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Appendix E - Third-Party Software and Hardware

 146

 ©2020 CAE 905K710052 v.1.1 

CAE

Air1

 

Hardware

The following table contains the hardware BOM (Bill of Materials) of third-party hardware with 
firmware used in the CAE Air1 ventilator.

CAE Part Number

Manufacturer

Manufacturer Part 

Number

Version Number

PS302659065621

ST Microelectronics

STM32F405RGT6

None

PS302659035621

NXT

MCIMX6D6AVT10AD

None

PS585428015840

Cyber Power

M550L

None

PS585708015842

Seimens

3SK2112-1AA10

None

PS585421015842

Elo

1502L

Rev. A

Summary of Contents for Air1

Page 1: ...CAEAir1 Mechanical Ventilator User Guide...

Page 2: ...ions 12 General 12 Cleaning 12 Ergonomics 13 Operations 13 Medical and Safety Symbols 14 Ventilator Symbols 14 Ventilator Warning Text Labels 18 Shipping Symbols and Definitions 21 Electromagnetic Com...

Page 3: ...spiratory Line 35 Inspiratory Air Filtration 35 Expired Air Filtration 35 Expiratory Line 36 Electrical System Description 36 Controllers 36 Power 36 Alarm Generation 36 User Interface 37 Ventilation...

Page 4: ...Notification 58 Test Buttons 58 Screen Navigation 59 Test Screens 60 Primary Alarm System 61 Backup Alarm System 63 Power Source Switch 64 Component Functional Check 65 Software Integrity Check 66 Br...

Page 5: ...Start New Patient 105 Power Off the Ventilator 106 Care and Maintenance 107 Exterior and Touchscreen Cleaning and Disinfecting 107 Cleaning Notes 107 Cleaning Cautions 108 Cleaning Procedure 108 Disi...

Page 6: ...B Alarms 131 Vitals Sensor Alarms 131 Vitals Alarm Criteria and Default Threshold Values 132 Ventilator Hardware and Software Alarms 133 Alarm Indications 134 Backup Alarm 135 Responses to Alarm Condi...

Page 7: ...vi 2020 CAE 905K710052 v 1 1 CAEAir1 INTENTIONALLY LEFT BLANK...

Page 8: ...oltage 90 VAC 150 VAC Output Voltage 120 VAC 5 Battery life Minimum 20 minutes Temperature Operating 0 C to 40 C 32 F to 104 F Storage 15 C to 45 C 5 F to 113 F Humidity Operating 0 to 95 non condensi...

Page 9: ...Specifications 2 2020 CAE 905K710052 v 1 1 CAEAir1 INTENTIONALLY LEFT BLANK...

Page 10: ...ventilator shipping materials Electromagnetic Compatibility identifies the emission and immunity details for electromagnetic interference of the ventilator Cybersecurity provides information regarding...

Page 11: ...ommended by CAE WARNING Use of accessories transducers and cables other than those specified or provided by CAE could result in increased electromagnetic emissions or decreased electromagnetic immunit...

Page 12: ...t intended to be a primary power source Batteries are intended for short term use only CAE recommends the ventilator s batteries be fully charged before using the ventilator on a patient If the batter...

Page 13: ...may occur from exposure to chemicals in cleaning and disinfecting agents WARNING Before placing in storage the ventilator must be cleaned and disinfected Cover the ventilator and plug all ports suppl...

Page 14: ...rupted rest and develop anxiety as a result of excessive lights from the display WARNING Do not cover or place the ventilator in an area that will compromise access to the patient or other equipment I...

Page 15: ...the ventilator including cables specified by CAE Otherwise degradation of the performance of this equipment could result WARNING Burns may occur if the patient or others are exposed to overheated comp...

Page 16: ...us deterioration of health or patient death WARNING Always connect the ventilator to a power plug that does not include other support devices and to a power outlet that is connected to a power generat...

