ResMed MIRAGE NV 2 Series User manual

MIRAGE® NV FULL FACE MASK SERIES 2
CLINICIAN’S
GUIDE
www.resmed.com
GUIDE CLINIQUE
GUÍA DEL MÉDICO
GUIA DO MÉDICO
RESMED

CLINICIAN’S GUIDE (ENGLISH) .............................................................................................1
GUIDE CLINIQUE (FRANÇAIS) ............................................................................................. 13
GUÍA DEL MÉDICO (ESPAÑOL) ............................................................................................ 25
GUIA DO MÉDICO (PORTUGUÊS) ........................................................................................ 37

1
CONTRAINDICATIONS ..................................................................... 2
WARNINGS..................................................................................... 2
PRECAUTIONS ................................................................................. 2
ADDITIONAL INFORMATION ............................................................ 3
PARTS OF THE MASK...................................................................... 4
FITTING THE MASK ........................................................................ 4
FOREHEAD PAD CLIP ASSEMBLY..................................................... 6
REMOVING THE MASK .................................................................... 6
QUICK RELEASE TAB ..................................................................... 6
CLEANING THE MASK IN THE HOME .............................................. 7
CLEANING AND DISINFECTING/STERILIZING THE MASK
BETWEEN PATIENTS ........................................................................ 7
REASSEMBLING THE MASK ............................................................ 10
MASK CHARACTERISTICS...............................................................1 1
ACCESSORIES AND REPLACEMENT PARTS.......................................1 1

2
MIRAGE® NV FULL FACE
MASK SERIES 2
The MIRAGE® NV FULL FACE MASK SERIES 2 system (non-
vented) is only indicated for the treatment of adult
patients using non-invasive ventilator systems that have
an active exhaust.
PRECAUTION
In the USA, federal la restricts this device to sale by,
or on the order of, a physician.
CONTRAINDICATIONS
• The MIRAGE NV FULL FACE MASK SERIES 2 must not
be used ithout appropriately qualified supervision
either hen the patient is at risk of not responding
to severe hypoxia or hypercapnia by arousal, or
hen the patient, having aroused, is unable to
remove the mask.
WARNINGS
• The mask must not be used on patients ith
impaired laryngeal reflexes or other conditions
predisposing to aspiration in the event of
regurgitation or vomiting.
• The mask should not be orn unless the ventilator
system is turned on and operating properly.
• At a fixed rate of supplemental oxygen flo (if
used), the inhaled oxygen concentration ill vary
depending on the pressure settings, patient
breathing pattern, mask selection, and the leak rate.
• The mask must not be used if the patient is kno n
to be allergic to any of the follo ing mask
component materials: polycarbonate, silicone
rubber, polyurethane rubber, nylon, polyester, and
cotton.
PRECAUTIONS
• The mask is not for use ith ventilators hich have
a combination of:
a) little or no ability to compensate for mask leak
and variation in mask leak (eg volume-cycled
ventilators ith no compensation for leak, or
pressure-cycled ventilators hich are unable to
deliver adequate extra flo in the presence of
increased leak); and

3
b) no expired ventilation alarms.
If a ventilator ith poor leak compensation is used,
special reliance is placed on the expired ventilation
alarm.
• As ith all mask ventilation systems, significant leak
may occur bet een the mask and the patient’s
face. The leak may vary depending on such factors
as the patient’s position and sleep stage. Variation
in leak may significantly affect patient ventilation,
potentially producing profound hypoventilation or
hyperventilation. The magnitude of this effect
depends on the ventilator’s ability to compensate
for leak.
• Leak or variation in the leak may cause
mistriggering of the ventilator.
• Increased face-to-mask leak ill reduce effective
deadspace by ashing out expired gases. In a
pressure-cycled ventilator hich tolerates moderate
leak, the effect may be a reduction in arterial PCO2
ith no change in ventilator settings.
ADDITIONAL INFORMATION
• ResMed has tinted the MIRAGE NV FULL FACE MASK
SERIES 2 blue to help you identify it as a non-
vented mask for use ith active-exhaust non-
invasive ventilator systems only.
• The mask has a standard female 22mm tapered
fitting (ISO5356-1) for external connection to the
ventilator.
• In determining the initial ventilator settings, and in
particular the tidal volume for volume-cycled
ventilators, make appropriate allo ance for mask
dead space and leak. Refer to the Mask
Characteristics section of these instructions for more
information.
• Refer to the relevant ventilator system operating
instructions for detailed information concerning
connecting the mask.

