Hologic MyoSure 40-250 Instrucciones De Uso página 3

Read these instructions completely prior to using the MyoSure Rod Lens Hysteroscope.
These instructions describe two MyoSure Rod Lens Hysteroscopes:
Catalogue Product
number
MyoSure
40-250
Rod Lens
Hysteroscope
MyoSure XL
50-250XL
Rod Lens
Hysteroscope
Device Description
The MyoSure Rod Lens Hysteroscope is intended for use
in visualizing the uterine cavity and performing operative
hysteroscopy procedures including use with the MyoSure Tissue
Removal Device. The MyoSure Rod Lens Hysteroscope system
includes a removable outflow channel and the hysteroscope. The
removable outflow channel is intended to be used to provide a fluid
outflow lumen when the hysteroscope is being used in a diagnostic
mode. The removable outflow channel includes a sealed entry port
to permit the introduction of instrumentation.
The reusable rod lens hysteroscope utilizes rod lenses for
visualization and fibers for illumination. The hysteroscope includes
a working channel designed to accommodate the respective
MyoSure Tissue Removal Device. (See Table 1.)
MyoSure
Instructions for Use
U.S. FEDERAL LAW RESTRICTS THIS DEVICE TO
SALE BY OR ON THE ORDER OF A PHYSICIAN
Hysteroscope
working
channel
diameter
3 mm
4 mm
TABLE 1.
Rod Lens Hysteroscope
®
Outflow Compatible MyoSure Tissue Removal Devices
Note: All Models may not be available in all regions.
channel part
Contact your Hologic Representative for a list of
number
models available in your region.
40-201 MyoSure Tissue Removal Device
MyoSure LITE Tissue Removal Device
MyoSure REACH Tissue Removal Device
50-201XL MyoSure Tissue Removal Device
MyoSure LITE Tissue Removal Device
MyoSure XL Tissue Removal Device
MyoSure REACH Tissue Removal Device
The Operative Hysteroscopy System can be combined with a
hysteroscopic fluid management system to provide continuous flow
hysteroscopy capability. The hysteroscope is normally coupled to a
camera and video display unit for visualization.
The Myosure Rod Lens Hysteroscope is a type BF applied part per
IEC 60601-1.
Performance Parameters
Scope Working Length
Angle of View
Field of View
1
10-401
30-401LITE
10-401FC
10-401
30-401LITE
50-501XL
10-401FC
184 mm
0°
80°
ENGLISH