User Guide
English
TM
Pixi
PEDIATRIC MASK
Download from Www.Somanuals.com. All Manuals Search And Download.
Mask components / Maskenkomponenten /
Composants du masque / Componenti della maschera /
Maskkomponenter / Maskedele / Maskens komponenter /
Maskin osat
3
A
2
4
1
5
8
9
6
10
7
11
13
18
14
12
15
16
17
ii
Download from Www.Somanuals.com. All Manuals Search And Download.
B
Mask components / Maskenkomponenten /
Composants du masque / Componenti della maschera /
Maskkomponenter / Maskedele / Maskens komponenter /
Maskin osat
Item /
Description / Beschreibung / Description /
Descrizione / Beskrivning / Beskrivelse /
Part number /
Teilenummer /
Code produit /
Codice prodotto /
Artikelnummer /
Delnummer /
Artikel /
Composant / Beskrivelse / Nimitys
Elemento /
Artikel / Del /
Artikkel /
Osa
Delenummer /
Tuotenumero
1.
Short tube assembly / Verbindungsschlauch-
—
Satz / Ensemble tuyau court / Gruppo circuito
corto (mount) / Kort slangmontering / Kort
slange / Kort slange / Lyhyt letku
2.
3.
Elbow / Kniestück / Coude / Gomito
girevole / Knärör / Vinkelstykke / Kneledd /
Kulmakappale
—
—
Plug tether / Verschlussbefestigung / Point
d’attache du bouchon d’obturation / Attacco
del tappo / Plugghållare / Propforankring /
Pluggforankring /Tulpan kiinnitysnauha
4.
Mask frame / Maskenrahmen / Entourage
rigide /Telaio della maschera / Maskram /
Maskeramme / Maskeramme / Maskin runko
—
iii
Download from Www.Somanuals.com. All Manuals Search And Download.
Item /
Description / Beschreibung / Description /
Descrizione / Beskrivning / Beskrivelse /
Part number /
Teilenummer /
Code produit /
Codice prodotto /
Artikelnummer /
Delnummer /
Artikel /
Composant / Beskrivelse / Nimitys
Elemento /
Artikel / Del /
Artikkel /
Osa
Delenummer /
Tuotenumero
5.
Frame nodes / Rahmenanschlüsse / Points
—
—
—
de fixation de l’entourage / Nodi del telaio /
Fäste för huvudband / Rammeknopper /
Rammenoder / Kiinnitysnystyrät
6.
Mask socket / Maskenfassung / Cavité
du masque / Scanalatura della maschera /
Mjukdelsfäste / Maskestudse / Maskens
tilkoblingshull / Maskin kiinnityskohdat
7.
Plug / Verschluss / Bouchon d’obturation /
Tappo / Plugg / Prop / Plugg /Tulppa
8.
9.
Cushion / Maskenkissen / Bulle / Cuscinetto / 61033
Mjukdel / Pude / Pute / Pehmike
Vent / Ausatemöffnung / Ensemble orifices
de ventilation / Fori per l’esalazione / Ventil /
Lufthul / Ventil / Ilma-aukko
—
10.
Cushion shoulder / Maskenkissenrand /
Rebord de la bulle / Spalla del cuscinetto /
Mjukdelskant / Pudeansats / Puteskulder /
Pehmikkeen uloke
—
11.
Pressure port / Druckanschluss / Port de
pression / Presa della pressione /Tryckport /
Trykport /Trykkslange / Paineletku
—
12.
13.
Headgear / Kopfband / Harnais / Copricapo /
Huvudband / Hovedbånd / Hodestropper /
Pääremmit
61034
—
Top headgear strap and buckle (light blue) /
Oberes Kopfband und Clip (hellblau) / Sangle
et boucle supérieures du harnais (bleu clair) /
Cinghia e fibbia superiore del copricapo
(azzurro) / Övre huvudbandsrem och spänne
(ljusblå) / Øverste hovedbåndsstrop og
-spænde (lyseblå) / Øvre hodestropp og
spenne (lyseblå) / Pääremmien ylempi hihna
ja solki (vaaleansiniset)
iv
Download from Www.Somanuals.com. All Manuals Search And Download.
Item /
Description / Beschreibung / Description /
Descrizione / Beskrivning / Beskrivelse /
Part number /
Teilenummer /
Code produit /
Codice prodotto /
Artikelnummer /
Delnummer /
Artikel /
Composant / Beskrivelse / Nimitys
Elemento /
Artikel / Del /
Artikkel /
Osa
Delenummer /
Tuotenumero
14.
