ERBOTOM ICC 80-50 Instruction Manual Release 08.00

ERBOTOM ICC 80 / 50 V 1.X 10122-103, 10122-101 10122-003, 10122-041

Instruction manual 08.00

ISO 9001 EN 46001

All rights to this instruction manual, particularly the right to reproduction, distribution and translation, are reserved. No part of this instruction manual may be reproduced in any form (including photocopying, microfilm or other means), or processed, reproduced or distributed by means of electronic systems without prior written permission from ERBE ELEKTROMEDIZIN GmbH. The information contained in this instruction manual may be revised or extended without prior notice and represents no obligation on the part of ERBE ELEKTROMEDIZIN GmbH.

©

ERBE ELEKTROMEDIZIN GmbH, Tübingen 2000

Printed by: ERBE ELEKTROMEDIZIN, Tübingen

Instruction manual no. 80104-451

Chapter

Title

Page

1 1.1 1.2

INTRODUCTION... 1-1 Intended purpose of the ICC 80/50 ... 1-1 Explanation of the safety instructions ... 1-1

2

INITIAL OPERATION ... 2-1

3

RISKS AND SAFETY OF HIGH-FREQUENCY SURGERY ... 3-1 Unintentional thermal tissue damage ... 3-1 - due to HF leakage currents ... 3-1 - due to unintentional activation of an HF generator ... 3-2 - due to inappropriate application ... 3-3 - due to inappropriate or nonapplication of the neutral electrode ... 3-3 - due to unsuitable and/or faulty accessories ... 3-4 - due to inattentiveness ... 3-5 - due to an output error ... 3-5 - due to the ignition of flammable liquids, gases and/or vapors ... 3-5 Unintentional burns due to hot electrodes ... 3-6 Electric shock ... 3-6 Stimulation of nerves and muscles ... 3-6 Cardiac pacemaker ... 3-7 Danger of explosion ... 3-7 Interference with other electronic equipment ... 3-7

3.1 3.1.1 3.1.2 3.1.3 3.1.4 3.1.5 3.1.6 3.1.7 3.1.8 3.1.9 3.2 3.3 3.4 3.5 3.6 4 4.1 4.2 1 2 3 4 5

DESCRIPTION OF THE HIGH-FREQUENCY SURGICAL UNIT ... 4-1 General description ... 4-1 Description of the controls ... 4-2

6 7 8 9 10 11 12

Power switch ... 4-2 CUT function field ... 4-3 COAG function field ... 4-4 Connecting socket for neutral electrodes ... 4-5 Connecting socket for monopolar cutting and coagulation instruments ... 4-5 Connecting socket for bipolar coagulation instruments ... 4-5 Safety field ... 4-6 Connecting socket for a dual-pedal footswitch ... 4-7 Loudspeaker for acoustic signals ... 4-7 Power connection ... 4-8 Power fuses ... 4-8 Terminal for potential equalization ... 4-8

5 5.1 5.2

TECHNICAL DATA, SIGNALS, DIAGRAMS... 5-1 Technical data ... 5-1 Diagrams ... 5-3

6

INSTALLATION ... 6-1

7

CLEANING AND DISINFECTION OF THE UNIT ... 7-1

8 8.1 8.2 8.3 8.4

PERFORMANCE CHECKS ... 8-1 Automatic performance test after switching on the unit ... 8-1 Acoustic signal check ... 8-1 Visual signal check ... 8-1 Automatic error documentation ... 8-2 Error list ... 8-4

9

SAFETY CHECKS ... 9-1

10

MAINTENANCE, CARE, DISPOSAL OF THE UNIT ... 10-1

11

CONDITIONS OF GUARANTEE ... 11-1 ADDRESSES ... 12-1

1

INTRODUCTION

1.1

Intended purpose of the ICC 80 / 50

The ICC is a high-frequency surgical unit for cutting and coagulation. 1.2

Explanation of the safety instructions

The WARNING

safety instruction indicates a danger which can result in personal injury.

The CAUTION

safety instruction indicates a danger which can result in property damage.

The IMPORTANT safety instruction indicates a danger which can cause functional failure of the unit.

