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Idiomas disponibles
8 After service
8.1
After the equipment is sold, the manufacturer will be responsible for quality problem ac-
cording to the warranty card. For specific items, please refer to the warranty instructions
in the warranty card.
8.2
This product does not contain self-maintaining parts. All maintenance, adjustment, cali-
bration, and modification of technical parameters of the product can only be carried out
by the technicians or special repair shops. If the customer needs to repair by himself,
the manufacturer can provide circuit diagrams, component lists, legends, calibration
rules, or other information necessary to help the user's qualified technicians repair the
equipment parts designated by the manufacturer, but the manufacturer will not bear the
consequences arising therefrom.
8.3
The user must use the original accessories, please contact your local dealer or the
manufacturer to purchase.
It is forbidden to use accessories of other brands to avoid damage to the equipment or
other dangers.
8.4
After the handpiece, tips and other accessories are damaged, users should not repair
them by themselves.
Please purchase new parts and replace them before use. If you need relevant informa-
tion, please contact the manufacturer.
8.5
Repair service only valid for the EU territory, for countries outside the EU please contact
your dealer. All the equipment distributed by us that will need technical interventions
during or outside the warranty period, must be sent directly to the company Vi.Vi.Med
srl who will manage the repair and invoice.
VI.VI.MED Srl - Technical Service
Via Tevere 11 - 51018 Pieve a Nievole (PT) – Italy
Tel. +39 0572 520910 - fax. +39 0572 520807 - Mobile: +39 347 5250335
e-mail: info@vivimedsrl.com – web www.vivimedsrl.com
9 EMC-Declaration of conformity
9.1 Instructions for use
The ME EQUIPMENT or ME SYSTEM is suitable for hospitals and dental clinics.
Warning: Don't near active HF surgical equipment and the RF shielded room of an ME
system for magnetic resonance imaging, where the intensity of EM disturbances is high.
Warning: Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, this equip-
ment and the other equipment should be observed to verify that they are operating normally.
Warning: Use of accessories, transducers and cables other than those specified or provided
by the manufacturer of this equipment could result in increased electromagnetic emissions
or decreased electromagnetic immunity of this equipment and result in improper operation.
Warning: Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any part
of the equipment, including cables specified by the manufacturer. Otherwise, degradation of
the performance of this equipment could result.
Note: The emissions characteristics of this equipment make it suitable for use in industrial
areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which
CISPR 11 class B is normally required) this equipment might not offer adequate protection to
radio-frequency communication services. The user might need to take mitigation measures,
such as relocating or re-orienting the equipment.
List of all cables
N O
Name
1
Power cord
2
Foot pedal cord
3
Ultrasonic handpiece cord
4
Air polishing handpiece cord
Replaceable accessories please refer to 1.6 replacement instruction for main accessories.
Performance of the me equipment
Xpower Ultrasonic Scaler & Air Polisher realizes the ultrasonic cleaning function by vibration
of ultrasonic handpiece. According to different applications, "G", "P", "E" modes can be se-
lected, "A" mode Air polishing function is adjusted by controlling the air pressure to achieve
adjustment of air polishing power; "C" mode is the cleaning mode of the ultrasonic handpiece
or air polishing handpiece. After the operation, the ultrasonic handpiece pipeline and the air
polishing handpiece pipeline need to be cleaned.When the me equipment essential perfor-
mance is lost or degraded due to em disturbances, the doctor should immediately stop using
it to ensure that there is no treatment error. And then remove the source of disturbances or
adjust the direction or position of me equipment to ensure me equipment can be used in
normal performance condition.
9.2 Technical description
9.2.1 All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PER-
FORMANCE with regard to electromagnetic disturbances for the excepted service
life.
(1) Portable and mobile RF communications equipment may affect the performance
of equipment , use of equipment should be avoided strong electromagnetic interfer-
ence, and do not closer to mobile phone, microwave oven, etc.
(2) Use of equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equip-
ment and the other equipment should be observed to verify that they are operating
normally.
(3) Except for the cables sold by manufacturers of as spare parts of internal compo-
nents, the use of accessories and cables other than those specified or provided by
the manufacturer may result in increased electromagnetic emissions or decreased
_R0_XPOWER ablatore_bug_6lingue.indd 7
_R0_XPOWER ablatore_bug_6lingue.indd 7
Lenght
Shielded or not Detachable or not Note
2.0m
No
Yes
2.8m
No
Yes
2.0m
No
No
2.0m
No
No
electromagnetic immunity of this equipment and result in improper operation.
