Service Manual
103 Pages
Preview
Page 1
AeroNOx 2.0
™
Portable Nitric Oxide Titration & Monitoring System Service Manual
INT-ENG
Aero A oNOx x 2.0 Porrtable e Nitrric O Oxide e Titra ation n & Monit M toring g Sys stem m Servi S ice M Manua al
Ph hone: (51 12) 873-00 033 Fa ax: (512) 873-9090 0 E-M Mail: salles@int-b bio.com We ebsite: http://www h w.int-bio..com
Ma ailing add dress: Intternational Biome edical 82 206 Cross s Park Dr. r. Au ustin, TX 78754 US SA
Au uthorized d represen ntative in n Europe for Regu ulatory Afffairs: mergo Eu urope Em Prrinsesseg gracht 20 25 514 AP Th he Hague,, The Nettherlands s
TABLE OF CONTENTS 1. 2.
3.
INTRODUCTION ... 11 1.1. Important Safety Considerations... 11 SPECIFICATIONS ... 16 2.1. Symbols Table ... 16 2.2. Abbreviations ... 18 2.3. Ventilator Compatibility... 19 2.4. Measurement Range and Accuracy ... 19 2.5. Backup Delivery Regulator ... 19 2.6. INOstat Bagger ... 19 2.7. AeroNOx 2.0 Delivery Regulator ... 20 2.8. AeroNOx 2.0 Physical Specifications ... 20 2.9. AeroNOx 2.0 Environmental Specifications ... 20 2.10. AeroNOx 2.0 Electrical Specifications ... 21 2.11. Sensor Specifications ... 21 2.12. EMC Compliance... 21 2.13. Physical Dimensions and Center of Mass ... 24 2.14. VESA Mounting Pattern ... 24 THEORY OF OPERATION ... 25 3.1. Front Panel ... 25 3.2. Front View - Labeled ... 25 3.3. Button Functions ... 26 3.4. Rear Panel ... 27 3.5. Rear View - Labeled ... 27 3.6. Connection to Ventilator Circuit ... 27 3.7. Delivery System ... 29 3.8. Sample Analysis System ... 30 3.9. General Features and Operation ... 31 3.9.1. Microprocessor ... 31 3.9.2. 4.3” Smart LCD ... 31 3.9.3. Startup ... 31 3.9.4. Battery, Charger, and Battery Monitor ... 32 3.9.5. Alarms, Messages, and Warnings ... 32 3.9.6. Safety On/Off ... 34 3.10. Environmental Effects ... 35 3.10.1. Nitric Oxide and Nitrogen Dioxide Sensors ... 35 3.10.2. Temperature Effects ... 36 3.10.3. Nitrogen Dioxide (NO2) Analyzer Circuit ... 36 3.10.4. Nitric Oxide (NO) Analyzer Circuit ... 37 3.10.5. NO / NO2 Circuit Calibration ... 37 3.10.6. Pressure Effects ... 37 3.10.7. Temperature Dependence ... 37 3.10.8. Humidity Effects ... 38 3.10.9. High Humidity, High Temperature... 38 3.10.10. Low Humidity, High Temperature ... 38
Part No. 715-0007, Rev. D
-1-
TABLE OF CONTENTS
4.
5.