Middle headgear strap and buckle (dark
blue) / Mittleres Kopfband und Clip
—
(dunkelblau) / Sangle et boucle du milieu
du harnais (bleu foncé) / Cinghia e fibbia
intermedia del copricapo (blu) / Mellersta
huvudbandsrem och spänne (mörkblå) /
Midterste hovedbåndsstrop og -spænde
(mørkeblå) / Midtre hodestropp og spenne
(mørkeblå) / Pääremmien keskimmäinen
hihna ja solki (tummansiniset)
15.
Lower headgear strap / Unteres
Kopfband / Sangle inférieure du harnais /
Cinghia inferiore del copricapo /
Nedre huvudbandsrem / Nederste
hovedbåndsstrop / Nedre hodestropp /
Alahihna
—
16.
17.
Quick release clip / Schnell zu öffnender
Clip / Clip de retrait rapide / Fermaglio di
rilascio rapido / Säkerhetsspänne / Klemme
til hurtig udløsning / Hurtigutløsningsklips /
Pikairrotuskiinnike
—
—
Lower headgear arms / Untere
Kopfbandhalter / Bras inférieurs du harnais /
Bracci inferiori del copricapo / Fäste för
maskram / Nederste hovedbåndsarme /
Nedre hodestropparmer / Alemmat
sivukappaleet
18.
22 mm Swivel / 22 mm Drehadapter /
Pièce pivotante 22 mm / Giunto rotante
da 22 mm / Swivel, 22 mm / 22 mm
drejestuds / 22 mm svivel / 22 mm:n
pyörivä liitin
—
A
B
Complete system / Komplettes System /
Masque complet / Sistema completo /
Komplett system / Komplet maske /
Fullstendig system / Maski täydellisenä
61031
61035
Frame system / Maskenrahmensystem /
Entourage complet /Telaio /
Maskramsystem / Rammesystem /
Rammesystem / Maskin koko runko
v
Download from Www.Somanuals.com. All Manuals Search And Download.
Pixi™
pediatric mask
Thank you for choosing the Pixi Pediatric mask. Please read the entire manual
before use.
Intended use
The Pixi Pediatric mask channels airflow noninvasively to a patient from a
continuous positive airway pressure (CPAP) or bilevel device (‘device’).
The Pixi Pediatric mask is:
•
to be used by children aged between 2 and 7 for whom continuous
positive airway pressure (CPAP) or bilevel therapy has been prescribed
intended for single-patient re-use in the home and single patient re-use in
the hospital/institutional environment.
•
WARNING
• This mask is designed to provide a stable effective air seal with
minimum headgear tension. High headgear tension may lead to facial
deformities with long-term use. Regular clinician review of growth
patterns and the use of different styles of mask is recommended.
• The mask must be used under qualified supervision for patients who
are unable to remove the mask by themselves.
• The mask may not be suitable for those predisposed to aspiration.
• If the mask is prescribed for children with serious congenital
conditions or cognitive impairments, then using a device with
appropriate alarms is recommended.The correct operation of the
complete patient circuit, including alarms must be tested before
commencing therapy.
• Follow all precautions when using supplemental oxygen.
• Oxygen flow must be turned off when the CPAP or bilevel device is
not operating, so that unused oxygen does not accumulate within the
device enclosure and create a risk of fire.
• Oxygen supports combustion. Oxygen must not be used while
smoking or in the presence of an open flame. Only use oxygen in well
ventilated rooms.
• The vent holes must be kept clear and must not sit against the nose.
• The mask should not be used unless the device is turned on. Once the
mask is fitted, ensure the device is blowing air.
1
Download from Www.Somanuals.com. All Manuals Search And Download.
Explanation: CPAP and bilevel devices are intended to be used
with special masks (or connectors) which have vent holes to allow
continuous flow of air out of the mask. When the device is turned on
and functioning properly, new air from the device flushes the exhaled
air out through the mask vent holes. However, when the device is not
operating, insufficient fresh air will be provided through the mask,
and the exhaled air may be rebreathed. Rebreathing of exhaled air
for longer than several minutes can, in some circumstances, lead to
suffocation.This applies to most models of CPAP or bilevel devices.
• This mask should only be used with CPAP or bilevel devices
recommended by a physician or respiratory therapist.
• Using a mask may cause tooth, gum or jaw soreness or aggravate an
existing dental condition. If symptoms occur, consult your physician
or dentist.
• Remove and dispose of all packaging before using the mask.
