Bowa ARC 400 Operating Manual

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OPERATING MANUAL ELECTROSURGICAL UNIT
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2 Operating Manual ARC 400 900-400_IFU_V1.0.0.6.17.9_20140-S2-20130604-EN
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Contents
1. Using this operating manual .......................................................................................................... 7
1.1. Revision index .................................................................................................................... 7
1.2. Validity ................................................................................................................................ 7
1.3. Other applicable documents .............................................................................................. 7
1.4. Icons and labeling .............................................................................................................. 7
1.4.1. Structure of warning instructions ........................................................................ 7
1.4.2. Risk levels in warning instructions ...................................................................... 8
1.4.3. Tips ..................................................................................................................... 8
1.4.4. Other symbols and marks ................................................................................... 8
2. Safety ................................................................................................................................................ 9
2.1. Intended use ...................................................................................................................... 9
2.2. General safety instructions .............................................................................................. 10
2.3. Personal safety instructions ............................................................................................. 11
2.3.1. Ambient conditions ........................................................................................... 11
2.3.2. Patients with pacemakers ................................................................................. 11
2.3.3. Hazard-free patient positioning ......................................................................... 12
2.3.4. Correct connection of the HF device ................................................................ 12
2.3.5. Correct use of the HF device ............................................................................ 12
2.3.6. Configuring HF device settings and using accessories .................................... 13
2.4. Product-related safety instructions ................................................................................... 14
2.5. Safe handling (general instructions) ................................................................................ 14
2.5.1. Operation area: avoiding ignition and explosions ............................................. 15
2.5.2. Applying the neutral electrode .......................................................................... 15
3. Description ..................................................................................................................................... 18
3.1. User interface components .............................................................................................. 18
3.1.1. Front panel user interface components ............................................................ 18
3.1.2. Monopolar connector module (left) ................................................................... 18
3.1.3. Bipolar connector module (right) ...................................................................... 19
3.1.4. Rear panel user interface components ............................................................. 20
3.2. Symbols used on the device ............................................................................................ 21
3.2.1. Rating label ....................................................................................................... 22
3.3. Scope of delivery .............................................................................................................. 22
3.4. Components required for operation ................................................................................. 22
3.5. Operating conditions ........................................................................................................ 22
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4. Prearrangement ............................................................................................................................. 23
4.1. Setting up the HF device .................................................................................................. 23
4.2. Switching on the HF device ............................................................................................. 24
4.3. Connecting instruments ................................................................................................... 24
4.3.1. Instruments for monopolar use ......................................................................... 25
4.3.2. Instruments for bipolar applications .................................................................. 25
4.3.3. Connecting a foot switch................................................................................... 25
4.4. Functional test .................................................................................................................. 26
4.4.1. Auto test function .............................................................................................. 26
4.4.2. Functional testing .............................................................................................. 26
4.4.3. Actions in case of problems .............................................................................. 27
4.5. Neutral electrode monitoring ............................................................................................ 27
4.5.1. General information .......................................................................................... 27
4.5.2. EASY neutral electrode monitoring (EASY monitoring) ................................... 28
5. Operation ........................................................................................................................................ 29
5.1. Connecting power ............................................................................................................ 29
5.2. Program overview ............................................................................................................ 29
5.2.1. Display .............................................................................................................. 29
5.2.2. Status bar ......................................................................................................... 30
5.3. Activating and deactivating connectors............................................................................ 30
5.4. Configuring output currents .............................................................................................. 31
5.4.1. Selecting the mode ........................................................................................... 31
5.4.2. Specifying power limits ..................................................................................... 32
5.4.3. Selecting the effect ........................................................................................... 33
5.4.4. Assigning the foot pedal ................................................................................... 34
5.4.5. Mode change .................................................................................................... 37
5.4.6. Selecting the neutral electrode ......................................................................... 38
5.4.7. Dr. Dongle ......................................................................................................... 40
5.4.8. Plug’n Cut COMFORT ...................................................................................... 41
5.4.9. Playing videos ................................................................................................... 42
5.5. Mode overview ................................................................................................................. 43
5.5.1. Monopolar modes ............................................................................................. 43
5.5.2. Bipolar cutting modes ....................................................................................... 45
5.6. Monopolar cutting modes ................................................................................................. 46
5.6.1. Standard ........................................................................................................... 46
5.6.2. Micro ................................................................................................................. 46
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5.6.3. Dry .................................................................................................................... 47
5.6.4. Argon ................................................................................................................ 47
5.6.5. Resection .......................................................................................................... 48
5.6.6. MetraLOOP ....................................................................................................... 48
5.6.7. Laparoscopy ..................................................................................................... 49
5.6.8. GastroCut Loop slow ........................................................................................ 49
5.6.9. GastroCut Loop medium................................................................................... 50
5.6.10. GastroCut Loop fast .......................................................................................... 50
5.6.11. GastroCut Knife slow ........................................................................................ 51
5.6.12. GastroCut Knife medium .................................................................................. 51
5.6.13. GastroCut Knife fast ......................................................................................... 52
5.7. Monopolar coagulation modes ......................................................................................... 52
5.7.1. Moderate ........................................................................................................... 52
5.7.2. Forced non cutting ............................................................................................ 53
5.7.3. Forced mixed .................................................................................................... 53
5.7.4. Forced cutting ................................................................................................... 54
5.7.5. Spray................................................................................................................. 54
5.7.6. Argon open ....................................................................................................... 55
5.7.7. Argon flexible .................................................................................................... 55
5.7.8. Argon flex. pulse ............................................................................................... 56
5.7.9. Resection .......................................................................................................... 56
5.7.10. Cardiac Mammary ............................................................................................ 57
5.7.10. Cardiac Thorax ................................................................................................. 57
5.7.11. SimCoag ........................................................................................................... 58
5.7.12. Gastro Coag ..................................................................................................... 58
5.7.13. Laparoscopy ..................................................................................................... 59
5.8. Bipolar cutting modes ....................................................................................................... 59
5.8.1. Standard ........................................................................................................... 59
5.8.2. Bipolar resection ............................................................................................... 60
5.8.3. Bipolar scissors ................................................................................................. 60
5.9. Bipolar coagulation modes ............................................................................................... 61
5.9.1. Standard forceps .............................................................................................. 61
5.9.2. Standard forceps AUTO ................................................................................... 61
5.9.3. Micro forceps .................................................................................................... 62
5.9.4. Forceps forced .................................................................................................. 62
5.9.5. LIGATION ......................................................................................................... 63
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5.9.6. TissueSeal PLUS .............................................................................................. 63
5.9.7. Bipolar scissors ................................................................................................. 64
5.9.8. Laparoscopy ..................................................................................................... 64
5.9.9. Bipolar resection ............................................................................................... 65
5.10. Menu dialogs .................................................................................................................... 66
5.10.1. Overview ........................................................................................................... 66
5.10.2. "System Settings" dialog ................................................................................... 67
5.10.3. "Volume" dialog ................................................................................................ 67
5.10.4. "System messages" dialog ............................................................................... 68
5.10.5. "BOWA Service" dialog ..................................................................................... 69
5.10.6. "Select program" dialog .................................................................................... 70
5.10.7. "Delete program" dialog .................................................................................... 71
5.10.8. "Favourites" dialog ............................................................................................ 72
5.10.9. "Save Program" dialog ...................................................................................... 72
5.10.10. "Argon" dialog ................................................................................................... 73
5.11. Basic programs ................................................................................................................ 74
6. Detecting and correcting faults ................................................................................................... 79
6.1. System informations ......................................................................................................... 79
6.2. Fault indications for EASY monitoring ............................................................................. 84
7. Preparation ..................................................................................................................................... 85
7.1. Preparation of the accessories ........................................................................................ 85
7.2. Disinfection and cleaning ................................................................................................. 85
8. Maintenance and repair ................................................................................................................ 86
8.1. Maintenance ..................................................................................................................... 86
8.1.1. Safety inspection .............................................................................................. 86
8.2. Repairs ............................................................................................................................. 87
9. Storage ........................................................................................................................................... 88
9.1. Technical service ............................................................................................................. 88
10. Technical specifications ............................................................................................................... 89
10.1. ARC 400 technical data ................................................................................................... 89
10.2. Output, voltage and current diagrams .............................................................................. 96
11. Accessories and replacement parts .......................................................................................... 134
12. EMC ............................................................................................................................................... 135
12.1. Guidelines and manufacturer’s declaration in accordance with IEC 60601-1-2
Section 6.8.3.201 ........................................................................................................... 135
13. Disposal ........................................................................................................................................ 139
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1 Using this operating manual
Unit version
Last revised
Valid from version 1.0.0.6.17.9
2013/06
SIGNAL WORD
"Risk type, source and consequences there of" (Personal injury)! Measure for risk prevention.
NOTE
"Risk type, source and consequences there of" (Property damage)!
Measure.
1. Using this operating manual
This operating manual is part of the device. BOWA-electronic GmbH & Co. KG, referred to in the following simply as BOWA,
assume no liability nor provide any warranty whatsoever for damage and consequential damages that arise due to non-compliance with the operating manual.
Read the operating manual carefully and thoroughly before using this device. Store the operating manual in a safe place throughout the service life of the
device. Keep the operating manual accessible to operating room personnel. Give the operating manual to each successive owner and/or user of this device. Always update the operating manual whenever you receive additional information
from the manufacturer.
1.1. Revision index
1.2. Validity
This operating manual applies only to the devices designated on the title page.
1.3. Other applicable documents
Comply with other applicable documents in the appendix or in the other sections.
1.4. Icons and labeling
1.4.1. Structure of warning instructions
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1 Using this operating manual
Symbol
Risk level
Probability of occurrence
Consequences of non-compliance
DANGER
Immediate risk
Death, serious injuries
WARNING
Possible risk
Death, serious injuries
CAUTION
Possible risk
Minor injuries
NOTE
Possible risk
Property damage
Tips and additional information to facilitate tasks
Symbol or mark
Meaning
Prerequisite for an activity
Activity with one step
1.
2.
3.
Activity with several steps in a binding sequence
Result of preceding activity
List (first level)
List (second level)
Emphasis
Emphasis
......, see Section xxx, page xxx
Cross reference
1.4.2. Risk levels in warning instructions
1.4.3. Tips
1.4.4. Other symbols and marks
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2 Safety
BOWA requires that the HF device is operated under the supervision of qualified and authorized personnel. The surgeon and medical staff must be trained in the fundamental principles, rules for use and risks of HF surgery and must be familiar with these in order to safely and reliably prevent putting patients, staff and equipment at risk. Contact your BOWA distributor for trainings and training material.
Any other use is neither intended nor proper and must be effectively prevented.
2. Safety
2.1. Intended use
The HF device is intended exclusively for the generation of electrical power for monopolar and bipolar cutting and coagulation on tissue structures in surgical operations.
It is used in the following areas:
General surgery  Endoscopy (GastroCut mode)  Gynecology  Hand surgery  ENT  Cardiac surgery (including open-heart surgery)  Neurosurgery  Pediatric surgery  Plastic surgery and dermatology  Thoracic surgery  Orthopedics  Urology, including transurethral resection (TUR)
Do not use the HF device if, in the opinion of an experienced physician or according to current professional literature, such use would endanger the patient, due for example to the general condition of the patient, or if other contraindications are present.
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2 Safety
To protect personnel, BOWA recommends the use of a smoke evacuator to extract electrosurgical smoke, e.g. BOWA SHE SHA.
2.2. General safety instructions
Ensure that no electronic devices that are subject to interference from electromagnetic fields are set up in the vicinity of the HF device.