4
PARTS OF THE MASK
Figure 1: Mask Parts
Mask
frame
Tapered
fitting
Luer lock
port cap/s
Mask
port
Mask
cushion
Cushion
clip
Top Velcro strap
Side
upper
Velcro
straps
Side
lower
Velcro
straps
Quick
Release
Tab
Figure : Headgear
FITTING THE MASK
The MIRAGE NV FULL FACE MASK SERIES 2 is supplied
fully assembled.
Fitting the mask correctly is essential to optimum
therapy delivery. Use the ResMed Mask Fitting
Template to help you choose the best mask size for
your patient.
1Connect the mask to the ventilator system by
follo ing the ventilator system operating
instructions and/or physician’s prescription.
2Seat the mask cushion over the patient’s nose and
mouth. On most patients, the bottom of the
cushion should rest belo the lo er lip and the top
of the cushion on the bridge of the nose, bet een
the eyes.
Note: The MIRAGE NV FULL FACE MASK SERIES 2 offers
two cushion sizes: standard and shallow. The shallow
cushion is designed to better fit those patients who
have a lower nasal bridge, higher cheek bones, or
receded jaw lines.
3Pull the headgear over the patient’s head. Make
sure the side lo er Velcro® straps pass belo the
patient’s ears, and that the side upper Velcro straps
pass over their forehead.

5
4Tighten the side lo er (Fig. 3) and then the side
upper Velcro straps (Fig. 4) to achieve a secure and
comfortable fit.
5Adjust the top Velcro strap (Fig. 5) ith very slight
tension to add stability to the fit of the mask. The
mask should be secure but not overly tight.
6The fitted mask should look like this (Fig. 6):
Note: The top of the mask frame should not touch the
patient’s forehead. In most cases, the top of the mask
frame should be some distance awa from the patient’s
forehead.
7Turn the ventilator on. If you detect air leaks
around the cushion, reposition the mask on the
patient’s face to achieve a better seal. You may
also need to readjust the Velcro straps.
Note: When the ventilator s stem is delivering positive
pressure, the Mirage cushion inflates to float gentl on
the patient’s face, forming a secure and comfortable
seal without the need for tight headgear. Pulling the
headgear too tightl ma reduce the effectiveness of
the mask.
Figure: 3 Figure: 4
Figure: 5
Figure: 6

6
FOREHEAD PAD CLIP ASSEMBLY
The MIRAGE NV FULL FACE MASK SERIES 2 is supplied
ith a forehead pad clip assembly kit. This kit is an
optional accessory. It is for the minority of patients ho
may require additional support and stability. For
assembly instructions, see section on Reassembling the
Mask (step 3).
WARNING
The forehead pad clip assembly is for single-patient
use only.
Note: When the mask is fitted with a forehead pad clip
assembl attached, the forehead pad should lightl
touch the patient’s forehead without the mask putting
pressure on the bridge of the nose.
REMOVING THE MASK
To remove the MIRAGE NV FULL FACE MASK SERIES 2,
release the lo er Velcro straps and pull the mask and
headgear up over the patient’s head.
Note: The Quick Release Tab should be used to remove
the mask onl in the event of an emergenc .
QUICK RELEASE TAB
The Quick Release Tab (Fig. 8)
allo s the mask to come a ay
from the face quickly in the
event of an emergency.
Simply pull the Quick Release
Tab and the rear Velcro
opening of the headgear
separates, allo ing you to
remove the mask from the
face.
Note: The Quick Release Tab should be used to remove
the mask onl in the event of an emergenc . Overuse
of the Quick Release Tab will result in the
deterioration of the Velcro opening.
Figure: 8
Forehead
pad clip
Forehead
pad
Figure 7: Forehead Pad Clip Assembly

