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ORAL VENTILATION MASK WITHOUT INTRABUCCAL PIECE

The EASY-RESP™ mask designed for non-invasive ventilation (NIV) or as a treatment for obstructive sleep apnoea (OSA), both at hospital as well as in the home.

The mask is for one or multiple patient usage, with care exercised in their use.
Characteristics conform to the recommendations of the Association Française contre les Myopathies (French Association against Myopathy) and the Haute Autorité de Santé (French National Authority for Health) at the Salon International des Inventeurs in Lyon. Patented in the USA and in EUROPE US Patent 5.660.174

MASK WITHOUT CONNECTOR LEAK

THE MASK AND HARNESS EASY-RESP™, IS PATENTED, EFFICIENT AND COMFORTABLE

THE MASK EASY-RESP™

Special design, one size for both adults and children
Built in pure silicone, guaranteed without latex.
Marked as CE class 2A by the certified body SNCH (French National Association for Certification and Homologation) in accordance with EC Directive 93/42/EEC and registered under number CE-0499.
Female connection of 22 mm in diameter is adaptable to all standard ventilation filters and connectors.
Hardness of 50 Shore for good stability and greater comfort.

THE HARNESS EASY-RESP™

Easy to fit and to remove.

The harness remains attached to the mask outside ventilation periods.
A single action is enough to remove the mask instantly from the patient’s face, thanks to its VELCRO®strap.
The tension of the straps only needs to be adjusted once for each patient.
The harness guarantees the best possible stability and comfort.

MALE CONNECTOR WITHOUT LEAK/FEMALE STANDARD 22mm

The connector without leak is located between the exit tube of a respirator, and the EASY-RESP™ mask. This arrangement allows the usage of non-invasive ventilation (NIV) to treat patients suffering from either acute or chronic respiratory failure.

MASK WITH AN INTENTIONAL CONNECTOR LEAK

THE MASK AND HARNESS EASY-RESP™, IS PATENTED, EFFICIENT AND COMFORTABLE

THE MASK EASY-RESP™

Special design, one size for both adults and children

Built in pure silicone, guaranteed without latex.
Marked as CE class 2A by the certified body SNCH (French National Association for Certification and Homologation) in accordance with EC Directive 93/42/EEC and registered under number CE-0499.
Female connection of 22 mm in diameter is adaptable to all standard ventilation filters and connectors.
Hardness of 50 Shore for good stability and greater comfort.

THE HARNESS EASY-RESP™

Easy to fit and to remove.

The harness remains attached to the mask outside ventilation periods.
A single action is enough to remove the mask instantly from the patient’s face, thanks to its VELCRO®strap.
The tension of the straps only needs to be adjusted once for each patient.
The harness guarantees the best possible stability and comfort.

MALE CONNECTOR WITH LEAK/STANDARD MALE 22mm

The connector with leak is located between the exit tube of a continuous positive pressure generator (with one or two levels of pressure) and the EASY-RESPTM mask. This arrangement allows treatment for patients suffering notably from obstructive sleep apnoea (OSA).

ADVANTAGES FOR THE PATIENT

THE MARK EASY-RESP™, AN ADVENTAGEOUS SOLUTION FOR THE PATIENT

Improves comfort and tolerance.
Completely clear visual field.
Without latex, it is therefore non allergenic.
Prevents feelings of claustrophobia.
No contact with the nose: no risk of injury to the bridge of the nose, nor leaks into eyes.
Comfortable, flexible, small and light.
During ventilation sessions, the patient can still wear glasses, read and watch television.

ADVANTAGES FOR DOCTOR

THE MASK EASY-RESP™, AN ADVENTAGEOUS SOLUTION FOR THE DOCTOR

Increase ventilation efficiency of NIV.
Less dead space.
The excellent air tightness allows for a treatment even for patients with beards.
The excellent seal even allows NIV+PEEP for patients with beards.
Facilitates tracheobronchic fibro-aspirations and BAL.
Naso-gastric tube in place without causing leakages.
Effective NIV in cases where there is temporary (congestion, cold) or permanent (deviation of nasal septum) reduction in nasal permeability.
NIV possible for certain facial trauma cases.

INSTRUCTION FOR USE

Download the instructions manual to use the Easy Resp ventilation mask.

