ResMed Mirage Swift II User manual

Global leaders in sleep and respiratory medicine www.resmed.com
Mirage Swift™II
NASAL PILLOWS SYSTEM
User Guide
English
608172/2 08 09
MIRAGE SWIFT II
USER
EUR2
608172
608172 Swift II Multi cover.qxp 18/09/2008 11:25 AM Page 1

ResMed Ltd (Manufacturer) 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia
ResMed Corp (US Designated Agent) 14040 Danielson Street Poway CA 92064-6857 USA
ResMed (UK) Ltd (EU Authorized Representative) 96 Milton Park Abingdon Oxfordshire OX14 4RY UK
ResMed Offices Australia, Austria, Belgium, Brazil, China, Finland, France, Germany, Greece, Hong Kong, India,
Ireland, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Portugal, Singapore, South Africa,
Spain, Sweden, Switzerland, UK, USA (see www.resmed.com for contact details).
Mirage Swift II Nasal Pillows System
Protected by patents: AU 785376, DE 20321468.4, DE 20321469.2, DE 20321470.6, DE 20321471.4, DE 20321472.2,
EP 1314445, NZ 562417, NZ 562418, NZ 562419, NZ 553756, NZ 553757, NZ 553822, NZ 553824, NZ 553825, US
6581594, US 6823865, US 7159587, US 7318437. Other patents pending.
Protected by design registrations: AU 301936, AU 301937, AU 301938, AU 301939, AU 301940, AU 301941, AU
301942, AU 301943, AU 302271, AU 302804, AU 311482, AU 311483, AU 311484, AU 311485, CN 200430102460.2,
CN 200430102461.7, CN 200430102462.1, CN 200430102463.6, CN 200430102464.0, CN 200430102465.5, CN
200430102466.X, CN 200430102467.4, CN 200430102468.9, CN 200630138503.1, CN 200630138504.6, CN
200730158310.7, EP 259056, EU 604632, HK 0412683.5, JP 1243021, JP 1243024, JP 1243272, JP 1243273, JP
1243274, JP 1243027, JP 1243025, JP 1242455, JP 1242456, JP 1243026, JP 1243475, JP 1303347, JP 1303348, JP
1312331, JP 1312517, JP 1312518, NZ 405576, NZ 407158, NZ 407159, NZ 407143, NZ 407144, NZ 407145, NZ
407155, NZ 407160, NZ 407161, NZ 407162, NZ 407163, NZ 407164, NZ 408220, NZ 408221, NZ 408222, US
D542912, US D545961, US D546441, US D549323, US D556899, US D556900, US D557409, US D557410, US
D557800, US D561893, US D562729, US D562976. Other designs pending.
Mirage, Mirage Swift, AutoSet CS 2 and VPAP Adapt SV are trademarks of ResMed Ltd and Mirage, Swift,
AutoSet CS and VPAP are registered in U.S. Patent and Trademark Office.
Dove is a trademark of Unilever.
© 2008 ResMed Ltd. 608172-Eng/2 08 09
608172 Swift II Multi cover.qxp 18/09/2008 11:25 AM Page 2

Tube retainer /
Tube-houder / Slangeholder /
Slangeholder / Letkun kiinnike
1
5
5
4
3
2b
2a
1
34b
2b 45
6
2
3
4a
1
BFitting the Mirage Swift II / Passend maken van de Mirage Swift II / Tilpasning af Mirage Swift II / Montering av Mirage Swift II / Mirage Swift II -nenäkanyylien sovittaminen
DReassembling the Mirage Swift II / In elkaar zetten van de Mirage Swift II / Genmontering af Mirage Swift II / Montering av Mirage Swift II igjen / Mirage Swift II -nenäkanyylien kokoaminen
CDisassembling for Cleaning / Uit elkaar halen voor reiniging / Adskillelse før rengøring / Demontering for rengjøring / Purkaminen puhdistamista varten
Headgear / Hoofdband / Hovedbånd / Hodeutstyr / Pääremmit
