F&P Nova Micro - Page 5

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Caution: Failure to fully disassemble the mask may compromise
the effectiveness of cleaning and the subsequent disinfection
steps which may result in a range of harms, some of which
are severe.
Cleaning: Masks should always be properly cleaned before further
reprocessing.
Warning: Failure to properly clean this device according to
these instructions or the use of an automated cleaning method
may result in ineffective disinfection/sterilization and adverse
health effects.
Cleaning the Cushion and Frame Assembly:
1. Soak Cushion and Frame Assembly in a solution of mild alkaline
anionic detergent according to the manufacturer’s instructions
(e.g. Alconox at 1% concentration and 50 °C) for 10 minutes,
ensuring that no air bubbles are present on the device surface.
(Alconox is a trademark of Alconox, Inc.)
2. Using a soft non-metallic brush (e.g. medium-hard toothbrush),
vigorously brush the mask parts until visibly clean but not for
less than 10 seconds. An additional narrow bottle brush is
required to access the Mask Tube. Pay close attention to crevices,
cavities and corners, such as the internal surfaces of the cushion
and frame.
3. Manually rotate both ends of the tube where it joins the swivel
and the frame for at least 10 seconds each, while submerged in
the detergent solution.
4. Rinse by submerging in 5 liters of fresh demineralized water and
agitating for at least 10 seconds.
5. Manually rotate both ends of the tube where it joins the swivel
and the frame for at least 10 seconds each, while submerged in
the demineralized water.
6. Repeat the submerged rinse in fresh demineralized water.
7. Ensure the Cushion and Frame Assembly are visibly clean before
continuing. If not, repeat steps 1-6.
Cleaning the Headgear:
1. Soak the Headgear in a solution of mild alkaline anionic
detergent according to the manufacturer’s instructions (e.g.
Alconox at 1% concentration and 50 °C) for 10 minutes, ensuring
that no air bubbles are present on the device surface.
2. Using a soft non-metallic brush (e.g. medium-hard toothbrush),
scrub the headgear until visibly clean but not for less than
30seconds. Pay close attention to crevices, cavities and corners.
3. Rinse under running water for at least 30 seconds, intermittently
wringing the fabric.
4. Submerge in 5 liters of demineralized water while agitating and
squeezing for at least 30 seconds.
5. Repeat submerged rinse in fresh demineralized water. Ensure
that all detergent residue is removed by repeating submerged
rinse as many times as necessary.
6. Ensure the Headgear is visibly clean before continuing. If not,
repeat steps 1-5.
Drying: Make sure mask components are thoroughly dry before
continuing by leaving them to air dry out of direct sunlight. Failure to
do this may result in ineffective disinfection.
Disinfection:
Caution: The use of STERRAD® or Autoclave as a reprocessing
method may lead to mask degradation and adverse health
effects.
 STERRAD is a trademark of Advanced Sterilization Products,
adivision of Ethicon Inc., a Johnson & Johnson company.
Thermal disinfection: Run a disinfection cycle in a legally marketed
automatic washer-disinfector using one of the time/temperature
combinations shown in the reprocessing table. These time/
temperature combinations are consistent with EN ISO 15883 and
are equivalent in terms of known thermal inactivation kinetics of
vegetative microorganisms, meeting an A of 600.
Chemical disinfection:
1. Immerse completely in an undiluted bath of CIDEX OPA,
MetriCide OPA Plus or RAPICIDE OPA/28 at 20 °C, ensuring that
no air bubbles are present on the device surface.
2. Manually rotate the tube where it joins the frame for at least
10seconds while submerged.
3. Leave the mask parts to soak for 12 minutes.
4. Repeat steps 2 and 3.
5. Rinse thoroughly following the manufacturer’s rinsing instructions.
Manually rotate the tube where it joins the frame for at least
10seconds while rinsing.
Drying: Allow all components to air dry out of direct sunlight.
Inspection: Before each use, inspect the mask for deterioration. Ifany
visible deterioration of a mask component is apparent, the mask
component should be discarded and replaced.
Reassembly: Reassemble the mask according to the ‘Assembling
your mask’ instructions provided in these instructions. To ensure
traceability, mask components belonging to an individual mask must
be reassembled back into the same mask after cleaning, excluding
the components requiring replacement as marked in the reprocessing
table.
Storage: Ensure the mask is completely dry before storing. Store
in clean conditions out of direct sunlight. Storage temperature:
-20 °C to 50 °C (-4 °F to 122 °F).
Oxygen/pressure port connector
If pressure readings and/or additional oxygen are required,
anF&POxygen/Pressure Port Connector is available (REF 900HC452).
