CooperSurgical Inc

Prima Series Vaginal LEEP Specula Directions for Use

10 Pages

PSV-1L and PSV-2L • Prima Series® Vaginal LEEP Specula Directions for Use (English) DESCRIPTION The latex free, Prima Series Vaginal reusable specula offers an ideal instrument solution for almost any situation. The Prima Series specula, available in two sizes [PSV-1L (medium) and PSV2L (large)], can be utilized for general office or operating room procedures, as well as for any procedures that require non-conductive properties. The Prima Series specula are non-conductive and can be sterilized in an autoclave. ®  WARNINGS  • •  To avoid electric shock to patient and/or user, use only plastic or coated specula instruments during a LEEP (electrosurgical) procedure. The patient should be informed when the speculum is to be introduced and removed. Adjustments may be necessary to provide improved comfort.  CAUTION  • •  U.S. Federal Law restricts this device to sale by or on the order of a physician. NON-STERILE: Sterilize before use.  DIRECTION FOR USE Sterilize Specula Before Use The size and type of speculum is determined by the patients’ anatomy and intended use of the instrument. With the patient in the lithotomy position, a warmed speculum is inserted, usually without lubrication, in a horizontal fashion holding the instrument in the dominant hand while the 2nd and 3rd fingers of the nondominant hand spread the labia minora and slightly depress the posterior fourchette. The speculum is gently advanced partially opened until the cervix is clearly visualized. The speculum is then opened more fully and fixed with the blade and handle locks allowing for optimum visualization and patient comfort. The introduction of a speculum cannot be forced and should not be painful. After visualization and completion of the examination or vaginal surgical procedure(s), the locks are loosened, the speculum slightly opened further, and then released as the instrument is gently removed. Lubrication may be used if no cytology or colposcopic exam will be done. CARE  INDICATIONS FOR USE Vaginal specula are indicated whenever a visual examination of the vagina or cervix is necessary. The instruments are also necessary for visualization when treating vaginal/cervical lesions. Some of the indications include (not a complete list): 1. General pelvic exam-visualization of the cervix or vagina, and for obtaining pap smears. 2. Visualization of cervical or vaginal secretions for obtaining cultures or wet smears. 3. Visualization for evaluation of the source of bleeding: vaginal, cervical, or uterine. 4. Evaluation of the vagina and/or cervix in presence of vulvar or perineal viral (Herpes or HPV) lesions. 5. Visualization of cervix and/or vagina as part of evaluation and treatment of CIN; abnormal pap, VAIN, HPV or other cervical lesions. 6. In conjunction with biopsy, LEEP (non-conductive), cryo or cold knife treatment methods. 7. Follow-up evaluation of treatment of cervical or vaginal lesions. 8. Pre-operative evaluation of vaginal and uterine supports relating to descent and prolapse. 9. Post-operative evaluation of vaginal apex after abdominal or vaginal hysterectomy. 10. Post-operative evaluation after vaginal or abdominal pelvic relaxation surgical procedures. CONTRAINDICATIONS Please refer to hysteroscope or electrosurgical generator manuals. PRECAUTIONS The size and shape of the speculum is determined by the patient’s anatomy and need for surgical procedure. For example, LEEP and laser procedures require special instrumentation and cannot be interchanged. Injury to the patient or examiner can occur if the proper speculum is not used. The following are some recommendations for the use of the various types of specula: ■ Stainless steel or reusable plastic • General Exam • Colposcopy  • Cervical Polypectomy • Endometrial Biopsy • Cryosurgery  These specula can also be used wherever stainless steel or coated specula are indicated.  • Bipolar Cauterization • Hysterography • Conization  ■ Prima Series must be used during LEEP/LLETZ procedures (monopolar electrosurgical procedures) when the patient must be grounded. The surfaces of these specula should be checked for smoothness and intactness prior to their use. If any flaws are seen, do not use the instrument. Smoke evacuation tubing should be inserted prior to use in LEEP procedures.  Thorough maintenance will ensure proper function of these specula. It is important to clean and sterilize each instrument immediately after each procedure. Proper maintenance will also extend the life of the instrument. • Handle each specula individually. Do not handle in groups or stacks.  •  Keep track of all components when disassembling. Place in tray or tub corresponding to the specula. Do not interchange components.  •  Inspect specula for integrity of movable parts (jaws, hinges, etc.), signs of damage (broken or cracked) or missing hardware (screws). Replacement parts should be kept on hand. Damage to movable parts can result in sub-standard performance of the specula.  •  Check insulation for cuts, voids, cracks, tears, abrasions, etc. on LEEP or coated specula to be used with an ESU (electrosurgical unit).  CLEANING Rinsing and cleaning must take place immediately following the instrument’s use for decontamination. Adherent particles may resist cleaning or cause staining. Instruments are to be completely cleaned of all foreign matter with special attention focused on channels and movable parts (e.g. smoke tube) in contact with body tissue and fluid. Thorough cleaning is essential prior to sterilization.  • • • • • A  Follow the instructions under “CARE” for proper handling of the instruments. Wear protective gloves during the cleaning procedure. Never use a corrosive cleaning agent (i.e. bleach). Fully immerse instruments in cleaning agent. Never use a glass sterilizer with LEEP or Prima Series specula. Disassembly Remove knurled nut holding the yoke/upper assembly to lower bill. Separate the two. If disposable smoke tubing was used, remove tubing and discard per local hazardous waste procedures.  B  Cleaning Agents and Equipment  • Cleaning agents and rinses at or near a neutral pH (7.0) are recommended.  • Use warm water and a mild soap. • Do not use an abrasive cleaning solution. • A soft bristle brush (toothbrush type) should be used. • Round bristle brushes should be used to clean inside channels of smoke tube connector.  • An enzymatic cleaner is recommended to remove protein deposits on the specula. Follow the manufacturer’s instructions and rinse thoroughly. Note: Soak and thoroughly rinse the specula in warm tap water to remove cleaning agents. A final rinse in distilled water is recommended.  35634-DFU • Rev. A • 7/14
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File Name: CooperSurgical Inc - LEEP - 35634-DFU - Prima Series Vaginal LEEP Specula Directions for Use - 2014-07 - Rev A.pdf

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