Maxium Smart C

Download as pdf or txt
Download as pdf or txt
You are on page 1of 128

Front Cover

English maxium® smart C Electrosurgery Unit with


maxium® smart Beam

Instructions for Use


Tested according to:
UL 60601-1:2003
CAN/CSA C22.2 No.601.1-M90

90-046-52-10
Revision 1
Date of Release: 2017-10 Valid from software version V1.3.35.3017
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

2 Revision 1
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

Revision 1 3
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Contents
1 Notices 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

2 Product 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

3 Intended 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

4 Working 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

5 Risk 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

4 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

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

6 Functions ................................................................................................................ 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

7 Accessories ............................................................................................................. 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

Revision 1 5
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

8 Installation 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

9 Commissioning 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

6 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

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

Revision 1 7
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

1 Notices 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 understood 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

8 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

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 injury!
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 lead to material damage (loss of time, data loss,
device/machine failure, etc.)!

Revision 1 9
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

2 Product 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. +49 7461 706-0 · Fax +49 7461 706-193
info@klsmartin.com · 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: +49 7461 706-243
Fax: +49 7461 706-190
• Should you have any technical questions or questions concerning maintenance contracts or training
courses, please contact our Martin Service Center:
Tel: +49 7461 706-343
Fax: +49 7461 706-408
E-Mail: service@klsmartin.com

To answer your technical 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.

10 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

2.3 Scope of Delivery

Electrosurgery unit
• maxium® smart C
– m-Version, REF 80-043-00-04 or
– i-Version, REF 80-043-01-04 or
– e-Version, REF 80-043-02-04
• Mains cable, country-specific variant
• Instructions for Use, REF 90-046-52-10
• Option: REF 80-094-00-04 (must be ordered separately)
• Option: Duo Prep, Duo Spray (must be ordered separately)
• Option: Neptun (must be ordered separately)

Argon Beamer
• maxium® smart Beam, REF 80-043-10-04
• Connection cable

Equipment Cart
• maxium® smart Cart, REF 80-048-00-04
• Mains cable (installed)
• Basket (installed)
• Standard rail for maxium® smart Cart, REF 80-048-01-04
• Isolating transformer maxium® smart Cart, REF 80-048-02-04
• Device holder for maxium® smart devices, REF 80-048-03-04
• Gas cylinder holder for maxium® smart Cart, REF 80-048-05-04
• Mounting kit for maxium® smart Vac, REF 80-048-06-04
• Instructions for Use, REF 90-027-58-10

2.4 User’s Inspection


• Immediately upon receipt, the goods must be checked for completeness and potential damage in
transit.
• Notice of any such damage must be given immediately.

2.5 Warranty
Our Standard Terms and Conditions of Sale effective at the time shall apply. Agreements diverging from
these Standard Terms and Conditions do not restrict the legal rights of the buyer.
Any warranty exceeding the above provisions shall require a contractual form and shall exclude
component-related vandalism, software updates and consumables.

Revision 1 11
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Maintenance information
The product may only be repaired by Gebrüder Martin or a qualified person or firm expressly authorized by
Gebrüder Martin to perform such work.
Modifications of the unit can lead to unforeseeable risks and are therefore not allowed.
If the repair is carried out by a person or firm specially authorized by Gebrüder Martin, the operator of the
product is required to obtain from the repairer a certificate with details about the nature and scope of the
repair work done. This certificate must show the date of the repair and the details of the person or firm
carrying out the work and must be signed.
In all cases where a party other than the product manufacturer performed the work, repaired products
must be additionally marked with the repairer’s ID label.
Improper interventions or alterations performed by third parties during the period of limitation shall void
any and all warranty claims. Performing unauthorized actions on the product is strictly prohibited at any
time. Non-compliance will void any liability claim against Gebrüder Martin.

3 Intended Use
3.1 Intended use of the maxium® smart C
The maxium® smart C electrosurgery unit, hereinafter referred to as “the maxium® smart C”, comprises an
HF generator and is used for electrosurgical cutting and coagulation of live human tissue. To this purpose,
electrical energy from the grid is converted into a high-frequency current which provides this surgical
property. The maxium® smart C provides the user with a large number of various currents individually
optimized to meet differing surgical requirements. The maxium® smart C is equipped for monopolar and
bipolar cutting and coagulation in micro- and macrosurgical operations.

Risk of injury by improper application!


Safe use of electrosurgery requires the user to be familiar with the technology and the applications.

With the maxium® smart C, Gebrüder Martin provides you with an electrosurgery unit that comprises state-
of-the-art technology, also for the safety of the patient and the user.
The operational safety of the unit must be verified at regular intervals, see section 14 “Periodic Safety
Checks (SC)”, page 114.
If the device is not functionally reliable and/or safe to operate, it must be marked as such and withdrawn
from service. A technical check is mandatory in any such case.

12 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

3.2 Intended use of the maxium® smart Beam


The maxium® smart Beam by Gebrüder Martin is a gas flow control unit for generation of a defined gas flow
in the range of 0–12 l/min which can be operated only in connection with the electrosurgery units
maxium®. The gas flow will be activated synchronously with the HF current. For cutting and coagulation,
individual gas flow rates can be selected. Gas and HF current are combined in the patient-side part of the
applicator. Only argon is used as a working gas. During electro-cutting, argon acts only as a shielding gas;
during electro-coagulation, however, its use results in improved surface coagulation compared to
conventional spray coagulation.

3.3 Instructions
The operator may use the device only if a function check has been performed before at the operating site
by Gebrüder Martin or a person authorized by Gebrüder Martin. In addition, a responsible person
designated by the operator must have been instructed in the proper handling, application, and operation as
well as in permissible combinations with other medical units, objects and accessories. This responsible
instructed person shall subsequently perform periodical training of the staff on behalf of the operator.
We recommend documenting the instruction sessions in a medical product log. A medicine product log is
available from Gebrüder Martin.

4 Working Principles
4.1 Preface
High-frequency (HF) electricity has been known for more than a century. As early as the 1890s, Tesla,
Nernst and d’Arsonval conducted first experiments into the physiological effects of currents with high
frequencies and high voltages.
In 1904, Cook was the first to gather surgical experience with high-frequency electricity in the treatment of
hypertrophic tonsils, removal of scars, and therapy of hemorrhoids and papillomata using sparks.
Since then, electrosurgery has definitely established itself in medicine, and modern therapy cannot be
imagined without it.
With technology and medicine advancing, electrosurgery devices were likewise improved continuously.
Apart from surgical qualities with HF current, achieving maximum safety for patients, users and third
parties has always been an essential criterion. Here enormous efforts were made to keep risks for these
persons as low as possible.
Gebrüder Martin has been one of these pioneers, producing ground-breaking technological innovations
which are still in use today. More than 40 years of experience in medical HF technology speak for
themselves.
Thus the maxium® smart C electrosurgery unit by Gebrüder Martin, too, has been developed and manu-
factured in accordance with the latest technological and medical findings. Special attention was paid to
clarity, simplicity and lucidity for the safe handling of the maxium® smart C. However, the user will be able
to fully exploit the features of the maxium® smart C by Gebrüder Martin only if he or she is completely
familiar with them. Below, the special handling features of this modern electrosurgery unit are described.
For any technical questions, please contact the Martin Service Center.

Revision 1 13
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

4.2 Monopolar application of HF current

In monopolar application, the HF current is


introduced into the operation field via an electrode
on an electrode handle or other instrument. This so-
called active electrode has a small surface. Thus at
the transition point from the electrode to the patient,
current density is high, resulting in the electrosurgical
effect desired by the user. From this contact point,
the current spreads radially. Its current density
decreases rapidly with increasing distance from the
contact point. This requires the anatomy of the
contact point to allow formation of a radial current
density distribution, also known as flow field.

For closing the circuit, the current delivered to the patient is collected again via an electrode applied to the
patient’s skin. This electrode has a large surface, so that the current density remains low and without
physiological effect. It is called the neutral electrode (NE).
Between the active electrode and the neutral electrode, the current flowing through the patient forms a
flow field, whose current density will at some distance from the contact point usually be so low that it
exerts no adverse effect. However, a living organism does not constitute a homogeneous mass: Bones and
cavities form insulating barriers, and the various tissue types exhibit differing electrical conductivities.
Unintended concentrations of the current density may result. This is why the anatomical features of the
operation field and its surroundings must be taken into account. Moreover, the current flowing through the
patient produces a voltage drop which may cause of a whole host of unwanted side-effects. For further
information, please refer to section 5 “Risk Minimization and Safety Measures”, page 17.
The HF generator for monopolar applications is activated optionally via foot switch or finger switch on the
surgical electrode handle.

4.2.1 Monopolar cutting


The high energy density on the surface of the active electrode leads to formation of a vapor layer between
electrode and tissue, in which the physical processes take place which lead to dissection of the tissue. With
specially designed electrodes, monopolar cutting, also known as electrotomy, allows shaping cuts which
cannot be achieved with knives. In addition to the cutting currents, there are also such as effect coagulation
simultaneously with the cutting and thus immediate hemostasis. The color yellow is used by convention for
the identification of the currents for cutting.

4.2.2 Monopolar coagulation


Basically, two types of coagulation are to be distinguished. If the HF current enters the tissue from the
active electrode, heating it, this is called contact coagulation. The intended use is to stop major
hemorrhages and denature tissue volumes.
Typical examples include hemostasis of bleeding from transected vessels by application of electricity
directly to a hemostat. Denaturation of larger tissue surfaces is also known as ablation, of major tissue
volumes as desiccation.

14 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

In the second type of coagulation, the energy enters the tissue not directly from the electrode, but by
arcing through a vapor or air layer, due to high electrical voltage. Here the energy is converted essentially
not in the tissue itself, but on its surface. Thus the purpose is hemostasis of superficial seeping
hemorrhages. Coagulation currents of this type are called spray coagulation or fulguration and are
particularly suited for superficial seeping hemorrhages. A special form of this type of coagulation is surface
coagulation with ionized argon gas (argon beamer). With the maxium® smart Beam, an accessory for
providing and controlling the necessary argon gas flow is available.
The maxium® smart C provides both types of currents for monopolar coagulation, as well as hybrid forms
which combine the properties of both coagulation types. The color blue is used by convention for the
identification of the currents for coagulations.

4.2.3 Neutral electrode


The current fed into the patient in monopolar application is returned to the unit by a large-surface
electrode applied to the surface of the patient’s skin. Such electrodes are available as reusable and as
disposable electrodes.
The neutral electrodes consist of soft, electrically conductive plastic material which can easily adapt to the
body contour.
The reusable neutral electrodes are equipped with a permanently attached cable.
Contact with the body is established using elastic straps or bandages, or by the weight of
the patient. The quality of the skin contact, however, is difficult to assess when using
single-piece neutral electrodes. In the case of two-piece neutral electrodes, it can be
monitored by the maxium® smart C.
Single-use neutral electrodes consist of a carrier made of soft plastic, onto which the
actual electrode surfaces is applied as a metal foil. Upon this, an electrically conductive
gel layer is applied, which establishes skin contact and attaches the electrode to the
patient’s skin. Connection to the maxium® smart C is established via a reusable cable
with connector clip. There are also disposable electrodes with permanently attached
cable.

For two-piece disposable electrodes, the quality of the skin contact can be monitored by
the maxium® smart C. To this end, a low monitoring current is led from one side of the
electrode via the patient to the other side.
The maxium® smart C is capable of monitoring single-piece as well as two-piece
electrodes. The status of the neutral electrode (NE status) is shown in the upper left
corner of the screen. When two-piece electrodes are used, additionally the relative
quality of the skin contact can be displayed.

Revision 1 15
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

4.3 Bipolar application of HF current

In bipolar application, the current flows only between


two electrodes in close spatial vicinity, which are
connected to the HF generator with both poles.
A flow field is formed which is essentially restricted
to the contact zone of the two electrodes with the
tissue. The depth of the effect is thus very limited.
A neutral electrode is not required. The problems
resulting from formation of an extensive flow field
are avoided in bipolar application.

4.3.1 Bipolar cutting


In contrast to monopolar cutting, in bipolar cutting the HF current flows – as in bipolar coagulation –
directly from one electrode to the nearby second electrode. A neutral electrode is not required. For bipolar
cutting, an asymmetric electrode arrangement with a small electrode that performs the cutting and a larger
electrode that acts as “local neutral electrode” is required.

4.3.2 Bipolar coagulation


In contrast to monopolar application, bipolar coagulation is exclusively pure contact coagulation.
The electrode pair on the instrument is usually designed symmetrically.

16 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

5 Risk Minimization and Safety Measures

Risk of serious injury in case of improper use!


Electrosurgery units comprise generators for high-frequency electrical energy, which can have high
amperage and voltage by design. In order to avoid hazards to the patient, the operators and third parties,
the procedure must be applied carefully. It is imperative to strictly observe and comply with all operating
and safety instructions.
As the maxium® smart Beam and other accessories will always be operated in combination with the
maxium® smart C, all safety instructions for the maxium® smart C also apply fully to the combination with
the maxium® smart Beam and any other accessories.

Possible malfunction of pacemakers and other active implants!


Electromagnetic interference from electrosurgical devices may disturb or completely block pacemakers or
other active implants!
For further information, refer to section 5.5, page 25.

5.1 Risks from Stray Currents


In the schematic representation of the flow of the current through the patient in section 4.2 “Monopolar
application of HF current”, page 14, the HF current entering the patient from the active electrode seems to
always return directly to the neutral electrode. In practice, a part of the electricity takes detours where
possible, and then HF currents will occur in positions where they are not expected to. Basically, here
according to the nature of the danger three types of stray currents are to be distinguished:
• Currents via patient shunts
• High-frequency and low-frequency leakage currents
• Leakage currents through other medical devices
These currents are generally insignificant, as they amount only to a small fraction of the total electricity
produced by the generator. If, however, they concentrate in small places on the body, burns may result.

Revision 1 17
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

5.1.1 Patient shunts

The spatial separation of operation field and neutral


electrode causes a very extensive flow field to be
formed. Here the currents do not necessarily all have
to flow within the body. They may exit the body and
re-enter it in another place before reaching the
neutral electrode. Depending on where the neutral
electrode is applied, such transitions may occur from
the body to a conductive surface (operating table),
from limbs to trunk or from one limb to another.
If any contact point where the current leaves or
enters the body is very small or poorly conductive
(e.g., small finger on the thigh or on the operating
table), then the current passing over may cause burns
there.

The decisive factor for burns by HF current is the current density (current per area).
The risk of burns is particularly high where high-power monopolar cutting and contact coagulation currents
are used, while it is very low in purely bipolar application.

5.1.2 High-frequency leakage currents

Wherever a circuit conducts high AC voltage against


the ground, power may “leak”, which is why this type
of currents is also commonly known as leakage
currents.
For an electrosurgery unit, that means that a small
portion of the power fed into the patient by the
active electrode will not flow back to the neutral
electrode but rather be dissipated to the ground,
whence it finds its way back to the generator via the
mains cable or the bonding connection.
These currents are usually distributed over a large
area; their current density is low and their physio-
logical effect insignificant (unlike the interference
effect on other electromedical units).

This changes when such leakage currents are absorbed by the patient in concentrated form via a conduc-
tive connection to the ground. If the area for transition from the patient to this ground connection is small
enough, then burns may result. Such a transition may also be formed between the patient and the user or a
member of his team which is also grounded.

18 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

The risk of burns is particularly high where high voltage monopolar currents are used, and in particular with
cutting currents and sparking coagulation currents.
Especially when using monopolar HF currents during endoscopic operations, consider that due to the
capacitive connection between an electrosurgical instrument and other electrically conductive components
(trocar, instrument shafts, ...) used in endoscopy, working current can be present and can cause tissue
burns when tissue comes into contact with such parts.

5.1.3 Leakage currents to other medical devices

A special form of leakage currents are the


leakage currents to other medical devices
also connected to the patient. Although
these units are not integrated into the
circuit of the electrosurgery unit, a small
portion of the HF current flows as
leakage current through the patient ports
of these devices. If the connections
(leads) have particularly small surfaces
and permit larger currents, burns at the
contact sites may result.

Basically, not even a direct electrical connection to the patient is necessary. Even local proximity to the
ground is sufficient (ground capacitance).
The risk of burns is particularly high where high voltage monopolar currents are used, and in particular with
cutting currents and sparking coagulation currents. With the bipolar currents of the maxium®, however, it is
low.

5.1.4 Measures against risks from stray currents


In order to prevent formation of shunts for HF current or concentrated leakage current paths, it is
mandatory to comply with the following instructions when placing the patient on the operating table:
• Place the patient to be isolated from grounded metal parts. Particular care is required to ensure that
the patient’s limbs do not touch any metal structures either.
• Ensure the required high-frequency insulation against the operating table by a sufficient number of
layers (insulating blankets). Since during the operation moisture, perspiration, etc. are to be expected,
a waterproof foil must be used to prevent wetting of these layers which serve as high-frequency
insulation.
• Fluid accumulation under the patient must be avoided under all circumstances. Use further dry cloth
layers where appropriate.
• Keep areas with stronger perspiration, extremities touching the trunk or skin-on-skin contact apart
from each other and dry (arm-trunk, leg-leg, breasts).
• Place the neutral electrode as close as possible to the operation field. For surgery on the trunk, the
upper arms and upper legs are good application positions.
• The above requirements for insulation must also be fulfilled if the patient is repositioned during the
operation.

Revision 1 19
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

To prevent high current densities by leakage currents to other medical devices, note the following:
• When simultaneously using electrosurgery and monitors on the same patient, use only such systems
where possible leakage currents are reduced to non-hazardous strength by constructive measures, e.g.
ECG monitors whose leads comprise protective resistors or HF reactors.
Do not use needle electrodes for monitoring – their low surface and resulting high current density are a
source of trouble.
Use the active electrode only at a distance of at least 15 cm from any ECG electrodes.
• Non-electrical medical units such as infusion cannulae or trocars may also cause a high density of
leakage currents if they have an electrically conductive connection to the ground. Such a connection
can also be formed by electrolytes such as sodium chloride solution.

5.2 Risks from Current Concentration


In the schematic representation of the flow of the current through the patient given in section 4.2
“Monopolar application of HF current”, page 14, the current density (field line density) of the HF current
entering the patient from the active electrode seems to decrease very quickly from the contact point of the
active electrode, the HF current then flowing to the neutral electrode at low current density. In fact, the
human body is an anatomically complex structure whose electrical conductivity is not homogeneous but
heavily structured by anatomical features. As a result, locally the flow field may deviate strongly from the
schematic diagram in section 4.2 “Monopolar application of HF current”, page 14. There is a risk of burns
whenever due to the anatomical features of the operating field the currents either cannot dissipate or
condense again. Basically, according to the nature of the danger two types of current condensations are to
be distinguished here:
• Current condensation in the area of the neutral electrode
• Current condensation inside the body
Experience has shown that most incidents in connection with the use of electrosurgery result from this
issue.

5.2.1 Current condensation in the area of the neutral electrode

Areas with low electrical conductivity in relation to


the rest of the body and immediately under the
neutral electrode can extremely distort the flow field
by casting a “shadow” within the flow field.
The neutral electrode is then no longer able to
absorb the power evenly over its entire surface.
Areas of higher current density result, with a risk of
burns.

20 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Conversely, metallic implants directly under the


neutral electrode may act as a collecting lens for the
current flowing to the neutral electrode. They cause
current concentrations entailing a risk of burns.
The current concentration caused by the implant
may lead to local overheating which presents an
additional risk for the integrity of the implant itself.
Similarly, metal parts on or in the skin surface, such
as rings, bracelets, chains, earrings, studs and body
piercings may cause a focusing of the flow field on
and under the surface of the skin.

