Olympus ESG-400 User manual

USA: CAUTION: Federal Law restricts this device to use by, or on the order of,
a physician.
INSTRUCTIONS
ELECTROSURGICAL GENERATOR
ESG-400

Contents i
W7.091.601 ELECTROSURGICAL GENERATOR ESG-400
Contents
Labels and Symbols.................................................................................................. 4
Important Information - Please Read Before Use ................................................... 5
Intended use .................................................................................................................................... 5
Application of high frequency treatment .......................................................................................... 5
Instruction manual ........................................................................................................................... 5
User qualifications ........................................................................................................................... 6
Electrosurgical generator compatibility............................................................................................ 6
Repair and modification ................................................................................................................... 6
Signal words .................................................................................................................................... 7
Dangers, warnings and cautions ..................................................................................................... 7
Legal information ............................................................................................................................ 16
Chapter 1 Checking the Package Contents......................................................... 17
Chapter 2 Nomenclature and Functions .............................................................. 18
2.1 Symbols and descriptions...................................................................................................... 18
2.2 Front panel ............................................................................................................................ 21
2.3 Rear panel ............................................................................................................................. 23
2.4 Bottom panel ....................................................................................................................... 24
2.5 All screen ............................................................................................................................... 25
2.6 Set screen.............................................................................................................................. 26
2.7 Mode screen .......................................................................................................................... 27
2.8 Footswitch with two pedals.................................................................................................... 27
2.9 Footswitch with one pedal (optional) ..................................................................................... 28
2.10 Neutral electrode cable “P-cord” (optional) ........................................................................... 28
2.11 Communication cable 0.25 m (MAJ-1871, optional, this cable is required for the
connection with the compatible ultrasonic generator) ........................................................... 29
2.12 Communication cable 10 m (MAJ-1872, optional, this cable is required for the
connection with the compatible high flow insufflation unit (UHI-2/3)).................................... 30
2.13 Adapter for UHI-2/3 (MAJ-1873, optional, this adapter is required for the connection
with the compatible high flow insufflation unit (UHI-2/3)) ...................................................... 31
Chapter 3 Installation and Connections .............................................................. 32
3.1 Flow chart for installation work ............................................................................................. 33
3.2 Installation of electrosurgical generator................................................................................. 34
3.3 Connection of peripheral equipment ..................................................................................... 35
3.4 Connection to an AC mains power supply ............................................................................ 36
3.5 Automatic mist & smoke evacuation system/function (when using the compatible
high flow insufflation unit) ...................................................................................................... 37
3.6 Connection of footswitch ....................................................................................................... 42
3.7 Connection of neutral electrode (for monopolar treatment only)........................................... 43
3.8 Connection of HF instruments ............................................................................................... 49

ii Contents
ELECTROSURGICAL GENERATOR ESG-400 W7.091.601
Chapter 4 Inspection............................................................................................. 52
4.1 Flow chart for inspection work ............................................................................................... 53
4.2 Inspection of power................................................................................................................ 54
4.3 Inspection of connection between peripheral equipment and the electrosurgical generator 56
4.4 Inspection of touch-screen and push buttons........................................................................ 57
4.5 Inspection of footswitch connection....................................................................................... 60
4.6 Inspection of alarm system.................................................................................................... 61
4.7 Procedure after inspection..................................................................................................... 61
Chapter 5 Operation.............................................................................................. 62
5.1 Flow chart for operation work ............................................................................................... 63
5.2 Turn on the electrosurgical generator.................................................................................... 64
5.3 Automatic mist & smoke evacuation system/function (when using the compatible
high flow insufflation unit) ...................................................................................................... 65
5.4 Output setting ........................................................................................................................ 67
HF instrument recognition...................................................................................................... 69
Bipolar cut / coagulation mode – SalineCut / SalineCoag..................................................... 72
Bipolar coagulation mode – RFCoag..................................................................................... 72
Overview of all modes ........................................................................................................... 75
5.5 Output of energy .................................................................................................................... 79
5.6 Procedure after use ............................................................................................................... 84
Chapter 6 Push Button Functions ....................................................................... 85
6.1 Function list............................................................................................................................ 85
6.2 Push button hierarchy list ...................................................................................................... 86
6.3 Select procedure.................................................................................................................... 87
6.4 Assign footswitch and autostart function ............................................................................... 88
6.5 Menu ...................................................................................................................................... 90
Save procedure: saving / overwriting of output settings........................................................ 91
Delete procedure: Deleting a procedure................................................................................ 96
Languages ............................................................................................................................. 97
Touch tone ............................................................................................................................. 100
Autostart setup....................................................................................................................... 101
Software version .................................................................................................................... 102
Safety test .............................................................................................................................. 103
Service ................................................................................................................................... 105
Output volume control............................................................................................................ 105
Brightness control .................................................................................................................. 107
Chapter 7 Care, Storage and Disposal ................................................................ 108
7.1 Care ....................................................................................................................................... 108
7.2 Storage .................................................................................................................................. 109
7.3 Disposal ................................................................................................................................. 110

