices and warnings used in the document.

Applicable Product Versions

Specifies the software versions for which these instructions are applicable.

Symbols Reference

Warnings, Cautions, and Notices

Always Observe Safety Guidelines

Key safety notes and warnings that must always be followed during operation.

Maintenance and Liability

Details on maintenance, liability for damages, and intended use of the device.

System Overview and Hardware

Scope of Delivery and Contraindications

Lists included items and conditions that contraindicate device use.

Front and Rear Panel Connections

Illustrates and describes front and rear panel connections and ports.

General Hardware Characteristics

Provides information on maximum connected loads for various ports and warnings.

System Functions and Displays

Control Panel Overview

Describes the touchscreen, function buttons, and rotary push knob of the control panel.

Display Elements

Details display areas, screen layout, information bar, numeric fields, graphics, and LEDs.

Ventilation Menu Navigation

Explains general operation, settings, parameter dependencies, and parameter locking.

Graphics and Trends

Covers accessing the graphics menu and viewing trend data.

System Operation Procedures

Preparing for Operation

Covers connecting power and gas supplies as preparation steps.

System Start-up and Device Check

Guides through powering on, self-test, audio alarm test, and mandatory pre-use checks.

Standby, Shutdown, and Emergency Procedures

Explains standby, normal shutdown, and emergency shutdown procedures.

Configurations Menu

Sensor Calibration

Procedures for calibrating flow, O2, and SpO2 sensors.

Display Settings

Configures touchscreen lock, automatic lock, and graph/trend display options.

Ventilation and Patient Data Settings

Adjusts ventilation parameters, patient data, language, date/time, tools, and information.

Service Mode Access

Details password-protected service mode access for trained technicians.

Alarms Management

Alarm Limits Management

Covers accessing the alarm limits menu, automatic adjustments, and configurable alarms.

Alarm Log and Nurse Call

Explains how to view the alarm log and the nurse call relay function.

Alarm Causes and Solutions

Provides a detailed table of alarm texts, causes, solutions, and priorities.

Pressure Release & Application Errors

Describes pressure release behavior and handling of application errors.

Watchdog Alarms

Details the watchdog circuit and procedures for handling watchdog alarms.

Power and Battery Operation

Battery Operation Details

Information on the internal battery, run time, and behavior during power failure.

Operating on External Power Source

Instructions for operating the device using an external 12-24V power source.

Ventilation Modes and Parameters

Ventilation Parameters

Lists and describes various ventilation parameters and their settings in different modes.

Ventilation Modes Overview

Overview of the intended ventilation modes: nCPAP, DUOPAP, and O2 Therapy.

Special Functions

Covers manual inspiration and O2 flush/preoxygenation features.

Accessories and Options

Accessories List

Lists approved accessories with images and warnings about non-approved items.

SpO2 Module Setup

Covers SpO2 module setup, Masimo sensor, sensitivity, Fast SAT, alarm delay, and averaging time.

PRICO Feature

Details PRICO information, setup, modes, disabling alarms, and error handling.

External Communication (PDMS)

Information on connecting the device to Patient Data Management Systems (PDMS).

Maintenance and Technical Specifications

Replacing the Oxygen Sensor

Step-by-step guide for replacing the oxygen sensor, including calibration and disposal.

Service and Maintenance Intervals

Details the recommended service and maintenance schedules for the ventilator.

Sterilization, Cleaning, and Disinfection

Procedures for preparing the device and accessories for disinfection and sterilization.

Parameter Ranges and Technical Specs

Shows parameter ranges and technical specifications for device operation.

Essential Performance

Details essential performance functions and compliance clauses as per ISO 80601-2-12.

Electromagnetic Compatibility Statement

EMC for SN AT-04000

EMC emissions and environment guidelines for devices with SN from AT-04000.

EMC for SN till AT-04000

EMC emissions and immunity guidelines for devices with SN till AT-04000.

Appendices

Appendix A: Glossary

Definitions of terms used throughout the manual.

Appendix B: Index

Alphabetical index of topics covered in the manual.

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