Electromagnetic Immunity - Tandem t:slim X2 User Manual

33.8 Electromagnetic Immunity

The pump and CGM are intended for use in home healthcare electromagnetic environments.
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
Immunity Test
Electrostatic Discharge (ESD) IEC 61000-4-2
Electrical Fast Transient/burst IEC 61000-4-4
Surge IEC 61000-4-5
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3
IEC 60601 Test Level
± 8 kV contact
± 15 kV air
± 2 kV for power supply lines
± 1 kV for input/ output lines (100 kHz repetition
frequency)
± 1 kV differential mode
± 2 kV common mode
3 Vrms 150 kHz to 80 MHz
10 V/m
80 MHz to 2.7 GHz
CHAPTER 33 • Technical Specifications
Compliance Level
± 8 kV contact
± 15 kV air
± 2 kV for power supply lines
± 1 kV for input/output lines (100 kHz
repetition frequency)
± 1 kV differential mode
± 2 kV common mode
10 Vrms
10 V/m
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