Материалы расходные для навигационных систем: хирургические инструменты

Страна: Беларусь

Язык: русский

Источник: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

Доступна с:

Medtronic Navigation, Inc., СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ

класс:

изделия медицинского назначения

Производитель:

Medtronic Navigation

Дата Авторизация:

2021-02-16

Характеристики продукта

TRACER
® POINTER (9735317)
DEVICE DESCRIPTION
The Tracer
®
Pointer is a handheld, sterile, single-use disposable device for use
during
stereotactic surgical navigation. A computer-assisted surgery system
tracks the device in an
electromagnetic field to localize patient anatomy (that is, to
identify the point on the patient
images that corresponds to the point touched on the patient anatomy).
The device is
compatible with AxiEM
™
-enabled StealthStation
®
S7
®
and i7
®
systems.
INTENDED USE
The Tracer
®
Pointer is intended for use in completing Tracer
®
patient registration with a
Medtronic computer-assisted surgery system. The Tracer
®
Pointer is intended to localize
patient anatomy during computer-assisted stereotactic surgery. The
handheld, sterile, single-
use device may come in contact with central nervous system fluids as
required by the surgical
procedure and at the surgeon's discretion, based on their experience
and training.
The Tracer
®
Pointer is intended for use only with Medtronic computer-assisted
surgery
systems using electromagnetic navigation and cranial software.
INDICATIONS FOR USE
The Tracer
®
Pointer is indicated for use in registering patient anatomy and in
precisely locating
anatomical structures during navigated cranial procedures in adult and
pediatric patients. It is
indicated for use with Medtronic computer-assisted surgery systems
using electromagnetic
navigation and cranial software.
The Medtronic computer-assisted surgery system and its associated
applications are intended
as an aid for precisely locating anatomical structures in either open
or percutaneous
procedures. Their use is indicated for any medical condition in which
the use of stereotactic
surgery may be appropriate, and where reference to a rigid anatomical
structure, such as the
skull, can be identified relative to a CT-based or MR-based model,
fluoroscopy images, or
digitized landmarks of the anatomy.
58
УКАЗАТЕЛЬ TRACER
® (9735317)
ОПИСАНИЕ УСТРОЙСТВА
Указатель Tracer
®
