BERCHTOLD ELEKTROTOM 530 User manual
1. General
1.1 Introduction
1.2 Manufacturer’s notes
1.3 General information
1.4 Notes on product responsibility
1.5
1.6 Guarantee
1.7 EC certification
1.8 Repairs
1.8.1
1.9
Routine checks following delivery
Replacement of fuses
Technical safety controls
2. Commissioning
Service Manual (E)
Valid for version 11 .lO - 11.24
ZLEKTROTOMO 640
2.1
2.2
2.3
2.4
2.5
2.5.1 Cleaning and disinfecting of the unit
2.5.2 Cleaning, disinfecting and sterilisation of accessories
Installation
Important notes for fafe usage
First usage
Visual and functional checks before each use
Cleaning, disinfecting and sterilisation
3. Ooeratinc the ELEKTROTOMB 530
3.1
3.1.1 The front of the ELEKTROTOMB 530
3.1.2 The rear of the ELEKTROTOMB 530
3.1.3 Description of the pushbuttons and symbols
3.1.4 The different current types
Pushbuttons and signal lights
4. Technical descrimion
4.1
4.1.1 Technical data
4.1.1 .l Mains connection
4.1 .1.2 HF current output and current characteristics
4.1 .1.3 Safety relevant data
4.1 .1.4 Dimensions and weight
4.1.1.5 Certification
4.2
4.2.1 Power output in relation
4.2.1.1 Current type: CUT I
4.2.1.2 Current type: CUT II
4.2.1.3 Current type: TUR
4.2.1.4 Current type: SPRAY COAGULATION
4.2.1.5 Current type: SOFT COAGULATION
4.2.1.6 Current type: BIPOLAR COAGULATION
4.2.2 Power output as a function of the position of the power regulator
4.2.2.1 Current type: CUT I
4.2.2.2
4.2.2.3 Current type: TUR
4.2.2.4 Current type: SPRAY COAGULATION
4.2.2.5 Current type: SOFT COAGULATION
4.2.2.6 Current type: BIPOLAR COAGULATION
4.3
4.3.1 Technical data
4.3.1 .l Mains connection
4.3.1.2 HF current output and current characteristics
4.3.1.3 Safety relevant data
4.3.1.4 Dimensions and weight
4.3.1.5 Certification
Technical description
Power output diagram
Current type: CUT II
Technical description
to Version 11.23
to
resistance
Version 11.24
ZLEKTROTOM@ 640
4.4
4.4.1
4.4.1.1 Current type: CUT I
4.4.1.2 Current type: CUT II
4.4.1.3 Current type: TUR
4.4.1.4 Current type: SPRAY COAGULATION
4.4.1.5 Current type: SOFT COAGULATION
4.4.1.6 Current type: BIPOLAR COAGULATION
4.4.2
4.4.2.1 Current type: CUT I
4.4.2.2 Current type: CUT II
4.4.2.3 Current type: TUR
4.4.2.4 Current type: SPRAY COAGULATION
4.4.2.5 Current type: SOFT COAGULATION
4.4.2.6 Current type: BIPOLAR COAGULATION
Power output diagram
Power output in relation to resistance (output characteristic)
Power output as a function of the position of the power regulator
5. Fault findinp without measurinp instruments
6. Connecting diagram ELEKTROTOMO 530
7. Power control circuit ELEKTROTOMB 530
8. Technical descriDtion of the individual boards
8.1 Power supply
8.2
8.3
8.3.1
8.4
8.5
8.6
8.7
8.8
8.8.1
RF-activation and application
Mains power supply
IIIustration mains power supply
Illustration Board for control elements
Illustration Display board
Illustration W-generator board
Illustration Patient circuit board
Control circuit board
Illustration Control circuit board
9. Neutral electrode setting
9.1
9.2
9.3
Neutral electrode setting, valid up to Version 11.21
Neutral electrode setting, valid up to Version 11.22 and 11.23
Neutral electrode setting, valid for Version 11.24
10. Localisation and descriDtion of boards
11. SDare Part list
12. TestDoints. Localisation of fuses
13. Trouble-ShootinP and adiustments
SLEKTROTOMB 640
13.1
13.2
13.3
13.4
13.5
13.6
13.7
13.8
13.9 No RF acoustic signal despite RF output and indication
13.10
13.11
13.12
13.13 Checking the control circuit board
13.14
13.15
13.16
13.17
13.18
13.18.1
13.18.2
13.19 Adjustment of
Unit cannot be switched on
How to check the mains supply circuit
The light beam indicator and/or the output power do not react to increase /
reduction of power regulators
One or several beams on the bar indicator remain dark
When the power is adjusted, a beam segment is skipped
The respective push buttons do not react when selecting the current mode
No RF indication/acoustic signal for foot/hand activation
No RF indication despite RF output with acoustic signal
No indication or acoustic signal despite RF output
No RF output/indication/acoustic signal despite activation
No RF output despite visual or acoustic signal
The automatic switch off with contact and bipolar coagulation is not functioning
Symbol at the front illuminates
The bipolar current is activated automatically without accessory in hand mode
The unit cannot be activated in monopolar mode
Adjustment of maximum RF power at level 10
Up to Version 11.23
Version 11.24
minimum RF power at level 1
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1. General
1.1 Manufacturer’s notes
The manufacturer of the products specified in the user’s manual is
BERCHTOLD GmbH & Co
Medizin-Elektronik
Ludwigstaler StraBe 25
Postfach 4052
D-78505 Tuttlingen
Internet: http: / /www.Berchtold.de
e-mail: Berchtold.Medininelektronik@Berchtold.de
Tel. (+49) 7461/ 181-O
Fax (+49) 7461/ 181-200
Telex 762 532 berth d
1.2 General information
~This user’s manual is considered part of the equipment. It must be kept in the vicinity of the equipment
at all times. Precise observance of the user’s manual is a prerequisite for the proper use and correct
operation of the equipment, which is essential for the safety of patients and operators alike.