Set up
Determine which side of the cushion the air tubing will be located. Ideally this
should be the side that is closest to the device.
Pixi Hint! If the child has a preference for sleeping on a particular
side, this should be considered when determining the location of the
device.
Changing the side of the air tubing
1.
To change the side of the air tubing, remove the plug from the cushion.
2.
Insert the combined elbow and air tubing until the cushion meets the
ridge on the elbow.
3.
Ensure the opposite side of the cushion is fully closed by securely
inserting the plug into the cushion opening.
Attaching the headgear
The mask frame has been designed to ensure the headgear is fitted correctly
every time.
4.
Latch the lower headgear arm with the star onto the frame node with
two stars, so that the frame is nested between the plastic and the
padding of the headgear.
5.
6.
Gently pull the headgear arm into place until it clicks.
Repeat steps 4-5 with the other side (without stars).
Set up is now complete and the mask is ready for fitting.
2
Download from Www.Somanuals.com. All Manuals Search And Download.
Set up
1
3
5
2
4
6
3
Download from Www.Somanuals.com. All Manuals Search And Download.
WARNING
• Ensure that the nasal cushion does not block the nostrils at any time
during fitting or use.
• Do not leave long lengths of air tubing around the top of the child’s
bed. It could twist around the child’s head or neck while sleeping.
Fitting
The fitting illustrations show the sequence for obtaining the best fit and
comfort when using the mask.
Pixi Hints!
• If fitting the mask for the first time, we recommend the child be
sitting in an upright position to ensure correct fit.
• To avoid possible anxiety by the child, ensure all parts of the
mask frame and headgear are kept clear from the eyes and eye
area.
• The child will best adapt to therapy if the mask is correctly fitted
before the device is turned on.
Fitting steps
1–2. Hold the mask gently against the child’s face, checking that the nose
is fully enclosed by the cushion and the mouth is clear – pull the
headgear up over the head. Move the middle strap down over the head
until it sits across the middle of the back of the head.
3.
Keeping your hand on the frame to maintain correct headgear position,
bring the lower headgear strap behind the back of the neck.
4–5. Attach the lower headgear strap to the mask by holding the tab and
hooking the quick release clip onto the lower headgear arm.
6.
When fully fitted, the mask and headgear should be positioned as
shown. Ensure the top strap is vertically aligned with the top of the
ears and the middle strap sits across the back of the head horizontally
aligned with the top of the ears.
7.
Finally, connect the free end of the short tube assembly to the device
air tubing.
4
Download from Www.Somanuals.com. All Manuals Search And Download.
Fitting
1
3
5
2
4
6
5
Download from Www.Somanuals.com. All Manuals Search And Download.
Adjustment
Pixi Hints!
• To achieve optimal seal, adjust the headgear straps starting at the
bottom strap and working upwards.
• If the child experiences nasal dryness or irritation, using a
humidifier is recommended.
Adjustment steps
1.
If necessary, adjust the straps by removing the Velcro and gently
tightening the lower headgear straps until comfortable. Do not
overtighten.
2–3. Repeat step 1 with both middle and top straps until comfortable.
Note:The mask is designed to fit loosely while still providing an
optimal seal. Do not overtighten the straps.
1
3
2
6
Download from Www.Somanuals.com. All Manuals Search And Download.
Attaching the pressure port
The pressure port is used to measure the air pressure at your mask so
that the correct pressure is set. This happens during the sleep study at the
hospital.
The pressure port is also used to deliver oxygen. This can take place in the
home or hospital environment. If necessary, your clinician will advise when
this is required.
Attachment steps
1.
Remove the plug from the cushion.
2.
3.
4.
Move the plug to the side so that it is not obstructing the vent holes.
Insert the larger end of the pressure port into the cushion.
Attach the other end of the pressure port to the oxygen system.
1
2
4
3
7
Download from Www.Somanuals.com. All Manuals Search And Download.
Cushion check
Cushion check steps
1–2. Ensure the cushion is not creased or folded or caught inside the
sockets of the mask frame.
3.
The Pixi cushion is designed to sit mid-bridge. Ensure that the mask
does not block the nose or mouth at any time.
1
3
2
8
Download from Www.Somanuals.com. All Manuals Search And Download.
Removal
Removal steps
1–2. Gently hold the mask against the child’s face. Unhook the quick release
clip from the lower headgear arm by pulling forward and away from the
arm.
3–4. Keep holding the mask and remove the headgear by pulling up and
over the head towards the face.
1
3
2
4
9
Download from Www.Somanuals.com. All Manuals Search And Download.
