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Instructions

Instructions for use

Electrosurgical Generators
Generators

BOWA-
BOWA-electronic GmbH & Co. KG Heinrich-
Heinrich-Hertz-
Hertz-Strasse 4-
4-10 72810 Gomaringen - Germany
CONTENTS

Foreword...............................................................................................................................
Foreword 5

1 Introduction
Introduction to Electrosurgery...................................................................................
Electrosurgery 6
1.1 Basic principles ...................................................................................................... 6
1.2 Application techniques .......................................................................................... 9
1.3 Safety features and equipment ............................................................................. 9
1.3.1 Preparing the operating table....................................................................... 10
1.3.2 Positioning the patient.................................................................................. 10
1.3.3 Risk of explosion and fire.............................................................................. 11
1.3.4 Neutral electrode........................................................................................... 11
1.3.5 Patient safety................................................................................................. 14
1.3.6 Rules for the operating procedure ............................................................... 15
1.3.7 Endoscopic operations.................................................................................. 17
1.3.8 Further safety information ............................................................................ 18
1.3.9 Information on the use of bipolar techniques ............................................. 19

2 Equipment description ............................................................................................. 20


2.1 Purpose................................................................................................................. 20
2.2 ARC technology .................................................................................................... 20
2.3 Monopolar modes ................................................................................................ 21
2.4 EASY neutral electrode monitoring ..................................................................... 21
2.5 Bipolar modes ...................................................................................................... 21

3 Displays and connections ........................................................................................ 22


3.1 Front ARC 200 and ARC 300e............................................................................. 22
3.2 Controls and connecting sockets ........................................................................ 23
3.3 Rear view of ARC 200 and ARC 300e ................................................................. 24

4 Special equipment and program functions ............................................................ 25


4.1 TUR - X for urology (optional ARC 300e)............................................................ 25
4.2 Micro Plastic......................................................................................................... 26
4.3 Argon assisted electrosurgery with ARC PLUS (Option “GASTRO CUT”)........ 26
4.4 GastroCut-Pol ....................................................................................................... 26
4.5 GastroCut-Pap ...................................................................................................... 27
4.6 Forced Coag Modi ................................................................................................ 27
4.6.1 Non Cutting Mode ......................................................................................... 27
4.6.2 Mixed Mode.................................................................................................... 27
4.6.3 Cutting Mode ................................................................................................. 27
4.7 Bipolar coagulation .............................................................................................. 27
4.8 Foot switch............................................................................................................ 28
4.8.1 Standard functions ........................................................................................ 28
4.8.2 Standard combinations................................................................................. 29
4.9 Other individual programs................................................................................... 30

5 Information: Before the surgical operation.............................................................


operation 31
5.1 Preparing the patient ........................................................................................... 31
5.2 Preparing the HF generator................................................................................. 31
5.3 Starting up the HF unit ........................................................................................ 31
5.4 Preparing the accessories ................................................................................... 34
5.5 Monopolar surgery ............................................................................................... 34
5.6 Bipolar surgery ..................................................................................................... 34

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6 Information: During the operation...........................................................................
operation 35
6.1 Power recommendations ..................................................................................... 35
6.2 Changing the settings .......................................................................................... 36
6.3 Checking the neutral electrode............................................................................ 37
6.4 Alarm functions .................................................................................................... 37
6.5 Activation tones .................................................................................................... 38

7 Information: After the operation .............................................................................. 39


7.1 Fault reports ......................................................................................................... 39
7.2 Cleaning, disinfection, sterilisation and storing of the accessories.................. 39
7.3 Cleaning and storing of the equipment .............................................................. 39
7.4 Disposal ................................................................................................................ 39

8 Fault displays and menu programs.........................................................................


programs 40
8.1 General.................................................................................................................. 40
8.2 EASY alarm ........................................................................................................... 40
8.3 System alarm messages ...................................................................................... 41
8.4 Menu programs .................................................................................................... 41
8.4.1 Menu program 1: Set Language.................................................................. 42
8.4.2 Menu program 2: Sound Level .................................................................... 42
8.4.3 Menu program 3: Forced Coag Mode ......................................................... 43
8.4.4 Menu program 4: Show Prev Inf-No ............................................................. 43
8.4.5 Menu program 5: Hide Fix Prog. ................................................................. 43
8.4.6 Menu program 6: Auto Start Delay ............................................................. 44
8.4.7 Menu program 7: Edit Prog. Names ........................................................... 44
8.4.8 Menu program 8: Restore Programs .......................................................... 44
8.4.9 Menu program 9: PANEL CHECK ................................................................ 44

9. Maintenance and repair............................................................................................


repair 45

10 Technical data...........................................................................................................
data 46
10.1 Technical features and data ................................................................................ 46
10.2 Diagrams............................................................................................................... 50
10.2.1 Performance diagrams.................................................................................. 50
10.2.2 Maximum open circuit voltage ..................................................................... 61
10.2.3 Power over display ........................................................................................ 69
10.3 Equipment standards and standard specifications ........................................... 71
10.3.1 Guidelines and Manufacturer's Declaration according to DIN EN 60601-1-2,
Para. 6.8.3.201................................................................................................ 71

11 Accessories................................................................................................................
Accessories 75

12 Warranty conditions..................................................................................................
conditions 76

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Foreword
Foreword
In the application of high-frequency surgery, electrical current is applied to and
passed through the body of the patient.
The surgeon and the specialist medical staff must be trained in the basic principles,
application rules and risks of electrosurgery
electrosurgery and must also be familiar with them in
order to safely and reliably avoid endangering the patient, personnel and equipment,

The following equipment is described in these instructions for use:


BOWA ARC 200 and ARC 300e HF surgical generators
Rated voltage: 100 V / 115 V / 230 V

BOWA Order Number: ARC 200:


200: 900-
900-200
ARC 300
300e: 900-
900-301

Manufactured by:
BOWA-electronic GmbH & Co. KG
Heinrich-Hertz-Strasse 4-10 0123
72810 Gomaringen I Germany
In accordance with Directive 93/42/EEC

You can obtain more information


information under the following number:
+49(0)7072-6002-0

or on the Internet at:


www.bowa.de

Distribution by authorised specialist medical dealers


dealers

Made in Germany
Printed in Germany
Modification status: 10711_S1 (Software Version 1.0)
Date of issue: Mai 2007

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1 Introduction to Electrosurgery

1 Introduction to Electrosurgery
Effect of HF current on biotissue
1.1 Basic principles
High-frequency surgery is the deliberate use of high-
frequency currents in the body for the purposes of
coagulation or cutting.

Electrical current flowing through biological tissue


has the following effects:
- Thermal effect (the objective)
- Faraday effect (unwanted)
- Electrolytic effect (unwanted)

Electrolytic effect: Frequency-


Frequency-dependent stimulation
threshold curve
When it flows through the bodily tissue, electrical
direct current has the effect of decomposing the
bodily fluid into its gaseous and solid constituents.
This effect is avoided by the use of alternating current
with a sufficiently high frequency.

Faraday effect:
Nerves and muscle cells can be stimulated by
electrical current. This stimulatory effect, also known
as the Faraday effect, is dependent upon the
magnitude of the current and the frequency.

Thermal effect:
Coagulation of a cell
The heating of the tissue depends on the specific
impedance of the tissue, the cross sectional area of
the entry point, the magnitude of the HF current and
the reaction time.

In the case of the thermal effect, a distinction is


drawn between two different possible applications:
- Tissue coagulation
- Tissue separation.

Tissue coagulation is achieved by the electrical


current slowly heating the tissue to be coagulated, so
that the water in the intra- and extracellular fluids has
Different coagulation depths
time to evaporate through the cell membrane.
At the same time, the constituents of the tissue,
which are capable of coagulating, can coagulate
thermally. Due to the loss of fluid, the cells draw
together and the cell walls become welded to each
other. Blood vessels that are treated in this way draw
together until the vessel is completely closed and no
more blood can flow out.
With otherwise identical conditions, rapid
coagulation, which is however only superficial and
closely defined, is achieved by using a high dose.
A reduction of the dose leads to a distended
coagulation for which, however, a considerably longer
time is needed.

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1 Introduction to Electrosurgery

Coagulations are often carried out indirectly by using


tweezers or clamps. The tissue in the jaw coagulates
after the active electrode touches the instrument and
HF current is activated.
Decomposition of a cell structure
Electrotomy
Tissue separation is achieved by the electrical current
heating the tissue at the separating point so quickly
that the water in the intra- and extracellular fluid has
no time to evaporate slowly. The vapour pressure
produced in the cell is sufficiently high to tear apart
the cell walls or the tissue (this occurs naturally but
on a microscopically small scale).

The shape of the electrodes (knife, lancet or needle


shape) enables cuts to be made as with a scalpel.
The advantages of tissue separation with the help of
HF currents or electrotomy are:
- Reduction of bleeding
- Prevention of carryover of germs
- Mechanical care of tissue
- The possibility of making cuts inside the body
through natural or artificial body orifices using
suitable endoscopic instruments (e.g. TUR or MIC)
- Sealing of the tissue and lymph fissures against
toxins, malignant cells and bacteria
- Reduction of post-operative pain, as nerve fibres
are no longer exposed.

Depending on the degree of coagulation, a distinction is drawn between:


- smooth cuts without the effect of staunching bleeding
- scabbed cuts with the effect of staunching bleeding

The smooth cut (without scab) is achieved with filtered, unmodulated HF current using fine
and clean electrodes. As the depth of necrosis, in the case of cuts without a scab, is only a
few 10s of µm, tissue samples taken by this means are particularly suitable for histological
examinations and the cut heals excellently.

In the case of cuts with a scab, bleeding from the capillary vessels is prevented by surface
coagulation of the cut surfaces while at the same time sealing the lymph vessels.
This type of cut is indicated particularly for the excision of malignant tumours or for the
prevention of heavy bleeding and thus for a better overview in the operating field.

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1 Introduction to Electrosurgery

The coagulating effect of the cut surfaces is


influenced by the following parameters:
Effect of electrode geometry
- Shape of the cutting electrode
The larger the area of the cutting electrode, the
deeper the coagulation zone.

Dose-
Dose-dependent coagulation effect

- Intensity of the HF current


The higher the effective HF power, the deeper the
coagulation zone.

- Cutting speed (cut guidance) Effect of cutting speed


The cutting and coagulation effect of the active
electrodes depends very heavily on the cutting
speed. The slower the cutting electrode is guided
through the tissue, the more strongly the cut
surfaces are coagulated.

- Modulation of the HF current


The degree of coagulation of the cut surfaces can
be influenced when cutting by the so-called crest
factor of the HF current. The crest factor
describes the ratio of the peak power to the
average power. The degree of coagulation
increases as the crest factor is increased.

Increasing degree of coagulation ➾


The surgeon has the option of combining all 4
parameters that affect the degree of coagulation when
cutting. Unfortunately, use is only rarely made of this
option, as the parameters described earlier are not
sufficiently well known. The surgeon thus often
expects too much from the modulation shape. The
fact is, however, that cutting speed and the
magnitude of the HF power have a considerably
greater effect. A test on meat shows this quite clearly.

HF generators with arc control enable cuts to be made with constant coagulation effect,
largely independently of the electrode shape, cutting speed and type of tissue. The
microprocessor-controlled cutting process works with an absolute minimum of power.

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1 Introduction to Electrosurgery

1.2 Application techniques


There are various techniques in Electrosurgery for
closing the electrical circuit between the high-
frequency surgical generator and the patient.
According to the way in which the HF current returns Monopolar current flow
to the generator, a distinction is made between:

- monopolar technique
- bipolar techniques

In the monopolar application, one pole of the


generator is fed to the operating point via the (small)
active electrode. The current flows from the operating
point through the patient's body to the large neutral
electrode and back to the second pole of the
generator. The monopolar technique is used for the
purpose of electrotomy and for coagulation.

Bipolar technique
In the bipolar application, both poles of the HF generator
are fed directly to the operating point via a bipolar
instrument. The electrical circuit is closed by the tissue
which lies between the jaws of the instrument (e.g. bipolar
tweezers). The high-frequency power required to produce
a particular coagulation effect with the bipolar technique
is only ¼ of the power required in the monopolar
application.
With bipolar cutting, precise bipolar cuts in the finest
tissue structures can be achieved using special
instruments.

