Erbe APC 300 User manual

APC 300
Handbook Standard Version
04.05
V 2.xx

ERBE APC 300
Handbook Standard Version

Manual part number: 80110-051
All rights reserved. No part of this document may be translated, stored in information retrieval systems, or
transmitted in any form or by any means - electronic or mechanical, including photocopying, recording or
otherwise - without the written permission of ERBE Elektromedizin.
Printed by: ERBE Elektromedizin
Printed in Germany
Copyright © ERBE Elektromedizin GmbH,Tübingen2005
APC 300 No. 10132-010 Standard Version
Qualitiy Management System according to: EN ISO 13485 EN ISO 9001

Contents
Chapter Title ........................................................................................ Page
1 How to Use these Operating Instructions? Intended Purpose
of APC 300. ............................................................................................1
2 Notes on Safety......................................................................................1
3 Notes on Safety in the Medical Specialties ........................................ 1
4 Installation ..............................................................................................1
5 Changing Cylinders...............................................................................1
6 Description of the Front and Back Panels ..........................................1
7 Description of the Graphical Interface of the APC 300 ......................1
8 Connection and Actuation Configurations for ERBE
Electrosurgical Equipment in Conjunction with the APC 300 ..........1
ICC 200
1.Configuration APC probe for flexible endoscopes .................................................................... 1
2.Configuration APC handle for APC and ARGON CUT .............................................................4
ICC 300
1.Configuration APC probe for flexible endoscopes .................................................................... 7
2.Configuration APC handle for APC and ARGON CUT, electrode handle for
CUT and COAG with two buttons, instrument for BIPOLAR COAG ................. 10
ICC 350
1.Configuration APC probe for flexible endoscopes .................................................................. 14
ICC Software V. 1.06 and V. 1.07
2.Configuration APC handle for APC and ARGON CUT, electrode handle for
CUT and COAG with two buttons, instrument for BIPOLAR COAG ................. 17
ICC Software V. 1.06 and V. 1.07
3.Configuration APC handle for APC and ARGON CUT, electrode handle for
CUT and COAG with two buttons, instrument for BIPOLAR COAG
(This actuation configuration differs from number 2) ........................................ 20
ICC Software V. 1.07 only
4.Configuration APC handle for APC and ARGON CUT,
instrument for BIPOLAR COAG and BIPOLAR CUT ...................................... 23
ICC Software V. 1.07 only

ACC 450
1.Configuration APC probe for flexible endoscopes .................................................................. 33
2.Configuration APChandle forAPC andARGONCUT,electrodehandle for
CUT and COAG with two buttons, instrument for BIPOLAR COAG ................. 37
9 Troubleshooting.................................................................................... 1
10 Cleaning, Disinfecting and Sterilizing................................................. 1
11 Maintenance .......................................................................................... 1
12 Service and Warranty ........................................................................... 1
13 Technical Data, Standard Parameters Programmed by ERBE ......... 1
14 Information on Electromagnetic Compatibility (EMC) ..............1
Addendums:
Notes on using electrosurgical devices of other manufacturers in
combination with the APC 300
Literature
Glossary
Addresses

1

2
Purge user programs
user
Flow adjustments

Priority cylinder number
Sound level adjustment
General cylinder information
Change cyl. data
Screen brightness
Instrument purging parameters

How to use the APC 300 Operating Instructions. Intended Purpose of the APC 300 • 1
1
CHAPTER 1
How to Use these Operating Instructions. Intended Purpose
of the APC 300
These operating instructions are very extensive. There are several reasons
for this: theAPC 300 can be used in many medical fields.The equipment can
becombinedwith anumber ofelectrosurgicaldevicesand instruments. Lastly,
the user can adapt the software of the equipment to his own requirements,
although it is not always necessary to do this. So in order to work safely and
effectively with theAPC 300, it is not necessary to read every chapter of the
operating instructions. Please proceed as follows:
•Please first read the Notes on safety and the Notes on safety in the medical
specialties: CHAPTER 2 and 3 à.
•If it has not already been done, carry out the electrical Installation:
CHAPTER 4 à.
•Connect the argon gas cylinders: CHAPTER 5 à.
•Makeyourselffamiliar withthe operatingelements: Foldout1, CHAPTER
6 à.
•If you wish to begin working with the APC 300 as soon as possible and
not preoccupy yourself with the equipment's additional functions: First
read Quick start: CHAPTER 7 à.
•Thenselecta suitableConnection andactuation configuration. Implement
it step by step: CHAPTER 8 à.
•If you wish to adapt the equipment to your particular needs, perhaps to
program and store your own COAG flow or CUT flow parameters for one
of the application programs: Read the section entitled Additionalfunctions
of the APC 300:CHAPTER 7 à.Foldout 2 can help you.
Intended purpose of the APC 300
TheAPC 300 is an argon plasma coagulator. It is designed for argon plasma
coagulation and argon-enhanced cutting in combination with ERBE HF
surgicalunits, ERBEAPC applicators, andAPC probes. TheAPC 300 can be
used in many medical disciplines. These include open surgery, flexible
endoscopy, and bronchoscopy. The range of applications is constantly
increasing.
Do I have to read all of the
Operating Instructions?
Preparation
Quick start
Additional functions

