Puritan Bennett Breeze SleepGear User manual

Breeze™SleepGear™
User’s Guide
Guide d’utilisation
Benutzerhandbuch
Manuale Operativo
Manual del usuario
Guia do utilizador
Gebruiksaanwijzing

User’s Guide – English ................................................................3
Guide d’utilisation – Français ....................................................17
Benutzerhandbuch – Deutsch ..................................................31
Manuale Operativo – Italiano ....................................................47
Manual del usuario – Español ..................................................61
Guia do utilizador – Português ..................................................75
Gebruiksaanwijzing – Nederlands ............................................89

Breeze SleepGear 3
Contents
Overview ...................................................................................... 5
Components ..................................................................5
Nasal Pillows ....................................................6
DreamSeal ........................................................6
Indications for Use .........................................................7
Technical Data ...............................................................7
Assembly ..................................................................................... 8
Use ............................................................................................... 9
Inspection ......................................................................9
Fitting .............................................................................9
Adjustment ...................................................................10
Cleaning ..................................................................................... 12
This manual is available online at:
http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/PBProductManuals.html
Nellcor Puritan Bennett Inc. is an affiliate of Tyco Healthcare. Breeze,
SleepGear, and DreamSeal are trademarks of Nellcor Puritan Bennett Inc.
© 2004 Nellcor Puritan Bennett Corporation. All rights reserved.
English

Contents
4 Breeze SleepGear
Warnings
Warnings are identified by the WARNING symbol shown above.
Warnings alert the user to potential serious outcomes (death, injury, or adverse events)
to the patient or user.
WARNINGS:
• Do not block or modify vent hole.
• To ensure sufficient air for respiration, do not wear mask and tubing until
they are connected to a properly operating CPAP machine.
• At low CPAP pressures, flow through the vent hole may be inadequate to
clear all exhaled gas from tubing. Some rebreathing may occur.
• If irritation develops, discontinue use and consult your physician.
• If oxygen is used with mask or CPAP machine turn oxygen flow off when
CPAP machine is off.
Cautions
Cautions are identified by the CAUTION symbol shown above.
Cautions alert the user to exercise care necessary for the safe and effective use of the
Breeze SleepGear.
Caution: By US Federal law, this device may be sold or used only as
ordered by a licensed physician.
Notes
Notes are identified by the NOTE symbol shown above and provide additional helpful
information.
English

Breeze SleepGear 5
7
Overview
The Puritan-Bennett Breeze SleepGear (Single Patient Use) is
offered in two airway assembly configurations:
• Nasal Pillows
• DreamSeal
User information for both configurations is presented in this guide.
Components
The primary components that comprise the Breeze SleepGear are:
• Nasal Pillows (or DreamSeal)
• Shell
• Vent Hole Insert
• Wing Knob
•Pivot
•Hose
• Hose Guide
•Clip
• Outrigger
• Spine Adapter
• Swivel Adapter
•Cradle
• Halo Straps
Refer to the figures on the following page.
English

Overview
6 Breeze SleepGear
Nasal Pillows
DreamSeal
English
1. Nasal Pillows
2. Shell
3. Vent hole insert (outside
of shell)
4. Wing knob (adjust angle
of Nasal Pillows shell)
5. Clip
6. Hose
7. Hose guide
8. Outrigger
9. Swivel adapter
10.Spine adapter
11. Cradle
12.Halo straps (not shown)
1
2 3
4
6
7
8
11
9
10 5
1. DreamSeal
2. Shell
3. Vent hole insert (outside
of shell)
4. Pivot (adjust angle of
DreamSeal shell)
5. Hose
6. Hose guide
7. Outrigger
8. Swivel adapter
9. Spine
10.Cradle
11.Halo straps (not shown)
2
1
3
4
5
6
7
10
8
9

Overview
Breeze SleepGear 7
Indications for Use
This product is intended for use with devices that deliver continuous
positive airway pressure (CPAP) and bi-level positive airway
pressure in patients weighing at least 30 kg. Refer to the warnings
on page 4.
Technical Data
The following table provides the technical data for both the Nasal
Pillow and DreamSeal configurations.
English
Vent Flow, Pressure Range, and Materials
Parameter CPAP Press.
(cm water) Flow Rate (L/min)
Vent Flow 3 13
516
821
10 23
12 25
15 28
18 31
20 32
25 34
30 38
35 40
Pressure Range 3 – 35 cmH2O
Materials Nasal Pillows: medical-grade silicone
DreamSeal Perimeter Seal: medical-
grade silicone
Halo Straps: Velstretch®

Assembly
8 Breeze SleepGear
Assembly
Before using the Breeze SleepGear for the first time, assemble
it as follows:
1. Insert the nasal airway assembly (item 1) into the SleepGear
assembly spine adapter (item 2). The hose guide slides back and
forth in the spine adapter with a ratcheting sound.
2. Nasal Pillows airway configuration: While pinching the Nasal
Pillows between the thumb and forefinger, insert the Nasal Pillows
into the shell holes with a gentle rotating motion.
3. DreamSeal airway configuration: Perform the following steps and
refer to the figure on the next page.
• Attach the DreamSeal to the shell by inserting the lip on the
bottom of the DreamSeal into the notch on the bottom of the
shell.
• Place your thumb and forefinger on the two raised circles on the
DreamSeal.
• Rotate the DreamSeal toward the shell and squeeze gently to
engage the two side latches.
English
1
2
a

