CAE Air1 User Manual

Mechanical ventilator

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CAEAir1

Mechanical

Ventilator

User Guide

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Page 1 CAEAir1 Mechanical Ventilator User Guide...
Page 2: Table Of Contents
The CAE Air1 Mechanical Ventilator ........
Page 8: Specifications
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 ©2020 CAE 905K71005 v.1.1...
Page 10: Safety
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.
Page 11: Accessories
• 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.
Page 12: Battery
• 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.
Page 13: Cleaning
Cover the ventilator and plug all ports (supplied with the ventilator) to prevent dust or insects from entering through ventilator connectors. • WARNING: The CAE Air1 ventilator is not for use with unapproved or unspecified inlet gases, including nitric oxide.
Page 14: Operations
• 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. ©2020 CAE 905K710052 v.1.1...
Page 15 • 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”...
Page 16: Oxygen
• 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. ©2020 CAE 905K710052 v.1.1...
Page 17: Preventive Maintenance
• WARNING: Replace the ventilator in the event blockage prevents proper ventilatory delivery. ©2020 CAE 905K710052 v.1.1...
Page 18 • 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. ©2020 CAE 905K710052 v.1.1...
Page 19: 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 •...
Page 20: Ergonomics
• 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. ©2020 CAE 905K710052 v.1.1...
Page 21: Medical And Safety Symbols
Ventilator Symbols and Definitions Symbol Definition Refer to Instruction Manual/Booklet Read Technical Manual Before Servicing General Warning Warning Electricity Hot Surface Protective Earth Ground Non-ionizing Electromagnetic Radiation Power Button, Stand-by, On Off Inspiratory Label—Gas Flow to Patient ©2020 CAE 905K710052 v.1.1...
Page 22 Protected against solid objects over 12.5 mm and protected against vertically falling drops of water or condensation. Type BF Applied Part Manufacturer per YYYY-DD Date of Manufacture Catalog number Mass of Mobile ME Equipment Serial Number ©2020 CAE 905K710052 v.1.1...
Page 23 Internal Battery Input Port Output Port Oxygen Inlet Port Unsafe to use the ventilator in magnetic resonance imaging environment The ventilator contains components manufactured with latex Operational Temperature Limitations Operational Barometric Pressure Limitations Operational Humidity Limitations ©2020 CAE 905K710052 v.1.1...
Page 24 Safety Ventilator Symbols and Definitions Symbol Definition No Stepping on Surface Dispose as e-waste laws and Regulations (Waste Electrical and Electronic Equipment) ©2020 CAE 905K710052 v.1.1...
Page 25: Ventilator Warning Text Labels
(ASI). Éteindre le dispostif avan de procéder á l’entretien. WARNING Electric Shock Hazard. Main disconnect switch does not remove UPS output power. Turn off UPS before servicing. ©2020 CAE 905K710052 v.1.1...
Page 26 This device complies with Part 15 of FCC Rules. Operation is following two conditions: 1. this device may not cause harmful interference, and 2. this device must accept any interference received, including interference that may cause undesired ©2020 CAE 905K710052 v.1.1...
Page 27 (ASI), veuillez déconnecter le câble d’alimentation principal avant toute maintenance. WARNING – Do not obstruct the openings at the rear of the ventilator. AVERTISSEMENT – Ne pas obstruer les ouvertures à l’arrière du ventilateur. ©2020 CAE 905K710052 v.1.1...
Page 28: Shipping Symbols And Definitions
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 if package is damaged. ©2020 CAE 905K710052 v.1.1...
Page 29: Electromagnetic Compatibility
Communications based on RF communications equipment in Equipment use at the time of publication of this collateral standard. The test specification IEC 61000-4-3 does not attempt to cover every frequency and service used in every country. ©2020 CAE 905K710052 v.1.1...
Page 30 CAE. Radiated Immunity 3 V/m (RF EM field) 80 MHz – 2.7 GHz IEC 61000-4-3 80% AM at 1 kHz Electrical fast transients ± 2 kV (EFT) /bursts 100 kHz repetition IEC 61000-4-4 frequency ©2020 CAE 905K710052 v.1.1...
Page 31 LTE Band 1, 3, 4, 217Hz 1970 25; UMTS Bluetooth, WLAN, Pulse 2450 2400 –2570 802.11 b/g/n, modulation RFID 2450, LTE 217Hz Band 7 5240 Pulse WLAN 5500 5100 - 5800 modulation 802.11 a/n 217Hz 5785 ©2020 CAE 905K710052 v.1.1...
Page 32: Cybersecurity
The system permits the update of the ventilator software and firmware only with CAE digitally signed packages. • The CAE Air1 offers a Self Test function as part of its routine start-up procedure which performs an integrity check of the software components.
Page 34: Introduction
Introduction NTRODUCTION This user guide is part of a set of supporting documentation for the CAE Air1 ventilator. The set includes the following documents furnished in either hardcopy or online formats: • Unpacking Instructions • Quick Reference Guide • User Guide •...
