Drager 9037547_XL_US_NeoFlow_Operating Instructions NeoFlow Neonatal Patient Mode Addendum to Operating Instructions EvitaXL

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MEDICAL

NeoFlow

™

Neonatal Patient Mode

Addendum to Operating Instructions Evita

Operating Instructions NeoFlow for EvitaXL, 1. ed.

* These Operating Instructions apply also

to Evita 4 with the XL option

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This document contains information in which Draeger Medical, Inc. claimed

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proprietary rights. The information may not be reproduced in whole or in part except as authorized in writing by Dräger. This information is the property of Draeger Medical, Inc., it is provided solely for the use intended.

RRRReeeeppppaaaaiiiirrrrssss////MMMMooooddddiiiiffffiiiiccccaaaattttiiiioooonnnnss Repairs on this device shall be performed only by DraegerService or factory authorized technical service personnel. Information about repairs can be obtained from Dräger or Authorized Dealers. Draeger Medical, Inc. will not be responsible for injury to persons or damage to property arising directly or indirectly out of unauthorized repairs or modiﬁcations to this device. Furthermore, any unauthorized repairs or modiﬁcations void any warranty extended by Dräger.

This document is provided for your information only. It will not be exchanged or updated without request.

The Dräger name and logo are registered trademarks of Dräger.

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. AutoFlow® is a registered trademark of Dräger.

NeoFlow™ is a trademark of Dräger.

Operating Instructions NeoFlow for EvitaXL, 1. ed.

Contents

Important Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . .4

Operator's Responsibility for Patient Safety . . . . . . . . . . . . . . 4

Limitation of Liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Summary of WARNINGS and CAUTIONS . . . . . . . . . . . . . . . 7

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Restrictions of Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

Before Using for the First Time . . . . . . . . . . . . . . . . . . . . . . . . 11

Preparing for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Device Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Calibrating the Neonatal Flow Sensor . . . . . . . . . . . . . . . . . . 14

Replacing the Neonatal Flow Sensor . . . . . . . . . . . . . . . . . . 15

Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

Selecting Neonatal Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Volume Controlled Ventilation in Neonatal Mode . . . . . . . . 17

Back-up Ventilation in Neonatal Mode . . . . . . . . . . . . . . . . . . 18

Pressure Support Ventilation (PSV) . . . . . . . . . . . . . . . . . . . . 18

Apnea Ventilation in Neonatal Mode . . . . . . . . . . . . . . . . . . . 19

NIV (Mask Ventilation) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Dismantling the Neonatal Flow Sensor . . . . . . . . . . . . . . . . . 32

Disinfecting/Cleaning/Sterilizing . . . . . . . . . . . . . . . . . . . . . . 32

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Maintenance Intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Neonatal Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Performance Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Display of Measured Values . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Materials Used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Theory of Operation

– Special Features of Neonatal Ventilation . . . . . . . . . . . . 39

Measuring Leakage Flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Airway Pressure Measurement . . . . . . . . . . . . . . . . . . . . . . . . 41

Trigger Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

AutoFlow

Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Operating Instructions EvitaXL, 1. US ed.

Flow Monitoring During Neonatal Ventilation . . . . . . . . . . . . 21

Flow Monitoring During Pediatric Ventilation . . . . . . . . . . . . 22

Nebulizing Pharmaceutical Aerosols . . . . . . . . . . . . . . . . . . . 23

Concentration When Using Nebulizer . . . . . . . . . . . . . . 27

Oxygenation for Bronchial Suction . . . . . . . . . . . . . . . . . . . . 27

Configuration of Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Setting the Patient Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Start-up Defaults for Ventilation Parameters and

Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Defining Start-up Defaults for Tube Compensation (ATC) . 31

Ordering Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Important Safety Information

Operator's Responsibility for Patient Safety Limitation of Liability

Important Safety Information

Operator's Responsibility for Patient Safety

WARNING !

Strictly follow this Operator's Instruction Manual Any use of the product requires full understanding and

strict observation of all portions of these instructions. The equipment is only to be used for the purpose speciﬁed under "Intended Use" on page 10. Observe all WARNINGS and CAUTIONS as rendered throughout this manual and on labels on the equipment.

The design of the equipment, the accompanying literature, and the labeling on the equipment take into consideration that the purchase and use of the equipment are restricted to trained professionals, and that certain inherent characteristics of the equipment are known to the trained operator. Instructions, warnings, and caution statements are limited, therefore, largely to the speciﬁcs of the Draeger design.

This publication excludes references to various hazards which are obvious to a medical professional and operator of this equipment, to the consequences of product misuse, and to potentially adverse effects in patients with abnormal conditions. Product modiﬁcation or misuse can be dangerous. Draeger Medical, Inc. disclaims all liability for the consequences of product alterations or modiﬁcations, as well as for the consequences which might result from the combination of this product with other products whether supplied by Draeger or by other manufacturers if such a combination is not endorsed by Draeger Medical, Inc.

Limitation of Liability

Draeger Medical, Inc.'s liability, whether arising out of or related to manufacture and sale of the goods, their installation, demonstration, sales representation, use, performance, or otherwise, including any liability based upon Draeger Medical, Inc.'s Product Warranty, is subject to and limited to the exclusive terms and conditions as set forth, whether based upon breach of warranty or any other cause of action whatsoever, regardless of any fault attributable to Draeger Medical, Inc. and regardless of the form of action (including, without limitation, breach of warranty, negligence, strict liability, or otherwise).

THE STATED EXPRESSED WARRANTlES ARE IN LlEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTlES OF MERCHANTABILITY, FITNESS FOR ANY PARTICULAR PURPOSE, OR NONINFRINGEMENT.

Draeger Medical, Inc. shall not be liable for, nor shall buyer be entitled to recover any special incidental, or consequential

damages or for any liability incurred by buyer to any third party in any way arising out of or relating to the goods.

Patient monitoring

The operators of the ventilator system must recognize their responsibility for choosing appropriate safety monitoring that supplies adequate information on equipment performance and patient condition. Patient safety may be achieved through a wide variety of different means ranging from electronic surveillance of equipment performance and patient condition to simple, direct observation of clinical signs.

The responsibility for the selection of the best level of patient monitoring lies solely with the equipment operator.

Operating Instructions NeoFlow for EvitaXL, 1. ed.

Warranty

Important Safety Information

Warranty

All Draeger products are guaranteed to be free of defects for a period of one year from date of delivery.

The following are exceptions to this warranty:

1. The defect shall be a result of workmanship or material. Defects caused by misuse, mishandling, tampering, or by modiﬁcations not authorized by Draeger Medical, Inc. or its representatives are not covered.

2. Rubber and plastic components and materials are warranted to be free of defects at time of delivery.

Any product which proves to be defective in workmanship or material will be replaced, credited, or repaired with Draeger Medical, Inc. holding the option. Draeger Medical, Inc. is not responsible for deterioration, wear, or abuse. In any case, Draeger Medical, Inc. will not be liable beyond the original selling price.

Application of this warranty is subject to the following conditions:

1. Draeger Medical, Inc. or its authorized representative must be promptly notiﬁed, in writing, upon detection of the defective material or equipment.

2. Defective material or equipment must be returned, shipping prepaid, to Draeger or its authorized representative.

3. Examination by Draeger or its authorized representative must conﬁrm that the defect is covered by the terms of this warranty.

4. Notiﬁcation in writing, of defective material or equipment must be received by Draeger or its authorized representative no later than two (2) weeks following expiration of this warranty.

The above is the sole warranty provided by Draeger Medical, Inc. No other warranty expressed or implied is intended. Representatives of Draeger are not authorized to modify the terms of this warranty.

Draeger Medical, Inc., Telford, PA

Operating Instructions NeoFlow for EvitaXL, 1. ed.

Important Safety Information

Definitions

Deﬁnitions

WARNING !

A WARNING statement refers to conditions with a possibility of personal injury if disregarded.

CAUTION !

A CAUTION statement designates the possibility of damage to equipment if disregarded.

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A NOTE provides additional information intended to

avoid inconveniences during operation.

