Professional Documents
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User Manual APC 3
User Manual APC 3
User Manual APC 3
APC 3
V 1.2.x
CE0124
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 2020
Table of Contents
Table of Contents
2 Safety 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
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Burns. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Risk of infection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Inadvertent tissue damage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
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4 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
APC 3 example accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Use of APC instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
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Table of Contents
8 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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
Fixing argon pressure cylinders, connection of the working cylinder,
detachment of the working cylinder on the VIO CART . . . . . . . . . . . . . . . . . . . . . . . .44
Refilling the working bottle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47
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Wipe disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
Selecting a suitable cleaning and disinfection agent . . . . . . . . . . . . . . . . . . . . . . . . .50
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Instructions for cleaning and disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
10 Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
14 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
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1 • General Instructions for Use
Chapter 1
General Instructions for Use
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-
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er Erbe equipment (e.g. Erbe Water Jet Model ERBEJET 2, etc.) and associated instru-
ments.
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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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1 • General Instructions for Use
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8 / 66
2 • Safety Instructions
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
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2 • Safety Instructions
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• Risks due to incorrect use of the return electrode
2020-12
• Defective unit
• Damage to the unit and accessories
• Notes
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 Elektromedizin. You will find the addresses in the ad-
dress list at the end of this User Manual.
10 / 66
2 • Safety Instructions
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
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acclimatization
If the device was stored or transported below or above a certain tem-
2020-12
NOTICE
Overheating of the device due to poor ventilation
If ventilation is poor, the device can overheat, sustain damage, and
fail.
Install the device in such a way that there is an unobstructed cir-
culation of air around the housing. Installation in confined wall re-
cesses is prohibited.
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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2 • Safety Instructions
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.
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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
2020-12
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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2 • Safety Instructions
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-
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ment cart.
2020-12
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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2 • Safety Instructions
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
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being performed on the head or thorax.
If use is unavoidable, you must extract the combustion-support-
2020-12
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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2 • Safety Instructions
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.
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Burns
2020-12
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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2 • Safety Instructions
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
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Unintentional activation of the instrument
Risk of burns to the patient and medical personnel!
2020-12
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
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.
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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.
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2 • Safety Instructions
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
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If the user does not understand the active settings of the unit, he can
cause the patient accidental tissue damage.
2020-12
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.
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2 • Safety Instructions
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 or on the patient’s body
Contact with metal hemostats, etc.
Risk of burns to the patient!
Do not touch metal objects in or on the patient’s body with the ac-
tive instrument.
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 instru-
ment.
CAUTION
HF leakage current flows through the skin of medical personnel
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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.
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.
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2 • Safety Instructions
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.
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-
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surgery.
Ensure that there is a sufficient safety margin between the active
2020-12
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.
WARNING
Low-frequency currents stimulate nerves and muscles (Neuro-
muscular Stimulation)
Low-frequency currents arise either due to low-frequency power
sources or partial rectification of the HF current. Spasms or muscle
contractions can occur.
Risk of injury to the patient.
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2 • Safety Instructions
Defective unit
WARNING
Undesirable rise in output level due to failure of electrosurgical
unit
Risk of accidental tissue damage to the patient!
The device shuts off independently.
To guard against a possible failure of the electrosurgical unit,
have the device checked for safety at least once a year.
WARNING
Technical safety checks not being done
Risk of injury or death for patients and medical staff! Risk of damage
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to property.
Have the device checked for safety at least once a year.
2020-12
WARNING
Failure of display elements
If display elements fail, you can no longer operate the device safely.
Risk of injury or death for patients and medical staff!
You must not use the unit.
WARNING
Electric load on instrument too high
The instrument can be damaged.
If the damaged area comes into contact with tissue, it can lead to un-
intentional coagulation.
Determine the electrical capacity of the instrument. It is either
printed on the instrument or can be found in the user manual.
Compare the electrical capacity of the instrument with the maxi-
mum HF peak voltage of the required mode.
