VALTCHEV VAGINAL DELINEATOR Instructions for Use

Instructions for Use Device Description/Intended Use / Indications for Use The Valtchev® Vaginal Delineator (VVD) is a reusable device used with a sterile Valtchev® Uterine Mobilizer (VUM-6). It is designed for use during Total Laparoscopic Hysterectomy (TLH). Contraindications The VVD should not be used in patients who are pregnant or who are suspected of being pregnant, in patients who suspected pelvic infections and cases where the surgeon decries it inadvisable or believes it to be difficult to insert the tips into the cervix or uterus. Warnings The Silicone rings are single use only, and should NEVER be reused. Do not reuse, reprocess, or re-sterilize. Reuse, reprocessing or re-sterilization may compromise the structural integrity of the silicone rings Using an incorrect Delineator size could result in patient injury. Precautions The vagina can be damaged and uterus can be perforated if an inappropriate sized obturator or cannula are used. Damage of the soft tissue can occur, if excessive force is applied or inappropriate size delineator is used. Cleaning and Inspection Cleaning should take place immediately after use. The instrument must be flushed, as the tube for dye injection may become blocked. Ultrasonic cleaning is acceptable and recommended. If ultrasonic is not available, manual cleaning with a brush and suitable detergent/enzymatic which has been designed for use with stainless steel surgical instrumentation is acceptable. Do NOT use metal-bristled brushes on the instruments. All moving/articulating components should be lubricated prior to steam sterilization with steam-penetrable lubrication which has been designed for use with surgical instruments. All instruments MUST be inspected for signs of damage, wear or residual soil each time they are reprocessed. If residual soil is noted during inspection, the cleaning process must be repeated for the instrument. Inspect all surfaces for potential trapped soil. Fully articulate the moving components by way of finger rings and locking ping. Ensure the lock, tenaculum holder, cannula/obturator lock move easily. Signs of damage or poor motion quality may indicate a need to replace the instrument or have it repaired. Manual Cleaning Process Detach accessories from the VUM-6. Prepare a neutral or alkaline enzymatic detergent specifically designed for cleaning medical instruments. Prepare a fresh solution of detergent at the detergent manufacturer’s recommended concentration using water at the detergent manufacturers recommended temperature. Ensure that the instruments are fully immersed in the prepared solution. Soak the instrument for a minimum of ten (10) minutes at room temperature (68° F / 20° C) or longer (refer to detergent manufacturer’s instructions for use). Using a soft bristled brush, scrub the regions with mated surfaces such as the space bar. Scrub regions with crevices, lumens and sides of the head and space bar. Actuate the moving parts while submerged to ensure contact between the instrument surfaces and the brush/detergent. Rinse the instrument in warm tap water (100° F / 38° C) for one (1) minute. Ensure that all crevices and lumens are flushed. Actuate the moving parts during rinsing. Place the instrument into a prepared ultra-sonicator containing a neutral or alkaline detergent. Ultra-sonicate the instrument in the detergent solution for ten (10) minutes. Rinse the instrument with water for at least (1) minute or until all visible signs of detergent residue are removed. Ensure that all crevices and lumens are flushed. Actuate the moving parts of the VUM-6 during rinsing. Examine the instrument for signs of residual soil. Repeat the cleaning process, if necessary. Dry the instrument with a lint-free towel or wipe.

Automated Cleaning Process Ensure that all gross soil has been wiped or rinsed from the surfaces of the instrument. Place the instruments loosely within a rack. Load the rack with the instruments into the washer/washer-disinfector and close the door. Select a cycle intended for instruments that has the following parameters at a minimum:

Parameter Detergent Pre-wash rinse

Wash

Post Wash Rinse

Drying

Tolerance Neutral or Alkaline medical device detergent One pre-wash rinse Cold tap water or better quality 30 seconds One Repetition Warm purified water (140° F / 60° C) Minimum concentration per detergent manufacturers IFU 2:00 minutes One post-wash rinse Warm purified water (158° F / 70° C) 2:00 minutes 15 minutes (176° F / 80° C)

NOTE: Automated washing processes having additional phases or longer phase durations are anticipated to deliver equivalent or better cleaning efficacy. Additional phases and longer phase durations may be added if they are within the healthcare facility’s normal procedures.