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

Guidance and Manufacturer's Declaration – Electromagnetic Immunity
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.
Specification
Test Method
Electromagnetic Environment –
Guidance
Guidance and Manufacturer's Declaration – Special Environment
The SPIDER2 is intended for use in a Special Environment using HF surgical equipment.
WARNING - HF Interference: This equipment was designed and tested to be used with HF ESU equipment. However, if interference occurs with other equipment 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.
Instructions for Use
SPIDER2™ Limb Positioner
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
EN 61000-4-2 (2009) / IEC 61000-4-2 (2008), Electromagnetic compatibility (EMC) – Part 4-2: Testing and measurement techniques – Electrostatic
discharge immunity test
EN 61000-4-3 (2010) / IEC 61000-4-3 +A1+A2 (2010), Electromagnetic compatibility (EMC) – Part 4-3: Testing and measurement techniques –
Radiated, radio-frequency, electromagnetic field immunity test
EN 61000-4-4 (2012) / IEC 61000-4-4 (2012), Electromagnetic compatibility (EMC) – Part 4-4: Testing and measurement techniques – Electrical fast
transient/burst immunity test
EN 61000-4-5 (2006) / IEC 61000-4-5 (2005), Electromagnetic compatibility (EMC) – Part 4-5: Testing and measurement techniques – Surge immunity
test
EN 61000-4-6 (2008) / IEC 61000-4-6 (2008), Electromagnetic compatibility (EMC) – Part 4-6: Testing and measurement techniques – Immunity to
conducted disturbances, induced by radio-frequency fields
EN 61000-4-8 (2010) / IEC 61000-4-8 (2009), Electromagnetic compatibility (EMC) – Part 4-8: Testing and measurement techniques – Power
frequency magnetic field immunity test
EN61000-4-11 (2004) / IEC 61000-4-11 (2004), Electromagnetic compatibility (EMC) – Part 4-11: Testing and measuring techniques – Voltage dips, short
interruptions and voltage variations immunity tests
EN55014-(2006) / IEC CISPR 14 (2005), Electromagnetic compatibility - Requirements for household appliances, electric tools and similar apparatus
Part 1: Emmission
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
All portable and mobile RF communications equipment, including cables, should be at least 30 cm (12 inches) from any part of the SPIDER2.
Field strengths from RF transmitters, such as base stations for radio, (cellular/cordless) telephones, land mobile radios, amateur radios, AM and FM
radio broadcasts, and TV broadcasts cannot be predicted. The Professional Healthcare Facility must assess the electromagnetic environment due to
RF transmitters, an electromagnetic site survey should be considered to ensure compatibility with the immunity levels contain in IEC/EN 60601-1-2.
The SPIDER2 normal operation is to control patient limb position throughout the duration of surgical procedures.
WARNING: Abnormal performance, due to Electromagnetic Disturbances, may be manifested by a failure to properly maintain
positioning of the limb. If abnormal performance is observed, additional measures may be necessary, such as:
Reorient or relocate this, the other equipment, or both.
–
– Increase the separation between the pieces of equipment.
– Consult a biomedical engineer.
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.
English
126-99-01 Rev. H
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