Lunar DPX-IQ, Operator'S Manual, Page: 3 / 166

DPX-IQ Operator’s Manual iii
General Product Warranty
LUNAR warrants that its products shall be free from defects in workmanship and materials and shall conform to published specifications for a period of one (1) year
from the date of installation under normal use as prescribed in the
Operator’s Manual for the product. This warranty does not apply to any products which have been
subjected to neglect, accident or modification or any use other than specified as standard operating procedure in the manual.
LUNAR densitometers are designed to work with specific computer models and operating systems. Operating a LUNAR densitometer with a computer or operating
system that does not meet LUNAR’s specifications voids the product warranty and could significantly affect system performance. LUNAR assumes no liability for
system failures caused by the use of computers or operating systems that have not been specified by LUNAR.
LUNAR’s sole obligation to the Buyer for products failing to meet this warranty shall be, at LUNAR’s discretion, to repair or replace the nonconforming product or part.
Any item, repaired or replaced, shall be warranted for the remaining warranty period or thirty (30) days, whichever is longer.
LUNAR provides no other warranties, expressed or implied, including but not limited to any implied warranties of merchantability or fitness for a particular
purpose, except as specifically provided in this warranty or as otherwise specifically stipulated in a written addendum.
In no event shall LUNAR be liable for loss of profits, indirect, special, consequential or other similar damages, arising out of any breach of this warranty.
LUNAR retains the right to void all warranties if payment is not received, as prescribed in the terms of purchase or lease.
General Product Information
The DPX-IQ bone densitometer is designed to estimate the bone mineral density of patients when medically indicated by their physicians. The User’s Manual provides
instructions for operating the software and scan table, system information, and maintenance information.
Variables Affecting Scan Results
Scan results can be affected by operator technique and patient variability:
• Operator technique refers to patient positioning and scan analysis. To minimize technique variables, 1) establish consistent positioning and scan analysis
routines by using anatomical landmarks when positioning patients, and 2) during analysis, manipulate raw scan data only when absolutely necessary.
• Patient variability refers to changes in the patient's medical history, metabolism, and diet. It also refers to diagnostic procedures that involve radionuclide
uptake and medical treatment, and the presence of external radiation (particularly the use of other radiation-generating devices in the vicinity of the
system). To minimize patient variability, 1) thoroughly familiarize yourself with the patient’s history, and 2) install the scanner in an environment
effectively shielded from other sources of external radiation.
Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician .
Training Information
LUNAR or authorized LUNAR distributors provide individual, hands-on training as part of the installation procedure for your system. (LUNAR distributors provide
training for systems installed outside the United States.) An Applications Specialist provides information on software and hardware operations, and reviews the
warnings and cautions in this manual.
IMPORTANT: Only trained technologists should operate the system. New technologists should receive training prior to unsupervised operation of the
system. Additional training sessions are available on request for a nominal fee. For more information, contact the LUNAR Customer Support
Department at 800-334-5831, or your local LUNAR distributor.
Cautions for DEXA Determinations
You should be aware of the following factors which may affect the clinical accuracy of DEXA spine estimates: marked distortions of skeletal architecture—e.g.,
osteophytes, degenerative disc disease, spinal arthritis, spondylolisthesis, kyphoscoliosis, and vertebral fractures—and significant calcium deposits in the aorta can
falsely elevate spine bone mineral values. Regions that contain these dystrophic calcifications can be excluded from the scan analysis in some cases. The scanner can be
used to monitor changes in bone mineral over time in patients with these disorders, but caution must be taken in interpretation. Use DEXA estimates as an aid to other
methods in the evaluation of patient bone mineral status in the clinical setting.
In addition, spine estimates will be difficult to interpret for patients with orthopedic metal devices and previous surgical interventions, such as laminectomy and bone
grafts. Radiographic contrast material and radiopharmaceuticals used for myelograms, barium enemas, and other diagnostic tests prevent accurate estimates. Barium
clears the body within a few days, but the oil-based dyes used in myelograms several years ago may remain within the body for years. A three-day waiting period is
sufficient time for barium and most radiopharmaceuticals to be completely discharged from the body.
Femur estimates usually are not affected by most of the above mentioned factors for the spine. The most common complicating factors for femur estimates are prosthetic
devices and surgical implants in the region of the bone scan. Results may be adversely affected if the patient has difficulty with the desired 25° inward rotation of the leg
or with maintaining this position without movement.
Total Body estimates require consistent patient positioning for accurate results. The operator should pay particular attention to the location of the patient's arms, keeping
the positioning the same for each scan. Results may be affected if the patient moves during the scan.