(4) Use of accessories, transducers and cables other than those specified or provid-
ed by the manufacturer together with equipment could result in increased electro-
magnetic emissions or decreased electromagnetic immunity of this equipment and
result in improper operation.
9.2.2 Guidance and manufacturer's declaration -electromagnetic emissions and Immunity
Table 1
Guidance and manufacturer's declaration - electromagnetic emissions
Emissions test
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations/ flicker
emissions IEC 61000-3-3
Table 2
Guidance and manufacturer's declaration - electromagnetic Immunity
Immunity Test
IEC 60601-1-2 Test level
Electrostatic discharge
±8 kV contact
(ESD)
±2 kV, ±4 kV, ±8 kV, ±15 kV air
IEC 61000-4-2
Surge IEC 61000-4-5
±0.5 kV, ±1 kV differential mode
±0.5 kV, ±1 kV, ±2 kV common mode
Voltage dips, short
0 % UT; 0,5 cycle. At 0° , 45° , 90° , 135°
interruptions and voltage
, 180° , 225° , 270° and 315° .0 % UT; 1
variations on power
cycle and 70 % UT; 25/30 cycles; Single
supply input lines IEC
phase: at 0° .0 % UT; 250/300 cycle
61000-4-11
Power frequency
30 A/m
magnetic
50Hz/60Hz
field IEC 61000-4-8
Conducted RF
3 V
IEC61000-4-6
0,15 MHz – 80 MHz
6 V in ISM bands between
0,15 MHz and 80 MHz
80 % AM at 1 kHz30 A/m
NOTE UT is the a.c. mians voltage prior to application of the test level.
Table 3
Guidance and manufacturer's declaration - electromagnetic Immunity
Test
Band
Frequency
(MHz)
(MHz)
385
380–390
450
430–470
Radiated RF
IEC61000-4-3
(Test
specifications
710
for ENCLOSURE
745
704–787
/
PORT
IMMUNITY to
780
/
RF wireless
810
communications
/
870
800-900
equipment)
/
930
1720
1845
1700-1990
1970
2400-2750
2450
5240
5100–5800
5500
5785
Table 4
Guidance and manufacturer's declaration - electromagnetic Immunity
Test Frequency
Radiated RF
IEC61000-4-39
(Test specifications
30 kHz
for ENCLOSURE
PORT
134,2 kHz
IMMUNITY
to proximity
13,56 MHz
magnetic fields)
Attachment Reprocessing instructions of cleaning,
disinfecting and sterilizing
1. Beginning work
1.1 Please read these operating instructions carefully as they explain all the most important
details and procedures. Please pay special attention to the safety precautions. Always
keep this instruction close at hand.
1.2 To prevent injury to people and damage to property, please heed the corresponding
directives.
Compliance
Group 1
Class A
Not Applicable
Not Applicable
Compliance level
±2 kV power supply lines
Not applicable
100 kHz repetition frequency
±0.5 kV, ±1 kV differential mode
Not applicable
0 % UT; 0,5 cycle. At 0° , 45° , 90°
, 135° , 180° , 225° , 270° and 315°
.0 % UT; 1 cycle and 70 % UT;
25/30 cycles; Single phase: at 0°
.0 % UT; 250/300 cycle
30 A/m
50Hz/60Hz
3 V
0,15 MHz – 80 MHz
6 V in ISM bands between
0,15 MHz and 80 MHz
80 % AM at 1 kHz
IEC 60601-1-2
Service
Modulation
Test Level
(V/m)
27
TETRA 400
Pulse
modulation
18 Hz
28
GMRS 460,FRS 460
FM ± 5 kHz
deviation
1 kHz sine
LTE Band 13,17
Pulse
9
modulation
217 Hz
GSM 800/900,TETRA 800,
Pulse
28
iDEN 820,CDMA 850,
modulation
LTE Band 5
18 Hz
GSM 1800;CDMA 1900;
Pulse
28
GSM 1900;DECT;
modulation
LTE Band 1, 3,4, 25; UMTS
217 Hz
Bluetooth,
Pulse
28
WLAN,802.11 b/g/n,
modulation
RFID 2450,LTE Band 7
217 Hz
WLAN 802.11 a/n
Pulse
modulation
9
217 Hz
Modulation
EC 60601-1-2
Compliance
I
Test Level (A/m)
level (V/m)
CW
8
Pulse modulation 2.1 kHz
65
Pulse modulation 50 kHz
7,5
Instruction Manual
EN
Compliance
level (V/m)
27
28
9
28
28
28
9
8
65
7,5
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02/07/24 16:55
02/07/24 16:55
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