Fisher & Paykel AIRVO™ 2 User Manual

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 via various patient interfaces. It is intended for patients who benefit from high-flow warmed and humidified respiratory gases, including those with bypassed upper airways. Flow rates range from 2 to 60 L/min, depending on the patient interface. The AIRVO 2 is for use in hospitals and long-term care facilities. USA Federal Law restricts this unit for sale by or on the order of a physician.

Warnings

• Nasal delivery of respiratory gases generates flow-dependent positive airway pressure (PAP). Consider this where PAP may adversely affect a patient.
• The unit is not intended for life support.
• To avoid burns: Use only specified interfaces, water chambers, and breathing tubes. Prolonged use of the breathing tube or interface may cause injury, including infection. Read warnings in the "Oxygen" section before using oxygen. Never operate the unit if the heated breathing tube is damaged (holes, tears, kinks), if it is not working properly, or if case screws are loose. Do not block airflow. Ensure adequate ventilation around the unit. Do not block air openings or place on soft surfaces where the filter area may be blocked. Keep air openings clear of lint and hair.
• To avoid electric shock: Do not store or use where the unit can fall into water. If water enters the unit, disconnect the power cord and discontinue use. Never operate if dropped, damaged, has a damaged power cord/plug, or has been dropped into water. Avoid unnecessary power cord removal; hold the connector when removing. Return the unit for service/repair if damaged.
• To avoid choking or foreign object inhalation: Ensure an air filter is fitted. Never drop or insert objects into openings or tubes.
• Miscellaneous: Do not use above 30°C (86°F) or below 10°C (50°F) as the unit may switch off. Humidity output is compromised below 18°C (64°F) and above 28°C (82°F). Not suitable for use with flammable anesthetic mixtures.

2. Setting up AIRVO 2

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).

2.2 Install Water Chamber

1. Remove blue port caps from the chamber by pulling the tear tab upwards. Remove the bracket holding the water supply tube.
2. Fit the supplied adapter over the two vertical ports on the chamber. Push on fully, then clip the water supply tube into position.
3. Fit the water chamber to the unit by pressing the finger guard down 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.
• The water in the chamber becomes hot during use. Exercise caution when removing and emptying.
• Do not touch the heater plate, water chamber, or chamber base during use.
• When handling the unit with the water chamber, avoid tilting to prevent water entering the unit. Empty all water before transporting.

Cautions

• For optimal therapy (MR290 only): Do not use the auto-fill MR290 chamber if dropped or run dry with the "water out" alarm activated.

2.3 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 fill automatically to the required level and maintain it until the bag is empty. Ensure the water chamber and/or water bag do not run out of water for continual humidification. Check that water flows into the chamber and stays below the fill line. If the level rises above, replace the chamber immediately.

MR290 Flow vs. Usage Time (2-litre sterile water bag)

2.4 Install Heated Breathing Tube

One end of the heated breathing tube has a blue plastic sleeve. Lift the sleeve and slide the connector onto the unit. 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 (e.g., covering with a blanket, heating in an incubator) 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 signal interference.

2.5 Select Patient Interface

The AIRVO 2 can be used with various patient interfaces. Refer to separate user instructions for each interface. The table below shows compatible interfaces and their settings.

• Nasal Cannula: OPT842 (Small), OPT844 (Medium), OPT846 (Large)
• Tracheostomy Interface: OPT870
• Mask Interface Adapter: RT013 (with mask) - for vented masks only. Do not use sealed masks.
• Junior Mode Interfaces: OPT316 (Infant), OPT318 (Pediatric)

Target Dew-Point Temperature and Target Flow Settings

Low ambient temperatures may prevent reaching 37°C at high flow settings. Consider decreasing the target flow.

Warnings

• Do not modify the breathing tube or interface.
• Do not use unlisted patient interfaces.

3. Using AIRVO 2

3.1 Switch On Unit

Plug the unit's power cord securely into the mains power supply and the unit. Ensure the unit is dry before plugging in. Press the On/Off button to switch on.

3.2 Check Disinfection Status

The unit displays its disinfection status. "Safe for use on a new patient" indicates it has been cleaned and disinfected.

3.3 Warm-Up

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

3.4 Junior Mode

For Optiflow Junior nasal cannulas (OPT316/OPT318), activate Junior Mode. This limits target settings to 34°C and 2-25 L/min (1 L/min increments). To activate: Hold the Mode button for 5 seconds. Target settings change automatically; colorful icons indicate Junior Mode. To deactivate: Hold the Mode button for 5 seconds.

3.5 Configure Target Settings

Target Dew-Point Temperature

Press the Mode button to view settings. Settings are locked by default. You can set the AIRVO 2 to 37°C (98.6°F), 34°C (93°F) [for compliance issues], or 31°C (88°F) [for face masks only]. Settings may be limited based on configuration or Junior Mode. The unit returns to 37°C after disinfection. To change settings: Hold Up and Down buttons for 3 seconds to unlock. An arrow shows accessible settings. Press Up/Down to choose. Press Mode to lock again.

Transport Mode

Activate by holding the "Audio pause" button for 5 seconds on the temperature setting screen. Enters low-power, low-humidity mode for 20 minutes for patient transport. Refer to REF 185048130 for details. Deactivate by holding the "Audio pause" button for 5 seconds.

Target Flow

Press Mode to advance. Set flows between 10-60 L/min (1 L/min increments for 10-25 L/min, 5 L/min increments for 25-60 L/min). Settings may be limited by Junior Mode or configuration. The unit remembers the last flow setting. To change: Follow the same unlock/lock sequence as for temperature.