Instructions are available in the "Accessories" chapter of the VIO
user manuals.
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2 • Safety Instructions
WARNING
Use of non-approved internal cables by Technical Service
This can result in the increased emission of electromagnetic waves or
reduce the immunity of the device.
Risk of injury to the patient.
The unit may fail or not perform properly.
Technical Service may only use the internal cables that are listed
in the service manual for the device.
Notes
Grounding Note: If necessary, the equipment can be connected to the external grounding system
of the room with the grounding pin on the back of the unit and/or Cart using a con-
necting cable designed for this purpose. Affects of low frequency leakage currents due
to a defective grounding system within the room may be eliminated through external
grounding.
Use of a defibrillator Note: All HF sockets and the return electrode socket (applied parts) meet Type CF re-
quirements and are protected against the effects of defibrillator discharge.
Measures against smoke during Note: Erbe recommends using a smoke extraction system, protective goggles, and a
electrosurgical procedures respirator.
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22 / 66
3 • Additional safety instructions for APC
Chapter 3
Additional safety instructions for APC
Fire / explosion
WARNING
Hot tissue, combustible materials, and oxygen in the tracheobron-
chial system
Due to APC the tissue can become so hot that it can ignite combusti-
ble materials in the vicinity, e.g. due to hot particles flying around.
Combustible materials are, for example, plastic insulation at the distal
80114-757_V23449
WARNING
Combustible gas mixture in the tracheobronchial system
Hemostasis and devitalization of tissue produce smoke. In conjunc-
tion with oxygen a highly combustible gas mixture develops.
Risk of burns to the patient!
Short activation pulses reduce development of the gas mixture.
Extract the gas mixture.
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3 • Additional safety instructions for APC
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.
Burns
CAUTION
An active APC electrode comes into contact with tissue during
coagulation
There is a cutting effect and uncontrolled coagulation!
Do not touch tissue with an active APC electrode during coagula-
tion.
CAUTION
The activated APC applicator presses into tissue or against the
organ wall
Risk of emphysemas / wall lesions!
Do not press the activated APC applicator into tissue or against
the organ wall.
80114-757_V23449
Risks due to gas embolisms or excessive intraluminal gas pressure
2020-12
WARNING
The activated APC applicator is pointing at an open vessel, argon
flow is too high, the power setting is too low
Risk of gas embolisms!
Do not point the APC applicator at open vessels.
Set argon flow as low as possible.
Do not press the activated APC applicator into tissue or against
the organ wall.
Observe the settings for APC recommended by Erbe.
WARNING
The argon introduced can not escape from body cavities
Risk of intraluminal pressure rise and distension! Risk of gas embo-
lisms!
Check intraluminal gas pressure regularly.
Extract.
Introduce a decompression catheter if required.
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3 • Additional safety instructions for APC
Risk of infection
WARNING
Body fluid flows to the argon connector on the device, particles
are blown from the device to the patient
Risk of infection!
Use an instrument with an integrated filter.
Do not touch the argon connector.
WARNING
Damage to the gas bottle or valve. Gas emerges at high pressure.
If the gas bottle has been weakened due to serious damage, this can
lead to cracks in the wall of the bottle. Considerable stresses and
strains occur at the cracks, causing the bottle to break open. Gas
emerges at high pressure. The gas bottle is propelled like a rocket.
Risk of injury or death for patients and medical staff! Risk of damage
to property.
Do not apply force to gas bottles, bottle connectors, valves, or
pressure regulators.
When transporting, storing, and using the gas bottle, prevent it
from falling over and dropping by securing it with chains, hoops,
80114-757_V23449
or retaining straps.
Only transport gas bottles with the valve guard fitted: bottle cap
or bottle collar.
2020-12
WARNING
Incorrect pressure regulator, incorrect pressure lines
The device has a certain input pressure. You will find it in the Techni-
cal Data.
If you connect the wrong pressure regulator or wrong pressure lines,
there is a risk of a gas embolism for the patient.