3.10.11. Cell Handling ... 38 3.10.12. Oxygen Sensor ... 39 3.10.13. Oxygen Analyzer Circuit ... 40 3.10.14. Linearity ... 40 3.10.15. Carrier Gas Effects ... 40 3.10.16. Cross Sensitivity... 40 3.10.17. Temperature / Pressure Dependence ... 41 3.10.18. Oxygen Concentration vs. Humidity ... 41 3.10.19. Oxygen Cell Handling Precautions ... 41 3.11. Mass Flow Meter Circuit ... 41 CALIBRATION ... 42 4.1. Low Range Calibration (Daily) ... 42 4.2. O2 High Range Calibration (Weekly) ... 43 4.3. NO High Range Calibration (Weekly) ... 45 4.4. NO2 High Range Calibration (Weekly) ... 47 MAINTENANCE ... 50 5.1. AeroNOx 2.0 Service Procedures Overview ... 50 5.2. Maintenance Tools... 51 5.3. Scheduled Maintenance ... 51 5.4. Cleaning the AeroNOx 2.0 ... 52 5.5. Preventive Maintenance ... 52 5.6. Replacing NO, NO2 and O2 Sensors ... 53 5.7. Battery Replacement ... 56 5.8. AeroNOx 2.0 MFM Flow Check/Leak Test Procedure ... 57 5.8.1. Tools and Materials... 57 5.8.2. Leak Check ... 58 5.9. AeroNOx 2.0 Sample Rate Adjustment Procedure ... 62 5.9.1. Tools and Materials... 62 5.9.2. Instructions... 62 5.10. AeroNOx 2.0 Gas Testing Procedure ... 67 5.10.1. Tools and Materials ... 67 5.10.2. Procedure ... 67 5.10.3. Battery / Charge Indicator Check ... 67 5.10.4. Zero Calibration ... 68 5.10.5. Oxygen Analyzer Calibration ... 68 5.10.6. Nitric Oxide (NO) Gas Testing ... 68 5.10.7. NO Alarm Testing ... 69 5.10.8. NO Safety Shutoff Alarm ... 69 5.10.9. Nitrogen Dioxide (NO2) Gas Testing ... 70 5.10.10. NO2 Alarm Testing ... 70 5.10.11. NO2 Safety Shutoff Alarm ... 70 5.10.12. Battery Disconnection ... 71 5.11. Repair Maintenance ... 73 5.11.1. Front External Layout ... 73
Part No. 715-0007, Rev. D
-2-
TABLE OF CONTENTS
6.
7.
5.11.2. Rear External Layout... 73 5.11.3. Rear Internal Layout ... 74 5.11.4. Front Internal Layout... 74 5.11.5. Service Parts List ... 75 5.11.6. General Disassembly ... 77 5.11.7. Power PCBA ... 77 5.11.8. Control PCBA ... 77 5.11.9. AeroNOx 2.0 4.3” LCD ... 77 5.11.10. Sample Assembly ... 77 5.11.11. Mass Flow Meter (MFM)... 78 5.11.12. Porter Valve Assembly ... 78 5.11.13. Sample Inlet Port ... 79 5.11.14. Delivery Port... 79 5.11.15. NO/N2 Inlet Port ... 79 TROUBLESHOOTING ... 80 6.1. Troubleshooting Alarms Guide ... 80 6.2. Troubleshooting Other Symptoms and Solutions ... 85 6.3. Customer Service ... 88 APPENDIX ... 89 7.1. External Power Supply Electrical Specifications ... 89 7.2. Isolation Diagram ... 90 7.3. Nitric Oxide Sensor Specifications ... 91 7.4. NO2 Sensor Specifications ... 93 7.5. Oxygen Sensor Specifications ... 95 7.6. Mass Flow Sensor Specifications ... 96 7.7. Recommended Practices for Handling of Gas Cylinders and Regulators to Maintain Gas Quality ... 97 7.8. System Wiring Diagram ... 100 7.9. Sensor Connection Block Diagram ... 101
Part No. 715-0007, Rev. D
-3-
1.
INTRO ODUCTION N This se ervice manual is intended for use e by qualifie ed service ttechnicianss with the to ools, facilitie es, and tra aining to repair a medical device.. For questtions, conta act Internatiional Biome edical. 1.1.
Important Safety Con nsiderations s Safety con ncerns or ad dditional pe ertinent info ormation will be displayyed using w warnings, cautions, and a notes, having the following s ignificance: A Alerts to p potential se erious inju ury, a adverse ev vent, or sa afety hazarrd. A Alerts to the possibilityy of minor iinjury or d damage to the equipm ment.
S: NOTES
Provides additional information to o clarify a point in th he manual.
he principal WARNING G and CAUTION notices to be ob bserved in u use of this d device are brought Th tog gether here e for empha asis.
