AW Technologies TrachFlush User manual
English | AWT-1030 #4.0 TrachFlush Instructions for Use
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Instructions for Use
TF-SA-XX
Software version 4.0.x.x
AWT-1030 | 2022-10-12
English | AWT-1030 #4.0 TrachFlush Instructions for Use
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TrachFlush
Instructions for Use
October 2022
AWT-1030
English | AWT-1030 #4.0 TrachFlush Instructions for Use
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Table of Contents
1. Device overview .......................................................................................................................................... 7
2. TrachFlush Connections ............................................................................................................................... 8
3. Getting started ............................................................................................................................................ 9
3.1. Connect the device to primary power ............................................................................................................. 9
3.2. Turning ON the device ................................................................................................................................... 10
3.3. Connect the Cuff Pressure Tube and Airway Tube to the device ................................................................... 12
3.4. Connect the Cuff Pressure Tube and Airway Tube to the patient .................................................................. 13
3.5. Adjust cuff pressure ....................................................................................................................................... 14
4. Flush Control ............................................................................................................................................. 15
4.1. Perform Flush Control on Pressure Control Ventilation (PCV) ....................................................................... 16
4.2. Perform Spont Flush Control on Pressure Support Ventilation (PSV) ............................................................ 20
5. Deflate ....................................................................................................................................................... 24
5.1. Perform deflate ............................................................................................................................................. 25
6. Cuff hold .................................................................................................................................................... 26
6.1. Perform cuff hold .......................................................................................................................................... 27
7. Turning OFF the device .............................................................................................................................. 28
8. Alarms and troubleshooting ...................................................................................................................... 29
8.1. Information Signals ....................................................................................................................................... 30
9. Mounting the TrachFlush device ................................................................................................................ 32
10. Cleaning and maintenance ......................................................................................................................... 33
10.1. Cleaning of TrachFlush device and equipment .............................................................................................. 33
10.2. Disposal of Cuff Pressure and Airway Tube set ............................................................................................. 33
10.3. Maintenance of TrachFlush device ................................................................................................................ 33
10.4. Disposal of TrachFlush device ........................................................................................................................ 33
11. Intended use and operators ....................................................................................................................... 34
12. Standards and approvals ............................................................................................................................ 34
13. EMC Declarations IEC 60601-1-2:2014 ........................................................................................................ 35
Electromagnetic environment – guidance ............................................................................................................ 36
14. Specifications ............................................................................................................................................. 39
14.1. Physical, performance, and environmental data .......................................................................................... 39
14.2. Symbols on labels .......................................................................................................................................... 40
15. Parts and accessories ................................................................................................................................. 41
16. Warranty ................................................................................................................................................... 42
16.1. Miscellaneous ................................................................................................................................................ 43
English | AWT-1030 #4.0 TrachFlush Instructions for Use
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© 2022 AW Technologies ApS, Amalienborgvej 57, DK-9400 Noerresundby. All rights reserved.
Printed in Denmark.
No part of this publication may be reproduced, stored in a database or retrieval system, or
transmitted in any form or by any means, electronic, mechanical, or by photocopying, recording,
or otherwise, without prior written permission of AW Technologies ApS.
This document may be revised, replaced, or made obsolete by other documents by AW
Technologies ApS at any time and without notice. Ensure that you have the most current
applicable version of this document; if in doubt, contact the technical support department of AW
Technologies ApS, Denmark. While the information set forth herein is believed to be accurate, it is
not a substitute for the exercise of professional judgment.
Nothing in this document shall limit or restrict in any way AW Technologies ApS’s right to revise or
otherwise change or modify the equipment (including its software) described herein, without
notice. In the absence of an express, written agreement to the contrary, AW Technologies ApS has
no obligation to furnish any such revisions, changes, or modifications to the owner or user of the
equipment (including software) described herein.
The equipment must be operated, serviced, or upgraded only by trained professionals. AW
Technologies ApS’s sole responsibility with respect to the equipment and its use is as stated in the
limited warranty provided in this document.
AW Technologies ApS shall not be liable for any loss, cost, expense, inconvenience, or damage that
may arise out of misuse of the product, or if non-AW Technologies ApS parts were used when
replacing parts, or if serial numbers were amended, deleted, or removed.
If returning parts to AW Technologies ApS, be sure to use the standard AW Technologies returned
goods authorization (RGA) procedure. Disposal of parts shall follow all local, state, and federal
regulation with respect to environmental protection.
Product and company names mentioned herein may be the trademarks and/or registered
trademarks of their respective owners.
AW Technologies ApS will make available, on request, circuit diagrams, component parts lists,
descriptions, calibration instructions, or other information that will assist appropriately trained
personnel to repair those parts of the equipment designated by AW Technologies ApS to be
repairable.
English | AWT-1030 #4.0 TrachFlush Instructions for Use
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Document conventions
WARNING
A WARNING alerts the user to the possibility of injury, death, or other serious adverse reactions
associated with the use or misuse of the device.