The skin under the neutral electrode may itself be


very heterogeneous, e.g. due to scars. The
assumption of a smooth transition of the monopolar
electricity from the patient to the neutral electrode is
based on the notion that the skin to which the
neutral electrode is applied covers a muscle layer
with good conductivity in the electrosurgical sense.
However, in the area of the upper limbs, which are a
preferred application site for the neutral electrode,
particular in obese patients there is actually a layer of
fatty tissue with poor conductivity. As a result, under
these conditions the current will return to a neutral
electrode not from the depths of the tissue, but
rather superficially from the direction of the opera-
tion field, with consequential current concentration
along the edge of the neutral electrode facing the
operation field.

The risk of burns under of the neutral electrode is particularly high if monopolar cutting or contact
coagulation currents with particularly high power and longer duration are used (e.g. TUR-P, endometrium
ablation).
Do not use adhesive electrodes whose gel layer is injured, nor adhesive electrodes that have been
detached. 2nd or 3rd degree burns might result.
The cable clip for the connection of the adhesive electrode must cover the gel-free connector straps so that
they cannot come into contact with the patient. Make sure that the cable clip and the connector straps
match.

Revision 1 21
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

5.2.2 Current condensation inside the body

Some anatomical structures are of filamentous


nature (e.g. fallopian tubes) or connected to the body
via filamentous structures (blood vessels, ducts).
When monopolar HF current is used, the effect of the
current may have adverse effects along the entire
length of a filamentous structure or affect the
connection to the body off the actual operation field,
causing coagulation in places where it is not desired.

5.2.3 Measures against the risks posed by current accumulation


In order to minimize the risk of burns or other problems in the area of the neutral electrode, during
application of the neutral electrode please mind the following:
• The neutral electrode must butt against the patient’s body as close to the operation field as possible,
reliably, and with its whole surface. For an operation field on the torso, the upper arms and thighs are
good application sites.
• Secure contact of the neutral electrode must be ensured for the total duration of the high frequency
application.
• When applying the neutral electrode to a limb, perfusion must not be affected. Particularly for longer
operation times it must be made sure that the patient does not lie on the cable connection clip of the
neutral electrode (risk of pressure necrosis).
• The current paths in the body should be as short as possible and run in the longitudinal or diagonal
direction of the body, not across it, the latter particularly not on the chest. Any metal parts in or on the
body should be removed if possible, insulated, or paid special attention to.
• After any repositioning of the patient, the neutral electrode and its connection must be controlled.
• Do not apply the neutral electrode above implants or other metal parts, nor above bone protrusions or
scarred tissue. Clean, degrease and epilate the application area. For removal do not use substances
(e.g. alcohol) that desiccate the skin.
• Do not use adhesive electrodes whose gel layer is injured, nor adhesive electrodes that have been
detached. 2nd or 3rd degree burns might result. The cable clip for the connection of the adhesive
electrode must cover the gel-free connector straps so that they cannot come into contact with the
patient. Make sure that the cable clip and the connector straps match.
• For removal, detach the neutral electrode at the edge; do not pull at the cable or the connector strap.
Quick removal of adhesive electrodes may hurt the skin.
• For work on filamentous structures use bipolar currents, if possible.

22 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

5.3 Risks from Arcing and Sparking


Under the intended conditions of usage, at the active electrode electric arcs or sparks (arcs of very short
duration) are formed which are capable of igniting combustible material. The plasma beam of the argon
beamer is also capable of this. This risk is considerably increased by the presence of medical oxygen, since
in an oxygen-rich atmosphere combustive reactions are easier to ignite and more violent. Nitrous oxide,
itself non-combustible, may work as a fire accelerant like oxygen.
Flammable substances in the operation area are:
• Anesthetics
Flammable anesthetics such as ether form explosive mixtures with breathing air even at concentrations
as low as those regularly used.
• Solvents in cleaning and disinfecting products
They are used before the actual surgery, so that the solvent will have evaporated from the skin.
However, these substances may accumulate in depressions such as the navel or moisten the cover of
the operating table and thus remain present for extended periods of time.
• Wipes, cotton wool, gauze
Under normal atmosphere, these substances are not easily ignitable by arcs or sparks. However, cotton
and products made of it are prone to adsorb oxygen, significantly increasing their flammability and the
violence of the combustion.
• Plastic hoses and films
Under a normal atmosphere, these substances are usually self-extinguishing and cannot be ignited by
the arc at the active electrode. Under an oxygen-rich atmosphere, however, they are combustible,
unless made of silicone or Teflon.
• Endogenous gases
In the gastrointestinal tract, digestion produces gases comprising combustible components (hydrogen,
methane). In case of opening of the gastro-intestinal tract by electrosurgery, inflammation and
deflagration of these gases may result.
• Pyrolysis and electrolysis gases
During electrosurgical cutting, thermal decomposition of the tissue lead to the formation of small
amounts of pyrolysis gas. In surgery under liquid, there also occurs electrolysis of water due to the high
voltage between active electrode and tissue. During interventions with long activation times such as
TUR, these gases formed at low rates may accumulate to form bubbles. If the active electrode enters
this gas bubble, deflagration may result.
• Metal parts in the body
In case of metal parts present in the body, such as hip stems, ensure that they are not exposed to
HF currents under any circumstances. HF currents can lead to surface damage (fusing) resulting in a
notching effect that can cause fatigue bending fractures of the metal part, even several years later.

In order to avoid fire and explosion hazards in the use of electrosurgery, the following rules must be
observed:
• Use no ignitable anesthetics.
• Accumulations of combustible liquid under the patient, in depressions such as the navel or in body
cavities such as the vagina must be removed before any electrosurgery unit may be used.

Revision 1 23
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

• In case of increased concentrations of oxygen and/or nitrous oxide in the area of the operation field,
special care must be taken.
• Remove bubbles of pyrolysis and electrolysis gas in body cavities by appropriate irrigation to avoid
formation of significant accumulations.

5.4 Risks from High Voltage

Danger of neuromuscular stimulation!


The application of a current with high voltage, and in particular of a monopolar high voltage coagulation
current, may cause neuromuscular stimulation in the patient.

Electrosurgery units are designed to generate high electrical voltages. In particular, some monopolar
coagulation currents, as well as the argon beamer coagulation, have especially high voltages of several
thousand volts. Not every electrosurgical instrument is suitable for such high voltages. In particular
endoscopic HF accessories, often of very delicate design, quickly reach their limits here. Therefore in
section 11 “Currents, their Properties and Technical Data”, page 68, the HF output voltages for all currents
are specified as a function of the power setting. Make sure that the maximum voltage specified by the
manufacturer of the accessory is not exceeded!
During hemostasis using HF current via a compressor, in practice arcing of the surgical glove occurs
frequently at the point where the compressor is held.
The high voltage coagulation currents may cause corona discharges between the supply cable of the active
electrode and the skin of the patient or the surgeon, if the cable has direct contact with the skin. Slight
burns may result.
In the maxium® smart C, the mains voltage is separated from the patient connections by two insulating
barriers. These barriers may be bridged, however, if large quantities of liquid penetrate into the unit.
Bedewing by transport of the unit from a very cold to a warm environment will also affect the insulation
negatively.
For avoidance of risks associated with high electrical voltages, observe the following instructions:
• For HF coagulation, it is imperative to use insulated hemostatic compressors! Surgical gloves do not
represent a defined insulation.
• The power supply cables to monopolar active electrodes must not be laid over the patient nor across
the cables of other medical units attached to the patient.
• Set up the electrosurgery unit so that it cannot be sprayed or poured over with liquids. If any liquid has
entered the unit, it must be taken out of operation. It may be put back into operation only after a
safety inspection has been performed successfully.
• If the unit comes from a cold environment, first make sure that there is no condensation water
contained in the unit. To this purpose, allow the unit to warm up in active state at least for half an
hour.

24 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

5.5 Risks from Electromagnetic Interference


Radios, cell phones, or other emitters in the immediate vicinity of the unit may affect the safe operation of
the same. For minimum distances from emitting devices see section 16 “Guidelines and Manufacturer’s
Declaration on Electromagnetic Compatibility (EMC)”, page 119.
Electrosurgery units with their high-frequency output voltages can be powerful sources of interference.
Other electromedical units are primarily affected not by emission of electromagnetic waves, as is usually
assumed, but, as described in section 5.1 “Risks from Stray Currents”, page 17, by HF leakage currents
which either spread via the power supply or are derived directly from the patient.
Monitors for vital signs may be affected in a particularly drastic manner. As these systems resume their
normal work after the end of the HF current activation, these brief disturbances will usually be tolerated.
In case of active implants such as cardiac pacemakers there is always the danger of damage or alteration of
the programming with unforeseeable consequences. Therefore, before electro-surgery on patients with
pacemakers a cardiologist should be consulted, and the following rules must be observed:
• Such patients are to be monitored using suitable technology.
• A defibrillator as well as an external pacemaker should be kept ready for use.
• Select the lowest possible output power on the electrosurgery unit.
• Do not use the active electrode of the electrosurgery unit closer than 15 cm to the implant or its
electrodes.
• Wherever possible, use bipolar technology.
If the maxium® smart C causes interference with other units, contact the Martin Service Center,
see section 2.2 “Hotline”, page 10.

5.6 Risks from Pressure Vessels and Argon Gas Flow


5.6.1 Pressure vessels
Through their high internal pressure and weight, the cylinders in which argon is usually delivered form a
potential source of danger. Toppling or falling cylinders may lead to serious accidents, in particular when
the angle valve is struck off, resulting in uncontrolled pressure release. The safety and work guidelines for
the transport, storage, and setting up of such pressure cylinders, which apply to the other medical gases as
well, must be complied with.
Observe the following rules:
• Never transport cylinders without protective cap!
After removal, keep the protective cap at a designated place in the vicinity of the pressure cylinder. If
the cylinder is set up on the maxium® smart Cart, it can be placed next to the pressure cylinder on the
floor of the cart.
• Cylinders must be secured against toppling by suitable means!
When the cylinder is set up in the maxium® smart Cart, it can be secured with the belt provided for the
purpose.
• Never open the angle valve if there is no pressure reducer connected!

Revision 1 25
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

• Use only argon as working gas!


The pressure reducer can be connected to other pressure cylinders for so-called special gases such as
carbon dioxide as well! Make sure that the cylinder which the pressure reducer is to be connected to
really does contain argon. Appropriate cylinders are labeled with a band reading “ARGON”.
There are inert gas coagulation systems on the market which use helium as the working gas. This is not
possible with the maxium® smart Beam, since the gas flow regulation is calibrated for argon. When
connecting to a helium cylinder, which is mechanically possible, the actual gas flow would be higher by
several orders of magnitude than that displayed!
• Use only a pressure reducer by Gebrüder Martin!
The function and safety of the system are guaranteed only when a pressure reducer by
Gebrüder Martin is being used!

5.6.2 Embolisms and emphysema


Insufflation of gas into the operation field always entails the dangers of this gas being also blown into
transected vessels. This leads to danger of gas embolism. Although argon, in contrast to air or oxygen, does
not induce blood coagulation, argon gas bubbles in the arterial blood flow may, through the ramifications
of the vessels which become finer and finer, reach a point where they obstruct the flow of blood and can
stop it in the immediate environment. If the gas outlet at the tip of the applicator is placed directly upon
the tissue, there is the danger of injecting argon into the underlying tissue (emphysema).
In tissue structures where a skin layer is located above a closed tissue layer or which several layers of skin
overlay each other, argon may be insufflated between these layers, leading to separation of these layers
and trapping of larger quantities of argon.
To prevent this, observe the following rules:
• Never place the gas outlet of the applicator directly onto the tissue!
If the striking properties of the exiting beam are poor, then either select a higher output power setting
at the maxium® smart C electrosurgery unit or replace the applicator tip (burning down of the ignition
electrode tip).
• Do not use the maxium® smart Beam for hemostasis of larger transected vessels!
Such bleeding cannot be controlled reliably with the purely superficially active maxium® smart Beam
and must be dressed with conventional monopolar or bipolar contact coagulation, using a hemostat if
necessary.
• If possible, move the applicator so that it is not perpendicular to the tissue but rather forms an angle
between 30° and 60°. This will allow for a clarification of the operation field and reduce the likelihood
of argon penetration into the tissue.

5.7 Additional insufflation for endosurgical applications


Through the application of the maxium® smart Beam, argon is blown into the operation field. If the
operation field is located in a body cavity, then there is the danger that such gas insufflation leads to an
unacceptably high increase of internal pressure if the gas cannot escape. In particular in laparoscopic
surgery there is the risk of a collapse of the large venae cavae with the danger of circulatory failure if the
insufflation pressure exceeds the diastolic pressure of the relevant blood vessel.

26 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

To prevent this, observe the following rules:


• Select low gas flow rate! Use endosurgical applicators working with low gas flow rates of no more than
of 3 l/min.
• When using an insufflator, it must be equipped with a pressure monitoring unit that gives alarm in case
of exceedance of a permitted limit value, alerting the user and enabling him to take measures for
reduction of the pressure.
• When no insufflator is used, provide for discharge of the accumulating argon if there is the danger of a
pressure increase by argon.

5.7.1 Contamination of the operation field


The cylinders for argon, the fittings attached to them and the valve block in the maxium® smart Beam with
the connection for gas inlet and applicator comprise no parts that are suitable as a habitat for germs. But
they are non-sterile and not intended to be sterilized either. If this is critical for an application, then there is
the possibility of inserting a sterile filter for single use with a pore width of 0.2 µm between the gas outlet
of the unit and the sterilizable applicator. Such filters are available as accessories, see section 7.1.4
“Argon”, page 40. These filters hold back germs that are larger than viruses.

5.7.2 Concentration of argon in the breathing air


Because of its inertness, argon – unlike carbon dioxide which is also used in medical technology – does not
affect gas exchange in the lungs, but it can displace the respiratory air if the concentration becomes very
high. In a normally ventilated room, under normal conditions of use of the maxium® smart Beam no argon
concentrations can form which entail danger of asphyxiation. Argon is a possible danger if it leaks in
unventilated locations or pits. Since argon is heavier than air, it can accumulate on the ground if sufficient
ventilation is not ensured.

5.8 Miscellaneous
5.8.1 Inadvertent emission of HF current
Accidental pressing of an activation element, triggering of the automatic activation system or malfunctions
of the unit or accessories may lead to uncontrolled activation of the generator. In order to minimize the
resulting risks for patients and users, observe the following rules:
• Do not deposit electrosurgical instruments on the patient.
• Deselect the permanently connected foot switch or lift it from the floor when it is currently not
required, see section 10.3.4 “Selecting the Activation Type/Foot Switch”, page 55.
• Certain foot switches have magnetically activated reed contacts and must therefore be kept out of the
immediate vicinity of magnetic fields (especially of MRTs).
Otherwise this can lead to unintentional activation of the foot switches. For the same reason, magnets
must be kept out of the immediate vicinity of the foot switches.
Further information can be found in the respective instructions for use of the foot switch.

Revision 1 27
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

• If an activation sound is audible although no current has been intentionally activated, then there is a
system malfunction. The ON/OFF key allows turning off the unit so that it cannot emit any energy.
The activation sound always accompanying activation of an HF current is an important safety element.
Therefore it can be turned down, but not off. Taping over of the sound outlet or other measures to
“muzzle” the unit constitute illegal manipulation of a safety device!
• In endo-surgical application, the automatic activation system of the bipolar coagulation currents must
not be switched on, since otherwise unwanted activation by accidental tissue contact or by unintended
contact with the metallic trocar sleeve during placement of the electrosurgical instrument might occur.
For this reason, in the case of the selection of a program comprising a bipolar current with automatic
activation, attention is drawn to this fact. The user must then decide whether he or she wants to have
the automatic activation in the program, otherwise it will automatically be shut off.

5.8.2 Combination with other devices


When combining the maxium® smart C with electro-medical devices other than those specified in this
manual or linking it to an integrated electromedical system, attention must be paid to the following points:
• Accessories to be connected to the analog and digital interfaces of the unit must demonstrably satisfy
the applicable IEC specifications (e.g. IEC Standard 60950 for data processing units and IEC 60601-1 for
electromedical equipment).
• Anyone who connects additional units to the input or output section thereby configures the system
and is thus responsible for compliance with section 16 of IEC 60601-1.
• In case of questions, the Martin Service Center provides information, see section 2.2 “Hotline”,
page 10.

5.8.3 HF output power


The hazard potential of electrosurgery increases with the power applied. Therefore the following rules are
to be observed:
• The HF output power should be selected as low as possible for the application in question, and not
higher than necessary for the application in question. On the other hand, it should also be kept in mind
that too lower power settings may also pose a risk, e.g. if due to insufficient power cutting is not
achieved and local coagulation results where it is not desirable or even dangerous.
• Insufficient effect in case of normal settings may have the following causes, which are to be checked
before increasing HF output power:
– Poor contact of the neutral electrode with the patient’s body
– Poor contact in plug-in connections
– Wires broken beneath the insulation
– Encrusted electrodes
• A defect in the electrosurgery unit may cause undesirable increases in the HF output power.

28 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

5.8.4 Use of two electrosurgical devices on one patient


Basically, due to the increased risk of accidental burns by high-frequency currents two electrosurgical units
should be used on one patient only if medical requirements necessitate this.
The following rules are to be observed in the concomitant operation of two electrosurgical devices:
• Only type CF electrosurgery units by Gebrüder Martin may be used.
• Each unit that is operated in monopolar application requires a neutral electrode separately attached to
the patient. It is mandatory to comply with the instructions for proper application of the neutral
electrode.
• Exclusively bipolar application of a unit obviates the need for a separate neutral electrode for this unit.
• The expected current paths from each active electrode to the corresponding neutral electrode must
not overlap or intersect. To this end, always place each neutral electrode in the immediate vicinity of
the operation field.
• The total power of the simultaneously applied currents must not exceed 400 W.

6 Functions
6.1 Overview
The maxium® smart C is a microprocessor-controlled high frequency surgery device according to the latest
state of the art. It converts electrical energy from the grid into high-frequency AC power for monopolar and
bipolar application.
In monopolar operation, the unit can be activated via finger switches on an electrode handle or via foot
switches, in bipolar operation also by automatic functions, see section 9.7 “Automatic Functions of Bipolar
Coagulation”, page 51. Only one output port can be activated at a time, with the exception of the
monopolar Duo coagulation current types, for which both outputs can be activated simultaneously.
In order to meet the different requirements of the global market, the maxium® smart C is available in three
variants with different connections for instruments:
• m-version (Martin)
Module for accessories by Gebrüder Martin
• i-version (International)
Module for international accessories
• e-version (Erbe)
Module for accessories by Erbe
These instrument connections are located on a socket module which can be replaced as a whole if
necessary to convert the maxium® smart C to a different connection system.

Revision 1 29
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

e i m socket modules

Fig. 6-1: maxium® with m, i and e socket modules


Symbols on maxium® smart C: Refer to “Symbol Explanation”, page 2.

30 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

1 M Monopolar HF output port 1


2 M Monopolar HF output port 2
3 B Bipolar HF output
4 Activation indicators for monopolar HF output ports
5 Activation indicators for bipolar HF output port
6 Touchscreen
7 Channel display Cutting for monopolar HF output ports
8 Channel display Cutting for bipolar HF output port
9 Channel display Coagulation for bipolar HF output port
10 Channel display Coagulation for monopolar HF output ports
11 Selection Service / Setup
12 ON/OFF key
13 Display “VAC connected”
14 Status indicator for neutral electrode
15 Activation indicators for neutral electrode
16 Socket for neutral electrode
17 Connection for mains cable
18 Connection for single-pedal foot switch
19 Connection for double-pedal foot switch
20 Connection for LAN
21 Connection for USB
22 Type plate
23 Speakers
24 Connection for bonding
25 Unlock device
26 Connection for MCB
27 Connection for maxium® smart Beam

Revision 1 31
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

6.2 Connections on the Front


The maxium® smart C by Gebrüder Martin can be equipped with three different versions (m, i and e) of
socket modules for the HF output ports, see section 6.1 “Overview”, page 29.

6.2.1 Monopolar connections

In the socket module of the m-version, the sockets M are suitable


for standard instruments by Gebrüder Martin.
The following cables can be connected here:
• Connecting cable with circular plug by Gebrüder Martin
• Connecting cable with US 3-pin plug
• Instrument with a plain 4-mm connector (banana plug)
For this plug, use the right socket. Insertion into either of the
neighboring control contacts will cause malfunction!

