Intended Use; Adverse Reactions - Pulmodyne Blom Manual Del Usuario

Latex Free Single Patient Use

INTENDED USE:

The Blom Tracheostomy Tube System is intended to provide tracheal access for airway management
of tracheostomized patients >30kg.
OD (mm) ID (mm)
# 4 9.4 5.0
# 6 10.8 6.4
# 8 12.2 7.6
#10 13.8 8.9
WARNINGS:
• This device is only to be used by qualified healthcare practitioners and caregivers.
• Contact with electro surgery electrodes or laser surgery beams must be avoided because the
materials will produce toxic fumes in the air or ignite in an enriched oxygen atmosphere.
• Patients should be adequately humidified to prevent mucosal damage and minimize encrustation
of the lumen or the tracheostomy tube and/or inner cannula.
• Tracheostomy Tubes must be changed regularly according to individual patient's requirements
to avoid blockage causing airway obstruction or reduction in lumen of the airway increasing the
patient's effort to breathe through the tube.
• If it is not possible to remove the inner cannula from the Tracheostomy Tube, do not try to forcibly
remove it. Both the inner cannula and Tracheostomy Tube should be removed together and
replaced with a new Tracheostomy Tube and inner cannula.
If using a Fenestrated Tracheostomy Tube: If using a Fenestrated Tracheostomy Tube:
• An inner cannula must be in place during deep pulmonary suctioning to prevent the suctioning
catheter from protruding through the fenestration of the Tracheostomy Tube. Suctioning without
an inner cannula in place could result in damage to the tracheal wall and could cause the suction
catheter to become caught in the fenestration.
• Devices used during or after cuff inflation must be clean and free from foreign matter.
• Prevent cuff damage by avoiding contact with sharp edges including cartilage, instruments and
other devices.
• As a further precaution for ventilator dependant patients, cuff inflation should be checked on a
regular basis and replacement Tracheostomy Tubes should be kept at bedside.

ADVERSE REACTIONS:

• Reported adverse reactions associated with tracheostomy tubes are many and diverse. Consult
standard textbooks and medical literature for information on specific adverse reactions.
I
Contains or Presence of Phthalates
CUFF RESTING LENGTH
DIAMETER (mm) (mm)
21 62
25 74
27 79
32 79
CAUTIONS:
• For Single Patient Use only
• Reuse or reprocessing of this device may compromise material and design characteristics
leading to device failure. Reuse may also create a risk of contamination leading to patient
infection or cross-infection
• DEHP is a commonly used platicizer. The potential effects of DEHP on nursing/pregnant
women and children have not been fully characterized and there may be concern for
reproductive and development effects.
• Contents sterile unless package is damaged or opened
• Read all provided information before using this product
• Patency of the Tracheostomy Tubes and inner cannulas must be checked prior to insertion and
be assured during use by regular suctioning. Inner cannulas must be checked regularly and
replaced regularly to maintain a patent airway. The maximum recommended period of use for
the Tracheostomy Tube is 30 days. The maximum recommended period of use for the Standard
Cannula, Subglottic Suctioning Cannula and Decannulation Plug is 24 hours or according to
local established protocols. The maximum recommended period of use for the Speech Cannula
and the LPV is 60 days.
• Use universal precautions when in contact with a tracheostomized patient's tube and/or inner
cannulas
• Proper sizing, insertion, and withdrawal of the Tracheostomy Tube should be in accordance with
accepted medical techniques and expert clinical judgment.
• When selecting an inner cannula, ensure that the size corresponds with the Tracheostomy Tube.
Size markings are provided on the tube, flange, and package label to help identify the correct
inner cannula size to use.
• Ventilator circuits should be well supported to reduce stress on the tracheostomy hub and the
patient's stoma site. A swivel adapter may be used to reduce torque and motion at the 15 mm
hub of the Tracheostomy Tube.
• Make sure all ventilator circuit connections are snug and that the inner cannula clips are
fastened securely
• Only sterile saline should be used to clean accessible parts. If the tube is removed it should be
discarded. No reusable device is included.
• Dispose of the product in a safe manner according to local established protocols.
If using the Fenestrated Cuffed Tracheostomy Tube:
• Cuff pressure or volume should be monitored and recorded to avoid over inflation and any
associated damage.
• The inflation line valve may interfere with MRI clarity. Ensure that the valve is positioned
away from the area being scanned.
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