1.3 Safety features and equipment

In the application of high-frequency surgery, electrical current is passed through the body
of the patient.
The surgeon and the specialist medical staff must be trained in the basic principles,
application rules and risks of electrosurgery and must also be familiar with them in order to
safely and reliably avoid endangering the patient, personnel and equipment,
When a HF generator is activated, a potential difference exists between the patient and the
ground.
When using the monopolar application technique, the patient must be protected against
any contact with conducting objects. This protection must be ensured at the very stage of
preparing the operating table for the patient.
Extended and modified rules are applicable to endoscopic operations, due to the fact that
only part of the operating field is visible on the monitor and the electrodes remain
permanently in contact with the patient's body, even in the de-activated state.
The safety measures designed into the latest microprocessor-controlled equipment are the
basis for the risk-free use of modern and progressive HF generators.
Technology can only support but never replace the knowledge of the nurses, carers and
doctors.
For this reason, the knowledge of the user should be deepened by means of training, in
order to protect both the user and the patient.

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1 Introduction to Electrosurgery

Operating table covers


1.3.1 Preparing the operating table
Operating table covers
In order to provide safe high-frequency insulation with
respect to the ground, the operating table covers
must be arranged as follows – starting from the
operating table:
- non-conducting covers 2-4 cm thick
- insulating cover impervious to moisture
- absorbent underlay for patient

Simple operating sheets alone provide unreliable HF


insulation as, in conjunction with the accumulation of
moisture, these can lead to thermal necroses.

Risks of incorrect positioning


1.3.2 Positioning the patient
Metal parts
The patient must not come into contact with
earthed metal parts such as the operating table,
holders etc. The use of antistatic cloths is
recommended for this purpose. Small-area contact
points up to approx. 10 cm² can otherwise lead to
considerable local current and power densities and
result in accidental burns.

Skin-to--skin contact
Skin-to
Skin-to-skin contact must be avoided by interposing
Avoid skin-to--skin contact
skin-to
cover sheets or dry muslin. A remedy is provided by
the use of insulated holder systems or interposed
cover sheets.

Pressure necroses
Particularly in the case of long operations or if the patient becomes hypothermic, it must be
ensured that the pressure of the cover is kept low by means of anti-decubitus covers, as
otherwise pressure necroses occur due to insufficient blood supply. Pressure necroses first
become recognisable one to two days after the operation and often run from the healthy
tissue to the decubitus. In contrast to HF burns, pressure necroses usually cover a larger
area.

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1 Introduction to Electrosurgery

1.3.3 Risk of explosion and fire


Risk of explosion due to chemicals
The sparks produced when using the HF generator in
accordance with the instructions must always be
regarded as a source of ignition.
- Do not use in an area at risk of explosion.
- Avoid the use of inflammable anaesthetics and
combustible gases (e.g. laughing gas, oxygen) or
extract these substances when carrying out
operations in the area of the head and thorax.
- If possible, use only non-inflammable cleaning
agents, disinfectants and solvents (for adhesives).
- If inflammable cleaning agents and disinfectants or
solvents are used, make sure that these substances
have evaporated before starting Electrosurgery.
- Ensure that no inflammable liquids accumulate under
the patient or in bodily orifices (e.g. vagina). Wipe
away all liquids before the HF generator is used.
- Make sure that there are no endogenous gases
around that could ignite.
- Make sure that materials impregnated with oxygen
(e.g. cotton wool, muslin) are kept far enough from
the HF environment not to ignite.

1.3.4 Neutral electrode


Spread of current in the body:
In the monopolar application technique, the neutral electrode has the task of returning the
current applied at the operating point to the generator.
The effect of the current at the entry point depends on the high current density at the small-
surface working electrode. If the geometrical dimensions at the current exit point (neutral
electrode) were the same, similarly high temperatures would necessarily occur here. In
practice, this is avoided by the use of a neutral electrode with as large an area as possible.
Neutral electrodes require
- a sufficiently large contact area and
- a high electrical conductivity between the body and the electrode.

Nowadays, adhesive electrodes for single use are normally used. More rarely, re-usable
neutral electrodes made of conductive rubber are used.
When split single-use neutral electrodes and modern HF generators with application
monitoring are used, the contact impedance of the neutral electrode to the tissue is reliably
monitored throughout the entire duration of the operation.
If non-split neutral electrodes are used, these must be checked for correct contact at
regular intervals. This applies especially when the patient's position is changed and in the
case of operations with a long HF activation phase.
If you connect a non-split electrode, the unit only monitors the connection between the unit
and the electrode. If this is correct, the electrode symbol lights up green (safety state
green). The monopolar mode can be activated.
When a non-split electrode is connected, the contact between the electrode and the
patient's skin is not monitored! There is no warning when the electrode comes off the skin
and there is a danger of burning.

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The point of application for the neutral electrode should be chosen according to the
operating point so that
- a muscular area that is well supplied with blood is preferred,
- the current paths are as short as possible,
- the heart and the ECG electrodes do not lie in the current path.

Place the whole surface of the neutral electrode securely against the patient's body. The
neutral electrode must be as close as possible to the operating field.
Push the contact tongue of the neutral electrode fully into the connecting clamp. The
contact tongue must not touch the patient's skin as otherwise there is a risk of burning.
Do not apply the neutral electrode over the heart or in the area of the heart.
If the power is insufficient, the connection of the neutral electrode and its cables should be
checked before a higher output power is selected.

Attention must also be paid to the following:

- Ensure that the orientation of the split neutral electrode with respect to the operating
field is made in a way that the high frequency current flows back uniformly to both
surfaces of the split neutral electrode, and that there is no increase in the current
density under one surface or at one edge of a surface. The EASY system does not
monitor the divided currents in both surfaces.
- Ensure that the split neutral electrode is arranged so that the high frequency current
flows back along the longest edge and there is thus no increase in the current
density at the short edge.
- Preferably, split or non-split neutral electrodes with a surface that is as symmetrical
as possible and therefore which have edges of relatively equal length should be used.
- The high frequency current is not usually split uniformly over the contact surfaces of
the neutral electrode. The current can be greater at the proximal corners or edges
than at the distal corners or edges. Therefore, when applying the neutral electrode,
make sure that the line of symmetry of the neutral electrode points towards the
operating field.

Where possible, the neutral electrode is to be applied to


the nearest thigh or upper arm.
When using self-adhesive single-use electrodes, please
observe the manufacturer's additional information with
regard to the application point.

- Make sure that the application point is free from


scar tissue and bone projections.
- Make sure that no implants (e.g. bone nails,
bone plates, endoprostheses) lie in the current
path.

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1 Introduction to Electrosurgery

Before applying the neutral electrode:


- Remove strong hair growth.
- Clean the application area (do not use alcohol, as it dries out the skin, which increases
the contact impedance).
- In the case of poor blood supply, massage or brush the application point.
- Apply the neutral electrode carefully and over the whole area. Secure re-usable neutral
electrodes with rubber bands or elastic ties, so that they do not come loose with the
movements of the patient. When doing so, ensure that there is no restriction to the
blood supply (risk of necroses)
- In order to avoid the increased contact impedance that results from the drying of wet
cloths or electrical pastes, do not use wet cloths or conducting gel under any
circumstances.
- In order to avoid burns due to partial Accumulation of liquid at the neutral
current concentrations and/or chemical electrode
necroses, ensure that no liquids (e.g.
rinsing liquids, disinfectants, blood,
urine) get between the patient and the
neutral electrode.
- Make sure that no ECG electrodes lie in
the current path of the HF generator.
- In order to avoid accumulations of
liquid, poor blood supply, pressure
necroses, displacement of the neutral
electrode and an increase in impedance,
do not place the neutral electrode under
the patient's bottom or back.

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1 Introduction to Electrosurgery

1.3.5 Patient safety


Switch on the HF unit / connect accessories
(see Chapter 5.2)

Functional test of the unit:


Before connecting the accessories, the HF unit should be switched on and the equipment
functions checked by means of the self-test.

Functional test of the accessories:


The accessories are now connected and tested for a proper function. With the neutral
electrode applied, briefly activate the handle by pressing the button, or activate the
instrument by means of the foot switch. If an error or other defect is indicated, this part
must be replaced immediately.

The HF leads should be as short as possible and routed in a way not to touch the patient or
other cables.
Maintain an adequate distance between all HF cables and patient cables.
With neutral electrodes, attention must also be paid to the following:
- The patient may be injured by sharp edges, protruding parts and cracks. Check the
neutral electrode accordingly.
- With reusable electrodes, particular attention must be paid to sharp edges, protruding
parts, cracks and wear.
See also Chapter 5.4 Preparing the accessories.

Monitoring electrodes
- As far as possible, use monitoring systems with protective resistors or HF chokes for
the limitation of high-frequency current.
- Apply electrodes of physiological monitoring equipment which do not have protective
resistors or HF chokes as far away from the HF electrodes as possible.
- Do not use needle electrodes for monitoring.
- Connect the cables of the monitoring equipment in a way not to lie on the skin.

Heart pacemaker patients


There is a risk of affecting or damaging the operation of the heart pacemaker or of the
internal heart defibrillator. Always consult the cardiological department before operating.

 Danger to the patient


Rules for the use of HF surgery on patients with pacemakers and other active implants:
- Use the bipolar HF process wherever possible
- Apply the HF neutral electrode close to the operating field
- Set the Demand pacemaker to fixed frequency
- Do not touch the heart pacemaker with the HF electrode
- Have a working defibrillator ready to hand
- Carry out a post-operative check on the heart pacemaker

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1 Introduction to Electrosurgery

1.3.6 Rules for the operating procedure


Clean electrodes
Immaculate and satisfactory cuts and coagulations are only guaranteed with clean and
metallically bright electrodes. Satisfactory results cannot be obtained with encrusted
electrodes.

Coagulations
Coagulations by means of haemostatic forceps or tweezers
Coagulations are often carried out indirectly by using tweezers or forceps. The tissue in the
jaw coagulates after the active electrode touches the instrument and HF current is
activated. For reliable application, we recommend the use of insulated monopolar tweezers.
If non-insulated instruments are used for medical reasons, may risk to the surgeon may feel
warm or suffer burns, as the result of a perforated glove.
This risk can be minimised by the following measures:
- As large a part of the tweezers or haemostatic forceps as possible is to be gripped
firmly in the fingers before the HF unit is activated. By this means, the current
concentration at the finger tips can be reduced to a minimum.
- The surgeon must not support himself on the patient, the table or the retractors while
activating the tweezers.
- The lowest power which can achieve the haemostasis must be selected.
- The HF unit must not be activated until the accessory makes contact with the tweezers
or haemostatic forceps. The formation of an arc must be avoided.

Elongated insulated tissue structures Unintended concentration of current


Use bipolar techniques in order to avoid unwanted
coagulation at other places when operating on parts
of the body with a small cross sectional area and in
areas with high impedance (bones, joints).

Endogenous gases
gases
Because of the risk of possible explosion due to endogenous gases, the use of
electrosurgery in the gastrointestinal tract is contraindicated. For safe application,
such gases must be reliably removed from these organs before and during the
operation. With transurethral resection, H2 and O2 are generated as a result of the
underwater arc. These highly explosive gases accumulate at the top of the bladder. If
a resection is carried out here, there is a risk of explosion.
The gas mixture must therefore be removed by rinsing before a subsequent resection
at the top of the bladder can take place.

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1 Introduction to Electrosurgery

Stimulation of muscles and


and nerves
HF current with a frequency above 300 kHz is no longer able to stimulate muscles and
nerves. Nevertheless, uncontrolled muscle contractions are among the known risks of
electrosurgery. This is based on a physical effect, which is minimised by the most
modern equipment but which cannot be totally avoided. When an arc is formed, part
of the HF current is rectified, as a result of which low-frequency components of the
current can lead to muscle contractions or spasms. For example, these occur with
TUR in the vicinity of the nervus obturatorius and with operations in the vicinity of the
nervus facialis.

Unintentional activation of the HF current


Unwanted activation of the HF current can be caused by unintentional operation of the
buttons, a defect in the handle or due to a penetration of liquid.
In order that such an occurrence does not lead to the patient being injured, the handle
or the active electrode must never be put down on or next to the patient in a way that
it could touch the patient directly or indirectly by means of electrically conducting
objects or wet cloths. The active electrode must therefore be placed in-between times
in a holster or in the dry area of the preparation table.
Always adjust the acoustic signal which indicates the active state of the HF generator,
so that it is clearly audible.

Output power
- Always set the power output of the HF unit to as low a level as possible.
- If the power is insufficient with normal settings, first ensure that:
- the neutral electrode has been applied correctly.
- the working electrodes are clean.
- the plug connections are correct.

before a higher output power is selected.

