Erbe VIO 300 D User manual

80113-751_V23791 2022-07
USER MANUAL
VIO®300 D
V 2.7.x
ELECTROSURGERY


USER MANUAL
VIO®300 D

Registered trademarks of Erbe Elektromedizin GmbH: autoCUT®, BiCision®, BiClamp®, CleverCap®, CleverView®, endoCUT®,
endoCOAG®, Erbe®, erbe power your performance.®, ERBECRYO®, ERBEFLO®, ERBEJET®, ERBOKRYO®, eTip®, FiAPC®,
forcedCOAG®, HybridKnife®, HybridTherm®, HYDRON®, IES VACpen®, KYRON®, NESSY®, NESSY Ω®, PLURA®, preciseAPC®,
Preflow®, pulsedAPC®, ReMode®, softCOAG®, sprayCOAG®, swiftCOAG®, thermoSEAL®, twinCOAG®, VIO®.
Registered trademark of Erbe, USA, Inc.: CleverCap®.
For an up-to-date list of all Erbe trademarks, please visit www.erbe-med.com/IP.
Unit Art. No. 10140-100
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 2022
MEDICAL — APPLIED CURRENT/ENERGY EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH AAMI ES60601-1 (2005) + AMD 1 (2012)
CSA-C22.2 No. 60601-1 (2014)
ANSI/AAMI/IEC 60601-2-2:2017
CSA-C22.2 No. 60601-2-2:19
19NA
CE0124

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Table of Contents
1General Instructions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Intended Use / Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Qualification of user. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Safety notations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Meaning of the note. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Who must read this User Manual? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Compliance with safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Structure of safety instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Operating errors and incorrect installation by persons without training . . . . . . . . . 12
Risks due to the environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Electric shock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Fire / explosion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Burns. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Inadvertent tissue damage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Risks due to incorrect use of the neutral electrode. . . . . . . . . . . . . . . . . . . . . . . . . . 21
Defective unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Interference caused by the unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Damage to the unit and accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Notes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
3Safety Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
NESSY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
How do I receive information about the safety status of the neutral
electrode? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Automatic monitoring of equipment output error . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Automatic monitoring of the ON time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Protection from operating errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
4Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
VIO 300 D example accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Check compatibility of instrument and CUT / COAG mode with the help of the
Upmax display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Check compatibility of the neutral electrode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Compatible footswitches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Adapter bipolar resection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
5Description of the Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Controls on the front panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Controls on the back . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

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6Working with the Electrosurgical Unit: a Tutorial . . . . . . . . . . . . . . 47
The tutorial and your electrosurgical system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47
Make power connection, switch on unit, self-test, assignment of active
program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47
Adopt Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
Select Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
The basic concept of the electrosurgical unit: focusing attention on the
functions of a socket (Focus View). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52
Changing settings of the Basic Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52
Setting Cut mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .53
Setting CUT effect . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54
Selecting CUT Max. Wattage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .55
Select COAG mode, COAG effect and COAG power limitation . . . . . . . . . . . . . . . . . . .56
Activation of CUT and COAG modes with footswitch . . . . . . . . . . . . . . . . . . . . . . . . .56
Activation of CUT and COAG modes with fingerswitch, AUTO START, AUTO
STOP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58
The Focus View and activation concept of the electrosurgical unit. What
points must I observe? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
NESSY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
How do I receive information about the safety status of the neutral
electrode? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61
Saving the amended Basic program under a new name . . . . . . . . . . . . . . . . . . . . . .65
Overwriting a program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .66
Creating all settings for a program from scratch . . . . . . . . . . . . . . . . . . . . . . . . . . . .67
Deleting a program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67
Creating programs for ReMode function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67
ReMode change-over with a 2-button handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . .72
Calling up Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72
7Description of socket hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Purchasing further sockets. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75
Sockets for different modes and instrument connectors . . . . . . . . . . . . . . . . . . . . . .75
Monopolar socket . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75
Bipolar socket . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76
Multifunctional socket. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77
Socket for neutral electrode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .78
8Monopolar Standard Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
AUTO CUT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81
HIGH CUT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
DRY CUT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85
DRY CUT °. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87
SOFT COAG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89
SWIFT COAG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91
SWIFT COAG ° . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93
FORCED COAG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .95
SPRAY COAG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97
CLASSIC COAG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .99
9Bipolar Standard Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
BIPOLAR CUT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
BIPOLAR CUT + . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

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BIPOLAR CUT ++. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
BIPOLAR SOFT COAG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
BIPOLAR SOFT COAG +. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
BIPOLAR SOFT COAG ++. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
BIPOLAR FORCED COAG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
10 Monopolar Optional Modes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
PRECISE CUT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
ENDO CUT Q . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
ENDO CUT I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
PRECISE COAG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
TWIN COAG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
11 Bipolar Optional Modes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
BiClamp. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
BIPOLAR PRECISE CUT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
BIPOLAR PRECISE COAG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
12 APC socket (only available with the APC module) . . . . . . . . . . . . . 131
APC socket . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
13 APC Standard Modes (Only Available with an APC Module) . . . . . 133
FORCED APC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
PRECISE APC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
PULSED APC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
Argon-assisted AUTO CUT Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
Argon-assisted HIGH CUT Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Argon-assisted DRY CUT Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
Argon-assisted DRY CUT ° Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
Argon-assisted SWIFT COAG Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
Argon-assisted SWIFT COAG ° Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
Argon-assisted FORCED COAG Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
Argon-assisted SOFT COAG Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152
14 APC Optional Modes (Only Available with an APC Module) . . . . . . 155
Argon-assisted TWIN COAG Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
15 Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
Ambient conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
Electrical installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
Install electrosurgical unit on overhead support . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
Installing the unit on an Erbe cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
16 Cleaning and disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
Wipe disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
Instructions for cleaning and disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
17 Status Messages, Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . 167
18 General Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171