Page 35: Contained In This Guide
Contained in this Guide This user guide provides information on how to use and maintain the CAE Air1 ventilator. It is intended for trained medical personnel and is to be read prior to the first use of the ventilator to ensure safe and proper handling of the equipment.
Page 36: Conventions Used In This Guide
Format: Safety Notice Customer Service CAE Healthcare Customer Service is available for service and support of the CAE Air1 ventilator. Contact Information Customer service can be contacted by email, through the CAE Healthcare website, or by phone: Email: caeair1support@cae.com Website: caehealthcare.com/caeair1...
Page 38: Intended Use And Indication For Use
SE AND NDICATION FOR The CAE Air1 is intended as a continuous mechanical ventilator for invasive applications with the provision of an adjustable percentage of oxygen in the breathing gas. The ventilator is indicated for use on adult patients in healthcare facilities under the supervision of a physician.
Page 39: Compatibility
This device can be serviced by trained technical personnel for certain tasks. Only those tasks defined in this user guide can be performed. Tasks beyond these must be done by CAE personnel or CAE- approved personnel. Contact CAE Customer Service for more information, as needed.
Page 40: Equipment Overview
Equipment Overview QUIPMENT VERVIEW The CAE Air1 ventilator includes: • Mechanical ventilator with steering handle bar, and installed on lockable casters. • Touchscreen interface for dedicated ventilator software. • UPS ventilator power backup and emergency power backup for alarms. • CAE-supplied oxygen tube.
Page 41 CAEAir1 Equipment Overview The CAE Air1 Ventilator 1. Hot Air Exhaust 5. O Inlet Port 9. Ambient Air Inlet #2 (Exhaust Fan Supported) 2. O Enriched Air Flow Outlet 6. O Enriched Air Flow Inlet 10. Communication Port (Exhaust Fan Supported) 3.
Page 42: Pneumatic System Description
A consumable antibacterial/antiviral filter is placed between the breathing circuit connection port and inspiratory segment of the breathing circuit. Expired Air Filtration A consumable filter is placed between the breathing circuit connection port and expiratory segment of the breathing circuit. ©2020 CAE 905K710052 v.1.1...
Page 43: Expiratory Line
Pressure in the expiratory line is regulated via a control valve. Expired air is exhausted into the surrounding environment. Electrical System Description Controllers The CAE Air1 ventilator includes three electrical controllers. Their roles are as follows: • Graphical User Interface (GUI) controller. • Primary alarm controller. Ventilation Controller •...
Page 44: User Interface
Visible Indicators The system is equipped with a red and yellow indicating LED to signal alarms 360 degrees around the CAE Air1 ventilator. Audible Indicators The system is equipped with a speaker to signal alarms. A backup buzzer is also present to signal a malfunction in the primary alarm controller including its power source.
Page 46: Setup
This section provides instructions for setting up the CAE Air1 ventilator. SAFETY NOTICE Prior to handling or using the CAE Air1 ventilator, all warnings and cautions must be read and understood. See the Safety section of this user guide for a comprehensive list.
Page 47: Setup Preparation
5. Roll the device away from the shipping materials onto a safe, dry surface. Setup Preparation To ensure that the CAE Air1 is ready for setup and to prevent damage to your ventilator, it is important to complete the preparation steps as instructed.
Page 48: Power Supply
• Power on the ventilator for a minimum of four hours prior to first use by pressing the Power button on the front of the CAE Air1 to charge the backup Lithium-ion battery. The four hours to charge the Lithium-ion battery are additional to the 12 hours for the UPS battery to charge.
Page 49: Step 1: Place Ventilator In Work Area
CAE recommends a work area of approximately 1 meter by 1 meter (3 feet x 3 feet). If using pressurized oxygen supply from an in-wall source, ensure the CAE Air1 is located in close proximity to the pressurized oxygen location. Secure the CAE Air1 using the wheel locks on the caster wheels.
Page 50: Step 3: Replace Ventilator Filters
The following consumables need to be replaced between uses: • Patient inspiration (antibacterial/antiviral) filter • Patient expiration (antibacterial/antiviral) filter The inspiration and expiration air filters are located on the front of the CAE Air1 ventilator behind the inspiration and expiration ports. Expiration...
Page 51: Step 4: Connect Patient Breathing Circuit
To power on, press the Power button on the front of the ventilator. Step 6: Perform Self Test After the ventilator is powered on, the Power On screen appears. Power On Screen If a patient is not detected, the Self Test prompt appears. ©2020 CAE 905K710052 v.1.1...