AParts of the Mirage Swift™II / Onderdelen van de Mirage Swift™II / Dele i
Mirage Swift™ II / Deler av Mirage Swift™ II / Mirage Swift™ II -nenäkanyylien osat
Pillow sleeve assembly (pillow sleeve, frame and clip) /
Kussentjeskokerconstructie (kussentjeskoker,frame en klem) /
Pudeholdersamling (pudeholder,ramme og clip) /
Putehylseenhet (putehylse, ramme og klemme) /
Nenäkanyylien muhviosa (muhvi, runko ja kiinnike)
Short tube assembly (elbow,short tube and swivel) / Korte tube-constructie (bocht, korte tube en draaibare kop) /
Kort luftslangesamling (vinkelstykke,kort luftslange og drejestuds) / Kort slangeenhet (kneledd, kort slange og svivel) /
Lyhyt letkuosa (kulmakappale, lyhyt letku ja pyörivä liitin)
Short tube / Korte tube /
Kort luftslange / Kort slange /
Lyhyt letkuosa
Elbow / Bocht / Vinkelstykke / Kneledd /
Kulmakappale
Vent holes / Luchtopeningen / Lufthuller / Lufteåpninger / Ilmareiät
Top buckle / Bovengesp / Øverste spænde /
Toppspenne / Yläsolki
Top strap / Band aan de bovenkant /
Øverste strop /Toppstropp / Ylähihna
Panel / Paneel / Panel / Panel / Sivutuki
Back strap / Band aan de achterkant /
Bagerste strop / Bakstropp /Takahihna
Back buckle / Achtergesp / Bagerste spænde /
Bakspenne / Takasolki
Seal ring (x2) / Afdichtring (x2) /
Pakningsring (x2) / Pakningsring (x2) /
Tiivisterengas (2 kpl)
Headgear ring / Hoofdbandring /
Hovedbåndsring / Hodeutstyrsring /
Pääremmien rengas
ResMed logo faces outward / ResMed logo wijst naar buiten /
ResMed-logo vender udad / ResMed-logo peker utover /
ResMed-logo on ulospäin
Adjust back straps / Banden aan de
achterkant aantrekken / Juster bagerste
stropper / Juster bakstroppene / Säädä
takahihnat
Adjust top straps / Banden aan de
bovenkant aantrekken / Juster øverste
stropper / Juster toppstroppene / Säädä
ylähihnat
Rotate pillow sleeve assembly for comfort and seal / Roteer de
kussentjeskokerconstructie voor comfort en afdichting / Roter
pudeholderen for at optimere komfort og tæthed / Roter
putehylseenheten for komfort og forsegling / Kierrä muhviosaa
saadaksesi nenäkanyylit mukaviksi ja tiiviiksi
Tube retainer (optional) /Tube-houder
(optioneel) / Slangeholder (ekstraudstyr) /
Slangeholder (ekstrautstyr) / Letkunkiinnike
(lisävaruste) Optional tube positions / Optionele tube-posities / Valgfri
slangeplaceringer / Valgfrie slangeposisjoner / Letkun sijoitteluvaihtoehdot
Elbow / Bocht /Vinkelstykke /
Kneledd / Kulmakappale Cap / Dop / Hætte / Lokk / Tulppa Headgear ring / Hoofdbandring / Hovedbåndets
ring / Hodeutstyrsring / Pääremmien rengas
Slide clip / Zijklem / Skydeklemme /
Glideklemme / Liukukiinnike
Pillow sleeve / Kussentjeskoker /
Pudeholder / Putehylse / Nenäkanyylien
muhvi
Note: The seal rings do not need to be removed for cleaning. /
N.B.: De afdichtringen hoeven voor het schoonmaken niet te worden
verwijderd. / Bemærk: Det er ikke nødvendigt at fjerne tætningsringene
under rengøring. / Merk: Forseglingsringene behøver ikke fjernes for
rengjøring. / Huomautus:Tiivisterenkaita ei tarvitse irrottaa puhdistamista
varten.
