Medtronic iPro2 Guia do Utilizador descarregar pdf (Página 25)

CGMS

iPro

Continuous Glucose Recorder User Guide 23

Guidance and Manufacturers Declaration – Electromagnetic Immunity

The CGMS iPro Digital Recorder (MMT-7709) is intended for use in the electromagnetic environment

specified below. The customer or the user of the CGMS iPro Digital Recorder should assure that it is

used in such an environment.

Immunity Test

IEC 60601 Test

Level

Compliance

Level

Electromagnetic Environment

Guidance

Electrostatic

discharge (ESD)

±6 kV contact Not applicable The CGMS iPro Digital Recorder should

not be affected by electrostatic

discharge that might occur under normal

conditions of use.

IEC 61000-4-2 ±8 kV air ±30 kV air

(<5% relative

humidity)

Electrical fast

transient/burst

±2 kV for power

supply lines

Not applicable

IEC 61000-4-4 ±1 kV for input/

output lines

Not applicable

Surge ±1 kV line(s) to

line(s)

Not applicable

IEC 61000-4-5 ±2 kV line(s) to

earth

Not applicable

Voltage dips, short

interruptions and

voltage variations on

power supply lines

IEC 61000-4-11

<5% U

(>95% dip in U

)

for 0.5 cycle

Not applicable

40% U

(60% dip in U

)

for 5 cycles

Not applicable

70% U

(30% dip in U

)

for 25 cycle

Not applicable

<5% U

(>95% dip in U

)

for 5 seconds

Not applicable

Power frequency

(50/60 Hz) magnetic

field

IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should

be at levels characteristic of a typical

location in a typical commercial or

hospital environment.

NOTE:

is the a.c. mains voltage prior to application of the test level.

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