INDICATION FOR USE
The VPro+ Vibration Device is intended to be used by the
orthodontic patient to aid with seating of removable aligners
during orthodontic treatment.
DEVICE DESCRIPTION
The VPro+ Vibration Device can be used as a portable vibration
device. When wearing removable aligners, the device can be
applied to the portion of the aligners overlying the occlusal
surface of the teeth. The device is a rechargeable portable battery
powered device. The device consists of the following
components: a vibration unit, mouthpiece adapter, charging
cradle, charging cable, and wall charging adapter. Once the
vibration unit and mouthpiece are coupled together the device can
be used orally to apply vibration to removable aligners overlying
the occlusal surfaces of the teeth.
PREPARATION AND USE OF VPro+ VIBRATION DEVICE
1.
The VPro+ Vibration Device is packaged ready for use.
2.
Inspect and clean prior to use. Rinse mouthpiece under
water prior to first use. Mouthpiece is an attachable and
detachable accessory which cannot cause harm.
3.
Charge the device fully prior to first use. (Refer to charging
section)
4.
Device is assigned with a specific patient ID using the Propel
VPro+ Mobile App. Once assigned, the device is ready for
use.
5.
Connect the VPro+ Mouthpiece to the Vibration Device.
Confirm that the device feels secure and stable before
inserting the mouthpiece end into the patient's mouth.
6.
Depress the on-switch to activate the device.
7.
Patients will apply vibrational forces from the device to areas
of the occlusal surface of the teeth when wearing removable
aligners
8.
The device will function for 5 minutes per use and will
automatically shut-off after the duration of treatment.
9.
Clean after use and charge the unit if necessary. Refer to
"Charging" and "Cleaning" section. Store used device at
room temperature.
10. Physicians can view usage summaries and stored records
on the Propel mobile application once the device has been
assigned/used.
11. The VPro+ Vibration Device should be used for a total of 5
minutes per day in a single session.
MOBILE APPLICATION
1.
Download "Propel VPro+" App from Apple App Store or
Google Play.
2.
Ensure mobile device's Bluetooth is on.
3.
Follow onscreen instruction to locate and pair device.
4.
Click on 'Enter Your Name' and type your name
5.
Click on the 'SELECT DEVICE' option. It will display your
Device ID similar to 'VPLUS_000B57A933E5'
6.
Click on the Device ID and the Device will flash a green light
7.
Click on the 'SELECT VPro+ DEVICE' button at the bottom
which will direct you to the previous screen
8.
Click on 'GET STARTED' to start using the device
9.
Upon successful pairing, a Yellow LED will blink twice.
10. Device can be located after pairing using the Locate function
in the settings tab.
11. Mobile app will monitor use and time for all sessions.
PRECAUTIONS
It is important to read the VPro+ Vibration Device
•
Instructions for Use prior to operation for proper use,
maintenance and care.
The device is intended to be re-used.
•
Before use, inspect the device and packaging to verify that
•
no damage has occurred as a result of shipping and
handling. Do not use damaged products.
DCN-0240
VPro+ Vibration Device
Always recharge the device in accordance with the
•
Instructions for Use prior to use. Refer to "CHARGING"
section.
Never use any other alternative power sources or
•
instruments in conjunction with the Device.
Do not use the device to clean or brush teeth.
•
Use the VPro+ Vibration Device only as instructed by the
•
physician.
Not recommended for patients with Vertigo or
•
Temporomandibular Joint (TMJ) Syndrome
Device should not be modified. Any modification will impair
•
functionality.
HOW SUPPLIED
The VPro+ Vibration Device is supplied with the portable vibrating
device, mouthpiece adapter, charging cradle, charging cord, wall
charging adapter.
CHARGING
Charge the device by placing the vibration device in the charging
cradle while the cradle is connected to a power source. A red light
will illuminate from the back of the device to indicate that the
device is charging. If the device is fully charged, the device will
not charge and instead will blink green. The device will not vibrate
while it is charging. Recommended charging time is once a week.
The device is internally powered (3.7 VDC) by a rechargeable
lithium-ion polymer battery pack. The wall charging adapter
operates within the range of 100-240V. The device is inoperable
while charging is occurring.
DEVICE NOTIFICATIONS
Green LED (1 Blink)
Yellow LED (2 Blinks)
Blue (Slowing Blinking)
Green (Slowing Blinking)
Blue (3 Blinks)
Green (3 Blinks)
Green Blinks and Vibration
Red (1 Blink)
Redlight backside
Red (2 Blinks)
STORAGE
The device should be stored in the original packaging. Proper
care should be taken to ensure that the devices are not damaged.
Used devices should be stored at room temperature.
Storage Temperature: -30°C to 60°C
Storage Humidity: 15 to 90%
Atmospheric Conditions: 700 kPa to 1060 kPA
CLEANING
The device should be cleaned after each treatment use. Detach
the mouthpiece from the Vibration Device. Rinse the Mouthpiece
and the vibration device under water and let dry.
EXPOSURE and INTERFERENCE
•
App has connected
Successful Pairing
Charging in progress
Charging complete
Session Start
Session End
Device Locate
Critical Battery
Firmware update or charging
Device Reset/Reboot
This equipment has been tested and found to comply
with the limits for a Class B digital device, pursuant to
Part 15 of the FCC Rules. These limits are designed to
provide reasonable protection against harmful
interference in a residential installation. This equipment
generates uses and can radiate radio frequency energy
PRT-10189 B
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