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Data Security; Guidance And Manufacturer's Declaration - Medtronic GUARDIAN LINK Manual De Instrucciones

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  • MEXICANO, página 107

Data security

The transmitter is designed to only accept radio frequency (RF) communications from
recognized and linked devices. You must pair your pump with the transmitter before the
pump will accept information from the transmitter.
The MiniMed™ insulin pumps and system components (meters and transmitters) ensure
data security via proprietary means and data integrity using error checking processes,
such as cyclic redundancy checks.
Traveling by air
Your transmitter is safe for use on commercial airlines. If questioned by airline personnel
about the use of your device, please show them your Medical emergency card.

Guidance and manufacturer's declaration

Guidance and Manufacturer's Declaration - Electromagnetic Emissions
Emissions Test
RF emissions
 CISPR 11
Harmonic
emissions
 IEC 61000-3-2
Voltage
fluctuations/flicker
emissions
 IEC 61000-3-3
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
Immunity Test
Electrostatic
discharge (ESD)
 IEC 61000-4-2
Compliance
CISPR 11
The transmitter uses RF energy only for system
communications. Therefore, its RF emissions are very low
 Group 1, Class
and are not likely to cause any interference in nearby
B
electronic equipment.
Not applicable
Note:
Not applicable
IEC 60601-1-2:2014
Test Level
±8 kV contact
 ±2 kV, ±4 kV, ±8 kV,
 ±15 kV air
Electromagnetic Environment - Guidance
The preceding statement is required by IEC
60601-1-2 for Group 1, Class B devices. Since the
transmitter is battery powered, its emissions will not
be affected by the establishment power supply and
there is no evidence of any issues associated with
the use of the system in domestic establishments.
Max foreseeable
use condition per
IEC
60601-1-2:2014
±8 kV contact
 ±2 kV, ±4 kV, ±8
kV,
 ±15 kV air
-24-
Electromagnetic
Environment Guidance
For use in a typical
domestic, commercial, or
hospital environment.

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