If you connect up the wrong pressure regulator or wrong pressure
lines, the device can be damaged.
Only connect argon bottles to the device using the pressure reg-
ulator and pressure lines specified by Erbe.
WARNING
Wrong gas
The device may only be operated with argon.
Risk of injury or death for patients and medical staff! Risk of damage
to property.
Check whether the gas bottle actually contains argon. Labels on
the gas bottle must not be damaged or removed.
Use argon 4.8 (99.998% purity) or higher, e.g. argon 5.0.
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3 • Additional safety instructions for APC
WARNING
Uncontrolled escape of argon
If the gas accumulates in air you are breathing, there is a risk of suf-
focation. Symptoms include drowsiness, rise in blood pressure, and
respiratory distress. In an atmosphere of pure argon a person would
fall unconscious immediately without any warning and suffocate.
When bottle valves are opened, there is a brief hissing sound. If
the hiss continues for more than 2 seconds, there is a leak. The
gas bottle must be closed again immediately. The device may only
be used when the leak has been stopped by a competent techni-
cian.
Make sure the connections of the pressure lines to the APC 3 are
gastight. The same applies to the connection of the pressure reg-
ulator to the gas bottle.
Close the safety valves on the gas bottles after use,
80114-757_V23449
2020-12
26 / 66
4 • Accessories
Chapter 4
Accessories
Introduction
The following offers an overview of example accessories for each accessory category.
A complete overview is available in the Erbe accessories catalog and on the Erbe web-
site. We recommend the use of Erbe accessories.
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4 • Accessories
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2020-12
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4 • Accessories
29 / 66
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4 • Accessories
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2020-12
5 • Description of the Controls
Chapter 5
Description of the Controls
Interconnections
Instrument
sockets
Fig. 5-1
Read the user manual before switching on and using the unit.
2020-12
31 / 66
5 • Description of the Controls
Fig. 5-2
Purge pin
Serves to purge the residual argon from the pressure line when changing the gas bot-
tle.
Argon connector
Connection for the pressure line from the gas bottle or from the central gas supply.
Pressure sensor terminal
Connection for the high pressure sensor of the argon bottle.
80114-757_V23449
Grounding terminal connection
2020-12
If necessary, connect the grounding pin of the unit to the grounding system of the op-
erating room using a grounding cable.
32 / 66
6 • Working with the APC 3
Chapter 6
Working with the APC 3
The APC 3 can only be operated together with the VIO 3. For this reason, you must be
familiar with the VIO 3 User Manual in order to work with the APC 3.
You can only connect an APC instrument and one further HF instrument to the APC 3
instrument sockets. You call up the instruments on the VIO 3 touchscreen and set the
VIO 3 on the touchscreen.
You will find the workflows, windows, screens, controllers, etc. in the VIO 3 User Man-
ual. Therefore, only the special features for using an APC instrument are examined at
this point.
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.
80114-757_V23449
Check the device and accessories for damage every time before
using them (e.g. footswitch, cords of instruments and the return
2020-12
33 / 66
6 • Working with the APC 3
Depending on the application, a lower argon flow may be appropriate (e.g. the risk of
blowing argon into body cavities, gas embolism) or also a higher flow.
1. If the instrument symbol for the required instrument is not highlighted, touch the
relevant instrument symbol.
Fig. 6-1
80114-757_V23449
2020-12
Fig. 6-2
The window with the effect display and the display for the Argon flow opens.
3. Touch the display for the Argon flow.
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6 • Working with the APC 3
Fig. 6-3
ists.
You can only save modified programs if you have access to the unit’s Protected set-
2020-12
35 / 66
6 • Working with the APC 3
Fig. 6-4
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2020-12
36 / 66
7 • Description of socket hardware
Chapter 7
Description of socket hardware
APC socket
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2020-12
Fig. 7-1
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7 • Description of socket hardware
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38 / 66
8 • Installation
Chapter 8
Installation
Ambient conditions
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.
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.
80114-757_V23449
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.
