Covidien ClosureRFG User manual

Operation Manual
ClosureRFGTM
Radiofrequency Generator
Covidien RFG3 Specs
Provided by www.AAATesters.com

ClosureRFG Radiofrequency Generator iii
Limited Warranty
Limited Warranty
Covidien warrants the covered Product listed below to be free from defects in material and
workmanship for normal use and service for the period(s) set forth below. Covidien’s
obligation under this warranty is limited to the repair or replacement, at its sole option, of
any Product, or part thereof, which has been returned to it (or its authorized distributor)
within the applicable time period shown below after delivery of the Product to the original
purchaser, and which examination discloses, to Covidien’s satisfaction, that the Product is
defective. This limited warranty does not apply to any Product, or part thereof, which has
been repaired or altered in a way so as, in Covidien’s judgment, to affect its stability or
reliability, or which has been subjected to misuse, neglect, or accident.
The warranty period for this Covidien Product is as follows:
ClosureRFGTM Radiofrequency Generator One year from date of shipping
Notwithstanding any other provision herein or in any other document or communication,
Covidien’s liability with respect to this limited warranty and the Products sold hereunder
shall be limited to the aggregate purchase price for the Products sold to the customer. This
limited warranty is non-transferable and runs only to the original purchaser of the covered
Product(s). There are no warranties which extend beyond the terms hereof. Covidien
disclaims any liability hereunder or elsewhere in connection with the sale of Products and
for any form of indirect, tort, or consequential damages.
This limited warranty and the rights and obligations hereunder shall be construed under
and governed by the laws of the Commonwealth of Massachusetts, USA. The sole forum
for resolving disputes arising under or relating in any way to this limited warranty is the
District Court of the County of Suffolk, Commonwealth of Massachusetts, USA.
Covidien reserves the right to make changes in covered Products built or sold by it at any
time without incurring any obligation to make the same or similar changes to equipment
previously built or sold by it.
THE OBLIGATION TO REPAIR OR REPLACE A DEFECTIVE OR NONPERFORMING PRODUCT
IS THE SOLE REMEDY OF THE CUSTOMER UNDER THIS LIMITED WARRANTY. EXCEPT AS
EXPRESSLY PROVIDED HEREIN, COVIDIEN DISCLAIMS ALL OTHER WARRANTIES,
WHETHER EXPRESS OR IMPLIED, ORAL OR WRITTEN, WITH RESPECT TO
PRODUCTS, INCLUDING WITHOUT LIMITATION ALL IMPLIED WARRANTIES,
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

iv ClosureRFG Radiofrequency Generator
Software License
Software License
The Product includes proprietary software and computer programs copyrighted and
owned by Covidien LP. Covidien LP retains all right, title and interest to the proprietary
software, computer programs, and all portions thereof, and any associated
documentation (collectively, the “Software”) provided to Customers as may be installed
in the Products and equipment addressed herein or provided separately, and it has the
sole right to grant license to the Software hereunder. Customer acknowledges and
hereby accepts that the Product contains certain software licensed from third parties,
including open source software (collectively, “Third Party Software”) that may be subject
to additional or different license terms.
The evaluation allowance herein and any ultimate price paid by Customer for the
Products incorporating the Software include as a portion of that evaluation allowance, or
price, a license fee granting Customer only the rights set forth in this Software License.
Customer further acknowledges and agrees that the Software is owned exclusively by
COVIDIEN. The Software is licensed to be used on only one computing device or Product,
and a valid license must be purchased for each computing device on which the Software
is installed.
Single User License Grant: COVIDIEN grants to Customer a limited, nonexclusive, non-
sublicensable, nontransferable and revocable license to use the Software, exclusively at
Customer’s location as identified by Customer as the ship-to location of the Product,
solely in machine-readable object code form only on a single central processing unit
owned or leased by Customer or otherwise embedded in equipment provided by
COVIDIEN, and for the sole purpose of Customer’s internal business purpose in the
operation of the Product or equipment purchased from, other otherwise provided by,
COVIDIEN or its affiliates.
Except to the extent expressly authorized in this Software License or by law, Customer
shall not and shall not cause any third party to: (i) decompile, disassemble, or reverse
engineer the Software; (ii) modify or create any derivative works (including, without
limitation, translations, transformations, adaptations or other recast or altered versions)
based on the Software, or alter the Software in any way; (iii) merge the Software with
any other software or product not supplied by Supplier; (iv) use, copy, sell, sublicense,
lease, rent, loan, assign, convey or otherwise transfer the Software except as expressly
authorized by the Agreement; (v) distribute, disclose or allow use of the Software, in any
format, through any timesharing service, service bureau, network or by any other means,
to or by any third parties; (vi) remove or modify any copyright, confidential and/or
proprietary markings, legends or restriction which are in the Software originally supplied
to Customer; or (vii) violate any obligations with regard to COVIDIEN’s Confidential
Information. To the extent that Customer is expressly permitted by applicable mandatory
law to undertake any of the activities listed in the preceding sentence, Customer will not
exercise those rights until Customer has given COVIDIEN thirty (30) days written notice of
Customer’s intent to exercise any such rights unless an order of a government agency of
competent jurisdiction will not so allow.
Except for the limited license rights expressly granted in this Software License, COVIDIEN
reserves all rights in and to the Software and any modifications thereto and derivations
thereof, including, but not limited to, all title, ownership, intellectual property rights and
all other rights and interests. Customer will own only the hardware or physical media on
which the Software is stored or processed, if any.

