BOWA-electronic

BOWA ARC 250 and 303 Operating Manual Ver 2.2 Oct 2013

Operating Manual

92 Pages

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File Size: 3.02 MB

File Name: BOWA-electronic - 900-301 - BOWA ARC 250 and 303 Operating Manual Ver 2.2 Oct 2013 - 2013-10.pdf

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Page 1

OPERATING MANUAL ELECTROSURGICAL UNIT

900-301_IFU-V2.2_11316-S0-20131023-EN

Operating Manual ARC 250 / 303

900-301_IFU-V2.2_11316-S0-20131023-EN

Operating Manual ARC 250 / 303

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)

21 22 23/24 25

27 28 29 30

"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

900-301_IFU-V2.2_11316-S0-20131023-EN

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

Legend

Operating Manual ARC 250 / 303

900-301_IFU-V2.2_11316-S0-20131023-EN

Contents

Contents Legend ...6 1.

Using this operating manual ...13 1.1.

Revision index ...13

1.2.

Validity...13

1.3.

Other applicable documents 

Comply with other applicable documents in the appendix or in the other sections.

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Operating Manual ARC 250 / 303

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.

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

Activity with several steps in a binding sequence

2. 3.



Result of preceding activity



List (first level)



List (second level)

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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Operating Manual ARC 250 / 303

2 Safety

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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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Operating Manual ARC 250 / 303

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.



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.

Operating Manual ARC 250 / 303

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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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Operating Manual ARC 250 / 303

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



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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Operating Manual ARC 250 / 303

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