Seal rings / Afdichtringen /
Tætningsringe / Forseglingsringer /
Tiivisterenkaat
Seal rings /
Afdichtringen / Tætningsringe /
Forseglingsringer / Tiivisterenkaat
2a
Pillow sleeve / Kussentjeskoker / Pudeholder /
Putehylse / Nenäkanyylien muhvi
Slide clip / Zijklem / Skydeklemme /
Glideklemme / Liukukiinnike
Elbow / Bocht /Vinkelstykke / Kneledd /
Kulmakappale
Cap / Dop / Hætte /
Lokk / Tulppa
Pillow sleeve /
Kussentjeskoker /
Pudeholder / Putehylse /
Nenäkanyylien muhvi
Frame / Frame / Ramme /
Ramme / Runko
Cap / Dop / Hætte /
Lokk / Tulppa
Nasal pillows / Neuskussentjes / Næsepuder / Neseputer /
Nenäkanyylit
Clip / Klem / Clip / Klemme / Kiinnike
Swivel / Draaibare kop / Drejestuds / Pièce pivotante / Svivel / Pyörivä liitin
© 2008 ResMed Ltd. © 2008 ResMed Ltd. © 2008 ResMed Ltd.
© 2008 ResMed Ltd.
Headgear ring / Hoofdbandring / Hovedbåndets ring /
Hodeutstyrsring / Pääremmien rengas
ResMed logo faces away from
headgear / ResMed Logo wijst van de
hoofdband af / ResMed-logoet vender
væk fra hovedbåndet / ResMed-logo
pekker vekk fra hodeutstyret /
ResMed-logo on pääremmeistä poispäin
608172 Swift II Illo sheets.qxp 18/09/2008 11:51 AM Page 1

2b2a
1
AB
C
D
3b3a
© 2008 ResMed Ltd.
Note: The headgear does not need to be taken apart for cleaning. Headgear reassembly instructions are provided here as additional information. / N.B.: De hoofdband hoeft voor het schoonmaken niet uit elkaar te worden gehaald. Instructies voor het in elkaar zetten van de
hoofdband zijn hier uitsluitend gegeven als aanvullende informatie. / Bemærk: Hovedbåndet behøver ikke at blive skilt ad under rengøring. Instruktioner til genmontering af hovedbånd er leveret her som yderligere oplysninger. / Merk: Hodeutstyret behøver ikke demonteres
for rengjøring. Instruksjoner for ny montering av hodeutstyr er gitt som tilleggsinformasjon. / Huomautus:Pääremmejä ei tarvitse purkaa osiin puhdistamista varten.Pääremmien kokoamisohjeet ovat tässä vain lisätietona.
Back straps / Banden aan de achterkant / Bagerste stropper /
Bakstropper / Takahihnat
Top straps / Banden aan de bovenkant / Øverste stropper /
Toppstropper / Ylähihnat
Back buckle / Bovengesp / Bagerste spænde / Bakspenne / Takasolki
Back straps / Achtergespen / Bagerste stropper / Bakstropper /
Takahihnat
Top buckle / Bovengesp / Øverste spænde / Toppspenne /Yläsolki
Top straps / Banden aan de bovenkant / Øverste stropper /
Toppstropper / Ylähihnat
Note: For complete instructions, read the text section in conjunction with the illustrations on
this sheet.
N.B.: Raadpleeg voor de volledige instructies de desbetreffende tekst samen met de illustraties
op dit blad.
Bemærk: For fuldstændige anvisninger bedes du læse tekstafsnittene i sammenhæng med
illustrationerne på dette ark.
Merk! For fullstendige instruksjoner bør du lese tekstavsnittet sammen med illustrasjonene på
denne siden.
Huomautus: Jotta saisit ohjeista parhaan hyödyn, lue teksti katsoen samalla tällä sivulla
olevia kuvia.
Illustrations Sheet / Illustratieblad / Illustrationsark / Illustrasjonsark / Kuvasivu
EReassembling the Headgear / In elkaar zetten hoofdband / Genmontering af hovedbåndet / Montere hodeutstyret igjen/ Pääremmien kokoaminen
Mirage SwiftTM II
NASAL PILLOWS SYSTEM
Component of: 608172/2
608172 Swift II Illo sheets.qxp 18/09/2008 11:51 AM Page 2

English
1
Mirage Swift™II
NASAL PILLOWS SYSTEM
Thank you for choosing ResMed’s Mirage Swift II Nasal Pillows System.
The nasal pillows system is light, flexible and quiet. It is designed to minimize
contact with your face, thus ensuring that you feel comfortable during therapy.
This user guide provides you with the information you need for the correct use
of your system.