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19 Notes on electromagnetic compatibility (EMC) . . . . . . . . . . . . . . . 173
Guidelines for avoiding, recognizing and rectifying unwanted electromagnetic
effects on other units or systems, which are the result of operating the VIO
system.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173
20 Maintenance, Customer Service, Warranty, Disposal . . . . . . . . . . . 179
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179
Customer service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179
Warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180
21 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181

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1 •General Instructions for Use
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Chapter 1
General Instructions for Use
This User Manual describes the normal use of the unit.
Intended Use / Indications for Use
The Erbe electrosurgical unit (ESU/Generator) model VIO 300 D with instruments and
accessories is intended to deliver high frequency (HF) electrical current for the cutting
and/or coagulation of tissue, as well as vessel sealing.
Compatibility
The VIO 300 D can be combined with suitable Erbe units and modules (e.g. APC 2,
EIP 2, ERBEJET 2), instruments and accessories.
See the Accessories chapter for information on the compatibility of instruments and
accessories.
Environment
For the intended use, the unit may only be operated in premises used for medical pur-
poses.
Qualification of user
For the intended use, the unit may only be operated by medical professionals who
have been trained in the use of the unit or combination of units on the basis of the
User Manual.

1 •General Instructions for Use
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Chapter 2
Safety Instructions
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.
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 unit.
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.

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Compliance with safety information
Working with medical units is associated with certain risks to patients, medical per-
sonnel and the environment. Risks cannot be entirely eliminated by design measures
alone.
Safety does not depend solely on the unit. Safety depends to a large extent on the
training of medical personnel and correct operation of the unit.
The safety instructions in this chapter must be read, understood and applied by every-
one who is working with the unit.
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 neutral 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 unit 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.
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.

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Risks due to the environment
NOTICE
Interference with the unit from portable and mobile HF telecom-
munications units (e.g. mobile phones, WLAN units)
Electromagnetic waves emitted by portable and mobile HF telecom-
munications units may affect the unit.
The unit may fail or not perform properly.
When using portable and mobile HF telecommunications units, in-
cluding their accessories, there must be a distance of at least
30 cm between them and the unit and its cords.
NOTICE
Unsuitable temperature or level of humidity during operation
If you operate the unit at an unsuitable temperature or level of hu-
midity, it may sustain damage, fail, or not perform properly.
Operate the unit 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 operation of the
unit, you will also find them in the Technical Data.
NOTICE
Unsuitable temperature or humidity in transit or storage
If you transport or store the unit at an unsuitable temperature or level
of humidity, it may sustain damage and fail.
Transport and store the unit at a suitable temperature and level
of humidity. You will find the tolerances for temperature and hu-
midity in the Technical Data.
If other ambient conditions must be observed for transport and
storage of the unit, you will also find them in the Technical Data.
NOTICE
Insufficient acclimatization time, unsuitable temperature during
acclimatization
If the unit 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 unit can sustain damage and fail.
Acclimatize the unit according to the rules in the Technical Data.
NOTICE
Overheating of the unit due to poor ventilation
If ventilation is poor, the unit can overheat, sustain damage, and fail.
Install the unit in such a way that there is an unobstructed circu-
lation of air around the housing. Installation in confined wall re-
cesses is prohibited.

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NOTICE
Penetration of liquid into the unit
The housing is not absolutely watertight. If liquid penetrates, the unit
can sustain damage and fail.
Make sure no liquid can penetrate the unit.
Do not place vessels containing liquids on top of the unit.
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 / 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 with a
national quality symbol for this purpose.
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 power fuse, defective unit
Risk of electric shock to the patient and medical personnel! Risk of
damage to property.
Blown power fuses may only be replaced by a competent techni-
cian. 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 Elektromedizin. You will find the
addresses in the address list at the end of this User Manual.
WARNING
Connection of unit / cart and power supply during cleaning and
disinfection
Risk of electric shock to the medical personnel!
Switch off the unit. Unplug the power plug of the unit / cart.

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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 evacuate the anesthetics before
performing 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 evacuate the combustion-sup-
porting gases before performing electrosurgery.
Remove any jeopardized (e.g. cotton wool or gauze) materials be-
fore performing electrosurgery.
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!

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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 unit / 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 unit.
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 unit in a potentially explosive atmosphere, anesthet-
ics, 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 unit in potentially explosive atmospheres.
Burns
WARNING
Damaged unit, damaged accessories, modified unit, and modified
accessories
Risk of burns and injury to the patient and medical personnel! Risk of
damage to property.
Check the unit and accessories for damage every time before us-
ing them (e.g. footswitch, cords of instruments and the neutral
electrode, cart).
You must not use a damaged unit or damaged accessories. Re-
place defective accessories.
If the unit or cart is damaged, please contact our customer ser-
vice.

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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 surgery 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
procedural 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.
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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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 unit 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 neutral electrode site increases during
long and continuous activations; therefore, ensure that the cool-
ing 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 neutral 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 neutral electrode site increases during
long and continuous activations; therefore, ensure that the cool-
ing phases between activations are sufficient.

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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.
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).
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