BOWA-electronic
BOWA ARC 300 and 350 Operating Manual Ver 2.6 Jan 2010
Operating Manual
116 Pages
Preview
Page 1
OPERATING MANUAL HIGH FREQUENCY SURGICAL DEVICE
Monopolar Cut
Program
Monopolar Coag
Bipolar Coag
Blend
1
ON
2
3
4
Bipolar Cut
Bipolar Coag
F
ARC 300
Monopolar Cut
Program
Monopolar Coag
15 18
Blend
1
2
Blend
3
ON
4
F
ARC 350
900-350_IFU_V2.6_10296-S13-20100111-EN
ARC 300 / ARC 350 Operating manual
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4
ARC 300 / ARC 350 Operating manual
900-350_IFU_V2.6_10296-S13-20100111-EN
900-350_IFU_V2.6_10296-S13-20100111-EN
ARC 300 / ARC 350 Operating manual
5
Legend
Legend
1
2
8
9
3
4
10
11
12
14
5 6 7
Blend
13
Monopolar Cut
Program
1 2 3/4 5/6 7
Monopolar Coag
Monopolar Cut
Monopolar Coag
Bipolar Cut
8 9 10/11 12 13 14
Bipolar Coag
15
16 17
15
15 18
Blend
18
19
Blend
ON
16/17 18 19
20
Bipolar Cut
Bipolar Coag
21
22
28
29
23
24
30
31
27
32
25 26
1
15 18
Blend
20
21 22 23/24 25/26 27
ON
2
3
4
42 43
44 45 46 47
28 29 30/31 32
F
33
34
35
36 37 38 39 40 41
48 49
33 34 35
36 1
2
3
37 38 3 +4
2 +3
39 50
51
52
53
54
55
56
"Monopolar Cut" indicator arrow (yellow) "Monopolar Cut" 7-segment indicator Power limitation for monopolar cutting Key for the degree of scabbing during monopolar cutting Blend factor indicator for "Monopolar Cut" Blend settings 0-9 Indicator arrow for "Monopolar Coag" (blue) "Monopolar Coag" 7-segment indicator Power limitation for monopolar coagulation Key/indicator for "Moderate Coagulation" current Key/indicator for "Forced Coagulation" current Key/indicator for "Spray Coagulation" current Indicator on main display: programs and information Current indicator on 2-line display Program key Error status indicator EASY neutral electrode monitoring for solid neutral electrode(EASY monitoring solid) EASY neutral electrode monitoring for split neutral electrode(EASY monitoring split) "Bipolar Cut" indicator arrow (yellow) "Bipolar Cut" 7-segment indicator Power limitation for bipolar cutting Key for the degree of scabbing during bipolar cutting Blend factor indicator for "Bipolar Cut" Blend settings 0–9 Indicator arrow for "Bipolar Coag" (blue) "Bipolar Coag" 7-segment indicator Power limitation for bipolar coagulation AUTOSTART key/indicator "Bipolar Output 3 or 4“ (connection socket 43 or 47) Only for bipolar coagulation! On/off switch Socket for the neutral electrode (NE) Key/indicator for "Monopolar Output 1" (connection socket 36) For monopolar instruments with manual switching Connection socket for monopolar instruments with manual switching "Monopolar Output 1" finger switch indicator "Monopolar Output 2" foot switch assignment indicator "Monopolar Output 2" key/indicator (connection socket 40)
ARC 300/350
6
ARC 300 / ARC 350 Operating manual
900-350_IFU_V2.6_10296-S13-20100111-EN
Legend
40
41 42 43 44 45 46 47 48 49
50 51 52 53 54 55 56 40
900-350_IFU_V2.6_10296-S13-20100111-EN
Connection socket for monopolar instruments with hand or foot switch or Bovie connector or 4 mm monopolar endoscope connector or 3-pin connector "Monopolar Output 2" finger switch indicator "Bipolar Output 3" foot switch assignment indicator Connection socket for bipolar instruments with foot switch or AUTOSTART (to be used in ligation) "Bipolar Output 3" key/indicator (connection socket 43) AUTOSTART indicator"Bipolar Output 3" (connection socket 43) active Foot switch indicator assignment to "Bipolar Output 4" Connection socket for bipolar instruments with foot switch or AUTOSTART "Bipolar Output 4" key/indicator (connection socket 47) AUTOSTART indicator"Bipolar Output 4" (connection socket 47) active Back side of ARC 300/350 Connection socket 1 for foot switch for outputs 3/4 Not assigned Connection socket 3 for foot switch for outputs 2/3 Rating label Connection for communications interface 901-045 Connection for equipotential bonding Power connection for cooling device connector Connection socket for monopolar instruments with hand or foot switch or Bovie connector or 4 mm monopolar endoscope connector or 3-pin connector
ARC 300 / ARC 350 Operating manual
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Legend
8
ARC 300 / ARC 350 Operating manual
900-350_IFU_V2.6_10296-S13-20100111-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.
