ResMed Mirage Kidsta User Manual

Page 1
B
Mask cushion
Mask frame
Mask elbow
Exhaust vent
Cuff
Short air tubing
Vent cover
Swivel
Crossover buckle
Side vertical strap
Rear strap
Strap loop
Lower strap
Angle Selector Tab
Headgear clip
Crossover
Ports cap
© 2004 ResMed Ltd.
Mask Parts
Manufactured by:
ResMed Ltd 1 Elizabeth MacArthur Drive Bella Vista NSW 2153 Australia
Tel: +61 (2) 8884 1000 or 1 800 658 189 (toll free) Fax: +61 (2) 8883 3114 Email: reception@resmed.com.au
ResMed Offices:
ResMed Corp 14040 Danielson Street Poway CA 92064-6857 USA
Tel: +1 (858) 746-2400 or 1-800-424-0737 (toll free) Fax: +1 (858) 746-2900 Email: reception@resmed.com
ResMed (UK) Ltd 65 Milton Park Abingdon Oxfordshire OX14 4RX UK Tel: +44 (1235) 862 997 Fax: +44 (1235) 831 336 Email: reception@resmed.co.uk
ResMed Asia Pacific Ltd 97 Waterloo Road North Ryde NSW 2113 Australia Tel: +61 (2) 9886 5000 or 1 800 991 900 (toll free) Fax: +61 (2) 9889 1471 Email: reception@resmed.com.au
ResMed Finland Niittykatu 6 FIN 02200 Espoo Suomi Tel: +358 9 8676820 Fax: +358 9 86768222 Email: reception@resmed.fi
ResMed GmbH & Co. KG Rudolfstraße 10 D-41068 Mönchengladbach Deutschland Tel: +49 (0) 2161-3521-0 (Reception), +49 (0) 180 22 22 668 (Service-Telefon; 0.06 s/Anruf), +49 (0) 180 22 66 888 (Wartungstelefon; 0.06 s/Anruf) Fax: +49 (0) 2161-3521-1499 Email: reception@resmed.de
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Labhardt AG Thannerstrasse 57 CH-4054 Basel Schweiz Tel: +41 (061) 307 9711 Fax: +41 (061) 307 9722 Email: info@labhardt.ch
Reorder No. 61809/2 04 08
Mirage Kidsta
Nasal Mask
USER'S GUIDE
English
US DESIGNATED AGENT: ResMed Corp EU AUTHORISED REPRESENTATIVE: ResMed (UK) Ltd
Mirage Kidsta Nasal Mask Protected by patents: AU 710733, AU 712236, AU 724360, DE 29724224, US 6112746, US 6357441, US 6439230, US 6561190, US 6561191, US 6581602, US 6634358. Other patents pending. Protected by design registrations: AU 155372, CN 3302716.1, DE 40300897, FR 03 0845, GB 3010608, GB 3014182, GB 3014183, GB 3014184, GB 3014185, GB 3014186, GB 3014187, GB 3014188, GB 3014189, JP 1200870, JP 1201246, NZ 403295, SE 77095, US D485905. Others pending.
Mirage, Kidsta and Mirage Kidsta are trademarks of ResMed Ltd. Dove is a registered trademark of Unilever.
© 2004 ResMed Ltd.
Waking people up to sleep
2
© 2004 ResMed Ltd.
O)
Mask Pressure (cmH
4567891011121314151617181920
0
10
Vent flow rate (L/min)
20
30
40
50
60
70
A
Pressure–Flow Curve
sheet. Note: Note:
Note: For complete instructions, read the text section in conjunction with the illustrations on this
Note: Note:
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C
BL
BR
BR
BL
BR
BLBRBR
Fitting
Crossover as far forward as possible
C-1
Lower strap sits below ear
C-3
C-5
Side strap is vertical
C-2
C-4
C-6
a
Headgear clip aligned with nose
a
Straps fit securely at base of head
a
b
Angle Selector Tab
D
D-1
Disassembling
D-2
E
Reassembling
E-1
Settings
© 2004 ResMed Ltd.
E-2
D-3
Note: The headgear does not need to be disassembled for cleaning. Headgear reassembly instructions are provided here as additional information.
B
A
D
F-1
A D
D-4
BR
BR
F-2
© 2004 ResMed Ltd.
C
BR
BL
A
E-3
F-3
BL
D
E-4
© 2004 ResMed Ltd.
F-4
A
A
D
B
D
B
F-5
© 2004 ResMed Ltd.
BL
C
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Mirage Kidsta™ Nasal Mask
ENGLISH
The MIRAGE KIDSTANASAL MASK is intended for multipatient use for children aged seven and over, prescribed continuous positive airway pressure (CPAP) or bilevel therapy in hospital, clinic and/or home environments.
MEDICAL INFORMATION
Note: The mask system does not contain
latex materials. If you have ANY reaction to any part of the mask system, discontinue use and consult your sleep therapist.