Please contact your healthcare provider for more information.
Warning: Mask use with supplemental oxygen will create a risk
of fire. Do not smoke, or be in the vicinity of someone smoking,
or any other ignition source while using supplemental oxygen
with your mask. This may result in ignition of the oxygen, leading
to serious burns or death.
Use with other PAP devices
Warning: When using the F&P Nova Micro mask with other
22 mm connector (ISO-5356-1) compatible PAP devices
(including F&P Oxygen/Pressure Port Connector
REF900HC452): Refer to the instructions for use for that
device as there may be additional warnings that if not followed
may result in a range of harms, some of which are severe.
Technical specifications
Exhaust flow information
Pressure
(cmHO) 4 6 8 10 12 14 16 18 20 22 24 25
Flow
(L/min)
13 16 19 22 24 27 29 31 33 35 37 38
Due to manufacturing variations, the exhaust flow rates may vary
from the nominal values shown above.
30
10
50
40
20
0
60
4 10 12 14 16 18 206 8
22 24 25
Exhaust Flow (L/min)
Pressure (cmH
2
O)
Resistance to flow
Pressure drop through the mask at 50 L/min:
- Small cushion 2.0±0.2 cmH
2
O
- Medium cushion 0.9±0.2 cmH
2
O
- Large cushion 0.7±0.2 cmH
2
O
Pressure drop through the mask at 100 L/min:
- Small cushion 7.9±1.0 cmH
2
O
- Medium cushion 3.8±1.0 cmH
2
O
- Large cushion 3.1±1.0 cmH
2
O
Mask dead space
Small = 14.1 cm Medium = 14.2 cm Large = 18.2 cm
Sound
The sound power level of the mask is 21.4 dBA, with uncertainty
2.5 dBA. The sound pressure level of the mask is 13.45 dBA, with
uncertainty 2.5 dBA.
Mask materials
The F&P Nova Micro mask and accessories are pyrogen free and not
made with natural rubber latex or DEHP.
Caution: If you are allergic or intolerant to any of the following
materials, consult your physician before using the F&P Nova
Micro mask, as this may cause an adverse reaction.
Component Material
Headgear
Nylon (PA)/Spandex/Polypropylene (PP)/Polyurethane foam
Cushion
Silicone
Frame
Nylon (PA)
Tube
Polycarbonate (PC), Polyurethane (PU)
Swivel
Nylon (PA)
Warranty statement
Fisher & Paykel Healthcare warrants that the mask (excluding
foams and material diffusers), when used in accordance with its
instructions for use, shall be free from defects in workmanship
and materials and will perform in accordance with Fisher & Paykel
Healthcare’s official published product specifications for a period of
90 days from the date of purchase by the end user. This warranty
is subject to the limitations and exceptions set out in detail in
www.fphcare.com/sleep-apnea/masks/warranty-mask/
Replacement parts
The following parts are available for replacement. Please contact your
healthcare provider for more information.
Product Code Description
400NVP111, 400NVP114* F&P Nova Micro Pillows Spare Cushion - Small
400NVP112, 400NVP115* F&P Nova Micro Pillows Spare Cushion - Medium
400NVP113, 400NVP116* F&P Nova Micro Pillows Spare Cushion - Large
400NVP121, 400NVP122* F&P Nova Micro Pillows Headgear
400NVP131*
F&P Nova Micro Pillows Mask -
Mask No Headgear Small
400NVP132*
F&P Nova Micro Pillows Mask -
Mask No Headgear Medium
400NVP133*
F&P Nova Micro Pillows Mask -
Mask No Headgear Large
400NVP141 F&P Nova Micro Pillows Frame Assembly Spare
*Not available in all countries.
Disposal
The F&P Nova Micro mask does not contain any hazardous materials
and may be disposed of with general waste or following hospital
procedure.
Intellectual property information
F&P, Nova Micro and myMask are trademarks of Fisher & Paykel
Healthcare Limited.
For patent information, see www.fphcare.com/ip
Symbol definitions
Catalogue number
Prescription only
CE Marking
Authorized European
Representative
Unique device
identifier
Batch code
Medical device
Single patient
multiple use
Blue symbol:
Follow instructions
for use
Consult instructions
for use
85%
30%
Humidity
limitation
50 °C
-20 °C
Storage temperature
limitation
Use by date
Caution/Warning
Date of
manufacture
Manufacturer
Small cushion size
Medium cushion size
Large cushion size
Low-Density
Polyethylene
Recycling symbol
Polyethylene
Terephthalate, Low-
Density Polyethylene
Importer
Distributor
Switzerland
Authorized
Representative
UK Responsible
Person