Patients with pacemakers...18
2.3.2.
Safe positioning of the patient ...18
2.3.3.
Correct connection of the HF device ...18
2.3.4.
Correct use of the HF device...19
2.3.5.
Adjusting the settings of the HF device and use of the accessories...19
2.4.
Device-related safety instructions...20
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 ...23
Functionality ...25 3.1.
3.2.
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
Bipolar modes ...28 3.2.1.
"Soft COAG" mode ...28
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ARC 300 / ARC 350 Operating manual
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Contents
4.
3.3.
Activation and alarm signals in monopolar and bipolar mode ...29
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) ...30
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
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
Function test ...39 5.4.1.
Automatic test functions ...39
5.4.2.
EASY neutral electrode monitoring (EASY monitoring) ...39
Operation...40 6.1.
Program overview ...40
6.2.
Basic program settings ...41
6.3.
6.2.1.
Calling up a program ...41
6.2.2.
Changing the program...41
Program descriptions ...43 6.3.1.
10
Rating label...33
Program 0 "Standard"...43
ARC 300 / ARC 350 Operating manual
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Contents
6.4.
6.3.2.
Program 1 “EndoLAP Bipolar Cut” (Bipolar Cut only for ARC 350 and ARC 350L)...43
6.3.3.
Program 2 “EndoLAP II Ligation” (ligation only for ARC 350L) ...44
6.3.4.
Program 3 “Abdominal Ligation” (ligation only for ARC 350L) ...45
6.3.5.
Program 4 “Argon Ligation” (ligation only for ARC 350L)...46
6.3.6.
Program 5 "Argon Open"...47
6.3.7.
Program 6 "Macro Plastic"...47
6.3.8.
Program 7 "Micro Plastic"...48
6.3.9.
Program 8 "Local Anaesthesia"...48
6.3.10.
Program 9 "ENT" ...48
6.3.11.
Program 10 "Micro Pediatric" ...48
6.3.12.
Program 11 "Micro Neuro"...48
6.3.13.
Program 12 "DryCUT" ...49
6.3.14.
Program 13 "SimCOAG" ...49
6.3.15.
Program 14 "Chest"...49
6.3.16.
Program 15 "Mammaria" ...50
6.3.17.
Program 16 “Gynaecology Ligation” (ligation only for ARC 350L) ...50
6.3.18.
Program 17 "Gynecology Hystero"...51
6.3.19.
Program 18 "TUR-P Bipolar TUR" (Bipolar TUR only for ARC 350 and ARC 350L)...51
6.3.20.
Program 19 "TUR-BT Bipolar TUR" (Bipolar TUR only for ARC 350 and ARC 350L)...52
6.3.21.
Program 20 “Resection Bipolar“ (bipolar resection only for ARC 350 and ARC 350L)...53
6.3.22.
Program 21 "GastroCUT Pol" (optional for ARC 300)...54
6.3.23.
Program 22: "GastroCUT Pap" (optional for ARC 300) ...55
6.3.24.
Program 23 “Argon Flex” (optional for ARC 300) ...56
Menu programs...57 6.4.1.
Overview...57
6.4.2.
Menu program 1 "Set Language" ...58
6.4.3.
Menu program 2 "Sound Level" ...58
6.4.4.
Menu program 3 "Moderate Coag Mode"...59
6.4.5.
Menu program 4 "Bip Coag Mode"...59
6.4.6.
Menu program 5 "Forced Coag Mode"...60
6.4.7.
Menu program 5a “GastroCut Mode” ...60
6.4.8.