Usse of the Ae eroNOx 2.0 0 is contra aindicated fo or patients with conge enital heart disease on n right-to-lefft sh hunt, congenital anoma alies, or con ngestive he eart failure. Do o not use th he AeroNOx x 2.0 in ox xygen rich environmen nts. If a an alarm oc ccurs, safeg guard patie ent before trroubleshoo oting or repa air procedures. Usse only pha armaceutica al grade NO O. Th he AeroNOx x 2.0 mus st be used in accordan nce with ind dications, ussage, contrraindication ns, warnings, an nd cautions described in this man nual. Th he use of de evices whic ch radiate high h intensitty electricall fields mayy affect the operation o of the Ae eroNOx 2.0. Constant assessm ment of the patient and d all life sup pport equipm ment is mandatory wh henever inte erfering dev vices are operating on n or near pa atient. When using the t AeroNO Ox 2.0 adjjacent to orr stacked w with other eq quipment, o observe the e operation of the e AeroNOx x 2.0 and the t other eq quipment to o ensure no ormal opera ation. Po ortable RF communica c ations equip pment (inclu uding perip pherals such h as antenn na cables a and external an ntennas) should be use ed no close er than 30 cm c to any p part of the A AeroNOx 2.0 and asssociated ca ables. Othe erwise, degrradation of the perform mance of th his equipme ent could occcur.
Parrt No. 715-000 07, Rev. D
- 11 -
Do not use the AeroNOx 2.0 with helium/oxygen mixtures. The AeroNOx 2.0 is only intended to deliver NO in conjunction with oxygen/air mixtures. Anytime a new NO gas cylinder and regulator is used, the user must purge to prevent inadvertent delivery of NO2 to the patient. If the AeroNOx 2.0 is not going to be used within 10 minutes, depressurize the regulator supply line. If the AeroNOx 2.0 is pressurized and not used within 10 minutes, repeat the purge procedure. If the AeroNOx 2.0 is not depressurized and not used within 12 hours, repeat the pre-use procedure. A backup NO delivery system must always be available in the event the primary system should fail. Set AeroNOx 2.0 alarm thresholds for the current patient conditions to monitor any inadvertent changes in treatment. For alarm information, see the ALARMS section in the Operator’s Manual (p/n 715-0006). Be certain all lines and cables are organized to prevent damage or occlusion. Use only parts, accessories, transducers, and cables designated by International Biomedical for use with the AeroNOx 2.0. Cables and accessories other than those supplied by International Biomedical may result in unacceptable operation of the AeroNOx 2.0 and will void the equipment warranty. The AeroNOx 2.0 samples gas at a rate of 220 mL/min; this can affect the sensitivity of flow triggered synchronized breath of some ventilators. The trigger sensitivity, if equipped, should be checked after connecting AeroNOx 2.0 to the breathing circuit. Do not change NO, NO2, or O2 sensors while in use. Do not attempt to maintain, diagnose, or repair the AeroNOx 2.0 while delivering NO to a patient. No modification of the AeroNOx 2.0 is allowed. Improper sensor or battery replacement will result in a non-functional or inaccurate device. Sample/Delivery accessories are single patient use only. DO NOT re-use. Improper maintenance or replacement of sensors may pose a safety risk to the patient. Maintenance should be performed by qualified service personnel per the instructions. Perform cylinder connection and purge procedures in well-ventilated areas to prevent inadvertent exposure to Nitric Oxide or nitrogen dioxide gas. Follow your facility’s safety procedures for handling medical gas cylinders. Overexposure to NO or NO2 can lead to physiological effects such as hypoxia which are not apparent to the operator. The IP33 rating applies when the AeroNOx 2.0 is on battery power with the DC Input jack properly sealed.