Observe the instructions on electromagnetic compatibility provided in section EMC, page 135.
Always connect the HF device to a mains power system with a protective earth lead in order to prevent electric shock.
Additional devices that are connected to electrical medical devices must satisfy relevant IEC or ISO standards (e.g. IEC 60950 for data processing devices). Furthermore, all configurations must comply with the standardised requirements for medical systems (see IEC 60601-1-1 or Section 16 of the 3rd edition of IEC 60601-1 as relevant). Anyone who connects additional devices to electrical medical devices is automatically a system configurator and thus responsible for meeting standardised system requirements. Please note that local laws prevail over the aforementioned standard requirements. In case of questions, please contact your local dealer or Technical Service, see section Technical service, page 88.
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2 Safety
2.3. Personal safety instructions
2.3.1. Ambient conditions
Do not use the HF device in the immediate vicinity of the patient. Observe the minimum distances recommended by BOWA, as shown in the following figure.
2.3.2. Patients with pacemakers
Malfunction or destruction of the pacemaker can endanger the life of the patient or result in irreversible injuries to the patient.
In the case of patients with pacemakers, consult the cardiologist before carrying out HF surgery.
Use bipolar HF methods. Attach the HF neutral electrode close to the operating field. Set the demand pacemaker to a fixed frequency. Ensure that the pacemaker does not come into contact with the HF electrode. Keep a fully operational defibrillator within reach. Carry out a postoperative pacemaker check.
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2 Safety
2.3.3. Hazard-free patient positioning
Position patients so that they are not touching any metal parts that are grounded or have considerable capacitance relative to ground (e.g. operating table brackets). If necessary, place anti-static cloths between the patient and the bedding.
Ensure that the patient does not touch any wet clothes or bedding. Place anti-static cloths between areas with heavy sweating and skin-to-skin
contact areas on the patient’s torso. Ensure that the patient is resting on a suitable surface in order to prevent pressure
necrosis. Drain urine via a catheter.
2.3.4. Correct connection of the HF device
Always ground the HF device to the equipotential rail. Also observe the requirements in Section 8.6.7 of IEC 60601-1 regarding medical electrical systems.
Do not use needle electrodes for monitoring. Attach electrodes of physiological monitoring devices without protective resistors
or HF chokes as far away from the HF electrodes as possible. Place lines from monitoring devices so that they do not lie on the patient’s skin. Keep the leads to the HF electrodes as short as possible and position them so that
they do not touch the patient or other leads. Do not place any objects on the HF device.
2.3.5. Correct use of the HF device
Inadvertent activation of the HF device outside the user’s field of vision can injure the patient.
Activate the HF device only when the electrode is in your field of vision and you can quickly deactivate the HF device at all times.
If the HF device is activated inadvertently, switch it off immediately using the on/off switch.
Take particular care when using a foot switch or manual switch. Improper preparation, user errors or faults in the HF device can cause damage to
the HF device. Use the automatic monitoring functions to ensure that the HF device is working
properly. See Section Functional testing, page 26 for information on the auto test functions.
Ensure that no conductive fluids (e.g. blood or amniotic fluid) have penetrated the foot switch or the manual switch.
Ensure that the cables for the foot switch and the manual switch are free from short circuits and broken leads.
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2 Safety
2.3.6. Configuring HF device settings and using accessories
Setting the output power too high can injure the patient. Therefore, before you increase the output power, ensure that:
the neutral electrode is attached properly;  the working electrodes are clean;  the plug connections are all correct.
Setting the HF device correctly
To prevent inadvertent (thermal) tissue damage during operations on body parts with small cross sections and in areas with high resistance (bones or joints), use the bipolar method in these areas.
Set the level of the acoustic signal that sounds when the electrode is activated so that it is always clearly audible.
Risk of nerve or muscle excitation by low-frequency currents. During HF surgical operations (especially when an arc is formed), part of the HF current is converted into a low-frequency current. This current can trigger muscle contractions in the patient.
To minimize the risk of injury to the patient, set the power and the effect as low as possible.
Correct use of accessories
Use only insulated accessories. Check all electrodes for sharp edges and projecting parts before use. Use only electrodes that are free of defects and in good working order. Never place active electrodes on or near the patient.
Do not remove hot electrodes from the patient’s body directly after cutting or
coagulation. Ensure that there is sufficient distance between the patient cables and the cables
of the HF device. Do not run the patient cable across the patient.
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2 Safety
2.4. Product-related safety instructions
Devices manufactured by BOWA are developed in accordance with the current state of technology and generally accepted safety rules. Despite this, using these products can lead to risks to the life and health of the user or third parties and/or damage to the device or other objects.
Use only accessories approved by BOWA, see Section Accessories and replacement parts, page 134.
Use the device only when it is in free of technical defects and in good working order and only for the intended purpose, always remaining aware of safety requirements and risks and complying with this operating manual.
Have malfunctions that can adversely affect safety (e.g. deviations from the permissible operating conditions) repaired without delay.
Wipe down the HF device only with cleaning agents and disinfectants that are approved in the country of use for surface cleaning. See Section Disinfection and cleaning, page 85.
Never immerse the device in water or cleaning agents. Never boil the device and never disinfect it mechanically. If any fluids penetrate the device, drain them immediately. Damage to the device can lead to an undesirable increase in output power due to
improper operation of the device. Certain units or accessories can cause danger in lower power settings. For
example, the risk of gas embolism in argon assisted coagulation rises, if the hf­power is insufficient for the fast creation of an impenetrable eschar layer on the target tissue.
2.5. Safe handling (general instructions)
Before each use of the device, check to ensure that it is functioning properly and is in good working order and connected properly.
Observe the instructions on intended use in conformance with standards (see Section Fault indications for EASY monitoring , page 84.
During use, always observe and comply with the acoustic signals and/or error messages of the HF device (see Section Fault indications for EASY monitoring , page 84).
The device and accessories may be operated and used only by people who have the necessary training, knowledge and experience.
Regularly inspect the accessories, especially the electrode cables, endoscopic accessories and neutral electrodes, for damage to the insulation, proper operation and expiration date.
Ensure that no instruments are being cleaned when AUTOSTART is activated. Wear suitable gloves during operations.
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2 Safety
Observe the instructions on the use of the neutral electrode in the user guide and the information on the package of the neutral electrode.
2.5.1. Operation area: avoiding ignition and explosions
Sparks are generated when the HF device is used as intended. Do not use the HF device in areas where there is a risk of explosion. Do not use any flammable or explosive liquids. If the display fails, do not use the HF device any longer. During operations (e.g. in the head or thoracic regions), avoid using ignitable
anesthetics and gases that support combustion (e.g. nitrous oxide or oxygen) or extract them using a vacuum system.
Use exclusively non-flammable cleaning agents, disinfectants and solvents (for adhesives). If you use flammable cleaning agents, disinfectants or solvents, ensure that they have fully evaporated before using HF surgical equipment.
Ensure that no flammable liquids collect beneath the patient or in body cavities (e.g. the vagina). Suction and/or flush body cavities before activating the device.
Wipe off all liquids before using the HF device. Ensure that no ignitable endogenous gases are present. Ensure that all materials saturated with oxygen (e.g. cotton or gauze) are kept far
enough away from the HF environment that they cannot ignite.
2.5.2. Applying the neutral electrode
In the monopolar HF method, the neutral electrode feeds the current introduced into the patient’s body at the surgical site back to the HF device.
To prevent a rise in temperature at the current exit point, the following conditions must be ensured:
sufficiently large contact surface between the neutral electrode and
the patient’s body;
high electrical conductivity between the neutral electrode and the
patient’s body.
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2 Safety
To prevent the patient being burned by the neutral electrode, you must comply with the following conditions:
Select the application point for the neutral electrode so that the
current paths between the active and neutral electrodes are as short as possible and run longitudinally or diagonally through the
patient’s body (because muscles are more conductive in the
direction of the fibrils).
Figure 2-1: Application point of neutral electrode
For surgery in the thoracic region, do not run the current path
transversely across the patient’s body and ensure that the patient’s
heart is never in the current path.
Depending on the surgical site, apply the neutral electrode to the
nearest upper arm or thigh if possible, but never closer than 20 cm.
In the case of self-adhesive disposable electrodes, comply with any
further manufacturer instructions regarding the point of application.
Ensure that the application area is free of scar tissue, bony
protuberances, surface hair and ECG electrodes.
Ensure that there are no implants (e.g. bone nails, bone plates or
endoprostheses) in the current path.
Ensure that no short circuits can occur at the neutral electrode
connection.
Avoid areas where fluids may collect.  Use split neutral electrodes with a sufficiently large surface area
(patient age and max. output power during operation have to be considered).
Before applying the neutral electrode
Shave the area where the neutral electrode will be applied. Clean the application site, but do not use any alcohol, since it dries out the skin
and increases the contact resistance. If the patient has poor circulation, massage or brush the application site.
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2 Safety
See Section Fault indications for EASY monitoring, page 84 regarding monitoring of the neutral electrode.
Attach the neutral electrode over the entire contact surface evenly. Secure reusable neutral electrodes with rubber bands or elastic straps so that they do not
loosen when the patient moves. Ensure that the patient’s circulation is not impaired
(risk of necrosis). Never use wet clothes or conductive pastes. Ensure that no liquids (e.g. cleaning fluids, disinfectants, blood or urine) penetrate
between the patient and the neutral electrode. Do not place the neutral electrode under the patient’s buttocks or back. Ensure that there are no ECG electrodes in the current path of the HF device. Check the neutral electrode before and after use for damage and to ensure that
they are working properly. Replace defective accessories immediately
Example application using a disposable electrode
Remove the protective film and attach the self-adhesive disposable electrode to the patient. Ensure that the long edge of the disposable electrode faces the operation site and the electrode is fully in contact with the skin. This avoids excessive current concentration on the short edge.
Using both hands, press the self-adhesive disposable electrode firmly against the patient’s skin.
Clamp the electrode tab to the neutral electrode cable. After the operation, remove the disposable electrode carefully to avoid skin
damage.
With a one-piece neutral electrode
Check the one-piece neutral electrode during surgery. Ensure that the one-piece electrode is not blocked at the device.
With a split neutral electrode
Apply the split neutral electrode correctly and without any additional objects, as otherwise the HF device may detect a path between the two sections due to other objects.
See that the current flows equally to both parts of the split neutral electrode.
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3 Description
While activating an instrument, the activation bar of the corresponding socket illuminates yellow or blue.
5 6 7 8 9
10
11 1 2 3
4
3. Description
3.1. User interface components
3.1.1. Front panel user interface components
1 Power switch 2 "CF-type device with defibrillation protection" icon 3 "Observe use instructions" icon 4 Touchscreen with mode selection buttons 5 Activation bar upper monopolar socket 6 Activation bar lower monopolar socket 7 Activation bar upper bipolar socket 8 Activation bar lower bipolar socket
3.1.2. Monopolar connector module (left)
9 Socket connector for monopolar instruments with hand or foot
switch*
10 Socket connector for monopolar instruments with hand or foot switch* 11 Socket connector for neutral electrode *
* Applied part type F according to IEC 60601-1
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3 Description
12
13
14
15
16
17
Monopolar connection socket
Version 1
12 3-pin US type 13 Bovie connector (for foot switch) 14 4-mm socket (for foot switch)
Version 2
12 3-pin US type 13 Erbe 5 mm 14 4-mm socket (for foot switch)
Connection socket for neutral electrode
15 Neutral (US type)
3.1.3. Bipolar connector module (right)
16 Socket connector for bipolar instruments with foot switch or
AUTOSTART*
17 Socket connector for bipolar instruments with foot switch or
AUTOSTART*
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3 Description
The USB connector can be used to perform software updates.
