Intended Use - PROVOX FreeHands FlexiVoice Set Plus Manual Del Usuario

ENGLISH
1. Descriptive information

1.1 Intended use

The Provox FreeHands FlexiVoice combines pulmonary rehabilitation using
a Heat and Moisture Exchanger with voice rehabilitation using an Automatic
Speaking Valve or Manual Occlusion, in laryngectomized patients using a
voice prosthesis.
1.2 CONTRAINDICATIONS
The Provox FreeHands FlexiVoice is not intended to be used by patients unable
to remove or operate the device, unless the patient is under constant supervision
of a clinician or a trained caregiver. For example, patients who are unable to
move their arms, patients with decreased levels of consciousness, or patients with
diseases that put them at risk for unpredictable periodic loss of consciousness.
1.3 Description of the devices
The Provox FreeHands FlexiVoice consists of two parts assembled together,
a speaking valve for single patient use and a disposable HME cassette (Fig. 1).
The speaking valve is made of plastic and the membrane is made of silicone.
The HME cassette is also made of plastic and a salt treated polyurethane foam.
The speaking valve has two modes; Automatic Speaking Mode and Locked
Mode (Fig. 2). Rotating the top of the speaking valve moves the device into
the automatic speaking or the locked position. Speaking can be done both by
using the automatic speaking valve and by manual occlusion of the opening
in the front. Manual occlusion is possible in both modes.
The speaking valve is in automatic speaking mode when the flexible membrane is
not locked by the hook (Fig. 3). In automatic speaking mode, the membrane can
be closed automatically by the exhaled air. The air is then redirected through the
voice prosthesis. The membrane opens again automatically when breathing in.
In locked mode, the flexible membrane is locked by a hook that goes into a loop
in the membrane (Fig. 4). This prevents the membrane from closing when
breathing heavily, for example, during physical activity.
There are four different speaking valves, each with a different strength membrane:
light, medium, strong and xtrastrong.
On the membrane part that protrudes on the top of the device, there are 1, 2, 3 or 4
dots visible. The number of dots represents the strength of the membrane (Fig. 5).
1 dot = Light membrane (easiest to close)
2 dots = Medium membrane
3 dots = Strong membrane
4 dots = XtraStrong membrane
The Arch is an accessory that can be used with the Provox FreeHands FlexiVoice
to keep fabric away from the opening of the device. It is simply pressed onto
the front of the Provox FreeHands FlexiVoice (Fig. 6). Please note that in some
positions the Arch may restrict the possibility of manual occlusion.
The Removal Aid (Fig. 7) can be used to remove the HME cassette from the
speaking valve.
Content of the sets
Provox FreeHands FlexiVoice Set &
Provox FreeHands FlexiVoice Set Plus
3 Speaking Valves (Light, Medium, and Strong)
1 Removal Aid
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