DISCOVER SomnuSeal User manual

SomnuSeal mask
Dear Customer,
The multi-use SomnuSeal™ Oral Mask allows a
single patient at home or multiple patients at a clinic
(hospital, sleeping lab, etc.) to undergo Positive Air
Pressure (PAP) treatment, provided that a physician
has prescribed PAP treatment.
The SomnuSeal™ is used to create the Positive Air
Pressure required to treat sleep apnea by
comfortably transferring air directly into the mouth in
order to keep the patient’s airways open.
Users can continue using their existing PAP
machine since the SomnuSeal™ can be connected
to any CPAP, Bi-level and Auto PAP machine, as
well as to any other PAP machine used to treat
sleep apnea.
Please read through and pay careful attention to
the following operating and maintenance
instructions.
Warnings indicate precautions and instructions
that may result in personal injury if they are not
followed.
Cautions indicate instructions that may result in
damage to the equipment or to the quality of
treatment if they are not followed.
Description
The intra-oral parts of the SomnuSeal™ mask are
made of medical grade silicone.
The SomnuSeal™ has four main parts:
1) main Body, 2) Strap Connector 3) Straps and 4)
SomnuSeal Air Vent (tube).
The strap connector (2) connects the body of the
mask (1) to both the straps (3) and the SomnuSeal
air vent (4), which connects in turn (at the other side)
to the PAP machine’s tube.
Package Contents:
1 SomnuSeal Mask (main Body)
1 Straps with Strap Connector
1 SomnuSeal Air Vent
The mask is offered in one size that fits all
.
Do NOT use the SomnuSeal™ if:
•You have a known sensitivity to silicone.
•You are incapable of removing the mask unaided.
•PAP treatment was not prescribed to you by a
physician.
•The PAP machine is not working properly.
•The SomnuSeal air vent is blocked.
•The mask provokes your gag reflex.
•Always use a humidifier when using the
SomnuSeal™.
•Always activate the PAP machine before placing
the mask in your mouth.
•Always breathe through your mouth.
•Never connect the SomnuSeal™ directly to the
PAP machine’s tube The SomnuSeal air vent must
be always positioned between them.
•Never insert the mask into your mouth any further
in than the teeth.
User Guide
If you are new to using the SomnuSeal™
1. The SomnuSeal masks require less air
pressure than traditional masks for the same
very good therapeutic result. Therefore the
recommended initial Auto PAP/Bi-level air
pressure setting:
lowest boundary air pressure: 3 or 4 cm H
2
O
(the lowest possible), highest boundary air
pressure 6 cmH
2
O.
In Continuous Positive Air Pressure (CPAP)
mode, set the air pressure level to 60% of the
original prescribed air pressure level (aimed at
traditional masks), not less than 5 cm H
2
O and
not more than 6 cm H
2
O – it is recommended to
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consult a sleep professional for the desired
change in air pressure.
2. Humidifier: begin with highest humidification
level.
3. Set the air flow parameters for your PAP
machine as recommended by a sleep
technician or other sleep professional.
Very important: lower maximal air pressure as
suggested in paragraph 1.
If possible choose mask setting type to: oral,
intra oral or full face mask.
If available, cancel air pressure resistance
control or if not possible set it to the minimal
resistance.
4. At first, activate the humidifier at its highest
level. After a few hours you may gradually
change humidification levels to best suit your
needs.
5. You may adjust the Straps as needed until the
mask is comfortably positioned (centered to the
lips). Do not fasten the straps tightly because
it will create air leaks and it is not required.
6. You may experience more salivation when you
start using the SomnuSeal but the amount will
decrease when you get used to it. You may also
see more salivation when you sit up. Salivation
will decrease drastically when you lie down.
Before going to sleep
1. Make sure the humidifier is full of water and turn
it on five minutes before you start using the
SomnuSeal™.
2. Activate the PAP machine after making sure its
tube is properly connected.
3. Connect the SomnuSeal Air Vent to the PAP
machine’s tube.
4. Connect the Strap Connector to the main Body
of the mask by pushing the Connector towards
the main Body and turning it until you hear a soft
click. Make sure that the “up” marking on the
strap connector is placed upwards.
NOTE: There is only one correct way to connect
the two pieces - the protruding triangle on the
mask’s Body must align with the socket in the
Strap Connector.
