Olympus ESG-410 User manual
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
INSTRUCTIONS FOR USE
ELECTROSURGICAL GENERATOR
ESG-410
WA91307W
ESG-410 UNIVERSAL 1 BIPOLAR
MONOPOLAR 1
MONOPOLAR 2
NEUTRAL
UNIVERSAL 2
SURGISABER
Contents
1 Using this document..........................................................................................................7
1.1 User instructions ............................................................................................................7
1.2 Conventions throughout this document..........................................................................7
1.3 Safety-related information in this document...................................................................7
2 Safety information..............................................................................................................9
2.1 Intended purpose ...........................................................................................................9
2.2 Contact.........................................................................................................................10
2.3 General safety notes ....................................................................................................10
3 Product description .........................................................................................................19
3.1 Scope of delivery .........................................................................................................19
3.2 Product functions .........................................................................................................19
3.3 Operating elements on the hardware...........................................................................21
3.4 Operating elements on the touchscreen ......................................................................22
3.5 Popups and messages.................................................................................................25
3.6 Symbols and icons.......................................................................................................26
3.7 Warranty.......................................................................................................................29
4 Installation ........................................................................................................................30
4.1 Safety notes for installation ..........................................................................................30
4.2 General inspection .......................................................................................................30
4.3 Placement of the electrosurgical generator..................................................................30
4.4 Connection of electrosurgical generator to the mains electricity..................................31
4.5 Connection of foot switches .........................................................................................32
4.6 Connection of peripheral equipment ............................................................................32
4.7 Connection for automatic smoke evacuation ...............................................................32
5 System settings................................................................................................................36
5.1 Operation of the touchscreen.......................................................................................36
5.2 Settings – Setup...........................................................................................................36
5.3 Volume control of activation tones ...............................................................................37
5.4 Brightness control ........................................................................................................38
5.5 Alarm tones..................................................................................................................38
5.6 Touch tone ...................................................................................................................39
5.7 Languages ...................................................................................................................39
5.8 Date, time and format...................................................................................................40
5.9 Monopolar modes ........................................................................................................40
5.10 Startup settings ..........................................................................................................41
5.11 Procedures.................................................................................................................41
5.12 Assigning foot switches..............................................................................................42
6 Safe use of neutral electrodes........................................................................................44
6.1 Split type and non-split type neutral electrodes and CQM...........................................44
6.2 Restriction to only split type neutral electrodes............................................................45
6.3 Safety feature for baby neutral electrodes ...................................................................46
6.4 Conditions of the CQM indicator ..................................................................................48
6.5 Selecting an appropriate neutral electrode ..................................................................49
6.6 Connection of a neutral electrode to the electrosurgical generator..............................49
6.7 CQM indicator verication............................................................................................51
7 Before use.........................................................................................................................52
7.1 Safety notes for before use ..........................................................................................52
7.2 Inspection before use...................................................................................................53
7.3 Overview of modes ......................................................................................................55
7.4 Description of modes ...................................................................................................55
7.5 Tissue effects depending on the power level and effect level......................................62
8 Use.....................................................................................................................................64
8.1 Safety notes for use .....................................................................................................64
8.2 Description of the output sockets.................................................................................65
8.3 Connection of instruments ...........................................................................................67
8.4 Selection of appropriate output settings.......................................................................67
8.5 Automatic instrument recognition.................................................................................69
8.6 Selecting a user-dened procedure .............................................................................71
8.7 Activation of HF output.................................................................................................71
8.8 Activating......................................................................................................................73
8.9 Alarm system ...............................................................................................................77
8.10 Troubleshooting..........................................................................................................78
9 After use ...........................................................................................................................83
10 Reprocessing of the ESG‑410.......................................................................................84
10.1 General information for reprocessing.........................................................................84
10.2 Cleaning.....................................................................................................................84
10.3 Disinfection.................................................................................................................84
10.4 Reprocessing of other HF equipment ........................................................................85
11 Maintenance ...................................................................................................................86
11.1 Regular safety checks................................................................................................86
11.2 Maintenance settings .................................................................................................87
12 Repair and shipment......................................................................................................92
12.1 Repair ........................................................................................................................92
12.2 Shipment....................................................................................................................92
13 Storage and disposal.....................................................................................................93
13.1 Storage.......................................................................................................................93
13.2 Disposal .....................................................................................................................93
14 Ordering information .....................................................................................................94
15 Compatible equipment ..................................................................................................95
15.1 System chart ..............................................................................................................95
15.2 Compatible neutral electrodes ...................................................................................96
15.3 Compatible foot switches ...........................................................................................98
16 Technical data ................................................................................................................99
16.1 Specications for the ESG-410..................................................................................99
16.2 Ambient conditions for operation, storage and transport ...........................................99
16.3 Plug requirements ...................................................................................................100
16.4 Resistance range for CQM.......................................................................................100
16.5 Specications for cables ..........................................................................................100
16.6 Specications for the USB ash drive......................................................................100
17 Additional information.................................................................................................101
17.1 Alarm system ...........................................................................................................101
17.2 Tone information ......................................................................................................102
17.3 Mode characteristics according to IEC 60601-2-2 ...................................................105
17.4 Characteristics of High Power Cut Support (HPCS) ................................................106
17.5 Output characteristic diagrams ................................................................................106
18 Electromagnetic compatibility....................................................................................133
19 Glossary........................................................................................................................136
20 Index..............................................................................................................................140
7
Using this document
1 Using this document
This chapter provides general information on how to use these instructions for use.