ClosureRFG Radiofrequency Generator v
Software License
Customer agrees that the Software, including the specific design and structure of
individual programs, constitute confidential information and trade secrets of COVIDIEN,
whether or not the programs may be copyrighted or copyrightable, and/or patented or
patentable. Customer agrees not to disclose, provide, or otherwise make available such
confidential information, trade secrets or copyrighted material in any form to any third
party. Customer agrees that it will make the Software available only to employees,
contractors, or consultants with a need to know, who are obligated to comply with all
license restrictions contained in this Software License Agreement and to maintain the
secrecy of the Software and all other Confidential Information. Customer is responsible
for the compliance of all users with these obligations.
Customer may, from time to time, request that COVIDIEN incorporate certain features,
enhancements or modifications into the Software. COVIDIEN may, in its sole discretion,
undertake to incorporate such changes and distribute the Software so modified to all or
any of COVIDIEN's customers. All such error corrections, bug fixes, patches, updates or
other modifications provided to COVIDIEN shall be the sole property of COVIDIEN.
This Software License is effective until terminated. Customer may terminate this License
at any time by destroying all copies of Software including any documentation. This
License will terminate immediately upon notice from COVIDIEN if Customer fails to
comply with any provision of this License or any supplier agreement. COVIDIEN may
terminate the Software licenses granted herein and exercise all available rights by giving
written notice, effective immediately, if within ten (10) business days of Customer’s
receipt of a reasonably detailed written request to cure, Customer has not cured all
breaches of this License’s limitations or restrictions. Upon such termination, Customer will
immediately pay all undisputed fees outstanding, cease use of all Software, return or
delete, at COVIDIEN’s request, all copies of the Software in Customer’s possession, and
certify compliance with all of the obligations herein to COVIDIEN in writing.
Limited Warranty: COVIDIEN represents and warrants to Customer that the Software
will perform substantially as described in COVIDIEN's then current documentation for
such Software for the longer of (a) the remaining warranty applicable to the Product with
which such Software was delivered (not to exceed one year) or (b) ninety (90) days from
the date such Software was shipped or first made available to Customer for electronic
download from COVIDIEN’s service site. If you notify COVIDIEN of defects during the
warranty period, COVIDIEN will replace the Software or, at its option, refund the
purchase price. Your remedy for breach of this limited warranty shall be limited to
replacement or refund and shall not encompass any other damages. No dealer,
distributor, agent or employee of COVIDIEN is authorized to make any modification or
addition to the warranty and remedies stated above.
Notwithstanding these warranty provisions, all of COVIDIEN's obligations with respect to
such warranties shall be contingent on Customer’s use of the Software in accordance
with this Agreement and in accordance with COVIDIEN's instructions as provided by
COVIDIEN in the documentation, as such instructions may be amended, supplemented,
or modified by COVIDIEN from time to time. COVIDIEN shall have no warranty
obligations with respect to any failures of the Software which are the result of accident,
abuse, misapplication, extreme power surge or extreme electromagnetic field.
This warranty does not apply to any damages, malfunctions, or non-conformities caused
to or by: (i) Customer’s use of Software in violation of the license granted under the
Agreement or in a manner inconsistent with any provided documentation; (ii) use of non-

