ResMed AirFit F10 Manual

Introduction

This document provides the user instructions for the AirFit F10 and AirFit F10 for Her masks referred to collectively as AirFit F10 throughout this manual. AirFit F10 has blue headgear while AirFit F10 for Her has pink headgear.

Intended Use

The AirFit F10 is a noninvasive accessory used for channeling airflow (with or without supplemental oxygen) to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel system.

The AirFit F10 is:

• to be used by patients (weighing >30 kg) for whom positive airway pressure therapy has been prescribed
• intended for single-patient reuse in the home environment and multipatient reuse in the hospital/institutional environment.

GENERAL WARNINGS

• The mask must be used under qualified supervision for users who are unable to remove the mask by themselves. The mask may not be suitable for those predisposed to aspiration.
• The elbow and valve assembly have specific safety functions. The mask should not be worn if the valve is damaged as it will not be able to perform its safety function. The elbow should be replaced if the valve is damaged, distorted or torn.
• The vent holes must be kept clear.
• The mask should only be used with CPAP or bilevel devices recommended by a physician or respiratory therapist.
• The mask should not be used unless the device is turned on. Once the mask is fitted, ensure the device is blowing air.
  Explanation: CPAP and bilevel devices are intended to be used with special masks (or connectors) which have vent holes to allow continuous flow of air out of the mask. When the device is turned on and functioning properly, new air from the device flushes the exhaled air out through the mask holes. When the device is turned off, the mask valve opens to atmosphere allowing fresh air to be breathed. However, a higher level of exhaled air may be rebreathed when the device is off. This applies to most full face masks for use with CPAP and bilevel devices.
• Follow all precautions when using supplemental oxygen.
• Oxygen flow must be turned off when the CPAP or bilevel device is not operating, so that unused oxygen does not accumulate within the device enclosure and create a risk of fire.
• Oxygen supports combustion. Oxygen must not be used while smoking or in the presence of an open flame. Only use oxygen in well ventilated rooms.
• At a fixed rate of supplemental oxygen flow, the inhaled oxygen concentration varies, depending on the pressure settings, patient breathing pattern, mask, point of application and leak rate. This warning applies to most types of CPAP or bilevel devices.
• The technical specifications of the mask are provided for your clinician to check that they are compatible with the CPAP or bilevel device. If used outside specification or if used with incompatible devices, the seal and comfort of the mask may not be effective, optimum therapy may not be achieved, and leak, or variation in the rate of leak, may affect the CPAP or bilevel device function.
• Discontinue using this mask if you have ANY adverse reaction to the use of the mask, and consult your physician or sleep therapist.
• Using a mask may cause tooth, gum or jaw soreness or aggravate an existing dental condition. If symptoms occur, consult your physician or dentist.
• As with all masks, some rebreathing may occur at low CPAP pressures.
• Refer to your CPAP or bilevel device manual for details on settings and operational information.
• Remove all packaging before using the mask.

Mask components

XS: Extra Small
S: Small
M: Medium
L: Large
Std: Standard

* Not available in all regions

Using your mask

When using your mask with ResMed CPAP or bilevel devices that have mask setting options, refer to the Technical specifications section in this user guide for mask selection options.

For a full list of compatible devices for this mask, see the Mask/Device Compatibility List on www.resmed.com on the Products page under Service & Support. If you do not have internet access, please contact your ResMed representative.

Use a standard conical connector if pressure readings and/or supplemental oxygen are required.

Fitting

The fitting illustrations in this guide show the sequence for obtaining the best fit and comfort when using your mask.

Fitting steps

1. Remove the elbow from the mask by pressing the side buttons and pulling the elbow away.
   
2. With both lower headgear straps released, hold the mask against your face and pull the headgear over your head. Ensure that the label on the back of the headgear faces outwards when the headgear is put on.
   
3. Undo the fastening tabs on the upper headgear straps. Pull the straps evenly until the mask is stable and positioned as shown in the illustrations. Reattach the fastening tabs.
   
4. Bring the lower straps below your ears and loop the headgear into the lower hooks on the frame.
   
5. Undo the fastening tabs on the lower headgear straps. Pull the straps evenly until the mask sits firmly on the chin and reattach the fastening tabs.
   