Part No. 715-0007, Rev. D
- 12 -
Ca aution: U. S. S Federal and a Canadian law res stricts this d device to sa ale by or on the order o of a physician or other licensed medica al practition ner. Outside Canada a and the U. S., check w with local la aws for ap pplicable res strictions. When using the t AeroNO Ox 2.0 Bagger or INO Ostat Bagge er, oxygen and NO mix in the resservoir bag. If no ot actively bagging b patient, turn NO N flow off to t prevent fformation o of NO2. Flussh the bagg ger for 20 se econds befo ore and afte er use to co ompletely re emove NO a and NO2. Co oncentration ns of NO2 in the reserv voir bag ma ay exceed 1 ppm. Larrge tidal vo olumes mayy expose pa atients to NO O2 in the re eservoir bag g. If any intterruption o occurs durin ng patient b bagging, syystem shoulld be e flushed for 20 second ds. When using the t AeroNO Ox 2.0 Bagger or INO Ostat Bagge er, short du uration, rapid fluctuatio ons in elivered gas s concentra ation including NO2 is possible. p T Therefore, the AeroNO Ox 2.0 Bag gger and de INOstat Bagg ger are designed for sh hort term us se only. Do o not use AeroNOx A 2.0 0 Bagger or INOstat Bagger to deliver con ncentration in excess o of 20 ppm. Th he generatio on of NO2 increases ra apidly abov ve this conccentration. Do o not alter the length of o the INOsttat Bagger gas supplyy tubing as tthis may ca ause genera ation of exxcessive lev vels of NO2. Do o not substiitute AeroN NOx 2.0 Bagger or IN NOstat Bagg ger compon nents. The e Bagger Syystems hav ve be een designe ed and teste ed for patie ent safety with w the com mponents in ncluded. Th he AeroNOx x 2.0 Bag gger and INOstat Bagg ger are inte nded to con nnect direcctly to the pa atient’s en ndotracheal tube. Do not n insert any a addition nal tubing b etween the e Bagger an nd the endo otracheal tu ube. Th he AeroNOx x 2.0 Bag gger and INOstat Bagg ger are sing gle patient u use. Do no ot reprocesss. Th he INOstat Kit is intend ded for use if the prima ary NO deliivery device e (AeroNOxx 2.0) fails. The INOstat Kit is s not intended as a prim mary NO de elivery dev ice. Th he back-up delivery reg gulator in th he INOstat Kit is prese et with a 0.2 25 L/min flo ow. It is inte ended to be e ussed only witth the INOs stat Bagger.. Do not us se this regu ulator for an ny other app plication. Pe ersons using the AeroN NOx 2.0 should s be trained and experience ed in the usse of this de evice to asssure effective adminis stration of NO, N and to avoid a injuryy to the patient or to otthers resultting from inh halation of excess e NO, NO2, or otther reactio on productss. Not for use by patie ents. Pe ersons using this devic ce who may y be particu ularly sensittive to Nitricc Oxide or nitrogen dio oxide, or who ma ay be exposed to thes se gases for prolonged d periods ass a result o of the use off this device e, should be aw ware that the AeroNOx x 2.0 does s not scave enge the exxhaust gas, and that th his gas is ve ented from the un nderside of the AeroNO Ox 2.0, orr through th he side ventt in the eve ent that the bottom porrt is occlude ed. Am mbient conc centrations of Nitric Ox xide or nitro ogen dioxid de expected d to result frrom the use e of this de evice are les ss than 50 ppb. On nly use Inte ernational Biomedical B approved a batteries b forr AeroNOx 2.0. Parrt No. 715-000 07, Rev. D
- 13 -
Disconnect the battery or leave charging when not in use for extended periods of time. Attempting to run the AeroNOx 2.0 for longer than five hours on battery only could result in an interruption of Nitric Oxide therapy. The specified power supply is defined as part of the ME Equipment. Use only the International Biomedical approved universal power supply for AeroNOx 2.0. No other devices are known to cause potential interference with the AeroNOx 2.0. If interference occurs, discontinue use of the AeroNOx 2.0 and use the INOstat Bagger. Never turn on the NO delivery gas without first turning on the ventilator or bagger flow. Failure to do this will result in undiluted gas delivery entering the sampling chamber and exposing the sensors to levels