AW TrachFlush UK Manuale utente
Operators Manual
TrachFlush UK
Revision #1.0 of 01.08.2020
Document no. AWT-1030
AW Technologies ApS, Amalienborgvej 57, 9400 Noerresundby, Denmark
Operators Manual UK
Copyright, AW Technologies ApS, Doc. AWT1030, rev. #1.0 01.08.2020 Page 2 of 22
Table of Contents
1 Introduction .................................................................................................................... 3
1.1 About this manual ................................................................................................................ 3
1.2 Units of measure .................................................................................................................. 3
1.3 General description and Intended Use .................................................................................. 3
1.8 Document conventions ......................................................................................................... 4
1.9 General notes ....................................................................................................................... 4
1.10 Symbols and markings ........................................................................................................ 5
2 TrachFlush Overview ...................................................................................................... 6
3 TrachFlush Operations .................................................................................................... 7
3.1 Setting up TrachFlush for use ................................................................................................ 7
3.2 Turning ON TrachFlush .......................................................................................................... 9
3.3 Setting Cuff Pressure ........................................................................................................... 10
3.4 Flush Control ...................................................................................................................... 14
3.2 Turning OFF TrachFlush ....................................................................................................... 17
4 System alarms .............................................................................................................. 18
5 Cleaning and maintenance ........................................................................................... 20
5.1 Cleaning the TrachFlush Mounting Bracket ......................................................................... 20
5.2 Cleaning the TrachFlush device ........................................................................................... 20
5.3 Disposal of the TrachFlush Cuff Pressure and Airway tube set ............................................. 20
6 Parts and accessories .................................................................................................... 21
7 Specifications ............................................................................................................... 22
Operators Manual UK
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1 Introduction
1.1 About this manual
This manual is written for clinical personnel using the TrachFlush device (TrachFlush); the
consumables and accessories intended for use with TrachFlush.
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 (AW Technologies).
This document may be revised, replaced, or made obsolete by other documents by AW Technologies
at any time and without notice. Ensure that you have the most current applicable version of this
document – if in doubt, contact the support department of AW Technologies, Denmark. While the
information set forth herein is believed to be accurate, it is not a substitute for the exercise of
professional judgement.
Nothing in this document shall limit or restrict in any way AW Technologies’ 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 has no obligation
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 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 parts were used when replacing parts,
or if serial numbers were amended, deleted, or removed.
TrachFlush and the TrachFlush logo are trademarks of AW Technologies. Other trademarks are the
property of their respective owners.
1.2 Units of measure
The document uses cmH2O representative of all pressure units. 1 cmH2O equals 0.981mbar,
which equals 0.981 hPa.
1.3 General description and Intended Use
TrachFlush is an add-on to standard mechanical ventilation systems used in the Intensive
Care Unit (ICU). TrachFlush has two functionalities:
Cuff Controller: TrachFlush continuously measures and automatically maintains the user set
cuff pressure of an endotracheal tube (ETT) cuff or tracheostomy tube (TT) cuff during
mechanical ventilation of adult patients.
Flush Controller: TrachFlush inflates and deflates the endotracheal tube (ETT) cuff or the
tracheostomy (TT) cuff in alignment with the ventilator flow of pressure during mechanical
ventilation of adults patients in the ICU when activated by the user.
TrachFlush is intended to be used in healthcare institutions and by trained healthcare
professionals.
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TrachFlush is NOT intended to be used on patients under the age of 18 years.
1.8 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.
1.9 General notes
WARNING
• MR UNSAFE. Keep away from magnetic resonance imaging (MRI) equipment. TrachFlush
poses unacceptable risks to patient, medical staff, or another person within the MR
environment.
• Modifications to the device are not permitted.
• To prevent increased emission, decreased immunity, or interrupted operation of the
TrachFlush device or any accessories, use only accessories or cables that are expressly stated
in this manual under Section 6.
CAUTION
• Use only AW Technologies disposable tubing with filter, valve and lock. Use of any other
tubing may results in malfunction of TrachFlush or the immediate loss of cuff pressure if
disconnected on the ventilator end. 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 or the Quick Guide before using the
device on a patient.
