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International Biomedical AeroNOx Operating Manual

Portable nitric oxide titration & monitoring system
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AeroNOx
Portable Nitric Oxide
Titration & Monitoring System
Where "NO Man
" has gone before.....
Operating Manual
0086

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Summary of Contents for International Biomedical AeroNOx

  • Page 1  AeroNOx Portable Nitric Oxide Titration & Monitoring System  Where “NO Man ” has gone before..Operating Manual 0086...
  • Page 2  AeroNOx Portable Nitric Oxide Titration & Monitoring System Operating Manual  Phone: (512) 873-0033  Toll Free: 1-800-433-5615  Fax: (512) 873-9090  E-Mail: sales@int-bio.com  Website: http://www.int-bio.com  Mailing address: International Biomedical 8508 Cross Park Dr. Austin, TX 78754 ...
  • Page 3 Document No. 715-7000 Revision E Page 2 of 63...

  • Page 4: Table Of Contents

    SECTION VI - NITRIC OXIDE DELIVERY ................. 45 Inspiratory Limb NO Titration in Constant Flow Ventilators............45 Precautions for Inspiratory Limb NO Titration ................45  Ventilators Safe for Use with the AeroNOx ................45 Nitric Oxide Concentration Profiles .....................46 SECTION VII - CALCULATIONS & TROUBLESHOOTING ............47 Calculations for Nitric Oxide Delivery..................47...
  • Page 5 Repairs and Replacement ......................57 Customer Service ........................57 Instructions for Disposal......................58 SECTION IX - WARRANTY ....................... 59 SECTION X - COMPETENCY BASED PERFORMANCE CHECK-OFF TOOL......61  Routine (Weekly) AeroNOx Calibration ..................62  AeroNOx Portable & Bedside Set-Up ..................63 Document No. 715-7000...

  • Page 6: Section I - Important Information About Nitric Oxide Delivery

    50 ppb.” WARNING The use of oxygen increases the danger of fire. Auxiliary equipment producing sparks should not be placed near the AeroNOx. Small quantities such as ether or alcohol left near the AeroNOx can cause fire. Classification According to the standard EN60601-1 of the International Electrotechnical Commission, ...

  • Page 7: Section Ii - Unpacking And Set-Up Instructions

    SECTION II - UNPACKING AND SET-UP INSTRUCTIONS Verify that the shipping carton (s) contain one of the following groups of equipment. Complete descriptions of these groupings can be found in this section.  AeroNOx Transport, P/N 731-9148 Nitric Oxide Titration & Monitoring System ...
  • Page 8 Symbols The following symbols appear in the AeroNOx documentation and labels. These internationally recognized symbols are defined by the International Electrotechnical Commission, IEC 417A and IEC 878 or by the Institute of Electrical and Electronics Engineers, 315(a).
  • Page 9 “Flush” your system according to “Suggested flush procedure for the delivery portion of   the AeroNOx system”, or according to the instructions for the AeroNOx Bagger. You are now ready to deliver NO gas and sample mixed inspired gases. CAUTION! Never turn on the NO delivery gas without first turning on the ventilator or bagger flow.
  • Page 10  Suggested “flush” procedure for the delivery portion of the AeroNOx system:   Set up the AeroNOx for delivery as outlined in “AeroNOx Transport Nitric Oxide Titration & Monitoring System for initial operation”. Hook up the ventilator to a test lung (patient should be manually ventilated during this procedure and the ventilator parameters should be set to the patient’s pre-NO gas...
  • Page 11 The valve on the tank must not be opened and left open until the regulator is purged. The stainless steel line must also be purged prior to  connection to the AeroNOx CAUTION! Should there be a sudden need to change therapy tanks, a second tank should always be purged and ready for immediate use.
  • Page 12 AeroNOx system should be purged. - NO EXCEPTIONS!!   AeroNOx Bagger: Instructions for use with the AeroNOx (See Diagram # 2.) CAUTION!  Oxygen and Nitric Oxide mix in the reservoir bag and stagnant flow will cause NO to be formed.
  • Page 13 SECTION III, Back-Up system.   The AeroNOx Bagger is intended to be connected directly to the patient’s endotracheal  tube. Do not insert any additional tubing between the AeroNOx Bagger and the endotracheal tube.   The AeroNOx Bagger is for single patient use only.
  • Page 14  Continue to run the AeroNOx Bagger with the test lung until the analyzed NO and NO values stabilize. This will prevent high doses of NO which can form in the bagger and  delivery line, from being delivered to your patient. The NO...
  • Page 15  Diagram # 2 NO Titration with AeroNOx Bagger Document No. 715-7000 Revision E Page 14 of 63...

