Erbe VIO 200 D User manual

2018-1280113-341
USER MANUAL
VIO®200 D
V 2.3.x
ELECTROSURGERY

USER MANUAL
VIO®200 D

Registered trademarks of Erbe Elektromedizin GmbH: AUTO CUT®, AXUS®, BICISION®, BiClamp®, classicCOAG®, classicCUT®,
CLEVERCAP®, DeCo®, dryCUT®, endoCUT®, endoCOAG®, ERBE®, erbe power your performance.®, ERBECRYO®, ERBEFLO®,
ERBEFLO AeroRinse®, ERBEJET®, ERBELift®, ERBOKRYO®, FIAPC®, forcedCOAG®, Hybrid knife®, HybridKnife®, ICC 200®,
ICC 80®, KYRON®, NESSY®, NESSY Ω®, PLURA®, preciseAPC®, Preflow®, pulsedAPC®, ReMode®, REMODE®, softCOAG®,
sprayCOAG®, swiftCOAG®, The Color Blue®, thermoSEAL®, twinCOAG®, VIO®.
User Manual Art. No. 80113-341
Device Art. No. 10140-200
All rights to this User Manual, in particular rights of duplication, dissemination and translation, are reserved. No part of this User
Manual may be reproduced in any form (by photocopying, microfilming or other methods) or processed, duplicated or dissemi-
nated by the use of electronic systems without the written consent of Erbe Elektromedizin GmbH.
The information contained in this User Manual can be changed or expanded without prior notice and without obligation on the
part of Erbe Elektromedizin GmbH.
The illustrations in this User Manual may differ in some details from your product.
Printed by Erbe Elektromedizin
Printed in Germany
Copyright © Erbe Elektromedizin GmbH, Tübingen 2018
MEDICAL — APPLIED CURRENT/ENERGY EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH ANSI/AAMI ES60601-1(2012)
CAN/CSA-C22.2 No. 60601-1:14
ANSI/AAMI/IEC 60601-2-2:2009
CAN/CSA-C22.2 No. 60601-2-2:2009
19NA
CE0124

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Table of Contents
80113-341 2018-12
Table of Contents
1Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Combination with other equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Safety notations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Meaning of the note. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Who must read this User Manual? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Compliance with safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Structure of safety instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Operating errors and incorrect installation by persons without training . . . . . . . . . 10
Risks due to the environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Electric shock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Fire / explosion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Burns. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Inadvertent tissue damage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Risks due to incorrect use of the return electrode . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Defective unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Interference caused by the unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Damage to the unit and accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Notes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
2Safety Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
NESSY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
How do I receive information about the safety status of the return electrode? . . . 26
Automatic monitoring of equipment output error . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Automatic monitoring of the ON time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Protection from operating errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
3Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
VIO 200 D example accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Check compatibility of instrument and CUT / COAG mode with the help of the
Upmax display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Check compatibility of the return electrode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Compatible footswitches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
4Description of the Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Controls on the front panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Controls on the back . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
5Working with the Electrosurgical Unit: a Tutorial . . . . . . . . . . . . . . 43
The tutorial and your electrosurgical system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Make power connection, switch on unit, self-test, assignment of active
program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Adopt Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Select Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

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The basic concept of the electrosurgical unit: focusing attention on the
functions of a receptacle (Focus View) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
Changing settings of the Basic Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
Setting Cut mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
Setting CUT effect . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
Selecting CUT Max. Wattage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51
Select COAG mode, COAG effect and COAG power limitation . . . . . . . . . . . . . . . . . . .52
Activation of CUT and COAG modes with footswitch . . . . . . . . . . . . . . . . . . . . . . . . .52
Activation of CUT and COAG modes with fingerswitch, AUTO START, AUTO
STOP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54
The Focus View and activation concept of the electrosurgical unit. What
points must I observe? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56
NESSY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56
How do I receive information about the safety status of the return electrode?. . . .57
Saving the amended Basic program under a new name . . . . . . . . . . . . . . . . . . . . . .61
Overwriting a program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62
Creating all settings for a program from scratch . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
Deleting a program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
Creating programs for ReMode function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
ReMode change-over with a 2-button handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . .67
Calling up Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68
6Description of receptacle hardware . . . . . . . . . . . . . . . . . . . . . . . . . 71
Purchasing further receptacles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71
Receptacles for different modes and instrument connectors . . . . . . . . . . . . . . . . . .71
Monopolar receptacle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71
Bipolar receptacle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72
Receptacle for return electrode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73
7Monopolar Standard Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
AUTO CUT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75
SOFT COAG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77
SWIFT COAG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79
FORCED COAG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81
8Bipolar Standard Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
BIPOLAR CUT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85
BIPOLAR SOFT COAG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87
BIPOLAR FORCED COAG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89
9Monopolar Optional Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
PRECISE CUT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93
DRY CUT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .95
ENDO CUT Q. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97
ENDO CUT I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .98
PRECISE COAG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
10 Bipolar Optional Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
BIPOLAR PRECISE CUT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
BIPOLAR PRECISE COAG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

