Atos Medical ProTrach DualCare User manual

Instructions for Use
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Prescription information
CAUTION: United States Federal law restricts this device
to sale, distribution and use by or on order of a physician or a
licensed practitioner. The availability of this product without
prescription outside the United States may vary from country
to country.
Disclaimer
Atos Medical offers no warranty – neither expressed nor
implied – to the purchaser hereunder as to the lifetime of the
product delivered, which may vary with individual use and
biological conditions. Furthermore, Atos Medical offers no
warranty of merchantability or tness of the product for any
particular purpose.
Patent and trademarks
ProTrach®is a registered trademark and DualCare™is a trademark
of Atos Medical AB. The products are protected by US patent
no. US 6,921,417, JP patent no. 4,156,832 as well as other patents.
Unregistered copy

Contents
ENGLISH..........................................................................9
DEUTSCH ..................................................................... 24
NEDERLANDS............................................................. 41
FRANÇAIS .................................................................... 58
ITALIANO...................................................................... 75
ESPAÑOL...................................................................... 92
PORTUGUÊS..............................................................109
SVENSKA ....................................................................127
DANSK.........................................................................142
NORSK.........................................................................158
SUOMI.........................................................................173
ORDERING INFORMATION..................................189
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9
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.
ENGLISH
Symbol explanation
Keep away from direct sunlight and heat.
Keep dry and away from rain and other moisture.
Contents
1. Descriptive information............................................................10
1.1 Intended use..........................................................................10
1.2 CONTRAINDICATIONS ........................................................10
1.3 Description of the devices................................................11
1.4 WARNINGS..............................................................................14
1.5 PRECAUTIONS .......................................................................16
2. Instructions for use.....................................................................17
2.1 Preparation and assembly of the speaking
devices............................................................................................17
2.2 Insertion and usage of Speaking Valve
with HME 15 / 22.........................................................................18
2.3 Insertion and usage of HME DigiTop and HME
DigiTop O2......................................................................................19
2.4 Removal of the HME from the speaking devices......20
2.5 Pediatric Use..........................................................................20
2.6 Cleaning and disinfection ................................................21
2.6.1 Cleaning of the speaking devices..........................21
2.6.2 Disinfection of the speaking devices....................22
2.7 Storage instructions............................................................23
2.8 Device lifetime......................................................................23
2.9 Disposal...................................................................................23
2.10 Accessories ..........................................................................23
3. Additional information.............................................................23
3.1 Compatibility with MRI Examination............................23
3.2 Ordering information.........................................................23
3.3 User assistance information.............................................23
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10
1. Descriptive information
1.1 Intended use
ProTrach DualCare is a combined Speaking Valve and Heat
and Moisture Exchanger (HME) intended for spontaneously
breathing tracheostomized patients using a tracheostomy
tube with a deated cuff, or a tracheostomy tube without cuff.
In HME-mode the device conditions inhaled air by retaining
heat and moisture from the exhaled air.
By turning the lid of the Speaking Valve into speaking mode
air is re-directed to enable speech.
The entire device is for single patient use and the HME-part
is for single use.
Patient Population: For spontaneously breathing tracheostomized
patients (adults and pediatric patients greater than 10 kg in
weight) using a tracheostomy tube with a deated cuff, or a
tracheostomy tube without cuff.
Environment of Use: Hospitals, ICU, sub-acute care institutions
and home.
1.2 CONTRAINDICATIONS
General
ProTrach HME 15 or 22 in combination with either ProTrach
DualCare Speaking Valve or ProTrach HME DigiTop are
contraindicated for:
- Use in combination with an in-line ventilator.
- Patients who are unable to handle or remove the device
themselves when needed, 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.
- Patients who cannot tolerate the added dead space of 5 ml,
or who cannot tolerate the added breathing resistance
of 170 Pa / 1.7 cm H2O. This should be evaluated by a
clinician.
- Unresponsive or sedated patients. The patient must be
responsive and attempting to communicate in order to use
the device. The patient should be able to follow instructions.
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