CAUTION
A CAUTION alerts the user to the possibility of a problem with the device associated with its use or
misuse, such as device malfunction, device failure, damage to the device, or damage to other
property.
NOTICE
A NOTICE emphasizes information of particular importance.
Units of measure
The document uses cmH2O representative of all pressure units. 1 cmH2O equals 0.981mbar, which
equals 0.981 hPa.
General notes
WARNING
• MR UNSAFE. Keep away from magnetic resonance imaging (MRI) equipment. TrachFlush is
not designed for the MR environment.
• Modifications to the device are not permitted.
• To prevent increased emissions, decreased immunity, or interrupted operation of the
TrachFlush device or any accessories, use only accessories or cables that are expressly
stated in this manual.
• Only for use on adults (+18 years of age).
CAUTION
• Use only the AW Technologies disposable Cuff Pressure and Airway Tube with filter, safety
valve, and lock. Use of any other tubing will damage the device and result in loss of cuff
pressure. Use of any other tubing without a filter may result in the device being
contaminated.
• Do NOT kink the tubing.
NOTICE
• The use of this equipment is restricted to one patient at a time who is intubated with an
endotracheal tube (ETT) or tracheostomy tube (TT).
• If there is visible damage to any part of the TrachFlush device, do not use the device.
Technical service is required.
• Familiarize yourself with these Instructions for Use before using this device on a patient.
English | AWT-1030 #4.0 TrachFlush Instructions for Use
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• Install the TrachFlush device in a position where the primary power supply can easily be
disconnected.
• To electrically isolate the TrachFlush device from all poles of the primary power supply
simultaneously, disconnect the power plug.
• The device is not protected against the effects of defibrillator use.
• The manufacturer can only be responsible for the safety, reliability, and performance of
the TrachFlush device if all the following requirements are met:
o Appropriately trained personnel carry out assembly operations, extensions,
readjustments, modifications, maintenance, or repairs.
o The electrical installation of the relevant room complies with the appropriate
requirements.
o The TrachFlush device is used in accordance with the Instructions for Use.
• The TrachFlush device requires special precautions regarding EMC and must be installed
and put into service according to the EMC information provided in the EMC declarations in
section 13.
English | AWT-1030 #4.0 TrachFlush Instructions for Use
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1.
Device overview
Not all elements are displayed at the same time and are only shown here for information
purposes.
Figure 1: Device overview
Alarms and power
1. Power ON / OFF button
2. Alarm bar
3. Alarm silence button
1
3
Pressure display
4. Actual cuff pressure
5. Set cuff pressure (target)
6. Unit of measure
7. Adjustment buttons
4
5
6
Control panel
8. Deflate button
9. Cuff hold information bar
10. Cuff hold button
11. Alarm bar (LED)
12. Flush Button
7
8
9
12
10
11
2
English | AWT-1030 #4.0 TrachFlush Instructions for Use
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2.
TrachFlush Connections
NOTICE
Only #1, #2, #3, and #4 above is a part of the TrachFlush device. The elbow connector (#5) and the
endotracheal tube (#6) is not a part of the TrachFlush device but is shown here for connectivity overview.
Figure 2: TrachFlush Setup Overview
English | AWT-1030 #4.0 TrachFlush Instructions for Use
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3.
Getting started
CAUTION
Prior to use, confirm that the ETT or TT cuff is made of Polyvinyl chloride (PVC) or Polyurethane (PU).
TrachFlush can ONLY be used with ETT cuffs or TT cuffs made of these materials.
Prior to use, confirm that the ETT or TT is between 5.0mm and 10.0mm in Inner Diameter (ID) as TrachFlush
only supports ETTs and TTs in these sizes.
3.1.
Connect the device to primary power
WARNING
Only use the supplied PSU with the device. Use of unauthorized PSU may damage the device. If the PSU is
damaged a new PSU should be ordered from AW Technologies.
NOTICE
Keep the power supply always connected to stable power. If disconnected from power or power is lost, the
TrachFlush device will alarm and shut down within 30 seconds.
The TrachFlush device is powered by a power supply unit (PSU) connected to AC power.
Connect the power cable as follows:
1. Connect the appropriate plug adaptor.
2. Plug the adapter into a mains AC power source.
3. Connect the power plug end of the power cable to the power port on the TrachFlush
device.
Figure 3: Connecting the device to primary power
English | AWT-1030 #4.0 TrachFlush Instructions for Use
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3.2.
Turning ON the device
Press and hold the Power ON / OFF button for three (3) seconds.
When turning on, the device performs a self-test, during which the display turns on, LED-bar lights
up and the alarm sounds, and the signal (booting) will appear on the screen. If this does not
occur, see Section 8.
Once the device is turned on, calibration is required. Remove tubes before calibration. To perform
calibration, press (accept) and await calibration. Once calibration is completed, connect
tubes, see section 3.3 and 3.4.
Figure 4: Turning on TrachFlush
Figure 5: TrachFlush Booting
Figure 6: Calibration process
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