Electromagnetic Interference - GE Cardiolab II Plus Service Manual

Introduction

Electromagnetic Interference

1-6
It is important that all of the instructions in this manual be followed,
however, these instructions in no way supersede current medical
practices regarding patient care and safety.
Parts and accessories used must meet the requirements of the applicable
IEC 601 series safety standards, and/or the system configuration must
meet the requirements of the IEC 601-1-1 medical electrical systems
standard.
Refer servicing of amplifiers under warranty to GE Medical Systems -
Information Technologies authorized service personnel. Any attempt to
repair equipment under warranty will void that warranty. It is the
responsibility of users of systems needing service to contact GE Medical
Systems - Information Technologies for servicing of the equipment.
Failure on the part of responsible individuals or institutions to
implement a satisfactory equipment maintenance schedule may lead to
undue equipment failure and possible health hazards.
The use of ACCESSORY equipment not complying with the equivalent
safety requirements of this equipment may lead to a reduced level of
safety of the resulting system. Consideration relating to the choice shall
include:
use of the accessory in the PATIENT VICINITY; and
evidence that the safety certification of the ACCESSORY has been
performed in accordance to the appropriate IEC 601-1 and/or IEC
601-1-1 harmonized national standard.
The CardioLab II Plus Amplifier is a component/accessory of a Class II
medical device.
Interference with the operation or signal integrity of this equipment is
unlikely as a result of proximity to general equipment. The user should
understand that the use of some electrosurgical equipment and medical
generators may cause some level of interference of the amplifier.
Users should be aware of known RF sources, such as radio or TV stations
and hand-held mobile two-way radios, and consider them when installing
a medical device or system.
Be aware that adding accessories or components, or modifying the
medical device or system, may degrade the EMI performance. Consult
with qualified personnel regarding changes to the system configuration.
The CardioLab II meets the requirements of EN60601-1-2 (1993-04)
Medical Electrical Equipment, Part 1: General Requirements for Safety,
Cardiolab® II Plus Amplifier Manual 2002938-002E