BMC F4 Full Face Mask User Manual

: June 3, 2024
: BMC

Table of Contents

Intended Use
Before Using the Mask
Fitting the Mask
Cleaning the Mask at Home
Troubleshooting
Technical Specifications
Symbols
Limited Warranty
References
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F4 Full Face Mask
User Manual

Full Face Mask (F4)
Thank you for choosing BMC’s Full Face Mask (F4). The mask is comfortable, flexible, and quiet. It is designed to minimize contact with your face, thus ensuring that you feel comfortable during therapy. This user manual provides you with the information you need for the correct use of your mask.
The Mask is not made with natural rubber latex.

Intended Use

The Full Face Mask (F4) channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system.
The Full Face Mask (F4) is:

to be used by adult patients (> 66 lb / 30 kg) for whom positive airway pressure therapy has been prescribed.
intended for single-patient re-use in the home environment and multi-patient re-use in the hospital/institutional environment.

CAUTION: In the US, Federal law restricts the sale of this device to sale by or on the order of a physician.
Contraindications
This mask should be used with caution for patients with the following conditions:

Facial deformity.
Injured facial skin will contact the mask during use.

Before Using the Mask

WARNINGS

The vent holes must be kept clear.
This mask should only be used with CPAP or bilevel devices recommended by a physician or respiratory therapist.
Explanation of Warning: CPAP systems are intended to be used with special masks with connectors that have vent holes to allow a continuous flow of air out of the mask. When the CPAP machine is turned on and functioning properly, new air from the CPAP machine flushes the exhaled air out through the attached mask exhalation port. However, when the CPAP machine is not operating, enough fresh air will not be provided through the mask, and exhaled air will be rebreathed. Rebreathing exhaled air for longer than several minutes can, in some circumstances, lead to suffocation. This warning applies to most models of CPAP systems.
At low CPAP pressures, the flow through the exhaled port may be inadequate to clear all exhaled gas from the tube. Some rebreathing may occur.
To minimize the risk of vomiting during sleep, the patient should avoid eating or drinking for three hours before using the mask. This mask is not recommended if the patient is taking a prescription drug that may cause vomiting.
Do not use the mask without the Non-Rebreathing Valve in place.
Not applicable to the silicone-allergy user.
This mask should not be used on patients who are uncooperative, obtunded, unresponsive, or unable to remove the mask.
Follow all precautions when using supplemental oxygen.
Oxygen flow must be turned off when the flow generator is not operating so that unused oxygen does not accumulate within the flow generator enclosure and create a risk of fire.
At a fixed flow 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.
The technical specifications of the mask are provided for your clinician to check if it is compatible with the flow generator. If it is used beyond technical specifications or 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 function of the flow generator.
Stop using the Full Face Mask (F4) and consult your physician or sleep therapist, if you have ANY adverse reaction to the use of the mask.
Refer to your flow generator manual for details on settings and operational information.
Remove all packaging before using the mask.
Images shown here are indicative only. If there is an inconsistency between the image and the actual product, the actual product shall govern.

Components of the Full Face Mask (F4)

BMC F4 Full Face Mask - Fig 1

Fitting the Mask

Pass the upper straps of the headgear through the installation hole of the mask as shown in the figure
and secure it, repeat the process with the lower straps to join the headgear clip.| Place the mask on the face and extend the headgear to the back of the head /Please confirm that the label on the back of the headgear faces outward when the headgear is worn.| Bring the lower-half straps beneath the ear and insert the clips into the fixed hook on the lower-half part of the mask frame.
BMC F4 Full Face Mask - Fig 3
Extend the upper-half straps of the headgear shown in the above figure until the mask is fixed properly.| Repeat the process for the lower-half headgear as shown in the above figure until the mask is fixed
properly.| Open the device for the air supply. Attach the respiratory hose with the swivel on the base of the mask.
Adjust the position of the mask to confirm a tight seal.

Disassembling the Mask
Notes:

The elbow assembly and the connector cannot be dissembled from the frame assembly.
The elbow assembly cannot be disintegrated.
The valve cannot be dissembled, or damage may be incurred and the re-installation will become more difficult.
Undo and remove the upper-half headgear straps out of the hole on the mask frame.
Remove the cushion from the mask frame.
Remove the Swivel from the Elbow.

Cleaning the Mask at Home

Notes:

The mask and headgear can only be cleaned through hand washing.
The elbow assembly and the connector cannot be dissembled from the frame assembly for washing.
The elbow and the valve cannot be dissembled from the elbow assembly for washing.

CAUTIONS

Do not use solutions containing bleach, chlorine, alcohol, aromatics, moisturizers, antibacterial agents, or scented oils to clean any part of the system or air tubing. These solutions may cause damage and reduce the life of the product.
Exposing any part of the system or tubing to direct sunlight or heat may cause deterioration.
If any visible deterioration of a component is apparent (cracking, crazing, tears, etc), the component should be discarded and replaced.

