Abbott Prodigy 3855 - Appendix D: Electromagnetic Compatibility Guidelines

Table 12. Symbols and denions
Symbol Denion
which could be caused by inappropriate waste handling of this product. The
recycling of materials will help to conserve natural resources.
For more informaon about how to return this product for recycling, please
contact
Abbo Medical
.
This device is listed by the Canadian Standards Associaon (CSA)
Internaonal as cered
Appendix D: Electromagnec Compability Guidelines
The
Prodigy
™ paent programmer, hereaer the device, is medical equipment and should be used with the
following guidance:
The device requires special precauons with regard to electromagnec compability (EMC) and should be
used in accordance with the informaon provided in this manual.
The device has no essenal performance, as dened by IEC 60601‑1/AMD1:2012 (Edion 3.1). Performance of
the device was maintained during electromagnec disturbance tesng. The device is intended for use in the
electromagnec environment specied in the following tables. The user should ensure that it is used in such
an environment.
CAUTION: The device complies with the limits for medical devices contained in IEC 60601‑1‑2:2014‑04
and CISPR11:2015 (BS EN 55011:2016). However, the device may cause radio interference or may disrupt
the operaon of nearby equipment. It may be necessary to migate this eect by reorienng or
relocang the receiving device.
CAUTION: To avoid increasing emissions or decreasing immunity from a device or system, use only
components approved by
Abbo Medical
with this system. Do not use
Abbo Medical
components with
devices or systems that are not approved by
Abbo Medical
.
Table 13. Guidance a nd Manufacturer's Declaraon
– Electromagnec Emissions
Emissions Test Compliance Electromagnec Environment Guidance
RF emissions
CISPR 11
Group 1 The device produces RF emissions as a result of its internal and system interface funcons. Its
RF emissions are very low and are not likely to cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11
Class B The device is suitable for use in all establishments including domesc establishments and
those directly connected to the public low-voltage power supply network that supplies
buildings used for domesc purposes.
Harmonic emissions
IEC 61000‑3‑2
Not applicable
Voltage uctuaons/icker
emissions IEC 61000‑3‑3
Not applicable
NOTE: The RF output frequency of the device is 87.5 kHz. The eld strength is 32 dBμA/m at 3 m
(inducvely coupled device).
Table 14. Guidance and Manufacturer's Declaraon
– Electromagnec Immunity
Immunity Test IEC 60601 Test Level Compliance Level Electromagnec
Environment
Guidance
Electrostac
discharge (ESD)
IEC 61000‑4‑2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
The
relave humidity should be at
least 30%.
Electrical fast transient/burst
IEC 61000‑4‑4
±2 kV for power supply lines
±1 kV for input/output lines
Not applicable No guidance for
baery-powered
devices.
Surge
IEC 61000‑4‑5
±1 kV line to line
±2 kV line to ground
Not applicable No guidance for
baery-powered
devices.
41