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ENGLISH

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NOTE:

 When the “Last Procedure” Icon is pressed, only 

the previous procedure will be displayed . Information for 
procedures prior to the most recent procedure will not be 
available .

NOTE:

 In the “Settings” screen, press the “-” or “+” buttons 

to adjust the volume and brightness . 

NOTE:

 The first time the Model 10 RFC is turned on, the 

“Select Your Language” screen will display . The default 
setting is in English . To select another language, press the 
button with the name of that language . Save the selection by 
pressing the flashing green button located at the bottom right 
center of the screen . The language selection will be retained . 
To change the language selection after the initial setup, use 
the “Setting” screen . Press the name of the language to 
change the language used on the screen display .  To save 
changes to the settings, press the flashing green button 
located at the bottom right center of the screen .  To cancel a 
selection, press the blue “X” located at the bottom left center 
of the screen .

Troubleshooting Most Common Alarms

CAVITY ASSESSMENT ALARM

If the cavity integrity assessment fails, a screen will display “Cavity 
Assessment Failure” with an abridged version of the troubleshooting tips 
below . The cause of the cavity integrity assessment (CIA) failure is the 
inability to pressurize the cavity . It  

may be caused by:

1 . Device leak: Ensure that the suction line desiccant filter has been 

installed . Check all tubing connections to ensure that they are tightly 
connected .

2 . Leak at the external os of the cervix: Look for visible bubbles or a 

“hissing” sound at the external os of the cervix .

  Use the tab on the cervical collar to advance the cervical collar 

towards the external os of the cervix to ensure there is a tight seal . 
Perform the CIA test again . If the CIA test fails again, use a second 
tenaculum to grasp the cervix around the sheath of the NovaSure 
disposable device . Perform the CIA test again .

3 . Uterine  perforation: 

If a perforation is suspected, the procedure 

should be terminated immediately .

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 .

NOTE:

 When following the troubleshooting steps on the Model 10 

RFC, press the “?” button on the screen and use the scroll buttons 
on the right for more information . To get back to the main screen 
from the additional troubleshooting tips, press the “X” in the top 
right corner of the screen .

If the cavity integrity assessment fails after reasonable attempts 
to implement the troubleshooting procedure (step 2 .36), abort the 
procedure .

VACUUM ALARM

The Vacuum alarm occurs when the vacuum level is outside its specified 
range . This can occur as a result of one or more of the following:
• An over-dilated cervix; 
• Poor contact between the cervical collar and the external cervical os;
• The vacuum relief valve is in the closed position;
• An obstruction in the disposable device filter(s) (two) or desiccant; or
• An obstruction within the disposable device .
If the Vacuum check fails, a screen will display “Vacuum Failure” with an 
abridged version of the following troubleshooting tips:
• Gently press a 2-3 .5 mm uterine dilator or sound inside the vacuum 

relief valve 

• Check the cervical collar position, and reposition if necessary . Use the 

tab on the cervical collar to advance the cervical collar towards the 
external os of the cervix to ensure there is a tight seal . Verify that air is 
not being drawn through the cervix by a loose fit between the cervical 
collar and the entrance to the cervical canal . If air is being drawn in 
through the cervical canal, try to reposition the cervical collar and 
disposable device shaft to prevent air ingress .

• Ensure the suction canister on the disposable device is vertical and the 

device tubing is not draped over the patient’s leg .

• Check all tubing connections to ensure that they are tightly connected . 

Check the push-on tubing connectors at the desiccant tube . Replace 
the desiccant if it is pink . Ensure that the filter located near the 
disposable connection on the vacuum feedback line is tightened . 

• Reattempt ablation .
If the “Vacuum Failure” screen displays again:
• Disconnect the disposable device from the RF controller .
• Remove the disposable device and replace with a new disposable 

device .

• Reattempt the ablation with the new device .

Model 10 RFC USERS ONL

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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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