eAdvantage User Manual Rev 11

TABLE OF CONTENTS 1. Safety

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2. General Information

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2.1. Intended Use

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2.2. Environment of Use

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2.3. Contraindications

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3. Overview

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3.1. Product Description

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3.2. Principles of Operation

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3.3. Controls, connections and indicators

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3.4. Control Functions

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3.5. LED Indicators

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3.6. Symbols and Notations

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4. Preparation for Use

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4.1. Component List

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4.2. Set up

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4.2.1. ON/OFF

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4.2.2. Installing / replacing the battery

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4.2.3. Connecting the gas supply hoses

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4.2.4. Connecting the patient circuit and Sensor line

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4.2.5. Turning the Mixer ON

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4.3. Testing Prior to introduction into Service 4.3.1. Input Leak test

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4.3.2. Output Leak test

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4.3.3. Demand Function

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4.3.4. Low Input Pressure Alarms

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4.3.5. Low Input Pressure Shut OFF

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4.3.6. Oxygen Flush key

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4.3.7. Oxygen Concentration

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4.4. Pre-use Checklist 2

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5. Operating Instructions

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5.1. Start-up and selecting settings

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5.2. Demand Mode

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5.3. Lock Feature

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5.4. Settings mode

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5.4.1. Date & time

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5.4.2. Passcode

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5.4.3. Software update

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5.4.4. Stored events

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5.4.5. Stored events transfer

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5.5. Use of the device

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5.6. Turning OFF the device

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6. Post Use

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6.1. Disconnecting the Device After Use

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6.2. Storage

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7. Alarms, Warnings and Notifications

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7.1. Functional Alarms

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7.2. Flow Valve Leak Alarm

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7.3. Battery Indicators

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8. Cleaning, Preventive Maintenance and Servicing

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8.1. Cleaning

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8.2. Charging the Battery

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8.3. Preventive maintenance and Servicing

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9. Technical Data

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9.1. Specifications

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9.2. Circuit Diagram

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9.3. Battery and Power Supply

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9.4. Electromagnetic Compatibility

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10. Troubleshooting

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11. Replacement parts and accessories

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12. Warranty

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eAdvantage User Manual

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1. SAFETY WARNINGS

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•

Federal Law restricts this device to sale by or on the order of a physician.

•

The eAdvantage® shall only be used by qualified healthcare professionals trained in its use for the purposes specified under “Intended Use”.

•

The eAdvantage® system is designed for patient self-administration.

•

Never attach the face mask to the patient using a head harness.

•

The eAdvantage® shall not be used in oxygen rich nor flammable gases or anaesthetic agents environments. Keep away from open flames, sparks and grease/oil.

•

It is recommended to use cylinders that are at least 1/4 full. Always turn ON the cylinder valve slowly and fully.

•

The nitrous oxide cylinder should be operated in an upright position. If the nitrous oxide cylinder is in a valve-down position while the post valve is open, liquid may be expelled through the vent passages. This liquid, Nitrous Oxide, can cause burns by freezing on exposed skin.

•

Never allow oil or grease to come into contact with any part of the cylinders, regulators or eAdvantage® system.

•

Always use the checklist to ensure that all components are reassembled correctly and that all disposable items are replaced.

•

Before use on a patient, the settings of the delivered gas should be checked to ensure they are in accordance with the intended use.

•

It is recommended to use an oxygen monitor complying with ISO 806012-55 whenever the gas mixer is in use by connecting it to the gas outlet on the device between the device and the circuit.

•

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

•

If the alarm sounds continuously, immediately discontinue use and shut OFF the gas supply.

•

After use, always turn OFF the cylinders to ensure that gas cylinders with sufficient volume are attached before returning the unit to its normal storage position.

•

After use always turn OFF the device.

•

Do not disassemble any part of the unit except where described in this manual as any unauthorized disassembly will invalidate the warranty.

•

NEVER obstruct the output port nor the scavenging connector outlet.

•

DO NOT use the Oxygen Flush function to provide positive pressure ventilations to a non-breathing patient.

eAdvantage User Manual

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After use, always turn OFF the cylinders and ensure that gas cylinders with sufficient volume are attached before returning the unit to its normal storage position.

•

Medical gases must be dry and free from dust and oil. A malfunction in the medical gas pipeline will cause this device to stop working.

