Emed ES300 Operation Manual

ELECTROSURGICAL SYSTEM
ES300
OPERATION
MANUAL
EMED
RYZOWA 69A , 05-816 OPACZ
POLAND
CE
www.emed.pl
(+48 22) 723-0-800, (+48 601) 29-85-30
emed@emed.pl
1011
ISO 9001
ISO 13485
IU ES300 2006:11:29 ANG 2.0
ES300 OPERATION MANUAL TU ES300 2006:11:29 ANG 2,0
ES300 OPERATION MANUAL IU ES300 2006:11:29 ANG 2.0
CONTENTS
1. Look and purpose of the ES300 system ..................... 5
1.1. Accessories for electrosurgical treatment ................... 5
2.Technicaldata.................................. 7
3. List of components ... .........................,,..,.... 9
4. Look, construction and working principle of the system........ 11
5.Preparationofthesystemforwork......................... 13
6. System operation and the performance of electrosurgical treatment 13
6.1. Switchingon......,..............................,... 13
6.2. Neutral electrode control ..................,..,......,... 15
6.3. System overload control. .................,.,.,,,,..... 17
6.4. Monopolar cutting ......................,,..,,.,.,...... 19
6.5. Monopolar coagulation .................,,..,,,......... 21
6-6.-Bipolar-coagulation............ 23
6.7. Switching off...................................,..... 23
7. Means of protection and warning .....................,...... 25
8. Checking the technical condition .....................,..... 27
9. System maintenance ........................,.,............ 27
9.1. Recommended agents for cleaning and sterilisation of accessories. 29
ES300 OPERATION MANUAL TU ES300 2006:11:29 ANG 2.0
Ce ~BICOAG
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HONOPOLAR
Fig. 1. Frontside view of ES300 system.
(o's)
Fig. 2. Backside view of ES300 unit.
1. Purpose of the ES300 system
The electrosurgical system ES300 is an all-purpose diathermy based on high-frequency

current flow. ES300 is designed for use in electrosurgical treatment.
The ES300ystem may be used for cutting and coagulation in open surgery. It is also
compatible with laparoscopes and fiberscopes. As the system is equipped with a CF-type
(floating) output, it may be used in the central nervous system and the heart.
- pure cutting,
- blend cutting with hemostasis,
- soft coagulation,
- forced coagulation,
- bipolar coagulation.
1.1. Accessories for electrosurgical operations
The system is equipped with high-quality surgical accessories permitting a variety of treatment
measures to be performed in general surgery, vascular surgery, gynaecology, oncology and
other fields.
The connection sockets for the neutral electrode output is made in accordance with the
6.35 mm 1-pin standard (Fig. 3, item 2)
Neutral electrode plug
The socket of the monopolar active electrode (Fig. 3, item 3) is also made in accordance with
the so-called 3-pin standard
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Active electrode plug Monopolar endoscope plug
Standard monopolar electrodes with the following diameters may be connected to the system:
- 4 mm - using handles with 4 mm diameter,
- 2.4 mm - using handles with 2.4 mm diameter,
The socket of the bipolar output (Fig. 3, item 4) is made in accordance with the 2-pin 4mm
standard.
ji
Two-part bipolar plug 2-pin bipolar plug
2. Technical data for the ES300 system
Table 1 shows the technical data for the electrosurgi cal system ES300.
SUPPLY
Supply voltage 230 V +10% 50 Hz
Rated power input 500 W
SAFETY CONDITIONS
Class 1
Type CF
Low-frequency leakage currents Acc. to IEC 601-1
High-frequency leakage currents Acc. to IEC 601-2-2
Generator working frequency version dependent, from
300 to 450 kHz kHz
Defibrillation impulse resistance acc. to EN60601-1
CONTROL SYSTEM FOR NEUTRAL ELECT RODE APPLICATION

Optical indication 8 levels
Required resistance < 240Q
(at least 1 green-coloured segment lighted)
POWER OUTPUT IN MONOPOLAR CIRCUI T

Pure cut 250 W for 3000
Blend cut 150 W for 300 Q
Soft coagulation 150 W for 150 Q
Forced coagulation 150 W for 300 Q
POWER OUTPUT IN BIPOLAR CIRCUIT -

Coagulation 99 W for 40 Q
OTHERS
Generator dimensions 340 x 360 x 160mm
Weight 6Kg
Table 1. Technical data for the ES300 system.
ES300 OPERATION MANUAL 1U ES300 2006:11:29 ANG 2.0
3. List of components
Table 2 shows standard components of the electrosurgical system ES300.
ITEM ITEM DESCRIPTION PCS.
1 ES 300 generator 4
2 Supply cable 4.5m 4
3 User manual 4
4 Guarantee document 4
Table 1. Standard system components.

