Integra LifeSciences Hemorrhoidal Ligator, McGivney - Manual

Description
Integra® McGivney Hemorrhoid Ligator is a device consisting of a straight sheath with
a built-in ligator head and pistol grip handle for actualization. The ligature is applied
by compressing the handle. The McGivney Hemorrhoid Ligators are made of stainless
steel, reusable and are supplied non-sterile.
Indications For Use
Integra® McGivney Hemorrhoid Ligator is indicated for use to cut off the blood flow to
hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base.
Contraindications
Hemorrhoid ligation is contraindicated, if:
• Patient is using anticoagulants
• Septic conditions in the anorectal region are present
• Any large grade IV hemorrhoids are evident
• Cases of hypertrophied anal papilla and/or chronic anal fissure
Warning
DO NOT flash sterilize the Integra® McGivney Hemorrhoid Ligators. These instruments
have not been validated for flash sterilization.
Discard instrument after suspected Creutzfeldt-Jakob Disease (CJD) exposure; the
Integra® McGivney Hemorrhoid Ligators have not been validated to withstand the
chemical and thermal exposures recommended to eradicate prions.
Damage to the product may occur if inappropriate cleaning/disinfecting agents are
used or if exposed to excessive temperatures.
Instructions For Use:
Ligation procedures are a frequently used treatment option for hemorrhoids due to its
simple and effective application which does not require anesthesia.
1. Load the ligator with a latex-free o-ring by
using the loading cone. Place the loading
cone onto the ligator barrel and roll o-ring
down the tip of the loading cone until it is
seated evenly around the end of the ligator
barrel in the maximum expanded diameter.
Remove the loading cone.
2. A proctoscope/anoscope should be inserted
into the anal opening to provide site
visualization. The largest hemorrhoid
should be treated first.
3. Grasp the hemorrhoid with forceps
approximately 1 centimeter proximal of
the dentate line and pull the hemorrhoid into the drum of the ligator. If the patient
indicates there is pain, a more proximal position for the band ligation should
be selected.
4. With the hemorrhoid pulled taut through the drum of the ligator and the ligator
pressed up against the base of the hemorrhoid, the trigger should be squeezed to
apply the ligation o-ring to the base of the hemorrhoid.
Integra
®
McGivney Hemorrhoid Ligator
Rx Only CAUTION: Federal (USA) law restricts
this device to sale by or on the order of a surgeon.
Instructions for Use/English
5. Remove the ligator from the hemorrhoid and repeat as necessary to treat any
additional hemorrhoids present.
6. Remove the proctoscope/anoscope from the anal opening. Provide patient
with instructions for follow-up visits and possible complications of band
ligation procedures.
Pre-Use, Handling, and Inspection of Instruments
• Read the Instructions for Use and keep them in a safe place.
• Use the product only in accordance with its intended use,
see
Indications For Use.
• Use of an instrument for a task other than that for which it is intended could
result in a damaged or broken instrument, or one which provides an
unsatisfactory performance.
• Instruments should be handled and operated by personnel completely familiar
with their use, assembly and disassembly.
• Instruments must be rendered safe for handling, inspection and assembly by
wearing appropriate personal protection equipment (PPE) as promulgated by
OSHA and AORN.
• Inappropriate use of instruments will lead to damage that is usually not repairable.
• Instruments must be thoroughly inspected upon receipt and prior to use to assure
proper functioning. Failure to make a complete inspection to assure proper
operation and function of instrument may result in unsatisfactory performance.
• Integra® McGivney Hemorrhoid Ligators are supplied non-sterile and must be
pre-cleaned, cleaned, visually examined and sterilized prior to use. Please see
pre-cleaning, cleaning, visual examination, and sterilization procedures below.
• Prior to each use, inspect the product for: loose, bent, broken, cracked, worn, or
fractured components.
• Do not use the product if it is damaged or defective. Set aside the product if
it is damaged.
• Replace any damaged components immediately with original spare parts.
• Store products in a dry, clean and safe place.
• General Working Conditions:
Temperature: +7°C to +30°C
Humidity: 40% to 60% relative humidity
Pre-Cleaning, Cleaning, and Sterilization Procedures
Before using the instruments pre-clean, clean (manual or automated), dry, visually
examine, and sterilize following the procedures below.
Personnel should follow accepted guidelines as recommended in ANSI/AAMI
ST79:2006, A1:2008, A2:2009 -Comprehensive guide to steam sterilization and
sterility assurance in health care facilities.
Precleaning:
Pre-cleaning should occur as soon as possible after instrumentation is used.
1. Remove gross debris from surgical instruments with a sponge and sterile water
after use to prevent drying of blood and body fluids on the instruments.
2. Place instruments in an instrument tray/container and saturate all surfaces for five
(5) minutes with a pre-cleaning enzymatic product such as Miltex® Instrument
Prep Enzyme Foam.
Cleaning:
Cleaning should occur as soon as possible after instrumentation is pre-cleaned.
After performing steps 1-6 below, perform either “Manual Cleaning” or
“Automated Cleaning”.
1. Rinse instrument with deionized water for two (2) minutes.
2. Use a clean, soft bristled brush to clean and remove visible soil from the lumens
and other surfaces of the instruments.
3. Vigorously flush lumens with 50ml of deionized water using a syringe or
similar apparatus.
4. Prepare enzymatic solution (e.g., Integra EZ-Zyme® All-Purpose Enzyme Cleaner)
per manufacturer’s recommendations/instructions for correct
dilution and temperature.
5. Immerse fully opened instruments in the prepared enzymatic solution
for ten (10) minutes.
6. Rinse instrument and flush lumens with deionized water for two (2) minutes.
7. Proceed either to “Manual Cleaning” or “Automated Cleaning” procedures below:
Manual Cleaning
1. Prepare enzymatic solution (e.g., Integra EZ-Zyme All-Purpose Enzyme Cleaner)
per manufacturer’s recommendations/instructions for correct dilution
and temperature.
2. Using a small, clean hand-held brush, remove soil from all surfaces of instrument
while fully immersed in solution.
3. Use a soft bristled brush to clean the lumens.
Note: Never use steel wool, wire brushes, scalpel blades or highly abrasive
detergent or cleansers to remove soil as these will damage the instruments’
protective surface and lead to corrosion.
4. Vigorously flush channels with deionized water. Rinse thoroughly and aggressively
for two (2) minutes with deionized water.
5. Using an ultrasonic cleaner sonicate instruments for ten (10) minutes.
• Prepare enzymatic solution per manufacturer’s recommendations/instructions
for correct dilution and temperature and place in the ultrasonic cleaner.
• Condition (de-gas) ultrasonic cleaner for 5 minutes.
• Place instruments in the ultrasonic cleaner manufacturer’s instrument tray.
• Ensure instruments are in the open position.
• Keep different metal types separated (i.e., separate stainless steel from
non-anodized aluminum, brass, copper and chrome-plating to avoid possible
transfer of one metal plating to another).
• Place tray with the instruments into the ultrasonic cleaner.
• Sonicate instruments for ten (10) minutes.
6. Remove instruments from sonicator and rinse for two (2) minutes with
deionized water.
7. Visually inspect instruments for cleanliness and ensure all parts are in proper
working order.
8. Force air though inner lumen until excess water can no longer be visually seen
evacuating the device before allowing instruments to dry on lint-free cloth for at
least twenty (20) minutes at a temperature of not more than 110°C (230°F).
9. Inspect instruments for visual dryness.