3
Instructions for Use
Rx Only: Federal (USA) law restricts this device to sale by or on the order
of a physician.
These instructions apply to the following families of
HALYARD* products:
• Double Swivel Elbow
• Regular Elbow
• T-Piece
• HALYARD* WET PAK*
• HALYARD* Turbo-Cleaning
These instructions also apply to the following
configurations of the above families of products:
• Dual Lumen
• Directional Tip
• Tracheostomy Length
• Metered Dose Inhaler Adapter
Warning:
1. Cap on HALYARD* T-Piece prevents continuous flow therapy.
Remove cap before starting continuous flow therapy.
Failure to remove cap prior to continu ous flow therapy may
result in serious injury or death.
2. Do not trim or cut the endotracheal tube (not supplied)
while the HALYARD* Turbo-Cleaning Closed Suction System
is attached, otherwise the HALYARD* catheter may also be
cut and that portion of the catheter may be aspirated into
the lower respiratory tract of the patient and may cause
death or serious injury.
3. Do not reuse, reprocess, or resterilize this medical device.
Reuse, reprocessing, or resterilization may 1) adversely
affect the known biocompatibility characteristics of the
device, 2) compromise the structural integrity of the device,
3) lead to the device not performing as intended, or
4) create a risk of contamination and cause the transmission
of infectious diseases resulting in patient injury, illness,
or death.
Cautions:
The following cautions apply to all
HALYARD*
products, as indicated:
1. Inspect
HALYARD*
catheter package before opening. Do not use
product if packaging has been compromised. Nonsterile contents
may cause infection.
2. Excess fluid in heat and moisture exchanger (HME) may increase
gas flow resistance. When introducing fluid into T-Piece, ensure that
fluid does not enter HME.
3. Always place the thumb valve in the locked position when not in use
to prevent inadvertent activation.
4. Single patient use only.
5. Do not use
HALYARD*
Turbo-Cleaning catheter for more than
72 hours. Do not use any other
HALYARD*
catheter for more than
24 hours.
6. Remove red wedge plug from
HALYARD*
Turbo-Cleaning prior to use.
7. Inspect sodium chloride vial prior to opening. Do not use product
if vial has been compromised. Compromised contents may cause
infection.
8. Do not use 54 cm (21.3 inch) catheters on tracheostomy patients.
Mucosal damage may result.
9. Select the appropriate size
HALYARD*
catheter. Most experts suggest
that the catheter selected should occupy no more than one half of
the internal diameter of the artificial airway.
10. Do not leave the catheter within the airway. Always pull back
until the black stripe is visible within the sleeve. Any catheter left
extended into the airway will cause increased airway resistance.
11. Use appropriate regulated vacuum levels. Most experts suggest -80
to -120 mm/Hg (-10.7 to -15.9 kPa).
12. Use appropriate suction technique. Most experts suggest that the
entire suction procedure should last no longer than 10 to 15 seconds
and that actual duration of negative pressure should be no longer
than 5 to 8 seconds per episode.
13. Always use caution and good clinical judgement no matter what
ventilator mode is in use. If the clinician notes any signs of suction
intolerance such as oxygen desaturation, negative ventilator system
pressures, patient stress or excessive discomfort, adjustments to
the ventilator settings may need to be made. These adjustments
(please refer to the ventilator’s instructions for use) may include
manipulation of the inspiratory trigger sensitivity, inspiratory
volume or flowrate, and selection of a different ventilator mode;
or may require the use of an alternate suction technique. Failure to
follow the above precautions may increase the risk of positive and
negative barotrauma.
14. This medical device contains DEHP (diethylhexylphthalate) that is
presently classified in the European Union as a presumed human
reproductive toxicant based on data from animal studies. There is
no conclusive scientific evidence that exposure to DEHP contained
in medical devices has caused harmful effects in humans. A risk
assessment, which took into account DEHP exposure of all indicated
patient populations, including those who are potentially at
increased risk, was performed for this device and the conclusion is
that the device is safe when used as directed.
e
HALYARD*
Turbo-Cleaning Closed Suction System for Adults
Summary of Contents for Turbo-Cleaning Closed Suction System for Adults with BALLARD...
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