Contents iii
W7.091.601 ELECTROSURGICAL GENERATOR ESG-400
Chapter 8 Troubleshooting ................................................................................... 111
8.1 Neutral electrode operation ................................................................................................... 112
8.2 Error screen, codes and measures ....................................................................................... 113
8.3 Periodic safety check............................................................................................................. 125
8.4 Returning the electrosurgical generator for repair................................................................. 125
Appendix .................................................................................................................... 126
System chart.................................................................................................................................... 126
Mode characteristics........................................................................................................................ 127
Output characteristics ...................................................................................................................... 129
Transportation, storage and operating environment........................................................................ 146
Specifications................................................................................................................................... 147
Electromagnetic compatibility (EMC) information............................................................................ 152
Alarm information............................................................................................................................. 156
Tone information.............................................................................................................................. 157
List of abbreviations
AC Alternating Current
EMC Electromagnetic Compatibility
ESG Electrosurgical Generator
FSM Fast Spark Monitor
HF High Frequency
HPCS High Power Cut Support
ICD Implanted Cardioverter Defibrillator
IED Implanted Electronic Device
RCAP Resistance Controlled Automatic Power

4 Important Information – Please Read Before Use
ELECTROSURGICAL GENERATOR ESG-400 W7.091.601
Caution, read
instructions
Refer to
instructions
Labels and Symbols
Safety-related labels and symbols are attached on the locations shown below. If
labels or symbols are missing or illegible, contact Olympus. Function-related
symbols are described in chapter 2.1, “Symbols and Descriptions”.
Date of
manufacture
CE marking
Non
-
ionizing electromagnetic
radiation
Output insulated from earth
(connection for neutral electrode)
Defibrillation proof type CF
applied part (cardiac application)
Waste electrical and electronic
equipment
cTUVus marking
Manufacturer
Potential equalization terminal
Fuse rating
Type plate

Important Information – Please Read Before Use 5
W7.091.601 ELECTROSURGICAL GENERATOR ESG-400
Important Information – Please Read
Before Use
Intended use
The ESG-400 is an electrosurgical generator intended for tissue cutting and
coagulation in open, laparoscopic and endoscopic surgery in conjunction with
electrosurgical accessories and ancillary equipment.
Contraindications:
Electrosurgical interventions are contraindicated if, in the judgment of the
physician, tissue coagulation and cutting could have a negative effect on the
state of the patient. Electrosurgical tissue coagulation and cutting may be
contraindicated for patients with cardiac pacemakers, a weakened immune
system or blood coagulation disorders.
Application of high frequency treatment
If there is an official standard on the applicability of high frequency treatment as
defined by a national or local medical administration, or other institution, such
as an academic society, follow that standard when performing the procedure.
Before performing any high frequency treatment, study the properties, purposes,
effects and possible risks thoroughly (nature, extent, probability and imminence)
associated with the planned treatment and any alternative therapeutic method
that can be performed. Carry out high frequency treatment only when its
benefits outweigh its risks. Fully explain to the patient the possible benefits and
risks of high frequency treatment as well as those of any therapeutic method(s)
that can be performed instead of electrosurgery, and perform high frequency
treatment only after patient consent is granted. During high frequency treatment,
continue to evaluate the potential benefits and risks, and stop the treatment if
the risks become greater than the possible benefits to the patient.
Instruction manual
This instruction manual contains essential information on using this
electrosurgical generator safely and effectively. Before use, thoroughly review
this instruction manual and the instruction manual of all equipment which will be
used during the procedure. Use the equipment as instructed. Keep this and all
related instruction manuals in a safe, accessible location. If you have any
questions or comments about any information in this instruction manual, please
contact Olympus.