of NO and /or NO2 which may damage the sensors. NO2 gas may have collected in the AeroNOx 2.0 delivery or ventilator circuit during setup. Run ventilator and AeroNOx 2.0 on a test lung 30 seconds prior to patient connection to ensure analyzed levels of NO2 and NO are appropriate. Only use the NO Worries Sample line with filter and Nafion tubing when operating the AeroNOx 2.0. Failure to do so may result in the egress of moisture which can impair function as well as damage internal components. NO flow must be continually evaluated during Nitric Oxide administration to ensure accurate dosing. NO cannot be administered during the calibration process. Do not sterilize or disinfect with power connected. Allow unit to dry thoroughly before use. Immediate use after exposure to excessive cleaning agents such as Isopropyl Alcohol can affect sensor performance. Do not push on LCD display. The VESA 75 mount is required for mounting during transport. Should there be a sudden need to change therapy tanks; a second tank should always be purged and ready for immediate use. Perform the purge procedure immediately upon installation of a new regulator. The flush procedure must be performed each time NO therapy is started. This includes initial therapy starts, tank changes, and re-starting therapy after NO has been off. Powering the unit off will shut off the delivery gas flow. Gas flow is terminated when the unit is powered off, whether intentionally, or during a complete loss of power. DO NOT exceed 2.00 LPM as displayed on the AeroNOx 2.0 flow display. Displayed values in excess of 2.00 LPM are not accurate. If the flow on the AeroNOx 2.0 flow meter is set at a value greater than 2.00 LPM, the delivered flow will be higher than the displayed flow value.
Part No. 715-0007, Rev. D
- 14 -
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. Setting alarm limits to extreme values can render the alarm system useless. After storage at the extremes of the allowable temperature range, it is recommended that the AeroNOx 2.0 be given at least an hour at room temperature before use. NOTES: The Low Cal does not require calibration gases. Connections to various ventilators are unique to each manufacturer as well as their corresponding disposable circuits. When AeroNOx 2.0 is connected to a ventilator and patient is breathing spontaneously, a slight change in NO ppm (< 10%) may be noted. When performing high range calibration, make sure to select the correct calibration gas and confirm expiration date before using. Never connect calibration circuit to a pressure source > 50 cm H2O; this could damage the sampling system. Protective cover not shown in many images throughout this manual should be used at all times to provide extra impact resistance if dropped. AeroNOx 2.0 is shipped with battery installed but disconnected. Follow connection procedure in Section 7. Do not mount or position the AeroNOx 2.0 such that the rear power connection, exhaust ports, or the NO inlet are blocked. The recommended storage temperature limits are within operational temperature limits to preserve sensor life. No specific time to cool or warm from storage temperature extremes is indicated. Before normal use, a pre-check must be performed to allow sensors to stabilize. Use the tethered rubber plug to seal the DC input jack from the environment when not in use.
Part No. 715-0007, Rev. D
- 15 -
2.
SPECIFICATION NS 2.1.
Symbols Table T The follow wing symbols appear in n the AeroN NOx 2.0 d documentation and lab bels. “ON”/””OFF” Powe er (Hold forr ~3 Secon nds to turn off) o
Soft Key (3)
Silenc ce Alarm Bu utton
D Date of Manufacture
Dim Backlight B Bu utton
M Manufacture er contact in nformation
Back Button B
G General Warning, C Caution, Rissk of Dange er
NO Sa ample Inlet
D Do not disca ard in trash
NO/N2 Delivery Outlet O
U Use indicate ed power su upply only
Nitric Oxide O Flow w Control (In ncreasing flow co ounter cloc ckwise)
Exhaust Do Not Block
ATTEN NTION: Ob bserve prec cautions for han ndling electtrostatic sensitive device es.
U Use only the e specified re eplacementt battery.