1-1

2

INITIAL OPERATION

Read carefully before initial operation of the unit. In the development and production of this high-frequency surgical unit, the relevant, generally recognized rules of technology, as well as the valid occupational safety and accident prevention regulations have been taken into consideration. This ensures that patients, employees and third parties are protected from dangers to life and health during intended application of the highfrequency surgical unit, to the extent permitted by the type of application intended. Initial operation Before delivery, every high-frequency surgical unit is tested by the manufacturer in regard to its function and safety. To ensure that the unit also functions safely after shipping and installation at the operator’s site, the following points should be observed: The operator should only operate the high-frequency surgical unit if the manufacturer or supplier 1.

has subjected the unit to a performance test on site

2.

has instructed the parties responsible for operation of the unit in handling of the unit by means of the instruction manual.

2-1

3

RISKS AND SAFETY OF HIGH-FREQUENCY SURGERY

3.1

Unintentional thermal tissue damage

High-frequency surgery is associated in principle with various risks for the patient, the personnel and surroundings. In order to avoid these risks in practice, the surgeon and his/her assistants must recognize these risks and observe the appropriate rules for prevention of damage. In the following, these risks and rules for prevention of damage are explained. 3.1.1 Unintentional thermal tissue damage due to HF leakage currents During high-frequency surgery, the patient unavoidably conducts high-frequency electrical current to ground potential. If the patient makes contact with electrically conductive objects during high-frequency surgery, a high-frequency electrical current can result at the contact point between the patient and this object, which can in turn cause thermal necroses. Not just objects made of metal are electrically conductive objects, but also wet cloths. WARNING

The patient must be insulated against electrically conductive objects during high-frequency surgery. The black elastic table covers on operating tables demonstrate a certain electrical conductivity for diverting electrical charges. Therefore they are never suitable for ensuring the required insulation of the patient against metal parts of the operating table. For this reason, an electrically insulating intermediate layer, for example dry cover cloths, must be laid between the patient and this black operating table cover during the application of high-frequency surgery.

Grounded operating table

Electrically insulated surface Fig.:

Insulated positioning of the patient on the operating table

If it is possible for this intermediate layer to become wet during the operation, for example due to perspiration, irrigation liquid, urine etc., wetting of these intermediate layers must be prevented by a watertight sheet of plastic. Urine should be carried away via catheter. Ÿ

Extremities lying against the trunk or skin-to-skin contact points should be insulated from one another by laying dry cover cloths between them.

Ÿ

Do not apply ECG electrodes closer than 15 cm next to the operating field.

Ÿ

Needle electrodes or injection cannulae should not be used as ECG electrodes during high-frequency surgery.

3-1

3.1.2 Unintentional activation of an HF generator Unintentional activation of an HF generator can lead to burns on the patient if the active electrode hereby touches the patient directly or indirectly through electrically conductive objects or wet cloths. Unintentional activation of an HF generator can, for example, be caused by: Ÿ

Unintentionally pressing a footswitch pedal

Ÿ

Unintentionally pressing a fingerswitch

Ÿ

Defective fingerswitches, footswitches or cables

Ÿ

Penetration of electrically conductive liquids (blood, amniotic fluid, urine, physiological saline solution, irrigation fluids etc.) into fingerswitches or footswitches.

Ÿ

Errors within the high-frequency surgical unit

WARNING

To prevent burns on the patient due to unintentional activation of a high-frequency generator, the following application rules should be heeded: Ÿ

Never lay active electrodes onto or beside a patient in such a way that they can touch the patient directly or indirectly through electrically conductive objects or wet cloths.

Ÿ

The lines to the active electrodes should be positioned in such a way that they touch neither the patient nor other lines.

Ÿ

Always set the acoustic signal, which indicates the active status of the high-frequency generator, so that it can be easily heard.