Page 17: ...nt patient monitoring Pulse oximeter etc is appropriate for the patient s condition WARNING Always examine the patient prior to examining the ventilator in the event a ventilator malfunction is suspec...

Page 18: ...s in this user guide WARNING The ventilator is a high flow device that can operate with flows above 60 l min and with high oxygen concentration WARNING The ventilator must be used by trained medical p...

Page 19: ...hypochlorite bleach label instructions for use before use for additional precautions Use personal protective equipment including gloves protective glasses and liquid resistant gowns To prevent possibl...

Page 20: ...nstructions for nebulizers humidifiers and pressurized oxygen supply Be aware when maneuvering the ventilator avoiding obstacles and surfaces that may cause damage to the ventilator enclosure Avoid sp...

Page 21: ...ventilator shipping containers Ventilator Symbols Ventilator Symbols and Definitions Symbol Definition Refer to Instruction Manual Booklet Read Technical Manual Before Servicing General Warning Warni...

Page 22: ...pertains to safety from electrical shock and fire and mechanical hazards SPE 3000 15 United States Federal Communications Commission IP21 Ingress protection classification Protected against ingress o...

Page 23: ...put Port Oxygen Inlet Port Unsafe to use the ventilator in magnetic resonance imaging environment The ventilator contains components manufactured with latex Operational Temperature Limitations Operati...

Page 24: ...2020 CAE 905K710052 v 1 1 17 Safety No Stepping on Surface Dispose as e waste laws and Regulations Waste Electrical and Electronic Equipment Ventilator Symbols and Definitions Symbol Definition...

Page 25: ...ion AVERTISSEMENT Ne Pas Obstruer L Entr e D Air Ce Qui Interf re Avec La Ventilation Du Patient WARNING Ensure Casters Are Locked Before Operating AVERTISSEMENT V rifier Que Les Roullettes Sont Verro...

Page 26: ...ENT With Respect to Electrical Shock Fire and Mechanical Hazards In Accordance to Model Code SPE 3000 This equipment has been investigated with regards to safety from electrical shock and fire hazard...

Page 27: ...battery and lead acid batteries AVERTISSEMENT Risque de feu ou d explosion Cet quipement contient des batteries au lilthium ion et plomb acide WARNING Fire hazard Keep all sources of ignition away fr...

Page 28: ...v 1 1 21 Safety Shipping Symbols and Definitions Symbol Description This side up Fragile Humidity limitations non condensing Shipping Temperature Limitations Do Not Stack Keep Dry Recycle Do not use i...

Page 29: ...ustrial areas and hospitals The ventilator uses RF energy only for its internal functions Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equi...

Page 30: ...45 90 135 180 225 270 and 315 0 UT 1 cycle and 70 UT 25 30 cycles 0 Magnetic Immunity IEC 61000 4 8 30 A m 60Hz Minimum distance between the ventilator and sources of power frequency magnetic field of...

Page 31: ...tion Maximum power W Distance m TEST LEVEL IMMUNITY V m 385 380 390 TETRA 400 Pulse modulation 18 Hz 1 8 0 3 27 450 430 470 GMRS 460 FRS 460 FM 5 kHz deviation 1 kHz sine 2 0 3 28 710 704 787 LTE Band...

Page 32: ...E of this guide CAE maintains a cybersecurity watch on software vulnerabilities CAE will advise users about issues that could impact the security of the device and provide guidance on how to address...

Page 33: ...Safety 26 2020 CAE 905K710052 v 1 1 CAEAir1 INTENTIONALLY LEFT BLANK...

Page 34: ...CAE Air1 ventilator is a mechanical ventilation system designed for continuous invasive ventilation for adult patients The ventilator utilizes gas intake from room air as well as a pressurized oxygen...

Page 35: ...dications for Use section defines the appropriate environment and use circumstances of the CAE Air1 ventilator The Equipment Overview section outlines the items that come standard with the purchase of...

