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Summary of Contents for Micro-Tech Polypectomy Snare
- Page 1 Polypectomy Snare Instructions for Use -Micro-Tech (Nanjing) Co., Ltd-...
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Page 2: Intended Use
If you have any questions or comments about any information in these instructions, please contact Micro-Tech. INTENDED USE 1. The Polypectomy Snares are used endoscopically in the removal of diminutive polyps, sessile polyps, and pedunculated polyps within the GI tract. -
Page 3: Potential Complications
Contamination of the device may lead to injury, illness or death of the patient. Micro-Tech assumes no liability with respect to instruments reused, re-sterilized or reprocessed . 2. Do not use this instrument for any purpose other than its intended use. - Page 4 field of view. Insertion without clear endoscopic field of view could cause patient injury, such as perforation, hemorrhage or mucous membrane damage. Damage to the endoscope and/or the instrument may also occur. 8. When applied to a patient with a pacemaker implanted, the instrument may cause malfunction or failure of the pacemaker, seriously affecting the patient.
- Page 5 17. Since supporting the use of Olympus endoscopic system, Olympus endoscopic system’s light source may affect Polypectomy Snare’s temperature to exceed 41℃,to minimize the risk of injury, please ensure the correct use of it according to Olympus endoscopic system and the manufacturer’s instructions.
- Page 6 STRUCTURE The Polypectomy Snare consists of a loop assembly which can be extended and retracted from the snare’s outer tube by manipulating the handle assembly.( Refer to Fig.3 ). Fig.3 Structural Sketch of Sterile Snare with type II handle 1. Oval Snare Loop 2. Outer Tube 3. Conductive Plug 4. Handle assembly Note: This is the sketch map of one kind of loop, the other loop shapes are not shown here.
- Page 7 Snare loop extends and retracts smoothly. The Snare loop shall be free of distortion, deformation, frayed wires, disconnections and sharp protrusions. Do not use if any abnormality is found. 8. Before use, remove inflammable gas which is accumulated in human body in case of the risk of explosion.
- Page 8 – electr omagnetic emissions The Polypectomy Snare is intended for use in the electromagnetic environment specified below. The customer or the user of the Polypectomy Snare should assure that it is used in such an environment. Electromag netic environment -...
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Page 9: Guidance And Manufacturer's Declaration - Electromagnetic
The Polypectomy Snare is intended for use in the electromagnetic environment the instructions for storage and use provided by Micro-Tech USA and in specified below. The customer or the user of the Polypectomy Snare should assure that it accordance with applicable regulatory requirements. Descriptions or is used in such an environment. - Page 10 The Polypectomy Snare is intended for use in the electromagnetic environment LOSS ARISING OUT OF OR IN CONNECTION WITH ANY PRODUCT OR specified below. The customer or the user of the Polypectomy Snare should assure that OTHER GOODS OR SERVICES FURNISHED BY MICRO-TECH USA, EVEN IF it is used in such an environment.
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Page 11: Product Disposal
Polypectomy Snare The Polypectomy Snare is intended for use in an electromagnetic environment in which radiated RF disturbances are control led. The customer or the user of the Polypectomy Snare can help prevent electromagnetic interference by maintaining a minimum distance between... -
Page 12: Limited Warranty And Disclaimers
Limited Warranty and Disclaimers： 1. Limited Warranty to Buyer. Micro-Tech USA warrants to Buyer that, for the earlier of one (1) year from the date of purchase, or until the product is used by Buyer, the products will be free from defects in... - Page 13 REVENUE, LOSS OF BUSINESS, LOST PROFIT, OR OTHER FINANCIAL LOSS ARISING OUT OF OR IN CONNECTION WITH ANY PRODUCT OR OTHER GOODS OR SERVICES FURNISHED BY MICRO-TECH USA, EVEN IF MICRO-TECH USA WAS AWARE OF THE POSSIBILITY OF SUCH DAMAGES OR LOSS.
- Page 14 Manufacturer Micro-Tech (Nanjing) Co., Ltd. No.10 Gaoke Third Road, Nanjing National Hi-Tech Industrial Development Zone, Nanjing 210032 ,Jiangsu Province, PRC TEL:+ 86 25 58609879, 58646393 FAX:+ 86 25 58744269 Email: info@micro-tech.com.cn www.micro-tech.com.cn; Distributed By Micro-Tech USA Inc. 2855 Boardwalk Drive, Ann Arbor, MI 48104 USA...
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