The device is not protected against the effects of defibrillator use.
Operators Manual UK
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1.10 Symbols and markings
Table 1: Symbols and markings
Symbol
Description
ATTENTION: Follow Operator’s Manual
The equipment should not be disposed of in the normal waste stream
MR Unsafe
Type BF Applied Part (IEC 60601-1) (protection against electrical shock)
DC Current/Voltage
Manufacturer information
Serial number
Batch code
AW Technologies Reference or Part Number
Date of manufacture
Do not reuse
Do not use if packaging is damaged
Use-by-date
Not made with natural rubber latex
Temperature limits
Class II Equipment (product has 2xMOPP)
Ingress Protection
Operators Manual UK
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2 TrachFlush Overview
Figure 1: TrachFlush Setup Overview
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
Operators Manual UK
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3 TrachFlush Operations
3.1 Setting up TrachFlush for use
CAUTION:
Check if the ETT or TT cuff is made of Polyvinyl chloride (PVC) or Polyurethane (PU) as
TrachFlush can ONLY be used with ETT cuff or TT cuff made of these materials.
Check if the ETT or TT is between 5.0mm and 10.0mm in Inner Diameter (ID) as TrachFlush
only supports ETT and TT in these sizes.
Device Connectivity:
Step 1: Connect the Cuff Pressure Tube (transparent tube) connector to the cuff inlet socket
of the TrachFlush device by twisting it on as shown in figure 2.
Figure 2: Device connectivity, connecting Cuff Pressure Tube
Step 2: Connect the Airway Tube (pink tube) connector to the airway inlet socket of the
TrachFlush by twisting it on as shown on figure 3.
Figure 2: Device connectivity, connecting Airway Tube
Operators Manual UK
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Airway and Cuff Connectivity:
Step 1: Connect the Airway Tube (pink tube) connector to the patients airway elbow or
straight connector by twisting it on as shown on figure 4.
Figure 4: Patient connectivity, connecting Airway Tube
NOTE: If no elbow or straight connector is mounted on the patients airway system, then
attach an elbow connector as shown on figure 5.
Figure 5: Patient connectivity, connecting Elbow Connector
Step 2: Connect the Cuff Pressure Tube (transparent tube) connector (labelled “Cuff”) to the
ETT or TT cuff connector by pushing it in as shown on figure 6.
Figure 6: Patient connectivity, connecting Cuff Pressure Tube
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3.2 Turning ON TrachFlush
Step 1: Turn on the TrachFlush device by pressing and holding the On/Off button for 3
seconds as shown on figure 7 below.
Figure 7: Turn on TrachFlush
Step 2: While turning on the signal (Booting) will appear on the TrachFlush screen as
shown on figure 8 below.
Figure 8: TrachFlush Booting
Step 3: Once turned on, the main screen will appear as shown on figure 9 and TrachFlush
will automatically enable the Cuff Control functionality (see section 3.3 Setting Cuff
Pressure).
Figure 9: TrachFlush Main Screen
NOTICE: On the mainscreen, the Actual Cuff Pressure measured ( ) will be shown.
When powering up, the Set Cuff Pressure ( ) will be the same as the measures Cuff
Pressure.
Operators Manual UK
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3.3 Setting Cuff Pressure
When TrachFlush is turned on, the main screen will appear as shown on figure 10 and
TrachFlush will automatically enable the Cuff Control functionality
Figure 10: TrachFlush Main Screen
NOTICE: TrachFlush Cuff Controller can regulate pressure between 5 and 50cmH2O.
In order to increase or decrease the set Cuff Pressure, follow the steps below:
Increase Cuff Pressure
Step 1: Increase the cuff pressure by pressing (arrow up) as shown on figure 11 below.
Figure 11: Increase cuff pressure
Step 2: To accept the new cuff pressure changes and apply a new pressure setting to the
cuff, press (accept) as shown on figure 12 below. The cuff will now be inflated until the
Actual and Set cuff pressure is the same.
Indice
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