Operation and Maintenance Manual
124 Pages
Preview
Page 1
(Delivery System)
Operation and Maintenance Manual (English)
Part No. 20003 Rev - 01
Part No. 20110 Rev - 01
User Responsibility This Product will perform in conformity with the description contained in this operating manual and accompanying labels and/or inserts, when assembled, operated, maintained and repaired in accordance with the instructions provided. This Product must be checked periodically. A defective Product should not be used. Parts that are broken, missing, plainly worn, distorted or contaminated should be replaced immediately. Should such repair or replacement become necessary, INO Therapeutics LLC d/b/a Ikaria® recommends that a telephone request for service advice be made to the nearest Field Technical Service Support Center. This Product or any of its parts should not be repaired other than in accordance with written instructions provided by Ikaria. The Product must not be altered without the prior written approval of Ikaria Quality Assurance Department. The user of this Product shall have the
20051234 Ref 10023 Ref 10031
sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than Ikaria. Caution: U. S. Federal and Canadian law restrict this device to sale by or on the order of a licensed medical practitioner. Outside the U. S. A. and Canada, check local laws for any restrictions that may apply. Inhaled Nitric Oxide mixtures must be handled and stored in compliance with federal, state and local regulations. Ikaria products have unit serial numbers with coded logic which indicates the year of manufacture and a sequential unit number for identification.
The first four numeric digits indicate the year of product manufacture, and the next 4 digits are the sequential unit number produced. INOmax® DSIR (Australia) INOmax® DSIR (UK/Ireland)
©2010 Ikaria, Inc. INOMAX®, INOmax® DSIR, INOblender®, INOcal® and INOvent® are registered trademarks of INO Therapeutics, LLC. No license is conveyed, either expressed or implied, with the purchase hereof under U.S. Patent 5,485,827 and U.S. Patent 5,427,729 and their foreign equivalents. U.S. Patent 5,558,083 and foreign equivalents.
Part No. 20110 Rev - 01
Contents 1.
General Information ... 1 Introduction to this Manual... 2 Theory of Operation ... 12 Environmental Effects ... 16
2.
Setup ... 17
3.
Pre-Use Checkout ... 19
4.
Patient Application ... 27 Backup NO Delivery ... 29 Transport Regulator/Cap Assembly Application ... 30 Changing INOMAX® Cylinders and Purging the Regulatory Assembly ... 34 Monitoring the Environment ... 39 Entering Patient Information ... 40 Connection to Various Breathing Systems ... 42
5.
Alarms... 61
6.
Troubleshooting ... 65
7.
Calibration... 73 Low Range Calibration ... 74 Oxygen Sensor High Range Calibration ... 76 NO Sensor High Range Calibration ... 78 NO2 Sensor High Range Calibration ... 81
8.
Maintenance ... 85 Cleaning... 86 Replacing the O2, NO, and NO2 Sensors ... 89 Replacing the H2O Separator Cartridge & INOMAX Reg. Tip ... 91 Preventative Maintenance ... 93 Parts and Accessories ... 94
9.
Product Specifications ... 97 Warranty ... 101
Part No. 20110 Rev - 01
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Part No. 20110 Rev - 01
General Information
(Delivery System)
1/ General Information
Part No. 20003 Rev - 01
Part No. 20110 Rev - 01
General Information
(Delivery System)
1/ General Information
Part No. 20110 Rev - 01
1/ General Information • The INOmax® DSIR (delivery system) delivers INOMAX® (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators. • The INOmax DSIR provides continuous integrated monitoring of inspired O2, NO2 , and NO and a comprehensive alarm system. • The INOmax DSIR incorporates a battery that provides up to 6 hours of uninterrupted INOMAX delivery in the absence of an external power source. • The INOmax DSIR includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm with an 800 ppm cylinder (10 ppm with a 400 ppm cylinder) in the gas flow to a patients breathing circuit. It may also use the INOblender for backup. • The target population is controlled by the drug labeling for INOMAX and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates. Important: Before using the INOmax DSIR, read through this manual. Read through the manuals for the ventilator, humidifier and any other accessory items used. Follow the manual instructions and obey the Warnings and Cautions. Keep this manual readily available to answer questions. Read the User Responsibility statement on the inside front cover of this manual; it describes what the user must do to maintain proper use and functioning of this product.