Page 36: ...thcare com caeair1 Phone 1 866 462 7920 Option 4 Available during regular business hours Text Item Usage Convention Note A supplemental piece of information to further the reader s under standing of a...

Page 37: ...Introduction 30 2020 CAE 905K710052 v 1 1 CAEAir1 INTENTIONALLY LEFT BLANK...

Page 38: ...r precise adjustment of ventilation parameters The parameters are viewable and adjustable through the user interface displayed on the ventilator touchscreen The breathing gases provided to the patient...

Page 39: ...ontact CAE Customer Service for more information as needed This device can be cleaned and disinfected by any trained cleaning and reprocessing personnel using common medical facility products and proc...

Page 40: ...or dedicated ventilator software UPS ventilator power backup and emergency power backup for alarms CAE supplied oxygen tube The ventilator is depicted with additional details in the following images T...

Page 41: ...haust Exhaust Fan Supported 5 O2 Inlet Port 9 Ambient Air Inlet 2 2 O2 Enriched Air Flow Outlet Exhaust Fan Supported 6 O2 Enriched Air Flow Inlet 10 Communication Port 3 Air Filter 7 Expiration Outle...

Page 42: ...mixing tank which includes an O2 sensor One of the outlets from the gas mixing tank leads to a safety pressure relief line and includes an electronically controlled valve which can be opened when need...

Page 43: ...Primary alarm controller Ventilation Controller Ventilation controller Backup alarm controller Safety Controller Monitors ventilation controller Halts ventilation and sets system to Fail Safe mode pa...

Page 44: ...interface device is a LCD touchscreen It connects to the CPU using HDMI and USB cables On Off Button The system is powered on and off by pressing the on off button It is illuminated to indicate that...

Page 45: ...Equipment Overview 38 2020 CAE 905K710052 v 1 1 CAEAir1 INTENTIONALLY LEFT BLANK...

Page 46: ...by 0 6 meters approximately 2 feet by 2 feet to store the shipping container before and after use For more information see the Care and Maintenance section of this user guide Verify the content of ea...

Page 47: ...erature range for at least two hours prior to use See the Specifications section for storage and operational temperatures Batteries The CAE Air1 ventilator contains two lead acid batteries comprising...

Page 48: ...hours to charge the Lithium ion battery are additional to the 12 hours for the UPS battery to charge Note This preparation step should take place before the ventilator is ready to be used and setup f...

Page 49: ...l Connect the CAE Air1 to a pressurized oxygen supply if the patient requires ventilation with an FiO2 above that of ambient air 21 Note Medical grade oxygen must be used The O2 supply should be regul...

Page 50: ...tion and expiration ports Breathing Circuit Ports and Filters To change the inspiration filter a Remove the used inspiration filter and dispose b Place the new inspiration filter in To change the expi...

Page 51: ...t one of the tubes to the expiration port b Connect the second tube to the inspiration port If using a humidifier connect the humidifier in accordance with the manufacturer s instructions Step 5 Power...

Page 52: ...p Yes to begin Self Test Follow the onscreen instructions Patient Detected If a patient is detected the Patient Detected Self Test prompt appears Patient Detected Self Test Prompt When a patient is de...

Page 53: ...hing circuit by inserting a plug into the patient connection port of the y junction e Depending on the degree of occlusion the Plimit threshold will be reached immediately sending the ventilator into...

Page 54: ...e Screen with Tests Passed Notification If the test has failed the Fail Safe screen is displayed after closing the notification screen Clear the Fail Safe screen and return to the Home screen by tappi...

Page 55: ...mation Home Screen with Tests Failed Notification Step 8 Perform O2 Calibration If pressurized oxygen is being used see Step 2 the O2 Calibration must be performed prior to the first use of CAE Air1 T...

Page 56: ...utions provided in the Safety section of this user guide User Interface Conventions The user interface is hosted on a touchscreen on the front of the ventilator The UI utilizes interactive screens and...

