Mallinckrodt INOmax DSIR User manual

For 24 Hour Assistance
Call 1-877-566-9466
Part No. 20751 Rev-01
2014-08
Pocket Guide
Series 3 software
(Delivery System)
Automated Pre-Use Procedure
Integrated Pneumatic Backup INOMAX®Delivery
Transport Regulator/Cap Assembly
Oxygen Dilution Chart
INOMAX Cylinder Duration Chart
Circuit Connection Diagrams
Changing INOMAX Cylinders
High Calibration Connection Diagrams
INOmax DSIR Disposable Adapters

2
Part No. 20751 Rev-01
2014-08
IMPORTANT: This guide is provided as a convenience
and for general information only. Do not use
this product without clearly and thoroughly
understanding the most recent revision of the
INOmax DSIR®Operation Manual. The Operation
Manual is the source for specic, updated
information regarding warnings, cautions,
checklists, diagrams, and/or instructions
contained in this guide.

3Part No. 20751 Rev-01
2014-08
Mallinckrodt, the “M” brand mark and the Mallinckrodt
Pharmaceuticals logo are trademark of a Mallinckrodt company.
Other brands are trademarks of a Mallinckrodt company or their
respective owner. ©2016 Mallinckrodt

4
Part No. 20751 Rev-01
2014-08
Contents
Automated Pre-Use Checkout......................................................................5
Integrated Pneumatic Backup INOMAX Delivery .........................................8
Transport Regulator/Cap Assembly............................................................10
Oxygen Dilution Chart ................................................................................14
INOMAX Cylinder 88-size Duration Chart ..................................................15
INOMAX Cylinder D-size Duration Chart....................................................16
Connection to Various Breathing Systems .................................................17
Acutronics Medical Systems AG Fabian +nCPAP Evolution ............... 18
Acutronics Medical Systems AG Fabian HFO ..................................... 19
A-Plus Medical Babi-Plus Bubble CPAP.............................................. 20
Bagging Systems While Using the Injector Module..............................22
Bunnell Life Pulse High Frequency Ventilator Circuit ...........................24
Connecting INOmax DSIR Sample Tee to the Bunnell Life
Pulse Circuit ....................................................................................28
Connecting INOmax DSIR Injector Module to the Bunnell Life
Pulse Circuit ....................................................................................28
Circle Anesthesia System.....................................................................29
 DrägerBabylogVN500/InnityAcuteCareSystemandHeinen&
Löwenstein Leoni-plus Ventilator..........................................................30
 Fisher&PaykelHealthcareBubbleCPAP ...........................................31
 Fisher&PaykelHealthcareInfantCircuitNasalCannula ....................32
 Fisher&PaykelHealthcareOptiowBreathingCircuit ........................33
Hamilton Arabella Nasal CPAP.............................................................34
ICU Ventilator Circuit ............................................................................35
Sensormedics 3100A/B High Frequency Oscillatory Ventilator
with a Filtered Circuit .......................................................................36
Sensormedics 3100A/B High Frequency Oscillatory Ventilator
with a Rigid or Flexible Circuit .........................................................38
SLE Life Support SLE5000...................................................................39
Spontaneous Breathing Patient on a Mask Circuit ...............................40
Spontaneous Breathing Patient on a Nasal Cannula ...........................41
 TeleexMedicalComfortFloHumidicationSystem............................42
Transport Ventilator Circuit ...................................................................43
Vapotherm 2000i ..................................................................................46
Vapotherm Precision Flow....................................................................47
Viasys Infant Flow CPAP System; Cardinal Airlife nCPAP System............... 48
Viasys Infant Flow SiPAP .....................................................................49
INOblender Circuit Connection...................................................................50
 Fisher&PaykelHealthcareNeopuffResuscitator ...............................51
Changing INOMAX Cylinders.....................................................................52
High Calibration Connection Diagrams ......................................................56
INOmax DSIR Disposable Adapters............................................................58

5Part No. 20751 Rev-01
2014-08
Automated Pre-Use Checkout
1. Turn INOmax DSIR ON, verify speaker function.
Note: A low range calibration automatically starts
following the self test.
A Pre-Use wizard will be displayed on the main screen,
which will provide step-by-step instructions to complete
the automated Pre-Use procedure.
Pre-Use Checkout
- Pressing the NEXT button initiates the Pre-Use wizard.
- Pressing the CANCEL button exits the Pre-Use
wizard. If you cancel the pre-use wizard, the
manual pre-use checkout procedure can be found
on the INOmax DSIR Plus Pre-Use card, or in the
INOmax DSIR Operation Manual, section 9/Appendix.
The Pre-Use wizard can also be initiated by entering
the menu screen and selecting the Pre-Use Checkout
button.

