Philips Respironics EE Leak 1 AF541 Bedienungsanleitung

AF541 EE Leak 1 Oro-Nasal Mask

Instructions for Use - e

Safety information

Intended Use

This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients.

The mask is for single use in the hospital/institutional environment only. The mask is to be used on

patients (>40lbs/20kg) for whom CPAP or bi-level therapy has been prescribed.

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.

Note: This mask is not made with natural rubber latex , BPA or DEHP.

Contraindications

This mask is not for use on patients with the following conditions: recent eye surgery or dry eyes,

hiatal hernia, excessive reﬂux, impaired cough reﬂex, and impaired cardiac sphincter function.

This mask should also not be used on patients who need life support ventilation, who are taking a

prescription drug that may cause vomiting, or on patients that are uncooperative, unresponsive, or

unable to remove the mask by themselves.

Warnings

•This mask requires a separate exhalation device.

•Use of this mask while the system is not on and operating may cause rebreathing of exhaled air.

Rebreathing of exhaled air for longer than several minutes can in some circumstances lead to

suﬀocation.

•Monitor or intervene if the patient experiences skin redness, irritation, discomfort, blurred vision, or

drying of the eyes.

•Monitor or intervene if any of the following symptoms occur: Unusual chest discomfort, shortness of

breath, stomach distension, belching, severe headache, eye pain or eye infections.

•Monitor or intervene if any of the following symptoms occur: tooth, gum, or jaw soreness. Use of a

mask may aggravate a patient’s existing dental conditions.

•This mask is for single use only and is not intended to be disinfected or cleaned after patient use.

Dispose of the mask after patient use.

•This mask is not designed for multi-patient use. Respironics cannot guarantee the performance

speciﬁcations once this mask has been disinfected.

•A minimum of 3cm H₂O (hPa) must be maintained when using this mask.

•Attaching an exhalation device requires therapy pressure level adjustment to compensate for

increased leak.

•Do not overtighten the headgear straps. Watch for signs of overtightening, such as excessive

redness, sores or bulging skin around the edges of the mask. Loosen the headgear straps to alleviate

symptoms.

•Do not block the anti-asphyxia valve.

Mask Parts and Mask Options

Mask Frame and Elbow

A Forehead Adjuster Button

B Forehead Adjuster Ball

C Mask Frame

D NIVO Nebulizer Port

E Entrainment Elbow with Anti-Asphyxia Valve

F Headgear Clip Post

CapStrap Headgear Four Point Headgear

G CapStrap Headgear Crown Strap

H CapStrap Forehead Pad

I Headgear Top Straps

J Headgear Ball Socket

K Headgear Bottom Straps

L Headgear Clips

M Four Point Headgear Crown Strap

N Four Point Headgear Forehead Pad

O Headgear Top Straps

P Headgear Ball Socket

Q Headgear Bottom Straps

R Headgear Clips

Cushion Options

S Over the Nose Mask Cushion with

Pressure Pick-Oﬀ Ports

T Under the Nose Mask Cushion Nostril

Opening

U Under the Nose Mask Cushion with Pressure

Pick-Oﬀ Ports

Before Use

•Wash the patient’s face. Do not use moisturizer/lotion on your hands or the patient’s face.

Safety Checks

1. Visually inspect the anti-asphyxia valve (ﬂapper). The ﬂapper

inside the elbow must lay ﬂat when the device is shut oﬀ a. This

allows the patient to breathe fresh air. Replace the mask if the

ﬂapper does not lay ﬂat when the device is shut oﬀ.

Warning: Do not block or seal the anti-asphyxia valve.

2. Inspect the mask for damage or wear (cracking, crazing, tears,

etc.). Discard and replace as necessary.

Achieving the Right Fit

Mask Cushion and Headgear Options

The AF541 Oro-Nasal EE Leak 1 Full Face Mask can be used with either the CapStrap Headgear or

the Four Point Headgear. The mask can also be used with either the Over the Nose Mask Cushion

or the Under the Nose Mask Cushion. Use the following instructions to achieve the right ﬁt with the

desired cushion and headgear conﬁgurations.

Fitting the Over the Nose Mask Cushion

The mask cushion should rest comfortably against the face. The bottom of the mask cushion

should rest just above the chin with the mouth slightly open bc.

Fitting the Under the Nose Mask Cushion

The mask should rest comfortably against the face. The cushion nostril opening goes under the

nostrils. The bottom of the mask cushion should rest just above the chin with the mouth slightly

open de.

Note: Do not place your nose in the cushion nostril opening.

Using the Mask with the CapStrap Headgear or Four Point Headgear

Note: Refer to the Fitting Illustrations below based on the headgear used (CapStrap

Headgear or Four Point Headgear).

1. Grip and twist the headgear clips away from the headgear clip posts.

2. Loosen the headgear straps as needed.

3. Pull the mask over head fl. Hold the mask against the face.

4. Press the headgear clips onto the headgear clip posts.

5. Pull back the headgear tabs to evenly adjust the crown gm, top hn, and bottom headgear

straps io.