Inspection examination of actual condition Service measures to maintain speciﬁed condition Repair measures to restore speciﬁed condition Maintenance inspection, service, and repair, where

necessary Preventive Maintenance maintenance measures at regular intervals

Typing conventions in this manual

Controls are designated as » Control Name « , e.g:

»PEEP«

Screen pages are indicated as »Screen page«, e.g. »Measured values«

Screen messages are printed in bold, e.g:

Flow Calibration

Screen messages rendered throughout the text are shown including the exclamation marks indicating their alarm level, e.g.

Standby activated !!!

Operating Instructions NeoFlow for EvitaXL, 1. ed.

Abbreviations and Symbols

Please refer to "Glossary" on page 45 for explanations.

Summary of WARNINGS and CAUTIONS

General Precautions

Important Safety Information

Summary of WARNINGS and CAUTIONS

WARNING !

Strictly follow this Operator's Instruction Manual Any use of the product requires full understanding and

WARNING !

DANGER, risk of explosion if used in the presence of ﬂammable gases or anesthetics.

This device is neither approved nor certiﬁed for use in areas where combustible or explosive gas mixtures are likely.

WARNING !

Never use ﬂammable medications (e.g. on the basis of ethanol) or other substances based on ﬂammable solvents in the patient circuit. Fire hazard!

Always provide adequate ventilation when using ﬂammable substances for disinfection.

CAUTION !

Accessories

Use only accessories listed in the Ordering Information (page 46).

Precautions during preparation

WARNING !

Installation of the NeoFlow option into Evita may only be performed by factory trained and authorized service personnel. Follow installation instructions in the respective documentation.

ventilators

WARNING !

The operator of the ventilator must still assume full responsibility for proper ventilation while ﬂow monitoring is not available during calibration.

Operating Instructions NeoFlow for EvitaXL, 1. ed.

WARNING !

Electrical connections to equipment or components not listed in these Operating Instructions should only be made after consultation with the respective manufacturers or a qualiﬁed expert.

CAUTION !

Restriction of Distribution

Federal Law and Regulations in the United States and Canada restrict this device to sale by or on the order of a physician.

Device for use in health care facilities only and exclusively by persons with speciﬁc training and experience in its use.

Precautions during operation

WARNING!

The alarm limit »P warning is triggered if airway pressure increases with reduced compliance or in the event of sudden changes in the size of the leak.

« must always be set so that a

WARNING!

Minute volume during neonatal ventilation cannot be monitored without the neonatal ﬂow sensor!

The operator of the ventilator must still assume full responsibility for proper ventilation while ﬂow monitoring is not available during neonatal ventilation.

Important Safety Information

Summary of WARNINGS and CAUTIONS

WARNING!

Effect of aerosols on sensors, ﬁlters,

and heat and moisture exchangers!

The measuring function of the ﬂow sensor may be impaired.

The ﬂow resistance of ﬁlters is liable to increase and may impair ventilation.

Do not put a bacteria ﬁlter on the nebulizer outlet when in use!

CAUTION !

Do not ventilate larger pediatric patients with serious infections and a severe cough using the neonatal ﬂow sensor. Instead, use the expiratory ﬂow sensor for ventilation. Otherwise, coughed up secretions may cause corrosion in the neonatal ﬂow sensor.

WARNING!

Do not use a heat/moisture exchanger simultaneously with a nebulizer or heated humidiﬁer!

Risk of increased breathing resistance due to condensation.

WARNING!

The nebulizer function integrated in Evita for nebulizers with a nebulizing ﬂow of 6 L/min at 29 psi (2 bar), for example nebulizer 84 12 935 (white central body). Other nebulizers may cause deviations in tidal volume and inspiratory O

concentration!

is designed

WARNING!

The wires of the ﬂow sensor are hot. If the neonatal ﬂow sensor is left in the patient circuit for some time during nebulizing without being cleaned, deposits from the medicated aerosols may build up and impair ﬂow measurement.

In the worst case, these deposits could catch ﬁre. Disconnecting the ﬂow sensor cable is not sufﬁcient to

prevent this. It is therefore important to remove the complete ﬂow

sensor before nebulizing medications.

WARNING!

Precautions during care procedures

WARNING !

Always follow accepted hospital procedures for handling equipment contaminated with body ﬂuids.

WARNING !

Vent ﬂow sensor after disinfection with ethanol for at least 30 minutes or rinse with sterile water. Otherwise, residual ethanol vapors might ignite and destroy the sensor during calibration.

CAUTION !

Certain components of the ventilator consist of materials that are sensitive to certain organic solvents sometimes used for cleaning and disinfecting (e.g., alkylamines, phenols, halogen releasing compounds, oxygen releasing compounds, strong organic acids, etc.). Exposure to such substances may cause damage that is not always immediately recognized. Sterilization with ethylene oxide (EtO) is also not recommended.

Operating Instructions NeoFlow for EvitaXL, 1. ed.

CAUTION !

Do not allow any liquid into the connector of the ﬂow sensor cable.

While ﬂow monitoring is not available during nebulizing, the operator of the ventilator must still assume full responsibility for proper ventilation.

CAUTION !

Flow sensor is not compatible with parts washer equipment and may not be autoclaved or steam-sterilized. It cannot withstand high temperatures and would be destroyed.

Do not use compressed air, brushes or similar tools to clean ﬂow sensor element as this would possibly damage the thin wires in the ﬂow sensor.

Precautions during maintenance

WARNING !

To avoid any risk of infection, clean and disinfect ventilator and accessories before any maintenance according to established hospital procedures - this applies also when returning ventilators or parts for repair.

WARNING !

Important Safety Information

Summary of WARNINGS and CAUTIONS

Preventive Maintenance work on the Evita and their components may be performed by factory trained and authorized personnel only.

ventilators

WARNING !

Never operate the ventilator if it has suffered physical damage or does not seem to operate properly. We recommend that you contact DraegerService for maintenance service for the Evita

ventilator.

WARNING !

When servicing the ventilator, always use replacement parts that are qualiﬁed to Draeger standards. Draeger cannot warrant or endorse the safe performance of third party replacement parts for use with Evita ventilators.

CAUTION !

Maintenance

This device must be inspected and serviced at regular intervals. A record must be kept on this preventive maintenance. We recommend obtaining a service contract with DraegerService through your vendor.

For repairs we recommend that you contact DraegerService.

Operating Instructions NeoFlow for EvitaXL, 1. ed.

Intended Use

Restrictions of Use

Intended Use

NeoFlow – neonatal mode with base ﬂow.

Extends the patient range of the Evita ventilator to infants and premature babies with a minimum body weight of 1.1 lbs (0.5 kg).

Extends the range of ﬂow monitoring with Evita pediatric and neonatal ventilation employing a proximal ﬂow sensor speciﬁcally designed for neonatal applications.

Restrictions of Use

intensive care

during

WARNING !

DANGER, risk of explosion if used in the presence of ﬂammable gases or anesthetics.

This device is neither approved nor certiﬁed for use in areas where combustible or explosive gas mixtures are likely.

WARNING !

Never use ﬂammable medications (e.g. on the basis of ethanol) or other substances based on ﬂammable solvents in the patient circuit. Fire hazard!

Always provide adequate ventilation when using ﬂammable substances for disinfection.

WARNING !

Electrical connections to equipment or components not listed in these Operating Instructions should only be made after consultation with the respective manufacturers or a qualiﬁed expert.

Operating Instructions NeoFlow for EvitaXL, 1. ed.

CAUTION !

Restriction of Distribution

Federal Law and Regulations in the United States and Canada restrict this device to sale by or on the order of a physician.

Device for use in health care facilities only and exclusively by persons with speciﬁc training and experience in its use.

Preparation

Before Using for the First Time

Installing the NeoFlow option

WARNING !

Preparation

Before Using for the First Time

Installation of the NeoFlow option into Evita may only be performed by factory trained and authorized service personnel. Follow installation instructions in the respective documentation.

Conﬁguring NeoFlow

Please refer to page 28 for instructions on conﬁguring NeoFlow.

ventilators

Operating Instructions NeoFlow for EvitaXL, 1. ed.

