Cooper Surgical LEEP PRECISION LP-20-120 User manual

Operating Manual (English)
Bedienungsanleitung (Deutsch / German)
Manual de funcionamiento (Español / Spanish)
Manuel d’utilisation (Français / French)
Manuale di funzionamento (Italiano / Italian)
Manual de funcionamento (Português / Portuguese)
操作手册 (简体中文 / Mandarin Chinese)
LEEP PRECISIONTM Generator
120 VAC
230 VAC
LP-20-120
LP-20-220

English.......................................................Page 3
Deutsch / German ............................................Seite 31
Español / Spanish . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Página 59
Français / French .............................................Page 87
Italiano / Italian ............................................ Pagina 115
Português / Portuguese ..................................... Página 143
简体中文 / Mandarin Chinese ....................................页码 171
95 Corporate Drive
Trumbull, CT 06611 USA
Phone: [phone]
Fax: [phone]
www.coopersurgical.com
International
Phone: [phone]
Fax: [phone]
EMERGO EUROPE
Prinsessegracht 20
2514 AP The Hague
The Netherlands
CooperSurgical, Inc.
95 Corporate Drive
Trumbull, CT 06611 USA

3
TABLE OF CONTENTS
Section Content Page
1. Introduction ...................................................................................................................................... 4
2. Special Features ............................................................................................................................. 4
3. Front and Rear Panels of the LEEP PRECISION Generator .......................................................... 5
3.1 Front Panel of the LEEP PRECISION Generator ........................................................................... 5
3.2 Rear Panel of the LEEP PRECISION Generator ............................................................................ 6
4. Assembly ......................................................................................................................................... 7
4.1 Installing the Foot Pedal Switch on the LEEP PRECISION Generator ........................................... 7
4.2 Installing the Active and Dispersive Electrodes .............................................................................. 7
5. Professional Use Guide ................................................................................................................ 10
5.1 Indications for OB/GYN Applications ............................................................................................ 10
5.2 Contraindications for OB/GYN Applications .................................................................................. 11
5.3 Electrosurgical Procedures ........................................................................................................... 11
6. Electrosurgical Precautions ........................................................................................................... 14
7. LEEP PRECISION Smoke Evacuator Operation .......................................................................... 14
7.1 Automatic Mode Option ................................................................................................................. 14
7.2 Purge Button ................................................................................................................................. 14
8. Setup and Operation of the LEEP PRECISION Generator ........................................................... 14
8.1 Practice ......................................................................................................................................... 14
8.2 The Power Setting ......................................................................................................................... 16
8.3 Cutting Techniques ....................................................................................................................... 17
8.4 Criteria of a Good Cutting Technique ............................................................................................ 17
8.5 Coagulating ................................................................................................................................... 17
8.6 Coagulating Technique ................................................................................................................. 18
8.7 Technique Guidance ..................................................................................................................... 18
9. LEEP PRECISION Patient Return Electrode ................................................................................. 19
10. Maintenance .................................................................................................................................. 19
11. Accessories ................................................................................................................................... 19
11.1 Disposable Hand Switch Pencils ................................................................................................... 20
12. Liability Statement ......................................................................................................................... 20
13. Warranty ........................................................................................................................................ 20
14. Service/Repair ............................................................................................................................... 21
15. Troubleshooting ............................................................................................................................ 22
16. Specifications ................................................................................................................................. 23
16.1 Power Output Characteristics . ...................................................................................................... 24
16.2 Power Output at Various Load Resistance ................................................................................... 25
17. EMC Compliance Information for the LEEP PRECISION Generator ............................................ 26
18. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ...................................... 27
19. Explanation of Symbols ................................................................................................................. 30

4
Section 1 Introduction
The LEEP PRECISIONTM Generator was designed for office use.
Read this manual carefully and follow the recommended program of practice. The manual covers applications
and techniques for use as well as setup and maintenance of your LEEP PRECISION Generator.
For any questions or problems, call the local CooperSurgical representative or write to:
CooperSurgical, Inc.
ATTN: Customer Service Department
95 Corporate Drive
Trumbull, CT 06611 USA
Phone: [phone]
Fax: [phone]
www.coopersurgical.com
International
Phone: [phone]
Fax: [phone]
Section 2 Special Features
• Electronic power level control
• Digitally derived waveforms
• Low inherent leakage rate
• Patient return monitor disables power automatically if Patient Return Electrode is loose
• Regulated system performance traceable to NIST Standards
• Automatic smoke evacuator signal function sends signal to detector for automatic smoke evacuator actuation
when generator is activated
• Self-monitors all detectors