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8 • Installation
NOTICE
Insufficient acclimatization time, unsuitable temperature during
acclimatization
If the device was stored or transported below or above a certain tem-
perature, it will take a certain time and temperature to acclimatize.
If you do not observe the rules, the device can sustain damage and
fail.
Acclimatize the device according to the rules in the Technical Da-
ta.
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.
80114-757_V23449
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
2020-12
once it has been checked by a service technician.
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.
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8 • Installation
WARNING
Damage to the gas bottle or valve. Gas emerges at high pressure.
If the gas bottle has been weakened due to serious damage, this can
lead to cracks in the wall of the bottle. Considerable stresses and
strains occur at the cracks, causing the bottle to break open. Gas
emerges at high pressure. The gas bottle is propelled like a rocket.
Risk of injury or death for patients and medical staff! Risk of damage
to property.
Do not apply force to gas bottles, bottle connectors, valves, or
pressure regulators.
When transporting, storing, and using the gas bottle, prevent it
from falling over and dropping by securing it with chains, hoops,
or retaining straps.
Only transport gas bottles with the valve guard fitted: bottle cap
or bottle collar.
Prevent the argon pressure bottle from being heated by radiators
or naked flames. The surface temperature must not exceed 50 °C.
WARNING
Incorrect pressure regulator, incorrect pressure lines
The device has a certain input pressure. You will find it in the Techni-
cal Data.
If you connect the wrong pressure regulator or wrong pressure lines,
80114-757_V23449
WARNING
Wrong gas
The device may only be operated with argon.
Risk of injury or death for patients and medical staff! Risk of damage
to property.
Check whether the gas bottle actually contains argon. Labels on
the gas bottle must not be damaged or removed.
Use argon 4.8 (99.998% purity) or higher, e.g. argon 5.0.
WARNING
Uncontrolled escape of argon
If the gas accumulates in air you are breathing, there is a risk of suf-
focation. Symptoms include drowsiness, rise in blood pressure, and
respiratory distress. In an atmosphere of pure argon a person would
fall unconscious immediately without any warning and suffocate.
When bottle valves are opened, there is a brief hissing sound. If
the hiss continues for more than 2 seconds, there is a leak. The
gas bottle must be closed again immediately. The device may only
be used when the leak has been stopped by a competent techni-
cian.
41 / 66
8 • Installation
Make sure the connections of the pressure lines to the APC 3 are
gastight. The same applies to the connection of the pressure reg-
ulator to the gas bottle.
Close the safety valves on the gas bottles after use,
Fig. 8-1
1. Screw the fixing bracket (1) to the rear of the VIO 3 (2.5 mm hex socket wrench).
80114-757_V23449
2020-12
Fig. 8-2
2. Pull off the cap* (1) from the HF contacts on the base plate of the VIO 3. For this
purpose, use the removal tool (40135-004). You may only remove the cap if you
install the VIO 3 on an APC 3. When the unit is activated, the interconnections
carry HF voltage. Keep the cap in a safe place. If you disconnect the VIO 3 from the
APC 3, you must replace the cap on the interconnections.
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8 • Installation
Fig. 8-3
Fig. 8-4
5. Screw the fixing bracket (1) to the rear of the APC 3 (2.5 mm hex socket wrench).
*Meaning of the symbols on the cap:
43 / 66
8 • Installation
Fig. 8-5
Purge pin
Serves to purge the residual argon from the pressure line when changing the gas bot-
tle.
Argon connector
Connection for the pressure line from the gas bottle or from the central gas supply.
Pressure sensor terminal
Connection for the high pressure sensor of the argon bottle.
80114-757_V23449
Grounding terminal connection
2020-12
If necessary, connect the grounding pin of the unit to the grounding system of the op-
erating room using a grounding cable.
Fig. 8-6
Press the bottle pad (1) into the left corner of the VIO CART. Should you wish to place
a reserve bottle in the right corner, install a bottle pad there too.