Preparation

Preparing for Use

Installing the neonatal ﬂow sensor

Prepare patient circuit – see chapter "Ventilating Infants" in the EvitaXL Operating Instructions.

● Only the neonatal ﬂow sensor (84 11 130) may be used.

WARNING !

Do not use the Y-piece with integral ﬂow sensor (part no. 84 10 185). This ﬂow sensor features a different ﬂow characteristic curve and would give inaccurate ﬂow measurements.

1 Plug the Y-piece to ventilator circuit. 2 Insert neonatal flow sensor into the Y-piece. 3 Plug the flow sensor cable into the socket.

● Route sensor cable to the ventilator along the patient

circuit.

00137566

4 Plug the flow sensor connector into the socket on the back

panel of the ventilator and tighten thumbscrews.

● Connect test lung complete with tracheal tube CH 12 and

ET-tube connector to the patient end of the neonatal ﬂow sensor.

00237566

Operating Instructions NeoFlow for EvitaXL, 1. ed.

00337566

Device Check

The NeoFlow option expands the EvitaXL pre-use check procedure by the following function:

— Calibration neo. ﬂow sensor

Preparation

Device Check

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Operating Instructions NeoFlow for EvitaXL, 1. ed.

Preparation

Calibrating the Neonatal Flow Sensor

— Before use, as part of the ventilator

check.

— After replacing the neonatal flow

sensor.

— At least once every 24 hours.

NOTE: The last calibration value

obtained is saved until the next calibration, even when the ventilator is switched off.

Before each calibration, the neonatal ﬂow sensor is automatically cleaned.

NOTE: Recalibration is not necessary if

the plug of the neonatal flow sensor has been temporarily unplugged.

Starting calibration for EvitaXL

● Press » Sensor Parameter« key.

The »Sensor Parameter«, menu is displayed. Select »NeoFlow« menu, ﬂow monitoring is activated.

Start calibration:

● Touch »Start« screen key.

The screen key turns green, the ventilator now calibrates the ﬂow sensor.

The »Start« screen key turns pale-green when calibration is complete.

Operating Instructions NeoFlow for EvitaXL, 1. ed.

13837683

Calibration procedure

● Remove ET-tube connector,

● Remove neonatal ﬂow sensor from Y-piece,

● Insert patient ET-tube connector directly into the Y-piece for

the duration of the calibration.

WARNING !

The operator of the ventilator must still assume full responsibility for proper ventilation while ﬂow monitoring is not available during calibration.

● Wearing a sterile glove, hold neonatal ﬂow sensor so that

both sides are sealed and ﬂow is zero, as required for calibration.

Preparation

Replacing the Neonatal Flow Sensor

● Start calibration = press dial knob.

Calibration is completed after approx. 1 second.

If the message Calibration ok is displayed:

● Remove ET-tube connector from Y-piece. Re-install

neonatal ﬂow sensor into the Y-piece. Reconnect tube connector.

If calibration is unsuccessful:

● Repeat calibration. If necessary, replace neonatal ﬂow

sensor. Check sensor cable.

Replacing the Neonatal Flow Sensor

If the following error message is displayed:

Neo ﬂow measurement inop.

1 Disconnect flow sensor cable from the neonatal flow

sensor.

2 Press buttons on both sides while pulling the flow sensor

element out of its housing. Insert new sensor until it engages.

3 The two oval markings on flow sensor element and sensor

housing must line up.

1 Reconnect flow sensor cable.

● Calibrate neonatal ﬂow sensor, see page 14.

0083756600937566

Operating Instructions NeoFlow for EvitaXL, 1. ed.

Operation

Selecting Neonatal Mode

Operation

Selecting Neonatal Mode

The required patient mode can be selected from the EvitaXL menu immediately after switching on or while in standby mode:

m Adult« = Adult

» Ped.« = Pediatric » Neo.« = Neonatal

The menu ranges can be conﬁgured, see "Conﬁguring Ventilation, Setting the patient range", on page 28.

● Touch » Neo.« screen key.

Display (example for neonatal mode): In the top line of the screen, after the

ventilation mode identiﬁer,

Neo. = Neonatal mode is displayed.

10437682

Operating Instructions NeoFlow for EvitaXL, 1. ed.

Volume Controlled Ventilation in Neonatal Mode

The AutoFlow® ventilation mode supplement is always active when using volume controlled ventilation (CMV, SIMV, MMV) in neonatal mode.

AutoFlow

"Insp. Flow" and "Pinsp". Evita

and regulate inspiratory ﬂow and providing a constant pressure throughout the inspiratory phase. The ventilator determines the lowest possible peak pressure for providing the selected VT at a given patient compliance, thereby avoiding pressure peaks.

Evita ﬂow if the patient breathes in. This ﬂow is limited by the alarm limit VTi >.

The patient can also breathe out during the inspiratory plateau phase.

Inspiratory pressure is limited by the alarm limit P

– for automatic regulation of

XL uses AutoFlow

XL delivers an additional inspiratory

AW >.

to decelerate

Operation

Volume Controlled Ventilation in Neonatal Mode

19337683

WARNING!

The alarm limit »PAW >« must always be set so that a warning is triggered if airway pressure increases with reduced compliance or in the event of sudden changes in the size of the leak.

Operating Instructions NeoFlow for EvitaXL, 1. ed.

* Refer to page 43 for a detailed

description of AutoFlow.

Operation

Back-up Ventilation in Neonatal Mode Pressure Support Ventilation (PSV)

Back-up Ventilation in Neonatal Mode

during volume-controlled neonatal ventilation

Volume-controlled ventilation during neonatal ventilation is only possible with intact ﬂow monitoring. If neonatal ﬂow monitoring fails or has been switched off during volumecontrolled ventilation, Evita pressure-controlled back-up ventilation.

NOTE: Apnea monitoring continues during back-up ventilation

and apnea ventilation is started if necessary. During back-up ventilation, inspiratory pressure will correspond to the mean value of the last mandatory inspiratory pressures applied while ﬂow monitoring was still active during volume-controlled neonatal ventilation. The ''T and ''PEEP'' ventilation parameters retain the same settings as before back-up ventilation.

XL automatically switches over to

insp'', '' f '', ''O2''

Pressure Support Ventilation (PSV)

As in adult and pediatric modes, spontaneous breathing in neonatal mode can be assisted with Pressure Support during PCV+, SIMV, CPAP, and MMV ventilation. Pressure Support Ventilation may be used for patients with adequate spontaneous breathing.

NOTE: Pressure supported spontaneous breathing during

neonatal ventilation is only possible if flow monitoring is

active!

● Set the ventilation pattern for PSV ventilation with the

parameters:

— Support pressure »P

— Pressure rise time »Slope«

— Maximum inspiratory time »T

A pressure supported breath during neonatal ventilation is ended at the latest after the set maximum inspiratory time T

Supp.«

insp«

insp.

Operating Instructions NeoFlow for EvitaXL, 1. ed.

Apnea Ventilation in Neonatal Mode

Unlike in adult or pediatric ventilation, pressure controlled apnea ventilation is started after the set alarm time (TApnea >) if an apnea occurs in ventilation modes with activated apnea ventilation. Apnea ventilation is controlled by adjusting the following settings:

Frequency »f« Pinsp »P

During apnea ventilation, the ratio of inspiration to expiration is 1:2.

Ventilation parameters "O2" and "PEEP" remain at their respective settings in use at the time apnea ventilation is started.

Apnea«

Operation

Apnea Ventilation in Neonatal Mode

Setting apnea ventilation parameters:

● Touch »Add. settings« screen key in

the desired ventilation mode. EvitaXL displays the possible additional settings.

● Touch »Apnoea ventilation...«

screen key. EvitaXL displays the menu for setting apnea ventilation parameters.

● Touch »PApnea« and »f« screen

knobs. Turn dial knob to set value, press dial knob to conﬁrm.

To switch on/off

● Touch »On« or »Off« screen key,

press dial knob to conﬁrm.

19237683

Operating Instructions NeoFlow for EvitaXL, 1. ed.