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11 APC receptacle (only available with the APC module). . . . . . . . . . 109
APC receptacle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
12 APC Standard Modes (Only Available with an APC Module) . . . . . 111
FORCED APC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
PRECISE APC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
PULSED APC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Argon-assisted AUTO CUT Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
Argon-assisted SOFT COAG Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Argon-assisted SWIFT COAG Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
Argon-assisted FORCED COAG Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
13 APC Optional Modes (Only Available with an APC Module) . . . . . . 125
Argon-assisted DRY CUT Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
14 Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Ambient conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Electrical installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
Install electrosurgical unit on overhead support . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
Installing the unit on an Erbe equipment cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
15 Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Wipe disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Instructions for cleaning and disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
16 Status Messages, Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . 137
17 General Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
18 Information on electromagnetic compatibility (EMC) . . . . . . . . . . 143
Guidelines for avoiding, recognizing and rectifying unwanted electromagnetic
effects on other equipment or systems, which are the result of operating the
VIO system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
19 Maintenance, Customer Service, Warranty, Disposal. . . . . . . . . . . 149
Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
Customer service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
20 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151

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1 •Safety Instructions
80113-341 2018-12
Chapter 1
Safety Instructions
Intended use
The VIO 200 D is an electrosurgical unit for cutting and coagulation. Thanks to its per-
formance features it offers universal applications.
Combination with other equipment
You can combine this unit with matching Erbe equipment: e.g. APC 2, EIP 2. You will
then have a well-conceived, coordinated system.
Safety notations
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.
NOTICE
indicates a potentially hazardous situation which, if not avoided, may
result in property damage.
Meaning of the note
"Note:"
Refers a) to manufacturer's information that relates directly or indirectly to the safety
of people or protection of property. The information does not relate directly to a risk
or dangerous situation.
Refers b) to manufacturer's information that is important or useful for operating or
servicing the unit.

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Who must read this User Manual?
Knowledge of the User Manual is absolutely essential for correct operation of the unit.
The User Manual must therefore be read by everyone who works with the equipment.
Anyone who prepares, sets, disassembles, cleans and disinfects the unit must also
read the User Manual.
Please pay particular attention to the safety instructions in each chapter.
Compliance with safety information
Working with medical equipment is associated with certain risks to patients, medical
personnel and the environment. Risks cannot be entirely eliminated by design mea-
sures alone.
Safety does not depend solely on the equipment. Safety depends to a large extent on
the training of medical personnel and correct operation of the equipment.
The safety instructions in this chapter must be read, understood and applied by every-
one who is working with the equipment.
Structure of safety instructions
The safety instructions are structured according to the following risks:
•Operating errors and incorrect installation by persons without training
•Risks due to the environment
•Electric shock
•Fire / explosion
•Burns
•Inadvertent tissue damage
•Risks due to incorrect use of the return electrode
•Defective unit
•Interference caused by the unit
•Damage to the unit and accessories
•Notes
Operating errors and incorrect installation by persons without training
WARNING
Operating errors and incorrect installation by persons without
training
Persons without training can operate or install the unit incorrectly.
Risk of injury or death for patients and medical staff! Risk of damage
to property.
The equipment may only be used and installed by persons who
have been trained on how to use and install it properly according
to this User Manual.

