Important; Intended Use - Philips Respironics I-neb AAD Guia Del Usuario

1 Important

The I-neb is a sensitive medical device and
should be handled with care. To make sure
that your I-neb works properly and lasts a long
time, follow the important instructions in this
user guide.
The I-neb is a 'clean, non-sterile' product and
is for single patient use only. The I-neb can only
be used with the battery and charger supplied.
Do not attempt to take the I-neb body apart or
tamper with the software or hardware in this
product.
Tested to IEC60601-1 and IEC60601-1-2.
Class ll Type B
This device complies with part 15 of the FCC
rules.
Compliant with the WEEE/RoHS
recycling directives. If you are subject
to the WEEE/RoHs directives, contact
Philips Respironics for the passport for
recycling this product.
1.1 Intended use
• The intended purpose of the I-neb AAD
system is that it is an ultrasonic (vibrating
mesh) nebulizer system designed to
aerosolize liquid medication approved for use
with the I-neb AAD System, for inhalation
by the patient in the home care, nursing
home, sub-acute institution, or hospital
environment.
• The I-neb has been developed for adults
and children aged 2 and upwards who can
co-ordinate breathing into a mouthpiece.
The I-neb should always be used in
conjunction with patient data supplied by the
specific drug licence.
• I-neb should only be used on conscious and
spontaneously breathing patients.
Important
12035_RRDD_InebPH_InstESUS_1056844_Issue1_v10.indd 5
• If you require any further information
about your treatments contact your nurse/
clinician/healthcare provider.
• If you have any problems with your I-neb,
contact the patient helpline.
This user guide will help you use your I-neb.
Pay special attention to the notes which will
help prevent damage to your I-neb and help
you get the best results.
Warnings
• As with all aerosol drug delivery devices, there
is a remote possibility that in a case in which the
amount of drug being inserted into the device
is greater than the dose that is to be delivered
by the device, a device malfunction may result
in an overdose of drug being delivered to the
user. In the event that you experience any of the
overdose symptoms listed in the drug information
for the drug you are taking with this device, you
should contact your physician immediately.
• The I-neb must not be used in the presence of
medical gases or in oxygen enriched atmospheres.
Do not run oxygen through the I-neb. If you use a
nasal cannula to deliver oxygen, you may continue
to use it while taking a treatment with the I-neb.
If you use an oxygen conserver (pulsed oxygen),
return to a continuous flow oxygen system while
taking a treatment.
• Before starting your treatment, remove or turn
off cell or cordless phones within 3.5 feet of the
I-neb. Even when turned off, they may interfere
with the operation of the I-neb.
• Refer also to the Warnings throughout this
manual.
Cautions
• Federal law restricts this device to sale by or
on the order of a physician.
• Operation is subject to the following two
conditions:
1. This device may not cause harmful
interference, and
2. This device must accept any interference
received, including interference that may
cause undesired operation.
• Refer also to the Cautions throughout this
manual.
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