Bowa ARC 100 User manual

OPERATING MANUAL
ELECTROSURGICAL UNIT

900-100_IFU-V1.0_11587-S0-20141209-EN ARC 100 Operating Manual 3

Legend
4ARC 100 Operating Manual 900-100_IFU-V1.0_11587-S0-20141209-EN
Legend
Front of ARC 100
1
Multifunction connection socket for monopolar instruments
with hand or foot switch or bipolar instruments with foot
switch *
2
Socket for the neutral electrode (NE) *
3
Activation indicator for bipolar coagulation (blue)
4
Activation indicator for monopolar cutting (yellow)
5
Activation indicator for monopolar coagulation (blue)
6
Key for "Pure" monopolar cutting current
7
Key for "Dry" monopolar cutting current
8
Key for "Moderate" monopolar coagulation current
9
Key for "Forced" monopolar coagulation current
10
Indicator for "Pure" monopolar cutting current
11
Indicator for "Dry" monopolar cutting current
12
Indicator for "Moderate" monopolar coagulation current
13
Indicator for "Forced" monopolar coagulation current
14
Neutral electrode monitoring, non-split
15
EASY neutral electrode monitoring, split
16
Indicator for EASY neutral electrode "Alarm" fault status
17
Key for foot switch assignment
18
Indicator for foot switched bipolar coagulation
19
Indicator for foot switched monopolar cutting
20
Indicator for foot switched monopolar coagulation
21/22
Keys for adjusting the power limitation
23
Power limitation indicator
24
Indicator for "Error" fault status
25
On/off switch
Rear of ARC 100
26
IEC chassis-mount power connector
27
Connection for equipotential bonding
28
Knob to adjust volume
29
Rating label
30
Connection socket for foot switch
*
Applied part of Type F according to IEC 60601-1

Table of contents
900-100_IFU-V1.0_11587-S0-20141209-EN ARC 100 Operating Manual 5
Table of contents
Legend .........................................................................................................................................................4
1. Using this operating manual ...........................................................................................................8
1.1. Revision index.....................................................................................................................8
1.2. Scope of validity..................................................................................................................8
1.3. Other applicable documents ...............................................................................................8
1.4. Symbols and notation .........................................................................................................9
1.4.1. Structure of warning instructions .........................................................................9
1.4.2. Hazard levels of warning instructions..................................................................9
1.4.3. Tips......................................................................................................................9
1.4.4. Other symbols and notation...............................................................................10
2. Safety...............................................................................................................................................11
2.1. Intended use .....................................................................................................................11
2.2. General safety instructions ...............................................................................................12
2.3. Personal safety instructions..............................................................................................13
2.3.1. Ambient conditions ............................................................................................13
2.3.2. Patients with pacemakers..................................................................................13
2.3.3. Safe positioning of the patient ...........................................................................14
2.3.4. Correct connection of the HF device .................................................................14
2.3.5. Correct use of the HF device.............................................................................14
2.3.6. Adjusting the settings of the HF device and use of the accessories.................15
2.4. Device-related safety instructions.....................................................................................16
2.5. Safe handling (general instructions) .................................................................................16
2.5.1. Surgical environment: Prevention of explosions and ignition............................17
2.5.2. Application of the neutral electrode ...................................................................17
3. Functionality ...................................................................................................................................20
3.1. Monopolar modes .............................................................................................................20
3.2. Bipolar mode.....................................................................................................................20
3.3. Monopolar/bipolar multifunction socket ............................................................................21
3.4. Connection socket for neutral electrode ...........................................................................21
3.5. Activation and alarm signals in monopolar and bipolar mode ..........................................21
3.6. Emergency stop ................................................................................................................22
3.7. Monitoring functions..........................................................................................................22
3.7.1. Self-test..............................................................................................................22

