56
LABORIE Urocap™ IV Owner’s Manual UC4-UM01
o
The voltage levels that can occur in normal practice and the damage that
can be done to electronic components if they are touched by an operator
who is electrostatically charged.
o
An explanation should be given of methods to prevent build-up of
electrostatic charge and how and why to discharge one’s body to earth or
to the frame of the equipment or bond oneself by means of a wristband to
the equipment or the earth prior to making a connection.
•
Portable and mobile RF communications equipment can affect the Urocap IV
®
.
•
This equipment/system is intended for use by health care professionals only. This
equipment/system may cause radio interference or may disrupt the operation of
nearby equipment. It may be necessary to take mitigation measures, such as
reorienting or relocating the equipment or shielding the location.
•
The equipment should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, the equipment should be observed to verify
normal operation in the configuration in which it will be used.
IEC 60601-1-2: 2014 - TABLE 1 REQUIREMENTS
Urocap IV
®
is intended for use in the electromagnetic environment specified below. The customer or the user of
the Urocap IV
®
should assure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic environment – guidance
RF Emissions
CISPR 11
Group 1
The
Urocap IV
®
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.
RF Emissions
CISPR 11
Class A
The
Urocap IV
®
is suitable for use in all establishments
including domestic establishments and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.
Warning: This equipment/system is intended for use by
health care professionals only. This equipment/ system
may cause radio interference or may disrupt the
operation of nearby equipment. It may be necessary to
take mitigation measures, such as re- orienting or
relocating the device or shielding the location.
Harmonic Emissions
IEC 61000-3-2
Class A
Voltage
Fluctuations/Flicker
Emissions
IEC 61000-3-3
Complies
Table 26 – Electromagnetic Environment Emissions Requirements, Compliance, and Guidance
IEC 60601-1-2:2014 – TABLE 2 REQUIREMENTS
The Urocap IV is intended for use in the electromagnetic environment specified below. The customer or the user
of the Urocap IV should assure that it is used in such an environment.
Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetic Environment -
Guidance
Electrostatic
Discharge (ESD)
IEC 61000-4-2
±8 kV Contact
±2kV, ±4kV, ±8 kV
and ±15kV Air
±8 kV Contact
±15 kV Air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.