Mallinckrodt INOmax DS - User Manual

IMPORTANT: This guide is provided as a convenience and for General Information only. Never
use this product without clearly and thoroughly understanding the most recent revision of the
INOmax DS, INOmax DS
IR
and INOvent Operation Manuals. The Operation Manual is the source
for specic, updated information regarding warnings, cautions, checklists, diagrams, and/or
instructions contained in this guide.
See set up diagram on the reverse side of this document
For assistance contact Technical Support 877-566-9466
WARNING:
1. Avoid recirculation of gases.
Undesired recirculation of gases
will occur if fresh gas ows are less
than the patient minute volume and
may result in:
• Higher NO
2
levels due to the
limited ability of the carbon
dioxide absorbent to remove
NO
2
.
• Higher concentrations
than those set due to NO
recirculated through the
absorber.
• Reduction in O
2
concentrations
because nitrogen is the
balance gas for nitric oxide
and will be present in the re-
circulated gases.
2. If the Injector Module was used
in the wet/humidied part of the
breathing circuit, it should be
sterilized between each patient use.
Caution:
1. Note airow direction on the
Injector Module: the ow out of the
absorber must pass through the
Injector Module in the direction of
the arrow on the module.
2. Nitrous oxide (N
2
O) will affect
the Set NO versus the measured
NO value. For a 50% N
2
O, 50%
O
2
composition, the measured
NO value will be approximately
7% indicated less than the
same Set NO value of 100%
O
2
. For example, at a Set NO
of 20 ppm, measured NO will be
approximately 18 ppm.
3. Similarly, the effect of 2%
v/v isourane will result in a
high measured NO value of
approximately 3% indicated for the
same Set NO value at 100% O
2
.
4. Sudden changes in anesthetic
agent concentration may cause
brief transient changes in the
measured NO and NO
2
values.
Connection to a Circle Anesthesia Ventilator System

Summary

Safety Warnings

Gas Recirculation Hazards

Avoid recirculation; can lead to higher NO2, altered NO concentrations, and reduced O2.

Injector Module Sterilization

Sterilize Injector Module between patient uses if in wet/humidified breathing circuit.

Operational Cautions

Injector Module Airflow

Ensure flow out of absorber passes through Injector Module in the direction of the arrow.

Effect of N2 O on NO Measurement

N2O affects Set NO vs. measured NO; 50% N2O/50% O2 composition shows ~7% less measured NO.

Effect of Isoflurane on NO Measurement

2% v/v isoflurane results in ~3% higher measured NO value compared to 100% O2.

Anesthetic Agent Concentration Changes

Sudden changes in anesthetic agent concentration can cause brief transient changes in measured NO/NO2 values.

System Setup Notes

Breathing Circuit Gas Flow

System performs as specified with fresh gas flow rates equal to or greater than patient minute volume.

Breathing Circuit Length

Circuit between sample tee and patient Y should be 6-12 inches for accurate gas sampling.

Injector Module Placement

For OR systems, place Injector Module upstream of inspiratory flow sensor.

Mallinckrodt INOmax DS Specifications

General

Device Type	Nitric Oxide Delivery System
Monitoring Capabilities	Continuous monitoring of NO, NO2, and O2 concentrations
Power Supply	100-240 VAC, 50/60 Hz
Brand Name	INOmax
Manufacturer	Mallinckrodt
Indication	Treatment of term and near-term infants with hypoxic respiratory failure.
Gas Source	Nitric Oxide (NO)
Concentration Range	0-80 ppm
Flow Rate	0.05 to 10 L/min
Alarms	High NO2, Low NO, High NO, Low O2, System Malfunction