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Document No. 715-7000

Revision E

Page 1 of 63

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:

[email protected]



Website: http://www.int-bio.com



Mailing

address:

International Biomedical
8508 Cross Park Dr.
Austin, TX 78754
USA



Authorized representative in Europe for Regulatory Affairs:

Emergo Europe
Molenstraat 15
2513 BH
The Hague, The Netherlands

0086

Содержание AeroNOx

Страница 1: ...AeroNOx Portable Nitric Oxide Titration Monitoring System Where NO Man has gone before Operating Manual 0086 ...

Страница 2: ...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 USA Authorized representative in Europe for Regulatory Affairs Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands 0086 ...

Страница 3: ...Document No 715 7000 Revision E Page 2 of 63 ...

Страница 4: ...uick Connect Gas Fittings 33 Luer Lock Connections 34 Battery 35 Universal Power Supply 37 SECTION IV SPECIFICATIONS 38 Functional Performance 38 Physical Specifications 41 Safety 41 SECTION V CALIBRATION 42 AeroNOx Calibration Procedure 43 SECTION VI NITRIC OXIDE DELIVERY 45 Inspiratory Limb NO Titration in Constant Flow Ventilators 45 Precautions for Inspiratory Limb NO Titration 45 Ventilators ...

Страница 5: ...CTION VIII CLEANING MAINTENANCE 57 Cleaning 57 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 ...

Страница 6: ...gen dioxide or who may be exposed to these gases for prolonged periods as a result of the use of this device should be aware that the 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 ...

Страница 7: ...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 1 AeroNOx Transport P N 731 9148 Nitric Oxide Titration Monitoring System 2 AeroNOx Bedside Option Nitric Oxide Titration Monitoring System ...

Страница 8: ...tor Sample Pak 731 9373 1 AeroNOx Calibration Circuit 415 0000 1 Single Calibration Screwdriver 416 0010 1 The AeroNOx must be used with calibration gas and accessories specified by the manufacturer 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 o...

Страница 9: ...e NO WORRIES sample line P N 415 0004 to the male luer connector marked ANALYSIS SAMPLE INLET on the AeroNOx 10 Select the appropriate sample gas connector from your NO WORRIES connector sample pak and attach it to the free end of the sample line NB if attaching the sample line to the bagger skip this step 11 Connect the sample gas connector to the patient breathing circuit The connector should be...

Страница 10: ...ff system by simultaneously depressing the NO and NO2 alarm silence buttons for at least 5 seconds or until the display reads SAFETY ON 7 Once the desired NO concentration has been reached ensure that NO2 level is acceptable for patient administration Below you will find a table which will give you the approximate NO2 values you can expect for a given NO concentration and ventilator flow at an FiO...

Страница 11: ...ave the regulator installed until it is time to change to a new cylinder 6 Repeat the purge procedure any time a regulator is reattached Any time a regulator is installed on a tank or cylinder of compressed gas certain precautions must be followed This is to prevent contamination of the gas in the tank and in the system by air that is trapped in the dead space of the regulator and fittings To elim...

Страница 12: ...and before each patient use the 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 NO2 to be formed Turn off NO flow when not actively bagging patient Flush the bagger with oxygen for a least 20 seconds to completely remove NO and NO2 before and after ...

Страница 13: ...the patient or to others resulting from inhalation of excess nitric oxide nitrogen dioxide or other reaction products Persons using this device who may be particularly sensitive to nitric oxide or who may be exposed to these gases for prolonged periods as a result of the use of this device should be aware that the gases exiting the AeroNOx Bagger are not scavenged 1 Connect the large end of the ba...

Страница 14: ...h fresh gas for at least 20 seconds prior to patient connection 8 Analyze NO and NO2 concentration prior to patient administration 9 Flush bagger with O2 after each patient use to flush out residual NO and prevent NO2 formation AeroNOx Bagger Specifications O2 Gas Flow 10 LPM NO Gas Flow 0 25 LPM Delivered NO 20 ppm NO2 Generated Maximum 0 2 ppm 20 ppm Delivered NO Reservoir Volume 0 5 L Bagger Di...

Страница 15: ...Document No 715 7000 Revision E Page 14 of 63 Diagram 2 NO Titration with AeroNOx Bagger ...

