Table Of Contents; Physician Checklist; System Description - Hologic NovaSure Advanced Instructions For Use And Controller Operator's Manual

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NovaSure
®
Instructions for Use and Controller
Operator's Manual

Table of Contents

Physician Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
System Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Adverse Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Anticipated Post-Procedural Complications . . . . . . . . . . . . . . 6
Other Adverse Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Clinical Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Patient Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Patient Counseling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Pretreatment Preparation of Patient . . . . . . . . . . . . . . . . . . . . . 9
NovaSure Impedance Controlled Endometrial Ablation System
Instructions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Periodic Maintenance and Service:
Model 08-09 RF Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
NovaSure Model 08-09 RF Controller LED Descriptions . . . . . 18
Troubleshooting Most Common Alarms:
Model 08-09 RF Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Periodic Maintenance and Service:
Model 10 RF Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
NovaSure Model 10 RF Controller Screen Icons . . . . . . . . . . . 21
Troubleshooting Most Common Alarms:
Model 10 RF Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Additional Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . 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
CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO
SALE BY OR ON THE ORDER OF A PHYSICIAN TRAINED IN THE
USE OF THE DEVICE .
Read all instructions, cautions and warnings prior to use . Failure
to follow any instructions or to heed any warnings or precautions
could result in serious patient injury .
NOTE: The manual that accompanied 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
controllers and/or RF generators, and the NovaSure RF
is not to be used with other disposable devices .
The NovaSure disposable device does not contain latex .

Physician Checklist

The physician must:
• have sufficient experience in performing procedures within the uterine
cavity, such as IUD insertion or dilation and curettage (D&C) and with
adequate training, knowledge and familiarity using the NovaSure
system;
• review and be familiar with the instructions and complete either
NovaSure training or be trained by a qualified physician;
• be aware of the appropriate sequence of actions detailed in the
Instructions for Use and Troubleshooting sections of this manual to
abort, resolve and/or continue the treatment in the event the system
detects a loss of CO during the cavity integrity assessment (CIA),
2
which indicates a possible uterine perforation .
Adjunct personnel must be familiar with these instructions and other
training materials prior to using the NovaSure system .

System Description

The NovaSure impedance controlled endometrial ablation system
consists of the NovaSure disposable device with connecting cord,
NovaSure RF controller (controller), NovaSure CO
foot switch and power cord, which are designed to be used together as
a system .
NovaSure Disposable Device with Connecting Cord,
Including Suction Line Desiccant
1
ENGLISH
controller
®
canister, desiccant,
2