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Overpressure safety (audible "clicks")
Should the tracheal wall seal pressure exceed 57 mmHg,
a safety valve will audibly "click" open and vent the
excess pressure. It will subsequently reset itself with a
second "click", at 27 mmHg for safe operation. The first
and second "clicks" may be simultaneous and be heard
as a double click.
CAUTION: If persistent clicking of the safety valve is
heard for any reasons other than a user setup error or
substantial patient movement, then there may be a
fault with the Venner PneuX TSM™. Contact the local
distributor for technical support.
ETT/TT pilot valve failure
In the event of a failed pilot valve, the Venner PneuX TSM™
may not be able to maintain an effective seal. Perform
re-intubation with a new Venner PneuX™ ETT/TT as
soon as the clinical circumstance allows.
2.4 Disconnection
Prior to disconnection, perform subglottic secretion
drainage to clear the subglottic space. If required,
proceed to disconnect the ETT/TT from the Luer slip
connector of the Extension Tube and subsequently,
disconnect the Luer lock connector of the Extension
Tube from the Venner PneuX TSM™.
Cuff pressure should be maintained temporarily (at
hourly intervals) with a standard cuff manometer until
a new Venner PneuX™ ETT/TT is reconnected to
Venner PneuX TSM™.
CAUTION: Note that the intracuff pressure is normally
maintained at 80 cmH
0 with the Venner PneuX™ ETT/
2
TT, this is equivalent to 30 cmH
0 when using a cuff
2
manometer, or 20 mmHg on the Venner PneuX TSM™.
Take care when using a cuff manometer or syringe for
inflation due to the potential for variations in pressure.
Positive End-Expiratory Pressure (PEEP) may provide
additional protection during manual cuff pressure
adjustments if it is indicated and deemed clinically safe.
2.5 Shutdown
Press the Power On/Off button to switch off the Venner
PneuX TSM™. Disconnect the system properly
(refer to
Section 2.4:
Disconnection) before unplugging the
Mains charger from the wall outlet.
Dispose of the Extension Tube as a contaminated item
and clean the Venner PneuX TSM™ following the cleaning
instructions
(refer to Section 4:
Decontamination).
6
3. Alarms, buttons and indicators
Alarm Reset button
(Figure
1a:B)
When pressed, this button will cancel sounding alarms
for about 1-2 minutes and if no intervention has taken
place during this time, the alarms will re-sound to alert
users for attention.
CAUTION: DO NOT ignore alarms or continuously
press the Alarm Reset button.
Leak, Malposition and Blockage alarm indicators
(Figure
1a:C)
These alarm indicators should be checked and
actioned upon immediately if sounded. DO NOT
ignore alarms and they should not replace the need
for continual patient monitoring.
Leak alarm indicator
This alarm indicator will illuminate RED and produce an
audible alarm when an exceptional air leak is detected.
This may suggest:
•
A detachment with the connection. Check both
connections of the ETT/TT pilot valve with the Luer
slip connector of the Extension Tube as well as the
Luer lock connector of the Extension Tube with the
Connector outlet on the Venner PneuX TSM™.
Perform reconnection if required.
•
A puncture with the Extension Tube or ETT/TT.
The cuff of the ETT/TT will deflate and an air leak with
patient ventilation may be audible. Should this occur,
disconnect the system
(refer to Section 2.4:
Disconnection), remove the damaged Extension Tube
or ETT/TT and inflate the cuff with a cuff manometer.
Proceed to reconnect a new Extension Tube and
ETT/TT to the Venner PneuX TSM™
(refer to
Section 2: Operating
instructions).
CAUTION: Note that the Venner PneuX™ ETT/TT will
remain inflated for up to an hour without connecting
to the Venner PneuX TSM™, however, cuff pressure
should still be monitored and maintained (where
necessary) with a cuff manometer.
Malposition alarm indicator
This alarm indicator will illuminate RED and produce
an audible alarm if a sustained and increased air
requirement for cuff inflation is detected. The alarm
will trigger for as long as there is an increased air
requirement (until the cuff is fully inflated within the
larynx or stoma).
If an ETT is in place, the cuff may have moved into the
larynx/pharynx resulting in a partial extubation. If a TT
is in place, there could be a withdrawal into an open
stoma or an accidental extubation.