Consu ult Instructio ons For Use e
N NO/N2 Supp ply Gas Inpu ut
Opera ating pressu ure limits
O Operating te emperature lim mits
(Blue Background)
Parrt No. 715-000 07, Rev. D
Type BF Applied Pa art
Class II E Equipment
Device se erial numbe er
Prescription use only y
- 16 -
Device part p number
Decrea ase Value
Conffirmation
Set Low A Alarm Limitt
Se elect High/L Low Alarm Limits L
Set High Alarm Limit
Increa ase Value
A AC Power P Plugged in and a Cha arging
Ala arm Temporrarily Silenc ced for Approximate A ely 60 Seco onds
Scree en Lock
Batte ery Level Full / Low
Screen Unlock (Hold to unlock)
Hold Button Timer T (Moving Pie Chart) C
Lock Prohibited with h unacknowledged alarm
Nitric c Oxide Con ncentration in Parts Per Million
Percent Oxygen
Nitro ogen Dioxid de Concentrration in Parts Per P Million
Z Zero Calibrration Scree en Sofft Key
Set NO O=0, NO2=0, and %O2=21 Soft Key (Ho old to zero)
High Calibrration Scree en Sofft Key
Parrt No. 715-000 07, Rev. D
- 17 -
2.2.
Abbreviations ABBREVIATION AC CISPR cm DC ESD FiO2 FSO ft HFOV IB in L/min mA mbar mL/min mm mmHg N2 NO NO2 O2 PM ppb ppm psi psig PTFE RH RF V VESA VRLA
Part No. 715-0007, Rev. D
DEFINITION Alternating Current International Special Committee on Radio Interference Centimeters Direct Current Electrostatic Discharge Fraction of Inspired Oxygen Full Scale Output Feet High Frequency Oscillatory Ventilation International Biomedical Inches Liters per Minute Milliamps Millibars Milliliters per Minute Millimeters Millimeters of Mercury Nitrogen Gas Nitric Oxide Gas Nitrogen Dioxide Gas Oxygen Gas Preventative Maintenance Parts per billion Parts Per Million Pounds per Square Inch Pounds per Square Inch Gauge Polytetrafluoroethylene Relative Humidity Radio Frequency Volts Video Electronics Standards Association Valve Regulated Lead Acid
- 18 -
2.3.
Ventilator Compatibility The AeroNOx 2.0 has been validated with the following ventilators: Conventional: 1. 2. 3. 4. 5.
Bio-Med Devices MVP-10 (CMV/IMV Mode) Bio-Med Devices CV2i+ (CMV/IMV Mode) Accutronic Fabian/TV-1 Evolution (IPPV Mode) HAMILTON-T1 (PCV Mode) Bio-Med Devices TV-100 (IPPV Mode)
High Frequency: 1.
2.4.
Percussionaire TXP-2D (frequencies between 5 Hz (300 bpm) and 8.3 Hz (500 bpm) and amplitude less than 30 cmH2O with mean airway pressures of 8-18 cmH2O)
Measurement Range and Accuracy
Parameter NO NO2 O2 NO/N2 Flow 2.5.
Measurement Range 0-99 ppm 0-9 ppm 18-100% 0-2 L/min
Meter Resolution 1 ppm 0.1 ppm 1% O2 0.01 L/min
Specification
Inlet Pressure Outlet Flowrate Cylinder Valve Connection
14-155 bar 0.25 L/Min Fixed flow of NO/N2 CGA 626
INOstat Bagger Parameter
Specification
O2 Gas Flow NO Gas Flow Delivered NO NO2 Generated
10 L/Min 0.25 L/Min 20 ppm 0.2 ppm Maximum 20 ppm NO Delivered 0.5 L Approximately 30 cm length 500 ml Max Tidal Volume Maximum 100 bpm at PIP 18 cmH2O PEEP 5 cmH2O. Maximum 50 bpm at PIP 40 cmH2O PEEP 5 cmH2O Variable
Reservoir Volume Bagger Dimensions Tidal Volume Breath Rate
I:E Ratio 1
Device1 Accuracy 2 ppm 2 ppm 3% O2 0.1 L/min
Backup Delivery Regulator Parameter
2.6.
Sensor Accuracy 1 ppm 0.1 ppm 2% O2 0.045 L/min
Device accuracy is affected by the ventilator that is attached.
Part No. 715-0007, Rev. D
- 19 -
2.7.
AeroNOx 2.0 Delivery Regulator
Parameter Inlet Pressure Outlet Pressure Cylinder Valve Connection 2.8.
