Guidance And Manufacturer's Declaration - Electromagnetic Emissions - Smith & Nephew SPIDER2 Modo De Empleo

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Guidance and Manufacturer's Declaration - Electromagnetic Emissions

The Smith & Nephew SPIDER2™ is intended for use in the electromagnetic environment specified below. The customer or the user of the SPIDER2 should assure that it is used in such an
environment.
The Smith & Nephew SPIDER2 was tested to the following:
IEC/EN 60601-1-2: 2014/2015
Specification
Test Method
Emissions Test
RF emissions CISPR 11
(2003)
RF emissions CISPR 11
(2003)
Harmonic emissions
EN 61000-3-2
Voltage fluctuations/flicker emissions
EN 61000-3-3
Guidance and Manufacturer's Declaration - Separation Distances
WARNING: Electrical Interference. This equipment is designed to be used as a stand-alone, in proximity too, and with other medical equipment. This equipment and
the other equipment should be observed to verify that they are operating normally. If interference does occur it may be corrected by one or more of the following
measures:
Reorient or relocate this equipment, the other equipment, or both.
–
Increase the separation between the pieces of equipment.
–
– Consult a biomedical engineer.
10
126-99-01 Rev. H
IEC 60601-1-2 (2014) / EN 60601-1-2 (2015) MEDICAL ELECTRICAL EQUIPMENT - Part 1-2: General requirements for basic safety and essential
performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
Hydraulic pressure cannot drop unexpectedly without adequate notice so that practitioner has time to switch to a more traditional means of
maintaining damaged joints or bone fractures separated during the surgical procedure.
IEC CISPR 11 (2010) / EN 55011 (2010), Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and
methods of measurement Radiated.
Compliance
Group 1
Environment, Professional Healthcare Facility, and
not compatible with a Magnetic Resonance (MR)
environment.
Class A
N/A
N/A
Electromagnetic Environment – Guidance
The SPIDER2 is suitable for use in a Professional Healthcare environment where utility mains
are privately used by the Healthcare Facility.
Note: The EMISSIONS characteristics of this equipment make it suitable for use in industrial
areas and hospitals (CISPR 11 class A), (2003). If it is used in a residential environment
(for which CISPR 11 class B is normally required) this equipment might not offer adequate
protection to radio-frequency communication services. The user might need to take
mitigation measures, such as relocating or re-orienting the equipment.
Warning: Use of accessories or cables with this equipment, other than those
specified or provided by the Smith & Nephew could result in increased
electromagnetic emissions or decreased electromagnetic immunity and
result in improper operation.
SPIDER2™ Limb Positioner
Instructions for Use