The maximum voltage at the SIP/SOP ports is 15 VDC.
18
19
19
21
20
23
22
24
25
26
27
28
29
18
Bipolar connection sockets
Upper bipolar socket: Lower bipolar socket:
18 2-pin US type (28.58 mm) 18 2-pin US type (28.58 mm)
19 Erbe VIO/ICC
* Applied part type F according to IEC 60601-1
3.1.4. Rear panel user interface components
20 Foot switch socket connector 1 21 Foot switch socket connector 2 22 Equipotential bonding terminal 23 IEC power cord connector 24 Fiber-optic signal input connector 25 Fiber-optic signal output socket connector Use the following connections only for service and training purposes: 26 Ethernet connector 27 USB connector 28 Audio In (not occupied) 29 UART communication interface
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3 Description
Symbol
Designation
Foot switch connector
Neutral electrode isolated from ground for HF
CF-type device with defibrillation protection
Alternating current
On/off switch
During activation (of the HF device) RF energy in the radio frequency range 9 kHz to 400 GHz is applied, which produces electromagnetic radiation.
Labeling of electrical and electronic devices in accordance with Directive 2002/96/EC (WEEE); see "Disposal"
(Active) HF output; caution: hazardous voltage Manufacturer
Date of manufacture
Observe use instructions
Equipotentiality connection
Fiber-optic signal input
Fiber-optic signal output
Ethernet connector
USB connector
Audio In
UART communication interface
3.2. Symbols used on the device
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3 Description
3.2.1. Rating label
Figure 3-1: ARC 400 rating label
3.3. Scope of delivery
You'll find detailed information on the scope of delivery in the current catalogs.
3.4. Components required for operation
Power cable  Foot switch  Neutral electrode for monopolar applications  Connection cable for neutral electrode or instrument  Instrument (monopolar or bipolar)  Dr. Dongle as an individual memory stick
3.5. Operating conditions
Temperature: +10 °C to +40 °C Relative humidity: 30 to 75%, non-condensing Atmospheric pressure: 700 to 1600 hPa Operating altitude (max.) 4000 m above sea level
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4 Prearrangement
NOTE
Electromagnetic fields are generated during normal use of the HF device. This can adversely affect other devices.
Ensure that no electronic devices are placed in the vicinity of the
HF device.
WARNING
Shock hazard
Always connect the HF device to a grounded power distribution
system in order to prevent electric shock.
DANGER
Risk of burns to patients due to excessive leakage current
Locate the HF device outside the immediate vicinity of the patient,
see section Ambient conditions, page 11.
HF devices may be used only in rooms used for medical purposes that meet the requirements of DIN VDE 0100-710.
If the HF device was previously stored or transported at temperatures below +10 °C, it will take approximately three hours to adjust to room temperature.
4. Prearrangement
4.1. Setting up the HF device
1. Observe the specified operating conditions (see Section Operating conditions, page 22.
2. Place the HF device on one of the following platforms:
a table;  an equipment trolley;  a console suspended from a ceiling support or wall-mounted
brackets.
3. Place the HF device a sufficient distance away from other electronic equipment, see Section EMC, page 135.
4. Position the HF device with the front of the device facing the patient and surgeon.
5. Do not place any other device on the HF device.
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Do not use the HF device if the display components are not working. See Section faults Detecting and correcting faults, page 73 for troubleshooting instructions.
6. Do not place any other objects on or above the HF device.
7. Place the HF device on top of ARC PLUS only, do not place it on other devices.
8. Connect the power cord.
4.2. Switching on the HF device
1. Switch the HF device on using the on/off switch.
The HF unit performs a self testing: All user interface components light up.
2. Check all controls and indicators for proper operation:
Power switch  Touchscreen  Monopolar socket connectors  Bipolar socket connectors  Activation bar for monopolar and bipolar sockets
The main screen appears, and the HF device is ready for use.
The parameters of the most recently selected program appear on the display.
4.3. Connecting instruments
Before connecting instruments, ensure that the following conditions are met:
Combinations of accessories not mentioned in the operating
manual may be used only if they are explicitly designed for the intended use. Always observe performance characteristics and safety requirements.
The insulation of the accessories (e.g. HF cables and instruments)
must be sufficient for the maximum peak output voltage (see IEC 60601-2-2 and IEC 60601-2-18).
Do not use accessories with defective insulation.
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One double-pedal foot switch and one single pedal foot switch can be connected. Foot switches without an orange changeover switch cannot be used. Only foot switch and fibre optics may be connected to the rear panel during operation.
Item no.
Designation
901-011
Single-pedal foot switch with switch
901-031
Double-pedal foot switch with switch
901-032
Double-pedal foot switch with switch and clip
4.3.1. Instruments for monopolar use
1. Plug the neutral electrode cable into the socket for the neutral electrode and choose the corresponding neutral electrode type, see chapter Selecting the neutral electrode, page 38.
The socket illumination goes dark.
The neutral electrode button changes from grey to the measurement color
(green, yellow or red).
2. Connect the electrode handpiece to one of the two monopolar socket connectors. – or – In the case of an accessory without a finger button, connect a footswitch to the socket connector. Connect the Bovie connector of the monopolar cable to the socket connector. – or – Connect the monopolar cable for endoscopy to one of the two monopolar socket connectors for monopolar instruments.
4.3.2. Instruments for bipolar applications
1. Connect the bipolar cable to the instrument (e.g. forceps).
2. Connect the bipolar cable to one of the two bipolar socket connectors.
3. For bipolar use without AUTOSTART, connect a footswitch to the socket
connector. – or – Use the AUTOSTART mode for the appropriate socket connector.
Once the instrument is connected, the application starts after the configured
delay time.
4.3.3. Connecting a foot switch
In addition to the manual switch, a foot switch can be used to activate various operating modes.
Connect the desired foot switch only during operation to one of the two socket connectors for foot switches.
The HF device automatically detects the connected foot switch and indicates
this on the front panel display, including the selected socket connector.
The following foot switch systems can be connected to the HF device:
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The accessories must be designed for the specified maximum voltage.
The neutral electrode used for this test may not later be used for an operation.
4.4. Functional test
4.4.1. Auto test function
The HF device automatically performs cyclic testing during operation. If any faults occur, see Section Detecting and correcting faults, page 73.
4.4.2. Functional testing
Perform the following functional test before putting the device into service:
1. Connect the neutral electrode and attach it securely to the patient’s arm. The EASY neutral electrode indicator changes to green.
2. Remove the neutral electrode. The indicator changes to red, acoustic signals sound.
3. Connect a monopolar HF handpiece to a monopolar socket connector if there
is a green EASY indicator and use the manual switch and footswitch to individually activate "Cut" and "Coag".
4. Check the settings on the display.
5. Now change to the bipolar output and connect bipolar forceps.
6. Select a mode with AUTOSTART, grasp moist gauze with the forceps, and
check the display.
7. Now change to a mode without AUTOSTART and use the footswitch to
activate the bipolar output. Check the settings and indicators in the bipolar section.
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The HF device can be switched off at any time by using on/off switch as an emergency stop switch.
Always use the largest possible electrode when attaching a neutral electrode.
BOWA recommends using split neutral electrodes, since only this type of electrode allows the HF device to detect detachment of the neutral electrode if this occurs.
4.4.3. Actions in case of problems
Proceed as follows in case of functional problems:
1. Immediately disconnect the patient from the HF device.
2. Inspect the HF device and perform a functional test.
3. Report incidents and near-accidents to the German Federal Institute for Medications and Medical Products in accordance with Section 3 of the German Ordinance on the Installation, Operation and Use of Medical Products (MPBetreibV). Observe the provisions of the in-house reporting system in this regard.
4. Consult the Technical Service department, see Section Technical service, page 88.
4.5. Neutral electrode monitoring
4.5.1. General information
Monitoring of the neutral electrode minimizes the risk of burns at the site where the neutral electrode is attached.
Two types of neutral electrodes can be monitored:
Split electrodes for infants (for use with reduced power)  Split neutral electrodes
The type of neutral electrode and its contact quality are selected and/or shown in Neutral Electrode Modes menu.
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The maximum output power of monopolar current types is reduced to 50 W when a children’s electrode is selected.
NOTE
Risk of incorrect application of the neutral electrode
Ensure compliance with the specifications for correct attachment of
the neutral electrode with regard to size, adhesive properties and full-surface contact of the complete electrode.
Figure 4-1: Neutral electrode modes
Faults related to the neutral electrode and possible remedies are shown on the display, see Section Detecting and correcting faults, page 73.
4.5.2. EASY neutral electrode monitoring (EASY monitoring)
The EASY monitoring function measures changes in the resistance between the patient and the high-frequency surgery device before and during HF activation. If necessary, it generates visual and audible alarms to request staff intervention. This requires using a split neutral electrode with appropriate contact areas and suitable
contact resistance, attached to the patient according to the manufacturer’s
instructions. The EASY system does not monitor the currents through the individual contact surfaces of the split neutral electrode.
An electrode with a surface area of at least 110 cm² must be used for the "Resection" programs and the "Moderate Coagulation" mode.
If an error message is generated, the display changes from green via yellow to red, depending on the type of fault.
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5. Operation
5.1. Connecting power
The line voltage must match the voltage specified on the rating label.
Connect the power cord to the generator and plug the cord into a grounded AC power outlet.
Using the power switch, switch the device on.
The device performs a functional test.
The bars of the activation display light up, while the connector surrounds light
up orange. Full functionality of the loudspeaker is indicated by the start melody.
The individually configurable start screen appears if it has been set up.
5.2. Program overview
5.2.1. Display
Figure 5-1: Main screen
The status bar is located at the top of the display. The settings of the four socket connectors are shown below the status bar. Settings can be configured for each of the connectors. The "Effect" button is used to set the effect of electrosurgical cutting. The "Pedal" button allows the activation of specific functions to be assigned to the
foot pedal. The "Mode" button allows the desired type of current to be selected. The "max. Watt" button is used to set the maximum output power.
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5.2.2. Status bar
Figure 5-2: Status bar with Favourite
Four buttons are located on the status bar: "Favourite", "EASY", "Help" and "Menu".
The “Argon” button is also displayed in conjunction with ARC PLUS and selection of an Argon mode.
Figure 5-3: Status bar with Argon
5.3. Activating and deactivating connectors
Figure 5-4: Deactivated socket
Figure 5-5: Unused socket
Figure 5-6: Activated socket
To activate a deactivated socket connector, plug a connecting cable into the connector. – or – Press the "activate socket" button.
appears.
The overview is grayed out if no instrument is connected to the socket connector.
The socket illumination extinguishes and connector lights up when an instrument is plugged in.
To hide the selection, press the "off" button next to the connector settings overview.
An overview of the connector settings
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All selection windows are closed after 30 seconds without assumption of the modification.
If selection screens are present, buttons outside the screen are inactive. In addition, activations not possible in this case.
A change to the currently loaded program, e.g. by adjusting the output, is indicated by the information “changed” below the program name.
5.4. Configuring output currents
5.4.1. Selecting the mode
Figure 5-7: Modes monopolar cutting
1. To select the type of current for monopolar cutting, first select one of the two
socket connectors on the left side.
2. Press the yellow icon under the "Mode" button.
A selection screen appears for the available modes, and the rim of the
associated connector starts blinking.