6. Press and hold the forehead adjuster button to slide the frame toward or away from the face

jp. This will decrease or increase the pressure on the nose and chin.

7. Connect the mask to the patient circuit disposable exhalation port (DEP).

8. Have the patient lie down. Turn the therapy device on. Instruct the patient to breathe normally

and to keep their mouth slightly open kq.

9. Monitor patient comfort. If there are any excessive air leaks, make ﬁnal adjustments. Some air

leaking is normal.

CapStrap Headgear Fitting Illustrations

76 8

910 11

Four Point Headgear Fitting Illustrations

13 14

916

15 17

Oral Access Without Removing the Headgear

1. Disconnect the headgear clips.

2. Swing the mask upward rs.

Removing the Mask and Headgear

1. Turn the headgear clips away from the headgear clip posts.

2. Pull the mask over the top of the head t.

19 2018

Using the Clean Clip Shell

The mask may be placed in the Clean Clip Shell when not in use for therapy. The shell helps the

mask stay clean when not in use.

1. Attach the shell to the post of the clean clip bracket (optional) on the ventilator stand u.

2. Place the mask in the Clean Clip Shell. The bottom headgear posts snap into the sides of the

Clean Clip Shell. The top of the mask frame rests in the bottom of the Clean Clip Shell v.

3. After therapy, pull the shell oﬀ of the clean clip bracket. Dispose of both the Clean Clip Shell and

the mask.

Note: Never re-use shell between patients. If any parts become soiled, dispose of shell

and mask.

Comfort Tips

•The headgear should ﬁt loose and comfortable. If the patient’s skin bulges around the mask or if

you see red marks on the patient’s face, loosen the headgear.

•Adjust the headgear lower side straps to manage leaks.

•Set forehead adjustment to manage comfort and mask leak.

Leak Symbol and Port Settings

Some ventilators use a leak value and symbol in the mask selection control. The leak value and

symbol represents the intentional leak of the mask. On ventilators equipped with a mask selection

control, enter .

Disassembly

Removing the Capstrap Headgear

1. Turn the headgear clips away from the headgear clip posts.

2. Pull the CapStrap headgear ball socket away from the forehead adjuster ball w.

Removing the Four Point Headgear

1. Turn the headgear clips away from the headgear clip posts.

2. Pull the Four Point headgear forehead pad ball socket away from the forehead adjuster ball.

Removing the Mask Cushion

1. Grasp the sides of the mask cushion, and pull it oﬀ the mask frame x.

Note: Do not pull the under the nose mask cushion by the cushion nostril opening.

Removing the Mask Elbow

1. Grasp and squeeze the elbow tabs and pull the elbow away from the mask frame y.

23 24 25

Assembly

Replacing the Mask Elbow

1. Push the elbow onto the mask frame until the tabs snap into

place (audible click).

Replacing the Mask Cushion

1. Grasp the sides of the mask cushion, and push it onto the

mask frame z.

Note: Do not pull the under the nose mask cushion by

the cushion nostril opening.

Replacing the CapStrap Headgear

1. Push the CapStrap headgear ball socket onto the forehead

adjuster ball.

2. Press the headgear clips onto the headgear clip posts.

Replacing the Four Point Headgear

1. Push the Four Point headgear forehead pad ball socket onto the forehead adjuster ball.

2. Press the headgear clips onto the headgear clip posts.

Symbols Glossary

Symbol Title and Meaning Reference

Manufacturer

Indicates the medical device manufacturer.

IEC 60878

ISO 7000-3082

Symbol 5.1.1, ISO 15223-1

Prescription device

Caution: U.S. federal law restricts this device by or on

the order of a physician.

Humidity limitation

Indicates the range of humidity to which the

medical device can be safely exposed.

IEC 60878

ISO 7000-2620

Symbol 5.3.8, ISO

15223-1

Temperature limit

Indicates the storage temperature limits to which

the medical device can be safely exposed.

IEC 60878

ISO 7000-0632

Symbol 5.3.7, ISO 15223-1

Not Made with Natural Rubber Latex

Indicates that this mask is not made with natural

rubber latex

Do not re-use (in the hospital/institutional

environment)

Indicates a medical device that is intended for one

use, or for use on a single patient during a single

procedure.

IEC 60878

ISO 7000-1051

Symbol 5.4.2, ISO

15223-1

Batch code

Indicates the manufacturer’s batch code so that the

batch or lot can be identified.

IEC 60878

ISO 7000-2492

Symbol 5.1.5, ISO 15223-1

Symbol Title and Meaning Reference

Reorder number

Indicates the manufacturer’s catalogue number so

the medical device can be identified.

ISO 7000-2493

Symbol 5.1.6,

ISO 15223-1

Mask leak symbol and value

Indicates the intentional leak of the mask.

ISO 7000:2014, Graphical symbols for use on equipment - Registered symbols

ISO 15223-1:2012, Medical devices - Symbols to be used with medical devices labels - General

requirements

IEC/TR 60878:2015, Graphical symbols for electrical equipment in medical practice

Specications

The technical speciﬁcations of the mask are provided to determine if it is compatible with your

therapy device, and that alerts and alarms function properly.

