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Appendix F - Applicable Standards

PPENDIX

F - A

PPLICABLE

TANDARDS

The following Standards apply:

• ISO 5356-1:2004 Anesthetic and respiratory equipment Conical connectors Part 1: Cones

and sockets.

• EN 5356-1:2004 Anesthetic and respiratory equipment Conical connectors Part 1: Cones

and sockets.

• ISO 10993-1:07-15-2010 Biological evaluation of medical devices - Part 1: Evaluation and

testing within a risk management process TECHNICAL CORRIGENDUM 1 - Fourth Edition.

• ISO 14971:2007/EN ISO 14971:2012, Medical devices - Application of risk management to

medical devices.

• ISO 15001:2010 Anaesthetic and respiratory equipment - Compatibility with oxygen.

• ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare

applications - Part 1: Evaluation and testing within a risk management process.

• IEC 60601-1-2:2018 Medical 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 electrical equipment - Part 1-6: General requirements for

basic safety and essential performance - Collateral Standard: Usability.

• IEC 60601-1-8:2006 Medical electrical equipment - Part 1-8: General requirements for

basic safety and essential performance - Collateral standard: General requirements, tests

and guidance for alarm systems in medical electrical equipment and medical electrical

systems.

• IEC 62304:2006 Medical device software - Software life cycle process.

• IEC 62366:2007 Medical devices - Application of usability engineering to medical devices.

• 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.

Содержание Air1

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

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

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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