RSR-000886-000 (5)
Page
17
of
20
7.4. FCC
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) this device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that may cause undesired operation.
Caution:
Any changes or modifications to this device not expressly approved by the manufacturer could void the user’s authority to
operate the equipment.
This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These
limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment.
This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction
manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful
interference in which case the user will be required to correct the interference at his own expense.
This device complies with FCC RF radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or
operating in conjunction with any other antenna or transmitter. The equipment should be installed and operated with minimum distance of 20 cm
between the radiator and your body.
7.5. ISED
This device contains license-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canada’s
license exempt RSS(s). Operation is subject to the following two conditions:
(1) This device may not cause interference.
(2) This device must accept any interference, including interference that may cause undesired operation of the device.
This Class B digital apparatus complies with Canadian ICES-003.
Radiation exposure statement:
This equipment complies with ISED radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and
operated with greater than 20cm between the radiator & your body.
7.6. Radio Equipment Directive (RED)
The device is SAR exempt based on the operation of the device being under the SAR exemption requirements.
7.7. Disposal
If you plan to discontinue the use of this laser system, and intend to dispose of it or any of its parts or accessories, you must observe
the applicable regional legal provisions for its disposal. You may also contact your local distributor, authorized service center, or
Customer Care for the disposal options for this laser system.
8.
Labeling
8.1.
Explanation of Symbols
Symbol
Title
Description
Manufacturer
Indicates the medical device manufacturer, as defined in EU Directives 90/386/EEC,
93/42/EEC and 98/79/EC.
Date of manufacture
Indicates the date when the medical device was manufactured.
Catalog number
Indicates the manufacturer’s catalog, or model, number so that the medical device
can be identified.
Serial number
Indicates the manufacturer’s serial number so that a specific medical device can be
identified.
Caution
Indicates the need for the user to consult the instructions for use for important
cautionary information such as warnings and precautions that cannot, for a variety
of reasons, be presented on the medical device itself.
Type B Applied Part
Refers to the part of the medical device which comes into physical contact with the
patient in order for the device to carry out its intended function.
Do not dispose in unsorted
municipal waste (WEEE)
Equipment must not be disposed of as unsorted municipal waste.
Laser Warning
Warning label for class 2 and higher laser radiation
Remote interlock connector
Identifies remote interlock connection port
