Hologic NovaSure Advanced Instructions For Use And Controller Operator's Manual
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Hologic NovaSure Advanced Instructions For Use And Controller Operator's Manual

Impendance controlled endometrial ablation system
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  • Page 2: Table Of Contents

    BACK TO TOC ENGLISH NovaSure ® Instructions for Use and Controller CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO Operator’s Manual SALE BY OR ON THE ORDER OF A PHYSICIAN TRAINED IN THE USE OF THE DEVICE . Table of Contents Read all instructions, cautions and warnings prior to use .
  • Page 3 ENGLISH BACK TO TOC NovaSure Disposable Device Description NovaSure Model 08-09 NovaSure Model 10 The NovaSure disposable device consists of a single-patient use, RF Controllers RF Controller conformable bipolar electrode array mounted on an expandable frame that can create a confluent lesion on the entire interior surface area of the uterine cavity .

  • Page 4: Indications

    BACK TO TOC ENGLISH • a patient who is pregnant or who wants to become pregnant in the NovaSure Suction Line Desiccant future . Pregnancies following ablation can be dangerous for both Description mother and fetus . The NovaSure suction line desiccant •...

  • Page 5: Precautions

    ENGLISH BACK TO TOC • If the cavity integrity assessment fails after reasonable attempts screen appears (Model 10 RFC) and an audible pulsed tone sounds to implement the troubleshooting procedures (step 2 .36), abort throughout the purge procedure . When the tone and the LED/screen the procedure .

  • Page 6: Adverse Events

    - who are post-menopausal . NovaSure Loop Resection • Do not attempt to repair the controller if problems are suspected . Plus Rollerball Call Hologic Technical Support or a Hologic sales representative for Adverse Event n=175 (%) n=90 (%) instructions .

  • Page 7: Anticipated Post-Procedural Complications

    ENGLISH BACK TO TOC Clinical Study Table 1D. Post-Operative Adverse Events > 2 Weeks – 1 Year Purpose: Safety and effectiveness of the use of the NovaSure system NovaSure Loop Resection was compared to wire loop resection of the endometrium followed by Plus Rollerball rollerball ablation in premenopausal women suffering from menorrhagia Adverse Event...
  • Page 8 BACK TO TOC ENGLISH Exclusion criteria Table 2. Patient Accountability • Presence of bacteremia, sepsis or other active systemic infection Number of Patients NovaSure Wire Loop • Active or recurrent chronic pelvic inflammatory disease Resection • Patient with documented coagulopathies or on anticoagulants Plus Rollerball •...
  • Page 9 ENGLISH BACK TO TOC Table 3. Effectiveness: Success Rates–Intent-To-Treat Patients Table 4. Effectiveness: Quality of Life (QOL) Wire Loop Resection Wire Loop Resection NovaSure Plus Rollerball NovaSure Plus Rollerball (n=175) (n=90) 12 Months 9 .9%* 8 .6%* Months post ablation 24** 36** 24**...

  • Page 10: Patient Selection

    BACK TO TOC ENGLISH Secondary endpoint: anesthesia regimen Patient Counseling As with any procedure, the physician needs to discuss risks, benefits Anesthesia was left to the discretion of each patient, clinical investigator and alternatives with the patient prior to performing endometrial and attending anesthesiologist .
  • Page 11 ENGLISH BACK TO TOC 1.0 Set-up 1 .3 Screw the CO canister into the regulator on the back panel of the controller until tightened . Toggle switch canister power cord NovaSureDISPOSABLE DEVICE WITH CONNECTING CORD, 1 .4 Fully rotate the CO regulator knob to the HI position (if equipped) .
  • Page 12 BACK TO TOC ENGLISH 2 .8 Take a sound measurement of the uterus to measure the length WARNING: Do not use the sterile single-patient use disposable from fundus to external cervical os . The efficacy of the NovaSure device if the packaging appears to be damaged or there is evidence system has not been fully evaluated in patients with a uterine of tampering .
  • Page 13 2 .16 above . If the WIDTH dial still reads less than 4 .0 cm, open a new disposable device and return the old disposable device to Hologic Technical Support . 2 .18 Unlock the disposable device by pressing the lock release button .
  • Page 14 BACK TO TOC ENGLISH NOTE: Once the disposable device handles are locked, the uterus should move in conjunction with the disposable device . WARNING: If the disposable device is difficult to insert into the cervical canal, use clinical judgment to determine whether or not further dilation is required .
  • Page 15 ENGLISH BACK TO TOC 2 .31 Hold the tenaculum, advance the disposable device slowly and 2 .33 Read the cornu-to-cornu measurement (2 .5 cm minimum) on the gently to the fundus . The WIDTH dial should read greater than or WIDTH dial indicator . equal to the previous measurement .
  • Page 16 BACK TO TOC ENGLISH MODEL 08-09 RF CONTROLLERS MODEL 10 RF CONTROLLER Follow next steps on pages 16 through 19. Follow next steps on pages 20 through 23. Table of Contents for both Models 08-09 and Model 10 RF Controllers Additional Troubleshooting .
  • Page 17 ENGLISH BACK TO TOC Operating the Model 08-09 RF Controllers B . If the CIA test fails again, check for leaks in the system, and between the cervix and cervical collar . Be sure to check all tubing connections, and ensure that a suction line desiccant has been installed . If the leak appears to be at the cervix and cannot be resolved by using the cervical collar, use another tenaculum to grasp the cervix around the sheath .