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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.
WARNING: • If an alarm occurs, safeguard the patient first before troubleshooting or repair procedures • Use only pharmaceutical grade NO/N2. • The INOmax DSIR 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 use of devices which radiate high intensity electrical fields may affect the operation of the INOmax DSIR. Constant surveillance of all monitoring and life support equipment is mandatory whenever interfering devices are in operation on or near a patient. • INO Therapeutics does not recommend that the INOmax DSIR be utilized with helium/ oxygen mixtures in any situation. The INOmax DSIR is intended to deliver INOMAX therapy gas only in conjunction with the delivery of air and oxygen. • Do not connect items, which are not specified as part of the system.
Part No. 20110 Rev - 01
Introduction to this Manual Definitions and abbreviations % v/v
% volume/volume
Control wheel
Rotary control used to change and confirm settings
Display
The electronic information panel on the front of the delivery system
HFOV
High frequency oscillating ventilator
Menu
A list of available choices for an operation
N2
Nitrogen
NO
INOMAX® (nitric oxide) for inhalation
NO2
Nitrogen dioxide
NO/N2
Nitric oxide (NO) and nitrogen (N2) gas mixture
O2
Oxygen
ppm
Parts Per Million
Resolved alarm
An alarm condition that has been corrected
Set NO
The dose of INOMAX set by the user
Touch screen
A display screen sensitive to touch used to select a function
This manual shows the Set NO displays associated with the 0-80 ppm range. 1
2
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7 1. 2. 3. 4. 5. 6. 7.
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Sample Line Inlet Main Power Indicator Display Screen Backup Switch Control Wheel Injector Module Tubing Outlet Injector Module Cable Inlet
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4 8. Water Trap Bottle 9. Purge Port 10. INOMAX Gas Inlets 11. Blender Gas Outlet 12. Ethernet Port 13. Infrared Connector 14. USB Port
Figure 1-1 INOmax® DSIR Front View
Part No. 20110 Rev - 01
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15. Water Separator Cartridge 16. Water Trap Bottle 17. Sample Gas Outlet Port 18. Power Cord Inlet 19. Ground 20. ON/Standby Switch 21. RS232 Port
Figure 1-2 INOmax DSIR Rear View
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1. 2. 3. 4. 5. 6. 7. 8. 9.
INOmax® DSIR Mounting Post INOMAX® Regulator (2) Small Part Bin INOMAX Cylinder Cylinder Holding Bracket Cylinder Mounting Strap Oxygen Cylinder Bracket Caster Lock Lever Caster (4)
Figure 1-3 INOmax® DSIR and Cart
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Part No. 20110 Rev - 01
Navigating the Display Screens There are five screens that can be displayed on the INOmax® DSIR. Note:
The specific level is identified by the highlighted card on the Menu Button. The red arrows indicate going back to a previous screen. Main Screen (first level)
Alarm History Screen (second level)
Patient Information Screen
Menu Screen (second level)
Calibration Screen (third level)
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Main Display Screen • On the Main Screen the user can view alarm messages, monitored values and graphical information.
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• By pressing the “Menu Button” on the touch screen (top right hand corner), the user can access the Menu Screen (see Figure 1-5).
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19 1. 2. 3. 4. 5. 6.
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Alarm Silence Button Upper Alarm Limit Button Lower Alarm Limit Button Monitored Value Menu Button Text Message Area
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7. Monitor Area 8. Graphical Area 9. Patient Information Button 10. Sample Line Icon 11. Water Trap Icon 12. Inspiratory Limb Icon
13. Injector Module Icon 14. Delivery Line Icon 15. Backup Line Icon 16. Backup Switch Icon 17. Delivery Setpoint Display 18. NO Delivery Setpoint Button 19. Cylinder Icon
Figure 1-4 Main Display Screen 1
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2
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Menu Screen (second level)
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• On the Menu Screen the user can change the alarm volume and the display brightness and view the software version. • To review the Alarm History Screen (second level), refer to Section 5/ Alarms.
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10 1. 2. 3. 4. 5.
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Software Revision Field Display Brightness Button Alarm Volume Button Return to Previous Level Button Monitor Area
• It also lets the user select different calibration options (third level) which will be covered in Section 7/ Calibration.
