F&P AIRVO 2

BEFORE YOU START

This User Manual is intended for healthcare professionals.

Read this User Manual including all warnings. Failure to do so may result in injury or increased risk of infection. Keep this manual in a safe place for future reference.

OTHER REFERENCES

• Refer to the AIRVO™ 2 User Manual for detailed instructions for use.
• Watch the training videos on the AIRVO 2 website www.fphcare.com/airvo
• For troubleshooting information, please see the AIRVO 2 / myAIRVO™ 2 Technical Manual.
• Download the AIRVO 2 Simulator App to learn how to use the AIRVO 2. You can change settings, simulate faults and test your skills. Available from the Apple, Google Play and Windows App stores.
• Visit the Fisher & Paykel education & resources website (https://www.fphcare.com/education) to find self-paced online courses and local training events.
• For further assistance, please contact your Fisher & Paykel Healthcare representative.

1. OVERVIEW

The 900PT600 Disinfection Kit is used to achieve high-level disinfection of the AIRVO 2 / myAIRVO 2 humidifier outlet elbow. This manual itself describes the recommended reprocessing procedures to be carried out between patients, including cleaning, high-level disinfection using the supplied disinfection tube and filter, and correct storage.

WARNINGS

• This disinfection kit should only be used with the Fisher & Paykel Healthcare AIRVO 2 / myAIRVO 2 humidifier, hereafter referred to as “the unit”/“AIRVO 2”.
• California residents please be advised of the following, pursuant to Proposition 65: This product contains chemicals known to the State of California to cause cancer, birth defects and other reproductive harm. For more information, please visit: www.fphcare.com/prop65

PACKAGE CONTENTS (900PT600)

• Disinfection tube
• Disinfection filter
• Disinfection kit manual
• Cleaning sponge-stick (x 2)
• Clean Storage Cover (x 3)

AVAILABLE SEPARATELY

• 900PT602 Cleaning sponge-stick (20-pack)
• 900PT603 Clean storage cover (20-pack)

2. REPROCESSING PROCEDURES

The AIRVO 2 humidifier must be cleaned and disinfected between patients. During use, the patient interface, heated breathing tube, water chamber and outlet elbow at the heated breathing tube connection port may become contaminated. It is particularly important that the outlet elbow at the heated breathing tube connection port is cleaned and disinfected properly. This should take place as soon as possible after use.

Note: Do not clean the left-hand chamber port.

The following steps must be carried out between patients:

In addition, consider replacing the air filter at the rear of the AIRVO 2 if a highly infectious patient is known to have used the unit.

Standard aseptic techniques to minimize contamination should be followed when handling the unit and accessories. This includes proper hand-washing, avoiding hand contact with connection ports, safe disposal of the used consumables and suitable storage of the unit after cleaning and disinfection. The use of protective gloves is strongly recommended.

The AIRVO 2 and its accessories are not compatible with washer-disinfector processes.

3. CLEANING

This cleaning step aims to remove any contamination from the outlet elbow (between the right-hand chamber port and the heated breathing tube connection port), before the disinfection cycle is carried out. It is important to carry out this cleaning step first to ensure that the disinfection cycle will be effective. In addition, it is important to clean the other outside surfaces of the unit.

Note: Do not clean the left-hand chamber port, as this can damage the non-return valve located at this port.

THE FOLLOWING EQUIPMENT IS REQUIRED:

• Cleaning Sponge-Stick (900PT602)
  Available from Fisher & Paykel Healthcare.
• Mild detergent
• 70% alcohol solution OR 70% alcohol wipes
• Clean, disposable, lint-free cloths

WARNINGS

The products above have been tested by Fisher & Paykel Healthcare. If none of these are available, other cleaning agents may be used as long as they are pH-neutral, non-abrasive, non-toxic and non-corrosive. Do not use any cleaning agents incompatible with polycarbonate plastic (including, but not limited to, ammonia, ammonium hydroxide, caustic soda, iodine, methanol, methylated spirits, turpentine and alkaline bleaches such as sodium hypochlorite). Always remove any residue with a clean, damp, lint-free cloth.

PREPARE THE AIRVO 2 FOR CLEANING

• Switch off the unit and unplug from the mains/utility power socket.
• Remove the water chamber, heated breathing tube and patient interface; and safely dispose of them.

CLEAN THE OUTLET ELBOW

You must physically clean the outlet elbow that connects the right-hand chamber port to the heated breathing tube connection port.

Note: Do not clean the left-hand chamber port, as this can damage the non-return valve located in this port.

There are two options for cleaning the elbow:

• Using the cleaning sponge-stick (recommended), with a solution of warm water and mild detergent, OR,
• Using a clean, damp, disposable lint-free cloth, with a solution of warm water and mild detergent.

USING THE CLEANING SPONGE-STICK

• Dip the cleaning sponge-stick in a solution of warm water and mild detergent.
• Thoroughly clean the outlet elbow from both ends, as far as possible, continuously rotating the sponge-stick.
• Ensure that all contamination is removed.
• Rinse the cleaning sponge-stick under running water and, using the same rotating action, remove any residue from the outlet elbow.
• Discard the cleaning sponge-stick.

USING A DISPOSABLE CLOTH

• Thoroughly clean the outlet elbow from both ends, as far as possible, continuously rotating the cloth with your finger.
• Ensure that all contamination is removed.
• Repeat with a clean, damp, lint-free cloth to remove any residue.

WIPE THE OUTSIDE SURFACES OF THE AIRVO 2

• Use an alcohol wipe, or apply alcohol solution to a clean, damp, disposable lint-free cloth, to wipe the outside surfaces of the unit. Let it air dry.
• If there is visible soiling (blood, mucus, etc), clean the outside surfaces of the unit with a cloth dipped in a solution of warm water and mild detergent. Use a clean, damp, disposable lint-free cloth to remove any residue, then complete the cleaning using the alcohol wipe or cloth.