6 Important Information – Please Read Before Use
ELECTROSURGICAL GENERATOR ESG-400 W7.091.601
User qualifications
If there is an official standard that defines the qualifications required for medical
personnel using electrosurgical generators as defined by a national or local
medical administration or other institution, such as an academic society, follow
this standard. If there is no such standard, the user must be a physician or
medical personnel under supervision of a physician and must have received
appropriate training in using this electrosurgical generator. This instruction
manual, therefore, does not explain or discuss endoscopic or electrosurgical
procedures.
In addition, the user must undergo an instruction / training for the use of this
electrosurgical generator. The instruction / training will be provided by
authorized representatives of Olympus during installation and commissioning.
Federal Law of the USA restricts this device to use by, or on the order of,
a physician.
Electrosurgical generator compatibility
Refer to the “System chart” and “Specifications” in the Appendix to confirm that
this electrosurgical generator is compatible with the ancillary equipment being
used. Using incompatible equipment can result in patient injury and / or
equipment damage.
For the electromagnetic compatibility (EMC), this electrosurgical generator
complies with edition 3 of the EMC standard for medical electrical equipment
(IEC 60601-1-2: 2007).
Repair and modification
This electrosurgical generator does not contain any user-serviceable parts. Do
not disassemble, modify, or attempt to repair it; patient or user injury and / or
equipment damage may result. Repairs must only be carried out by Olympus or
a firm authorized by Olympus. Some problems that appear to be malfunctions
may be corrected by referring to chapter 8, “Troubleshooting”. If the problem
cannot be resolved using the information in chapter 8, contact Olympus.

Important Information – Please Read Before Use 7
W7.091.601 ELECTROSURGICAL GENERATOR ESG-400
Signal words
The following signal words are used throughout this instruction manual:
DANGER
Indicates an imminently hazardous situation
which, if not avoided, will result in death or serious
injury.
WARNING
Indicates a potentially hazardous situation which,
if not avoided, could result in death or serious
injury.
CAUTION
Indicates a potentially hazardous situation which,
if not avoided, may result in minor or moderate
injury. It may also be used to alert against unsafe
practices or potential equipment damage.
NOTE
Indicates additional helpful information.
Dangers, warnings and cautions
High frequency leakage current or spark discharge may cause user and / or
patient burns. Always prepare for an emergency operation in case of
unintentional patient burn, bleeding and perforation.
Follow the dangers, warnings and cautions given below when handling this
electrosurgical generator. This information is to be supplemented by the
dangers, warnings and cautions given in each chapter.

8 Important Information – Please Read Before Use
ELECTROSURGICAL GENERATOR ESG-400 W7.091.601
User-related error prevention
WARNING Improper use
The safety and effectiveness of electrosurgical
interventions depend not only on the design of
the equipment used, but also to a major extent
on factors which are under the control of the
user. It is therefore extremely important to read,
understand and follow the instructions supplied
with the electrosurgical generator and the
accessories in order to ensure safety and
effectiveness.
Always use the electrosurgical generator as
outlined in this instruction manual. Improper use
will not only impede functions and prevent
optimum performance, but may cause
equipment damage and / or complications.
Before each use, always inspect the equipment
as outlined in this instruction manual.
CAUTION Annual safety checks
The electrosurgical generator and the footswitch
must undergo a safety check in yearly intervals in
accordance with the national statutory regulations
(refer to chapter 8.3 “Periodic safety check”).
Environmental conditions
CAUTION Interference with other equipment
Be sure that this electrosurgical generator is not
used adjacent to or stacked with other
equipment (other than the components of this
electrosurgical generator or system) to avoid
electromagnetic interference.
Before use, thoroughly confirm the compatibility
of all equipment.
To ensure electrical safety, the electrosurgical
generator should not be used in conjunction
with:
−Electrical equipment whose safety against
leakage current is not guaranteed.
−Electrosurgical equipment whose safety in
combined use is not guaranteed.
The electrosurgical generator complies with the
electromagnetic compatibility (EMC) standard.
Nevertheless, when the electrosurgical
generator is active it may disturb neighboring