Operation

NIV (Mask Ventilation)

NIV (Mask Ventilation)*

See EvitaXL Operating Instructions for details on Non Invasive Ventilation (NIV).

Set ventilation parameters

● As described for »Tube« application

mode.

An additional screen knob »T

insp« is

displayed for CPAP/PSupp. In patient modes »Pediatric« or

»Neonate«, Evita

XL limits the maximum

duration of a pressure support breath to

1.5 seconds .

● The maximum duration of a pressure

support breath may be further limited

with the »Tinsp« screen knob. »T

insp« also limits the duration of

pressure supported breaths in the other ventilation modes which can be combined with PSV.

Leakage compensation in »Mask« mode

Depending on the selected patient mode, EvitaXL compensates for leaks up to the following values in order to detect a patient trigger:

Pediatric mode: 15 L/min Neonatal mode: 7 L/min

EvitaXL compensates for calculated leaks up to 200 % of the set tidal volume, but not more than max. 2 L (regardless of the patient mode).

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Operating Instructions NeoFlow for EvitaXL, 1. ed.

* Available Option

Flow Monitoring During Neonatal Ventilation

Flow monitoring with the neonatal ﬂow sensor can be deactivated, for instance if the sensor has failed, but cannot be replaced immediately.

Flow monitoring can also be deactivated to permit ventilation in the event of a major ET-tube leak.

NOTE: When flow monitoring is

deactivated, neither volume controlled nor patient-triggered ventilation is possible. Apnea monitoring, however, is maintained even without the neonatal flow sensor.

Operation

Flow Monitoring During Neonatal Ventilation

WARNING!

Minute volume during neonatal ventilation cannot be monitored without the neonatal ﬂow sensor!

The operator of the ventilator must still assume full responsibility for proper ventilation while ﬂow monitoring is not available during neonatal ventilation.

Deactivating neonatal ﬂow monitoring

● Press the » Sensor Parameter«

key. EvitaXL displays the »Sensor Parameter« menu.

● Touch screen key for the sensor to be

deactivated, in this case »NeoFlow«.

● Touch »Off« screen key,

the screen key turns yellow.

● Press dial knob to conﬁrm,

the screen key turns green.

Neonatal ﬂow monitoring is deactivated, and the corresponding measured values disappear from the screen.

The alarm function is deactivated.

Operating Instructions NeoFlow for EvitaXL, 1. ed.

After replacing the neonatal ﬂow sensor:

● Reactivate neonatal ﬂow monitoring

and calibrate the neonatal ﬂow sensor – see page 14.

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Operation

Flow Monitoring During Pediatric Ventilation

If the neonatal ﬂow sensor is present and intact during ventilation in pediatric patient mode, it will perform the function of pediatric ﬂow monitoring if neonatal ﬂow monitoring is activated.

If the neonatal ﬂow sensor is defective or if neonatal ﬂow monitoring is deactivated, ﬂow monitoring is performed by the expiratory ﬂow sensor installed in Evita in neonatal patient mode, volume-controlled ventilation remains possible.

CAUTION !

XL. In this case, unlike

Operating Instructions NeoFlow for EvitaXL, 1. ed.

Nebulizing Pharmaceutical Aerosols

In neonatal mode, it is only possible to nebulize pharmaceutical aerosols during pressure controlled ventilation.

WARNING!

Effect of aerosols on sensors, ﬁlters,

and heat and moisture exchangers!

The measuring function of the ﬂow sensor may be impaired.

The ﬂow resistance of ﬁlters is liable to increase and may impair ventilation.

Do not put a bacteria ﬁlter on the nebulizer outlet when in use!

Operation

Nebulizing Pharmaceutical Aerosols

WARNING!

Do not use a heat/moisture exchanger simultaneously with a nebulizer or heated humidiﬁer!

Risk of increased breathing resistance due to condensation.

WARNING!

The nebulizer function integrated in EvitaXL is designed for nebulizers with a nebulizing ﬂow of 6 L/min at 29 psi (2 bar), for example nebulizer 84 12 935 (white central body). Other nebulizers may cause deviations in tidal volume and inspiratory O2 concentration!

WARNING!

While ﬂow monitoring is not available during nebulizing, the operator of the ventilator must still assume full responsibility for proper ventilation.

Notes for aerosol treatment:

● Before nebulizing medications, remove the complete

ﬂow sensor from the Y-piece.

● Calibrate ﬂow sensor at least once every 24 hours,

see “Calibrating the Neonatal Flow Sensor” on page 14.

● Replace/clean ﬂow sensor if there is visible soiling

(see page 32).

Operating Instructions NeoFlow for EvitaXL, 1. ed.

Operation

Nebulizing Pharmaceutical Aerosols

Removing the neonatal ﬂow sensor

WARNING!

In the worst case, these deposits could catch ﬁre. Disconnecting the ﬂow sensor cable is not sufﬁcient to

prevent this. It is therefore important to remove the complete ﬂow

sensor before nebulizing medications.

1 Remove complete flow sensor (housing and insert) from

Y-piece.

2 Insert ET-tube connector into Y-piece.

NOTE: Minute volume is not monitored without the neonatal

flow sensor.

WARNING!

While ﬂow monitoring is not available during nebulizing, the operator of the ventilator must still assume full responsibility for proper ventilation.

Preparation

● Use only nebulizers with a nebulizing ﬂow of 6 L/min at

29 psi (2 bar), for example nebulizer 84 12 935 (white

central body), listed in the Ordering Information.

● Assemble nebulizer as detailed in its speciﬁc Instructions

for Use. 3 Insert the ET-tube connector (ISO tapered Ø15 / Ø11) into

the input.

4 Insert the adapter (ISO tapered Ø22 / Ø11) into the outlet. 5 Connect the corrugated silicone tubing (0.13 m (5 " ) long)

to the outlet adapter.

02037566

Operating Instructions NeoFlow for EvitaXL, 1. ed.

01837566

Operation

Nebulizing Pharmaceutical Aerosols

1 Remove corrugated silicone tubing of the patient circuit

from the inspiratory adapter of the Y-piece and re-connect it to the input adapter of the nebulizer.

2 Using the Y-piece inspiratory adapter, connect the free end

of the corrugated tubing to the nebulizer.

3 Attach the nebulizer supply line to the nipple on the front of

Evita

XL.

When using with an incubator

● Push the outlet adapter of the nebulizer into the upper

access grommet in the incubator hood, if available.

01937566

02137566

Operating Instructions NeoFlow for EvitaXL, 1. ed.

0223756602337566

When using without incubator

● Press the nebulizer sleeve into one side of the clip of a

patient circuit support arm bracket and the expiratory circuit into the other.

● Position the nebulizer upright and ﬁll it.

Operation

Nebulizing Pharmaceutical Aerosols

Starting nebulization

● Deactivate neonatal ﬂow monitoring,

page 21.

● Touch »Special Procedure...« screen

function key, EvitaXL opens the

»Additional Function« menu.

● Touch » Nebulizer« screen key,

the key turns yellow.

● Press dial knob to conﬁrm,

the screen key turns green.

The nebulizer is in operation.

The advisory message

Nebulizer on !

is displayed.

Ending nebulization

● Touch the » Nebulizer« screen

key.

Nebulization is stopped automatically after 30 minutes.

● Remove any residual medication from

the nebulizer.

Follow Instructions for Use of the

nebulizer.

● Re-install neonatal ﬂow sensor into

the Y-piece.

● Activate neonatal ﬂow monitoring –

see page 21.

13437683

Operating Instructions NeoFlow for EvitaXL, 1. ed.

O2 Concentration When Using Nebulizer

The nebulizer for medication aerosols operates continuously, when activated in the neonatal range.

During nebulizer treatment, the base ﬂow is increased from 6 L/min to 9 L/min.

Depending on the set O supplied with medical compressed air, oxygen, or a mixture of medical air and oxygen in order to keep deviations in O2 concentration as low as possible.

For nebulizers with a nebulizing ﬂow of 6 L/min at 29 psi (2 bar) and respiratory rates greater than 12 bpm, the graph in the side column applies. The maximum possible deviations are ±4 % Vol.