Страница 16: ...l Power Supply 293 0040 1 SS Hose with Quick Connect Fittings 731 9371 1 Medical Grade Power Cord 711 0179 1 CGA 626 NO Delivery Regulators 731 9142 2 AeroNOx NO WORRIES Connector Sample Pak 731 9373 1 AeroNOx Calibration Circuit 415 0000 1 Single Calibration Screwdriver 416 0010 1 Recommended Bedside Gases Not Included Concentration 800 ppm NO in balance N2 of pharmaceutical grade gas Size 38 1 m...

Страница 17: ...oNOx 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 sample line P N 415 0004 to the male luer connector marked ANALYSIS SAMPLE INLET on the AeroNOx 10 Select the appropriate sample gas connector from your NO WORRIES connector sample pak and attach it to the free end of the sample line 11 Connect the sa...

Страница 18: ...NO and NO2 alarm silence buttons for at least 5 seconds or until the display reads SAFETY ON 7 Once the desired NO concentration has been reached ensure that NO2 level is acceptable for patient administration Following you will find a table which will give you the approximate NO2 values for a given NO concentration and ventilator flow at an FiO2 of 1 0 Minute Volume Ventilator Flow NO 5 10 15 20 5...

Страница 19: ...e you will require the 3100A 3100B sample port adapter P N 415 0009 The port can be placed in one of three positions All three positions are labeled as temperature probe ports in the 3100A 3100B literature The set back temperature port is pictured in Figure 1 and Figure 2 The proximal temperature port is pictured in Figure 3 The third port not shown is the second proximal temperature probe port lo...

Страница 20: ...Document No 715 7000 Revision E Page 19 of 63 Sampling Ports for the Sensormedics 3100A 3100B Figure 1 The Set Back Temperature Probe Port Figure 2 The Set Back Temperature Probe Port ...

Страница 21: ...Document No 715 7000 Revision E Page 20 of 63 Figure 3 The Proximal Temperature Probe Port ...

Страница 22: ...rt with two locking wheels It can hold two 2040 L Aluminum cylinders which are 38 1 meter in height and 7 18 cm in diameter Beneath the basket holder is a medical grade 120 V power bar with a 3 prong plug and four power outlets The AeroNOx platform has a handle to allow movement of the cart and a hook designed to mount to the bed s foot or headboard which allows the cart cylinders and AeroNOx syst...

Страница 23: ...sition AeroNOx and Cart partially lifted by raising the bed when the cart is attached to the bed rail CAUTION A fully loaded AeroNOx system with tanks weighs over 150 lbs 68 kgs Do not use the bed to lift the system completely off of the floor due to risk of serious injury to the patient clinicians or damage to the bed Stability Safety The cart and monitor platform are designed to be stable when a...

Страница 24: ...ts per million ppm concentrations The construction materials are compatible with NO and will not contaminate the gas stream Recommended Use The AeroNOx Portable Nitric Oxide Titration Monitoring System is designed for use with continuous flow systems as either a Primary nitric oxide delivery system Transport system Backup delivery system in case of emergency The AeroNOx has been tested for use wit...

Страница 25: ...Document No 715 7000 Revision E Page 24 of 63 Diagram 6 The INOstat Flow Inflating Bagger Use as a back up system independent of the AeroNOx system ...

Страница 26: ...s inlet port on the bagger 2 Connect the back up delivery regulator P N 731 9143 to the INOstat NO gas delivery line 3 Ensure that the sampling port on the bagger gas supply tubing is capped 4 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 ...

Страница 27: ...Kit is for use only in the event of primary nitric oxide delivery device AeroNOx failure and is not intended for use as a primary system The Back Up delivery regulator in the INOstat Kit has a preset flow and is for use only with the INOstat Bagger Do not attempt to use this regulator as a delivery regulator for any other application Persons using this device should be trained and experienced in t...

Страница 28: ...ible in the event of an emergency Using the Bagger 1 Start the oxygen flow at exactly 10 LPM 2 Open up the valve on the back up delivery gas cylinder NO flow is preset at 0 25 LPM 3 Allow 20 seconds for the combined gas supply to flow freely from the bagger This will flush out any residual NO2 that may have formed in the bagger or delivery system since the bagger was last used 4 Begin manually ven...