6
Part No. 20751 Rev-01
2014-08
Pre-Use Checkout

7Part No. 20751 Rev-01
2014-08
Pre-Use Checkout
(Intentionally left blank)

8
Part No. 20751 Rev-01
2014-08
Note: Use the integrated pneumatic backup function only for
a short time, until a replacement delivery system can
be obtained. The INOblender can also be used as a
backup.
If the main delivery system fails, the INOmax DSIR has an
integrated pneumatic backup delivery function that allows
the patient to remain connected to the ventilator. Backup NO
delivery does not rely on the operation of the main system.
The INOmax DSIR backup function:
· Uses a pneumatic on/off switch and a restrictor built into
the delivery side of the system.
·ProvidesaxedowofINOMAX(250mL/min)intothe
injectormodule.Thisxedowprovides20ppmofNO
whenaddedtoacontinuousventilatorgasowof10L/min.
WARNING:
When using the integrated pneumatic backup with
breathing circuit gas ows of 5 L/min, the delivered NO
dose will be approximately 40 ppm. Breathing circuit
gas ows less than 5 L/min will deliver an NO dose
greater than 40 ppm.
The table below indicates the nominal concentrations
delivered for different ventilator gas ows.
Integrated Pneumatic
Backup INOMAX Delivery
Ventilator/Gas
Flow (L/min) 5 7.5 10 15 20
NO
Concentration
(ppm)
40 27 20 13 10
INOMAXcylinderconc.X0.25L/min/ventilatorow=estimateddose

9Part No. 20751 Rev-01
2014-08
The main screen:
· Indicates that backup delivery is on and that the set dose is
turned off.
· Displays the estimated dose that the patient should be
receiving,basedontheventilatorow.
· Displays the NO concentration table
Note: If the injector module is not functioning, the estimated
backup dose graphic will be inactive.
Backup delivery mode OFF.
Backup delivery mode ON (with a Low Priority alarm).
Integrated Pneumatic
Backup INOMAX Delivery

10
Part No. 20751 Rev-01
2014-08
Transport Regulator/
Cap Assembly
Figure 1 Figure 2
Transport Regulator/Cap Assembly
WARNING:
• A new INOMAX cylinder and regulator must be purged
before use to ensure the patient does not receive an excess
level of NO2.
• Loss of communication between the INOmax DSIR and the
INOMAX cylinder for more than one hour will result in
interruption of INOMAX delivery.
Caution: When using the Transport Regulator/Cap Assembly
(PN 10022) ensure the cap is in place on the cylinder
and the infrared cable is connected to the infrared
connector port on the back of the INOmax DSIR.
Note: Check the INOMAX cylinder for the correct product identity
labels, cylinder concentration and expiration date. Ensure
the INOMAX gas cylinder has more than 500 psig.
Step One
Note: Ensure the white plastic tip is in place on the regulator
connector and not chipped or cracked (see Figure 2).
Connect a high
pressure regulator
to an INOMAX
cylinder and tighten
thettingtothe
INOMAX cylinder
(see Figure 1).

11 Part No. 20751 Rev-01
2014-08
Transport Regulator/
Cap Assembly
Figure 3
Figure 4
Step Two
Connect the INOMAX
regulator hose to one of
the INOMAX inlets on the
back of the INOmax DSIR
(see Figure 3).
Step Three
Connect the Infrared cable from the
Transport Regulator/Cap Assembly
to the back of the INOmax DSIR
(see Figure 4).