7
CLEANING THE MASK IN THE HOME
Note: Wash the headgear before first time use, as the
d e ma run. It is important to alwa s handwash the
headgear.
1Detach the mask from the ventilator and separate
the headgear, luer lock port caps, cushion clip,
mask cushion, and forehead pad clip assembly (if
attached).
2Hand ash the headgear in arm, soapy ater. Use
a mild detergent such as pure soap. Rinse ell and
allo it to air dry out of direct sunlight. Do this at
least once per eek.
3Hand ash the mask components in arm, soapy
ater. Use a mild detergent such as pure soap.
Rinse the components ell and allo them to air
dry out of direct sunlight. Do this after each use.
PRECAUTION
• Do not use bleach-, chlorine-, alcohol-, or aromatic-
based solutions, moisturizing or antibacterial soaps,
or scented oils to clean any part of the mask
system, including headgear. These solutions may
cause damage and reduce the life of the product.
• Do not expose any part of the mask system or
tubing to direct sunlight as it may cause the
product to deteriorate.
CLEANING AND DISINFECTING/STERILIZING
THE MASK BETWEEN PATIENTS
The follo ing are the recommended and validated
procedures for cleaning, disinfection, and sterilization of
the MIRAGE NV FULL FACE MASK SERIES 2. We advise that
each healthcare facility consult its o n procedures
before carrying out the follo ing instructions.
WARNING : ResMed cannot give any assurance
that deviations from the procedures listed belo , and
their effect on the performance of the product, ill
be acceptable.
1Detach the mask from the ventilator. Disassemble
the mask by separating the headgear, luer lock port
caps, cushion clip, mask cushion, and forehead pad
clip assembly (if attached).
2After disassembly, thoroughly clean the mask
components according to the follo ing cleaning
procedure:

8
CLEANING PRIOR TO DISINFECTION OR STERILIZATION
aHand ash the headgear in arm ater using a
mild detergent, such as pure soap. Rinse ell
and allo it to air dry out of direct sunlight.
bClean the individual parts of the mask ith a
soft bristle brush for one minute hile soaking
them in detergent. Pay particular attention to all
crevices and cavities.
cRinse the components t ice by agitating them
vigorously in ater and allo them to air dry
out of direct sunlight.
PRECAUTION
• Do not expose any part of the mask system or
tubing to direct sunlight as it may cause the
product to deteriorate.
• Do not disinfect or sterilize the headgear and
forehead pad clip assembly. This part cannot be
disinfected or sterilized.
3After disassembly and cleaning, disinfect the
reusable mask components according to the
follo ing procedure for chemical or thermal
disinfection.
OR
After disassembly and cleaning, sterilize the mask
according to the follo ing procedure for the
STERRAD® Sterilization Process.
Note: The mask must be disassembled and cleaned
prior to disinfection or sterilization.
OPTION 1: CHEMICAL DISINFECTION
aSoak the reusable mask components in a
commercially available solution of glutaraldehyde
3.4% (eg CIDEX Plus®), peracetic acid 0.08%, or
ortho-phthalaldehyde 0.55% (eg CIDEX OPA®)
as described in the manufacturer’s instructions.
bRinse the mask components as described in the
manufacturer’s instructions and allo them to
air dry out of direct sunlight.
cPerform a visual inspection of each mask
component. If any visible deterioration of a mask
component is apparent (eg cracking, tears etc),
the mask component should be discarded and
replaced. Yello discoloration of the cushion
may occur. This discoloration is acceptable.
Testing b ResMed has shown that the mask
components can withstand 15 c cles using
solutions of glutaraldeh de 3.4% (eg CIDEX Plus®),
peracetic acid 0.08%, or ortho-phthalaldeh de
0.55% (eg CIDEX OPA®) when following the
manufacturer’s instructions.