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1.4 WARNINGS

Speaking Valve specifi c
(Speaking Valve in combination with HME 15 or 22).
WARNING
If a tracheostomy tube with a cuff is used, the cuff must be
completely defl ated before placing, and during all use of the
Speaking Valve. The patient cannot breathe if the cuff is not
completely defl ated. There should be suffi cient airfl ow around
the tracheostomy tube and the defl ated cuff. DO NOT use the
Speaking Valve for patients who use a tracheostomy tube with
a self-infl ating or foam-fi lled cuff.
Use of Warning Labels: Attach warning labels provided
with Speaking Valve to the tracheostomy tube pilot balloon
infl ation line (Figure 1).
Monitoring: Patients with a tracheostomy tube with a cuff using
the Speaking Valve must be monitored according to physician
direction. Continuous observation is needed to make sure that
the patient can exhale through the upper airway.
Education: To ensure correct use of the Speaking Valve, the
patient, family, caregivers, and all personnel working with
the patient must be instructed on how to use Speaking Valve,
including contraindications, warnings, warning labels and
precautions.
Do
- Do make sure the patient has the respiratory ability to
exhale around the tracheostomy tube and out of the nasal
and oral cavities.
- Do make sure the patient has been cleared by the physician
for cuff defl ation. Cuff defl ation is mandatory with the
Speaking Valve to allow exhaled air to pass around the
tracheostomy tube and upper airways.
- Do make sure the tracheostomy tube is sized to allow
for suffi cient airfl ow around the tracheostomy tube to
facilitate speech. The cuff on the tube can also generate an
obstruction even when defl ated and this should be taken
into consideration during airway patency assessment.
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