O-Two eAdvantage 01EQ3000 User Manual
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O-Two eAdvantage 01EQ3000 User Manual

Electronic nitrous oxide/oxygen analgesic gas mixing and delivering system
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USER MANUAL
eAdvantage®
Electronic Nitrous Oxide/Oxygen
Analgesic Gas Mixing and Delivering System
01EQ3000
Made in Canada by O-Two™ Medical Technologies Inc.
Part Number: 15PL1033 Rev. 7, July 2022
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Summary of Contents for O-Two eAdvantage 01EQ3000

  • Page 1 USER MANUAL eAdvantage® Electronic Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivering System 01EQ3000 Made in Canada by O-Two™ Medical Technologies Inc. Part Number: 15PL1033 Rev. 7, July 2022...

  • Page 2: Table Of Contents

    TABLE OF CONTENTS 1. Safety 2. General Information 2.1. Intended Use 2.2. Environment of Use 2.3. Contraindications 3. Overview 3.1. Product Description 3.2. Principles of Operation 3.3. Controls, connections and indicators 3.4. Control Functions 3.5. LED Indicators 3.6. Symbols and Notations 4.
  • Page 3 5. Operating Instructions 5.1. Start-up and selecting settings 5.2. Demand Mode 5.3. Lock Feature 5.4. Settings mode 5.4.1. Date & time 5.4.2. Passcode 5.4.3. Software update 5.4.4. Stored events 5.4.5. Stored events transfer 5.5. Use of the device 5.6. Turning OFF the device 6.

  • Page 4: Safety

    • This device must be used with the O-Two™ Breathing Circuit, 01CV8037. It is recommended to connect the expiratory tubing of the circuit to an Anaesthetic Gas Scavenging System complying with ISO 80601-2-13 •...

  • Page 5: General Information

    The patient shall be constantly monitored by trained healthcare professionals while using the eAdvantage. 2. GENERAL INFORMATION 2.1 Intended Use The O-Two eAdvantage® N electronic analgesic gas mixing and delivery systems are intended to administer an operator adjustable mixture of nitrous oxide analgesic/anxiolytic gas and oxygen, on demand, to a conscious, spontaneously breathing patient.

  • Page 6: Overview

    3. OVERVIEW 3.1 Product Description The eAdvantage® is an electronically controlled (mains supply or battery), gas pressure operated, self-administered mixing system for the delivery of a variable concentration of a gaseous mixture of nitrous oxide and oxygen (N ), on demand fl ow to spontaneously breathing, conscious patients via a unique patient circuit with monitoring line.

  • Page 7: Controls, Connections And Indicators

    Note: The eAdvantage® mixer is considered a critical device, and its components considered critical components. Only those individuals trained in the operation of nitrous oxide/oxygen analgesic gas delivery systems (and this device) should use this equipment. Thoroughly review the instruction manual before use. 3.3 Controls, Connections and Indicators Green LED for battery Output Connection...

  • Page 8: Control Functions

    3.4 Control Functions Control Knob (K): The Control Knob is used to turn ON the mixer (by depressing it for 1 second) or turn the mixer OFF (by depressing it for 4 seconds). It is also used to navigate between the options and settings on the screen, by rotating it in either direction when needed and for confi...

  • Page 9: Symbols And Notations

    3.6 Symbols and Notations Consult the instructions for use. Warning! Risk of injury and possible negative patient outcome. WARNING Warns of material damage with potential patient consequences. O ers useful tips to assist in the proper use of the equipment. NOTE: Keep away from open fl...

  • Page 10: Preparation For Use

    4. PREPARATION FOR USE 4.1 Component List Ensure that all the following components have been received: eAdvantage® mixer Single use patient circuit with mouthpiece Oxygen supply hose Nitrous oxide supply hose External power supply with power supply cord Battery pack Operating manual If any components are missing from the shipping carton, call the supplier immediately.

