Atos Medical Provox FreeHands FlexiVoice, Инструкция по эксплуатации

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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 ............................................................................................................9
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
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
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