There is a risk of injury to the patient due to an


unwanted increase in the HF output power if the unit
should fail.

▶ Do not continue using the equipment when there is


the slightest irregularity.

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1 Introduction to Electrosurgery

1.3.7 Endoscopic operations


Special care is demanded in endoscopic operations,
as the operating area is only partially and indirectly
visible on the monitor and the active electrodes
remain permanently in the patient's body, even in the
non-active state.
Insulation effect

Instrument insulation
The insulation of laparoscopic instruments must be
checked for damage before each use. Damaged
insulation can cause unintentional burns.

Hybrid trocars
Hybrid trocars made of metal and plastic parts must
not be used, as the capacitive coupling of the HF
current causes burns. Consequently, only systems
which are either made completely of metal or of
plastic may be used in the operating theatre.

Metal cannulas
cannulas
There is a risk of burning on the abdominal wall if
laporoscopic instruments with metal cannulas are
used.

Inserting the electrodes


Active electrodes should be inserted in the cannula as carefully as possible and removed
with equal care, so that possible damage to the instruments and/or injury to the patient
can be avoided.

HF activation
Current flow to other instruments
In order to reduce the risk of accidental burning, the
electrosurgical generator must only be activated when
the active electrode is in contact with the target tissue
and in the field of view of the surgeon.
If the electrode is activated outside the field of view, it
can cause unintentional injury to the patient, which
may also go undetected by the surgeon.
Electrodes should not be activated while they are in
contact with other instruments, as otherwise the
surrounding tissue could be damaged.
Even after switching off the HF current, the tip of the
electrode can still be hot enough to cause burns.
Do not remove the hot electrode from the body
immediately after cutting or coagulation. If necessary,
cool by rinsing.

Unintentional HF activation
If an electrode is activated unintentionally by mistake, this activated electrode should not
be removed from the body in an uncontrolled manner, but the HF unit should be switched
off at the mains switch.
If a permanently activated electrode is removed from the body, burns can occur at any
point within the body that comes into contact with the activated electrode.

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1 Introduction to Electrosurgery

1.3.8 Further safety information


Interference with other equipment!
equipment!
Electromagnetic interference fields are produced
when the HF unit is used in accordance with the
instructions.

Make sure that no electronic devices are used in the


vicinity of the HF unit that can be adversely affected
by electromagnetic interference fields.

The following measures are recommended:


- Set up sensitive equipment separately
- Separate power supply
- HF cables not longer than necessary
- Do not run HF cable and camera cables parallel to
each other
- Pay attention to adequate illumination when
making video recordings

Potential equalisation cable


If required by the applicable regulations, e.g in heart surgery, the electrosurgical generator
must be connected to the clinic's equipotential bonding terminal by means of a potential
equalisation cable.

Formation of
of smoke
Studies have shown that smoke produced in electrosurgical operations can be potentially
harmful to patients and the clinical personnel. For this reason, it is recommended to
evacuate smoke with appropriate equipment.

Connection to the power supply


Connect the units directly to the power supply. Avoid using multi-way sockets. Additional
multi-way sockets and extension cables must not be used. When installing, care must
always be taken to comply with the permissible limiting values for leakage current and the
resistance of the protective conductor. The specified limiting values may be exceeded if
different devices (medical and non-medical) are connected to one multi-way socket. All
devices connected to one multi-way socket form a system and must be considered as one
unit.
If a multi-way socket is used via an isolating transformer, it must be ensured that no parts
of the system are supplied from the normal supply network at the same time, as otherwise
the galvanic isolation will be ineffective. If a multi-way socket is not supplied via an isolating
transformer, it must only be possible to connect units in the medical application with the
help of tools.
If movable multi-way sockets are used, these must not be placed on the floor.

Instructions for use - Electrosurgical Generators Page 18 of 76


1 Introduction to Electrosurgery

1.3.9 Information on the use of bipolar techniques


In bipolar applications, two electrodes, insulated against each other, are fed directly to the
operating point.
The HF current flows from one tip of the tweezers to the other via the tissue in-between.
Advantage is primarily taken of this limited current flow in operations where damaging
effects on adjacent tissue structures are feared, e.g. in neuro-, micro-, child and eye
surgery.

Bipolar electrode diameter -


Dosage power in Watt
0.2 mm – max. 1W
0.5 mm – max. 3- 4 W
2 mm – max. 8-10 W

In order to achieve an objective coagulation while caring for the tissue, and to prevent or
keep adhesion as low as possible during these highly sensitive operative procedures, the
following instructions must be followed:
- Switch off the HF current as soon as there is sufficient coagulation.
- Prolongation only leads to increased adhesion of the tissue.
- Only work with clean, metallically bright coagulation surfaces (regular swabbing with a
damp pad)

The coagulation surfaces are moistered by bodily fluid with each coagulation. This fluid
dries on and leaves an electrically insulating coating.
If such a pair of tweezers is re-used before removing the coating, it is not possible for
sufficient HF current to flow. If, instead of cleaning the coagulation surfaces, the power is
now increased, it will be difficult to avoid adhesion when carrying out further coagulations.
- Dry tissue must be moistened with sterile water or physiological saline solution before
coagulation.
- Where possible from an operative point of view, coagulation tweezers with a wide
gripping surface (0.5 – 1 mm tip width) should be used.
-
A lower and more even pressure distribution on the gripped tissue reduces the tendency to
adhesion. Furthermore, a dosage which is often set at too high a level does not immediately
lead to adhesion when the coagulation is ended in good time.
As only a low power is required for bipolar coagulations while at the same time caring for
the tissue, a moderate dosage setting is the first and most important step in avoiding
adhesion of the coagulation necrosis to the tips of the tweezers. The finer the tips of the
tweezers, the more important it is to set the dosage to a moderate level.
If, in spite of the advice given above, adhesion of the coagulate should occur, this should
not be forcibly torn from the tissue but should be left on the tissue for a few seconds. Due
to capillary action, tissue fluid flows from the region of the coagulate to the boundary area
between the coagulate, and the surface of the electrode and reduces the adhesive effect.
Rinsing also helps in this case.

Instructions for use - Electrosurgical Generators Page 19 of 76


2 Equipment description

2 Equipment description
The BOWA electrosurgical generators ARC 200 and ARC 300e are equipped with a powerful
monopolar and a universal bipolar generator.

Exemplary operation, simple handling


Time is valuable in the operating theatre; seconds sometimes make all the difference to the
success of an operation. Just as important is a clear design of the equipment and simple
communication between the human and the device. BOWA has attached great importance
to this aspect.

- A special HF effect can be assigned to each monopolar and bipolar output socket if
required. The settings of the unit can all be read off individually. This eliminates
irritation for the surgeon and the operating personnel.
- Many freely selectable programs enable work to be carried out reproducibly and
produce consistent results.
- All set-up parameters are displayed clearly and well arranged on the front panel. Time-
consuming "paging" or "scrolling" through further menus is obsolete.
- If required, accessories from other manufacturers can be connected using suitable
adapters without any problems. Logistical problems in daily routine use are thus
avoided.
- Thought has even been given to a possible expansion of the system for the use of argon
plasma coagulation.
- An equipment trolley for HF and argon modes, developed from ergonomic as well as
from functional points of view, is available as an option.

2.1 Purpose
Monopolar cutting and coagulation can be used in the following micro- and macro-surgical
operations:
- General surgery
- Endoscopy (only with option “GASTRO CUT”)
- Gynaecology
- Hand surgery
- ENT
- Neurosurgery
- Urology, incl. transurethral resection (TUR) (ARC 300e only)

2.2 ARC technology


“ARC control” takes into account varying cutting surfaces and cutting speeds, detects
differences in human tissue and the impedance changes resulting from this and adapts the
monopolar power output optimally to suit the lowest level required in each case. An
extremely fast computer processes all factors in real time and instantly provides the
optimum current-voltage value.

With the “ARC” equipment concept, you have acquired far-reaching options for the future.
As the software essentially determines the electrical characteristics of the HF generator,
new effects for future applications can be implemented at any time by means of updates.

Instructions for use - Electrosurgical Generators Page 20 of 76


2 Equipment description

2.3 Monopolar modes


Cutting
Powerful HF current up to 200 W (ARC 200) and 300 W (ARC 300e) with a low crest
factor for cuts in low impedance tissue.
By implementing the “blend” function, it is possible to set a degree of sloughing of the
surface, which is variable from step 0 to 9.

Moderate coagulation
Contact coagulation for suppressing haemorrhages, staunching bleeding in larger areas
of tissue and for coagulation in small areas.

Forced coagulation
Contact coagulation with greater capacity and lower range in the tissue, preferably for
coagulation with small-area and fine electrodes.

Spray coagulation
Non-contact surface coagulation by means of spark discharge. Serves to stop the flow
of blood in parenchymatous tissue or in poorly accessible intercellular spaces.This is
mostly used in conjunction with argon coagulation.

2.4 EASY neutral electrode monitoring


Safety for patient and personnel
The EASY electrode application system meets the current requirements for an efficient
neutral electrode monitoring system. EASY measures any changes in impedance between
the patient and the unit both before and during HF activation. If necessary, the personnel
are summoned to intervene by means of an optical-acoustic alarm. The prerequisite for this
is a split neutral electrode with appropriate contact areas and suitable contact impedances
applied to the patient in the specified manner. BOWA neutral electrodes 812-131 and
814-131 for adults and children fulfil the design requirements. The split BOWA baby
electrodes 812-071 and child electrodes 814-071 cannot be monitored due to their low
contact area.
For TUR and moderate coagulation, the minimum area must be set to 160 cm².
A split neutral electrode is generally recommended for high-current applications.
The largest possible neutral electrode must generally be applied.
In high current applications, despite a good contact resistance between patient and neutral
electrode, inadmissibly high temperatures or burns can occur if the neutral electrodes are
too small.

2.5 Bipolar modes


Bipolar techniques
Good coagulation results are achieved with low powers when using bipolar coagulation
techniques. A neutral electrode is not required when using bipolar techniques.

Using bipolar techniques and, in particular, in minimal invasion surgery, optimum results
can only be obtained with special instruments. The bipolar mode is suitable for most
operations.

Instructions for use - Electrosurgical Generators Page 21 of 76


3 Displays and connections

3 Displays and connections


3.1 Front ARC 200 and ARC 300e
300e

ARC 200

ARC 300e
300e

Take note of the information in the instruction manual

Unit Type CF. The unit has high protection against electric shock, in
particular with regard to permissible low-frequency leakage currents.
The unit is therefore suitable for direct application to the heart.

"FLOATING OUTPUT", i.e. the neutral electrode is insulated from earth at


both high and low frequencies.

Voltage higher than 1500V possible

Instructions for use - Electrosurgical Generators Page 22 of 76


3 Displays and connections

3.2 Controls and connecting sockets


Number Description
Program selector, current indication on 2-line display "4".

Power limitation for monopolar cutting, can be read on display "9".


Can be set for output "23".
Power limitation for monopolar coagulation, can be read on display "16".
Can be set for output "23".
Power limitation for bipolar coagulation, can be read on display "25".
Can be set for output "30".
Selector switch for degree of sloughing for monopolar cutting. Blend
settings "0" – "9" on display "14".
Selector switch / display for current type "moderate coagulation".

Selector switch / display for current type "forced coagulation".

Selector switch / display for current type "spray coagulation".

Selector switch / display for AUTO START output "30". For


bipolar coagulation only.
Monopolar output for monopolar instruments with hand or foot switching.

Display for bipolar output for bipolar instruments with foot switching or
AUTO START.

Socket for the neutral electrode (NE)

On/Off switch

Indicator for fault condition

Indicator system for EASY Electrode Application System for the


neutral electrode.
Main display: Programs and information

7-segment display Monopolar Cut

7-segment display Monopolar Coag

7-segment display Bipolar Coag

Blend factor indicator Monopolar Cut

Indicator arrow Monopolar Cut (yellow)

Indicator arrow Monopolar Coag (blue)

Indicator arrow Bipolar Coag (blue)

Selector switch /Indicator foot switch assignment to bipolar output.

