Passy-Muir PMV 005 Mode D'emploi page 3

PASSY-MUIR TRACHEOSTOSTOMY AND VENTILATOR SPEAKING VALVES
CONTENTS: This package contains one of the following Passy-Muir Tracheostomy and
Ventilator Speaking Valves (PMVs): PMV 005 (White), PMV 007 (Aqua), PMV 2000 (Clear),
or PMV 2001 (Purple); Instruction Booklet and Warning Labels for use on the trach tube pilot
balloon. A PMV Secure-It™ is also included in the PMV 2000 (Clear) and PMV 2001 (Purple)
Packaging. The PMV 005 (White), PMV 007 (Aqua), PMV 2000 (Clear) and PMV 2001 (Purple)
contain no latex. Contents are nonsterile.
READ ALL WARNINGS, PRECAUTIONS AND INSTRUCTIONS CAREFULLY PRIOR
!
TO USE
The following instructions are applicable to the PMV 005 (White), PMV 007 (Aqua), PMV
2000 (Clear) and PMV 2001 (Purple) unless otherwise indicated. See additional
instructions on ventilator application of the PMVs. These directions are intended for
use by qualified Healthcare Personnel.
INSTRUCTIONS FOR USE OF THE PASSY-MUIR TRACHEOSTOMY AND VENTILATOR
SPEAKING VALVES SHOULD BE POSTED AND PROVIDED TO THE PATIENT AND ALL
PERSONNEL INSTRUCTED IN TRACHEOSTOMY CARE.
CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician.
Store in cool, dry place.
WARNING: SINGLE PATIENT USE ONLY. THIS DEVICE IS NOT DESIGNED, SOLD, OR
INTENDED FOR USES EXCEPT AS INDICATED.
WARNING: PATIENTS USING THE PMV MUST BE OBSERVED AND/OR MONITORED
PER PHYSICIAN DIRECTION.
WARNING: TRACHEOSTOMY TUBE CUFF MUST BE COMPLETELY DEFLATED BEFORE
PLACING THE PMV. PATIENT WILL BE UNABLE TO BREATHE IF CUFF IS NOT
COMPLETELY DEFLATED .
TRACHEOSTOMY TUBE. OBSERVE PATIENT WITH PMV IN PLACE TO ASSURE
PATIENT HAS ADEQUATE AIRWAY.
WARNING: DO NOT USE WITH SEVERE AIRWAY OBSTRUCTIONS SUCH AS TRACHEAL
AND/OR LARYNGEAL STENOSIS. CAUTION SHOULD BE USED WITH END STAGE
PULMONARY DISEASE. DO NOT USE WITH PATIENTS WHO HAVE UNMANAGEABLE
PULMONARY SECRETIONS. NOT A DEVICE FOR LARYNGECTOMIZED PATIENTS.
DO NOT USE WITH ENDOTRACHEAL TUBES. DO NOT USE WHILE SLEEPING.
WARNING: USE CAUTION WHEN USING A PMV WITH A HEAT MOISTURE EXCHANGER
(HME) DEVICE OR HYGROSCOPIC CONDENSER HUMIDIFIER (HCH). THESE
DEVICES OBTAIN HUMIDITY FROM THE EXHALED BREATH OF A PATIENT. WITH
THE PMV IN PLACE, AIR IS NOT EXHALED VIA THE TRACHEOSTOMY TUBE AND
THIS MAY AFFECT THE PERFORMANCE OF THE HME OR HCH. ADDITIONAL
HUMIDIFICATION MAY BE NEEDED.
CAUTION: When using a PMV 005 (White) with a tracheostomy tube that has a disposable
inner cannula with grasp ring, the inner cannula may need to be removed prior to PMV
placement if the grasp ring extends beyond the 15mm hub of the tracheostomy tube. Failure
to remove the inner cannula prior to use may obstruct opening movement of the PMV 005
(White) diaphragm.
CAUTION: Remove PMV prior to delivery of medicated nebulizer treatments. If the PMV is
inadvertently used during a medicated nebulizer treatment it should be removed immediately
and rinsed thoroughly to remove medication residue as some medications may adversely affect
the PMV diaphragm.
DESCRIPTION
The Passy-Muir Tracheostomy and Ventilator Speaking Valves (PMVs) are designed to eliminate
the necessity of finger occlusion for the patient with a tracheostomy tube while allowing the
patient full-power, uninterrupted speech.
INSTRUCTIONS FOR USE
DO NOT USE WITH FOAM FILLED CUFFED
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