Page 57: ...to indicate statuses and some touchscreen functions Black and white are used for most screen content The screen backgrounds are black with white font to facilitate legibility Grey is used for popups...

Page 58: ...rms that have been triggered Tapping the button opens the Alarm History popup screen Alarm History Button The alarm configuration screen is called up by a button using the bell symbol encircled by a g...

Page 59: ...ked when the screen lock function has been selected A colour change accompanies the padlock symbol change unlocked white locked blue Locked and Unlocked Buttons Start and Standby Symbols The Start Ven...

Page 60: ...re always associated with the colour green checkmarks and red Xs Passed and Failed Symbols In Progress Symbol The circling arrows symbol is used to indicate a test or action that is in progress in the...

Page 61: ...ace are Power On screen Home screen Tests screens Setup screen Operation screens Settings screens These are described in the following pages Power On Screen When the ventilator is started the Power On...

Page 62: ...screens A Self Test prompt screen may appear overlaid on the Home Screen in some instances Note The Start Setup button will not be available for selection if any of the tests Self Test or Breathing C...

Page 63: ...roperly installed Refer to the Setup section for instructions Test Buttons The Self Test button and Breathing Circuit Characterization Test button access tests that need to be run prior to using the v...

Page 64: ...ator tap No to close the popup and return to the Home screen The test will not be run Patient must be Disconnected Popup Confirmation Screen Navigation From the Home screen the operator can navigate t...

Page 65: ...ed in the event that patient safety is compromised by delaying ventilation in order to perform the Self Test A Self Test prompt appears if there is no patient detected Self Test Prompt A different scr...

Page 66: ...tests follow the onscreen instructions As each test is passed a green checkmark appears beside the test name on the left side of the screen If a test fails a red X will appear beside the test name ins...

Page 67: ...v 1 1 CAEAir1 Refer to Appendix B Alarms for a complete description of the different alarm priorities and how each are indicated by the alarm system Primary Alarm System Test In Progress Screen Prima...

Page 68: ...erface Overview Backup Alarm System The Backup Alarm System test verifies the Backup Alarm which is used in the event of a Primary Alarm System failure Backup Alarm System Test Start Screen Backup Ala...

Page 69: ...ir1 Backup Alarm System Test Confirmation Screen Power Source Switch The Power Source Switch verifies the successful switchover of the ventilator from external power to battery power and then back to...

Page 70: ...E 905K710052 v 1 1 65 Interface Overview Power Source Switch Test Completion Screen Component Functional Check The Component Functional Check tests a number of systems Component Functional Check Start...

Page 71: ...Note If there is no oxygen source connected to the ventilator the O2 Valve Test part of the Component Functional Check is skipped and is indicated as skipped in the test results Software Integrity Ch...

Page 72: ...2020 CAE 905K710052 v 1 1 67 Interface Overview Software Integrity Test In Progress Screen Software Integrity Test Completion Screen...

Page 73: ...tests do not successfully pass the Self Test is shown as Failed Self Test Failed IMPORTANT While the Self Test can be repeated if the ventilator continues to fail it cannot be used and must be taken...

Page 74: ...ircuit Characterization Test should be run before using the ventilator for each new patient Follow the onscreen instructions to run the test Breathing Circuit Characterization Test Start Screen Breath...

Page 75: ...ew 70 2020 CAE 905K710052 v 1 1 CAEAir1 Breathing Circuit Characterization Test Completed Tap the Done button The Test Passed or Test Failed notification screen appears Breathing Circuit Characterizat...

Page 76: ...nnot be used if the Breathing Circuit Characterization Test fails it must be taken out of service Refer to the Troubleshooting section for more information Tap the Close button In the case of an assoc...

Page 77: ...overheating pressure generation system Electronics failure or overheating Cooling fans failure Failure of communication between software and firmware Failure of any of these tests results in a high pr...

Page 78: ...ed the Setup screen is displayed The Setup screen details vary depending on the ventilator status Once a patient is ventilated the Setup screen is only displayed as an overlay of the Operation screen...