Intended Use
The Mirage Swift II is intended for multipatient use by adult patients
(>30 kg) prescribed continuous positive airway pressure or bilevel therapy for
use in home, hospitals or clinics.
Note: The Mirage Swift II is not compatible for use with ResMed
AutoSet CS™2 and VPAP™Adapt SV devices.
Medical Information
Note: The Mirage Swift II does not contain latex, PVC, or DEHP materials. If
you have ANY reaction to any part of the system, discontinue use and consult
your sleep therapist.
. Warnings and Cautions
•This system should be used only with flow generators (CPAP or bilevel)
recommended by your physician or respiratory therapist. It should not be
used unless the flow generator is turned on and operating properly. The vent
holes should never be blocked.
Explanation of the Warning: Flow generators are intended to be used with
special interfaces with connectors which have vent holes (vent holes are
located on the frame—see section Aon the illustrations sheet) or separate
exhalation devices to allow continuous flow of air out of the interface. When
the flow generator is turned on and functioning properly, new air from the
flow generator flushes the exhaled air out through the attached exhalation
608172 Eng.fm Page 1 Monday, September 22, 2008 10:56 AM

2
port. However, when the flow generator is not operating (eg, power failure),
not enough fresh air will be provided through the system, and exhaled air
may be rebreathed. In this situation, remove the Mirage Swift II
immediately.
•The exhaust vent flow is lower at lower system pressures (see section
“Technical Specifications” for Pressure-Flow Curve details). If the system
pressure during expiration is too low, there may not be enough exhaust vent
flow to completely flush the air delivery hose of exhaled air before the start
of the next inspiration.
•Discontinue using the Mirage Swift II if you frequently experience nasal
irritation, and consult your physician.
•The Mirage Swift II must be cleaned and disinfected/sterilized if it is used
between patients. See section “Reprocessing the Mirage Swift II between
Patients” for details.
•If oxygen is used with the flow generator, the oxygen flow must be turned
off when the flow generator is not operating.
Explanation of the Warning: When the flow generator is not in operation,
and the oxygen flow is left on, oxygen delivered into the ventilator tubing
may accumulate within the flow generator enclosure. Oxygen accumulated
in the flow generator enclosure will create a risk of fire. This warning applies
to most types of flow generators.
•Please refrain from smoking while oxygen is in use.
Note: At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen
concentration will vary, depending on the pressure settings, patient
breathing pattern, interface selection and the leak rate.
Parts of the Mirage Swift II
See section A on the illustrations sheet.
Fitting the Mirage Swift II
Note: Refer to your flow generator manual for details on settings and
operational information.
See section B on the illustrations sheet.
1Put the headgear on your head and place the nasal pillows below your nose.
Make sure the top strap passes over the top of your head. Make sure the
ResMed logo on the pillow sleeve faces outward; away from your face
(B-1).
2Insert the nasal pillows into your nostrils. Gently tighten the headgear
straps; first the back straps (B-2a) and then the top straps (B-2b). Alternate
the adjustment of each set of straps, so that the headgear panels rest
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3
English
between the eye and the ear. The pillow sleeve should rest comfortably
above your upper lip.
3Adjust the angle of the nasal pillows. To do this, rotate the pillow sleeve
assembly forward or backward so that the nasal pillows sit comfortably
inside your nostrils (B-3).
4Tube Retainer (optional).
Use the tube retainer if you prefer to have the short tube assembly secured
to the headgear in the up position (B-4).
5The short tube assembly can be attached in four different ways (B-5).
Note: The short tube assembly and cap can be connected to either side of
the pillow sleeve. See “Disassembling for Cleaning” and “Reassembling
the Mirage Swift II” for instructions on how to remove and attach the short
tube assembly and cap.
6Connect one end of the main air tubing to your flow generator and the other
end to the swivel. Turn your flow generator on.
Notes:
•Flow generator mask setting: If available, select “Swift”; otherwise
select “Mirage” as the mask option when using the Mirage Swift II with
ResMed flow generators that have mask setting options.
•SmartStop feature: This feature may not operate effectively when using
the Mirage Swift II with some ResMed flow generators that have the
SmartStop feature. This is particularly relevant when using the small size
pillow sleeve.
If you feel air leaks, readjust the angle of the nasal pillows to get a better
seal. You may need to readjust the headgear straps. Do not overtighten the
headgear straps.
