DreamWisp Nasal Mask

The DreamWisp Nasal Mask was designed to help patients sleep comfortably every moment. Combining the revolutionary, space-saving DreamWisp top-of-head tube with the proven, under-the-nose seal Wisp cushion creates a mask that allows patients to sleep the way they want, without having a tube in front of their face. The mask comes with a set of cushions of different sizes.

Tube located at the top of the head
Patients can sleep in any position, on their stomach, side or back, without having the tube in front of their face.

Minimalist headgear design
The DreamWisp mask provides airflow within the frame and offers a clear field of vision, as well as a reduced bulk compared to traditional nasal masks.

Easy-to-use magnetic clips
Magnetic clips allow for quick assembly and removal of the harness, which can be particularly helpful for patients with dexterity issues.

Minimal contact nasal cushion
The proven technology of the Wisp cushion allows minimal contact with the face while ensuring an optimal seal for patients while they sleep.

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.