maxium and maxium Beamer System Instructions for Use V 8.0 Oct 2013

Instructions for Use maxium® electrosurgery unit with maxium® Beamer

Symbol explanation Observe safety-related information concerning this product

Observe Instructions for Use

Store in a dry places

Fragile, avoid pressure and shaking

Arrows pointing up, transport and store upright

This product may not be disposed of as normal household garbage

CE Mark 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

2

V. 8.0

Instructions for Use maxium® electrosurgery unit with maxium® Beamer

Contents 1

List of Abbreviations ... 7

2

Product Liability and Warranty ... 8

2.1 2.2 2.3

General Information ... 8 Scope of Delivery ... 8 Intended Use ... 9

2.3.1

Intended Use of the maxium® ... 9

2.3.2

Intended Use of the maxium® Beamer ... 9

2.3.3

Instructions ...10

2.4 2.5 2.6 2.7

Warranty ... 10 Inspection by User ... 10 Hotline... 11 Validity of these Instructions for Use ... 11

3

Notices concerning this Document ... 12

3.1

Symbols Used in this Document ... 12

4

Working Principles ... 13

4.1 4.2

Preface ... 13 Monopolar application of HF energy ... 14

4.2.1

Monopolar cutting ... 15

4.2.2

Monopolar coagulation ...15

4.2.3

Neutral electrode ... 16

4.3

Bipolar Application of HF Energy ... 17

4.3.1

Bipolar cutting ... 17

4.3.2

Bipolar coagulation ... 17

4.3.3

Sealing using SealSafe® / SealSafe® IQ ... 18

4.3.4

Bipolar TUR ...19

5

Risk Minimization and Safety Measures ... 20

5.1

Risks from Stray Currents ... 20

5.1.1

Patient shunts ... 21

5.1.2

High-frequency leakage currents ...22

5.1.3

Leakage currents to other medical devices ... 23

5.1.4

Measures against risks from stray currents ... 23

5.2

Risks from Current Concentration... 24

5.2.1

Current condensation in the area of the neutral electrode ...25

5.2.2

Current condensation inside the body ... 27

5.2.3

Measures against the risks posed by current accumulation ...28

5.3 5.4 5.5

Risks from Arcing and Sparking ... 29 Risks from High Voltage ... 30 Risks from Electromagnetic Interference ... 31

V. 8.0

3

Instructions for Use maxium® electrosurgery unit with maxium® Beamer

5.6

Risks from Pressure Vessels and Argon Gas Flow ... 32

5.6.1

Pressure vessels... 32

5.6.2

Embolisms and emphysema...32

5.6.3

Additional insufflation for endosurgical applications...33

5.6.4

Contamination of the operation field ...33

5.6.5

Concentration of argon in the breathing air... 34

5.7

Miscellaneous ... 34

5.7.1

Inadvertent emission of HF energy ...34

5.7.2

Combination with other devices...35

5.7.3

HF output power ... 35

5.7.4

Use of two electrosurgical devices on one patient ...36

6

Functions ... 37

6.1 6.2

Overview ... 37 Connections on the Front ... 40

6.2.1

Monopolar connections ...40

6.2.2

Bipolar connections ... 41

6.2.3

Neutral electrode connection...43

6.3

Connections on the Rear ... 44

6.3.1

Foot switch connections ...44

6.3.2

Interface for the maxium® Beamer ...44

6.3.3

Serial interfaces ... 45

6.3.4

Equipotential bonding connection ...45

6.3.5

Mains connection ... 45

6.4

Controls ... 46

6.4.1

ON/OFF key ...46

6.4.2

Channel selector keys ...47

6.4.3

MENU key ...47

6.4.4

Backlit rotary switch ... 48

7

Accessories... 49

7.1

maxium® Beamer... 49

7.1.1

General Information ... 49

7.1.2

Control and display elements, connections ... 51

7.1.3

Gas supply ...52

7.1.4

Argon ...53

7.1.5

Connection of beamer instruments ...54

7.2 7.3

Instruments, Electrode Handles, Electrodes, Foot Switches and Cables for maxium® and maxium® Beamer ... 54 Bipolar Port Expander ... 55

8

Installation of the maxium® and the maxium® Beamer ... 59

8.1 8.2

Standalone Installation of the maxium® ... 59 Installation of the maxium® with maxium® Beamer ... 60