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Fig. 3. Frontside view of the ES300 unit.
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Fig. 4. Backside view of the ES300 unit.
10
ES300 OPERATION MANUAL TU ES300 2006:11:29 ANG 2,0
4. Look and construction
The system encasing is made of plastic material without ventilation openings. It is easy to keep
the system clean; it can be cleaned with disinfectants.
On the back wall of the encasing there are (Fig. 4):

- the socket of the mains power lead (5),
- the socket of the mains fuses 250V/4 A (6),
- the socket of the double foot-operated switch (7),
- additional grounding pin (8).
On the front wall of the encasing there are (fig. 3):

- the mains switch (1),
- the sockets of:

- the neutral electrode (2),
- the monopolar electrode (3),
- the bipolar electrode (4),
- the selection push-buttons for operation types:

-pure-cut (Kb),
- blend cut (K2),
- soft coagulation (K5),
- forced coagulation (K6),
- bipolar coagulation time limit (K9),
- bipolar automatic start (K10)
- the power control push-buttons:

- cut - increase (K3) and decrease (K4),
- coagulation - increase (K7) and decrease (K8),
- bipolar coagulation - increase (K11) and decrease (K12),
- push-buttons for working modes of the foot-operated switch:

~ monopolar output contro! (K13),
- bipolar output control (K 14),
- set power displays for:

- cut (D1),
- monopolar coagulation (D2),
- bipolar coagulation (D3),
- line display - neutral electrode application control (D4),
- system overload control (DS).
11
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MONOPOLAR HANDLE e ?
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BIPOLAR CABLE
Fig. 5. Mode of connection of accessories to the ES300 system and mode of laparoscope
connection.
12
E3300 OPERATION MANUAL IU ES300 2006:11:29 ANG 2.0
5. Preparation of the system for work
The system is prepared for work by connecting the power lead and accessories.
As the only one, the power lead can be connected and disconnected only when the system is
switched off. The system should be supplied from a socket equipped with an earth bolt. The
supply socket is located in the back wall of the encasing (Fig. 4, item 5).
The system does not require connecting the additional grounding pin. It is used for grounding if
a non-grounded socket is used or in sites where the system of protection against electric shock
requires such connection.
The pedal is connected to socket 7 in the back wall of the encasing (Fig. 4).
The connection mode of the accessories is explained in Fig. 5.

The neutral electrode is not required for bipolar operations.
More information about the neutral electrode can be found in Section "6.2. Neutral electrode
control".
Power settings
Prior to an operation the correct power should be set. It is set
independently for the operations of cutting, coagulation and
bicoagulation. The maximum wattage is indicated on displays assigned to
each type of operation. The settings are changed by arrow-marked keys.
CJ
Before the first use of the system it is well-advised to become familiar with the effects of
different settings by performing tests on fresh beef.
6. System operation and the performance of electrosurgical operations
6.1. Switching on
The system is switched on using a mains switch 1 (Fig. 3). The accessories can also be
connected to the system when it is on, obviously while keeping appropriate safety conditions.
At this point, care should be taken to prevent a possible switch-on of the generator by
accidental pressing of the push button or pedal.
13
ES300 OPERATION MANUAL IU ES300 2006:11:29 ANG 2,0
Fig. 6. Connection ofa reusable neutral electrode
294-030
Fig. 7. Connection of a disposable neutral electrode
14
6.2. Neutral electrode control

In the monopolar operation mode, the system controls correct connection of the neutral
electrode cables. The electrode application quality is shown on 8 LED linear indicator D4
(Fig. 3).
A significant advantage of the neutral electrode control system is the fact that the
control is performed continuously, also during generator operation. The neutral electrode
control system has no effect on bipolar mode operation.
- One-piece, reusable neutral (rubber) electrode