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6. Calibration Due Dates 7. NO Calibration Button 8. NO2 Calibration Button 9. Oxygen Calibration Button 10. Room Air Calibration Button
Figure 1-5 Menu Screen (second level)
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Display and user controls The INOmax® DSIR has a color touch screen display and a control wheel for adjusting and entering user settings. The buttons on the touch screen and the control wheel perform a variety of functions using a threestep procedure (see “Setting and making changes on the INOmax DSIR”). Note:
If a button has been selected and no activity has been sensed within 20 seconds, the display will return to its previous condition. If a button is de-emphasized (grayed out), it is not accessible.
When a value is being changed, pressing the "Cancel Active Status" button during editing will stop the change and return the parameter to its original value (similar to the escape key on a computer).
Dose settings The range of NO dose settings is dependent on the cylinder concentration of INOMAX® (nitric oxide) that the unit has been configured for. The INOmax DSIR can be configured by the distributor for cylinder concentrations of 400 or 800 ppm. If configured for 400 ppm the range of NO dose setting is 0 to 40 ppm and if set up for 800 ppm the range is 0 to 80 ppm, see below. 400 ppm
800 ppm
Each click on the control knob corresponds to a known change in dose. The incremental dose per click corresponds to a value dependent upon the dose range in which the change is made, as illustrated in the table below. Dose Setting Range < 1 ppm 1 to 40 ppm 40 to 80 ppm
Dose Change Per Click 400 ppm 0.1 ppm 1 ppm NA
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Dose Change Per Click 800 ppm 0.1 ppm 1 ppm 2 ppm
Setting and making changes on the INOmax® DSIR The touch screen buttons and control wheel are used to: • Set the concentration of delivered NO • Adjust alarm limits • Silence alarms • Calibrate the sensors • Review alarm history • Define setup options • Enter patient identifier 1. SELECT (press) a button on the touch screen associated with the desired function. (an audible beep will sound when a button is selected, and the button will be displayed in inverse video)
2. ROTATE the control wheel clockwise or counterclockwise to adjust the value.
3. CONFIRM the selection by pressing the control wheel or the button associated with the desired function again. Note:
After confirming a desired dose, the NO alarm setting (high and low) will automatically be set for the first setting only. Any other changes will require the high and low alarm settings to be adjusted. Also, a two minute lockout period will prevent monitoring alarms from occurring while measured values stabilize.
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Part No. 20110 Rev - 01
Settings Access the menu screen (second menu level). Alarm Volume setting 1. Push the alarm volume button on the touch screen. 2. Turn the control wheel to indicate the volume level you want. Choices range from 1 (softest) to 5 (loudest). 3. Push the control wheel to confirm your selection. 4. If you are finished with the Menu Screen push the return to previous level button on the touch screen.
Display Brightness setting 1. Push the display brightness button on the touch screen. 2. Turn the control wheel to indicate the display brightness level you want. Choices range from 1 (darkest) to 10 (brightest). 3. Push the control wheel to confirm your selection. 4. If you are finished with the Menu Screen, push the return to previous level button on the touch screen.
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Infrared Communication between the INOMAX® Cylinders and the INOmax® DSIR The INOmax DSIR has an interface using infrared technology which will allow the INOmax DSIR to communicate with the INOmeter® (which is mounted to each INOMAX cylinder). The INOmax DSIR checks the INOMAX cylinder for the correct expiration date and cylinder concentration. The INOmax DSIR also transmits a confirmed patient identifier and dose settings to the INOmeter on any open INOMAX cylinder. The INOmax DSIR cart (PN 10018) has a cover ( 1 ) with an infrared transceiver mounted directly above each INOMAX cylinder. When INOMAX cylinders are loaded, communication will take place between the INOmax DSIR and the INOmeter ( 2 ) (after the boot up phase of the INOmax DSIR is complete). A cylinder icon will be displayed on the main screen when an INOMAX cylinder is recognized by the INOmax DSIR (see “Loading INOMAX Cylinders onto the INOmax DSIR Cart”, page 10).
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Part No. 20110 Rev - 01
Loading INOMAX® Cylinders onto the INOmax® DSIR Cart Note:
Check the INOMAX gas cylinders for the correct product identity labels, cylinder concentration and expiration date.
