ResMed 63114 AirFit F10 Full Face Mask User Guide

AirFit ™ F10

Full Face Mask

Fitting Removal Disassembly  Reassembly   This document provides the user instructions for:

• AirFit F10 (blue headgear) and AirFit F10 for Her (headgear) are collectively referred to as AirFit F10.

Intended Use

The AirFit F10 is a noninvasive accessory used for channeling airflow (with or without supplemental oxygen) to a patient from 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 >66 lb (30 kg)) for whom positive airway pressure therapy has been prescribed
• intended for single-patient reuse in the home environment and multi-patient reuse in the hospital/institutional environment.

Using the mask

• Refer to the Technical specifications section in this user guide for mask setting options.

• Follow the instructions provided by your physician or sleep therapist.

• To fit, remove, disassemble or reassemble your mask, follow the illustrations at the front of this guide.

• Do not overtighten the headgear straps. If you feel air-leaks you may need to:
  – refit or reposition your mask
  – adjust your headgear
  – check that your mask is assembled correctly
  – contact your physician or sleep therapist to have your mask refitted.

• For a full list of compatible devices and mask set options, see the “Mask/Device Compatibility List” on www.resmed.com on the Products page under Service & Support.

• The mask system does not contain natural rubber latex, PVC, DEHP, or phthalates materials.

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

**Cleaning the mask at home

**

The mask and headgear can only be gently hand washed in warm (30°C) water using a mild soap. Daily/After each use:

• Disassemble the mask components according to the disassembly instructions.
• Handwash the separated mask components (excluding headgear and soft sleeves).
• To optimize 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 sterilization instructions are available from the ResMed website,
www.resmed.com/masks/sterilization.
If you do not have internet access, please contact your ResMed representative.

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.

AirFit F10

3
4
8
10
12
16
20
24
28
30
32
36
40| 19
22
32
37
41
48
54
60
66
69
72
77
82

Deadspace: Empty volume of the mask to swivel. The dead space of the mask varies according to cushion size.
<222 mL (Large)

Therapy pressure (cm H2O)
3-40

Resistance: Drop-in pressure measured (nominal) (cm H2O)
at 50 L/min ……0.2
at 100 L/min…..0.9

Inspiratory and Expiratory Resistance (cm H2O)
Inspiration …0.6
Expiration ..1.0

AirFit F10

Sound: DECLARED DUAL-NUMBER NOISE EMISSION VALUES in accordance with ISO 4871. The A-weighted sound power level and the A-weighted sound pressure level of the mask, at a distance of 1 m, with the uncertainty of 3 dBA, are shown.
Power level… 28 dBA
Pressure level at 1 m …20 dBA

Anti Asphixia Valve (AAV) open-to-atmosphere pressure
≤1.6 cm H2O

Anti Asphixia Valve (AAV) closed-to-atmosphere pressure
≤1.8 cm H2O

Gross Dimensions : Mask fully assembled – no headgear.The largest variant is only shown.
Height ..140 mm
Width ..146 mm
Depth ..142 mm

Environmental conditions
Operating temperature: +5°C to +40°C
Operating humidity: 15% to 95% non-condensin
Storage and transport temperature: -20°C to +60°C
Storage and transport humidity: up to 95% non-condensing

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.

Disposal
This mask does not contain any hazardous substances that may be disposed of with your normal household refuse.

Symbols

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.

  GENERAL WARNINGS

• 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.

• 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.

• The mask must be used under qualified supervision for users who are unable to remove the mask by themselves.
  The mask ay is not suitable for those predisposed to aspiration.

• The elbow and valve assembly have specific safety functions. They allow you to breathe fresh air if the airflow from your CPAP or bilevel device to your mask is impeded. The mask should not be worn if the valve is damaged as it will not be able to perform its safety function. The valve or elbow should be replaced if the valve is damaged, distorted, or torn.

• This mask must be disinfected and/or sterilized when used between users.

• Do not combine components from different mask systems.

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

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

Consumer Warranty
ResMed acknowledges all consumer rights granted under the EU Directive 1999/44/EC and the respective national laws within the EU for products sold within the European Union.

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