  • Page 16: Aeronox  Bedside

     The AeroNOx Bedside Nitric Oxide Titration & Monitoring System Component Part Number Quantity  731-9138 AeroNOx  AeroNOx Operating Manual 715-7000  715-7001 AeroNOx Technical Manual  AeroNOx Cart including Stand, Platform, Basket, & Power Bar  AeroNOx Mounting Block...
  • Page 17 Turn on nitric oxide gas supply.   Attach the AeroNOx delivery line (P/N 415-0001) found in the AeroNOx “NO WORRIES” connector sample pak to the female luer connector marked “NITRIC OXIDE  DELIVERY OUTLET” on the AeroNOx .
  • Page 18  Suggested “flush” procedure for the delivery portion of the AeroNOx system:   Set up the AeroNOx for delivery as outlined in “AeroNOx Bedside Set-Up”. Hook up the ventilator to a test lung (patient should be manually ventilated during this procedure and the ventilator parameters should be set to the patient’s pre-NO gas...
  • Page 19   To set up the AeroNOx for use with the 3100A & 3100B, tee in the AeroNOx Delivery Line (P/N 415-0001) immediately post humidifier. To connect the “NO WORRIES” sample line, you will require the 3100A / 3100B sample port adapter (P/N 415-0009). The port can be placed in one of three positions.
  • Page 20 Sampling Ports for the Sensormedics 3100A / 3100B: Figure 1 The “Set Back” Temperature Probe Port Figure 2 The “Set Back” Temperature Probe Port Document No. 715-7000 Revision E Page 19 of 63...
  • Page 21 Figure 3 The Proximal Temperature Probe Port Document No. 715-7000 Revision E Page 20 of 63...

  • Page 22: Aeronox  Portable Cylinder Cart And Platform

     to mount to the bed’s foot or headboard which allows the cart, cylinders, and AeroNOx system to be transported with the patient within the hospital. (See Diagram # 5.) ...
  • Page 23 Diagram # 4  Room to Room Transport with the AeroNOx & Cart  The AeroNOx bedside system and tanks can be moved short distances with the patient by hooking the black platform onto the bed’s foot or head board, and raising the bed slightly, so as to partially un-weight the wheels.

  • Page 24: Section Iii - Device Description

      The AeroNOx has been tested for use with the AeroNOx Bagger, the Bird VIP (in continuous flow modes only), the Sechrist 100IVB, the SensorMedics 3100A & 3100B, the Infant Star 100 Neonatal Ventilator, the MVP-10 Ventilator, the CV2i Ventilator, and the Percussionaire Bronchotron Ventilator.
  • Page 25 Diagram # 6 The INOstat Flow Inflating Bagger:  Use as a back-up system (independent of the AeroNOx system). Document No. 715-7000 Revision E Page 24 of 63...

  • Page 26: Back-Up System

    For this reason International Biomedical has an available back-up system,  the INOstat Kit (P/N 731-9147), for use in the event that your AeroNOx system should fail. This system consists of a flow inflating bagger, and a specially designed regulator with a preset NO delivery flow of 0.25 LPM.
  • Page 27  be aware that the gases exiting the AeroNOx Bagger are not scavenged. When used according to the instructions in this manual, the INOstat Kit will deliver a fixed concentration of 20 ppm NO (...
  • Page 28 INOstat Kit: Instructions for Use Your back-up system should be set up and ready for use at all times during inhaled nitric oxide therapy. Clinicians should familiarize themselves with the use of the INOstat Kit. The adjustable overflow valve in the flow inflating manual resuscitator (Bagger) will help to control the amount of PEEP delivered.

  • Page 29: Titration Delivery System

    WORRIES” delivery line (P/N 415-0001) into the breathing circuit. The mass flow meter’s range is from 0 - 2 LPM in 10 mL/min (0.01 LPM) increments. CAUTION!  DO NOT exceed 2.00 LPM as displayed on the AeroNOx flow meter digital display. Displayed values in excess of 2.00 LPM are not ...

  • Page 30: No / No

    Failure to  do so may impair the function of the AeroNOx as well as decrease the life of the internal components. WARRANTY MAY NOT BE HONORED FOR DAMAGE CAUSED IN THIS MANNER! ...

  • Page 31: Electrochemical Sensors

    Unbiased sensors will read a value greater than zero when exposed to room air. This value will  continue to drop as the sensor biases. Once the value has dropped to zero, the AeroNOx must be re-calibrated prior to use.

  • Page 32: Alarms

    NO concentrations will be known as soon as possible. CAUTION!  There are no alarms for the oxygen analysis portion of the AeroNOx  An auxiliary oxygen analyzer, such as the MiniOX 3000 by MSA, with audible and visual alarms must be used in conjunction with the ...