PUBLICATIONS

VENTILATION POSTOPÉRATOIRE NON INVASIVE PAR MASQUE BUCCAL
T.Lherm-Hôpital Gilles de Corbeil, Corbeil - Essonnes
(Annales Françaises d'Anesthésie et de Réanimation 1998)

TOLÉRANCES ET COMPLICATIONS DE LA VENTILATION NON INVASIVE EN RÉANIMATION
P.Beuret, MJ.Carton, K.Nourdine, E.Renoux, JC.Ducreux
Service de réanimation de Roanne
(XXIV Congrès de la Société de Réanimation de langue Française)

EVALUATION DE LA TOLERANCE DE LA VENTILATION NON INVASIVE EN SERVICE DE REANIMATION
A.Labdaoui, K.Wloch, JJ.Merle, P.Beuret - Centre Hospitalier de Roanne (Congrès de la Société Française des Infirmiers en Soins Intensifs 1997

A PHYSIOLOGIC COMPARISON OF NASAL AND ORAL POSITIVE AIRWAY PRESSURE
Smith Pl, O'Donnell CP, Alian L, Schwartz AR
Johns Hopkins University Baltimore (Chest. 2003 Mar ; 123(3) : 662 4)

FAQ

Can the buccal mask be used on a patient with a beard or a moustache ?
Yes, the silicone lip guarantees that the mask has a very good seal, even with a beard or a moustache.

Doesn't air go into the stomach, risking gastric dilatation ?
No, the upper oesophageal sphincter is effective up to pressures of 20 or 25 cm H20. If there is gastric dilatation in hospital, an NGT may be inserted with buccal mask for siphoning without any leakages.

Can the buccal mask be used on a patient without teeth ?
Yes, more easily than a naso-buccal mask, because the mask does not slip, as the pressures are distributed all around the mouth. It is preferable first to try keeping the dentures.

What connector should be used for NIV ?
A standard ringed connector, with pivoting coupling, connected directly between the Easy-Resp mask and the Y-connector of the respirator circuit.

Does ventilation via the mouth cause salivation ?
No, the Easy-Resp mask does not contain any intra-buccal parts which only causes salivation (because the suction actions stimulate salivation).

Is buccal ventilation just as effective as nasal or naso-buccal ventilation ?
Yes, a number of studies have shown this, both for NIV in intensive care unit and for the CPAP for treatment of sleep apnoeas (Chest, Reanimation, AFAR)

Is it a problem that it is impossible to spit, speak, drink or eat during ventilation sessions ?
NIV is an intermittent mode of ventilatory assistance, so there is no real problem in eating and drinking and performing respiratory therapy between the ventilation sessions. The patient can very easily put on and take off the mask himself, as the adjustments are kept for each patient.

Breathing through the mouth does not seem very natural ?
All dyspnoeic patients breathe through the mouth (least resistance). This is the respiration which was selected for undersea diving (more comfortable).

Is the mouth dry during the sessions ?
In NIV the system is humidified and heated. For CPAP the flow of pressurised air via the mouth poses fewer problems than via the nose, because any dryness caused is easily reversed (drinking is enough). When nasal masks are used, the nose is unable sufficiently to reheat and humidify the pressurised air, which can cause bleeding, congestion or rhinitis in addition to nasal dryness. However, it is preferable to place a heated humidification system in the circuit.

If the circuit is humidified and heated, what if condensation water suddenly gets into the mouth ?
The inconvenience is less serious than the unpleasantness and suffocation encountered when, on changing position, water abruptly goes into the nose of a patient wearing a nasal mask.

Could there be leakages via the nose ?
In about 10% of patients, there may be leakages via the nose, but it is very easy to stop them, either using a nose clip, or with balls of modellable silicone.

Are there any red marks or indentations at the contact points of the mask ?
The whole peri-buccal area is sufficiently fleshy (even in malnourished patients).
The pressure is evenly distributed (there are no zones which are more difficult to seal, which would require a tighter fit, thus creating over-pressures). There is no shearing between the skin and the mask during each respiratory movement, since the mask seals run perpendicularly to the skin, and not parallel, like the masks which encircle the nose.

Are there any risks of inhalation of gastric liquid in case of vomiting ?
Yes, just as there are with naso-buccal masks, but the Easy-Resp™ mask can be removed instantly by simply pulling on the rapid release fastener, and the mask is transparent.

When treating SAS cases, does it cause a problem when pressing on the mandible ?
As the contact points are distributed over the upper and lower jaws, there is a harmonious balance and no particular retropulsion of the chin is caused, which could aggravate the phenomenon of SAS.

Is the sight of the patient wearing the device more acceptable for him and his immediate family ?
The patient recognises himself when wearing this mask, and his family is less “shocked”, because his face is almost entirely uncovered. The patient accepts this equipment more readily because it is less invasive and more “human”.

DISTRIBUTOR

In France:
Air Liquide Medical Systems S.A.
Parc de Haute Technologie
6, rue Georges Besse
92182 Antony CEDEX – France
Tél : +33 (0)1 40 96 66 00
Fax : +33 (0)1 40 96 67 00

In Europe: Espagne, Italie, Portugal, Allemagne, Belgique, Grèce, Pays-Bas...

MANUFACTURED BY

www.cva-silicone.com

CONTACT US

Further informations : contact@easy-resp.com