Erbe APC 3 User manual

80114-770_V23802 2021-01
USA
USER MANUAL
APC®3
V 1.3.x
PLASMASURGERY


USER MANUAL
APC®3

Erbe Elektromedizin GmbH owns these trademarks in the United States: APC, APC 300, AUTO CUT, BICLAMP, ENDO CUT, ERBE,
ERBECRYO, erbe power your performance., ERBEJET, ERBELIFT, ERBOKRYO, FIAPC, FORCED COAG, HYBRIDAPC, HYBRIDKNIFE,
ICC 200, KYRON, NESSY, NESSY Ω, PRECISE APC, PULSED APC, REMODE, SOFT COAG, SWIFT COAG, THERMO SEAL, TWIN COAG, VIO.
Erbe USA, Inc. owns these trademarks: CLEVERCAP, ECO2, ERBEFLO, ERBEFLO AeroRinse, THE TRUE BLUE PROBE FOR APC, THE
TRUE BLUE PROBE FOR ARGON PLASMA COAGULATION and the color blue for APC probes.
Caution: Federal law (USA) restricts this device to sale, distribution, or use by or on the order of a physician.
Device Art. No. 10135-000
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 2021
CE0124

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Table of Contents
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Table of Contents
1General Instructions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Intended Use / Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Qualification of user. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Performance characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Safety notations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Meaning of the note. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Who must read this User Manual? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
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
Malfunctions to other equipment caused by the unit, malfunctions to the unit
caused by other equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Electric shock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Fire / explosion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Burns. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Risk of infection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Inadvertent tissue damage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Stimulation of nerves and muscles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Risks due to incorrect use of the return electrode . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Defective unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Damage to the unit and accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Notes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3Additional safety instructions for APC . . . . . . . . . . . . . . . . . . . . . . . 23
Fire / explosion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Burns. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Risks due to gas embolisms or excessive intraluminal gas pressure. . . . . . . . . . . . 24
Risk of infection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Risks due to the pressure gas bottle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
4Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
APC 3 example accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Use of APC instruments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
5Description of the Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Controls on the front panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Controls on the back . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

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6Working with the APC 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Checking the unit and accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Automatic purging of the APC instrument. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Changing the argon flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Changing further APC settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
7Description of socket hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Individual socket configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
Purchasing further sockets. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
APC socket . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
8Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Ambient conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
State of the unit and accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
Risks due to the pressure gas bottle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
Installation of the VIO 3 on an APC 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42
Installation of the APC 3 on an overhead suspension arm system . . . . . . . . . . . . . .43
Installation of the APC 3 on an Erbe equipment cart . . . . . . . . . . . . . . . . . . . . . . . . .43
Installation of the rear of the APC 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44
Installation of the argon gas cylinder into the VIO Cart, connection of the
APC 3 pressure reducer with sensor to the cylinder and APC 3, as well as
disconnection of the cylinder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45
9Cleaning and disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Safety Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
Wipe disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
Selecting a suitable cleaning and disinfection agent . . . . . . . . . . . . . . . . . . . . . . . . .50
Instructions for cleaning and disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
10 Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
11 General Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
12 Information on electromagnetic compatibility (EMC) . . . . . . . . . . . 57
Guidelines for avoiding, recognizing and rectifying unwanted electromagnetic
effects on other equipment or systems, which are the result of operating the
VIO system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57
13 Maintenance, Customer Service, Warranty, Disposal . . . . . . . . . . . . 63
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
Customer Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
Warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
14 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

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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.
Note: Report serious incidents with the product to your local dealer or Erbe. If you are
a user in the European Union, also report incidents to the responsible authority in your
Member State.
Please observe the Warnings in Chapter 2.
Intended Use / Indications for Use
The Erbe APC 3 with accessories is intended to deliver argon gas for argon plasma co-
agulation and ablation of tissue as well as argon-assisted cutting of tissue when used
in conjunction with a compatible Erbe VIO Electrosurgical Generator (ESU) and appli-
cators or probes.
Compatibility
The Argon Plasma Coagulation (APC) Unit Model APC 3 is to be used with an Erbe Elec-
trosurgical Unit Model VIO 3 and argon gas. It can also be used in conjunction with oth-
er Erbe equipment (e.g. Erbe Water Jet Model ERBEJET 2, etc.) and associated instru-
ments.
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.
Performance characteristics
Performance characteristics relating to the intended use are:
Provision of a defined Argon gas flow.

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2 •Safety Instructions
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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 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.

2 •Safety Instructions
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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
•Malfunctions to other equipment caused by the unit, malfunctions to the unit
caused by other equipment
•Electric shock
•Fire / explosion
•Burns
•Risk of infection
•Inadvertent tissue damage
•Stimulation of nerves and muscles
•Risks due to incorrect use of the return electrode
•Defective 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.
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 USA. You will find the addresses in the address list
at the end of this User Manual.

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Risks due to the environment
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 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 re-
cesses is prohibited.
WARNING
Penetration of fluid into the device during operation or when
cleaning the device
Risk of electric shock to the medical personnel.
The unit may become damaged and fail.
Make sure no liquid can penetrate the device.
Do not place vessels containing liquids on top of the device.
If fluid has penetrated into the device, take the device out of op-
eration immediately. You can only start using the device again
once it has been checked by a service technician.