Emergency removal
In the event of an emergency, remove the mask by placing your finger under
the lower headgear strap and firmly pulling it away from the child – this will
activate the quick release clip. Do not use this removal method under normal
circumstances.
Disassembly
Disassembly steps
1.
Detach the headgear from the mask frame by unlatching each of the
lower headgear arms from the frame nodes.
2.
3.
Remove the combined elbow and air tubing from the mask.
Remove the plug from the cushion.
4–5. Remove the cushion from the frame by gently pushing it through from
the front of the frame and pulling it away from the rear of the mask
frame.
WARNING
When disassembling the mask, always keep all accessories and
components out of the reach of small children as small parts might
present a choking hazard. Seek immediate medical attention if choking
occurs or if any small part has been swallowed.
10
Download from Www.Somanuals.com. All Manuals Search And Download.
Disassembly
1
3
5
2
4
11
Download from Www.Somanuals.com. All Manuals Search And Download.
Headgear reassembly
Pixi Hints!
• You don’t need to disassemble your Pixi headgear to wash it.
• The Velcro straps and plastic buckles have been color coded for
ease of assembly.
Headgear reassembly steps
1.
Lay the headgear and plastic buckles out on a flat surface as shown,
ensuring the lower headgear arms are facing up.
2.
3.
4.
Thread each light blue strap up and over the light blue buckle, then
secure into place.
Thread each dark blue strap up and over the dark blue buckle, then
secure into place.
Thread the Velcro only end of the lower headgear strap through the
lower headgear arm, then secure into place. There is no need to
attach the quick release clip to the headgear now.
Ensure that any Velcro or plastic parts are on the outer side of the mask,
otherwise your headgear may be incorrrectly assembled. The headgear is
now ready for fitting. Refer to the Set up illustrations in this guide.
1
2
3
12
Download from Www.Somanuals.com. All Manuals Search And Download.
4
13
Download from Www.Somanuals.com. All Manuals Search And Download.
Reassembly
Reassembly steps
1.
Insert each side of the cushion into the sockets of the mask frame.
Ensure the cushion is oriented correctly. The arrows on the cushion
should be pointing up towards the plug tether. The raised vented area
of the cushion should also be sitting up against the mask frame.
2.
Pull the arms of the cushion through until the collar of the cushion
shoulder is sitting against the mask frame.
3.
4.
Replace the plug into the appropriate side of the cushion.
Insert the combined elbow and air tubing into the other side of the
cushion, ensuring that it is fully inserted.
5.
Reattach the headgear. Refer to the Attaching the headgear illustrations
in this user guide.
1
3
2
4
14
Download from Www.Somanuals.com. All Manuals Search And Download.
Cleaning the mask
The mask and headgear should only be gently handwashed.
Daily/After each use:
•
•
•
Disassemble the mask components according to the disassembly
instructions.
Thoroughly clean the separated mask components (excluding headgear),
by gently rubbing in warm (approximately 30°C) water using mild soap.
To optimise the mask seal, facial oils should be removed from the
cushion after use.
•
•
Use a soft bristle brush to clean the vent.
Inspect each component and, if required, repeat washing until visually
clean.
•
•
Rinse all components well with drinking quality water and allow to air dry
out of direct sunlight.
When all components are dry, reassemble according to the reassembly
instructions.
Weekly:
Handwash the headgear. It can be washed without being disassembled.
•
WARNING
Do not use aromatic-based solutions or scented oils (eg, eucalyptus or
essential oils), bleach, alcohol or products that smell strongly (eg, citrus)
to clean any of the mask components. Residual vapours from these
solutions can be inhaled if not rinsed thoroughly.They may also damage
the mask.
CAUTION
If any visible deterioration of a system component is apparent (cracking,
crazing, broken parts, tears etc), or, if after cleaning, any component
remains unclean, the component should be discarded and replaced.
15
Download from Www.Somanuals.com. All Manuals Search And Download.
Troubleshooting
Problem / possible cause
Solution
Mask is too noisy
Vent is blocked or partially blocked.
If the vent requires cleaning, use a soft
bristle brush.
Elbow or plug is incorrectly inserted.
Remove the elbow and plug from the
mask and then reassemble according
to the instructions.
Mask leaks around the face
Mask is not positioned correctly.
Gently pull the cushion away from the
face to reinflate. Reposition the mask
according to the instructions.
Air leaking around the nose
Mask is not tightened correctly.
Tighten the bottom and middle
headgear straps. The top strap is
designed to sit quite loosely. Do not
overtighten.