vi ClosureRFG Radiofrequency Generator
Software License
COVIDIEN furnished equipment, software, or facilities with its equipment or Products; (iii)
Customer’s failure to follow COVIDIEN’s installation, operation, repair or maintenance
instructions; (iv) Customer’s failure to permit COVIDIEN timely access, remote or
otherwise, to Products; (v) failure to implement all new Updates to Software provided
under the Agreement; (vi) Products or equipment with their original manufacturer’s serial
numbers altered, defaced or deleted; (vii) Products or equipment that have been altered,
serviced or modified by a party other than COVIDIEN or an authorized COVIDIEN
provider; or (viii) Software that has been subjected to abnormal physical or electrical
stress, misuse, negligence or accident by Customer or a third party.
DISCLAIMER: EXCEPT AS SPECIFIED IN THIS WARRANTY, ALL EXPRESS OR IMPLIED
CONDITIONS, REPRESENTATIONS, AND WARRANTIES INCLUDING, WITHOUT
LIMITATION, ANY IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, OR ARISING FROM A COURSE OF DEALING, USAGE, OR TRADE
PRACTICE, ARE HEREBY EXCLUDED TO THE EXTENT ALLOWED BY APPLICABLE LAW.
IN NO EVENT WILL EITHER PARTY BE LIABLE FOR ANY LOST REVENUE, PROFIT, OR DATA,
OR FOR SPECIAL, INDIRECT, CONSEQUENTIAL, INCIDENTAL, OR PUNITIVE DAMAGES
HOWEVER CAUSED AND REGARDLESS OF THE THEORY OF LIABILITY ARISING OUT OF
THIS SOFTWARE LICENSE EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY
OF SUCH DAMAGES. IN NO EVENT SHALL ONE PARTY’S LIABILITY TO THE OTHER PARTY,
WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE, EXCEED THE
PRICE PAID OR TO HAVE BEEN PAID BY CUSTOMER. THE FOREGOING LIMITATIONS SHALL
APPLY EVEN IF THE ABOVE-STATED WARRANTY FAILS OF ITS ESSENTIAL PURPOSE. SOME
STATES DO NOT ALLOW LIMITATION OR EXCLUSION OF LIABILITY FOR CONSEQUENTIAL
OR INCIDENTAL DAMAGES.
U.S. Government Rights. The Software is a “commercial item” developed exclusively at
private expense, consisting of “commercial computer software” and “commercial
computer software documentation” as such terms are defined or used in the applicable
U.S. acquisition regulations. The Software is licensed hereunder (i) only as a commercial
item and (ii) with only those rights as are granted to all other customers pursuant to the
terms and conditions of this License. Customer shall not use, duplicate, or disclose the
Software in any way not specifically permitted by this License. Nothing in this License
requires COVIDIEN to produce or furnish technical data for or to Customer.
If any provision of this Agreement shall be held by a court of competent jurisdiction to be
illegal, invalid or unenforceable, the remaining provisions shall remain in full force and
effect.
This License Agreement contains the entire understanding and agreement between the
parties respecting the Software. This Agreement may not be supplemented, modified,
amended, released or discharged except by an instrument in writing signed by each party's
duly authorized representative. All captions and headings in this Agreement are for
purposes of convenience only and shall not affect the construction or interpretation of any
of its provisions. Any waiver by either party of any default or breach hereunder shall not
constitute a waiver of any provision of this Agreement or of any subsequent default or
breach of the same or a different kind.
The construction and performance of this Agreement will be governed by the laws of the
Commonwealth of Massachusetts without reference to its choice of law principles. The

ClosureRFG Radiofrequency Generator vii
Software License
parties hereby submit to the jurisdiction of the courts of the Commonwealth of
Massachusetts.