Page 52 If a patient is detected, the Patient Detected Self Test prompt appears. Patient Detected Self Test Prompt When a patient is detected, the only option available is to tap Yes to Skip Self Test. To perform a self test, the patient must be disconnected from the ventilator. ©2020 CAE 905K710052 v.1.1...
Page 53: Step 7: Breathing Circuit Characterization Test
Breathing Circuit Test Prompt c. Tap Start. The CAE Air1 initiates ventilation (e.g. Pressure Support mode with default settings) on a test lung. d. Block the breathing circuit by inserting a plug into the patient connection port of the y- junction.
Page 54 Clear the Fail Safe screen and return to the Home screen by tapping the Acknowledge button. Fail Safe Screen The Home screen displays the failed test status as well. Verify that the ventilator is correctly setup and repeat any failed tests. ©2020 CAE 905K710052 v.1.1...
Page 55: Step 8: Perform O2 Calibration
Step 8: Perform O Calibration If pressurized oxygen is being used (see Step 2), the O Calibration must be performed prior to the first use of CAE Air1. To perform O Calibration: a. Make sure the ventilator is connected to a pressurized O source.
Page 56: Interface Overview
NTERFACE VERVIEW The CAE Air1 ventilator User Interface (UI) consists of screens designed for specific functions. Usage screens, such as Setup and Operation are strictly for use by trained medical personnel. Settings screens are intended for technical personnel to perform software updates and to set some basic ventilator features, when the ventilator is not otherwise in use.
Page 57: Colours And Symbols
• Green is associated with affirmative statuses including: passed self tests, confirmation of setup and starting the ventilator. • Blue is associated with the active operation mode and “Patient Ventilated” status, as well as some selectable screen items. ©2020 CAE 905K710052 v.1.1...
Page 58 The battery status indications use the symbols and colours as shown below. The symbols are accompanied by a percentage value indicating the amount of battery power remaining. Low battery / charging Fully charged required soon battery Battery depleted / Battery charging charging required Battery Status Indications ©2020 CAE 905K710052 v.1.1...
Page 59 Sound volume is represented by a speaker symbol and vertical lines indicate the set volume. The volume is adjusted in percentage increments; four lines is equal to 100% of an alarm’s set dB value. Sound Volume Symbols ©2020 CAE 905K710052 v.1.1...
Page 60 The circling arrows symbol is used to indicate a test or action that is in progress in the software. In Progress Symbol Home and Settings Screen Symbols The Home and Settings screen buttons are indicated respectively by a house symbol and a gear wheel. Home Screen and Settings Screen Buttons ©2020 CAE 905K710052 v.1.1...
Page 61: User Interface Screens
These are described in the following pages. Power On Screen When the ventilator is started, the Power On screen is displayed on the touchscreen. The Power On screen will remain displayed while the system is initializing. Power On Screen ©2020 CAE 905K710052 v.1.1...
Page 62: Home Screen
Note: The Start Setup button will not be available for selection if any of the tests (Self Test or Breathing Circuit Characterization Test, or Oxygen Sensor Calibration) result in a failure. Home Screen The elements of the CAE Air1 Home screen are identified in the following image: Status bar Settings...
Page 63: Status Bar
Refer to the Tests Screens section for a description of all of the tests and to view their associated screens. Tap No to cancel the self test or tap Yes to proceed with the test. When Yes is selected a popup appears requesting confirmation that no patient is connected to the ventilator. ©2020 CAE 905K710052 v.1.1...
Page 64: Screen Navigation
From the Home screen, the operator can navigate to other screens using the buttons available. To navigate away from the Home screen: 1. Select the Start Setup button to open the Setup screen. 2. Select the Settings button to navigate to the Settings screen. ©2020 CAE 905K710052 v.1.1...
Page 65: Test Screens
Patient Detected Self Test Prompt When a patient is on the ventilator, the Self Test can be skipped or, when it is safe to do so, remove the patient from the ventilator and run the test. ©2020 CAE 905K710052 v.1.1...
Page 66: Primary Alarm System
The Self Test is determined to Pass only if all of these sub-tests are passed. Primary Alarm System The Primary Alarm System test verifies the functioning of the ventilator’s audible and visible alarms. Follow the onscreen instructions: Primary Alarm System Test - Start Screen ©2020 CAE 905K710052 v.1.1...
Page 67 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 Primary Alarm System Test - Confirmation Screen ©2020 CAE 905K710052 v.1.1...
Page 68: 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 Alarm System Test - In Progress Screen ©2020 CAE 905K710052 v.1.1...