Ÿ

For operations in which the cutting or coagulation electrode unavoidably remains in contact with the patient even in a nonactive condition, e.g. for endoscopic operations, particular care is required. If such an electrode is unintentionally activated due to an error, this activated electrode should then not be removed from the body without special supervision. When removing the activated electrode from the patient’s body, burns can result on all areas within the body which come into contact with the activated electrode. For this reason, in case such errors occur, the power switch for the high-frequency surgical unit should be switched off immediately before an attempt is made to remove the activated electrode from the body.

3-2

3.1.3 Unintentional thermal tissue damage due to inappropriate application Generally speaking, the bipolar coagulation technique should be applied in preference to the monopolar coagulation technique. This particularly applies to coagulations on straight organs, on which the high-frequency current flows over longer areas through diameters which are approximately equal or become even smaller.

Fig.: Thermal damage of lateral tissue The tissue is always first heated at places on the tissue where the diameter is smallest. If the HF current flows through the same diameter (a) over longer distances, the tissue coagulates over this entire distance. If the diameter of the tissue next to the application point of the coagulation electrode is smaller than at the point of application, coagulation will also occur next to the application point (b).

WARNING

Always make certain that the HF current does not flow through thin tissue structures or vessels with a small diameter. 3.1.4 Unintentional thermal tissue damage due to inappropriate or nonapplication of the neutral electrode With inappropriate or even nonapplication of the neutral electrode, there is a large risk of unintentional thermal tissue damage both at the application point of the neutral electrode as well as to other areas on the patient’s body. The neutral electrode must be applied with its entire surface as closely and reliably as possible to the operating field on the patient’s body.

3-3

WARNING

The effective contact surface, i.e. the electrical conductive value between the neutral electrode and the patient must correspond to the HF capacity used, meaning the intensity of the HF current. Here the effective contact surface means the surface of the neutral electrode which has electrically conductive contact to the skin of the patient during high-frequency surgery.

a)

b)

Fig.: The neutral electrode must be applied at an appropriate location on the patient’s skin using the entire contact surface available (a). If the neutral electrode has only partial contact to the patient’s skin (b), there is a risk that burning will occur at this location

3.1.5 Unintentional thermal tissue damage due to unsuitable and/or faulty accessories It must be ensured that only accessories in perfect condition are used for high-frequency surgery. Only accessories that are compatible or tested by the unit manufacturer must be used. This applies both to the active electrodes including cable and plugs, as well as to the neutral electrodes including cables and plugs. When using an instrument with electric insulation, it is necessary to be certain that these insulations are not overloaded and destroyed by overly high electric voltages. The electric output voltages for the high-frequency surgical unit are indicated for the various cutting and coagulation modes relative to the possible settings in this instruction manual. The electric strength of the instrument insulation can be found in the technical data for the instruments or, in case of doubt, can be requested from the manufacturer of the respective instrument. WARNING

All insulation on electrodes, electrode holders, cables, plugs etc. must be in perfect condition.

3-4

3.1.6 Unintentional thermal tissue damage due to inattentiveness Like a scalpel, high-frequency surgery is always a potential source of danger if handled without care. WARNING

The cutting or coagulation electrodes should always be handled with care and laid aside in the intervals between use so that neither the patient nor other persons can come in contact with the electrodes. Laying unused electrode handles or coagulation forceps on the patient, next to the patient or within folds on the cover cloths is dangerous. Cases of burns on patients are known which were caused by laying the coagulation forceps within folds on the cover cloths which penetrated through the cloths into the patient’s skin and resulted in burns without being noticed. 3.1.7 Unintentional thermal tissue damage due to output error The risk of unintentional thermal tissue damage is proportionate to the intensity and time limit set on the unit for cutting or coagulation. WARNING

The intensity for cutting or coagulation should only be set and only activated for as long as necessary for the intended purpose. An insufficient effect at a standard setting can, for example, be caused by poor attachment of the neutral electrode, poor contact in the connectors, defective cables or electrically insulating tissue remnants on the active electrode. This must be checked before setting at a higher power.

3.1.8 Unintentional thermal tissue damage due to the ignition of flammable liquids, gases and/or vapors During high-frequency surgery, electric sparks or arcs that can ignite flammable liquids, gases or vapors occur at the active electrode.