12
Part No. 20751 Rev-01
2014-08
iButton
The electrical
cord exits the
cap directly
above the
iButton
keyway
-CLOSE +OPEN
Figure 5 Figure 6
Figure 7 Figure 8
Transport Regulator/
Cap Assembly
Step Four
Place the Cap Assembly over the INOmeter (see Figure 5).
Note: Be sure to align the keyway inside the Cap Assembly with the
iButton on the INOmeter (see Figure 5 and 6).
Step Five
Grasp the Cap Assembly to open cylinder valve (see Figure 7 and 8).

13 Part No. 20751 Rev-01
2014-08
Figure 9
Transport Regulator/
Cap Assembly
Final Set-up Diagram
The following diagram and photo illustrates all of the components connected.
Additional Information
Communication will take place between the INOmax DSIR and the
INOmeter after the boot up phase of the INOmax DSIR is complete.
Note: Cylinder icons are not visible and the dose control button
will remain inactive until the INOmax DSIR recognizes an
INOMAX cylinder.
Note: When using the Transport
Regulator/Cap Assembly
only one cylinder will be
displayed (see Figure 9).
Proceed with the
INOmax DSIR Pre-Use
Checkout
(see page 6)

14
Part No. 20751 Rev-01
2014-08
Oxygen Dilution Chart
For delivery with 800 ppm cylinder of
INOMAX (nitric oxide) for inhalation.
(Illustrative Only)
Caution FiO2 less than 21%
Please Note:
The calculations on this chart have been determined based on an
800 ppm cylinder of INOMAX (nitric oxide) for inhalation.
This chart is representative of a range of doses available on the
INOmax DSIR and doses higher than 20 ppm are not intended as the
recommended therapeutic dose.
Calculations are considered estimates and may vary under clinical
conditions.
All numbers have been rounded to the nearest hundredth.
0.21
0.20
0.20
0.19
0.40
0.39
0.38
0.36
0.59
0.59
0.57
0.54
0.79
0.78
0.76
0.72
.21 .40 .60 .80
Set FiO2
10
20
40
80
1.00
0.99
0.98
0.95
0.90
Actual FiO2
!
!
!
INOMAX Dose

15 Part No. 20751 Rev-01
2014-08
For an 88-Size 800 ppm Cylinder Concentration*
(Illustrative Only)
* All calculations in the table above are based on a full cylinder, 138 bar (2000
psig), 1963 liter “88” cylinder, with a cylinder change at 14 bar (200 psig). The
guresarecalculatedbasedonatotalcontinuousbreathingcircuitgasowand
a cylinder conversion factor of 14.2 liters per bar/0.98 liters per psig.
•INOMAXow=[Desireddose×totalventilatorow]÷[Cylinderconcentration
-desireddose]
•Cylindervolume=Cylinderconversionfactor×cylinderpressure(bar/psig)
•Cylinderduration(hours)=(Cylindervolume÷INOMAXowrate)÷60
Calculations are considered estimates and may vary under clinical
circumstances. For more information, call 1-877-KNOW-INO (1-877-566-9466).
INOMAX Cylinder 88-Size
Duration Chart
(88-size)
This chart is representative of a range of doses available
on the INOmax DSIR and doses higher than 20 ppm are not
intended as the recommended therapeutic dose.
FLOW
5 L/min 10 L/min 20 L/min 40 L/min
539 Days 19.5 Days 9.8 Days 4.9 Days
10 19.4 Days 9.7 Days 4.8 Days 2.4 Days
20 9.6 Days 4.8 Days 2.4 Days 1.2 Days
40 4.7 Days 2.3 Days 1.2 Days 14 Hours
80 2.2 Days 1.1 Days 13.3 Hours 6.6 Hours
INOMAX Dose (ppm)

