LUMENIS smart532 - 1.4. Physician Responsibility; 1.5. Maintenance; 1.6. Modification of the Device; 1.7. Resale Inspection

UM-1151140EN, Rev. C, May 2016
1-3
Smart532
™
Overview
A Warning is a statement that alerts the operator to the possibility
of injury, death, or serious adverse reactions associated with the
use or misuse of the device.
1.4. Physician
Responsibility
1.5. Maintenance
1.6. Modification of the
Device
Federal (USA) law restricts prescription medical devices to sale by or on
the order of a physician, or properly licensed practitioner.
The properly licensed practitioner will be responsible for the use and
operation of the device and for all user qualifications. Lumenis makes no
representations regarding federal, state or local laws or regulations that
might apply to the use and operation of any medical device. The physician
is responsible for contacting his or her local licensing agencies to
determine any credentials required by law for clinical use and operation of
the device.
The Smart532 laser system is a precision, technical medical device that
requires routine service. All service must be performed by a Lumenis
technician and all parts must be purchased from Lumenis. Failure to obtain
service and parts through Lumenis voids all warranties, expressed and
implied. Please call Lumenis or your local representative for details.
Unauthorized modification of the hardware, software or specifications of
the Smart532 voids all warranties, expressed and implied. Lumenis takes
no responsibility for the use or operation of such a device.
Changes or modifications not expressly approved by the
manufacturer could void the user’s authority to operate the
equipment.
1.7. Resale Inspection
If any Lumenis device is resold by anyone other than an authorized sales
representative, Lumenis offers a resale inspection by a Lumenis technician
to assure that the device is working in accordance with manufacturer’s
specifications. Using the device after it has been resold and before it has
been inspected is a misuse of the device, which may result in injuries and
voids all warranties, express and implied.
Lumenis also offers service contracts and extended warranties for its
devices. For more information about the services or about the costs of
inspections or service calls, please call Lumenis or your local
representative.
Caution
Warning