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Immunity 

Test

EN/IEC 

60601

Test Level

Compliance 

Level

Electromagnetic 

Environment – Guidance

Power 

Frequency
50/60Hz
Magnetic 

Field
EN/IEC 

61000-4-8

3A/m

3A/m

Power frequency magnetic 

fields should be that of 

a typical commercial or 

hospital environment .

Portable and mobile 

RF communications 

equipment should be 

used no closer to any 

part of the RF generator, 

including cables, than the 

recommended separation 

distance calculated from 

the equation applicable 

to the frequency of the 

transmitter .

Recommended separation 

distance

Conducted 

RF
IEC 

61000-4-6

3 Vrms
150 kHz to 

80MHz

3 Vrms

 

150 kHz to 

80 MHz

Radiated RF
IEC 

61000-4-3

3 V/m
80 MHz to 

2 .5 GHz

3 V/m

 80 MHz to 

800 MHz

 800 MHz to 

2 .5 GHz
where 

P

 is the maximum 

output power rating 

of the transmitter in 

watts (W) and 

d

 is the 

recommended separation 

distance in meters (m) .
Field strengths from 

fixed RF transmitters, 

as determined by an 

electromagnetic site 

survey,

a

 should be less 

than the compliance level 

in each frequency range .

b

Interference may occur in 

the vicinity of equipment 

marked with the following 

symbol:

Immunity 

Test

EN/IEC 

60601

Test Level

Compliance 

Level

Electromagnetic 

Environment – Guidance

NOTE 1:

 At 80 MHz and 800 MHz, the higher frequency range 

applies .

NOTE 2:

 These guidelines may not apply in all situations . 

Electromagnetic propagation is affected by absorption and 

reflection from structures, objects and people .

a

  Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) 

telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast 
cannot be predicted theoretically with accuracy . To assess the electromagnetic environment due to 
fixed RF transmitters, an electromagnetic 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 should be observed to verify normal operation . If abnormal 
performance is observed, additional measures may be necessary, such as re-orienting or relocating 
the RF generator .

b

  Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m .

Recommended separation distances between portable

and mobile RF communications equipment and the 

NovaSure  RF controller

The NovaSure RF controller is intended for use in the 
electromagnetic environment in which radiated RF disturbances 
are controlled . The customer or the user of the NovaSure RF 
controller can help prevent electromagnetic interference by 
maintaining a minimum distance between portable and mobile RF 
communications equipment (transmitters) and the NovaSure RF 
controller as recommended in the following table, according to the 
maximum output power of the communications device . 

Recommended separation distance

Rated 

maximum 

output power of 

transmitter

W

Separation distance according to frequency of 

transmitter

m

150 kHz to 

80 MHz 

80 MHz to 

800 MHz

800 MHz to 2 .5 GHz

0 .01

0 .12

0 .12

0 .23

0 .1

0 .37

0 .37

0 .74

1

1 .2

1 .2

2 .3

10

3 .7

3 .7

7 .4

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation 
distance 

d

 in meters (m) can be estimated using the equation applicable to the frequency of the 

transmitter, where 

P

 is the maximum output power rating of the transmitter in watts (W) according 

to the transmitter manufacturer .

NOTE 1:

 At 80 MHz and 800 MHz, the separation distance for the 

higher frequency range applies .

NOTE 2:

 These guidelines may not apply in all situations . 

Electromagnetic propagation is affected by absorption and 

reflection from structures, objects and people .

INSTR

UCTIONS FOR USE      ALL USERS

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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