Bowa ARC 400 Manual de usuario

OPERATING MANUAL

ELECTROSURGICAL UNIT

2Operating Manual ARC 400 900-400_IFU_V1.0.0.6.17.9_20140-S2-20130604-EN

Contents

900-400_IFU_V1.0.0.6.17.9_20140-S2-20130604-EN Operating Manual ARC 400 3

Contents

1. 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

2. 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

3. Description ..................................................................................................................................... 18

3.1. 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

3.2. 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

Contents

4Operating Manual ARC 400 900-400_IFU_V1.0.0.6.17.9_20140-S2-20130604-EN

4. Prearrangement ............................................................................................................................. 23

4.1. Setting up the HF device.................................................................................................. 23

4.2. Switching on the HF device ............................................................................................. 24

4.3. Connecting instruments ................................................................................................... 24

4.3.1. Instruments for monopolar use......................................................................... 25

4.3.2. Instruments for bipolar applications.................................................................. 25

4.3.3.Connecting a foot switch................................................................................... 25

4.4. 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

4.5. Neutral electrode monitoring............................................................................................ 27

4.5.1. General information .......................................................................................... 27

4.5.2. EASY neutral electrode monitoring (EASY monitoring) ................................... 28

5. Operation........................................................................................................................................ 29

5.1. Connecting power ............................................................................................................ 29

5.2. Program overview ............................................................................................................ 29

5.2.1. Display .............................................................................................................. 29

5.2.2. Status bar ......................................................................................................... 30

5.3. Activating and deactivating connectors............................................................................ 30

5.4. Configuring output currents.............................................................................................. 31

5.4.1. Selecting the mode........................................................................................... 31

5.4.2. Specifying power limits ..................................................................................... 32

5.4.3. Selecting the effect ........................................................................................... 33

5.4.4. Assigning the foot pedal ................................................................................... 34

5.4.5. Mode change .................................................................................................... 37

5.4.6. Selecting the neutral electrode ......................................................................... 38

5.4.7. Dr. Dongle......................................................................................................... 40

5.4.8. Plug’n Cut COMFORT ...................................................................................... 41

5.4.9. Playing videos................................................................................................... 42

5.5. Mode overview ................................................................................................................. 43

5.5.1. Monopolar modes............................................................................................. 43

5.5.2. Bipolar cutting modes ....................................................................................... 45

5.6. Monopolar cutting modes................................................................................................. 46

5.6.1. Standard ........................................................................................................... 46

5.6.2. Micro ................................................................................................................. 46

Contents

900-400_IFU_V1.0.0.6.17.9_20140-S2-20130604-EN Operating Manual ARC 400 5

5.6.3. Dry .................................................................................................................... 47

5.6.4. Argon ................................................................................................................ 47

5.6.5. Resection.......................................................................................................... 48

5.6.6. MetraLOOP....................................................................................................... 48

5.6.7. Laparoscopy ..................................................................................................... 49

5.6.8. GastroCut Loop slow ........................................................................................ 49

5.6.9. GastroCut Loop medium................................................................................... 50

5.6.10. GastroCut Loop fast.......................................................................................... 50

5.6.11. GastroCut Knife slow........................................................................................ 51

5.6.12. GastroCut Knife medium .................................................................................. 51

5.6.13. GastroCut Knife fast ......................................................................................... 52

5.7. Monopolar coagulation modes......................................................................................... 52

5.7.1. Moderate........................................................................................................... 52

5.7.2. Forced non cutting............................................................................................ 53

5.7.3. Forced mixed .................................................................................................... 53

5.7.4. Forced cutting ................................................................................................... 54

5.7.5. Spray................................................................................................................. 54

5.7.6. Argon open ....................................................................................................... 55

5.7.7. Argon flexible .................................................................................................... 55

5.7.8. Argon flex. pulse ............................................................................................... 56

5.7.9. Resection.......................................................................................................... 56

5.7.10. Cardiac Mammary ............................................................................................ 57

5.7.10. Cardiac Thorax ................................................................................................. 57