4

V. 8.0

Instructions for Use maxium® electrosurgery unit with maxium® Beamer

8.3 8.4

Installation on the maxium® Cart II ... 62 Integration of the maxium® into the Karl Storz OR1™ System ... 63

9

Commissioning of the maxium® and the maxium® Beamer ... 64

9.1 9.2 9.3

General Information ... 64 Switching on the maxium® ... 64 Switching on the maxium® Beamer ... 66

9.3.1

Noise during operation ...66

9.4 9.5

Connection of the active electrodes ... 67 Connection of the neutral electrode ... 67

9.5.1

Application of the neutral electrode ...67

9.5.2

KLS Martin Patient Control System (PCS) ... 68

9.6 9.7

Argon Filling Level ... 70 Automatic Functions of Bipolar Coagulation ... 70

9.7.1

Information about the limitations of the auto-start function ...72

10

Using the maxium® ... 73

10.1 10.2 10.3

General Information ... 73 Selection and Deselection of Working Channels... 73 Setting the Values for the Working Channels ... 74

10.3.1

Selecting the HF output power ...75

10.3.2

Selecting a current ... 75

10.3.3

Assignment of an activation source ...76

10.4 10.5

Navigation within the Programs and Functions of the maxium® ... 77 Working with Programs ... 78

10.5.1

Base program ... 78

10.5.2

Selecting Programs ... 79

10.5.3

Saving modified programs ...80

10.5.4

Saving a program under a new name... 81

10.5.5

Deleting programs ... 82

10.5.6

SWAP mode ...83

10.6

The Setup Menu... 86

10.6.1

Sound settings ... 87

10.6.2

Screen Settings... 89

10.6.3

Setting of time frames (Menu timeout) ... 90

10.6.4

Neutral electrode ... 91

10.6.5

Parameters for coagulation automatics... 92

10.6.6

Argon mode ...93

10.6.7

Use of the marVAC® fume suction system with the maxium® ... 94

10.6.8

Hotline ... 100

10.6.9

Service Menu ... 101

V. 8.0

5

Instructions for Use maxium® electrosurgery unit with maxium® Beamer

11

Currents, their Properties and Technical Data ... 102

11.1 11.2 11.3 11.4

Monopolar Cutting Currents ... 102 Monopolar Coagulation Currents ... 128 Bipolar Cutting Currents... 158 Bipolar Coagulation Currents ... 172

12

Cleaning and Disinfection ... 184

13

Messages of the Unit ... 185

13.1 13.2 13.3 13.4 13.5 13.6

Messages during Self-Test... 185 Messages in Case of Activation Errors ... 187 Input Feedback ... 188 Messages in Connection with Programs ... 189 Messages from the Argon Beamer and the Fume Suction System ... 190 System Errors ... 191

14

Replacement Parts and Accessories ... 192

15

Technical Specification ... 193

15.1 15.2 15.3 15.4

Technical Specifications of the maxium® ... 193 Technical Data for maxium® ... 194 Technical Data for maxium® Beamer ... 196 Guidelines and Manufacturer’s Declaration on Electromagnetic Compatibility (EMC) ... 197

16

Periodic Safety Checks (SC)... 201

17

Environment-Relevant Information ... 206

17.1 17.2 17.3

Packaging ... 206 Environmentally Sound Device Operations... 206 Disposal of the Product ... 206

6

V. 8.0

Instructions for Use maxium® electrosurgery unit with maxium® Beamer

1

List of Abbreviations

Abbreviation

Name

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

V. 8.0

7

Instructions for Use maxium® electrosurgery unit with maxium® Beamer

2

Product Liability and Warranty

2.1

General Information

We thank you for having decided to buy a KLS Martin product. This product carries the CE mark, 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 [email protected] · www.klsmartin.com

2.2

Scope of Delivery

Electrosurgery unit: •

Maxium® - m-Version, item no. 80-042-00-04 or - i-Version, item no. 80-042-02-04 or - e-Version, item no. 80-042-04-04

•

Mains cable, country-specific variant

•

Instructions for Use, item no. 90-169-52-80

•

Option: bipolar TUR, item no. 80-093-00-04

•

Option: OR1 integration, item no. 80-093-01-04

Argon Beamer: •

Maxium® Beamer, item no. 80-044-00-04

•

Connection cable, item no. 08-041-00-60

•

Mounting kit

Equipment Cart: •

Maxium® Cart II, item no. 80-047-00-04

•

Mains cable (installed)

