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TM
Benesta
Tissue Removal Device
Instructions for Use
CAL-TR1511 (1 pack)
CAL-TR1513 (3 pack)
Manufactured by:
Caldera Medical, Inc.
5171 Clareton Drive
Agoura Hills, CA 91301
U.S. Toll Free: 866-4-CALDERA
Telephone: 818-879-6555
Fax: 818-879-6556
www.calderamedical.com
CONTROLLED COPY
1
10-418 Rev A
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Summary of Contents for Caldera Benesta CAL-TR1511
- Page 1 CONTROLLED COPY Benesta Tissue Removal Device Instructions for Use CAL-TR1511 (1 pack) CAL-TR1513 (3 pack) Manufactured by: Caldera Medical, Inc. 5171 Clareton Drive Agoura Hills, CA 91301 U.S. Toll Free: 866-4-CALDERA Telephone: 818-879-6555 Fax: 818-879-6556 www.calderamedical.com 10-418 Rev A...
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Page 2: Symbol Glossary
Symbol Glossary The following is an explanation of symbols that may be used on Caldera Medical’s products and packaging: ISO 7000 ISO 15223- Symbol Title/ Meaning/ Referent Function/ Description Reg. no. 1 or Other Manufacture Manufacturer Indicates the medical device manufacturer. -
Page 3: Device Description
The brief operating instructions in this guide will make the system easier to – The Benesta Tissue Removal Device cutting window is facing use. As with any surgical instrument, there are important health and safety away from (i.e., 180° opposite) the implant; considerations. - Page 4 Exercise care when inserting or removing the device. Excessive bending – Inflow tubing • of the device distal tip can cause the Benesta Tissue Removal Device – Y-tubing cutter to come out of the cutting window. If such damage occurs, replace –...
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Page 5: Troubleshooting
– Connect the outflow vacuum tubing to the tissue trap connection on 13. Excised tissue is collected in the tissue trap. the cannister lid. Ending the Procedure OPERATION 1. Retract the Benesta Tissue Removal Device into the hysteroscope 1. Prior to opening the device, inspect the package for any signs of until the cutting window is within the hysteroscope working channel. - Page 6 Interconnections conditions require the applied parts of other medical • Table 2. Declaration of Electromagnetic Immunity electrical equipment used within the configuration for hysteroscopic Electromagnetic Environment Immunity Test Test Level / Limits / Recommendations application to be type BF applied parts or type CF applied parts Floors should be wood, Electrostatic concrete, or ceramic tile.
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Page 7: Warranty
Table 4. Recommended separation distance between potable and mobile RF All Caldera Medical Instruction for Use (IFU) documents are available in print form at no additional cost upon request. If you would like to request a copy please communications equipment and the Benesta Tissue Removal Device contact us at 818.879.6555, fax 818.879.6556,...