If you are unable to resolve any leaks you may need an alternative pillow
sleeve size.
7Take time to adjust the following to achieve a secure and comfortable fit:
•headgear straps
•angle of the pillow sleeve assembly
•position of the short tube assembly.
Removing the Mirage Swift II
To remove the Mirage Swift II, pull the pillow sleeve assembly away from your
nose and lift the headgear off your head. You do not need to loosen the
headgear straps.
608172 Eng.fm Page 3 Monday, September 22, 2008 10:56 AM

4
Disassembling for Cleaning
See section C on the illustrations sheet.
Before disassembling the Mirage Swift II, disconnect the flow generator
tubing. To do this, hold the swivel and pull it away from the flow generator
tubing.
CAUTION
Do not pull on the short tube or the flow generator tubing as they may get
damaged.
•To disassemble the Mirage Swift II for daily cleaning, follow steps 1–3.
•To disassemble the Mirage Swift II for weekly cleaning, follow steps 1–5.
1Detach the short tube assembly. To do this, hold the elbow and pull it away
from the seal ring (C-1).
Note: The short tube assembly cannot be taken apart.
2Remove the cap by pulling it away from the seal ring (C-2).
3Detach the headgear ring from the pillow sleeve assembly. Simply pull the
headgear rings from the ends of the frame (C-3).
4Disassemble the pillow sleeve assembly. To do this, slide off the clip (C-4a)
and then peel the pillow sleeve off the frame (C-4b).
Note: When sliding the clip, hold it at one end, not in the middle.
5The seal rings do not need to be removed from the headgear (C-5).
Cleaning the Mirage Swift II in the Home
Notes:
•Wash your hands before cleaning the mask.
•Wash the headgear before first time use, as the dye may run. It is important
to always handwash the headgear.
•The headgear may be washed without being disassembled.
Daily
Handwash the pillow sleeve assembly, short tube assembly and cap in warm
(approx. 30°C), soapy water for one minute. Use pure soap. Rinse the
components well with drinking quality water and allow to air dry out of direct
sunlight and heat.
Note: Ensure that the vent holes are not blocked. Use a soft bristle brush to
clean the vent.
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5
English
Weekly
Handwash the headgear, tube retainer and all components in warm,
(approx. 30°C), soapy water. Use pure soap. Rinse the components well and
allow them to air dry out of direct sunlight.
. CAUTION
•Do not use solutions containing bleach, chlorine, alcohol, aromatics,
moisturizers, antibacterial agents, or scented oils to clean any part of
the system or air tubing. These solutions may cause damage and
reduce the life of the product.
•Exposing any part of the system or tubing to direct sunlight or heat
may cause deterioration.
•If any visible deterioration of a component is apparent (cracking,
crazing, tears etc), the component should be discarded and replaced.
Reprocessing the Mirage Swift II between
Patients
The Nasal Pillows System should be reprocessed when used between
patients. Cleaning, disinfection and sterilisation instructions are available from
the ResMed website, www.resmed.com/masks/sterilization.
If you do not have Internet access, please contact your ResMed
representative.
Reassembling the Mirage Swift II
CAUTION
Components of the Mirage Swift II pillow sleeve assembly (pillow sleeve,
frame and clip—see section A on the illustration sheet) are not compatible
for use with Mirage Swift components. Combining these components
from the two systems may result in rebreathing of exhaled air.
See section D on the illustrations sheet.
1Make sure both seal rings are properly fitted to the headgear rings (D-1).
2Assemble the pillow sleeve assembly. To do this:
aWrap the pillow sleeve around the frame. Then insert the pillow sleeve
edges into the groove of the frame (D-2a).
bHold the clip at one end and then slide it onto the frame to secure the
pillow sleeve in place (D-2b).
608172 Eng.fm Page 5 Wednesday, September 24, 2008 10:52 AM

6
Note: If the clip does not slide easily, check that the pillow sleeve edge is
fitted flush to the groove of the frame.
3Attach the headgear ring to the pillow sleeve assembly. To do this, firmly
push the headgear rings onto the ends of the frame (D-3). When attaching
the pillow sleeve assembly make sure:
•the headgear panels are facing out
•the nasal pillows are pointing upwards
•the ResMed logo faces out—away from the headgear.