has no feature of controlling the application, i.e. adhesion to the patient’s body. Only correct
connection of the electrode to the system is controlled. With correct connection, all LEDs on
linear indicator D4 (Fig. 3) should be on.
Therefore, when using one-piece rubber electrodes, special attention should be paid to correct
placement of the neutral electrode, to prevent burns in its application site during the procedures.
e The electrode should adhere to the body with the entire surface and be fixed to prevent
accidental movement.
The electrode may not be positioned with a corner towards the operating field.
The electrode may not be wet or wrapped with anything.
No fluids may enter between the body and the electrode.
It should be remembered that rubber electrode looses its conductive properties over the time
due to washing out of active substances from the rubber. Such electrode increases the risk
of patient burn. Therefore, reusable electrodes should_be sent to periodic inspections along
with the systems.
Neutral reusable electrodes should be disinfected before use (see Section 9 "System
maintenance”),
The medical practice shows that the patient is best protected against burns by the use of splitted
single-use electrodes.
- Splitted, single-use neutral electrode
enables to control neutral electrode application. The risk of burns from this electrode is
therefore significantly limited. Maximum resistance at which the system will operate is
240 Ohm. In practice, it means that at least one green LED must be on in the linear indicator. If
an attempt to use the generator is made when the electrode application is not adequate, the
device signals the fact with modulated sound.
Consult instructions for use provided on the single-use electrode packaging.
15
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Mode of neutral electrode's application at the patient with a pacemaker.
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Correct neutral electrode's application areas at the adult patient.
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Correct neutral electrode's application areas at the child.
6.3. System overload control
The system has a working time limit, protecting it from overload (OVERLOAD). The limit
depends on the set power and the type of operation. In practice, for a pure cut the overload
control allows for operation with a rate of 33%, i.e., for | minute of work and 2 minutes of
break for the full power of 250 W.
- System overload
is signalled by the lighting of the red-coloured overload controller. The system then forces an
end to the operation until the controller goes out (about 30 seconds). With attempts to continue
cutting or coagulation, a pulsed, unmodulated sound will be heard, indicating overload.
OVERLOAD (D5)
MED BS 300
ン NEUTRAL
ELECTRODE (D4)
17
ES300 OPERATION MANUAL TU E8300 2006: 11:29 ANG 2.0
8 cur о COAG Cr BICOAG
Wa ng = © 00 © ©
MONOPOLAR BIPOLAR
Fig. 8. Cutting power display and push-buttons for cutting types and power regulation
18
ES300 OPERATION MANUAL IU E5300 2006:1 1:29 ANG 2.0
6.4. Monopolar cutting
As arule, cutting is performed by a knife or loop electrode.

The manner of connecting electrodes is explained in Fig. 5.
Prior to cutting the kind of expected effect should be selected: pure cut or one with hemostasis.
The selection is made with push-buttons K1 and K2.
と Pure cut (K1)
./ Cutting with hemostasis (K2)
Cutting with hemostasis (blend) intensifies the coagulation of the edges of the tissue being cut.
In the cutting mode the system is switched on by the yellow-coloured push-button in the
electrode handle or the yellow-coloured push-button of the pedal. In order to cut using the
pedal, it should be set for the monopolar work mode (with push-button K13).
Pedal for monopolar operations (13)
19
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MONOPOLAR BIPOLAR
Fig. 9. Coagulation power display and push-buttons for coagulation types and
power regulation
20
6.5. Monopolar coagulation
As a rule, coagulation is performed with a ball or plate electrode.

Prior to the operation the type of coagulation should be selected: soft coagulation or forced
coagulation. The selection is made with push-buttons K5 and Κ6.
/Soft coagulation (K5)
Forced coagulation (K6)
In the monopolar mode the system is switched on by the blue-coloured push-button in the
electrode handle or the blue-coloured push-button of the pedal. In order to use the pedal, it
should be set for the monopolar work mode (with push-button 113).
L for monopolar operations (K13)
21
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THA CHE Os © O © ©
MONDPOLAR BIPOLAR
Fig. 10. Bipolar coagulation power display and push-buttons for time limit and power
regulation
22
6.6. Bipolar coagulation
In the bicoagulation mode the system can be switched on in two ways - automatically after
tissue has been grasped and using the pedal.
Automatic work occurs when the push-button K10 is switched on.
Bipolar automatic start (K10)
When tissue has been grasped and 1 second has elapsed, the generator switches on. It switches
off when pliers come apart or tissue has coagulated.
Pedal-controlled work is possible after the pedal has been set for bipolar operation with push-
button K14.
== Pedal for bipolar operations (K14)