Menu program 6 "Show Prev Inf-No" ...60
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ARC 300 / ARC 350 Operating manual
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Contents
7.
6.4.9.
Menu program 7 "Hide Fix Prog"...61
6.4.10.
Menu program 8 "Autostart Delay"...61
6.4.11.
Menu program 9 "Edit Prog Names" ...62
6.4.12.
Menu program 10 "Restore Programs" ...63
6.4.13.
Menu program 11 "Panel Check" ...63
Detecting and correcting errors ...64 7.1.
System- errors ...64 7.1.1.
7.2. 8.
9.
Error list ...64
Errors in the EASY monitoring...68
Preparation ...69 8.1.
Preparation of the accessories ...69
8.2.
Disinfection and cleaning ...69
Maintenance/Repair ...70 9.1.
Maintenance ...70 9.1.1.
Safety inspection ...70
9.2.
Repairs...71
9.3.
Technical service ...72
10.
Positioning ...73
11.
Technical specifications...74 11.1.
Technical specifications for the HF devices ARC 300 and ARC 350 ...74
11.2.
Output, voltage and current diagrams ...80
12.
Accessories/Replacement parts...109
13.
EMC...110 13.1.
14.
12
Guidelines and manufacturer's declaration in accordance with DIN EN 606011-2, Section 6.8.3.201...110
Disposal...114
ARC 300 / ARC 350 Operating manual
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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. X
Read the operating manual carefully and thoroughly before using this device.
X
Store the operating manual in a safe place throughout the service life of the device.
X
Keep the operating manual accessible to operating room personnel.
X
Give the operating manual to each successive owner and/or user of this device.
X
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
2.6
2010/01
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1.2.
Validity This operating manual applies only to the devices designated on the title page. Pos: 6 /679-BOWA/ARC 300/350/2 Umgang mit/2.3 Mitgeltende Dokumente @ 4mod_1261040285210_6.doc @ 34406 @ 2
1.3.
Other applicable documents X
Comply with other applicable documents in the appendix or in the other registers.
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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)! X
Measure for risk prevention.
NOTE "Risk type, source and consequences there of" (Property damage)! X
1.4.2.
Measure .
Risk levels in the warning instructions Icon
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/Additional information to facilitate tasks.
14
ARC 300 / ARC 350 Operating manual
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1 Using this operating manual
1.4.4.
Other icons and labeling Icon/Labeling
Meaning
;
Prerequisite for an activity
X
Activity with one step
1.
Activity with several steps in a binding sequence
2. 3.
ª
Result of preceding activity
•
Listing (first level)
•
Listing (second level)
Emphasis
Emphasis
..., see Chapter xxx, Page xxx
Cross reference
... “Monopolar output 1” 35
Bold numbers (e.g.: 35) refer to a schematic diagram of the ARC 300 / 350 and the respective legend (page 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 and bipolar cutting and coagulation in surgical interventions. It is used in the following areas: •
general surgery
•
endoscopy
•
gynecology
•
hand surgery
•
ENT
•
cardiac surgery (including open-heart surgery)
•
neurosurgery
•
orthopedics
•
urology, including transurethral resection (TUR)
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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ARC 300 / ARC 350 Operating manual
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2 Safety
2.2.
General safety instructions X
Ensure that no electronic devices that are subject to interference from electromagnetic fields are set up in the vicinity of the HF device.
X
Please comply with the instructions on electromagnetic compatibility (EMC), see Chapter EMC, page 110.
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 standard requirements for medical systems (see IEC 60601-1-1 or Section 16 of the 3rd edition of IEC 60601-1). Anyone who connects additional devices to electrical medical devices is automatically a system configurator and thus responsible for meeting standard system requirements. Please note that local laws prevail over the aforementioned standard requirements. For further advice, please contact your local specialist retailer or the Technical Service Department.
To protect personnel, BOWA recommends the use of a smoke evacuator to extract electrosurgical smoke, e.g. BOWA SHE SHA.
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ARC 300 / ARC 350 Operating manual
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2 Safety
2.3.
Personal safety instructions
2.3.1.
Patients with pacemakers Malfunctions or destruction of the pacemaker can endanger the life of the patient or result in irreversible injuries to the patient.
