FACIAL DREAMWEAR

The DreamWear facial mask's unique design offers three cushion configuration options (nose, nostril, and full face) to allow patients to choose the interface that works best for them. This face mask is more comfortable and offers them greater freedom of movement than the mask prescribed for them. Patients feel like they are not wearing a mask.

Exceptional positioning and comfort
Users find the DreamWear mask more comfortable, aesthetic and easier to position than their prescribed mask. In fact, its flexible silicone conduit and soft fabric straps soften contact with the patient's cheek.

Designed to forget you're wearing a mask
The DreamWear mask's unique design offers three cushion configuration options to allow patients to choose the interface that works best for them. Its remarkable design directs airflow at the frame so patients can sleep comfortably. Additionally, the bubble located under the nose provides minimal contact; patients therefore do not have red marks, irritation or feelings of discomfort in the nostrils or the bridge of the nose.

Freedom of movement
With the DreamWear mask, users benefit from greater freedom of movement during the night. They are not bothered by bulky tubes and can sleep in any position they want - on their stomach, side or back.

Easy replacement of cushions without having to change masks
The DreamWear mask design makes it quick and easy to change the cushion type without having to change masks. Additionally, the DreamWear mask can reduce the number of masks a user needs to try to find the right one.

WARNING

Mask use is contraindicated only in patients, their spouses, caregivers and household members who are in close proximity to mask users and are wearing metal medical devices/implantable metal objects that may be affected by magnets. .

These masks may continue to be used according to the instructions and updated labeling if patients or persons near the patients do not have implantable metal medical devices or metal objects in the body.

What is a contraindication or warning?

A contraindication is a condition in which the device should not be used because the risk of use clearly outweighs any possible benefit. A warning is used to alert patients to a situation which, if not avoided, could result in death or serious injury. Additionally, a warning may describe serious adverse reactions and potential safety risks. In summary, a contraindication tells the user when a device should not be used, and a warning tells the user how to avoid sources of danger when using the device.

Contraindication

Mask use is contraindicated only in patients, their spouses, caregivers, and household members in close proximity to mask users and wearing implantable devices that may be affected by magnets, including but not including limit yourself to:

• Pacemakers
• Implantable cardiovector defibrillators (ICDs)
• Neurostimulators
• Magnetic metal implants/electrodes/valves placed in the upper limbs, torso, or higher (i.e., neck and head)
• CSF (cerebrospinal fluid) diversion (or shunt) (e.g. VP (ventriculoperitoneal) shunt)
• Aneurysm clips
• Metal embolization coils
• Devices for disrupting intravascular flow during intracranial aneurysm
• Metal skull plates, screws, burr hole shields and bone substitute devices
• Metal chips in the eye
• Eye implants (e.g. glaucoma implants, retinal implants)

• Some contact lenses containing metal
• Implants to restore hearing or balance, which contain an implanted magnet (such as cochlear implants, implantable bone conduction hearing implants, and hearing brainstem implants)
• Magnetic denture attachments
• Metal gastrointestinal clips
• Metal stents (e.g., aneurysm, coronary, tracheobronchial, biliary stent)
• Implantable ports and pumps (e.g., insulin pumps)
• Hypoglossal nerve neurostimulators
• Devices marked as not compatible with MRI (magnetic resonance imaging)
• Magnetic metal implants not marked as MRI compatible or assessed for safety in a magnetic field

Warning
Magnets with a magnetic field strength of less than 400 mT are used in the mask. With the exception of devices identified in the contraindication, ensure that the mask is kept at a distance of at least 15.24 cm (approximately) from any other implant or medical device that may be affected by the fields magnetic fields, in order to avoid the possible effects of localized magnetic fields. This includes household members, caregivers and spouses who may be in close proximity to patients using the masks.