6. Connect the air tubing from your device to the elbow. Attach the elbow to the mask by pressing the side buttons and pushing the elbow into the mask. Turn on your device so that it is blowing air.
   
7. Undo the fastening tabs on the upper headgear straps. Readjust the straps evenly only enough that a seal is achieved and reattach the fastening tabs. Overtightening may cause leaks.
   
8. Your mask and headgear should be positioned as shown.
   

Removing your mask

Refer to the removal illustrations:

Removal steps

1. Disconnect one or both of the lower headgear straps from the hook.
   
2. Pull the mask away from your face and back over your head.
   

Disassembly

Refer to the disassembly illustrations:

Disassembly steps

1. Unhook the upper headgear straps from the frame. There is no need to undo the fastening tabs.
   
2. Remove the elbow from the mask by pressing the side buttons and pulling the elbow away. Remove the elbow from the air tubing.
   
3. While holding the bottom of the hook, pull the corner of the frame slightly away from the side of the mask.
   
4. Remove the frame from the rest of the mask.
   
5. If the soft sleeves are fitted, remove them by pulling them off of the frame.
   

Reassembly

Refer to the reassembly illustrations:

Reassembly steps

1. Press the top of the frame onto the rest of the mask, ensuring it clicks into place.
   
2. Press the bottom corners of the frame onto the rest of the mask, ensuring they click into place.
   
3. To fit the optional soft sleeves, pull them over the upper arms of the frame.
   
4. Attach the top headgear straps to the frame by looping through each of the upper headgear hooks. Ensure that the ResMed logo on the headgear is facing outward and right side up.
   
5. Attach the elbow to the air tubing. Attach the elbow and air tubing to the mask by pressing the side buttons and pushing the elbow into the mask. Pull on the elbow to check that it sits securely in the mask.
   

Cleaning your mask in your home

Your mask and headgear should only be handwashed by gently rubbing in warm (approximately 30°C) water using mild soap. All components should be rinsed well with drinking quality water and allowed to air dry out of direct sunlight.

Always follow cleaning instructions and use mild soap. Some cleaning products may damage the mask, its parts and their function, or leave harmful residual vapours that could be inhaled if not rinsed thoroughly.

If any visible deterioration of a system component is apparent (cracking, discoloration, tears etc.), the component should be discarded and replaced.

Daily/After each use:

• Disassemble the mask components according to the disassembly instructions.
• Handwash the separated mask components (excluding headgear and soft sleeves).
• To optimise the mask seal, facial oils should be removed from the cushion after use.
• Use a soft bristle brush to clean the vent.
• Inspect each component and, if required, repeat washing until visually clean.
• Rinse all components well with drinking quality water and allow to air dry out of direct sunlight.
• When all components are dry, reassemble according to the reassembly instructions.

Weekly:

• Handwash the headgear and soft sleeves.

Reprocessing the mask between patients

This mask should be reprocessed when used between patients. Cleaning, disinfection and sterilisation instructions are available from the ResMed website, www.resmed.com/masks/sterilization. If you do not have internet access, please contact your ResMed representative.

Troubleshooting

Technical specifications

Pressure-flow curve
The mask contains passive venting to protect against rebreathing. As a result of manufacturing variations, the vent flow rate may vary.

Tab.1

Tab.2

Notes:

• The mask system does not contain PVC, DEHP or phthalates.
• This product is not made with natural rubber latex.
• The manufacturer reserves the right to change these specifications without notice.

Storage

Ensure that the mask is thoroughly clean and dry before storing it for any length of time. Store the mask in a dry place out of direct sunlight.

Symbols

Catalog number	Batch code
Humidity limitation	Temperature limitation
Fragile, handle with care	Not made with natural rubber latex
Manufacturer	European Authorized Representative
Keep away from rain	This way up

Indicates a Warning or Caution and alerts you to a possible injury or explains special measures for the safe and effective use of the device.

Caution, consult accompanying documents.

ResMed.com

Documents / Resources

References

• Sleep apnea and COPD - learn about symptoms and treatment | ResMed
• Gebruikershandleidingen en conformiteitsverklaringen voor ResMed-producten | ResMed Nederland
• Sleep apnea and COPD - learn about symptoms and treatment | ResMed

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