Fisher & Paykel AIRVO™ 2 User Manual
Brand: Fisher & Paykel Healthcare
This manual provides comprehensive instructions for the setup, operation, and maintenance of the AIRVO™ 2 humidifier.
Before You Start
This User Manual is intended for healthcare professionals and applies to AIRVO 2 units with LOT numbers 130621 and above. It is crucial to read this manual, including all warnings, and to watch the AIRVO 2 Video Guide for safe and effective use. Both resources should be kept for future reference. Before initial use, the AIRVO 2 must be set up according to the AIRVO 2 Technical Manual. Cleaning and disinfection between patients must follow the Disinfection Kit Manual (900PT600). For assistance, contact your Fisher & Paykel Healthcare representative.
Table of Contents
- Overview (Intended Use, Warnings, AIRVO 2 and Accessories)
- Setting up AIRVO 2
- Using AIRVO 2 (Target dew-point temperature, Target flow, Oxygen, Alarms)
- Reprocessing (Schedule for changing accessories, Filter replacement, Servicing)
- Technical Information
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 designed for use in hospitals and long-term care facilities. The unit is restricted by USA Federal Law for sale by or on the order of a physician.
Intended Use
The AIRVO 2 is intended for the treatment of spontaneously breathing patients who benefit from high-flow, warmed, and humidified respiratory gases, including those with bypassed upper airways. The flow rate can range from 2 to 60 L/min, depending on the patient interface.
Warnings
- Nasal delivery of respiratory gases can generate flow-dependent positive airway pressure (PAP), which must be considered for patient safety.
- 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 can cause injury, including infection. Read warnings in the "Oxygen" section before using oxygen. Never operate if the heated breathing tube is damaged, the unit is not working properly, or case screws are loose. Do not block airflow. Ensure adequate ventilation around the unit and keep air openings clear of lint and hair.
- To avoid electric shock: Do not store or use the unit where it can fall into water. If water enters the unit, disconnect the power cord and discontinue use. Never operate if the unit, power cord, or plug is damaged, or if it has been dropped into water. Avoid unnecessary removal of the power cord; hold the connector when removing. Return the unit for service if damaged.
- To avoid choking or inhalation of a foreign object: Ensure an air filter is fitted. Never insert objects into openings or tubes.
- Miscellaneous: Do not use if the room temperature is outside 10°C to 30°C (50°F to 86°F), as humidity output may be affected. The unit is not suitable for use with flammable anesthetic mixtures.
AIRVO 2 and Accessories
The AIRVO 2 system includes the main unit, heated breathing tube, chamber, and various patient interfaces. Key components include:
- Main Unit: Features controls for power, mode, display, and connections for power, oxygen, and heated breathing tubes.
- Heated Breathing Tube: Delivers warmed and humidified air to the patient.
- Water Chamber (MR290): Holds sterile water for humidification. Features an auto-fill mechanism.
- Patient Interfaces: Various options include nasal cannulas (infant, pediatric, small, medium, large), tracheostomy interface, and mask interface adapter.
- Accessories: Hospital stand, pole mounting tray, air filters, cleaning supplies, and oxygen tubing.
Tube & Chamber Kits and Patient Interfaces:
| Tube & Chamber Kit | Interfaces |
|---|---|
| 900PT531 (Heated breathing tube, MR290 auto-fill chamber and adapter) | OPT316 (Nasal Cannula - Infant), OPT318 (Nasal Cannula - Pediatric), OPT842 (Nasal Cannula - Small), OPT844 (Nasal Cannula - Medium), OPT846 (Nasal Cannula - Large), OPT870 (Tracheostomy Interface), RT013 (Mask Interface Adapter - 22mm) |
| 900PT501 (Heated breathing tube, MR290 auto-fill chamber and adapter) | (For use with OPT316/OPT318 only) |
Cleaning and Disinfection: Disinfection Kit (900PT600), Disinfection Filter (900PT601), Cleaning Sponge-Stick (900PT602), Clean Storage Cover (900PT603).
Miscellaneous: Pole mounting tray (900PT405), Hospital stand (900PT421), Oxygen inlet extension kit (900PT422), Filter holder (900PT912), Air filter (900PT913), Wigglepads (OPTO12), Oxygen Tubing (OPT014).
2. Setting Up AIRVO 2
- Before You Begin: Mount the AIRVO 2 on a pole mounting tray (900PT405) below patient head height. Unpack the tube & chamber kit.
- Install Water Chamber: Remove blue port caps, attach the adapter, and connect the water supply tube. Fit the water chamber to the unit by pressing the finger guard and sliding it until it clicks. Ensure the chamber is securely in place.
- Warnings: Do not start the unit without the chamber. The water becomes hot during use. Avoid tilting the unit to prevent water entry. Empty the chamber before transport.