Risk of injury from unauthorized accessories!


On the aftermarket, there are connection cables for bipolar accessories available which can also be
connected to the monopolar standard connector M1 or M2. For safety reasons such cables may not be
used here!

In the socket module of the i-version, the sockets M are suitable for
the international standard.
The following cables can be connected here:
• Connector cable with 8-mm “Bovie Plug”
• Connecting cable with US 3-pin plug
• Instrument with a plain 4-mm connector (banana plug)
For this plug, use the right socket. Insertion into either of the
neighboring control contacts will cause malfunction!

32 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

In the socket module of the e-version, the sockets M are suitable


for instruments with 5-mm plug (coaxial circular connector with
5-mm inner conductor).
The following cables can be connected here:
• Connector cable with coaxial circular connector with 5-mm
inner conductor
• Connecting cable with US 3-pin plug
• Instrument with a plain 4-mm connector (banana plug)
For this plug, use the right socket. Insertion into either of the
neighboring control contacts will cause malfunction!

6.2.2 Bipolar connections

The socket of the socket module of the m-version is suitable for


standard instruments by Gebrüder Martin. The socket can be used
to connect bipolar connection cables by Gebrüder Martin as well as
cables with US-2 flat connectors.

The socket of the socket module of the i-version is suitable for the
international instrument standard. The socket can be used to
connect bipolar connection cables having Erbe bipolar connectors
and US-2 flat-connectors.
The socket of the socket module of the e-version is suitable for the
international instrument standard. The socket can be used to
connect bipolar connection cables having Erbe bipolar connectors
and US-2 flat-connectors.

Revision 1 33
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

6.2.3 Neutral electrode connection

The connection socket (9, Fig. 6-1) for connection of the neutral
electrode cable is suitable for a symmetrical (angular) plug
according to US standard.

Risk of injury due to failure of power control!


Extensive neutral electrodes which are not in direct contact with the patient’s skin (so-called capacitive
neutral electrodes) limit or disable the control of the HF output power for some monopolar cutting
currents. When using such neutral electrodes, note the instructions for the use of the respective cutting
currents in section 11.1, page 68!
The neutral electrode used must be selected in the selection menu, which may lead to restrictions of
possible current types and power settings.

6.3 Connections on the Rear


6.3.1 Foot switch connections
Two foot switches can be connected to the maxium® smart C:
• One double-pedal foot switch at the connection socket (18, Fig. 6-1),
• one single-pedal foot switch at the connection socket (19, Fig. 6-1).

At the connection socket (18, Fig. 6-1) for the double-pedal foot switch, in
accordance with its intended purpose the yellow pedal is used for both
monopolar and bipolar cutting and the blue pedal for monopolar and bipolar
coagulation. The yellow pedal can be freely assigned to any cutting channel, the
blue to any coagulation channel.

The additional connection of a further single-pedal foot switch (19, Fig. 6-1)
allows activation of an instrument both in the monopolar (cutting/coagulation)
and also in the bipolar area (cutting/coagulation). The pedal can be freely
assigned to any cutting or coagulation channel.

6.3.2 Interface for the maxium® smart Beam

For connection of the maxium® smart Beam, the socket (20, Fig. 6-1) is provided.
This connection is used both for control of and power supply to the maxium®
smart Beam.

34 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

6.3.3 Serial interfaces

The MCB interface (22, Fig. 6-1) serves for linking to an integrated surgery system,
as well as for the control of external accessories such as fume suction.
Accessories to be connected to the analog and digital interfaces of the unit must
demonstrably satisfy the applicable IEC specifications (e.g. IEC Standard 60950 for
data processing devices and IEC 60601-1 for electromedical equipment). Anyone
who connects additional units to the input or output section thereby configures
the system and is thus responsible for compliance with IEC 60601-1, sections 14.3
and 16, as most recently amended.
These external systems are not required to ensure the intended use. Malfunctions
of accessory equipment whose use on the interfaces is explicitly allowed by the
manufacturer in this documentation do not result in the maxium® smart C not
being used within its intended use. No other devices may be connected, especially
simultaneously with the regular use. In addition, the installation and version notes
of the manufacturers of these systems apply. Other PC systems may be connected
only for servicing and as long as the device is not used for medical purposes.
Devices by the manufacturer that are connected to these interfaces may undergo
an immediate update or upgrade via software. However, the maxium® ensures
that this does not lead to any unacceptable risks. Activation of the maxium®
smart C during the update/upgrade is not possible.
In case of any questions, contact the authorized dealer or the
Martin Service Center.
The USB connection (21, Fig. 6-1) is used for software updates.

6.3.4 Equipotential bonding connection

Equipotential bonding, aka potential equalization, is the conductive electrical connection of


the casings of units to each other and the ground. It ensures that the units will always, even
in case of an electric defect, have the same potential. Equipotential bonding is mandatory
for certain operating rooms, e.g. those for intracardiac interventions. It can be established
via the equipotential bonding connection (23, Fig. 6-1). The necessary connection cable is
not included in the scope of delivery and can be purchased as REF 80-260-50-04 if required.

Revision 1 35
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

6.3.5 Mains connection

The maxium® smart C is equipped with a wide-range power supply, so that the nominal
value of the mains voltage can be from 100 V to 240 V without need for switching the
network connection. The power connector (24, Fig. 6-1) also comprises the fuse
protection of the unit with two fuses T 6.3 AH, 250 V.

6.4 Controls
For control of the maxium® smart C, a touchscreen is provided next to the ON/OFF key (6, Fig. 6-1).

6.4.1 ON/OFF key

After proper preparation and installation of the maxium® smart C (see national
installation and operation regulations and national rules for fire and explosion
protection), in the designated areas the unit can be set into operational condition by
pressing the ON/OFF key (6, Fig. 6-1).

The maxium® smart C is set to display the last used program after each switching on. However, in the
Service menu, the base program can be defined as autostart program (factory default, see section 10.6.7
“Service”, page 66).

If the automatic function of the bipolar coagulation Auto Start is to be used, for safety reasons it must be
activated after each switching on of the maxium® smart C.
If any setting of the program which was active during the last switching off has been modified, there
appears a notification that the program will be started with the default settings. This is done for safety
reasons in order to alert the user to the fact that the settings of the program on the screen are not the
same as during the last switching off.

The ON/OFF key will not disconnect the unit from the grid!
To disconnect the unit from the grid, the plug of the connecting cable must be pulled – at the unit or from
the outlet.

6.4.2 Touchscreen
For control of the maxium® smart C, the corresponding menu items are controlled directly via the
touchscreen.

36 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

7 Accessories

Only accessories approved by the manufacturer or compatible accessories may be used.

7.1 maxium® smart Beam


7.1.1 General Information
The maxium® smart Beam is an accessory for the maxium® smart C electrosurgery unit that serves to
generate a defined gas flow in the range of 0–12 l/min.
The gas flow will be activated synchronously with the HF current. For cutting and coagulation, individual gas
flow rates can be selected. Argon gas and HF current are combined in the patient section of the applicator.
For flushing the applicator upon connection to the beamer with argon and displacing the remaining air
therein, a gas flow without HF current can be triggered via the PURGE key.
The easy ionization of the noble gas argon can be used in coagulation by directing the coagulation current
in the form of an ionized gas jet (Argon Beam) onto the tissue surface, allowing this to coagulate in more
targeted and more uniform fashion than with conventional spray coagulation.
During cutting, argon can flow around the cutting electrode as a shielding gas, displacing atmospheric
oxygen and thereby reducing the formation of combustion products. In both cases the gas jet helps to clear
the operation field by displacing existing liquids from the surface sideward and blowing off the smoke
produced.
Argon is usually supplied from pressure cylinders with a filling pressure of 20 MPa (200 bar). This high
pressure is reduced directly on the cylinder to 250–450 kPa (2.5–4.5 bar) and fed to the maxium® smart
Beam with this pressure.
Only the MABS pressure reducer described in section 7.1.3 “Gas supply”, page 39, may be connected to
the maxium® smart Beam.
Alternatively, the maxium® smart Beam may be connected to a central argon supply, if such a system is
present and its operating pressure in the required range. To this purpose a special adapter hose will be
necessary, which is available upon request as an optional extra.

Risk of injury due to excessive gas pressure!


A central argon gas supply must be equipped with an additional safety system to guard against
unacceptably high pressure. It must be ensured that the inlet pressure at the gas inlet of the maxium®
smart Beam does not exceed a value of 600 kPa (6 bar)!

Revision 1 37
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

With its regulator, the maxium® smart Beam controls the gas throughput so that at the patient end of the
applicator the selected gas pressure will result. Different flow resistances of the applicators are auto-
matically taken into account in the process and do not affect the value of the gas flow. This makes the
maxium® smart Beam suitable also for endosurgical applications, in which the applicators comprise
particularly thin lumens.
The gas flow is activated synchronously with the HF current. Here the maxium® smart C, which also supplies
power to the maxium® smart Beam, activates the latter via the connecting cable.

7.1.2 Control and display elements, connections

Fig. 7-1: maxium® smart Beam

1 Gas outlet, Luer-lock connection for applicator


2 PURGE key for flushing the applicator with argon gas
3 Operating status indicator
4 Label for classification of the unit as type CF. The unit is defibrillation-proof.
5 Connector for connection to the maxium®
6 Decompression pin

7 Threaded connection for permanent installation


8 Connection of the argon gas supply
9 Type plate

38 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

7.1.3 Gas supply

For the operation of the maxium® smart Beam, the noble gas argon is needed. Argon is
available in cylinders of various sizes with a nominal filling pressure of 200 bar. For
installation on the maxium® smart Cart, Gebrüder Martin recommends to use 5-liter
cylinders with argon of quality 4.8 (purity higher than 99.998%, see section 7.1.4 “Argon”,
page 40). Expanded to atmospheric pressure, these cylinders contain 1,000 liters of argon
each, enough for approximately 3–6 hours of activation time (depending on the selected
flow value). The connection is made at the inlet (8, Fig. 7-1) on the rear of the unit.

When connected to a gas cylinder, the corresponding pressure


reducer reduces the high pressure to 2.5–4.0 bar. Before connecting
the pressure reducer to the cylinder, the latter must be set up safely.
To this end, the workplace safety guidelines and procedures for
handling pressure vessels must be complied with. When the
maxium® smart Beam is installed on the cart, the cylinder can be
placed there and secured with a strap. Once the cylinder has been
set up safely, remove the protective cap from the angle valve and
screw on the pressure reducer.
Fig. 7-1: MABS pressure reducer
Tighten the knurled screw only as far as manually possible without
effort!
Only then open the angle valve of the cylinder (at least half a
rotation in counter-clockwise direction). The pressure indicated on
the gauge of the pressure reducer shows the filling level of the
cylinder.
When the maxium® smart Beam is connected to a central gas supply, compliance with the inlet pressure of
2.5–4.5 bar must be ensured.
The hose installed on the pressure reducer has at its end a quick coupler which is snapped onto the gas
connector pin of the maxium® smart Beam. This quick coupler comprises a locking device which closes the
outlet in case of separation from the gas connector pin so that no gas can escape. If the hose is already
under pressure, then more force will be needed for snapping it on than under zero-pressure conditions,
and during the snapping on a small amount of gas will escape. This is harmless.
Close the angle valve to replace the cylinder. For bleeding the pressure reductor,
• disconnect the quick coupler from the gas connector pin of the beamer and place it
briefly on the decompression pin (6, Fig. 7-1),
• alternatively leave the gas hose on the beamer and produce a gas stream by
– activating the maxium® smart Beam on the electrosurgery unit or
– pressing the PURGE key on the maxium® smart Beam.
Then unscrew the pressure reducer from the cylinder.

Revision 1 39
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Never empty the cylinder completely!


At a residual pressure of 30 bar or less, the cylinder should be replaced. Pay attention to indicator on the
maxium® smart C screen!
If the system is not used for an extended period of time, close the valve on the pressure cylinder to avoid
argon loss from the system while it is not used.

Risk of injury by use of improper pressure reducer!


The function and safety of the maxium® smart Beam are guaranteed only when a MABS pressure reducer
by Gebrüder Martin is being used!

7.1.4 Argon
The chemical element argon (atomic number 18) is a noble gas which accounts for 0.93% of the
atmospheric air and is obtained from the latter by liquefaction. As a noble gas, argon will not participate in
chemical reactions (intrinsic chemical inertness). Therefore it is non-toxic, odorless, non-flammable, and
non-corrosive, and in the plasma of the argon beams no decomposition products of argon can be formed.
Its release into the ambient air, from which it has been obtained, causes no environmental problems.
Although in principle all noble gases are suitable for the operation of a beamer, the maxium® smart Beam is
designed to work with argon, since this gas is by far the cheapest and most easily available noble gas.
Gebrüder Martin recommends the use of argon of quality 4.8 with a purity of more than 99.998%. This
purity is per se not required for the process of the maxium® smart Beam. But only these high-purity gases
primarily intended for analytics are filled into pressure cylinders which do not run in the same circulation as
pressure cylinders for production and handicraft area, which may be very dirty. The use of a quality level
higher than 4.8 is possible, but will not present any advantages.
Because of its inertness, argon – unlike carbon dioxide which is also used in medical technology – does not
affect the gas exchange in the lungs, but it can displace the respiratory air if the concentration becomes
very high and thus lead to asphyxiation. In a normally ventilated room, under normal conditions of use of
the maxium® smart Beam no argon concentrations can form which entail danger of asphyxiation. Argon is a
possible hazard if it leaks in poorly ventilated locations or pits. Since argon is heavier than air, it can
accumulate on the ground if sufficient ventilation is not ensured.

7.1.5 Connection of beamer instruments


The electrode handles for argon-supported cutting and/or coagulation have separate connections for the
supply of HF current and gas. The HF connector with its flat-pin plug (US 3pin) is inserted into one of the
monopolar output ports M of the maxium® smart C. Activation is possible both via finger and foot switch. If
an argon-supported current has already been selected, e.g. in the context of a program start, and is
displayed on the screen, then the plug is to be inserted into the channel which the argon-supported current
belongs to.

40 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

The gas supply at the electrode handle is part of a Luer-lock


connection and to be connected to the socket (1, Fig. 7-1) on the
front of the maxium® smart Beam. In order to flush out any air
present in the applicator, by pressing the PURGE key (2, Fig. 7-1) an
argon gas flow can be initiated without activating the
electrosurgery unit.

The components of the gas supply and the gas flow control inside the unit up to the outlet are non-sterile.
For more protection against microbial contamination, there is the possibility of inserting a sterile single use
filter (REF 80-181-90-04) with a pore width of 0.2 µm between the gas outlet of the unit and the sterilizable
applicator, which will hold back potential germs (with the exception of viruses).

7.2 Instruments, Electrode Handles, Electrodes, Foot Switches and Cables for
maxium® and maxium® smart Beam
The maxium® smart C as well as the maxium® smart Beam may be used only with accessories, wear parts
and single use articles whose safety of use has been demonstrated by a declaration of conformity. The use
of uncertified accessories by other manufacturers may constitute a source of danger. In case of doubt,
consult the manufacturer.
The accessories certified for electrosurgery units by Gebrüder Martin can be taken from the accessories
catalog of Gebrüder Martin, which can be requested or directly downloaded from www.klsmartin.com.
Combinations of accessories which are not mentioned in these Instructions for Use may be used only if
expressly designed for the intended application. Features and safety requirements must not be affected
adversely.

Revision 1 41
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

8 Installation of the maxium® smart C and the


maxium® smart Beam
8.1 Standalone Installation of the maxium® smart C
The maxium® smart C is designed to be set up on a level surface such as a table or a shelf.
Connection to a power outlet is established with the supplied mains cable to be inserted into the mains
port on the backside. The maxium® smart C can use any AC mains voltage in the nominal range of
100–240 V. Thus no special adaptation to the mains voltage at the installation is required.
If the maxium® smart C is to be connected on-site to a grounded equipotential bonding network, then this
can be done using the connection pin on the rear via the equipotential bonding cable, REF 80-260-50-04.
This cable is optional and not included in the scope of delivery of the maxium® smart C.
Usually, on the rear also a double-pedal switch will be connected. If required, in addition a small single-
pedal switch can be connected.
After connection of the electrode cables, the maxium® smart C is then ready for commissioning.

Risk of electric shock!


In order to avoid the risk of electric shock, this unit may be connected only to a grounded mains supply.

Risk of damage to property


In order to be able to completely separate the unit from the grid in the event of danger, either the power
socket of the unit or the outlet into which the mains cable is plugged in should remain accessible.

For the decommissioning of the unit, no special measures are necessary.

42 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

8.2 Installation of the maxium® smart C with maxium® smart Beam

Typically, the maxium® smart C and maxium® smart Beam system


components are stacked one upon the other with the beamer
below, and connected to each other by the interlocking
connections.

• Place the maxium® smart Beam on the front edge of the


mounting plate (1) of the maxium® smart Cart.
• Press down the maxium® smart Beam until it snaps into
place on the mounting plate

The mounted maxium® smart Beam

• Mount the maxium® smart C (3) in the same manner on the


maxium® smart Beam (2).

Revision 1 43
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

• To unmount the maxium® smart C and maxium® smart


Beam, insert a round object into the opening provided for
this purpose and simultaneously lift the device.

Perform the gas installation as follows:


• Set up the pressure vessel with the argon gas so that it is secured against toppling.
• Remove the protective cap and screw on the pressure reducer. Tighten the knurled screw of the
pressure reducer only manually!
• Snap the hose of the pressure reducer onto the argon inlet at the rear of the beamer. If the angle valve
of the pressure vessel is already open, then a bit of force is required, and a small amount of gas will
escape in a loud hiss.
After turning the angle valve open by at least half a turn in counterclockwise direction, the system is ready
for commissioning.

Risk of injury by use of improper pressure reducer!


Do not connect any pressure reducer to the maxium® smart Beam other than that offered as a standard
accessory by Gebrüder Martin!

44 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

8.3 Installation on the maxium® smart Cart

For accommodation of the complete system consisting of


maxium® smart Beam, maxium® smart C electrosurgery unit,
argon cylinders and the respective accessories in a self-
contained unit, Gebrüder Martin recommends installation on
the maxium® smart Cart, REF 80-048-00-04.
The maxium® smart C electrosurgery unit and the maxium®
smart Beam are stacked one upon the other and connected
to the maxium® Smart Cart using the same elements which
also connect the maxium® smart C and the maxium® smart
Beam to each other.
For installation, a device holder REF 80-048-03-04 must
be ordered in addition to the maxium® smart Cart
REF 80-048-00-04.

The lower part of the cart can safely accommodate a 5-liter


argon cylinder. After inserting the pressure cylinder into the
cart, screw on the pressure reducer. Turn the cylinder so that
the pressure gauge on the pressure reducer is easy to read.
Lead the hose to the beamer out through the lateral
opening. The protective cap of the cylinder can be stored on
the bottom of the cart next to the cylinder. For installation/
attachment of the gas cylinder, the gas cylinder holder
REF 80-048-05-04 must be ordered.
Lines for connection to a central argon gas supply are
available upon request.

Revision 1 45
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

9 Commissioning of the maxium® smart C and the


maxium® smart Beam
9.1 General Information
The maxium® smart C may be used only by persons trained in the proper and safe use of the unit.
The Instructions for Use are to be adhered to in instruction and application.

9.2 Switching on the maxium® smart C

If the unit is correctly set up and connected to the power supply,


it can be switched on by pressing the ON/OFF key. Before the
maxium® smart C is ready, it will perform a number of self-tests to
identify any system errors. This takes some time. During this time,
the startup screen is displayed. The progress bar at the bottom of
the screen shows the status of the self-test.