2
1 • How to use the APC 300 Operating Instructions. Intended Purpose of the APC 300

1
Notes on Safety • 2
CHAPTER 2
Notes on Safety
Thischapter containsgeneralnotes onsafety.Forsafetynotesrelatingtospecial
applications or special fields of application, please refer to CHAPTER 3 à.
Safety instructions marked with an exclamation mark (!) should always be
read before using the APC 300.
The safety instructionWARNING denotes a danger which can cause damage
to persons.
The safety instruction CAUTION denotes a danger which can cause damage
to property.
The safety instruction ATTENTION denotes a danger which can cause failure
of the device.
Argon Plasma Coagulation, a safe and learnable technique
Argon Plasma Coagulation (APC) is a high frequency surgical method. When
used according to instructions and safety notes, APC does not represent a
danger either to users, patients or to the environment.
Working with high high frequency voltages and compressed argon always
holds certain risks for medical personnel and patient. Design precautions
alone do not suffice to completely rule out risks. The safety of theAPC does
not depend only on the equipment. Safety is dependent to a large extent on
factors which are in the hands of the user. These factors are discussed in the
safety notes and warnings of this chapter.
APC 300 and ERBE electrosurgical equipment meet all relevant generally
recognized rules of technology as well as the applicable work safety and
accident-avoidance regulations. The combination of theAPC 300 and one of
the electrosurgical units listed below together with an ERBEAPC applicator
is a well-thought-out system of interrelated elements. This is especially true
ofthe level ofelectricalsafety, thepneumatics, argondosage, errormonitoring,
error messages, and protection against operating errors and confusion. These
operatinginstructionsrepresent animportant componentin thesafety concept.
Onlyinstrumentsand accessoriesauthorized byERBE Elektromedizinshould
be used. Otherwise ERBE Elektromedizin cannot be held in any way
responsible.
WARNING!
CAUTION!
ATTENTION
Safety of the method
Safety role of medical
personnel
Safety of the equipment

2
2 • Notes on Safety
The following electrosurgical units are suitable for use in conjunction with
the APC 300:
ERBOTOM ACC 450
ERBOTOM ICC 200 ARGON COAG
ERBOTOM ICC 300
ERBOTOM ICC 350
Instructions, training of medical personnel
All those involved in preparing, setting, working with, stripping down,
cleaning or disinfecting the equipment and instruments should read the
operating instructions of the APC 300 and the notes on the use of the
instruments. Please pay particular attention to the notes on safety and the
warnings contained in each chapter.
Operationofthe electrosurgicalequipment isnot thesubjectoftheseoperating
instructions. Aside from the following notes on safety, all safety regulations
concerning monopolar HF surgery apply to argon plasma coagulation. This
is particularly the case for the correct handling of the neutral electrode. It is
imperative that you refer to the notes on safety contained in the operating
instructions of the electrosurgical equipment.
TheAPC 300 may only be used by persons who have been given training in
the correct use of theAPC 300 or the combination of appliances (APC 300 -
electrosurgical equipment, instrumentation) which has taken these operating
instructions into consideration.
Training may only be conducted by persons whose knowledge and practical
experience qualify them to do so.
ERBE Elektromedizin GmbH cannot be held responsible for damage caused
by improper usage.
If anything is unclear or questions arise, please contact an ERBE employee
or the ERBE office nearest to your location. We will be glad to help you and
appreciate comments on these operating instructions.
Safety precautions against the threat of electric shocks
The APC 300 complies with the requirements of type CF (cardiac floating)
according to EN 60-601-1 and it has a patient leakage current of less than 10
µA. TheAPC 300 is protected against defibrillator voltages.
WARNING! Only connect the APC 300 using the mains lead supplied by
ERBE, or one of at least the same quality, to a faultlessly installed grounded
socket. If you use an equipment trolley, this applies to the mains lead of the
trolley. The mains lead must bear the national mark of conformity.
For safety reasons multiple sockets and extension leads should not be used.
If their use isunavoidable, they, too, must be provided with faultless protective
grounding.
Who should read these
operating instructions?
Reading the operating
instructions of the
electrosurgical equipment
Training
Mains lead, mains socket