Instructions for use - Electrosurgical Generators Page 23 of 76


3 Displays and connections

3.3 Rear
Rear view of ARC 200 and ARC 300
300e

Socket for foot switch


(for foot switch concept, see Chapter 4.11)

Socket “out” for fibre optic cable for connection to the ARC PLUS

Socket “in”for fibre optic cable for connection to the ARC PLUS

Nameplate

Mains connection for inlet connector for non-heating apparatus

Equipotential bonding pin

Instructions for use - Electrosurgical Generators Page 24 of 76


4 Special equipment and program functions

4 Special equipment and program functions


The following recommended parameters for fixed programs are based on values
obtained from experience and must be verified in each individual case and, if
necessary, adapted by the surgeon to the current requirements of the situation in the
operating theatre.

Monopolar Bipolar
P Cut Monopolar Coag Coag
50W 25W
0 Standard 20W
Blend 3 Forced Coag
60W 40W
1 Gyn-Abdominal 30W
Blend 3 Forced Coag
15W 25W
2 Micro Plastic 10W
Blend 3 Forced Coag
15W 25W
3 Pediatric 15W
Blend 3 Forced Coag
15W 10W
4 ENT 12W
Blend 2 Forced Coag
160W 70W
5 TUR-P2) 20W
Blend 5 Spray Coag
80W 70W
6 TUR-BT2) 20W
Blend 4 Spray Coag
250W 70W
7 TUR-VAP2) 20W
Blend 5 Spray Coag
60W 40W
8 Macro Plastic2) ---
Blend 4 Forced Coag
90W 40W
11 Argon1)3) 30W
Blend 5 Spray Coag
15W
12 Argon-Flex1)3) --- ---
Spray Coag
3) PoL. 15W
13 GastroCut Pol ---
Blend 5 Forced Coag
3) PAP. 15W
14 GastroCut Pap ---
Blend 3 Forced Coag

1)
In conjunction with ARC PLUS only
2)
ARC 300e only
3)
Additional option ARC 200 / ARC 300e

Examples of fixed programs

4.1 TUR - X for urology (optional ARC 300e)


Programs "TUR-P", "TUR-BT", "TUR-Vap" can be selected with program selector switch 2 or 3.

These programs allow optimum staunching of blood when cutting under water in
transurethral resection and in the operative treatment of vesical tumours. The careful control
of power enables the prostate tissue to vaporise immediately and produces excellent cutting
effects while staunching bleeding at the same time. In TUR, cutting and coagulation take
place by means of the resection loop. The arc control produces an excellent cut effect while
at the same time minimising the power output. ARC control effects an immediate cut and
prevents the sticking of the electrode. The TUR-Vap program also provides sufficient power
reserves for vaporisation with the help of the "rollerblade" electrode.

Instructions for use - Electrosurgical Generators Page 25 of 76


4 Special equipment and program functions

4.2 Micro Plastic


The "Micro Plastic” program can be selected with program selector switch 2 or 3.

Microsurgical working for plastic, neuro, hand, and oral and maxillofacial surgery.
This program was created especially for the lower power range with fine electrodes and
microscopic tissue structures. The finest power doses of even less than 10 W output
power allow precise working for an accurate cut or a tightly restricted contact coagulation.
Special power limits exist here both for monopolar and for bipolar application with fine
needle electrodes or tweezers. All outputs are preset to standard values.

4.3 Argon assisted electrosurgery with ARC PLUS


(Option “GASTRO CUT”)
The "Argon" program for open surgical operations or "Argon-Flex" for endoscopic use with
flexible probes can be selected with program selector switch 2 or 3.

The settings stored under the "Argon or Argon Flex" program allow operation an in
combination with the auxiliary unit ARC PLUS for argon-assisted electro-coagulation.
When suitable instruments are connected, argon coagulation with rigid or flexible
electrodes as well as argon-assisted cutting is possible.

4.4 GastroCut-
GastroCut-Pol
The "GastroCut Pol" program can be called up with program selector switch 2 or 3. It is
available as an option with ARC 200 and ARC 300e.

This program has been specially designed for gastroenterology and is used for
removing polyps with polypectomy loops which are positioned at the operating area by
means of flexible endoscopes.
With this program, the polypectomy loops are connected to the monopolar output
(using an adapter if necessary). The HF current is activated by means of the yellow
button on the foot switch. The degree of coagulation can be varied by means of the
blend factor of the monopolar Cut Field. The degree of coagulation increases with
increasing blend factor. Power setting is not required due to the arc control. If
bleeding occurs, a clip should be used if possible (a special non-cutting coagulation
current is available, however, which can be used by actuating the forced coagulation
mode button 20).
20
The ARC PLUS argon unit can be connected to the polypectomy loop by means of a
hose (standard LL connectors), which enables argon-assisted coagulation to be carried
out in spray mode (button 21)
21 with the loop retracted. The blue button on the
footswitch must be activated for this purpose.

Instructions for use - Electrosurgical Generators Page 26 of 76


4 Special equipment and program functions

4.5 GastroCut-
GastroCut-Pap
The "GastroCut Pap" program can be selected with program selector switch 2 or 3. It is
available as an option with ARC 200 and ARC 300e.

This program is used for expanding the papilla using a papillotome, which can be
positioned in the operating area by means of a flexible endoscope.
In this program, the polypectomy loops are connected to the monopolar output 23 (using
an adapter if necessary). The HF current is activated by means of the yellow button on the
foot switch. The resulting arc can be varied by means of the blend factor of the monopolar
Cut Field. The arc is reduced with increasing blend factor. Power setting is not required
due to the arc control.

4.6 Forced
Forced Coag Modi
With this basic setting, the general behaviour of the forced coag current can be set
with reference to the cutting or coagulation tendency.
These behaviour modes apply to all HF programs except the "GastroCut-Pol" and
"GastroCut-Pap" programs.
The mode currently set is shown in the display for three seconds after the front panel
test.
For changing the Forced Coag mode, please see Chapter 8.4.3.

4.6.1 Non Cutting Mode


This Forced Coag mode is distinguished by its high degree of coagulation and very
low cutting tendency. This mode is suggested for all applications where a good
coagulation is required without invasion of the tissue.

4.6.2 Mixed Mode


The most important feature of this Forced Coag mode is the good coagulation
effect with simultaneous moderate cutting effect. This mode can be used for all
standard applications. This mode is pre-set in the delivery status.

4.6.3 Cutting Mode


The Forced Coag cutting mode has been specially created for applications where
the operator is used to making preparatory cuts with the "blue button". This mode
is distinguished by its outstanding cutting action with simultaneous good
haemostasis.

4.7 Bipolar coagulation


In bipolar coagulation, there is the option of activating the AUTOSTART function for
the bipolar output by pressing the selector switch 29.
29 The AUTOSTART function is
deactivated again by pressing the selector switch 29 again. The coagulation current is
switched on automatically when contact is made with the bipolar instrument; in this
mode, activation by means of the foot switch is not necessary. If an output working in
the AUTOSTART mode is activated by means of a foot switch, the AUTOSTART is
deactivated and the foot switch signal is used.
The AUTOSTART function can only be activated for bipolar coagulation.

Instructions for use - Electrosurgical Generators Page 27 of 76


4 Special equipment and program functions

4.8 Foot
Foot switch

4.8.1 Standard functions

Footswitch LWL – Connector for ARC PLUS


connecter socket

Several foot switch systems can be connected to the ARC 200 / ARC 300e
generator.

Description BOWA No.


EP Single pedal footswitch 901-011

DP Double pedal footswitch 901-021

Double pedal footswitch with additional


DP+ 901-031
button

Arrangement of footswitch

The ARC200/ARC300e has a feature displaying the effective allocation of the


footswitch by means of the footswitch allocation button in the Bipolar Coag field.
The yellow pedal of the footswitch is always assigned to the function “Monopolar
Cut”. The function of the blue pedal can be changed to either “Monopolar Coag” or
“Bipolar Coag”.
If the footswitch allocation button lights up, the blue pedal of the footswitch is
allocated to the Bipolar Coag function. In this mode, an acoustic signal confirms the
activity of switching.

Instructions for use - Electrosurgical Generators Page 28 of 76


4 Special equipment and program functions

4.8.2 Standard combinations

Assigned output Possible switching


Foot switch Comment
(front panel) functions

“23” Mono. COAG Changing of the


1 single pedal output by means of
oder
(EP) pressing the button
“30” Bip. COAG 28 for 1.5 seconds
Changing of the
“23” Monop. CUT / COAG output by means of
1 double pedal
with/ without pressing the button
28 for 1.5 seconds or
button or/ and Monop.
Monop. CUT/ via the additional
(DP/DP+) “30” Bip. COAG button on the
footswitch.

Note:
While AUTO START mode is activated for bipolar coagulation,
coagulation the
CUT button on the foot switch can be used for cutting.

Instructions for use - Electrosurgical Generators Page 29 of 76


4 Special equipment and program functions

4.9 Other individual programs


The BOWA ARC family offers many individual programs with special functions to be
set up.
These include, for example, the limitation of parameters in the case of bipolar LAP
instruments, individual setting of the arc intensity or even the assignment of foot
switches to certain instruments.
With the generators of the ARC series, the parameter settings for all programs can be
saved.
To do this, the parameters such as power, blend factor, coagulation mode and foot
switch assignment are set up and then saved by pressing button 29 (button AUTO
START).
Note: button 29 must be pressed for more than 5 seconds (until "->|" appears in the
display).
In order to reset the factory settings for the fixed programs, see Chapter 8.4,
menu program 8.

Instructions for use - Electrosurgical Generators Page 30 of 76


5 Information: Before the surgical operation

5 Information:
Information: Before
Before the surgical operation
5.1 Preparing the patient
The following checklist for operations using electrosurgical techniques must be
observed:
- The cardiological or specialist department must be consulted in the case of
pacemaker patients and wearers of active implants.
- In the case of gastrointestinal surgery, the endogenous gases must be reliably
removed by rinsing before and during the operation.
- Determine the point of application of the neutral electrode according to the
operation (observe distance from ECG electrodes).
- Clean the point of application, if necessary, and remove only strong hair growth.
- Apply the neutral electrode securely and reliably.
- Use insulated operating table covers including anti-decubitus covers.
- Make sure that the patient is not in touch with any metal parts that are earthed for
HF.
- Avoid skin-to-skin contact.
- Do not use inflammable cleaning agents and disinfectants.
- The neutral electrode cable must be securely and reliably connected to the neutral
electrode.
- Do not use needle electrodes for ECG electrodes.
- Drain urine by means of a catheter.

5.2 Preparing the HF generator


High-frequency electrosurgical generators may only be operated in rooms used for
medical purposes which fulfil the requirements of DIN VDE 0100-710.
The ARC units can be set up on tables, on the consoles of ceiling supports or wall
arms as well as on equipment trolleys provided for the purpose. Do not place any
other equipment except the ARC PLUS argon unit on the HF generator, and do not
place this on top of any other equipment. Keep as far away as possible from other
electronic equipment. It is likewise forbidden to place other objects on the unit. If the
unit has been stored or transported at temperatures below +10°C, it will require
approx. 3 hours to acclimatise at room temperature.

5.3 Starting up the HF unit


The HF unit is put into operation in the following steps:
a) Switch on the mains switch 1
All the display indicators will illuminate. This
gives an opportunity for visual checking. The unit
must not be used any longer if any indicators
fail. By acknowledging with any button, all the
parameters of the last program selected or, after
approx. 2 minutes, the standard program "0 0" will
appear.

b) The preselection of the program is carried out by


means of the program switches 2 or 3. Various
preset programs "00" – "X
X" are provided. Programs
"X+1
X+1"
X+1 – "99
99"
99 can be set up as required.

Instructions for use - Electrosurgical Generators Page 31 of 76


5 Information: Before the surgical operation

c) The power limitation of the monopolar cutting


current is adjusted with the Up/Down buttons 11
or 10.
10 The Up/Down buttons 12 and 13 enable the
blend factor to be set from step "1"
1" – "9"
9" (i.e. the
degree of coagulation of the cut). "0
0" means a cut
without coagulation.

d) The type of current for the coagulation is


pre-selected with the buttons 19, 20 and 21.
21

= moderate coagulation (equivalent to desiccation)


= forced coagulation (equivalent to fulguration). Mode
changing: see Chapter 8.4, Menu program 3
= Spray coagulation

e) The power limitation of the monopolar coagulation


current is set with the Up/Down buttons 18 and 17.
17

Instructions for use - Electrosurgical Generators Page 32 of 76


5 Information: Before the surgical operation

f) The power limitation of the bipolar coagulation current is


set with the Up/Down buttons 27 and 26.26

g) The AUTOSTART function for the bipolar coagulation


current can be activated or deactivated with the selector
switch 29.
29

h) With selector switch 28,


28 the footswitch allocation of the
blue pedal can be switched over. If the button is
unlighted, the blue pedal of the preselected type of
current “Monopolar Coag” is assigned. If button 28
illuminates, the blue pedal activates the type of
current “Bipolar Coag”.

i) Connect the HF accessories from left to right to


the generator sockets 22, 23, and 30.
30

j) Check on the EASY display 6 or 7 whether the type of neutral


electrode corresponds with the illuminated symbol.
Should a deviation of the shown types of electrodes appear,
please check the complete cable and electrode.

