1.2 Indications for Use
The OnPoint
1.2mm Scope System is indicated to be used by a trained
physician to provide illumination and visualization of an interior cavity of
the body through a natural or surgical opening in diagnostic and operative
arthroscopic and endoscopic procedures.
1.3 Contraindications
The OnPoint
1.2mm Scope System is contraindicated for use in applications
where high intensity light might damage tissue, such as neonate
transillumination and ophthalmic procedures. For other contraindications,
consult the literature accompanying the instrumentation utilized with this
device.
1.4 Regulatory Compliance
The OnPoint
1.2mm Scope System complies with all regulations to be
marketed in the United States of America, Canada, and the European Union.
This device complies with EN60601-1 and all collateral standards.
This device complies with part 15 of the FCC rules.
This device complies with the Medical Device Directive (Council Directive
93/42/EEC).
Federal law restricts this device to sale by or on order of a physician
licensed by the law of the state in which he practices to use or order the
use of this device.
Operation and Care Manual
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