D
MEDICAL
NeoFlow
™
Neonatal Patient Mode
Addendum to
Operating Instructions
Evita
XL
*
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.
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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.
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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.
© Dräger Medical AG & Co. KGaA, 2002
All rights reserved, Subject to modifications
ss
Operating Instructions NeoFlow for EvitaXL, 1. ed.
2
Contents
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
O
2
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
3
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.
4
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.
5
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.
::
NNNNOOOOTTTTEEEE::
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.
6
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
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.
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.
XL
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.
>
AW
« 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.
7
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
2
concentration!
XL
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.
8
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.
XL
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
XL
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.
XL
Operating Instructions NeoFlow for EvitaXL, 1. ed.
9
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
XL
intensive care
XL
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.
10
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.
XL
ventilators
Operating Instructions NeoFlow for EvitaXL, 1. ed.
11
Preparation
Preparing for Use
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.
1
3
2
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.
4
00237566
Operating Instructions NeoFlow for EvitaXL, 1. ed.
12
00337566
Device Check
The NeoFlow option expands the EvitaXL
pre-use check procedure by the
following function:
— Calibration neo. flow sensor
Preparation
Device Check
10237683
Operating Instructions NeoFlow for EvitaXL, 1. ed.
13
Preparation
Calibrating the Neonatal Flow Sensor
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
14
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
3
3
2
1
Operating Instructions NeoFlow for EvitaXL, 1. ed.
15
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