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Operating the Model 08-09 RF Controllers

A .  Automatic mode

  To operate the system in automatic mode, press the ENABLE 
button prior to beginning the Cavity Integrity Assessment (CIA) . 
Proceed to step 2 .36, but do not follow step 2 .37 if operating the 
system in automatic mode . 

B .  Manual mode

  To operate the system in the manual mode, do not press the 
ENABLE button prior to beginning the Cavity Integrity Assessment 
(CIA) . Follow steps 2 .36 and 2 .37 .
2 .36 Begin the CIA procedure by stepping on the foot switch once . 
The CAVITY ASSESSMENT LED flashes green in conjunction with 
an audible tone at a rate of once per second when the system 
is performing a CIA . The duration of the test will range between 
approximately 7 and 30 seconds . A steady green LED appears 
when the CIA has passed and the system can deliver RF energy . 
Power cannot be applied to the disposable device until the CAVITY 
ASSESSMENT LED is a steady green light .
If the cavity integrity assessment fails, then the CAVITY 
ASSESSMENT LED on the NovaSure RF controller will flash red, 
and a rapid audible tone will sound at a rate of four times per 
second .

If the cavity integrity assessment fails, press the foot switch to stop the 
sound . Next:
A . If a perforation is suspected, the procedure should be terminated 

immediately .

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 . Repeat the CIA by pressing the foot switch .

NOTE:

 CO

2

 leakage may occur at the external cervical os due to the 

presence of an over-dilated cervix . Visible bubbles or the “hissing” 
sound of escaping gas may accompany CO

2

 leakage under either of 

these conditions .

C . 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 
ablation . 

2 .37 Manual mode only

 

 When operating the system in manual mode, the ablation cycle 
will not start automatically after the successful completion of the 
CIA . Once a successful CIA has been completed, press the ENABLE 
button and depress the foot switch a second time to initiate the 
ablation cycle .

NOTE:

 In some Model 09 RF controllers, a vacuum pre-check 

occurs automatically prior to initiation of the ablation cycle . The 
VACUUM LED will flash and an audible tone will be heard for up to 
10 seconds during the vacuum pre-check .

 

 During the ablation cycle, a blue RF ON LED will illuminate . At the 
completion of the ablation cycle, the RF power delivery (RF ON 
LED), as well as suction, will switch off automatically . The physician 
can stop the progress of the procedure at any time by depressing 
the foot switch . 

NOTE:

 RF power delivery can be stopped at any time by pressing 

the foot switch

Model 08-09 RFC USERS ONL

Y

MANUAL MODE

Содержание NovaSure Advanced

Страница 1: ......

Страница 2: ...d the disposable device may contain a more recent revision of the NovaSure system instructions than the manual provided with the controller The NovaSure disposable device is not to be used with other...

Страница 3: ...suctioning The disposable device is connected to the controller via a cord containing the RF cable suction tubing used for pressure monitoring during the cavity integrity assessment cycle and for suct...

Страница 4: ...hyperplasia a patient with any anatomic condition e g history of previous classical cesarean section or transmural myomectomy or pathologic condition e g long term medical therapy that could lead to...

Страница 5: ...the disposable device external to the patient to eliminate the risk of air or gas embolism The NovaSure RF controller CAVITY ASSESSMENT LED flashes red Model 08 09 RFCs or a purging device screen app...

Страница 6: ...after inserting the disposable device and proceed directly from the seating procedure to the CIA Electrically conductive objects e g monitoring electrodes from other devices that are in direct contact...

Страница 7: ...e g hormone D C or patient timing Patients randomized into the control arm received wire loop resection as an endometrial pretreatment Study endpoints The primary effectiveness measure was a validated...

Страница 8: ...rameters between the treatment groups between the age groupings or among the nine investigational sites Table 2 Patient Accountability Number of Patients NovaSure Wire Loop Resection Plus Rollerball E...

Страница 9: ...culty Performing Work Or Other Activities Due to Menses Pre operatively 66 3 65 5 Table 4 Effectiveness Quality of Life QOL NovaSure Wire Loop Resection Plus Rollerball 12 Months 9 9 8 6 24 Months 14...