. WARNINGS AND CAUTIONS
Your physician should determine the
degree of arousability before commencing CPAP treatment. Use of secondary sensing devices such as apnoea monitors and transcutaneous carbon dioxide monitors is advisable. These will help determine whether nasal CPAP treatment should be applied.
Ensure that the nasal cushion does not
block the nostrils at any time during fitting or use.
The MIRAGE KIDSTA 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 contains small parts which
could result in a choking risk. Your clinician should assess the suitability of the selected mask.
This mask should be used only with
flow generators recommended by your physician or respiratory therapist. A mask should not be used unless the flow generator is turned on and operating properly. The exhaust vent should never be blocked. Explanation of the Warning: Flow generators are intended to be used with special masks with connectors which may have vent holes or separate exhaust vents to allow continuous flow of air out of the mask. When the flow generator is turned on and functioning properly, new air from the flow generator flushes the exhaled air out through the attached mask exhaust vent. However, when the flow generator is not operating, enough fresh air will not be provided through the mask, and exhaled air may be rebreathed. Rebreathing of exhaled air for longer than several minutes can in some circumstances lead to suffocation. This warning applies to most models of flow generators.
Page 4
At low CPAP pressures, the flow
through the exhaust vent may be
ENGLISH
inadequate to clear all exhaled gas from the tubing. Some rebreathing may occur. Explanation of the Warning: The exhaust vent flow is lower at lower mask pressures (see Pressure/Flow curve— Figure A). To avoid rebreathing it is recommended that a mask pressure of
O or more be used.
4cmH
2
The MIRAGE KIDSTA features an elbow
that can be easily removed while the mask is fitted. The mask should not be used with the elbow attached unless the flow generator is turned on and operating properly.
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 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 rate of supplemental
oxygen flow, the inhaled oxygen concentration will vary, depending on the pressure settings, patient breathing pattern, mask selection and leak rate.
PARTS OF THE MASK
See Figure B.
FITTING THE MASK
See Figure C.
Note: Before fitting the mask, refer to the
section “Cleaning the Mask in the Home”.
1 Place the headgear on the head. Adjust
the side vertical straps so that the lower strap sits just below the ear (not touching it) and at the base of the head (Fig. C-1).
2 The headgear clip should be parallel
with the nose and not in the line of vision. Check that the crossover is as far forward as possible (Fig. C-2). To adjust the crossover to a forward position, slide the crossover buckle along one strap (Fig. C-2a) and then along the other strap (Fig. C-2b). Alternate the movement on each side until the crossover is as far forward as possible.
3 Ensure that the crossover and the rear
straps lie flat against the head.
4 Place the mask on the nose (Fig. C-3).
Clip the mask to the headgear.
5 Adjust the lower straps by pulling firmly
(Fig. C-4) so that the rear straps fit
securely around the base of the head (Fig. C-4a).
Note: Ensure that the nostrils are not
blocked by the cushion.
6 Connect one end of the main air tubing
to your flow generator and the other end to the swivel.
Note: The swivel, short air tubing and
mask elbow are supplied assembled.
7 Turn your flow generator on. 8 Connect the mask elbow to the mask
frame. To do this, hold the sides of the mask elbow (Fig. C-5) and firmly push the elbow onto the mask frame until it clicks into place.
Page 5
Check that you have connected the mask elbow correctly by rotating it. Be careful not to squeeze the sides of the elbow. If the mask elbow is fitted correctly, it should rotate freely and not separate from the mask frame.
9 Adjust the angle of the mask by selecting
the setting that provides a comfortable fit with minimum or no leak. To test each setting, hold down the Angle Selector Tab (Fig. C-6) and move the headgear clip up or down (Fig. C-6a) as required. You may need to raise the headgear clip when moving it from one setting to the next. The mask can be tilted at five different positions. If you feel excessive pressure on the middle of the nose, tilt the mask down. Alternatively, if you feel excessive pressure on your upper lip, tilt the mask up.
10 If you feel air leaks around the cushion,
reposition the mask on your face to achieve a better seal. Take time to adjust all straps and the position of the mask so that you can achieve a secure and comfortable fit.
Notes:
If you are unable to resolve any leaks you
may need to try another cushion size.
Excess headgear length may be trimmed
to a suitable length if required. Leave at least 30 mm free length on the straps.
Select "Standard" as the mask option
when using the M
IRAGE KIDSTA with
ResMed flow generators that have mask setting options.
REMOVING THE MASK
To remove the MIRAGE KIDSTA, squeeze one of the headgear clips. This releases one side of the headgear from the mask. Pull the mask and headgear away from your head.
Notes:
Do not pull the headgear off your head
without releasing the headgear clips first.
You can detach the elbow from the mask
frame while wearing the mask. This is useful when therapy needs to be stopped for a short time; for example if you need to go to the bathroom.
