13
SYMBOLS
Type B device
Ground protection
Safety fuse
Switch “OFF”
Switch “ON”
Alternating current
Do not use the unit when taking a bath or a shower
It is compulsory to carefully read the instructions before using this device
Keep dry
Single use
Sterilisation by ethyl oxid
3A HEALTH CARE S.r.l.
Via Marziale Cerutti, 90F/G
25017 Lonato del Garda (BS) - ITALY
DISPOSAL PROCEDURE (Dir. 2012/19/Ue-WEEE)
The symbol on the bottom of the device indicates the separated collection
of electric and electronic equipment. At the end of life of the device, do not dispose it as mixed solid municipal waste, but dispose it
referring to a specific collection centre located in your area or returning it to the distributor, when buying a new device of the same type
to be used with the same functions. This procedure of separated collection of electric and electronic devices is carried out forecasting
a European environmental policy aiming at safeguarding, protecting and improving environment quality, as well as avoiding potential
effects on human health due to the presence of hazardous substances in such equipment or to an improper use of the same or of parts
of the same.
Caution!
The wrong disposal of electric and electronic equipment may involve sanctions.
Conforms to Directive 93/42/EEC for medical devices
Electromagnetic Compatibility
Compliance levels according to EN 60601-1-2:2015 standard
- ESD immunity: 15 kV air, 8 kV contact (EN 61000-4-2)
- Burst immunity: 2 kV/100 kHz (EN 61000-4-4)
- Surge immunity (EN 61000-4-5): 1 kV common mode /2 kV differential mode
- Magnetic field (EN 61000-4-8): 30 A/m
- Immunity to rf currents in the 150 kHz-80 MHz range (EN 61000-4-6) 3 V modulation 80% 1 kHz
- RF emissions, CISPR 11: Class B
- Harmonics emissions, EN 61000-3-2: Class A
Rf field immunity (EN 61000-4-3):
Field (V/m)
Frequency
Modulation
3
80MHz 2700MHz
1kHz AM 80%
27
380MHz 390MHz
18Hz PM 50%
28
430MHz 470MHz
18Hz PM 50%
9
704MHz 787MHz
217Hz PM 50%
28
800MHz 960MHz
18Hz PM 50%
28
1700MHz 1990MHz
217Hz PM 50%
28
2400MHz 2570MHz
217Hz PM 50%
9
5100MHz 5800MHz
217Hz PM 50%
For transmitters with rated maximum output power not listed above, the recommended separation distance d in metres (m) may be determined using the equation
adopted for the transmitter frequency, where P is the maximum rated output power of the transmitter in Watts (W) stated by the transmitter manufacturer.
Notes:
(1) At 80 MHz and 800 MHz the highest frequency range applies.
(2) These guidelines might not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
0,01
0,12
0,12
0,23
0,1
0,38
0,38
0,73
1
1,2
1,2
2,3
10
3,8
3,8
7,3
100
12
12
23
Rated maximum
output power
of transmitter
(W)
from 150 kHz to 80 MHz
d = 1,2 √P
from 80 MHz to 800 MHz
d = 1,2 √P
from 800 MHz to 2,5 GHz
d = 2,3 √P
Separation distance (m) in relation to transmitter frequency
Warnings:
Although compliant with the EN 60601-1-2 standard, the ASPEED PROFESSIONAL medical device may interfere with other devices
in the vicinity. The device must not be used in proximity to or stacked on top of other equipment. Install the device well away from
other equipment that emits high frequencies (short waves, microwaves, electric scalpels, cell phones).
The device is intended for use in an electromagnetic environment in which radiated RF disturbances are under control. The customer
or user can help prevent electromagnetic interference by maintaining a minimum distances between mobile and portable RF communication
equipment (transmitters) and the medical device as recommended below, according to the maximum output power of the radio
communication equipment.