Microline Surgical M/L-10 Manual Del Usuario

M/L-10 Reusable Multifire Clip Applier – Instructions For Use
INDICATIONS FOR USE
The M/L-10 Clip Applier is indicated for occluding and ligating vessels, ducts, tracts and other tubular structures during
laparoscopic and general surgical procedures.
CONTRAINDICATIONS
•
The M/L-10 Clip Applier is not intended for use except as indicated.
•
The titanium clips are not intended to be used in the heart or blood vessels that are part of the central circulatory
system.
WARNING
•
If during the inspection of the shipping carton, any of the above items show any signs of damage, do not use the
instrument.
•
A thorough understanding of the principles and techniques involved in laparoscopic and electrosurgical procedures
is essential to avoid shock and burn hazards to both patient and medical personnel and damage to the device or
other medical instruments.
•
The product is sterile unless the package is opened or damaged.
•
Do not use if package is opened or damaged. Examine this device prior to use, do not use if damage is found.
•
Do not reuse or resterilize.
•
Not intended for use with non-Microline, third party devices.
•
This single patient use device has not been designed with the intent of reprocessing (cleaning,
disinfecting/sterilizing) and used on another patient
•
Reprocessing and/or resterilization may compromise the integrity of the product which may result in its
malfunctioning and unintended patient injury
•
The physical characteristics and quality of this device may be adversely affected and the device may not remain
safe and effective for its intended use when reprocessed and/or resterilized
•
If an adverse event occurs using this device please report it to Microline Surgical Customer Service as well as the
Competent Authority in your Member State (EU).
MR Compatibility
Non-clinical testing has demonstrated that the M/L-10 clips are MR Conditional. These devices can be scanned safely
under the following conditions:
•
Static magnetic field of 1.5-Tesla (1.5T) or 3.0-Tesla (3.0T).
•
Spatial gradient field of up to:
o 6,020 G/cm (60.20 T/m) for 1.5T systems
o 3,010 G/cm (30.10 T/m) for 3.0T systems.
•
Maximum whole body averaged specific absorption rate (SAR) of:
o 4.0 W/kg for 15 minutes of scanning at 1.5T.
o 4.0 W/kg for 15 minutes of scanning at 3.0T.
1.5T RF heating
In non-clinical testing with body coil excitation, the ligation clips produced a temperature rise of 1.0ºC or less at a
maximum whole body averaged specific absorption rate (SAR) of 4.0 W/kg, as assessed by calorimetry for 15 minutes
of scanning in a 1.5T Siemens Espree MRC30732) MR scanner with SYNGO MR B17 software.
3.0T RF heating
In non-clinical testing with body coil excitation, the ligation clips produced a temperature rise of less than 1.0ºC or less
at a maximum whole body averaged specific absorption rate (SAR) of 4.0 W/kg, as assessed by calorimetry for 15
minutes of scanning in a 3.0T Siemens Trio (MRC20587) MR scanner with SYNGO MR A30 4VA30A software.
Caution: The RF heating behavior does not scale with static field strength. Devices which do not exhibit detectable
heating at one field strength may exhibit high values of localized heating at another field strength.
MR Artifact
In testing using a 3.0T system with gradient-echo sequencing, the shape of the image artefact produced follows the
approximate contour of the device and extends radially up to 9 mm from the implant.
PRE-CHECK INSTRUCTIONS
Carefully inspect the packaging to ensure that there are no signs of damage. If damage is visible, do not use the
device. The device is:
•
Not made with natural rubber latex.
•
Not made with bisphenol-A.
•
Not made with Vinyl or Poly Vinyl Chloride (PVC).
•
Not made with phthalates.
LOADING CLIP APPLIER
1. Peel the clip cartridge pouch open and remove cartridge from the pouch.
2. Fully squeeze the handpiece trigger against the handle (Fig. 1).
3. Align the arrow on the back of the clip applier with the arrow of the cartridge. The arrow of the cartridge should be
seen on the "non-clip" side of the cartridge (Fig. 2).
4. Insert the cartridge all the way into the back of the handpiece (Fig. 3), making sure the cartridge is handled by its
sides or proximal end behind "the ladder" in order to avoid any displacement of clips or ladder.
5. Release the trigger. This will engage a clip into the handpiece jaws.
6. The instrument is ready to be used.
OPERATION NOTE
Before firing a clip, verify that the ligation site is free of any obstructions.
1. Verify that there is a clip properly loaded in the jaws prior to inserting the clip applier through the cannula.
2. Position the clip carefully around the vessel to be ligated.
3. With full visualization of the ligation site, squeeze the trigger all the way so that the trigger touches the handle to
close the clip around the vessel. The trigger will not reopen until the trigger is beyond the 7th click (see step 5
below).
4. Releasing the trigger will open the clip applier jaws and automatically engage the next sequential new clip. The clip
applier is now ready for re-firing.
5. For:
a. the cholangiogram procedure, whereby a clip is used to temporarily secure the catheter inside the common bile
duct without occluding the catheter, the degree of clip closure can be adjusted. This is accomplished by
releasing the trigger any time after the 7th click. This earlier release capability allows for the desired amount of
clip closure.
b. maximum vessel occlusion (clip fully closed), simply depress instrument trigger fully so that the trigger and
handle are touching and then fully release so that the subsequent clip can be engaged in the jaws.
CAUTIONS
1. If all the clips are to be used, be advised that the last two clips are colored blue to warn the surgeon that the
cartridge is almost out of clips. The clip applier should be removed from the cavity once the last colored (blue) clip
has been fired. The cartridge should then be removed and discarded.
2. Engaging the jaws over a previously applied clip should be avoided, as it may cause the handpiece to misfire.
3. The application of clips over a staple line has not been validated for use with M/L-10 devices.
4. The cartridge must be removed from the handpiece after use, or prior to the cleaning and sterilizing processes.
Microline Surgical shall not be responsible for any damage occurring because of non-compliance with this warning.
ENVIRONMENTAL PROTECTION
To reduce contamination risks, the device 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.
This product is an original MICROLINE™ product, manufactured for single patient use only by Microline Surgical, Inc.
Microline Surgical, Inc. is the owner of, and has exclusive rights to, the MICROLINE trademark. Unauthorized use of
single patient use MICROLINE products, as well as any false designation of origin, or false or misleading description or
representation of fact on or in connection with the MICROLINE trademark, will be considered to constitute trademark
infringement and/or unfair competition.
CAUTION
Federal law (USA) restricts this device to sale by or on the order of a physician.
SYMBOL DEFINITIONS
Manufacturer
Catalog Number
Batch code
Use By Date
Do not use if package is damaged
Global Trade Item Number
Sterilized by Ethylene Oxide
Date of Manufacture
Consult instructions for use
M/L-10 Multi-Fire Clip Applier
Instructions For Use
Microline Surgical, Inc.
迈克兰器械有限公司.
50 Dunham Road, Suite 1500
Beverly, MA 01915 U.S.A.
Tel: +1(978) 922-9810 | Fax: +1(978) 922-9209
Web: www.microlinesurgical.com | Email: [email protected]
09-39-00444-00-ART Rev B 03/2020
ENGLISH
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