Appendix Aapplied Parts; Fms Vue Ii Isolation Diagram - Johnson & Johnson DePuy Synthes FMS VUE II Manual Del Usuario

Appendix A
Applied Parts
The FMS VUE II is a Class I Type BF device, according to the Electrical Safety Standard
IEC 60601-1 for medical devices (no electrical contact with patient) .
Applied Parts are:
• Handpiece shaver, blades and burrs (disposables), electrical cable, and saline tubing from
shaver that touches the patient .
• Saline tubes from the Arthroscope sheath, and outflow sheaths that return to the pump
Isolated Parts are:
• FMS Connect with electrical cable
• Foot pedal with electrical cable
• Remote control with electrical cable
A.1 FMS VUE II Isolation Diagram
Refer to Figure 18 .
*Note 1. 240VAC 1MOPP is required due to a connection to the applied part. Also, note that
the shaver has additional 500VAC insulation between the shaver handle and the shaver circuit.
**Note 2. The Foot Pedal and Remote Control are required to have 2 MOOP from Mains based
on a working voltage of 240 VAC and 2 MOOP from Earth based on a working voltage of 5 Vdc.
However, due to close proximity of these two connectors to the applied part (shaver) and the
possibility of shorting these connectors to the shaver connector with the connector's metal cap
and strap, the Foot Pedal and Remote Control circuits were connected to the isolation circuits
for the shaver. As a result, the foot pedal and remote control have the higher level of isolation
required for the shaver applied part; 2 MOPP from mains at 240 VAC and the most restrictive
of 1 MOPP from earth at a working voltage of 240 VAC or 2 MOPP from earth at a secondary
circuit (working) voltage of 5VDC.
8.5.2.1 F-TYPE APPLIED PARTS
The PATIENT CONNECTION(S) of any F-TYPE APPLIED PART shall be separated from all
other parts, including the PATIENT CONNECTION(S) of other APPLIED PARTS, by means
equivalent to one MEANS OF PATIENT PROTECTION for a WORKING VOLTAGE equal to the
MAXIMUM MAINS VOLTAGE and shall comply with the specified limit for PATIENT LEAKAGE
CURRENT with 110 % of the MAXIMUM MAINS VOLTAGE applied .
NOTE: The separation means between an F-TYPE APPLIED PART and other parts are
subject both to these tests, related to the MAXIMUM MAINS VOLTAGE, and to tests related
to the voltages present within the respective circuits as specified in 8.5.4. Depending on the
magnitude of the latter voltages, one set of tests or the other could be more stringent.
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