USER MANUAL (Instruction for Use) SW 2.9
EMC Guidance and Manufacturer’s Declaration
Version 2.9.7 dated 2020-12-23 Page 68 of 75
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ASTM F1929
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by
Dye Penetration
12 EMC GUIDANCE AND MANUFACTURER’S DECLARATION
12.1 Electromagnetic Interference
Medical electrical equipment needs special precautions regarding electromagnetic compatibility
(EMC).
The SCHWIND Carriazo-Pendular has been tested and found to comply with the limits defined in
the IEC 60601-1-2 standard (version 2014) for devices classified as Group 1, Class A according to
the CISPR 11 standard.
This equipment needs to be installed and put into service according to the EMC information and
instructions provided in the present chapter. The device only shall be installed and operated
according to the SCHWIND instructions, otherwise there is no guarantee that no abnormal
interference will occur.
WARNING
Risk of electromagnetic interference!
Portable and mobile RF communications equipment such as cellular phones,
non-OEM Bluetooth or wireless LAN devices, wireless surveillance monitors or
microwave ovens have the potential to adversely affect medical electrical
equipment.
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 Carriazo-Pendular, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result.
For Information about respective frequency range and the maximum output
power ratings of the RF appliances, the recommended separation distance
between any part of Carriazo-Pendular and the RF appliance refer to Table 3:
ELECTROMAGNETIC IMMUNITY (2):
The use of components, transducers and cables other than those specified or
supplied by the manufacturer of the Carriazo-Pendular may result in increased
electromagnetic emissions or decreased electromagnetic immunity of the
Carriazo-Pendular. Refer to chapter 12.3 List of Replacable Cables and
Components.
The essential performance of the Carriazo-Pendular can be lost or degraded due
to EM disturbances. Refer to chapter12.2 Essential Performance.
Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary,
this equipment and the other equipment should be observed to verify that they
are operating normally. Tested equipment is listed in chapter 4.5 Approved
System Combinations.
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