Page 79: ...at section Mode Selection The CAE Air1 ventilator can operate in one of three possible modes selected from the Setup screen 1 Pressure Control PC ensures the patient s airway pressure during exhalatio...

Page 80: ...2020 CAE 905K710052 v 1 1 75 Interface Overview Setup Screen PC Mode Setup Screen PS Mode Setup Screen VC Mode...

Page 81: ...of the control widget parameters and alarms to their default values When selected a confirmation popup appears Select Cancel or Confirm as desired The New Patient button is not available on the Setup...

Page 82: ...eration screen are available These views identified as Views 1 to 4 are described in greater detail later in this section Note View 1 is used as the starting point to describe the layout of the Operat...

Page 83: ...ll open the Alarm History screen Alarm History Notification Power status indicates the ventilator battery power level and charging status Refer to the Symbols and Colours section of this guide for a d...

Page 84: ...tion The Mode Selection button opens the Setup screen overlay view when selected with access to the three ventilator modes of operation PC PS and VC To change modes tap on the button and then select t...

Page 85: ...the alerting condition is resolved When high priority alarms are resolved the alarm banner remains onscreen but changes colour from red to black to indicate that it is no longer active The black banne...

Page 86: ...splay purposes Vitals display widgets and waveforms occupy the main portion of the center of the screen Operation Screen Center Vitals Displays The content of these displays varies depending on both t...

Page 87: ...lt view of the screen is View 1 Operation Screen View 1 The differences among the four views are captured in the following table View Operation Screen Content 1 default view Waveforms and critical num...

Page 88: ...ws 2 to 4 are shown in the following images Operation Screen View 2 Operation Screen View 3 Operation Screen View 4 The content of each view also varies somewhat depending on the mode of operation of...

Page 89: ...widgets are used to set target values for the ventilator parameters To modify a parameter tap on the associated widget A popup will appear in the place of the widget Operation Screen with Control Widg...

Page 90: ...touch until it has been unlocked Select the Unlocked button to activate the screen lock function The button turns blue and the label changes to Locked To restore screen responsiveness simply tap the L...

Page 91: ...arm Setup screen and return to the Operation screen Alarm Setup Screen Inspiratory and Expiratory Hold Maneuvers When the Maneuvers button is tapped an additional panel opens at the bottom of the scre...

Page 92: ...y The Standby button allows the operator to pause the ventilator function Standby Button When the button is selected a confirmation popup window appears Select Yes Standby to suspend ventilator functi...

Page 93: ...ontrol parameters are Pi RR and I E If the patient is breathing on their own these backup controls are inactive If the patient becomes apneic not breathing and the Tapnea threshold is surpassed these...

Page 94: ...ime the ventilator has been in use for the current patient is displayed Language selection options The operator can set the preferred language for the user interface Oxygen sensor calibration The oper...

Page 95: ...he calibration procedure If a patient is connected tap Cancel The calibration will not be performed Oxygen Sensor Calibration Popup The status of the calibration is indicated onscreen beside the Calib...

Page 96: ...2020 CAE 905K710052 v 1 1 91 Interface Overview Oxygen Sensor Calibration In Progress Oxygen Sensor Calibration Passed Oxygen Sensor Calibration Failed Select the Close button to close the screen...

Page 97: ...d button A passcode screen opens Using the numeric keypad enter the correct passcode to unlock the Administrator Settings Enter Passcode Screen With the Administrator Settings unlocked the passcode Ch...

Page 98: ...ode screen appears Enter the new code Enter Current Passcode Enter New Passcode and Confirm New Passcode Screens Use the Backspace and Cancel buttons as needed if the wrong number is touched while ent...

Page 99: ...mperature Sensor Calibration is to be performed as needed by trained service personnel On the Settings screen tap the associated Calibrate button and follow the onscreen instructions Temperature Senso...