Ensure at least one INOMAX gas cylinder (with more than 200 psig) is available. Refer to Section 3 / Pre-Use Checkout prior to use.
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Loading the first INOMAX cylinder on the cart 1 will result in a cylinder icon displayed on the screen 2 .
Part No. 20110 Rev - 01
Loading a second INOMAX cylinder onto the cart 3 will result in a second cylinder icon displayed on the screen 4 .
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Symbols used in this manual or on the system Symbols replace words on the equipment and/or in this manual. These symbols include:
134˚C
Alarm Silence
Not Autoclavable
Attention, consult accompanying documents!
On
Autoclavable
Pneumatic Inlet
CE European Representative
Pneumatic Outlet
Rx ONLY Prescription use only
CE Mark
Equipotential Stud
Purge Location
Ethernet Port
Running on Battery
Fuse Rating
Sample Gas Inlet Port
Infrared Input/Output
Sample Gas Outlet Port
Injector Module
Separate Collection
SN
Low Cal Low Range Calibration
Standby
Main Power Connected
MAX
Serial Number
REF
Maximum
Stock Number
NO Backup OFF
Type B Electrical Equipment
NO Backup ON
Use by yyyy-mm
NO Gas Inlet
USB Port
NO Gas Outlet
Water Separator Cartridge
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Part No. 20110 Rev - 01
Theory of Operation The INOmax® DSIR provides a constant dose of INOMAX® into the inspiratory limb of the ventilator circuit. The INOmax DSIR uses a “dual-channel” design to ensure the safe delivery of INOMAX. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas sensors (NO, NO2, and O2 sensors) and the user interface, including the display and alarms. The dualchannel approach to delivery and monitoring permits INOMAX delivery independent of monitoring. This allows the monitoring system to shutdown INOMAX delivery, if it detects a fault in the delivery system. For example, INOMAX delivery will shut down should the monitored NO concentration become greater than 100 ppm. (See Figure 1-5 for a schematic diagram).
6. A flow sensor inside the INOmax DSIR also monitors the NO flow out of the machine. A check valve is included prior to the INOmax DSIR drug outlet to prevent pressure effects from the ventilator breathing circuit interfering with the NO flow sensor reading. 7. Gas Monitoring - The INOmax DSIR gas monitoring system provides monitored values for inspired NO, NO2, and O2. The sample gas is withdrawn from the breathing circuit and goes through a water trap, a zero valve, a sample pump and finally a sample flow sensor to the gas monitoring sensors. • The zero valve allows the gas sensors to be zeroed (during low calibration) without having to disconnect the sample line from the breathing circuit.
1. INOMAX drug is stored as a gas mixture of NO/N2 in an aluminum cylinder at a concentration of 400 or 800 ppm depending on territory.
• The pump and sample flow sensor ensure a sample gas flow rate is maintained to the monitoring sensors.
2. The cylinder is attached to a high pressure regulator, which incorporates a pressure gauge that indicates cylinder pressure when the cylinder valve is open. The cylinder regulator is attached via tubing to the INOmax DSIR using one of the two NO/ N2 quick connect inlets on the back of the machine.
• The gas monitoring sensors are electrochemical; they are specific to each gas and provide an electronic signal which is proportional to the concentration of the gas present.
3. The INOmax DSIR checks the INOMAX cylinder for the correct expiration date and cylinder concentration.
8. Backup Delivery - If the delivery system does go into shut down, the INOmax DSIR has an integrated backup function which provides a fixed flow of INOMAX (250 mL/min) into the injector module using a pneumatic on/off switch and a restrictor built into the delivery side of the system. This fixed flow of INOMAX will provide 20 ppm of NO when using 800 ppm cylinders (10 ppm when using 400 ppm cylinders) when added to a continuous ventilator gas flow is 10 L/min. The backup is only for short term use until a replacement delivery system can be obtained. An alarm will warn the user if the backup system is turned on while the main delivery system is in use for INOMAX delivery. The INOblender can also be used as a backup.