Use
Breeze SleepGear 9
4. Optional: Thread the halo straps through the slots in the cradle
(see figure below, item 1). Then thread the halo straps through the
outrigger (item 2) or through the optional clip accessory (item 3 –
Nasal Pillows only). Engage the Velcro®fasteners on the straps.
Note: You may wish to try fitting the Breeze SleepGear
without the halo straps first, then add the straps if a
better fit is required. Refer to the Adjustment section
on the following page.
Use
Inspection
Inspect the Breeze SleepGear and its components before each use
to ensure all parts are firmly connected and no visible leaks exist.
Fitting
1. Insert the Nasal Pillows into your nostrils or place the DreamSeal
over your nose.
English
2
Nasal Pillows - Side View
3
1

Use
10 Breeze SleepGear
Caution: Avoid excessive bending of the nasal airway
assembly when putting on the Breeze SleepGear.
2. Place the cradle (back pad) below the curve at the back of your
head.
Adjustment
1. Adjust the position of the cradle on the spine so that the cradle sits
comfortably at the base of your head.
2. Place your hand on the spine and hold it firmly to the back of your
head. Adjust the length of the Breeze SleepGear with your free
hand by moving the nasal airway assembly toward your face.
Refer to the following figure.
3. Adjust the height and angle of the shell so that the Nasal Pillowsor
DreamSeal device is comfortable and there are no audible leaks.
4. Optional: Use the halo straps, if needed, to add stability and
enhance the fit of the Breeze SleepGear.
English

Use
Breeze SleepGear 11
• Adjust the tension of the halo straps for a comfortable fit. Do not
overtighten the straps.
• If using the optional clip accessory, adjust by first lifting the clip;
then, slide the clip to one of the three available positions along
the hose guide that provides the most comfortable fit.
5. Pressurize the interface with your positive airway pressure device
and readjust as required to eliminate leaks.
Notes:
• The amount of force on your nose should be just enough to
prevent air leaks.
• You may need to readjust the fit of Breeze SleepGear when you
lie down.
English
Closeup of Clip AdjustmentUsing Halo Straps With Clip

Cleaning
12 Breeze SleepGear
Cleaning
Note: To prolong the life of the product, it is recommended that
the Breeze SleepGear be cleaned thoroughly at least
once per week.
Caution: Hand clean only. To avoid damage to the Breeze
SleepGear, never use a dishwasher or other
mechanical device to clean the Breeze SleepGear
or any of its components.
1. Disconnect the back half of the nasal airway assembly (item 1)
where the hose guide attaches to the spine adapter (item 2).
2. Remove the Nasal Pillows or the DreamSeal from the shell.
To remove the Nasal Pillows, pinch the Nasal Pillows between
your thumb and forefinger; then, pull the Nasal Pillows out of the
shell holes with a gentle rotating motion.
To remove the DreamSeal from the shell, do the following and
refer to the next figure.
• Place your thumb and forefinger on the two raised circles on the
DreamSeal.
English
1
2

Cleaning
Breeze SleepGear 13
• Squeeze gently to disengage the two side latches.
• Rotate the DreamSeal away from the shell.
• Disengage the lip on the bottom of the DreamSeal from the
notch on the bottom of the shell.
3. Disconnect and remove the hose.
Caution: To avoid damaging the hoses when connecting or
disconnecting them, use the methods described in
the following instructions. Never pull on or twist the
ribbed portions of hoses. Refer to the figures below.
To remove the hose from the shell:
• Place your thumb and forefinger on the smooth end of the hose
where it attaches to the shell.
• Disconnect the hose from the shell.
• Slide the hose out of the hose guide.
To disconnect the hose at the swivel adapter:
• Grasp each hose at its rubber cuff.
• Gently pull hoses apart.
English

Cleaning
14 Breeze SleepGear
4. Remove the vent hole insert from the Nasal Pillows shell or the
DreamSeal shell. Slide your fingernail under the end of the insert
with the raised indicator dot(s) and pull the insert up and out.
Note: It is recommended that you confirm that you have the
correct vent insert. The Nasal Pillows vent hole insert
features two raised indicator dots, while the DreamSeal
vent hole insert has a single raised indicator dot.
Caution: Do not immerse components with foam pads
attached. Do not sterilize. Do not use bleach-,
chlorine-, or aromatic-based solutions, scented oils,
or moisturizing, antibacterial, deodorizing, or
fragranced soaps to clean the nasal pillows, mask,
headgear, padding, or air tubing. Use of such
substances may cause hardening of your Breeze
SleepGear, thereby reducing the life of the product.
Caution: Do not expose the mask or tubing to direct sunlight.
Exposure to direct sunlight may cause deterioration
of the product.
5. Wash the nasal airway assembly parts in warm, soapy water as
necessary to remove dirt, body oils, cosmetics, etc. Rinse them
thoroughly in clean running water and air dry on a clean,
absorbent surface. Foam pads may be wiped with a mild soap
applied to a moist cloth.
6. To install the vent hole insert, align the indicator dot(s) on the
insert with the single dot on the shell. Press the vent hole insert
into the opening in the shell. Make sure the inner lip on the vent
hole insert is fully inserted into the shell.
English

