Hologic Nova Sure 08 RF Mode D'emploi Et Manuel page 26

NovaSure disposable device
1. The NovaSure disposable device does not contain latex.
2. The NovaSure disposable device is a Class III device by FDA
regulation.
3. The NovaSure disposable device is a Class IIB device according to
the MDD 93/42/EEC.
4. The NovaSure disposable device tip nominal diameter: 6 mm.
5. The NovaSure disposable device overall dimensions:
19" x 6" x 12" (48.3 cm x 15.2 cm x 5 cm).
6. The NovaSure disposable device has a voltage rating of 153 V.
NovaSure RF controller
1. The NovaSure RF controller can be used with outlets providing 100 to
240 VAC and will draw a maximum of 5 Amps.
2. The NovaSure RF controller is a Class I, defibrillator-proof Type BF
instrument, according to IEC 60601-1.
3. The NovaSure RF controller is a Class III device by FDA regulation.
4. The NovaSure RF controller is a Class IIB device according to the
MDD 93/42/EEC.
5. The RF controller has been tested and found to comply with the
limits for medical devices according to IEC 60601-1-2 ED 4.0: 2014.
These limits are designed to provide reasonable protection against
harmful interference in a typical medical installation. This equipment
generates, uses and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause
harmful interference to other devices in the vicinity. However, there
is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to
other devices, which can be determined by turning the equipment off
and on, the user is encouraged to try to correct the interference by
one or more of the following measures:
• Re-orient or relocate the receiving device
• Increase the separation between equipment
• Connect the equipment 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.
6. The controller meets the requirements of IEC 60601-1/UL 60601-1,
IEC 60601-2-2 and CSA C22.2 No.601.1.
7. Shipment of the controller should be done only in the original Hologic
packaging. Environmental requirements for use, shipping and
storage are indicated below.
8. The absolute maximum peak voltage generated by the
NovaSure RF controller is 153 volts. Accessories used with the RF
controller should have a voltage rating equal to or greater than
153 volts.
9. The absolute maximum peak power generated by the
NovaSure RF controller is 216 watts.
10. NovaSure RF controller weight: 24 lbs (11 kg), unpacked.
11. Height: 12.5"; Width: 7.5"; Depth: 14.5"
(32 cm x 19 cm x 35.5 cm).
12. The maximum pressure of CO
controller and disposable device shall be 90 ± 10 mmHg.The
maximum flow rate of CO
connected to the disposable device shall be 95 ± 15 ml/
min. (The maximum flow rate of CO
controller without a NovaSure disposable device attached is
117 ± 13 ml/ min.)
13. The Novasure RF Generator should be used without a neutral
electrode.
Actual Power vs. Power Setting into a 20 Ohm Load
Operating, non-packaged conditions
Altitude 0 to 10,000 ft
Temperature 10° C to 40° C
Humidity 15 to 85% RH at 40° C (non-condensing)
Non-operating, packaged conditions
Altitude 0 to 40,000 ft
Temperature –30° C to 60° C
Humidity 85% RH, 72 hr, at 38° C (non-condensing)
25
delivered from the NovaSure RF
2
from the NovaSure RF controller
2
from the NovaSure RF
2
Power vs. Resistance
Load Resistance (Ohms)
Power Setting (Ohms)
(0 to 3,030 m)
(50° F to 104° F)
(0 to12,120 m)
(–22° F to 140° F)
ENGLISH