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Dräger Medical NeoFlow - User Manual

Dräger Medical NeoFlow
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NeoFlow
Neonatal Patient Mode
Operating Instructions NeoFlow for EvitaXL, 1. ed.
MEDICAL
D
Addendum to
Operating Instructions
Evita
XL
*
* These Operating Instructions apply also
to Evita 4 with the XL option
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Summary

Important Safety Information

Operators Responsibility for Patient Safety

Highlights the user's responsibility in ensuring patient safety through proper operation and monitoring of the ventilation system.

Limitation of Liability

Defines Draeger Medical, Inc.'s liability regarding product use, modifications, and warranty, excluding consequential damages.

Warranty Information

Details the product warranty terms, exceptions, conditions for application, and exclusions for defects and unauthorized modifications.

Definitions of Terms and Symbols

Explains warnings, cautions, notes, typing conventions, and abbreviations used throughout the operating instructions.

Summary of Warnings and Cautions

Provides a consolidated overview of critical warnings and cautions related to general precautions, preparation, and operation.

Intended Use and Restrictions

Product Intended Use

Describes the NeoFlow mode's purpose: extending EvitaXL ventilator range to infants and premature babies for neonatal applications.

Restrictions on Product Use

Outlines essential restrictions including flammability hazards, electrical connections, and distribution limitations for the device.

Preparation and Setup Procedures

Initial Setup and Configuration

Covers initial installation of the NeoFlow option by authorized personnel and configuration guidance.

Preparing the Device for Use

Details the steps for installing the neonatal flow sensor and connecting the patient circuit for the first time.

Pre-Use Device Check

Describes the pre-use check procedure for the NeoFlow option, including calibration of the neonatal flow sensor.

Neonatal Flow Sensor Calibration

Explains the procedure for calibrating the neonatal flow sensor, including frequency and steps for starting calibration.

Replacing the Neonatal Flow Sensor

Provides instructions on how to replace the neonatal flow sensor if it becomes defective or displays measurement errors.

Ventilator Operation Modes

Selecting Neonatal Mode

Guides users on how to select the neonatal patient mode on the EvitaXL ventilator interface.

Volume Controlled Ventilation in Neonatal Mode

Details the AutoFlow® supplement for volume controlled ventilation, automatic flow regulation, and pressure limits.

Back-up Ventilation in Neonatal Mode

Explains the automatic switch to pressure-controlled back-up ventilation when flow monitoring fails during volume-controlled mode.

Pressure Support Ventilation (PSV)

Describes how PSV can assist spontaneous breathing in neonatal mode, requiring active flow monitoring.

Apnea Ventilation in Neonatal Mode

Covers pressure-controlled apnea ventilation triggered after a set alarm time, with adjustable frequency and pressure settings.

Non-Invasive Ventilation (NIV) Mask Ventilation

Details NIV parameters and leakage compensation for mask ventilation in pediatric and neonatal modes.

Flow Monitoring During Neonatal Ventilation

Explains how to deactivate and reactivate neonatal flow monitoring and the implications for ventilation modes.

Flow Monitoring During Pediatric Ventilation

Describes how the neonatal flow sensor functions for pediatric flow monitoring and alternative sensor use if defective.

Nebulizing Pharmaceutical Aerosols

Provides instructions and warnings for nebulizing aerosols in neonatal mode during pressure-controlled ventilation.

Removing the Neonatal Flow Sensor

Details the procedure for safely removing the neonatal flow sensor, especially before nebulizing, due to hot sensor wires.

Using the Nebulizer with Incubator

Instructions for positioning the nebulizer's outlet adapter when using with an incubator.

Using the Nebulizer Without Incubator

Instructions for attaching the nebulizer sleeve to the support arm bracket when not using an incubator.

Starting Nebulization Procedure

Steps to start the nebulizer function, including deactivating flow monitoring and accessing the special procedure menu.

Ending Nebulization Procedure

Describes how to stop nebulization, including removing residual medication and reinstalling the flow sensor.

Oxygen Concentration During Nebulization

Explains how O2 concentration is managed during nebulizer operation and the effect of base flow adjustments.

Oxygenation for Bronchial Suction

Details the FiO2 adjustments for pre- and post-oxygenation during bronchial suction in neonatal mode.

Ventilation Configuration Settings

Setting the Patient Range

Guides users on selecting the appropriate patient range (Adults, Pediatrics, Neonates) for ventilation configuration.

Defining Start-up Defaults for Parameters and Alarms

Explains how to set initial ventilation parameters and alarm limits based on ideal weight or patient mode.

Configuring Tube Compensation (ATC) Start-up Defaults

Details how to define start-up defaults for the Airway Tube Compensation (ATC) feature, including tube type and diameter.

Device Care and Cleaning

Dismantling the Neonatal Flow Sensor

Provides step-by-step instructions for safely disconnecting and removing the neonatal flow sensor from the device.

Disinfection, Cleaning, and Sterilization Procedures

Outlines procedures and precautions for cleaning, disinfecting, and sterilizing device components, emphasizing material compatibility.

Maintenance and Servicing

Maintenance Intervals and Service

Specifies the recommended maintenance schedule, including preventive maintenance every six months by trained personnel.

Troubleshooting Alarms and Faults

Technical Specifications

Neonatal Ventilation Settings

Lists the technical data for neonatal settings including tidal volume, frequency, inspiratory time, and tube compensation parameters.

Performance Data and Measurements

Details performance data such as base flow, inspiratory/expiratory flow ranges, and measured values for minute volume and leakage.

Monitoring and Materials Used

Covers monitoring parameters like expiratory minute volume alarms and lists the materials used for key sensor components.

Theory of Operation: Neonatal Ventilation Features

Measuring Leakage Flow

Explains the concept of leakage flow in neonatal ventilation and how EvitaXL measures and accounts for it in its calculations.

Airway Pressure Measurement

Describes how EvitaXL measures airway pressure indirectly using internal sensors and accounts for patient circuit resistance.

Trigger Response Mechanism

Details how EvitaXL detects patient's spontaneous breathing using the neonatal flow sensor and triggers synchronized breaths.

AutoFlow Functionality

Explains AutoFlow® as a mode extension optimizing flow control, automatically adjusting inspiratory flow based on patient demands.

Glossary of Terms

Abbreviations Used

Provides a comprehensive list of abbreviations and their corresponding explanations used in the operating instructions.

Ordering Information and Parts

Dräger Medical NeoFlow Specifications

General IconGeneral
ManufacturerDräger Medical
ModelNeoFlow
ApplicationNeonatal resuscitation and stabilization
Oxygen concentration21-100%
Flow Range0.5-20 L/min
Gas CompatibilityOxygen, air
Operating Temperature10°C to 40°C
Storage Temperature-20°C to 60°C
Humidity Range15 to 95 % RH, non-condensing
SterilizationAutoclavable components available (check specific parts)

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