Electromagnetic Compatibility Guidance - Physio Control TrueCPR 80596-000001 Instructions For Use Manual

Electromagnetic Compatibility Guidance

Electromagnetic Compatibility Guidance
Electromagnetic Emissions
Table 1 Guidance and Manufacturer's Declaration - Electromagnetic Emissions
The TrueCPR coaching device, model 80596-000001, is intended for use in the electromagnetic environment
specified below. The customer or user should ensure that the TrueCPR device is used in such an environment.
Emissions Test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
The TrueCPR device emits a continuous wave signal at 12 ± 0.1 kHz. The maximum Effective Isotropic Radiated
Power (EIRP) and Effective Radiated Power (ERP) levels are -40 dBm, measured at a distance of 3 m (10 ft).
Essential Performance
The TrueCPR device maintains safe and effective performance (accurate depth and recoil) when operated in the
electromagnetic environment specified in Table 2 through Table 4.
Electromagnetic Immunity
Table 2 Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The TrueCPR device, model 80596-000001, is intended for use in the electromagnetic environment specified
below. The customer or user should ensure that the TrueCPR device is used in such an environment.
Immunity Test
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast transient/
burst
IEC 61000-4-4
Surge
IEC 61000-4-5
18
Compliance
Group 1 The TrueCPR device uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
Class B The TrueCPR device is suitable for use in all establishments including
domestic and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic purposes.
Not applicable
The TrueCPR device is battery-powered.
Not applicable
IEC 60601 Compliance
Test Level
±6 kV contact ±6 kV contact
±8 kV air ±8 kV air
±2 kV for power Not applicable
supply lines
±1 kV for input/
output lines
±1 kV line(s) to Not applicable
line(s)
±2 kV line(s) to
earth
Electromagnetic Environment - Guidance
Electromagnetic Environment - Guidance
Level
Floors should be wood, concrete, or ceramic
tile. If floors are covered with synthetic material,
the relative humidity should be at least 30%.
The TrueCPR device is battery-powered.
The TrueCPR device is battery-powered.
TrueCPR Device Instructions for Use