AW TrachFlush UK User manual

Operators Manual
TrachFlush UK
Revision #1.0 of 01.08.2020
Document no. AWT-1030
AW Technologies ApS, Amalienborgvej 57, 9400 Noerresundby, Denmark

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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

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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.

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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

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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

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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

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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
12

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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.

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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.

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Figure 12: Accept increased cuff pressure
Following the cuff pressure changes, TrachFlush will automatically enable the Cuff Control
functionality
To cancel the new changes, press (cancel) as shown on figure 13 below.
Figure 13: Cancel increased cuff pressure

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Decrease Cuff Pressure
Step 1: Decrease the cuff pressure by pressing (arrow down) as shown on figure 14
below.
Figure 14: Decreasing 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 15 below. The cuff will now be deflated until the
Actual and Set cuff pressure is the same. .
Figure15: Accept decreased cuff pressure
Following the cuff pressure changes, TrachFlush will automatically enable the Cuff Control
functionality

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To cancel the new changes, press (cancel) as shown on figure 16 below.
Figure 16: Cancel decreased cuff pressure

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3.4 Flush Control
Please follow the following steps when you want to perform a Flush Control maneuver
CAUTION: Check if the mechanical ventilator is ventilating in either Pressure Control
Ventilation (PCV) mode or Pressure Support Ventilation (PSV) mode as a Flush Control can
only be performed in these two modes of ventilation
CAUTION: Check if ICU Ventilator settings are set at the following:
- P-insp is minimum 20cmH2O
- PEEP is minimum 5cmH2O
- Rf/RR is maximum 12b/min
- P-ramp is maximum 100ms
If the ICU ventilator setting is below these settings, adjust the ventilator settings to the
above settings. Remember the current ventilator settings.
CAUTION: A Flush can only be performered with a cuff pressure of 15-35cmH2O .
NOTICE: TrachFlush will only perform the Flush Control if these ventilator settings are met.
WARNING: Only adjust the ICU Ventilator setting if it is clinically safe for the patient.
Step 1: Press and hold the Flush button for more than 3 seconds as shown on figure 17
below.
Figure 17: Performing a Flush

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When flush is activated, then on the TrachFlush screen, the signal (Flush in Progress)
will be shown and the LED-bar will flash cyan until flush has completed, as shown on figure
18.
Figure 18: Flush in Progress
NOTICE:
When flush is activated, then the TrachFlush device uses the two (2) first inspiratory cycles
to check for correct ventilator settings as defined in section 3.4.
If the ventilator settings are correct, on the third inspiratory cycle the Flush will be
performed.
If the ventilator settings are not correct, TrachFlush will not perform the Flush until
corrected, and will reverts to Cuff Controller mode.
Once the flush has completed, the signal (Flush Complete) will appear on the screen as
shown on figure 19
Figure 19: Flush Complete
Once complete, TrachFlush reverts to Cuff Controller mode, goes back to main screen and
the LED-bar stops flashing cyan as shown in Figure 20.

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Step 2: Repeat step 1 three (3) times.
Following the flush, TrachFlush will automatically enable the Cuff Control functionality
Step 3 (OPTIONAL): Re-adjust the ventilator settings of pressure (P-insp), PEEP and T-insp
back to original settings (see Section 3.4 above).
Figure 20: Main screen

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3.2 Turning OFF TrachFlush
Step 1: Turn off the TrachFlush device by pressing and holding the On/Off button for 3
seconds as shown on figure 20 below.
Figure 21: Turn off TrachFlush
Step 2: Disconnect
• the cuff pressure connector from the cuff
• the airway conector from the elbow or t-piece connector
• the cuff pressure and airway connector from the TrachFlush device
Step 3: Dispose the cuff pressure and airway tube as described in section 5.3