•

This device and its associated breathing system are compatible for use with N2O and O2.

•

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® N2O/O2 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.

2.2 Environment of Use The device is suitable for use in hospitals, medical, dental and doctor’s offices, where short-term or intermittent inhalation analgesia is required for a wide range of procedures.

2.3 Contraindications The contraindications for this device include, but may not be limited to: • Hypersensitivity to the medication • Head injuries with impaired consciousness • Maxillofacial injuries • Artificial, traumatic or spontaneous pneumothorax • Air embolism • Middle ear occlusion, ear infection • Decompression sickness • Abdominal distension / intestinal obstruction Note: Nitrous oxide/oxygen (N2O/O2) mixtures must never be used in any condition where air is trapped in the body and expansion (up to 3x original size) would be dangerous. For example, it will exacerbate a pneumothorax and increase pressure in any intracranial air. Air in any other cavities such as the sinuses, middle ear and abdomen may also expand.

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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 (N2O/O2), on demand flow to spontaneously breathing, conscious patients via a unique patient circuit with monitoring line.

Note: This device shall be used by the patient under the guidance of qualified personnel trained in its use.

Intended Patient Population:

Conscious, spontaneously breathing patients who are able to comprehend the activity, understand verbal commands and selfadminister the set analgesic gas mixture.

3.2 Principles of Operation

The eAdvantage® System utilizes variable flow control and measurement to deliver accurate concentrations of N2O/O2 from pressurized and regulated gas supplies (either cylinder or pipeline) at flow rates equivalent to that demanded by the patient. Two input connectors are provided on the device for the connection of pressure regulated gas sources of nitrous oxide and oxygen. The device has only one control for turning ON or OFF as well as adjusting the setting selections. When it is turned ON, and the device auto-calibration is completed, the display changes to the operation screen with Demand Flow mode set at 50%-50% mixture as the default setting. The gas mixture output can be selected on the screen from a range of percentages from 0%/100% (N2O/O2) to 70%/30% (N2O/O2) in 5% increments. The gas specific built-in alarm systems will generate both visual and audible alarms should either the nitrous oxide or oxygen input pressure fall below 45 PSI, and the device will be automatically shut OFF should the oxygen input pressure fall below 21 PSI. An oxygen flush function allows the healthcare professional to provide a constant flow of 100% oxygen to the patient.

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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 P

O N

A

M

B

L K C

J D

I E

F

G

H

A

Green LED for battery operation indicator

I

Output Connection

B

N2O Input Connection

J

LED Confirmation Indicator

C

Power Input Connection

K

Control Knob

D

USB Connection

L Cancel Key

E

Alarm Buzzer

M Audio Paused Key

F

Green LED indicator for AC power

N Oxygen Flush Key

G H

Orange LED indicator for battery charging Airway pressure monitoring port

eAdvantage User Manual

O Oxygen Input Connection P LCD Screen

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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 confirming the setting selection (by depressing the knob). Cancel Key (L): Pressing the Cancel Key will cancel the current selection stage to go back to the previous stage until the main screen with no selection is reached. Audio Paused key (M): The eAdvantage® is equipped with an Audio Paused key to silence the Audible Alarm for 2 minutes. The Audio paused function will be activated any time the Audio Paused key is depressed even without an active alarm. Oxygen Flush key (N): The eAdvantage® is equipped with the ability to manually deliver a constant flow of 40 L/min of 100% oxygen as long as this key is pressed.

3.5 LED Indicators Green LED – Continuously illuminated when unit is ON and flashes when unit is OFF. Green LED – Continuously illuminated when unit is connected to an external power source during both ON and OFF phases. Orange LED – Continuously illuminated when unit is charging and OFF when battery is fully charged during both ON and OFF phases. During OFF state this light will start flashing when battery capacity drops to around 60%. Green LED – Continuously illuminated when the unit is operated using the internal battery.

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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.

NOTE:

Offers useful tips to assist in the proper use of the equipment. Keep away from open flames. No smoking around mixer.