  • Page 18: Periodic Maintenance And Service

    BACK TO TOC ENGLISH 2 .38 After automatic termination of the ablation cycle (approximately 2 .41 Turn off the NovaSure RF controller . Close the CO regulator . 90 seconds), fully retract the cervical collar by using the tab on 2 .42 Perform postoperative patient care according to standard the cervical collar .

  • Page 19: Novasure Model 08-09 Rf Controller Led Descriptions

    . Follow the troubleshooting guide in this position, when a blockage is detected in the disposable device or the manual . If problems persist, call Hologic Technical Support connection tubing or when the system has a leak . Such a situation for instructions .
  • Page 20 BACK TO TOC ENGLISH canister low or empty sound of escaping gas may accompany CO leakage under either of these conditions . The NovaSure RF controller will generate an audible tone at a rate of four times per second during this alarm condition . LEDs that If the cavity integrity assessment fails after reasonable attempts to were illuminated prior to the alarm will remain in the same state implement the troubleshooting procedures (step 2 .36), abort the...
  • Page 21 ENGLISH BACK TO TOC Operating the Model 10 RF Controller If the cavity integrity assessment fails after reasonable attempts to implement the troubleshooting procedures (step 2 .36), abort the procedure . NOTE: Removing the disposable device from the uterine cavity after completing a cavity integrity assessment will require an additional CIA test to be performed upon disposable device re-insertion (whether or not the CIA previously passed) prior to initiating an...

  • Page 22: Periodic Maintenance And Service

    Troubleshooting section, “Difficulty closing and removing are suspected . Follow the troubleshooting guide in this the disposable device post-ablation” . manual . If problems persist, call Hologic Technical Support for instructions . CAUTION: To avoid damaging the device, employ gentle technique when retracting the array .

  • Page 23: Troubleshooting Most Common Alarms

    ENGLISH BACK TO TOC NOTE: CO leakage may occur at the external cervical os due to the NOTE: When the “Last Procedure” Icon is pressed, only presence of an over-dilated cervix . Visible bubbles or the “hissing” the previous procedure will be displayed . Information for sound of escaping gas may accompany CO leakage under either of procedures prior to the most recent procedure will not be...
  • Page 24 BACK TO TOC ENGLISH NOTE: When following the troubleshooting steps on the Model 10 4 . If the Array Position message still displays, fully retract the RFC, press the “?” button on the screen and use the scroll buttons disposable device array and remove the disposable device on the right for more information .

  • Page 25: Additional Troubleshooting

    . Assembly is the reverse of these steps . 1 . The ENABLE button is firmly depressed; Any potentially defective NovaSure product must be returned to Hologic 2 . The NovaSure RF controller is plugged in;...
  • Page 26 5 . The controller meets the requirements of IEC 60601-1/UL 60601-1, Power Setting (Ohms) IEC 60601-2-2 and CSA C22 .2 No .601 .1 . 6 . Shipment of the controller should be done only in the original Hologic Operating, non-packaged conditions packaging . Environmental requirements for use, shipping and storage are indicated below .
  • Page 27 ENGLISH BACK TO TOC Guidance and manufacturer’s declaration – ELECTROMAGNETIC IMMUNITY electromagnetic emissions and immunity Immunity EN/IEC Compliance Electromagnetic The NovaSure RF controller is intended for use in the Test 60601 Level Environment – Guidance electromagnetic environment specified below . The customer Test Level or user of the NovaSure RF controller should ensure that it is Electrostatic...
  • Page 28 BACK TO TOC ENGLISH Immunity EN/IEC Compliance Electromagnetic Immunity EN/IEC Compliance Electromagnetic Test 60601 Level Environment – Guidance Test 60601 Level Environment – Guidance Test Level Test Level NOTE 1: At 80 MHz and 800 MHz, the higher frequency range Power 3A/m 3A/m...

  • Page 29: Cleaning And Sanitizing

    The use of nonflammable agents for cleaning and sanitizing Manufactured Equipment . Hologic does not warrant that use of Products is recommended . Flammable agents or solvents for cleaning will be uninterrupted or error-free, or that Products will operate with or sanitizing should be allowed to evaporate before use of the non-Hologic authorized third-party products .

  • Page 30: Symbol Definitions

    Category non-AP equipment Hologic, SureSound, NovaSure and associated logos are Dangerous voltage trademarks and/or registered trademarks of Hologic, Inc . and/or its subsidiaries in the United States and/or other countries . Date of manufacture The NovaSure impedance controlled endometrial ablation system is manufactured and distributed by Hologic, Inc .
  • Page 31 MAN-03523-001 Rev. 009...

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