Страница 10: ...use only in women who do not desire to bear children because the likelihood of pregnancy is significantly decreased following the procedure Patients of childbearing capacity should be cautioned of pot...

Страница 11: ...5 Press the toggle switch on the back panel of the controller into the on position 1 6 Connect the foot switch to the appropriate port on the front panel of the controller NOTE The first time the Mode...

Страница 12: ...ay can be extended CONTRAINDICATION Do not treat a patient with a uterine cavity length that is less than 4 cm as cervical canal damage may occur NOTE Patients with a uterine cavity length greater tha...

Страница 13: ...2 18 Unlock the disposable device by pressing the lock release button Close the disposable device by holding the front handle stationary and gently pulling the rear handle backwards until the closed...

Страница 14: ...eeze the disposable device handles together while gently moving the disposable device 0 5 cm to and from the fundus and rotating the handle of the disposable device 45 counterclockwise from the vertic...

Страница 15: ...m 2 34 Select the value indicated on the WIDTH dial into the NovaSure RF controller input screen by depressing the UP DOWN arrows 2 35 The system can be operated in either automatic mode or manual mod...

Страница 16: ...ting 24 Replacement Instructions 24 Specifications 24 Cleaning and Sanitizing 28 Parts List 28 Warranty 28 Technical Support and Product Return Information 28 Symbol Definitions 29 MODEL 08 09 RF CONT...

Страница 17: ...o be at the cervix and cannot be resolved by using the cervical collar use another tenaculum to grasp the cervix around the sheath Repeat the CIA by pressing the foot switch NOTE CO2 leakage may occur...

Страница 18: ...modification of this equipment is allowed Periodic maintenance Recommended periodic maintenance includes RF power output testing and standard safety tests such as leakage current in accordance with UL...

Страница 19: ...ated when the array is not fully deployed The ENABLE LED cannot be toggled on nor can power be delivered to the array when the ARRAY POSITION LED is illuminated VACUUM LED illuminates in two condition...

Страница 20: ...e new device 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 dis...

Страница 21: ...2 leakage may occur at the external cervical os due to the presence of an over dilated cervix Visible bubbles or the hissing sound of escaping gas may accompany CO2 leakage under either of these condi...

Страница 22: ...ng and standard safety tests such as leakage current in accordance with UL 60601 1 along with regular cleanings described in the Cleaning and Sanitizing section RF power output test The NovaSure RF co...

Страница 23: ...r dilated cervix Visible bubbles or the hissing sound of escaping gas may accompany CO2 leakage under either of these conditions NOTE When following the troubleshooting steps on the Model 10 RFC press...

Страница 24: ...t still displays proceed with the following 2 Attempt gentle reseating of the NovaSure disposable device A Partially retract the array into the sheath by releasing the disposable device handle lock re...

Страница 25: ...ot appear Model 10 RFC Remove the NovaSure disposable device from the uterus after fully retracting the disposable device array into the sheath A Release the disposable device lock release button B Ho...

Страница 26: ...ent into an outlet on a circuit different from that to which the other device s is are connected Contact Hologic Technical Support or the manufacturer of the other equipment for assistance 5 The contr...

Страница 27: ...t s hand placed on her thigh should be avoided for example by insertion of dry gauze between skin surfaces WARNING With any electrosurgical device the potential for arcing exists and neuromuscular sti...

Страница 28: ...lectromagnetic site survey should be considered If the measured field strength in the location in which the RF generator is used exceeds the applicable RF compliance level above the RF generator shoul...

Страница 29: ...non Hologic Manufactured Equipment is warranted through its manufacturer and such manufacturer s warranties shall extend to Hologic s customers to the extent permitted by the manufacturer of such non...

Страница 30: ...Follow instructions for use Fragile Fuse High pressure HP Humidity limitation non condensing Keep dry Manufacturer No oil Not made with natural rubber latex Protect from heat Radio frequency RF energ...

Страница 31: ...MAN 03523 001 Rev 009...

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