1.1 User instructions
Before use, thoroughly read these instructions for use and the instructions for use of all
other products that will be used during the procedure.
If the required instructions for use are missing, immediately contact an Olympus
representative.
Keep the instructions for use in a safe, accessible location.
1.2 Conventions throughout this document
Element Explanation
This is the safety alert symbol. It is used to alert the user to potential physical
injury hazards. Observe all safety messages that follow this symbol to avoid
possible injury.
This symbol indicates additional helpful information.
1.
2.
3.
A numeration indicates a sequence of actions.
●Bullet points indicate individual actions.
►Arrows indicate the results of actions.
–
–
–
Dashes indicate the listing of data, options or objects.
1)
2)
3)
Numbers with right parenthesis name elements in illustrations.
[...] Bracketed terms refer to elements in the graphical user interface or keys.
Elements in the graphical user interface can be:
- buttons
- menu items
- dialog elements
1.3 Safety‑related information in this document
For safe and efcient use of this product it is important to read the complete instructions for
use. The safety related information of these instructions for use is not only described in this
chapter. All information and instructions in this document are to ensure a safe and efcient
use.
Safety information are described in 3 categories:
‒General safety notes
‒ Specic safety notes
‒Safety messages
8
Using this document
1.3.1 General safety notes
General safety notes are located at the beginning of the instructions for use. They address
safety issues that apply to the general use and handling of the product.
1.3.2 Specic safety notes
Specic safety notes are located at the beginning of a chapter or section. They address
safety issues that are specic to the information and actions described in the chapter or
section.
1.3.3 Safety messages
Safety messages focus on unexpected incidents that can occur during the intended
use. They are placed in the context of such risks and actions. The safety messages are
highlighted by a signal word.
WARNING
Indicates a potentially hazardous situation which, if not avoided, can result in death or
serious injury.
CAUTION
Indicates a potentially hazardous situation which, if not avoided, can result in minor or
moderate injury.
NOTICE
Indicates a property damage message.
9
Safety information
2 Safety information
This chapter provides general safety information for using the product. The safety
information includes:
‒Intended purpose
‒Manufacturer information
‒General safety notes
2.1 Intended purpose
2.1.1 Intended use and indications
The electrosurgical generator, in conjunction with electrosurgical accessories and ancillary
equipment, is intended for cutting and coagulation of tissue in the following medical elds:
‒Open surgery
‒Laparoscopic surgery
‒ Endoscopic surgery
Only for use by a qualied physician in an adequate medical environment.
2.1.2 Contraindications
Absolute contraindications
There are no absolute contraindications.
Relative contraindications
At the discretion of the physician, electrosurgical procedures can be contraindicated under
the following circumstances:
‒If tissue coagulation and cutting can have a negative effect on the state of the patient.
‒For patients with implanted electronic devices, e.g. cardiac pacemaker, cardioverter
debrillators.
‒For patients with a weakened immune system.
‒For patients with blood coagulation disorders.
2.1.3 Patient target group
Not dedicated to a specic patient population. Patient target groups are dened by the
individual applicator used with the device.
2.1.4 Intended users
Medical use
Only for use by a qualied physician or medical personnel under the supervision of a
physician.
Only for use in an adequate medical environment.
These instructions for use do not explain or discuss clinical procedures.
Reprocessing
Reprocessing of reusable products may only be performed by qualied hygiene personnel.
10
Safety information
Repair
Repair of the product must only be performed by trained qualied servicing personnel that
has been authorized by Olympus. Otherwise, Olympus cannot be held responsible for the
safety and performance of the product.
Be aware that also fuses must only be changed by an authorized service center.
Installation and setup
The electrosurgical generator and its peripheral equipment must be properly installed and
set up by qualied personnel that has been authorized by Olympus.
Regular safety check
The regular safety check must only be performed by a qualied electrician with sufcient
experience in maintaining medical electrical devices.
The regular safety check must only be performed in a technical laboratory with appropriate
equipment.
Software update
Software updates must only be performed by qualied personnel.
2.1.5 Clinical benets
Clinical benets depend on the applied part used with the device.
2.2 Contact
2.2.1 Manufacturer
Olympus Winter & Ibe GmbH
Kuehnstr. 61
22045 Hamburg
Germany
Country-specic information
Refer to the contact information for customers included in the scope of delivery for country-
specic information.
2.2.2 Incident reporting
If a serious incident occurs with the device, report it to the manufacturer and/or the relevant
national authority according to national legislation.
2.3 General safety notes
The following safety information address points that apply to the general handling and use of
the product. This information is to be supplemented by the information given in each chapter
of this document.
Read all instructions for use thoroughly
Before use, read this instructions for use and the instructions for use for all other equipment
which will be used during the procedure.
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