Page 100: ...ure Sensor Calibration is to be performed as needed by trained service personnel On the Settings screen tap the associated Calibrate button and follow the onscreen instructions Oxygen Pressure Sensor...

Page 101: ...the ventilator is no longer needed it can be powered off The Powering Off screen displays while the device is shutting down Powering Off Screen To power off the ventilator in an emergency situation pr...

Page 102: ...ventilation mode using the Setup Screen 1 Select a ventilation mode Pressure Control Pressure Support or Volume Control Setup Screen Patient Not Ventilated 2 On the Setup screen make any necessary mo...

Page 103: ...View 1 Note For a full description of all four views of the Operation screen refer to the Interface Overview section Set the Alarms The ventilator is equipped with alarms to call attention to critical...

Page 104: ...Setup Window 2 Adjust the minimum and maximum threshold values of the alarm when applicable 3 Tap the Done button 4 Repeat the steps for each Display widget alarm setting as needed Note Only Display...

Page 105: ...1 Tap the Locked button to access the screen controls 2 Tap the control widget to be modified The control widget edit window opens Operation Screen Control Widget Edit Window 3 Adjust the parameter v...

Page 106: ...lator View Alarms History To view the Alarm History tap the Alarms Notifications button Alarm Notifications Button The Alarm History screen appears Alarm History Window To clear notifications tap Clea...

Page 107: ...ote The maneuver is completed with a maximum hold time of seven seconds The countdown timer begins when the button is pressed and is stopped automatically when seven seconds is reached The calculated...

Page 108: ...n and the settings of the last patient are retained To pause the ventilator 1 On the Operation screen tap the Standby button to suspend ventilation A confirmation window opens The Standby Ventilator C...

Page 109: ...ventilation mode in the upper left corner of the screen The Setup overlay appears Setup Overlay Select a Mode Note The patient is still being ventilated with the current mode and settings during this...

Page 110: ...tandby The Setup screen overlay view appears 2 Tap New Patient on the Setup screen overlay view Setup Screen Overlay Patient Not Ventilated The New Patient confirmation prompt appears New Patient Conf...

Page 111: ...entilation Power Off the Ventilator To power off the ventilator 1 Pause the ventilator using the Standby button and tap Yes Standby 2 Press the physical power button on the front of the ventilator for...

Page 112: ...atients High level disinfection of respiratory equipment takes place after cleaning and is typically accomplished by chemical germicides or physical methods as outlined in this user guide The exterior...

Page 113: ...h the touchscreen in direct sunlight for any extended time Ultraviolet light and excessive heat can damage the touchscreen Cleaning Procedure The cleaning procedure is always to be performed before th...

Page 114: ...d be saturated but not dripping 3 Wipe all surfaces and areas including the touchscreen 4 Allow disinfectant to remain on the wetted surfaces for at least 10 minutes 5 After the required contact time...

Page 115: ...Materials The following table lists materials that are most often used by the ventilator operator Note Asterisk indicates item under warranty Note The breathing circuit filters should have a low resis...

Page 116: ...items are covered under the warranty Air Inlet Filter 3 replacements Oxygen Line Filter 1 replacement Service Personnel Consumable Materials Description CAE Part Number Backup battery Lithium ion 3 7...

Page 117: ...iratory Filters Between patients or according to local protocol Run preoperational self checks Entire Ventilator Between patients or according to local protocol Empty any water from breathing circuit...

Page 118: ...batteries for a minimum of 12 hours UPS Battery Every 3 months if not in use Replace PEEP proportional valves Solenoid Valves Every 18 months Replace FiO2 sensor FiO2 Sensor Every 5000 hours of use Re...

Page 119: ...ce the room air inlet filter 1 On the back cover use a 2 Phillips screwdriver to remove the two screws that secure the air inlet filter grill Set aside the grill and screws in a safe location Air Inle...

