CAE Air1 User manual

CAEAir1
Mechanical
Ventilator
User Guide

©2020 CAE 905K710052 v.1.1 i
TABLE OF CONTENTS
Specifications .............................................................................................................. 1
Safety............................................................................................................................ 3
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Biological . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Gas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Operations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Oxygen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Power Supply. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Temperature. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Cautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .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 Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
Electromagnetic Emission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
Cybersecurity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
Introduction .............................................................................................................. 27
The CAE Air1 Mechanical Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
Contained in this Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
Conventions Used in this Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29
Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29
Contact Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29

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Intended Use and Indication for Use...................................................................... 31
Purpose and Function of Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
Intended Population . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
Intended Environment of Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Serviceability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Contraindications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Equipment Overview................................................................................................ 33
Pneumatic System Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
Un-pressurized Fresh Air Intake Line. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
Pressurized O2 Intake Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
Gas Mixing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
Inspiratory 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 Control and Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
Setup .......................................................................................................................... 39
Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
Unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
Setup Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
Batteries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
Power Supply. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
Cleaning and Disinfecting before Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
Setup Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
Step 1: Place Ventilator in Work Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42
Step 2: Connect the Oxygen Supply (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42
Step 3: Replace Ventilator Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43
Step 4: Connect Patient Breathing Circuit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44

©2020 CAE 905K710052 v.1.1 iii
Step 5: Power On Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44
Step 6: Perform Self Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44
Step 7: Breathing Circuit Characterization Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46
Step 8: Perform O2 Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
Interface Overview................................................................................................... 51
User Interface Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51
Screen Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51
Colours and Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52
User Interface Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56
Power On Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56
Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57
Status Bar. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58
Hardware Setup 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
Breathing Circuit Characterization Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69
Automated Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72
Setup Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73
Status Bar. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74
Mode Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74
Control Widgets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76
New Patient Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76
Screen Navigation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76
Operation Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77
Operation Screen Layout - Top. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .78
Operation Screen Layout - Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81
Operation Screen Layout - Bottom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84
Screen Navigation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87
Settings Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89
Oxygen Sensor Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89

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Software and Firmware Updates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .92
Change Passcode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93
Temperature Sensor Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .94
Oxygen Pressure Sensor Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .95
Powering Off Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .96
Using the Ventilator ................................................................................................. 97
Configuring Ventilation Mode and Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97
Start Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .98
Set the Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .98
Adjust Control Widget Values. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100
View Alarms History. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .101
Perform Inspiratory/Expiratory Hold . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .102
Pause the Ventilator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .103
Change Mode During Ventilation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .104
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
Disinfecting Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109
Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .110
Consumable Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .110
Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .111
Preventive Maintenance Schedule. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .112
Air Inlet Filter Replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .114
Maintenance Tasks using the Touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .116
Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .122
Troubleshooting...................................................................................................... 123
Fail Safe and Pressure Safe Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125
Appendix A - Parameter Descriptions .................................................................. 127
Control Widgets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .127
Pi (Inspiratory Pressure) / Pi Backup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .127
PSupp (Support Pressure) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .127
PEEP (Positive End Expiratory Pressure) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .127

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Pressure Trigger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .127
FiO2 (Fraction of Inspired O2). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .128
I:E ratio (Inspiratory Time) / I:E Backup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .128
RR (Respiratory Rate) / RR Backup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .128
PSafety (Maximum Limited Pressure) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .128
Tapnea (Apnea Time) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .128
Tidal Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .129
Accuracy Tolerances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .129
Volume Control Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .129
Pressure Control Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .129
Oxygen Concentration Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .129
Appendix 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 Conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .135
Medical Personnel Responses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .135
Automated Ventilator Responses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .136
Appendix C - Operation Modes.............................................................................. 137
Appendix D - Ventilator Fault Logs ....................................................................... 139
Platform Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .139
Alarm Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .143
Appendix E - Third-Party Software and Hardware.............................................. 145
Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .145
Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .146
Appendix F - Applicable Standards ....................................................................... 147
Glossary.................................................................................................................... 149
List of Acronyms and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .149
List of Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .151

