16
Electromagnetic Compatibility
A. The use of accessories, lead wires or replacement parts other than those supplied by Zimmer
Biomet may result in increased emissions or decreased immunity of the equipment or system.
B. This equipment should not be used adjacent to or stacked upon other equipment.
C. Portable and mobile RF communications equipment may adversely affect the operation of Medical
Electrical Equipment.
D. In the event this equipment interferes with the operation of other equipment, or experiences
interference from other equipment, to continue treatment, move the Biomet
®
OrthoPak
®
Non-invasive Bone Growth Stimulator System away from the source of the interference as indicated
in Table 4.
Cleaning Instructions
Use a damp cloth for cleaning any part of the Biomet
®
OrthoPak
®
Non-invasive Bone Growth
Stimulator System. Do not use cleaning products or detergents.
Guidance and manufacturer’s declaration -
electromagnetic emissions
The Biomet
®
OrthoPak
®
Non-invasive Bone Growth Stimulator System is intended for use in the
electromagnetic environment specified below. The customer or the user of the Biomet
®
OrthoPak
®
Non-invasive Bone Growth Stimulator System should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The Biomet
®
OrthoPak
®
Non-invasive Bone Growth Stimulator System uses RF
energy only for its internal function. Therefore, its RF emissions are very low and
not likely to cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
The Biomet
®
OrthoPak
®
Non-invasive Bone Growth Stimulator System is suitable
for use in all establishments, including domestic establishments 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
Table 1