  • Page 11: Connecting The Gas Supply Hoses

    Yellow/black knob Connector Insert the battery with the connector on the right hand side. WARNING • A fully charged battery must always be installed for safety reasons, even when operating from an external power supply, so that continuous operation is not interrupted in the absence of external power. Never run the device with the battery removed or unplugged.
  • Page 12 Attach the N input hose here. Attach the input hose here. Attach a new patient circuit and monitoring line Insert power to the device here Supply plug here Fig. 1 Connecting the Supply hoses, Patient Circuit and Power Supply WARNING Using a wrench or applying excessive force in tightening the supply hose may damage the seal or the thread of the connection.

  • Page 13: Connecting The Patient Circuit And Sensor Line

    4.2.4. Connecting the patient circuit and Sensor line Connect a new patient circuit (01CV8037) to the 22mm outlet connection port, remove the monitoring line plug and connect to the monitoring line connection port (Fig. 2). Note: Ensure both the monitoring line and patient circuit are securely connected.

  • Page 14: Testing Prior To Introduction Into Service

    Vacuum generator with a minimum 30 L/min fl ow rate. 4.3.1. Input Leak test Having connected the supply hoses to the device (refer to section 4.2.3 for connection of hoses), ensure that the O-Two™ eAdvantage® mixer is OFF and turn ON the N O and O Gas sources.

  • Page 15: Low Input Pressure Alarms

    Note: The vacuum source can be as simple as a 500 ml calibrated syringe. 4.3.4. Low Input Pressure Alarms Note: To fully test this function it is necessary to have a supply regulator with an adjustable output pressure and a release valve (Not supplied). Checking of the alarm may be undertaken by simply slowly closing the cylinder valve.

  • Page 16: Pre-Use Checklist

    4.4 Pre-use Checklist When the device is turned ON it will undertake an internal self- diagnostic test protocol to ensure that the device is fully functional (see section 5.1). Ensure that the patient circuit and monitoring line are securely connected to the device. Note: It is important that the device is turned OFF after each patient use and turned ON prior to use to allow this self-diagnostic protocol...
  • Page 17 Once this screen is displayed the mixer is ready for operation. Note: Start Up Calibration Error (Startup calibration results and during use technical failure): The eAdvantage® will not switch ON if any of the problems listed below are detected: Valve Failure. O Valve Failure.

  • Page 18: Demand Mode

    5.2 Demand Mode To select (or make changes to) the device settings, rotate the Control Knob (K) and a frame will move around the selected fi gures following the direction of the Control Knob rotation. Below is an illustration of clockwise knob rotation: Note: If the screen is locked the selection of the mode, gas mixture and setting will be inactive until the screen is un-locked.

  • Page 19: Lock Feature

    Press Control Knob (K) to confi rm selection. Once confi rmed, the 2 numbers stop fl ashing and the screen will display the new gas mixture selection. 5.3 Lock Feature The eAdvantage® is equipped with a “lock” feature (protected by passcode) to prevent patients from making changes to the setting selected by their caregivers.

  • Page 20: Settings Mode

    5.4 Settings Mode Within the Settings Mode, Users can set the date & time, change the passcode, display and transfer “Stored event information” or perform software upgrades. Note: The screen must be unlocked to access this mode. To access the setting mode, rotate the Control Knob (K) until the selection frame surrounds the settings symbol as shown below: Note: The selection frame will disappear if no action is taken within 10 seconds.

  • Page 21: Date & Time

    Once confi rmed the related setting information will be displayed (as shown in the Passcode setting example below): follow the instructions below to change the setting parameters. Note: Pressing the Cancel Key at any time within the setting mode will move the process back to a previous step until exiting the setting.

  • Page 22: Passcode

    Using the Control Knob (K) move the square frame to the desired cell to be changed. The green dotted lines shown above indicates the sequence of cell selection based on Control Knob rotation. At the desired cell, press the Control Knob (K) to activate this cell. The cell now changes to solid color as shown below.
  • Page 23 At the desired cell, press the Control Knob (K) to activate this cell. The cell now changes to a solid color as shown below. To increase the numbers 0-9 rotate the knob clockwise or counter clockwise to decrease. Press the Control Knob (K) to confi rm the change otherwise the selection will be cancelled if no confi...
  • Page 24 Once the new passcode is entered, another line appears under the fi rst prompting the User to confi rm the new passcode. Once confi rmed the screen will revert to the setting screen in the passcode setting mode as shown below: eAdvantage User Manual (15PL1033 Rev.