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Training may only be carried out by persons who are suitable on
the basis of their knowledge and practical experience.
In the event of uncertainties or if you have any questions, please
contact Erbe Elektromedizin. You will find the addresses in the ad-
dress list at the end of this User Manual.
Risks due to the environment
NOTICE
Interference with the unit from portable and mobile HF telecom-
munications equipment (e.g. mobile phones, WLAN equipment)
Electromagnetic waves emitted by portable and mobile HF telecom-
munications equipment may affect the unit.
The unit may fail or not perform properly.
When using portable and mobile HF telecommunications devices,
including their accessories, there must be a distance of at least
30 cm between them and the device and its cords.
NOTICE
Unsuitable temperature or level of humidity during operation
If you operate the equipment at an unsuitable temperature or level of
humidity, it may sustain damage, fail, or not perform properly.
Operate the equipment at a suitable temperature and level of hu-
midity. You will find the tolerances for temperature and humidity
in the Technical Data.
If other ambient conditions must be observed for operation of the
equipment, you will also find them in the Technical Data.
NOTICE
Unsuitable temperature or humidity in transit or storage
If you transport or store the equipment at an unsuitable temperature
or level of humidity, it may sustain damage and fail.
Transport and store the equipment at a suitable temperature and
level of humidity. You will find the tolerances for temperature and
humidity in the Technical Data.
If other ambient conditions must be observed for transport and
storage of the equipment, you will also find them in the Technical
Data.
NOTICE
Insufficient acclimatization time, unsuitable temperature during
acclimatization
If the device was stored or transported below or above a certain tem-
perature, it will take a certain time and temperature to acclimatize.
If you do not observe the rules, the device can sustain damage and
fail.
Acclimatize the device according to the rules in the Technical Da-
ta.

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80113-341 2018-12
NOTICE
Overheating of the device due to poor ventilation
If ventilation is poor, the device can overheat, sustain damage, and
fail.
Install the device in such a way that there is an unobstructed cir-
culation of air around the housing. Installation in confined wall re-
cesses is prohibited.
NOTICE
Penetration of liquid into the device
The housing is not absolutely watertight. If liquid penetrates, the de-
vice can sustain damage and fail.
Make sure no liquid can penetrate the device.
Do not place vessels containing liquids on top of the device.
Electric shock
WARNING
Defective grounded power outlet, power supply network without
proper grounding, inferior-quality power cord, incorrect line volt-
age, multiple power outlets, extension cords
Risk of electric shock and other injuries to the patient and medical
personnel! Risk of damage to property.
Connect the unit / the equipment cart to a properly installed
grounded power outlet.
Only connect the unit to a power supply network with proper
grounding.
Only use the Erbe power cord or an equivalent power cord for this
purpose. The power cord must bear the applicable national test
symbol.
Check the power cord for damage. You must not use a damaged
power cord.
The supply voltage must match the voltage specified on the unit's
rating plate.
Do not use multiple power outlets.
Do not use extension cords.
WARNING
Incorrect line fuse, defective device
Risk of electric shock to the patient and medical personnel! Risk of
damage to property.
Blown line fuses may only be replaced by a competent technician.
Only replacement fuses that have the same rating as the one
specified on the unit’s rating plate may be used.
When a fuse has been changed, the function of the unit must be
verified. If the unit does not function properly or if there are any
concerns, please contact Erbe.

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WARNING
Connection of unit / equipment cart and power supply during
cleaning and disinfection
Risk of electric shock to the medical personnel!
Switch off the device. Unplug the power cord of the device/equip-
ment cart.
Fire / explosion
In electrosurgery electric sparks and arcs occur at the instrument. Flammable gases,
vapors, and liquids can be set alight or caused to explode.
DANGER
Flammable anesthetics
Risk of explosion to the patient and medical personnel! Risk of dam-
age to property.
Do not use flammable anesthetics when an operation is being
performed on the head or thorax.
If use is unavoidable, you must extract the anesthetics before per-
forming electrosurgery.
WARNING
Flammable gas mixture in TUR (Transurethral Resection) and TCR
(Transcervical Endometrial Resection)
Hydrogen and oxygen can ascend into the roof of the bladder, the up-
per part of the prostate, and the upper part of the uterus. If you resect
into this gas mixture, it could combust.
Risk of combustion to the patient!
Allow the gas mixture to escape through the resectoscope sheath.
Do not resect into the gas mixture.
DANGER
Flammable endogenous gases in the gastrointestinal tract
Risk of explosion to the patient!
Extract the gases before performing electrosurgery or irrigate
with CO2.
DANGER
Combustion-supporting gases, e.g. oxygen, nitrous oxide
The gases can accumulate in materials like cotton wool or gauze. The
materials become highly flammable.
Risk of fire to the patient and medical personnel! Risk of damage to
property.
Do not use combustion-supporting gases when an operation is
being performed on the head or thorax.
If use is unavoidable, you must extract the combustion-support-
ing gases before performing electrosurgery.
Remove any jeopardized (e.g. cotton wool or gauze) materials be-
fore performing electrosurgery.