After a successful self-test, the display switches to the base program (optionally also the previously used
program can be selected as the autostart program). This setting can be modified via the Setup/Service
menu.
If the mains supply was interrupted without the unit being switched off before, a message “Restart after
mains power interruption” will appear once the power supply is restored.
If the self-test is not passed, a message will appear in the status line of the screen, in case of serious errors
together with an error number.
Typical messages during the self-test of the maxium® smart C include the following:
• Self-test: XX switch engaged upon unit startup!
During self-test, the maxium® has received a signal from an activation element. Either an attempt to
activate an HF current was made already during self-test, or the switch of some activation element is
blocked. Possibly the cable of the foot switch, when it is not intended to be used, is wrapped around
the foot switch so that a pedal is actuated. In case of doubt disconnect all accessories from the
maxium® smart C and switch the unit off and on again. If the message appears again, then there is a
malfunction, and the unit must be taken out of operation.
• Unplug bipolar instrument from B during self-test!
During self-test, the maxium® smart C registers that between the active electrodes of a bipolar
instrument connected to output B there exists a contact which should not be there yet at that time.
Unplug cable from the indicated output port B. Either the maxium® smart C continues the self-test,
or it must be switched off and on again. If the message appears again, although no instrument is
connected to the bipolar output, then there is a malfunction, and the unit must be taken out of
operation.
For additional messages see section 13 “Messages”, page 107.
During the self-test, the lights for indication of activation and NE status will be lit in groups. They must all
be visible, and the activation sounds must be audible.

46 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

9.3 Switching on the maxium® smart Beam


The maxium® smart Beam is fed and controlled by the maxium® smart C. When switched on, independently
of the maxium® smart C it will perform a self-test, checking the functions of the gas flow control and the
status of the argon gas supply.
If the active program of the maxium® smart C does not comprise any argon-supported currents, after the
self-test the beamer will change to a passive mode, its status light remaining dark. If the program comprises
any argon-supported currents, after passing the self-test the status light will be lit green.
In case of an error the status light will be lit red, and the status line on the screen will show a message
together with an error number.
Typical messages during the self-test of the maxium® smart Beam are the following:
• Argon Beamer Warning: Inlet pressure too low
The pressure measured at the gas inlet is too low to ensure the required gas flow at the end of the
applicator under all operation conditions. Make sure that the argon gas supply from the pressure
reducer is connected to the rear of the beamer, and the angle valve of the cylinder opened. If the
gauge at the pressure reducer indicates a pressure of less than 10 bar, operation with the residual
pressure is not expedient.
The cylinder should never be completely emptied!
• Argon Beamer E55-59: Offset failure
The pressure sensors of the maxium® smart Beam are sensitive to temperature changes. In case of
temperature changes, the temperatures of the individual components of the unit will adapt to the new
temperature, but often with very different speeds. If components of the pressure sensors have
different temperatures, the pressure sensors will yield output signals which are liable to incorrect
interpretation. If a beamer is moved from a very cold to a warm environment, due to the resulting
temperature gradient the self-test may not be passed. In this case, allow the maxium® smart Beam to
warm up for half an hour with the unit switched on. If the self-test is again not completed successfully,
there is a malfunction.
For additional messages see section 13.5 “Messages from the Argon Beamer and the Fume Suction
System”, page 112.

9.3.1 Noise during operation


In intervals of a few minutes, the maxium® smart Beam will check the calibration of the gas flow control.
To this purpose, a small amount of gas is released into the inside of the beamer, and both the activity of the
solenoid valves and the gas flow will be heard. This is not a malfunction of the beamer, but serves to ensure
maintenance of the accuracy of the operating data.

Revision 1 47
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

9.4 Connection of the active electrodes


Active electrodes, their sockets and lines must be examined for defects of the insulation before being
connected. Active electrodes with insulation defects present a risk for the patient and the surgeon.
If current types with high output voltages are to be used, it must be made sure that the accessories
combined with the active electrode are approved for use with the potential voltage. For each current,
section 11 “Currents, their Properties and Technical Data”, page 68, lists the voltages as function of the
power settings.
If a monopolar instrument is to be connected to one of the M output ports with a simple cable with a 4-mm
connector (banana plug), it must be made sure that this plug is always inserted into the right single socket
of the US 3-pin connector. In the version by Gebrüder Martin, optionally also the inner conductor of the
coaxial combo socket can be used, see section 6.2.1 “Monopolar connections”, page 32.
If the two sockets mentioned above are being attempted to be used simultaneously, or if any other socket
is being tried to be used, an error message notifying the user about the incorrect assignment appears on
the display.
The lines to the active electrode should not be placed over the patient nor over patient lines of other
electromedical units.

9.5 Connection of the neutral electrode


If a monopolar HF current is to be used, then a neutral electrode must be placed on the patient, or a
capacitive neutral electrode must be used. Also in cases where bipolar application is intended but
additional application of monopolar electricity is likely in case of complications, a neutral electrode should
at least be kept ready.

9.5.1 Application of the neutral electrode


By overwhelming majority of troubles in the application of electrosurgery have to do with the neutral
electrode. That is why it is worthwhile to pay special attention to this issue in daily routine.
For application of the neutral electrode, the following rules must be observed:
• The neutral electrode must butt against the patient’s body as close to the operation field as possible,
reliably, and with its whole surface. For an operation field on the torso, the upper arms and thighs are
good application sites.
• Safe contact of the neutral electrode must be ensured for the whole duration of the HF application.
When applying the neutral electrode to a limb, perfusion must not be affected. Particularly for longer
operation times it must be made sure that the patient does not lie on the cable connection clip of the
neutral electrode. Otherwise there is a danger of pressure necrosis.
• The current paths in the body should be as short as possible and run in the longitudinal or diagonal
direction of the body, not across it, the latter particularly not on the chest. Any metal parts in or on the
body should be removed if possible, insulated, or paid special attention to.
• After any repositioning of the patient, the neutral electrode and its connection must be controlled for
proper attachment.
• For applications with high power and long activation times, such as TUR-P and endometrium ablation,
it is strongly recommended to use monitored adhesive two-piece electrodes.

48 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

• Do not apply the neutral electrode above implants or other metal parts, nor above bone protrusions
or scarred tissue. If necessary, prepare the application site by cleaning and degreasing it; strong hair-
growth is to be removed. For removal do not use substances (e.g. alcohol) that desiccate the skin.
• Do not use adhesive electrodes whose gel layer is injured, nor adhesive electrodes that have been
detached. 2nd or 3rd degree burns might result. The cable clip for the connection of the adhesive
electrode must cover the gel-free connector straps so that they cannot come into contact with the
patient. Make sure that the cable clip and the connector straps match.
• For removal of the neutral electrode, do not pull at the cable or the connector strap. Quick removal of
adhesive electrodes may hurt the skin.
• When using a Baby, a capacitive, or a Twin Pad II neutral electrode, it is mandatory to make the
corresponding selection in the sub-menu.
An explanation for better understanding of these rules is provided in section 5.1 “Risks from Stray
Currents”, page 17, and in section 5.2 “Risks from Current Concentration”, page 20.

9.5.2 Gebrüder Martin Patient Control System (PCS)


Correct application of the neutral electrode is of particular importance. The maxium® smart C can be used
both with single-piece and with monitored two-piece electrodes.
The Patient Control System (PCS) by Gebrüder Martin is a tried and tested system for monitoring the
connection and body contact of neutral electrodes. The PCS automatically detects whether a connected
neutral electrode is single-piece or two-piece; user input is not required.
Monitoring of the quality of contact and confirmation via the indicator are possible only in case of split
neutral electrodes (as well as Baby NE or Twin Pad II) Non-split neutral electrodes cannot be monitored;
there is only an insertion detection on the device that informs the user that an instrument is connected.

The status of the neutral electrode is indicated by a light next to the NE


connection socket, as well as in the lower left corner of the screen. If no neutral
electrode is connected, the light at the socket will be flashing red, while the
screen shows the representation of a red neutral electrode, and next to that an
indicator representing the application state of the neutral electrode as a variable
signal (only in case of split preselection of a neutral electrode). This indicator can
be shut off if desired, see section 10.6.4 “Neutral electrode”, page 65. In this
condition no monopolar HF current can be activated. When an attempt is made to
activate an HF current, an intermittent acoustic warning signal is sounded and a
message displayed in the status line of the screen.

Upon connection of a two-piece neutral electrode that adheres correctly to the


patient's skin, after a short run-in the color of the status indicator light next to the
NE socket will change to green. The representation of the NE on the screen will
change to green. The pointer of the indicator is now in the green field. Now
monopolar HF currents can be activated, too.

Revision 1 49
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

During the time in which the neutral electrode is applied to the skin of the
patient, the PCS will monitor the resistance of the skin. The lowest measured
resistance is used as reference for the contact quality and represents the right-
most position of the pointer. If the resistance measured between the two halves
of the neutral electrode should increase again over the further course of the
application, the pointer of the indicator will move leftward, signaling deteriora-
tion of the skin contact. This may be caused by loss of contact of the neutral
electrode with the skin due to repositioning of the patient or drying up of a self-
adhesive electrode (absorption of water through the skin) during very long
operations.
This permanent representation of contact changes is very helpful in the localization of contact problems
with the neutral electrode. Sometimes, in the case of two-piece electrodes after application of the
electrode on the skin the NE alarm will not go out. If the pointer of the indicator slowly moves away from
the left edge into the yellow field, the patient has a particularly high electrical resistance. This may be due
to the age of the patient, his/her ethnic background or other reasons. Generally it is to be expected that in
such a case the alarm will end with delay. If the pointer does not move, there is a probability of an inter-
ruption in the monitoring circuit, e.g. at the transition from the cable connection clip to the NE. Oscillations
of the pointer indicate an unstable contact in the monitoring circuit, which will most likely be found in the
area of the connector at the maxium® smart C or in the vicinity of the cable connection clip.

Upon connection of a non-split reusable NE or adhesive NE for single use, the status light at
the NE connection will turn green. On the screen, a non-split green NE without contact
indicator will appear, since with such electrodes no patient contact supervision takes place.
Section 10.6.4 “Neutral electrode”, page 65, describes how to set up the maxium® so that it
will accept only PCS-monitorable two-piece electrodes. If the maxium® is set up like this,
then the NE status display will remain red upon connection of single-piece electrodes. The
screen will show a red NE, and HF activation is not possible.

Danger of injuries from detached neutral electrode!


When using a single-piece NE, there is no alarm triggered when it detaches from the patient!

50 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

9.6 Argon Filling Level

If an argon beamer is connected to the maxium® smart C and the current program
comprises an argon current, a pressure cylinder with the remaining filling level is
displayed on the bottom of the screen.

The level indicator is based on a special feature of the MABS pressure reducer, not on measurement of the
pressure on the input side of the pressure reducer. This is also why it will work only with the former and
only if no argon gas flow is activated. During activation, the previously measured level will be frozen.
If the level indicator on the screen deviates strongly from the pressure gauge on the pressure reducer, the
display should be re-calibrated, see the maxium® smart C Service Manual. If in doubt, the display of the
pressure gauge is authoritative.

9.7 Automatic Functions of Bipolar Coagulation


The bipolar coagulation current types BiCoag and Neptun can be activated either via a foot switch or
automatically upon tissue contact of the instrument. A delay of the automatic activation of HF current can
be selected in the activation menu, see section 10.3.4 “Selecting the Activation Type/Foot Switch”, page 55.
The activation type is assigned to a current type in a sub-menu:

BiCoag und Neptun


The HF current is activated and deactivated by the user via the foot switch or,
if present, finger switch. The automatic functions are disabled.

BiCoag und Neptun Auto Start


HF current is activated upon tissue contact, if desired with pre-selected delay.
However, the HF current is not turned off before the instrument is removed
from the tissue. For very fine forceps or very strongly desiccated tissue, the
current may be switched off due to the very high tissue resistance even though
the instrument still has tissue contact.

Revision 1 51
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

9.8 Information about the limitations of the auto-start function

Danger of injury by burns!


In endoscopic surgery, do not use the auto-start function!

For technical reasons, a bipolar output cannot be associated with a cutting current and a coagulation
current with auto-start function at the same time. Selection of a coagulation current with Auto Start will
automatically deselect the parallel cutting channel, see also section 10.2 “Selection and Deselection of
Working Channels”, page 53. Conversely, selection of a cutting current will deselect the parallel coagulation
channel, if a current with Auto Start is selected there. If the coagulation channel is selected again, then the
original current appears without auto-start function.
Particularly in endoscopy the auto-start function carries the risk of burns and coagulation necroses due to
unnoticed and unintended automatic activation of HF current in the placement of endoscopic instruments.
For this reason, the auto-start function of the maxium® smart C is equipped with some restrictions which
are intended to exclude inadvertent activation of this function as far as possible:
• In none of the factory-preset programs an auto-start function is enabled. This is to ensure that users
not yet familiar with this feature cannot be exposed to a risk of uncontrolled HF emission which they
are unaware of. If a user wants to deliberately use a current with auto-start function, he/she can
manually select it and save the program under a new name, see section 10.5.4 “Saving a program
under a new name”, page 59.
• Selection of a program comprising a current with auto-start function invokes a confirmation dialog
asking the user to confirm or reject the auto-start function. If the user declines, the program is not
loaded and the previous menu item is opened.

52 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

10 Using the maxium® smart C


10.1 General Information
To each instrument connection, on the screen a cutting channel as a yellow field and a coagulation channel
as a blue field are assigned in horizontal direction. All settings of the device for clinical day-to-day operation
are done via the touchscreen. Further adjustments which will generally be made only once for the intended
workplace and rarely changed, are available in the Setup and Service menus, see section 10.6.7 “Service”,
page 66. In daily routine, the parameters of the unit for a specific application are selected quickly and easily
using pre-defined programs, which can then be modified or extended on a case-by-case basis as needed.

10.2 Selection and Deselection of Working Channels


If there is no cutting or coagulation function assigned
to a channel, this part is displayed on the screen as a
gray field. If the user touches the gray field at any
position, it is activated, and the parameters can be
adjusted accordingly.
In order to improve the clarity of the screen layout,
channels not required for the current application can
be deselected. For this purpose, touch the corres-
ponding area on the screen for at least two seconds.
The channel display of the corresponding channel
disappears from the screen and is replaced by a gray
area. Thus up to five of the six channels can be de-
selected. This approach is especially recommended
when working with programs that are tailored to very
specific applications.
Deselection of an HF output port that is not used
makes it much clearer to which of the two monopolar
HF output ports an instrument for a specific applica-
tion is to be connected (in the example: to the upper
of the two HF output ports)

When attempting to activate a deselected channel with its activation source, the gray channel will display a
message, accompanied by an intermittent acoustic signal. The HF current itself is disabled. To use the
deselected channel again, touch the corresponding area on the screen to activate it.
The maxium® smart C is equipped with an insertion detection, i.e. if a channel is activated via a foot switch
and no instrument is inserted, a message is displayed on the screen that informs the user that no
instrument is inserted into the channel that has been assigned to the foot switch.

Revision 1 53
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

10.3 Setting the Values for the Working Channels


The channel fields are used for
• selecting the HF output power, page 54,
• selecting the current, page 54,
• in the case of argon-supported currents also for setting the gas flow, page 54.
• setting of the effect, page 55,
• selection of the activation type/foot switch, page 55.

10.3.1 Setting the HF Output Power

Below the number for the power setting there is a


horizontal bar indicating the power relative to its
maximum value. This indicator is not linear.
After pressing of the power value to be adjusted,
a red frame appears around the power value and a
window is opened.
The power can now be adjusted using the slider
and/or the +/- buttons. Any adjustment can be
confirmed by tapping the check mark or canceled
by tapping the cross.

10.3.2 Selecting the current


The maxium® smart C is equipped with various current types for monopolar and bipolar applications,
for cutting and coagulation, depending on the application and instrument.
The individual icons indicate the differences in performance in form of the dots (more dots stand for
increased coagulation) and the type of instrument to be used (e.g. cutting loop of a resectoscope).

After pressing the current type to be adjusted, a red


frame appears around the current type, and a window
is opened. Here, another current type can be selected
by pressing the icon (a black frame appears).
The selection can be confirmed by tapping the check
mark or canceled by tapping the cross.
Each current type has a default value for the power
and effect stored, which will be used when the
selection of the current type is confirmed. If these
default values are changed, they must be sub-
sequently changed separately.

54 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

10.3.3 Setting the Effect


The performance of the maxium® smart C can be changed via setting the effect. For this purpose, there are
several effect settings for all current types, which result in different degrees of hemostasis, regardless of
the selected power. When the effect is being adjusted, the corresponding voltage values and the change in
hemostasis are displayed in a diagram.

After selecting the effect to be adjusted by pressing,


a red frame appears around the effect value, and a
window is opened.
• The effect can now be adjusted using the slider
and/or the +/- buttons.
Any adjustment can be confirmed by tapping the
check mark or canceled by tapping the cross.

10.3.4 Selecting the Activation Type/Foot Switch


The maxium® smart C can be activated via finger switches on the instrument, via foot switches, and for
bipolar coagulation currents also automatically. While each finger switch is always unambiguously assigned
to the channel to which its instrument is connected, foot switches must first be assigned to a channel by
the user.
Two foot switches can be connected to the maxium® smart C, a double-pedal foot switch with a yellow
pedal for cutting and a blue pedal for coagulation, as well as a single-pedal foot switch with a neutral black
pedal.

After pressing of the area on the right to the effect,


an activation menu is opened. The respective
activation type can be selected here.
The following selection options for activation are
available:
Monopolar cutting:
• using the finger switch
• using the yellow pedal
• using the black pedal

Monopolar coagulation:
• using the finger switch
• using the blue pedal
• using the black pedal

Revision 1 55
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Bipolar cutting:
• using the finger switch
• using the yellow pedal
• using the black pedal

Bipolar coagulation:
• using the finger switch
• using the blue pedal
• using the black pedal
• using auto start function without time delay
• using auto start function and time delay

The selection can be confirmed by tapping the check


mark or canceled by tapping the cross.
If an already assigned foot switch is assigned to
another channel, it is removed from the previous
channel.

10.4 Navigation within the Programs and Functions of the maxium® smart C
The maxium® smart C starts with the previously used
program (which can also be changed to the base
program in the setup).
When pressing the screen, the following sub-menus
can be activated:
• Program settings
• Neutral electrode
• VAC Smoke evacuator
• Sound settings
• Display
• Clock menu timeouts
• Argon
• Message history
• Help
• Interactive language
• Service
• Hotline

56 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

By pressing the respective display areas, the setting


and menu area can be opened, which must then be
confirmed by tapping the check mark. By pressing the
cross, the higher-level menu item will be opened.
Activation of HF current while any of the settings
described above is being changed will cancel the
operation automatically, since availability of HF current
for the surgeon enjoys higher priority than adjustment
of device parameters.

10.5 Programming Settings


Setting each channel parameter before the operation is time-consuming due to the variety of options and
carries the risk of operating errors. Therefore, such settings, called programs, will be saved under a name in
the unit. Up to 50 such programs can be stored in the maxium® smart C. By factory default, there are
already some programs saved which are denoted with applications for which they are particularly suitable.
The operator can use, modify and save or delete these programs or create custom programs.

10.5.1 Base program


The maxium® smart C can be set to automatically start with the base program upon activation.

The settings of the base program can be changed, like


those of every other program. In case of a deviation
from the basic setting, the addition “modified” will
appear suffixed to name in the status line on the
screen, and “Save” will appear next to it. This
modification, however, cannot be saved in the base
program, as this is read-only. If the modifications are
to be saved permanently, then the modified program
must be saved under a new name, see section 10.5.4
“Saving a program under a new name”, page 59.

The base program cannot be deleted or overwritten.


With the function Power-up with Base Program, the
Service menu offers the option of setting up the unit
so that upon start-up the base program appears,
rather than the last-used program. Here the settings
of the base program can be changed as well, if this is
explicitly desired. The procedure is described in the
maxium® smart C Service Manual.