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4 System alarms
When an alarm is generated, the device emits audible beeps and the alarm lamp lights
yellow or red, depending on the alarm priority. The TrachFlush device has three alarm
priorities: high, medium, and low. See Table 2 and 3 for details.
To silence an alarm
- Review the alarm, and if appropriate, press the Alarm silence button, which
silences the alarm for 2 minutes.
Table 2. TrachFlush alarm types
Alarm type
Alarm lamp
Audio response
Action required
High-priority alarm
Red, flashing
A sequence of beeps,
repeated until the
alarm is reset
Depends on the
alarm; see Table 3
Medium-priority
alarm
Yellow, flashing
A sequency of beeps,
repeated periodically
Depends on the
alarm; see Table 3
Low-priority alarm
Yellow, constant on
A sequency of beeps
Depends on the
alarm; see Table 3
Technical alarm
Cyan, constant on
A sequency of beeps
Depends on the
alarm; see Table 3
Information signal
Cyan, constant on
A sequency of beeps
Depends on the
alarm; see Table 3
Table 3. TrachFlush alarm names and symbols.
Alarm name
Alarm type
Possible causes
Action required
Cuff Pressure
Extremely High
High-priority alarm
Cuff pressure is
>70cmH2O
Lower cuff pressure
Cuff Pressure High
Medium-priority
alarm
Cuff pressure is
>50cmH2O
Lower cuff pressure
Cuff Regulation Error
Medium-priority
alarm
- Cuff loses
pressure
- Device
error;
cannot
maintain
cuff
pressure
Check or change
ETT/TT if needed
Check Cuff Pressure
and Airway tube
Change Cuff Pressure
and Airway tube if
needed
Disconnect device
Cuff Pressure Low
Medium-priority
alarm
Cuff pressure is
<5cmH2O
Increase cuff pressure

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Power Failure
Low-priority alarm
Power supply has
been disconnected
Make sure the power
supply is connected to
the device and a
power source
Cuff Pressure Tube
not Connected
Technical alarm
Cuff pressure tube not
connected correctly
Check cuff pressure
tube connection
Airway Tube not
Connected
Technical alarm
Airway tube not
connected correctly
Check airway tube
connection
Incorrect Ventilator
Settings
Technical alarm
Respiratory frequency
is too high/low
I:E Ratio is too
high/low
Airway pressure is too
low
Manually
lower/increase Rf on
the ventilator
Manually
lower/increase I:E
Ratio on the ventilator
Manually increase
Airway pressure on
the ventilator
User Shutdown
Denied
Technical alarm
Flush or cuff
adjustment in
progress.
Wait 20 sec and try
again.
Flush Complete
Information signal
Flush completed
Reset ventilator
settings if adjusted
before perfoming a
flush
Flush in Progress
Information signal
Flush in progress
Wait until flush is
complete.
Booting
Information signal
Booting in progress
Wait until the device
is fully booted.
Processing
Information signal
Preparing for Flush
Control
Wait until the device
is ready before
activating Flush
Control.
Service
Information signal
Service for the device
is required
Disconnect the device
and send to service.

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5 Cleaning and maintenance
5.1 Cleaning the TrachFlush Mounting Bracket
Before cleaning or disinfecting the TrachFlush Mounting Bracket, turn off TrachFlush and
unscrew the Mounting Bracket.
Clean the equipment with a soft cloth moistened in water or a mild soap solution. To
disinfect the equipment, wipe with 70% isopropyl alcohol.
5.2 Cleaning the TrachFlush device
Always disconnect the device from electrical power before cleaning.
Notice:
- Strong solvents, such as acetone or trichlorethylene, may damage the surface.
- Be sure to only clean around the connection ports, not inside them.
- Be particularly careful with infectious patients and follow your hospital infection protocol
procedures.
Clean the equipment with a soft cloth moistened in water or a mild soap solution. To
disinfect the equipment, wipe with 70% isopropyl alcohol.
5.3 Disposal of the TrachFlush Cuff Pressure and Airway tube set
The TrachFlush Cuff Pressure and Airway Tube set
• Is intended for single patient use only and must not be used on multiple patients in
order to avoid cross infections between patients.
• is a single use device, which shall not be cleaned, disinfected or re-processed in any
way.
• should be disposed in accordance with local regulations for contaminated and
biologically hazardous items.