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©2020 CAE 905K71005 v.1.1 1
Specifications
SPECIFICATIONS
Ventilator
Power Admissable Voltage Range: 110-120 VAC 60Hz ± 5%
Maximum Current: 6A
Temperature Shipping: 10ºC to 45ºC (50ºF to 122ºF)
Operating: 10ºC to 35ºC (50ºF to 95ºF)
Storage: 10ºC to 45ºC (50ºF to 122ºF)
Humidity Shipping: 10% to 95% non-condensing
Operating: 10% to 85% non-condensing
Storage: 10% to 95% non-condensing
Altitude Shipping, Operating , and Storage : ≤ 2000 meters (≤ 6562 feet)
UPS Battery
Power Input Voltage: 90 VAC - 150 VAC
Output Voltage: 120 VAC ± 5%
Battery life Minimum: >20 minutes
Temperature Operating: 0ºC to 40ºC (32ºF to 104ºF)
Storage: -15ºC to 45ºC (5ºF to 113ºF)
Humidity Operating: 0% to 95% non-condensing
Lithium-ion Battery
Power Discharge
Trip Current: 4.0A
Under Voltage Trip Voltage: 2.3V
Charge
Maximum Allowable Charge Current: 2.8A
Over Voltage Trip: 4.28V
Temperature Operating: -40ºC to 85ºC (-40ºF to 185ºF)
LCD Monitor
Power Consumption: 8.7W
Input: 12VDC +/- 5%; 100-240VAC, 50/60Hz
Temperature Operating: 0ºC to 40ºC (32ºF to 104ºF)
Storage: -20ºC to 60ºC (-4ºF to 140ºF)
Oxygen Input
Supply Pressure Range: 40 to 60 psi
Connector Type Standard Adapter DISS 1240 Male

Specifications
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©2020 CAE 905K710052 v.1.1 3
Safety
SAFETY
Read all of the pages in this Safety section before using the ventilator. Information is included
regarding:
•Warnings - identify potential hazards to the patient, medical personnel, or other
individuals, including possible life-threatening situations.
•Cautions - identify minor hazards to ensure the safety of patients as well as the safety of
medical personnel as well as guidance for proper handling of the equipment to avoid
damage and undue wear.
•Medical and Safety Symbols - identify medical and safety symbols displayed on the
ventilator case and ventilator shipping materials.
•Electromagnetic Compatibility - identifies the emission and immunity details for
electromagnetic interference of the ventilator.
•Cybersecurity - provides information regarding security implemented to prevent cyber
attacks on the CAE Air1.
Warnings
Warnings are provided to identify dangerous and potentially life-threatening conditions. All warnings
in this document must be read and followed when using the CAE Air1 ventilator. Failure to follow
these may result in ventilator malfunction leading to patient death or serious deterioration of health.
This section provides a list of all warnings organized in the following categories:
• Accessories • Cleaning • Power Supply
• Alarms • Gas • Preventive Maintenance
• Battery • Operations • Temperature
• Biological • Oxygen • Ventilation

Safety
4 ©2020 CAE 905K710052 v.1.1
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Accessories
•WARNING: In the event of a breathing circuit disconnect alarm activation, prior to
reconnecting, ensure the breathing circuit is free of debris or foreign materials or liquids.
•WARNING: Always verify breathing circuits are compatible with a second backup
ventilator in the event ventilators must be switched as a result of ventilator failure.
•WARNING: When replacing the breathing circuit on the ventilator, always perform the
Breathing Circuit Characterization Test prior to using the ventilator on a patient. During
use, verify the proper ventilation is delivered to the patient.
•WARNING: Always replace all filters prior to ventilator use. Verify the correct filters and all
of the filters are attached prior to each use.
•WARNING: Use only accessories (including oxygen accessories) and parts recommended
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 immunity of this equipment and result in improper operation.
•WARNING: To reduce the risk of fire, use only breathing circuits intended for use in
oxygen-enriched environments.
•WARNING: Do not use anti-static or electrically conductive tubing.
Alarms
•WARNING: Replace the ventilator if unable to manually reset the alarm when the alarm
condition is resolved.
•WARNING: The CAE Air1 ventilator does not currently provide a distributed alarm system
for remote monitoring. Medical staff must monitor the ventilator alarm status locally.
•WARNING: Adjust the alarm volume relative to the ventilator’s operating environments.
Risk to the patient may occur if operators are unresponsive to low, unheard alarm
volumes. Alarm volumes that are too high may create anxiety for the patient.
•WARNING: Setting alarm limits to extreme values can render the alarm system useless.

