Microline Surgical M/L-10 Manual Del Usuario página 2

2.
Remove the outer tube (Fig. 6) by fully squeezing the trigger and unscrewing the knob clockwise (Fig. 5).
Use only Microline SURGICAL's sterile disposable back-loading slide cartridge. Microline SURGICAL
Notes:
will not be responsible for any damage caused by other clips.
RECOMMENDED CLEANING & STERILIZATION STEPS
Warning
Prior to cleaning the clip applier instrument, make sure that the disposable cartridge is removed and discarded.
Microline SURGICAL shall not be responsible for any damages occurring as a result of a non-compliance with this
warning.
Note
The M/L-10 clip applier should be stored and reprocessed in a protective sterilization tray or tube.
CLEANING
Immediately after surgical use, remove the shaft's outer tube. The instrument and its outer tube should be
1)
soaked in an enzymatic solution containing 60mL of ENZOL® Enzymatic Detergent per 4 L of water @ 22-
40°C.
2)
After the soaking cycle, the clip applier and its outer tube should be removed from the enzyme solution and
rinsed with regular tap water.
3)
The handle, shaft and rotation knob should be cleaned with a soft cloth or sponge soaked in concentrated
ENZOL® Enzymatic Detergent until no further bioburden is observed on brush or towel. The distal end of the
instrument must be cleaned with a "soft bristle" brush to avoid any damage.
4)
The clip applier handpiece and its outer tube should be rinsed in normal tap water, and then rinsed 3 times
with deionized water for a final rinse. Wipe instrument with a clean soft cloth.
5)
After the hospital cleaning procedure is completed, an inspection of the instrument should be done to ensure it
is thoroughly cleaned.
6)
It is important, prior to sterilization, that a water-soluble lubricant is used to preserve the articulation and action
of all movable parts of the instrument.
7)
Re-assemble the outer tube on the instrument. To perform this, squeeze the handpiece trigger, mount the
outer tube over the clip applier shaft, and then secure it by screwing the tube knob counterclockwise until it is
fully threaded.
Notes
The hospital's reprocessing protocol may require that the applier and the outer tube be reassembled after the
sterilization process.
Prior to wrapping the instrument for storage, it must be completely dry. Any residual moisture could result in
oxidation and corrosion that could affect its performance, function and useful life.
STERILIZATION
Warning
Prior to sterilizing the clip applier instrument, make sure that the cartridge is removed. Microline SURGICAL shall
not be responsible for any damages occurring as a result of a non-compliance with this warning.
1. Prior to sterilization, the instrument must be thoroughly cleaned.
2. Wrap the instrument, use sterilization tray (Cat #3705/3707), or tube.
Microline SURGICAL recommends the following validated sterilization cycles as guidelines:
Gravity Cycle:
Gravity Cycle:
Pre-Vacuum Cycle:
STERILIZATION PARAMETERS FOR EUROPEAN COUNTRIES
Microline SURGICAL recommends the following parameters as minimum sterilization cycle parameters for
Europe, except for France and Switzerland:
Pre-Vacuum Cycle: 3-5 minutes at 134°C
For France and Switzerland, the following minimum sterilization cycle parameters are recommended:
Pre-Vacuum Cycle: 18 minutes at 134°C, 2x10
INSPECTION
NOTE
M/L-10 Inventory Inspection Procedure (to be performed once a month). An abbreviated inspection should
be performed in the OR each time before handing the M/L-10 to the surgeon for use:
1. Check jaws for misalignment, damage and caked on bioburden.
2. Check shaft for straightness. Remove outer tube and check inner shaft for damage and caked on bio-
burden.
3. Squeeze and release handle 20 plus times to check for sticking. Check handle for damage. Never pry
handle and trigger open.
4. Fire a minimum of 2 clips to check clip closure, engagement into jaws and clip/jaw alignment.
5. In addition to proper and thorough cleaning (see instructions) make sure the M/L-10 is properly lubricated
between cases:
a. Fully immerse the instrument in an approved instrument lubricant.
b. If unable to fully immerse the instrument make sure to thoroughly lubricate both jaw and rotation
knob area.
c. After lubrication process perform step 3 and 4 of the inspection if the applier handle was sticking or
locking.
WARRANTY
Microline Surgical warrants that its instruments are free from any defects in both material and workmanship.
Microline Surgical shall not be held liable for any incidental or consequential damage of any kind. Work
performed on an instrument will void this warranty.
instrument will void this warranty.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
CONTACT INFORMATION
Microline SURGICAL, Inc.
50 Dunham Road
Beverly, MA 01915, USA
Tel:
Fax:
Web: www.microlinesurgical.com
E-mail: info@microlinesurgical.com
EC REP
Fully Squeeze
Fully Squeeze
Fig. 4
Unscrew
Unscrew
Knob
Knob
Clockwise
Clockwis
e
Fig. 5
4 minutes @ 270F (132C)
30 minutes @ 250F (121C)
4 minutes @ 270F (132C)
(978) 922-9810
(978) 922-9209
Medical Device Safety Service GmbH
Schiffgraben 41
D-30175 Hannover, Germany
Triger
Trigger
Outer Tube
Outer Tube
Removed
Removed
2
kPa.
Gross abuse or neglect of a Microline Surgical
Remove Cartridge
Remove Cartridge
Fig. 6