Table of contents
6ARC 100 Operating Manual 900-100_IFU-V1.0_11587-S0-20141209-EN
3.7.2. Cyclical test during operation ............................................................................22
3.8. Neutral electrode monitoring.............................................................................................22
3.8.1. General information...........................................................................................22
3.8.2. EASY neutral electrode monitoring (EASY monitoring) ....................................23
3.9. Foot switches ....................................................................................................................23
4. Description......................................................................................................................................24
4.1. Symbols on the device......................................................................................................24
4.1.1. Rating label........................................................................................................24
4.2. Scope of delivery ..............................................................................................................25
4.3. Components required for operation ..................................................................................25
4.4. Operating conditions .........................................................................................................25
5. Preparation......................................................................................................................................26
5.1. Setting up the HF device...................................................................................................26
5.2. Switching on the HF device ..............................................................................................27
5.3. Connecting instruments ....................................................................................................27
5.3.1. Instruments for monopolar applications ............................................................27
5.3.2. Instruments for bipolar applications...................................................................27
5.3.3. Connecting the foot switch ................................................................................28
5.3.4. Assigning a foot switch output...........................................................................28
5.4. Functional test...................................................................................................................28
5.4.1. Autotest function................................................................................................28
5.4.2. Functional test execution...................................................................................28
5.4.3. Actions in case of problems...............................................................................29
5.4.4. EASY neutral electrode monitoring (EASY monitoring) ...................................29
6. Operation.........................................................................................................................................30
6.1. Mode overview..................................................................................................................30
6.2. Basic settings....................................................................................................................31
6.2.1. Selecting the mode............................................................................................31
6.2.2. Setting power levels ..........................................................................................31
6.2.3. Changing the volume.........................................................................................31
6.3. Mode descriptions.............................................................................................................31
6.3.1. Monopolar cutting, "Pure"..................................................................................31
6.3.2. Monopolar cutting, "Dry"....................................................................................31
6.3.3. Monopolar coagulation, "Moderate" ..................................................................32
6.3.4. Monopolar coagulation, "Forced" ......................................................................32

Table of contents
900-100_IFU-V1.0_11587-S0-20141209-EN ARC 100 Operating Manual 7
6.3.5. Bipolar coagulation............................................................................................32
7. Detecting and correcting faults ....................................................................................................33
7.1. System errors....................................................................................................................33
7.1.1. Error list .............................................................................................................33
7.2. Fault indications for EASY monitoring ..............................................................................34
8. Cleaning ..........................................................................................................................................35
8.1. Preparation of the accessories .........................................................................................35
8.2. Disinfection and cleaning..................................................................................................35
9. Maintenance and repair .................................................................................................................36
9.1. Maintenance .....................................................................................................................36
9.1.1. Safety inspection ...............................................................................................36
9.2. Repairs..............................................................................................................................37
9.3. Technical service ..............................................................................................................38
10. Storage ............................................................................................................................................38
11. Technical specifications................................................................................................................39
11.1. Technical data for ARC 100..............................................................................................39
11.2. Power, voltage and current charts ....................................................................................42
12. Accessories and replacement parts.............................................................................................47
13. EMC..................................................................................................................................................47
13.1. Guidelines and manufacturer's declaration in accordance with DIN EN 60601-
1-2, para. 6.8.3.201...........................................................................................................47
14. Disposal...........................................................................................................................................51

1Using this operating manual
8ARC 100 Operating Manual 900-100_IFU-V1.0_11587-S0-20141209-EN
1. Using this operating manual
This operating manual is part of the product.
BOWA-electronic GmbH & Co. KG, referred to in the following simply as
BOWA, assume no liability nor provide any warranty whatsoever for any
damage or consequential damages arising from 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 theatre
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.
-Index @ 7\mod_1308730384316_258.doc @ 52335 @ 2
1.1. Revision index
Software version
Last revised
1.0
2014/12
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1.2. Scope of validity
This operating manual applies only to the devices designated on the title
page.
1.3. Other applicable documents
Comply with other applicable documents mentioned in the
appendix or in the other sections.
Provided in addition to this operating manual is an introductory
video; see accompanying CD.

1 Using this operating manual
900-100_IFU-V1.0_11587-S0-20141209-EN ARC 100 Operating Manual 9
1.4. Symbols and notation
1.4.1. Structure of warning instructions
SIGNAL WORD
Type, source and consequences of the risk (personal injury)!
Measure for avoiding the risk.
NOTE
Type, source and consequences of the risk (property damage)!
Measure.
1.4.2. Hazard levels of warning instructions
Symbol
Hazard level
Probability of
occurrence
Consequences of
non-compliance
DANGER
Immediate risk
Death or serious
injuries
WARNING
Possible risk
Death or serious
injuries
CAUTION
Possible risk
Minor injuries
NOTE
Possible risk
Property damage
1.4.3. Tips
Tips and additional information for easier working.

