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AMO Catalys OptiMedica - Electromagnetic Compatibility

AMO Catalys OptiMedica
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Chapter 5 Maintenance
Page 206 of 314 Part Number: 0160-6411, Rev A, 02/2019
Software Release: cOS 5.00
5.3 Electromagnetic Compatibility
Like other electrical medical devices, the CATALYS® System requires special precautions to
ensure electromagnetic compatibility with other electrical medical devices. To ensure
electromagnetic compatibility (EMC), the CATALYS® System must be installed and operated
according to the EMC information provided in this manual. Consult the tables on the following
pages for guidance in placing the CATALYS® System.
WARNINGS
Use of accessories, transducers, and cables other than those provided with the CATALYS® System
could cause increased electromagnetic emissions or decreased electromagnetic immunity of this
equipment, resulting in improper operation.
Use of the CATALYS® System adjacent to or stacked with other equipment could result in
improper operation and should be avoided. If such use is necessary, observe and verify normal
operation of the CATALYS® System in the configuration in which it will be used prior to use.
Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the CATALYS®
System, including cables specified by OPTIMEDICA. Otherwise, degradation of the performance
of this equipment could result.
This equipment/system is intended for use by healthcare 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 CATALYS®
System or shielding the location.
NOTES
The CATALYS® System has been designed and tested to comply with IEC 60601‐12 Ed. 4.0: 2014
requirements for EMC with other devices.
Table 5.1 Guidance and Manufacturer's Declaration: Electromagnetic Emissions
The CATALYS® System is intended for use in the electromagnetic environment specified below. The customer or
the user of the CATALYS® System should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic Environment: Guidance
RF emissions
CISPR 11
Group 1
The CATALYS® System 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 CATALYS® System is suitable for use in all establishments
other than domestic and those directly connected to the public
low-voltage power supply network that supplies buildings used for
domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage Fluctuations/
flicker emissions IEC
61000-3-3
Complies

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