IPX2

Ingress protection rating: “Dripping Water”. Do not immerse. Type BF applied part complying with the specified requirements of IEC60601-1 to provide a higher degree of protection against electric shock. Separate selection for waste of electrical and electronic components Read the User Manual before use. Demanded flow delivery during Patient effort. Return for Service Audio paused Caution: Federal law restricts this device to sale by or on the order of a physician

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4. PREPARATION FOR USE 4.1 Component List

Ensure that all the following components have been received: 1. 2. 3. 4. 5. 6. 7.

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.

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 specified 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. (Fig. 1)

Note: Power supply cords are available for most countries. Please specify the country of use at time of purchase.

Should external power be lost, the device will automatically switch to internal battery power (providing the battery is charged) and the green battery LED on the left of the front panel will illuminate.

WARNING

Do not place this device in a position that limits access to the mains power inputs.

4.2.2. Installing / replacing the battery

The battery is inserted into the battery compartment on the right side of the device by unscrewing the yellow/black knob anti-clockwise and allowing the compartment door to open.

WARNING

The replacement of lithium batteries by personnel not specifically trained in the use of this device may be hazardous.

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Yellow/black knob

Connector Insert the battery with the connector on the right hand side.

WARNING

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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.

•

The use of batteries, other than those specified, may cause the mixer to fail and/or endanger the patient and operator.

•

Connect the mixer to an external electrical source right away if the “Battery Empty” alarm is triggered.

4.2.3. Connecting the gas supply hoses

The eAdvantage® mixer is designed to operate on medical nitrous oxide and oxygen from either pressure regulated medical gas cylinders or “piped-in” systems. The entrance fittings on the device are non-interchangeable fittings specifically for nitrous oxide and oxygen. The device is designed to operate between 50 – 70 PSI (3.5 - 4.8 Bar) input pressures for both N2O and O2 gas supplies. The nitrous oxide supply hose provided shall be attached to the N2O input connection on the left side (when facing the device). The oxygen supply hose provided shall be attached to the O2 input connection on the right side of the device. Tighten the supply hoses.

WARNING

“Finger tight” only – DO NOT USE A WRENCH (Fig. 1).

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1 Attach the N2O input hose here. 2 Attach the O2 input hose here.

3 Attach a new patient circuit and monitoring line to the device here

4 Insert power 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.

Note: Power supply cords are available for most countries. Please specify the country of use at time of purchase. Should external power be lost, the device will automatically switch to internal battery power (providing the battery is charged) and the green battery LED on the left of the front panel will illuminate.

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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.

Remove the plug and connect to the monitoring line connection port.

Fig. 2

WARNING

The use of patient circuits, other than those approved by the manufacturer, may interfere with the correct operation of this device. Therefore, the use of non-approved circuits with this device will void the product warranty.

WARNING

NEVER obstruct the output port nor 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.

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4.3 Functional Checks Prior to Introduction into Service Along with the contents of the shipping cartons you will require the following items to enable you to undertake the functional check prior to introduction of the device into service: 1.

Nitrous oxide and oxygen pressure sources with 50-70 PSI output capable of providing a minimum of 100 L/min at no less than 45 PSI (3.1 Bar).

2.

Vacuum generator with a minimum 30 L/min flow 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 N2O and O2 Gas sources. Using a mild soap solution, spray the input connections (B and O) to check for leaks. If any leak is present, tighten the connection and re-test. Once no leakage is confirmed, turn the device ON.

Note: Connections should be “finger tight” only. 4.3.2. Output Leak test The eAdvantage® is equipped with leak detection feature which will notify the User if a leak is detected inside the device. It is recommended to perform this test before introduction into service: Connect one gas at a time to the corresponding input connection, spray the other input connectors, no bubbles should be observed coming from either the other connection or the output connector (I). Testing of the Individual Features of eAdvantage® System The following features can be individually tested or measured using a calibrated pressure gauge and flowmeter during the pre-use Functional Checks: 4.3.3. Demand Function Apply a vacuum to the patient connector equivalent to a flow rate of 30 L/ min for a minimum of 1 second. The mixer will provide a flow rate equivalent to that demanded. Remove the vacuum from the patient connector; the flow from patient connector should stop.