Revision 1 57
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

10.5.2 Selecting Programs

There are two ways to select and activate a program


stored in the unit:
• via the list of recently used programs
• via the Program settings menu
Selection via the list of recently used programs
(LUPs):
• Press the current program name
• Mark the desired program and confirm by
tapping the check mark
The settings of the program are applied on the
screen.
Selection via the Program settings menu:
• Press the symbol to open the Setup
• Press Program settings
• Press Select program
• Press Show All Programs
• The list of all programs appears in alphabetical
order
• Find the desired program by moving the scrollbar
or wiping over the program names
• Select the program by pressing it
• Confirm by pressing the check mark
As soon as a program has been selected, a preview of
the channel fields with the settings for this program is
displayed on the right side.

58 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

10.5.3 Saving modified programs

Changes made to a program can be made permanent.


• Press Save.
• Confirm by tapping the check mark or the Return
button
or:
• Press the symbol to open the Setup
• Press Program settings
• Press Overwrite program
• Confirm by tapping the check mark or Overwrite
program
The base program and programs with the “padlock”
icon can be neither deleted nor overwritten. Changes
can only be saved under a different program name,
see section 10.5.4 “Saving a program under a new
name”, page 59.

10.5.4 Saving a program under a new name

If a setting is to be saved as an independent program,


this setting must be given a new name.
• Press Save.
• Enter the new name
• Confirm by tapping the check mark or the Return
button
or:
• Press the symbol to open the Setup
• Press Programming settings
• Press Save as
• Enter the new name
• Confirm by tapping the check mark or Return

Revision 1 59
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

10.5.5 Deleting programs

To delete a program, proceed as follows:


• Press the symbol to open the Setup
• Press Program settings
• Press Delete Program
• Find the program to be deleted and mark it
• Confirm by tapping the check mark or Delete
program
• Confirm again by tapping the check mark
The base program and programs with the “padlock”
icon can be neither deleted nor overwritten. Changes
can be saved only under a new program name, see
section 10.5.4 “Saving a program under a new name”,
page 59.

10.5.6 SWAP® mode (optional)


The SWAP® mode allows switching to and fro between two pre-set programs by using the foot switch or
the finger switch on electrode handle.
This new function allows the operator to use different settings during the operation, without the need for
switching to be made by a non-sterile person directly at the maxium® smart C. It is useful where there is a
need to change any settings of the unit in the course of a surgery.
Switching from a user program to the associated parallel program is possible by using the special double-
pedal foot switches with SWAP® mode or by simultaneously activating both finger switches of any two-key
electrode handle. This function cannot be used with electrode handles in which the two keys are combined
into a rocker switch.
The maxium® smart C confirms the switching by a multiple acoustic signal.
For using the SWAP® mode, the following conditions must be created:

First, for the active program a SWAP® program must


be defined.
To this purpose, an already existing program can be
used, otherwise first a program must be generated
and saved, for which purpose usually the program
will be used which it is to be assigned to afterwards.

60 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

The name of this SWAP® program should reflect the


link with the initial program.
The assignment is done as follows:
• Press the symbol to open the Setup
• Press Program settings
• Press Link to a SWAP progr.
• Find the program and mark it
• Press Link to a SWAP progr.
• Find the second program and mark it
• Confirm by tapping the check mark or Apply link
The linkage of the two programs is immediately
shown in the program list, where the letters “A” and
“B” are prefixed to the program names.
To remove a SWAP® linkage, follow the steps below:
• Press the symbol to open the Setup
• Press Program settings
• Press Unlink SWAP program
• Find the program and mark it
• Confirm by tapping the check mark or Unlink
SWAP program
• Confirm again by tapping the check mark.

Revision 1 61
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

10.6 The Setup Menu


In the Setup menu, various unit and service settings can be made:
• Programming Settings (section 10.5, page 57)
• Neutral electrode (section 10.6.4, page 65)
• Sound settings (section 10.6.1 “Setting sound level”, page 63)
• Display (section 10.6.2 “Setting display”, page 64)
• Clock menu timeouts (section 10.6.3 “Setting the Time/Menu Timeouts”, page 64)
• Argon (section 10.6.5 “Argon mode”, page 66)
• Message History (section 10.6.10, page 67)
• Help (section 10.6.9, page 67)
• Interface Language (section 10.6.8, page 66)
• Service (section 10.6.7, page 66)
• Hotline (section 10.6.6, page 66)

Some settings will affect the current program only


(local settings). Others will affect all programs (global
settings).
Whereas global settings are saved automatically,
changes to local settings are considered temporary
modifications which will be lost when the power is
turned off. If local setting are to be preserved, they
must be saved manually with the program, see
section 10.5.3 “Saving modified programs”, page 59.
As the base program cannot be saved after changes,
changes to the base program will always be
temporary.

62 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

10.6.1 Setting sound level


In this menu, the volume of activation and alarm tones can be set. These settings are global.

The function Activation tone volume serves to adjust


the volume of the sound which indicates activation of
an HF current. The sound itself is audible, so that the
volume can be adjusted to an acceptable value. The
display shows a bar and the relative value in percent.
As the sound has a safety function, it cannot be
turned down arbitrarily. The applicable standard
IEC 60601-2-2 prescribes a minimum of 40 dB(A).
For this reason, reduction of the volume to less than
40% is not possible.

This function is used to adjust the volume of the


alarm tone.
The sound itself is audible, so that the volume can be
adjusted to an acceptable value. The display shows
a bar and the relative value in percent. As the sound
has a safety function, it cannot be turned down
arbitrarily. The applicable standard IEC 60601-2-2
prescribes a minimum of 65 dB(A).
For this reason, reduction of the volume to less than
40% is not possible.

This function is used to adjust the volume of the


warnings and information notes.

This function is used to adjust the sound of the


button for touchscreen operation that signals an
activation to the user.

Revision 1 63
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

The maxium® electrosurgery unit is equipped with an


automatic sound level increase function that
increases the activation sound after a preset period
of time.
Options: 15, 30, 60 seconds, or Never.
This function can serve to acoustically alert the user
to unintentional activation of the HF current and thus
to avoid possible burns.

10.6.2 Setting display

In the Display menu, the brightness of the screen can


be adjusted to adapt it to the environment. For this
purpose, a day or night design can be selected.
With the function Brightness, brightness of the
screen can be set to a minimum value of 10%.
The change will take effect immediately, so that an
acceptable brightness level can be set directly.

10.6.3 Setting the Time/Menu Timeouts

This menu can be used to set the date and time.


The menu Clock menu timeout can be used to
globally set a time window that determines after
what time a menu level is automatically exited to
return to the main menu. The shortest possible time
window is 30 seconds; the highest setting is “never”.
The countdown is reset whenever a confirmation is
made within a menu.

64 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

10.6.4 Neutral electrode

In this menu, restrictions or permissions for certain


features of neutral electrodes can be set.
It can be determined whether the unit is to allow
operation with single-piece as well as with two-piece
electrodes, or with two-piece electrodes only.
Furthermore, various types of neutral electrodes can
be selected that do not allow certain current types, or
restrict their power for safety reasons.
The global default setting provides for operation with
split neutral electrodes only.
Using the function Use Non-split NEs too, use of a non-
split neutral electrode can be allowed.

The function Mega Soft® Baby NE allows use of


especially small-sized neutral electrodes for neonates
and babies.
With the unit setting for these electrodes, there come
some limitations regarding the current types. In case of
monopolar current types, additionally the maximum
HF output power that can be selected is limited.

The function Mega Soft® NE allows use of capacitive


large-surface NEs for operations on neonates or infants.
With the unit setting for these electrodes, there come
some limitations regarding the current types. In case of
monopolar current types, additionally the maximum HF
output power that can be selected is limited.
The function Mega Soft® allows use of capacitive large-
surface NEs.
With the unit setting for these electrodes, there come
some limitations regarding the current types.
The function Twin Pad II allows use of split, reusable
NEs.
With the unit setting for these electrodes, there come
some limitations regarding the current types.
Using the NE-Indicator, the display for the patient
contact of a two-piece NE is automatically visualized.
This function is available only if split NEs are used, i.e. if
a non-split NE is used, the display disappears.

Selection of Baby NE, Mega Soft® Baby NE, Mega Soft® or Twin Pad II is a local setting, i.e. the restriction
originating from the combination applies only to the saved program.

Revision 1 65
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

If a SWAP program is to be created using a program with a specific NE, for safety reasons the specific NE is
applied for the other program as well. This NE is then displayed in the other program as “modified”.
Channels with current types that may potentially not be allowed are deactivated.
When using third-party accessories, always observe the manufacturer's instructions, and especially safety
notes and information concerning the parameters to be used.

10.6.5 Argon mode


This menu can be used to define whether the argon currents and the functions of the maxium® smart Beam
are to be displayed in the menu levels even if no maxium® smart Beam is connected. If the argon mode is
not activated, in some of the menus some functions will be eliminated, making the menus easier to read.
Thus the currents with argon beamer are not displayed in the list of selectable currents if beamer operation
is deselected. If a maxium® smart Beam is connected to the unit, then argon mode will be activated
automatically. By default, the unit is set not to display the beamer-relevant functions if no beamer is
connected. This is a global setting which, however, does not apply to the base program, where the beamer
parameters will always be displayed. There, deactivation of beamer operation causes only a temporary
hiding until the unit is turned off and on again.

10.6.6 Hotline
Under Hotline, contact information for direct help in case of questions about or problems with the
maxium® smart C can be found.

10.6.7 Service
The Service menu provides access to the functions which are not needed in the clinical operation of the
maxium® smart C. They are therefore accessible for technicians and service only. This includes, inter alia,
the following functions:
• Adjustment of the gas cylinder filling level
• Beamer parameters: Setting of the alarm threshold and other argon-related parameters.
• Adjustment of the starting process: Autostart with base program or previously used program
• Special use of the base program
• Program settings: Locking and unlocking of programs
• Unit status: Display of the hardware and software configuration, detection of peripherals.
• Reset to factory default settings
Since custom settings can be deleted irreversibly (e.g. Reset to factory defaults will delete all personal user
settings) in this menu, it is password-protected. Details are described in the Service Manual for the
maxium® smart C by Gebrüder Martin.

10.6.8 Interface Language


Selection of the user interface language: The texts of the menus, functions, and fields, as well as the
messages in the status line, can be displayed in various national languages.

66 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

10.6.9 Help
Help elements such as the Instructions for Use or video clips explaining the operation of the device or
accessory can be found here.

10.6.10 Message History


All data will be displayed here, such as:
• Information shown on the display
• Warnings given
• Errors displayed
• Activations carried out

Revision 1 67
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

11 Currents, their Properties and Technical Data


11.1 Monopolar Cutting Currents

Pure Cut

Pure Cut is a cutting current with a low proportion of coagulation. Since the edges of the cut are coagulated
only weakly, a low hemostatic effect results. A so-called “clean cut” results, which comes most closely to
the classic scalpel cut and favors wound healing. Using the effect setting, the voltage can be changed and
thus the hemostatic effect slightly varied.
This current is equipped with a cutting effect regulation adapted to the power settings and varying
commensurately with them. Thus always consistent cutting results are achieved, independent of cutting
depth. The delivered power will usually be well below the selected power level, which is to be understood
only as setting with power reserve. However, the selected power will never be exceeded.

Risk of injury due to failure of power control!


The output power of the Pure Cut current can be set to up to 400 W. At a power of more than 150 W, the
risks of burns described in section 5.1, 5.2 and 5.3 will increase. The safety measures described therein
shall be applied with increased diligence.
When using large-surface capacitive neutral electrodes that do not have direct contact to the patient’s
body, the cutting effect regulation will not work. As a result, the current type is not available when
selecting the Mega Soft NE.
Active accessories to be used with this current must be able to withstand an HF voltage of at least 700 V
(depending on the selected effect).

68 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Technical Data

Power setting range: 1–400 W at 500 Ω


Max. periodic HF output voltage: 900 Vp at maximum effect setting
Fundamental frequency: 404 kHz
Crest factor: 1.5

Output curves

Output power versus set power Repetitive peak output voltage versus set effect

HF voltage in voltspeak
HF power in watts

Setting Effect
Output power versus resistance at 50% and 100% of max.
Repetitive peak output voltage versus set power
power setting
HF voltage in voltspeak
HF power in watts

Load resistance in Ω Setting

Revision 1 69
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Blend Cut

Blend Cut is a cutting current with a moderate proportion of eschar formation. The wound edges are
simultaneously coagulated during cutting, coagulating the extensive bleeding from transected capillaries
immediately during cutting. This is not possible when using a scalpel for cutting. However, the effect has
disadvantageous effects on wound healing in comparison to the Pure Cut current. Using the effect setting,
the voltage can be changed and thus the hemostatic effect slightly varied.
The Blend Cut current can be used universally wherever extensive active electrodes are to be used and a
certain hemostasis effect immediately during cutting is expected. For needle electrodes or electrodes with
wire loops, this current is less suitable. With such electrodes, hemostasis is achieved more easily with
contact-free coagulation.

Risk of injury from excessive power!


The output power of the Blend Cut current can be set to up to 250 W. At a power of more than 150 W,
the risks of burns described in section 5.1, 5.2 and 5.3 will increase. The safety measures described
therein shall be applied with increased diligence.
Active accessories to be used with this current must be able to withstand an HF voltage of at least 900 V
(depending on the selected effect).

70 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Technical Data

Power setting range: 1–150 W at 800 Ω


Max. periodic HF output voltage: 2,000 Vp at maximum effect setting
Fundamental frequency: 404 kHz
Crest factor: 2.6–5.5

Output curves

Output power versus set power Repetitive peak output voltage versus set effect

HF voltage in voltspeak
HF power in watts

Setting Effect

Output power versus resistance at 50% and 100% of max. Repetitive peak output voltage versus set power
power setting
HF voltage in voltspeak
HF power in watts

Load resistance in Ω Setting

Revision 1 71
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Uro Pure Cut

When cutting under irrigation fluid, the basic conditions differ fundamentally from those of open-surgery.
Uro Pure Cut takes this into account and provides a cutting current with low hemostasis specifically for
urology in TUR-P or TUR-B applications. Using the effect setting, the voltage can be changed and thus the
hemostatic effect slightly varied.
This current is equipped with a cutting effect regulation adapted to the power settings and varying
commensurately with them. Thus always consistent cutting results are achieved, independent of cutting
depth. The delivered power will usually be well below the selected power level, which is to be understood
only as setting with power reserve. However, the selected power will never be exceeded.
This current is specially designed for resection under liquid. For resection under open-surgery conditions,
the other cutting currents (Pure Cut, Soft Cut) are better suited.

Risk of injury from excessive power!


The output power of the Uro Pure Cut current can be set to up to 400 W. At a power of more than 150 W,
the risks of burns described in section 5.1, 5.2 and 5.3 will increase. The safety measures described therein
shall be applied with increased diligence.
When using large-surface capacitive neutral electrodes that do not have direct contact to the patient’s
body, the cutting effect regulation will not work. As a result, the current type is not available when
selecting the Mega Soft NE.
Attention is drawn in particular to the danger of formation of pyrolysis and electrolysis gases, which may
accumulate upon cutting within body cavities such as the bladder or the uterus. These gases can form
explosive mixtures, leading to danger of deflagrations which may result in ruptures if such accumulations
are permitted to occur and electrosurgery is used in the area of such an accumulation. For further
information, refer to section 5.3, page 23.
Active accessories to be used with this current must be able to withstand an HF voltage of at least 1,100 V
(depending on the selected effect).

Risk of injury due to mix-up of irrigation fluid!


Ensure use of the non-conductive irrigation fluid sorbitol-mannitol sugar solution.
When using saline or any other conductive solution, there is no cutting effect, and application of
HF current may cause severe local burns.

72 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Technical Data

Power setting range: 1–400 W at 800 Ω


Max. periodic HF output voltage: 1,100 Vp at maximum effect setting
Fundamental frequency: 404 kHz
Crest factor: 1.5

Output curves

Output power versus set power Repetitive peak output voltage versus set effect

HF voltage in voltspeak
HF power in watts

Setting Effect

Output power versus resistance at 50% and 100% of max. Repetitive peak output voltage versus set power
power setting
HF voltage in voltspeak
HF power in watts

Load resistance in Ω Setting

Revision 1 73
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Uro Blend Cut

When cutting under irrigation fluid, the basic conditions differ fundamentally from those of open-surgery.
Uro Blend Cut takes this into account and provides a cutting current with concomitant hemostasis for
applications such as TUR-P or TUR-B in urology or endometrium ablation. Using the effect setting, the
voltage can be changed and thus the hemostatic effect slightly varied.
Depending on the selected power, this is kept constant over a wide application range in order to ensure a
reproducible surgical result.
This current is specially designed for resection under liquid. For resection under open-surgery conditions,
the other cutting currents (Blend Cut and Pure Cut) are better suited.

Risk of injury from excessive power!


The output power of the Uro Blend Cut current can be set to up to 250 W. At a power of more than
150 W, the risks of burns described in section 5.1, 5.2 and 5.3 will increase. The safety measures described
there shall be applied with increased diligence.
Attention is drawn in particular to the danger of formation of pyrolysis and electrolysis gases, which may
accumulate upon cutting within body cavities such as the bladder or the uterus. These gases can form
explosive mixtures, leading to danger of deflagrations which may result in ruptures if such accumulations
are permitted to occur and electrosurgery is used in the area of such an accumulation. For further
information, refer to section 5.3, page 23.
Active accessories to be used with this current must be able to withstand an HF voltage of at least 1,500 V
(depending on the selected effect).

Risk of injury due to mix-up of irrigation fluid!


Ensure use of the non-conductive irrigation fluid sorbitol-mannitol sugar solution.
When using saline or any other conductive solution, there is no cutting effect, and application of
HF current may cause severe local burns.

74 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Technical Data

Power setting range: 1–150 W at 800 Ω


Max. periodic HF output voltage: 2,000 Vp at maximum effect setting
Fundamental frequency: 404 kHz
Crest factor at 600 Ω: 3–5.2

Output curves

Output power versus set power Repetitive peak output voltage versus set effect

HF voltage in voltspeak
HF power in watts

Setting Effect

Output power versus resistance at 50% and 100% of max. Repetitive peak output voltage versus set power
power setting
HF voltage in voltspeak
HF power in watts

Load resistance in Ω Setting

Revision 1 75
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Soft Cut

Soft Cut offers precise and smooth cutting specifically for the use of applicators with wires as active
electrode, such as fine wire loops or needle electrodes. Thus this current causes only minimal injury to the
tissue edge. The hemostatic effect is weak. Using the effect setting, the voltage can be changed and thus
the hemostatic effect slightly varied.
The Soft Cut current is equipped with a cutting effect regulation which is constant over the power
adjustment range. This achieves a consistent cutting result independent of cutting depth and power
selected. The power actually delivered will usually be well below the selected power level, which is to be
understood only as setting with power reserve. However, the selected power will never be exceeded.
Soft Cut can be used for the work with electrode arrangements such as needle or with wire loop electrodes,
as well as for portio conisation with wire loop electrodes. The high power reserve allows serving all
applications where a cutting current with low hemostasis is demanded.

Risk of injury from excessive power!


The output power of the Soft Cut current can be set to up to 400 W. At a power of more than 150 W, the
risks of burns described in section 5.1, 5.2 and 5.3 will increase. The safety measures described therein
shall be applied with increased diligence.
When using large-surface capacitive neutral electrodes that do not have direct contact to the patient’s
body, the cutting effect regulation will not work. As a result, the current type is not available when
selecting the Mega Soft NE.
Active accessories to be used with this current must be able to withstand an HF voltage of at least 650 V
(depending on the selected effect).

