CareFusion V. Mueller Gebrauchsanweisung Seite 4

en
Catalog Numbers:
GU4140 GU4141
Product Description
Refer to Figure 1.
A. Removable attachments
B. Shaft
C. Scale (French)
D. Blade
E. Set screw
F. Ring
G. Knife blade
H. Knife shaft
I. Handle
J. Guide channel
K. Blade guide
Indications for Use
The Otis Urethrotome is inserted into the urethra to cut urethral
strictures and enlarge the urethra.
Explanation of Symbols
Refer to the BD Symbols Glossary for symbol definitions at
www.bd.com/symbols-glossary.
How Supplied
Devices are packaged as non-sterile. Cleaning and sterilization
of devices must occur prior to use.
Limitations on Reprocessing
Repeated processing has minimal effect on these devices. End
of life is normally determined by wear and damage due to use.
Warnings
Refer to Figure 1.
The knife blade (G) poses a risk of injury
The accessory articles intended for use with the instrument are
subject to wear and tear and mechanical loads even when used
normally. To prevent failures or mechanical damage to the
instrument during the operation, all parts should be inspected
for mechanical integrity, distortion, cracks, scratches, corrosion
and complete functioning before every use. The knife blade
must not be damaged. Instruments which are not in perfect
condition must not be used.
Functional test:
• Smooth operation of the set screw (E).
• When the set screw (E) is turned, the shaft (B) must open
and close (spread).
• The indicator on the scale (C) must change accordingly.
Only use the accessories specially approved by CareFusion in
order to avoid risks associated with the compatibility of the
accessory articles with the urethrotome.
Devices shall be used in accordance with these Instructions for
Use (IFU). Read all sections of this IFU prior to use. Improper
use of these devices may cause serious injury. In addition,
improper care and maintenance of the devices may render the
devices non-sterile prior to patient use and may cause serious
injury to the health care provider or the patient.
Cautions
If there are any variations between this IFU and either your
facility's policies and/or your cleaning/sterilizing equipment
manufacturer's instructions, those variations should be brought
to the attention of the appropriate responsible hospital
personnel for resolution before proceeding with cleaning and
sterilizing your devices.
Use of a device for a task other than what it is intended for will
usually result in a damaged or broken device.
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