16
Part No. 20751 Rev-01
2014-08
Duration Chart
(D-size)
* All calculations in the table above are based on a full cylinder, 138 bar (2000
psig), 353 liter “D” cylinder, with a cylinder change at 14 bar (200 psig). The
guresarecalculatedbasedonatotalcontinuousbreathingcircuitgasow
and a cylinder conversion factor of 2.6 liters per bar/0.18 liters per psig.
•INOMAXow=[Desireddose×totalventilatorow]÷[Cylinderconcentration
-desireddose]
•Cylindervolume=Cylinderconversionfactor×cylinderpressure(bar/psig)
•Cylinderduration(hours)=(Cylindervolume÷INOMAXowrate)÷60
Calculations are considered estimates and may vary under clinical
circumstances. For more information, call 1-877-KNOW-INO (1-877-566-9466).
This chart is representative of a range of doses available
on the INOmax DSIR and doses higher than 20 ppm are not
intended as the recommended therapeutic dose.
INOMAX Cylinder D-Size
Typically used in transport
FLOW
5 L/min 10 L/min 20 L/min 40 L/min
57.0 Days 3.5 Days 1.8 Days 21 Hours
10 3.5 Days 1.7 Days 21 Hours 10.5 Hours
20 1.7 Days 20.7 Hours 10.3 Hours 5.2 Hours
40 20 Hours 10 Hours 5 Hours 2.5 Hours
80 9.5 Hours 4.8 Hours 2.4 Hours 1.2 Hours
INOMAX Dose (ppm)

17 Part No. 20751 Rev-01
2014-08
Circuit Connection
Diagrams
Proper use of these products depends on careful reading and
understanding of labeling and instructions. Please refer to the
INOmax DSIR and INOblender operation manuals for guidance. Also
refertothespecicbreathingdeviceoperationmanualorinstructions
for use.
INOmax DSIR Warnings:
• INOmax DSIR subtracts gas from the breathing circuit via the
gas sampling system at 230 mL per minute; this can affect the
sensitivity of a ow triggered synchronized breath mode of
some ventilators. The trigger sensitivity of the ventilator should
be checked after connecting the INOmax DSIR to the breathing
circuit.
• Patient disconnect and high-pressure alarms are required for
the ventilator.
INOmax DSIR Cautions:
• Insert the Injector Module on the dry side of the breathing circuit
priortothehumidier(thiswillensurecorrectowmeasurement).
• Avoid medications interfering with the gas monitoring system;
administer any aerosolized medications distal to the sampling tee.

18
Part No. 20751 Rev-01
2014-08
Circuit Connection
Diagrams
Acutronics Medical Systems AG Fabian
+nCPAP Evolution (validated for use outside
of the United States)
1. Fabian+ nCPAP Evolution
2. PatientGasSampleLinewithNaon
3. Injector Module Electrical Cable
4. INOmax DSIR
5. NO/N2Injector Tube
6. Connecting Tube (15 inches)
7. Injector Module
8. 22F X 15M Adapter
9. Humidier
10. Inspiratory Breathing Circuit Hose
11. Gas Sample Tee
12. Patient Wye
13. Proximal Pressure Tube
14. Expiratory Breathing Circuit Hose
9
3
10
2
12
11
1
5
4
14
13
8
7
6

19 Part No. 20751 Rev-01
2014-08
Circuit Connection
Diagrams
Acutronics Medical Systems AG Fabian HFO
(validated for use outside of the United States)
1. Fabian HFO Ventilator
2. PatientGasSampleLinewithNaon
3. Injector Module Electrical Cable
4. INOmax DSIR
5. NO/N2Injector Tube
6. Injector Module
7. T-Connector Assembly, #7209.e
8. Connecting Tube (15 inches)
9. 22F X 15M Adapter
10. Humidier
11. Inspiratory Breathing Circuit Hose
12. Gas Sample Tee
13. Patient Wye
14. Proximal Pressure Tube
15. Expiratory Breathing Circuit Hose
10
3
11
2
13
12
1
9
8
5
6
7
4
15
14

20
Part No. 20751 Rev-01
2014-08
Circuit Connection
Diagrams
A-Plus Medical Babi-Plus Bubble CPAP
1. Oxygen Source
2. Oxygen Tubing
3. Pressure Relief Manifold
4. Injector Module
5. Temperature Probe
6. 90 Degree Sample Port Adapter
7. Nasal Prongs
8. Babi Plus Bubble PAP Valve
9. Tee Adapter
10. Breathing Circuit
11. Humidier
12. NO/N2Injector Tube
13. Injector Module Electrical Cable
14. INOmax DSIR
15. PatientGasSampleLinewithNaon
98
11 7
10
14
3
4
6
2
5
12
13
1
15