ResMed Mirage NV Full Face Mask Series 2 User manual

MIRAGE™ NV FULL FACE MASK SERIES 2
CLINICIAN’S
GUIDE GUÍA DEL USUARIO
GUIA DO USUÁRIO
BRUKSANVISNING
GUIDA PER L’UTENTE
MODE D’EMPLOI
GEBRAUCHSANWEISUNG

USER’S GUIDE (ENGLISH) ....................................................................................................1
GEBRAUCHSANWEISUNG (DEUTSCH)................................................................................... 13
MODE D’EMPLOI (FRANÇAIS) ............................................................................................. 24
GUIDA PER L’UTENTE (ITALIANO)......................................................................................... 35
GUÍA DEL USUARIO (ESPAÑOL)........................................................................................... 46
GUIA DO USUÁRIO (PORTUGUÊS)....................................................................................... 57
BRUKSANVISNING (SVENSKA) ............................................................................................. 68

1
CONTRAINDICATIONS ..................................................................... 2
WARNINGS..................................................................................... 2
PRECAUTIONS ................................................................................. 2
ADDITIONAL INFORMATION ............................................................ 3
PARTS OF THE MASK...................................................................... 4
FITTING THE MASK ........................................................................ 4
REMOVING THE MASK .................................................................... 6
QUICK RELEASE TAB ..................................................................... 6
CLEANING THE MASK IN THE HOME .............................................. 6
CLEANING AND DISINFECTING/STERILISING THE MASK
BETWEEN PATIENTS ........................................................................ 7
REASSEMBLING THE MASK .............................................................. 9
MASK CHARACTERISTICS............................................................... 10
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.
CONTRAINDICATIONS
• The MIRAGE NV FULL FACE MASK SERIES 2 must not
be used without appropriately qualified supervision
either when the patient is at risk of not responding
to severe hypoxia or hypercapnia by arousal or
when the patient having aroused is unable to
remove the mask.
WARNINGS
• The mask must not be used on patients with
impaired laryngeal reflexes or other conditions
predisposing to aspiration in the event of
regurgitation or vomiting.
• The mask should not be worn unless the ventilator
system is turned on and operating properly.
• At a fixed rate of supplemental oxygen flow (if
used) the inhaled oxygen concentration will 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 known
to be allergic to any of the following mask
component materials: polycarbonate silicone
rubber polyurethane rubber nylon polyester and
cotton.
PRECAUTIONS
• The mask is not for use with ventilators which have
a combination of:
a) little or no ability to compensate for mask leak
and variation in mask leak (eg volume-cycled
ventilators with no compensation for leak or
pressure-cycled ventilators which are unable to
deliver adequate extra flow in the presence of
increased leak); and
b) no expired ventilation alarms.
If a ventilator with poor leak compensation is used
special reliance is placed on the expired ventilation
alarm.

3
• As with all mask ventilation systems significant leak
may occur between 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 will reduce effective
deadspace by washing out expired gases. In a
pressure-cycled ventilator which tolerates moderate
leak the effect may be a reduction in arterial PCO2
with 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 with 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 allowance 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 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
following 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 below the lower lip and the top
of the cushion on the bridge of the nose between
the eyes.
3Pull the headgear over the patient’s head. Make
sure the side lower Velcro® straps pass below the
patient’s ears and that the side upper Velcro straps
pass over their forehead.
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 2: Headgear

5
4Tighten the side lower (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) with 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 away 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 system is delivering positive
pressure, the irage cushion inflates to float gently on
the patient’s face, forming a secure and comfortable
seal without the need for tight headgear. Pulling the
headgear too tightly may reduce the effectiveness of
the mask.
Figure: 3 Figure: 4
Figure: 5
Figure: 6

6
REMOVING THE MASK
To remove the MIRAGE NV FULL FACE MASK SERIES 2
release the lower 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 only in the event of an emergency.
QUICK RELEASE TAB
The Quick Release Tab (Fig. 7) allows the mask to
come away 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 allowing you to
remove the mask from the face.
Note: The Quick Release Tab should be used to remove
the mask only in the event of an emergency. Overuse
of the Quick Release Tab will result in the
deterioration of the Velcro opening.
CLEANING THE MASK IN THE HOME
Note: Wash the headgear before first time use, as the
dye may run. It is important to always handwash the
headgear.
1Detach the mask from the ventilator and separate
the headgear luer lock port caps cushion clip and
mask cushion.
2Handwash the headgear in warm soapy water. Use
a mild detergent such as pure soap. Rinse well and
allow it to air dry out of direct sunlight. Do this at
least once per week.
3Handwash the mask components in warm soapy
water. Use a mild detergent such as pure soap.
Rinse the components well and allow them to air
dry out of direct sunlight. Do this after each use.
PRECAUTION
• Do not use bleach- chlorine- alcohol- or aromatic-
based solutions moisturising 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.
Figure: 7

7
CLEANING AND DISINFECTING/STERILISING
THE MASK BETWEEN PATIENTS
The following are the recommended and validated
procedures for cleaning disinfection and sterilisation of
the MIRAGE NV FULL FACE MASK SERIES 2. We advise that
each healthcare facility consult its own procedures
before carrying out the following instructions.
WARNING : ResMed cannot give any assurance
that deviations from the procedures listed below and
their effect on the performance of the product will
be acceptable.
1Detach the mask from the ventilator. Disassemble
the mask by separating the headgear luer lock port
caps cushion clip and mask cushion.
2After disassembly thoroughly clean the mask
components according to the following cleaning
procedure:
CLEANING PRIOR TO DISINFECTION OR STERILISATION
aHandwash the headgear in warm water using a
mild detergent such as pure soap. Rinse well
and allow it to air dry out of direct sunlight.
bClean the individual parts of the mask with a
soft bristle brush for one minute while soaking
them in detergent. Pay particular attention to all
crevices and cavities.
cRinse the components twice by agitating them
vigorously in one litre of water and allow 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 sterilise the headgear. This
part cannot be disinfected or sterilised.
3After disassembly and cleaning disinfect the
reusable mask components according to the
following procedure for chemical or thermal
disinfection.
OR
After disassembly and cleaning sterilise the mask
according to the following procedure for the
STERRAD® Sterilisation Process.
Note: The mask must be disassembled and cleaned
prior to disinfection or sterilisation.

8
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%
(eg CIDEX PA®) or orthopthalaldehyde 0.55%
(eg CIDEX OPA®) as described in the
manufacturer’s instructions.
bRinse the mask components as described in the
manufacturer’s instructions and allow 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. Yellow discolouration of the cushion
may occur. This discolouration is acceptable.
Testing by Res ed has shown that the mask
components can withstand 15 cycles using
solutions of glutaraldehyde 3.4% (eg CIDEX Plus®),
peracetic acid 0.08% (eg CIDEX PA®) or
orthopthalaldehyde 0.55% (eg CIDEX OPA®) when
following the manufacturer’s instructions.
OPTION 2: THERMAL DISINFECTION
aUsing a certified hot water disinfection system
soak the mask components for one of the
following times:
• 70°C for 100 minutes or
• 75°C for 30 minutes or
• 80°C for 10 minutes.
• 90°C for 1 minute.
bPerform 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. Yellow discolouration of the cushion
may occur. This discolouration is acceptable.
Testing has shown that the mask components can
withstand 15 cycles of disinfection using the above
time-temperature combinations.
OPTION 3: STERRAD® 100S STERILISATION
PROCESS
aSterilise the mask components as described in
the manufacturer’s instructions for the
STERRAD 100S Sterilisation System.