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Malfunctions to other equipment caused by the unit, malfunctions to
the unit caused by other equipment
WARNING
Interference with electronic equipment due to the electrosurgical
unit
The activated electrosurgical unit can affect the performance of elec-
tronic equipment by causing interference.
Risk of injury to the patient.
The equipment may fail or not perform properly.
Position the electrosurgical unit, the cords of the instruments, and
the cord of the return electrode as far away as possible from elec-
tronic equipment.
Position the cords as far away as possible from the cords of elec-
tronic equipment.
WARNING
Stacked devices
If you place the device next to or stack it with other equipment, the
devices may affect each other.
Risk of injury to the patient.
The unit may fail or not function properly.
The unit may only be placed next to or stacked with VIO-series de-
vices.
If it is necessary to operate the device near or stacked together
with non-VIO-series equipment, keep as much distance as possi-
ble between the devices. Check whether the devices are affecting
each other: Are the devices behaving unusually? Are faults occur-
ring?
WARNING
Use of non-approved EMC-relevant accessories
This can result in the increased emission of electromagnetic interfer-
ence or reduce the electromagnetic immunity of the device.
Risk of injury to the patient.
The unit may fail or not function properly.
Only use cable that is specified in the table “EMC-relevant acces-
sories“, see chapter “Information on electromagnetic compatibil-
ity (EMC)“.
If you are using accessories from other manufacturers, check
whether the Erbe device is interfering with other devices or being
affected by interference itself. You cannot use the device if there
is any interference.
WARNING
Interference with cardiac pacemakers, internal defibrillators, or
other active implants
Activation of the electrosurgical unit may affect the performance of
active implants or damage them.
Risk of injury or death for patients!

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In the case of patients having active implants, consult the manu-
facturer of the implant or the competent department of your hos-
pital prior to performing surgery.
Do not position the return electrode near cardiac pacemakers, in-
ternal defibrillators, or other active implants.
WARNING
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.
Risk of injury to the patient.
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.
Electric shock
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.
WARNING
The user touches the patient and the connections on the unit at
the same time.
The patient can be put at risk by compensating currents.
Risk of injury to the patient. The unit can fail.
Do not touch the patient and the connections on the unit at the
same time.
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.
WARNING
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.

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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.
WARNING
Flammable endogenous gases in the gastrointestinal tract
Risk of explosion to the patient!
Extract the gases before performing electrosurgery or irrigate
with CO2.
Or scavenge with argon.
WARNING
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 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.

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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.
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.
CAUTION
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.

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2021-01
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.
CAUTION
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.
CAUTION
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.
WARNING
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.

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2 •Safety Instructions
80114-770_V23802
2021-01
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 so that they are as far apart as pos-
sible.
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.
In electrosurgical contact procedures: Touch the tissue before ac-
tivating the instrument.
In electrosurgical non-contact procedures (APC, spray coagula-
tion): Place the instrument at the usual working distance from the
tissue before activating the instrument.
WARNING
Capacitive coupling between the instrument and the hybrid trocar
When an instrument is activated, current can be transferred to the
trocar without any contact (capacitive coupling).
Risk of burns to the patient and medical personnel!
Do not use hybrid trocars (i.e., a combination of metal and plastic)
if you are using monopolar instruments.

2 •Safety Instructions
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80114-770_V23802
2021-01
WARNING
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
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 with the APC (Argon Plasma Coagulation), be-
cause 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 sufficient judging from experience, this
can be due to a problem with the electrosurgical unit or accesso-
ries:
Check the instrument regularly for soiling with insulating tissue
remnants. Clean the instrument if it has become soiled.
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 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 mod-
ified 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 rela-
tively small cross-section, there is a risk of unintentional coagulation
for the patient!
If possible, use the bipolar coagulation technique.

19 / 70
2 •Safety Instructions
80114-770_V23802
2021-01
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.If signal is
still not audible, please contact Erbe USA.
WARNING
Undesirable contact between the active instrument and metal
objects in or on the patient’s body. The active instrument is too
close to metallic objects in or on the patient’s body.
Contact with metal hemostatic clamps or too close to metal hemo-
static clamps, etc.
Risk of burns to the patient!
Do not touch metal objects in or on the patient’s body with the ac-
tive instrument.
Keep the active instrument as far away as possible from metallic
objects in or on the patient's body.
WARNING
A hand-held metal instrument is touched with the active instru-
ment (electrode)
Risk of hand burns!
Do not touch a hand-held metal instrument with the active instrument.
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.
WARNING
The instrument is inserted into an adapter or cable that is plugged
into an activated socket
Risk of burns to the patient and medical personnel!
Do not insert instruments into an adapter that is plugged into an
activated socket.
Do not insert instruments into a cable that is plugged into an ac-
tivated socket.
CAUTION
Activation of the unit during cleaning of an instrument
Risk of burns for the medical personnel!
Do not activate the unit while you are cleaning an instrument.

2 •Safety Instructions
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80114-770_V23802
2021-01
Risk of infection
WARNING
The unit is contaminated
Danger of infection to the patient and medical personnel.
Follow the instructions for cleaning and disinfecting the unit.
WARNING
Alternate use of disinfectant solutions based on different active
ingredients
The agents may affect one another. The disinfection effect of the dis-
infectant solution may be weakened. Danger of infection to the pa-
tient and medical personnel.
The housing plastic may become brittle and break. A color reaction
may occur with plastics.
Do not use these substances alternately.
Inadvertent tissue damage
WARNING
Unwanted spark formation in the softCOAG, softCOAG argon, soft-
COAG bipolar, thermoSEAL modes
Risk of thermal damage to tissue.
If you see a spark, end activation.
If the error reoccurs, inform Technical Service.
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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