The unit is now ready for use.

Instructions for use - Electrosurgical Generators Page 33 of 76


5 Information: Before the surgical operation

5.4 Preparing the accessories


As a routine, accessories should be subject to a visual inspection before each use. In
particular, electrode leads and accessories used for endoscopic purposes should be
checked for possible damage to the insulation.

5.5 Monopolar surgery


- Before connecting, check accessories to ensure that they are free from damage,
with particular check for faulty insulation.
- Plug in the neutral electrode cable and check that the neutral electrode display on
the unit indicates correctly.
- Connect the electrode handle or monopolar cable to the appropriate output
socket. For accessories without finger buttons, a foot switch must be connected.
- To connect a monopolar cable with Bovie plug, the blanking plug must be
removed from the output socket by using a tool (e.g. tweezers or forceps).
- Activate the handle or foot switch briefly and check that the HF unit works
correctly and is set properly. The insulation of the accessories must be adequately
rated for the maximum output peak voltage.
- Place the active accessory on a dry, electrically insulated part of the accessory
table or in the surgeon's holster.

5.6 Bipolar surgery


- Check to ensure that the bipolar cable and the instrument are free from damage
- Connect bipolar cable and instrument and connect the cable to the output socket.
- If the AUTO START function is not being used, the foot switch must be connected.
- Activate the bipolar function briefly and check that the HF unit works correctly and
is properly set. The insulation of the accessories must be adequately rated for the
maximum output peak voltage.
- Place the active bipolar instrument on a dry, insulated part of the accessory table
or in the surgeon's holster.
- Before cleaning the bipolar instruments, the AUTO START function must be
deactivated in order to avoid burns to the user.

Instructions for use - Electrosurgical Generators Page 34 of 76


6 Information: During the operation

6 Information:
Information: During the operation
6.1 Power recommendations
These values, gleaned from experience, are a recommendation for working with the
BOWA ARC 200 and ARC 300e HF electrosurgical generators. Individual ways of
working may require alternative settings. Further recommendations: see Chapter 4.

Monopolar application

Indication Type of current Power


setting
in Watts
Open operation
Cutting into muscular tissue with Monopolar CUT 40-50
needle electrode
Cutting with fine lancet electrode Monopolar CUT 40-60
Cutting with knife electrode Monopolar CUT 40-60
If it is intended to coagulate with cutting instruments in direct contact with the
tissue, the COAG power must be set significantly below the recommended value
for cutting.
Coagulating with the tips of cutting Monopolar COAG moderate 20-30
electrodes
Coagulating by means of clamps Monopolar COAG forced or 30-40
(Jaw width 2-3 mm) Monopolar CUT
Coagulating by means of finer Monopolar COAG forced 20-30
tweezers (Tip width 1-1.5 mm)
Fulguration by means of fine Monopolar COAG spray/ forced 15-25
electrode tips
Fulguration by means of large-area Monopolar COAG spray/ forced 30-50
electrode tips
Transurethral resection
TUR-P with mannitol-sorbitol Monopolar CUT 160
solution (cutting)
TUR-P with mannitol-sorbitol Monopolar spray COAG 70
solution (coagulation)

Instructions for use - Electrosurgical Generators Page 35 of 76


6 Information: During the operation

Bipolar applications

Indication Type of current


current Power
setting
in Watts
Coagulations
Bipolar tweezers, tip width 0.2 mm Bipolar COAG 10-20
Bipolar tweezers, tip width 0.4 mm Bipolar COAG 10-20
Bipolar tweezers, tip width 0.7 mm Bipolar COAG 10-20
Bipolar tweezers, tip width 1.0 mm Bipolar COAG 20
Bipolar tweezers, tip width 1.5 mm Bipolar COAG 20
Bipolar tweezers, tip width 2.0 mm Bipolar COAG 30
Bipolar forceps, narrow jaw Bipolar COAG 20-30
Bipolar forceps, wide jaw Bipolar COAG 30-40

6.2 Changing the settings


Particular care must be taken especially when making changes to the power deviating
from normal dose settings. Experience has shown that an increase in power of 15-20%
is necessary to achieve a clearly discernable increase in the effect.
Therefore, in monopolar mode, the secure contact and the correct function of the
neutral electrode must be checked.
The maximum power selection must be checked when changing the type of current,
for example from Cutting blend "8" to Cutting without scab or from Moderate
coagulation to Forced coagulation.

Instructions for use - Electrosurgical Generators Page 36 of 76


6 Information: During the operation

6.3 Checking the neutral electrode


In the monopolar mode, the correct application and function of the neutral electrode
is particularly important. A check is necessary after changing the patient's position
and during the operation when there is a long activation phase, particularly when
using non-split electrodes.
In the case of split neutral electrodes, in the EASY operating mode, attention should
be paid to any optical-acoustic alarm that should occur. In the case of a sustained
warning, the position and application of the neutral electrode including its cable must
be checked and corrected if necessary.
Further information on the use of neutral electrodes can be found in Chapters 1.3.4
and 2.4.

Indicator "7
7" must light up green when split
electrodes are used, and indicator "6 6" for non-split
electrodes. Neither of the two symbols in display "6 6"
and "77" must light up if no neutral electrode cable
or only one neutral electrode cable without an
electrode is connected.
If a symbol lights up, check whether the cable has a
short circuit.
If an electrode cable is plugged into the NE socket
together with a split electrode and if the electrode
has not yet been attached to the patient, no symbol
must light up. If a symbol lights up, check whether
the electrode and cable are correctly connected.

6.4 Alarm functions


If system faults should occur during
operation, the indicator "5
5" "output errors"
may light up red.

In the ARC 200 / ARC 300e model, this


appears as "INF
INF"
INF and "xxx
xxx"
xxx on the displays
"9
9" and "16
16"
16 of the monopolar power
limitation.
Fault messages of this kind do not
necessarily lead to a shutting down of the
generator and may disappear again in the
course of the unit's self check.

Instructions for use - Electrosurgical Generators Page 37 of 76


6 Information: During the operation

6.5 Activation tones


Tones with the following characteristics sound for monopolar and bipolar activation:
Mode Display in menu Frequency Type of signal
program [Hz]
Monopolar Cut TON 1 500 Continuous tone
Monopolar Coag TON 2 420 Continuous tone
Bipolar Coag TON 4 340 Continuous tone
GastroCut Pulsating alternating tone
complete
Alarm 1000 Intermittent

The alarm and operating signals have a specified minimum volume. If necessary, the
volume must be adjusted to suit a more noisy environment in order to ensure that they
are audible.

Instructions for use - Electrosurgical Generators Page 38 of 76


7 Information: After the operation

7 Information:
Information: After
After the operation
7.1 Fault reports
reports
Any faults that may have occurred can be called up from the unit when the operation
has been completed.
For the exact procedure, please read Chapter 8.3 and 8.4

7.2 Cleaning, disinfection, sterilisation and storing of the


accessories
Re-usable HF accessories such as handles, cables, electrodes, adapters etc. must be
cleaned and disinfected in accordance with the manufacturer's instructions. In
particular, the manufacturer's recommendations with regard to cleaning agents and
disinfectants and the procedures to be used must be followed both for manual and
automated disinfection.
Defective and irreparable products must be replaced.
Reusable HF accessories are to be steam-sterilised in accordance with DIN EN 554 or
ANSI AAMI ISO 11134 at 134°C for 20 min.
The storage of HF accessories for future use must be carried out in accordance with
DIN EN 868, Part 1 or ANSI AAMI ISO 11607.

Storage and transport conditions must be maintained as follows:


Temperature: -20 °C to + 50 °C.
Relative humidity: 0 to 75 %, non-condensing.
Air pressure: 500 to 1600 mbar.

Accessories that are identified as being for single use or identified in some other way
as being single use items must not be re-sterilised or used a second time. They must
be disposed of, taking into account the regulations applicable in the hospital.

7.3 Cleaning and storing of the equipment


The equipment must always be switched off before cleaning and unplugged from the mains
due to the possible risk of electric shock.
Wipe the outside surfaces of the HF unit and the mains lead carefully with a mild detergent
solution or a disinfectant using a damp cloth.
Do not use any abrasive materials that could scratch or damage the housing.
Follow the procedure laid down in your hospital or use a proven method for controlling
infection. Liquids must not be allowed to get inside the housing.

Storage and transport conditions must be maintained as follows:


Temperature: -20 °C to + 50 °C.
Relative humidity: 0 to 75 %, non-condensing.
Air pressure: 500 to 1600 mbar.

The HF generator can be stored for an unlimited time. If it is stored for longer than
one year, it is recommended to carry out a special function check before putting it
back into use.

7.4 Disposal
The disposal of medical products, packaging material and accessories has to be
effected according to the country-specific directives and laws.

Instructions for use - Electrosurgical Generators Page 39 of 76


9 Maintenance and repair

8 Fault displays and menu programs


8.1 General
The ARC 200 and ARC 300e allow for a continuous
monitoring of all relevant functions of the equipment.
Faults that occur are indicated by the message "INF"
and by "xxx" on the displays "9
9" and "16
16".
16

The fault codes are classified and displayed in one of


the following five groups:

Generator block, LNT module from INF "001


001"
001 to "015
015"
015
Equipment/Operator error from INF "040
040"
040 to "081
081"
081
EASY monitoring from INF "100
100"
100 to "105
105"
105
Sensors from INF "110
110"
110 to "149
149"
149
System self-monitoring from INF "150
150"
150 to "255
255"
255

The principle of "fleeting faults" is generally applicable.


The fault is indicated as long as it actually occurs. If the fault code goes off, it is possible to
continue working with the unit normally. Errors which occurred can be read out again in a
menu program. Please see chapter 8.4.4 for more information.

8.2 EASY alarm


The EASY neutral electrode monitoring system has been
conceived for applications with split electrodes (for more
information, see also Chapter 2.4).
When used with split neutral electrodes in accordance with the
instructions, the appropriate symbol will light up green (see
indicator "7
7").

If the resistance increases significantly, the indicator "7


7" starts to
flash yellow. It is not necessary to interrupt the application at this
stage however. In this case the user has to decide if the
convenience/ risk ratio is still acceptable. Depending on
indication and current selection, it may lead to an excessive
heating if the indicator flashes yellow.
If a significant problem occurs when activating the monopolar
current, the EASY indicator changes from green to permanently
red. At the same time, an acoustic signal will sound and an
appropriate "INF" "xxx" message will appear on the displays "9 9" and "16
16".
16

If an electrode comes loose, the electronics in the unit switches off the monopolar output. In
order to clear this fault, the neutral electrode must be changed or applied correctly. If
necessary, the neutral electrode cable must also be checked for a secure contact or external
damage.
When a non-split electrode is used in a proper manner, the indicator "6 6" lights up green. EASY
monitoring as described is not possible with this type of neutral electrode.

Instructions for use - Electrosurgical Generators Page 40 of 76


9 Maintenance and repair

8.3 System alarm messages


If faults should occur, the indicator "5 5" illuminates
and "INF" appears in display "9 9" and a three-digit
number in display "1616".
16
If this occurs even before the current is activated,
the error list may give an explanation as to
possible causes of the fault. If necessary, the fault
can be cleared by switching off the unit and
switching it on again. When display "5 5" and
displays "99" and "16
16"
16 go off, the unit is completely
ready for use again.
If not, the unit must be serviced by an authorised
agency. For more information see also Chapter 9.

The fault codes are classified and displayed in one of the


following five groups:

Generator block, LNT module from INF "001


001"
001 to "015
015"
015
Equipment/Operator error from INF "040
040"
040 to "081
081"
081
EASY monitoring from INF "100
100"
100 to "105
105"
105
Sensors from INF "110
110"
110 to "149
149"
149
System self-monitoring from INF "150
150"
150 to "255
255"
255

8.4 Menu programs


To access the menu program level, the unit must be switched on with button 1 while
simultaneously pressing button 3. The current software version will be displayed.
Pressing button 2 again gives access to the "menu programs".
The following menu programs can be invoked:

Menu program 1: Set Language


Menu program 2: Sound Level
Menu program 3: Forced Coag Mode
Menu program 4: Show Prev Inf-No
Menu program 5: Hide Fix Prog.
Menu program 6: Auto Start Delay
Menu program 7: Edit Prog. Names
Menu program 8: Restore Programs
Menu program 9: PANEL CHECK

Other menu programs are described in the Service Manual and can only be called up
by using a password.

