Mallinckrodt INOMAX DSir Plus, Operation Manual

Page: 53 / 206

Part No. 20717 Rev-01
2014-07
3-1
3/ Patient Application
Before Operation
Complete the initial connections and Pre-Use Checkout procedure as described in the previous sections
before connecting the INOmax DS
IR
into the patient’s breathing circuit. (See the ventilator/breathing device
manual for its setup and operation)
WARNING:
• Set the INOmax DS
IR
alarm thresholds for the current patient conditions to
monitor any inadvertent changes in treatment. For alarm information,
see Section 5/ Alarms.
• The use of pediatric and neonatal ventilator settings with adult size breathing
circuits can result in high levels of NO
2
. Always use the size of breathing circuit
that is appropriate for the patient.
• Abrupt discontinuation of INOMAX may lead to worsening oxygenation and
increasing pulmonary artery pressure, i.e., Rebound Pulmonary Hypertension
Syndrome. To avoid abrupt discontinuation, utilize the INOblender or integrated
pneumatic backup if necessary. If Rebound Pulmonary Hypertension occurs,
reinstate INOMAX therapy immediately (See the INOMAX prescribing Information
for further details.)
• If the high NO
2
alarm activates, the delivery system should be assessed for
proper set up while maintaining INOMAX delivery. Adjust INOMAX and/or FiO
2
as appropriate. (See INOMAX Prescribing Information for further details on
the effects of Nitrogen Dioxide, NO
2
). If unable to determine the cause of the
increased NO
2
levels, call technical support, do not discontinue therapy.
Use Outside of Product Labeling
• The INOmax DS
IR
must only be used in accordance with the indications, usage,
contraindications, warnings and precautions described in the INOMAX (nitric
oxide) drug package inserts and labeling. Refer to this material prior to use.
• The manufacturer does not recommend that the INOmax DS
IR
be utilized with
helium/oxygen mixtures in any situation. The INOmax DS
IR
is intended to deliver
INOMAX therapy gas only in conjunction with the delivery of air and oxygen. The
use of helium/oxygen mixtures will lead to over-delivery of INOMAX which may
lead to interruption of therapy.
• The use of devices which radiate high-intensity electrical fields may affect the
operation of the INOmax DS
IR
. Constant surveillance of all monitoring and life
support equipment is mandatory whenever interfering devices are in operation
on or near a patient.
• Do not connect items which are not specified as part of the system.
• The approved patient population for the INOmax DS
IR
, as specified in the drug
labeling for INOMAX (nitric oxide) for inhalation, is limited to neonates. The
INOmax DS
IR
is not intended to be used in other patient populations.
Caution:
• Use distilled water in the humidifier to prevent the formation of bases or acids.
• High frequency and/or high intensity light emission, in the area of the INOmeter, may
interfere with communication between the INOmax DS
IR
and the INOmeter on the INOMAX
cylinder (see page 1-16).
•
The gas sensors in the INOmax DS
IR
monitoring system require humidity in the sample
gas to function correctly over the long term. Using the INOmax DS
IR
without water in the
humidifier will shorten the life of the gas sensors.