Propel Trampolines VPro+ User manual

VPro+ Vibration Device
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.
•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
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
•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
Green LED (1 Blink)
App has connected
Yellow LED (2 Blinks)
Successful Pairing
Blue (Slowing Blinking)
Charging in progress
Green (Slowing Blinking)
Charging complete
Blue (3 Blinks)
Session Start
Green (3 Blinks)
Session End
Green Blinks and Vibration
Device Locate
Red (1 Blink)
Critical Battery
Redlight backside
Firmware update or charging
Red (2 Blinks)
Device Reset/Reboot
DCN-0240 PRT-10189 B

VPro+ Vibration Device
and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio
communications. However, there is no guarantee that
interference will not occur in a installation. If this
equipment does cause harmful interference to radio or
television reception, which can be determined by
turning the equipment off and on, the user is
encouraged to try to correct the interference by one of
the following measures: Reorient or relocate the
receiving antenna. Increase the separation between the
equipment and receiver. Connect the equipment into an
outlet on a circuit different from that to which the
receiver is connected. Consult the dealer or an
experienced radio/TV technician for help.
•Changes or modifications not expressly approved by
the party responsible for compliance could void the
user's authority to operate the equipment
•This device complies with part 15 of the FCC Rules.
Operation is subject to the following two conditions: (1)
This device may not cause harmful interference, and (2)
this device must accept any interference received,
including interference that may cause undesired
operation
•In order to comply with FCC/ RF Exposure
requirements, this device must be installed to provide
at least 20 cm separation from the human body at all
times
TECHNICAL SPECIFICATIONS AND SYMBOLS
Warning: No modification of this equipment is allowed
Power supply
3.7 Volt Battery, Internally Powered
Equipment Type
Ingress Protection
Rating: IP X7
Protected when device is submerged
in water up to 1 meter
!Type B Applied Part
Guidance and Manufacturer’s Declaration –
Electromagnetic Emissions
The VPro+ Vibration Device is intended to be used by the
orthodontic patient to aid with the seating of removable
aligners during orthodontic treatment.
Emissions test
Complian
ce
Electromagnetic
Environment –
Guidance
RF emissions
CISPR 11
Group 1
The Propel VPro+
Vibration Device uses
RF energy only for its
internal function.
Therefore, its RF
emissions are very low
and are not likely to
cause any interference in
nearby electronic
equipment.
RF emissions
CISPR 11
Class B
The Propel VPro+
Vibration Device is
suitable for use in all
establishments, including
domestic establishments
and those directly
connected to the public
low-voltage power supply
network that supplies
buildings used for
domestic purposes.
Harmonic
emissions EN
61000-3-2
N/A
Voltage
fluctuations/flicker
emissions EN
61000-3-3
N/A
Guidance and Manufacturer’s Declaration –
Electromagnetic Immunity
The VPro+ Vibration Device is intended to be used by the
orthodontic patient to aid with seating of removable aligners
during orthodontic treatment
Immunity
Test
EN 60601
Test Level
Complianc
e Level
Electromagnetic
Environment
Guidance
Electrostat
ic
Discharge
(ESD)
EN
61000-4-2
±6 kV
contact
±8 kV air
N/A
±8kV air
Floors should be
wood, concrete, or
ceramic tile. If floors
are covered with
synthetic material,
the relative humidity
should be at least 30
%.
Radiated
Immunity
EM
61000-4-3
80-1000
MHz V/H
1000-2500
MHz V/H
N/A
N/A
Electrical
fast
transient/
burst
EN
61000-4-4
±2 kV for
power
supply lines
±1 kV for
input/output
lines
±2 kV for
power
supply lines
N/A
Mains power quality
should be that of a
typical commercial
or hospital
environment.
Surge
EN
61000-4-5
±1 kV line(s)
to line(s)
±2 kV line(s)
to earth
±1 kV
differential
mode
±2 kV
common
mode
Mains power quality
should be that of a
typical commercial
or hospital
environment.
DCN-0240 PRT-10189 B

VPro+ Vibration Device
Pat. www.orthopats.com
Voltage
dips, short
interruptio
ns and
voltage
variations
on power
supply
input lines
EN
61000-4-1
1
<5 % UT
(>95 % dip
in UT) for 0,5
cycle
40 % UT (60
% dip in UT)
for 5 cycles
70 % UT (30
% dip in UT)
for 25 cycles!
<5 % UT
(>95 % dip
in UT) for 5
s
0% Ut
(100% dip
in Ut) for
0,5 cycle
0% Ut
(100% dip
in Ut) for 1
cycle
70% Ut
(30% dip in
Ut) for 25
cycles
0% Ut
(100% dip
in Ut) for
250 cycles
Mains power quality
should be that of a
typical commercial
or hospital
environment. If the
user of the Propel
VPro+ Vibration
Device requires
continued operation
during power mains
interruptions, it is
recommended that
the Propel VPro+
Vibration Device be
powered from an
uninterruptible
power supply or a
battery.
Power
frequency
(50/60 Hz)
magnetic
field
EN
61000-4-8
3 A/m
30 A/m
Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial
or hospital
environment.
NOTE
UTis the a.c. mains voltage prior to application of
the test level.
Guidance and Manufacturer’s Declaration –
Electromagnetic Immunity
The VPro+ Vibration Device is intended to be used by the
orthodontic patient to aid with seating removable aligners
during orthodontic treatment.
Immunity
Test
EN 60601
Test
Level
Compliance
Level
Electromagnetic
Environment -
Guidance
DCN-0240 PRT-10189 B

VPro+ Vibration Device
!For:
Propel Orthodontics
394 S Abbott Ave.
Milpitas, CA 95035 USA
Tel: [phone]
!
European Authorized Representative:
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
Australian Sponsor
Emergo Australia
Level 20 Tower II,
Darling Park
201 Sussex Street
Sydney, NSW 2000
Australia
!0459
Conducted RF
EN 61000-4-6
Radiated RF
EN 61000-4-3
3 Vrms
150 kHz
to 80
MHz
3 V/m
80 MHz
to 2.5
GHz
3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
NOTE 1 At 80 MHz and 800 MHz, the higher frequency
range applies.
NOTE 2 These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
The portable and
mobile RF
communications
equipment should
not be used close
to any part of the
Propel VPro+
Vibration Device
than the
recommended
separation
distance
calculated from
the equation
applicable to the
frequency of the
transmitter.
Recommended
Separation
Distance
!
!80
MHz to 800 MHz
!
800 MHz to 2.5
GHz
Where Pis the
maximum output
power rating of
the transmitter in
watts (W)
according to the
transmitter
manufacturer and
dis the
recommended
separation
distance in
meters (m)
Interference may
occur in the
vicinity of
equipment
marked with the
following symbol:
Catalog Number
Lot Number
!
!
Non-sterile
Manufacturer
Authorized Representative, EU
Use By
Caution, consult accompanying
documents
Follow Instructions for Use
Type B Applied Part
Prescription
Australian Sponsor
Authorized Representative
Australia
!
!
!
!
!
!
!
!
DCN-0240 PRT-10189 B