Instructions for use - Electrosurgical Generators Page 41 of 76


9 Maintenance and repair

ARC 200

ARC 300e

8.4.1 Menu program 1: Set Language


The national language of the fixed programs can be changed with this program
(German, English, French, Italian or Spanish). The menu remains in the English
language and cannot be changed.
Button 11 must be pressed to start the menu program. The language can then be set
up as required by pressing button 12 or 13.
13
The chosen setting is automatically saved when the unit is switched off. Return to the
menu programs menu by pressing button 10. 10

8.4.2 Menu program 2: Sound Level


The volume of the individual activation tones can be changed with this program.
Button 11 must be pressed to start the menu program. The volume can then be
changed by pressing button 12 or 13.
13 The next tone can be selected by pressing
button 18.
18 The number of different tones varies depending on the unit (ARC 200/ ARC
300e). The chosen setting is automatically saved when the unit is switched off. Return
to the menu programs menu by pressing button 10. 10

Instructions for use - Electrosurgical Generators Page 42 of 76


9 Maintenance and repair

8.4.3 Menu program 3: Forced Coag Mode


The forced coagulation mode can be changed with this program.
Button 11 must be pressed to start the menu program. The mode can then be
changed by pressing button 12 or 13.
13 The following modes are available: Non-Cutting
Mode, Mixed Coag Mode or Cutting Mode.
The chosen setting is automatically saved when the unit is switched off. Return to the
menu programs menu by pressing button 10. 10

8.4.4 Menu program 4: Show Prev Inf-


Inf-No
The errors stored in the unit can be called up with this program.
Button 11 must be pressed to start the menu program. The error numbers that have
occurred and the quantity can then be displayed by repeatedly pressing button 12 and
13.
13 The last 10 error numbers can be called up in chronological order by pressing
button 29;
29; they can also be displayed by pressing the buttons 12 and 13.
13 Please refer
to the service manual for more details.
The selected settings are automatically saved when the unit is switched off.
Return to the menu programs menu by pressing button 10. 10

8.4.5 Menu program 5: Hide Fix Prog.


Fixed programs can be shown and hidden with this program.
First press button 11 and then button 29 to start the menu program.
After that, the respective programm can be selected by pressing button 2 or 3. In the
second line of the display of the indicator “4”, the status “active” or “inactive” of the
selected program is shown. Button 17 has to be pressed for hiding and for showing
button 18. To show or hide another program, the respective program must be
selected with button 2 or 3. With button 27 all programmes can be shown, and with
button 26 they can be hidden.
The chosen setting is automatically saved when the unit is switched off.
Return to the menu programs menu by pressing button 10. 10

Instructions for use - Electrosurgical Generators Page 43 of 76


9 Maintenance and repair

Display 1 Display 2 Display 3 Display 4

8.4.6 Menu program 6: Auto Start Delay


The delay and follow-up time of the HF current in bipolar AUTO START mode can be
changed with this program.
Button 11 must be pressed to start the menu program. The delay time can then be
changed in 50 ms steps (from 50- 2,500 ms) by pressing button 17 or 18. 18 The chosen
setting is automatically saved when the unit is switched off. Return to the menu
programs menu by pressing button 10.10

8.4.7 Menu program 7: Edit Prog. Names


The freely available programs can be edited with this program.
Button 11 must be pressed to start the menu program.
The program to be edited can be selected with the buttons 2 and 3.
To start the editing programm button 19 has to be pressed. The required letter or
figure can be selected by means of pressing the button 12 or 13. 13 Selection between
upper and lower case can be made by pressing button 18 and 17. 17 With button 11 the
next letter or figure can be selected. To delete the last letter or figure, button 10 has
to be used. In order to save the given name, button 29 has to be pressed. If a further
program should be edited, it has to be selected with buttons 2 or 3, then button 12
hast to be pushed again. By pressing button 26 and 29, 29, the entry of the selected
program can be deleted.
All entries in the freely selectable programs can be deleted by pressing buttons 27
and 29.
29
The chosen setting is automatically saved when the unit is switched off. Return to the
menu programs menu by pressing button 10. 10

8.4.8 Menu program 8: Restore Programs


All fixed program parameters that have been changed can be reset to the delivery
status with this program. The reset only applies to the fixed programs. First button 11
must be pressed to start the menu program and then button 29. 29.
The chosen modification is automatically saved when the unit is switched off. Return
to the menu programs menu by pressing button 10. 10

8.4.9 Menu program 9: PANEL CHECK


All lamps on the control section can be activated with this program.
Button 11 must be pressed to start the menu program, which will activate all lamps.
Return to the menu programs menu by pressing button 10. 10

Instructions for use - Electrosurgical Generators Page 44 of 76


9 Maintenance and repair

9. Maintenance and repair


BOWA-electronic GmbH & Co. KG accepts liability for safety, reliability and
performance of the HF generator under the following conditions:

a) All instructions for installation and for proper use in accordance with this user
manual are followed exactly.

b) Modifications, repairs, readjustments etc. have only been undertaken by persons


authorised by BOWA to carry out this work.

c) Electrical installations in the room where the generator is used comply with the
local specifications and the statutory regulations.

Check the unit or the equipment trolley and the accessories (e.g. foot switch, cable)
for damage after every use. A damaged unit, equipment trolley or damaged
accessories must not be used. Replace damaged accessories. If the unit or the
equipment trolley is damaged, please contact the Customer Service.

Further information on the conditions of the warranty can be found in Chapter 12.

With regard to regular safety checks, please refer to the appropriate national
regulations such as the Statutory Regulation for Users of Medical Products
(MPBetreibV).

BOWA-electronic recommends that a safety check is carried out on all ARC units
at regular intervals of one year.
A test schedule, which has been prepared in advance by BOWA, will assist in this.
If the safety check is not carried out properly or completely, errors in calibration
are to be expected. This can result in possible risks to the patient and the operating
personnel during use.

The unit must be serviced at the latest when a fault message appears and/or a
functional fault occurs. Before returning the unit, please contact a BOWA Sales
Representative or your authorised dealer. The following information is particularly
important:

- full address
- model number
- serial number
- software version
- description of the problem or the repair to be carried out

It must be agreed, in every individual case, whether remote diagnosis is possible or


whether it is necessary to return the unit, possibly in conjunction with an exchange
unit for a limited time.

Instructions for use - Electrosurgical Generators Page 45 of 76


10 Technical data

10 Technical data
10.1 Technical features and data
HF electrosurgical
electrosurgical generator ARC 200 and ARC 300
300e

Monopolar cutting
CCS: CUT
C Control
C System,
S permanent start of cut support yes
Cutting with "ARC-Control" yes
Form of HF voltage sinusoidal
Rated frequency 330 kHz
Max. peak voltage for Monopolar Cut, TUR 950 Vp
Max. peak voltage for Micro Plastic Cut, ENT/ HNO 570 Vp
Power indication, 7-segment display 3 digits
Max. output power ARC 200 / 300e 200W / 300 Watt
Max. output power for Micro Plastic Cut, Paediatric 30 Watt
Max. output power for ENT/ HNO 50 Watt
Max. output power for Macro Plastic Cut 75 Watt
HF power limitation 1 to 200/300 Watt, adjustable in 1 Watt steps yes
Accuracy of HF power limit 1 digit or ±15 %
BLEND adjustment 10 steps
Outputs 1 off 3-pin type
+ Bovie
Activation by finger switch yes
Activation by foot switch yes

Monopolar Moderate Contact Coagulation


Coagulation
Controlled coagulation without forming an arc yes
Form of HF voltage sinusoidal
Rated frequency 330 kHz
Max. peak voltage 190 Vp
Max. peak voltage Micro Moderate Contact Coagulation 150 Vp
Power indication, 7-segment display 3 digits
Max. output power 120 Watt
Max. output power Micro Moderate Contact Coagulation 30 Watt
Max. output current 2A
HF power limitation 1 to 120 Watt, adjustable in 1 Watt steps yes
Accuracy of HF power limit 1 digit or ±15 %
Outputs 1 off 3-pin type
+ Bovie
Activation by finger switch yes
Activation by foot switch yes

Instructions for use - Electrosurgical Generators Page 46 of 76


10 Technical data

Monopolar Forced Coagulation


Coagulation
Form of HF voltage pulse, modulated
Rated frequency 1 MHz
Max. peak voltage Cutting Mode 1660 Vp
Max. peak voltage Mixed Coag Mode 3180 Vp
Max. peak voltage Non Cutting Mode 4770 Vp
Max. peak voltage Micro Cutting Mode 1020 Vp
Max. peak voltage Micro Mixed Coag Mode 2610 Vp
Max. peak voltage Micro Non Cutting Mode 4000 Vp
Power indication, 7-segment display 3 digits
Max. output power Non Cutting Mode, Mixed Coag Mode 120 Watt
Max. output power Cutting Mode 75 Watt
Max. output power Micro Forced Coagulation 30 Watt
HF power limitation 1 to 120 Watt, adjustable in 1 Watt steps yes
Accuracy of HF power limit 1 digit or ±15 %
Outputs 1 off 3-pin type
+ Bovie
Activation by finger switch yes
Activation by foot switch yes

Monopolar Spray Coagulation


Coagulation
Form of HF voltage pulse, modulated
Rated frequency 1 MHz
Power indication, 7-segment display 3 digits
Max. output power 120 Watt
Max. output power Micro Spray Coagulation 30 Watt
Max. peak voltage 4600 Vp
Max. peak voltage Micro Spray Coagulation 3450 Vp
HF power limitation 1 to 120 Watt, adjustable in 1 Watt steps yes
Accuracy of HF power limit 1 digit or ±15 %
Outputs 1 off 3-pin type
+ Bovie
Activation by finger switch yes
Activation by foot switch yes

Monopolar Argon-
Argon-Plasma Coagulation
Coagulation (option)
Automatic ARC PLUS unit detection yes
Form of HF voltage pulse, modulated
Rated frequency 1 MHz
Power indication, 7-segment display 3 digits
Max. peak voltage "Argon" program 3840 Vp
Max. peak voltage "Argon flex" program 4600 Vp
Max. output power 120 Watt
HF power limitation 1 to 120 Watt, adjustable in 1 Watt steps yes
Accuracy of HF power limit 1 digit or ±15 %
Outputs 1 off 3-pin type
+ Bovie
Activation by finger switch yes
Activation by foot switch yes

Instructions for use - Electrosurgical Generators Page 47 of 76


10 Technical data

Bipolar
Bipolar Contact Coagulation
Coagulation
Controlled coagulation without forming an arc yes
Form of HF voltage sinusoidal
Rated frequency 330 kHz
Max. peak voltage Bipolar Contact Coagulation 175 Vp
Max. peak voltage Micro Bipolar Contact Coagulation 140 Vp
Power indication, 7-segment display 3 digits
Max. output power Bipolar Contact Coagulation 120 Watt
Max. output power Micro Bipolar Contact Coagulation 30 Watt
Max. output current 2A
HF power limitation 1 to 120 Watt, adjustable in 1 Watt steps yes
Accuracy of HF power limit 1 digit or ±15 %
Outputs 1 off 2-pin type
Activation by foot switch yes
Activation with AUTOSTART yes

Programs
Number of programs in the unit 100
Fixed programs, pre-set by the supplier yes
Individually programmable yes
Indication of program number and information on the display yes

Monitoring of the neutral electrode


EASY: Electrode
El Application
A System
S yes
Indication of one-piece or split electrodes on the front panel yes
Indication of the transition resistance between the subareas of split
Neutral electrodes on the display (contact quality monitor) yes
Indication on the display of cable resistance when
using one-piece electrodes (contact quality monitor) yes
Max. measurement range possible between the partial areas of NEs 999 Ohm
Max. impedance allowed between the partial areas NEs 300 Ohm
Warning signal in the case of danger under the neutral electrode optical, acoustic
Warning indication as text on the display yes

Safety devices
ISSys: Integrated Safety
S System
S yes
Permanent monitoring of HF leakage currents with fault indication yes
Monitoring of dosing, fault message on display yes
Permanent self-test yes
Permanent status indication on the display yes
Indication of operator errors on the display yes
Indication of system faults on the display yes

Documentation
Recording and saving of data in the unit:
Fault conditions yes
Operator faults yes
Display of these data yes

Instructions for use - Electrosurgical Generators Page 48 of 76


10 Technical data

Indicating devices
2-line display yes
7-segment display for parameter indication yes, 4 pieces
Warning tone yes
Activation tone for each function yes

Communication
External interface for communication with ARC PLUS yes
External PC interface using BOWA software yes
Service support using BOWA software yes

Mains connection
Power consumption in stand-by mode 25 Watt
Mains frequency 50 / 60 Hz
Max. power consumption at an HF output power 500 Watt
Connector for equipotential bonding yes

Voltage range 230 V


Input voltage range 198 V to 260 V
Current consumption in stand-by mode 110 mA
Current consumption at max HF power 3.2 A
Mains fuse 2 x 4 A slow acting

Voltage range 100 V,


V, 115 V
Input voltage range 90 V to 130 V
Current consumption in stand-by mode 220 mA
Current consumption at max HF power 6.4 A
Mains fuse 2 x 8 A slow acting

Service support
Service support integrated into the unit by means of service programs yes
Service support using the ISSys yes

Dimensions and weight


Outside dimensions width x height x depth (mm) 430 x 150 x 400
Weight ca. 10 kg

Cooling
Convection yes
Fan, continuously on or temperature controlled no

Insulation type
Protection class to EN 60601-1 I
Type according to EN 60601-1 CF

Operating mode
INT 10 sec / 30 sec

Classification according to EC Directive 93/42/EEC


Class IIb

Instructions for use - Electrosurgical Generators Page 49 of 76


10 Technical data

10.2 Diagrams
The diagrams for Monopolar Cut/ TUR are shown

a) without arc formation


b) with previous arc formation.

