Hologic Omni 60-250-1 Gebrauchsanleitung Seite 7

To remove these deposits, a tube of bio-compatible polishing paste
is enclosed with each hysteroscope.
To remove the deposits, dab some polishing paste onto a clean,
cotton-tipped swab. Gently press the swab onto the optical surface
to be cleaned and scrub the surface with a circular motion. Rinse
the optical surface with water to remove any remaining polishing
paste.
NOTE: Cleaning should only be performed when the image as
viewed through the scope is cloudy, and not as part of your
routine cleaning procedures.
NOTE: Do not use any ultrasonic cleaning methods. The energy
transmitted through fluid cavitations will damage seals and
optical surfaces and will void the warranty.
NOTE: Foreign matter remaining on the fiber surface of the
light post after cleaning may tend to burn and discolor the
surface when exposed to a high intensity light source.
Sterilization
The hysteroscope, sheath(s), removable outflow channel(s), and
accessory components should be sterilized prior to use according
to the parameters listed below. Be sure the distal working length
does not experience any undue forces or stress which can damage
the delicate internal optics.
Sterrad — (100NX Systems – Standard Cycle Setting, 100S
®
System - Short Cycle Setting) Device meets guidelines for Sterrad
100S, and 100NX systems and requires the use of a Sterrad-
compatible tray or container system (APTIMAX® tray REF: 13831
or equivalent). Refer to manufacturer's Instructions for Use for
more information. Trays should be wrapped with two layers of
a sterilization wrap that is cleared by the FDA for the indicated
sterilization cycle (Halyard Health H400 or equivalent).
Steam Autoclave— Prior to sterilization, the hysteroscope,
sheath(s), removable outflow channel(s) and accessory components
should be prepared in the following configuration:
• Double pouched in sterilization pouches that are cleared by the
FDA for the indicated sterilization cycle (Cardinal Health pouch
CAT #T90009 or equivalent).
Follow standard hospital procedures:
Pre-vacuum method: 132° C (270° F) for 4 minutes and 35 minutes dry time
IMPORTANT: It is recommended that the institution employ
procedures which include the use of biological indicators in order
to determine the effectiveness of the sterilization process.
Maintenance
We recommend that you inspect the hysteroscope, sheath(s) and
outflow channel(s) carefully before and after the procedure for
possible signs of damage.
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First, check the image quality of the scope by viewing the monitor.
If image quality is impaired:
• Check the distal and proximal lenses of the hysteroscope for
cracked or scratched lenses.
• Check the surface cleanliness of the distal and proximal lenses. A
foggy or cloudy image can be the result of moisture entering the
optical system or lack of cleanliness of exterior surfaces. When
viewing reflected light, the surfaces should appear smooth and
shiny.
As a second step, check the illumination system of the scope.
Reduced brightness can result from fiber damage:
• Check for fiber optic damage in the scope by holding the distal
end of the scope toward a low power light and observing the
light post on the hub. The center of the light post should appear
clear or white. Noticeable black spots indicate serious damage
to the fiber illumination bundle in the scope. This will affect light
transmission and the brightness of the image viewed on the
monitor.
• Check the light cable for damaged fibers by holding one end
of the cable toward a low power light and observing the other
end. Broken fiber will appear as black spots in the light field. A
damaged light cable will affect its ability to transmit light and the
brightness of the image viewed on the monitor.
Storage
The Omni Hysteroscope System should be stored either in their
shipping box or in a sterilization tray. In either case, proper care
should be taken to ensure that the base hysteroscope, sheath(s)
and outflow channel(s) are immobile to prevent any damage.
Service - Accessories
The following are replacement/service parts for the Omni
Hysteroscope System:
REF Description
40-201 Replacement MyoSure Outflow
Channel
50-201XL Replacement MyoSure XL Outflow
Channel
ASY-04996 Hysteroscope Light Source Adapters -
1 each: Wolf and Storz
40-902 MyoSure Single Use Seal Set - 10 per
box
40-904 MyoSure Hysterscope and Outflow
Channel Seal Cap
60-201 Omni 3.7mm Diagnostic Sheath
60-202 Omni 5.5mm Operative Sheath
60-203 Omni 6mm Operative Sheath
WARRANTY, SERVICE, AND REPAIR
WARRANTIES
Except as otherwise expressly stated in the Agreement: i)
Equipment manufactured by Hologic is warranted to the original
Customer to perform substantially in accordance with published
product specifications for one (1) year starting from the date of
shipment, or if Installation is required, from the date of Installation
("Warranty Period"); ii) digital imaging mammography x-ray tubes
are warranted for twenty-four (24) months, during which the x-ray
tubes are fully warranted for the first twelve (12) months and are
ENGLISH