For respiratory rates less than 12 bpm, the deviations may be much greater in extreme cases.

We therefore recommend to discontinue use of the nebulizer if respiratory rates fall below 12 bpm.

2 concentration, the nebulizer is

100

Applied O2 concentration FiO2 Vol.%

90 80

70 60 50

40 30

O2 Concentration When Using Nebulizer

Oxygenation for Bronchial Suction

30 40 50 60 70 80 90 100

2 concentration FiO2 Vol.%

Set O

Operation

02637682

Oxygenation for Bronchial Suction

The timing sequence of bronchial suction in neonatal mode is the same as described for adult ventilation – see EvitaXL Operating Instructions.

However, during pre- and post-oxygenation, the FiO concentration is increased by only 25 % – relative to the set FiO2 concentration.

See table:

Set FiO

Vol.%

FiO2 for pre- and post-oxygenation

Vol.% 21 26 30 37 60 75 80 100

Current FiO

2 concentration is displayed at the bottom of the

screen during the oxygenation phases.

Operating Instructions NeoFlow for EvitaXL, 1. ed.

Conﬁguration of Ventilation

Setting the Patient Range

Conﬁguration of Ventilation

Setting the Patient Range

Select the required patient mode from the list on the conﬁguration page, see EvitaXL Operating Instructions.

The following ranges are available:

Adults only Pediatrics only Neonates only Adults or Pediatrics Pediatrics or Neonates Adults, Pediatrics, or Neonates

● Press » System Setup« function

key.

● Touch »Therapy« screen key.

● Touch »Patient Range« screen key

and enter access code 3032.

● Touch »l« screen key,

EvitaXL displays the selection list.

● Select the desired patient mode.

Turn dial knob to select, press dial knob to conﬁrm.

16137683

Operating Instructions NeoFlow for EvitaXL, 1. ed.

Start-up Defaults for Ventilation Parameters and Alarm Limits

Start-up default values, i.e. the values for tidal volume VT and ventilator rate f activated whenever EvitaXL is switched on, may be deﬁned as a function of either ideal body weight or of the patient mode.

● Press » System Setup« function

key.

● Touch »Therapy« screen key.

● Touch »Mode & Settings« screen key

and enter access code 3032.

● Touch »VT, f...« screen key.

Conﬁguration of Ventilation

Start-up Defaults for Ventilation Parameters and Alarm Limits

Change speciﬁc values as required by hospital protocol:

● Touch the corresponding screen key.

● Turn dial knob to set.

● Press dial knob to conﬁrm.

To restore factory default settings:

● Touch »Dräger Default« screen key .

● Press dial knob to conﬁrm.

16337683

Operating Instructions NeoFlow for EvitaXL, 1. ed.

Conﬁguration of Ventilation

Start-up Defaults for Ventilation Parameters and Alarm Limits

To select the initial values for VT and f as a function of the ideal weight, the Radford nomogram has been extended to an ideal weight of 0.5 kg:

Factory-set default Hospital-set default

Weight

0.5 3 35 ................ ................

15 110 26 ................ ................

65 450 13 ................ ................

100 700 10 ................ ................

Tidal volume VT

Ventilator rate f

bpm

Tidal volume VT

Ventilator rate f

bpm

Table for selecting default values V patient mode:

Patient mode Tidal volume VT

Neo. 9 31 ................ ................

Ped. 50 29 ................ ................

Adult 500 12 ................ ................

NOTE: Factory default settings may be adjusted to hospital-

specific settings for start-up values.

T and f as a function of the

Factory-set default Hospital-set default

Ventilator rate f

bpm

Tidal volume VT

Ventilator rate f

bpm

Operating Instructions NeoFlow for EvitaXL, 1. ed.

Conﬁguration of Ventilation

Defining Start-up Defaults for Tube Compensation (ATC)

Deﬁning Start-up Defaults for Tube Compensation (ATC)

● Press » System Setup« function

key.

● Touch »Therapy« screen key.

● Touch »Mode & Settings« screen key

and enter access code 3032.

● Touch »Add. settings...« screen key.

● Touch the respective screen key to

switch ATC on or off.

● Press dial knob to conﬁrm.

● Touch the respective screen keys to

set individual tube compensation parameters.

● Set and conﬁrm values with the dial

knob.

16537683

The following start-up defaults may be selected

Tube compensation: »On«/»Off« Degree of tube compensation: »Comp.« 0 to 100 % Expiratory tube compensation

(Exp. Comp.): »On«/»Off« (immediately effective) Tube type: »ET« (endotracheal tube) or

»Trach.« (tracheostomy tube)

Inside diameter of the tube: »Tube I.D.« 2.5 to 5 mm for neonates

XL is delivered with the following

Evita start-up defaults

Tube compensation: »Off« Degree of tube compensation: »Comp.« 80 % Expiratory tube compensation

(Exp. Comp.): »On« (immediately effective) Type of tube: »ET« (endotracheal tube) Inside diameter of the tube: »Tube I.D.« 3.0 mm for neonates

Operating Instructions NeoFlow for EvitaXL, 1. ed.

* Available Option

Care

Dismantling the Neonatal Flow Sensor Disinfecting/Cleaning/Sterilizing

Care

Dismantling the Neonatal Flow Sensor

1 Unplug ﬂow sensor cable from both the sensor and the

back panel of EvitaXL.

2 Remove the sensor element:

Press the buttons on both sides while pulling the sensor out of the housing at the same time.

3 Detach sensor housing from Y-piece.

● Dismantle and process the other components as described

in the EvitaXL Operating Instructions.

03037566

Disinfecting/Cleaning/Sterilizing

WARNING !

Always follow accepted hospital procedures for handling equipment contaminated with body ﬂuids.

CAUTION !

To prevent any damage, we recommend that only detergents and disinfectants that are compatible with the device are used for disinfection, e.g. surface disinfectants based on aldehydes or quarternary ammonium compounds.

Ensure that all disinfectants are registered with the U.S. Environmental Protection Agency for use as intended. Always follow the instruction labels speciﬁcally with respect to prescribed concentrations and the necessary exposure times.

Disinfectants often contain – in addition to their main active agents – additives that can also damage materials. When in doubt, ask the supplier/manufacturer of the disinfectant/ cleaning agent.

For a list of materials used in the ventilator, please refer to Evita

XL Operating Instructions.

Operating Instructions NeoFlow for EvitaXL, 1. ed.

Flow sensor cable

● Disinfect by wiping with disinfectant based on the

recommended active ingredients. Follow instruction labels with respect to prescribed concentrations and the necessary exposure times.

CAUTION !

Do not allow any liquid into the connector of the ﬂow sensor cable.

Neonatal ﬂow sensor element

CAUTION !

Flow sensor is not compatible with parts washer equipment and may not be autoclaved or steam-sterilized. It cannot withstand high temperatures and would be destroyed.

Do not use compressed air, brushes or similar tools to clean ﬂow sensor element as this would possibly damage the thin wires in the ﬂow sensor.

Care

Disinfecting/Cleaning/Sterilizing

Any residue of dried mucus shortens the service life of the ﬂow sensor. Therefore:

● Proceed with bath disinfection immediately after use.

Use a disinfectant based on the recommended active ingredients. Follow instruction labels with respect to prescribed concentrations and the necessary exposure times.

● Then clean the sensor by gently stirring in a bath of distilled

water. Thoroughly shake off any residual water.

Then:

● Steam autoclave at 134

C (273 oF).

WARNING !

Vent ﬂow sensor after disinfection with ethanol for at least 30 minutes or rinse with sterile water. Otherwise, residual ethanol vapors might ignite and destroy the sensor during calibration.

Flow sensor housing

● Disinfect by high temperature wet autoclaving

(93 oC/200 oF, 10 minutes) using detergent only.

● Steam autoclave at 134

C (273 oF).

03137566

Operating Instructions NeoFlow for EvitaXL, 1. ed.

Maintenance

Maintenance Intervals

Maintenance

CAUTION !

Maintenance

For repairs we recommend that you contact DraegerService.

WARNING !

