Fisher & Paykel AIRVO 2 User Manual

Before You Start

This User Manual is intended for healthcare professionals. It applies to AIRVO™ 2 units with a manufacturing date after 2016-08-04.

Read this manual, including all warnings. Failure to do so may result in injury. Keep it in a safe place for future reference.

Before first use, the AIRVO 2 must be set up according to the AIRVO 2 Technical Manual.

Some accessories may not be available in all countries. Contact your local Fisher & Paykel Healthcare representative for more information.

Other References

• Refer to the AIRVO 2 User Manual for detailed instructions for use.
• Refer to all relevant accessory User Instructions.
• Watch training videos at www.fphcare.com/airvo.
• For troubleshooting, refer to the AIRVO 2 Technical Manual.
• Download the AIRVO 2 Simulator App to learn how to use the device. Available on the Apple, Google Play, and Windows App stores.
• Visit the Fisher & Paykel education & resources website at www.fphcare.com/education for online courses and training events.
• If the unit is used by multiple patients, it must be cleaned and disinfected between patients according to the Disinfection Kit Manual (900PT600).
• For further assistance, contact your Fisher & Paykel Healthcare representative.

1. Overview

The AIRVO 2 is a humidifier with an integrated flow generator that delivers high-flow warmed and humidified respiratory gases to spontaneously breathing patients through various patient interfaces.

Intended Use

The AIRVO 2 is for the treatment of spontaneously breathing patients who benefit from high-flow warmed and humidified respiratory gases, including those with bypassed upper airways. Flow can range from 2 - 60 L/min depending on the patient interface. The AIRVO 2 is intended for use in hospitals and long-term care facilities.

The AIRVO 2 provides respiratory support through a nasal cannula interface, promoting slower, deeper breathing and increasing alveolar ventilation. For patients with nasal cannula or tracheostomy interfaces, it provides airway hydration and may be used with supplemental oxygen.

Warnings

• The unit is not intended for life support.
• Appropriate patient monitoring must be used at all times. Loss of therapy will occur if power is lost.
• Nasal delivery of respiratory gases generates flow-dependent positive airway pressure (PAP). This must be considered where PAP could have adverse effects on a patient.

To avoid burns:

• Use only interfaces, water chambers, and breathing tubes specified in this user manual.
• Using the breathing tube or interface for longer than the specified time can result in serious injury, including infection.
• Before using oxygen, read all warnings in the "Oxygen" section.
• Never operate the unit if: the heated breathing tube is damaged, it is not working properly, or case screws have been loosened.
• Do not block the flow of air through the unit and breathing tube.
• Ensure the unit is positioned where ventilation is not restricted.
• Never block air openings or place the unit on soft surfaces where the filter area may be blocked. Keep air openings free of lint and hair.

To avoid electric shock:

• Do not store or use the unit where it can fall or be pulled into water. If water enters the unit, disconnect the power cord and discontinue use.
• Never operate the unit if it has been dropped, damaged, has a damaged power cord, or has been dropped into water.
• Avoid unnecessary removal of the power cord. If removal is necessary, hold the connector during removal.
• Return the unit to an authorized service center for examination and repair, except as outlined in this manual.

To avoid choking, or inhalation of a foreign object:

• Ensure an air filter is fitted when operating the unit.
• Never insert any object into any opening or tube.

Miscellaneous:

• Humidity output may be compromised below 18°C (64°F) and above 28°C (82°F).
• The unit is not suitable for use with flammable anesthetic mixtures with air or oxygen or nitrous oxide.
• Prior to each patient use, ensure the auditory alarm is audible by conducting the alarm system functionality check described in the Alarms section.

2. Setting Up AIRVO 2

1. Before You Begin

The AIRVO 2 should be fixed on a pole mounting tray (900PT405) below patient head height. Open the packaging of the tube & chamber kit (heated breathing tube, MR290 auto-fill chamber, and adapter).

2. Install Water Chamber

Remove blue port caps from the chamber. Remove the bracket holding the water supply tube. Fit the supplied adapter over the two vertical ports on the chamber and push on fully. Clip the water supply tube into position.

Fit the water chamber to the unit by pressing the finger guard and sliding the chamber on, aligning with the blue chamber port ends. Push firmly until the finger guard clicks.

