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Troubleshooting
Related Manuals for International Biomedical AeroNOx
Summary of Contents for International Biomedical AeroNOx
- Page 1 Portable Nitric Oxide Titration & Monitoring System Operator’s Manual...
- Page 2 AeroNOx Portable Nitric Oxide Titration & Monitoring System Operator’s Manual Phone: (512) 873-0033 Fax: (512) 873-9090 E-Mail: sales@int-bio.com Website: http://www.int-bio.com Mailing address: International Biomedical 8206 Cross Park Dr. Austin, TX 78754 Authorized representative in Europe for Regulatory Affairs:...
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Page 4: Table Of Contents
Inspiratory Limb NO Titration in Constant Flow Ventilators ............43 Precautions for Inspiratory Limb NO Titration ................43 Ventilators Safe for Use with the AeroNOx ................. 43 Nitric Oxide Concentration Profiles ..................... 44 SECTION VII - CALCULATIONS & TROUBLESHOOTING ............43 Calculations for Nitric Oxide Delivery .................. -
Page 5: Section Ii - Unpacking And Set-Up Instructions
Instructions for Disposal ......................56 SECTION IX - WARRANTY ....................... 55 SECTION X - COMPETENCY BASED PERFORMANCE CHECK-OFF TOOL ......57 Routine (Weekly) AeroNOx Calibration ..................60 AeroNOx Portable & Bedside Set-Up ..................61 Part No. 715-7000 , Rev. J - 2 -... -
Page 6: Section I - Important Information About Nitric Oxide Delivery
AeroNOx does not scavenge the exhaust gas, and that this gas is vented from the underside of the AeroNOx, or through the side vent in the event that the bottom port is occluded. Ambient concentrations of nitric oxide or nitrogen dioxide expected to result from the use of this device are less than 50 ppb.”... - Page 7 SECT TION II - U UNPACKIN NG AND SET-UP INSTRUC CTIONS Verify tha t the shippi ng carton ( (s) contain o one of the f following gr roups of eq quipment. C C omplete descriptio ns of these e groupings s can be fou und in this s section.
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Page 8: Aeronox Transport P/N 731-9148
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 “NITRIC OXIDE DELIVERY OUTLET” on the AeroNOx. Tee the other end of the delivery line into the patient breathing circuit at least 30 - 40 cm upstream of the sampling site (see Diagram # 1).
- Page 10 Turn on the NO gas flow to 2 lpm by turning the knob on the precision metering valve in a counter-clockwise direction. This knob is located in the bottom right hand quadrant of the front panel of the AeroNOx below the LCD flow display. Allow the gas to flow into the ventilator circuit.
- 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 Repeat Step 3 and Step 4 above five times (five complete purge cycles). Connect equipment and open the tank valve as needed. Any time a regulator is installed onto a cylinder and before each patient use, the AeroNOx system should be purged. - NO EXCEPTIONS!! AeroNOx Bagger: Instructions for use with the AeroNOx (See Diagram # 2.)
- Page 13 A backup system must always be available in the event that the primary system should fail. For instructions for use of a Back-Up System in the event of a failure of the AeroNOx system, please see SECTION III, Back-Up system.
- Page 14 O fter each p patient use e to flush o out residua al NO and p prevent formatio AeroNOx B Bagger Spe ecification s Flow 10 LPM NO Gas s Flow 0.25 LPM ~ 20 ppm...
- Page 15 Diagram # 2 NO Titration with AeroNOx Bagger Part No. 715-7000 , Rev. J - 12 -...
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Page 16: Aeronox Bedside
Concentration: 800 ppm NO in balance N of pharmaceutical grade gas Size: 38” (1 meter) height by 7” (18 cm) diameter The AeroNOx must be used with calibration gas and accessories specified by the manufacturer. Part No. 715-7000 , Rev. J... - Page 17 “NITRIC OXIDE DELIVERY OUTLET” on the AeroNOx. Tee the other end of the delivery line into the patient breathing circuit at least 30 - 40 cm upstream of the sampling site. Attach the “NO WORRIES”...
