Beyond EaseFit FMI-NV User Manual

CPAP/BIPAP Masks EaseFit FMI-NV User Manual
Please read it carefully before using this product

Intended Use

The Easefit FMI-NV (Full Face Mask I Non-Vented) is intended to provide an interface to patients, which is applied to
the CPAP or bi-level systems with active-exhaust-valve. The mask is for single patient use in the
home/hospital/institutional environment. The mask is to be used on patient (>30kg) for whom CPAP or bi-level therapy
has been prescribed.

Contraindications

The mask may not be suitable for use on patients with the following conditions:
• Unconsciousness.
• Patient unable to remove mask.
• Open wounds that are prone to infection.
• Hemodynamic or cardiorespiratory instability.
• Facial or nasopharyngeal deformity, beard, or other inability to fit mask and seal properly.
• Excessive reflux, Gastrointestinal bleeding or other secretions
• Impaired cough reflex, hiatal hernia, or inability to swallow or clear secretions.
• Upper airway obstruction or facial trauma.
• Barotrauma.
• Recent facial, esophageal or gastric surgery.
• Patients under medication with a drug that may cause vomiting.
• Patients requiring immediate intubation.
Product description
Easefit FMI-NV
(elbow connection type 1) (elbow connection type 2)
Fig 1
Elbow connection type:
• elbow connection type 1(male connector): the components 6&7 are intended to be used together, the component 6
is of 22mm outer diameter (tube connector).
• elbow connection type 2(female connector): the component 11 is intended to be used independently, the component
11 is of 22mm inner diameter.

Warnings

⚫ The mask is not suitable for providing life support ventilation.
⚫ The mask is designed for use with CPAP or bi-level systems with active-exhaust-valve recommended by your health
care professional or respiratory therapist. Do not wear this mask unless the CPAP or bi-level system is turned on and
operating properly. Do not block or try to seal the active-exhaust-valve. Explanation of the Warning: CPAP systems are
intended to be used with special masks with connectors which have active-exhaust-valve to allow 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 active-exhaust-valve. However, when the CPAP machine is not
operation, enough fresh air will not be provided through the mask ,and exhaled air may be rebreathed .This warning
applies to most models of CPAP system .
⚫ If oxygen is used with the device, the oxygen flow must be turned off when the device is not operating. Explanation of
the warning: when the device is not in operation, and the oxygen flow is left on, oxygen delivered into the ventilator
tubing may accumulate within the device enclosed. Oxygen accumulated in the device enclosure will create a risk of
fire.
⚫ Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an open flame.
⚫ At a fixed flow rated of supplemental oxygen flow, the inhaled oxygen concentration will vary, depending on the
pressure setting, patient breathing pattern, mask selection, and the leak rate. This warning applies to most types CPAP
and bi-level machines.
⚫ Some users may experience skin redness, irritation, or discomfort. If this happens, discontinue use and contact your
healthcare professional.
⚫ The patient's physician should be contacted if the patient experience the flowing symptoms while using the mask or
after removing it: Unusual chest discomfort, shortness of breath, stomach distension, belching, or sever headache;
drying of the eyes, eye pain, or eye infections; blurred vision.(Consult an ophthalmologist if symptoms persist.)
⚫ At low CPAP or EPAP pressure, the flow through the active-exhaust-valve may be inadequate to clear all exhaled gas
from the tubing .some rebreathing may occur.
⚫ This mask should not be used for patients who are uncooperative, obtunded, unresponsive, or unable to remove the
mask.
⚫ This mask is not recommended for patients who are taking a prescription drug that may cause vomiting.
⚫ If an additional exhalation device is added to the patient circuit, you may need to adjust the pressure level to
compensate for the additional leak of the exhalation device.
⚫ Hand wash prior to first use. Inspect the mask for damage or wear (cracking, crazing, tear, etc).Discard and replace any
components as necessary.
⚫ Use of a mask may cause tooth, gum, or jaw soreness or aggravate an existing dental condition. Consult your physician
or dentist if symptoms occur.
⚫ The Mask does not contain natural rubber latex or DEHP.
List of Symbols
The symbols on the device as follows:
Symbol
Wearing the mask
① Remove packaging.
② Check if there any damage or abrasion.
③ Fasten the part of broader headgear with the forehead bracket, Narrow fasten the buckle.
④ Put the mask on the face in good position.
⑤ Trap the headgear on head. Make the headgear upper and under the ear, Trap the headgear buckle into the rod of mask
frame.
⑥ Adjust the headgear by elastic, make sure comfortable.
⑦ Rotate Worm knob to adjust the bracket of the mask, make comfortable enough.
Remove the mask
Push the buckle in the direction far away from face until to hear" Pop" sound, The mask can be removed from the
frame.
Note:
① If the height of the mask does not fit your face, bracket can be removed from the mask frame after reassembly it into
another position, the mask will change the height,.(see Fig.4& Fig.5)
② If the leakage situation can't be solved, other size cushion of mask is required.
③ Do not remove the headgear directly not by removing the buckle.
Disassemble the mask
elbow connection type 1
Easefit FMI-NV
Fig.2
Definition
Serial number of the product
Date of the product
Follow instructions for use
The authorized EU-representative
Fig.4
Symbol
1
Fig.3
Definition
Information of manufacture
CE Mark
Caution or Warning
Fig.5