Idiomas disponibles
Idiomas disponibles
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 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 an
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 during
charging.
NOTICE OF SERIOUS INCIDENT REPORTING
If a serious incident occurs with this medical device, report it to the
manufacturer and to the competent medical authority for the user/patient's
country.
GUIDANCE AND MANUFACTURER'S DECLARATION (ELECTROMAGNETIC EMISSIONS)
Emissions Test
Compliance
RF emissions
Group 1
CISPR 11
Class B
Harmonic emissions
N/A
IEC 61000-3-2
Voltage fluctuations /
flicker emissions
N/A
IEC 61000-3-3
GUIDANCE AND MANUFACTURER'S DECLARATION (ELECTROMAGNETIC IMMUNITY)
IEC 60601
Immunity Test
Test level
± 2 kV, ± 4 kV,
Electrostatic Discharge
(ESD)
± 8 kV, contact
IEC 61000-4-2
± 8 kV, ± 15 kV, air
Electrical fast transient
N/A
/ burst
Dentsply LLC
1301 Smile Way
York PA 17404 USA
www.dentsplysirona.com
PRT-10238-E Rev. 4
Issued 01-2024
Electromagnetic Environment (Guidance)
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.
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.
N/A
N/A
Compliance Level
± 2 kV, ± 4 kV,
± 8 kV, contact
± 8 kV, ± 15 kV, air
N/A
European Authorized Representative:
DeguDent GmbH
Rodenbacher Chaussee 4
63457 Hanau-Wolfgang
Germany
Tel. +49/6181/5950
Australian Sponsor
Dentsply Sirona Pty Ltd
11-21 Gilby Road
Mount Waverley, VIC 3149
Australia
Covered by one or more Patents, Pat.: US10,449,015; US10,806,545; US10,500,019
REPLACEMENT
If your SureSmile VPro Vibration Device, or any of its components, no
longer works properly or needs repair, immediately contact the physician in
charge of your orthodontic treatment. Do not attempt to service or perform
maintenance on the device. No modification of the SureSmile VPro Vibration
Device is allowed.
LIMITED WARRANTY
Dentsply Sirona, Inc. warrants to the original purchaser that the SureSmile
VPro Vibration Device will be free from defects for one (1) year from the date
of the original purchase.
Dentsply Sirona's sole obligation will be, at Dentsply Sirona's discretion, to
replace the device with a comparable product or to refund the purchaser the
original price paid for the device upon verification of eligible defect. Warranty
can only be claimed by the original orthodontist or dentist who made the
purchase from Dentsply Sirona. This warranty does not apply to normal wear
and tear that does not affect the device's functionality, nor any defect or
malfunction in the device caused by misuse, neglect, or any cause other than
the intended normal use.
TECHNICAL SPECIFICATIONS AND SYMBOLS
Warning: No modification of this equipment is allowed
This device has a minimum service/useful life of one year
Power supply
3.7 Volt Battery, Internally Powered
Equipment Type
Type BF Applied Part
Vertical dripping water shall have no harmful effect
Ingress Protection
when the device is tilted at an angle of 15° from its
Rating: IP22
normal position.
Electromagnetic Environment (Guidance)
Floors should be wood, concrete, or ceramic tile. If floors are covered with
synthetic material, the relative humidity should be at least 30%.
N/A
Switzerland Representative
Maillefer Instruments
Holding Sàrl
Chemin du verger 3
CH-1338 Ballaigues
