Mallinckrodt INOblender 10026, Operation And Maintenance Manual

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Part No. 20732 Rev-02
2014-02
3
Cautions and Warnings
WARNINGS:
• The purge procedure must be followed
to help ensure NO
2
is purged from the
pressure regulator, INOblender and hoses
before the manual resuscitator bag or nasal
cannula is connected to the patient. The
manual bag should be squeezed repeatedly
during use to avoid NO
2
building up in the
bag. If the bag is not squeezed repeatedly
while delivering INOMAX the bag should
be removed from the patient and the purge
procedure performed before continuing.
• The INOblender should only be used
in accordance with the indications,
usage, contraindications, warnings and
precautions described in the INOMAX drug
package insert and labeling. Refer to this
material prior to use.
• Persons using this device should be trained
on and experienced in the use of this
device to assure effective administration of
INOMAX and to avoid injury to the patient
or others resulting from inhalation of
excess INOMAX, nitrogen dioxide or other
reaction products.
• The National Institute for Occupational
Safety and Health (NIOSH) in the U.S. has
a recommended time-weighted (8 hours)
average concentration of 25 ppm for NO
and a limit of 1 ppm for NO
2
. Persons using
the INOblender who may be particularly
sensitive to NO or NO
2
, or who may be
exposed to these agents for prolonged
periods as a result of the use of this device,
should be aware that the INOblender
does not scavenge the exhaust drug,
and that this is vented at the resuscitator
bag. Ambient concentrations of NO or
NO
2
are expected to be less than 0.2 ppm
when using the INOblender, see Section 1
Environmental Effects.
Cautions:
• Outside the U.S. and Canada, check local
laws for any restrictions that may apply.
U.S. federal law and Canadian law restrict this
device to sale by or on the order of a licensed
medical practitioner.
• Proper use of this product depends on careful
reading and understanding of labeling and
instructions.
• To help ensure proper operation of this
product, complete the pre-use checkout prior
to each use.
• When not in use, the O
2
flow meter and the
INOMAX cylinder valve should be turned off.
• When cleaning, do not submerge in liquid.
• Do not autoclave.
• Refer to the manufacturer’s procedures for
using the resuscitation bag.
WARNING:
Warnings tell you about dangerous conditions
that can cause injury to the operator or the
patient if you do not obey all of the instructions
in this manual.
Caution:
Cautions tell you about how to properly use
the equipment and conditions that could cause
damage to the equipment.
Read and obey all warnings and cautions.
Note:
Notes provide clarification or supplemental information.
Blue arrow denotes required user action.