Daily/After Each Use

Disassemble the mask components according to the disassembly instructions.
Thoroughly clean the separated mask components (excluding headgear), by gently rubbing in warm (approx. 30°C) water using mild liquid detergent for 10 min.
Use a soft bristle brush to clean the vent.
Rinse all components well with drinking-quality water and allow them to air dry out of direct sunlight.
When all components are dry, reassemble them according to the reassembly instructions.

Weekly
Handwash the headgear and all components in warm (approx. 30°C) and mild liquid detergent for up to 10 minutes. Rinse the components well and allow them to air dry out of direct sunlight.
Reprocessing the Mask between Patients
This mask should be reprocessed when used between patients. Cleaning and disinfection instructions are available from the BMC website, www.bmc- medical.com. If you do not
have internet access, please contact your BMC representative.

Reassembling the Mask

Install the Swivel onto the Frame and confirm that the Swivel is reliable.
Install the Cushion onto the Frame and confirm that the Cushion is reliable.
Install the upper-half headgear onto the upper-half installation hole of the Frame assembly.

Troubleshooting

Problem	Possible Reason	Possible Solution
Mask won’t seal properly or is uncomfortable.	Mask may have been fitted
incorrectly.	Carefully follow the instructions in the “Fitting the Mask”

section.
Make sure the headgear is not over-tightened.
The Mask size is wrong.| Consult your clinician.
Mask leaks around the face.| The cushion is misplaced on the cushion frame.| Check the insertion of the cushion and reinsert it correctly according to the instructions in the “Reassembling the Mask” section.
Mask is too noisy.| The Mask size is wrong.| Consult your clinician.
Vents are blocked or partially blocked.| Clean the vents according to the instructions in the “Cleaning the Mask at Home” section.

Technical Specifications

BMC F4 Full Face Mask - Fig 10 Mask Pressure (cmH 2O)

Pressure (cmH 2O)	4	10	12	17	24	30
Flow Rate (L/min)	22	37	41	49	59	67
Dead Space Information	Dead space is the empty volume of the mask up to the

swivel. The dead space of the mask varies according to cushion sizes but is less than 260 ml.
---|---
Therapy Pressure| 4 to 30 cmH2O
Resistance| Drop in Pressure measured (average for 3 sizes) at 50 L/min: 0.15 cmH2O, at 100 L/min: 0.5 cmH2O
Inspiratory and Expiratory Resistance| The inspiratory resistance of the mask (in combination with the Non-Rebreathing Valve) is 1.8 cmH2O at 50 L/min.
The expiratory resistance of the mask (in combination with the Non-Rebreathing Valve) is 2.0 cmH2O at 50 L/min.
Anti Asphyxia Valve open-to-atmosphere pressure| ≤ 4 cmH2O
Anti Asphyxia Valve closed-to-atmosphere pressure| ≤ 4 cmH2O
Sound| DECLARED DUAL-NUMBER NOISE EMISSION VALUES in accordance with ISO 4871. The A-weighted
the sound power level of the mask is 30 dBA, with an uncertainty of 3 dBA. The A-weighted sound pressure level of the mask at a distance of 1 m is 22 dBA, with an uncertainty of 3 dBA.
Environmental Conditions| Operating temperature: +5°C to +40°C (41°F to 104°F)
Operating humidity: 0% ～ 93% relative humidity non-condensing
Storage and transport: -25°C to +70°C (-13°F to 158°F)
Storage and transport humidity: 0% ～ 93% relative humidity 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
The mask does not contain any hazardous substances and may be disposed of with your normal household refuse.

Symbols

System and Packaging

| Caution, consult accompanying documents.
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.
---|---
| Lot number
| Catalog number
| Temperature limitation
| Humidity limitation
****| Manufacturer
| Authorized Representative in the European Community

Limited Warranty

It is warranted that the Full Face Mask (F4), including Frame Assembly, Cushion, Headgear, Swivel, and other accessories shall be free from defects in material and workmanship for a period of ninety (90) days from the date of purchase by the initial consumer.
To exercise the rights under this warranty, contact the local authorized dealers.
The expected service life of Full Face Mask (F4) is one year.
MANUFACTURER:
BMC MEDICAL CO., LTD.
Room 110 Tower A Fengyu Building, No. 115 Fucheng Road,
Haidian, 100036 Beijing, PEOPLE’S REPUBLIC OF CHINA
URL: en.bmc-medical.com
E-mail: intl@bmc-medical.com
Tel: +86-10-51663880
Fax: +86-10-51663880 Ext. 810
EU AUTHORISED REPRESENTATIVE:
Shanghai International Holding Corp. GmbH (Europe)
Eiffestraβe 80, 20537 Hamburg, Germany
Tel: 0049-40-2513175
Fax:0049-40-255726
Manufacturing Site:
BMC (Tianjin) Medical Co., Ltd.
2/F North Area and 3/F, Building No.4, No.1 Xinxing Road,
Wuqing District, (301700) Tianjin, P.R.China
Tel: +86-22-82939881