USER MANUAL PART NUMBER 50-02-07-212/5
This medical device is compliant with:
IEC 60601.1 3rd edition Medical electrical equipment safety and essential performance
IEC 60601.1.11 Home healthcare environment
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity (IEC 60601-1-2)
Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetic Environment - Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6kV contact
± 8kV air
± 6kV contact
± 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%.
Electrical fast
transient/burst IEC
61000-4-4
± 2 kV For mains supply lines
± 1kV For input/output lines
± 2 kV For mains supply lines
± 1kV For input/output lines
Mains supply quality for the mains adapter should be
that of a typical commercial and/or hospital environment.
Surge
IEC61000-4-5
± 1kV line(s) to line
± 1kV line(s) to line
Mains supply quality for the mains adapter should be
that of a typical commercial and/or hospital environment.
Voltage dips, short
interruptions and
voltage variations
on mains supply
IEC 61000-4-11
<5%Ur (>95%Ur) for 0.5 cycle
<5%Ur (>95%Ur) for 0.5 cycle
Mains supply quality for the mains adapter should be
that of a typical commercial and/or hospital environment.
In the event of a mains interruption the ATTIVO™
system will automatically use internal battery power,
unless the battery is exhausted.
40%Ur (60% dip in Ur) for 5 cycles
40%Ur (60% dip in Ur) for 5 cycles
70%Ur (30% dip in Ur) for 25 cycles 70%Ur (30% dip in Ur) for 25 cycles
>5%Ur (>95% dip in Ur) for 5 secs
>5%Ur (>95% dip in Ur) for 5 secs
Mains frequency
(50/60Hz) magnetic
field IEC61000-4-8
3 A/m
3 A/m
Mains frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial
and/or hospital environment.
Note: Ur is the A.C. mains voltage prior to application of the test level.
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity (IEC 60601-1-2)
Immunity
Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment - Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 V rms
150 kHz ~ 80 MHz
3 V/m
80 MHz ~
2.5 GHz
3 V rms
3 V/m
Portable and mobile RF communications equipment should be used no closer to any part of the
ATTIVO™ including cables, than the recommended separation distance calculated from the equation
appropriate to the frequency of the transmitter.
Recommend separation distance
d = 1.2 √P
d = 1.2 √P 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2.5 GHz
where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters as determined by an electromagnetic site
survey,
a
should be less than the compliance level in each frequency range.
b
Interference may occur in the vicinity of equipment marked with the following symbol:
Note1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and
people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radio, AM and FM radio broadcast,
and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromag
-
netic site survey should be considered. If the measured field strength in the location in which the
ATTIVO™ is used exceeds the applicable RF compliance
level above, the ATTIVO™ should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the ATTIVO™.
b
Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3 V/m.
Recommended Separation Distance Between Portable and Mobile RF Communications Equipment and the ATTIVO™
The ATTIVO™ is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the ATTIVO™ can help
prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and
the ATTIVO™ as recommended below, according to the maximum output power of the communications equipment.
Output Power of Transmitter in
Watts (W)
Separation distance according to frequency of transmitter in Meters (m)
150 kHz to 80 MHz d = 1.2 √P
80 MHz to 800 MHz d = 1.2 √P
800 MHz to 2.5GHz d = 2.3 √P
0.01
0.01
0.01
0.01
0.12
0.12
0.12
0.12
0.12
0.12
0.12
0.12
0.23
0.23
0.23
0.23
0.1
0.1
0.1
0.1
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in Meters (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in Watts (W) according to the
transmitter manufacturer. Note: At 80MHz and 800MHz, the separation distance for the higher frequency range applies. Note: These guidelines may not
apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
02/2017
Talley Group Limited
Premier Way, Abbey Park Industrial Estate, Romsey, Hampshire, SO51 9DQ England
TEL
:
+
44(0)1794 503500
FAX
:
+44(0)1794 503555
:
www.talleygroup.com