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8 • Installation
Fig. 8-7
Thread the fixing strap into the left eyelet of the VIO CART (1). The fluffy side of the
fixing strap has to face outwards. Should you wish to place a reserve bottle in the right
corner, thread a fixing strap there too.
Fig. 8-8
Place the working bottle into the recess. Place the reserve bottle, if present, on the
right next to it.
Hook the fixing strap into the eyelet (1). Secure the fixing strap with the Velcro strip
(2). If you use a reserve bottle, secure this in the same way.
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8 • Installation
Fig. 8-9
80114-757_V23449
of the pressure regulator by hand (clockwise on the bottle). Do not use tools! To
avoid contamination of the valve connection, screw the pressure regulator onto
2020-12
the bottle immediately.
2. Route the pressure line and the high pressure sensor cable through the opening
(3) above the argon gas bottle.
Fig. 8-10
1. Attach the connector on the pressure line (1) to the argon connector of the APC 3.
2. Attach the high pressure sensor cable (2) to the pressure sensor terminal of the
APC 3. Tighten the retainer nut by hand.
3. Open the bottle valve (2) smoothly by turning the handwheel counter-clockwise.
After one turn, the bottle valve is fully open (see Fig. 8-9).
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8 • Installation
6. Dismantling empty bottles 1. Close the bottle valve by turning the handwheel clockwise. The bottle valve may
be a little difficult to turn in some cases.
2. Pull off the pressure line from the argon bottle connector of the APC 3.
3. Place the opening of the pressure line on the drainage pin (3) of the APC 3 and
press. There is still residual argon in the line. This now escapes with a loud hissing
sound.
4. Turn the retainer nut of the pressure regulator counter-clockwise by hand and
take down the pressure regulator.
47 / 66
48 / 66
8 • Installation
80114-757_V23449
2020-12
9 • Cleaning and disinfection
Chapter 9
Cleaning and disinfection
Safety Instructions
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 unit is contaminated
Danger of infection to the patient and medical personnel.
Follow the instructions for cleaning and disinfecting the unit.
WARNING
80114-757_V23449
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.
49 / 66
9 • Cleaning and disinfection
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.
Wipe disinfection
For cleaning and disinfecting the surfaces of the unit or of the equipment cart, Erbe
recommends a wipe disinfection. Use only disinfectant which complies with the rele-
vant national standards.
Observe the cleaning agent and disinfectant manufacturer’s instructions for use re-
garding material compatibility.
80114-757_V23449
• Agents based on formaldehyde/glutaraldehyde compounds
• Alcohol-based agents
2020-12
• Agents based on guanidine
• Agents based on active oxygen-based per compounds
• Agents based on peracetic acid
• Chlorine-based agents
Frequent use of the abovementioned agents may cause harmless discoloration to sur-
faces.
Do not use a cleaning and disinfection agent containing the following substances:
• Sodium hydroxide, strong organic acids, strong oxidizing agents, and agents with
a high chlorine content
These substances may attack metal parts due to their corrosive effect.
• Quaternary ammonium cations, phenolic compounds (e.g., phenoxyethanol)
• Solvents and benzine
These substances cause damage to plastics.
50 / 66
9 • Cleaning and disinfection
3. Carry out a visual inspection after cleaning. If you find any residual contamination,
repeat cleaning until all contamination has been removed.
4. Carry out wipe disinfection. Make sure the surfaces are treated uniformly. Observe
the information provided by the manufacturer regarding the prescribed reaction
time.
What should you do if it is not Note: If it is not possible to carry out a full clean, do not carry out a wipe disinfection.
possible to carry out a full clean? Do not use the device. Contact Technical Service.
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9 • Cleaning and disinfection
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52 / 66
10 • Messages
Chapter 10
Messages
A message consists of a title, a message text and a code. The VIO system displays three
different types of messages:
a) Messages that prompt you to inform Technical Service, as the VIO 3 or a VIO module
(e.g. APC 3) cannot be used. These messages are not listed individually in the User
Manual, because the messages only differ in their code. The title and the message text
are all identical: Note: The unit cannot be used. Please contact the service department.
b) Status messages.
c) Messages that prompt you to take action.
