Atos Medical PROVOX FreeHands FlexiVoice Instrucciones De Uso página 7

The Instructions for Use, which accompanies this product, may be revised
from time to time and must therefore be reviewed prior to each procedure in
which the product is used.
Contents
1. Descriptive information ................................................................................................7
1.1 Intended use ..............................................................................................................7
1.2 CONTRAINDICATIONS .............................................................................................7
1.3 Description of the device ......................................................................................7
1.4 WARNINGS ..................................................................................................................8
1.5 PRECAUTIONS ............................................................................................................8
2. Instructions for use .........................................................................................................9
2.1 Checkout procedures ...............................................................................................9
2.2 Operating instruction ........................................................................................9
2.3 Storage instructions ............................................................................................. 11
2.4 Device lifetime ........................................................................................................ 11
2.5 Disposal ..................................................................................................................... 11
2.6 Accessories............................................................................................................... 11
3. Troubleshooting information .................................................................................. 11
4. Additional information .............................................................................................. 12
4.1 Compatibility with MRI Examination.............................................................. 12
4.2 Travel or international use .................................................................................. 12
4.3 User assistance information .............................................................................. 12
4.4 Ordering information ........................................................................................... 12
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.
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.
ENGLISH
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