3. Select the desired mode by pressing the corresponding button.
- or ­Deactivate the mode by pressing the button “mode off”.
4. Press the "?" button for more information on this selection.
5. Additional selection options are available in the selection window. To select
indication-related modes, press the “Indications” button.
6. Confirm your selection by pressing the "OK" button.
The main screen will be displayed.
- or -
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If a mode is changed within a socket, the set parameters, e.g. effect and max. Watt, remain the same for the respective mode. However, if, for example, the factory default setting of a mode is adapted and subsequently changed to a different mode and then back again, the user changes are not undone.
Press the "Back" button to return to the main screen without changing the selection.
5.4.2. Specifying power limits
Figure 5-8: Power limit monopolar cutting
1. To select the maximum current for monopolar cutting, first select one of the
two socket connectors on the left side and press the yellow icon under the “max. Watt” button.
2. Use the "+" and "-" buttons to adjust the power level in single steps.
– or – Use the slider to set the power level in steps of 10.
3. Press the "?" button for more information on this selection.
4. Confirm your selection by pressing the "OK" button.
- or ­Press the "Back" button to return to the main screen without changing the selection.
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5.4.3. Selecting the effect
Figure 5-9: Effect monopolar cutting
1. To select the effect for monopolar cutting, first select one of the two socket connectors on the left side and press the yellow icon under the “Effect” button.
2. Use the "+" and "-" buttons to adjust the effect in individual steps. – or – Use the slider to set the effect.
3. Press the "?" button for more information on this selection.
4. Confirm your selection by pressing the "OK" button.
- or ­Press the "back" button to return to the main screen without changing the selection.
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Handpieces and instruments with manual switches can be activated without a configuration setting.
5.4.4. Assigning the foot pedal
A single-pedal foot switch and/or double-pedal foot switch, each with a changeover switch, can be connected,
The changeover switch enables switching between pedal levels.
Figure 5-10: Foot switch selection cutting
1. Select the footswitch menu by pressing the button “Pedal”.
2. Select the desired foot switch by pressing the corresponding button. For example, choose the active pedal level for cutting and coagulation of the upper left socket.
- or ­Deactivate the foot switch by pressing the button marked with a „x“.
The edge of the selected button lights up green.
3. Confirm the selection by pressing the "OK" button.
- or ­Press the "Back" button to return to the main screen without changing the selection.
The socket is assigned to the active pedal level.
4. Pedal levels can be changed using the foot switches. Press the orange button to change the socket.
The orange background indicates that the lower left-hand socket is activated.
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If two footswitches are connected, either a single-pedal footswitch or a double-pedal footswitch can be selected for coagulation.
Figure 5-11: Foot switch changeover
Figure 5-12: Foot switch selection coagulation
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Icon / Button
Description
Icon / Button
Description
Double pedal foot switch CUT active
Double pedal foot switch COAG active
Double pedal foot switch CUT inactive
Double pedal foot switch COAG inactive
Double pedal foot switch not connected
Double pedal foot switch not connected
Single pedal foot switch COAG active
Single pedal foot switch not connected
Single pedal foot switch COAG inactive
Deactivate foot switch
The following pedal icons can be differed:
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With a present mode change, the lower bipolar socket can only be used with two bipolar ERBE plugs. The AUTOSTART mode is not available if the socket is split.
5.4.5. Mode change
The lower bipolar socket can be split, which means that you can connect a total of three bipolar instruments.
1. Use the mode selection for cutting of the lower bipolar socket.
Figure 5-13: Mode change
2. To change the mode to coagulation, touch the “Mode change” button.
Now three bipolar connections are at your disposal.
An indicator of the mode change is shown next to the button „Effect“.
Figure 5-14: Double operation lower bipolar socket
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The maximum power output of monopolar current types is reduced to 50 W when a children’s electrode is selected.
When using the „EASY“ and „BABY“ mode, no unsplit electrodes are accepted. Using the „MONO“ mode, no split electrodes are accepted.
5.4.6. Selecting the neutral electrode
1. Press the "EASY" button on the status bar to select the neutral electrode.
Figure 5-15: Neutral electrode
2. Select the type of connected electrode by pressing the corresponding icon:
EASY: for monitoring split neutral electrodes BABY: for monitoring split neutral electrodes for infants MONO: to select a one-piece neutral electrode
3. Press the "?" button for more information on this selection.
4. Confirm your selection by pressing the "OK" button.
- or ­Press the "Back" button to return to the main screen without changing the selection.
The selected type of neutral electrode in connection with a colour-indicator for
the contact quality is shown in the status bar.
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Icon / Button
Description
Icon / Button
Description
Split neutral electrode contact quality OK
Non split neutral electrode contact quality OK
Split neutral electrode contact quality not optimum
Non split neutral electrode not detected or contact quality insufficient
Split neutral electrode contact quality insufficient
Non split neutral electrode not connected / recognised
Split neutral electrode not connected / recognised
Display contact quality
Split baby neutral electrode contact quality OK
Split baby neutral electrode contact quality not optimum
Split baby neutral electrode contact quality insufficient
Split baby neutral electrode not connected / recognised
According to the contact quality, several icons are shown for neutral electrodes:
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5.4.7.Dr. Dongle
Dr. Dongle is an individual memory stick on which up to six programs can be saved for subsequent use.
Insert your Dr. Dongle with your personal settings into every ARC 400 at any
bipolar socket.
The data is read as soon as you insert Dr. Dongle or after changing a
program with Dr. Dongle inserted:
Figure 5-16: COMFORT function detected
After a short loading period, an overview of the saved programs appears
automatically as a new user interface.
Figure 5-17: Dr. Dongle program selection
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In order to save another program, it is necessary to either carry out a program change or to remove and re-insert Dr. Dongle. The aforementioned steps 1-4 can now be repeated.
Save current program on Dr. Dongle:
The program currently loaded in ARC 400 can be saved on Dr. Dongle:
1. In the overview, select a program storage space to be overwritten.
2. Press “save” to save the currently loaded program at the selected space.
3. A keyboard appears which can be used to enter a name for the program. The program is now saved on Dr. Dongle.
4. Press the "back" button to return to the main screen.
Dr. Dongle can now be removed
Load a program from Dr. Dongle:
A program saved on Dr. Dongle can be loaded onto any ARC 400:
1. Select a program saved on Dr. Dongle from the overview by touching the program name.
2. Press "load" to load the selected program.
- or­Press "back" to return to the main screen without carrying out changes to the selection.
The selected program is now active in the main screen of ARC 400.
Dr. Dongle can be removed
- or­Save the loaded program in the program list, see "Save program" dialog,
page 72.
5.4.8. Plug’n Cut COMFORT
The automatic instrument identification Plug’n Cut COMFORT recognises the connected BOWA COMFORT instrument and selects the default parameters automatically.
1. Insert the COMFORT instrument into a socket of ARC 400. The instrument data is read
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Figure 5-18: Plug’n Cut COMFORT
A description of the instrument appears:
Instrument name Recognised socket Item number Lot number Remaining uses
The parameters are accepted automatically after 5s and shown on the main
screen.
If the COMFORT instrument is connected to a socket without preset
parameters, the ideal settings for the BOWA COMFORT instrument are
loaded via Plug’n Cut COMFORT.
If the COMFORT instrument is connected to a socket with preset
parameters, a plausibility check is carried out. The preset values for the
COMFORT instrument are not overwritten if they are within a permissible range. The COMFORT instrument can now be used with the preset parameters.
- or- Press "OK" to accept the selection.
Press "back" to return to the main screen without carrying changes to the selection.
The COMFORT instrument can now be used.
The permissible parameters for the BOWA COMFORT instrument remain
accessible; all other modes are greyed out.
5.4.9. Playing videos
1. Plug the delivered BOWA USB stick into the connection on the rear side of the ARC 400.
2. Switch the unit on.
Saved videos are played automatically in succession.
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Bildzeichen Modus Schneiden
Bezeichnung
Bildzeichen Modus Koagulieren
Bezeichnung
Standard
Moderate
Micro
Forced non cutting
Dry
Forced mixed
MetraLOOP
Forced cutting
Resection
Spray
Laparoscopy
Laparoscopy
Argon*
Argon open*
GastroCut Loop slow
Argon flexible*
GastroCut Loop medium
Argon flex. pulse*
GastroCut Loop fast
Gastro Coag
* These modes can only be used in connection with the argon coagulation unit ARC PLUS (900-001).
5.5. Mode overview
An overview of the programs that can be executed with the HF device is shown below.
5.5.1. Monopolar modes
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Bildzeichen Modus Schneiden
Bezeichnung
Bildzeichen Modus Koagulieren
Bezeichnung
GastroCut Knife slow
Resection
GastroCut Knife medium
Cardiac Mammary
GastroCut Knife fast
Cardiac Thorax
SimCoag
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Cutting mode icon
Designation
Coagulation mode icon
Designation
Standard
Standard forceps
Bipolar resection
Standard forceps AUTO
Bipolar scissors
Micro forceps
Forceps forced
LIGATION
TissueSeal PLUS
Bipolar scissors
Laparoscopy
Bipolar resection
The information and data regarding settings, application points, application duration and instrument use are based on clinical practice. However, these are only basic guidelines which must be tested for suitability by the operator. Depending on individual conditions, it may be necessary to deviate from the provided data. Medical practice is continuously evolving as a result of R&D and clinical experience. This may also make deviations from the provided data necessary.
5.5.2. Bipolar cutting modes
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5.6. Monopolar cutting modes
5.6.1. Standard
In this mode a high-performance HF current with a low crest factor is used for cutting biological tissue. ARC CONTROL quickly adjusts the power output to the minimum required level in response to variations in tissue type and changes in the cutting area or speed.
Application areas
Cutting tissue with low electrical resistance, such as muscle tissue or vascular tissue.
Cutting or preparing fine structures
Suitable instruments
Needle electrodes  Knife electrodes  Spatula electrodes  Sling electrodes
5.6.2. Micro
This mode is used for electrosurgical cutting using micro-electrodes. It enables extremely fine control of the power level and precise work.
Application areas
Pediatric surgery, neurosurgery, plastic surgery
Suitable instruments
Micro needle electrodes
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5.6.3. Dry
This mode is used for monopolar dry cutting. A large, controlled arc is generated, which allows significantly deeper coagulation to be obtained.
Application areas
Cardiac surgery and blood coagulation in retracting blood vessels in the sternum region.
Suitable instruments
Knife electrodes
5.6.4. Argon
This mode is used to perform open surgical interventions in combination with the ARC PLUS companion device for argon-assisted cutting. With suitable instruments connected, argon-assisted cutting can be performed using rigid electrodes.
Application areas
Visceral surgery
Suitable instruments
Rigid argon electrodes  Argon handpiece
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Use non-conductive irrigation fluids.
5.6.5. Resection
This mode is used in gynecology and urology. ARC control generates the cutting effect with simultaneously minimized output power. ARC control facilitates direct cutting and prevents electrode adhesion.
Application areas
Hysteroscopy, transurethral prostate resection (TUR-P), surgical treatment of bladder tumors (TUR-B), vaporization of prostate tissue (TUR-VAP).
Suitable instruments
Resectoscope (monopolar)  Resection sling  Rollerblade electrode
5.6.6. MetraLOOP
This mode is used in gynecology for laparoscopic hysterectomy. Removal of the uterus can be achieved by applying monopolar cutting current and pulling on the sling at the same time.
Application areas
Gynecology; laparoscopic hysterectomy
Suitable instruments
Gynecological slings
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5.6.7. Laparoscopy
This mode is used in laparoscopy and arthroscopy for monopolar cutting.
Application areas
Laparoscopy, arthroscopy
Suitable instruments
Arthroscopy electrodes  Laparoscopy electrodes
5.6.8. GastroCut Loop slow
This mode is used in gastroenterology. Polypectomy snares are used for cutting and coagulation. ARC control generates the cutting effect with simultaneously minimized output power. This mode consists of a series of cutting current pulses followed by a coagulation phase. With a relatively slow pulse rate of 1 cutting pulse per second, this mode is suitable for especially cautious work.
Application areas
Polyp removal using polypectomy snares and flexible endoscopy
Suitable instruments
Polypectomy snares
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5.6.9. GastroCut Loop medium
This mode is used in gastroenterology. Polypectomy snares are used for cutting and coagulation. ARC control generates the cutting effect with simultaneously minimized output power. This mode consists of a series of cutting current pulses followed by a coagulation phase. With an accelerated pulse rate of 1.8 cutting pulses per second, this mode is suitable for experienced users.
Application areas
Polyp removal using polypectomy snares and flexible endoscopy, with accelerated pulse rate for experienced users.
Suitable instruments
Polypectomy snares
5.6.10. GastroCut Loop fast
This mode is used in gastroenterology. Polypectomy snares are used for cutting and coagulation. ARC control generates the cutting effect with simultaneously minimized output power. This mode consists of a series of cutting current pulses followed by a coagulation phase. With an accelerated fast pulse rate of 3.2 - 5 cutting pulses per second, this mode is suitable for advanced users.
Application areas
Polyp removal using polypectomy snares and flexible endoscopy, with accelerated fast pulse rate for advanced users.
Suitable instruments
Polypectomy snares
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5.6.11. GastroCut Knife slow
This mode is used in gastroenterology. Instruments for papillotomy and endoscopic resections are used for cutting and coagulation. ARC control generates the cutting effect with simultaneously minimized output power. This mode consists of a pulse sequence of cutting current and coagulation phase. With a relatively slow pulse rate of 1.3 cutting pulse per second, this mode is suitable for especially cautious work.
Application areas
Papilla incision using a papillotome and flexible endoscopy, resection with needle knives; slow pulse rate for cautious work.
Suitable instruments
Papillotome  Needle knives
5.6.12. GastroCut Knife medium
This mode is used in gastroenterology. Instruments for papillotomy and endoscopic resections are used for cutting and coagulation. ARC control generates the cutting effect with simultaneously minimized output power. This mode consists of a pulse sequence of cutting current and coagulation phase. With an accelerated pulse rate of 1.7 cutting pulses per second, this mode is suitable for experienced users.
Application areas
Papilla incision using a papillotome and flexible endoscopy, resection with needle knives; accelerated pulse rate for experienced users.
Suitable instruments
Papillotome  Needle knives
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5.6.13. GastroCut Knife fast
This mode is used in gastroenterology. Instruments for papillotomy and endoscopic resections are used for cutting and coagulation. ARC control generates the cutting effect with simultaneously minimized output power. This mode consists of a pulse sequence of cutting current and coagulation phase. With an accelerated fast pulse rate of 2.2 cutting pulses per second, this mode is suitable for advanced users.
Application areas
Papilla incision using a papillotome and flexible endoscopy, resection with needle knives; accelerated fast pulse rate for advanced users.
Suitable instruments
Papillotome  Needle knives
5.7. Monopolar coagulation modes
5.7.1. Moderate
This mode is used with contact coagulation to stop hemorrhagic oozing, for hemostasis of relatively large tissue areas, and for small-area coagulation. Tissue carbonization is prevented and electrode adhesion to the tissue is strongly reduced. Greater coagulation depth is achieved in this mode than in other coagulation modes. The degree of surface scabbing can be controlled by adjusting the "Effect" setting in the range of 1 to 3.
Application areas
Coagulation with relatively high penetration depth; low electrode adhesion to tissue
Suitable instruments
Electrodes with large contact areas, such as ball electrodes
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5.7.2. Forced non cutting
This mode is used for contact coagulation with low tissue penetration, preferably using fine electrodes and electrodes with small contact areas. It achieves a high degree of coagulation with low cutting tendency.
Application areas
Fast coagulation with small penetration depth
Suitable instruments
Ball electrodes  Knife electrodes  Spatula electrodes
5.7.3. Forced mixed
This mode is used for contact coagulation with low tissue penetration, preferably using fine electrodes and electrodes with small contact areas. It achieves a high degree of coagulation with moderate cutting tendency.
Application areas
Fast coagulation with small penetration depth and moderate cutting tendency
Suitable instruments
Knife electrodes  Spatula electrodes  Insulated monopolar forceps
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5.7.4. Forced cutting
This mode is used for contact coagulation with low tissue penetration, preferably using fine electrodes and electrodes with small contact areas. It achieves good hemostasis with very good cutting tendency.
Application areas
Fast coagulation with small penetration depth and very good cutting tendency
Suitable instruments
Knife electrodes  Spatula electrodes  Needle electrodes
5.7.5. Spray
This mode is used with non-contact surface coagulation using an arc, for hemostasis in parenchymal tissue, in poorly accessible crevices, and in conjunction with argon coagulation.
Application areas
Promoting coagulation of diffuse bleeding
Suitable instruments
Ball electrodes  Knife electrodes  Spatula electrodes  Needle electrodes
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5.7.6. Argon open
This mode is used for open surgical interventions in conjunction with the ARC PLUS accessory device for argon-assisted electrocoagulation.
This is the current type Spray. With suitable instruments connected, argon-assisted coagulation can be performed
using rigid electrodes.
Application areas
Visceral surgery
Suitable instruments
Rigid argon electrodes  Argon handpiece
5.7.7.Argon flexible
This mode is used for argon-assisted electrosurgery in conjunction with the ARC PLUS accessory device.
This is the current type Spray. For argon-assisted coagulation, flexible probes are used in combination with
endoscopes.
Application areas
Gastroenterology, homogeneous surface coagulation
Suitable instruments
Flexible argon probes
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Use non-conductive irrigation fluids.
5.7.8. Argon flex. pulse
This mode is used for argon-assisted electrosurgery in conjunction with the ARC PLUS accessory device.
This is the current type Spray. For argon-assisted coagulation, flexible probes are used in combination with
endoscopes. The puls frequency changes with the effect setting. The higher the effect level, the
faster the pulse sequence.
Application areas
Gastroenterology, homogeneous surface coagulation
Suitable instruments
Flexible argon probes
5.7.9. Resection
This mode is used for monopolar hemostasis in gynecology and urology.
Application areas
Hysteroscopy, transurethral prostate resection (TUR-P), surgical treatment of bladder tumors (TUR-B), vaporization of prostate tissue (TUR-VAP).
Suitable instruments
Resectoscope (monopolar)  Resection sling  Rollerblade electrode
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5.7.10. Cardiac Mammary
This mode is used in mammary surgery and cardiac surgery. It produces forced coagulation.
Application areas
Mammary surgery and cardiac surgery
Suitable instruments
Knife electrodes
5.7.10. Cardiac Thorax
This mode is used in thoracic surgery. It produces forced coagulation.
Application areas
Thoracic surgery
Suitable instruments
Knife electrodes
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The output power setting applies to both output sockets, and the power is distributed according to the tissue structure.
5.7.11. SimCoag
This mode is used for simultaneous preparation. Two monopolar socket connectors can be activated at the same time to enable the simultaneous use of two manually switched instruments. Both handpieces can be switched on and off independently.
The current type changes with the effect setting: Effect 1: Forced cutting Effect 2: Forced mixed Effect 3: Spray
Application areas
Simultaneous coagulation and preparation, e.g. for cardiac or mammary surgery
Suitable instruments
Ball electrodes  Knife electrodes  Spatula electrodes
5.7.12. Gastro Coag
This mode is used in gastroenterology with contact coagulation for the coagulation of small areas.
Application areas
After bleeding associated with polypectomies or papillotomies.
Suitable instruments
Polypectomy snares  Papillotome
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5.7.13. Laparoscopy
This mode is used in laparoscopy and arthroscopy for monopolar coagulation.
Application areas
Laparoscopy, arthroscopy
Suitable instruments
Arthroscopy electrodes  Laparoscopy electrodes
5.8. Bipolar cutting modes
5.8.1. Standard
This mode is used for cutting with bipolar laparoscopic instruments.
Application areas
Laparoscopic cutting
Suitable instruments
Laparoscopic instruments
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Make sure that NaCl is used as an irrigation medium. Secure a continuous irrigation during the application. Always use conductive lubricants to avoid damages of the urethra. Avoid continuous activations.
Optimum results are provided exclusively when using BOWA COMFORT resection cables.
Bipolar scissors should only be operated with the current type bipolar scissors cutting or bipolar scissors coagulation.
5.8.2. Bipolar resection
This bipolar mode is used in gynecology and urology for cutting under saline. ARC control technology generates the cutting effect with simultaneously minimized output power. ARC Control facilitates immediate cutting and prevents electrode adhesion.
Application areas
Hysteroscopy, transurethral prostate resection (TUR-P), surgical treatment of bladder tumors (TUR-B), vaporization of prostate tissue (TUR-VAP).
Suitable instruments
Resectoscope (bipolar)  Resection sling  Rollerblade electrode
5.8.3. Bipolar scissors
This mode is used with bipolar scissors. It can be used for coagulation before or during cutting, point coagulation, coagulation of cuts and surface coagulation.
Application areas
Preparation, coagulation and cutting of tissue
Suitable instruments
Bipolar scissors
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Setting the AUTOSTART mode can result in unintentional coagulations, e.g. when bipolar forceps are used for gripping while the AUTOSTART Mode is on.
5.9. Bipolar coagulation modes
5.9.1. Standard forceps
This mode is used for arcless contact coagulation with forceps.
Application areas
Bipolar coagulation
Suitable instruments
Bipolar forceps
5.9.2. Standard forceps AUTO
This mode is used for arcless contact coagulation with forceps. Activation starts automatically on contact with tissue. The adjustable delay time can be set under MENU – SYSTEM SETTINGS – AUTOSTART DELAY.
Application areas
Bipolar coagulation with AUTOSTART
Suitable instruments
Bipolar forceps
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5.9.3. Micro forceps
This mode is used for arcless contact coagulation with micro forceps. It enables extremely fine control of power output down to 0.1 W and precise work for tightly restricted bipolar contact coagulation.
Application areas
Bipolar coagulation in pediatric surgery, neurosurgery, plastic surgery, etc.
Suitable instruments
Bipolar forceps  Micro forceps
5.9.4. Forceps forced
This mode is used for forced coagulation with forceps.
Application areas
Fast bipolar coagulation
Suitable instruments
Bipolar forceps
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5.9.5. LIGATION
This mode is used for the permanent sealing of veins, arteries and tissue bundles. Conventional instruments cannot be used in this mode. The output power is preconfigured and automatically regulated.
Application areas
Vessel sealing open and laparoscopic
Suitable instruments
TissueSeal®  TissueSeal® PLUS  NightKNIFE®  LIGATOR®
5.9.6. TissueSeal PLUS
This mode is used for the permanent sealing of veins, arteries and tissue bundles with TissueSeal PLUS® for open surgical applications. Conventional instruments cannot be used in this mode. The output power is preconfigured and automatically regulated.
Application areas
Vessel sealing in open surgery
Suitable instrument
TissueSeal PLUS®
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Bipolar scissors should only be operated with the current type bipolar scissors cutting or bipolar scissors coagulation.
