Bowa ARC 350 User manual

OPERATING MANUAL
HIGH FREQUENCY SURGICAL DEVICE

900-350_IFU_V2.6_10296-S13-20100111-EN ARC 300 / ARC 350 Operating manual 3
Program
Monopolar Cut Bipolar CoagMonopolar Coag
F
Blend ON
321 4
ARC 300
Program
Monopolar Cut Bipolar Cut Bipolar CoagMonopolar Coag
F
Blend Blend ON
321 4
15
18
ARC 350

4ARC 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
6ARC 300 / ARC 350 Operating manual 900-350_IFU_V2.6_10296-S13-20100111-EN
Monopolar Cut
Blend
Bipolar Coag
ON
Bipolar Cut
Blend
15
18
Monopolar Coag
Program
F
321 4
Monopolar Cut Bipolar Cut Bipolar CoagMonopolar Coag
Blend Blend ON
15
18
1
3 4
2
5
6
7
8
10 11
12 14
9
13
21
23 24
25
26 27
22 28
30
32
31
29
16
15
17
36 37 41 42 46353433 38 40 43
201918
4744 45 494839
1
3+
23
42+3
50 51 52 54 5653 55
ARC 300/350
Legend 1 "Monopolar Cut" indicator arrow (yellow)
2 "Monopolar Cut" 7-segment indicator
3/4 Power limitation for monopolar cutting
5/6 Key for the degree of scabbing during monopolar cutting
7 Blend factor indicator for "Monopolar Cut"
Blend settings 0-9
8 Indicator arrow for "Monopolar Coag" (blue)
9 "Monopolar Coag" 7-segment indicator
10/11 Power limitation for monopolar coagulation
12 Key/indicator for "Moderate Coagulation" current
13 Key/indicator for "Forced Coagulation" current
14 Key/indicator for "Spray Coagulation" current
15 Indicator on main display: programs and information
Current indicator on 2-line display
16/17 Program key
18 Error status indicator
19 EASY neutral electrode monitoring for solid neutral
electrode(EASY monitoring solid)
20 EASY neutral electrode monitoring for split neutral
electrode(EASY monitoring split)
21 "Bipolar Cut" indicator arrow (yellow)
22 "Bipolar Cut" 7-segment indicator
23/24 Power limitation for bipolar cutting
25/26 Key for the degree of scabbing during bipolar cutting
27 Blend factor indicator for "Bipolar Cut"
Blend settings 0–9
28 Indicator arrow for "Bipolar Coag" (blue)
29 "Bipolar Coag" 7-segment indicator
30/31 Power limitation for bipolar coagulation
32 AUTOSTART key/indicator "Bipolar Output 3 or 4“
(connection socket 43 or 47)
Only for bipolar coagulation!
33 On/off switch
34 Socket for the neutral electrode (NE)
35 Key/indicator for "Monopolar Output 1"
(connection socket 36)
For monopolar instruments with manual switching
36 Connection socket for monopolar instruments with manual
switching
37 "Monopolar Output 1" finger switch indicator
38 "Monopolar Output 2"
foot switch assignment indicator
39 "Monopolar Output 2" key/indicator
(connection socket 40)

Legend
900-350_IFU_V2.6_10296-S13-20100111-EN ARC 300 / ARC 350 Operating manual 7
40 Connection socket for monopolar instruments with hand or
foot switch or Bovie connector or 4 mm monopolar
endoscope connector or 3-pin connector
41 "Monopolar Output 2" finger switch indicator
42 "Bipolar Output 3" foot switch assignment indicator
43 Connection socket for bipolar instruments with foot switch or
AUTOSTART (to be used in ligation)
44 "Bipolar Output 3" key/indicator (connection socket 43)
45 AUTOSTART indicator"Bipolar Output 3"
(connection socket 43) active
46 Foot switch indicator assignment to "Bipolar Output 4"
47 Connection socket for bipolar instruments with foot switch or
AUTOSTART
48 "Bipolar Output 4" key/indicator (connection socket 47)
49 AUTOSTART indicator"Bipolar Output 4"
(connection socket 47) active
Back side of ARC 300/350
50 Connection socket 1 for foot switch for outputs 3/4
51 Not assigned
52 Connection socket 3 for foot switch for outputs 2/3
53 Rating label
54 Connection for communications interface 901-045
55 Connection for equipotential bonding
56 Power connection for cooling device connector
40 Connection socket for monopolar instruments with hand or
foot switch or Bovie connector or 4 mm monopolar
endoscope connector or 3-pin connector

Legend
8ARC 300 / ARC 350 Operating manual 900-350_IFU_V2.6_10296-S13-20100111-EN

Contents
900-350_IFU_V2.6_10296-S13-20100111-EN ARC 300 / ARC 350 Operating manual 9
Contents
Legend.........................................................................................................................................................6
1. 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
2. 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
3. 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
3.2.1. "Soft COAG" mode ............................................................................................28