In this mode the surgeon controls the beginning and end of coagulation.
In addition, it is possible to use a function, which limits the coagulation time to 1 second. This
function is switched on and off with key K9 (Fig. 3).
/Function limiting the operation time in the bipolar coagulation mode (K9)
6.7. Switching off the system
After finishing the operation the system should be switched off with the mains switch 1 (Fig. 3)
and the plug should be removed from the mains socket. After the system has been switched off
the electrodes and pliers should be disconnected from cables, and then the electrode cables
should disconnected from the system.
23
24
7. Means of protection and warning
7.1, During electrosurgical procedures, the risk of burns should be minimised by:
a) using only compatible accessories according to the description (see Section 1.1.),
b) checking the connecting cables of application electrodes each time, and especially their insulation,
c) careful application of the neutral electrode (see Section “Neutral electrode control"),
d) preventing any fluids from entering between the neutral rubber electrode and the patient’s body,
e) protecting the patient against contact with metal and grounding elements,
f) avoiding touching the patient’s skin — e.g. dry gauze should be used as an insulator, if necessary,
g) the patient’s individual body parts may not be in contact (e.g. hand to thigh),
h) the neutral electrode should be applied as close to the procedure site as possible,
i) bipolar technique should be used during procedures performed on body parts (organs) which have
narrow connections with the rest of the body.
7.2. During procedures performed in patients connected to monitoring devices (ECG), the monitoring
electrodes should be placed as far as possible from the electrosurgery electrode application sites.
Moreover, it is recommended to use monitoring devices equipped with protection systems against
high-frequency currents.
7.3. The application electrode cables should be connected in a way not to:
- touch the patient,
- be intertwined with other cables.
7.4. During procedures in which high-frequency current could flow through low cross-section body
parts, bipolar technique should be used to minimise the risk of accidental coagulation.
7.5. The output power setting should not exceed the power necessary for a given procedure,
7.6. Evident output power drop with normal settings may indicate incorrect application of the neutral
(rubber) electrode.
7.7, Soiled active electrodes may impair the operating quality of diathermy.
It applies in particular to soft and bipolar coagulation.
7.8. Flammable anaesthesiological agents and oxidative gases (such as N3O or O2) should be avoided.
If they must be used, particular caution should be exercised.
7.9. Non-flammable disinfectants should be used. Otherwise, they should be left to evaporate before
the procedure. There is also a risk of spilling these agents under the patient’s body or into the body
cavities. In this case, the affected places should be carefully dried. A flammable agent may ignite from a
sparkle occurring during normal operation of the system.
25
ES300 OPERATION MANUAL 1U ES300 2006:11:29 ANG 2.0
7.10. Sparkles at the active electrode pose a risk of ignition for dressings and metabolic gases.
7.11. During the procedures, there is a risk of malfunction or damage of a heart pacer. In these
patients, bipolar technique is recommended. Prior to electrosurgery, seek an advice of an authorised
representative of the pacer manufacturer. The use of electrosurgery systems is not allowed in patients
with heart pacers in outpatient settings.
7.12. lt should be remembered that reusable accessories enclosed to the system are not sterile.
7.13. High-frequency leakage currents may cause burns in locations distant from electrode application
sites, if the places are in contact with conductive elements.
7.14. The frequently used technique of coagulation "through the instruments" should only be performed
using appropriate insulated pliers. There are special pliers with insulated handle (contact EMED
representatives for additional information). Surgical gloves do not protect the operator from burns
adequately. Spray coagulation should not be used in this technique.
7.15. When using spray coagulation, a safe distance from the fingers and metal parts of
endoscope/fiberscope optical parts should be maintained.
7.16. During the construction of electrosurgery systems, EMED paid special attention to EMC
requirements which are becoming more restrictive. As a result, solutions ensuring minimum emission
levels to meet current and future requirements have been selected. Laboratory measurements have
confirmed high electromagnetic safety level of the EMED diathermy.
In typical operating conditions, a field corresponding to 8-hour daily exposure occurs at a distance of 5
to 15 cm from working cables. Above 20-40 cm, the field decreases to an admissible value without time
limit. The electromagnetic fields occur mainly around the cables, the diathermy itself is practically not
an emitting component.
During breaks in operation, diathermies do not emit any high-frequency power. As the field distribution
depends on a specific stand, equipment and cable arrangement, you may ask a local unit for diseases
control and prevention to determine a detailed distribution of the emission zones.
26
8. Checking the technical condition
After each operation the condition of power leads, electrodes and the pedal switch should be
checked.
À more accurate inspection of the technical condition should be performed by an authorised
producer's service.
After switching on of the unit the Power On Self Test is performed:

If any error occurs it is displayed in a form below
Err XXX 00
where XXX means malfunction of
01 — Handle switch CUT,
02 — Handle switch COAG,
04 — Foot switch CUT,
08 — Foot switch COAG,
16 — Bipolar circuit shorted.
If any other code is given an authorised service should be contacted.
9. System maintenance
CLEANING
The system should be cleaned in a way to prevent any liquid from entering inside.
ACCESSORIES STERILISATION
Sterilisation should be performed according to the recommendations of a specific accessory