Table of Contents
ClosureRFG Radiofrequency Generator ix
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Conventions Used in This Guide . . . . . . . . . . . . . . . . . . . . . . . ii
Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iii
Software License . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iv
Chapter 1. Overview & General Features
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Equipment Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Supported Accessories and Equipment. . . . . . . . . . . . . . . . . . . . 1-2
Visual Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Audible Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Rear Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Side Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
General Safety Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Warnings and Safety Notices: Setting Up the
ClosureRFG Generator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Warnings and Safety Notices: During RF Treatment. . . . . 1-8
Unpacking and Inspection of Components . . . . . . . . . . . . 1-9
Chapter 2. ClosureRFG Generator Setup
Installation Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Applying AC Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Standby Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Setting System Language . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Setting System Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Setting System Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Adjusting Display Brightness . . . . . . . . . . . . . . . . . . . . . . . 2-7
Adjusting Sound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Total Treatment Summary Readout. . . . . . . . . . . . . . . . . . 2-8
Functional and Advisory Limits. . . . . . . . . . . . . . . . . . . . . . 2-8
Connecting a Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9

xClosureRFG Radiofrequency Generator
Chapter 3. Covidien ClosureFast Endovenous
Radiofrequency Catheter Treatment
Ready-to-Treat Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
ClosureFast Catheter Gauges . . . . . . . . . . . . . . . . . . . . . . . 3-2
ClosureFast Catheter RF Treatment – Ready to Treat . . . . 3-3
Functional and Advisory Limits. . . . . . . . . . . . . . . . . . . . . . 3-3
Starting RF Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Stopping RF Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Chapter 4. Covidien ClosureRFS Endovenous
Radiofrequency Stylet Treatment
Ready-to-Treat Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
ClosureRFS Stylet Gauges . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
ClosureRFS Stylet RF Treatment—Ready to Treat . . . . . . . 4-3
Functional and Advisory Limits. . . . . . . . . . . . . . . . . . . . . . 4-3
Starting RF Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Stopping RF Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Chapter 5. Treatment Times
Retain Total Treatment Timer—Connecting a New Catheter . . 5-1
Treatment Time Reset—Using the Same Catheter. . . . . . . . . . . 5-2
Export—RF Treatment Data Storage . . . . . . . . . . . . . . . . . . . . . 5-3
Using Memory Cards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
USB Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
SD Cards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Chapter 6. Messages, Tones, and Responses
Condition and System Responses . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Audible Signals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Chapter 7. Error Codes
Chapter 8. Troubleshooting
Technical Assistance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Generator Fails to Power On . . . . . . . . . . . . . . . . . . . . . . . 8-1
RF Treatment Difficulties . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Error Codes—Generator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Chapter 9. Technical Specifications
Equipment Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Electrical: ClosureRFG Generator . . . . . . . . . . . . . . . . . . . . 9-1
100-120 VAC, 5 A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
220-240 VAC, 5 A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Conditions for Transporting and Storing the ClosureRFG

ClosureRFG Radiofrequency Generator xi
Generator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Conditions for Operating the ClosureRFG Generator. . . . 9-2
RF Power Delivery Performance . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Maximum Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Duty Cycle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
Description of Sub-systems . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
General Description and Operating Conditions . . . . . . . . . . . . 9-6
Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Transportation and Storage . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Common Symbols and Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8
Power Output Charts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10
Chapter 10. Service & Maintenance
Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
General Safety Guidelines. . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Fuse Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
Repairs and Returns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Return for Repair. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Cleaning and Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4
Chapter 11. Electrical Safety Tests
Electrical Safety Tests 220-240 V . . . . . . . . . . . . . . . . . . . . . . . . 11-1
Electrical Safety Tests 110-120 V . . . . . . . . . . . . . . . . . . . . . . . 11-3
Electromagnetic Compliance (EMC) . . . . . . . . . . . . . . . . . . . . . 11-4
Electromagnetic Interference (EMI) . . . . . . . . . . . . . . . . . . . . . 11-8
Biomedical Department Inspection and Power Output Test. . 11-9
Set-up Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9
Test Method. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-10
Power Delivery Verification . . . . . . . . . . . . . . . . . . . . . . 11-10
Chapter 12. Glossary of Terms