Page 69: Power Source Switch
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 external power. Power Source Switch Test - Start Screen ©2020 CAE 905K710052 v.1.1...
Page 70: Component Functional Check
Interface Overview Power Source Switch Test - Completion Screen Component Functional Check The Component Functional Check tests a number of systems. Component Functional Check - Start Screen ©2020 CAE 905K710052 v.1.1...
Page 71: Software Integrity Check
Component Functional Check) is skipped and is indicated as “skipped” in the test results. Software Integrity Check The Software Integrity Check verifies that the ventilator software is functioning as designed. Software Integrity Test - Start Screen ©2020 CAE 905K710052 v.1.1...
Page 72 Interface Overview Software Integrity Test - In Progress Screen Software Integrity Test - Completion Screen ©2020 CAE 905K710052 v.1.1...
Page 73 In the case that malfunctions are responsible for the test failures, the Fail Safe screen will be displayed when the Test Failed screen is closed. Refer to the Troubleshooting section for more information. ©2020 CAE 905K710052 v.1.1...
Page 74: Breathing Circuit Characterization Test
Follow the onscreen instructions to run the test. Breathing Circuit Characterization Test - Start Screen Breathing Circuit Characterization Test - In Progress Screen Note: Once the test is in progress, canceling the test will result in test failure. ©2020 CAE 905K710052 v.1.1...
Page 75 CAEAir1 Interface Overview Breathing Circuit Characterization Test - Completed Tap the Done button. The Test Passed or Test Failed notification screen appears. Breathing Circuit Characterization Test Passed ©2020 CAE 905K710052 v.1.1...
Page 76 Refer to the Troubleshooting section for more information. Tap the Close button. In the case of an associated, unrecoverable malfunction, the Fail Safe screen appears. Fail Safe Screen Refer to the Troubleshooting section for more information about the ventilator’s Fail Safe mode. ©2020 CAE 905K710052 v.1.1...
Page 77: Automated Tests
Fail Safe mode. IMPORTANT: The ventilator cannot be used if any of the automated tests identify a ventilator failure; it must be taken out of service. Refer to the Troubleshooting section for more information. ©2020 CAE 905K710052 v.1.1...
Page 78: Setup Screen
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, ensuring the alarm panel is always visible. Setup Screen - Patient Not Ventilated Setup Screen (overlay) - Patient Ventilated ©2020 CAE 905K710052 v.1.1...
Page 79: Status Bar
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 exhalation is maintained at a constant, operator-defined level.
Page 80 Interface Overview Setup Screen - PC Mode Setup Screen - PS Mode Setup Screen - VC Mode ©2020 CAE 905K710052 v.1.1...
Page 81: Control Widgets
1. Select the Confirm or Cancel button to save or reject settings changes. Cancel and Confirm Buttons The Operation screen is displayed. Note: Only the Operation screens or the Setup screen can be accessed when a patient is ventilated. ©2020 CAE 905K710052 v.1.1...
Page 82: Operation Screen
The Operation screen is organized into three main areas: top, center and bottom, as shown below: Status bar - Mode selection - Alarms - Vitals waveforms- Display widgets - CENTER View selection - Control widgets - Screen lock - BOTTOM Alarm setting - Volume control - Standby - Operation Screen ©2020 CAE 905K710052 v.1.1...
Page 83: Operation Screen Layout - Top
The alarm name and the time the alarm was triggered are displayed. Once the alarm history information has been reviewed, select the Clear History button to clear the screen or select the Close button to retain the information and close the screen. ©2020 CAE 905K710052 v.1.1...
Page 84 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 the desired mode from the Setup screen. Mode Selection Button Setup Screen (Overlay) ©2020 CAE 905K710052 v.1.1...
Page 85 If a new alarm starts after the Silence Alarms button has been pressed, all active alarms sounds will resume. Silence Alarms Button Note: The visible alarms are not impacted by pressing the Silence Alarms button, only the audible alarms are paused. ©2020 CAE 905K710052 v.1.1...
Page 86: Operation Screen Layout - Center
Views list Vitals Vitals Display widgets Waveforms Operation Screen - Center Vitals Displays The content of these displays varies depending on both the mode of operation and the selected view. Vitals Waveforms Vitals Numerical Display Widgets ©2020 CAE 905K710052 v.1.1...
Page 87 2 waveforms (pressure vs time, flow vs time) Waveforms and loop: 2 waveforms (pressure vs time, flow vs time) 1 loop (pressure volume) All numerics: 12 numerics (PEEP, Ppeak, FiO , MVe, RRtotal, VTe, Peak Insp Flow, Pmean, I:E, Pplateau, Ti, RRsp) ©2020 CAE 905K710052 v.1.1...
Page 88 Operation Screen - View 3 Operation Screen - View 4 The content of each view also varies somewhat depending on the mode of operation of the ventilator. Different parameters are displayed, as appropriate, for the active mode. ©2020 CAE 905K710052 v.1.1...