5. Attach the Strap Connector to the SomnuSeal
Air Vent, (by now the SomnuSeal air vent should
already be connected to the PAP machine’s
tube) by pushing the SomnuSeal Air Vent
towards the Strap Connector and turning it.
6. Lie down where you intend to sleep and place
the Body of the mask in your mouth between
your teeth and lips (in front of the teeth).
NOTE: The arrow pointing up, which you can
see on the inner part of the mask, indicates the
mask’s top part. Also make sure that the “up”
marking on the strap connector is also placed
upwards. Make sure they are positioned
correctly before you insert the mask into your
mouth.
7. The mask will easily adjust itself to your mouth
structure. Simply move it slightly left and right
with your lips or with a hand holding the mask.
8. Place the straps as shown in the following
figures. It is recommended that the part that
should encompass the nape will be moved first.
Fasten the straps lightly until the main Body of
the mask is centered to your lips and no part of
the straps pulls more tightly than the others.
If air leaks from your lips during use, be sure that
the main Body of the mask is placed in the
center of your mouth.
Please note that in low air pressures the straps
are used to stabilize the mask in contrast to
traditional masks that use the straps to create a
seal and therefore are tightened forcefully.
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Do not tighten the SomnuSeal straps.
9. Now you are ready for sleep.
On waking up
1. Remove the Straps from your head and the Body
of the mask from your mouth.
2. Turn the PAP machine and humidifier off.
3. Detach the Strap Connector and the Straps from
the main Body of the mask.
4. Detach the SomnuSeal Air Vent from the Strap
Connector.
5. Thoroughly clean the main Body of the mask
according to the instructions in the Maintenance
section of this document.
6. The Strap Connector and Straps do not need to be
cleaned every day and should not get wet while
you are cleaning the main Body of the mask.
SomnuSeal Maintenance
•Store the mask and its accessories in a cool dry
place
(5-50 Celsius = 40-120 Fahrenheit).
•Do not expose the mask to direct sunlight for a
prolonged period of time.
•Replace and discard the mask if it shows any
mechanical deterioration such as deformation
and/or color change.
For home users:
Every Day:
1. Detach the Strap Connector (with the Straps and
the SomnuSeal Air Vent attached to it) from the
main Body of the mask.
Detach the SomnuSeal Air Vent from the strap
connector.
2. Thoroughly wash the main Body of the mask
and the SomnuSeal air vent with warm water
and soap. Make sure you also clean the inner
part of the main Body and the SomnuSeal Air
Vent. Please refrain from using sharp objects or
finger nails during the cleaning process.
Rinse with lukewarm water and place to dry out
of direct sunlight.
Every 7 days:
3. Hands wash the straps with soap dissolved in
lukewarm water and place to dry out of direct
sunlight.
For institutional users:
1. Detach the Strap Connector (with the Straps and
the SomnuSeal Air Vent attached to it) from the
main Body of the mask.
Detach the SomnuSeal Air Vent from the strap
connector.
2. Immerse the main Body of the mask and the
SomnuSeal air vent completely, filling all lumens
and eliminating air pockets, in a CIDEX OPA
Solution for a minimum of 12 minutes at 20°C or
higher.
3. After removing the Body of the mask and the
SomnuSeal air vent from the CIDEX OPA
Solution, thoroughly rinse it by immersing it
completely in a large volume (e.g., 8 liters) of
water.
4. Keep the mask’s Body and the SomnuSeal air
vent completely immersed for at least one (1)
minute.
Manually flush all lumens with large volumes of
rinse water (at least 100ml).
5. Remove the Body of the mask and the
SomnuSeal air vent and discard the rinse water.
6. Repeat the procedure two (2) more times, for a
total of three (3) rinses, with large volumes of
fresh water.
7. Hand wash the straps with antiseptic soap
dissolved in lukewarm water and place to dry out
of direct sunlight.
•The SomnuSeal mask and the SomnuSeal air
vent must be disinfected before treating
another patient.
•You must perform three (3) separate, large
volume water immersion rinses,
to remove all CIDEX OPA Solution residues, as
they may cause serious side effects.
•Always use fresh volumes of water for each
rinse. Do not reuse the water for any purpose.
Use sterile water unless potable water is
acceptable.
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