Disassembling the Suture Cutter:
The suture cutter must be disassembled prior to cleaning and sterilization.
1. Depress the button on the top of the handles (1).
2. Pull the central cutting rod out of the cannulated shaft (2).
3. Prior to use, reassemble the Suture Cutter carefully. The proximal end of the central
rod must be oriented as shown below. Verify that handle and trigger actuation
moves the central rod.
Cleaning:
Warnings:
• Cleaning should be performed as soon as possible
blood, saline and debris are dry.
• Do not use metallic brushes, scrub pads, or other abrasive cleaning aids, as these
are likely to damage the instruments.
• Do not use highly alkaline solutions or harsh chemicals such as chlorine, caustic
soda, and organic or ammoniated acids or solvents (such as acetone), as these are
likely to damage the instruments.
• Follow the instructions and warnings issued by the suppliers of any cleaning and
disinfection agents and equipment used.
• Complex devices, such as those with tubes, hinges, retractable features, and matte
or textured surface finishes, require special attention during cleaning. Manual
pre-cleaning of such device features is required before automated cleaning.
(1) 30 minutes was used for the Cleaning Validation.
Manual cleaning:
1. Rinse instruments with distilled or demineralized water.
2. Prepare an enzymatic detergent
3. Submerge the instruments in the enzymatic detergent solution for 20 minutes. Use
a 5 ml syringe and needle to flush enzymatic detergent through lumens, and use a
soft bristled brush to scrub the lumens, crevices, and slots.
4. Rinse instruments with distilled or demineralized water, agitating for one minute;
repeat rinse twice.
5. Dry all instruments thoroughly before storage.
6. Inspect the instruments after each cleaning cycle to ensure proper functionality
and safety:
6.1 If you suspect a problem, do not use the instrument.
6.2 Inspect all components for cleanliness: activate all moving parts to their
maximum positions while inspecting for blood or debris. Place a pipe cleaner
down any cannulation or crevice, and then inspect the pipe cleaner for blood
or debris. If blood or debris is present, repeat the above cleaning procedure.
(2) Cleaning efficacy was validated using ENZOL® at 1 oz./gal. of water at 35-40°C (95-104°F)
according to the manufacturer's instructions.
(2)
7
after each procedure, before
(1)