3
Notes on Safety • 2
Mains fuses
Ventilation
Potential equalization
Visual check
of the electrical insulation
Ambient temperature,
humidity
Protection against moisture
Confusion
No force of any kind
Pressure reducer
WARNING! The unit is protected by mains fuses. If one of these fuses
blows, the unit must not be used on patients until it has been checked by
an experienced technician. Only replacement fuses of the rating specified
on the unit's name plate may be used.
Connect the potential equalization pins of the electrosurgical unit and
the APC 300 to the equipment trolley via potential equalization conductors.
Connect the potential equalization of the equipment trolley to the potential
equalization of the operating theatre.
WARNING! A high frequency voltage of several thousand V is needed to
ionize argon. Check that there is no visible damage to the electrical insulation
of the applicators and all leads prior to every use.
Environment
ATTENTION: The APC 300 can be operated at a room temperature of
between 10 and 40° C. The effective humidity can be between 30 and 75 %,
non-condensing. If these tolerances are exceeded either way, the unit may
break down.
ATTENTION: If theAPC 300 has been stored or transported at temperatures
below +10° C, or especially below 0°, the equipment will require about 3
hours to acclimatize to room temperature.
ATTENTION: TheAPC 300 must be set up in a way thatpermits air to freely
circulate around the case. The unit must not be set up in narrow niches or
shelves.
CAUTION!TheAPC300is protectedagainstpenetrationby liquidsaccording
to EN 60-601-2-2 . The case is not absolutely watertight. For this reason, do
not set up the unit in the direct vicinity of tubes or vessels containing liquids.
Do not place any liquids on the APC 300.
Portable and mobile communication equipment HF can influence the
device.
Cautionwhenhandlingargoncylinders
Argon is a non-flammable, non-toxic, physiologically inactive, odorless
and colorless noble gas.
WARNING! No force of any kind should be exerted on cylinders, cylinder
connections or pressure reducers. Protect the argon cylinder by means of
chains, straps, or safety belts from tipping over or falling during transport,
storage and use.
WARNING! Argon cylinders may only be transported with valve protection
(cylinder cap) in vertical position and secured in place.
WARNING! Argon cylinders may only be connected to the APC 300 with
the pressure reducers and hoses provided by ERBE.
Portableandmobile
communicationequipmentHF

4
2 • Notes on Safety
Danger of suffocation:
uncontrolled argon flow
Precautionary measures
Operating errors
Disregarding or falsely
interpreting error messages
Confusing actuation switches
and actuation signals
Do not use laser safety goggles
WARNING! The APC 300 may only be operated with argon. A cylinder
containing a dangerous gas could be connected to the cylinder
connection of the unit. Check each cylinder to ensure that it really does
contain argon: identification must not be damaged or missing.
WARNING! Argon build-up in the air being breathed can cause
suffocation. Symptoms are drowsiness, rising blood pressure and
breathing difficulties. In an atmosphere of pure argon, sudden loss of
consciousness and suffocation occur without prior warning.
When the APC is used in the manner intended the concentration of argon
in a room reaches about 1% in a room measuring 6m x 6m x 3m in 100
min. this argon/air mixture is completely harmless.
A short hissing noise will be heard when the gas valves are opened due
to the argon flowing in the hoses. If this hissing continues for longer
than 2 sec. when a cylinder is opened, there is a leak and the argon
cylinder must be closed again immediately. The unit may not be used
until the leak has been rectified.
Make sure that the hoses are faultlessly (tightly) connected to the APC
300 and the gas cylinder. This also applies to the connection of the
pressure reducer to the argon cylinder.
Close the safety valves of the argon cylinders after use.
Operatingerrors, confusion,disregardingerrormessages
WARNING! The APC 300 possesses an instrument identification facility
which assigns to each instrument appropriate CUT flow and COAG flow
values (l/min) for the application. The set values can naturally be altered
within limits. If an insufficient flow rate is selected, the applicator can
sustain damage. Read CHAPTER 7: Description of the graphical interface
of the APC 300 à.
WARNING! A large number of different instruments can be connected
to the APC 300 or to the electrosurgical unit, e.g. for cutting, bipolar
cutting, coagulation, bipolar coagulation and for argon plasma
coagulation. Depending on the actuation concept and setting, these can
be activated via foot and/or finger switches. Do not confuse the actuation
switches and actuation signals. Read CHAPTER 8: Actuation concepts
à. Please comply at all costs with the settings and connections described.
If in doubt, check which instrument is actuated by which key and which
pedal! Never place instruments on the patient or in the immediate vicinity
of the patient.
WARNING! The APC 300 is equipped with an error recognition and
error reporting system. Take note of visual and audible error indications.
Do not set the volume of the actuation signals for COAG, CUT and
PURGE too low.
It is possible that the APC 300 display may no longer be visible with
laser safety goggles.

