Table of Contents
Advertisement
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
manual for its setup and operation)
• A strong magnetic field such as that from an MRI system can affect the ability of the
WARNING:
INOmeter to detect if the cylinder valve is open. This can cause a "Cylinder Valve Closed"
alarm to occur when the cylinder valve is actually open. If this alarm occurs, reposition/
rotate the INOmax DS
interference in the area of the INOmeter until the cylinder handle graphic on the display
turns green. This will resolve the "Cylinder Valve Closed" alarm. Typically the required
INOmax DS
degrees. Note that Interruption of INOMAX therapy will occur one hour from point when
the "Cylinder Valve Closed" alarm is activated if the alarm is not resolved
• Only use a size "88" (1,963 liters) cylinder that is marked "MR Conditional. Keep cylinder
at 100 gauss or less." with the DS
cylinder may create a projectile hazard.
• The INOmax DS
or 3.0 Tesla strength ONLY in areas where the field strength is less than 100 gauss.
• This device contains ferromagnetic components and hence will experience strong
attraction close to the magnet. It should be operated at a fringe field of less than 100
gauss.
• Do not exceed 100 Gauss; system operation may be impacted.
• Confirm cart auto-brake function. Optionally connect tether.
• Arrange power cord, MR patient gas sample line, MR injector tubing and MR injector
module cable to avoid entanglement, strangulation and/or a trip hazard.
• Set the INOmax DS
monitor any inadvertent changes in treatment.
• The use of pediatric and neonatal ventilator settings with adult size breathing circuits
can result in high levels of NO
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
set up while maintaining INOMAX delivery. Adjust the dose as described in the
INOMAX Prescribing Information - The Effects of Nitrogen Dioxide. If unable to
determine the cause of the increased NO
discontinue therapy.
Use Outside of Product Labeling
• The INOmax DS
usage, contraindications, warnings and precautions described in the INOMAX (nitric
oxide) drug package inserts and labeling. Refer to this material prior to use.
• Helium/oxygen mixtures should not be used with the INOmax DS
• The use of devices which radiate high-intensity electrical fields may affect the
operation of the INOmax DS
life support equipment is mandatory whenever interfering devices are in operation
on or near a patient.
• Only use parts/accessories designated for use with this system.
• The target patient population is controlled by the drug labeling for INOMAX and is
currently neonates. The INOmax DS
patient populations.
Part No. 20568 Rev-02
2015-08
Plus MRI into the patient's breathing circuit. (See the ventilator/breathing device
IR
Plus MRI cart outside the 100 Gauss area to reduce the magnetic
IR
Plus MRI cart location adjustment is less than 6 inches (15 cm) / 90
IR
Plus MRI is classified as MR Conditional with MR scanners of 1.5
IR
Plus MRI alarm thresholds for the current patient conditions to
IR
alarm activates, the delivery system should be assessed for proper
2
Plus MRI must only be used in accordance with the indications,
IR
IR
Plus MRI while in the scanner room. Use of any other
IR
. Always use the size of breathing circuit that is
2
levels, call technical support, do not
2
Plus MRI. Constant surveillance of all monitoring and
Plus MRI is not intended to be used in other
IR
Plus MRI.
IR
3-1
Advertisement
Table of Contents