3.6 Oxygen

Connect supplementary oxygen (up to 60 L/min) to the AIRVO 2's oxygen inlet port. The unit has an oxygen analyzer. Use continuous monitoring for patients prone to desaturation.

Warnings

• Oxygen use increases fire risk. Keep ignition sources away. Do not smoke or use near open flames. Ensure ventilation.
• Keep oil, grease, or greasy substances away from oxygen equipment.
• Ensure the AIRVO 2 is on before connecting oxygen.
• Connect oxygen only via the dedicated inlet port. Ensure the port and filter holder are properly fitted. Secure the power cord connector.
• Do not connect more than 60 L/min O₂.
• Oxygen concentration can be affected by flow setting, oxygen setting, patient interface, or obstructions.
• Turn off oxygen source and remove from inlet port when finished. Do not allow oxygen to build up in the device.
• The oxygen analyzer uses ultrasonic measurement and requires no calibration. Use only with pure oxygen; other gases will cause incorrect function.

Connect Oxygen

Connect the oxygen source output to the unit's oxygen inlet port. Push the oxygen tube firmly onto the port.

Adjust Oxygen

Adjust oxygen source level until the desired oxygen fraction is displayed. The reading may take minutes to stabilize. Set between displayed min/max values. If oxygen fraction exceeds 95%, the reading pulses red and the device beeps.

Warnings

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

Press Mode to return to the Summary screen.

3.7 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, adjusting oxygen as needed. The air will feel warm initially, which is normal. The patient should breathe normally.

3.8 During Use

If the "Ready for use" symbol is displayed for 1 minute with no button presses, a screensaver activates. If excess condensate forms in the heated breathing tube, drain it by lifting the patient end of the tube, allowing condensate to run into the water chamber.

3.9 After Use

Switch off the unit by pressing the On/Off button.

4. Alarms

The AIRVO 2 has visual and auditory alarms for treatment interruptions. An intelligent alarm system processes sensor data and target settings against pre-programmed limits.

Alarm Signals

• Visual Alarm: Displays a message indicating an alarm condition.
• Auditory Alarm: 3 beeps every 3 seconds, repeating every 5 seconds.
• Audio Pause Button: Mutes auditory alarms for 115 seconds. Press again to reactivate.

Alarm Conditions

All alarms are "Medium Priority." Simultaneous alarms display the highest priority. The table below lists alarms, causes, solutions, and delays.

Alarm Limits

Most limits are pre-programmed but can be changed by authorized personnel. Changes are preserved after power loss.

Warnings

Alarm presets on different units in the same area can create hazards. Extreme values can render the alarm system useless.

Checking Alarm System Functionality

Check functionality anytime the unit is on. Remove the heated breathing tube; "Check tube" visual and auditory alarms should sound. If absent, do not use the unit; contact Fisher & Paykel Healthcare.

Auditory Information Signals

• Ascending sequence of 5 tones: "Ready for use" symbol appeared.
• Ascending sequence of 3 tones: Junior Mode activation/deactivation.
• Single tone every 5 seconds: Measured oxygen level > 95%, OR Measured oxygen level > 32% at turn-off.

5. Technical Information

Symbol Definitions

• Caution: Consult accompanying documents.
• Type BF Applied Part: Protection against electric shock.
• Hot Surfaces: Do not touch.
• IPX1: Drip Proof.
• ATTENTION: Do not throw away.
• Alternating Current: Power symbol.
• Class II Double Insulated: Protection against electric shock.
• Power On/Off (Standby): Power button.
• CE 0123: CE marking with notified body number.
• 93/42/EEC Class lla: Medical device classification.

Product Specifications

• Dimensions: 295 mm x 170 mm x 175 mm (11.6" x 6.7" x 6.9")
• Weight: 2.2 kg (4.8 lb) unit only; 3.4 kg (7.5 lb) packaged with accessories.
• Humidity: >33 mg/L at 37°C target; >10 mg/L at 34°C target; >10 mg/L at 31°C target.
• Maximum temperature of delivered gas: 43°C (109°F).
• Supply frequency: 50-60 Hz.
• Supply voltage/current: 100-115 V 2.2 A (2.4 A max); 220-240 V 1.8 A (2.0 A max).
• Sound pressure level: Alarms exceed 45dbA @ 1m.
• Auditory alarm pause: 115 seconds.
• Serial port: For downloading product data using F&P Infosmart™ software.
• Maximum flow range (default): 10-60 L/min.
• Maximum flow range (Junior Mode): 2-25 L/min.
• Maximum oxygen input: 60 L/min.
• Warm-up time: 10 mins to 31°C (88°F), 30 mins to 37°C (98.6°F) using MR290 chamber at 35 L/min and 23°C (73°F) starting temp.
• Oxygen analyzer accuracy: < ± (2.5% + 2.5% of gas level) within 25-95% O₂.
• Operating conditions: 18-28°C (64-82°F), 30-70% RH.

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
• IEC 60601-1-2 (Electromagnetic compatibility)

Accessory equipment connected to the serial port must be certified to IEC 60601-1 or IEC 60950-1. Configurations must comply with IEC 60601-1-1. Consult technical services if unsure.

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 electronics disposal guidelines (WEEE directive).
• Consumables Disposal: Place interface, breathing tube, and chamber in a waste bag at end of use. Hospitals should discard according to their standard method for disposing of contaminated product.