Should this occur, disconnect the system
(refer to
Section 2.4:
Disconnection) and deflate the cuff for
re-intubation using a cuff manometer. Proceed to
reconnect a new Venner PneuX™ ETT/TT to the
Venner PneuX TSM™
(refer to Section 2: Operating
instructions).
CAUTION: A malposition false alarm is possible
if a patient is coughing excessively or experiencing
laboured breathing.
Blockage alarm indicator
This alarm indicator will illuminate RED and produce an
audible alarm if the standard cyclical pressure variability
associated with mechanical ventilation is lost. This may
suggest:
•
An occlusion with the Extension Tube or ETT/TT
inflation line. Check to confirm and if so, disconnect
the system
(refer to Section 2.4:
Disconnection) and
replace with a new Extension Tube or ETT/TT for
reconnection with the Venner PneuX TSM™
(refer to
Section 2: Operating
instructions).
•
An occlusion with the inflation lumen within the
airway tube due to external compression, e.g.,
an overtightened lock nut or external tie around the
ETT/TT. If so, loosen the lock nut or tie to correct this.
•
A blockage of the airway lumen possibly with
secretions, causing the cyclical cuff pressure
changes to be lost. Confirm by other clinical
observations and if so, re-intubate the patient or use
standard techniques to re-establish a patent airway.
CAUTION: A blockage false alarm is possible if the
patient is breathing very gently.
Target Seal Pressure indicator
(Figure
1a:D)
This indicator illuminates GREEN next to the seal
pressure being set: 10, 20, 30, 40 or 50 mmHg.
The default seal pressure setting is 20 mmHg (approx.
30 cmH
O) and should not be changed unless
2
necessary following clinical review. Use the Target Seal
Pressure Selector Keys to change and set the required
seal pressure.
The following situations may require an increase in
seal pressure above 20 mmHg (approx. 30 cmH
O)
2
temporarily:
•
Patients with high intrathoracic pressures who have
a translaryngeal air leak with ventilation (particularly
with high PEEP and peak pressure requirements).
If increased seal pressure is required to prevent a
translaryngeal air leak, check the cuff position for
unintentional carinal or laryngeal placement.
•
Patients with abnormal tracheal anatomy
•
Patients intubated with an incorrect (smaller)
ETT/TT size (normally size 8.0 mm for a female
and size 9.0 mm for a male)
Venner PneuX TSM™ Cuff Pressure Controller and Extension Tube IFU
•
A volume recruitment manoeuvre which requires
greater sustained intrathoracic pressure to prevent
a translaryngeal air leak past the cuff (some clinicians
may choose to allow an air leak during recruitment
manoeuvre to create a "PEEP purge" and propel
residual upper airway secretions into the oral cavity
for removal)
•
To introduce fluid into the subglottic space at a higher
pressure in order to perform subglottic irrigation
CAUTION: If the seal pressure is set to 40 or
50 mmHg for more than three minutes, its indicator
will flash to visually alert users that the current seal
pressure is higher than normal.
Target Seal Pressure Selector Keys
(Figure
1a:E)
The (+) and (-) selector keys allow users to move up
or down to select the five levels of seal pressure setting.
Mains Power indicator
(Figure
1a:F)
This indicator illuminates GREEN when the device
is switched on and working normally.
Power On/Off button
(Figure
1a:G)
This button switches the device on or off.
Fault indicator
(Figure
1a:H)
This indicator illuminates RED when the device detects
an internal fault. Other display lights may show at the
same time. Should this happen, do not use the device
and contact the local distributor for technical support.
Standby Power indicator
(Figure
1a:I)
This indicator illuminates RED when the device is on
standby mode for power on.
Seal Pressure Attained indicator
(Figure
1a:J)
This indicator illuminates GREEN after the set seal
pressure has been achieved. It normally illuminates
alongside the Target Seal Pressure indicator and Mains
Power indicator during normal operations.
Mains charger indicator
(Figure
1b:M)
This indicator illuminates GREEN when there is power
supply to the Venner PneuX TSM™ once connected
to a power outlet.
4. Decontamination
The Venner PneuX TSM™ must be cleaned and
disinfected before first use and between each patient
use, in accordance with local cleaning regime for
non-autoclavable, non-metallic devices.
Visit
www.VennerPneuX.com/IFU
for a list of
recommended cleaners and disinfectants.
All Venner PneuX™ ETT/TT and Extension Tube are
single use, they should be disposed of in accordance
with standard departmental practices after use.
7
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