Chapter 1
ClosureRFG Radiofrequency Generator 1-1
Overview & General Features
Overview
Caution
U.S. federal law restricts the ClosureRFG generator to sale by or on the order of a physician.
Important
Prior to using the Covidien ClosureRFG radiofrequency generator, read this manual and review the
warnings and cautions in it for important safety information.
The ClosureRFG generator is a product of Covidien. It is designed to provide controlled
delivery of radiofrequency (RF) energy to RF catheters marketed by Covidien.
The ClosureRFG generator is for use with Covidien ClosureFast™ endovenous
radiofrequency catheters and Covidien ClosureRFS™ endovenous radiofrequency stylets.
Throughout this manual, the term “catheter” generally refers to both compatible
ClosureFast catheters and ClosureRFS stylets that can be attached to the ClosureRFG
generator.
Important
Please refer to the instructions for use included with the RF catheters for more information, such
as clinical procedures, cautions, warnings, precautions, potential complications, and
contraindications.
Additional technical details for the ClosureRFG generator are contained in Chapter 10,
Service & Maintenance.
Indications for Use
The ClosureRFG generator is used with radiofrequency catheters intended for vessel and
tissue coagulation.

1-2 ClosureRFG Radiofrequency Generator
Intended Use
Intended Use
The ClosureRFG radiofrequency generator supplies, measures, and displays RF output
power, load impedance (ClosureRFS only), and elapsed time of RF delivery. The ClosureRFG
generator also interfaces with a sensor in the catheter to provide a continuous display of
measured temperature during RF delivery.
Equipment Type
The Class I ClosureRFG generator is designed to work with Type CF, defibrillator-
proof RF catheters. The ClosureRFG generator will withstand an application of an
external defibrillator while the RF catheter is in use.
Supported Accessories and Equipment
The ClosureRFG radiofrequency generator supports the following accessories
• Power cords as required for each geographical region
• The following RF treatment catheters
– Covidien ClosureRFS endovenous radiofrequency stylets with cord length of 8 ft.
– Covidien ClosureFast 7 cm endovenous radiofrequency catheters with cord length
of 8 ft.
– Covidien ClosureFast 3 cm endovenous radiofrequency catheters with cord length
of 8 ft.
Important
The catheters listed above have a voltage rating that is higher than the maximum delivered by the
ClosureRFG generator.
Refer to the RF treatment catheter’s instructions for use for more information.
Caution
Use of unapproved RF delivery catheters or accessories may result in unanticipated performance,
patient/operator safety hazard and increased emissions or decreased immunity.
• A USB drive for data export
• An SD data card to store generator treatment data (used for troubleshooting)
• A calibration test cable for connecting the ClosureRFG generator to a calibrated test
load

ClosureRFG Radiofrequency Generator 1-3
Visual Indicators
Overview & General Features
Visual Indicators
The ClosureRFG radiofrequency generator includes the following visual indicators, not
including the screen (see Front Panel on page 1-4)
•RF Power: Two software-controlled LEDs in the upper corners of the front illuminate
blue when RF power is being delivered (RF power-delivery indicators)
•AC Power Switch: Indicates when the ClosureRFG generator is turned on
Audible Indicators
The ClosureRFG generator has audible indicators designed to alert the operator. Sound
levels of alarm tones can be set to be compatible with the treatment environment.
•Alarm, medium priority: Three rapid, mid-frequency mixed tones
•Informational: Single short, high-frequency pure tone
•RFS Advisory: Two short informational tones
•Power On: Three ascending-scale pure tones
•RF Start: Single, long mid-frequency pure tone
•RF Stop: Single, long mid-frequency pure tone (Same as RF Start)
•RF Ramp up: Single, long, lower-volume mid-frequency pure tone
•RF On: Two short mid-frequency tones, the first at a higher frequency than the second
•Valid key entry or button pushed: Single short, high-frequency pure tone
•Invalid entry: Single short, low-frequency raspy tone
Important
Each button press produces a tone. If a button fails to sound, this indicates a button malfunction,
and the ClosureRFG generator needs to be serviced.