Page 89: Operation Screen Layout - Bottom
Using the + (plus) and - (minus) buttons, incrementally increase or decrease each parameter value to the desired setting. Note: Values can be adjusted in this manner while the ventilator is in use, and they can be adjusted prior to use through the Setup screen. ©2020 CAE 905K710052 v.1.1...
Page 90 Once the screen has been locked, a notification will appear briefly onscreen any time the screen is touched. To use the screen, tap the Locked button to unlock the screen and restore access to the controls. Screen Locked Notification ©2020 CAE 905K710052 v.1.1...
Page 91 Pplateau value is displayed until the value is calculated. The Expiratory Hold maneuver allows intrinsic PEEP to be viewed on the waveform. Refer to the Using the Ventilator section for additional information. Manual Hold Maneuvers ©2020 CAE 905K710052 v.1.1...
Page 92: Screen Navigation
Setup overlay screen to change the operation mode and make adjustments. The only way to navigate away from the Operation screen is to pause the ventilator function by selecting the Standby button when it is safe and appropriate to do so. ©2020 CAE 905K710052 v.1.1...
Page 93 (not breathing) and the Tapnea threshold is surpassed, these backup control parameters are activated. The active status is displayed onscreen on the control widgets. Operation Screen - PS Mode Backup Parameters showing Active Status Note: When the backup parameters are inactive, there is no onscreen indication. ©2020 CAE 905K710052 v.1.1...
Page 94: Settings Screen
Settings Screen Oxygen Sensor Calibration The calibration procedure can only be done when no patient is attached to the ventilator. When the Calibration button is selected, a popup appears onscreen: Oxygen Sensor Calibration Popup ©2020 CAE 905K710052 v.1.1...
Page 95 Oxygen Sensor Calibration Popup The status of the calibration is indicated onscreen beside the Calibrate button. The possible statuses are: Passed, Failed, or Not Performed. Select the Start button to run the calibration. Oxygen Sensor Calibration ©2020 CAE 905K710052 v.1.1...
Page 96 Interface Overview Oxygen Sensor Calibration In Progress Oxygen Sensor Calibration - Passed Oxygen Sensor Calibration - Failed Select the Close button to close the screen. ©2020 CAE 905K710052 v.1.1...
Page 97: Software And Firmware Updates
Settings Screen - Administrator Settings Unlocked To update the software and firmware, the ventilator must be attached to a network computer with Internet access. Tap the Network button and follow the onscreen instructions. For more information, refer to the Settings section. ©2020 CAE 905K710052 v.1.1...
Page 98: Change Passcode
Use the Backspace and Cancel buttons as needed if the wrong number is touched while entering the passcode. If the passcode entered is incorrect at any time, an error message is displayed, prompting the operator to retry. Incorrect Passcode Screens ©2020 CAE 905K710052 v.1.1...
Page 99: Temperature Sensor Calibration
Temperature 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 Sensor Calibration Temperature Sensor Calibration - Passed Temperature Sensor Calibration - Failed ©2020 CAE 905K710052 v.1.1...
Page 100: Oxygen Pressure Sensor Calibration
Oxygen Pressure 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 Calibration Oxygen Pressure Sensor Calibration - Passed Oxygen Pressure Sensor Calibration - Failed ©2020 CAE 905K710052 v.1.1...
Page 101: Powering Off Screen
When 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, press and hold the power button for 10 seconds. The Fail Safe mode will be initiated. ©2020 CAE 905K710052 v.1.1...
Page 102: Using The Ventilator
The tests should always be run before the ventilator is used. SAFETY NOTICE Prior to handling or using the CAE Air1 ventilator, all warnings and cautions must be read and understood. See the Safety section of this user guide for a comprehensive list.
Page 103: Start Ventilation
For more information on the alarm values, see Appendix B - Alarms. To set the alarm thresholds: 1. Tap the Alarm Setup button. Alarm Setup Button ©2020 CAE 905K710052 v.1.1...
Page 104 Note: Only Display widgets that include the Alarm symbol (bell) are adjustable. 5. When no further changes are required, tap the Unlocked button to secure the screen and ventilator operation. The Unlocked button will change to Locked. ©2020 CAE 905K710052 v.1.1...
Page 105: Adjust Control Widget Values
Note: The parameter ranges and default values are provided in Appendix A - Parameter Descriptions. 4. Tap Confirm to accept the changes or tap Cancel to reset the widget parameter to the previous value. 5. Tap the Unlocked button to secure the screen. ©2020 CAE 905K710052 v.1.1...
Page 106: View Alarms History
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 Clear History. To maintain alarm history, tap Close. ©2020 CAE 905K710052 v.1.1...