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Check the oxygen-carrying tubes and connections for leaks.
Check the endotracheal tubes and their cuffs for leaks.
Before using argon plasma coagulation (APC) in the tracheobron-
chial system it is absolutely essential that you observe the specific
safety information and instructions in the User Manual for the ar-
gon plasma unit!
WARNING
Active or hot instruments in contact with combustible materials
Materials like gauze, swabs, and cloths can catch fire.
Risk of fire to the patient and medical personnel! Risk of damage to
property.
Do not bring active or hot instruments into contact with combus-
tible materials.
Put instruments down in a safe place: sterile, dry, non-conductive,
and easy to see. Instruments that have been put down must not
come into contact with the patient, medical personnel, or com-
bustible materials.
WARNING
Flammable detergents and disinfectants, flammable solvents in
adhesives used on the patient and on the device / equipment cart
Risk of fire and explosion to the patient and medical personnel! Risk
of damage to property.
Use products that are not flammable.
If the use of flammable products is unavoidable, proceed as fol-
lows:
Allow the products to evaporate completely before switching on
the device.
Check whether flammable liquids have accumulated under the
patient, in body recesses such as the navel, or in body cavities
such as the vagina. Remove any liquids before performing elec-
trosurgery.
WARNING
Ignition of anesthetics, skin cleansers, and disinfectants in poten-
tially explosive atmospheres
If you place the device in a potentially explosive atmosphere, anes-
thetics, skin cleansers, and disinfectants can ignite.
Risk of fire and explosion to the patient and medical personnel! Risk
of damage to property.
Do not place the device in potentially explosive atmospheres.
Burns
WARNING
Damaged device, damaged accessories, modified device, and
modified accessories
Risk of burns and injury to the patient and medical personnel! Risk of
damage to property.

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Check the device and accessories for damage every time before
using them (e.g. footswitch, cords of instruments and the return
electrode, equipment cart).
You must not use damaged equipment or damaged accessories.
Replace defective accessories.
If the equipment or equipment cart is damaged, please contact
our customer service.
For your safety and that of the patient: Never attempt to perform
repairs or make modifications yourself. Any modification will in-
validate liability on the part of Erbe Elektromedizin GmbH.
WARNING
HF leakage current flows through metal parts
The patient must not have contact with electrically conductive ob-
jects. That includes metal parts of the operating table, for example.
HF current can be discharged through points of contact accidentally
(HF leakage current).
Risk of burns to the patient!
Position the patient on dry, antistatic drapes.
If the drapes can become wet during the operation due to sweat,
blood, irrigation liquid, urine, etc., lay a waterproof plastic sheet
under the drapes.
WARNING
HF leakage current flows through monitoring electrodes
HF current can be discharged through points of contact between the
skin and monitoring electrodes accidentally (HF leakage current).
Risk of burns to the patient!
Position monitoring electrodes as far away as possible from the
surgical field (area where electrosurgical instruments are used).
Do not use needle electrodes for monitoring during electrosur-
gery.
Where possible, use monitoring electrodes that contain devices to
limit high-frequency current.
WARNING
HF leakage current flows through skin-to-skin points of contact
HF current can be discharged through skin-to-skin points of contact
accidentally (HF leakage current).
Risk of burns to the patient!
Prevent skin-to-skin points of contact. For example, lay dry gauze
between the patient's arms and body.
WARNING
Unintentional activation of the instrument
Risk of burns to the patient and medical personnel!
Put instruments down in a safe place: sterile, dry, non-conductive,
and easy to see. Instruments that have been put down must not
come into contact with the patient, medical personnel, or com-
bustible materials.

