CooperSurgical Inc
Prima Viginal LEEP Specula Meduim W33 L113
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](https://public.bioclinicalservices.com.au/library/representations/proxy/eyJfcmFpbHMiOnsiZGF0YSI6MTkxMDkzLCJwdXIiOiJibG9iX2lkIn19--af7a8f73e46031fd6044089f7f9775231a1ba4f3/eyJfcmFpbHMiOnsiZGF0YSI6eyJyZXNpemUiOiIzMjB4In0sInB1ciI6InZhcmlhdGlvbiJ9fQ==--4214356078d1f110e449cda512a9432562da3e70/CooperSurgical%20Inc%20-%20LEEP%20-%2035634-DFU%20-%20Prima%20Series%20Vaginal%20LEEP%20Specula%20Directions%20for%20Use%20-%202014-07%20-%20Rev%20A.pdf.png)
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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
PSV-1L and PSV-2L • Prima Series® Vaginal LEEP Specula Directions for Use • English (continued) C
Cleaning Method (after each use) 1. Rinse and/or pre-soak. 2. Manually clean with brushes using a mild soap and warm water. 3. Using a round bristle brush, clean inside the tip channel using warm water, then cleaning agent, then warm water again. 4. Rinse. 5. Enzymatic cleaner. 6. Rinse. 7. Dry with cloth or gauze and compressed air. 8. Inspect. 9. Prepare for storage and/or sterilization.
NOTE: Dry instruments completely with filtered compressed air (including inside channels) and/or a dry oven [maximum temperature 280 °F (138 °C)]. SPECIAL LEEP SPECULA CLEANING 1. Although stain resistant, Prima Series® specula may be stained by Lugol’s and therefore should be cleaned immediately after use with StainEnder™ or a similar solution. 2. Wash the specula after use with hot soapy water. Rinse with hot water. To minimize the potential of contaminating the StainEnder solution, disinfectant should be used prior to inserting them into the cleaning solution. 3. Completely immerse the disinfected specula in undiluted StainEnder. Allow the instrument to soak until all stains are removed. Any permanent Lugol stains will appear as a whitish discoloration after autoclaving. D
• Specula should be thoroughly cleaned of all foreign matter prior to sterilization following A through C.
• Follow the manufacturer’s instructions for operating and loading the sterilizer and utilize a valid EO cycle.
• There must be direct exposure to all surfaces of the instruments being sterilized.
• Instruments should be sterilized in their “open” position. • Contact of plastic to bare metal should be avoided. Ethylene Oxide Cycle Temperature
Reassembly Reassemble the yoke to the remainder of the speculum assembly using the knurled nut removed earlier.
125 °F–130 °F (52 °C–54 °C)
50% RH (pre-humidity) 60 minutes -0/+10 minutes Pre-vacuum
24” Hg ± 2” Hg (61 cm Hg ± 5 cm Hg)
Gas Pressure
6–8 PSIG (550–660 mg/L EO)
Exposure Time
4 hours minimum -0/+0.25 hours
Post Vacuum
24” Hg 2X ± 2” Hg (61 cm Hg 2X ± 5 cm Hg)
Aeration
12 -0/+1 hours at 120 °F (49 °C)
NOTE: The particular EO cycle must be validated per the equipment manufacturer’s requirements. It is recommended that each institution employ procedures, which include the use of biological indicators in order to determine the effectiveness of the ethylene oxide process. EXPLANATION OF SYMBOLS
REF
Reorder Number
Sterilization with an Approved Liquid Chemical Sterilant Specula must be cleaned thoroughly following A, B and C, prior to cold sterilization. Cold soak solutions with 2% glutaraldehyde solution can be used for sterilizing the instruments. Specula are to be fully immersed. Follow the manufacturer’s instructions for sterilization times. Soak and rinse thoroughly in two separate sterile, deionized water baths. Dry specula.
E
RECOMMENDED HOSPITAL ETHYLENE OXIDE STERILIZATION PARAMETERS
Consult instructions for use. LATEX
Not made with natural rubber latex.
Non Sterile
NON STERILE
Federal law restricts this device to sale by or on Rx Only U.S. the order of a licensed physician. Product conforms to the Medical Device Directive 93/42/EEC
EC REP Authorized Representative in the European Community.
STORAGE Thoroughly dried specula should be stored individually in a moisture-free area in a protective tray with partitions. Protect with cloth or gauze if stored in drawers.
Manufacturer
RECOMMENDED STEAM AUTOCLAVE STERILIZATION PARAMETERS
• The specula should be thoroughly cleaned of all foreign matter prior to sterilization following A through C.
• Follow the manufacturer’s instructions for operating and loading the steam autoclave.
• There must be direct steam exposure to all surfaces of the specula being sterilized.
• Autoclave temperatures should not exceed 280 °F (138 °C); pressure should not exceed 32 PSI (2.2 atmospheres). • Standard cycle of 270 °F (132° C) for 10 minutes will vary depending on autoclave model, autoclave size, load size, and load configuration. Allow longer times for lower temperatures. Allow instruments to cool down from autoclave to room temperature. Do not immerse in any fluid until the instrument has been allowed to cool.
Prima® & Prima Series® are registered trademarks of CooperSurgical, Inc. CooperSurgical is a registered trademark of CooperSurgical, Inc. StainEnder™ is a trademark of CooperSurgical, Inc. © 2014 CooperSurgical, Inc.
CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT 06611 USA
95 Corporate Drive Trumbull, CT 06611 USA Phone: (800) 243-2974 Fax: (800) 262-0105
International Phone: (203) 601-9818 Fax: (203) 601-4747
www.coopersurgical.com
EC REP EMERGO EUROPE Molenstraat 15 2513 BH, The Hague The Netherlands
35634-DFU • Rev. A • 7/14
Made in the USA