Preventive Maintenance work on the EvitaXL ventilators and their components may be performed by factory trained and authorized personnel only.

WARNING !

Never operate the ventilator if it has suffered physical damage or does not seem to operate properly. We recommend that you contact DraegerService for maintenance service for the EvitaXL ventilator.

WARNING !

Maintenance Intervals

Operating Instructions NeoFlow for EvitaXL, 1. ed.

Preventive maintenance Every 6 months by trained and

factory authorized service personnel.

The Evita scheduled preventive maintenance of the Evita every six months.

XL NeoFlow option is serviced as part of the

XL ventilator

Troubleshooting

Maintenance Intervals

Operating Instructions NeoFlow for EvitaXL, 1. ed.

Alarm messages in the alarm display ﬁeld are displayed in order of priority.

For example, if two faults are detected at the same time, the more urgent of the two is displayed ﬁrst.

The priority of the alarm messages is indicated by exclamation marks:

Warning = top-priority message !!! Caution = medium-priority message !! Advisory = low-priority message !

Message Cause Remedy Apnea !!! No spontaneous breathing by the patient. Ventilate patient in a controlled mode.

Neonatal ﬂow sensor not calibrated or defective.

Neonatal ﬂow sensor connected but not in the Y-piece.

Tube obstructed. Check tube.

Back-up ventilation !!! Only in neonatal patient range:

In volume-controlled ventilation, a neonatal ﬂow monitoring fault was detected or neonatal ﬂow monitoring was switched off.

Tube obstructed. Check tube.

Neo ﬂow measurement inop. !!! Only in neonatal patient range:

Neonatal ﬂow monitoring is defective or the sensor cable is not connected.

Neo ﬂow measurement inop. ! Only in pediatric patient range:

Neonatal ﬂow monitoring is defective or the sensor cable is not connected.

Neo ﬂow monitoring off ! Neonatal ﬂow monitoring is deactivated. Activate neonatal ﬂow monitoring. Neo ﬂow sensor ? !!! Neonatal ﬂow sensor not installed in the

breathing circuit.

Neo ﬂow sensor ? ! Neonatal ﬂow sensor not installed in the

breathing circuit and ﬂow monitoring via expiratory ﬂow sensor switched on.

Psupp. > Tinsp ! Only in neonatal patient range:

Pressure support phase was terminated by a time limit.

This message is not generated during Ventilation with Pressure support in PCV+, SIMV or MMV.

In the table below, the additional messages speciﬁc to NeoFlow are listed in alphabetical order. The table can be used as reference for rapidly identifying and remedying the cause of any alarm.

NOTE: Alarm texts of the same wording as in adult/pediatric

patient modes may have a different cause in neonatal mode. In these cases, a patient mode specific help text is provided.

Calibrate neonatal ﬂow sensor, see page 14. Replace if necessary, see page 15, recalibrate.

Insert neonatal ﬂow sensor into the Y-piece.

Calibrate neonatal ﬂow sensor, see page 14. Replace if necessary, see page 15. Recalibrate or activate neonatal ﬂow monitoring.

Calibrate neonatal ﬂow sensor, see page 14. Replace if necessary, see page 15, recalibrate. Connect sensor cable.

Call DraegerService. Calibrate neonatal ﬂow sensor, see page 14.

Replace if necessary, see page 15, recalibrate. Connect sensor cable.

Call DraegerService.

Install neonatal ﬂow sensor in breathing circuit.

Technical Data

Neonatal Settings

Technical Data

For neonatal mode, supplements Technical Data section in the EvitaXL Operating Instructions.

Neonatal Settings

Tidal volume VT

Range 3 to 100 mL, BTPS* Resolution 1 mL Accuracy greater of ±8 % of set value or 1 mL

Trigger sensitivity

Range 0.3 to 5 L/min 5 to 15 L/min Resolution 0.1 L/min 0.5 L/min

Weight of patient

Range 0.5 to 6 kg Resolution 0.1 kg

Ventilation frequency f

Range 0 to 10 bpm 10 to 150 bpm Resolution 0.5 bpm 1 bpm

Inspiratory time T

Range 0.1 to 1 s 1 to 10 s Resolution 0.05 s 0.1 s

Set values for ATC (with Option ATC): Inside diameter of the tube (Tube I.D.)

Range 2.5 to 5 mm Resolution 0.5 mm

Degree of compensation (Comp.)

Range 0 to 100 % Resolution 1 %

insp (CPAP, CPAP/ Psupp.)

Operating Instructions NeoFlow for EvitaXL, 1. ed.

BTPS

Body Temperature, Pressure, Saturated. Measured values referenced to patient lung conditions: Body temperature 37 oC, gas saturated with water vapor, ambient pressure.

Technical Data

Display of Measured Values

Performance Data

Control principle Base ﬂow with demand system,

pressure-controlled, time-controlled

Base ﬂow 6 L/min (this can be changed by DraegerService to 9 L/min) Base ﬂow during medicament nebulisation 9 L/min

Insp. Flow up to 30 L/min Exp. ﬂow (measuring range) up to 30 L/min

Device compliance — (with Fisher & Paykel MR 730 humidiﬁer

and reusable silicone pediatric patient circuit) <1 mL/cmH

Inspiratory resistance — during operation with Fisher & Paykel

humidiﬁer 0 cmH2O (basic ﬂow) at 5 L/min

— following a ventilator failure while using a

Fisher & Paykel humidiﬁer <1.5 cmH

2O at 5 L/min

Performance Data

Expiratory resistance — during operation <3 cmH2O at 5 L/min — following device failure <1.1 cmH

2O at 5 L/min

Deadspace volume

Neonatal ﬂow sensor ISO 15, including Y-piece <2 mL

Display of Measured Values

Flow measurement (with neonatal ﬂow sensor 84 11 130)

Range 0.25 to 30 L/min

Minute volume MV (without leak compensation)

Range 0 to 9.9 L/min, BTPS 10 to 99 L/min, BTPS Resolution 0.01 L/min 0.1 L/min Accuracy greater of ±8 % of the measured value or 1 mL x f T

0...90 approx. 35 s

Spontaneous breathed minute volume MV

Range 0 to 9.9 L/min, BTPS 10 to 99 L/min, BTPS Resolution 0.01 L/min 0.1 L/min Accuracy greater of ±8 % of the measured value or 1 mL x f T0...90 approx. 35 s

spn (not leak compensated)

spn

Operating Instructions NeoFlow for EvitaXL, 1. ed.

Leakage minute volume MV

Leak

Range 0 to 9.9 L/min, BTPS 10 to 99 L/min, BTPS Resolution 0.01 L/min 0.1 L/min T

0...90 approx. 35 s

Technical Data

Monitoring Materials Used

Tidal volume V

Range 0 to 999 mL, BTPS 1000 to 4000 mL, BTPS Resolution 0.1 mL 10 mL Accuracy greater of ±8 % of the measured value or 1 mL

Tidal volume V

Ti, VT

Range 0 to 999 mL, BTPS 1000 to 4000 mL, BTPS Resolution 1 mL 10 mL Accuracy greater of ±8 % of the measured value or 1 mL

Spontaneous breathing rate f

spn

Range 0 to 300 bpm Resolution 1 bpm

Monitoring

Expiratory minute volume MV

Alarm, upper alarm limit when the upper alarm limit is exceeded. Range 0.1 to 0.99 L/min 1 to 41 L/min Resolution 0.01 L/min 0.1 L/min

Alarm, lower alarm limit when the value drops below the lower alarm limit. Range 0.01 to 0.99 L/min 1 to 40 L/min Resolution 0.01 L/min 0.1 L/min

Volume monitoring

Alarm, upper alarm limit Inspiration is interrupted and the expiratory valve opens when the

applied tidal volume exceeds the upper alarm limit.

Range 4 to 4000 mL

Rapid shallow breathing When the measured spontaneous breath rate f

spn exceeds the

alarm limit

Range 5 to 120 bpm

Materials Used

Part Appearance Material

Neonatal ﬂow sensor yellow, transparent polysulphone Neonatal ﬂow sensor

housing yellow, transparent polysulphone Flow sensor cable grey/grey polyurethane

Operating Instructions NeoFlow for EvitaXL, 1. ed.