Make sure the pillow sleeve assembly is properly fitted to the headgear
before going on to the next step.
4Attach the short tube assembly to your preferred side of the pillow sleeve
assembly. To do this, push the elbow into the seal ring until it clicks into
place (D-4).
5Insert the cap into the other seal ring until it clicks into place (D-5).
6The assembled system should look like this (D-6). Make sure the ResMed
logo on the pillow sleeve faces out—away from the headgear.
Additional Information
Reassembling the Headgear
See section E on the illustrations sheet.
If taken apart, the headgear has four parts:
A: Left strap; B: Right strap; C: Back buckle; D: Top buckle.
1Lay out the four parts of the headgear as shown in (E-1). The panels must
face up.
Note: Before threading the straps, make sure that the buckles are positioned
as shown in (E-2) and (E-3).
2Thread the back straps through the back buckle (part C) as shown in
(E-2a) and (E-2b).
3Thread the top straps through the top buckle (part D) as shown in
(E-3a) and (E-3b).
Disposal
The Mirage Swift II Nasal Pillows System does not contain any hazardous
substances and may be disposed of with your normal household refuse.
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7
English
Technical Specifications
Pressure–Flow Curve
Note: As a result of manufacturing variations, the vent flow may vary from the
values listed in the table.
Dead Space Information
Dead space is the empty volume of the pillow sleeve and short tube assembly
up to the swivel.
The dead space of the Mirage Swift II for all pillow sleeve sizes is 91 mL.
Standards
CE designation in accordance with EC directive 93/42/EEC, class IIa.
EN ISO 14971, ISO 5356-1, ISO 10993-1 and EN ISO 17510-2.
Therapy Pressure
4 to 20 cm H2O
Resistance
Drop in pressure measured (average for three pillow sleeve sizes)
at 50 L/min: 0.4 cm H2O
at 100 L/min: 1.6 cm H2O
0
10
20
30
40
50
60
4 6 8 10 12 14 16 18 20
Mask Pressure (cm H2O)
Vent Flow Rate (L/min)
Pressure
(cm H2O)
Flow
(L/min)
420
829
12 37
16 43
20 49
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8
Symbols
System and Packaging
User Guide
Ordering Information
Caution, consult accompanying documents
Lot number
Part number
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.
Part No. Item
System
60513 Mirage Swift II Nasal Pillow System - EUR
60514 Mirage Swift II Nasal Pillow System - ANZ
60515 Mirage Swift II Nasal Pillow System - AP
60516 Mirage Swift II Nasal Pillow System - UK
60518 Mirage Swift II Nasal Pillow System - FRA
Replacement Parts
60541 Pillow sleeve, Small (1 pk.)
60542 Pillow sleeve, Medium (1 pk.)
60543 Pillow sleeve, Large (1 pk.)
60523 Headgear buckle (4 pk.)
60524 Seal ring (10 pk.)
60525 Cap (1 pk.)
60526 Headgear (1 pk.)
60536 Frame with Clip and Cap (1 pk.)
60528 Short tube assembly (1 pk.)
60529 Short tube assembly (10 pk.)
60530 Tube retainer (3 pk.)
60545 Mirage Swift II Bag (1 pk.)
60537 Frame System with Pillow sleeve (excluding headgear), Small
60538 Frame System with Pillow sleeve (excluding headgear), Medium
LOT
REF
608172 Eng.fm Page 8 Monday, September 22, 2008 10:56 AM

9
English
Limited Warranty
ResMed warrants that your ResMed system, including its components—
frame, pillow sleeve, headgear, tubing and other accessories (“Product”)—
shall be free from defects in material and workmanship for a period of ninety
(90) days from the date of purchase by the initial consumer.
For further details refer to the Warranty.
60539 Frame System with Pillow sleeve (excluding headgear), Large
60540 Clip (1 pk.)
Accessories
61121 Distal pressure port (1 pk.)
61124 Distal pressure port (10 pk.)
Note: Translations are based on the English version in this guide. However,
there may be minor variations based on the disinfection/sterilization proce-
dures applicable in some countries. ResMed has reviewed these changes and
all procedures included here have been validated.
Part No. Item
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10
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