BOWA-electronic
BOWA ARC 350 Operating Manual Ver 2.0.0 May 2015
Operating manual
124 Pages
Preview
Page 1
OPERATING MANUAL ELECTROSURGICAL UNIT
2
Operating Manual ARC 350
900-351_IFU_V2.0.0_20221-S0-20150520-EN
Contents
Contents 1.
2.
3.
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
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
Description ... 18 3.1.
3.2.
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
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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Contents
4.
Prearrangement ... 23 4.1.
Setting up the HF device ... 23
4.2.
Switching on the HF device ... 24
4.3.
Connecting instruments ... 24
4.4.
4.5.
5.
4.3.1.
Instruments for monopolar use ... 25
4.3.2.
Instruments for bipolar applications ... 25
4.3.3.
Connecting a foot switch... 25
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
Neutral electrode monitoring ... 27 4.5.1.
General information ... 27
4.5.2.
EASY neutral electrode monitoring (EASY monitoring) ... 28
Operation ... 29 5.1.
Connecting power ... 29
5.2.
Program overview ... 29 5.2.1.
5.3.
Activating and deactivating connectors... 31
5.4.
Configuring output currents ... 31
5.5.
5.6.
4
Display ... 30
5.4.1.
Selecting the mode ... 31
5.4.2.
Specifying power limits ... 33
5.4.3.
Selecting the effect ... 33
5.4.4.
Assigning the foot pedal ... 34
5.4.5.
Selecting the neutral electrode ... 35
5.4.6.
Plug’n Cut COMFORT ... 37
Mode overview ... 38 5.5.1.
Monopolar modes ... 38
5.5.2.
Bipolar modes ... 39
Monopolar cutting modes ... 40 5.6.1.
Standard ... 40
5.6.2.
Micro ... 40
5.6.3.
Dry ... 40
5.6.4.
Argon ... 41
5.6.5.
Resection ... 41
5.6.6.
MetraLOOP ... 42
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Contents
5.7.
5.8.
5.9.
5.6.7.
Laparoscopy ... 42
5.6.8.
GastroLOOP 1 (optional) ... 42
5.6.9.
GastroLOOP 2 (optional) ... 43
5.6.10.
GastroLOOP 3 (optional) ... 43
5.6.11.
GastroKNIFE 1 (optional) ... 44
5.6.12.
GastroKNIFE 2 (optional) ... 44
5.6.13.
GastroKNIFE 3 (optional) ... 45
Monopolar coagulation modes ... 45 5.7.1.
Moderate ... 45
5.7.2.
Forced coag ... 46
5.7.3.
Forced mixed ... 46
5.7.4.
Forced cutting ... 46
5.7.5.
Spray... 47
5.7.6.
Argon open ... 47
5.7.7.
Argon flexible (optional) ... 48
5.7.8.
Argon flex. pulse (optional) ... 48
5.7.9.
Resection ... 49
5.7.10.
Cardiac Mammary ... 49
5.7.10.
Cardiac Thorax ... 49
5.7.11.
SimCoag ... 50
5.7.12.
Gastro Coag (optional) ... 50
5.7.13.
Laparoscopy ... 50
Bipolar cutting modes... 51 5.8.1.
Standard ... 51
5.8.2.
Bipolar resection (optional) ... 51
5.8.3.
Bipolar scissors ... 52
Bipolar coagulation modes ... 52 5.9.1.
Standard forceps ... 52
5.9.2.
Standard forceps AUTO ... 52
5.9.3.
Micro forceps ... 53
5.9.4.
Forceps forced ... 53
5.9.5.
LIGATION (optional) ... 54
5.9.6.
TissueSeal PLUS (optional) ... 54
5.9.7.
Bipolar scissors ... 55
5.9.8.
Laparoscopy ... 55
5.9.9.
Bipolar resection (optional) ... 55
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Contents
5.10.
6.
7.
8.
Menu dialogs ... 56 5.10.1.
Overview ... 56
5.10.2.
"System Settings" dialog ... 56
5.10.3.
“Neutral electrode“ dialog ... 57
5.10.4.
“Program“ dialog ... 58
5.10.5.
“Language“ dialog ... 60
5.10.6.
"System messages" dialog ... 60
5.10.7.
“System information“ dialog ... 61
5.10.8.