5
Notes on Safety • 2
Dangersassociatedwithargonplasmacoagulation
Argon Plasma Coagulation is a monopolar high frequency surgical
method i.e., high frequency current flows through the patient's body to
the neutral electrode, as is generally the case in monopolar electrosurgery.
WARNING! All safety regulations concerning monopolar high frequency
surgery are applicable. One must therefore particularly ensure in endoscopic
applications that adjacent tissue structures are not inadvertently damaged
thermally by uncontrolled high frequency currents.
The active electrode must not directly contact the tissue, as this could trigger
the cutting effect and lead to uncontrolled coagulation of the contacted tissue.
WARNING! When performing electrosurgery on the gastrointestinal tract,
no flammable or potentially explosive endogenic gases must be present.
Particular care is required during the resection or coagulation of tumors
obstructing the colon using an HF loop or argon plasma coagulation.
Flammable gases must be suspected behind every stenosis in the colon. Be
certain to flush out at-risk sections of the intestine with CO2or argon before
activating the electrosurgical unit or argon plasma coagulator.
WARNING!Argon gas is non-combustible. It does not cause fire in burnable
materials or help them to burn. The high temperature of argon plasma, on
the other hand, can cause easily burning materials to ignite if oxygen or other
burnable gases are nearby or are mixed with argon when applied to these
materials (for example plastic insulation at the distal end of the bronchoscope
or a tracheal tube). This is especially true of highly concentrated or pure
oxygen. For this reason, please always observe the following rules:
1. Never permit oxygen or other combustible gases or fluids to enter the
tracheobronchial system before or above all during APC in the
tracheobronchial system.
2. When using APC in the tracheobronchial system for more than a few
seconds, alternate oxygen ventilation of the patient with APC, that is, use
them in turns.
3.Always keep the distal end of theAPC applicator in view in the endoscope
before and during activation of the argon plasma. Never activate argon plasma
if you cannot see the distal end.
Please read the special notes on this topic in CHAPTER 3: APC in flexible
endoscopy, APC in bronchoscopy à.
WARNING! The use ofArgon Plasma Coagulation units during laparoscopy
has been associated with gas embolisms in a small number of cases. The use
of argon should be limited to those situations where the advantages outweight
the risks.
To avoid gas embolisms, the argon flow rate should not be set so high that
argon is blown into open vessels.
To avoid gas embolisms and emphsema, do not direct the distal end of APC
applicators toward open vessels or press against tissue.
Burns, damage to tissue
Gas embolisms, gas emphysema
Danger of explosion of
endogenic gases, particularly in
the colon
Danger of fires in the
tracheobronchial system

6
2 • Notes on Safety
WARNING! When applying APC in body cavities, it is imperative to
ensure that the endoluminal gas pressure does not rise excessively.
Maintenance
The APC 300 should be safety-checked at least once a year. Alterations
and repairs may only be performed by ERBE or by persons expressly
authorized by ERBE.
Portableandmobilecommunicationequipment HF
ATTENTION: Portable and mobile communication equipment HF can
influence the device.
Pressure rise in body cavities

