Somno
Guard
AP 2
Medical oral appliance to treat snoring and
mild or moderate obstructive sleep apnoea in adults
Content:
2 oral trays (upper and lower jaw tray), 2 stainless steel adjusting screws (12 and 16 mm), locknut, spanner, adjusting tool, storage case, user instructions
To achieve an optimal therapeutic result, it is recommended that SomnoGuard
®
AP 2 is fitted by a physician (e.g., dentist, ENT physician, physician in the
sleep laboratory) or his/her trained medical staff.
Instructions
(read carefully before use) Date of information: 01.02.2021
Description:
SomnoGuard
®
AP 2 is a two-piece mandibular advancement device that is laterally mo-
vable. The two oral trays consist of a hard outer tray shell and a thermoplastic material.
After heating the trays in a boiling water bath, the thermoplastic material becomes easily
mouldable. Deep teeth impressions are formed when biting into the soft thermoplastic
material. After the appliance cools down in a cold water bath, the material hardens and
maintains its new shape. The part with the guide bar ("C-bar") characterises the upper tray
designed for the upper jaw. The C-bar is the track for the screw head of the lower tray. The
lower jaw advancement can be infinitely adjusted by turning the screw. The opening of the
respiratory tract depends on the extent of the adjusted lower jaw advancement.
Indications:
Fig. 1: SomnoGuard
AP 2
-
Treatment of primary snoring and mild or moderate obstructive sleep apnoea in adults
-
In case of CPAP intolerance and in order to reduce CPAP pressure
-
Sporadic use by patients with obstructive sleep apnoea instead of CPAP when travelling, according to the advice of a medical professional
Contraindications:
-
Patients under 18 years
-
Central sleep apnoea
-
Severe respiratory disorders
-
Epilepsy
-
Temporomandibular joint disorder
-
Insufficient number of teeth, large gaps between the teeth
-
Periodontitis, loose teeth, unstable dental crowns or prostheses, tooth decay
-
(Strong) gag reflex
-
Limited mandibular advancement
Attention:
If the patient’s dental condition appears uncertain and in case of occlus
al abnormalities, a dental check-up is strongly recommended before starting the
treatment. For patients with a retrognathic bite, the oral appliance is suitable to only a limited extent.
Possible side effects:
-
Mouth dryness or initial hypersalivation, which normalises with adaptation to the appliance
-
Morning soreness or discomfort in the temporomandibular joint, jaw or teeth, which normally reduces with adaptation
-
Transitory bite changes, which will normally disappear within 30-60 minutes after removing the appliance from the mouth
-
In case of a long-term treatment, changes of tooth position and bite are possible.
-
During the first few nights the appliance might not be kept in the mouth for the whole night. This is normal. The adaptation process may take 1
–
2 weeks.
In case of any persisting or severe side effects stop using the appliance and consult your medical professional.
Warnings:
-
Snoring can be a symptom of breathing arrests that may contribute to serious health problems such as cardiovascular diseases. Ask for your medical
professional’s help to find out why you snore.
-
The therapeutic effect of the oral appliance therapy should be controlled by adequate diagnostic measures quite soon after the beginning of treatment,
especially with those patients having breathing arrests at night due to obstructive sleep apnoea. Consult your medical professional.
-
In case of severe pain from TMJ or other persistent discomfort, stop using the appliance and consult your medical professional. He or she will then find
out whether this condition had been caused by the oral appliance and can modify the appliance if necessary.
-
You should visit your dentist at regular intervals, especially if you are wearing your appliance every night.
Take your appliance with you.
Special notes:
-
Thoroughly check the appliance for any uncommon changes (such as cracks or debonding) before and after every use. Do not use the appliance if it is
damaged in any way.
-
Make sure that the locknut is fixed against the screw housing and that the adjusting screw in the front part of the tray does not protrude from the screw
housing. Use the longer screw if necessary.
-
The average durability of SomnoGuard
®
AP 2 is about 1 ½ years. Bruxism and strong
jaw movements might decrease the average durability of your oral
appliance. Consult your medical professional for therapeutic alternatives especially designed for bruxists.
-
Please also refer to the visual material for fitting our SomnoGuard
®
oral appliances on the internet at
www.tomed.com
Care:
Clean your ora
l appliance every morning with a soft toothbrush and a special cleaning product (e.g. Curaprox “daily” gel for daily cleaning, Curaprox “weekly”
concentrate for weekly cleaning; available from TOMED or their distributors) or 1
–
2 drops of a colourless washing-up liquid.
Do not clean it with products that
contain bleach as it could damage the appliance.
Always rinse the appliance with cold water, let it dry in the open air and keep it in the storage case provided.