(Colored, numbered boxes are
also located later in this manual)
Section 3 Front and Rear Panels of the LEEP PRECISION Generator
3.1 Front Panel of the LEEP PRECISION Generator
Controls
Operator Pushbuttons
a) PURGE Turns LEEP PRECISION Smoke
Evacuator on for 5 sec.
b) RAISE Increases Power Setting
c) LOWER Decreases Power Setting
d) WAIT Stand-by Mode
e) BLEND Cutting Mode Selection
f) CUT Cutting Mode Selection
g) COAG Cutting Mode Selection
Foot Switch Socket
A/C Power (rear panel)
Active Electrode Socket
Dispersive Electrode Socket
Remote Pencil Buttons (not shown)
Indicator Lights
WAIT = Red
CUT = Yellow
BLEND = Yellow
COAG = Blue
Power Indications
Digital LED Display
Acoustical
Piezo Annunciator
Pilot Lights
PATIENT PAD LOOSE
R/F LEAKAGE ERROR
SYSTEM READY
R/F ON
5
7
8
1a - 1g
1
3
4
25
1
5
6
7
8
2
3
4
(Colored, numbered boxes are
also located later in this manual)

6
6
10
9
11
3.2 Rear Panel of the LEEP PRECISION Generator
Rear Panel - LEEP PRECISION Generator
ON/OFF Switch
A/C Power Cord Connector
Fuse Holder
Figure 2 (Rear Panel)
“Communication” Infrared LED between the LEEP PRECISION
Generator and LEEP PRECISION Integration Unit (ON/OFF)
10
9
611
Symbols on the LEEP PRECISION Generator
Classification I Type BF protected against defibrillator effects
Floating output circuit (Applied Part)
Cautions – consult this manual for safety precautions
Dangerous voltage
Equipotentiality Symbol (Ground)
IMPORTANT
The LEEP PRECISION Generator user must be thoroughly trained in the techniques of Loop Electrosurgical
Excision Procedures (LEEP). This system has been designed for use with only the CooperSurgical LEEP
PRECISION Electrosurgical Accessories. DO NOT use this equipment for any purpose other than that for
which it has been designed. See Warnings and Caution statements throughout this manual.

7
Section 4 Assembly
4.1 Installing the Foot Pedal Switch on the LEEP PRECISION Generator
Connect the Foot Pedal Switch to the socket shown in Figure 1 if foot control is desired.
4.2 Installing the Active and Dispersive Electrodes
4.2.1 Placement of the Active Electrode
Connect the Active Electrode to socket shown in Figure 1.
4.2.1.1 For Foot Switch-Operated Electrode Use (with Adapter)
A 4 mm Reusable Electrosurgical Adapter is supplied with the LEEP PRECISION
Generator (found in the LEEP PRECISION Generator box). Use the Foot
Switch-Operated Electrode with the Adapter. The Electrode is plugged into the
Adapter, which is then plugged into socket shown in Figure 1.
4.2.2 Placement of the Dispersive Electrode or Patient Return Electrode
When using an electrosurgical system, it is very important that all of the current delivered to the patient
returns correctly to the LEEP PRECISION Generator via the Patient Return Electrode only.
• Connect the Dispersive Electrode to socket . Refer to Figure 1.
• The patient must be positioned correctly on the operating table. The patient and operator must not
come in contact with any metal conductive surfaces.
• The Patient Return Electrode must securely contact a vascular area close to the operating site. For a
gynecology procedure, the preferred site is the patient’s thigh. The contact area must be clean, free of
body lotions, shaved, and massaged for good circulation. The Patient Return Electrode contact area
must be maximized and frequently checked for uniform contact during the procedure, especially
if the patient has moved or if liquids have come in contact with the Patient Return Electrode.
The Patient Return Electrode must NEVER be placed so as to allow the patient’s heart to be in the
pathway from the active electrode.
• Power delivery to the operative site may be decreased appreciably if alternate pathways exist; for
example, through the metal operating table, crossed Active Electrode/Patient Return Electrode
Cables, etc.
4.2.2.1 Patient Return Electrode Use
There are two varieties of Patient Return Electrodes that can be used with the LEEP PRECISION Generator:
( ): If the Patient Return Electrode with the built-in cable is purchased, the Patient Return
Electrode Cable is plugged directly into socket .
( ): If the Patient Return Electrode and a separate Reusable Cable are purchased, the
Patient Return Electrode is connected to the Reusable Cable, which is then plugged
into socket .
5
7
7
8
Patient Return Electrode
With Connector
Patient Return Electrode
Without Connector
The Cable is built in Reusable Cable is purchased
separately from CooperSurgical
1 2
1
2
8
8

IMPROPER
LEEP PRECISION Generator Burn occurs at small
grounded contact
Surgeon touches electrode
to grounded object
Isolated
ESU
RF current flows from ground
through EKG pad, through
patient to Patient Return Electrode
LEEP PRECISION
Generator RF current flows from
electrode
Burn occurs at small
grounded contact
Isolated or
grounded ESU
Patient Return Electrode
touches grounded table RF current returns to Patient Return
Electrode via ground path
RF EKG
IMPROPER
LEEP PRECISION
Generator RF current through
patient to Patient Return
Electrode
Active Electrode
Grounded
Metal Case
Patient
Two-conductor patient
electrode continuity
monitor
Patient Return Electrode
(Thigh)
Patient may be grounded
PROPER
EKG
RF
Figure 3
Figure 4
Figure 5
Figures 3 through 5 show the proper and improper ways of hooking up and using the various Active
Electrodes and Patient Return Electrodes on the patient.
8

