O-Two eAdvantage User Manual

O-Two eAdvantage 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. 13, Jan. 2024

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Summary of Contents for O-Two eAdvantage

  • 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. 13, Jan. 2024...
  • Page 2: Table Of Contents

    4.3. Testing Prior to introduction into Service 4.3.1. Input Leak test 4.3.2. Output Leak test 4.3.3. Demand Function 4.3.4. Low Input Pressure Alarms 4.3.5. Low Input Pressure Shut OFF 4.3.6. Oxygen Flush key 4.3.7. Oxygen Concentration 4.4. Pre-use Checklist eAdvantage User Manual...
  • Page 3 8.1. Cleaning 8.2. Charging the Battery 8.3. Preventive maintenance and Servicing 9. Technical Data 9.1. Specifi cations 9.2. Circuit Diagram 9.3. Battery and Power Supply 9.4. Electromagnetic Compatibility 10. Troubleshooting 11. Replacement parts and accessories 12. Warranty eAdvantage User Manual...
  • Page 4: Safety

    • The eAdvantage® shall not be used in oxygen-rich, fl ammable, or anesthetic agents environments. Keep away from open fl ames, sparks, and grease/oil.
  • Page 5: General Information

    This device and its associated breathing system are compatible for use with N O and O • 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...
  • Page 6: Overview

    Furthermore, the device will automatically shut o if the oxygen input pressure falls below 21 PSI. Additionally, the eAdvantage® includes an oxygen fl ush function, enabling healthcare providers to deliver a constant fl ow of 100% oxygen to the patient.
  • Page 7: Controls, Connections, And Indicators

    Note: The eAdvantage® mixer is classifi ed as a critical device, and its components are considered critical components. Therefore, only individuals specifi cally trained in operating nitrous oxide/oxygen analgesia gas delivery systems, including this particular device, are authorized to use this equipment. Thoroughly review the instruction manual before operating the device.
  • Page 8: Control Functions

    Audio Paused key (M): The eAdvantage® includes an Audio Paused key, designed to temporarily silence the Audible Alarm for 2 minutes. This function can be activated at any time by pressing the key, regardless of whether an alarm is currently active.
  • Page 9: Symbols And Notations

    Separate selection for waste of electrical and electronic components Read the User Manual before use. Demanded fl ow delivery during Patient e ort. Return for Service Audio paused Caution: Federal law restricts this device to sale by or on the order of a physician eAdvantage User Manual...
  • Page 10: Preparation For Use

    4.2 Set-Up 4.2.1. Connecting the electrical power supply The eAdvantage® mixer is supplied with a regulated power supply with the customer-specifi ed power cord for the country of use. The power supply plugs into the socket on the left-hand side of the unit. This socket is protected with a dust cap when not in use.
  • Page 11: Connecting The Gas Supply Hoses

    Empty” alarm is triggered. 4.2.3. Connecting the gas supply hoses The eAdvantage® mixer operates with medical grade nitrous oxide and oxygen from either pressure-regulated medical gas cylinders or piped-in systems. Specifi cally designed entrance fi ttings on the device ensure non-interchangeable connections for nitrous oxide and oxygen, enhancing safety and preventing cross-connection.
  • Page 12 Note: Power supply cords compatible with the electrical standards of most countries are available for the eAdvantage® system. It is important to specify the intended country of use when purchasing to ensure the correct power supply cord is provided.
  • Page 13: Connecting The Patient Circuit And Sensor Line

    WARNING NEVER obstruct the output port or the scavenging connector outlet. 4.2.5. Turning the Mixer ON To turn the mixer ON, depress the ON/OFF Control Knob for 1 second. eAdvantage User Manual...
  • Page 14: Testing Prior To Introduction Into Service

    4.3.2. Output Leak test The eAdvantage® is equipped with an automatic leak detection feature that alerts the user to any detected leaks inside the device. Alternatively, you can manually perform the Output Leak Test.
  • Page 15: Demand Function