1Using this operating manual
10 ARC 100 Operating Manual 900-100_IFU-V1.0_11587-S0-20141209-EN
1.4.4. Other symbols and notation
Symbol or notation
Meaning

Prerequisite for an activity

Activity with one step
1.
2.
3.
Activity with several steps in strict
sequence

Result of preceding activity

List (first level)

List (second level)
Emphasis
Emphasis
...; see Section xxx, page xxx
Cross reference
... "On/off switch" 25
Bolded numbers (here: 25) refer to a
schematic diagram of the ARC 100 and the
respective legend
(page 4)

2 Safety
900-100_IFU-V1.0_11587-S0-20141209-EN ARC 100 Operating Manual 11
2. Safety
2.1. Intended use
The HF device is intended exclusively for the generation of electrical
power for monopolar cutting or monopolar and bipolar coagulation in
surgical operations.
It is used in the following areas:
General surgery
Paediatric surgery
Gynaecology
Hand surgery
Neurosurgery (not on the central nervous system)
Dermatology
Plastic surgery
Oral and maxillofacial surgery
Dentistry
ENT
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.
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.
Any other use is neither intended nor proper and must be effectively
prevented.

2Safety
12 ARC 100 Operating Manual 900-100_IFU-V1.0_11587-S0-20141209-EN
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.
Please comply with the instructions on electromagnetic
compatibility (EMC); see Section EMC, page 47.
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
demonstrably satisfy the 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 medical electrical
devices is perforce a system configurator and therefore responsible for
meeting standardised system requirements. Please note that local laws
prevail over the aforementioned standard requirements. For further
advice, please contact your local specialist retailer or our technical
service; see Section Technical service, page 38.
To protect personnel, BOWA recommends the use of a smoke evacuator
to extract electrosurgical smoke, e.g. BOWA SHE SHA.

2 Safety
900-100_IFU-V1.0_11587-S0-20141209-EN ARC 100 Operating Manual 13
2.3. Personal safety instructions
2.3.1. Ambient conditions
Excessive leakage currents may create a risk of burns to the patient.
Do not operate 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 cases of patients with pacemakers, consult the cardiologist
before carrying out HF surgery.
Use bipolar HF methods when possible.
Move 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.

2Safety
14 ARC 100 Operating Manual 900-100_IFU-V1.0_11587-S0-20141209-EN
2.3.3. Safe positioning of the patient
Position the patient so that the patient is 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 towels between the patient and the bedding.
Ensure that the patient does not touch any wet towels or bedding.
Place anti-static towels between areas of heavy sweating and skin-
to-skin contact on the patient's trunk.
Ensure a suitable support surface in order to prevent pressure
necrosis.
Drain urine via the catheter.
2.3.4. Correct connection of the HF device
Always ground the HF device via the equipotential bonding.
Also observe the requirements in Section 8 of ISO 60601-1
regarding medical electrical systems.
Do not use any needle electrodes for monitoring.
Attach electrodes of physiological monitoring devices without
protective resistors or HF regulators as far as possible from the HF
electrodes.
Attach 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 in the non-visible area of the HF device 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.
After inadvertent activation of the HF device, switch off the device
immediately using the on/off switch.
Pay particular attention whenever you use the foot switch or the
manual switch.
Lack of preparation, errors in usage or faults in the HF device can cause
damage to the HF device.
Use the automatic monitoring functions to ensure that the HF
device works properly without errors. For information on the
automatic test functions, see Section Monitoring functions,
page 22.
Ensure that no conductive fluids (e.g. blood, amniotic fluid) have
penetrated the foot switch or the manual switch.
Ensure that the cables for the foot switch and manual switch are
free from short circuits and broken leads.

2 Safety
900-100_IFU-V1.0_11587-S0-20141209-EN ARC 100 Operating Manual 15
2.3.6. Adjusting the settings of the HF device and use of the
accessories
Setting the output power too high can injure the patient. Therefore,
before you increase the output power, ensure that:
the neutral electrode is correctly positioned,
the working electrodes are clean,
and 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 acoustic signal that sounds when the electrode is activated
so that it is always clearly audible.
Nerve and muscle stimulation by low-frequency currents.
In HF surgical applications (especially applications in which an arc is
formed) part of the HF current is converted into a low-frequency current.
This current can trigger muscle contractions in patients.
To minimise the risk of patient injury, set the power and effect as
low as possible.
Correct usage of the 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.

