Lowenstein Medical LUISA User Manual

US Instructions for Use for devices of type LM150TD
Device Firmware Version 1.3
LUISA
Ventilators

Lowenstein Medical LUISA Specifications

General

Brand	Lowenstein Medical
Model	LUISA
Category	Medical Equipment
Language	English

Summary

Introduction to the LUISA Ventilator

Indications for Use

Specifies patient conditions and applications for mechanical ventilation support.

Description of Function

Explains how the blower, sensors, and user interface work together.

User Qualification

Details the necessary training and familiarity for device operators.

Safety Information and Precautions

Side Effects

Lists potential short-term or long-term undesired effects of using the device.

General Safety Information

Covers essential safety rules for handling, components, accessories, and general use.

Electromagnetic Compatibility (EMC)

Details precautions for EMC to prevent device malfunction or injury.

Energy Supply

Information on powering the device using power supply units or batteries.

Handling Oxygen Safely

Guidelines for safe oxygen supply to prevent fire hazards and injury.

Device Transport Guidelines

Instructions for proper transport to maintain device performance and patient safety.

Product Description and Overview

Device Overview and Components

Illustrates and labels the main parts and connections of the LUISA device.

Control Panel and Display Functions

Describes the functions of keys, icons, and the display interface.

Display Symbols and Indicators

Explains the meaning of various symbols shown on the device display.

Accessories and Operating States

Lists optional accessories and describes device operating states (On, Standby, Off).

Batteries and Trolley System

Details internal/external battery management and the LUISA Trolley 2.0.

Data Management and Firmware Updates

Covers saving therapy data, transmitting it, and updating the device firmware.

Preparation and Operation Guide

Setting Up and Connecting the Device

Step-by-step instructions for initial setup and connecting power.

Connecting Breathing Circuits

Guidance on connecting different types of breathing circuits (leakage, single, double).

Starting and Ending Therapy

Procedures for initiating, stopping, and switching off the device.

Circuit Tests and FiO2 Cell Calibration

Procedures for performing circuit tests and calibrating the optional FiO2 cell.

Navigating Device Settings

Navigating and Menu Structures

Explains how to navigate menus and details the patient menu structure.

Patient and Expert Menus

Describes accessing and using the Patient and Expert menus for configuration.

System Settings and Ventilation Programs

Covers system configurations, device settings, and program management.

Hygiene, Servicing, and Checks

Hygiene Treatment Procedures

Instructions for cleaning and disinfecting the device and its components.

Function and Alarm Checks

Procedures for performing device function checks and verifying alarm functionality.

Servicing and Disposal

Information on device service life, battery replacement, and proper disposal.

LUISA Ventilation Modes

Basic Ventilation Modes

Details CPAP, HFT, S, and ST modes with adjustable parameters.

Pressure Support Modes

Explains PSV, aPCV, and PCV modes and their adjustable parameters.

Volume and SIMV Modes

Covers VCV, P-SIMV, and V-SIMV modes and their adjustable parameters.

Mouthpiece Modes and Circuit Overview

Describes MPVp/v modes and an overview of modes available per circuit type.

Understanding and Configuring Alarms

Alarm Display and Muting

Explains alarm priorities, display sequence, and how to mute alarms.

Physiological Alarm Configuration

Details how to activate and set physiological alarms for patient needs.

Technical Alarms

Lists and explains technical alarms related to device configuration and faults.

Troubleshooting Device Faults

Troubleshooting Device Faults

Provides solutions for common device issues like no display or pressure problems.

Nurse Call and Remote Alarm

Information on connecting the device for remote patient and device monitoring.

Technical Specifications

General Device Specifications

Covers dimensions, weight, temperature, humidity, and air pressure ranges.

Electrical and Power Specifications

Details input voltage, power output, consumption, and electrical connections.

Battery and Performance Specifications

Includes battery type, capacity, life, and performance metrics.

Annex: Diagrams, Data, and Accessories

Pneumatic Diagrams and System Resistances

Visual representations of circuit airflow and data on circuit pneumatic resistances.

EMC and Markings

Details EMC compliance, immunity tests, and device markings/symbols.

Accessories, Parts, and Warranty

Lists available accessories, removable parts, and warranty information.