Cleaning
Breeze SleepGear 15
7. If you are using the halo straps, release the ends and pull the
straps through the outrigger and cradle slots. The cradle may be
separated from the spine adapter for cleaning.
8. Extend the cradle (item 1) to its maximum adjustment and then
pull on the cradle more forcefully to separate it from the spine
adapter (item 2).
English
1
2

Cleaning
16 Breeze SleepGear
English

Breeze SleepGear 17
Sommaire
Vue d’ensemble ........................................................................ 19
Composants ................................................................19
Coussinets nasaux .........................................20
DreamSeal ......................................................20
Mode d’emploi .............................................................21
Caractéristiques techniques ........................................21
Montage ..................................................................................... 22
Utilisation .................................................................................. 23
Contrôle .......................................................................23
Mise en place ..............................................................23
Réglage .......................................................................24
Nettoyage .................................................................................. 26
Ce manuel est disponible en ligne à l’adresse suivante :
http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/PBProductManuals.html
Nellcor Puritan Bennett Inc. est une filiale de Tyco Healthcare. Breeze,
SleepGear et DreamSeal sont des marques commerciales de Nellcor Puritan
Bennett Inc.
© 2004 Nellcor Puritan Bennett Corporation. Tous droits réservés.
Français

Sommaire
18 Breeze SleepGear
Avertissements
Les avertissements sont identifiés par le symbole AVERTISSEMENT illustré ci-après.
Ils préviennent l’utilisateur d’éventuelles graves conséquences (mort, blessure ou effets
inverses) pour le patient ou l’utilisateur.
AVERTISSEMENTS :
• Ne bouchez pas ou ne modifiez pas l’orifice d’évacuation.
• Pour garantir suffisamment d’air pour respirer, ne portez pas de masque
et de flexible tant qu’ils n’ont pas été reliés à un appareil de ventilation
spontanée avec pression expiratoire positive appropriée et en
fonctionnement.
• Avec des pressions positives continues, le débit à travers l’orifice
d’évacuation peut être inadapté pour supprimer tout le gaz exhalé du
flexible. Une certaine réaspiration peut se produire.
• En cas d’irritation, interrompez l’utilisation et consultez votre médecin.
• Si de l’oxygène est utilisé avec le masque ou l’appareil de ventilation
spontanée avec pression expiratoire positive, arrêtez le débit d’oxygène
lorsque l’appareil est éteint.
Attention
Les mentions Attention sont identifiées par le symbole ATTENTION illustré ci-après.
Elles préviennent l’utilisateur d’appliquer les précautions requises pour une utilisation
efficace et en toute sécurité du Breeze SleepGear.
Attention : conformément au droit fédéral américain, cet appareil ne
peut être vendu ou utilisé que sur ordonnance d’un médecin agréé.
Remarques
Les remarques sont identifiées par le symbole REMARQUE illustré ci-après et
fournissent des informations complémentaires utiles.
Français

Breeze SleepGear 19
Vue d’ensemble
Le dispositif Breeze SleepGear de Puritan-Bennett (utilisation pour
un seul patient) est proposé en deux configurations respiratoires :
• Coussinets nasaux
• DreamSeal
Ce guide présente les informations d’utilisation pour les deux
configurations.
Composants
Les principaux composants du Breeze SleepGear sont les suivants :
• Coussinets nasaux (ou DreamSeal)
• Coque
• Pastille de l’orifice d’évacuation
• Molette papillon
•Pivot
• Tubulure flexible
• Guide de tubulure
• Attache
• Stabilisateur
• Armature réglable
• Raccord pivotant
• Coussinet arrière
• Brides serre-tête
Reportez-vous aux figures de la page suivante.
Français

Vue d’ensemble
20 Breeze SleepGear
Coussinets nasaux
DreamSeal
Français
1. Coussinets nasaux
2. Coque
3. Pastille de l’orifice
d’évacuation (extérieur
à la coque)
4. Molette papillon (réglage
de l’angle de la coque
à coussinets nasaux)
5. Attache
6. Tubulure flexible
7. Guide de tubulure
8. Stabilisateur
9. Raccord pivotant
10.Armature réglable
11. Coussinet arrière
12.Brides serre-tête
(non illustrées)
1
2 3
4
6
7
8
11
9
10 5
1. DreamSeal
2. Coque
3. Pastille de l’orifice
d’évacuation (extérieur
à la coque)
4. Pivot(réglagedel’angle
de la coque DreamSeal)
5. Tubulure flexible
6. Guide de tubulure
7. Stabilisateur
8. Raccord pivotant
9. Armature réglable
10.Coussinet arrière
11.Brides serre-tête
(non illustrées) 2
1
3
4
5
6
7
10
8
9