©2020 CAE 905K710052 v.1.1 5
Safety
Battery
•WARNING: Replace the ventilator in the event battery level indication appears inaccurate,
or battery indicator is not readable or displayed.
•WARNING: Do not open or damage the battery. Released electrolyte is harmful to the skin
and eyes and may be toxic.
•WARNING: Ensure backup battery is charged once every 3 months if ventilator is inactive.
•WARNING: If battery fails to charge, qualified service personnel will be required to
perform system maintenance.
•WARNING: Never expose a battery to direct flame or heat. Burns may result from smoke
associated with the device or accessories.
• WARNING: Replace the ventilator in the event the low battery level indicator is displayed
after charging, or at any time during operation of the ventilator while it is connected to an
AC power source.
• WARNING: The backup batteries are not 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 batteries are not fully charged, pay
close attention to the battery charge levels, in the event the AC power fails.
• WARNING: In the event the ventilator is placed in long term storage, remove the battery.
Leakage from the battery could be harmful or cause damage to the ventilator.
Biological
•WARNING: Do not use the ventilator if contamination of the breathing air pathway inside
the ventilator is suspected. Contact CAE to return the ventilator. See the contact
information section in this user guide.
•WARNING: Exercise universal precaution including washing your hands thoroughly
before and after handling the ventilator or accessories. Patients treated by mechanical
ventilation are highly vulnerable to risks of infection.
• WARNING: Remove all breathing circuits and filters prior to storing or using on a new
patient. Dispose of all consumable products appropriately.

Safety
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Cleaning
•WARNING: Use and follow CAE recommended cleaning and disinfecting products and
procedures. Non-compatible products or methods may cause damage to the enclosure or
display screen causing ventilator malfunction. Infection may occur from use of a dirty or
contaminated ventilator.
•WARNING: Do not perform any cleaning or disinfecting while a patient is connected to the
CAE Air1 ventilator.
•WARNING: Follow all cleaning and disinfecting instructions. Chemical toxicity and injury
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 (supplied with the ventilator) to prevent dust or
insects from entering through ventilator connectors.
Gas
•WARNING: The CAE Air1 ventilator is not for use with unapproved or unspecified inlet
gases, including nitric oxide.
•WARNING: Do not use the ventilator with flammable anesthetic or other gases than air
and medical grade O2 substances. Fire and burns may occur.
•WARNING: Setup and use ventilator with caution. Burns may result from release of
pressurized gas. Gas tanks that fall may break at release valve and cause release of gas.

©2020 CAE 905K710052 v.1.1 7
Safety
Operations
•WARNING: Do not use the ventilator outside the clinical indication as described in this
user guide.
•WARNING: Never use the ventilator as an emergency transport ventilator. Use the
ventilator only in a healthcare-type facility.
•WARNING: Always examine the patient first when an alarm is activated.
•WARNING: Always install and operate the ventilator according to the environmental
conditions specifications in this user guide.
•WARNING: Position the ventilator so that the display is turned away from patient's view.
Patient may have disrupted 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. Injury may occur to the patient, or operator, in the event
ventilator cables or accessories become entangled.
•WARNING: During use, do not cover or place the ventilator in an area that will
compromise the entry of fresh air to the ventilator. Reduction in the fresh air intake will
affect ventilation to the patient.
•WARNING: Equipment may malfunction due to inadequate space or interference with
other equipment.
•WARNING: Do not cover the ventilator or block any intake or exhaust openings, thereby
causing the equipment to overheat, and thereby interfering with patient ventilation.