Page 120: ...115 Care and Maintenance 3 Install the new air filter in the opening Ensure the air flow marking on the air filter points inwards Install New Air Inlet Filter 4 Secure the air inlet filter grill in p...

Page 121: ...the number of hours the ventilator has been used Network Activation Required prior to performing software updates and collecting log data Software Updates Required on a periodic basis Log Collection...

Page 122: ...he Total Operational Time will be displayed in the General Section of the Settings screen Network Activation Prior to performing software updates or collecting log data the network will require activa...

Page 123: ...creen select the Locked button A passcode screen opens Enter Passcode Screen 4 Using the numeric keypad enter the correct passcode to unlock the Administrator Settings The default passcode is 00000 On...

Page 124: ...are Updating the software will be required periodically The following equipment will be required Laptop computer intended for ventilator maintenance use Ethernet cable To update the software from a we...

Page 125: ...r PIN 6 Enter the passcode previously selected from the ventilator touchscreen interface If passcode was not modified the default is 000000 7 Select Login The Upload page will appear Upload Page and F...

Page 126: ...ur types of logs which can be collected from a web browser Alarms Log records all information regarding all alarms triggered and cleared Refer to Appendix D Ventilator Fault Logs for details Maintenan...

Page 127: ...og page appears Log Page 2 Select the type of log to download Updating the Date and Time The ventilator date and time will need to be set prior to first use and following each software update To updat...

Page 128: ...tch The power cord is not connected correctly The power cord is damaged AC power is not available from the wall outlet and UPS batteries are fully discharged Confirm the power cord is securely connect...

Page 129: ...When a ventilator is removed from service secure an OUT OF SERVICE HORS SERVICE label on the power cord to avoid accidental usage Symptom Probable Cause Remedy Battery is low or discharged UPS batter...

Page 130: ...Triggers Ventilator Responses Fail Safe Mechanical failure wherein the safe operating parameters of the ventilator cannot be maintained Repeated power surges from MCU Ventilation halted and valves op...

Page 131: ...Troubleshooting 126 2020 CAE 905K710052 v 1 1 CAEAir1 INTENTIONALLY LEFT BLANK...

Page 132: ...ry breath applied by mechanical ventilation Default 15 cmH2O Range 10 50 cmH2O PSupp Support Pressure The Psupp parameter controls the support pressure for a spontaneous patient breath Default 15 cmH2...

Page 133: ...inute and impacts the inspiratory time expiratory time ratio I E ratio Default 15 breaths per minute Range 4 50 breaths per minute PSafety Maximum Limited Pressure The ventilator includes protection t...

Page 134: ...of the set FiO2 0 15 FiO2 for 300 VT 500mL and 7 5 of the set FiO2 for VT 300mL Pressure Control Accuracy Ppeak 2 6 cmH2O PEEP 1 1 4 of the set PEEP cmH2O FiO2 1 9 6 of the set FiO2 Oxygen Concentrati...

Page 135: ...Appendix A Parameter Descriptions 130 2020 CAE 905K710052 v 1 1 CAEAir1 INTENTIONALLY LEFT BLANK...

Page 136: ...It is possible for multiple alarms to be active at the same time Note The alarm name appears on the touchscreen as an alarm banner when that alarm condition occurs See Alarm Indications for additiona...

Page 137: ...eshold for 50 ms PC mode 10 cmH2O of set Pi value PS mode 10 cmH2O of set Psupp value VC mode 40 cmH2O Ppeak Low alarm low threshold for 3 breaths PC mode 10 cmH2O of set Pi value PS mode 10 cmH2O of...

Page 138: ...s listed in the alarm history Touchscreen Failure High Visible and audible alert Touchscreen failure detected Breathing Circuit Disconnect High Visible and audible alert A disconnect is detected in th...

Page 139: ...re indicated by visible alarms in the form of an LED on the ventilator case and an alarm banner on the touchscreen The priority of the alarm is indicated by the colour as well as by flashing or steady...