- Cautions: For MR290, do not use if dropped or run dry with the "water out" alarm activated.
- Connect Water Bag: Attach the sterile water bag to the hanging bracket above the unit and insert the bag spike. Open the vent cap. The chamber will auto-fill. Ensure the water bag or chamber does not run dry. Check that water flow is maintained below the fill line.
MR290: Flow setting vs usage time (2-litre sterile water bag)
| L/min | 2 | 5 | 10 | 15 | 20 | 25 | 30 | 35 | 40 | 45 | 50 | 55 | 60 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| hrs | 379 | 152 | 76 | 51 | 38 | 30 | 25 | 22 | 19 | 17 | 15 | 14 | 13 |
3. Using AIRVO 2
- Switch On Unit: Plug in the power cord securely. Ensure the unit is dry. Press the On/Off button.
- Check Disinfection Status: The unit displays whether it is safe for use on a new patient based on its last disinfection.
- Warm-up: The unit warms up, displaying target temperature, flow, and oxygen values. These values pulse until they reach their targets. This is the "Summary screen".
- Junior Mode: For Optiflow Junior nasal cannulas (OPT316/OPT318), activate Junior Mode by holding the Mode button for 5 seconds. This limits target settings to 34°C and 2-25 L/min. The screen icons indicate Junior Mode. Deactivate by holding the Mode button for 5 seconds.
4. Configure Target Settings
Target Dew-Point Temperature
The AIRVO 2 can be set to three target dew-point temperatures: 37°C (98.6°F), 34°C (93°F) [for compliance issues], and 31°C (88°F) [for face masks only]. Settings may be limited by Junior Mode or pre-set configurations. The unit defaults to 37°C after disinfection.
To change the target dew-point temperature setting: Hold Up and Down buttons for 3 seconds to unlock. Use Up/Down buttons to select the new setting. Press Mode to lock.
Transport Mode
Activate Transport Mode by holding the "Audio pause" button for 5 seconds. This enables a low-power, low-humidity mode for 20 minutes during patient transport. Deactivate similarly.
Target Flow
Set flows between 10-60 L/min (10-25 L/min in 1 L/min increments, 25-60 L/min in 5 L/min increments). Settings may be limited by Junior Mode or pre-set configurations. The unit remembers the last flow setting.
To change the target flow setting: Follow the same steps as for changing the dew-point temperature.
5. Oxygen
Supplementary oxygen can be connected (up to 60 L/min). The AIRVO 2 has an oxygen analyzer. Use continuous oxygen monitoring for at-risk patients.
Warnings
- Keep ignition sources away from the unit when using oxygen. Do not smoke or use open flames.
- Keep oil, grease, and greasy substances away from oxygen equipment.
- Ensure the AIRVO 2 is switched on before connecting oxygen.
- Connect oxygen only through the designated inlet port. Ensure the filter holder and power cord connector are properly fitted.
- Do not connect more than 60 L/min of O₂.
- Oxygen concentration can be affected by flow settings, oxygen levels, patient interface, or obstructions.
- Turn off the oxygen source when not in use.
- The oxygen analyzer uses ultrasonic technology and does not require calibration. Use only with pure oxygen.
Connect Oxygen
Connect the oxygen source output to the oxygen inlet port on the back of the unit. Push the tube firmly.
Adjust Oxygen
Adjust the oxygen source to achieve the desired oxygen fraction. The reading may take minutes to stabilize. The display shows the acceptable range. If the fraction exceeds 95%, the reading pulses red and the device beeps.
Warnings: If patient's peak inspiratory demand exceeds the unit's flow, the inspired oxygen fraction may be lower due to ambient air entrainment. Ensure adequate blood saturation levels.
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 and adjust oxygen as needed. The initial airflow will feel warm, which is normal. The patient should breathe normally through their interface.
7. During Use
A screensaver activates if no button is pressed for 1 minute after the "Ready for use" symbol appears. If excess condensate accumulates in the heated breathing tube, drain it into the water chamber by lifting the patient end of the tube.
8. After Use
Switch off the unit by pressing the On/Off button.
Alarms
The AIRVO 2 features visual and auditory alarms to alert users to interruptions in patient treatment. An intelligent alarm system processes sensor data and compares it to pre-programmed limits.
Alarm Signals
- Visual Alarm: A yellow indicator with a message signifies an alarm condition.
- Auditory Alarm: 3 beeps every 3 seconds, repeating every 5 seconds.
- Audio Pause: Pressing the button mutes the auditory alarm for 115 seconds. Pressing again reactivates it.