1-4 ClosureRFG Radiofrequency Generator
Front Panel
Front Panel
START
1
22
3
4
The ClosureRFG radiofrequency generator front panel has the following buttons and
indicators:
཰AC Power Switch: Illuminates when AC power is provided to the ClosureRFG
generator.
ཱRF Power -Delivery Indicators: Turns on when the ClosureRFG generator is first
powered on, and when RF power is being delivered.
ིCatheter Connector: Receptacle for the catheter.
ཱིTouch Screen: Controls all functions of the ClosureRFG generator.

ClosureRFG Radiofrequency Generator 1-5
Rear Panel
Overview & General Features
Rear Panel
ClosureRFS
1
23
4
5
6
The ClosureRFG radiofrequency generator rear panel includes these features:
཰Vent Openings: Provide cooling air to the electronics. Do not block these openings.
ཱAC Power Cord Wrap: When the ClosureRFG generator is not in use, unplug the unit
from the AC power source and wrap the cord around this wrap area.
ིTop Handle: Best way to lift and carry the ClosureRFG generator.
ཱིFuse Holder: Includes two 5A/250V, 5x20 mm fuses.
ུAC Power Inlet: Connects the AC power cord to the ClosureRFG generator.
ཱུEquipotential Grounding Lug: Provides a point for an auxiliary earth ground or ESD
wrist-strap connection.

1-6 ClosureRFG Radiofrequency Generator
Side Panels
Side Panels
Right Left
3
4
5
6
1
2
཰Handles: The ClosureRFG radiofrequency generator has a handle on each side. Use
these handles (or the top handle) while lifting or carrying the unit.
Caution
Be careful not to exert force to an attached USB device when picking up the ClosureRFG generator
by the side handles.
ཱVent Openings: Cooling air for the electronics.
ིUSB Slot: Accepts a USB 2.0 device to export/store procedure data.
ཱིSD Slot: Accepts an SD card.
ུEthernet Service Port: Used for calibration and repairs. For qualified service
personnel only.
ཱུRubber Port Cover: Provides a seal to limit liquid splashes getting into ports.
General Safety Guidelines
The safe and effective use of RF energy is highly dependent on factors under the operator’s
control. There is no substitute for properly trained staff. It is important to read,
understand, and follow these directions.
The ClosureRFG radiofrequency generator is classified as an electrosurgical product. It
must be operated in accordance with the guidelines in this section to ensure a safe
environment and safe delivery of RF energy to the catheter. Failure to adhere to these
guidelines might result in damage to the ClosureRFG generator and/or injury to the patient
or user.

ClosureRFG Radiofrequency Generator 1-7
General Safety Guidelines
Overview & General Features
The ClosureRFG generator is for prescription use only. It is intended for use only by trained
clinicians (operators) in a hospital or clinical environment.
The ClosureRFG generator contains no operator-serviceable parts. It must be returned to
the factory for service.
Warnings and Safety Notices: Setting Up the ClosureRFG
Generator
Warning
Electric Shock Hazard
• Do not use 3-to-2-prong grounding adapters.
• Always use an AC power center-tap configuration for 240 V single phase circuit.
• The ClosureRFG generator must only be connected to a supply mains with protective earth.
• Do not remove the cover of the ClosureRFG generator.
Fire and Explosion Hazard
• Do not operate the ClosureRFG generator in the presence of a flammable anesthetic mixture
with air, oxygen, or nitrous oxide.
• Do not operate the ClosureRFG generator in contact with flammable materials, chemicals, or
substances.
• Do not place active instruments near or in contact with flammable materials (such as gauze or
surgical drapes). Electrosurgical instruments that are activated or hot from use can cause a fire.
When not in use, place electrosurgical instruments in a safety holster or safely away from
patients, the surgical team, and flammable materials.
• Prevent pooling of flammable fluids and the accumulation of flammable or oxidizing gases or
vapors under surgical drapes or near the surgical site. These fluids should be removed before
use of electrosurgery.
• Use of electrosurgery may create arcing or embers that pose a fire hazard, especially in oxygen-
enriched environments. Keep the device clean and free of all debris.
The ClosureRFG generator’s performance may be affected by the use of portable and mobile
communications equipment operating in near proximity. Refer to Electromagnetic Interference
(EMI) on page 11-8 for more information.
Caution
Do not use the ClosureRFG radiofrequency generator if the AC power cord is damaged. Inspect
the cord regularly for wear or damage. Damaged cords could result in patient or user injury.
The ClosureRFG generator produces high voltages on the catheter. Inspect all cables regularly for
wear or damage. Discontinue use and discard the cable if damaged. Damaged cables could result
in patient or user injury from electric shock.