Page 140: ...l Personnel Responses The following table provides some general instructions to medical personnel in the event of an alarm condition IMPORTANT Local protocol regarding medical responses take priority...

Page 141: ...ained Refer to the Troubleshooting section for additional information on Pressure Safe and Fail Safe modes Alarm Priority Automated Response Ppeak High High The ventilator attempts to reduce the press...

Page 142: ...inspiratory pressure relative to atmospheric pressure Mode Description Parameters Pressure Control PC The ventilator delivers a breath to the patient based on the set Respiratory Rate and the detectio...

Page 143: ...upp value which is maintained for the duration of the inspiration phase The ventilator s inspiratory flow stops when it reaches 25 of the peak inspiratory flow rate If the patient does not make an ins...

Page 144: ...t the unit If the alarm persists contact CAE customer service 1002 Operating Medium Shutdown and restart the unit If the alarm persists contact CAE customer service 1003 Operating Medium Shutdown and...

Page 145: ...ersists contact CAE customer service 1017 Operating Medium Shutdown and restart the unit If alarm persists contact CAE customer service 1018 Operating Medium Shutdown and restart the unit If alarm per...

Page 146: ...e unit If alarm persists contact CAE customer service 1201 Operating Medium Shutdown and restart the unit If alarm persists contact CAE customer service 1202 Operating Medium Shutdown and restart the...

Page 147: ...rmation for CAE engineer for cause of FailSafe mode triggering 1215 Operating Info Additional information for CAE engineer for cause of FailSafe mode triggering 1216 Operating Info Additional informat...

Page 148: ...customer service 2001 Gas Supply Failure High Verify Oxygen tank Requires attention of medical personnel 2002 Touch Screen Failure High Shutdown and restart the unit If the alarm persists contact CAE...

Page 149: ...2400 FiO2 High High Requires attention of medical personnel 2401 FiO2 Low High Requires attention of medical personnel 2500 RR High High Requires attention of medical personnel 2501 RR Low High Requir...

Page 150: ...s used in the CAE Air1 software OTS SOUP Identifier Name Version Build Boost 1 69 0 Keil CMSIS RTX 5 5 1 Keil MDK 5 29 0 meta freescale 2 6 4 Thud meta freescale 3rdparty 2 6 4 Thud meta freescale dis...

Page 151: ...rials of third party hardware with firmware used in the CAE Air1 ventilator CAE Part Number Manufacturer Manufacturer Part Number Version Number PS302659065621 ST Microelectronics STM32F405RGT6 None P...

Page 152: ...ical electrical equipment Part 1 2 General requirements for basic safety and essential performance Collateral Standard Electromagnetic disturbances Requirements and tests IEC 60601 1 6 2010 Medical el...

Page 153: ...Appendix F Applicable Standards 148 2020 CAE 905K710052 v 1 1 CAEAir1 INTENTIONALLY LEFT BLANK...

Page 154: ...pli Gratia for example EMC Electromagnetic Compatibility ESD Electrostatic Discharge etc Et Cetera and so on ETT Endotracheal Tube FiO2 Fraction of Inspired Oxygen GUI Graphical User Interface also kn...

Page 155: ...ressure Pplateau Plateau Pressure PS Pressure Support mode Psafety Pressure Safety Maximum Limited Pressure Value Psupp Support Pressure RF Radiofrequency RR Respiratory Rate RRsp Spontaneous Respirat...

Page 156: ...lungs of a patient Inspiratory Referring to inhalation the flow of breathing gas into the lungs of a patient Maintenance Tasks undertaken to ensure the continued correct function of a device at a sta...

Page 157: ...AE Air1 Ventilator A medical device used for the support or control of breathing for persons experiencing respiratory distress or failure Warning A written text calling attention to a critical topic t...

Page 158: ...ustomer support website caehealthcare com caeair1 caehealthcare com For information about CAE Healthcare products in the U S Canada contact your regional sales manager visit our website or call 1 941...

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