    4.3.3. Demand Function To test the Demand Function of the eAdvantage® mixer, apply a vacuum to the patient connector. This vacuum should be equivalent to a fl ow rate of 30 L/min and maintained for at least 1 second. The mixer is designed to respond by providing a fl...
  • Page 16: Pre-Use Checklist

    5. OPERATING INSTRUCTIONS 5.1 Start-up and Calibration To start the eAdvantage®, press and hold the Control Knob (K) for 1 second. You will notice the associated green LED (J) beginning to fl ash at a high frequency. After holding the knob for 1 second, the eAdvantage® turns ON and initiates the calibration process.
  • Page 17 Once the operation screen is displayed with all the relevant parameters, the eAdvantage® 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

    fi xed 50/50% mixture of each gas, or a maximum concentration of 50% nitrous oxide. This customization allows for adjustments according to local medical protocols or specifi c customer requests. eAdvantage User Manual...
  • Page 19: Lock Feature

    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 a passcode, to prevent patients from changing the settings selected by their healthcare providers.
  • Page 20: Settings Mode

    Rotate the Control Knob (K) in either direction to navigate through the fi ve setting selections. The solid color frame will move accordingly until you reach the desired option. Once you’ve selected the appropriate setting, press the Control Knob (K) again to confi rm your choice. eAdvantage User Manual...
  • Page 21: Date & Time

    To set the Date and time, follow the steps detailed in 5.4 above under “Setting mode” to activate the Date and Time cell and do the following: Once the ‘Date & Time’ setting is activated, a yellow square frame will appear around the hours setting window, as shown below. eAdvantage User Manual...
  • Page 22: Passcode

    To change the Passcode, follow the steps detailed in 5.4 above under “Setting mode” to activate its cell and do the following: Once the “Passcode” is activated the page below will open requesting users to enter the current passcode. eAdvantage User Manual...
  • Page 23 To adjust a specifi c cell in the eAdvantage® system settings, follow these steps: 1 - Press the Control Knob (K) when the desired cell is highlighted. The cell will change to a solid color, indicating it is ready for adjustment, as shown below.
  • Page 24 Once the new passcode is confi rmed, the screen will automatically revert back to the settings screen within the passcode setting mode, as shown below: 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: eAdvantage User Manual...
  • Page 25: Software Update

    Insert a USB key with the new software revision to update, or select the ‘Cancel’ symbol to exit without updating. Upon inserting the boot loader USB key into the eAdvantage® system, the confi rmation indicator light (J) will start fl ashing, indicating the need to confi rm the selection manually before initiating the software update process.
  • Page 26 • If the device loses power during update – the software update process will cease and the device will restore the previous revision until the user updates the software as per the above process. eAdvantage User Manual...
  • Page 27: Stored Events

    If multiple events occur at the same time, their events will be saved sequentially with no particular priority. Once completed the user can exit the mode by pressing the Cancel Key. Note: Individual stored events cannot be deleted by the user. eAdvantage User Manual...
  • Page 28: Stored Events Transfer

    Once confi rmed by pressing the Control Knob (K), the screen changes to the one below with a fl ashing fi le transfer symbol until the data transfer is complete. Upon successful transfer, the screen will display the following message: eAdvantage User Manual...
  • Page 29: Use Of The Device

    USB loses its connection during transfer, the message below will be shown: 5.5 Use of Device The eAdvantage® system is designed for patient self-administration under the supervision of healthcare professionals. Nurses or physicians attending to the patient should provide the following instructions for use: 5.5.1.
  • Page 30: Turning Off The Device

    Note: When the mixer is brought back to room temperature from the minimum storage temperature, it is designed to operate within 5 minutes. Conversely, if the mixer is brought back from the maximum storage temperature to room temperature, it will be ready to operate within 2 minutes. eAdvantage User Manual...
  • Page 31: Alarms, Warnings And Notifications

