CooperSurgical Inc

LEEP Non-Conductive Rose-Coated Instruments Instructions for Use

2 Pages

Euro-Med® • LEEP Non-Conductive Rose-Coated Instruments  STORAGE Thoroughly dried instrument(s) should be stored individually in a moisture-free area in a protective tray with partitions. Protect with cloth or gauze if stored in drawers. WARRANTY CooperSurgical, Inc., warrants that the LEEP coated instruments (the “Product”) will be free from defects in materials and workmanship for a period of two (2) years from the original date of purchase. If the Product should become inoperable due to a defect in material or workmanship during this two-year warranty period, CooperSurgical will, at its option, repair or replace the Product. This limited warranty does not include replacement or service to repair damage resulting from improper installation, external electrical fault, accident, disaster, use for a purpose other than that for which originally designed or indicated in this manual, negligence, modification, service or repair by personnel not authorized by CooperSurgical or normal wear and tear, and also does not apply to disposable or single- or limited-use items or components. The sole and exclusive remedy under this limited warranty shall be repair or replacement as provided herein. The foregoing limited warranty states the sole warranty made by CooperSurgical with respect to the Product and all parts thereof, and is in lieu of any other warranty by CooperSurgical with respect to Product. COOPERSURGICAL NEITHER MAKES NOR GRANTS ANY OTHER WARRANTY, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCT, INCLUDING WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT WILL COOPERSURGICAL BE LIABLE FOR ANY DAMAGES ARISING OUT OF THE LOSS OF USE OF THE PRODUCT, OR ANY OTHER INCIDENTAL OR CONSEQUENTIAL DAMAGES, WHETHER OR NOT COOPERSURGICAL HAS ADVANCE KNOWLEDGE OF THE POSSIBILITY OF SAME. No person, agent, distributor, dealer or company is authorized to change or modify the terms of this limited warranty. Explanation of Symbols  REF Reorder Number LOT Batch Code NON STERILE  Do not use if package is damaged LATEX  Non-sterile Consult instructions for use  Specula • Retractors • Forceps • Hooks • Tenaculums • Rulers Instructions for Use  Non-Sterile: sterilize before use  DESCRIPTION The Euro-Med® LEEP Non-Conductive Rose-Coated Instruments are reusable, manual instruments designed for use in LEEP procedures in a office or operating room setting. The Euro-Med LEEP Instruments are made from coated stainless-steel and can be sterilized in an autoclave. The Euro-Med LEEP Instruments are available in a variety of styles that include Specula, Retractors, Forceps, Hooks, Tenaculums and Rulers. Many of the Specula styles include either permanent or disposable smoke evacuator tubing. INDICATIONS FOR USE The Euro-Med LEEP Non-Conductive Rose-Coated Instruments are intended for use during LEEP procedures for the following: 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  Not made with natural rubber latex  8. Pre-operative evaluation of vaginal and uterine supports relating to descent and prolapse  Manufacturer  9. Post-operative evaluation of vaginal apex after abdominal or vaginal hysterectomy  U.S. Federal law restricts this device to  10. Post-operative evaluation after vaginal or abdominal pelvic relaxation surgical procedures  Rx Only sale by or on the order of a physician  Note: The Euro-Med LEEP Non-Conductive Rose-Coated Instruments can also be used in applications where stainless-steel instruments are indicated.  Euro-Med® is a registered trademark of CooperSurgical, Inc. CooperSurgical is a registered trademark of CooperSurgical, Inc.  CAUTION Rx Only: U.S. Federal Law restricts this device to sale by or on the order of a physician. CONTRAINDICATIONS Refer to the LEEP Precision Generator Operating Manual for a list of Contraindications. WARNINGS • To avoid electric shock to patient and/or user, use only plastic or coated specula instruments during a LEEP (electrosurgical) procedure.  95 Corporate Drive Trumbull, CT 06611 USA Phone: (800) 243-2974 Fax: (800) 262-0105 LEEPCOATED-IFU • Rev. A • 10/19  International Phone: +1 (203) 601-9818 Fax: +1 (203) 601-4747 www.coopersurgical.com © 2019 CooperSurgical, Inc.  Made in the USA  •  The patient should be informed when the speculum is to be introduced and removed. Adjustments may be necessary to provide improved comfort.  •  Only use these instruments with CooperSurgical LEEP Electrosurgical units in order to achieve the maximum usage of the device. All CooperSurgical LEEP Electrosurgical units have floating returns and carry the marking: F
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