5.9.7. Bipolar scissors
This mode is used with bipolar scissors. It can be used for coagulation before or during cutting, point coagulation, coagulation of cuts and surface coagulation.
Application areas
Preparation, coagulation and cutting of tissue
Suitable instruments
Bipolar scissors
5.9.8. Laparoscopy
This mode is used for coagulation in combination with bipolar laparoscopic instruments.
Application areas
Laparoscopic coagulation
Suitable instruments
Laparoscopic instruments
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Use NaCl as irrigation fluid.
Make sure that the instrument has contact with the tissue while activating bipolar coagulation to avoid an unintended heating of the irrigation fluid.
5.9.9. Bipolar resection
This mode is used for bipolar hemostasis in gynecology and in urology for cutting under saline.
Application areas
Hysteroscopy, transurethral prostate resection (TUR-P), surgical treatment of bladder tumors (TUR-B), vaporization of prostate tissue (TUR-VAP)
Suitable instruments
Resectoscope  Resection sling  Rollerblade electrode
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The menu dialogs specify the settings of basic parameters, such as the user interface language and audio, display and memory options.
5.10. Menu dialogs
5.10.1. Overview
The following menu dialogs are available:
Figure 5-19: Menu dialogs
Selecting a dialog
Press the button of the desired dialog to launch the program.
Exiting a dialog
Press the "back" button to return to the main screen.
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5.10.2. "System Settings" dialog
The following parameters can be configured in the "System Settings" dialog:
Figure 5-20: “System settings” dialog
The following languages are selectable in „language selection“: German, English, French, Italian, Spanish, Russian, Polish, Turkish
5.10.3. "Volume" dialog
Use the "Volume" dialog to set the volume of the individual acoustic signals.
Figure 5-21: "Sound Level" dialog
Incremental setting
Press the "+" and "-" buttons.
Fast setting
Move the slider in the desired direction.
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The volume of the activation signal should be increased as necessary for use in relativey noisy surrouondings. The alarm tones have a minimum volume and limited changeability.
Mode
Category
Frequency (Hz)
Signal type
Monopolar Cut
Activation tones
635
Continuous sound
Monopolar Coag
Activation tones
475
Continuous sound
Bipolar Cut
Activation tones
565
Continuous sound
Bipolar Coag
Activation tones
505
Continuous sound
Sim Coag
Activation tones
755
Continuous sound
GastroCut /LIGATION end
Alarm tones
-
alternating sound Error
Alarm tones
-
Signal tone
Warning
Alarm tones
-
Signal tone
Note
Alarm tones
-
Signal tone
5.10.4. "System messages" dialog
In the "System messages" dialog, it is possible to open the saved system messages which have occurred since switching on the HF device.
These messages are not saved when switching off the HF device.
Opening saved system messages:
1. Select a system message.
2. The selected system message is displayed again with "?".
3. Press "OK" to return to the overview.
Opening the instructions of use:
1. Press the "instructions of use" button.
The instructions of use are displayed chapter for chapter
2. Use the arrow buttons to select the desired chapter.
3. Press "OK" to open the selected chapter.
Use the arrow buttons to open the individual pages of the chapter.
4. Press "back" to return to the chapter overview.
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Figure 5-22: "System messages" dialog
5.10.5. "BOWA Service" dialog
After entering a password, you can use the "BOWA Service" dialog to access additional options, such as resetting the device to the factory default configuration or viewing the instructions of use.
Moreover, the software version and the next TSI date is displayed, see chapter Safety inspection, page 86.
Figure 5-23: "BOWA Service" dialog
Opening the operating instructions:
1. Press the "Operating instructions" button. The operating instructions are displayed chapter for chapter.
2. Use the arrow buttons to select the desired chapter.
3. Press "OK" to open the selected chapter. Use the arrow buttons to open the individual pages of the chapter.
4. Press "back" to return to the chapter overview.
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Up to eight programs can be put on the favourites list.
5.10.6. "Select program" dialog
1. Use the "Select program" dialog to select programs from a list and to add them
to the favourites.
- or ­Fast settings of this menu are possible by tapping on the present program name in the main screen.
2. For the selection of a program, tap on the desired program name.
3. The vertical and horizontal navigation is possible using the arrows.
4. The programs can be shown in alphabetic order or in order of date saved.
5. The assignment to the favourites is possible using the star button in the lower
area of the screen. Use the green arrow to add programs to your list of favorites or use the red arrow to delete them from the favourites.
6. Press "OK" to load the selected program.
- or ­To return to the main screen click on "back".
Figure 5-24: "Select program" dialog
If the eight places are full and a new program is being assigned to the favourites, the following screen is shown.
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Figure 5-25: Favourites memory
For the selection of the location for saving, tap on the desired program name. The overwritten program is integrated in the program list. The vertical and horizontal navigation is possible using the arrows. Confirm with "OK" to accept the selection. To return to the main screen click on "back".
5.10.7. "Delete program" dialog
In the "Delete program" dialog, it is possible to delete saved programs.
Figure 5-26: "Delete program" dialog
1. Touch the program name in the program list to select the program you wish to delete.
Vertical and horizontal navigation is also possible via the arrow buttons
2. Press the "recycle bin" button to fully delete the selected program.
The selected program will be deleted without any further prompt.
The default program appears.
The default program cannot be deleted.
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5.10.8. "Favourites" dialog
Use the "Favorites" dialog to select previously defined favorite programs. A fast selection of the favourites is possible using the star button in the main
screen.
Figure 5-27: "Favourites" dialog
Confirm with "OK" to accept the selection. To return to the main screen click on "back".
5.10.9. "Save Program" dialog
Use the "Save Program" dialog to save the current program settings under the same name or a different name.
Figure 5-28: "Save program" dialog
With a keypad texts program names can be created. Several symbols, capital or small letters or numbers are selection options.
Confirm with "OK" to accept the selection. To return to the main screen click on "back".
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Default settings for argon flow rates according to the different modes are selected automatically:
Argon open: CUT flow rate: 4.0 l/min COAG flow rate: 3.0 l/min
Argon flexible: COAG flow rate: 0.4 l/min
5.10.10. "Argon" dialog
In case of the selection of an argon mode and a successful connection to ARC PLUS, this dialog is selectable in the status bar.
The "Argon" dialog enables the selection of argon flow rates for cutting and coagulation, as well as the selection of argon bottles and the display of filling levels.
Figure 5-29: "Argon" dialog
1. Use the "+" and "-" buttons to adjust the argon flow rate for cutting (Cut) or coagulation (Coag).
- or ­Use the slider to set the flow rate.
2. In case of two connected argon bottles use the buttons for output "1" or "2" to select the desired gas source.
Pressure reducers with electronic pressure sensor enable the display of exact filling levels of argon bottles.
3. Press the "?" button for more information on this selection.
4. Confirm your selection by pressing the "OK" button.
- or ­Press the "Back" button to return to the main screen without changing the selection.
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5.11. Basic programs
The following basic programs are provided with the full version of ARC 400 (incl. the resection bipolar option and the LIGATION option):
3 Bipolar Argon flex Argon Cardiac GastroCut Laparoscopy Macro Micro Open Surgery Resection bipolar Resection monopolar SimCoag Standard
Figure 5-30: Basic program "3 Bipolar"
LIGATION is only available in this program with the LIGATION option.
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Figure 5-31: Basic program "Argon flex"
Figure 5-32: Basic program "Argon"
Figure 5-33: Basic program "Cardiac"
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Figure 5-34: Basc program "GastroCut"
Figure 5-35: Basic program "Laparoscopy"
LIGATION is only available in this program with the LIGATION option.
Figure 5-36: Basic program "Macro"
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Figure 5-37: Basic program "Micro"
Figure 5-38: Basic program "Open Surgery"
Figure 5-39: Basic program "Resection bipolar"
This program is only available with the resection bipolar option.
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Figure 5-40: Basic program "Resection monopolar"
Figure 5-41: Basic program "SimCoag"
Figure 5-42: Basic program "Standard"
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6 Detecting and correcting faults
6. Detecting and correcting faults
Two types of faults can occur:
system faults  EASY monitoring faults
6.1. System informations
A warning message appears on the display when a system fault occurs.
Figure 6-1: Confirmation of AUTOSTART Mode
Further information to the cause and corrective measures for this message are available pressing the button “?“ in the lower area of the screen.
System informations have three different categories:
Notice (grey screen)  Warning (orange screen)  Error (red screen)
Notices are shown for five seconds on the display. Warnings and errors are shown for ten seconds.
While an error is present, activations are prohibited. The message is available using the orange marked „?“ in the system bar. Moreover, these messages are available in the menu program system settings and
will be deleted when switching off the unit.
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Heading
Fault message
Confirmation of AUTOSTART Mode
You have selected an AUTOSTART mode. Setting the AUTOSTART mode can result in unintentional
coagulations, e.g. when bipolar forceps are used for gripping while the AUTOSTART Mode is on.
AUTOSTART Error
The instrument is in contact with tissue. AUTOSTART cannot be selected when the instrument is in contact
with tissue. Open up the instrument.
TSI Warning
The annual Technical Safety Inspection (TSI) is due.
Neutral Electrode Error
No neutral electrode connected. No neutral electrode connected. Connect a neutral electrode.
Neutral Electrode Error
Wrong neutral electrode connected.. The selection does not match the neutral electrode connected.
Connect the neutral electrode which matches the selected mode, or change the mode to match the neutral electrode.
Neutral Electrode Error
Poor contact with the patient. The resistance between the neutral electrode and the patient is too
high. Establish better contact of the neutral electrode.
Neutral Electrode Warning
Poor contact with the patient. The contact resistance between the neutral electrode and the
patient is increasing. Establish better contact of the neutral electrode.
Neutral Electrode Error
No cable for neutral electrode connected. No cable for neutral electrode connected. Connect a cable for
neutral electrodes.
Neutral Electrode Notice
No cable for neutral electrode connected. The cable for neutral electrode has been removed. Monopolar
activation is not possible.
Mode Error
No mode selected. No mode was selected for this type of activation.
Select the desired mode or change the foot switch assignment.
Mode Error
This mode is not allowed for baby neutral electrodes. Use split neutral electrodes with a large conductive surface for this mode.
Mode Error
This mode is not allowed for this socket. The current mode remains active. Choose another socket for this mode.
Foot Switch Error
Foot switch not assigned to a socket. The foot switch has not been assigned to a socket yet.
Assign a socket to the foot switch using the "Pedal" button.
The following table describes the cause of the fault and the appropriate corrective action.
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Heading
Fault message
Foot Switch Notice
The assignation of the foot switch has been changed. The orange button on the foot switch enables switching from socket
A to B and back. The active foot switch assignation is displayed in the form of an orange dot.
Foot Switch Warning
Second foot switch assignment has not been set. There is no second foot switch assignment in place.
The current assignment remains active. To allocate the second foot switch assignment press the "Pedal" push button on the desired socket.
Foot Switch Error
Fault on foot switch connection. Check the foot switch. If this message appears again, please
contact the Technical Support. Internet: www.bowa.de Telephone: +49707260020
Finger Switch Error
Fault on finger switch connection. Check the handle and the connection cable. Please replace them if
damaged. If this message appears again please contact the Technical Support. Internet: www.bowa.de Telephone: +49707260020
Finger Switch Error
Fault on finger switch connection. Check the handle and the connection cable. Please replace them if
damaged. Instruments with one pin have to be connected to the marked socket. If this message appears again please contact the Technical Support. Internet: www.bowa.de Telephone: +49707260020
Finger Switch Error
Fault on finger switch connection. Check the handle and the connection cable. Please replace them if
damaged. If this message appears again please contact the Technical Support. Internet: www.bowa.de Telephone: +49707260020
Temperature Warning
The temperature of the device is higher than normal. The temperature of the device is elevated. This leads to a reduction
of the maximum power.