Theory of Operation – Special Features of Neonatal Ventilation

Theory of Operation

– Special Features of Neonatal Ventilation

Measuring Leakage Flow

A small amount of respiratory gas almost always escapes between the tracheal wall and endotracheal tubes when ventilating newborns and infants with uncuffed tubes. This ﬂow is termed the leakage ﬂow.

Model for determining the leakage ﬂow: The proximal (neonatal) ﬂow sensor is located at the Y-piece

upstream of the leak. During inspiration, it measures both the leakage ﬂow and the amount of breathing gas reaching the patient's lung. During expiration, it only measures part of the gas applied during inspiration. However, assuming that another leakage ﬂow escapes during expiration, the amount measured is less than the amount actually expired by the patient.

Measuring Leakage Flow

The value of greatest importance for patient monitoring is the amount of gas that actually reaches the patient's lung and thus contributes towards ventilation. The measured value for leak displayed by Evita

XL is the mean leakage ﬂow MVLeak.

MVLeak corresponds to the difference averaged over time between the inspiratory and expiratory ﬂow. (The gas which does not ﬂow back through the sensor during expiration must have escaped through the leak).

This value for leak, in combination with the expiratory minute volume MV, can therefore be used to estimate the minute volume MV

Patient that contributed to ventilation:

MV ≤ MV

Patient ≤ MV + MVLeak

MVPatient : Minute volume of the patient MV : Expiratory minute volume without correction for

leak

Leak : Mean leakage ﬂow

EvitaXL takes into account the calculated leakage ﬂow in the displayed values V

Ti, VTe and Flow. For this purpose, the

leakage ﬂow at each instant is calculated as a function of the actual airway pressure:

Flow

Leak = MVLeak * PAW / Pmean

Operating Instructions NeoFlow for EvitaXL, 1. ed.

Leak : Actual leakage ﬂow

Flow MVLeak : Leakage minute ﬂow – mean leakage ﬂow,

averaged over inspiration and expiration PAW : Airway pressure at the Y-piece Pmean : Mean airway pressure at the Y-piece

Theory of Operation – Special Features of Neonatal Ventilation

Measuring Leakage Flow

Patient ﬂow and tidal volume are then calculated as follows:

Inspiration:

Patient, insp = Flowinsp – FlowLeak

Flow

VTi = ∫ FlowPatient, insp dt

Expiration:

Flow

Patient, exp = Flowexp + FlowLeak

VTe = ∫ FlowPatient, exp dt

Flow

Patient : Actual patient ﬂow, corrected for leaks

Flowinsp : Actual inspiratory ﬂow, not corrected for leaks Flowexp : Actual expiratory ﬂow, not corrected for leaks FlowLeak : Actual leakage ﬂow VTi : Inspiratory tidal volume VTe : Expiratory tidal volume MVLeak : Mean leakage ﬂow, averaged over inspiration and

expiration

➞

Inspiratory flow through the sensor

Inspiratory leakage

Patient flow

➞

➞➞➞

➞

Expiratory flow through the sensor

Expiratory leakage

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Operating Instructions NeoFlow for EvitaXL, 1. ed.

Theory of Operation – Special Features of Neonatal Ventilation

Airway Pressure Measurement

EvitaXL measures airway pressure indirectly by means of two internal pressure sensors in the apparatus. The sensors are installed in the inspiratory and expiratory lines, thereby eliminating the need for an external pressure measuring line between the Y-piece and the ventilator. As long as one side is without ﬂow, the measured value of the ﬂowless pressure sensor corresponds to the airway pressure at the Y-piece.

During neonatal ventilation, a continuous base ﬂow is applied. Due to this base ﬂow, the zero-ﬂow condition is never met either on the inspiratory or expiratory side. The pressure measured by the inspiratory pressure sensor continues to vary with the variations in airway pressure but it is increased by the amount of the pressure drop in the inspiratory line of the patient circuit.

The pressure measured by the expiratory pressure sensor likewise is reduced by the amount of the pressure drop in the expiratory line of the patient circuit. These pressure differences are caused by the ﬂow resistance of the patient circuit.

Airway Pressure Measurement

During expiration, the value measured at the inspiratory pressure sensor (P

insp) is reduced by the pressure drop

caused by the base ﬂow (Flowbf) in the inspiratory limb of the patient circuit (Rinsp):

AW = Pinsp – Rinsp * Flowbf

AW : Airway pressure at the Y-piece

P Pinsp : Airway pressure at the inspiratory sensor Rinsp : Flow resistance of the inspiratory limb of the

patient circuit Flowbf : Base ﬂow

During inspiration, the value measured by the expiratory pressure sensor (Pexp) is lower than the airway pressure by the amount of the pressure drop (Rexp) caused by the ﬂow (normally Flowout ≤ Flowbf) through the expiratory limb of the patient circuit:

AW = Pexp + Rexp * Flowout

AW : Airway pressure at the Y-piece

Pexp : Airway pressure at the expiratory limb Rexp : Flow resistance of the expiratory limb Flowout : Flow through the expiratory valve during inspiration

Operating Instructions NeoFlow for EvitaXL, 1. ed.

EvitaXL determines patient circuit resistances during the ventilator check procedure.

Theory of Operation – Special Features of Neonatal Ventilation

Trigger Response

In neonatal mode, EvitaXL detects a patient's spontaneous breathing using the neonatal ﬂow sensor proximal to the patient. When spontaneous inspiration is detected, a synchronized, mechanical, and pressure controlled breath, or a pressure support breath is triggered according to the selected mode of ventilation.

In order to avoid incorrect triggering due to leak ﬂows, Evita not only takes into account the ﬂow signal from the neonatal ﬂow sensor (Flowinsp) but also the calculated leak ﬂow (MVLeak). For this purpose, the leak ﬂow is referenced to the momentary pressure level (PAW):

Patient, insp = Flowinsp – MVLeak * PAW / Pmean

Flow

Patient : Patient ﬂow

Flowinsp : Inspiratory ﬂow, without correction for leak MVLeak : Leakage minute volume – mean leakage ﬂow,

averaged over inspiration and expiration PAW : Airway pressure at the Y-piece Pmean : Average airway pressure at the Y-piece

Spontaneous inspiration is only detected if the corrected measured value of the neonatal ﬂow sensor exceeds the set ﬂow trigger threshold. The trigger threshold covers a range from 0.3 L/min to 15 L/min, but only the range from 0.3 L/min to 3 L/min is recommended for neonatal ventilation.

The trigger threshold should be set so that self-triggering is just avoided.

If the neonatal ﬂow sensor in neonatal mode is defective, EvitaXL can no longer detect attempts at spontaneous inspiration, and therefore cannot trigger a ventilator breath.

Operating Instructions NeoFlow for EvitaXL, 1. ed.

Theory of Operation – Special Features of Neonatal Ventilation

AutoFlow

AutoFlow is a ventilation mode extension that optimizes ﬂow control during mandatory breaths in the volume constant ventilation modes CMV, SIMV, and MMV.

In neonatal mode, AutoFlow is always active in all volume controlled ventilation modes (CMV, SIMV, MMV).

Ventilation with AutoFlow is only possible if the neonatal ﬂow sensor is intact.

With AutoFlow, the inspiratory ﬂow is automatically adjusted to changes in lung conditions (C, R) and to the demands of the spontaneously breathing patient.

WARNING!

The alarm limit »PAW >« must always be set so that a warning is triggered if airway pressure increases with reduced compliance or in the event of sudden changes in the size of the leak.

PEEP

PAW

Pinsp = f (VT,C)

insp Te

Flow

without spontaneous breathing with spontaneous breathing

AutoFlow

PAW >

03337682

Typically, the selected inspiratory time T

insp is much longer

than the time required to ﬁll the lungs. Inspiratory pressure Pinsp corresponds to the minimum value calculated from tidal volume VT and lung compliance C.

The volume required to calculate inspiratory pressure is derived from the measured value V

Te of the neonatal ﬂow

sensor proximal to the patient. Contamination of the neonatal ﬂow sensor can lead to incorrect measured volumes. Airway pressure will increase if measured volume is too low.