Alarm Conditions
All alarms are classified as "Medium Priority". The unit prioritizes alarms if multiple conditions occur simultaneously.
| Message | Meaning | Affects Delivery Of: | Delays |
|---|---|---|---|
| Fault (E###) | Internal fault, unit shut down. Restart unit. If persists, contact representative. | Oxygen, humidity | < 5 seconds |
| Check tube | Cannot detect heated breathing tube. Check for damage and correct connection. Replace if persists. | Oxygen, humidity | < 5 seconds |
| Check for leaks | System leak detected. Check water chamber seating and connection. Check tube for damage and connection. Check nasal interface and filter fit. | Oxygen, humidity | < 5 seconds |
| Check for blockages | System blockage detected. Check tube, interface, air filter, and filter holder for blockage. Activate Junior Mode if applicable. | Oxygen, humidity | < 10 seconds |
| O₂ too low | Measured oxygen level below limit. Check oxygen source connection and adjust level. | Oxygen | < 20 seconds |
| O₂ too high | Measured oxygen level exceeds limit. Adjust oxygen source level. | Oxygen | < 20 seconds |
| Cannot reach target flow | Unit cannot reach target flow. Check tube/interface for blockage. Verify target flow setting is appropriate for the interface. Unit may select new settings. | Oxygen | 10 +/- 1 minutes |
| Check water | Chamber has run out of water. Replace chamber and water bag. Unit enters Warm-up Mode upon replacement. Ensure water bag/chamber does not run dry. | Humidity | Flows > 20 L/min: < 20 minutes. Flows ≤ 20 L/min: < 40 minutes |
| Cannot reach target temperature | Unit cannot reach target temperature. Likely cause: high flow rate in low ambient conditions. Consider decreasing target flow. | Humidity | 30 +/- 3 minutes |
| Check operating conditions | Unit operating in unsuitable ambient conditions (below 10°C or above 30°C). Allow unit to acclimatize or restart. | Humidity | 60 +/- 6 seconds |
| [Power out] | Unit disconnected from mains power. Auditory alarm sounds for 120 seconds. | Oxygen, humidity | < 5 seconds |
Alarm Limits
Most alarm limits are pre-programmed but can be adjusted by authorized personnel. Examples include O₂ too low (factory set at 21%) and O₂ too high (factory set at 95%).
Checking Alarm System Functionality
To check the alarm system, remove the heated breathing tube. The "Check tube" visual and auditory alarms should activate. If not, do not use the unit and 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.
4. Reprocessing
The AIRVO 2 must be cleaned and disinfected between patients per the Disinfection Kit Manual (900PT600). Follow aseptic techniques to minimize contamination. Proper hand hygiene, avoiding contact with ports, and safe disposal of consumables are essential.
Schedule for Changing Accessories
Accessories require frequent replacement to prevent infection risk. Replace immediately if damaged or discolored, or within the following periods:
| Maximum Period of Use | Part Number and Description |
|---|---|
| 1 week (single-patient use) | All patient interfaces: OPT316 (Nasal Cannula - Infant), OPT318 (Nasal Cannula - Pediatric), OPT842 (Nasal Cannula - Small), OPT844 (Nasal Cannula - Medium), OPT846 (Nasal Cannula - Large), OPT870 (Tracheostomy Interface), RT013 (Mask Interface Adapter - 22mm) |
| 2 weeks (single-patient use) | All tube & chamber kits: 900PT501, 900PT531 (Heated breathing tube, MR290 auto-fill chamber and adapter) |
| 3 months or 1000 hours | 900PT913 (Air filter) |
Filter Replacement
When prompted for a filter change:
- Remove the filter holder from the unit and take out the old filter.
- Replace with a new filter.
- Reattach the filter holder, ensuring clips engage correctly.
- Press the Mode button to proceed.
Servicing
This device contains no serviceable parts.
5. Technical Information
Symbol Definitions
The manual includes definitions for various symbols used on the device and in the documentation, such as Caution, Type BF Applied Part, Hot Surfaces, IPX1 Drip Proof, Do Not Throw Away, Consult Accompanying Documents, Alternating Current, Class II Double Insulated, Power On/Off, and CE 0123 (93/42/EEC Class IIa).
Product Specifications
| Specification | Details |
|---|---|
| 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 |
| 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 | Used for downloading product data with 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 minutes to 31°C (88°F); 30 minutes to 37°C (98.6°F) (with MR290 chamber, 35 L/min flow, 23°C 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 |
Compliance
The unit is designed to conform to IEC 60601-1, UL 60601-1, CSA C22.2/No. 601.1, AS 3200.1.0, and EN 60601-1 standards. It complies with electromagnetic compatibility requirements (IEC 60601-1-2). Ensure system compliance with IEC 60601-1-1 when connecting external equipment.
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 and the WEEE directive.
Consumables Disposal: Place used consumables (interface, breathing tube, chamber) in a waste bag. Hospitals should discard according to their standard procedures for contaminated products.