Warnings

• Do not start the unit without the water chamber in place.
• Do not touch the heater plate, water chamber, or chamber base during use. The water becomes hot. Exercise caution when removing and emptying the chamber.

Cautions

• When handling the unit with the water chamber, avoid tilting to prevent water entering the unit. Empty the chamber before transporting.
• For optimal therapy (MR290 only): Do not use the auto-fill MR290 chamber if dropped or allowed to run dry, as this could lead to overfilling.

3. Connect Water Bag

Attach the sterile water bag to the hanging bracket 20cm (8") above the unit. Push the bag spike into the fitting at the bottom of the bag. Open the vent cap on the bag spike. The chamber will automatically fill and maintain the level until the bag is empty.

Ensure the water chamber and/or water bag are never allowed to run out of water for continual humidification.

Check that water flows into the chamber and stays below the maximum water level line. If the level rises above, replace the chamber immediately.

Cautions

• For optimal therapy (MR290 only): Do not use the MR290 chamber if the water level rises above the maximum water level line, as this may lead to water entering the patient's airway.

4. Install Heated Breathing Tube

Attach the heated breathing tube to the unit. Lift the blue plastic sleeve, slide the connector onto the unit, and push the sleeve down to lock.

Warnings

• Do not modify the breathing tube or interface.
• Do not allow the breathing tube to contact skin for prolonged periods.
• Adding heat to the breathing tube (e.g., covering with a blanket) can cause serious injury.
• Do not use insulating sleeves or accessories not recommended by Fisher & Paykel Healthcare.

Cautions

• Position the heated breathing tube away from electrical monitoring leads (EEG, ECG/EKG, EMG) to minimize interference.

5. Select Patient Interface

The AIRVO 2 can be used with various patient interfaces. Refer to the separate user instructions for each interface.

Nasal Cannula: Optiflow™™+, OPT942, OPT944, OPT946; Optiflow™™, OPT842, OPT844, OPT846; Optiflow™™ Junior, OPT316, OPT318.

Tracheostomy Interface: Optiflow™™+, OPT970; Optiflow™™, OPT870.

Mask Interface Adapter: OPT980 / RT013 (with mask). Note: The OPT980/RT013 Mask Interface Adapter is for vented masks only. Do not use sealed masks.

The following table shows target dew-point temperature and target flow settings for different interfaces:

Low temperature ambient conditions may prevent the unit from reaching a 37°C target temperature setting at high target flow settings. In these cases, consider decreasing the target flow setting.

At altitude, maximum achievable flow rates may be lower than those in the table by 5 L/min per 1000 m (3000 ft).

Warnings

• Do not modify the breathing tube or interface in any way.
• Do not use any patient interfaces not listed here.

3. Using AIRVO 2

1. Switch On Unit

Plug the unit's power cord into a mains/utility power socket. Ensure the connector is well secured to the rear of the unit. Switch on the unit using the On/Off button.

Warnings

• Ensure the unit is dry before plugging it in.

2. Check Disinfection Status

The unit indicates if it is safe for use on a new patient:

• Green indicator: This AIRVO 2 is safe for use on a new patient.
• Yellow indicator: This AIRVO 2 has not been cleaned and disinfected since last use.
• Red indicator: This AIRVO 2 is NOT safe for use on a new patient.

3. Warm-Up

The unit warms up, displaying current output dew-point temperature, flow, and oxygen values. These numbers pulse until they approach their target settings. This screen is the "Summary screen".

4. Junior Mode

If using an Optiflow Junior nasal cannula (OPT316/OPT318), activate Junior Mode. This limits target settings to 34°C and 2-25 L/min (in 1 L/min increments).

To activate Junior Mode: Hold the Mode button for 5 seconds. The target settings will change automatically. Colorful icons indicate Junior Mode.

To deactivate Junior Mode: Hold the Mode button for 5 seconds.

5. Configure Target Settings

Press the Mode button to view target settings. These are locked by default.

Target Dew-Point Temperature

You can set the AIRVO 2 to three target dew-point temperatures:

• 37°C (98.6°F)
• 34°C (93°F) [if compliance at 37°C is a problem]
• 31°C (88°F) [for face masks only]

Access to all settings may be limited if the unit is in Junior Mode (limited to 34°C) or if initially set up with tighter limits. The AIRVO 2 returns to the default 37°C after every disinfection cycle.

