gc AADVA IOS 100 P, Manual

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17
GC AADVA
™
IOS 1 00 P
This equipment is subject to the European
WEEE Directive 2012/19/EU.
This symbol alerts the user not to dispose of
electrical and electronic
equipment in accordance with Directive
2012/19/EU WEEE (Waste Electrical and
Electronic Equipment) as waste or as unsorted
municipal waste, but separately at an appropriate
collection.
Date of manufacture
This symbol indicates: MANUFACTURER
Type BF applied part (Scanner Application Device)
Table 1: Symbols
36 Care with the Unit
• Keep the device dust-free and covered when not in use for a long time;
• Do not attempt to open the hand piece as this may damage the device;
• While cleaning the device make sure that the capacitors or other electrical parts of the AADVA IOS 100 P do not come into
contact with any moisture;
• Always switch off and unplug the main power source before cleaning/disinfecting.
37 Information for electromagnetic compatibility (EMC)
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 IOS100 HP, including cables specified by the manufacturer. Otherwise, degradation of the performance of this e
quipment could result.”
▪
This product has been tested in accordance and, to the most actual EMC standard IEC.
▪
In case of excessive influence of electromagnetic disturbances, malfunctions can occur on the device. In such case, please contact the appropriate services described in
the chapter ‘Warranty, Service & Repair’
▪
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.
▪
Due to no essential performance, malfunctions of the device will not lead to a risk for dentist, patient or third persons. Also, no essential performance is degraded due
to EM disturbances which does not lead to any health risks.
▪
There is no photobiological risk for the dentist, patient or third persons when looking into the scanner light. The device is tested according IEC 62471 (2006) and
evaluated as class 0 which means no danger or risk for health. However, for precaution avoid looking directly into the light.
ENCLOSURE PORT
Input a.c. power PORT
Phenomenon Basic EMC
standard or test
method
IMMUNITY TEST LEVELS Phenomenon Basic EMC
standard
IMMUNITY TEST LEVELS
Professional healthcare facility
environment
Profes sional healthcare facility
environment
Electrostatic discharge IEC 61000-4-2 ±8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 IV air
Electrical fast transients /
bursts
a) l) o)
IEC 61 000-4-4 ± 2 kV
100 kHz repetition frequency
Radiated RF EM fields
a)
IEC 61 000-4-3 3 V/m
f)
80 MHz — 2,7 G Hz b)
80% AM at 1 kHz c)
Surges
a) b) j) o)
Line-to-
line
I EC 61000-4-5 ± 0, 5 kV, ± 1 kV
Proximity fields from RF wireles s
communications equipment
IEC 61000-4-3 See 8.10. Surges a) b) j) k) o) Line-to-
ground
IEC 61000-4-5 ± 0,5 kV, ± 1k V, ± 2 kV
Rated power frequency
magnetic fields d) e)
I EC 61 000-4-8 30 A/M g) 50 Hz or 60
Hz
Conducted disturbances
induced by RF fields
c) d) o)
IEC 61000-4-6 3 V m)
0,15 MHz - 80 MHz
6 V m) in ISM bands between
0,15 MHz and 80 MHz n)
80 % AM at 1 kHz e)
Voltage dips f) p) r) IEC 61000-4-11 0% U
t
; 0,5 cycle g)
At 0° , 45° , 90°, 135°, 180° ,
225°, 270° and 31 5° q)
0 % U
t
; 1 cycle and
70% U
t
; 25/30 cycles h)
Single phase: at 0 °
Voltage interruptions f) i) o) r) IEC 61000-4-11 0%, U
t
; 250/300 cycle h)
Input d.c. power PORT Patient coupling port
Phenomenon Basic EMC
standard
IMMUNITY TEST LEVELS Phenomenon Basic EMC
standard
IMMUNITY TEST LEVELS
Professional healthcare facility
environment
Professional healthcare facility
environment
Electrical fast transients / bursts
a) g)
IEC 61000-4-4 ±2 kV
100 kHz repetition frequency Electrostatic discharge c) IEC 61000-4-2 ±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
Surges a) b) g) Line-to-line IEC 61000-4-5 ±0,5 kV, ±1 kV Conducted disturbances
induced by RF fields
a)
IEC 61000-4-6 3 V b)
0,15 MHz - 80 MHz
6 V
b) in ISM bands between 0,15 MHz
and 80 MHz
Surges a) b) g) Line-to-ground IEC 61000-4-5 ±0,5 kV, ±1kV, ±2 kV
Conducted disturbances
induced by RF fields
a) c) d) i)
IEC 61000-4-6 3 V h)
0,15 MHz - 80 MHz