Safety
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•WARNING: Use of this ventilator adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are operating
normally.
•WARNING: Be aware when maneuvering the ventilator, avoiding the patient or others.
•WARNING: Injury may occur to the patient or others in the event the ventilator moves,
falls, or tips over.
•WARNING: Always lock the caster wheels on the ventilator to stabilize the ventilator when
in use. Risk of harm to the patient or others may occur if the ventilator tips over.
•WARNING: Always lock the caster wheels of the ventilator to ensure stability after setup.
The ventilator is HEAVY. Risk of falling occurs during manipulation of the ventilator.
•WARNING: This device may cause interference or may disrupt the operation of nearby
equipment. It may be necessary to take mitigation measures, such as re-orienting or
relocating the device or shielding the location.
•WARNING: Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to
any part of 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
components.
•WARNING: In case of fire, immediately secure the patient’s ventilatory needs, switch off
the ventilator, and disconnect it from its gas and electrical sources.
•WARNING: To minimize the risk of fire, do not use high-pressure gas hoses that are worn,
or hoses or any equipment contaminated with combustible materials like grease or oil.
•WARNING: Secure and properly handle all breathing tubes to prevent introduction of
debris. Infection may occur from use of a dirty or contaminated ventilator.
•WARNING: Filters may require more frequent replacement when using humidifiers.
•WARNING: If using water traps with a humidification device, discard fluid from water
traps properly per local ordinance.
•WARNING: Always position a humidification device so that it is lower than both the
ventilator and the patient. Use water traps, if necessary, to limit water in the patient trap.
•WARNING: Replace the ventilator if the ventilator produces a burning smell or odor.
•WARNING: Do not modify this equipment without authorization of the manufacturer.
•WARNING: The CAE Air1 ventilator is not for use in a hyperbaric chamber.
•WARNING: Do not use the ventilator during magnetic resonance imaging (MRI) scanning
unless it has the appropriate “MRI conditional” label.

©2020 CAE 905K710052 v.1.1 9
Safety
•WARNING: Due to the weight of the ventilator, three people are required to lift the
ventilator. Failure to do so could cause serious injury to personnel and damage to the
equipment.
Oxygen
•WARNING: Ensure the responsible organization has verified the oxygen source is
compatible with the rated range of pressure with the ventilator. This ventilator is
compatible to operate only with standard hospital medical grade supply line.
•WARNING: In the event there is loss of or insufficient oxygen delivered to the ventilator,
an alarm will be activated. Replace the ventilator if necessary.
•WARNING: Use only accessories (including oxygen accessories) and parts recommended
by CAE.
Power Supply
•WARNING: Never shut down the ventilator without disconnecting the patient from the
ventilator. Failure to do so, may cause serious 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 generator. Risk to the
patient may occur if there is loss of AC external power.
•WARNING: Replace the ventilator if it fails to power off.
•WARNING: Replace the ventilator if the power on pushbutton is not illuminated when the
ventilator is turned ON, it is an indication of malfunction.
•WARNING: Replace the ventilator in the event it shuts down and becomes inoperable
during use.
•WARNING: Restore AC power as soon as possible, in the event it becomes disconnected.
•WARNING: Verification of power rating of the power outlet must be performed by
qualified personnel.
•WARNING: To minimize the risk of electrical shock, plug the ventilator power cord into a
grounded AC power receptacle. It is the healthcare facility's responsibility to ensure that
the receptacle is properly grounded (earth). To ensure grounding reliability, use a special
hospital-grade receptacle.