76 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Technical Data

Power setting range: 1–80 W at 400 Ω


Max. periodic HF output voltage: 650 Vp at maximum effect setting
Fundamental frequency: 500 kHz
Crest factor: 1.5

Output curves

Output power versus set power Repetitive peak output voltage versus set effect

HF voltage in voltspeak
HF power in watts

Setting Effect
Output power versus resistance at 50% and 100% of max.
Repetitive peak output voltage versus set power
power setting
HF voltage in voltspeak
HF power in watts

Load resistance in Ω Setting

Revision 1 77
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Argon Cut

The Argon Cut current corresponds to the Pure Cut current with additional application of argon. Under an
argon gas atmosphere, this current supports a cutting which causes even less eschar formation than
Pure Cut. The argon gas displaces the oxygen in the thermally induced cutting channel, strongly reducing
tissue carbonization. Such cutting under inert gas produces less combustion products with proportionally
lower release of smoke. In addition to the electrical parameters, after selection of this cutting current the
argon gas flow of the maxium® smart Beam can also be easily adjusted via the user interface of the
maxium® smart C. Using the effect setting, the voltage can be changed and thus the hemostatic effect
slightly varied.
Argon Cut is equipped with a cutting effect regulation adapted to the power settings and varying
commensurately with them. Thus always consistent cutting results are achieved, independent of cutting
depth. The delivered power will usually be well below the selected power level, which is to be understood
only as setting with power reserve. However, the selected power will never be exceeded.
This current can be used universally wherever tissue-conserving work with large-surface active electrodes is
to be done.

Risk of injury from excessive power!


The output power of the Argon Cut current can be set to up to 400 W. At a power of more than 150 W,
the risks of burns described in section 5.1, 5.2 and 5.3 will increase. The safety measures described therein
shall be applied with increased diligence. The argon beam increases the risk of the ignition of flammable
substances, see section 5.3, page 23.
When using large-surface capacitive neutral electrodes that do not have direct contact to the patient’s
body, the cutting effect regulation will not work. As a result, the current type is not available when
selecting the Mega Soft NE.
Active accessories to be used with this current must be able to withstand an HF voltage of at least 900 V
(depending on the selected effect).

78 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Technical Data

Power setting range: 1–400 W at 500 Ω


Max. periodic HF output voltage: 900 Vp at maximum effect setting
Fundamental frequency: 404 kHz
Crest factor: 1.4

Output curves

Output power versus set power Repetitive peak output voltage versus set effect

HF voltage in voltspeak
HF power in watts

Setting Effect
Output power versus resistance at 50% and 100% of max.
Repetitive peak output voltage versus set power
power setting
HF voltage in voltspeak
HF power in watts

Load resistance in Ω Setting

Revision 1 79
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

11.2 Monopolar Coagulation Currents

Forced Clamp

The Forced Clamp coagulation current type is preferably applied indirectly via surgical instruments (e.g.
hemostat, surgical forceps) for hemostasis. The needle, knife or lancet electrode of the electrode handle is
brought into contact with the surgical instrument for activation (recommendation: first bring the active
electrode into contact with the surgical instrument, only then start HF activation). Application is also
possible directly via ball or paddle electrodes of the electrode handle. The current penetrates deep into the
tissue, resulting in volume coagulation.
If the instrument or electrode is only slightly in contact with the tissue, by design some sparking between
the tissue and the electrode will be observed. Thus the tissue at the point of contact will be strongly
desiccated; slight tissue carbonization will take place. Due to quickly occurring coagulation, the effective
depth is limited. Using the effect setting, the voltage can be changed and thus the hemostatic effect slightly
varied.
Basically, under the condition that the same amount of HF energy is required the following apply:
• Low penetration:
Short application time and correspondingly high HF output power
• Deep penetration:
Long application time and correspondingly low HF output power

Danger of injury by operating errors!


In case of indirect application via a hand-held instrument, this should be insulated so as not to expose the
surgeon to the HF voltage transmitted directly from the active electrode to the instrument. Despite
common practice it must be kept in mind that the surgical glove is no defined electrical insulation, and
arcing may occur.
Active accessories to be used with this current must be able to withstand an HF voltage of at least 2,000 V
(depending on the selected effect).

80 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Technical Data

Power setting range: 1–150 W at 400 Ω


Max. periodic HF output voltage: 1,200 Vp at maximum effect setting
Fundamental frequency: 404 kHz
Crest factor: 3.1 … 3.7

Output curves

Output power versus set power Repetitive peak output voltage versus set effect

HF voltage in voltspeak
HF power in watts

Setting Effect
Output power versus resistance at 50% and 100% of max.
Repetitive peak output voltage versus set power
power setting
HF voltage in voltspeak
HF power in watts

Load resistance in Ω Setting

Revision 1 81
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Forced Prep

In comparison to the Forced Clamp current, the forced coagulation current Forced Prep effects coagulation
more quickly. This makes this current suitable for preparation, since despite its dominant coagulation it has
an effective cutting power. If the instrument or electrode is only slightly in contact with the tissue, by
design sparking between the tissue and the electrode will be observed. Thus the tissue at the point of
contact will be strongly desiccated; slight tissue carbonization will take place. Due to quickly occurring
coagulation, the effective depth is limited. Using the effect setting, the voltage can be changed and thus the
hemostatic effect slightly varied.
Basically, under the condition that the same amount of HF energy is required the following apply:
• Low penetration:
Short application time and correspondingly high HF output power
• Deep penetration:
Long application time and correspondingly low HF output power

Activation is done via the blue switches (finger or foot).

Danger of injury by operating errors!


In case of indirect application via a hand-held instrument, this should be insulated so as not to expose the
surgeon to the HF voltage transmitted directly from the active electrode to the instrument. It must be
kept in mind that the surgical glove is no defined electrical insulation for this current, and arcing is indeed
likely.
Active accessories to be used with this current must be able to withstand an HF voltage of at least 2,000 V
(depending on the selected effect).

82 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Technical Data

Output power setting range (sum of both outputs): 1–150 W at 500 Ω


Max. periodic HF output voltage: 2,500 Vp at maximum effect setting
Fundamental frequency: 404 kHz
Crest factor: 3.4–7.5

Output curves

Output power versus set power Repetitive peak output voltage versus set effect

HF voltage in voltspeak
HF power in watts

Setting Effect
Output power versus resistance at 50% and 100% of max.
Repetitive peak output voltage versus set power
power setting
HF voltage in voltspeak
HF power in watts

Load resistance in Ω Setting

Revision 1 83
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Contact Coag

The “gentle” Contact Coag coagulation current is preferably applied via ball or paddle electrodes for
hemostasis. The current penetrates deep into the tissue, resulting in volume coagulation. The user himself
determines the degree of coagulation by the duration of the activation. Using the effect setting, the voltage
can be changed and thus the hemostatic effect slightly varied.
Basically, under the condition that the same amount of HF energy is required the following apply:
• Low penetration:
Short application time and correspondingly high HF output power
• Deep penetration:
Long application time and correspondingly low HF output power

Risk of injury from excessive power!


The output power of the Contact Coag current can be set to up to 250 W. At a power of more than 150 W,
the risks of burns described in section 5.1 and 5.2 will increase. The safety measures described therein
shall be applied with increased diligence.
Active accessories to be used with this current must be able to withstand an HF voltage of at least 200 V
(depending on the selected effect).

84 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Technical Data

Power setting range: 1–200 W at 250 Ω


Max. periodic HF output voltage: 650 Vp
Fundamental frequency: 382 kHz
Crest factor: 2.6–3.2

Output curves

Output power versus set power Repetitive peak output voltage versus set effect

HF voltage in voltspeak
HF power in watts

Setting Effect
Output power versus resistance at 50% and 100% of max.
Repetitive peak output voltage versus set power
power setting
HF voltage in voltspeak
HF power in watts

Load resistance in Ω Setting

Revision 1 85
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Forced Coag

In comparison to the Contact Coag current, the forced coagulation current Forced Coag effects coagulation
more quickly. The application technique is the same as for the Contact Coag current. If the instrument or
electrode is only slightly in contact with the tissue, by design some sparking between the tissue and the
electrode will be observed. Thus the tissue at the point of contact will be strongly desiccated; slight tissue
carbonization will take place. Due to quickly occurring coagulation, the effective depth is limited. Using the
effect setting, the voltage can be changed and thus the hemostatic effect slightly varied.
Basically, under the condition that the same amount of HF energy is required the following apply:
• Low penetration:
Short application time and correspondingly high HF output power
• Deep penetration:
Long application time and correspondingly low HF output power

Forced Coag can be used like a non-contact coagulation current for purely superficial coagulation, too.

Risk of injury by insufficient insulation!


Active accessories to be used with this current must be able to withstand an HF voltage of at least 2,500 V
(depending on the selected effect).

86 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Technical Data

Power setting range: 1–150 W at 600 Ω


Max. periodic HF output voltage: 2,400 Vp
Fundamental frequency: 412 kHz
Crest factor: 4.4–5.0

Output curves

Output power versus set power Repetitive peak output voltage versus set effect

HF voltage in voltspeak
HF power in watts

Setting Effect
Output power versus resistance at 50% and 100% of max.
Repetitive peak output voltage versus set power
power setting
HF voltage in voltspeak
HF power in watts

Load resistance in Ω Setting

Revision 1 87
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Uro Coag

Uro Coag is a specialized coagulation current for use under liquids in combination with resectoscope loops.
Similar to surface coagulation (see section 4.2.2 “Monopolar coagulation”, page 14), here the HF energy is
directed into the tissue without or only with slight tissue contact. In this process, the energy independently
finds its way to the source of the hemorrhage through the blood, which is more conductive than the non-
conductive irrigation fluid (monopolar work, sorbitol-mannitol-sugar solution). The quality of the current
prevents “sinking in” of the electrode loop into the tissue upon tissue contact. Using the effect setting, the
voltage can be changed and thus the hemostatic effect slightly varied.

Danger of injury by ruptures!


Active accessories to be used with this current must be able to withstand an HF voltage of at least 2,500 V
(depending on the selected effect).
For the special risks posed by high electrical voltages, see section 5.4, page 24.
Attention is drawn in particular to the danger of the formation of pyrolysis and electrolysis gases, which
may accumulate upon application of HF current in fluid in body cavities such as the bladder or the uterus.
These gases can form explosive mixtures, leading to danger of deflagrations which may result in ruptures
if such accumulations are permitted to occur and electrosurgery is used in the area of such an
accumulation. For further information, refer to section 5.3, page 23.

Risk of injury due to mix-up of irrigation fluid!


Ensure use of the non-conductive irrigation fluid sorbitol-mannitol sugar solution.
When using saline or any other conductive solution, coagulation is very poor, and application of HF
current may cause severe local burns.

88 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Technical Data

Power setting range: 1–150 W at 600 Ω


Max. periodic HF output voltage: 2,500 Vp at maximum effect setting
Fundamental frequency: 420 kHz
Crest factor: 5.2–5.9

Output curves

Output power versus set power Repetitive peak output voltage versus set effect

HF voltage in voltspeak
HF power in watts

Setting Effect
Output power versus resistance at 50% and 100% of max.
Repetitive peak output voltage versus set power
power setting
HF voltage in voltspeak
HF power in watts

Load resistance in Ω Setting

Revision 1 89
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Spray

Spray is a high-voltage coagulation current for non-contact surface coagulation with very low depth and
carbonization. The current is expediently used for hemostasis in thoracic surgery (hemostasis on the
sternum) or parenchyma tissue surgery. Using the effect setting, the voltage can be changed and thus the
hemostatic effect slightly varied.
For contact coagulation, this current is less well suited.

Danger of injury by sparking!


Active accessories to be used with this current must be able to withstand a combination of an HF voltage
of at least 4,500 V (depending on the selected effect).
For the special risks posed by high electrical voltages, see section 5.4, page 24.
The powerful sparking may cause ignition of combustible substances or mixtures of substances, see
section 5.3, page 23.
Do not use this current for indirect contact coagulation via surgical instruments. There is great danger of
arcing.

90 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Technical Data

Power setting range: 1–80 W at 700 Ω


Max. periodic HF output voltage: 4,500 Vp
Fundamental frequency: 500 kHz
Crest factor: 4.2–7.4

Output curves

Output power versus set power Repetitive peak output voltage versus set effect

HF voltage in voltspeak
HF power in watts

Setting Effect
Output power versus resistance at 50% and 100% of max.
Repetitive peak output voltage versus set power
power setting
HF voltage in voltspeak
HF power in watts

Load resistance in Ω Setting

Revision 1 91
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Duo Prep

If two monopolar patient circuits can be activated simultaneously via independent hand or foot switches,
the selected power of the generator feeding the circuits can be split between the two channels. The
corresponding technical standard (IEC 60601-2-2) provides this possibility only for coagulation currents
allowing contact-free application. To a certain extent such coagulation currents can also be used for tissue
preparation.
Duo Prep qualitatively corresponds to the Forced Prep current, with the difference that in addition to
individual activation there is also simultaneous activation of the monopolar outputs M1 and M2 possible.
This current can be used specifically in cases where one patient is to be operated upon at two different
surgical locations at the same time, for example in cardiac surgery (preparation of the crural vein with a low
coagulation component and simultaneous preparation of the mammaria in the thoracic area). Activation is
done via the blue switches (finger or foot).
If this current is selected for either of the coagulation channels of the M output ports, it will appear also on
the other output port. The power can be set only to the same value on both channels. If the current of one
channel is switched off or replaced by any other, the parallel channel will switch to “single version” Forced
Prep.
In case of individual activation of the currents, they behave like the Forced Prep current. In case of
synchronous activation, the power is split between the two outputs. Reasonable splitting of the power that
allows for simultaneous will, however, work only in non-contact mode.

Risk of injury from inadequate insulation!


In case of indirect application via a hand-held instrument, this should be insulated so as not to expose the
surgeon to the HF voltage transmitted directly from the active electrode to the instrument. It must be
kept in mind that the surgical glove is no defined electrical insulation for this current, and arcing is indeed
likely.
Active accessories to be used with this current must be able to withstand an HF voltage of at least 2,000 V
(depending on the selected effect).

Risk of injury from excessive power!


The output power of the active electrodes may change during use, due to switching on or off of the
parallel patient output port or unbalanced and varying application conditions!

92 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Technical Data

Output power setting range (sum of both outputs): 1–150 W at 500 Ω


Max. periodic HF output voltage: 2,500 Vp at maximum effect setting
Fundamental frequency: 404 kHz
Crest factor: 3.4–7.5

Output curves

Output power versus set power Repetitive peak output voltage versus set effect

HF voltage in voltspeak
HF power in watts

Setting Effect
Output power versus resistance at 50% and 100% of max.
Repetitive peak output voltage versus set power
power setting
HF voltage in voltspeak
HF power in watts

Load resistance in Ω Setting

Revision 1 93
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Duo Spray

If two monopolar patient circuits can be activated simultaneously via independent hand or foot switches,
the selected power of the generator feeding the circuits can be split between the two channels. The
corresponding technical standard (IEC 60601-2-2) provides this possibility only for coagulation currents
allowing contact-free application. To a certain extent such coagulation currents can also be used for tissue
preparation.
Duo spray qualitatively corresponds to the Spray current with the difference that in addition to individual
activation also simultaneous activation of the monopolar outputs M is possible. This type can be used
specifically in cases where one patient is to be operated upon at two different locations at the same time,
for example in cardiac surgery (preparation of the crural vein with a very strong coagulation component
and simultaneous preparation of the mammaria in the thoracic area). Activation is done via the blue
switches (finger or foot).
If this current is selected for either of the coagulation channels of the M outputs, it will appear also on the
other output port. The power can be set only to the same value on both channels. If the current of one
channel is switched off or replaced by any other, the parallel channel will switch to “single version” Spray.
In case of individual activation of the currents, these behave like the Spray current. In case of synchronous
activation, the power is split between the two outputs.

Danger of injury by sparking!


Active accessories to be used with this current must be able to withstand a combination of an HF voltage
of at least 4,500 V (depending on the selected effect).
For the special risks posed by high electrical voltages, see section 5.4, page 24.
The powerful sparking may cause ignition of combustible substances or mixtures of substances, see
section 5.3, page 23.
Do not use this current for indirect contact coagulation via surgical instruments. There is great danger of
arcing.

Risk of injury from excessive power!


The output powers of the active electrodes may change during use due to switching on or off of the
parallel patient output port or unbalanced and varying application conditions!

94 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Technical Data

Output power setting range (sum of both outputs): 1–80 W at 700 Ω


Max. periodic HF output voltage: 4,500 Vp
Fundamental frequency: 500 kHz
Crest factor: 4.2–7.4

Output curves

Output power versus set power Repetitive peak output voltage versus set effect

HF voltage in voltspeak
HF power in watts

Setting Effect
Output power versus resistance at 50% and 100% of max.
Repetitive peak output voltage versus set power
power setting
HF voltage in voltspeak
HF power in watts

Load resistance in Ω Setting

Revision 1 95
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Argon Beam

Argon Beam is a current for surface coagulation by ionized argon gas for use in open surgery. For use of this
current, a maxium® smart Beam and an MABS applicator are required.
If this current is selected and a maxium® smart Beam connected, the argon gas flow can also be selected
directly via the user interface of the maxium® smart C. The argon gas flow is adjustable from 0.1–12 l/min.
This current is characterized by its outstanding striking properties and large application distance. Using the
effect setting, the voltage can be changed and thus the hemostatic effect slightly varied.
This current can be selected if a maxium® smart Beam is connected.

Risk of injury from excessive voltage!


Active accessories to be used with this current must be able to withstand a combination of an HF voltage
of at least 4,500 V (depending on the selected effect).
For the special risks posed by high electrical voltages, see section 5.4, page 24.
Because of the extremely high voltage, this current should not be used in endoscopy. For this application,
there is the Argon Endo current with significantly lower voltage.
The argon beam may cause ignition of combustible substances or mixtures of substances, see section 5.3,
page 23.

96 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Technical Data

Power setting range: 1–80 W at 700 Ω


Max. periodic HF output voltage: 4,500 Vp
Fundamental frequency: 500 kHz
Crest factor: 4.2–7.4

Output curves

Output power versus set power Repetitive peak output voltage versus set effect

HF voltage in voltspeak
HF power in watts

Setting Effect
Output power versus resistance at 50% and 100% of max.
Repetitive peak output voltage versus set power
power setting
HF voltage in voltspeak
HF power in watts

Load resistance in Ω Setting

Revision 1 97
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

11.3 Bipolar Cutting Currents

Bipol Pure Cut

The Bipol Pure Cut current offers the safety benefits of bipolar technology for tissue dissection as well.
No stray currents, no leakage currents and no need for a neutral electrode – these are the prime benefits.
Bipol Pure Cut provides a smooth cut with a low degree of eschar formation and low hemostasis effect.
Using the effect setting, the voltage can be changed and thus the hemostatic effect slightly varied.

For bipolar cutting, special bipolar instruments with asymmetric electrode design are necessary. The
commonly used forceps for bipolar coagulation are unsuitable for bipolar cutting.
Active accessories to be used with this current must be able to withstand an HF voltage of at least 700 V
(depending on the selected effect).

98 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Technical Data

Power setting range: 1–120 W at 300 Ω


Max. periodic HF output voltage: 390 Vp
Fundamental frequency: 404 kHz
Crest factor: 1.5

Output curves

Output power versus set power Repetitive peak output voltage versus set effect

HF voltage in voltspeak
HF power in watts

Setting Effect
Output power versus resistance at 50% and 100% of max.
Repetitive peak output voltage versus set power
power setting
HF voltage in voltspeak
HF power in watts

Load resistance in Ω Setting

Revision 1 99
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Forfex

The Forfex bipolar cutting current supports mechanical cutting using scissors. The tissue between the two
blades is coagulated by the Forfex current during cutting. Forfex is specifically designed for bipolar scissors,
i.e. the mechanical blades of the scissors are maximally conserved by the Forfex current. This results in a
long service life of the blades.
In addition to tissue coagulation synchronously with cutting, contact coagulation can also be performed, in
which the slightly opened blades touch the location to be coagulated in a flat or point-shaped manner.
Using the effect setting, the voltage can be changed and thus the hemostatic effect slightly varied.

Bipolar scissors must not be used with the Bipol Pure Cut or Bipol Blend Cut currents. These current types
would quickly result in blunting of the scissor blades due to the increased voltage.
Active accessories to be used with this current must be able to withstand an HF voltage of at least 180 V
(depending on the selected effect).