•

Basket (installed)

•

Instructions for Use, item no. 90-329-58-10

8

V. 8.0

Instructions for Use maxium® electrosurgery unit with maxium® Beamer

2.3

Intended Use

2.3.1

Intended Use of the maxium®

The maxium® electrosurgery unit, hereinafter referred to as “the maxium®”, comprises an HF generator and is used for electrosurgical cutting and coagulation of live human or animal tissue. To this purpose, electrical energy from the grid is converted into a high-frequency current which provides this surgical property. The maxium® provides the user with a large number of various currents individually optimized to meet differing surgical requirements.

WARNING 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®, 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 maxium® is equipped for monopolar and bipolar cutting and coagulation in micro- and macrosurgical operations. The operational safety of the unit must be verified at regular intervals, see section 16 “Periodic Safety Checks (SC)”, Seite 201. 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. 2.3.2

Intended Use of the maxium® Beamer

The maxium® Beamer by KLS 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 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 energy 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.

V. 8.0

9

Instructions for Use maxium® electrosurgery unit with maxium® Beamer 2.3.3

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.

2.4

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. Important Notices The product may only be repaired by Gebrüder Martin or a qualified person or firm expressly authorized by Gebrüder Martin to perform such work. 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. Unauthorized actions performed on the product shall invalidate any liability claims vis-à-vis Gebrüder Martin.

2.5

Inspection by User

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

10

V. 8.0

Instructions for Use maxium® electrosurgery unit with maxium® Beamer

2.6 •

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, please do not hesitate to turn to our Martin Service Center Tel:

+49 7461 706-343

Fax:

+49 7461 706-408

E-Mail: [email protected] •

Should you have any questions concerning maintenance contracts or training courses, please contact our Technical Service Manager: Tel:

+49 74 61 706-332

E-Mail: [email protected]

NOTICE 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 37.

2.7

Validity of these Instructions for Use

These instructions for use are valid from software version V3.400 and hardware status HW 06. If older hardware or software versions are used, it may be that functions described in this user manual are not available. Via the information provided on the starting screen, the maxium® indicates which version of the user manual matches the software version currently implemented. This ensures that it is always clear which software statuses are covered by these Instructions for Use.

V. 8.0

11

Instructions for Use maxium® electrosurgery unit with maxium® Beamer

3

Notices concerning this Document

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! Be sure to read, understand and follow the instructions given below! •

Every user is required to read this document completely and follow them carefully.

•

In particular, be sure to heed all cautions, warnings and danger notices.

•

Keep this document accessible to users at all times.

3.1

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:

WARNING Danger of death or serious injury! Indicates a situation which, if not avoided, could result in death or serious injury!

CAUTION Danger of minor injury! Non-compliance involves risk of bodily injury!

NOTICE Risk of property damage! Non-compliance may lead to property damage (loss of time, loss of data, machinery defects, etc.)!

12

V. 8.0

Instructions for Use maxium® electrosurgery unit with maxium® Beamer

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 energy, 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. KLS 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® electrosurgery unit by KLS Martin, too, has been developed and manufactured 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®. However, the user will be able to fully exploit the features of the maxium® by KLS 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.

V. 8.0

13

Instructions for Use maxium® electrosurgery unit with maxium® Beamer

4.2

Monopolar application of HF energy

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 20. The HF generator for monopolar applications is activated optionally via foot switch or finger switch on the surgical electrode handle.

14

V. 8.0

Instructions for Use maxium® electrosurgery unit with maxium® Beamer 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 energy 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. 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® Beamer, an accessory for providing and controlling the necessary argon gas flow is available. The maxium® 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.

V. 8.0

15

Instructions for Use maxium® electrosurgery unit with maxium® Beamer 4.2.3

Neutral electrode

The current fed into the patient in monopolar application is returned to the unit by a largesurface 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. In the case of split neutral electrodes, it can be monitored by the maxium®. 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® 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®. To this end, a low monitoring current is led from one side of the electrode via the patient to the other side. The maxium® is capable of monitoring both non-split and split electrodes. The status of the neutral electrode (NE status) is shown in the upper right corner of the screen. In split electrodes, additionally the relative quality of the skin contact can be displayed.