- Page 18 Turn on the NO gas flow to 2 lpm by turning the knob on the precision metering valve in a counter-clockwise direction. This knob is located in the bottom right hand quadrant of the front panel of the AeroNOx below the LCD flow display. Allow the gas to flow into the ventilator circuit.
- Page 19 Diagra am # 3 AeroNO Ox Bedside e Set-Up The Sens sormedics 3100A or 3 3100B To set up the AeroNO Ox for use with the 31 00A & 310 0B, tee in t the AeroNO Ox Delivery Line (P/N 415-0001 ) immediate ely post hu...
- Page 20 Sampling g Ports for the Senso ormedics 3 3100A / 310 00B: Figure 1 The “Se et Back” Te emperature e Probe Po Figure 2 The “Se et Back” Te emperature e Probe Po Figure 3 The Pro oximal Tem mperature Probe Por Part No.
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Page 21: Aeronox Portable Cylinder Cart And Platform
10- screws (Ite em 22) prov vided. Descriptio e AeroNOx x Cart is a s strong six-w wheeled car rt with two l ocking whe eels. It can hold two 40 L Alumin... - Page 22 AUTION! fully loaded d AeroNOx x system w with tanks weighs ov ver 150 lbs (~ 68 kgs) o not use th he bed to l...
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Page 23: General
ansport sys ckup delive ery system in case of e emergency e AeroNOx x has been tested for u use with the e AeroNOx Bagger, th e Bird VIP ntinuous flo ow modes o only), the Se... -
Page 24: Back-Up System
Place the system in a place that is readily accessible in the event of an emergency. CAUTION! Confirm that the system is functional and delivering 20 ppm on initial set up by connecting the sampling system of the AeroNOx to the port that is normally kept capped on the bagger. Recheck functionality periodically. - Page 25 20 ppm NO ( 4 ppm). For this reason, the INOstat Kit should be used only during periods when the AeroNOx has failed or cannot be used for other unanticipated reasons, unless the patient is known to have no adverse effects at 20 ppm.
- Page 26 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.
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Page 27: Titration Delivery System
Nitric oxide gas is regulated to 50 psig by a CGA 626 nitric oxide regulator. It is then delivered via stainless steel high pressure hose to the AeroNOx unit. (See Diagram # 7.) A precision metering valve (controlled by the operator on the front panel) regulates the NO gas flow to the patient circuit. -
Page 28: No And O Sampling
NO / NO and O Samplin The AeroN NOx system m continuou usly draws a mixed ga as sample @ @ ~ 150 mL L/min from breathing circuit at a point in the e inspirator ry circuit ne earest the p atient conn nection. -
Page 29: Electrochemical Sensors
100 ppm NO and 10 ppm NO respectively. The AeroNOx sensors must have a bias voltage going to them at all times. The battery must be charged in order to maintain this “bias voltage”. The AeroNOx maintains this voltage even when the power button is in the “off”... -
Page 30: Alarms
AeroNOx. Safety Shut Off For patient safety, the AeroNOx has incorporated a “safety” shut-off system for the delivery of NO gas. The system is designed to avoid inadvertent high doses of NO being delivered to the patient by terminating the flow of NO gas to the delivery line. The system is activated when the... -
Page 31: Front Panel
Diag gram # 8 AeroN NOx Front Panel Aero NOx Front t Panel NTROL NCTION Display o of NO & NO ack-lit, digit tal liquid cr rystal displa ay of NO an nd NO pm, calibra ation status and battery y condition. -
Page 32: Gas Connections
Deliver ry line (P/N 415-0001) a attaches h CAUTION Luer fittin ngs are co ommon to b both the A AeroNOx an nd to most intraveno ous system ms. Carefu ul attention n must be paid when connecti ng and dis... -
Page 33: Luer Lock Connections
To attach h the delive ry line to th he AeroNOx x, fit the ma ale end of th he delivery line onto th he female luer locate ed below an... -
Page 34: Battery
Battery The AeroNOx is supplied with a rechargeable 6 volt sealed lead acid battery. The unit is shipped with the battery disconnected to prevent the battery from fully discharging during shipping. To re-connect the battery, remove the battery compartment panel on the back of the AeroNOx. - Page 35 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.