Warning: Use outside of these speciﬁcations may result in ineﬀective therapy. The

pressure ﬂow curve shown below is an approximation of expected performance. Exact

measurements may vary.

Pressure Flow Curve

Flow Rate (SLPM)

0 5 10 15 20 25 30 35 40

AF541 EE Leak 1

AF541 EE Leak 1 with Disposable Circuit (DEP)

Pressure cm H

Resistance with Anti-Asphyxia Valve Closed to Atmosphere

Drop in Pressure at

50 SLPM 100 SLPM

All sizes 0.3 cm H

O 0.6 cm H

Closed to Atmosphere: A minimum of 3 cm H

O must be maintained to ensure that the

anti-asphyxia valve closes.

Open to Atmosphere: In the absence of positive airway pressure (0 cm H

O), the anti-asphyxia

valve will open.

Inspiratory and Expiratory Resistance with Anti-Asphyxia Valve Open to Atmosphere at

50SLPM

Inspiratory Resistance 1.6 cm H

Expiratory Resistance 1.0 cm H

Deadspace

Over-the-Nose Mask Cushion Under-the-Nose Mask Cushion

S 277 mL XS 218 mL

M 288 mL A 215 mL

L 303 mL B 213 mL

XL 315 mL C 230 mL

Sound Levels at 10 cm H2O

A-weighted Sound Power Level 18.5 dBA

A-weighted Sound Pressure Level at 1m 11.4 dBA

Disposal

Dispose of in accordance with local regulations.

Storage Conditions

Temperature: -4° F to 140° F (-20° C to 60° C)

Relative Humidity: 15% to 95%, non-condensing

Masque naso-buccal AF541EELeak1

Mode d’emploi – f

Informations de sécurité

Usage préconisé

Ce masque sert d’interface patient pour l’application d’un traitement par PPC ou à deux niveaux.

Le masque est destiné à un usage unique en établissement hospitalier/institution spécialisée

uniquement. Il est réservé aux patients (> 20 kg) pour lesquels un traitement par PPC ou à deux

niveaux a été prescrit.

Remarque: Ce masque n’est pas fabriqué avec du latex naturel, du BPA ou du DEHP.

Contre-indications

Ce masque ne convient pas aux patients qui présentent les pathologies suivantes : chirurgie

oculaire récente ou sécheresse oculaire, hernie hiatale, reﬂux excessif, altération du réﬂexe

tussigène et dysfonctionnement du sphincter cardiaque. Ce masque ne doit pas non plus être

utilisé sur les patients qui ont besoin d’une assistance ventilatoire ou qui prennent un médicament

sur ordonnance susceptible d’entraîner des vomissements, ou sur des patients qui ne sont pas

coopératifs, qui ne réagissent pas ou qui sont incapables de retirer le masque par eux-mêmes.

Avertissements

•Ce masque requiert l’utilisation d’un dispositif d’expiration distinct.

•L’utilisation de ce masque alors que le système n’est pas mis en marche et ne fonctionne pas peut

entraîner la réinhalation de l’air expiré. Dans certains cas, la réinhalation d’air expiré pendant plusieurs

minutes peut provoquer la suﬀocation.

•Surveillez le patient ou intervenez si le patient présente des rougeurs de la peau, des irritations, une

gêne, une vision ﬂoue ou une sécheresse oculaire.

•Surveillez le patient ou intervenez si l’un des symptômes suivants se produit : gêne thoracique

inhabituelle, essouﬄement, distension de l’estomac, éructation, maux de tête importants, douleurs

ou infections oculaires.

•Surveillez le patient ou intervenez si l’un des symptômes suivants se produit : douleurs au niveau des

dents, des gencives ou de la mâchoire. L’utilisation d’un masque peut aggraver les éventuelles

aﬀections dentaires du patient.

•Ce masque est destiné à un usage unique et ne doit être ni désinfecté, ni nettoyé après son

utilisation par un patient. Jetez le masque après son utilisation par un patient.

•Ce masque n’est pas destiné à être réutilisé par d’autres patients. Respironics ne garantit pas les

performances précisées dans les caractéristiques techniques de ce masque lorsque celui-ci a été

désinfecté.

•Une pression d’au moins 3 cm H₂O doit être maintenue lors du port de ce masque.

•Lors de la ﬁxation d’un dispositif expiratoire, le niveau de pression du traitement devra être réglé aﬁn

de compenser l’augmentation de fuites d’air associée.

•Ne serrez pas trop les sangles du harnais. Soyez attentif aux signes de serrage excessif, comme une

rougeur importante, des lésions ou des renﬂements cutanés autour des bords du masque. Desserrez

les sangles du harnais pour atténuer les symptômes.

•N’obstruez pas la valve anti-asphyxie.

Pièces du masque et options

Coque et coude du masque

A Bouton de réglage frontal

B Bille de réglage frontal

C Coque du masque

D Port du nébulisateur NIVO

E Coude d’entraînement avec valve anti-asphyxie

F Barre de ﬁxation du harnais

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