BIOMET innerVue II, Руководство по эксплуатации и уходу

Страница: 5 / 40

3
Operation and Care Manual
1.2 Indications for Use
The InnerVue
™
II Diagnostic 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 InnerVue
™
II Diagnostic Scope System is contraindicated for use in applications
where high intensity light might damage tissue, such as neonate transillumination
and ophtalmic procedures. For other contraindications, consult the literature
accompanying the instrumentation utilized with this device.
1.4 Regulatory Compliance
The InnerVue
™
II Diagnostic 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.
1.4.1 Electromagnetic Compatibility (IEC 60601-1-2)
Guidance and Manufacturer’s Declaration—Electromagnetic Emissions
The InnerVue
™
II Diagnostic Scope System is intended for use in electromagnetic environment specified
below. The customer or the user of the InnerVue
™
II Diagnostic Scope System should assure that it is
used in such an environment.
Emissions Test Compliance Electromagnetic Environment—Guidance
RF Emissions
CISPR 11
Group 1 InnerVue
™
II Diagnostic Scope System used only energy only for its
internal function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.
RF Emissions
CISPR 11
Class B The InnerVue
™
II Diagnostic Scope System is suitable for use in all
establishments other than domestic 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
Class A
Voltage
Fluctuations/
Flicker
Emissions
IEC 61000-3-3
Complies
Introduction