Operator's Manual

Chapter 14 Specifications and standards
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 254
CAUTION
For the purposes of compliance with IEC60601-1-2, all vital signs and communications
functions were regarded as essential performance.
14.6.2
Manufacturer's Declarations
Electromagnetic Emissions (IEC EN 60601-1-2)
The Tempus Pro is intended for use in an electromagnetic environment as described below. The customer
or user of the device should ensure that the device is used in such an environment.
Emission
Measurements
Compliance Electromagnetic Environment
HF emissions acc. to
CISPR11
Group 2 The Tempus Pro must emit RF energy in order to perform its
function. Nearby electronic devices may be affected.
Note that the Tempus Pro can be configured for not to emit RF
energy in which case it will be group 1 and will not be likely to
cause any interference in nearby electronic equipment.
HF emissions acc. to
CISPR11
Class B The Tempus Pro is intended for use in all facilities including
living quarters and such ones which are connected directly to a
public power supply that supplies also buildings used for living
purposes.
Emission of overtones
acc. to IEC61000-3-2
Class B
Emission of voltage
fluctuation/flicker acc.
to IEC61000
-
3
-
3
Complies
Electromagnetic Emissions (IEC EN 60601-1-2)
The Tempus Pro is intended for use in an electromagnetic environment as described below. The customer
or user of the device should ensure that the device is used in such an environment.
Interference
Resistance Test
IEC 60601 Test
Level
Compliance Level
Electromagnetic Environment
- Guidelines
Electrostatic
discharge (ESD) acc.
to IEC 61000-4-2
± 8 kV contact
discharge
± 15 kV air discharge
± 8 kV contact
discharge
± 15 kV air discharge
Floors should be of wood,
concrete or ceramic tiles. If the
floor is tiled with synthetic
material the relative air humidity
must have 30 % at least.
Fast transient electric
disturbances / bursts
acc. to IEC 61000-4-
4
± 2 kV for power
lines
± 1 kV for input and
output lines
± 2 kV for power
lines
± 1 kV for input and
output lines
The quality of the supply
voltage should conform to a
typical business or clinic
environment.
Surge voltage
acc. to IEC 6100-4-5
± 1 kV normal mode
voltage
± 2 kV common
mode voltage
± 1 kV normal mode
voltage
± 2 kV common
mode voltage
Mains power should be that of a
typical hospital or commercial
environment.