Check that you can remove the headgear
clip, the quick release swivel or the headgear unaided.
DISASSEMBLING FOR CLEANING
See Figure D. 1 Detach the mask elbow. To do this,
squeeze the sides of the mask elbow at the finger grips while pulling it away from the mask frame (Fig. D-1).
2 Disconnect and separate the main air
tubing, short air tubing, mask elbow and vent cover (Fig. D-2).
Notes:
To prevent damage to the short air
tubing, disconnect it by holding it at the cuff.
The swivel does not need to be
disconnected from the short air tubing.
3 Detach the headgear from the mask
frame by squeezing and releasing both headgear clips.
4 Remove the ports cap from the mask
frame (Fig. D-3).
5 Firmly pull the mask cushion away from
the mask frame (Fig. D-4).
ENGLISH
Page 6
CLEANING THE MASK IN THE
OME
H
ENGLISH
Notes:
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/AFTER EACH USE
Handwash the mask components in lukewarm, soapy water. Use pure soap (an example of pure soap is Dove®soap, unscented; made by Unilever). Rinse the components well and allow them to air dry out of direct sunlight.
WEEKLY
Handwash the headgear in warm, soapy water. Use pure soap. Rinse well and allow it to air dry out of direct sunlight.
. CAUTIONS
Do not use solutions containing
bleach, chlorine, alcohol, aromatics, moisturisers, antibacterial agents, or scented oils to clean any part of the mask system or air tubing. 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 deteriorate.
If any visible deterioration of a mask
component is apparent (cracking, crazing, tears etc), the mask component should be discarded and replaced.
CLEANING THE MASK BETWEEN
ATIENTS
P
The mask system (excluding the swivel and short tube) is validated for multipatient use. Clinicians should refer to the Masks Disinfection/Sterilisation Guide for details.
To clean the headgear between patients, use the method described in the previous section “Cleaning the Mask in the Home”.
REASSEMBLING THE MASK
See Figure E. 1 Insert the mask cushion into the groove
of the mask frame (Fig. E-1). Fit the top section first and then work your way around, pushing the mask cushion into the mask frame.
Note: The diamond markers on the mask
frame and on the mask cushion (one on top, two at the bottom) must line up.
2 Push the ports cap onto the mask ports
(Fig. E-2).
3 Attach the vent cover to the mask
elbow. To do this, insert the elbow into the ring of the vent cover (Fig. E-3). Push the ring to the top so that the vent cover is over the back of the elbow. Then, press the lip of the vent cover to ensure that it is securely seated in the groove of the elbow.
4 Connect the short air tubing to the mask
elbow.
5 Connect the swivel to the main air
tubing, ready for next use (Fig. E-4).
Page 7
ADDITIONAL INFORMATION
REASSEMBLING THE HEADGEAR
Note: You do not need to disassemble the
headgear for cleaning. However, if you choose to do so, the reassembly procedure is explained in this section.
When disassembled, the headgear has four parts:
A: Left strap, B: Middle strap, C: Crossover buckle, D: Right strap
1 Lay out the four parts of the headgear as
shown in Figure F-1.
2 As shown in Figure F-2, thread the
straps BR and BL through the crossover buckle (Part C).
3 Thread strap BR through the buckle on
Part A. Thread strap BL through the buckle on Part D (Fig. F-3).
4 Thread the straps of Part A and Part D
through the buckles on Part B (Fig. F-4).
5 With the headgear clip facing down, fit
the headgear clip onto the hole on the headgear. While pressing the headgear tab down, rotate the headgear clip away from the tab to lock it into place (Fig. F-5). Repeat this with the other headgear clip.
TECHNICAL SPECIFICATIONS
PRESSURE–FLOW CURVE
See Figure A.
DEAD SPACE INFORMATION
Dead space is the empty volume of the mask up to the swivel.
The dead space of the mask for all cushion sizes is 81 mL.
REPLACEMENT PARTS
Part No. Item
61020 Headgear Assembly, Small
60013 Cushion, Small
61025 Headgear clip - blue (2 pk.)
61026 Headgear clip - blue (10 pk.)
60023 Crossover buckle - blue
60024 Crossover buckle - blue
(10 pk.)
60924 Mask Frame
60925 Elbow Assembly
60014 Swivel Assembly (10 pk.)
60926 Inlet Tube and Swivel Assembly
60927 Inlet Tube and Swivel Assembly
(10 pk.)
16570 Ports cap (2 pk.)
16571 Ports cap (10 pk.)
61011 Mask System, Small
LIMITED WARRANTY
ResMed warrants that your ResMed mask system, including its components: mask frame, cushion, 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.
ENGLISH
Note: Translations are based on the English version in this guide. However, there may be minor
variations based on the disinfection/sterilisation procedures applicable in some countries. ResMed has reviewed these changes and all procedures included here have been validated.
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Component of: 61809/2 04 08
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