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 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


10-418 Rev A



Summary of Contents for Benesta CAL-TR1511

Page 1: ...ns 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 cal...

Page 2: ...Not Re use Indicates a medical device that is intended for one use or for use on a single patient during a single procedure 1051 5 4 2 Consult Instructions for Use Indicates the need for the user to...

Page 3: ...presence of cancer cells Exercise extreme caution when resecting tissue in patients who have implants that extend into the uterine cavity Do not use the BenestaTM Tissue Removal Device to resect tissu...

Page 4: ...e IV Pole pressure cuff or fluid management system FMS Distending media Vacuum source suction canister and tissue trap BenestaTM Hysteroscope and outflow channel Inflow tubing Y tubing Hysteroscope an...

Page 5: hard into target pathology Excessive leverage on the device does not improve cutting performance and may result in decreased performance and or unintended excision of tissue pathology 13 Excised ti...

Page 6: earth Not Applicable device is battery operated Radio Frequency RF Common Mode IEC 61000 4 6 3 Vms 150kHz to 80MHz Not Applicable device is battery operated Power Frequency Magnetic Field IEC 61000...

Page 7: Caldera Medical at its option of any product found to be defective during the warranty period Damage inflicted to a product by the user will result in additional charges and may void the warranty T...