100 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Technical Data

Power setting range: 1–120 W at 50 Ω


Max. periodic HF output voltage: 240 Vp
Fundamental frequency: 457 kHz
Crest factor: 1.5

Output curves

Output power versus set power Repetitive peak output voltage versus set effect

HF voltage in voltspeak
HF power in watts

Setting Effect
Output power versus resistance at 50% and 100% of max.
Repetitive peak output voltage versus set power
power setting
HF voltage in voltspeak
HF power in watts

Load resistance in Ω Setting

Revision 1 101
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

11.4 Bipolar Coagulation Currents

BiCoag

BiCoag is a current for open surgery and laparoscopy with bipolar forceps. BiCoag can be selected using a
foot switch, automatic start or automatic start with time delay; for further information, refer to section 9.7
“Automatic Functions of Bipolar Coagulation”, page 51. Using the effect setting, the voltage can be changed
and thus the hemostatic effect slightly varied.
Basically, under the condition that the same amount of HF energy is required the following apply:
• Low penetration:
Short application time and correspondingly high HF output power
• Deep penetration:
Long application time and correspondingly low HF output power

The start delay for Auto Start can be varied, see section 10.3.4 “Selecting the Activation Type/Foot Switch”,
page 55.

Danger of injury by operating errors!


• For laparoscopic/endoscopic applications, the instrument may not be used in auto-start mode.
For further information, refer to section 9.7, page 51, and section 5.8.1, page 27.
• Arcing can occur in case of bipolar electrodes arranged in relative close vicinity. Arcing can occur
especially when lifting up the instrument while a current or the generator is active and there is no
contact to tissue/liquid.
Active accessories to be used with this current must be able to withstand an HF voltage of at least 200 V
(depending on the selected effect).

102 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Technical Data

Power setting range: 1–120 W at 50 Ω


Max. periodic HF output voltage: 240 Vp
Fundamental frequency: 457 kHz
Crest factor: 1.5

Output curves

Output power versus set power Repetitive peak output voltage versus set effect

HF voltage in voltspeak
HF power in watts

Setting Effect
Output power versus resistance at 50% and 100% of max.
Repetitive peak output voltage versus set power
power setting
HF voltage in voltspeak
HF power in watts

Load resistance in Ω Setting

Revision 1 103
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Neptun

Neptun is a bipolar current type for fluid-assisted coagulation (EHT method = electrohydrothermosation)
Preferentially, isotonic saline solution is fed to the instrument tip through the flushing channel(s) of a
bipolar instrument and dropwise applied to the tissue to be coagulated. When the electrodes come into
contact with the tissue, only a small amount of HF current flows through the tissue itself; the larger amount
of HF energy heats the electrically conductive saline solution. The coagulation effect is based on the liquid
thus caused to boil. The resulting temperature is limited to the boiling temperature of water (approx. 100°C
[212°F]), which avoids carbonation of the tissue. A large amount of energy is used for the vaporization of
flushing liquid. Thus an output of 120–180 W must be set for the generator, depending on the supplied
amount of liquid and the selected electrode size. Using the effect setting, the voltage can be changed and
thus the hemostatic effect slightly varied.
This method has been tried and tested particularly in the field of parenchyma surgery (liver, spleen,
kidney). However, it can also be beneficial in other applications in visceral surgery or neurosurgery.
The supply of liquid before coagulation allows the origin of the bleeding to be localized more easily.
Bleeding tissue is not carbonated and the traumatized wound area is smaller.
No coagulated tissue can stick to the active HF electrode, and therefore the inherent risk of initiating
secondary bleedings is avoided.
This type of current can also be applied without supply of liquid. In this case, the generator output must be
adjusted to 40–60 W. The start delay for Auto Start can be varied, see section 10.3.4 “Selecting the
Activation Type/Foot Switch”, page 55.

Risk of property damage!


When putting the instrument down in auto-start mode, ensure that the instrument tip does not come into
contact with a cloth soaked in liquid.

Risk of injury!
• For laparoscopic/endoscopic applications, the instrument may not be used in auto-start mode.
For further information, refer to section 9.7, page 51, and section 5.8.1, page 27
• Arcing can occur in case of bipolar electrodes arranged in relative close vicinity. Arcing can occur
especially when lifting up the instrument while a current or the generator is active and there is no
contact to tissue/liquid.
Active accessories to be used with this current must be able to withstand an HF voltage of at least 240 V
(depending on the selected effect).

104 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Technical Data

Power setting range: 1–250 W at 50 Ω


Max. periodic HF output voltage: 245 Vp
Fundamental frequency: 457 kHz
Crest factor: 1.5

Output curves

Output power versus set power Repetitive peak output voltage versus set effect

HF voltage in voltspeak
HF power in watts

Setting Effect
Output power versus resistance at 50% and 100% of max.
Repetitive peak output voltage versus set power
power setting
HF voltage in voltspeak
HF power in watts

Load resistance in Ω Setting

Revision 1 105
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

12 Cleaning and Disinfection


The responsibility for cleaning and disinfection lies with the operator/user of the product. Be sure to
observe your local cleaning and hygiene regulations!
The manufacturer recommends wiping disinfection according to the instructions of the manufacturer of the
disinfection agent.

Danger of serious injury when using defective accessories!


Using a unit that is not in perfect working order or using defective accessories can pose a hazard to
patients or users and compromise the proper functioning of the device.
• Be sure to maintain the unit and its accessories in perfect operating condition.
• Perform a visual inspection and check the system for insulation damage, cleanliness and integrity.
• A unit or accessories found to be unfit for use must be withdrawn from service.

• Never sterilize the unit!


• Always disconnect the unit from the supply before cleaning and disinfecting it.
• No liquid must be allowed to enter the unit. Therefore clean and disinfect it with care. Do not use
sprays!
• Never clean the unit with abrasive cleaners, disinfectants or solvents that could scratch the housing or
damage the device in other ways.
• For surface cleaning and surface disinfection, use the procedure recommended by your hospital or use
another nationally recognized and approved method.
• When disinfecting accessories (by surface disinfection or immersion), be sure to observe the
instructions of the manufacturer of the disinfectant regarding material compatibility, dosage and
exposure time.
• Accessories not suitable for sterilization, such as the foot switch, must be cleaned with a disinfecting
detergent.
• All disinfectant residues must be completely removed before putting the unit in operation.
• If accessories must be disinfected or sterilized, be sure to observe the respective Instructions for Use.

106 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

13 Messages of the Unit


The bottom line of the screen text is used to display texts indicating operating or error conditions. Below,
the messages are explained which help the user to determine the current status of the unit or perform to
troubleshooting. All other messages are described in the maxium® Service Manual.

13.1 Messages during Self-Test


After switching on, the unit displays the startup screen. If the unit remains in the starting phase and any of
the following messages appears, then proceed as described.

Message Description
Self-test: “Cut” foot switch engaged upon The unit expects that during the self-test no activation element is
startup! engaged. If during self-test is a foot switch is actuated, the unit will
Self-test: “Coag” foot switch engaged upon notice this.
startup! Check whether the cable is wrapped around the foot switch so that
Self-test: Universal foot switch engaged the pedal is actuated.
upon startup! Turn the unit off and then on again. If the message appears again,
Self-test: Backup foot switch engaged upon disconnect the foot switch from the unit and turn the latter off and
startup! on again. If the self-test is now completed successfully, the circuit of
the instrument is shorted, otherwise there is a malfunction.
Self-test: “Cut” finger switch before startup! The unit expects that during the self-test no activation element is
(Cable?) engaged. If during the self-test is a finger switch is actuated, the unit
Self-test: “Coag” finger switch before will notice this.
startup! (Cable?) Turn the unit off and then on again. If the message appears again,
disconnect the instrument from the unit and turn the latter off and
on again. If the self-test is now completed successfully, the circuit of
the instrument is shorted, otherwise there is a malfunction.
Self-test: Pressed or stuck key during system The unit expects that during the self-test no activation element is
start! engaged, otherwise the self-test will end with an error.
Turn the unit off and then on again. If the self-test is again not
completed successfully, there is a malfunction.
Self-test: Rotary switch active during system The unit expects that during the self-test no control element is
start! engaged. The unit detects the movement of the rotary switch during
the self-test.
Turn the unit off and then on again. If the self-test is again not
completed successfully, there is a malfunction.

Revision 1 107
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Message Description
Unplug bipolar instrument from B during The unit expects that during the self-test there is no tissue contact.
self-test! If during the self-test tissue contact is established with the
instrument connected on B1, which may already be positioned on
or in the patient, the unit will notice this.
Disconnect the instrument from port B1.
If the unit continues the self-test, then connect the instrument
again. Check whether tissue contact is really plausible or whether
there is rather a short circuit within the instrument. If the unit
remains in self-test mode and does not proceed beyond it after
switching off and on again either, then there is a malfunction in the
unit.
Restart after interruption of mains power The appearance of this message during self-test informs the user
that the unit has been disconnected from the grid without having
been regular turned off at the power switch before, and is now
starting up again after return of the grid power. Here it will not go
directly into operation readiness but enter a standby mode, and the
user will be prompted to confirm or correct the default settings of
the loaded program. This is to prevent the settings of the unit from
being changed by a temporary power failure without the user
noticing.

108 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

13.2 Messages in Case of Activation Errors


If upon actuation of a foot switch, a finger switch on the instrument or, in case of a bipolar coagulation
current with automatic activation upon tissue contact, no activation of the HF current takes place and
instead one of the messages listed below appears, then carry out the measures described.

Message Description
First assign double foot switch CUT to a The actuated foot switch has not been assigned to any channel of
channel! the current program yet.
First assign double foot switch COAG to a Assignment the foot switch as described in section 10.3.4, page 55.
channel! If upon actuation of a foot switch no effect on the instrument is
First assign a channel to the single foot perceptible although the activation sound is heard, then verify that
switch! the foot switch is assigned to the desired channel.
This channel must be selected first: There was an attempt to activate a deselected channel. Is activabi-
No activation! lity is intended, first the channel must be selected by pressing the
channel selection key so that its settings appear on the screen, see
section 10.2, page 53.
Conflicting activation actions -> HF Both pedals of the foot switch were actuated at the same time.
interrupted! Simultaneous activation of both finger switches of a monopolar
instrument triggers the SWAP® mode.
Connection error on monopolar channel M: A monopolar instrument was activated via foot switch, which is
Please swap the connections! connected to the port output M via a single 4-mm connector. This
plug is not connected to the leftmost 4-mm socket but to one of the
sockets on its right, see section 6.2.1, page 32.
Unplug the 4-mm connector and insert it into the leftmost socket;
for the m-version this is the inner conductor of the 13-mm coaxial
socket.
Caution: Instrument has tissue contact, no This message appears when on a bipolar channel a coagulation
activation! current with auto-start function is selected while the instrument
already has tissue contact. Automatic activation upon tissue contact
is possible only after the instrument has been separated from the
tissue and brought into contact again.
Bipolar instrument has tissue contact… The bipolar auto-start/auto-stop function shows this message after
activation has been stopped automatically. For reactivation, tissue
contact must be interrupted and established again.
No activation due to error of the neutral It was attempted to activate a monopolar current although the
electrode! neutral electrode monitor shows no correct attachment and the
status light next to the socket flashes red, see section 9.5, page 48.
Single-piece NE is prohibited by Setup, The unit has detected connection of a single-piece neutral
hence NE error! electrode, although this in not permissible in accordance with the
change of the setting in the Setup menu. Activation of monopolar
power is not possible in this fashion. If the unit is to be used (again)
with single-piece electrodes, the setting must be reverted in the
Setup menu, see section 10.6.4, page 65.

Revision 1 109
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

13.3 Input Feedback


The maxium® smart C will not accept illegal input or settings. A message will appear. In order to resolve the
conflict, proceed as described in the table.

Message Description
This current is not available due to selection An attempt was made to select a monopolar current excluded by
of a Baby NE the setting Baby NE in the Setup menu, see section 10.6.4, page 65.
An attempt was made to select a monopolar current excluded by
This current is not available due to selection
the setting Mega Soft-NE in the Setup menu, see section 10.6.4,
of a Mega Soft NE
page 65.
The unit has detected connection of a single-piece neutral
electrode, although this in not permissible in accordance with the
Single-piece NE is prohibited by Setup, change of the setting in the Setup menu. Activation of monopolar
hence NE error! power is not possible in this fashion. If the unit is to be used (again)
with single-piece electrodes, the setting must be reverted in the
Setup menu, see section 10.6.4, page 65.
The alternating activation of bipolar cutting current and bipolar
coagulation current with automatic function on the same output is
The incompatible current on the same
not possible. Either current can be selected. Selection of one
output port was disabled
current will, however, automatically lead to deselection of the
other.

110 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

13.4 Messages in Connection with Programs


The maxium® smart C will not accept illegal input or settings. A message will appear. In order to resolve the
conflict, proceed as described in the table.

Message Description
The base program cannot be overwritten! The base program is designed as an immutable program to serve as
The base program cannot be deleted! the basis for own programs which can then be saved under their
own names.
In the Service menu it is possible to change the settings of the base
program, see the maxium® Service Manual.
Program name already exists! Overwrite? This query is intended to prevent the user from accidentally
overwriting a program.
Program memory full, first delete a Up to 50 programs can be stored in the maxium® smart C. This
program! message indicates that the capacity of the memory has been
reached. It is necessary to delete programs first before new ones
can be stored.
Current program may not be its own SWAP An attempt was made to establish a SWAP® connection of a
partner… program with itself. Such a connection is pointless. Possibly
adaptation of the parameters of one of the programs was forgotten.
A locked program cannot be deleted. Before a program can be changed or deleted, it must be unlocked.
A locked program cannot be overwritten. This can be done only via the Service menu, see the maxium®
Service Manual.
Program name already exists in one of the If for a new program a name is selected which already exists as a
foreign languages! program name in another language, a logical problem may arise,
which is why such names are not allowed.

Revision 1 111
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

13.5 Messages from the Argon Beamer and the Fume Suction System
The maxium® smart Beam and the maxium® smart Vac fume suction system can display malfunctions and
status messages on the screen of the maxium® smart C.

Message Description
Argon Beamer warning: Underdosage Argon gas flow lower than specified. May be due to a constricted
hose or a too high set-point value for a small hose.
Argon Beamer warning: The inlet pressure at the gas inlet of the maxium® smart Beam is too
Argon inlet pressure too low low. Possibly opening the angle valve at the gas cylinder has been
forgotten, or the cylinder may be empty, which can be read on the
gauge of the pressure reducer.
Argon Beamer warning: Obstruction No or only very low argon gas flow. May be due to a kinked hose or,
for applicators with a very small outlet, obstruction of the nozzle by
encrustrations.
Argon Beamer warning: Replace cylinder, the required residual pressure for replacement of
Argon cylinder empty the cylinder is reached. The pressurized cylinder must not be
emptied completely.
Argon Beamer warning: This warning appears if the residual pressure of the gas cylinder
Low argon reserve drops below 30 bar. It is intended to inform the user that the argon
reserve is running low.
Argon Beamer E52: The pressure at the gas inlet of the maxium® smart Beam is higher
Inlet pressure too high! than 4.5 bar.
If the unit is supplied via a MABS pressure reducer, the reason for
the failure may be warming of the gas volume trapped in the
pressure reducer. Disconnect hose from the pressure reducer to the
maxium® smart Beam and reconnect it to allow some gas to escape.
If the pressure is still too high, then there is the pressure reducer is
malfunctioning.
In case of central gas supply, the working pressure may be too high.
In this case, an intermediary pressure reducer must be used.
Argon Beamer E75: Purge key during power- During the self-test, the Purge key on the maxium® smart Beam was
on test! actuated. Turn the device combination off and then on again. If the
message appears again, then the maxium® smart Beam is
malfunctioning.
The fume filter is missing or not properly The maxium® smart Vac fume suction system reports absence or
inserted! improper seating of the filter.
Check that the filter is present and fully inserted.
Argon Beamer E55-59: Offset failure The pressure sensors of the maxium® smart Beam are sensitive to
temperature changes. If the maxium® smart Beam is moved from a
very cold to a warm environment, due to the resulting temperature
gradient the self-test may not be passed.
Allow the maxium® smart Beam to warm up for half an hour with
the unit switched on. If the self-test is again not completed
successfully, there is a malfunction.

112 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

13.6 System Errors


Below, a number of messages are listed which the user can take care of on his own if necessary.

Message Description
The HF generator is overheated from high power output over a longer
period and needs a few minutes to cool down. As soon as the text
Overtemperature: Power output message disappears, re-activation is possible.
interrupted!
If this message is displayed after moderate power output a well, the
unit should be checked.
The bipolar instrument detection reads an unknown instrument code
and cannot support this instrument.
B1: Unknown bipol instrument It may be a new instrument which is not known to the installed
connected! Code: xx software yet. In this case a software update will be necessary. If it is
B2: Unknown bipol instrument an instrument which was always detected before, then connect the
connected! Code: xx instrument to the other Bipolar Output. If it is detected correctly
there, then there is a malfunction in the unit, otherwise the
instrument itself is defective.
There was an error in the detection of the hardware configuration
Error 285: Board scan failed – please
during self-test. Turn the unit off and then on again. If the message
restart system!
appears again, then there is a malfunction in the unit.
The unit is or was located in a cold environment. If is set up in a much
Error 298: Unit massively too cold, please warmer environment, then there is the risk of condensation inside the
switch off for 1 h! unit and thus an electrical safety risk. The unit may be put back into
operation only after the condensate has been completely evaporated.

Revision 1 113
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

14 Periodic Safety Checks (SC)


At least every 24 months the system (maxium® smart C with maxium® smart Beam) must be subjected to
the following controls to be performed by people who, by virtue of their training, knowledge and expe-
rience gained from practical activities are able to properly perform such safety checks and not obliged to
adhere to instructions with regard to such control activities. If the maxium® smart C is equipped with a
maxium® smart Beam, this shall be inspected during the control of the maxium® smart C, too. A suitable
protocol form can be requested from the Martin Service Center.

A: Visual inspections and function checks


• Readability of type plate and markings.
The information on the type plates of the maxium® smart C and, if applicable, maxium® smart Beam,
as well as the labels on the rear side of the units, in particular those indicating the nominal value for
the fuses of the units in the power cable connection, must be clearly legible. On the maxium® smart
Beam, the indication of the permissible pressure range at the gas inlet must be clearly legible.
• The instructions for use must be available in a version suitable for the unit. Updated instructions for
use can be obtained from the Martin Service Center.
• The software version number VX.xxx shown on the startup screen upon switching on of the unit is to
be entered into the protocol sheet. Note messages during the self-test.
• Make sure the two activation lamps are working (uniform illumination of the field of view). Clear
rendering of the icons and correct reproduction of the colors blue and yellow must be verified.
• Visual inspection of all ports on the unit.
– Check the HF sockets M and B for visible damage.
– Check sockets for foot switches, equipotential grounding connection and socket for maxium®
smart Beam on the rear for damage and tight fit.
– Pull the mains cable out of the socket on the unit and test the connection socket for damage and
tight fit.
– On the maxium® smart Beam, check connection socket for the connection cable to the maxium®
smart C for damage and tight fit.
– Check gas inlet, decompression pin and grounding connection for tight fit.
– Check the gas outlet on the front for damage and tight fit.
• Check the cables of all reusable accessories used with the unit for damage to the insulation and the
connector plug, especially in the area of the particularly strained ends.
• Function check of activation, activation lamps and activation sound.
– Disable NE alarm with jumper plug,
– connect electrode handle to M and
– press the two finger switches.

