Ambu aView Manual de instruções de utilização - Página 9
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Guidance and manufacturer's declaration – electromagnetic immunity
The system is intended for use in the electromagnetic environment specified below.
The customer or the user of the system should assure that it is used in such an environment.
Immunity test
IEC 60601
Compliance
test level
level
Conducted
3 V RMS
3 V RMS
Radio
0,15 MHz –
0,15 MHz –
Frequency
80 MHz
80 MHz
IEC 61000-4-6
6 V RMS
6 V RMS
in ISM bands
in ISM bands
80% AM at
80% AM at
1 kHz
1 kHz
Radiated
3 V/m 80 MHz
3 V/m
Radio
to 2.7 GHz
80-2700 MHz
Frequency
80% AM at
80% AM at
IEC 61000-4-3
1 kHz
1 kHz
NOTE 1: At 80 MHz, the higher frequency range applies.
NOTE 2: 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 (celluar/cordless)
telephones and land mobile radios, amateur 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 electromagnetic site survey shall be considered.
If the measured field strength in the location in which the system is used exceeds the
applicable RF compliance level above, the system shall be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the system.
b) Over the frequency range 150kHz to 80MHz, field strengths shall be less than 3 V/m.
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Electromagnetic
Environment Guidance
Portable and mobile RF
communications equipment
should be used no closer to any
part of the system, including its
cables, than the recommended
separation distance calculated
from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
d = 1.17√P
d = 1.17√P 80 MHz to 800 MHz
d = 2.33√P 800 MHz to 2.7 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 metres (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.
Recommended Separation Distances Between Portable and Mobile RF Communication
Equipment and system.
The system is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The user of the system can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters and the system as recommended below,
according to the maximum output power of the communication equipment.
Separation distance (m) according to frequency of transmitter
Rated maximum
output power (W)
150kHZ to 80MHz
of transmitter
D = 1.17√P
0.01
0.12 m
0.1
0.37 m
1
1.17 m
10
3.70 m
100
11.7 m
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 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
Appendix 2. Warranty and Replacement Program
The warranty period for the aView is one year from delivery to the customer. Ambu agrees
to replace an aView free of charge if proof can be provided of faulty materials or faulty
workmanship. In doing so Ambu cannot accept the cost of transportation or risk of shipment.
Repair of an aView due to faulty materials or faulty workmanship may be offered in situations
where this option is available. Ambu holds the right to make the choice between repair or
replacement in every situation.
Ambu holds the right to ask the technical department at the customer site, or a similar
department, to carry out repair of an aView under proper guidance by Ambu.
A defective aView must be handled exclusively by persons authorised by Ambu A/S.
To prevent infection, it is strictly forbidden to ship contaminated medical devices.
The medical device (aView or Ambu visualization device) must be decontaminated on site
before shipment to Ambu. The cleaning and disinfection procedures explained in section 5
shall be followed. Ambu reserve the right to return contaminated medical devices to the sender.
80MHz to 800MHZ
800MHz to 2.7GHz
D = 1.17√P
D = 2.33√P
0.12 m
0.23 m
0.37 m
0.74 m
1.17 m
2.33 m
3.70 m
7.37 m
11.7 m
23.3 m
17