Messages of categories b) and c) that concern APC 3 are found in the following table.
The messages are sorted alphabetically by their code.
APC-A-10 Argon - high input pressure The input pressure of the APC 3 argon plasma module is too high.
Check the pressure regulator and the gas bottle.
If you do not use gas bottles, check the pressure of the central gas
80114-757_V23449
supply.
Please contact the service department.
2020-12
APC-A-11 Argon gas (Ar) Argon gas is required for the selected program, but no argon gas
pressure is detected.
Connect the gas hose at the rear of the APC 3 argon plasma module.
APC-A-12 Argon gas (Ar) Argon gas is required for the selected program, but no argon gas
pressure is detected.
Connect the sensor cable of the pressure regulator to the APC 3
argon plasma module.
Connect the gas hose at the rear of the APC 3 argon plasma module.
If you work with a central gas supply, switch to "Central gas supply"
under "Further settings".
APC-A-13 Argon gas flow blocked Ensure that the APC instrument is free from blockages.
APC-A-148 Gas bottle almost empty The supply in the argon gas bottle is almost used up.
Change the argon gas bottle at the next opportunity.
APC-A-150 Argon gas pressure regulator No signal is detected from the fill level sensor of the argon gas bottle.
Connect the sensor cable of the pressure regulator to the APC 3
argon plasma module.
If you work with a central gas supply, switch to "Central gas supply"
under "Further settings".
53 / 66
10 • Messages
APC-A-151 Argon gas (Ar) Argon gas is required for the selected program, but no argon gas
pressure is detected.
Connect the gas hose at the rear of the APC 3 argon plasma module.
S-A-152 APC instrument Automatic argon gas filling of the instrument has been started.
S-A-166 APC 3 argon plasma module The argon plasma module APC 3 is not ready for operation.
Open the valve of the argon gas bottle.
Ensure that the gas hose and the sensor cable of the pressure regu-
lator are connected at the rear of the APC 3 argon plasma module.
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54 / 66
11 • General Technical Data
Chapter 11
General Technical Data
Connections
Gas specification
Argon minimum purity Argon 4.8 (99.998% purity) or higher, e.g. argon 5.0.
Adjustable gas flow 0.1 - 8 l/min limited by the respective instrument connected,
settable in 0.1 l steps
Tolerance of the nominal flow ±20% (in the range 0.1 - 8 l/min)
If you use a compressed gas bottle, the residual volume dis- 25 x 105 Pa 25 bar 362.6 psi ±7.5 FS1
play is activated at
1Tolerance in relation to the entire measuring range of the
55 / 66
11 • General Technical Data
The APC 3 switches off at an input pressure of < 3 x 105 Pa < 3 bar < 43.5 psi
Weight 5.3 kg
80114-757_V23449
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Acclimatizing
If the unit has been stored or transported at temperatures below +10 °C or above +40 °C, the unit will require approx. 3 hours
to acclimatize at room temperature.
Standards
56 / 66
12 • Information on electromagnetic compatibility (EMC)
Chapter 12
Information on electromagnetic
compatibility (EMC)
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 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.
57 / 66
12 • Information on electromagnetic compatibility (EMC)
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
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.
80114-757_V23449
The unit may fail or not perform properly.
When using portable and mobile HF telecommunications devices,
2020-12
including their accessories, there must be a distance of at least
30 cm between them and the device and its cords.
WARNING
Use of non-approved internal cables by Technical Service
This can result in the increased emission of electromagnetic waves or
reduce the immunity of the device.
Risk of injury to the patient.
The unit may fail or not perform properly.
Technical Service may only use the internal cables that are listed
in the service manual for the device.
The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the
equipment should ensure that it is used in such an environment.