Page 107: Perform Inspiratory/Expiratory Hold
The rise in PEEP pressure during the maneuver will be visible on the Pressure/Time graph. Note: The Expiratory Hold maneuver may activate the apnea alarm. 4. Tap the Maneuvers button again to close the Maneuvers panel. ©2020 CAE 905K710052 v.1.1...
Page 108: Pause The Ventilator
The Standby Ventilator Confirmation Window 2. Tap Yes, Standby to pause the ventilator function or tap Cancel to continue ventilator operation. 3. When the ventilator is in Standby mode, tap the Start button to resume ventilation. ©2020 CAE 905K710052 v.1.1...
Page 109: Change Mode During Ventilation
Note: The patient is still being ventilated with the current mode and settings during this time. 2. Tap the desired ventilation mode. 3. Ensure that the correct mode and settings are displayed. Manually adjust any settings as needed. 4. Tap Confirm to return to Operation screen. ©2020 CAE 905K710052 v.1.1...
Page 110: Start New Patient
Setup Screen (Overlay) - Patient Not Ventilated The New Patient confirmation prompt appears. New Patient Confirmation 3. Tap Yes. 4. Refer to Configuring Ventilation Mode and Settings section for instructions to configure the settings for a new patient in the software. ©2020 CAE 905K710052 v.1.1...
Page 111: Power Off The Ventilator
In the event the system is unresponsive, press the power button for 10 seconds. This will initiate the safe shutdown of the electronic subsystems and UPS. This action will also trigger the Fail Safe mode whereby the emergency breathing circuit is enabled. ©2020 CAE 905K710052 v.1.1...
Page 112: Care And Maintenance
The exterior surfaces of the CAE Air1 should be cleaned and then disinfected before its initial use, and thereafter before or after each patient use according to the procedures defined in the following sections.
Page 113: Cleaning Cautions
6. Rinse with a clean, water-dampened cloth and allow to dry completely. 7. Dispose of the cleaning products according to the product’s instructions or other use and disposal information. ©2020 CAE 905K710052 v.1.1...
Page 114: Disinfecting Procedure
6. Wipe all surfaces with dry, lint-free cloths, and allow to dry completely before re-use. 7. Dispose of the cleaning products according to the product’s instructions or other use and disposal information. Note: These steps can also be used for the power cord, as needed. ©2020 CAE 905K710052 v.1.1...
Page 115: Preventive Maintenance
Preventive Maintenance The ventilator is designed to operate with minimal scheduled maintenance For additional information on any maintenance-related topics, refer to the CAE Air1 Service Manual. Consumable Materials Consumable materials are used by both the ventilator operator and by service personnel.
Page 116: Warranty Information
Note: Dispose of all parts removed from the ventilator during servicing according to local protocol. Warranty Information IMPORTANT: Not all consumables listed herein are covered under warranty. Please refer to the CAE Air1 Warranty agreement or contact Customer Service for complete details.
Page 117: Preventive Maintenance Schedule
Visually inspect the exhaust air Exhaust Air Filter Monthly filter for dust build-up. If dirty, use a cloth tissue to remove the dust build-up on the filter mesh. Air Inlet Filter Every 6 months Replace air inlet filter ©2020 CAE 905K710052 v.1.1...
Page 118 Qualified technicians are to perform the following preventive maintenance tasks on the ventilator, according to the following schedule. For complete instructions, refer to the CAE Air1 Service Manual. Note: For required tasks based on the number of hours used, these ‘hours used’ details may be found on the Settings screen of the ventilator user interface.
Page 119: Air Inlet Filter Replacement
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 Inlet Filter - Ventilator Back Cover 2. Remove the air filter from the opening. Remove Air Inlet Filter ©2020 CAE 905K710052 v.1.1...
Page 120 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 place using the two screws. ©2020 CAE 905K710052 v.1.1...
Page 121: Maintenance Tasks Using The Touchscreen
To obtain the number of hours that the ventilator has been used: 1. Press the Power button to turn the ventilator on. The Home screen will appear. Home Screen 2. From the Home screen select Settings. ©2020 CAE 905K710052 v.1.1...
Page 122 Prior to performing software updates or collecting log data, the network will require activation. To activate the network: 1. Power on the ventilator. The Home screen will appear. Home Screen 2. From the Home screen select Settings. ©2020 CAE 905K710052 v.1.1...
Page 123 There is no way to reset passcode. If the passcode is forgotten, the SD (Secure Digital) card will required re-flashing (files recopied). With the Administrator Setting unlocked, the passcode Change button and the software Network button become available. ©2020 CAE 905K710052 v.1.1...