2Safety
16 ARC 100 Operating Manual 900-100_IFU-V1.0_11587-S0-20141209-EN
2.4. Device-related safety instructions
Devices manufactured by BOWA are developed in accordance with the
current state of technology and generally accepted safety rules. Despite
this, risks to the life and health of the user or other parties and/or
damage to the device and other objects can occur.
Use only accessories that are approved by BOWA; see
Section Accessories and replacement parts, page 47.
Use the device only if it is free from technical defects and in good
working order and only for the intended purpose, always remaining
aware of safety requirements and risks while 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 nationally approved for surface cleaning. See
Section Disinfection and cleaning, page 35.
Never immerse the device in water or cleaning agents.
Never boil the device and never disinfect it mechanically.
Immediately drain any fluid that may have penetrated the device.
If the device is damaged, a malfunction may cause an undesirable
increase in output power.
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.
Comply with the instructions for use as specified by the standard;
see Section Error list, page 33.
Pay attention to and comply with the acoustic signals and error
indicators of the HF device during use; see Section Error list,
page 33.
The device and accessories may be operated and used only by
persons who have the necessary training, knowledge and
experience.
Regularly inspect the accessories, especially electrode cables,
endoscopic accessories and neutral electrodes, for proper
operation, damage to the insulation, and expiration date.
Do not place any instruments on the patients or on the devices.
Wear suitable gloves during surgery.

2 Safety
900-100_IFU-V1.0_11587-S0-20141209-EN ARC 100 Operating Manual 17
2.5.1. Surgical environment: Prevention of explosions and
ignition
Sparks fly during proper use of the HF device.
Do not use the HF device in areas where there is a risk of
explosion.
Do not use any flammable or explosive liquids.
If display components fail, do not use the HF device any longer.
During surgery in regions such as the head or thorax, avoid using
ignitable anaesthetics and gases which support combustion (e.g.
nitrous oxide or oxygen) or suck them away.
Wear suitable gloves during surgery.
Use only 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 the 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 endogenous gases are present that could ignite.
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. Application of the neutral electrode
Observe the instructions for use of the neutral electrode in the operating
instructions and the instructions on the packaging of 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 emergence 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

2Safety
18 ARC 100 Operating Manual 900-100_IFU-V1.0_11587-S0-20141209-EN
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 to the patient's body (because muscles are
more conductive in the direction of the fibrils).
Figure 2-1: Application site for the neutral electrode
During 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 path of the
current.
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 specifications
regarding the point of application.
Ensure that the application point is free of scar tissue,
bony protuberances, surface hair and ECG electrodes.
Ensure that there are no implants (e.g. bone nails, bone
plates, endoprostheses) in the current path.
Ensure that no short circuits can occur at the neutral
electrode connection.
Avoid sites where liquids can collect.

2 Safety
900-100_IFU-V1.0_11587-S0-20141209-EN ARC 100 Operating Manual 19
Before applying the neutral electrode
Shave the area where the neutral electrode will be applied.
Clean the application site, and do not use alcohol, as this dries out
the skin and increases contact resistance.
In case of poor circulation, massage or brush the application site.
Apply the neutral electrode using the entire contact surface. Secure
reusable neutral electrodes with rubber bands or elastic ties so that
they do not loosen or fall off when the patient moves. Ensure that
the patient's circulation is not impaired (risk of necrosis).
Never use wet towels or electropastes.
Ensure that no liquids (e.g. cleaning fluids, disinfectants, blood,
urine) get 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.
Example application using a disposable electrode
Remove the protective film and attach the self-adhesive disposable
electrode to the patient. Ensure that the long side of the disposable
electrode faces the operation site and the electrode is fully in
contact with the skin. This prevents the current density from
becoming excessive at 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.
Use of a one-piece neutral electrode
Check the one-piece neutral electrode during the surgery.
Use of a split neutral electrode
Apply the split neutral electrode correctly and without any additional
objects, as the HF device does not recognize the bridging of the
section surfaces by other objects.
For monitoring of the neutral electrode, see Section EASY neutral
electrode monitoring (EASY monitoring), page 23.
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3Functionality
20 ARC 100 Operating Manual 900-100_IFU-V1.0_11587-S0-20141209-EN
3. Functionality
The HF device is controlled by a microprocessor and converts the mains
voltage into a high-frequency alternating current for monopolar or
bipolar applications.
For descriptions of the individual modes and their areas of application
as well as appropriate instruments, see Section Mode descriptions,
page 31.
3.1. Monopolar modes
In monopolar operation, the HF device has the following operating
modes:
"Pure" for cutting in low-resistance tissue
"Dry" for cutting with strong haemostasis
"Moderate" for contact coagulation
"Forced" for coagulation with light contact
Instruments can be connected to the multifunction socket 1.
3.2. Bipolar mode
Special instruments are necessary in order to achieve optimal results
using the bipolar method (particularly with minimally invasive surgery).
Advantages of the bipolar method:
The required high-frequency output is only one-fourth of the
output required for the monopolar method.
It is not necessary to apply a neutral electrode to the patient,
which eliminates the associated risks to the patient.
Instruments can be connected to the multifunction socket 1.