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12 • Information on electromagnetic compatibility (EMC)
HF emissions CISPR 11 Class A The properties of this device in terms of its emissions
mean it can only be used in medical facilities that are
Harmonic emissions IEC 61000-3-2 Class A connected to supply systems specifically provided for
Voltage fluctuations/flicker emissions Complies that purpose (usually supplied via isolating transform-
IEC 61000-3-3 ers). For domestic use (for which class B is usually
required as per CISPR 11), this device may not offer
adequate protection against radio services. The user
may need to take corrective measures such as relocat-
ing or reorienting the device.
The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the
equipment should ensure that it is used in such an environment.
Immunity test IEC 60601-1-2 test level Compliance level Electromagnetic environment
- guidance
Discharge of static ±8 kV contact discharge ±8 kV contact discharge The floor should be made from
electricity (ESD) in wood or concrete or be covered
accordance with ±15 kV air discharge ±15 kV air discharge with ceramic tiles. If the floor is
IEC 61000-4-2 covered with non-conductive
synthetic material, the relative
humidity must be at least 30%.
Electrical fast tran- ±2 kV for power supply lines ±2 kV for power supply lines Mains power quality should be
sient/burst IEC 61000- that of a typical commercial or
80114-757_V23449
Surge IEC 61000-4-5 ±1 kV differential mode ±1 kV differential mode Mains power quality should be
2020-12
Voltage dips, short- 0% UT for 0.5 cycle, 0% UT for 0.5 cycle, Mains power quality should be
term interruptions and at 0, 45, 90, 135, 180, 225, at 0, 45, 90, 135, 180, 225, that of a typical commercial or
voltage fluctuations on 270 and 315 degrees 270 and 315 degrees hospital environment.
power supply input
lines as per 0% UT for 1 cycle, 0% UT for 1 cycle, If the user of the equipment
IEC 61000-4-11 single-phase at 0 degrees single-phase at 0 degrees requires continued operation
during power mains interrup-
70% UT for 25/30 cycles, 70% UT for 25/30 cycles, tions, it is recommended that
single-phase at 0 degrees single-phase at 0 degrees the equipment be powered
Voltage monitoring as 0% UT for 250/300 cycles 0% UT for 250/300 cycles from an uninterruptible power
per IEC 61000-4-11 (50/60 Hz) (50/60 Hz) supply or a battery.
Note: UT is the a.c. mains voltage prior to application of the test level.
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12 • Information on electromagnetic compatibility (EMC)
The equipment is intended for use in the electromagnetic environment specified below. The user of the equipment should
ensure that it is used in such an environment.
Immunity test IEC 60601-1-2 test Compliance level Electromagnetic environment - guidance
level
Conducted HF distur- 3 Veff 3 Veff The field strengths of fixed transmitters, as deter-
bances as per 150 kHz to 80 MHz 150 kHz to 80 MHz mined by an electromagnetic site survey should be
IEC 61000-4-6 below the compliance level in each frequency
6 Veffa) in ISM fre- 6 Veffa) in ISM fre- range. b)
quency bands quency bands
150 kHz to 80 MHz 150 kHz to 80 MHz Interference may occur in the vicinity of equipment
marked with the following symbol.
Radiated high-fre- 3 V/m 3 V/m
quency electromag- 80 MHz to 2.7 GHz 80 MHz to 2.7 GHz
netic fields as per
IEC 61000-4-3
Note: These guidelines may not apply in all cases. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
a)
The ISM bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz, 13.553 MHz to 13.567 MHz, 26.957 MHz to
27.283 MHz and 40.66 MHz to 40.7 MHz.
b)
The field strengths of fixed transmitters, such as base stations for radio (cellular/cordless) telephones and terrestrial radio
equipment, amateur radio stations, AM and FM radio and TV channels cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment with regard to fixed transmitters, a site inspection should be considered. If the field
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strength measured at the site where the device is used exceeds the abovementioned compliance level, the device must be
monitored to ensure it is functioning properly. In the event of any unusual operating behavior, additional measures may be
required, such as changing the orientation or location of the device.