Notes on Safety in the Medical Specialties • 3
1
CHAPTER 3
Notes on Safety in the Medical Specialties
Argon Plasma Coagulation in Flexible Endoscopy
WARNING! For Argon Plasma Coagulation (APC) use only endoscopes
whose electric insulation is absolutely reliable both exteriorly and in the
instrumentchannel. Defectiveor inadequateinsulation cancause patientburns.
TheAPC 300 may only be used by persons who have been given training in
the correct use of the equipment or the combination of appliances (APC 300-
electrosurgical equipment) which has taken these operating instructions into
consideration.
Please read the operating instructions for the electrosurgical equipment and
CHAPTERS 4 and 8 of this handbook à.
Check the function of the APC probe as follows before inserting it into the
working channel of an endoscope:
1. Hold the tip of theAPC probe approx. 3-5 mm from a non-insulated, bare
metal object. This must not have any electrically conductive contact with
the patient, other people or electrical appliances.
2. Activate the APC unit.
3. Note whether argon plasma develops between the probe tip and the metal
object.
WARNING! Do not touch the tip with bare fingers when it is activated!
Electric insulation of the
endoscope
Training
1. Installation, connection and
actuation configuration
2. PreoperativeTest of APC probe
function
Figure 1: Test of APC Probe Function
3 - 5 mm

3 • Notes on Safety in the Medical Specialties
2
Insert the APC probe into the working channel of the endoscope until the
distal end emerges at least 10 mm from the distal end of the endoscope. This
is indicated when the first black ring on the distal end of the probe is seen to
emerge from the endoscope.
Figure 2: The distal end of the endos-
cope with the first black ring
Power should be set as low as possible:
3. Insert APC probe into the
endoscope
4. Select power limitation
•WARNING!When performing electrosurgeryonthe gastrointestinaltract,
no flammable or potentially explosive endogenic gases must be present.
Particular care is required during the resection or coagulation of tumors
obstructing the colon using an HF loop or argon plasma coagulation.
Flammable gases must be suspected behind every stenosis in the colon.
Be certain to flush out at-risk sections of the intestine with CO2or argon
before activating the electrosurgical unit or argon plasma coagulator.
•The distal end of the APC probe should be not less than 3 mm and no
more than 5 mm from tissue to ensure safe ignition and application of the
argon plasma.
The recommended dosages as noted above apply for ERBE electrosurgical units
ICC 200, 300, 350. Of course the physician takes the final responsibility in each
case.
5. Application of the APC probe

Notes on Safety in the Medical Specialties • 3
3
6. Prevention of excessive argon
insufflation within the
GIT or TBS
8. Postoperative cleaning,
disinfection and sterilization of
reusable APC probe
7. Intraoperative cleaning of the
APC probe's distal tip
•Never activate the APC probe while it is in contact with tissue.
•Never press the distal tip of the APC probe against an organ wall before
or during activation.
During APC, distention of the organ being treated can cause discomfort to
the patient. To avoid this:
•Set the argon flow rate as low as possible.
•Apply repeated suction if using a single-channel endoscope.
•Apply continuous or interrupted suction through the second channel if
using a double-channel therapeutic endoscope.
•Insert a deflation tube (3 - 5 mm ø) parallel to the endoscope, e.g. when
using APC in the rectum.
•Always monitor the patient’s abdominal wall tension.
Coarse crusts of debris or tissue on the tip of the APC probe may inhibit
argon flow through the probe. In such a case, remove the APC probe and
clean its tip with a wet swab. Before reinserting the APC probe into the
endoscope, recheck its function as described under No. 2 above.
Thoroughly rinse theAPC probe from proximal to distal as soon as possible
afterusewith asuitable rinsingordisinfection solution.Also cleanits exterior.
The APC probes can be resterilized in autoclaves to 134 °C.
(Where applicable)

3 • Notes on Safety in the Medical Specialties
4
The 10 Commandments of APC in Flexible Endoscopy
1. You shall not confuse Argon Plasma Coagulation with Argon Laser.
The two are completely different.
2. You shall always testArgon Plasma ignition and the electric arc outside
the endoscope before inserting the APC probe into the working chan-
nel.
3. You shall insert theAPC probe at least far enough into the endoscope’s
working channel that the first distal black ring becomes visible.
4. You shall always carry out Argon Plasma Coagulation (as long as you
are not expert in its use) under visual control.