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Instruments that have been put down must not come into contact
with the patient, not even indirectly. An instrument can come into
contact with the patient indirectly through electrically conductive
objects or wet drapes, for example.
CAUTION
Hot instruments
Even non-active instruments that are still hot can burn the patient or
medical personnel.
Put instruments down in a safe place: sterile, dry, non-conductive,
and easy to see. Instruments that have been put down must not
come into contact with the patient, medical personnel, or com-
bustible materials.
Instruments that have been put down must not come into contact
with the patient, not even indirectly. An instrument can come into
contact with the patient indirectly through electrically conductive
objects or wet drapes, for example.
WARNING
Unintentional activation of the instrument during an endoscopic
application
If the instrument is activated and remains activated during an endo-
scopic application, the patient can suffer burns when the instrument
is removed.
All points that come into contact with the active part of the instru-
ment are at risk. The cause of unintentional activation can be a fault
in the footswitch or device for example.
You will recognize unintentional activation from the continuous acti-
vation signal, even though you have released the footswitch.
Risk of burns to the patient!
Turn off the power switch on the electrosurgical unit immediately.
Only then should the instrument be removed from the patient’s
body.
WARNING
Capacitive coupling between the cords of two instruments
When one instrument is activated, current can be transferred to the
cord of another instrument (capacitive coupling).
The patient can suffer burns if the non-active but still live instrument
has direct or indirect contact with the patient.
Risk of burns to the patient!
Lay the cords of instruments in such a way that they are as far
apart as possible.
Put instruments down in a safe place: sterile, dry, non-conductive,
and easy to see.
Instruments that have been put down must not come into contact
with the patient, medical personnel, or combustible materials.
Instruments that have been put down must not come into contact
with the patient, not even indirectly. An instrument can come into
contact with the patient indirectly through electrically conductive
objects or wet drapes, for example.

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WARNING
Power setting too high, ON time too long, effects too high
The higher the power setting the longer the ON time of the unit and
the higher the effect the higher the risk of accidental tissue damage.
Risk of accidental tissue damage to the patient!
Set power as low as possible relative to the required surgical ef-
fect. However, power settings that are too low can be dangerous,
e.g. gas embolisms with the APC (Argon Plasma Coagulation).
Activate the unit for as short a time as possible relative to the re-
quired surgical effect.
The temperature at the return electrode site increases during long
and continuous activations; therefore, ensure that the cooling
phases between activations are sufficient.
Set effect as low as possible relative to the required surgical ef-
fect.
If you are unable to achieve a surgical effect with a power setting
/ ON time / effect level that is sufficient judging from experience,
this can be due to a problem with the electrosurgical unit or ac-
cessories:
Check the instrument for soiling with insulating tissue remnants.
Check the return electrode to make sure it is secure.
Check the connectors on all cords to make sure they are secure.
WARNING
Activation of the unit with no knowledge of active settings
If the user does not understand the active settings of the unit, he can
cause the patient accidental tissue damage.
Check the active settings on the display of the unit, after: switch-
ing on the unit, connecting up an instrument, and changing the
program.
WARNING
The user was not informed of a change in maximum ON time
Risk of accidental tissue damage to the patient!
All users must be informed of any change in maximum ON time at
an early stage. That is, before the user works with the modified
maximum ON time for the first time.
The temperature at the return electrode site increases during long
and continuous activations; therefore, ensure that the cooling
phases between activations are sufficient.
WARNING
Tissue structures / vessels with a cross-section that is small or
becoming smaller
If monopolar HF current flows through parts of the body with a rela-
tively small cross-section, there is a risk of unintentional coagulation
for the patient!
If possible, use the bipolar coagulation technique.