9
WARNINGS
• THIS DEVICE IS A BF-TYPE DEVICE. BF-TYPE EQUIPMENT IS B-TYPE DEVICE WITH AN F-TYPE
APPLIED PART.
A B-Type device is piece of equipment providing a particular degree of protection against electric shock,
particularly regarding:
• Allowable leakage current
• Reliability of the protective earth connection.
• An F-Type isolated applied part. The applied part is isolated from all other parts of the equipment to
such a degree that the patient leakage current allowable in single fault condition is not exceeded
when a voltage equal to 1.1 times the highest rated mains voltage is applied between the applied
part and earth.
• AVOIDING PATIENT BURNS
1. Do not activate the electrode until all components are in place.
2. Be certain to have an unobstructed path and view.
3. Use only non-conductive ancillary instruments.
4. Remove patient jewelry, metal drape clips, (etc.) and needles.
5. A Patient Return Electrode must be used. The entire area of the Patient Return Electrode should
be reliability attached to the patient’s body and as close to the operating field as possible.
6. Place Foot Switch in safe position, out of traffic.
7. Turn console OFF or place in WAIT state when not in use.
8. Do not use unit on small appendages due to current density. Bipolar techniques may be desirable
for use on small appendages.
• THERMAL INJURY AND DEFECTS OF TISSUE TREATED WITH LOOP ELECTRODES
Possible injury to cervical tissue may include:
1. Thermal coagulation injury of the cervix, up to one-third the thickness of the normal cervical
epithelium,
2. Fragmentation of squamous cervical epithelium attributable to long exposure periods along the
excision site that allows heat to dissipate laterally, and
3. Partial coagulation of the endocervical epithelium because of lateral heat radiation. Loop
Electrosurgical Excision Procedures may also produce thermal defects at the periphery of the
excised tissue and may make histopathologic interpretation difficult or impossible, preventing
accurate diagnosis and evaluation of the need for further treatment.
• FLAMMABLE GASES/SOLUTIONS
1. When using a flammable preparatory solution, such as alcohol, be certain that the solution has
completely evaporated before using electrosurgery.
2. Electrosurgery should not be used in the presence of flammable or explosive gases.
3. It is recommended that only non-flammable agents be used for cleaning and disinfection.
SMOKE FROM PROCEDURES CONTAINS LIVE CELLS THAT MAY PRESENT BIOHAZARDS
(HIV, ETC.); USE A SMOKE EVACUATION DEVICE.
CONSULT THE PACEMAKER MANUFACTURER’S LITERATURE AND THE PATIENT’S PHYSICIAN
BEFORE USING THIS INSTRUMENT ON A PATIENT USING A PACEMAKER.

10
CAUTIONS
• U.S. Federal law restricts this device to sale by or on the order of a physician. This device SHOULD
NOT be used without proper training and preceptorship.
• For monopolar systems it is recommended to keep the voltage/power as low as possible to achieve the
desired end effect (due to the potential for capacitive coupling and inadvertent burning at high voltages).
• Adequate anesthesia is indicated for all electrosurgical procedures.
• Inspect loop and ball for adequate insulation.
• Avoid using an electric extension cord (danger of separation).
• Use a smoke evacuator with this device.
• This device generates high frequency energy that could, under some circumstances, cause interference
to other equipment.
• For situations where the MAXIMUM OUTPUT VOLTAGE is less than or equal to 1600V, ASSOCIATED
EQUIPMENT and ACTIVE ACCESSORIES should be selected that have a RATED ACCESSORY
VOLTAGE equal to or greater than the MAXIMUM OUTPUT VOLTAGE.
- ASSOCIATED EQUIPMENT and ACTIVE accessories should be selected with RATED
  ACCESSORYVOLTAGE≥MAXIMUMOUTPUTVOLTAGEwhenthesmallerofvariabley
  (seebelow)orthenumber6is≤CRESTFACTORforthatHFSURGICALMODE.
- When MAXIMUM OUTPUT VOLTAGE (Umax) is > 1600 V, and the CREST FACTOR is < the
variable y calculated below, indicating that any ASSOCIATED EQUIPMENT and ACTIVE
ACCESSORIES used in such mode or setting must be rated to withstand the combination of actual
voltage andm CREST FACTOR.
• No modification of this equipment is allowed.
• No customer-serviceable parts.
• Only replacment of power cords or fuses can be done by the user. Only replace with these items with
the exact replacement part(s) available from CooperSurgical.
Warning: To avoid risk of Electrical Shock, this equipment must only be connected to a supply mains with
protected earth.
y= Umax – 400 [Volts]
600 [Volts]
Section 5 Professional Use Guide
5.1 Indications for OB/GYN Applications
• Cervical conization
• External anogenital lesion
• Large vaginal intraepithelial neoplastic (VAIN) lesions
• Large Loop Excision of the Transformation Zone (LLETZ) in the diagnosis and treatment of some
cervical intraepithelial neoplasias (CIN) and dysplasias