Страница 29: ...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 accurate If the flow on the AeroNOx flow meter is set at a value greater than 2 00 LPM the delivered flow will be higher than the displayed flow value The suggested titration point is in the inspiratory circuit at least 30 40 cm upstream of the samplin...

Страница 30: ...sample gas is then drawn through a 5 micron hydrophobic filter into the device and into the sensor housing where gas analysis of NO ppm NO2 ppm and O2 takes place CAUTION Do not use the AeroNOx without the NO WORRIES sample line P N 415 0004 which includes both the Nafion tubing and the hydrophobic filter for removing condensing humidity from the sample gas Failure to do so may impair the function...

Страница 31: ...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 CAUTION The NO2 sensor may easily be damaged by inadvertent high levels of NO2 Use nitrogen or air to flush the system after high levels of NO 100 ppm or NO2 20 ppm have been introduced to the sensor CAU...

Страница 32: ...default setting for this alarm is activated that is no action is required by the user to enable the safety system To verify that the system is activated simultaneously depress the NO and NO2 alarm silence buttons The display will read SAFETY ON Do not depress the alarm silence buttons for more than 4 seconds as this will disable the safety shut off system Should the safety shut off system be trigg...

Страница 33: ...maintain the sensor in a state of readiness 4 LITE Illuminates a back light for the LCD when depressed 5 HIGH LOW Adjustable Alarm Settings Adjustable thumb wheel alarm settings for high alarms NO NO2 and low alarms NO 6 Alarm Silence Silences audible alarms for one minute 7 Cal NO Cal NO2 Calibration Pots Turning these potentiometers adjusts the digital display to calibrate the analyzer against a...

Страница 34: ...n of NO gas into a patient I V system Quick Connect Gas Fittings The AeroNOx was designed with quick connect gas fittings for quick and easy connection from the AeroNOx to the delivery gas regulators This can be utilized either when changing from an empty to a full cylinder or when switching from a bedside to a transport cylinder and vice versa CAUTION Ensure the regulator is purged prior to conne...

Страница 35: ...er on the hydrophobic filter on the sample line to the male luer located below and to the left of the handle on the AeroNOx and turn the hydrophobic filter in a clockwise direction until a firm connection is established To remove turn the hydrophobic filter in a counterclockwise direction then gently pull the sample line free To attach the delivery line to the AeroNOx fit the male end of the deliv...

Страница 36: ... BATTERY message will appear alternately with the sensor data when the battery no longer carries enough charge to reliably operate the electronics This message will remain on the screen for approximately 4 minutes depending on the condition of the battery If the unit remains disconnected from the power supply the screen will begin to alternately display the messages CONNECT CHARGER DATA INVALID an...

Страница 37: ...ue will continue to drop as the sensor biases Once the value has dropped to zero the AeroNOx must be re calibrated prior to use CAUTION Use only P N 888 0115 as the battery source for the AeroNOx CAUTION Disconnect the battery when the unit is not in use for extended periods of time or if the system must remain unplugged for extended periods of time CAUTION Attempting to run the AeroNOx for longer...

Страница 38: ...rge the internal battery The internal charging circuit is self regulating and will sense the condition of the battery charging and not charging as required It is recommended that the power supply be used whenever possible to ensure the battery is kept fully charged The analyzer is powered by the internal battery at all times The plugging in or unplugging of the external power supply from either en...

Страница 39: ...ppm nitrogen dioxide 5 to 100 oxygen Meter Resolution 1 0 ppm nitric oxide 0 1 ppm nitrogen dioxide 0 1 oxygen Sensor Accuracy 1 ppm nitric oxide 0 1 ppm nitrogen dioxide 2 oxygen1 Sensor Response Time 90 response to a change in NO in 20 sec 90 response to a change in NO2 in 30 sec 95 response to a change in O2 FiO2 in 30sec Sensor Stability 2 signal loss per month Device Accuracy2 2 ppm nitric ox...

Страница 40: ...are thus unaffected by altitude changes during transport 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 corr...

Страница 41: ...a level Alarms Manually adjusted thumb wheel switches with 1 ppm resolution NO Low adjustable from 0 99 high adjustable from 0 99 Audible and visual alarm when actual value is at set alarm value NO2 High audible and visual alarm when actual value is at set alarm value Factory default setting for high NO2 alarm is 11 ppm when thumb wheels are adjusted to 11 ppm or higher thumb wheels adjustable to ...