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Electromagnetic immunity against high-frequency wireless communication devices as per IEC 61000-4-3
Frequency band (MHz) Test frequency (MHz) Modulation Compliance level (V/m)
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12 • Information on electromagnetic compatibility (EMC)
Electromagnetic immunity against high-frequency wireless communication devices as per IEC 61000-4-3
Note: A minimum safety distance of 30 cm should be maintained between the device and portable HF telecommunications
equipment that transmits in the stated frequency band. This includes mobile phones, WLAN and RFID, and Bluetooth devices.
Failure to comply may lead to a reduction in the device’s performance features.
Interference may occur in the vicinity of equipment marked with the following symbol.
a) The pulse modulation is defined as a square-wave signal with a 50% duty factor.
The cables/cords used on the device must not exceed the lengths specified below.
EMC-relevant accessories a)
Multifunction cable 4 m b)
APC cable 6m
a) EMC-relevant accessories refers to the cable specified. The cable can affect the device’s electromagnetic interference or
the electromagnetic immunity of the device.
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b) When connecting Erbe instruments, the overall cord length increases by max. 0.5 m.
Operating environment
For the intended use, the unit may only be operated in premises used for medical pur-
poses.
The device may be operated in the vicinity of an electrosurgical unit. The safety in-
structions for the device and the electrosurgical unit must be observed. Please read
the safety instructions on the following subjects in particular:
• distance between the device and the electrosurgical unit. In this user manual,
refer to the safety instruction Stacked devices.
• Distances between the device and the electrosurgical unit’s cords.
• Distances between the device's cords and the electrosurgical unit’s cords.
Position the devices and cords so that they are as far apart as possible.
Essential performance features
The device does not have any essential performance features within the meaning of
IEC 60601-2-2.
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12 • Information on electromagnetic compatibility (EMC)
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13 • Maintenance, Customer Service, Warranty, Disposal
Chapter 13
Maintenance, Customer Service, Warranty,
Disposal
Maintenance
Modifications and repairs Modifications and repairs must not impair the safety of the equipment or equipment
cart and accessories for the patient, user and the environment. This condition is met
when changes to the structural and functional characteristics are not detrimental to
safety.
Authorized persons Modifications and repairs may only be undertaken by Erbe or by persons expressly au-
thorized by Erbe. Erbe accepts no liability if modifications and repairs to the unit or
accessories are made by unauthorized persons. This will also invalidate the warranty.
Technical safety checks The technical safety checks determine whether the safety and operational readiness
of the unit or the equipment cart and accessories conform to a defined technical re-
quired status. Technical safety checks must be performed at least once a year.
What technical safety checks must For this device the following technical safety checks have been stipulated:
be performed?
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Customer service
If you are interested in a maintenance contract, please contact Erbe Elektromedizin in
Germany, or your local contact in other countries. This may be an Erbe subsidiary, an
Erbe representative or a distributor.
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13 • Maintenance, Customer Service, Warranty, Disposal
Warranty
The General Terms and Conditions or the conditions of the purchase contract apply.
Disposal
Your product bears a crossed-out garbage can icon (see picture). Meaning: In all EU
countries this product must be disposed of separately in accordance with the national
laws implementing EU Directive 2012/19/EU of 07/04/2012, WEEE.
In non-EU countries the local regulations must be observed.
If you have any questions about disposal of the product, please contact Erbe Elektro-
medizin or your local distributor.
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14 • Symbols
Chapter 14
Symbols
Individual details of the symbols in this chapter may deviate from your product. Not all
symbols may necessarily appear on your device or its packaging.
Symbol Explanation
Catalogue number
Serial number
Manufacturer
Date of manufacture
Keep dry
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Temperature limit
Humidity limitation
Quantity (x)
X
Warning; Electricity
Foot switch
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14 • Symbols
Symbol Explanation
Equipotentiality
Refers to the grounding terminal.
Off, On
Computer network
Refers to the computer network itself or the network connections.
Input
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European conformity marking
CE
Medical device
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