This product is a system that conforms to the EMC (electromagnetic compatibility) standard, IEC 60601-1-2:2007 required for the
safe use of medical electrical equipment.
EMC (Electromagnetic Compatibility)
EMC (electromagnetic compatibility) refers to the ability to satisfy the following two items:
• It does not produce noises which cause unacceptable damage or interference to surrounding electronic equipment. (Emission)
• It can withstand an electromagnetic environment in which radio frequency interference are emitted from surrounding electronic
equipment and can continue to perform the functions of the equipment. (Immunity)
The EMC standards, typified by IEC 60601-1-2:2007, are standards prescribed to ensure that effects of noise generated by medical
equipment on other equipment and the effects received from electromagnetic waves generated by other equipment (mobile phones
and the like) is kept under a certain level so that medical electrical equipment is used safely.
IEC 60601-1-2:2007 (sect. 6.8.2.201) requires that detailed information regarding EMC environment for the safe functioning
of equipment be provided to the user, so technical explanation regarding EMC is given below. (For details, refer to
IEC 60601-1-2:2007.)
EMC Technical Information
Medical electrical equipment requires particular care in regards to EMC, and it is necessary to install and use the equipment in
accordance with the following EMC information.
Table 1 – Guidance and MANUFACTURER’S declaration – ELECTROMAGNETIC EMISSIONS –
for all ME EQUIPMENT and ME SYSTEMS (see 5.2.2.1 c)
Guidance and manufacturer’s declaration – electromagnetic emissions
The CAPIOX Centrifugal Pump Controller SP-200 is intended for use in the electromagnetic environment specified below.
The customer or the user of the CAPIOX Centrifugal Pump Controller SP-200 should assure that it is used in such an
environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1 The CAPIOX Centrifugal Pump Controller SP-200 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 CAPIOX Centrifugal Pump Controller SP-200 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
Not applicable
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Not applicable
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For Medical Staff
Warnings
• This system requires special attention to electromagnetic compatibility and must be used in accordance with the EMC
information described in “For Medical Staff” in this instructions for use.
• When using devices (mobile phones, radio devices, electrosurgical knives, defibrillators, etc.) that emit an electromagnetic
wave near this system, they should be used as far away as possible. This system should use a power supply isolated from
these devices and should obtain secure grounding. Malfunction in this system caused by electronic interference may result
in critical harm to the patient.
• Do not use this system with other equipment placed next to it or stacked together.
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