BOWA-electronic
BOWA ARC 250 and 303 Operating Manual Ver 2.21 June 2014
Operating Manual
92 Pages
Preview
Page 1
OPERATING MANUAL ELECTROSURGICAL UNIT
900-303_IFU-V2.21_11316-S1-20140625-EN
Operating Manual ARC 250 / 303
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4
Operating Manual ARC 250 / 303
900-303_IFU-V2.21_11316-S1-20140625-EN
900-303_IFU-V2.21_11316-S1-20140625-EN
Operating Manual ARC 250 / 303
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Legend
Legend 1 2 3/4 5/6 7 8 9 10/11 12 13 14 15
Indicator on main display: programs and information Current indicator on 2-line display
16/17 18 19
Program key Error status indicator EASY monitoring for one-piece neutral electrode (EASY one-piece monitoring) EASY monitoring for split neutral electrode (EASY split monitoring)
20
21 22 23/24 25
26
27 28 29 30
31
*
6
"Monopolar Cut" indicator arrow (yellow) "Monopolar Cut" 7-segment display Power limitation for monopolar cutting Key for the degree of scabbing during monopolar cutting "Monopolar Cut" blend factor indicator Blend settings 0–9 "Monopolar Coag" indicator arrow (blue) "Monopolar Coag" 7-segment display Power limitation for monopolar coagulation Key/indicator for "Moderate Coagulation" current mode Key/indicator for "Forced Coagulation" current mode Key/indicator for "Spray Coagulation" current
Indicator arrow for "Bipolar Coag" (blue) "Bipolar Coag" 7-segment display Power limitation for bipolar coagulation Key/indicator for "Bipolar Output" FOOT SWITCH (socket connector 31) Only for bipolar coagulation! Key/indicator for AUTOSTART "Bipolar Output" (socket connector 31) Only for bipolar coagulation! On/off switch Socket for the neutral electrode (NE)* Socket connector for monopolar instruments with hand switch* (only for ARC 303) Socket connector for monopolar instruments with hand or foot switch, Bovie connector or 4 mm monopolar endoscope connector, or 3-pin connector* Socket connector for bipolar instruments with foot switch or AUTOSTART* Application part F according to IEC 60601-1
Operating Manual ARC 250 / 303
900-301_IFU-V2.2_11316-S0-20131023-EN
Legend
32 33 34 35 36 37
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Back side of ARC 250/303 Socket connector for foot switch for sockets 30 and 31 Fibre optic signal output socket connector (with ARC 250/303 with GastroCut option) Fibre optic signal output socket connector (with ARC 250/303 with GastroCut option) Rating label Connection for equipotential bonding Power connection for cooling device connector
Operating Manual ARC 250 / 303
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Legend
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Operating Manual ARC 250 / 303
900-303_IFU-V2.21_11316-S1-20140625-EN
Contents
Contents Legend ...6 1.
2.
3.
Using this operating manual ...13 1.1.
Revision index ...13
1.2.
Validity...13
1.3.
Other applicable documents ...13
1.4.
Icons and labeling ...14 1.4.1.
Structure of warning instructions ...14
1.4.2.
Risk levels in the warning instructions ...14
1.4.3.
Tips ...14
1.4.4.
Other icons and labeling ...15
Safety ...16 2.1.
Intended use ...16
2.2.
General safety instructions ...17
2.3.
Personal safety instructions ...18 2.3.1.
Ambient conditions ...18
2.3.2.
Patients with pacemakers...18
2.3.3.
Safe positioning of the patient ...19
2.3.4.
Correct connection of the HF device ...19
2.3.5.
Correct use of the HF device ...19
2.3.6.
Adjusting the settings of the HF device and use of the accessories ...20
2.4.
Device-related safety instructions ...21
2.5.
Safe handling (general instructions) ...21 2.5.1.
Surgical environment: prevention of explosions/combustion ...22
2.5.2.
Application of the neutral electrode ...22
Functionality ...25 3.1.
Monopolar modes ...25 3.1.1.
