Pulmodyne Blom Manual Del Usuario página 4

USE OF THE BLOM SPEECH CANNULA
Intended Use
The Speech Cannula is designed to be used only in conjunction with the Blom Fenestrated Cuffed
Tracheostomy Tube. The Speech Cannula is intended to allow ventilator dependent adults, >30kg,
with a functional larynx and unobstructed upper airway, to vocalize/phonate while full cuff inflation is
maintained.
CONTRAINDICATIONS:
Do not use this device for patients with abnormal upper airway anatomy or pathology as this may
result in partial or total airway obstruction.
Patient Requirements:
• The patient must be ventilator dependent on a standard or portable ventilator
• The patient must have a Fenestrated Cuffed Blom Tracheostomy Tube
• The patient must be arousable and have the potential to communicate
• The patient may be in volume or pressure ventilation in any ventilatory mode
• The patient does not need to be breathing spontaneously
• The patient does not need to be able to tolerate cuff deflation
• FIO 2 should not exceed 60%
• PEEP should not exceed 10
Warning: Patients who require PEEP should be placed on ventilators with
Flow Trigger or supplemental bled in oxygen.
• The patient should not have copious, thick secretions requiring suctioning more than five times
per hour
• The patient should have a patent, unobstructed upper airway
Warning: A partially or completely obstructed upper airway will result in increased airflow resistance
and work of breathing for the patient, which may cause further medical complications.
• The patient must first be evaluated and monitored by a qualified healthcare professional when
trying the Speech Cannula for the first time to ensure patient safety and proper use of this
device. Each person involved with the care and use of this device requires appropriate training
to ensure patient safety. These Directions for Use along with hands-on training should be
completed.
• The recommended duration of use for the Speech Cannula is as tolerated by the patient
• Use under qualified supervision only. If the Speech Cannula were to become occluded the
intrathoracic pressure will rise to a degree governed by the pressure-limiting features of the
ventilator.
• The Speech Cannula has a series of valves which if obstructed could prevent phonation or
be occluded like an inner Standard Cannula with secretion blockage. If the ventilator's high
pressure limit alarm continuously sounds, remove the Speech Cannula.
Blom Speech Cannula Directions for Use
1. The Speech Cannula is available in four sizes: #4, 6, 8, 10 and should only be used with the
equivalent size Blom Fenestrated Cuffed Tracheostomy Tube.
2. If used, ensure that the Exhaled Volume Reservoir (EVR) is in the appropriate location in
the circuit. For proper locations, see Directions for Use provided for the EVR.
3. Baseline heart rate, respiratory rate, oxygen saturation and ventilator parameters
should be noted prior to use and during use of the Speech Cannula.
Suggestion: Prior to inserting the Speech Cannula, use the Subglottic
Suctioning Cannula to suction above the cuff before the speech cannula is inserted. Also,
to confirm NO upper airway obstruction by blowing air into the suction port, providing air to
the mouth for verification.
4. Select the appropriate size Speech Cannula.
5. Suction the patient (if required) prior to removing the existing inner cannula and
inserting the Speech Cannula.
6. Disconnect any device tubing and adapters connected to the hub of the existing
inner cannula and slowly remove the cannula from the Tracheostomy Tube.
Warning: The Speech Cannula should be used under qualified
supervision only.
Note: With the Speech Cannula, during the inhalation cycle the Peak Pressures as measured
at the ventilator show a higher value; but the actual delivered, intra-pulmonary peak pressures
are at the clinically expected values.
7. Insert the Speech Cannula and ensure that it is securely fastened.
8. Reconnect any device tubing and adapters to the hub of the Speech Cannula.
9. Confirm proper function by observing airflow exiting the patient's mouth and nose on
EACH expiration and/or requesting the patient to phonate.
Warning: If the Speech Cannula is obstructed, it may be occluded with secretions. If the
ventilator alarms, investigate the alarm, assess the problem, and if necessary, remove the
Speech Cannula.
10. After use of the Speech Cannula, remove it and remove the EVR from the ventilator
circuit.
11. Insert a new Standard Cannula or Subglottic Suctioning Cannula and ensure that it is
securely fastened.
12. Reconnect any device tubing and adapters to the hub of the inner cannula.
13. After use, the Speech Cannula should be cleaned, air dried and stored in the
supplied container. The maximum recommended period of use for the Speech
Cannula is 60 days. See Cleaning Instructions.
USE OF THE EXHALED VOLUME RESERVOIR (EVR)
Intended Use:
The EVR is designed to be used only in conjunction with the Blom Fenestrated Cuffed
Tracheostomy Tube and Speech Cannula. The EVR is to be inserted into the ventilator
circuitry to impede the function of the low exhaled tidal/minute volume alarm during the
use of the Speech Cannula. The EVR is intended to deliver a reduced volume of air to the
ventilator monitoring apparatus to fulfill the requirements of the low exhaled tidal/minute
volume alarm setting when this parameter is synchronized at the minimum level.
EVR Position in the Circuit:
For Ventilators which measure exhaled volumes at the machine:
Install the EVR at the end of the expiratory limb of the circuit just prior to the
exhalation inlet port.
For volumes which are measured via a proximal flow sensor:
Install the EVR between the flow sensor and the patient.
EVR Directions for Use:
1. The low exhaled tidal/minute volume alarm must be set to the lowest possible
active position when using the EVR.
2. During the inspiratory phase of the ventilator, a small portion of gas fills and
expands the bellows of the EVR (approximately 30-50ml).
3. When the ventilator cycles to the expiratory phase, the bellows contracts and the
volume of gas is then returned to the ventilator for measurement. This will diminishthe
amount of "nuisance" alarms that may occur during the use of the Speech
Cannula thus allowing the practitioner to reduce the low exhaled tidal/minute volume
alarm threshold instead of completely disabling it and the ability of the ventilator to
warn of disconnects.
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