supplier.
The accessories supplied by the manufacturer, unless specified otherwise, are non-sterile and
require sterilisation before use.
The offered electrosurgery accessories, unless specified otherwise, may be steam sterilised at
up to 134°C at 2.3 Bar. If other accessories are used, the manufacturer’s instructions should be
observed.
FUSE REPLACEMENT
The fuse sockets are located in the back panel (Fig. 4). WTA-T 4A, 250V fuses (20 mm size,
F type) should be used. To replace the fuses:
- disconnect the system from the mains,
- unscrew the fuse sockets using flat screwdriver,
- replace the fuses.
27
28
9.1. Recommended agents for cleaning and sterilisation of multiple-use

electrosurgical accessories
1. MANUAL CLEANING
The components strongly soiled with the remaining tissues should be pre-cleaned using a
plastic cleaning plate or plastic brush. Then one of the following recommended agents should
be used:
Manufacturer Product
Braun Melsungen Stabimed
Helipur H plus N
Prontocid N
Henkel Hygiene Sekucid konz.
Sekusept forte
Sekusept forte S
Johnson & Johnson CIDEX
Schuelke & Mayr Gigasept FF
Lysetol FF
Anios Aniosyme PLA
Salvanios PH10
For disinfection of neutral (rubber) electrodes, we recommend:

Henkel Hygiene Incidin perfekt
Minutil
Incidur F
2. MECHANICAL CLEANING
Henkel Hygiene Sekumatic FR / Mycie
Sekumatic FRE/ Mycie
Sekumatic FD /Dezynfekcja
Schuelke & Mayr Thermosept RKF / Mycie
Thermosept DK / Dezynfekcja
Dr Weigert Neodisher FE / Mycie
Neodisher Septo DN / Dezynfekcja
CAUTION!
To avoid mechanical damage, electrode handles should not be dried in compressed air under
pressure exceeding 3 bar.
3. AUTOCLAVE STERILISATION
Multiple-use products are designed for autoclave sterilisation (according to DIN 58946):
- temperature: 134°C,
- time: 20 minutes,
- pressure: 2 bar.
4. DO NOT USE FORMALDEHYDE STERILISATION.
29
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ELECTROSURGICAL SYSTEM

Fig. 1. Frontside view of ES300 system.

1. Purpose of the ES300 system

The electrosurgical system ES300 is an all-purpose diathermy based on high-frequency

1.1. Accessories for electrosurgical operations

Neutral electrode plug

Active electrode plug Monopolar endoscope plug

2. Technical data for the ES300 system

CONTROL SYSTEM FOR NEUTRAL ELECT RODE APPLICATION

POWER OUTPUT IN MONOPOLAR CIRCUI T

POWER OUTPUT IN BIPOLAR CIRCUIT -

Table 2 shows standard components of the electrosurgical system ES300.

ITEM ITEM DESCRIPTION PCS.

2 Supply cable 4.5m 4

Table 1. Standard system components.

4. Look and construction

On the back wall of the encasing there are (Fig. 4):

On the front wall of the encasing there are (fig. 3):

- the sockets of:

- the selection push-buttons for operation types:

- the power control push-buttons:

- push-buttons for working modes of the foot-operated switch:

- set power displays for:

- line display - neutral electrode application control (D4),

- system overload control (DS).

Oeste CEO Es --- e

5. Preparation of the system for work

The connection mode of the accessories is explained in Fig. 5.

6. System operation and the performance of electrosurgical operations

Fig. 6. Connection ofa reusable neutral electrode

Fig. 7. Connection of a disposable neutral electrode

6.2. Neutral electrode control

- One-piece, reusable neutral (rubber) electrode

- Splitted, single-use neutral electrode

Consult instructions for use provided on the single-use electrode packaging.

Mode of neutral electrode's application at the patient with a pacemaker.

6.3. System overload control

8 cur о COAG Cr BICOAG

6.4. Monopolar cutting

As arule, cutting is performed by a knife or loop electrode.

と Pure cut (K1)

./ Cutting with hemostasis (K2)

Pedal for monopolar operations (13)

6.5. Monopolar coagulation

As a rule, coagulation is performed with a ball or plate electrode.

/Soft coagulation (K5)

Forced coagulation (K6)

L for monopolar operations (K13)

a CUT | © COAG ©. BICOAG

6.6. Bipolar coagulation

The manner of connecting electrodes is explained in Fig. 5.

Bipolar automatic start (K10)

== Pedal for bipolar operations (K14)

6.7. Switching off the system

7. Means of protection and warning

8. Checking the technical condition

After switching on of the unit the Power On Self Test is performed:

Sterilisation should be performed according to the recommendations of a specific accessory

9.1. Recommended agents for cleaning and sterilisation of multiple-use

For disinfection of neutral (rubber) electrodes, we recommend: