Professional Documents
Culture Documents
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
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
Manufactured by:
BOWA-electronic GmbH & Co. KG
Heinrich-Hertz-Strasse 4-10 0123
72810 Gomaringen I Germany
In accordance with Directive 93/42/EEC
Made in Germany
Printed in Germany
Modification status: 10711_S1 (Software Version 1.0)
Date of issue: Mai 2007
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.
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.
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.
Dose-
Dose-dependent coagulation effect
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.
- monopolar technique
- bipolar techniques
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.
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.
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.
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.
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.
- 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.
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.
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.
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.
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.
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.
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.
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.
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.
2 Equipment description
The BOWA electrosurgical generators ARC 200 and ARC 300e are equipped with a powerful
monopolar and a universal bipolar generator.
- 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)
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.
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.
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.
ARC 200
ARC 300e
300e
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.
Display for bipolar output for bipolar instruments with foot switching or
AUTO START.
On/Off switch
3.3 Rear
Rear view of ARC 200 and ARC 300
300e
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
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
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.
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.
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.
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.
4.8 Foot
Foot switch
Several foot switch systems can be connected to the ARC 200 / ARC 300e
generator.
Arrangement of footswitch
Note:
While AUTO START mode is activated for bipolar coagulation,
coagulation the
CUT button on the foot switch can be used for cutting.
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.
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
Bipolar applications
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.
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.
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
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.
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.
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.
Other menu programs are described in the Service Manual and can only be called up
by using a password.
ARC 200
ARC 300e
a) All instructions for installation and for proper use in accordance with this user
manual are followed exactly.
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
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 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
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
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
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
Service support
Service support integrated into the unit by means of service programs yes
Service support using the ISSys yes
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
10.2 Diagrams
The diagrams for Monopolar Cut/ TUR are shown
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.
300
250
200
150
100
50 Blend 4-9
Blend3
Blend2
Blend 0,1
0
10 100 1000 10000
R [Ohm]
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
ENT
Diagram of output power P(W) as a function of the load resistance R (Ohm) for the setting
“MicroPlastic / ENT” = 25W / 50W
Diagram of output power P(W) as a function of the load resistance R (Ohm) for the setting
“Pediatric” = 15W / 30W
Diagram of output power P(W) as a function of the load resistance R (Ohm) for the setting
“Moderate Coagulation” = 60W / 120W
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
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
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
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
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
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
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
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
Diagram of output power P(W) as a function of the load resistance R (Ohm) for the setting
“GastroCut Forced Coag” = 25W / 50W
Diagram of output power P(W) as a function of the load resistance R (Ohm) for the setting
“Spray / Argon Coagulation” = 60W / 120W
Diagram of output power P(W) as a function of the load resistance R (Ohm) for the setting
“Micro Spray Coagulation” = 60W / 120W
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
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
Diagram of output power P(W) as a function of the load resistance R (Ohm) for the setting
“Bipolar Coagulation” = 60W / 120W
Display value
Display value
Diagram of HF output voltage U[Vp] as function of the "Moderate Coagulation" setting in the
program ENT (open-circuit operation)
Display value
Diagramm of HF output voltage U[Vp] as function „Micro Moderate Coagulation“ (open circuit
operation)
1600
1400
1200
1000
800
600
400
200
0
0 10 20 30 40 50 60 70
Display value
Anzeigewert
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)
3500
3000
2500
2000
U [Vp]
1500
1000
500
0
0 20 40 60 80 100 120
Display value
Anzeigewert
Display value
Display value
Display value
Diagram of HF output voltage U[Vp] as function of the "Micro Spray Coagulation" setting.
(open-circuit operation)
Display value
Display value
Diagram of HF output voltage U[Vp] as function of the "Argon Flex Coagulation" setting.
(open-circuit operation)
Display value
Display value
Display value
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
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
140
Pmax = 120W
120
100
80
60
0
0 20 40 60 80 100 120 140
140
Pmax = 120W
120
100
80
60
40
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
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.
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.
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.
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.
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.