Contents
10 ARC 300 / ARC 350 Operating manual 900-350_IFU_V2.6_10296-S13-20100111-EN
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
4. Description......................................................................................................................................32
4.1. Icons on the device ...........................................................................................................32
4.1.1. Rating label........................................................................................................33
4.2. Scope of delivery ..............................................................................................................33
4.3. Components required for operation ..................................................................................33
5. Preparation .....................................................................................................................................34
5.1. Setting up the HF device...................................................................................................34
5.2. Switching on the HF device ..............................................................................................35
5.3. Connecting instruments ....................................................................................................35
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
5.4. Function test .....................................................................................................................39
5.4.1. Automatic test functions ....................................................................................39
5.4.2. EASY neutral electrode monitoring (EASY monitoring) ....................................39
6. Operation.........................................................................................................................................40
6.1. Program overview .............................................................................................................40
6.2. Basic program settings .....................................................................................................41
6.2.1. Calling up a program .........................................................................................41
6.2.2. Changing the program.......................................................................................41
6.3. Program descriptions........................................................................................................43
6.3.1. Program 0 "Standard"........................................................................................43

Contents
900-350_IFU_V2.6_10296-S13-20100111-EN ARC 300 / ARC 350 Operating manual 11
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
6.4. 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

Contents
12 ARC 300 / ARC 350 Operating manual 900-350_IFU_V2.6_10296-S13-20100111-EN
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
7. Detecting and correcting errors ...................................................................................................64
7.1. System- errors ..................................................................................................................64
7.1.1. Error list .............................................................................................................64
7.2. Errors in the EASY monitoring..........................................................................................68
8. Preparation .....................................................................................................................................69
8.1. Preparation of the accessories .........................................................................................69
8.2. Disinfection and cleaning..................................................................................................69
9. 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. Guidelines and manufacturer's declaration in accordance with DIN EN 60601-
1-2, Section 6.8.3.201.....................................................................................................110
14. Disposal.........................................................................................................................................114

1 Using this operating manual
900-350_IFU_V2.6_10296-S13-20100111-EN ARC 300 / ARC 350 Operating manual 13
Pos: 1 /679-BOWA/ARC 300/350/ 1 Legende/1 Legende @ 4\ mod_1261040244069_6. doc @ 34330 @
Pos: 2 /679-BOWA/ARC 300/350/ 1 Legende/1.1 Legende @ 4\mod_1261040303163_6.doc @34444 @
Pos: 3 /679-BOWA/ARC 300/350/ 2 Umgang mit/2 Umgang mit di eser Gebrauchsan weisung @ 4\mod_1261040269 100_6.doc @ 34349 @
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.
XRead the operating manual carefully and thoroughly before using
this device.
XStore the operating manual in a safe place throughout the service
life of the device.
XKeep the operating manual accessible to operating room
personnel.
XGive the operating manual to each successive owner and/or user
of this device.
XAlways update the operating manual whenever you receive
additional information from the manufacturer.
Pos: 4 /679-BOWA/ARC 300/350/ 2 Umgang mit/2.1 Revi sions-Index @ 4\mod_126 1040274897_6.doc @34368 @ 2
1.1. Revision index
Software version Last revised
2.6 2010/01
Pos: 5 /679-BOWA/ARC 300/350/ 2 Umgang mit/2.2 Gül tigkeit @ 4\mod_12610402 80413_6.doc @ 34387 @ 2
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 Mitge ltende Dokumente @ 4\mod_12 61040285210_6.doc @34406 @ 2
1.3. Other applicable documents
XComply with other applicable documents in the appendix or in the
other registers.
Pos: 7 /679-BOWA/ARC 300/350/ 2 Umgang mit/2.4 Sy mbole und Kennzeichnungen @ 4\m od_1261040289491_6.doc @34425 @

1 Using this operating manual
14 ARC 300 / ARC 350 Operating manual 900-350_IFU_V2.6_10296-S13-20100111-EN
1.4. Icons and labeling
1.4.1. Structure of warning instructions
SIGNAL WORD
"Risk type, source and consequences there of" (Personal injury)!
XMeasure for risk prevention.
NOTE
"Risk type, source and consequences there of" (Property damage)!
XMeasure .
1.4.2. Risk levels in the warning instructions
Icon 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
1.4.3. Tips
Tips/Additional information to facilitate tasks.