To change the target dew-point temperature setting:

1. Hold the Up and Down buttons for 3 seconds to "unlock" the setting. A lock symbol disappears and is replaced by an arrow showing minimum and maximum settings.
2. Press Up and Down buttons to choose the new setting.
3. Press the Mode button to "lock" the setting again. The lock symbol reappears.

Target Flow

You can set the AIRVO 2 to flows between 10 L/min and 60 L/min (in 1 L/min increments for 10-25 L/min, and 5 L/min increments for 25-60 L/min). Access may be limited in Junior Mode (2-25 L/min) or with tighter initial limits.

The AIRVO 2 remembers its target flow setting when switched off.

To change the target flow setting: Follow the same steps as for changing the target dew-point temperature.

Oxygen

Supplementary oxygen can be connected to the AIRVO 2 (up to 60 L/min). The unit has an oxygen analyzer to help determine the delivered oxygen fraction. Your unit may have tighter initial limits.

Use continuous oxygen monitoring for patients who may desaturate if oxygen supply is interrupted.

Warnings

• Take special care to reduce fire risk when using oxygen. Keep ignition sources away from the unit and preferably out of the room. Do not smoke or use near open flames. Ensure adequate ventilation.
• Oil, grease, or greasy substances contacting oxygen under pressure can cause spontaneous and violent ignition. Keep these away from all oxygen equipment.
• Ensure the AIRVO 2 is switched on before connecting oxygen.
• Connect oxygen only through the special oxygen inlet port on the back of the unit. Ensure the port, filter holder, and power cord connector are properly fitted.
• Do not connect supplementary oxygen at flow rates higher than the AIRVO 2 target flow rate. Excess oxygen will be vented.
• The delivered oxygen concentration can be affected by changes in flow setting, oxygen setting, patient interface, or if the airpath is obstructed.
• When finished, turn off the oxygen source and remove it from the inlet port. Turn off oxygen flow when the unit is not operating to prevent oxygen buildup.
• The AIRVO 2 oxygen analyzer uses ultrasonic technology and does not require in-field calibration. It is designed for pure oxygen; other gases will cause incorrect function.

Connect Oxygen

Connect the oxygen source output to the oxygen inlet port on the side of the unit. Push the oxygen tube firmly onto the port.

Adjust Oxygen

Adjust the oxygen source level until the desired oxygen fraction is displayed. Readings may take several minutes to stabilize. The oxygen fraction can be set between the displayed minimum and maximum values.

Real-time O₂ measurement is displayed when O₂ is between 25% and 95%. Fractions below 25% and above 95% are displayed as 21% and 100% respectively.

If the oxygen fraction exceeds 95%, the reading pulses red, and the device beeps.

Warnings

• If the patient's peak inspiratory demand exceeds the unit's flow, the inspired oxygen fraction will be lower than displayed due to ambient air entrainment.
• Check that suitable blood saturation levels are achieved at the prescribed flow.

6. Connect Your Patient

Wait for the "Ready for use" symbol on the Summary screen. Connect the patient interface to the heated breathing tube. Monitor flow and oxygen values on the Summary screen. Adjust oxygen from the source as needed. The air will feel warm initially; this is normal. The patient should breathe normally through the nose/mouth or tracheostomy.

7. During Use

If the "Ready for use" symbol is displayed for 2 minutes with no button presses, a screensaver will launch.

Condensate Management

Place the unit below head height and flat to allow condensate to drain towards the water chamber, away from the patient.

If excess condensate forms in the heated breathing tube, disconnect the patient interface, lift the patient end of the tube to drain condensate into the water chamber.

At higher target flow rates, reduce the target flow to 30 L/min or below to ensure condensate drains into the chamber.

Minimize local cooling sources acting on the heated breathing tube (e.g., fans, air conditioning). If condensate persists, consider lowering the target temperature, which will decrease humidity output and condensation.

8. After Use

Switch off the unit using the On/Off button.

ALARMS

The AIRVO 2 has visual and auditory alarms to warn of treatment interruptions. An intelligent alarm system processes sensor and target setting information against pre-programmed limits.

Alarm Signals

• Visual alarm signal: Indicates an alarm condition.
• Audio paused: Indicates the audio alarm is paused.

Auditory Alarm Signal

3 beeps in 3 seconds, repeated every 5 seconds. Press the button to mute the auditory alarm for 15 seconds. The alarm can be reactivated by pressing the button again.

Alarm Conditions

All alarms are assessed as "Medium Priority" for operator proximity within 1 meter. The unit uses an internal priority-ranking system. If multiple alarms occur, the highest priority alarm is displayed.

The following table lists alarm conditions from highest to lowest priority, with causes, solutions, and delays. Alarms affecting oxygen delivery require immediate response to assess patient saturation. Alarms affecting humidity delivery require prompt response to assess potential mucus drying and blockages.

Alarm Limits

Most alarm limits are pre-programmed. Exceptions are listed below. Authorized personnel can change these limits.

Warnings: Hazard exists if different alarm presets are used in the same area (e.g., intensive care unit). Extreme alarm limits can render the system useless.

Checking Alarm System Functionality

Remove the heated breathing tube. You should see the "Check tube" visual alarm and hear the auditory alarm. If either is absent, do not use the unit. Refer to the AIRVO 2 Technical Manual for troubleshooting. Contact Fisher & Paykel Healthcare representative if problems persist.

Auditory Information Signals

Auditory information signals are provided:

4. Reprocessing

The AIRVO 2 must be cleaned and disinfected between patients per the Disinfection Kit Manual (900PT600). This should be done as soon as possible after use. The unit uses warmed water and can pose a risk of bacterial colonization and infection if procedures are not followed.

Follow standard aseptic techniques to minimize contamination, including proper hand washing, avoiding contact with connection ports, safe disposal of consumables, and suitable storage after cleaning and disinfection.

Schedule for Changing Accessories

Accessories must be changed frequently to avoid infection risk. Replace parts immediately if damaged or discolored; otherwise, replace within the periods shown:

Filter Replacement

After 1000 hours of operation, a prompt will appear to change the air filter. Follow these steps:

1. Take the filter holder from the back of the unit and remove the filter.
2. Replace the old filter with a new filter (900PT913).
3. Reattach the filter holder to the unit, clipping the bottom in first, then rotating upwards until the top clips into place.
4. Press Mode to move to the "Replace now" screen.
5. Press Up to select "Now".
6. Press Mode to confirm. The hours counter resets to zero.

If "Later" is chosen, the prompt will reappear at subsequent disinfection cycles.

Servicing

This device has no internal serviceable parts. AIRVO 2 humidifiers do not require routine servicing or calibration. Refer to the AIRVO 2 Technical Manual for external spare parts.

5. Technical Information

Symbol Definitions

Caution: Consult accompanying documents.

Type BF Applied Part.

Hot Surfaces.

IPX1: Drip Proof.

ATTENTION.

Do not throw away.

Alternating Current.

Class II, Double Insulated.

Power On/Off (Standby).

CE 0123

93/42/EEC Class IIa.

Product Specifications

Designed to conform to the requirements of: IEC 60601-1, UL 60601-1, CSA C22.2/No. 601.1, AS 3200.1.0, EN 60601-1, ISO 8185.

The unit complies with electromagnetic compatibility requirements of IEC 60601-1-2. If interference occurs, try moving the unit, the interfering equipment, or consult your healthcare provider.

Accessory equipment connected to the serial port must be certified to IEC 60601-1 or IEC 60950-1. All configurations must comply with IEC 60601-1-1. If unsure, consult the technical services department or your local representative.

Operating Conditions

• Ambient temperature: 18-28 °C (64-82 °F)
• Humidity: 10-95% RH
• Altitude: 0-2000 m (6000 ft)
• Mode of operation: Continuous operation

Storage and Transport Conditions

Store and transport in environmental conditions of -10 °C to 60 °C (14 °F to 140 °F), 10 to 95% RH, non-condensing.

Disposal Instructions

• Unit Disposal: Contains electronics. Do not discard with regular waste. Return to Fisher & Paykel Healthcare or dispose according to local guidelines for electronics. Dispose according to the WEEE directive.
• Consumables Disposal: Place interface, breathing tube, and chamber in a waste bag. Hospitals should discard according to their standard method for disposing of contaminated product.