    ‘Warning’ symbol, while medium and low-priority alarms have a yellow symbol. The eAdvantage® device can display multiple alarm symbols simultaneously if there are several failures occurring at the same time. In such cases, the audible alarm will correspond to the highest-priority alarm.
  • Page 32 ≥ 80 PSI Solid symbol with a 1 Burst with 10 Empty High Directly fl ashing red warning pulses each, repeat Battery symbol every 7.5 seconds The solid yellow symbol with a fi xed Battery yellow warning symbol eAdvantage User Manual...
  • Page 33: Flow Valve Leak Alarm

    7.2 Flow Valve Leak Alarm The eAdvantage® system includes a fl ow valve leak detection feature that functions when the unit is supplied with gas. While the device is ON, it continually monitors the outputs from both fl ow sensors.
  • Page 34: Battery Indicators

    7.3 Battery Indicators The eAdvantage® system provides visual indications of the battery status on the screen. There are two distinct types of battery status indicators: - Discharge Status Indicator: This displays the current battery level during normal operation of the device, indicat ing how much charge is remaining.
  • Page 35: Cleaning, Preventive Maintenance And Servicing

    8.1.7 Attach a new patient circuit and connect the unit to the gas supplies prior to use with the next patient. WARNING Do not attempt to clean and sterilize any components that are designated for single-patient use. eAdvantage User Manual...
  • Page 36: Charging The Battery

    The battery pack should be replaced after its life expectancy. The same goes if the battery pack will not fully charge (as indicated on the battery display on the mixer) or if the mixer doesn’t run for more than 5 hours on a single charge. eAdvantage User Manual...
  • Page 37: Preventive Maintenance And Servicing

    To ensure proper operation of the eAdvantage®, regular inspection and checking of the device and accessories for correct function should be undertaken by a responsible member of sta .
  • Page 38 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 Procedure Criterion Schedule Factor: User Manual Device in working Visual Chapter 8.3...
  • Page 39: Technical Data

    AUDIO ALARM PAUSED Yes, 120 second max ALARM SOUND 60 dB PRESSURE LEVEL BUILT-IN SCAVENGING SYSTEM DIMENSIONS (mm) 305 x 210 x 130 WEIGHT WITH & W/O BATTERY (KG) 2.80 & 2.20 Note: All values are measured at STPD eAdvantage User Manual...
  • Page 40: Circuit Diagram

    MAX. CHARGING CURRENT 4.62 A MAX. CHARGING VOLTAGE 16.8 V ± 0.1 V DIMENSION 167.2 x 107.5 x 21.5 mm WEIGHT 590 g Note: The behavior of the mixer will not be a ected while the battery is charging. eAdvantage User Manual...
  • Page 41: Electromagnetic Compatibility

    HF surgical equipment where the intensity of electromagnetic disturbance is high. The user of eAdvantage® should ensure that it is not used in environments outside those specifi ed below:...
  • Page 42 WARNING Use of accessories, transducers, and cables other than those specifi ed or provided by the manufacturer of eAdvantage® could result in increased electromagnetic emission or decreased electromagnetic immunity of eAdvantage® and result in improper operation. The eAdvantage® is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled.
  • Page 43: Troubleshooting

    Change the gas cylinder Battery discharges 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...
  • Page 44: Replacement Parts And Accessories

    01FM4999-CS Universal Face Mask Case/12 01CV0106* Power supply cord (Canada and the US) Each 01CV0104 External power supply Each 01CV7040-1 eAdvantage® Mounting Bracket w/ C-Clamp Each eAdvantage® Mounting Bracket 01CV7040-2 Each w/ Medirail clamp 01CV9200 Li-Ion Smart Battery Each 02RT1303...
  • 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

    Each part is subject to strict quality control tests to ensure exceptionally high standards. The manufacturer warrants to the purchaser of the eAdvantage® N2O/ O2 Analgesic Gas Mixing and Delivery System that its parts are free from defects in material and workmanship for two years from the date of purchase.
  • Page 47 User Manual...
  • 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 IIb 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.

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01eq3000

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