5.7.11. SimCoag ........................................................................................................... 58

5.7.12. Gastro Coag ..................................................................................................... 58

5.7.13. Laparoscopy ..................................................................................................... 59

5.8. Bipolar cutting modes....................................................................................................... 59

5.8.1. Standard ........................................................................................................... 59

5.8.2. Bipolar resection ............................................................................................... 60

5.8.3. Bipolar scissors................................................................................................. 60

5.9. Bipolar coagulation modes............................................................................................... 61

5.9.1. Standard forceps .............................................................................................. 61

5.9.2. Standard forceps AUTO ................................................................................... 61

5.9.3. Micro forceps .................................................................................................... 62

5.9.4. Forceps forced.................................................................................................. 62

5.9.5. LIGATION ......................................................................................................... 63

Contents

6Operating Manual ARC 400 900-400_IFU_V1.0.0.6.17.9_20140-S2-20130604-EN

5.9.6. TissueSeal PLUS.............................................................................................. 63

5.9.7. Bipolar scissors................................................................................................. 64

5.9.8. Laparoscopy ..................................................................................................... 64

5.9.9. Bipolar resection ............................................................................................... 65

5.10. Menu dialogs.................................................................................................................... 66

5.10.1. Overview........................................................................................................... 66

5.10.2. "System Settings" dialog................................................................................... 67

5.10.3. "Volume" dialog ................................................................................................ 67

5.10.4. "System messages" dialog ............................................................................... 68

5.10.5. "BOWA Service" dialog..................................................................................... 69

5.10.6. "Select program" dialog .................................................................................... 70

5.10.7. "Delete program" dialog.................................................................................... 71

5.10.8. "Favourites" dialog............................................................................................ 72

5.10.9. "Save Program" dialog...................................................................................... 72

5.10.10. "Argon" dialog ................................................................................................... 73

5.11. Basic programs ................................................................................................................ 74

6. Detecting and correcting faults ................................................................................................... 79

6.1. System informations......................................................................................................... 79

6.2. Fault indications for EASY monitoring ............................................................................. 84

7. Preparation..................................................................................................................................... 85

7.1. Preparation of the accessories ........................................................................................ 85

7.2. Disinfection and cleaning ................................................................................................. 85

8. Maintenance and repair ................................................................................................................ 86

8.1. Maintenance..................................................................................................................... 86

8.1.1. Safety inspection .............................................................................................. 86

8.2. Repairs............................................................................................................................. 87

9. Storage ........................................................................................................................................... 88

9.1. Technical service ............................................................................................................. 88

10. Technical specifications ............................................................................................................... 89

10.1.ARC 400 technical data ................................................................................................... 89

10.2. Output, voltage and current diagrams.............................................................................. 96

11. Accessories and replacement parts.......................................................................................... 134

12. EMC............................................................................................................................................... 135

12.1. Guidelines and manufacturer’s declaration in accordance with IEC 60601-1-2

Section 6.8.3.201 ........................................................................................................... 135

13. Disposal........................................................................................................................................ 139

1 Using this operating manual

900-400_IFU_V1.0.0.6.17.9_20140-S2-20130604-EN Operating Manual ARC 400 7

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 1.0.0.6.17.9

2013/06

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.

1Using this operating manual

8Operating Manual ARC 400 900-400_IFU_V1.0.0.6.17.9_20140-S2-20130604-EN

1.4.2. Risk levels in warning instructions

Symbol

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 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

Activity with several steps in a binding

sequence



Result of preceding activity



List (first level)



List (second level)

Emphasis

......, see Section xxx, page xxx

Cross reference

2 Safety

900-400_IFU_V1.0.0.6.17.9_20140-S2-20130604-EN Operating Manual ARC 400 9

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

Pediatric 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.

2Safety

10 Operating Manual ARC 400 900-400_IFU_V1.0.0.6.17.9_20140-S2-20130604-EN

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 135.

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 88.

To protect personnel, BOWA recommends the use of a smoke evacuator

to extract electrosurgical smoke, e.g. BOWA SHE SHA.

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