Страница 42: ...g Valve 12 turns to fully open Gas Supply Recommend NO 800 ppm N2 Gas Fittings CGA 626 Quick Connect Luer Power Supply Internal 6 V sealed lead acid battery charged by Universal power supply Battery Life Fully charged will last at least 5 hours Battery life 1 year Safety EMC Compliance with EN60601 1 2 Flammable anesthetics Not for use in the presence of flammable anesthetics Regulatory Approvals ...

Страница 43: ...n E Page 42 of 63 SECTION V CALIBRATION Calibration of the AeroNOx NO NO2 O2 Analyzer The AeroNOx must be used with calibration gas and accessories specified by the manufacturer Diagram 10 AeroNOx Calibration Circuit P N 415 0000 ...

Страница 44: ...down The words ZERO NO appear on the screen The sensor is zeroed when the word DONE appears 8 NO2 Zero Procedure Zero the NO2 sensor by depressing and holding the NO2 zero button down The words ZERO NO2 appear on the screen The sensor is zeroed when the word DONE appears CALIBRATE NO2 SENSOR 9 Disconnect calibration circuit from the AeroNOx 10 Disconnect the O2 and attach NO2 calibration gas to th...

Страница 45: ...roNOx until the NO and NO2 displays return to zero and the Oxygen sensor reads 21 This is to flush out any calibration gas remaining in the AeroNOx sampling circuit after calibration This step will help ensure the longevity of the AeroNOx sensors READY TO GO The AeroNOx is calibrated and ready for use Important Reminders 1 The AeroNOx has been designed and tested for use with calibration gases spe...

Страница 46: ...approximately 1 minute prior to patient connection 4 Ensure that the dose measured by the AeroNOx is the actual desired nitric oxide concentration and that NO2 values are acceptable For acceptable limits see the NO2 in ppm table in SECTION VII Ventilators Safe for Use with the AeroNOx In general any ventilator which functions as a true continuous flow ventilator may be used with the AeroNOx Some v...

Страница 47: ...itator Target 20 ppm 0 5 10 15 20 25 30 0 20 40 60 80 Time s NO ppm Pressure cmH 2 O NO ppm Pressure cmH2O Rate 10 150 bpm PIP PEEP 20 4 Mean 20 13 ppm SD 0 29 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 Time Nitric Oxide NO Concentration ...

Страница 48: ...rmine what NO flow to set and what the NO flow reading should be during NO administration for the desired dose To determine the initial Nitric Oxide NO flow rate given your NO source gas concentration 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 O2 flow for vent...

Страница 49: ...alues you can expect when delivering the NO concentrations listed in the column on the left Minute Volume Ventilator Flow NO 5 10 15 20 5 ppm 0 5 0 1 0 1 0 1 10 ppm 0 5 0 2 0 2 0 1 20 ppm 0 5 0 3 0 2 0 2 40 ppm 0 8 0 6 0 4 0 4 80 ppm 2 0 1 5 1 2 1 1 NO2 in ppm The tables above are for reference only Factors such as the accuracy of the ventilator flow percent error in delivery apparatus and human e...

Страница 50: ...1 0 31 10 31 LPM 0 97 Estimated O2 1 0 31 10 31 LPM 100 97 When delivering 25 ppm NO 0 31 LPM in 10 LPM of 100 oxygen you can expect the O2 to be diluted by 3 In this case the maximum FiO2 you can expect is 0 97 How are we doing Oxygen Index Calculation Oxygen Index OI Paw FiO2 100 PaO2 mmHg Interpretation Most centers interpret less than 15 as good Mean airway pressure in cmH2O Paw Fraction of in...

Страница 51: ...5 7000 Revision E Page 50 of 63 Post Nitric Oxide Data FiO2 0 55 55 PaO2 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 ...

Страница 52: ...unt of therapeutic gas remaining in a cylinder can be estimated in minutes or hours provided that three things are known 1 Tank Factor 2 Tank Pressure 3 Flow Rate Cylinder Pressure psig Factor L psig Cylinder Duration Minutes Flow Rate LPM The two following nomograms can be used to estimate cylinder duration CYLINDER DURATION Below you will find an example of how to determine cylinder duration bas...

