Tomed SomnoGuard AP Instructions

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SomnoGuard AP
Medical oral appliance to treat snoring and sleep apnoea in adults in adults
Content: 2-part mouthpiece, storage case, user instructions, 2 stainless steel adjustment screws (12 and 16 mm – 12 mm screw fitted in appliance),
1 stainless steel stainless steel locknut, 1 stainless steel spanner, 1 adjusting tool
Read instructions carefully before use.
Instructions
Date of information: 10 August 2011

Description:

SomnoGuard AP is a laterally movable and infinitely adjustable two-part
mandibular advancement device. The adjustable appliance consists of an
upper and a lower tray. The upper and the lower trays are each made of
two components: A clear transparent polycarbonate outer tray shell filled
with a thermoplastic copolymer. After heating the trays in boiling water,
the thermoplastic material becomes mouldable. Deep teeth and jaw
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Fig. 1: SomnoGuard AP
impression are easily formed when firmly biting into the soft thermo-
plastic material. The part with the guide bar ("C-bar") and the engraved line in the thermoplastic material characterises the upper tray designed for the upper
jaw ("upper tray"). The C-bar is the track for the screw head of the lower tray and allows advancement of the lower jaw from 0 to approx. 10 millimetres
depending upon the length of the adjusting screw used.

Indications:

- Primary snoring and mild to moderate obstructive sleep apnea in adults
- CPAP-intolerance
- Sporadic use by patients with obstructive sleep apnoea instead of CPAP when travelling according to the advice of their medical professional.

Contraindications:

If any of the following conditions exist, seek advice from a medical professional before using this appliance:
- Central sleep apnoea
- Mandibular joint disorder
- (Strong) gag reflex, larger gaps between the teeth, unstable dental crowns, decay, parodontosis
- Limited mandibular advancement. Patients with sleep apnoea should be able to extend their lower jaw forward at least 7mm.
If the patient's dental condition appears uncertain and in case of occlusal abnormalities (e.g. crossbite, overbite, underbite) a check up visit with a dentist is
necessary and strongly recommended prior to the start of treatment. In case of long term use regular dental check-ups are required.

Possible side effects:

- Initial hypersalivation which normalises with adaptation to the appliance.
- Morning discomfort by temporary pain from TMJ or teeth, reducing commonly with adaptation
- Mouth dryness
- During the first days it may happen that the device cannot be kept in the mouth for the whole night. This is normal. The adaptation may take 1 to 2 weeks.
In case of any persisting or severe side effects stop using the appliance immediately and consult your medical professional.

Mode of action

SomnoGuard AP has been developed to reposition the lower jaw forward by any degree up to 10 millimetres. At the same time a limited sideward movement
®
is possible. Due to the advanced lower jaw position the upper airway is wider and you can breathe more easily without snoring. In addition nocturnal breathing
arrests are reduced. SomnoGuard ® AP allows you to breathe through your mouth when you have difficulties breathing through your nose (e.g. when you have
a cold).

Fitting the appliance

1. Fill a medium sized saucepan with about 1 litre of water to a depth of about 7 cm and boil vigorously. Immerse the upper part of the appliance (i.e. the part
with the guide bar or C-bar) for 3½ minutes in the boiling water. As the device heats up the thermoplastic filling will become clear and the device will rise to the
surface.
2. Take the upper part out with a spoon and allow it to cool for 15 seconds. Make sure that the temperature of the device is acceptable for fitting whilst being
hot enough to allow the mouthpiece to be moulded.
3. If you fit the appliance yourself practise especially steps 4 and 8 in front of a mirror.
4. Place the upper tray on the upper jaw teeth with the incisors as near to the front wall as possible. Press the bottom of the tray beginning from the front to the
rear with your thumbs and forefingers firmly against the teeth. Press the excessive still mouldable thermoplastic behind the teeth firmly against the teeth and
gums at the interior side of the mouth with a finger to achieve a good grip. Keep the oral appliance for another 30 seconds in place before removing the upper
jaw tray carefully by the rigid shell out of the mouth.