| HCU 40 |
12 Applied Standards
| 143 |
Instructions for Use | 1.0 | EN | 01
Copyright Maquet Cardiopulmonary GmbH
12 Applied Standards
12.1 Electromagnetic Compatibility (EMC)
The objective of the EMC declaration is to enable the responsible organization to
decide whether the HCU 40 is suitable for its electromagnetic environment.
Essential performance characteristics:
n
Water output temperature < 42.0 ± 0.5 °C
n
If the temperature limit is exceeded (risk to patient), the pumps and heaters
are stopped immediately and an alarm is emitted.
n
If the outlet pressure limit is exceeded, the corresponding pump is switched
off and an alarm emitted.
Guidance and manufacturer's declaration – electromagnetic emissions
The HCU 40 is intended for operation in the electromagnetic environment detailed
below. The customer or the user of the device should ensure that it is used in
such an environment.
Emissions test
Compliance
Electromagnetic environment –
guidance
RF emissions in accordance with
CISPR11
Group 1
The device uses RF energy only for its
internal function. Therefore, its RF
emissions are very low and not likely
to cause any interference in nearby
electrical equipment.
RF emissions in accordance with
CISPR11
Class B
The device is suitable for use in all es
tablishments, including domestic es
tablishments and those directly con
nected to the public lowvoltage power
supply network that supplies buildings
used for domestic purposes.
Harmonic emissions IEC 6100032 Class A
Voltage fluctuations/flicker emis
sions IEC 6100033
Complies
Guidance and manufacturer's declaration – Electromagnetic immunity
The HCU 40 is intended for operation in the electromagnetic environment detailed
below. The customer or the user of the device should ensure that it is used in
such an environment.
Summary of Contents for HCU 40
Page 1: ...INSTRUCTIONS FOR USE HEATER COOLER UNIT HCU 40...
Page 147: ......