  • Page 25: Software Update

    5.4.3. Software Update To update software, follow the steps detailed in 5.4 above under “Setting mode” to activate its cell and do the following: After confi rming the passcode select software update. Insert the USB key with the new software revision or select the Cancel Symbol to abandon this process.
  • Page 26 Once the update is completed, the device will shut down and restart automatically. Once it’s on, the technician must confi rm that the software version shown on the startup page (Fig. 1) is identical to the revision number written on the new USB key. Note: Should the update process fail to write the new software to the device, note the following: •...

  • Page 27: Stored Events

    5.4.4. Stored Events Note: The “Data display” is not protected by a passcode. To display the stored events, follow the setting mode steps below and press the “Data display” cell and the screen will change to: The mixer will store any event including all alarms and their related actions, turning the device ON or OFF, pressing the Oxygen Flush key, setting changes after confi...

  • Page 28: Stored Events Transfer

    5.4.5. Stored Events Transfer This feature allow the users to transfer and display the stored event on a computer or mobile devices. follow the steps to activate the Data Transfer cell. Insert the USB key or press the Cancel Button (L) if the user wishes to abandon this process.

  • Page 29: Use Of The Device

    The user can press Cancel to exit and go back to the main screen or it will exit automatically if no action occurs within 10 seconds. If the Data Transfer failed or the USB key is removed while transferring fi les or the USB loses its connection during transfer, the message below will be shown: 5.5 Use of Device The eAdvantage®...

  • Page 30: Turning Off The Device

    5.6 Turning OFF the Device To turn OFF the mixer, press and hold the Control Knob (K) for 4 seconds. During this time the green power LED will start fl ashing at a high frequency. After 4 seconds the mixer will turn OFF. At the same time the Oxygen Valve will open to deliver a 40 L/min fl...

  • Page 31: Alarms, Warnings And Notifications

    7. ALARMS, WARNINGS AND NOTIFICATIONS 7.1 Functional Alarms Note: Visual and audible alarms will continue until the cause of the alarm is resolved. During alarm activation the user may press the audio paused key to silence the Audible Alarm for 2 minutes, the visual alarm will continue to fl...
  • Page 32 Alarm/Warning priorities with corresponding visual/ audible alarms Cell On Screen Symbol Name Priority Alarm delay Audible Alarm Visual Alarm Sensor error (U13 Solid symbol 1 Burst with 10 and/or U14 High Directly with fl ashing red pulses each, repeat sensors warning symbol every 7.5 seconds failure)

  • Page 33: Flow Valve Leak Alarm

    Cell Alarm On-Screen Symbol Name Priority Audible Alarm delay Visual Alarm (Medium) 1 Burst with Low O Follow the 3 pulses each, repeat Medium After 3 6% volume visual alarm logic every 20 seconds or highbelow consecutive lower than depending on the (high) 1 Burst with 27% of O breaths...
  • Page 34 Battery discharge status on screen indicators: Full capacity No alarm 75% at full capacity No alarm 50% at full capacity No alarm Solid yellow symbol with 25% at full capacity solid yellow WARNING symbol Corrected symbol with fl ashing red warning symbol 5% at full capacity at 1.4 Hz with 50% usage Battery charging status on screen indicators...

  • Page 35: Cleaning, Preventive Maintenance And Servicing

    8. CLEANING, PREVENTIVE MAINTENANCE AND SERVICING 8.1 Cleaning Routine cleaning of the device shall be undertaken to maintain the device in a clean condition. The patient circuit with mouth piece (or facemask) is intended for single patient use only and shall be discarded after each patient (in accordance with local protocols) and replaced with a new circuit.

  • Page 36: Charging The Battery

    8.2 Charging the Battery 8.2.1 Connect one end of the external power supply/charger to its supply (100 to 240 Volts or on-board vehicle socket) and the other end to the DC input socket (C) in Fig. 1 located on the side panel of the mixer.

