Beyond EaseFit FMI-NV User manual

1
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 Easefit FMI-NV Fig.3
(elbow connection type 1) (elbow connection type 2)
Fig 1 Fig.2
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
Definition
Symbol
Definition
Serial number of the product
Information of manufacture
Date of the product
CE Mark
Follow instructions for use
Caution or Warning
The authorized EU-representative
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.
Fig.4 Fig.5
Disassemble the mask
elbow connection type 1

2
Fig.6
elbow connection type 2
Reference to the above Fig 6 to disassemble the mask (elbow connection type 2), but only to skip the step 4.
Assemble the mask
elbow connection type 1
Note:
When the worm knob assembly, the first forehead bracket snaps into the bracket, while forehead bracket slipped away
bracket position, then the worm knob insert bracket, make ensure that the worm knob and bracket substantially flat state
under the control clockwise rotation of the worm knob until the worm knob snaps into the bracket. (See Fig. 8)
Fig.7
Fig.8
elbow connection type 2
Reference to the above Fig 7 to assemble the mask (elbow connection type 2), but only to skip the step 2.
Technical specifications
Tube connector
Both 22mm conical male (elbow connection type 1) and 22mm conical female (elbow connection type 2) are available (in
compliance with ISO 5356-1). It’s used to connect an external ventilator tube.
Dead space information
Physical dead space is the empty volume of the mask to the end of the elbow. The dead space of the mask varies
according to cushion sizes but is less than 320ml.
Pressure range: 4-30cmH2O
Environmental conditions
Operating temperature: + 5 ℃to + 40 ℃; Operating humidity, 15-95% relative humidity, non-condensing.
Storage and transport temperature: -20 ℃to + 60 ℃; Storage and transport humidity: not exceeding 95% RH,
non-condensing .
External dimensions
S: 175.9mm (height) × 110mm (width) × 112.4mm (thickness)
M: 183.9mm (height) × 118mm (width) × 114.4mm (thickness)
L: 194.9mm (height) × 122mm (width) × 114.4mm (thickness)
The above external dimensions are for reference only. Goods in kind prevail!
Cleaning instructions
Cleaning the mask should be carried out before the first use and should be cleaned daily. Headgear should be cleaned
once a week, or if necessary, cleaned.
⚫with warm soapy water to clean the mask and headgear, and avoid soaking over 10 minutes, To clean up the vent
with a soft brush.
⚫Mask all parts of drinking water in addition to applications outside of the headgear rinse, and dry naturally in a
dark place. Before each use, make sure the mask is dry.
⚫Headgear after cleaning rinses with water and placed in a place, away from direct sunlight to dry naturally.
⚫Mask and breathing circuit cannot be exposed to direct sunlight place, this will accelerate the aging of the
product.
⚫Mask before use, check for damage or wear (cracking, crazing, tears, etc), when necessary, discard and replace
the parts.
Note: Mask need to be asked for a daily cleaning when used.
Expired products
In consideration of the time limit for the component and medical equipment safety, the service life for the mask shall not
exceed 2 years after the production date. The expired products should be handled following local laws. It is dangerous to
use these expired products.
Trouble shooting
problem
possible cause
solution
Mask wearer
uncomfortable
headband strap is too tight
even adjust the headgear, that forehead bracket "fixed" mask,
should be secured at the forehead
wearing tight
Loosen knob worm
mask too
noisy
cushion buckle is not
inserted correctly
Remove cushion from frame and then re-upholstered trap snaps
on the frame.
If the buckle is fixed properly installed, the problem still exists,
please consult your doctor.
Mask leaks
around the
face
mask not positioned
correctly will cushion
gently pulled away from the face, making it swell again, follow
the instructions to put the mask back in place.
air leakage around the nose
tighten the worm knob
air leakage around the top of
the lip
loosen worm knob and / or tightening headgear
worm knob is
not smooth
forehead bracket slide to the
stroke limit position
in the opposite direction of rotation of the worm knob
worm knobs and forehead
bracket is installed
incorrectly
direction toward the worm knob push forehead bracket, the
worm support bracket and rotate the knob from the forehead
from the forehead bracket, follow the instructions to reassemble
Storage
Ensure that the mask is thoroughly clean and dry before storing it for any length time. Store the mask in a dry place out of
direct sunlight.
Disposal
This mask does not contain any hazardous substances, according to the general household refuse discarded.
Packing list
mask ×1,headgear ×1, user manual ×1.
Warranty
It is warranty that the mask, including Frame, Cushion, Forehead pad, Headgear 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.
Manufacturer
Hunan Beyond Medical Technology Co.,Ltd.
Add: Lijiacun Rd, Xueshi Street, Yuelu District, Changsha, Hunan, China.
Tel: [phone]
www.csbeyond.com
EC Rep Information
Well Kang Limited
The Black Church,St.Mary’s Place,Dublin7,Ireland
The copyright of the Manual should belong to Hunan Beyond Medical Technology Co.,Ltd. It is subject to change
without prior notice.
Version No: A3/20200512/EaseFit FMI-NV