Safety
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Preventive Maintenance
•WARNING: Always disconnect power cord and power off ventilator to avoid an electrical
hazard or damage to the ventilator before cleaning/disinfection. Never immerse any part
of the system in a cleaning agent or other liquids, and do not drip or spray any liquids
directly onto any surface including the front monitor.
•WARNING: Perform all preventive maintenance tasks according to the schedule in this
user guide. Only qualified service personnel must perform system maintenance.
•WARNING: Perform ventilator scheduled maintenance and software upgrades only when
ventilator is disconnected from the patient.
Temperature
•WARNING: Always monitor the temperature of the gas delivered to the patient if a heated
humidifier is used. Burning of the patient's airway may occur if the gas from a heated
humidifier is too hot.
•WARNING: Replace the ventilator in the event an alarm indicating inspiratory gas
temperature has exceeded thresholds. Rise in inspired gas temperature may lead to
patient thermal injury and burns.
Ventilation
•WARNING: Always ensure adequate independent 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 suspected.
•WARNING: Always have an alternative means of ventilation shall be available whenever
the ventilator is in use.
•WARNING: Always inspect equipment on a daily basis to ensure that it shows no signs of
damage, is properly connected, and is operating correctly without leakage.
•WARNING: Always perform a Self Test and visually inspect for damages or abnormal
behavior of the ventilator prior to every use, including the initial installation. The Self Test
should only be skipped in the event that patient safety is compromised by delaying ventilation
in order to perform the Self Test.
•WARNING: Always position the breathing circuit to avoid occlusions and hindering of the
patient's movement. This may cause accidental disconnection or leakage and cause
decreased ventilation pressure, flow, or volume.
•WARNING: If abnormal equipment behavior or malfunction is observed (noise, over
heating, sensor failure, false alarm or alarm failure, power failure, display and touch
screen issues etc.), replace the ventilator until appropriate service is performed.
•WARNING: Replace the ventilator in the event blockage prevents proper ventilatory
delivery.

©2020 CAE 905K710052 v.1.1 11
Safety
•WARNING: Replace the ventilator in the event it automatically resets during use.
•WARNING: Replace the ventilator in the event the ventilator fails the Self Test.
•WARNING: Self Tests that take longer than expected may be an indication of system
failure.
•WARNING: Store the ventilator according to specifications 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 personnel under the
responsibility of a physician, and patient ventilation settings must be as per physician
recommendations.
•WARNING: Values displayed on the ventilator that are inaccurate may lead to setting
changes or replacement of the ventilator.
• WARNING: Ventilator malfunction may lead to patient death or serious deterioration of
health.

Safety
12 ©2020 CAE 905K710052 v.1.1
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Cautions
Cautions are provided to identify items or situations that may pose a hazard to the equipment or a
risk of minor injury to persons operating the equipment. All cautions in this document must be read
and followed when using the CAE Air1 ventilator.
General
• Do not use equipment in a manner that is not specified by the manufacturer.
• Keep all electronic equipment free from high humidity or liquids.
• Do not leave the hardware powered on when not in use.
• Cover the ventilator when not in use.
• Do not leave the ventilator with the touchscreen in direct sunlight for any extended time.
Ultraviolet light and excessive heat can damage the touchscreen.
• The pressurized oxygen source should be closed or disconnected from the ventilator
when the ventilator is not in use.
Cleaning
• Read Medivators Intercept Detergent and sodium 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 possible damage to the ventilator, do not drip or spray any liquids directly onto
any surface including the front panel, touchscreen, and navigation ring.
• Do not use solvents or abrasive cleaning materials (e.g. steel wool, metal brushes) as they
will damage the equipment and cause irreparable damage to the touchscreen.
• Use only approved cleaning products.
• Use of cleaning and disinfecting agents other than the ones recommended per these
instructions may cause damage to the enclosure, touchscreen, or other parts of the
ventilator.
• Do not attempt to sterilize or autoclave the ventilator.
• Do not leave the ventilator with the touchscreen in direct sunlight for a long time.
Ultraviolet light and excessive heat can damage the touchscreen display.
• To prevent damage to the ventilator exterior surface and touchscreen, only use the
cleaning and disinfecting agents listed in this guide.

©2020 CAE 905K710052 v.1.1 13
Safety
Ergonomics
• Viewing a display screen for an extended period of time may result in eye strain.
Operations
• This equipment is not intended for use in residential environments and may not provide
adequate protection to radio reception in such environments.
• Follow manufacturer’s instructions 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 spilling fluids from the ventilator or it’s accessories. Falling may occur due to
slipping on spilled fluids.
• Always lock the caster wheels of the ventilator to ensure proper orientation of console
display and buttons. Equipment misuse and ergonomic related injuries may result from
improper setup of the ventilator.