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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. With the adjustable outlet pressure regulator set with an outlet pressure of 50 PSI, gradually reduce the outlet pressure of the regulator to around 45 PSI while slowly releasing the gas from the device until the audible and visual Low Input Pressure Alarm is activated. 4.3.5. Low Input Pressure Shut OFF Continue to decrease the oxygen regulator outlet pressure to around 20 PSI, the device should automatically shut OFF. 4.3.6. Oxygen Flush key When pressed with the ON/OFF switch set to ON, oxygen should flow from the patient circuit. 4.3.7. Oxygen Concentration If required, the oxygen concentration of the delivered gas can be determined by: A. Connecting an oxygen monitor to the output connection of the eAdvantage® using a T-Connector. B. Utilizing a 1 Liter calibrated syringe connected to the output of the eAdvantage®, draw 5 full breaths (1 Liter each) from the unit. C. Check the corresponding reading of the oxygen percentage, ensure the reading falls within +/- 5 % V-V of the preset value.

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4.4 Pre-use Checklist When the device is turned ON it will undertake an internal selfdiagnostic 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 to take place

5. OPERATING INSTRUCTIONS 5.1 Start-up and Calibration To start the eAdvantage®, press the Control Knob (K) for 1 second, the associated green LED (J) will commence flashes at a high frequency. After 1 second, the eAdvantage® will turn ON and begin the calibration process. A calibration progress bar will be displayed commencing from the left to the right of the screen. The calibration process takes 5 seconds.

Once calibration is completed, the display changes to the operation screen. Demand flow mode is the default mode during start up. The screen will display the concentration of each gas (with 50%-50% mixture as the default setting), the time, battery status and lock status as shown below:

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eAdvantage User Manual

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: 1.

O2 Valve Failure.

2.

N2O Valve Failure.

3.

O2 Flow Sensor Failure.

4.

N2O Flow Sensor Failure.

5.

U12 (Paw) Sensor Failure.

6.

U13 (O2 input pressure) Sensor Failure.

7.

U14 (N2O input pressure) Sensor Failure.

Instead, a new screen will display the cause of the malfunction and request the mixer to be checked or returned for service. At the same time a continuous Audible Alarm will sound.

The above failures will be saved in the events log under specific failure as listed in “Stored History” section If multiple failures were detected the mixer will switch between the messages related to the failures.

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5.2 Selecting the Gas Concentration To select (or make changes to) the device settings, rotate the Control Knob (K) and a frame will move around the selected figures 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. To change the gas concentration, rotate the Control Knob (K) until selection frame surrounds the gas mixture display on the screen as shown below: Press the Control Knob (K) to activate the selection. At this point the percentages of both O2 and N2O will commence flashing indicating that a change is being initiated. Note: The setting change will be automatically cancelled if no change is made within 10 seconds. The Cancel Key (L) can be also used to exit this mode prior to making any changes.

Rotate the Control Knob (K) to change the concentration as listed below: 0/100, 5/95, 10/90, 15/85, 20/80, 25/75, 30/70, 35/65, 40/60, 45/55, 60/40, 65/35, 70/30.

Note: The unit offers 3 settings of concentrations which can be preset by the manufacturer or an authorized distributor. The full range as mentioned above, fixed 50/50% of each gas or a maximum of 50% of nitrous oxide gas according to local protocol or customer request.

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eAdvantage User Manual

Press Control Knob (K) to confirm selection. Once confirmed, the 2 numbers stop flashing 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. Note: When the lock is activated the mixer will not permit changes to the selected concentration and will inactivate the Setting mode and Oxygen Flush function.

To activate the lock feature, rotate the Control Knob until the selection frame surrounds the lock symbol as shown below:

Press the selection knob (K) to activate the selection. At this point the symbol changes from solid to flashes accompanied by a color change from light grey to yellow.

Rotating the Control Knob (K) in either direction will result in changing the symbol from lock to unlock or vice versa. Press Control Knob (K) to confirm selection. Once confirmed, a 3-digit passcode will appear. The default passcode number shipped with each unit is 000. Users may change the passcode in the setting mode (see section 5.6). To unlock the screen, repeat the same steps required to lock the screen.

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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.

A. 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. B. Press the Control Knob (K) to confirm the selection. C. Once confirmed the screen will change to the setting page with a solid reversed color “Date & time” window as shown below.

D. Rotate the Control Knob (K) in either direction and the solid color frame will move between the 5 setting selections until the desired selection is reached. Press Control Knob (K) to confirm selection.

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eAdvantage User Manual