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WARNING
Activation signal not audible
You do not hear the signal when the electrosurgical unit is activated.
Risk of burns to the patient and medical personnel!
Adjust the activation signal so that it is clearly audible.
WARNING
Undesirable contact between the active instrument and metal
objects in the patient's body
Contact with metal hemostats, etc.
Risk of burns to the patient!
Do not touch metal objects (e.g. implants) in the patient's body
with the active instrument.
CAUTION
A hand-held metal instrument is touched with the active instru-
ment (electrode)
Risk of hand burns!
Such practice is not recommended. The risk of burns cannot be
ruled out.
CAUTION
HF leakage current flows through the skin of medical personnel
Risk of burns to the patient and medical personnel!
Do not come in contact with the patient while the surgeon is using
an active electrosurgical instrument on the patient.
Inadvertent tissue damage
WARNING
Safety margin between the active instrument and sensitive tissue
structures too narrow
Adjacent structures can be damaged by the thermal effect of electro-
surgery.
Ensure that there is a sufficient safety margin between the active
instrument and sensitive tissue structures (e.g. nerves, muscles).
CAUTION
Electrically conductive implants can redirect or concentrate cur-
rent flow.
Risk of burns for the patient and possible damage to the implant.
In the case of patients wearing electrically conductive implants,
consult the manufacturer of the implant or the relevant specialist
department of your hospital prior to surgery.
Position the return electrode so that the implant is not located be-
tween the active electrode (monopolar instrument) and the return
electrode.

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Risks due to incorrect use of the return electrode
CAUTION
Non-compatible or single surface return electrode
When applying a non-compatible return electrode, it should be ex-
pected that monitoring the contact between return electrode and skin
is faulty.
When applying a single surface return electrode, the contact between
return electrode and skin is not monitored. If contact between return
electrode and skin is inadequate, the unit does not emit any visual
and acoustic signal.
Risk of burns for the patient under the return electrode!
Check in the accompanying papers of the manufacturer whether
the return electrode is suitable for the VIO device used.
Use only suitable return electrodes.
When applying a single surface return electrode: Regularly check
the return electrode for good skin contact.
Check in the accompanying papers of the manufacturer whether
the return electrode cable is suitable for the return electrode
used.
Use only suitable return electrode cables.
WARNING
Positioning the return electrode above the heart
Risk of ventricular fibrillation and cardiac arrest for the patient!
Do not position the return electrode over the heart or in the region
of the heart.
CAUTION
Incorrect application of the return electrode
Risk of burns to the patient!
Apply the entire contact surface of the return electrode to a mus-
cular part of the body with good blood circulation.
Apply the return electrode as close as possible to the surgical site.
Insert the contact tab of the return electrode completely into the
connecting clamp. The contact tab must not touch the patient's
skin. (For reusable cord with disposable pads only.)
Align the symmetry line of the return electrode towards the oper-
ating field. The current should flow from the active electrode (in-
strument) to the symmetry line of the return electrode.
Check the return electrode regularly for good contact with the pa-
tient's skin.
Check the return electrode especially when the patient has been
repositioned and after surgical steps where the device was acti-
vated frequently and for a long time.

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Fig. 1-1
CAUTION
Short circuit in the connecting cord or in the clip of a dual surface
return electrode
With the NESSY setting "NE: either way" setup and a short circuit in
the connecting cord or in the clip of a dual surface return electrode
the device can no longer monitor the contact with the patient's skin
or the application direction of the contact surface. You will not receive
a warning if the electrode becomes detached from the skin. You will
not receive a warning if the application direction of the return elec-
trode is incorrect.
Risk of burns to the patient!
To rule out the possibility of a short circuit in the connecting cord
and the clip before use, see Chapter 2 of this Manual "Safety Fea-
tures" for NESSY.
Note: Erbe recommends the use of split return electrodes in combination with the
NESSY setting set to “NE: dynamic” or “NE: dual surface”. With this combination the
optimal use of the safety monitoring functions are given (see chapter 2 “NESSY Safety
Features). If the unit is activated in a monopolar mode using a cable with a short, the
unit will give an audible warning signal and will display a "B-B" error message on the
screen.
Defective unit
WARNING
Undesirable rise in output level due to failure of electrosurgical
unit
Risk of accidental tissue damage to the patient!
The device shuts off independently.
To guard against a possible failure of the electrosurgical unit,
have the device checked for safety at least once a year.
WARNING
Technical safety checks not being done
Risk of injury or death for patients and medical staff! Risk of damage
to property.
Have the device checked for safety at least once a year.
You must not use a device that is not safe.