BOWA-electronic
BOWA ARC 100 Operating Manual V 1.04 Dec 2014
Operating Manual
52 Pages
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Page 1
OPERATING MANUAL ELECTROSURGICAL UNIT
900-100_IFU-V1.0_11587-S0-20141209-EN
ARC 100 Operating Manual
3
Legend
Legend Front of ARC 100 1
2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21/22 23 24 25
Multifunction connection socket for monopolar instruments with hand or foot switch or bipolar instruments with foot switch * Socket for the neutral electrode (NE) * Activation indicator for bipolar coagulation (blue) Activation indicator for monopolar cutting (yellow) Activation indicator for monopolar coagulation (blue) Key for "Pure" monopolar cutting current Key for "Dry" monopolar cutting current Key for "Moderate" monopolar coagulation current Key for "Forced" monopolar coagulation current Indicator for "Pure" monopolar cutting current Indicator for "Dry" monopolar cutting current Indicator for "Moderate" monopolar coagulation current Indicator for "Forced" monopolar coagulation current Neutral electrode monitoring, non-split EASY neutral electrode monitoring, split Indicator for EASY neutral electrode "Alarm" fault status Key for foot switch assignment Indicator for foot switched bipolar coagulation Indicator for foot switched monopolar cutting Indicator for foot switched monopolar coagulation Keys for adjusting the power limitation Power limitation indicator Indicator for "Error" fault status On/off switch Rear of ARC 100
4
26 27 28 29 30
IEC chassis-mount power connector Connection for equipotential bonding Knob to adjust volume Rating label Connection socket for foot switch
*
Applied part of Type F according to IEC 60601-1
ARC 100 Operating Manual
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Table of contents
Table of contents Legend ...4 1.
2.
3.
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
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
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
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Table of contents
3.7.2. 3.8.
3.9. 4.
Neutral electrode monitoring ...22 3.8.1.
General information ...22
3.8.2.
EASY neutral electrode monitoring (EASY monitoring) ...23
Foot switches ...23
Description ...24 4.1.
Symbols on the device ...24 4.1.1.
5.
Scope of delivery ...25
4.3.
Components required for operation ...25
4.4.
Operating conditions ...25
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
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
Operation...30 6.1.
Mode overview ...30
6.2.
Basic settings ...31
6.3.
6
Rating label ...24
4.2.
5.4.
6.
Cyclical test during operation ...22
6.2.1.
Selecting the mode ...31
6.2.2.
Setting power levels ...31
6.2.3.
Changing the volume...31
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
ARC 100 Operating Manual
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Table of contents
6.3.5. 7.
Detecting and correcting faults ...33 7.1.
System errors ...33 7.1.1.
7.2. 8.
9.
Bipolar coagulation ...32
Error list ...33
Fault indications for EASY monitoring ...34
Cleaning ...35 8.1.
Preparation of the accessories ...35
8.2.
Disinfection and cleaning ...35
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.
14.
Guidelines and manufacturer's declaration in accordance with DIN EN 606011-2, para. 6.8.3.201 ...47
Disposal...51
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1 Using this operating manual
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.
1.1.
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.
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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.
8
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.
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1 Using this operating manual
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)!
1.4.2.
Measure.
Hazard levels of warning instructions Symbol
1.4.3.
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
Tips
Tips and additional information for easier working.
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1 Using this operating manual
1.4.4.
Other symbols and notation Symbol or notation
Meaning
Prerequisite for an activity
Activity with one step
1.
Activity with several steps in strict sequence
2. 3.
Result of preceding activity
List (first level)
10
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)
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2 Safety
2. 2.1.
Safety 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.
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2 Safety
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.
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2 Safety
2.3.
Personal safety instructions
2.3.1.
Ambient conditions Excessive leakage currents may create a risk of burns to the patient.
2.3.2.
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.
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.
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2 Safety
2.3.3.
2.3.4.
2.3.5.
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 antistatic 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 skinto-skin contact on the patient's trunk.
Ensure a suitable support surface in order to prevent pressure necrosis.
Drain urine via the catheter.
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.
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.
14
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.
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2 Safety
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.
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2 Safety
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.
16
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.
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2 Safety
2.5.1.
Surgical environment: Prevention of explosions and ignition Sparks fly during proper use of the HF device.
2.5.2.
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.
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
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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 to the patient's body (because muscles are more conductive in the direction of the fibrils).
Figure 2-1:
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ARC 100 Operating Manual
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.
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2 Safety
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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3 Functionality
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.
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3 Functionality
3.3.
Monopolar/bipolar multifunction socket a
a
BOWA multifunction (monopolar and bipolar) 3-Pin US type (monopolar)
b c
Martin (bipolar) 4 mm (monopolar, foot switched)
b c
The multifunction socket 1 allows the connection of a monopolar instrument with hand or foot switching, or a bipolar instrument with foot switching. The BOWA multifunction cable REF 220-345 for ARC 100 combines a monopolar handpiece and the connecting cable for bipolar forceps in one connection.
3.4.
Connection socket for neutral electrode US-type neutral Applied part of Type F according to IEC 60601-1 The neutral electrode connector socket is suitable for neutral electrode plugs with two sockets.
3.5.
Activation and alarm signals in monopolar and bipolar mode The volume of the activation signal should be increased as necessary by turning the knob 28 for use in relatively noisy surroundings. The alarm sound and the startup melody cannot be changed.
Mode
Frequency (Hz) Signal type
Monopolar Cut
635
Continuous sound
Monopolar Coag
475
Continuous sound
Bipolar Coag
505
Continuous sound
Alarm
-
Beep sound
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