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Page 36: 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 37: 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. Part No. 715-7000 , Rev. - Page 38 Oxygen Sensor The oxygen sensor in the AeroNOx is affected by altitude (partial pressure) changes. The above graph shows a predictable linear slope for the first 4000 feet and then a nominal change between 4000 and 12,000 feet. As altitude increases, the oxygen percentage display will decrease to reflect the change in partial pressure at the corresponding change in altitude.
- Page 39 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 ...
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Page 40: Physical Specifications
Physical Specifications 25.4 30.5 12.7 cm Dimensions (H W D) 10 12 5 inches Weight (AeroNOx only) ~ 11 lb. (~ 4.8 kg.) NO Flow Meter: Range 0 - 2 LPM Display Resolution 10 cc ... - Page 41 SECTION N V - CAL LIBRATIO Calibratio on of the A AeroNOx N NO / NO Analyze The Aer roNOx mu ust be us sed with c calibratio on gas an nd access sories sp ecified by the m manufact urer.
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Page 42: Section V - Calibration
Run wall O through the cal. circuit @ 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 43 (clockwise to increase, counterclockwise to decrease) until the display matches the chemist’s reported “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%.
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Page 44: Section Vi - Nitric Oxide Delivery
AeroNOx. Some ventilators have modes labeled “continuous flow” but may not function as true continuous flow ventilators. Please consult the manufacturer of the ventilator you intend to use with the AeroNOx to determine if, and in what modes, your ventilator will operate as a continuous flow ventilator. -
Page 45: Nitric Oxide Concentration Profiles
Time (s) 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 46: 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 47 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] 0.03...
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Page 48: 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 49 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. Part No.
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Page 50: Calculation Of Cylinder Duration
Calculat tion of Cy ylinder D Duration How lon g will this tank last? e volume o f gas in you ur cylinder( s) is a func ction of the filling press sure and th e capacity (siz ze) of the c ylinder. -
Page 51: 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 52: 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 Visual alarm persists until rectified... - Page 53 “DATA INVALID” The battery voltage has dropped alternately Connect the AeroNOx to the power below a point where data can be displayed with supply and plug into a wall outlet. accurately displayed. “CONNECT CHARGER”...
- Page 54 Screen remains 1. Internal battery has Plug “Universal Power Supply” into blank when unit is become discharged. the AeroNOx and allow to charge for powered up. at least 30 min. Pump will not run 2. Internal battery requires Have Biomedical Engineering when unit is replacement.
- Page 55 (-) hash mark Water is preventing the Run room air or oxygen through the NO / NO values sampling gas from AeroNOx to dry out the sampling drop suddenly reaching the sensor chamber. Calibrate the analyzer as after water has membrane.
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Page 56: Section Viii - Cleaning & Maintenance
SECTION VIII - CLEANING & MAINTENANCE CLEANING Clean the AeroNOx system with mild detergent. Clean the AeroNOx analyzer and cable assembly surfaces by wiping them with a cloth moistened with a mild detergent or bactericidal agent. Avoid using alcohol on the liquid crystal display. -
Page 57: Instructions For Disposal
Remove the battery and dispose of it in accordance with local regulations, or recycle it by calling the toll free number listed on the battery. 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. - Page 58 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 59 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.
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Page 60: 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 61: Routine (Weekly) Aeronox Calibration
NO concentration on the NO calibration gas tank. 15. Disconnect the calibration circuit and allow room air to be sampled into the AeroNOx until the NO and displays return to zero and the Oxygen sensor reads 21%. This will flush out any calibration gas remaining in the AeroNOx sampling circuit after calibration. -
Page 62: Aeronox Portable & Bedside Set-Up
3. SOURCE GAS: Attach high pressure quick connect from regulator(s) to AeroNOx. 4. DELIVERY: Attach delivery tubing (P/N 415-0001) from AeroNOx to pt. circuit at least 30 - 40 cm upstream from the sampling site. 5. SAMPLING: Attach AeroNOx luer sample line from AeroNOx to inspiratory limb / bagger near patient connection.
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