KLS Martin maXium smart C User manual

Front Cover
English
Tested according to:
UL 60601-1:2003
CAN/CSA C22.2 No.601.1-M90
maxium
® smart C Electrosurgery Unit with
maxium
® smart Beam
Instructions for Use
90-046-52-10
Revision 1
Date of Release: 2017-10
Valid from software version V
1.3.35.3017

2Revision 1
Symbol Explanation
Safety alert symbol
CAUTION Indicates a situation which, if not avoided, could result in minor or
moderate injury.
WARNING Indicates a situation which, if not avoided, could result in death or
serious injury.
DANGER Indicates a situation which, if not avoided, will result in death or
serious injury.
Follow Instructions for Use
Reference number for ordering Gebrüder Martin products (item number)
Serial number
Store in a dry place
Fragile, avoid pressure and shock
Arrows pointing up, transport and store upright
CE marking of conformity
Warning: Dangerous high voltage!
This product may not be disposed of as normal household garbage, see section 15.3
“Disposal of the Device”, page 118

Revision 1 3
Connection for the neutral electrode.
Neutral electrode insulated against ground (floating)
Symbol for classification of the unit as type CF:
The unit is defibrillation-proof
CAUTION! High-voltage high-frequency currents
Manufacturer

Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam
4Revision 1
Contents
1Notices Concerning this Document..........................................................................8
1.1 Safety...................................................................................................................................8
1.2 Terms & Acronyms.............................................................................................................. 8
1.3 Validity of this Document....................................................................................................9
1.4 Symbols Used in this Document ......................................................................................... 9
2Product Liability and Warranty...............................................................................10
2.1 General Information ......................................................................................................... 10
2.2 Hotline............................................................................................................................... 10
2.3 Scope of Delivery .............................................................................................................. 11
2.4 User’s Inspection...............................................................................................................11
2.5 Warranty ........................................................................................................................... 11
3Intended Use ..........................................................................................................12
3.1 Intended use of the maxium® smart C ............................................................................. 12
3.2 Intended use of the maxium® smart Beam ...................................................................... 13
3.3 Instructions .......................................................................................................................13
4Working Principles..................................................................................................13
4.1 Preface .............................................................................................................................. 13
4.2 Monopolar application of HF current ............................................................................... 14
4.2.1 Monopolar cutting .........................................................................................................................14
4.2.2 Monopolar coagulation..................................................................................................................14
4.2.3 Neutral electrode...........................................................................................................................15
4.3 Bipolar application of HF current...................................................................................... 16
4.3.1 Bipolar cutting................................................................................................................................16
4.3.2 Bipolar coagulation ........................................................................................................................16
5Risk Minimization and Safety Measures ................................................................17
5.1 Risks from Stray Currents.................................................................................................. 17
5.1.1 Patient shunts ................................................................................................................................18
5.1.2 High-frequency leakage currents...................................................................................................18
5.1.3 Leakage currents to other medical devices ...................................................................................19
5.1.4 Measures against risks from stray currents...................................................................................19
5.2 Risks from Current Concentration ....................................................................................20
5.2.1 Current condensation in the area of the neutral electrode ..........................................................20
5.2.2 Current condensation inside the body ..........................................................................................22
5.2.3 Measures against the risks posed by current accumulation .........................................................22
5.3 Risks from Arcing and Sparking......................................................................................... 23

Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam
Revision 1 5
5.4 Risks from High Voltage ....................................................................................................24
5.5 Risks from Electromagnetic Interference .........................................................................25
5.6 Risks from Pressure Vessels and Argon Gas Flow............................................................. 25
5.6.1 Pressure vessels .............................................................................................................................25
5.6.2 Embolisms and emphysema ..........................................................................................................26
5.7 Additional insufflation for endosurgical applications....................................................... 26
5.7.1 Contamination of the operation field............................................................................................27
5.7.2 Concentration of argon in the breathing air..................................................................................27
5.8 Miscellaneous ................................................................................................................... 27
5.8.1 Inadvertent emission of HF current ...............................................................................................27
5.8.2 Combination with other devices....................................................................................................28
5.8.3 HF output power............................................................................................................................28
5.8.4 Use of two electrosurgical devices on one patient........................................................................29
6Functions ................................................................................................................29
6.1 Overview ........................................................................................................................... 29
6.2 Connections on the Front .................................................................................................32
6.2.1 Monopolar connections.................................................................................................................32
6.2.2 Bipolar connections .......................................................................................................................33
6.2.3 Neutral electrode connection........................................................................................................34
6.3 Connections on the Rear...................................................................................................34
6.3.1 Foot switch connections ................................................................................................................34
6.3.2 Interface for the maxium® smart Beam.........................................................................................34
6.3.3 Serial interfaces..............................................................................................................................35
6.3.4 Equipotential bonding connection.................................................................................................35
6.3.5 Mains connection...........................................................................................................................36
6.4 Controls.............................................................................................................................36
6.4.1 ON/OFF key....................................................................................................................................36
6.4.2 Touchscreen...................................................................................................................................36
7Accessories .............................................................................................................37
7.1 maxium® smart Beam.......................................................................................................37
7.1.1 General Information ......................................................................................................................37
7.1.2 Control and display elements, connections...................................................................................38
7.1.3 Gas supply ......................................................................................................................................39
7.1.4 Argon..............................................................................................................................................40
7.1.5 Connection of beamer instruments...............................................................................................40
7.2 Instruments, Electrode Handles, Electrodes, Foot Switches and Cables for maxium®
and maxium® smart Beam................................................................................................ 41

Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam
6Revision 1
8Installation of the maxium® smart C and the maxium® smart Beam ....................42
8.1 Standalone Installation of the maxium® smart C ............................................................. 42
8.2 Installation of the maxium® smart C with maxium® smart Beam.................................... 43
8.3 Installation on the maxium® smart Cart ...........................................................................45
9Commissioning of the maxium® smart C and the maxium® smart Beam .............46
9.1 General Information ......................................................................................................... 46
9.2 Switching on the maxium® smart C .................................................................................. 46
9.3 Switching on the maxium® smart Beam ...........................................................................47
9.3.1 Noise during operation ..................................................................................................................47
9.4 Connection of the active electrodes................................................................................. 48
9.5 Connection of the neutral electrode ................................................................................48
9.5.1 Application of the neutral electrode..............................................................................................48
9.5.2 Gebrüder Martin Patient Control System (PCS).............................................................................49
9.6 Argon Filling Level .............................................................................................................51
9.7 Automatic Functions of Bipolar Coagulation.................................................................... 51
9.8 Information about the limitations of the auto-start function.......................................... 52
10 Using the maxium® smart C ...................................................................................53
10.1 General Information ......................................................................................................... 53
10.2 Selection and Deselection of Working Channels..............................................................53
10.3 Setting the Values for the Working Channels................................................................... 54
10.3.1 Setting the HF Output Power.........................................................................................................54
10.3.2 Selecting the current......................................................................................................................54
10.3.3 Setting the Effect............................................................................................................................55
10.3.4 Selecting the Activation Type/Foot Switch....................................................................................55
10.4 Navigation within the Programs and Functions of the maxium® smart C........................ 56
10.5 Programming Settings....................................................................................................... 57
10.5.1 Base program .................................................................................................................................57
10.5.2 Selecting Programs.........................................................................................................................58
10.5.3 Saving modified programs .............................................................................................................59
10.5.4 Saving a program under a new name ............................................................................................59
10.5.5 Deleting programs..........................................................................................................................60
10.5.6 SWAP® mode (optional).................................................................................................................60
10.6 The Setup Menu................................................................................................................ 62
10.6.1 Setting sound level.........................................................................................................................63
10.6.2 Setting display................................................................................................................................64
10.6.3 Setting the Time/Menu Timeouts..................................................................................................64
10.6.4 Neutral electrode...........................................................................................................................65
10.6.5 Argon mode ...................................................................................................................................66

Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam
Revision 1 7
10.6.6 Hotline............................................................................................................................................66
10.6.7 Service............................................................................................................................................66
10.6.8 Interface Language.........................................................................................................................66
10.6.9 Help ................................................................................................................................................67
10.6.10 Message History.............................................................................................................................67
11 Currents, their Properties and Technical Data .......................................................68
11.1 Monopolar Cutting Currents............................................................................................. 68
11.2 Monopolar Coagulation Currents .....................................................................................80
11.3 Bipolar Cutting Currents ...................................................................................................98
11.4 Bipolar Coagulation Currents.......................................................................................... 102
12 Cleaning and Disinfection.....................................................................................106
13 Messages of the Unit............................................................................................107
13.1 Messages during Self-Test ..............................................................................................107
13.2 Messages in Case of Activation Errors............................................................................109
13.3 Input Feedback................................................................................................................110
13.4 Messages in Connection with Programs.........................................................................111
13.5 Messages from the Argon Beamer and the Fume Suction System ................................112
13.6 System Errors ..................................................................................................................113
14 Periodic Safety Checks (SC) ..................................................................................114
15 Disposal.................................................................................................................118
15.1 Packaging ........................................................................................................................118
15.2 Ecological Aspects of Operation .....................................................................................118
15.3 Disposal of the Device..................................................................................................... 118
15.4 National Regulations.......................................................................................................118
16 Guidelines and Manufacturer’s Declaration on Electromagnetic Compatibility
(EMC) ....................................................................................................................119
17 Technical Specification .........................................................................................123
17.1 Technical Specifications of the maxium®........................................................................123
17.2 Technical Data for maxium® smart C..............................................................................124
17.3 Technical Data for maxium® smart Beam....................................................................... 126

Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam
8Revision 1
1Notices Concerning this Document
1.1 Safety
Non
-observance of this document can lead to serious or even lethal patient injury!
Improper handling and care as well as non
-intended use can lead to premature wear and/or pose a risk to
patients and users!
It is the operator’s responsibility to ensure that all personnel handling the product have underst
ood and
do observe the notes and instructions in this document.
•Every user is required to read this document completely and follow it carefully.
•In particular, be sure to heed all cautions, warnings and danger notices.
•Keep this document accessible to users at all times.
1.2 Terms & Acronyms
Designation Description
EMC Electromagnetic compatibility
G-grades Gradation Levels
HF High Frequency
LUP Last Used Program
MABS Martin Argon Beamer System
NE Neutral electrode
PCS Patient Control System
TUR Transurethral Resection
W Watt
Vac Smoke Evacuator

Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam
Revision 1 9
1.3 Validity of this Document
This document is valid from software version V1.3.35.3017. If older software versions are used, it may be
that newer functions described in this document are not available. Via the information provided on the
starting screen, the maxium® smart C indicates which version of this document matches the software
version currently implemented. This ensures that it is always clear which software statuses are covered by
this document.
1.4 Symbols Used in this Document
Throughout this document, important information (such as general or safety-related notices) is marked
with the following symbols and signal words:
Life hazard or serious injury!
Indicates a situation which, if not avoided,
could result in death or serious injury!
Risk of in
jury!
Indicates a situation which, if not avoided, could result in minor or moderate injury!
Risk of material damage!
Indicates a situation which, if not avoided, could lea
d to material damage (loss of time, data loss,
device/machine failure, etc.)!

Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam
10 Revision 1
2Product Liability and Warranty
2.1 General Information
We thank you for having decided to buy one of our products. This product bears the CE-marking, which
means that it satisfies the essential requirements laid down in the EC Directive concerning medical devices.
We are the manufacturer of this product:
Gebrüder Martin GmbH & Co. KG
A company of the KLS Martin Group
KLS Martin Platz 1 · D-78532 Tuttlingen · Germany
Postfach 60 · D-78501 Tuttlingen · Germany
Tel. [phone] · Fax [phone]
[e-mail] · www.klsmartin.com
2.2 Hotline
•Should you have any questions on how to handle the unit/product or question on its clinical
application, please do not hesitate to contact the Product Management:
Tel: [phone]
Fax: [phone]
•Should you have any technical questions or questions concerning maintenance contracts or training
courses, please contact our Martin Service Center:
Tel: [phone]
Fax: [phone]
E-Mail: [email protected]
To answer your tec
hnical questions as efficiently as possible, our service technicians will require the serial
number of the product. Therefore, please have this number at hand when contacting our hotline. The
serial number is to be found on the type plate, see section 6.1 “Overview”, page 29.