User Guide

User Guide
User Guide
English
Pixi
TM
PEDIATRIC MASK
Pixi™
pediatric mask
Contents / Contenu / Contenido / Conteúdo
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Mask components / Composants du masque /
Piezas de la mascarilla / Componentes da máscara
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4
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9
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6
10
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18
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B
Mask components / Composants du masque /
Piezas de la mascarilla / Componentes da máscara
Item /
Composant /
Pieza / Item
Description / Description / Descripción /
Descrição
Part number /
Code
produit /
Número
de pieza /
Número da
peça
1.
Short tube assembly / Ensemble tuyau court /
Conjunto del tubo corto / Conjunto de tubo curto
—
2.
Elbow / Coude / Codo / Cotovelo
—
3.
Plug tether / Point d’attache du bouchon
d’obturation / Cabo del tapón / Limitador da
tampa
—
4.
Mask frame / Entourage rigide / Armazón de la
mascarilla / Armação da máscara
—
5.
Frame nodes / Points de fixation de l’entourage /
Nudos del armazón / Ressaltos da armação
—
6.
Mask socket / Logement du masque / Enchufe
de la mascarilla / Cavidade da máscara
—
7.
Plug / Bouchon d’obturation / Tapón / Tampa
—
8.
Cushion / Bulle / Almohadilla / Almofada
61033
9.
Vent / Ensemble orifices de ventilation / Orificios
de ventilación / Respiradouro
—
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Item /
Composant /
Pieza / Item
Description / Description / Descripción /
Descrição
Part number /
Code
produit /
Número
de pieza /
Número da
peça
10.
Cushion shoulder / Rebord de la bulle / Hombro
de la almohadilla / Projeção da almofada
—
11.
Pressure port / Port de pression / Puerto de
presión / Porta de pressão
—
12.
Headgear / Harnais / Arnés / Arnês
61034
13.
Top headgear strap and buckle (light blue) /
Sangle supérieure du harnais et boucle
(bleu clair) / Correa superior del arnés y hebilla
(celeste) / Correia superior do arnês e fivela
(azul claro)
—
14.
Middle headgear strap and buckle (dark blue) /
Sangle centrale du harnais et boucle (bleu
foncé) / Correa del medio del arnés y hebilla
(azul) / Correia central do arnês e fivela (azul
escuro)
—
15.
Lower headgear strap / Sangle inférieure du
harnais / Correa inferior del arnés / Correia
inferior do arnês
—
16.
Quick release clip / Clip de retrait rapide / Broche
de abertura inmediata / Presilha de liberação
rápida
—
17.
Lower headgear arms / Bras inférieurs du
harnais / Brazos inferiores del arnés / Braços
inferiores do arnês
—
18.
22 mm Swivel / Pièce pivotante 22 mm /
22 mm Pieza giratoria / 22 mm Peça giratória
—
A
Complete system / Masque complet / Sistema
completo / Sistema completo
61030
B
Frame system / Support / Sistema del armazón /
Sistema da armação
61035
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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.
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Pixi™
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.
Gently pull the headgear arm into place until it clicks.
6.
Repeat steps 4-5 with the other side (without stars).
Set up is now complete and the mask is ready for fitting.
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Set up
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.
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Fitting
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.
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Attaching the pressure port
English
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 clincian will advise when
this is required.
Attachment steps
1.
Remove the plug from the cushion.
2.
Move the plug to the side so that it is not obstructing the vent holes.
3.
Insert the larger end of the pressure port into the cushion.
4.
Attach the other end of the pressure port to the oxygen system.
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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.
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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.
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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.
Remove the combined elbow and air tubing from the mask.
3.
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.
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Disassembly
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.
Thread each light blue strap up and over the light blue buckle, then
secure into place.
3.
Thread each dark blue strap up and over the dark blue buckle, then
secure into place.
4.
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.
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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.
Replace the plug into the appropriate side of the cushion.
4.
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.
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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 86°F/30°C) water using mild
soap.
•• To optimize 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.
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Cleaning the mask
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.
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•• 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.
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WARNING
Technical specifications
The mask contains passive venting to protect against
rebreathing. As a result of manufacturing variations, the
vent flow rate may vary.
Pressure–flow
curve
Vent flow rate (L/min)
70
60
50
40
30
Pressure
(cm H2O)
Flow
(L/min)
3
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7
28
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20
49
20
10
0
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4
6
8
10
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20
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
3 to 20 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
Environmental
conditions
Operating temperature: +41°F to +104°F
(+5°C to +40°C)
Operating humidity: 15% to 95% non-condensing.
Storage and transport: -4°F to +140°F
( -20°C to +60°C)
Storage and transport humidity: up to 95% noncondensing.
Gross
dimensions
Mask fully assembled with elbow assembly – no
headgear.
1.38“ (H) x 16.93“ (W) x 1.57“ (D)
35 mm (H) x 430 mm (W) x 40 mm (D)
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.
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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
Caution, consult accompanying documents;
REF
Catalogue number;
LOT
Batch Code;
Temperature limitation;
Does not contain natural rubber latex;
Humidity limitation;
Manufacturer;
Indicates
a Warning or Caution and alerts you to a possible injury or explains special
measures for the safe and effective use of the device;
from rain;
This way up;
Authorised Representative;
Keep away
Fragile, handle with care.;
European
Prescription only (In the US, Federal law
restricts these devices to sale by or on the order of a physician).
Limited warranty
ResMed Ltd (hereafter ’ResMed’) warrants that your ResMed mask system
(including mask frame, cushion, headgear and tubing) shall be free from
defects in material and workmanship from the date of purchase for the period
of 90 days or in the case of disposable masks the maximum use period.
This warranty is only available to the initial consumer. It is not transferable.
If the product fails under conditions of normal use, ResMed will repair or
replace, at its option, the defective product or any of its components.
This limited warranty does not cover: a) any damage caused as a result of
improper use, abuse, modification or alteration of the product; b) repairs
carried out by any service organization that has not been expressly authorized
by ResMed to perform such repairs; and c) any damage or contamination due
to cigarette, pipe, cigar or other smoke.
Warranty is void on product sold, or resold, outside the region of original
purchase.
Warranty claims on defective product must be made by the initial consumer
at the point of purchase.
This warranty replaces all other expressed or implied warranties, including
any implied warranty of merchantability or fitness for a particular purpose.
Some regions or states do not allow limitations on how long an implied
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English
Storage
warranty lasts, so the above limitation may not apply to you.
ResMed shall not be responsible for any incidental or consequential damages
claimed to have resulted from the sale, installation or use of any ResMed
product. Some regions or states do not allow the exclusion or limitation of
incidental or consequential damages, so the above limitation may not apply
to you. This warranty gives you specific legal rights, and you may also have
other rights which vary from region to region. For further information on your
warranty rights, contact your local ResMed dealer or ResMed office.
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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.
See www.resmed.com for other ResMed locations worldwide.
Protected by patents: AU 712236, AU 724360, EP 0968022, JP 3687981, JP 4188883,
JP 4653188, US 6561190, US 6561191, US 7207335, US 7845354. Other patents pending.
Pixi is a trademark of ResMed Ltd.
© 2011 ResMed Ltd.
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618162/4 2011-06
Pixi
USER
AMER ENG
618162
Global leaders in sleep and respiratory medicine www.resmed.com
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