Page 124 (attach the cable at the back of the ventilator). 2. Power on the laptop. 3. Launch the web browser. 4. From the browser enter the following address: https://172.20.4.17:58080 Note: Default static IP of MPIC: 172.20.4.17 5. Select Go on to the web page. ©2020 CAE 905K710052 v.1.1...
Page 125 CAEAir1 Care and Maintenance The CAE Air1 Login page appears. CAE Air1 Web Page - Enter PIN 6. Enter the passcode previously selected from the ventilator touchscreen interface. If passcode was not modified, the default is 000000. 7. Select Login.
Page 126 Appendix D - Ventilator Fault Logs for details. • Maintenance Log - a record of the self test result. • System Log - records information intended only for CAE engineers. • Platform Log - Any hardware malfunction will be shown in this log. Each error recorded in the platform log has an ID associated with the entry and is defined in Appendix D - Ventilator Fault Logs.
Page 127: Storage
CAEAir1 Care and Maintenance To access the logs: After activating the network and logging in, the CAE Air1 Web Home page appears. Web Home Page - Title Bar 1. Select Log. The Log page appears. Log Page 2. Select the type of log to download.
Page 128: Troubleshooting
SAFETY NOTICE Prior to handling or using the CAE Air1 ventilator, all warnings and cautions must be read and understood. See the Safety section of this user guide for a comprehensive list.
Page 129 Clear the Fail Safe screen and return to the Home screen by tapping the Acknowledge button. Authorized CAE service personnel will have to access the Platform log file to determine the details of the ventilator malfunction.
Page 130: Fail Safe And Pressure Safe Modes
• Plimit is reached ≥ 200 ms. • High priority alarm indications. • Pressure Safe mode persists for three seconds and then resumes ventilation with the previous settings. • Pressure Safe mode may occur an unlimited number of times. ©2020 CAE 905K710052 v.1.1...
Page 132: Appendixa - Parameter Descriptions
ARAMETER ESCRIPTIONS This section describes the parameter ranges for the Control widgets and accuracy tolerances used in the CAE Air1 ventilator. Control Widgets Parameter values can be adjusted and set to meet the patient’s changing ventilation needs. Pi (Inspiratory Pressure) / Pi Backup The Pi parameter controls the inspiratory pressure of a mandatory breath applied by mechanical ventilation.
Page 133: I:e Ratio (Inspiratory Time) / I:e Backup
When in Pressure Support mode, Tapnea is set. When Tapnea is reached, the ventilator will fall back into a control breath mode at the set backup values of Pi, RR and I:E. Default: 20 seconds Range: 15 - 45 seconds ©2020 CAE 905K710052 v.1.1...
Page 134: Tidal Volume
21% to 90% is defined below: Vtidal ≥ 300 ml ≥ 82 sec (1 minute 22 seconds) 300 ml ≥ Vtidal ≥ 200 ml ≥ 153 sec (2 minutes 33 seconds) ©2020 CAE 905K710052 v.1.1...
Page 136: Appendix B - Alarms
PPENDIX LARMS The CAE Air1 ventilator is equipped with visual and audible alarm systems. LED indications on the ventilator case and alarm banners on the touchscreen are accompanied by audible alarm signals with matching priority alert levels. The LED provides a visual indication of the ventilator status, visible to medical staff from a distance.
Page 137: Vitals Alarm Criteria And Default Threshold Values
Note: For alarms that are directly related to a control parameter, when the control parameter is adjusted, the alarm thresholds are temporarily expanded to include the range between the parameter’s current value and its new set value. ©2020 CAE 905K710052 v.1.1...
Page 138: Ventilator Hardware And Software Alarms
Less than 10 minutes of operating time Low Battery Medium audible alert remaining. Visible and Switching ventilator to battery power. Battery Power audible alert Software Visible and Loss of communication between the UI and High Malfunction audible alert MPIC. ©2020 CAE 905K710052 v.1.1...
Page 139: Alarm Indications
Yellow Yellow banner and alert recorded in the Touchscreen Banner Alarm History log. Ventilator Yellow LED Solid yellow omni-directional LED. Case Low Priority Yellow Yellow banner and alert recorded in the Touchscreen Banner Alarm History log. ©2020 CAE 905K710052 v.1.1...
Page 140: Backup Alarm
• Connect ventilator to external power source. (Air Temp Low) Hardware Alarm Attention required: (power source) • Connect ventilator to external power source. Immediate response required: Backup Alarm High • Replace the ventilator. Refer to the Troubleshooting section for additional information. ©2020 CAE 905K710052 v.1.1...
Page 141: Automated Ventilator Responses
When Fail Safe mode is triggered the ventilator must be replaced if the cause of Fail Safe cannot be resolved and normal operation cannot be maintained. Refer to the Troubleshooting section for additional information on Pressure Safe and Fail Safe modes. ©2020 CAE 905K710052 v.1.1...
Page 142: Appendix C - Operation Modes