16

V. 8.0

Instructions for Use maxium® electrosurgery unit with maxium® Beamer

4.3

Bipolar Application of HF Energy

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.

The maxium® allows activation of bipolar power via a foot switch or finger switch. In addition, the maxium® can be set up so that bipolar coagulation currents will be activated automatically also upon contact with the tissue. 4.3.1

Bipolar cutting

In contrast to monopolar cutting, in bipolar cutting the HF energy 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.

V. 8.0

17

Instructions for Use maxium® electrosurgery unit with maxium® Beamer 4.3.3

Sealing using SealSafe® / SealSafe® IQ

The SealSafe® and SealSafe® IQ currents are special currents for the sealing of blood vessels and tissue layers. These currents were designed specifically for use with marClamp® and marSeal instruments. Here in comparison to traditional bipolar technology high power is used in conjunction with low voltage. The current has been optimized to exclude adhesion and carbonization of the tissue when used properly. The special interplay of this particular HF current and the high pressure applied by the instrument will transform natural structure proteins such as collagen and elastin to create a permanently sealed zone. Here the special thing is that only the tissue between the electrodes is sealed. Lateral thermal tissue damage is limited to an absolute minimum. Effective sealing is possible without prior individual isolation / preparation. The maxium® is able to continuously monitor the degree of sealing of the tissue using tissue impedance monitoring. Individual energy packets are sequentially emitted into the tissue in the form of high-frequency pulses, until the desired degree of sealing has been reached and the process is completed. With the SealSafe® IQ current, energy is continuously emitted during the process. The end of the sealing process is acoustically acknowledged by the maxium®. This shuts down the current automatically before carbonization of the tissue can occur. The primary benefit of this method for the users consists in a significant reduction of clips and suture materials and significant time savings. The maxium® offers two SealSafe® currents which can be used for a number of different surgical disciplines in combination with the instruments by KLS Martin: •

Current SealSafe® with marClamp® or marSeal instruments

•

Current SealSafe® IQ with marClamp® IQ or marSeal IQ instruments

When using the IQ instruments, please note the following: All IQ instruments have an instrument detection system. The maxium® will automatically provide the instrument inserted with the required current, with a factory-preset default power value. If a foot switch is required for activation, this will also be offered automatically. If users prefer to work with a power setting other than the default value, this change of the power or the foot switch mapping can be regularly saved in the program used, i.e. the usual behavior of the program remains. Another difference is in the power display. For the SealSafe® IQ current, the power is selected in gradation stages (G-grades), for the SealSafe® current it is displayed in watts. These G-grades can be selected from G1 to G5, the switch-off impedance and sealing time increasing with increased G-grade.

18

V. 8.0

Instructions for Use maxium® electrosurgery unit with maxium® Beamer 4.3.4

Bipolar TUR

In contrast to classic monopolar TUR, where an electrically non-conductive irrigation fluid (sorbitol-mannitol-sugar solution) is used, for bipolar TUR an electrically conductive NaCl solution is used as irrigation fluid. The following instructions must be followed: •

Use correct fluid (pre-warmed NaCl solution). Under no circumstances may unipolar TUR be performed with NaCl or bipolar TUR with sugar solution! Bipolar → conductive NaCl solution Monopolar → non-conductive sorbitol-mannitol-sugar solution

WARNING Danger of burns! Use of NaCl solution as irrigation fluid in monopolar application of HF power may cause burns of the rinsed area! •

Avoid long activation times! In contrast to monopolar TUR which is performed with an electrically insulating irrigation fluid, in bipolar TUR energy flows continuously through the electrically conductive NaCl solution, as long as HF power is applied. The irrigation fluid is heated and may reach critical temperatures, especially in case of discontinuous irrigation.

The use of bipolar TUR currents is an option. In older units it can be retroactively activated via an unlock code. This must be entered into the input window of the Service menu. If this option is included in a new order, it is already enabled.

V. 8.0

19

Instructions for Use maxium® electrosurgery unit with maxium® Beamer

5

Risk Minimization and Safety Measures

WARNING 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® Beamer and other accessories will always be operated in combination with the maxium®, all safety instructions for the maxium® also apply fully to the combination with the maxium® Beamer and any other accessories.

WARNING 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 31.

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 energy”, page 14, the HF energy 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.

20

V. 8.0