Limitation of Continuous Activation
The maximum activation time has been exceeded. Please only activate the generator in short intervals, in order to
avoid harming the patient and damaging the connected instruments or the generator.
Mains Voltage Error
The mains voltage is too low. Please ensure a constant mains voltage. If necessary, connect a
UPS (Uninterrupted Power Supply).
Activation Error
While switching on the device, there is an activation by foot switch, finger switch or AUTOSTART.
Check the handles or foot switches for malfunctions. Disconnect the handles / foot switches from the device. If the error persists, please contact the Technical Support. Internet: www.bowa.de Telephone: +49707260020
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Heading
Fault message
Activation Error
There is an activation while connecting the foot switch or finger switch. Check the handles or foot switches for malfunctions. Disconnect the handles / foot switch from the device. If the error persists, please contact the Technical Support. Internet: www.bowa.de Telephone: +49707260020
Activation Error
There is no instrument connected on the activated socket. Connect an instrument on the designated socket.
Activation Warning
The mode for safety inspections is active. Activation is not possible. Quit this mode before activating again.
Bipolar Resection Warning
No activation of the bipolar resection. Check the irrigation medium, the connection cable, the instrument and the selected settings.
Make sure that NaCl is used as an irrigation medium.
GastroCut Notice
The polypectomy has been completed.
GastroCut Warning
Polypectomy snare not in contact with tissue, or check connection cable at snare or generator. Please apply the snare and reactivate.
First of all establish contact between tissue and polypectomy snare, or check the connection cable at the snare or the generator. Then activate with the yellow foot pedal.
LIGATION Notice
The LIGATION has been completed.
LIGATION Warning
There is a short-circuit in the area of the sealing instrument. Please check the instrument for foreign material or contact with other objects. The sealing point must be free of foreign objects.
LIGATION Warning
The sealing instrument is not in contact with tissue. Please grasp tissue and reactivate LIGATION.
Check the connection between instrument and generator. To perform LIGATION of vessel and tissue bundles it is necessary to grasp tissue and close the sealing instrument before activating.
ARC PLUS Fault
Please check if the argon bottles are connected and open. Empty bottles should be replaced. Subsequently restart ARC PLUS by activating the flashing ""Purge"" button.
ARC PLUS Fault
The argon inlet pressure is too high. Max. inlet pressure: <4.5bar Close a source of argon gas in the appropriate pressure range. Subsequently restart ARC PLUS by activating the flashing "Purge" button.
ARC PLUS Fault
The argon inlet pressure has exceeded the permissible limits. Inlet pressure range: 2 - 4.5bar Close a source of argon gas in the appropriate pressure range. Subsequently restart ARC PLUS by activating the flashing "Purge" button.
ARC PLUS Warning
Please check if the argon bottles are connected and open. Empty bottles should be replaced. Subsequently restart ARC PLUS by activating the flashing "Purge" button.
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Heading
Fault message
ARC PLUS Warning
Mixed operation of argon bottles with and without an electric bottle pressure gauge is not recommended Connect two identical pressure reducers.
ARC PLUS Warning
Please check if the instrument is free of adhesions, and purge it with argon. If repeated purging does not solve the problem, the instrument and cable must be replaced.
ARC PLUS Warning
The argon flow settings at ARC 400 are invalid
ARC PLUS Warning
The filling level of the argon bottle is low. Please make sure that a replacement is available. You can connect two argon bottles. The unit shifts automatically to the second bottle.
ARC PLUS Fault
The argon bottle is empty. Connect a replacement bottle to enable activation. You can connect two argon bottles. The unit shifts automatically to the second bottle
ARC PLUS Notice
The argon bottle is empty. The unit has shifted automatically to the replacement bottle. Please make sure that a replacement is available
TSI ARC PLUS Warning
The annual Technical Safety Inspection (TSI) for ARC PLUS is due.
Plug'n Cut COMFORT Notice
The lifetime of the instrument is ending soon. Please order a replacement in good time. Any use of the instrument beyond its lifetime is not covered by
warranty. Please contact your BOWA dealer in good time to purchase a new instrument.
Plug'n Cut COMFORT Warning
The maximum lifetime of the instrument has been reached. Any further use is not covered by warranty. The maximum service lifetime of the instruments must not be exceeded, in order to guarantee safe usage. Any further use is at the user's risk.
Plug'n Cut COMFORT Notice
You have connected a BOWA RFID instrument. X applications remain available. The maximum lifetime of the instruments must not be exceeded, in order to guarantee safe usage. Any further use is at the user's risk.
Dr. Dongle Notice
You can save up to six of your preferred programs on your Dr. Dongle and run them in a flexible way. With the "Load" button you can call a selected program. You can use the "Save" button to enter an explanatory text for the selected program.
Plug'n Cut COMFORT Warning
A software update is necessary to use Plug'n Cut COMFORT with this instrument. Only carry out manual settings at this instrument. Please contact the Technical Support. Internet: www.bowa.de Telephone: +49707260020
Internal Error 4177
If this message appears again, please contact the Technical Support. Internet: www.bowa.de Telephone: +49707260020
Internal Errors have a number next to the description. Please advise the Technical Service of this number.
900-400_IFU_V1.0.0.6.17.9_20140-S2-20130604-EN Operating Manual ARC 400 83
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6 Detecting and correcting faults
EASY monitoring
Cause
Indication
Corrective measures
Flashes yellow
Significant increase in resistance
Depending on the indication, there may be heating under the neutral electrode
–
Stopping the application is not necessary.
Check the proper application of the neutral electrode.
Switches from green to continuous red
A significant problem occurred when the monopolar current was activated
An acoustic signal sounds. A warning message appears on the display
Check the neutral electrode and neutral electrode cable (see Section EASY neutral
electrode monitoring (EASY monitoring), page
28. Check the neutral electrode
cable for proper connection and external damage.
Loosened electrode
An acoustic signal sounds. A warning message appears on the display
Reattach the neutral electrode. If the fault persists, replace the neutral electrode.
6.2. Fault indications for EASY monitoring
Fault indications are displayed in three stages (green, yellow and red) when problems occur.
When working with a split neutral electrode, the following faults may occur:
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7 Preparation
NOTE
Incorrect handling of the HF device can cause damage to the unit! Never sterilize the ARC 400 device. Instead, clean or disinfect it.
WARNING
Risk of electric shock and fire!
Unplug the power connection before cleaning the device. For cleaning surfaces, use the approved cleaning
agents/disinfectants only as specified by the manufacturer.
Ensure that no liquid penetrates the device. Ensure that the AUTOSTART function is deactivated.
7. Preparation
7.1. Preparation of the accessories
Prepare the accessories (e.g. surgical handles, instruments, active
electrodes, neutral electrodes and cables) as described in the corresponding operating manuals.
Check the accessories before and after use for damage and to ensure that
they are working properly.
7.2. Disinfection and cleaning
1. Apply the cleaning agent and disinfectant.
2. Wipe the agent off with a sponge moistened with clean water or with a cloth.
3. Dry the device using a clean, lint-free cloth.
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8 Maintenance and repair
DANGER
Infection hazard!
Carry out a surface disinfection and wrap the device in addition to
the shipping packaging material before allowing the device to leave the hospital or office to avoid spreading germs and infections.
Any shorter safety inspection cycles specified in national regulations must be observed.
8. Maintenance and repair
8.1. Maintenance
Check the device, the device trolley and the accessories (e.g. foot switch,
cable) after each use for damage or defects. In particular, make sure that the insulation is intact on all cables.
Do not use any damaged device, damaged device trolley or damaged
accessories.
Replace defective accessories immediately. Have the safety inspection for the device performed once a year. Please
consult and comply with the respective service instructions for additional technical information.
8.1.1.Safety inspection
Safety inspections must be performed once a year. The next safety inspection date of ARC 400 can be displayed in the dialog,
see “BOWA Service” dialog, page 69 A warning message appears during system start-up if a safety inspection is
due. Press OK to confirm this message.
The device and accessories may be inspected only by persons who have the
required training, knowledge or experience and who can perform the inspection independently.
With regard to the safety inspection, you must comply with the country-
specific rules and regulations.
The inspector documents the inspection results and measured values corresponding to the printed inspection protocol.
In the case of severe deviations from the values of the attached final acceptance report, or if the specified maximum values were exceeded:
Send the HF device to the service center, see section Technical service,
page 88.
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8 Maintenance and repair
NOTE
You can damage the HF device by doing your own repairs and modifications of medical equipment!
If a repair is necessary, have it done only by the service center
specified below.
Never carry out any repairs yourself.
Fast and satisfactory repairs can only be guaranteed when all required data have been supplied in full.
8.2. Repairs
BOWA is liable for safety, reliability and performance of the HF device under the following conditions:
Full compliance with all instructions regarding the installation and
proper use for the intended purpose contained in this operating manual was maintained.
Changes, repairs, new settings and similar procedures were carried out
only by persons authorized to do this work by BOWA.
The electrical installations in the relevant room meet the local
requirements and statutory provisions.
The following information is required for returning the device:
complete address  model number  serial number  software version
Describe the problem, the appropriate application and the accessories used.
– or –
Describe the repairs to be made.
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9 Storage
9. Storage
If you store the HF device for longer that one year, pay specific attention to
the indicators during automatic functional testing, see section Functional test, page 26.
Clean the HF device thoroughly before you put it into storage. Store the HF device in a clean, dry place in accordance with the storage
conditions.