3-5

WARNING

Make certain during high-frequency surgical operations that anesthetics, skin cleaning agents and disinfectants are nonflammable. If their use is unavoidable, they must have completely evaporated and the vapor must be removed from the area of spark formation before switching on the high-frequency surgical unit.

Before application of high-frequency surgery in the gastro-intestinal tract, it must be ensured that no flammable (endogenous) gases are present here. There is danger of explosion if flammable gases are present. For this reason, these gases must be extracted and/or eliminated by flushing out the affected lumen with CO2before using high-frequency surgery. During transurethral resection (TUR), H2O molecules may dissociate into H2 and O2 in the arc between the resection loop and the irrigation liquid. These gases may collect on the roof of the urinary bladder as a highly explosive gas mixture. If resection is performed in this gas mixture, dangerous explosions may occur. 3.1.9 Unintentional burns due to hot electrodes Cutting and/or coagulation electrodes become hot during cutting and/or coagulation procedures indirectly through the heated tissue and through the electric arc. WARNING

Tissue can be unintentionally burnt immediately after cutting and/or coagulation procedures if electrodes that are still hot touch the tissue. Attention must be especially paid to this during endoscopic operations, such as during pelviscopic fallopian tube coagulation or during endoscopic polypectomy. 3.2

Electric shock

An electric shock may occur if the high-frequency surgical unit delivers a too heavy low-frequency current or if a too heavy low-frequency current flows through the patient into the high-frequency surgical unit from another voltage source. 3.3

Stimulation of nerves and muscles

A known risk of high-frequency surgery is the unintentional electric stimulation of the patient’s nerves and muscles. This stimulation can result from low-frequency electrical currents that are caused either by low-frequency current sources or due to electrical arcs between an active electrode and the patient’s tissue. Electric alternating current with a frequency above 300 kHz is unable to stimulate nerves and muscles.

3-6

During cutting procedures, forced coagulation and spray coagulation, the unavoidable electric arcs between an active electrode and the tissue nevertheless have the effect that a portion of the high-frequency alternating current is rectified, from which more or less strongly modulated, low-frequency current components result which stimulate electrically stimulable structures such as nerves and muscles. This can result in more or less strong spasms or muscle contractions. WARNING

When using high-frequency surgery on electrically stimulable structures, contractions of the affected muscles must be taken into account. This can occur, for example, during endoscopic operations in the urinary bladder in the vicinity of the obturator nerve and during operations in the area of the facial nerve. 3.4

Cardiac pacemaker

For patients with implanted cardiac pacemakers or pacemaker electrodes, irreparable damage to the pacemaker and disturbance of the pacemaker function, which can lead to ventricular fibrilation, must be reckoned with. 3.5

Danger of explosion

High-frequency surgical units always generate sparks during operation on the active electrode. For this reason, it is necessary to make certain during interventions that anesthetics, degreasers and disinfectants are neither flammable nor explosive. They should at least have evaporated completely before switching on the high-frequency surgical unit and be removed from the area of spark formation. 3.6

Interference with other electronic equipment

High-frequency surgical units normally generate high-frequency electrical voltages and currents which can interfere with other electronic equipment. When installing or arranging sensitive electronic equipment in the operating room, this problem should be taken into consideration. In principle, sensitive electronic equipment should be set up as far as possible from the high-frequency surgical unit and particularly from the cables providing HF current. In addition, the cables providing HF current, which act like broadcast antennas, should not be unnecessarily long and should never be positioned parallel or too close to cables from sensitive electronic equipment. The unit has been fitted with a special generator in consideration of the disturbance of sensitive electronic equipment, which generates a relatively low interference level as compared to conventional high-frequency surgical units.