  • Page 37: Preventive Maintenance And Servicing

    It is recommended that the routine preventive maintenance be carried out, and the eAdvantage® mixer be returned to O-Two™ Medical Technologies (or its authorized service center) for maintenance and service every 2 years as follows:...
  • Page 38 The device shall be returned to the manufacturer or a service center authorized by the manufacturer for level II service every 2 years. Manufacturer full service The device shall be returned to O-Two™ Medical Technologies for manufacturer full Service every 6 years. Description...

  • Page 39: Technical Data

    9. TECHNICAL DATA 9.1 Specifi cations GAS SOURCE Compressed oxygen + nitrous oxide CIRCUIT CONTROL SOURCE Electronic MAXIMUM FLOW RATE (L/MIN) >260 combined or 160 from oxygen input only 30-100 % continuous adjustment with 5% incremental changes. OXYGEN CONCENTRATION (O Accuracy: ±5% V@ min.

  • Page 40: Circuit Diagram

    9.2 Circuit diagram Exhaust Flow Sensor Input Connector 10. N O Flow Sensor O Input Connector Respiratory Pressure Sensor Input The Pressure Sensor 12. Sensor Hose O Input The Pressure Sensor 13. Removal Kit Inlet Manifold 14. Patient Circuit O Inlet Manifold 15.

  • Page 41: Electromagnetic Compatibility

    AC/DC Power Supply MODEL PMP90-13-2 01CV0104 INPUT VOLTAGE 100 - 240 VAC INPUT CURRENT 1.06 - 0.45 A INPUT FREQUENCY 47 - 63 Hz OUTPUT VOLTAGE 19 VDC OUTPUT CURRENT 4.74 A Maximum DC OUTPUT PLUG 2.5 x 5.5 x 11 mm DC OUTPUT CABLE LENGTH 6’...
  • Page 42 Electromagnetic Immunity Immunity test Immunity test level Electrostatic discharge ± 8 kV contact (ESD) IEC61000-4-2 ± 2, ±4, ±8, ±15 kV air Electrical fast transient/ ± 2 kV for power supply lines Burst IEC61000-4-4 ± 1 kV for input/output lines ±0.5, ±1 kV line to line;...

  • Page 43: Troubleshooting

    No proper charging/faulty Charge battery as per quickly battery instructions/replace battery Change battery/connect Battery empty/no power eAdvantage® cannot power supply/ send to be switched ON supply connected/defective O-Two™ for repair or service eAdvantage User Manual (15PL1033 Rev. 7, July 2022)

  • Page 44: Replacement Parts And Accessories

    Each 02RT1303 Disposable Mouthpiece (Individually Wrapped) Case/50 OXYGEN HOSES PART # DESCRIPTION UNIT O-Two™ 6 Foot (1.85 Meter) O supply hose 01FV4303-AFNR with AFNOR probe and 9/16” DISS nut Each device connection O-Two™ 6 Foot (1.85 Meter) O supply hose 01FV4303-AGA with AGA probe and 9/16”...
  • Page 45 NITROUS OXIDE HOSES PART # DESCRIPTION UNIT O-Two™ 6 Foot (1.85 Meter) N O supply 01FV4303-AFN-N Hose with AFNOR Gas supply fi tting and Each N2O DISS nut Device Connection O-Two™ 6 Foot (1.85 Meter) N O supply 01FV4303-AGA-N Hose with AGA Gas supply fi tting and...

  • Page 46: Warranty

    12. WARRANTY WARRANTY O-Two™ Medical Technologies Inc. products are manufactured from the fi nest quality materials. Each individual part is subject to strict quality control tests to ensure exceptionally high standards. The manufacturer warrants to the purchaser of the eAdvantage® N...
  • Page 47 eAdvantage User Manual (15PL1033 Rev. 7, July 2022)
  • Page 48 Your Representative is: O-TWO MEDICAL TECHNOLOGIES INC. For your nearest Authorized O-Two™ Distributor In North America call Toll Free 1-800-387-3405 MedNet EC-REP GmbH SERIAL N Borkstrasse, 10 48163 Münster, Germany www.otwo.com 45A Armthorpe Road, Brampton, ON, Canada, L6T 5M4 Telephone: +1 905 792-OTWO (6896) N.A. Toll Free: +1 800 387 3405 Facsimile: +1 905 799 1339 Email: resuscitation@otwo.com...

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