Turn off the device and remove the
mask. Refit the mask according to the
instructions. Ensure you position the
cushion correctly on the face before
pulling headgear over the head.
The mask does not fit properly
Mask may be incorrectly assembled.
Disassemble the mask and reassemble
according to the instructions.
Cushion may be dirty.
Clean the cushion according to the
instructions.
16
Download from Www.Somanuals.com. All Manuals Search And Download.
WARNING
• The technical specifications of the mask are provided for your clinician
to check that they are compatible with the CPAP or bilevel device. If
used outside specification or if used with incompatible devices, the
seal and comfort of the mask may not be effective, optimum therapy
may not be achieved, and leak, or variation in the rate of leak, may
affect the device function.
• Discontinue using this mask if the child has any adverse reaction to
the use of the mask, and consult your physician or sleep therapist.
• At a fixed rate of supplemental oxygen flow, the inhaled oxygen
concentration varies, depending on the pressure settings, patient
breathing pattern, mask, point of application and leak rate.This
warning applies to most type of CPAP or bilevel devices.
• As with all masks, some rebreathing may occur at low CPAP
pressures.
• Refer to your device manual for details on settings and operational
information.
17
Download from Www.Somanuals.com. All Manuals Search And Download.
Technical specifications
Pressure–flow
curve
The mask contains passive venting to protect against
rebreathing. As a result of manufacturing variations, the
vent flow rate may vary.
70
60
50
40
30
20
10
0
Pressure
(cm H2O) (L/min)
Flow
2
14
31
43
53
61
9
16
23
30
2
4
6
8
10
12
14
16
18
20
22
24
26
28
30
Mask pressure (cm H2O)
Dead space
information
Physical dead space is the empty volume of the mask
to the end of the swivel.
It is 101.7 mL.
Therapy pressure 2 to 30 cm H2O
Compliance
Mask compliance between 5 cm H2O and 15 cm H2O is
less than 1.57 mL/cm H2O
Resistance
Drop in pressure measured (nominal)
at 50 L/min: 0.8 cm H2O
at 100 L/min: 3.1 cm H2O
Sound
DECLARED DUAL-NUMBER NOISE EMISSION
VALUES in accordance with ISO 4871. The A-weighted
sound power level of the mask is 40.6 dBA, with
uncertainty 4 dBA. The A-weighted sound pressure
level of the mask at a distance of 1 m is 32.6 dBA, with
uncertainty 4 dBA.
Environmental
conditions
Operating temperature: +5°C to +40°C
Operating humidity: 15% to 95% non-condensing.
Storage and transport: -20°C to +60°C
Storage and transport humidity: up to 95% non-
condensing.
Gross
dimensions
Mask fully assembled with elbow assembly – no
headgear.
35 mm (H) x 430 mm (W) x 40 mm (D)
18
Download from Www.Somanuals.com. All Manuals Search And Download.
Notes:
•
•
•
The mask system does not contain PVC, DEHP or phthalates.
This product does not contain natural rubber latex.
The manufacturer reserves the right to change these specifications
without notice.
Storage
Ensure that the mask is thoroughly clean and dry before storing it for any
length of time. Store the mask in a dry place out of direct sunlight.
Disposal
This mask does not contain any hazardous substances and may be disposed of
with your normal household refuse.
Symbols
LOT
Caution, consult accompanying documents;
Batch Code;
Humidity limitation;
Manufacturer;
Indicates a Warning or
REF
Catalogue number;
Temperature limitation;
Does not contain natural rubber latex;
European Authorised Representative;
Caution and alerts you to a possible injury or explains special measures for the
safe and effective use of the device;
Fragile, handle with care.
Keep away from rain;
This way up;
Consumer warranty
ResMed acknowledges all consumer rights granted under the EU Directive
1999/44/EG and the respective national laws within the EU for products sold
within the European Union.
19
Download from Www.Somanuals.com. All Manuals Search And Download.
Manufacturer:
ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia.
Distributed by:
ResMed Corp 9001 Spectrum Center Boulevard San Diego CA 92123 USA.
ResMed (UK) Ltd 96 Milton Park Abingdon Oxfordshire OX14 4RY UK.
Pixi is a trademark of ResMed Ltd.
Velcro is a trademark of Velcro Industries B.V.
© 2011 ResMed Ltd.
Download from Www.Somanuals.com. All Manuals Search And Download.
2
4
6
1
3
5
618215/1 2011-09
Pixi
618215
USER
EUR ENG
Download from Www.Somanuals.com. All Manuals Search And Download.
|