4. The INOMAX enters the back of the INOmax DSIR, passes through a filter, then a safety shutoff valve, which is open under normal operation. 5. An injector module is placed in the ventilator gas flow between the ventilator inspiratory outlet and the humidifier. Based on the ventilator flow, the INOMAX cylinder concentration and set INOMAX dose, the proportional solenoid valve delivers INOMAX into the ventilator circuit via the injector module. This allows the INOmax DSIR to deliver a constant dose of INOMAX regardless of the ventilator flow pattern or breath rate (see Figure 1-7).
Part No. 20110 Rev - 01
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Infrared
Regulator INOMAX® Cylinder 800/400 ppm Sample Gas Outlet Port
DSIR Link CPU
Sensors O2 NO
Monitor CPU
F NO Backup ON/OFF
Delivery CPU
F
Pressure Switch
NO2
Pressure Shut off valve Restrictor
Sample Flow Sensor
Proportional Valve
Sample Pump
INOMAX Flow Sensor
Zero Valve
Water Trap
Ventilator
Injector Tubing
Sample Line
Injector Module Cable
Patient Expiratory Limb Breathing Circuit Sample Tee
Inspiratory Limb Injector Module
INOMAX Sample Gas
Figure 1-6 Schematic Diagram of INOmax® DSIR
Electronic Humidifier
Delivered Nitric Oxide (NO) Concentration using INOmax DS IR Delivery System Ventilator Flow
Time
Figure 1-7 INOMAX injection method provides a constant NO concentration
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Part No. 20110 Rev - 01
Effect of the INOmax® DSIR in a ventilator circuit There are two main effects of connecting and using the INOmax DSIR in a ventilator breathing circuit.
Minute Volume When using volume ventilation with the INOmax DSIR, the measured tidal volume delivered to the patient shows small changes depending on the NO setting being used due to the addition and subtraction of gases by the delivery system. Some minor ventilator adjustments to the minute volume may be required. The net result of the INOmax DSIR on the delivered minute ventilation can be calculated as follows:
• First, the INOmax DSIR adds NO/N2 gas to the breathing circuit in proportion to the NO setting and the ventilator flow rate. For example, at the maximum NO setting (80 ppm with 800 ppm cylinders and 40 ppm with 400 ppm cylinders) the INOmax DSIR adds 10% more gas to that delivered by the ventilator and proportionally less for lower NO settings.
If the patient’s minute ventilation is 10 L/min (500 cc X 20 breaths/min)
• Second, the INOmax DSIR subtracts gas from the breathing circuit via the gas sampling system at a nominal flow rate of 0.23 L/min.
The additional minute volume due to the INOMAX can be calculated as follows:
These two effects of adding and subtracting gas from the ventilator breathing circuit have the following effects:
INOMAX dose x Minute Volume Additional INOMAX volume = added per minute Cylinder Concentration -- INOMAX Dose
Oxygen Dilution
For a dose of 20 ppm (800 ppm cylinder) the additional volume would be (20 X 10 / 800 – 20) = 0.25 L/min
The INOmax DSIR adds gas to the breathing circuit in proportion to the NO setting as described above. The NO/N2 mixture added to the ventilator gas dilutes the oxygen in proportion to the set INOMAX® dose. At the maximum INOMAX dose setting (40 ppm or 80 ppm) the added gas is 10%. Thus, the O2 concentration is reduced by 10% of its original value. For example, if the original O2 concentration was 50% v/v, then the O2 value after injection, at the maximum setting is 45% v/v. Set Dose (ppm) 800 ppm cylinder 80 40 20
Set Dose (ppm) 400 ppm cylinder 40 20 10
Part No. 20110 Rev - 01
To calculate the net change in minute volume: 0.25 L/min INOMAX added - 0.23 L/min removed (sample system) = 0.02 L/min (net change) This formula may be used when calculating the changes to continuous flow on continuous flow ventilators as well (using the continuous flow in place of minute ventilation). Trigger Sensitivity
Oxygen Dilution % v/v
The addition and subtraction of gases by the INOmax DSIR may affect the trigger sensitivity of the ventilator when using synchronized modes of ventilation. This may cause the ventilator to autotrigger in ventilators which have flow trigger modes, especially where the trigger flow is set to less than 1 L/min. The trigger sensitivity of the ventilator should be checked after connecting the INOmax DSIR delivery system.
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