3-7

Standard

International

Standard

International

4

DESCRIPTION OF THE HIGH-FREQUENCY SURGICAL UNIT

4.1

General description

Cutting with automatic control of the HF voltage (Cut) The ERBOTOM ICC is equipped with automatic open and closed loop control systems which control and regulate the parameters relevant to the cutting quality so that each respectively selected cutting quality is guaranteed to be reproducible and constant. Adjustable power limitation in the cutting mode Since the ICC units are equipped with automatic control of the HF voltage in the cutting mode, a power setting in regard to cutting quality is not required. The adjustable power limitation is primarily intended to guarantee the safety of the patient from unintentional thermal tissue damage, and to protect fine cutting instruments, such as fine needle electrodes, from destruction due to overly high HF currents if these come in contact in activated condition with other metallic instruments. Soft coagulation Soft coagulation can be activated by key or pedal. Forced coagulation Forced coagulation is advantageous if an efficient hemostasis is to be achieved with relatively small-surface electrodes. Forced coagulation can be activated by key or pedal. Bipolar coagulation In bipolar coagulation mode, the ICC provides an unmodulated HF voltage with such a low amplitude that electric arcs between the coagulation electrode and tissue can hardly occur. In this way, both carbonization as well as adhesion of the coagulum to the coagulation electrode is extensively prevented. The adjustable power limitation serves the purpose of protecting fine bipolar coagulation instruments, such as pointed bipolar coagulation forceps, from being thermally destroyed in case of a short between the two forcep tips. The footswitch is used for activation.

4-1

4.2

Description of the controls This symbol, in accordance with EN 60 601-1, is intended to indicate to the user that this unit must only be used on the patient if the user is acquainted with the operation and features of this unit.

1

Power switch Using this power switch, the unit is switched on and off. Each time after being switched on, the unit automatically proceeds with various performance checks. If an error in the unit or in the accessories is recognized here, a warning signal sounds and the determined error is indicated by a corresponding error number. (See Chapter 8.1, Automatic performance checks after switching on the unit). If no error is determined, the unit is ready to operate. After the automatic performance check, the basic setting appears on the front panel, whereby all relevant optical displays blink and the unit cannot be activated until any key on the front panel is briefly depressed as confirmation that the basic setting should be used. Then the relevant displays light continuously and the unit can be activated using the setting available. These settings can be changed or adapted to the respective requirements at any time.

2 - 3 Function fields The CUT and COAG function fields can be adjusted separately from one another, although not activated simultaneously for reasons of safety. WARNING

Function fields that are not used may be switched off completely to prevent unintentional activation. To do this, the power limitation must be set down so far in the corresponding function field until a beep is heard and “ -“ appears on the digital display. The corresponding function field cannot be activated in this condition.

4-2

2

CUT function field

2.1 Setting of the coagulation EFFECT when cutting Here the required cutting quality in regard to the coagulation effect on the cutting edges can be adjusted. Level 1 corresponds to a low coagulation effect. Level 2 corresponds to a high coagulation effect. 2.2 Setting of the power limitation ICC 50 The HF power output can be limited in 1 watt steps from 50 watts to 1 watt. If the display shows “ -“, the Cut mode is switched off. ICC 80 The HF power output can be limited in 1 watt steps from 80 watts to 1 watt. If the display shows “ -“, the Cut mode is switched off.

2.3 Display of the set power limitation in watts This display shows the respectively set power limitation Activation This can be done using either the yellow key on the electrode handle or the yellow pedal on the footswitch. Activation is visually signaled by continuous illumination of the triangle symbol in the upper part of the CUT function field and also acoustically signaled. Cutting instruments are connected to the CUT/COAG socket.

4-3

3

COAG function field

3.1

Selection of the coagulation mode By pressing this key, one of the following coagulation modes can be selected:

3.2

Forced coagulation

3.3

Soft coagulation

3.4

Bipolar coagulation

3.5

Power limitation The HF power output can be limited in FORCED, SOFT and BIPOLAR-COAG mode in 1 watt steps from 50 watts to 1 watt. If the display shows “ -“ , the Coag mode is switched off.

3.6 Display of the adjusted power limitation in watts This display shows the respectively adjusted power limitation Activation Forced and Soft coagulation can be activated using the blue key on the electrode handle or the blue pedal. Bipolar coagulation can be activated via the blue pedal. Activation is signaled by illumination of the triangle symbols in the COAG function field as well as acoustically. Monopolar instruments are connected to the CUT / COAG socket, bipolar instruments to the BIPOLAR socket.

4-4