ERBE Elektromedizin VIO3 User Manual

USER MANUAL

VIO® 3

V 1.0.x

ELECTROSURGERY

Dok.-Nr: D110127-EN, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: MZECEVIC/02.06.16, Ausdruck nicht maßstäblich und kein Original.Dok.-Nr: D110127-EN, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: MZECEVIC/02.06.16, Ausdruck nicht maßstäblich und kein Original.

03.1680114-601

Dok.-Nr: D110127-EN, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: MZECEVIC/02.06.16, Ausdruck nicht maßstäblich und kein Original.Dok.-Nr: D110127-EN, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: MZECEVIC/02.06.16, Ausdruck nicht maßstäblich und kein Original.

USER MANUAL

VIO® 3

Dok.-Nr: D110127-EN, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: MZECEVIC/02.06.16, Ausdruck nicht maßstäblich und kein Original.Dok.-Nr: D110127-EN, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: MZECEVIC/02.06.16, Ausdruck nicht maßstäblich und kein Original.

Registered trademarks of Erbe Elektromedizin GmbH: AXUS®, BICISION®, BiClamp®, classicCOAG®, classicCUT®, CLEVERCAP®,

CE0124

CE0700

®

, dryCUT®, endoCUT®, endoCOAG®, ERBE®, ERBECRYO®, ERBEFLO®, ERBEFLO AeroRinse®, ERBEJET®, ERBELift®,

DeCo
ERBOKRYO
preciseAPC
thermoSEAL

®

, FIAPC®, forcedCOAG®, Hybrid knife®, HybridKnife®, ICC 200®, ICC 80®, KYRON®, NESSY®, NESSY Ω®, PLURA®,

®

, Preflow®, pulsedAPC®, ReMode®, REMODE®, softCOAG®, sprayCOAG®, swiftCOAG®, The Color Blue®,

®

, twinCOAG®, VIO®.

EN ISO 9001 EN ISO 13485

User Manual Art. No. 80114-601

All rights to this User Manual, in particular rights of duplication, dissemination and translation, are reserved. No part of this Us
Manual may be reproduced in any form (by photocopying, microfilming or other methods) or processed, duplicated or dissemi­nated by the use of electronic systems without the w

The information contained in this User Manual can be changed or expanded wi
part of Erbe Elektromedizin GmbH.

Printed by Erbe El

Printed in Germany

Copyright © Erbe Elektromedizin GmbH, Tübingen 2016

Dok.-Nr: D110127-EN, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: MZECEVIC/02.06.16, Ausdruck nicht maßstäblich und kein Original.Dok.-Nr: D110127-EN, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: MZECEVIC/02.06.16, Ausdruck nicht maßstäblich und kein Original.

tromedizin

ek

ritten consent of Erbe Elektromedizin GmbH.

thout prior notice and without obligation on the

er

Table of Contents

1 Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Intended purpose. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Safety notations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Meaning of the note. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Who must read this User Manual? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Compliance with safety information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Structure of safety instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Operating errors and incorrect installation by

Risks due to the environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Electric shock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fire / explosion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Burns. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Risks due to incorrect use of the return electrode

Defective unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Interference caused by the unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Damage to the unit and accessories. . . . . . . . . .

Notes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Table of Contents

. . . . 9

. . . . 9

. . . . 9

. . . 10
. . . 10
. . . 10

persons without training . . . . . . . . . 11

. . . 11
. . . 12
. . . 13
. . . 15

. . . . . . . . . . . . . . . . . . . . . . . . . . 19

. . . 21
. . . 21

. . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

. . . 23

2 Safety Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

NESSY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

VIO 3 detects no return electrode . . . . . . . . . . .

80114-601

03.16

Split return electrode connected. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Non-split return electrode connected. . . . . . . . .

Neonatal monitoring . . . . . . . . . . . . . . . . . . .

Automatic monitoring of the HF output par

power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Automatic monitoring of the maximum a

Protection from operating errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

. . . 28

. . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

ameters electrical voltage and

. . . 32

ctivation time . . . . . . . . . . . . . . . . . . . . . . 32

. . . 33

3 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

VIO 3 example accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Use of APC instruments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Check compatibility of instrument and CUT / COAG mode with the help of the

Upmax display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Check compatibility of the return electrode . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Compatible footswitches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . 36
. . . 38

. . . 38
. . . 40
. . . 40

4 Description of the Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Controls on the front panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

VIO 3 main screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Controls on the back . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . 43
. . . 46

5 / 158

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Table of Contents

5 Working with VIO 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Make power connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47

Switching on, self-test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Selecting the program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Connecting return electrode, applying it on the patient

. . . . . . . . . . . . . . . . . . . . . .49

Check return electrode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Connecting the first instrument . . . . . . . . . . . . . . .