"Cut" mode...25
3.1.2.
"Moderate Coag" mode ...25
3.1.3.
"Forced Coag" mode ...26
3.1.4.
"Spray Coagulation" mode ...26
3.1.5.
"GastroCut" mode ...27
3.2.
Bipolar modes ...28
3.3.
Activation and alarm signals in monopolar and bipolar mode ...29
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Contents
4.
3.4.
Emergency shutoff ...29
3.5.
Monitoring functions ...29 3.5.1.
Self-test...29
3.5.2.
Cyclical test during operation ...29
3.6.
ARC Control technology ...30
3.7.
Neutral electrode monitoring ...30 3.7.1.
General information ...30
3.7.2.
EASY neutral electrode monitoring (EASY monitoring) ...31
3.8.
Foot switch ...31
3.9.
Memory functions ...31
Description ...32 4.1.
Icons on the device ...32 4.1.1.
5.
4.2.
Scope of delivery ...33
4.3.
Components required for operation ...33
4.4.
Operating conditions ...33
Preparation...34 5.1.
Setting up the HF device...34
5.2.
Switching on the HF device ...35
5.3.
Connecting instruments ...35
5.4.
6.
5.3.1.
Instruments for monopolar applications ...36
5.3.2.
Instruments for bipolar applications ...36
5.3.3.
Connecting the foot switch ...36
5.3.4.
Assigning a foot switch output ...37
Functional test ...37 5.4.1.
Autotest function ...37
5.4.2.
Functional test execution ...37
5.4.3.
Actions in case of problems...38
5.4.4.
EASY neutral electrode electrode monitoring (EASY monitoring) ...38
Operation...39 6.1.
Program overview ...39
6.2.
Basic program settings ...40
6.3.
10
Rating label ...32
6.2.1.
Calling up a program ...40
6.2.2.
Changing the program ...40
Program descriptions ...41
Operating Manual ARC 250 / 303
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Contents
6.4.
7.
6.3.1.
Program 0 "Standard" ...41
6.3.2.
Program 1 "Macro" ...41
6.3.3.
Program 2 "Micro" ...41
6.3.4.
Program 3 "Resection" ...41
6.3.5.
Program 4 "Argon" (only with GastroCut option) ...42
6.3.6.
Program 5 "Argon-Flex" (only with GastroCut option) ...42
6.3.7.
Program 6 "Gastro LOOP" (only with GastroCut option) ...43
6.3.8.
Program 7 "Gastro KNIFE" (only with GastroCut option) ...44
Menu programs ...45 6.4.1.
Overview ...45
6.4.2.
Menu program 1 "Set Language" ...46
6.4.3.
Menu program 2 "Sound Level"...46
6.4.4.
Menu program 3 "Forced Coag Mode" ...46
6.4.5.
Menu program 3A "GastroCut-Modes" ...47
6.4.6.
Menu program 4 "Show Prev Inf-No" ...48
6.4.7.
Menu program 5 "Hide Fix Prog" ...48
6.4.8.
Menu program 6 "Autostart Delay" ...49
6.4.9.
Menu program 7 "Edit Prog Names" ...49
6.4.10.
Menu program 8 "Restore Programs" ...50
6.4.11.
Menu program 9 "Panel Check" ...50
Detecting and correcting faults ...51 7.1.
System errors ...51 7.1.1.
7.2. 8.
Error Display in EASY monitoring ...55
Preparation...56 8.1.
9.
Error list ...51
Disinfection and cleaning ...56
Maintenance and repair ...57 9.1.
Maintenance ...57 9.1.1.
Safety inspection ...57
9.2.
Repairs ...58
9.3.
Technical service ...59
10.
Storage ...60
11.
Technical specifications ...61 11.1.
Technical specifications of ARC 250 and ARC 303 HF devices ...61
11.2.
Power, voltage and current charts ...66
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Operating Manual ARC 250 / 303
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Contents
12.
Accessories and replacement parts ...85
13.
EMC...86 13.1.
14.