AeroNOx 2.0 Physical Specifications
Parameter Weight (device + protective cover only) WDH Precision Metering Valve Service Life Gas Supply Alarm Sound Pressure Level 2.9.
Humidity Ambient Pressure Altitude Ingress Protection AeroNOx 2.0 Power Supply
3
Specification 4.0 kg 33 cm 14 cm 25cm ~12 turns to fully open 8 years with preventative maintenance Recommend NO @ 800ppm Balance N2 High Alarm 56dB Max @ 1m Medium Alarm - 54dB Max @ 1m
AeroNOx 2.0 Environmental Specifications
Temperature
2
Specification 14-155 Bar 1.7-2.3 Bar CGA 626
Operating 0 C to 39 C
15-90% RH non-condensing 62-120 kPa 3657 m (12,000 ft) IP332 IP223
Transport/Storage -40 C to 5 C 5 to 35 C up to 90% RH 35 C to 70 C vapor pressure up to 50hPa See above 620-120 kPa 3657 m (12,000 ft)
15-90% RH non-condensing Not rated Not rated
IP332 IP223
Not rated Not rated
(Falling liquid spray 60 from vertical for 5 min and 2.5 mm object protection) (Dripping water at 15 from vertical for 2.5 min, and 12.5 mm object protection)
Part No. 715-0007, Rev. D
Transient -20 C to 50 C
- 20 -
2.10. AeroNOx 2.0 Electrical Specifications Parameter Medical Rated AC Supply Input Fuse Classification AeroNOx 2.0 Input Voltage Battery Standards
Specification Meanwell GSM40B09-P1J 3A Self-resetting Class II, 2 X MOPP 120-240VAC, 50/60 Hz Sealed lead acid 6V, 4.5Ah battery provides standalone power for 5 hours. IBL P/N 888-0115. 1 year life. 1. 60601-1 (General Requirements for basic safety and essential performance) 2. 60601-1-2 (Electromagnetic Compatibility) 3. 60601-1-8 (Alarms) 4. 60601-1-12 (EMS Environment)
2.11. Sensor Specifications
Max Overload Linearity
NO 1500 ppm Linear
NO2 200 ppm Linear
O2
Flow
N/A N/A Within 2% of N/A reading Response Time <10s <50s >22s for 97% of 10ms (T90) change Effect of Temp on N/A N/A 3% error from Compensated Accuracy -40 C to 40 C 0 to 50 C For further sensor details visit the datasheets in the Appendix. 2.12. EMC Compliance The AeroNOx 2.0 has been tested and found to comply with limits for electromagnetic interference and susceptibility as defined by IEC60601-1-2. However, this equipment may radiate radio frequency (RF) energy and may cause harmful interference to other devices. The AeroNOx 2.0 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the AeroNOx 2.0 can help prevent electromagnetic interference by maintaining operating the device in the environments and with the minimum separation distances specified below. Additionally, periodic maintenance as specified by International Biomedical will allow the device to continue to provide basic safety and essential performance.
Part No. 715-0007, Rev. D
- 21 -
GUIDANCE AND MANUFACTURER’S DECLARATION - EMISSIONS The AeroNOx 2.0 is intended for use in the electromagnetic environment specified below. The customer or user of the AeroNOx 2.0 should ensure that it is used in such an environment. ELECTROMAGNETIC ENVIRONMENT EMISSIONS TEST COMPLIANCE GUIDANCE The AeroNOx 2.0 does not use RF energy for its internal function. Therefore, its RF RF Emissions CISPR 11 Group 1 emissions are very low and are not likely to cause any interference in nearby electronic equipment. Conducted Emissions The AeroNOx 2.0 is suitable for use in all Class B CISPR 11 establishments, including domestic, and those directly connected to the public low-voltage Harmonics IEC 61000Class A power supply network that supplies buildings 3-2 used for domestic purposes. Flicker IEC 61000-3-3 Complies RTCA/DO-160F Section 21 RTCA/DO-160F Section 21
Category M
Maximum level of conducted RF interfacePower line
Category M
Maximum level of radiated RF interface
GUIDANCE AND MANUFACTURER’S DECLARATION - IMMUNITY The AeroNOx 2.0 is intended for use in the electromagnetic environment specified below. The customer or user of the AeroNOx 2.0 should ensure that it is used in such an environment. COMPLIANCE ELECTROMAGNETIC IMMUNITY IEC 60601 LEVEL ENVIRONMENT TEST TEST LEVEL GUIDANCE Floors should be wood, ESD concrete, or ceramic tile. If 8 kV Contact 8 kV Contact IEC 61000-4-2 floors are synthetic, the r/h 2/4/8/15 kV Air 2/4/8/15 kV Air should be at least 30%. Mains power quality Surge 0.5/1 kV Differential 0.5/1 kV Differential should be that of a typical IEC 61000-4-5 0.5/1/2 kV Common 0.5/1/2 kV Common commercial or hospital environment. Power Power Frequency Frequency magnetic fields should be 50/60 Hz 30 A/m 30 A/m that of a typical Magnetic Field commercial or hospital IEC 61000-4-8 environment.