Inspiratory ﬂow is automatically controlled in such a way as to prevent the occurrence of a pressure peak caused by ET-tube and airway resistance. As is common in constant-volume ventilator breaths, plateau pressure P

plat is allowed to ﬂuctuate

with changes in compliance C. With AutoFlow, these ﬂuctuations occur in increments with a maximum of 3 cmH

between ventilator breaths.

If the tidal volume V

T (inspiratory ﬂow = 0) is reached before

inspiratory time Tinsp has elapsed, the inspiratory and expiratory valve are controlled in such a way that the patient can still breathe in and out during the remainder of inspiratory time, even while constant plateau pressure Pplat is applied.

If the patient breathes in or out during mandatory inspiration, the plateau pressure P

plat remains unchanged for the duration

of this ventilator breath. Only inspiratory and expiratory ﬂow are adapted to the patient's demand. The applied tidal volume VT can deviate from the set tidal volume VT in individual ventilator breaths, but as an average over time, a constant tidal volume VT is supplied.

Operating Instructions NeoFlow for EvitaXL, 1. ed.

Theory of Operation – Special Features of Neonatal Ventilation

AutoFlow

Tidal volume VT can be limited by the alarm limit »VV

>«.

If the set alarm limit is exceeded once, EvitaXL will generate an advisory message (!). If the alarm limit is exceeded three times in succession, the EvitaXL will generate a warning (!!!). Tidal

volume is actively limited to the value of the alarm limit »VV

>«

by switching to PEEP level (expiration) when necessary.

An inspiratory time T

insp set to a value shorter than the time

required to ﬁll the lungs can be recognized in the ﬂow waveform: the ﬂow at the end of inspiration has not dropped to zero. In such a case, it must be decided whether the patient's momentary situation will permit a longer inspiratory time Tinsp in order to further reduce peak pressure.

The effect described can also develop in the course of ventilation, e.g. due to a buildup of secretions. In this situation,

pressure is limited by the alarm limit »PP rise is held to 5 cmH2O below the alarm limit »PP

>«. The pressure

>«. The

"Volume not constant" alarm will only become active when the set tidal volume VT is no longer fully applied.

PEEP

PAW

Pinsp = f (VT,C)

insp Te

Flow

without spontaneous breathing with spontaneous breathing

PAW >

03437682

The beginning of a mandatory inspiration can be synchronized with a patient's attempted inspiration using the adjustable ﬂow trigger. Only while in CMV mode can the ﬂow trigger be completely switched off (CMV

Assist -> CMV).

In SIMV and MMV, steepness of the pressure rise from PEEP level to the inspiratory level may be even more closely adapted to a patient’s needs by adjusting pressure rise time via the ventilation parameter pressure rise time »Slope«.

Initial response of AutoFlow in neonatal mode

When activating a volume-controlled ventilation mode, Evita

will initially apply a test breath with an inspiratory pressure 5 cmH2O greater than PEEP. This test breath is used by EvitaXL to calculate inspiratory pressure for the next inspiration. With the inspiration of the second breath, however, EvitaXL will only set 75 % of the previously calculated inspiratory pressure in order to verify the ﬁrst result and calculate a new inspiratory pressure. From the third breath on, EvitaXL sets the inspiratory pressure as calculated. All further adjustments of the inspiratory pressure are limited to ±3 cmH2O.

PAW

PEEP

75 %

insp

5 cmH2O

1st stroke 2nd stroke 3rd stroke

Pinsp

Operating Instructions NeoFlow for EvitaXL, 1. ed.

02029563

Glossary

Abbreviations

Abbreviation Explanation

f Mechanical ventilation frequency (setting) fspn Spontaneous breathing rate (measured value) Flow Displayed real-time waveform, patient ﬂow

(measured value), with correction for leak Flowout Flow through the expiratory valve during inspiration Flowbf Base ﬂow (system setting), see technical data

page 36 Flowinsp Inspiratory ﬂow, without correction for leak Flowexp Expiratory ﬂow, without correction for leak FlowLeak Actual leakage ﬂow FlowPatient Inspiratory/expiratory ﬂow, with correction for leak

(measured value) MV Expiratory measured minute volume, without

correction for leak (measured value) MVLeak Leakage minute volume – mean leakage ﬂow,

averaged over inspiration and expiration

(measured value) MVPatient Inspiratory/expiratory measured minute volume,

with correction for leak PAW Airway pressure at the Y-piece (measured value) Pexp Airway pressure in the expiratory limb of the

patient circuit Pmean Mean airway pressure at the Y-piece (measured

value) Rexp Flow resistance in the expiratory limb of the patient

circuit Rinsp Flow resistance of the inspiratory limb of the

patient circuit TApnea Apnea alarm delay time (setting) VT Tidal volume (setting) V

Ti Inspiratory tidal volume (measured value) Te Expiratory tidal volume (measured value)

Glossary

Abbreviations

Operating Instructions NeoFlow for EvitaXL, 1. ed.

Ordering Information

Abbreviations

Ordering Information

Name/Description Article No. NeoFlow kit 84 13 563

consists of Extension PCB "Pediatric Flow" Neonatal ﬂow sensor cable Reusable neonatal ﬂow sensor housing

ISO 15 "Water trap" kit for expiratory valve (2x) Pediatric cuvette for CO2 measurement

(2x) Corrugated patient circuit segment

(reusable, silicone) 0.13 m (5") (2x)

Replacement Parts:

Replacement parts designed for use with the basic ventilator unit.

Neonatal ﬂow sensor cable 84 09 626 Neonatal ﬂow sensor housing for ISO 15 84 11 130 "Water trap" kit for expiratory valve 84 13 125 Pediatric cuvette for CO2 measurement 68 70 280 Corrugated patient circuit segment

(reusable, silicone) 0.13 m (5") 84 09 634

Operating Instructions NeoFlow for EvitaXL, 1. ed.

Index

Operating Instructions NeoFlow for EvitaXL, 1. ed.

Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Advisory message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Airway pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Alarm limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Apnea ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

AutoFlow

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Back-up ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Body fluids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8, 32

Calibrating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Caution message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Configuration of ventilation . . . . . . . . . . . . . . . . . . . . . . . . . 28

Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Device check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Display

of measured values . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Flow monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Flow sensor

calibrating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

installing replacing

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Initial values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Intended Use

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Leakage compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Leakage flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Materials, used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Monitoring

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Nebulizing

pharmaceutical aerosols . . . . . . . . . . . . . . . . . . . . . . . 23

Neonatal ventilation

flow monitoring during

NIV mask ventilation

. . . . . . . . . . . . . . . . . . . . . . . . . 21

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Ordering information

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Parts washer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8, 33

Patient safety

operator's responsibility for . . . . . . . . . . . . . . . . . . . . . . 4

Pediatric ventilation

Performance data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Preparing for use

Pressure Support Ventilation (PSV) . . . . . . . . . . . . . . . . . . 18

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Selecting neonatal mode . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Set values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Solvents, organic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8, 32

Start-up defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Sterilizing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Trigger response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Typing conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Ventilation parameter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

These Instructions for Use apply only to

Evita

with Serial No.:

If no Serial No. has been ﬁlled in by Dräger, these Instructions for Use are provided for general information only and are not intended for use with any speciﬁc machine or device.

Manufactured by

Dräger Medical AG & Co. KGaA

Germany

z Moislinger Allee 53 – 55

D-23542 Lübeck

y +49 451 8 82- 0

x 26 80 70

FAX+49 451 8 82- 20 80

! http://www.draeger.com

Distributed by

Draeger Medical, Inc.

z 3136 Quarry Road

Telford, PA 18969

U.S.A.

y (215) 721-5400

(800) 4DRAGER (800 437-2437)

FAX(215) 723-5935

Drager 9037547_XL_US_NeoFlow_Operating Instructions NeoFlow Neonatal Patient Mode Addendum to Operating Instructions EvitaXL

Specifications and Main Features

Frequently Asked Questions

User Manual