4. HIGH-LEVEL DISINFECTION

This step involves running the AIRVO 2 disinfection cycle, using the red disinfection tube and blue disinfection filter from the AIRVO 2 Disinfection Kit 900PT600. This cycle should be carried out at the recommended ambient temperature and humidity levels (see below).

This cycle has been validated to achieve high-level disinfection, by heating the outlet elbow at the heated breathing tube connection port to at least 87 °C (189 °F) for at least 30 minutes.

To ensure that these conditions are met for every disinfection cycle, the AIRVO 2 logs time and temperature (from two independent sensors) throughout the cycle. A successful disinfection cycle is assured only when the countdown reaches zero.

THE FOLLOWING EQUIPMENT IS REQUIRED:

• Disinfection tube
• Disinfection filter

OPERATING CONDITIONS:

• Ambient temperature: 18 - 30 °C (64 - 86 °F)

WARNINGS

• Disconnect any oxygen supply from the unit before starting the disinfection cycle.
• Do not operate the disinfection kit in a sterile room.
• Ensure that the external surfaces of the unit are dry before operating the disinfection kit.
• Do not modify the disinfection tube or filter in any way.
• Always switch off the unit when connecting or removing the disinfection tube.
• Never spray any sanitizing liquid or cleaning fluid into the disinfection tube.
• Covering any part of the disinfection tube or blocking the filter could result in serious damage to the unit.
• If the disinfection tube becomes damaged, a new kit must be ordered. Replacement filters are available separately.
• To avoid burns: Do not touch the disinfection tube or filter during the disinfection cycle.

1. CONNECT THE RED DISINFECTION TUBE TO THE AIRVO 2

One end of the disinfection tube has a blue plastic connector. Lift the sleeve and slide the connector onto the unit. Push the sleeve down to lock.

Connect the red end of the disinfection tube to the left-hand chamber port as shown and push fully into position.

2. FIT THE BLUE FILTER

Fit the blue filter to the right hand chamber port as shown. Push it firmly into position.

3. START THE DISINFECTION CYCLE

Connect the power cable to the mains/utility power socket and start the disinfection cycle by holding the On/Off button for 3 seconds until the unit beeps.

WARNING: Disconnect any oxygen supply from the unit before starting the disinfection cycle.

4. WARM-UP AND CALIBRATION

The unit will first go through a series of calibration checks for approximately 2 minutes, during which a warm-up symbol will be displayed on screen.

5. DURING DISINFECTION

After a successful calibration, the disinfection cycle begins and runs for 55 minutes.

Press the Mode button at any time to view a graph of the current disinfection cycle. The graph shows:

• Time (mins)
• Temperature (°C)

If no button has been pushed for 1 minute, a screensaver will be launched.

6. AFTER DISINFECTION

After a successful disinfection, the display will reach zero as shown and an audible information signal will sound. This display will alternate with the current disinfection cycle number. See Section 6, “Disinfection History", for more information.

7. SWITCH OFF THE AIRVO 2

Switch off the unit and unplug from the mains/utility power socket. The unit is now ready for storage.

TROUBLESHOOTING

For full troubleshooting instructions, please refer to the ‘Troubleshootingʻ section in the AIRVO 2 / myAIRVO 2 Technical Manual. If problem still persist, please contact your Fisher and Paykel Healthcare representative.

5. STORAGE

After the disinfection cycle, it is imperative that the unit is stored appropriately. This involves using the Clean Storage Cover (900PT603) or an alternative method which will keep the outlet elbow free from contamination while being stored between patients.

USING THE CLEAN STORAGE COVER (900PT603)

• Remove the disinfection tube and filter from the AIRVO 2. To remove the disinfection tube, always push the sleeve up to avoid tube damage.
• Wrap the AIRVO 2 in the Clean Storage Cover, such that the identification label sits prominently above the display and buttons of the AIRVO 2.
• To record the previous disinfection process: Fill in the details on the identification label.
• Seal the Clean Storage Cover with the adhesive tabs.
• After the unit is sealed: Store the unit and disinfection kit in an area suitable for medical devices, which is clean, dry and dust-free.

ALTERNATIVE STORAGE METHOD

If the Clean Storage Cover is not used, the alternative storage method is to leave the disinfection tube and filter attached to the AIRVO 2. Store the unit (with disinfection tube and filter attached) in an area suitable for medical devices, which is clean, dry and dust-free.

6. DISINFECTION HISTORY

The disinfection cycle number is a unique number that can be recorded for keeping a log of disinfection cycles.

AFTER EACH DISINFECTION CYCLE

The first time that the disinfection cycle is successfully completed, “#1” will be displayed. This number will increment by 1 after each successful disinfection cycle. #7 indicates that seven successful disinfection cycles have been carried out on this AIRVO 2.

AT AIRVO 2 STARTUP

When the AIRVO 2 is switched on for patient use, the following is displayed onscreen:

• a traffic light symbol (explained below)
• the disinfection cycle number from the last successful disinfection cycle.
• the time, in days and hours, since the last successful disinfection cycle.

If this is the first switch-on after a successful disinfection cycle: A green traffic light will be displayed. This AIRVO 2 is safe for use on a new patient.

If this is NOT the first switch-on after a successful disinfection cycle: An orange traffic light will be displayed. This AIRVO 2 is NOT safe for use on a new patient.

7. SYMBOL DEFINITIONS

• i Consult instructions for use
• ? Do not throw away
• CE0123
• 93/42/EEC Class lla