Connecting a second instrument . . . . . . . . . . . . . .

Meaning of the instrument symbols in different displays
Connecting an instrument which is not stored in the pr

. . . . . . . . . . . . . . . . . . . . . . . . . . .50

. . . . . . . . . . . . . . . . . . . . . . . . . . .52

. . . . . . . . . . . . . . . . . . . . .53

ogram . . . . . . . . . . . . . . . . .54

Checking program settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Changing mode and effect . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Assigning activation type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Activating VIO 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Subprograms, changing between subprograms . . . . .

Functions in the “Menu” screen . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . .60

. . . . . . . . . . . . . . . . . . . . . . . . . . . . .61

Overwriting a modified program or saving as a new program . . . . . . . . . . . . .

. . . .47

. . . .48

. . . .49

. . . .54

. . . .55

. . . .57

. . . .58

. . . .64

6 Editing mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Authorized persons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67

Editing options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Renaming, adding and deleting elements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Creating a new program with two subprograms. . . . . . . . . . . . . . . . . . . . . . . . .

. . . .67

. . . .67

. . . .70

7 Description of receptacle hardware . . . . . . . . . . . . . . . . . . . . . . . . . 75

Individual socket configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75

Purchasing further receptacles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Monopolar socket MO 3-pin; 9/5 . . . . . . . . . . . . .

Monopolar socket MO 3-pin; Bovie . . . . . . . . . . . .

Bipolar socket BI 2-pin 22–28; 8/4 . . . . . . . . . . .

Multifunction socket MF . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . .75

. . . . . . . . . . . . . . . . . . . . . . . . . . .75

. . . . . . . . . . . . . . . . . . . . . . . . . . .76

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76

MF-U socket. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

return electrode socket NE 6; 2-pin. . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . .77

. . . .75

. . . .76

8 Monopolar CUT modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

autoCUT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79

highCUT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

®

dryCUT
endoCUT
endoCUT

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83

®

I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85

®

Q . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87

. . . .81

80114-601

03.16

9 Monopolar COAG modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

softCOAG®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89

forcedCOAG
swiftCOAG
sprayCOAG

preciseSECT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

twinCOAG

®

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91

®

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93

®

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .95

. . . .97

®

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .99

6 / 158

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Table of Contents

10 Bipolar CUT modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

autoCUT bipolar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

highCUT bipolar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . 103

11 Bipolar COAG modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

softCOAG® bipolar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

forcedCOAG
thermoSEAL

®

bipolar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108

®

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110

12 APC modes (only available with the APC module). . . . . . . . . . . . . 113

forcedAPC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113

preciseAPC
pulsedAPC

®

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

®

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117

13 Argon-supported modes (only available with the APC module) . . 119

autoCUT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

highCUT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

®

dryCUT
softCOAG
forcedCOAG
swiftCOAG

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

®

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

®

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

®

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129

preciseSECT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

twinCOAG

®

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

. . 121

. . 131

14 Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

Ambient conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

Electrical installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

80114-601

03.16

Installation of the rear of the VIO 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Installation of the VIO 3 on an overhead suspension arm system . . . . . . . . . . .

Installation of the VIO 3 on an Erbe equipment cart

. . . . . . . . . . . . . . . . . . . . . . . . 139

. . 136
. . 138
. . 139

15 Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

Wipe disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Instructions for cleaning and disinfection . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . 142

. . 142

16 Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143

17 General Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

18 Information on electromagnetic compatibility (EMC)

Guidelines for avoiding, recognizing and rectifying unwanted electromagnetic
effects on other equipment or systems, which are the result of operating the

O system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

VI

. . . . . . . . . . 151

. 149

. . 151

19 WiFi explanations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

Explanation on compliance with FCC Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

Explanation on compliance with IC Rules. . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . 155

7 / 158

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Table of Contents

20 Maintenance, Customer Service, Warranty, Disposal . . . . . . . . . . . 157

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

Customer service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . 157
. . 158
. . 158

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Chapter 1

DANGER

WARNING

CAUTION

NOTICE

Safety Instructions

Normal use

The VIO 3 can be combined with suitable Erbe units and modules (e.g. APC 3) and ac­cessories. The VIO 3 may only be used in rooms used for medical purposes. The VIO 3
may only be used by medical
unit or combination of units on the basis of the User Manual.

Intended use

The VIO 3 is an electrosurgical unit for cutting and coagulation, as well as for vessel
sealing. Thanks to its performance features, it offers universal applications.

1 • Safety Instructions

professionals who have been trained in the use of the

Safety notations

indicates an imminently hazardous situation which, if not avoided,
will result in death or serious injury.

