EN-34
Electromagnetic Compatibility
Like other electrical medical equipment, the Crossre2 System requires special precautions
to ensure electromagnetic compatibility with other electrical medical devices. To ensure
electromagnetic compatibility (EMC), the Crossre2 System must be installed and operated
according to the EMC information provided in this manual.
The Crossre2 System has been designed and tested to comply with IEC 60601-1-2:2001
requirements for EMC with other devices.
Warnings
• This equipment is intended for use by health care professionals only. This equipment
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.
• Portable and mobile RF communications equipment can aect the normal function
of the Crossre2 System even if such equipment meets the applicable emissions
requirements.
• Do not use cables or accessories other than those provided with the Crossre2
System, as this may result in increased electromagnetic emissions or decreased
immunity to such emissions.
• If the Crossre2 System is used adjacent to or stacked with other equipment, observe
and verify normal operation of the Crossre2 System in the conguration in which
it will be used prior to using it in a surgical procedure as interference may occur.
Consult the tables below for guidance in placing the Crossre2 System.
• When the Crossre2 System is interconnected with other medical electrical
equipment, leakage currents may be additive. To minimize total patient leakage
current, any Type BF applied part should be used together with other Type BF applied
parts. Ensure all systems are installed according to the requirements of IEC 60601-1-1.
Guidance and Manufacturer’s Declaration: Electromagnetic Emissions
The Crossre2 System is intended for use in the electromagnetic environment specied below. The customer or the user of
Crossre2 System should ensure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
RF emissions CISPR11 Group 1 The Crossre2 System must emit electromagnetic
energy in order to perform its intended function. Nearby
electronic equipment may be aected.
RF emissions CISPR11 Class A Crossre2 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/icker
emissions IEC 61000-3-3
Complies
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