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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

Radio

0,15 MHz –

Frequency

80 MHz

IEC 61000-4-6

6 V RMS

in ISM bands

80% AM at

1 kHz

Radiated

3 V/m 80 MHz

3 V/m

Radio

to 2.7 GHz

80-2700 MHz

Frequency

80% AM at

IEC 61000-4-3

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.

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

1.17 m

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