  • Page 33: Front Panel

     Diagram # 8 AeroNOx Front Panel  AeroNOx Front Panel CONTROL FUNCTION Display of NO & NO Back-lit, digital liquid crystal display of NO and NO ppm, calibration status and battery condition. (See “Battery” SECTION III.) A “plug” character in the display indicates that the wall power is connected and that the unit is charging.

  • Page 34: Gas Connections

    Female luer connector. Delivery line (P/N 415-0001) attaches here CAUTION!  Luer fittings are common to both the AeroNOx and to most intravenous systems. Careful attention must be paid when connecting and disconnecting luer connections to avoid inadvertent administration of NO gas into a patient I. V. system.

  • Page 35: Luer Lock Connections

    , fit the male end of the delivery line onto the female  luer located below and to the right of the handle on the AeroNOx and turn in a clockwise direction until a firm connection is established. To remove, turn the male fitting in a counterclockwise direction.

  • Page 36: Battery

     Should you completely lose battery function to the AeroNOx  Plug in the 12 V universal power supply and allow the internal charging circuit to recharge the battery.
  • Page 37 48 hours to become functional again. Unbiased sensors will read a value greater than zero when exposed to room air. This value will continue to drop as the  sensor biases. Once the value has dropped to zero, the AeroNOx must be re-calibrated prior to use.

  • Page 38: Universal Power Supply

    The universal power supply accepts a 100 - 240 V A/C ~ 50 - 60 Hz input, and supplies a +12 V D/C @ 3.3 A max. output.  For the AeroNOx , the universal power supply is both a voltage source for the internal charging circuit and an A/C power supply.

  • Page 39: Section Iv - Specifications

     2 ppm nitrogen dioxide   3% oxygen  At the altitude at which it is calibrated, see next page for Effect of Altitude on the AeroNOx Device accuracy is affected by the ventilator that is attached. Document No. 715-7000 Revision E...
  • Page 40  Effect of Altitude on the AeroNOx Effect of Altitude on AeroNOx Oxygen Sensor Test Conditions: PIP: 30 cmH2O, PEEP: 5 cmH2O, Ti: 0.3 seconds, RR: 60, Flow: 10 LPM FiO2: 1.0, NO: 20 ppm, ASCENDING 96.5 (0.3) 88.3 (0.3) 76.1 (0.6)
  • Page 41 For example:  If the reading on the AeroNOx is 60% at an altitude of 2000 feet above sea level, then to calculate what the oxygen will be reading at a flying altitude of 8,000 feet above sea level you would calculate as follows: = (-2.56 ...

  • Page 42: Physical Specifications

    Physical Specifications 25.4  30.5  12.7 cm Dimensions (H  W  D) 10  12  5 inches  ~ 11 lb. (~ 4.8 kg.) Weight (AeroNOx only) NO Flow Meter: Range 0 - 2 LPM Display Resolution...

  • Page 43: Section V - Calibration

    SECTION V - CALIBRATION  Calibration of the AeroNOx NO / NO Analyzer  The AeroNOx must be used with calibration gas and accessories specified by the manufacturer.  Diagram # 10 AeroNOx Calibration Circuit (P/N 415-0000) Document No. 715-7000...

  • Page 44: Aeronox  Calibration Procedure

    @ 0.5 LPM.  Connect the luer connector of the calibration circuit to the sample inlet of the AeroNOx Allow the O reading to stabilize for 2 - 4 minutes. Calibrate oxygen sensor @ 100% by adjusting the calibration potentiometer using the calibration screwdriver (P/N 416-0010) provided.
  • Page 45 “ACTUAL” NO reading on the gas cylinder label.  Disconnect the calibration circuit and allow room air to be sampled into the AeroNOx until the NO and NO displays return to zero and the Oxygen sensor reads 21%. This is ...

  • Page 46: Section Vi - Nitric Oxide Delivery

     The following ventilators have been tested for use with the AeroNOx Sechrist 100IVB in all modes Bird VIP in conjunction with the Infant Flow Sensor in the following time cycled modes:...

  • Page 47: Nitric Oxide Concentration Profiles

    The graph below represents the concentration of nitric oxide representative of the delivered concentration to the patient during mechanical ventilation with each ventilator tested for use with  the AeroNOx Nitric Oxide Concentration Ventilator Pressure NO = 20  1 ppm...

  • Page 48: Section Vii - Calculations & Troubleshooting

    [NO], ventilator minute ventilation & desired NO dose, use the formula below.   To determine NO flow for use with the AeroNOx Bagger or other respiratory gas administration systems, substitute O flow for ventilator flow in the equation below.
  • Page 49 The chart below was developed using the previous calculations. You may use it as a starting point for setting your NO flow rate. Please note that these are reference points only. The  actual dose delivered must be measured by the analysis portion of the AeroNOx Minute Volume / Ventilator / Bagger Flow [NO] 5 ppm 0.03...

