Microline Surgical M/L-10 Multi-Fire Mode D'emploi page 2

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.
MANUAL CLEANING
1. Immediately after surgical use, remove the shaft's outer tube. The instrument and its outer tube should be soaked in an enzymatic
detergent solution.
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 and brush soaked in a concentrated enzymatic detergent until no
further bioburden is observed. 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.
AUTOMATED CLEANING
1. Remove the outer tube from the shaft of the M/L-10 Reusable Multifire Clip Applier.
2. Rinse the device (s) with cold running tap water to remove gross soil and actuate any movable parts while rinsing.
3. Use a syringe to flush any lumen-like channels of the M/L-10 Reusable Multifire Clip Applier with lukewarm tap water while fully immersed
in a bath of lukewarm tap water.
4. Load the device (s) into the automated washer.
5. Ensure the following set of cycle parameters are properly programmed:
5.1 Instrument cycle HIGH
Phase
Pre-Wash
Wash 1
Rinse 1
PURW Rinse
Dry
6. Visually inspect to ensure that all visible soil has been removed.
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. Insert device and outer tube into sterilization tray (Cat #3706). Wrap tray in two layers of 1-ply polypropylene wrap of appropriate basis
weight to accomodate the weight of the sterilization tray and device using sequential envelope folding techniques.
Microline Surgical recommends the following validated sterilization cycles as guidelines:
Sterilization Cycle
Gravity Cycle
Pre-Vacuum Cycle
STERILIZATION PARAMETERS FOR EUROPEAN COUNTRIES
Microline Surgical recommends the following sterilization cycle parameters for Europe, except for France and Switzerland:
Sterilization Cycle
Pre-Vacuum Cycle
For France and Switzerland, the following sterilization cycle parameters are recommended:
Sterilization Cycle
Pre-Vacuum Cycle
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.
ENVIRONMENTAL PROTECTION
To reduce contamination risks, the M/L-10 Clip Applier and cartidge with unused clips shall be disposed of in compliance with all applicable local,
state and federal laws and regulations.
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. Gross abuse or neglect
of a Microline Surgical instrument will void this warranty.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
SYMBOL DEFINITION
Following are the graphical symbols and their descriptions used in the labeling of the M/L-10 Reusable Multifire Clip Applier:
Do not use if package is damaged.
Consult instructions for use
Manufacturer
Refer to instruction manual/booklet
Federal law (USA) restricts this device to sale
by or on the order of a physician.
Not made with natural rubber latex.
Medical Device Safety Service GmbH
Schiffgraben 41
D-30175 Hannover
Germany
Time (minutes)
2:00
2:00
00:15
1:00
6:00
Exposure Time
15 minutes at 270°F (132°C)
4 minutes at 270°F (132°C)
Exposure Time at 134°C
3 minutes
Exposure Time at 134°C
18 minutes
Temperature
Cold Tap Water
65.5°C
Hot Tap Water
90°C
98.8°C
Drying Time
30 minutes
30 minutes
Drying Time
30 minutes
Drying Time
30 minutes
Catalog Number
Lot Number
Serial Number
Non Sterile
Date of Manufacture
Detergent
N/A
Alkaline or Enzymatic Detergent
N/A
N/A
N/A