2.3.2.
2.3.3.
18
X
In cases of patients with pacemakers, consult the cardiologist before carrying out HF surgery.
X
Use bipolar HF methods.
X
Move the HF neutral electrode close to the operating field.
X
Set the demand pacemaker to a fixed frequency.
X
Ensure that the pacemaker does not come into contact with the HF electrode.
X
Keep a fully operational defibrillator handy.
X
Carry out a postoperative pacemaker check.
Safe positioning of the patient X
Position the patient so that he is not touching any metal parts that are grounded or have considerable capacity against ground (e.g. operating table brackets). Lay anti-static towels between the patient and the bedding.
X
Ensure that the patient does not touch any wet towels or bedding.
X
Place anti-static towels between areas of heavy sweating and skinto-skin contact on the patient's trunk.
X
Ensure that you are using a suitable support surface in order to prevent pressure necrosis.
X
Drain urine via the catheter.
Correct connection of the HF device X
Always ground the HF device via the equipotential bonding.
X
Do not use any needle electrodes for monitoring.
X
Attach electrodes of physiological monitoring devices without protective resistors or HF regulators as far as possible from the HF electrodes.
X
Attach lines from monitoring devices so that they do not lie on the patient's skin.
X
Keep the lines to the HF electrodes as short as possible and position them so that they do not touch the patient or other lines.
X
Do not place any objects on the HF device.
ARC 300 / ARC 350 Operating manual
900-350_IFU_V2.6_10296-S13-20100111-EN
2 Safety
2.3.4.
Correct use of the HF device Inadvertent activation in the non-visible area of the HF device can injure the patient. X
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.
X
After inadvertent activation of the HF device, switch off the device immediately using the on/off switch.
X
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.
2.3.5.
X
Use the automatic monitoring functions to ensure that the HF device works properly without errors. For information on the automatic test functions, see Chapter Monitoring functions, Page 29.
X
Ensure that no conductive fluids (e.g. blood, amniotic fluid) have penetrated the foot switch or the manual switch.
X
Ensure that there are no short circuits in the foot and manual switches.
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 power output, 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 X
To prevent inadvertent (thermal) tissue damage during interventions on body parts with small cross-sections and in areas with high resistance (bones, joints), use the bipolar method in these areas.
X
Always set the power output of the HF device as low as possible.
X
Set the acoustic signal that sounds when the electrode is activated so that it is always clearly audible.
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ARC 300 / ARC 350 Operating manual
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2 Safety
Correct usage of the accessories X
Use only insulated accessories.
X
Check all electrodes for sharp edges and projecting parts before use.
X
Use only electrodes that are free of defects and in good working order.
X
Never place active electrodes on or near the patient.
X
Do not remove hot electrodes from the patient's bodydirectly after cutting or coagulation.
X
Ensure that there is sufficient distance between the patient cables and the cables of the HF device.
X
Do not run the patient cable across the patient.
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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. X
Use only of accessories approved by BOWA; see Chapter , Page .
X
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.
X
Have malfunctions that can adversely affect safety (e.g. deviations from the permissible operating conditions) repaired without delay.
X
Wipe down the HF device only with cleaning agents and disinfectants that are nationally approved for surface cleaning. See Chapter Disinfection and cleaning ,Page 69.
X
Never immerse the device in water or cleaning agents.
X
Never boil the device and never disinfect it mechanically.
X
Immediately drain any fluid that might have penetrated the device.
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ARC 300 / ARC 350 Operating manual
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2 Safety
2.5.
Safe handling (general instructions) X
Before each use of the device, check to ensure that it is functioning properly and is in good working order.
X
Comply with the instructions for use as specified by the standard; see Chapter Risk levels in the warning instructions, Page 14.
X
Pay attention to and comply with the acoustic signals and error indicators of the HF device during use; see Chapter Error List, Page 64.
X
The device and accessories may be operated and used only by people who have the necessary training, knowledge and experience.
X
Inspect the accessories, particularly electrode cables and endoscopic accessories for damage to the insulation.
X
Do not place any instruments on the patients or on the devices.
X
Ensure that no instruments are being cleaned when AUTOSTART is activated.
X
Wear suitable gloves during operations.
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ARC 300 / ARC 350 Operating manual
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