Страница 53: ...51 34 25 5 17 1000 136 69 34 22 5 17 11 25 500 68 34 17 11 25 8 5 5 5 250 34 17 8 5 5 5 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 ...

Страница 54: ...inute ALARM SILENCE Visual alarm persists until rectified ZERO NO Sets calibration baseline for selected sensor CAL NO after 5 seconds DONE ZERO NO2 Sets calibration baseline for selected sensor CAL NO2 after 5 seconds DONE ZERO NO ZERO NO2 PRESSED TOGETHER Displays the total time in hours that both sensors have been in service SENSOR TIME after 5 seconds time in hours that both sensors have been ...

Страница 55: ...er back on This will re set pump flow SAFETY OFF alternately displayed with sensor data Safety shut off system has been disabled To re enable the safety shut off a simultaneously depress the NO and NO2 alarm silence buttons for 5 seconds until the display reads SAFETY ON or b power the unit off then back on again NITRIC OFF alternately displayed with sensor data NO gas flow to your patient has bee...

Страница 56: ... clinical use 1 Sensors may need replacing Please refer to the section on Sensors for sensor life 2 Sensors may need additional time to be biased 3 Incomplete gas mixing in your patient circuit may be occurring 1 Have Biomedical Engineering replace sensor s 2 Allow 24 48 hours for sensors to bias Calibrate as per SECTION V 3 Refer to SECTION VI Nitric Oxide Delivery Techniques Screen remains blank...

Страница 57: ...low zero 1 Zero sensors as outlined in the calibration procedure SECTION V NO NO2 values drop suddenly after water has entered the AeroNOx sampling block 1 Water is preventing the sampling gas from reaching the sensor membrane 1 Run room air or oxygen through the AeroNOx to dry out the sampling chamber Calibrate the analyzer as in SECTION V prior to putting the AeroNOx back into clinical use Use s...

Страница 58: ...e Technical manual For all clinical or technical issues not addressed in the manual please contact International Biomedical directly at In North America Call Toll Free 1 800 433 5615 Internationally Call 1 512 873 0033 FAX 512 873 9090 CUSTOMER SERVICE Should you need clinical or technical information please feel free to contact International Biomedical To help us to help you please have the follo...

Страница 59: ...e the battery and dispose of it in accordance with local regulations or recycle it by calling the toll free number listed on the battery 2 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 ...

Страница 60: ...ational Biomedical A complete list of such components and accessories is maintained at the factory e International Biomedical makes no warranty with respect to components or accessories not manufactured by it in the event of defect in any such component or accessory International Biomedical will give reasonable assistance to the Buyer in obtaining from the respective manufacturer whatever adjustme...

Страница 61: ...Y FOR SPECIAL OR CONSEQUENTIAL DAMAGES OF ANY KIND OR FORM ANY CAUSE WHATSOEVER ARISING OUT OF THE MANUFACTURE USE INABILITY TO USE SALE HANDLING REPAIR MAINTENANCE OR REPLACEMENT OF ANY OF THE PRODUCTS SOLD UNDER THIS SALES ORDER Representations and warranties made by any person including dealers and representatives of International Biomedical which are inconsistent or in conflict with the terms ...

Страница 62: ...s 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 c...

Страница 63: ... the NO2 cal gas 0 5 LPM Re attach calibration circuit as in Step 5 Allow the NO2 reading to stabilize for 2 4 minutes Adjust the NO2 potentiometer on the front panel with the calibration screwdriver until the reading matches the chemist s reported NO2 concentration on the NO2 calibration gas tank PURGE NO NO2 SENSORS Check 12 Disconnect the NO2 calibration gas and run oxygen through the calibrati...

Страница 64: ... inspiratory limb bagger near patient connection 6 Double check NO of the cylinder record ppm 7 Double check NO tank pressure psig 8 Calculate initial NO flow to achieve the desired NO see SECTION V 9 Ventilator flow gas flow LPM 10 Tank NO ppm 11 Desired NO ppm 12 Calculated Initial NO flow LPM 13 Calculate maximal FiO2 see SECTION VII Maximum FiO2 14 Perform flush procedure 15 Set NO flow the in...

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