This is necessary as the arc formation cannot be simulated correctly using ohmic
resistors in conjunction with new arc-controlled generators such as BOWA ARC.
Some cutting currents cannot be displayed individually in dependence of the blend
steps by means of ohmic resistors. This is only possible when biological tissue is
used.

10.2.1 Performance diagrams

10.2.1.1 Monopolar Cut/ TUR


Monopolar Cut
P [W]
350

300

250

200

150

100

50 Blend 4-9
Blend3
Blend2
Blend 0,1
0
10 100 1000 10000
R [Ohm]

Measurement on ohmic resistors without arc formation


1. ARC300e: Diagram of output power P[W] as a function of the load resistance R(Ohm) for the
setting "Monopolar
Monopolar Cut"
Cut = 300 W
2. ARC300e: Diagram of output power P[W] as a function of the load resistance R(Ohm) for the
setting "Monopolar
Monopolar Cut"
Cut = 150 W
3. ARC200: Diagram of output power P[W] as a function of the load resistance R(Ohm) for the
setting "Monopolar
Monopolar Cut"
Cut = 200 W
4. ARC200: Diagram of output power P[W] as a function of the load resistance R(Ohm) for the
setting "Monopolar
Monopolar Cut"
Cut = 100 W

Instructions for use - Electrosurgical Generators Page 50 of 76


10 Technical data

Measurement on ohmic resistors with previous arc formation


1. ARC300e: Diagram of output power P[W] as a function of the load resistance R(Ohm) for the
setting "Monopolar
Monopolar Cut"
Cut = 300 W
2. ARC300e: Diagram of output power P[W] as a function of the load resistance R(Ohm) for the
setting "Monopolar
Monopolar Cut"
Cut = 150 W
3. ARC200: Diagram of output power P[W] as a function of the load resistance R(Ohm) for the
setting "Monopolar
Monopolar Cut"
Cut = 200 W
4. ARC200: Diagram of output power P[W] as a function of the load resistance R(Ohm) for the
setting "Monopolar
Monopolar Cut"
Cut = 100 W

10.2.1.2 Monopolar Cut: Macro Plastic


Macro Plastic Cut
P [W]
80

70

60

50

40 Blend 9
Blend 8
Blend 7
30 Blend 6
Blend 5
Blend 4
20 Blend 3
Blend 2
Blend 1
10
Blend 0

0
10 100 1000 10000
R [Ohm]

Diagram of output power P[W] as a function of the load resistance R (Ohm) for the
setting.”Macro Plastic Cut” = 38W / 75W

Instructions for use - Electrosurgical Generators Page 51 of 76


10 Technical data

10.2.1.3 Monopolar Cut: ENT

ENT

Diagram of output power P(W) as a function of the load resistance R (Ohm) for the setting
“MicroPlastic / ENT” = 25W / 50W

10.2.1.4 Monopolar Cut: Pediatric

Diagram of output power P(W) as a function of the load resistance R (Ohm) for the setting
“Pediatric” = 15W / 30W

Instructions for use - Electrosurgical Generators Page 52 of 76


10 Technical data

10.2.1.5 Monopolar Coag:


Coag: Moderate Coag

Diagram of output power P(W) as a function of the load resistance R (Ohm) for the setting
“Moderate Coagulation” = 60W / 120W

10.2.1.6 Monopolar Coag: Moderate Coag ENT


ENT

Diagram of output power P(W) as a function of the load resistance R (Ohm) for the setting
“Moderate Coagulation” in the program ENT = 15W / 30W

Instructions for use - Electrosurgical Generators Page 53 of 76


10 Technical data

10.2.1.7 Monopolar Coag: Moderate Coag Pediatric

Diagram of output power P(W) as a function of the load resistance R (Ohm) for the setting
“Moderate Coagulation” in the program Pediatric = 15W / 30W

10.2.1.8 Monopolar Coag: Forced Cutting Mode

Diagram of output power P(W) as a function of the load resistance R (Ohm) for the setting
“Forced Coagulation” in “Forced Cutting” mode = 38W / 75W

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10 Technical data

10.2.1.9 Monopolar Coag: Forced Non-


Non-Cutting Mode

Display value

Diagram of output power P(W) as a function of the load resistance R (Ohm) for the setting
“Forced Coagulation” in “Forced Non-Cutting” mode = 60W / 120W

10.2.1.10 Monopolar Coag: Forced Mixed Mode

Diagram of output power P(W) as a function of the load resistance R (Ohm) for the setting
“Forced Coagulation” in “Forced Mixed Mode” = 60W / 120W

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10 Technical data

10.2.1.11 Micro Forced Non Cutting Coag


Micro Forced Coag Non Cutting Mode
P [W]
35

30

25

20

15

30W
10

5 15W

0
10 100 1000 10000
Display value
R [Ohm]

Diagram of output power P(W) as a function of the load resistance R (Ohm) for the setting
“Forced Coagulation”in the “Forced Non Cutting Mode” in the “Micro” program = 15W / 30W

10.2.1.12 Micro Forced Mixed Coag


Micro Forced Coag Mixed Mode
P [W]
35

30

25

20

15

30W

10

15W

0
10 100 1000 10000
Display value
R [Ohm]

Diagram of output power P(W) as a function of the load resistance R (Ohm) for the setting
“Forced Coagulation” in the “Forced Mixed Mode” in the “Micro” program = 15W / 30W

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10 Technical data

10.2.1.13 Micro Forced Cutting


Cutting Coag
Micro Forced Coag Cutting Mode
P [W]
35

30

25

20

15

10
30W

5
15W

0
10 100 1000 10000
Display
R [Ohm]value

Diagram of output power P(W) as a function of the load resistance R (Ohm) for the setting
“Forced Coagulation” in the “Forced Cutting Coag Mode” in the “Micro” program = 15W / 30W

10.2.1.14 Monopolar Coag: Forced GastroCut

Diagram of output power P(W) as a function of the load resistance R (Ohm) for the setting
“GastroCut Forced Coag” = 25W / 50W

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10 Technical data

10.2.1.15 Monopolar Coag: Spray / Argon

Diagram of output power P(W) as a function of the load resistance R (Ohm) for the setting
“Spray / Argon Coagulation” = 60W / 120W

10.2.1.16 Monopolar Coag: Micro Spray

Diagram of output power P(W) as a function of the load resistance R (Ohm) for the setting
“Micro Spray Coagulation” = 60W / 120W

Instructions for use - Electrosurgical Generators Page 58 of 76


10 Technical data

10.2.1.17 Micro Bipolar Coag

Display value

Diagram of output power P(W) as a function of the load resistance R (Ohm) for the setting
“Micro Bipolar Coagulation” = 15W / 30W

10.2.1.18 Bipolar Coag ENT


ENT

Diagram of output power P(W) as a function of the load resistance R (Ohm) for the setting
“Bipolar Coagulation” in program ENT = 15W / 30W

Instructions for use - Electrosurgical Generators Page 59 of 76


10 Technical data

10.2.1.19 Bipolar Coag

Diagram of output power P(W) as a function of the load resistance R (Ohm) for the setting
“Bipolar Coagulation” = 60W / 120W

Instructions for use - Electrosurgical Generators Page 60 of 76


10 Technical data

10.2.2 Maximum open circuit voltage

10.2.2.1 Monopolar Cut


Blend Voltage [Vp]
0 590
1 590
2 680
3 760
4 760
5 760
6 880
7 880
8 950
9 950

10.2.2.2 Monopolar Cut Micro


Blend Voltage[Vp]
Voltage[Vp]
0 260
1 280
2 310
3 340
4 370
5 400
6 430
7 470
8 510
9 570

10.2.2.3 Monopolar Coag: Moderate Coag

Display value

Diagram of HF output voltage U[Vp] as function “Moderate Coagulation”. (open circuit


operation)

Instructions for use - Electrosurgical Generators Page 61 of 76


10 Technical data

10.2.2.4 Monopolar Coag:


Coag: Moderate Coag ENT
ENT

Display value

Diagram of HF output voltage U[Vp] as function of the "Moderate Coagulation" setting in the
program ENT (open-circuit operation)

10.2.2.5 Monopolar Coag: Moderate Coag Pediatric

Display value

Diagramm of HF output voltage U[Vp] as function „Micro Moderate Coagulation“ (open circuit
operation)

Instructions for use - Electrosurgical Generators Page 62 of 76


10 Technical data

10.2.2.6 Monopolar Coag: (Micro) Forced Cutting Mode


Forced Coag Cutting Mode
U [Vp]
1800

1600

1400

1200

1000

800

600

400

200

0
0 10 20 30 40 50 60 70
Display value
Anzeigewert

Diagram of HF output voltage U[Vp] as function "Forced coagulation” mode-setting “Forced


Cutting Mode” (open-circuit operation)

10.2.2.7 Monopolar Coag: (Micro) Forced


Forced Non-
Non-Cutting Mode
Forced Coag Non-Cutting-Mode

6000

5000

4000
U [Vp]

3000

2000

1000

0
0 20 40 60 80 100 120
Display value
Anzeigewert

Diagram of HF output voltage U[Vp] as function "Forced Coagulation” mode setting “Forced Non
Cutting Mode" (open-circuit operation)

Instructions for use - Electrosurgical Generators Page 63 of 76


10 Technical data

10.2.2.8 Monopolar Coag: (Micro) Forced Mixed Mode


Forced Coag Mixed-Coag-Mode

3500

3000

2500

2000
U [Vp]

1500

1000

500

0
0 20 40 60 80 100 120
Display value
Anzeigewert

Diagram of HF output voltage U[Vp] as function "Forced Coagulation”mode setting“


Forced Mixed Mode” (open-circuit operation)

10.2.2.9 Monopolar Coag: Forced GastroCut

Display value

Diagram of HF output voltage U[Vp] as function "Forced Coagulation” setting in the


programs GastroCut (open-circuit operation)

Instructions for use - Electrosurgical Generators Page 64 of 76


10 Technical data

10.2.2.10 Monopolar Coag:


Coag: Spray

Display value

Diagram of HF output voltage U[Vp] as function of the "Spray Coagulation" setting.


(open-circuit operation)

10.2.2.11 Monopolar Coag: Micro Spray

Display value

Diagram of HF output voltage U[Vp] as function of the "Micro Spray Coagulation" setting.
(open-circuit operation)

Instructions for use - Electrosurgical Generators Page 65 of 76


10 Technical data

10.2.2.12 Monopolar Coag: Argon

Display value

Diagram of HF output voltage U[Vp] as function of the "Argon Coagulation" setting.