12
Guidelines and manufacturer's declaration in accordance with IEC 60601-1-2, Section 6.8.3.201 ...86
Disposal...90
Operating Manual ARC 250 / 303
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1 Using this operating manual
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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.
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1.1.
Revision index Software version
Last revised
2.21
2014/06
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1.2.
Validity This operating manual applies only to the devices designated on the title page. Pos : 6 /679-BOWA/HF-Geräte/ARC 300/350/1 U mgang mi t/Mitgeltende D okumente @ 4mod_1261040285210_6.doc @ 34406 @ 2
1.3.
Other applicable documents
Comply with other applicable documents in the appendix or in the other sections.
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1 Using this operating manual
1.4.
Icons and labeling
1.4.1.
Structure of warning instructions 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)!
1.4.2.
Measure.
Risk levels in the warning instructions Symbol
1.4.3.
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
Tips and additional information to facilitate tasks.
14
Operating Manual ARC 250 / 303
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1 Using this operating manual
1.4.4.
Other icons and labeling Icon/Labeling
Meaning
Prerequisite for an activity
Activity with one step
1.
Activity with several steps in a binding sequence
2. 3.
Result of preceding activity
List (first level)
List (second level)
Emphasis
Emphasis
..., see section xxx, page xxx
Cross reference
... "Monopolar output" 29/30
Bold numbers (e.g. 29/30) refer to the schematic depiction of the ARC 250 / 303 and the associated legend see pages 6– 7)
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2 Safety
2.
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2.1.
Intended use The HF device is intended exclusively for the generation of electrical power for monopolar cutting as well as monopolar and bipolar coagulation in surgical interventions involving tissue. It is used in the following areas:
general surgery
endoscopy (only with the "GastroCut" option)
gynecology
hand surgery
ENT
cardiac surgery (including open-heart surgery)
neurosurgery
pediatric surgery
plastic surgery and dermatology
thoraxic 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 cause endangerment of 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, personnel and devices at risk.
Any other use is neither intended nor proper and must be effectively prevented.
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Operating Manual ARC 250 / 303
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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.
Observe the instructions on electromagnetic compatibility provided in section EMC, page 86.
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 Techical Service, see section Technical service, page 59.
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 use 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 Malfunctions or destruction of the pacemaker can endanger the life of the patient or result in irreversible injuries to the patient.
18
In cases of patients with pacemakers, consult the cardiologist before carrying out HF surgery.
Use bipolar HF methods.
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 handy.
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 he is not touching any metal parts that are grounded or have considerable capacitance relative to ground (e.g. operating table brackets). Lay 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 skinto-skin contact on the patient's trunk.
Ensure that you are using 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 note the requirements of chapter 8.6.7 of ISO 60601-1 for 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.
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2 Safety
Lack of preparation, errors in usage or faults in the HF device can cause damage to the HF device.
2.3.6.
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 29.
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.
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 irritations due to low-frequency currents! In electrosurgical applications (particularly applications generating an arc), a part of the HF current is converted to a low-frequency current. This can trigger muscle spasms in patients.
To minimize the risk of injury to the patient, set the power and effect as low as possible.
Correct usage of the accessories
20
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.
Operating Manual ARC 250 / 303
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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 third parties and/or damage to the device and other objects can occur.
Use only accessories approved by BOWA, see section Accessories and replacement parts, page 85).
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 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 56.
Never immerse the device in water or cleaning agents.
Never boil the device and never disinfect it mechanically.
Immediately drain any fluid that might have penetrated the device.
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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 for use with regard to standards, see section Risk levels in the warning instructions, page 14.
Always observe and obey the acoustic signals or error indications during use, see section Error list, page 51.
The device and accessories may be operated and used only by people who have the necessary training, knowledge and experience.
Check the accessories regularly for damage to the isolation, for proper function, and the expiration date, especially the electrode cable, endoscopic accessories, and neutral electrodes.
Do not place any instruments on the patients or on the devices.
Ensure that no instruments are being cleaned when AUTOSTART is activated.
Wear suitable gloves during operations.
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