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indicates a potentially hazardous situation which, if not avoided,
could result in death or serious injury.

indicates a potentially hazardous situation which, if not avoided, may
result in minor or moderate injury.

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 direct
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
servicing the unit.

Dok.-Nr: D110127-EN, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: MZECEVIC/02.06.16, Ausdruck nicht maßstäblich und kein Original.Dok.-Nr: D110127-EN, Ver.: 000, ÄM-Nr: 16446, Gültig ab: 10.05.16, Gedruckt: MZECEVIC/02.06.16, Ausdruck nicht maßstäblich und kein Original.

important or useful for operating or

ly or indirectly to the safety

9 / 158

1 • Safety Instructions

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, disa
read the User Manual.

Please pay particular attention to the s

ssembles, cleans and disinfects the unit must also

fety instructions in each chapter.

a

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 mea­sures alone.

Safety does not depend solely on the equipment. Safety d
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-

e who is working with the equipment.

on

epends to a large extent on

Structure of safety instructions

The safety instructions are structured according to the following risks:

• Operating errors and incorrect installation by

• Risks due to the environment

• Electric shock

• Fire / explosion

• Burns

• Risks due to incorrect use of the return electrode

• Defective unit

• Interference caused by the unit

• Damage to the unit and accessories

• Notes

persons without training

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1 • Safety Instructions

WARNING

NOTICE

NOTICE

NOTICE

Operating errors and incorrect installation by persons without training

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.

 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 ad­dress list at the end of this User Manual.

Risks due to the environment

Interference with the unit by portable and mobile HF communica­tion devices (e.g. mobile phones, WLAN equipment)

Electromagnetic waves emitted by portable and mobile HF commu­nication devices can effect the unit.

The unit may fail or not perform properly.

 Please see the table "Recommended separation distances be-

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tween portable and mobile HF communications equipment and
the equipment" at the end of this User Manual.

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.

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.

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1 • Safety Instructions

NOTICE

Insufficient acclimatization time, unsuitable temperature during
acclimatization

If the device was stored or transported below or above a certain tem­perature, 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 Data.

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 re­cesses is prohibited.

NOTICE

Penetration of liquid into the device

The housing is not absolutely watertight. If liquid penetrates, the de­vice 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 volt­age, 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.

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1 • Safety Instructions

WARNING

WARNING

DANGER

WARNING

DANGER

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.

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.

Flammable anesthetics

Risk of explosion to the patient and medical personnel! Risk of dam­age to property.

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 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.

Flammable gas mixture in TUR (Transurethral Resection) and TCR
(Transcervical Endometrial Resection)

Hydrogen and oxygen can ascend into the roof of the bladder, the
upper 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.

Flammable endogenous gases in the gastrointestinal tract

Risk of explosion to the patient!

 Extract the gases before performing electrosurgery or irrigate

with CO

.

2

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1 • Safety Instructions

WARNING

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.

 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 ar­gon 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 com­bustible materials.

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 fol­lows:

 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 elec­trosurgery.

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1 • Safety Instructions

WARNING

WARNING

WARNING

WARNING

Ignition of anesthetics, skin cleansers, and disinfectants in poten­tially explosive atmospheres

If you place the device in a potentially explosive atmosphere, anes­thetics, 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

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.

 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 in­validate liability on the part of Erbe Elektromedizin GmbH.

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HF leakage current flows through metal parts

The patient must not have contact with electrically conductive ob­jects. 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.

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 electrosurgery.

 Where possible, use monitoring electrodes that contain devices to

limit high-frequency current.

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1 • Safety Instructions

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 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.

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 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.

WARNING

Unintentional activation of the instrument during an endoscopic
application

If the instrument is activated and remains activated during an endo­scopic application, the patient can suffer burns when the instrument
is removed.

All points that come into contact with the active part of the instru­ment 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 acti­vation 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.

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1 • Safety Instructions

WARNING

WARNING

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.

Activation time too long, effects too high

The longer the activation 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!

 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

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phases between activations are sufficient.

 Set the effect as low as possible relative to the required surgical

effect. However, an effect level that is too low can be dangerous,
e.g. gas embolisms in connection with the APC (Argon Plasma Co­agulation), because the plasma does not ignite at an effect level
that is too low.

 If you are unable to achieve a surgical effect with an activation

time / effect level that is normally sufficient judging from experi­ence, this can be due to a problem with the electrosurgical unit or
accessories:

 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.

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.

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1 • Safety Instructions

WARNING

The user was not informed of a change in maximum activation
time

Risk of accidental tissue damage to the patient!

 All users must be informed in good time of any change in maxi-

mum activation time. That is, before the user works with the mod­ified maximum activation 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 rela­tively 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 instru­ment (electrode)

Risk of hand burns!

 Such practice is not recommended. The risk of burns cannot be

ruled out.

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