114 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

HF current must be activatable. The activation lights assigned to the outputs M must be lit in the color
of the activated current – yellow or blue –, and the activation sound must be audible.
– For combo connections, test the alternative accessories, if any are used.
– Connect double-pedal foot switch to the large foot switch socket and check whether the channels
assigned on the screen are activated upon actuation of the yellow and the blue pedal; if necessary,
assign foot switch pedals first.
– Connect single-pedal foot switch to the small foot switch socket and check whether any previously
assigned channel is activated.
– Connect bipolar test cable successively to the bipolar output ports B.
– Select the coagulation current with auto-start function and set to minimum power.
– Check whether a bipolar coagulation current is activated in case of short circuiting of the banana
plugs and deactivated upon opening of the contact.
• Check the function of the neutral electrode monitoring.
When the NE socket is open, the screen must show the symbol of a red two-piece neutral electrode,
with the pointer of the NE indicator on the left end. Upon activation of a monopolar channel (electrode
handle at M), the intermittent NE alarm is sounded in a clearly audible manner.
– Insert jumper plug.
The icon of a green single-piece NE must be displayed on the screen (if a non-split NE is allowed,
see section 10.6.4 “Neutral electrode”, page 65); the NE indicator disappears.
– Insert test connector with 270 Ω resistor. The pointer of the NE indicator must be in the yellow
field.
• In the presence of a maxium® smart Beam, first switch off the maxium® smart C, disconnect any argon
gas supply connection from the maxium® smart Beam and then switch on the unit again. The base
program appears on the screen without argon current (select base program if necessary). The indicator
on the maxium® smart Beam must remain dark. On one of the monopolar channels, select an argon-
supported current. The indicator on the maxium® smart Beam must switch to red. The unit may first
have to be set up for operation with the maxium® smart Beam by selecting the function Argon mode.
When connecting the gas supply to the gas inlet, the self-test must begin, after whose completion the
indicator will change to green.
• Check pressure reducer and connecting hose to the unit for leaks.
• Pressing the key PURGE must activate a gas flow without HF current for 3 seconds to displace the air
from the applicator.
• Function check of activation and activation lamps of the maxium® smart Beam.
On the maxium® smart C, select one argon-supported cutting current and one coagulation current each
and consecutively activate both. Upon activation, the indicator on the maxium® smart Beam must be
lit yellow or blue according to the activated current.
• Function check of the steadily argon gas flow at the maxium® smart Beam.
Usually a flow measuring unit calibrated for Argon will not be available. As the gas flow, however, is
adjusted by the user not according to the figures measured but according to the visible surgical result,
control of the continuous adjustability of the gas flow is sufficient. Connect argon applicator to the
maxium® smart Beam, not to the electrosurgery unit! Via the foot switch, activate an argon-supported
current at the flow rates of 0.3 l/min, 1 l/min, 3 l/min and 10 l/min, in this order. Ascertain by the
sound of the blowing noise that the gas flow increases at each higher stage.

Revision 1 115
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

B. Measurement of the output data


• Measure the HF output power for some exemplary currents.

C. Safety measurements according to IEC 60601-1


These measurements are often carried out using an automated safety tester. During the automatic test
sequence, the supply voltage is turned on and off again several times. After a power failure of up to
4 seconds, the maxium® smart C will start again after return of the supply voltage; after longer breaks, it
will remain switched off. This is to be taken into account in case of automated testing; it may be necessary
to carry out the test procedure manually.
For the periodic safety checks, the following measurements should be carried out according to IEC 60601-1:
• Measurement of the ground conductor resistance between the ground conductor contact of the
appliance inlet and the equipotential grounding pin on the maxium® smart C. According to IEC 60601-1
section 8.6.4, this value must not exceed 0.1 Ω.

Earth Leakage Current


• Normal condition
Measurement of the current in the protective grounding conductor of the mains cable without error
simulation. This value must not exceed 1.5× the value of the initially measured value according to the
factory testing sheet which accompanies the unit, and it must also comply with the absolute upper
limit of 500 µA according to IEC 60601-1.
• Single fault condition
Measurement of the current in the protective grounding conductor of the mains cable during
simulation of an interruption of the near-ground phase N (causes the unit to switch off). This value
must not exceed 1.5× the value of the initially measured value according to the factory testing sheet
which accompanies the unit, and it must also comply with the absolute upper limit of 1,000 µA
according to IEC 60601-1. Its value amounts to 2× the ground leakage current in the normal case.

Touch current
• Normal condition
Measurement of the current that flows from the equipotential grounding connection of the maxium®
smart C to the ground. Since this current path forms a parallel path to the protective grounding
conductor, its value is normally very low and also undefined, since it depends on the undefined ratio of
the partial ground resistances. Its value must not exceed the absolute upper limit of 100 µA.
• Single fault condition ground conductor
Corresponds to the value of the ground leaking current under normal conditions, since now the
measurement path takes over the function of the ground conductor. Up to 1.5× the initially measured
value, but according to IEC 60601-1 with an absolute maximum of 500 µA.
• Single fault condition mains
Measurement of the current that flows from the equipotential grounding connection of the maxium®
smart C to the ground when the near-ground phase N is interrupted (causes the unit to turn off). Since
this current path forms a parallel path to the protective grounding conductor, its value is normally very
low and also undefined, since it depends on the undefined ratio of the partial ground resistances. Its
value must not exceed the absolute upper limit of 500 µA.

116 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Patient leakage current


• Normal condition
Measurement of the current from the instrument connections M, B and NE to the ground in non-
activated condition. To this purpose, multiple ports can be connected in parallel. However, if this leads
to indication of a value that exceeds the upper limit of 10 µA according to IEC 60601-1, the connections
must be measured individually, and the highest value is to be logged. Use measuring cables that are
connected only to one pole of the B output port, or perform this measurement manually after
completion of the self-test, where, however, no current with auto-start function may be selected.
• Single fault condition PE conductor
Measurement of the current from the instrument connections M, B and NE in non-activated condition
to the ground, with the protective conductor interrupted. The absolute upper limit according to
IEC 60601-1 is 50 µA. The same applies as described under “Patient leakage current, Normal
condition”.
• Single fault condition voltage on the applied part
Measurement of the current from the instrument connections M, B and NE in non-activated condition
after grounding, where ground-related mains voltage is externally applied to the connectors of the
maxium® smart C through the measurement device! The absolute upper limit according to
IEC 60601-1 is 50 µA. The same applies as described under “Patient leakage current, Normal
condition”.

Performance of the safety check must be entered into the equipment log, and the results are to be
documented!

Revision 1 117
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

15 Disposal
15.1 Packaging
Gebrüder Martin will, as a matter of course, take back the full packaging if so desired, to recycle as many
parts of the packaging as possible.
If you do not wish to make use of this offer, you can dispose of the packaging with the normal paper or
domestic garbage.

15.2 Ecological Aspects of Operation


During regular cutting and coagulation of tissue, combustion products are formed that should not be
inhaled over a longer period or for a longer time.
During regular use of the unit, no pollutants other than these combustion products will be formed.
In the interest of low-energy use, we recommend switching off the unit during longer treatment breaks.

15.3 Disposal of the Device


In designing the device, we tried to avoid using composite materials wherever possible. This allows a high
degree of recycling. We therefore offer to take the device back for proper disposal and recycling.

Marking of electric and electronic equipment in accordance with Directive 2002/96/EC


(WEEE Directive) and the German Electrical and Electronic Equipment Act (ElektroG)
This symbol on the product or its packaging indicates that the product may not be
disposed of as normal household garbage.

15.4 National Regulations


The national regulations and disposal provisions must be observed for all disposal measures.

118 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

16 Guidelines and Manufacturer’s Declaration on Electromagnetic


Compatibility (EMC)

Guidance and manufacturer’s declaration – Electromagnetic interference emission


The device maxium® smart C with or without maxium® smart Beam is designed for use in an electromagnetic
environment as specified below. The user must ensure that it is operated in such an environment.
Immunity tests Compliance level Electromagnetic environment – Guidelines
The device must emit electromagnetic energy in
HF emissions according to CISPR 11 Group 2 order to fulfill its intended function. Nearby
electronic units may be affected.
The requirements of the class are complied with
HF emissions according to CISPR 11 Class B only in operation readiness without activation of
HF current!
Emission of harmonics according to The device is suitable for use in any facilities,
Class A
IEC 61000-3-2 including residential areas and such as are
Emissions of voltage fluctuations/flicker directly connected to the normal public supply
Complies network for residential buildings.
according to IEC 61000-3-3

Revision 1 119
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Guidance and manufacturer’s declaration – Electromagnetic immunity


The device is designed for use in the electromagnetic environment specified below. The user of the device must
ensure that it is operated in such an environment.
Electromagnetic environment –
Immunity test IEC 60601 test level Compliance level
Guidelines
Floors should be of wood or
Electrostatic discharge ±6 kV contact concrete or covered with ceramic
±6 kV contact discharge
(ESD) according to discharge tiles. If the floor is fitted with
IEC 61000-4-2 ±8 kV air discharge synthetic material, relative
±8 kV air discharge
humidity must be at least 30%.
Electrical fast ±2 kV for mains power ±2 kV for mains power
lines lines Mains power quality should be that
transient/bursts
of a typical commercial or hospital
according to ±1 kV for input and ±1 kV for input and environment.
IEC 61000-4-4 output lines output lines
±1 kV symmetrical ±1 kV symmetrical
voltage voltage Mains power quality should be that
Surges according to
of a typical commercial or hospital
IEC 61000-4-5 ±2 kV asymmetrical ±2 kV asymmetrical environment.
voltage voltage
<5% UT 0% UT
(>95% drop of UT) for ½ (100% drop of UT) for
period ½ period Mains power quality should be that
40% UT 40% UT of a typical commercial or hospital
Voltage dips, short (60% drop of UT) for 5 (60% drop of UT) for 5 environment. If the user requires
power interruptions periods periods continued operation during mains
and supply voltage
70% UT 70% UT power interruptions, it is
fluctuations according
(30% drop of UT) for 25 (30% drop of UT) for 25 recommended to power the device
to IEC 61000-4-11
periods periods from an uninterruptible power
<5% UT 0% UT supply.
(>95% drop of UT) for 5 (100% drop of UT) for 5
seconds seconds
Power-frequency magnetic fields
Magnetic field at
should be at levels characteristic of
supply frequency
30 A/m 30 A/m a typical location in a typical
(50/60 Hz) according to
commercial or hospital
IEC 61000-4-8
environment.
Note UT is the a. c. mains voltage prior to application of the test level.

120 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Guidance and manufacturer’s declaration – Electromagnetic immunity


The device is designed for use in the electromagnetic environment specified below. The user of the device must
ensure that it is operated in such an environment.
IEC 60601 test
Immunity test Compliance level Electromagnetic environment – Guidelines
level
Portable and mobile RF communications equip-ment
should be used no closer to any part of the device
(including cables) than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance:
d = 0,6 P

Conducted RF 6 Veff 6 Veff d = 0,4 P for 80 MHz to 800 MHz


according to 150 kHz to 150 kHz to d = 0,7 P for 800 MHz to 2.5 GHz
IEC 61000-4-6 80 MHz 80 MHz
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
Radiated RF 10 V/m 10 V/m
manufacturer and d is the recommended separation
according to 80 MHz to 80 MHz to
distance in meters (m).
IEC 61000-4-3 2.5 GHz 2.5 GHz
Field strengths from fixed RF transmitters, as
a
determined by an electromagnetic site survey , should
be less than the compliance level in each frequency
b
range.
Interference may occur in the vicinity of equipment
marked with the following symbol.

Note 1 At 80 MHz and 800 MHz, the higher frequency range applies
These guidelines may not apply in all situations. Electromagnetic propagation is affected by
Note 2
absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio stations and AM and FM radio and TV stations, cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the device is used exceeds the
applicable RF compliance level specified above, the device should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the
device.
b
Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

Revision 1 121
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Recommended separation distances between portable and mobile RF telecommunications equipment and the
Gebrüder Martin maxium® smart C with or without maxium® smart Beam
The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The user can help prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF telecommunications equipment (transmitters) and the device as recommended below, depending on the
maximum output power of the communications equipment.
Separation distance according to frequency of transmitter (in m)
Rated maximum 150 kHz – 80 MHz 80 MHz – 800 MHz 800 MHz – 2.5 GHz
output P of transmitter
in watts d = 0,6 P d = 0,4 P d = 0,7 P
0.01 0.06 0.04 0.07
0.1 0.19 0.13 0.22
1 0.6 0.4 0.7
10 1.9 1.3 2.2
100 6.0 4.0 7.0
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer
Note 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected
Note 2
by absorption and reflection from structures, objects and people.

122 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

17 Technical Specification
17.1 Technical Specifications of the maxium®
The maxium® smart C is a microprocessor-controlled electrosurgery unit for interdisciplinary use. The
maxium® smart C conforms to the latest state of the art and offers a high degree of safety.
The maxium® is characterized, among other things, by the following features:
• Ergonomically designed user interface (Touchscreen)
• 7″ screen with clear layout
• Various national languages available
• 50 individual memory slots
• 17 default programs
• 19 currents for all disciplines
• High cost-efficiency
• Coverage of all disciplines with a single unit configuration
• Two monopolar and one bipolar output ports
• Monopolar arc-free cutting up to max. 400 W
• Effect adjustment regardless of power setting
• Bipolar cutting with bipolar marCut® scissors and Forfex current
• Bipolar coagulation with automatic functions
• Duo currents for simultaneous activation
• PCS – Patient Control System with NE indicator guarantees NE monitoring with top safety standard
• Function Baby NE for safe work in infant surgery
• Function for capacitive neutral electrodes
• Various socket modules (m-, i-, e-version)
• Argon plasma coagulation with maxium® smart Beam
• Combination with maxium® smart Cart for equipment
• Future-oriented system, updatable and upgradeable
• SWAP mode®: Program change using double-pedal foot switch with SWAP mode® or electrode handle
with 2 finger switches
• Bidirectional communication with the maxium® smart Vac fume suction system

Revision 1 123
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

17.2 Technical Data for maxium® smart C

Description maxium® smart C


Mains connection 100–240 V ± 10%; 50/60 Hz
Mains power max. 6.3 A
Mains fuse 6.3 A
without HF output 45 VA
Power consumption
at maximum output power 550 VA
Maximum cutting power 400 W
Output power
Maximum coagulation power 200 W
Protection class I
Classification acc. to Medical Devices Act II b
Leakage currents LF and HF according to IEC 60601-1 and IEC 60601-2-2
Type (Application Part) CF; defibrillation-proof
Operating mode Intermittent INT 10 s / 30 s corr. to 25% duty factor
Unit fuses 2 × T 6.3 AH, 250 V, Type G 5 × 20 mm
HF display: 55 dB(A); adjustable 45–60 dB
Signal level
Alarm: 65 dB(A)
Weight 9 kg
The maxium® smart C meets the requirements of IEC 60601-1-2 also in
conjunction with the maxium® smart beam, but with the restrictions
Radio interference suppression
pursuant to IEC 60601-2-2 Section 202.6.1 only during operation
readiness.
Width 390 mm
Dimensions Height 160 mm
Depth 436 mm
Ambient temperature -25°C to +70°C (-13°F to +158°F)
Environmental conditions for transport
Relative humidity 10–100%
and storage
Air pressure 500–1,060 hPa
Ambient temperature +10°C to +40°C (50°F to +104°F)
Environmental conditions for operation Relative humidity 30–75%
Air pressure 700–1,060 hPa

Compliant with 93/42/EEC

The technical data for the individual currents are to be found in the description of the individual currents in
section 11 “Currents, their Properties and Technical Data”, page 68.

124 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

When the neutral electrode for babies is selected, only the following monopolar currents and maximum
powers are permitted:

Monopolar cutting currents Monopolar coagulation currents


Pure Cut up to 30 W Forced Clamp up to 30 W
Blend Cut up to 30 W Forced Prep up to 30 W
Super Cut up to 30 W Spray up to 30 W
Contact Coag up to 30 W
Forced Coag up to 30 W
Argon Beam up to 30 W

The bipolar current types are fully available.

In case of selection of the Mega Soft neutral electrode, only the following monopolar current types are
allowed:

Monopolar cutting currents Monopolar coagulation currents


Blend Cut Forced Clamp
Uro Blend Cut Forced Prep
Spray
Contact Coag
Forced Coag
Uro Coag
Agon Beam

The bipolar current types are fully available.

Revision 1 125
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

17.3 Technical Data for maxium® smart Beam

Description maxium® smart Beam


Power supply via the maxium® smart C
Argon supply Only approved for MABS pressure reducer.
Fuse M1.6A, internal
Power consumption max. 40 W
Protection class I
Classification acc. to Medical
II b
Devices Act
Argon gas flow for CUT 0.1–12 l/min ± 20%
Argon gas flow for COAG 0.1–12 l/min ± 20%
according to IEC 60601, Part 1
Leakage currents LF and HF
(to be tested together with the HF generator of the maxium® smart C)
Type (Application Part) CF; defibrillation-proof
Operating mode INT 10s/30s
Weight 3.5 kg
See section 17.2. The maxium® smart C meets the requirements of
Radio interference suppression IEC 6060112 also in conjunction with the maxium® smart beam, but with the
restrictions pursuant to IEC 6060122 Section 202.6.1.
Width 390 mm
Dimensions Height 108 mm
Depth 425 mm
Ambient temperature -25°C to +70°C (-13°F to +158°F)
Environmental conditions for
Relative humidity 10–100%
transport and storage
Air pressure 500–1,060 hPa
Ambient temperature +10°C to +40°C (50°F to +104°F)
Environmental conditions for
Relative humidity 30–75%
operation
Air pressure 700–1,060 hPa

Compliant with 93/42/EEC

126 Revision 1
Instructions for Use
maxium® smart C Electrosurgery Unit with maxium® smart Beam

Revision 1 127
KLS Martin Group

KLS Martin Australia Pty Ltd. KLS Martin do Brasil Ltda. KLS Martin Medical (Shanghai) KLS Martin India Pvt Ltd.
Sydney · Australia São Paulo · Brazil International Trading Co. Ltd. Chennai · India
Tel.: +61 2 9439 5316 Tel.: +55 11 3554 2299 Shanghai · China Tel. +91 44 66 442 300
australia@klsmartin.com brazil@klsmartin.com Tel. +86 21 5820 6251 india@klsmartin.com
china@klsmartin.com

Martin Italia S.r.l. Nippon Martin K.K. KLS Martin SE Asia Sdn. Bhd. Martin Nederland/Marned B.V.
Milan · Italy Tokyo · Japan Penang · Malaysia Huizen · The Netherlands
Tel. +39 039 605 67 31 Tel. +81 3 3814 1431 Tel.: +604 505 7838 Tel. +31 35 523 45 38
italia@klsmartin.com nippon@klsmartin.com malaysia@klsmartin.com nederland@klsmartin.com

Gebrüder Martin GmbH & Co. KG Gebrüder Martin GmbH & Co. KG KLS Martin UK Ltd. KLS Martin LP
Moscow · Russia Dubai · United Arab Emirates London · United Kingdom Jacksonville · Florida, USA
Tel. +7 499 792-76-19 Tel. +971 4 454 16 55 Tel. +44 1189 000 570 Tel. +1 904 641 77 46
russia@klsmartin.com middleeast@klsmartin.com uk@klsmartin.com usa@klsmartin.com

Gebrüder Martin GmbH & Co. KG


A company of the KLS Martin Group
KLS Martin Platz 1 · 78532 Tuttlingen · Germany
Postfach 60 · 78501 Tuttlingen · Germany
Tel. +49 7461 706-0 · Fax +49 7461 706-193
info@klsmartin.com · www.klsmartin.com

Back Cover

Date of Release: 2017-10 · 90-046-52-10 · Printed in Germany · Copyright by Gebrüder Martin GmbH & Co. KG · Alle Rechte vorbehalten ·
Technische Änderungen vorbehalten · We reserve the right to make alterations · Cambios técnicos reservados · Sous réserve de modifications techniques ·
Ci riserviamo il diritto di modifiche tecniche · Revision 1

You might also like

pFad - Phonifier reborn

Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.

Note: This service is not intended for secure transactions such as banking, social media, email, or purchasing. Use at your own risk. We assume no liability whatsoever for broken pages.


Alternative Proxies:

Alternative Proxy

pFad Proxy

pFad v3 Proxy

pFad v4 Proxy