Part No. 715-0007, Rev. D
- 22 -
GUIDANCE AND MANUFACTURER’S DECLARATION - IMMUNITY The AeroNOx 2.0 is intended for use in the electromagnetic environment specified below. The customer or user of the AeroNOx 2.0 should ensure that it is used in such an environment. COMPLIANCE ELECTROMAGNETIC IEC 60601 IMMUNITY TEST LEVEL ENVIRONMENT TEST LEVEL GUIDANCE Portable and mobile communications equipment should be separated from the Transport Incubator by no less than the distances calculated/listed below: 3 Vrms 3 Vrms Conducted RF 150 kHz to 80 MHz 150 kHz to 80 MHz D= . √ IEC 61000-4-6 (AC/DC) (AC/DC) 6 Vrms (in ISM Bands between 150kHz and 80MHz)
6 Vrms (in ISM Bands between 150kHz and 80MHz)
D=
.
√
80 to 800 MHz D=
√
800 MHz to 2.7 GHz Radiated RF IEC 61000-4-3
10 V/m 80 MHz to 2.7 GHz
10 V/m 80 MHz to 2.7 GHz
Where P is the max power in watts and D is the recommended separation distance in meters.
(V1) Vrms
Field strengths from fixed transmitters, as determined by an electromagnetic site survey, should be less than the compliance levels (V1 and E1).
(E1) V/m
Interference may occur in the vicinity of equipment containing a transmitter. Proximity fields from RF Wireless Communication Equipment IEC61000-4-3
Part No. 715-0007, Rev. D
See IEC60601-1-2:2014 8.10
See IEC60601-1-2:2014 8.10
- 23 -
This equipment should be placed no closer than 30cm from the nearest RF Wireless communication device.
2.13. Physical Dimensions D and Cente er of Mass
2.14. VESA Mou unting Patte ern
Parrt No. 715-000 07, Rev. D
- 24 -
3.
THEORY OF OPERATION The Ae eroNOx 2.0 0 is a dura able, light-w weight, porttable, battery operated d device de esigned to deliverr Nitric Oxid de (NO) to a ventilatorr circuit and d continuously monitorr and displa ay concen ntration lev vels of Nitric c Oxide, Nittrogen Dioxxide (NO2), and Oxyge en (O2). 3.1.
Front Pane el The front panel p conta ains a 4.3” smart s displa ay and a de edicated green LED fo or indicating g that the de evice is plug gged in. Six push butttons located on the fro ont panel allow setting g of the High and Low con ncentration alarm poin nts for NO a and O2 and the High cconcentratio on alarm poin nt for NO2. The right th hree button ns are soft kkeys that ha ave varying g function depending g on which menu m is dis splayed. Th he three lefft push buttons are ded dicated to “Alarm Pau use”, “Scre een Dim”, an nd “Back” ffunctions. T The manua al flow contrrol knob is located tow ward the low wer right side of the frront panel. The On/Offf button is located in the t lower rightt corner.
3.2.
Front View w - Labeled
Parrt No. 715-000 07, Rev. D
- 25 -