PERATION ODES The CAE Air1 ventilator supports three distinct modes of operation. These modes define the breathing pressure, volume and degree of breathing assistance that a patient receives from the ventilator. The modes are selectable through the graphical user interface on the touchscreen.
Page 143 Pi, RR and I:E backup values. The ventilator switches back into Pressure Support mode after three consecutive assist breaths in backup PC mode. Note: For additional information on mode parameters, refer to Appendix A. ©2020 CAE 905K710052 v.1.1...
Page 144: Appendix D - Ventilator Fault Logs
Ventilator overheating. Shutdown and leave it cool for 15 minutes. Restart the unit. If problem persists contact CAE customer service. 1009 Operating Medium Sound may not work. Shutdown and restart the unit. If alarm persists, contact CAE customer service. ©2020 CAE 905K710052 v.1.1...
Page 145 Operator Action Status 1010 Operating Medium Fan failure. Ventilator will overheat. Shutdown and restart the unit. If alarm persists, contact CAE customer service. 1011 Operating Medium Fan failure. Ventilator will overheat. Shutdown and restart the unit. If alarm persists, contact CAE customer service.
Page 146 Ventilator Error Level Operator Action Status 1108 Auto High Shutdown and restart the unit. If alarm persists, shutdown contact CAE customer service. 1109 Auto High Shutdown and restart the unit. If alarm persists, shutdown contact CAE customer service. 1110 Operating Medium Shutdown and restart the unit.
Page 147 Medium Shutdown and restart the unit. If alarm persists, contact CAE customer service. 1214 Operating Info Additional information for CAE engineer for cause of FailSafe mode triggering. 1215 Operating Info Additional information for CAE engineer for cause of FailSafe mode triggering.
Page 148: Alarm Log
Hardware Malfunction with ID 1200 to 1299 raised. Malfunction Verify Platform log for user action. 2000 Software High Shutdown and restart the unit. If the alarm persists Malfunction contact CAE customer service. 2001 Gas Supply High Verify Oxygen tank. Requires attention of medical Failure personnel. 2002...
Page 149 2600 Ppeak High High Requires attention of medical personnel. 2601 Ppeak Low High Requires attention of medical personnel. 2700 PEEP High High Requires attention of medical personnel. 2701 PEEP Low High Requires attention of medical personnel. ©2020 CAE 905K710052 v.1.1...
Page 150: Appendix E - Third-Party Software And Hardware
PPENDIX HIRD ARTY OFTWARE AND ARDWARE Software The following table contains the software BOM (Bill of Materials) of third-party software components 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...
Page 151: Hardware
CAEAir1 Appendix E - Third-Party Software and Hardware 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 Version Number Number PS302659065621...
Page 152: Appendixf - Applicable Standards
• ISO 80601-2-12 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators. • ISO 80601-2-55 2018, Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitor. ©2020 CAE 905K710052 v.1.1...
Page 154: Glossary
HTTPS Hypertext Transfer Protocol Secure Inspiration:Expiration (ratio of inspiratory time to expiratory time) International Electrotechnical Commission Internet of Things International Organization for Standardization Liquid Crystal Display Medical Electrical Equipment Medical Electrical Systems MPIC Multi-Processor Interrupt Controller ©2020 CAE 905K710052 v.1.1...
Page 155 User Interface (also known as GUI) Uninterruptable Power Supply Universal Serial Bus Volts of Alternating Current Volume Control (mode) VHDL VHSIC Hardware Description Language VHSIC Very High Speed Integrated Circuits Tidal Volume WEEE Waste Electrical and Electronic Equipment ©2020 CAE 905K710052 v.1.1...
Page 156: List Of Terms
A combination of room air and pressurized oxygen provided to a patient through the ventilator. CAEAir1 Mechanical ventilator designed and manufactured by CAE. Caution A written text calling attention to a serious topic that could have negative consequences if instructions are not followed correctly.
Page 157 Term Definition User Interface The ventilator display monitor and software that allows operator input and interaction with the CAE 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 that could have serious negative consequences if instructions are not followed correctly.
Page 158 Email for Support: caeair1support@cae.com Customer 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 +1 941-377-5562 or Toll-free number 866-233-6384...

CAE Air1 User Manual

Specifications

Safety

Introduction

Intended Use and Indication for Use

Equipment Overview

Setup

Interface Overview

Using the Ventilator

Care and Maintenance

Troubleshooting

Appendix A - Parameter Descriptions

Appendixa - Parameter Descriptions

Appendix B - Alarms

Appendix C - Operation Modes

Appendix D - Ventilator Fault Logs

Appendix E - Third-Party Software and Hardware

Appendixf - Applicable Standards

Appendix F - Applicable Standards

Glossary

Quick Links

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