(open-circuit operation)

10.2.2.13 Monopolar Coag: Argon Flex

Display value

Diagram of HF output voltage U[Vp] as function of the "Argon Flex Coagulation" setting.
(open-circuit operation)

Instructions for use - Electrosurgical Generators Page 66 of 76


10 Technical data

10.2.2.14 Micro Bipolar Coag

Display value

Diagram of HF output voltage U[Vp] as function”Bipolar Coagulation” in the Micro programs


(open-circuit operation)

10.2.2.15 Bipolar Coag ENT


ENT

Display value

Diagram of HF output voltage U[Vp] as function”Bipolar Coagulation” in program ENT


(open-circuit operation)

Instructions for use - Electrosurgical Generators Page 67 of 76


10 Technical data

10.2.2.16 Bipolar Coag

Display value

Diagram of HF output voltage U[Vp] as function”Bipolar Coagulation” setting


(open-circuit operation)

Instructions for use - Electrosurgical Generators Page 68 of 76


10 Technical data

10.2.3 Power over display

10.2.3.1 Monopolar Cut


LeistungPower over display
über Anzeigewert value Cut Stromarten
Monopolar

350

300
Pmax Cut ARC 300

250

200
Pmax Cut ARC 200
P[W]

150

100

Pmax MacroPlastic

50
Pmax HNO
ENT

Pmax MicroPlastic
Pediatric
0
0 50 100 150 200 250 300 350
Anzeigewert
Display value

Diagram of output power P[W] as a function of the "Monopolar Cut" settings.


Rated load resistance = 500Ohm

10.2.3.2 Moderate / Bipolar Coag


Powerüber
Leistung overAnzeigewert
display value

140
Pmax Moderate Coag
Bipolare Coag
120

100

80
P[W]

60

40

Pmax Micro-Moderate /-
Bipolar
20

0
0 20 40 60 80 100 120 140
Display value
Anzeigewert

Diagram of output power P[W] as a function of the "Moderate / Bipolar Coagulation" setting.
Rated load resistance = 75 Ohm

Instructions for use - Electrosurgical Generators Page 69 of 76


10 Technical data

10.2.3.3 Forced Coag


Forced Coag

140

Pmax = 120W
120

100

80

Pmax = 75W: Cutting Mode

60

Pmax = 50W: Programme


40 GastroCut

Pmax = 30W: Programm


HNO,
ENT Pediatric, MicroPlastic
20

0
0 20 40 60 80 100 120 140

Diagram of output power P[W] as a function of the "Forced Coagulation" setting.


Rated load resistance = 500 Ohm

10.2.3.4 Spray / Argon Coag


Spray / Argon Coag

140

Pmax = 120W
120

100

80

60

40

Pmax = 30W: Programm


HNO,
ENT Micro Plastic, Pediatric
20

0
0 20 40 60 80 100 120 140

Diagram of output power P[W] as a function of the "Moderate / Bipolar Coagulation" setting.
Rated load resistance = 500 Ohm

Instructions for use - Electrosurgical Generators Page 70 of 76


10 Technical data

10.3 Equipment
Equipment standards and standard specifications
The ARC 200 and ARC 300e HF units were developed according to the internationally
applicable safety standards pertaining to the development of high-frequency surgical
generators.

These are in particular:

IEC 60601-1: 1988, IEC 60601-1-A1: 1991, IEC 60601-1-A2: 1995, IEC 60601-1-
A2C1: 1995
IEC 60601-1-2: 2001
IEC 60601-1-4: 2000
IEC 60601-2-2: 1998
IEC 61000-3-2: 2001
ISO 14971: 2000

In addition, the Medical Products Act (MPG) of 7th August 2002 also applies.

10.3.1 Guidelines and Manufacturer's Declaration according to


DIN EN 60601-1-2, Para. 6.8.3.201

Electromagnetic emissions (DIN EN 60601-


60601-1-2, Table 201)
The ARC 200 and ARC 300e are intended for use in an electromagnetic environment as specified below.
The customer or the user of the ARC 200 or ARC 300e should ensure that it is operated in such an
environment.
Emissions measurements Compliance Guide to electromagnetic environment
HF emissions according to Group 2 The ARC 200 and ARC 300e must emit electro-
CISPR 11 magnetic energy in order to guarantee their
intended function. Electronic equipment in the
vicinity may be affected.
HF emissions according to Class B The ARC 200 and ARC 300e are suitable for use in
CISPR 11 facilities other than the living area and such like,
Emission of harmonics Class A which are connected directly to the public supply
according to IEC 61000-3-2 network, that also supplies buildings used for
Emission of voltage variations Complies dwelling purposes.
/ flicker according to IEC
61000-3-3

Instructions for use - Electrosurgical Generators Page 71 of 76


10 Technical data

Electromagnetic immunity (DIN EN 60601-60601-1-2, Table 202)


The ARC 200 and ARC 300e are intended for use in the electromagnetic environment specified below. The
customer or the user of the ARC 200 or ARC 300e should ensure that it is used in such an environment.
IEC 60601 test
Immunity tests Compliance level Guide to electromagnetic environment
level
Electrostatic discharge ± 6 kV Contact ± 6 kV Contact Floors should be made of wood or
(ESD) discharge discharge concrete or covered with ceramic tiles.
according to IEC If the floor is covered with synthetic
61000-4-2 ± 8 kV Air ± 8 kV Air material, the relative humidity must be
discharge discharge at least 30%.
Fast transient electrical ± 2 kV ± 2 kV The quality of the supply voltage
interference / bursts for mains for mains cables should be that of a typical commercial
according to IEC cables or hospital environment.
61000-4-4 ±1 kV
±1 kV for input and
for input and output cables
output cables
Surge voltages (surges) ± 1 kV voltage ± 1 kV voltage The quality of the supply voltage
according to IEC outer conductor outer conductor – should be that of a typical commercial
61000-4-5 – outer outer conductor or hospital environment.
conductor
± 2 kV voltage
± 2 kV voltage outer conductor –
outer conductor earth
– earth
Voltage drops, short- < 5 % UT < 5 % UT The quality of the supply voltage
term interruptions and for ½ period for ½ period should be that of a typical commercial
variations of the supply (> 95 % drop) (> 95 % drop) or hospital environment.
voltage 40 % UT 40 % UT If the user of the ARC 200 or ARC 300e
according to IEC for 5 periods for 5 periods requires continued operation even
61000-4-11 (60 % drop) (60 % drop) when the power supply is disrupted, it
is recommended that the ARC 200 or
70 % UT 70 % UT
ARC 300e be fed from an
for 25 periods for 25 periods
uninterruptible power supply or
(30 % drop) (30 % drop)
battery.
< 5 % UT < 5 % UT
for 5 s for 5 s
(> 95 % drop) (> 95 % drop)
Comment: UT is the AC mains voltage before applying the test levels.

Instructions for use - Electrosurgical Generators Page 72 of 76


10 Technical data

Electromagnetic immunity (DIN EN 60601-


60601-1-2, Table 204)
The ARC 200 and ARC 300e are intended for use in the electromagnetic environment specified below. The
customer or the user of the ARC 200 or ARC 300e should ensure that it is used in such an environment.
IEC 60601 test
Immunity tests Compliance level Guide to electromagnetic environment
level
Portable and mobile wireless
equipment should not be used closer
to the ARC 200 or ARC 300e including
the leads than the recommended
safety distance calculated in
accordance with the equation
applicable to the transmission
frequency.
Recommended safety distance:
d = 0,35 ⋅ P
Conducted HF
interference 3 Veffective value
according to IEC 150kHz to 10 V d = 0,35 ⋅ P for 80 MHz to 800 MHz
61000-4-6 80MHz

Radiated HF 3V/m 10 V/m d = 0,35 ⋅ P for 800 MHz to 2.5 GHz


interference 80MHz to 2.5
according to IEC GHz where P is the rated power of the
61000-4-3 transmitter in Watts (W) according to
the transmitter manufacturer's data,
and d is the recommended safety
distance in metres (m).
The field strength of stationary radio
transmitters should be less than the
compliance levelb at all frequencies
according to an on-site investigationa.
Interference is possible in the
vicinity of equipment,
bearing the following symbol.
Comment 1 At 80 MHz and 800 MHz the higher frequency range applies.
Comment 2 These guidelines may not be applicable in all cases. The spread of electromagnetic
quantities is affected by the absorption and reflection of buildings, objects and people.
a
The field strength of stationary transmitters, such as radio telephone and land mobile radio base
stations, amateur radio stations and AM and FM radio and television transmitters, cannot be
determined theoretically in advance with accuracy. In order to determine the electromagnetic
environment with regard to stationary transmitters, a study of the electromagnetic phenomena at the
location should be considered. If the field strength measured at the location the ARC 200 or ARC 300e
is to be used exceeds the above compliance levels, where the ARC 200 or ARC 300e should be
monitored to ensure that it operates properly. If unusual performance characteristics are observed,
additional measures may be necessary, such as a different alignment or a different location for the ARC
200 or ARC 300e.
b
The field strength should be less than 10 V/m over the frequency range from 150 kHz to 80 MHz.

Instructions for use - Electrosurgical Generators Page 73 of 76


10 Technical data

Recommended safety distances between portable and mobile HF telecommunicat


telecommunications
cations equipment
and the ARC 200 or ARC 300300e (DIN EN 60601-
60601-1-2, Table 206)
The ARC 200 and ARC 300e are intended for use in an electromagnetic environment in which the HF
interference is controlled. The customer or the user of the ARC 200 or ARC 300e can help to avoid
electromagnetic interference by maintaining the minimum distance between portable and mobile HF
telecommunications equipment (transmitters) and the ARC 200 or ARC 300e – depending on the output
power of the communication equipment as specified below.
Rated power of Safety distance depending on the transmission frequency (m)
transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
(W) d = 0,35 ⋅ P d = 0,35 ⋅ P d = 0, 7 ⋅ P
0.01 0.035 0.035 0.07
0.1 0.11 0.11 0.22
1 0.35 0.35 0.70
10 1.1 1.1 2.2
100 3.5 3.5 7.0
For transmitters whose maximum rated power is not specified in the above table, the recommended
safety distance d in metres (m) can be determined using the equation associated with the appropriate
column, where P is the maximum rated power of the transmitter in watts (W) according to the transmitter
manufacturer's data.
Comment 1 At 80 MHz and 800 MHz the higher frequency range applies.
Comment 2 These guidelines may not be applicable in all cases. The spread of electromagnetic
quantities is affected by the absorption and reflection of buildings, objects and people.

Instructions for use - Electrosurgical Generators Page 74 of 76


11 Accessories

11 Accessories
The original accessories are suitable for use with the BOWA generators ARC 200, ARC
300e and ARC PLUS.
When using accessories from other suppliers, the user must ensure that these are
designed for and compatible with the maximum HF peak voltage of the HF unit.
For the use and correct preparation of autoclavable products, please refer to the
instructions for use provided with them.

Instructions for use - Electrosurgical Generators Page 75 of 76


12 Warranty conditions

12 Warranty conditions
BOWA-electronic GmbH & Co. KG guarantees that its products are free from defects in
material and manufacture for the periods of time listed below when used in
accordance with the instructions. During this period of time, BOWA´s liability is
limited to the repair or to the provision of a replacement of a product or of a part of a
product. The warranty shall not apply to a product or to part of a product when this
has been repaired outside the factory in a manner which in BOWA's opinion adversely
affects its functionality or was subject to inadmissible, negligent handling or damage.

The warranty periods are as follows:

HF units or argon units: Two years from date of invoice

Assembly parts: One year from date of invoice

Foot switch: One year from date of invoice

Unauthorised opening of the housing will invalidate the warranty.

BOWA-electronic GmbH & Co. KG does not accept any liability in connection with the
sale or use of its products. Irrespective of other stipulations in this document or other
comments or agreements, BOWA's liability in connection with this agreement and the
products sold under this agreement shall be limited to the total price of the goods
sold by BOWA to the customer. No guarantees are provided that would extend the
scope of these conditions.
BOWA declines all liability for indirect damages or consequential damages under this
or any other agreement in connection with the sale of this product.

The warranty and the rights and obligations that fall under it are to be interpreted in
conformity with the legislation of the Federal Republic of Germany and are governed
by this. The sole court of jurisdiction for settling any disputes is Tübingen.

BOWA-electronic GmbH & Co. KG and the dealers and agents of the company reserve
the right to make changes to its equipment without entering into any obligation to
carry out the same changes to equipment built and/or sold at an earlier time.

Instructions for use - Electrosurgical Generators Page 76 of 76

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