1-8 ClosureRFG Radiofrequency Generator
General Safety Guidelines
Warnings and Safety Notices: During RF Treatment
Protect the ClosureRFG generator from exposure to extreme moisture to avoid electric shock and
damage to the equipment.
To avoid unintentional burns, position the catheter away from the patient when the catheter is
connected to the ClosureRFG generator but is not in use.
Important
The ClosureRFG generator is for use without a Neutral Electrode connection.
To allow generator heat to escape, verify that the ClosureRFG generator’s vent openings, located
on the sides and back of the unit, are not obstructed.
Avoid covering the speaker openings, to allow the operator to detect auditory tones.
Ensure the AC power switch on the front is accessible so that the ClosureRFG generator can be
turned on and off.
Always refer to Covidien authorized personnel for service.
The ClosureRFG generator must be connected to an appropriate power source. Mains power
quality should be that of a typical commercial or hospital environment.
If continued operation is required during power interruptions, the ClosureRFG generator must be
powered from an uninterruptible power supply.
Warning
Use the ClosureRFG generator only with Covidien ClosureFast endovenous radiofrequency
catheters or ClosureRFS endovenous radiofrequency stylets. DO NOT use catheters from any other
manufacturer with the ClosureRFG generator as this may increase emissions, decrease immunity
to interference, or injure the patient or user.
Be alert for potential interference with pacemakers and other active implants. In case of doubt,
approved qualified advice should be obtained.
When the ClosureRFG generator is activated, the conducted and radiated electrical fields might
interfere with other medical electrical equipment. Refer to Electromagnetic Interference (EMI) on
page 11-8 for more information.
To prevent patient injury, always check if the measured temperature, impedance (RFS stylets), and
RF power shown in the data display area are within safe operating ranges.
To avoid electric shock, while using the ClosureRFG radiofrequency generator, do not allow the
patient to come into direct contact with grounded metal objects.
To avoid electric shock, avoid contact of cords and cables with the patient, leads, or other
equipment.
Caution

ClosureRFG Radiofrequency Generator 1-9
General Safety Guidelines
Overview & General Features
Unpacking and Inspection of Components
Upon receiving the ClosureRFG radiofrequency generator, carefully unpack and inspect
the items listed below:
• ClosureRFG generator without physical damage anywhere on the outside housing and
screen
• Approved hospital-grade AC power cord, without cracks, frays, or any visible cord or
plug damage
• CD-ROM, containing this operation manual
All damaged items must be repacked and returned to the Covidien Customer Service
Department with prior approval. See Repairs and Returns on page 10-3 for contact
information.
Do not wrap the catheter cable around metal objects, as this might induce hazardous currents into
the patient.
The ClosureRFG generator requires special precautions regarding Electromagnetic Compliance and
needs to be installed and put into service according to Electromagnetic Compliance (EMC) on page
11-4.
ClosureRFG generator failure could result in an unintended increase in RF output.
Use of electrosurgery could result in neuromuscular stimulation resulting in patient injury.
Electrodes and probes for monitoring, stimulating, and imaging devices can provide paths for high-
frequency current even if battery powered, insulated, or isolated at line frequency. The risk of burns
can be reduced, but not eliminated, by placing these electrodes or probes as far away from the
ablation site as possible. Protective impedance (Ω) incorporated into the monitoring leads may
further reduce the risk of burns and permit continuous monitoring during RF energy delivery, Do
not use needles as monitoring electrodes during procedures.
Caution
To prevent injury to the patient, do not start RF power until the catheter is properly positioned in
the patient.
RF power activation tones and lights are important safety features. Do not obstruct indicator lights
or the screen. Do not disable auditory tones.
The ClosureRFG generator should not be used adjacent to or stacked with other equipment. If
adjacent use is necessary, the ClosureRFG generator should be observed to verify normal operation
in the configuration in which it will be used.
Do not plug a wet catheter connector into a receptacle as it may damage the ClosureRFG
generator.
Warning