Storage conditions:
Temperature: -20 °C to +50 °C  Relative humidity 0 to 75 %, non-condensing  Atmospheric pressure: 500 to 1600 hPa
9.1. Technical service
Contact the following service center for maintenance and repair work: BOWA-electronic GmbH & Co. KG Heinrich-Hertz-Strasse 4–10 72810 Gomaringen, Germany Phone +49 (0) 7072-6002-0 Fax +49 (0) 7072-6002-33 Email [email protected] or visit our website: www.bowa.de
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10 Technical specifications
Insulation type / Classification
EMC
IEC 60601-1-2
Level of protection provided by the housing
IP 21
Protection class according to EN 60601-1
I
Application component type according to EN 60601-1
CF
Standards compliance
IEC 60601-1: 2005, IEC 60601-1-2: 2007, IEC 60601-2-2: 2009, ISO 14971: 2007, ISO 13485: 2003 + Cor.1_2009
Classification according to EC Directive 93/42/EEC
IIb
Power connection
Power consumption in standby mode
40 W / 85 VA
Line frequency
50 / 60 Hz
Maximum power consumption with 300 W HF output power
550 W / 975 VA Terminal for potential equalization
Yes
Voltage range 220 V – 240 V
Input voltage range
198 V to 264 V
Current consumption in standby mode
110 mA
Current consumption at maximum HF output
4 A
Line fuses
2 x 5 A slow-blow
Voltage range 100 V - 115 V
Input voltage range
90 V to 130 V
Current consumption in standby mode
220 mA
Current consumption at maximum HF output
8 A
Line fuses
2 x 10 A slow-blow
Dimensions and weight
External dimensions: width x height x depth (mm)
430 x 180 x 475
Weight
approx. 12.5 kg
10. Technical specifications
10.1. ARC 400 technical data
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10 Technical specifications
Programs
Number of programs in the device
400
Default programs, factory set
Individually programmable
Program number and data shown on the display
Neutral electrode monitoring
EASY (Electrode Application System)
Display indication of one-piece or split or Baby electrode in the main and neutral electrode menu
Contact resistance between individual sections of split neutral electrodes shown on display with column for control
Lead resistance shown on the display when a one-piece neutral electrode is used
Maximum allowable resistance between the sections of a split electrode
300 Ohm
Warning signal for hazardous conditions beneath the neutral electrode
Visual, acoustic
Warning messages on display:
Text messages with further information
Safety features
ISSys (Integrated Safety System)
Continuous monitoring of HF leakage current with fault indication
Text messages with further information
Dosage monitoring with fault indication on the display
Continuous self-test
Continuous status indication on the display
Operating errors shown on the display
Text messages with further information
System faults shown on the display
Text messages with further information
Documentation
Data acquisition and storage in the device
System information with date
Fault states
Operating errors
Data retrieval via the display
Text messages with further information
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10 Technical specifications
Communication
External interface for communication with ARC PLUS (light wire cables)
USB interface for software updates
External PC interface, UART, using BOWA software
Service support using BOWA software
Service support
Network port for service support
Service support by service programs integrated in the device
Service support via ISSys
Cooling
Convection
Temperature-controlled fan
Duty factor
Intermittent
10 s / 30 s (on/off)
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10 Technical specifications
Mode icon
Description
CCS
ARC
CONTROL
Form of HF
voltage
Max. power output
Peak
voltage
Default values
Effect
Power range
Effect
Max. Watt
Modes Monopolar Cutting
Standard
Yes
Yes
sinusoidal
constant
1 2 3 4 5 6 7 8 9
1 W - 400 W
400 Vp 450 Vp 560 Vp 650 Vp 650 Vp 700 Vp 700 Vp 700 Vp 750 Vp
5
100
Micro
Yes
yes
sinusoidal
constant
1 2 3 4 5 6 7 8 9
1 W - 50 W
280 Vp 340 Vp 380 Vp 400 Vp 400 Vp 400 Vp 450 Vp 450 Vp 450 Vp
5
20
Dry
Yes
yes
sinusoidal
modulated
1 2 3 4 5 6 7 8 9
1 W - 200 W
1.4 kVp
1.4 kVp
1.4 kVp
1.4 kVp
1.5 kVp
1.6 kVp
1.6 kVp
1.6 kVp
1.6 kVp
5
100
Argon
Yes
yes
sinusoidal
constant
1 2 3 4 5 6 7 8 9
1 W - 300 W
400 Vp 450 Vp 560 Vp 650 Vp 650 Vp 700 Vp 700 Vp 700 Vp 750 Vp
5
100
Resection
Yes
yes
sinusoidal
constant
1 2 3 4 5
250 W
650 Vp 700 Vp 700 Vp 700 Vp 750 Vp
2
---
MetraLOOP
Yes
Yes
sinusoidal
constant
1 2 3
100 W 150 W 200 W
650 Vp 1 ---
Laparoscopy
Yes
Yes
sinusoidal
constant
1 2 3 4 5 6 7 8 9
1 W - 200W
400 Vp 450 Vp 560 Vp 650 Vp 650 Vp 700 Vp 700 Vp 700 Vp 750 Vp
5
100
GastroCut Loop slow
Yes
Yes
sinusoidal alternating Coag, Cut
and break
phases
1 2 3 4 5 6 7 8 9
-
750 Vp 5 ---
GastroCut Loop medium
Yes
Yes
sinusoidal alternating Coag, Cut
and break
phases
1 2 3 4 5 6 7 8 9
-
750 Vp 5 ---
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10 Technical specifications
Mode icon
Description
CCS
ARC
CONTROL
Form of HF
voltage Max. power output
Peak
voltage
Default values
Effect
Power range
Effect
Max. Watt
Modes Monopolar Cutting
GastroCut Loop fast
Yes
Yes
sinusoidal alternating Coag, Cut
and break
phases
1 2 3 4 5 6 7 8 9
-
750 Vp 5 ---
GastroCut Knife slow
Yes
Yes
sinusoidal alternating
Coag and Cut
phases
1 2 3 4 5 6 7 8 9
-
650 Vp 5 ---
GastroCut Knife medium
Yes
Yes
sinusoidal alternating
Coag and Cut
phases
1 2 3 4 5 6 7 8 9
-
650 Vp 5 ---
GastroCut Knife fast
Yes
Yes
sinusoidal alternating
Coag and Cut
phases
1 2 3 4 5 6 7 8 9
-
650 Vp 5 ---
Modes Monopolar Coagulation
Moderate
sinusodial
constant
1 2 3 1 W - 120 W
250 Vp 2 60
Forced non cutting
pulsed
modulated
-
1 W - 80 W
3.5 kVp
---
50
Forced mixed
sinusoidal modulated
1 2 3 1 W - 120 W
2.3 kVp
2.5 kVp
2.8 kVp
2
60
Forced cutting
sinusoidal modulated
1 2 3 4
1 W - 250 W
1.5 kVp
1.5 kVp
1.3 kVp
1.3 kVp
2
80
Spray
pulsed
modulated
1 2 3 4
1 W - 120 W
3.0 kVp
3.8 kVp
4.6 kVp
5.0 kVp
2
80
Argon open
pulsed
modulated
-
1 W - 120 W
4.6 kVp
---
80
Argon flexible
pulsed
modulated
-
1 W - 120 W
4.4 kVp
---
40
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10 Technical specifications
Mode icon
Description
CCS
ARC
CONTROL
Form of HF
voltage Max. power output
Peak
voltage
Default values
Effect
Power range
Effect
Max. Watt
Modes Monopolar Coagulation
Argon flex. pulse
pulsed
modulated
1 2 3 1 W – 80 W
4.4 kVp 2 20
Resection
sinusoidal modulated
-
1 W -120 W
2.6 kVp
---
60
Cardiac Mammary
sinusoidal modulated
-
1 W - 60 W
2.3 kVp
---
15
Cardiac Thorax
sinusoidal modulated
-
1 W - 100 W
2.3 kVp
---
40
SimCoag
sinusoidal modulated
pulsed
modulated
pulsed
modulated
1 2 3 1 W - 120 W
1.5 kVp
2.3 kVp
4.6 kVp
2
60
Gastro Coag
sinusoidal modulated
1 2 3 1 W - 50 W
2.3 kVp
2.6 kVp
3.1 kVp
2
15
Laparoscopy
sinusoidal modulated
-
1 W - 120 W
1.8 kVp
---
60
Modes Bipolar Cutting
Standard
Yes
Yes
sinusoidal
constant
-
1 W - 200 W
400 Vp
---
100
Bipolar resection
Yes
Yes
sinusoidal
constant
1 2 3 250 W
500 Vp 2 ---
Bipolar scissors
sinusoidal
constant
-
1 W - 120 W
200 Vp
---
60
Modes Bipolar Coagulation
Standard forceps
sinusoidal
constant
-
1 W - 120 W
150 Vp
---
40
Standard forceps AUTO
sinusoidal
constant
-
5 W - 120 W
150 Vp
---
40
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10 Technical specifications
Mode icon
Description
CCS
ARC
CONTROL
Form of HF
voltage Max. power output
Peak
voltage
Default values
Effect
Power range
Effect
Max. Watt
Modes Bipolar Coagulation
Micro forceps
sinusoidal
constant
-
0.1 W - 20 W
150 Vp
---
10
Forceps forced
sinusoidal
modulated
-
1 W - 100 W
550 Vp
---
70
LIGATION
sinusoidal
modulated
-
200 W
190 Vp
---
---
TissueSeal PLUS
sinusoidal
modulated
-
200 W
190 Vp
---
---
Bipolar scissors
sinusoidal
constant
-
1 W - 120 W
200 Vp
---
60
Laparoscopy
sinusoidal
constant
-
1 W - 120 W
150 Vp
---
50
Bipolar resection
sinusoidal
constant
-
1 W - 350 W
190 Vp
---
200
The max. values are not necessarily created at rated load resistance.
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10 Technical specifications
Measurement of resistances
Diagram of power output P [W] as a
function of the load resistance R [] for the setting "Monopolar Cutting Standard" = 200 W
Measurement of resistances
Diagram of power output P [W] as a
function of the load resistance R [] for the setting "Monopolar Cutting Standard" = 400 W
Diagram of power output P [W] as a
function of the setting "Monopolar Cutting Standard" Rated load resistance = 500
Effect
U (Vp)
1
400
2
450
3
560
4
650
5
650
6
700
7
700
8
700
9
750
Table of HF output voltage U [Vp] as a
function of the setting "Monopolar Cutting Standard" (idle mode)
10.2. Output, voltage and current diagrams
Monopolar Cutting – Standard
Pos: 53 /679-BOWA/HF-Geräte/ARC 300/
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10 Technical specifications
Measurement of resistances
Diagram of power output P [W] as a
function of the load resistance R [] for the setting "Monopolar Cutting Micro" = 25 W
Measurement of resistances
Diagram of power output P [W] as a
function of the load resistance R [] for the setting "Monopolar Cutting Micro" = 50 W
Diagram of power output P [W] as a
function of the setting "Monopolar Cutting Micro" Rated load resistance = 500
Effect
U (Vp)
1
280
2
340
3
380
4
400
5
400
6
400
7
450
8
450
9
450
Table of HF output voltage U [Vp] as a
function of the setting "Monopolar Cutting Micro" (idle mode)
Monopolar Cutting – Micro
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10 Technical specifications
Measurement of resistances
Diagram of power output P [W] as a
function of the load resistance R [] for the setting "Monopolar Cutting Dry" = 100 W
Measurement of resistances
Diagram of power output P [W] as a
function of the load resistance R [] for the setting "Monopolar Cutting Dry" = 200 W
Diagram of power output P [W] as a
function of the setting "Monopolar Cutting Dry" Rated load resistance = 500
Effect
U (Vp)
1
1400
2
1400
3
1400
4
1400
5
1500
6
1600
7
1600
8
1600
9
1600
Table of HF output voltage U [Vp] as a
function of the setting "Monopolar Cutting Dry" (idle mode)
Monopolar Cutting – Dry
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10 Technical specifications
Measurement of resistances
Diagram of power output P [W] as a
function of the load resistance R [] for the setting "Monopolar Cutting Argon" = 150 W
Measurement of resistances
Diagram of power output P [W] as a
function of the load resistance R [] for the setting "Monopolar Cutting Argon" = 300 W
Diagram of power output P [W] as a
function of the setting "Monopolar Cutting Argon" Rated load resistance= 500
Effect
U (Vp)
1
400 2 450 3 560 4 650 5 650 6 700 7 700 8 700 9 750
Table of HF output voltage U [Vp] as a
function of the setting "Monopolar Cutting Argon" (idle mode)
Monopolar Cutting – Argon
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10 Technical specifications
Measurement of resistances
Diagram of power output P [W] as a
function of the load resistance R [] for the setting "Monopolar Cutting Resection"
Effect
P (W)
1
250
2
250
3
250
4
250
5
250
Table of power output P [W] as a
function of the setting "Monopolar Cutting Resection" Rated load resistance= 500
Effect
U (Vp)
1
650
2
700
3
700
4
700
5
750
Table of HF output voltage U [Vp] as
a function of the setting "Monopolar Cutting Resection" (idle mode)
Monopolar Cutting – Resection
100 Operating Manual ARC 400 900-400_IFU_V1.0.0.6.17.9_20140-S2-20130604-EN
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