1 Using this operating manual
900-350_IFU_V2.6_10296-S13-20100111-EN ARC 300 / ARC 350 Operating manual 15
1.4.4. Other icons and labeling
Icon/Labeling Meaning
;Prerequisite for an activity
XActivity with one step
1.
2.
3.
Activity with several steps in a binding
sequence
ªResult 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)
Pos: 8 /679-BOWA/ARC 300/350/ 3 Sicherheit/3 Sic herheit @ 4\mod_1261040 342069_6.doc @ 34463 @ 1

2 Safety
16 ARC 300 / ARC 350 Operating manual 900-350_IFU_V2.6_10296-S13-20100111-EN
2. Safety
Pos: 9 /679-BOWA/ARC 300/350/ 3 Sicherheit/3.1 Bes timmungsgemäße Ver wendung @ 4\mod_12610403475 22_6.doc @ 34482 @ 2
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!
Pos: 10 /679-BOWA/ARC 300/35 0/3 Sicherheit/ 3.2 Allgemeine Sicherhei tshinweise @ 4\mod_12 61040351975_6.doc @ 34501 @ 2

2 Safety
900-350_IFU_V2.6_10296-S13-20100111-EN ARC 300 / ARC 350 Operating manual 17
2.2. General safety instructions
XEnsure that no electronic devices that are subject to interference
from electromagnetic fields are set up in the vicinity of the HF
device.
XPlease 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.
Pos: 11 /679-BOWA/ARC 300/35 0/3 Sicherheit/ 3.3 Personenbezogene Sic herheitshinweise @ 4\ mod_1261040358116_6. doc @ 34520 @ 233333

2 Safety
18 ARC 300 / ARC 350 Operating manual 900-350_IFU_V2.6_10296-S13-20100111-EN
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.
XIn cases of patients with pacemakers, consult the cardiologist
before carrying out HF surgery.
XUse bipolar HF methods.
XMove the HF neutral electrode close to the operating field.
XSet the demand pacemaker to a fixed frequency.
XEnsure that the pacemaker does not come into contact with the HF
electrode.
XKeep a fully operational defibrillator handy.
XCarry out a postoperative pacemaker check.
2.3.2. Safe positioning of the patient
XPosition 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.
XEnsure that the patient does not touch any wet towels or bedding.
XPlace anti-static towels between areas of heavy sweating and skin-
to-skin contact on the patient's trunk.
XEnsure that you are using a suitable support surface in order to
prevent pressure necrosis.
XDrain urine via the catheter.
2.3.3. Correct connection of the HF device
XAlways ground the HF device via the equipotential bonding.
XDo not use any needle electrodes for monitoring.
XAttach electrodes of physiological monitoring devices without
protective resistors or HF regulators as far as possible from the HF
electrodes.
XAttach lines from monitoring devices so that they do not lie on the
patient's skin.
XKeep the lines to the HF electrodes as short as possible and
position them so that they do not touch the patient or other lines.
XDo not place any objects on the HF device.

2 Safety
900-350_IFU_V2.6_10296-S13-20100111-EN ARC 300 / ARC 350 Operating manual 19
2.3.4. Correct use of the HF device
Inadvertent activation in the non-visible area of the HF device can injure
the patient.
XActivate the HF device only when the electrode is in your field of
vision and you can quickly deactivate the HF device at all times.
XAfter inadvertent activation of the HF device, switch off the device
immediately using the on/off switch.
XPay 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.
XUse 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.
XEnsure that no conductive fluids (e.g. blood, amniotic fluid) have
penetrated the foot switch or the manual switch.
XEnsure that there are no short circuits in the foot and manual
switches.
2.3.5. 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
XTo 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.
XAlways set the power output of the HF device as low as possible.
XSet the acoustic signal that sounds when the electrode is activated
so that it is always clearly audible.

2 Safety
20 ARC 300 / ARC 350 Operating manual 900-350_IFU_V2.6_10296-S13-20100111-EN
Correct usage of the accessories
XUse only insulated accessories.
XCheck all electrodes for sharp edges and projecting parts before
use.
XUse only electrodes that are free of defects and in good working
order.
XNever place active electrodes on or near the patient.
XDo not remove hot electrodes from the patient's bodydirectly after
cutting or coagulation.
XEnsure that there is sufficient distance between the patient cables
and the cables of the HF device.
XDo not run the patient cable across the patient.
Pos: 12 /679-BOWA/ARC 300/35 0/3 Sicherheit/ 3.4 Produktbezogene Sic herheitshinweis @ 4\ mod_1261040363772_6. doc @ 34539 @ 2
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.
XUse only of accessories approved by BOWA; see Chapter , Page .
XUse 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.
XHave malfunctions that can adversely affect safety (e.g. deviations
from the permissible operating conditions) repaired without delay.
XWipe down the HF device only with cleaning agents and
disinfectants that are nationally approved for surface cleaning. See
Chapter Disinfection and cleaning ,Page 69.
XNever immerse the device in water or cleaning agents.
XNever boil the device and never disinfect it mechanically.
XImmediately drain any fluid that might have penetrated the device.
Pos: 13 /679-BOWA/ARC 300/35 0/3 Sicherheit/ 3.5 Sichere Handhabung (al lgemein) @ 4\mod_126104036 9350_6.doc @ 34558 @ 233