Esaote O-scan eXP, Руководство пользователя

Страница: 23 / 242

350004900 Rev. 07 3 / 4
•
•
•
•
•
•
Essential prescribing information
Intended Use
O-scan is a Magnetic Resonance (MR) system that produces transversal,
sagittal, coronal and oblique section images of limbs and joints. It is
designed for imaging portions of the arm, including hand, wrist, forearm,
and elbow, but excluding the upper part of the arm and portions of the leg,
including foot, ankle, calf, and knee, but excluding the thigh. The M.R.
images produced by O-scan correspond to the spatial distribution of the
protons (hydrogen nuclei) which verify the properties of magnetic
resonance and depend on the MR parameters spin-lattice relaxation time
(T1), spin-spin relaxation time (T2), nucleus density, flow velocity and
“chemical shift”. When interpreted by a medical expert trained in use of
MR equipment, the images can provide diagnostically useful information.
Contraindications
The use of the O-scan MR system is contraindicated :
☛
for patients with implants or internal devices that are electrically,
magnetically or mechanically activated
☛
for patients who rely on electrically, magnetically or mechanically
activated life support systems
☛
for patients with implanted surgical clips or metal objects in the cranial,
ocular and vascular areas, unless the supervising physician has
ascertained that the clip or implants is not ferromagnetically active
(See chapter 3, “Instructions for Safe Use” in this document).
General Warning and Precautions
The user must define a controlled access area around the O-scan
system, to ensure that the magnetic fringe field outside this area does not
exceed 0.5 mT and that the level of electromagnetic interference complies
with Standard EN 60601-1-2 and subsequent amendments.
It is also necessary that the user establishes adequate rules for access to
the controlled area, by patients, operators, personnel and persons in
general, in order to restrict undesired exposure of the latter to the
magnetic fields and RF.
☛
Never allow persons whose condition and characteristics lead to
contraindications on exposure to the magnetic field and RF generated by
O-scan, to enter the controlled access area.
☛
All metal objects must be kept clear of the 0.5 mT controlled access
area limit.
☛
Use only peripheral equipment, including patient monitoring, life
support and emergency care equipment, that is recommended for use in
the controlled access area.
The M.R. examination requires
special precautions :