  • Page 50: What Is The Diluted Fio

    What is the diluted FiO Estimating your FiO after dilution with NO gas, given your NO flow setting, and total ventilator gas flow Estimated FiO + Total NO Flow)  100 Initial FiO - (NO Flow / Total Flow O Example: ...
  • Page 51 Post Nitric Oxide Data  = 0.55 (55%)  = 75 mmHg  Paw = 12 mmHg Oxygen Index (OI) = 12  0.55  100 / 75 = 8.8 In this example, OI improved markedly (23 to 8.8) after inhaled nitric oxide administration. Document No.

  • Page 52: Calculation Of Cylinder Duration

    Calculation of Cylinder Duration How long will this tank last?  The volume of gas in your cylinder(s) is a function of the filling pressure and the capacity (size) of the cylinder. For compressed gases, this relationship is linear and can be expressed as a tank factor which is equal to cylinder volume / pressure expressed in LPM.

  • Page 53: How Much Calibration Gas Do I Need

    Flow Rate (LPM) Pressure .125 2000 45.25 22.5 1500 25.5 1000 22.5 11.25 11.25 4.25 2.75 Time in Hours How much calibration gas do I need? Calibration gas regulators have a preset flow of 0.5 LPM. Since sensor stabilization usually takes ~ 2 - 4 minutes, one sensor calibration should take ~ 2 - 4 minutes and use ~ 2 L of calibration gas.

  • Page 54: Aeronox  Troubleshooting Guide

     AERONOX TROUBLESHOOTING GUIDE FRONT PANEL - OPERATIONAL MESSAGES BUTTON PURPOSE MESSAGE PRESSED Alarm Silences audible alarm for 1 ALARM SILENCE Silence NO minute Visual alarm persists until rectified Alarm Silences audible alarm for 1 ALARM SILENCE Silence NO minute...
  • Page 55 Power unit off and then back on. FAILURE” corrupted. Calibrate as per SECTION V. “ROM Data stored in read only memory Return to International Biomedical for has been corrupted or damaged. repair. FAILURE” Check sample line for occlusion. “CHECK Sample line has become occluded, Remove occlusion.
  • Page 56 Screen remains 1. Internal battery has Plug “Universal Power Supply” into  blank when unit is become discharged. the AeroNOx and allow to charge powered up. for at least 30 min. Pump will not run 2. Internal battery requires Have Biomedical Engineering when unit is replacement.
  • Page 57 “21” sensor has been Allow room air or oxygen to be  exposed to NO values in aspirated into the AeroNOx screen excess of 21 ppm. sampling block until NO value displays 21 and returns to zero. Calibrate the NO will not change channel.

  • Page 58: Section Viii - Cleaning & Maintenance

    Return Merchandise Authorization (RMA) should you need to send anything back for repair. Any equipment sent to International Biomedical without an RMA will not be accepted for delivery. Do not ship any products to International Biomedical without first obtaining an RMA.

  • Page 59: Instructions For Disposal

     The remainder of the AeroNOx can be disposed of as per your hospital’s policy for non- hazardous materials, or it may be returned to International Biomedical for disposal. Document No. 715-7000 Revision E Page 58 of 63...

  • Page 60: Section Ix - Warranty

    Biomedical, and if any such products should prove to be defective within such one year period International Biomedical agrees, at its option, (i) to correct by repair or at International Biomedical’s election, by replacement with equivalent product any such defective product, provided that investigation and factory inspection discloses that such defect developed under normal and proper use (ii) to refund the purchase price.
  • Page 61 Representations and warranties made by any person, including dealers and representatives of International Biomedical, which are inconsistent or in conflict with the terms of this warranty, shall not be binding upon International Biomedical unless reduced to writing and approved by an expressly authorized officer of International Biomedical.

  • Page 62: Section X - Competency Based Performance Check-Off Tool

    100% accuracy is recommended for completion of the clinical performance check-off.  Employees are strongly encouraged to review the Operating manual for the AeroNOx Nitric Oxide Titration & Monitoring System in order to familiarize themselves with the equipment functions, and to practice performing these functions independently as per the competency based check-off prior to the actual check-off by a clinician.

  • Page 63: Routine (Weekly) Aeronox  Calibration

    @ 0.5 LPM.  4. Connect the luer connector of the calibration circuit to the sample inlet of the AeroNOx 5. Allow the O reading to stabilize for 2 - 4 minutes. Calibrate oxygen sensor @ 100% by using the calibration screwdriver to adjust the calibration potentiometer.

  • Page 64: Aeronox Portable & Bedside Set-Up

    (see SECTION VII). Maximum FiO 14. Perform flush procedure. 15. Set NO flow @ the initial flow rate you calculated (# 12).  16. After readings stabilize, record the following from the AeroNOx  Record [NO]  Record [NO ...

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