"Service" dialog ... 61
5.10.9.
"Argon" dialog ... 63
Detecting and correcting faults ... 64 6.1.
System informations... 64
6.2.
Fault indications for EASY monitoring ... 69
Preparation ... 70 7.1.
Preparation of the accessories ... 70
7.2.
Disinfection and cleaning ... 70
Maintenance and repair ... 71 8.1.
Maintenance ... 71 8.1.1.
8.2. 9.
Repairs ... 72
Storage ... 73 9.1.
10.
Safety inspection ... 71
Technical service ... 73
Technical specifications ... 74 10.1.
ARC 350 technical data ... 74
10.2.
Output, voltage and current diagrams... 81
11.
Accessories and replacement parts ... 119
12.
EMC ... 120 12.1.
13.
6
Guidelines and manufacturer’s declaration in accordance with IEC 60601-1-2 Section 6.8.3.201 ... 120
Disposal ... 123
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1 Using this operating manual
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
Unit version
Last revised
Valid from version 2.0.0
2014/02
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
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.
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1 Using this operating manual
1.4.2.
Risk levels in 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
1.4.4.
Other symbols and marks
Symbol or mark
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)
8
List (second level)
Emphasis
Emphasis
..., see Section xxx, page xxx
Cross reference
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2 Safety
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
Paediatric 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.
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.
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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 120.
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 73.
To protect personnel, BOWA recommends the use of a smoke evacuator to extract electrosurgical smoke, e.g. BOWA SHE SHA.
10
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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.
12
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 119.
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 70.
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.
14
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 69.
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 69).
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
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
Observe the instructions on the use of the neutral electrode in the user guide and the information on the package 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 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
16
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
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.
See Section Fault indications for EASY monitoring, page 69 regarding monitoring of the neutral electrode.
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3 Description
3. Description 3.1.
User interface components
3.1.1.
Front panel user interface components
12
8
13 9
6
7
6
7
6
7
6
7
14
5
1 2
7
6
7
6
7
6
7
6
10
15
16 11
4 3
1 2 3 4 6 7 8 9 10 11
On/-Off button "CF-type device with defibrillation protection" icon "Observe use instructions" icon Touchscreen Button Effect Button maximum output power Activation indication Monopolar 1 Activation indication Monopolar 2 Activation indication Bipolar 3 Activation indication Bipolar 4
While activating an instrument, the Activation indication of the corresponding socket illuminates yellow or blue.
3.1.2. 12 13 11
Monopolar connector module (left) Monopolar 1 Socket connector for monopolar instruments with hand or foot switch* Monopolar 2 Socket connector for monopolar instruments with hand or foot switch* Socket connector for neutral electrode *
* Applied part type F according to IEC 60601-1
18
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3 Description
Monopolar connection sockets
a
b c
Alternative 1 a BOWA COMFORT 3-Pin US type b Bovie (footswitch) c 4 mm Socket (footswitch) Alternative 2 a BOWA COMFORT 3-Pin US type b Erbe 5 mm c 4 mm socket (footswitch)
Connection socket for neutral electrode
14
14
Neutral (US type)
3.1.3. 15
Bipolar connector module (right) Bipolar 3 Socket connector for bipolar instruments with foot switch, finger switch or AUTOSTART* Bipolar 4 Socket connector for bipolar instruments with foot switch, finger switch or AUTOSTART*
16
Bipolar connection sockets Alternative 1:
Alternative 2:
b
b
a
a
c
a b
BOWA COMFORT 2-pin US type (28.58 mm)
a b c
BOWA COMFORT 2-pin US type (28.58 mm) Erbe VIO/ICC
* Applied part type F according to IEC 60601-1
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3 Description
3.1.4.
Rear panel user interface components 20 17
18
27 19
21
17 18 19 20 21 22
22
23
24
25
26
Foot switch socket connector 1 Foot switch socket connector 2 Equipotential bonding terminal IEC power cord connector Fiber-optic signal input connector Fiber-optic signal output socket connector
Use the following connections only for service and training purposes: 23 24 25 26 27
Ethernet connector USB connector Audio In (not occupied) UART communication interface Power switch
The USB connector can be used to perform software updates. The maximum voltage at the SIP/SOP ports is 15 VDC.
20
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