ZQuiet Pro-Plus Assembly instructions

Product Description
The ZQuiet® Pro-Plus consists of separate upper and lower
components custom made for each individual paent. The appliance
incorporates small ns on each side of the appliance that maintains
the lower jaw slightly forward and this opens the airway to permit
unobstructed breathing. These ns also enable independent
movement of the jaw so the paent can open and close their mouth
while wearing the appliance. To maximize performance and paent
comfort, the device contains embedded screws that allow for
micro adjustments at the me of delivery and thereaer on an
as-needed basis.
Patient Instructions for Use and Care
Indications for Use
The ZQuiet® Pro-Plus oral appliance is intended to reduce
or alleviate nighme snoring and/or mild to moderate
obstrucve sleep apnea (OSA) in adult paents 18 years of
age or older.
Package Contains:
• ZQuiet® Pro-Plus Appliance
• Protecve Storage Case
• Adjustment Screw Key
Instructions
1. Make sure the device is clean and inspect it prior to each
use for damage. Do not use if any parts are cracked, chipped
or missing.
2. Clean your teeth properly before inserng your appliance
to prevent tooth decay and periodontal problems.
3. If your appliance has the so lining (absence of metal ball
clasps that contact the teeth) hold the appliance under warm
water for 30-45 seconds to soen the acrylic lining. This aids
in placing the appliance over your teeth.
4. Insert the upper component into the mouth and over
the top teeth pressing the device rmly into place using your
thumbs to ensure it is seated securely.
5. Slide your lower jaw slightly forward and then place
lower component gently by hand onto lower teeth (do
not bite into place). Press down on both sides to ensure
appliance is seated securely and ts comfortably.
6. In the morning, remove your ZQuiet® Pro-Plus device
carefully beginning with the lower tray rst. Using your
ngers gently pry the device up and o of the teeth. Due to
the snug custom t, it may require working each side a lile
bit at a me. Repeat with the upper tray using cauon not
to stress or bend the components during removal.
7. Follow the easy cleaning instrucons aer each use.
8. Adjustments to the ZQuiet® Pro-Plus device should only
be made by the clinician or under the clinician’s guidance
and recommendaon. It takes 10 turns keyhole to keyhole in
the direcon of the arrow per 1mm of advancement. Note:
each side should be adjusted by the exact number of keyhole
turns in relaon to the arrow to maintain jaw alignment.

Cleaning Instructions
ZQuiet® Pro-Plus is for single paent use only and should
be cleaned aer each use to keep it free of harmful germs
and bacteria.
To clean the ZQuiet® Pro-Plus appliance, follow these
simple instrucons:
1. Using a so toothbrush, scrub all surfaces with warm
water and a cleaner designed for dental appliances or
alternavely a small amount of mild soap or non-abrasive
toothpaste.
2. Rinse thoroughly with clean warm water.
3. Aer rinsing, shake o all excess water and pat dry
with a clean towel.
4. Store ZQuiet® Pro-Plus at room temperature in the
supplied case to prevent accidental damage.
DO NOT bleach the appliance or soak in mouthwash
containing alcohol.
DO NOT place appliance in boiling water or expose to
excessive heat. This may distort appliance and render it
unusable.
Comfort Tips & Maintenance
You may experience an adjustment period using ZQuiet®
Pro-Plus. Your jaw muscles may experience temporary
soreness, like the soreness that may happen to muscles
when trying a new exercise. During the inial break-in
period it is recommended to wear the device for short
periods of me during waking hours. Insert ZQuiet® Pro-
Plus for 30-60 minutes while reading or watching TV.
Upon waking in the morning, the lower jaw may connue
to feel more forward than usual. This sensaon should go
away slowly within a period of a couple of hours. Note: If
you experience sharp or persistent pain lasng more than
several hours aer use, you should disconnue use and
contact your Denst.
Your denst will schedule follow-up visits to ensure
proper t and therapeuc posion. Minimally, you should
return to the denst who t you for the ZQuiet® Pro-Plus
appliance every six months for a roune examinaon
and device inspecon. If the appliance becomes loose,
damaged or does not t properly at any me, contact
your denst to have it repaired immediately.
Possible Side Effects
Some of the following possible side eects can be
associated with use of The ZQuiet® Pro-Plus. Many of
these are normal during the roune adjustment period
and should disappear with connued use:
• Slight tooth or gingival discomfort
• Excessive salivaon inially
• Pain or soreness to the temporomandibular joint
• Tooth movement or changes in dental occlusion
Most paents experience lile, if any, discomfort aer
a few weeks of adapng to the ZQuiet® Pro-Plus. If
discomfort connues past this point, disconnue use and
see your denst.
Contraindications
The device is contraindicated for paents who
• Have central sleep apnea
• Have severe respiratory disorders
• Have loose teeth or advanced periodontal disease
• Are under 18 years of age
• Are allergic to Acrylic (Methyl Methacrylate)
Precautions
Densts should consider the medical history of the
paents, including history of asthma, breathing or
respiratory disorders, or other relevant health problems
and refer the paent to the appropriate healthcare
provider before prescribing the device. All Paents who
have been diagnosed with OSA should undergo some
type of objecve sleep tesng (home sleep tesng device
or an overnight Polysomnogram) to evaluate the ecacy
of the ZQuiet Pro-Plus Appliance.
Warranty
The ZQuiet® Pro-Plus appliance is custom made from
high quality materials for each paent. Materials and
workmanship is warraned against defect for 3 years.
For more informaon visit: www.zquietproplus.com
Copyright ©2015 Gergen’s Orthodonc Laboratory, Inc. & Sleeping Well, LLC | ZQuiet® is a registered trademark of Sleeping Well, LLC ZQPP-IFU.GL.10.15
Manufactured by:
Gergen’s Orthodonc Laboratory, Inc. | 1745 W. Deer Valley Road | Building 1, Suite 112
Phoenix, AZ 85027 | U.S.A. | Phone [phone] | [e-mail]