* Only accessories which are specified in this user’s manual and which have been tested together with the
equipment may be used. If accessories are used which are not specified in the user’s manual, their ability
to be used in accordance with safety regulations must be proved.
*All literature relates to the equipment model and the prevailing basic safety regulations when printed. All
rights are reserved for equipment, switches, procedures, software programs and names.
SLEKTROTOMO 640
1.3 Notes on product responsibility
The BERCHTOLD company can only consider themselves responsible for the safety, reliability and
function of the product under the following conditions:
a) installation, modifications
expressly authorized by BERCHTOLD to do so,
b) the electrical installation of the room complies with regulations VDE 0107 or IEC 364-710,
c) the product is used in accordance with the operating instructions.
or repairs have been performed only by BERCHTOLD or by an agent
1.4 Routine checks following delivery
The product and accessories should be inspected for possible transport damage or other defects
immediately on arrival.
Reclamation regarding damage or defects can only be entertained by the selling organisation
(BERCHTOLD GmbH & C )
complaint, the forwarding agent or the BERCHTOLD sub-agency must immediately be informed, prior
to the submission of a damage / deficiency report to the BERCHTOLD main offices in Germany for
further processing by our insurance agents.
When returning a unit or one of its components to BERCHTOLD or to a BERCHTOLD service centre,
every effort should be made to use the original packaging material. The following
information/documentation must also accompany the returned items: Name and address of the owners,
product identification number (See plate affued to unit), Detailed description of the defect.
o. or the delivering agency when they are immediately reported. In case of
1.5 Guarantee
The product is guaranteed for a period of twelve months starting from the day of delivery to the end user.
Within the guarantee period, all defects or components shown to be due to manufacturing or material
failure, will be car-rected by either BERCHTOLD or their official, representative agency.
Misuse of the unit or interference from a third party will negate any customer entitlement under this
guarantee.
Please note the contents
Important!
Repairs or a&stments must onb be made by BERCHTOLD or their @e$cal& nominated representative.
Should repairs or a+stments be made b a .rpecQ%aill nominated BERCHTOLD representative, tbe user is required to
obtain a detailed reportfrom tbat agent showing the kind and extent of repairs cmied out. This report sbouldfhber show
the date of afy intervention and an approved signature of tbe company (age@ who unde?-took tbe work. Where repairs are
not cam&d out direct4 by BERCHTOLD, repaired vstems or ystez? parts must bear the mark or indicator of the
repairing agent.
of the
guarantee
card and retain it for future reference.
1.6 EC certification
The equipment complies with the requirements of the EC guideline regarding medical products,
93/42/EEC.
1.7 Repairs
By obvious defect, either of the unit or its connecting cable, it must be repaired or its cable renewed
ZLEKTROTOMB 640
before being used again.
The ELEKTROTOMB
Should the unit be repaired by an officially appointed agent, the user is required to obtain written
confirmation of the work carried out. This signed confirmation should bare the date of the repair and the
details of the officially appointed agent. When repairs are not carried out by BERCHTOLD direct, the
repairing organisation must append their details to the unit or, that part of the unit which has been
repaired.
530 may only be repaired by BERCHTOLD or their officially appointed agent.
1.7.1 Replacement of fuses
* Remove mains cable from the connection socket (38).
*The unit fuses are located in the plug-in module (37) at the back of the unit (see page 5). The fuse
module can be removed by squeezing the sides. The fuse value (at 230 V - T 2.5 A) given on the fuse
carrier must be observed at all times.
* Replace the fuse carrier and connect the mains cable to the socket (38).
1.8 Technical safety controls
The following controls must be carried out at least on a yearly basis:
0 Visual checking for any mechanical or functional defect
* Safety relevant markings on the unit must be readable
* Checking of the mains fuses against nominal electrical value
* Checking the calibration of the HF current output against the setting of the pressure sensitive pad of
the control panel
* The actual output measurement for the current modes cut I, spray and softcoagulation should be
checked to the values the laid down in the specifications for the unit.
* Checking of optical and acoustic signalisation
* Compare protected resistance according to EN 60601-l with mains connection. Limit is 0,2 IR
* Measure leak values to earth. According to EN 60601-l
* Measure case leakage according to EN 60601-l
Limit 0,50 mA (NC.) *
Limit 1,00 mA (S.F.C.) **
Limit 0,lO mA (NC.) *
Limit 0,50 mA (S.F.C.) **
* Measure patient leakage according to EN 60601-l
* Measure patient leakage according to EN 60601-l
(Mains voltage at used instrument)
* N.C. = Normal condition
** S.F.C. = Single fault condition
The results of the technical safety checks should be documented.
Should the unit proofe to be defective or otherwise unsafe it must not be used until repaired.
Limit 0,05 mA (S.F.C.) **
Limit 0,Ol mA (NC.) *
Limit 0,05 mA (S.F.C.) **
<LEKTROTOM@ 640
2. Commissioning
2.1 Installation
The unit is intended for use only in a medical environment and connection to the mains must be in
accordance with the IEC 364-710 regulations. Further, connection to the mains should be via a suitably
protected socket using the mains lead and plug provided by the manufacturer or one of an equivalent
quality. For safety reasons, extension leads or multi-socket connections should not be used. The mains
socket must be protected by a fuse rated at not less than 10 Amperes.
The ELEKTROTOMB can be placed on any flat surface with a tilt angle not in excess of 10”. The
surface itself should be equivalent in size to that of the unit. Care must be taken not to block the air vents
on the underside of the generator and ensure a free flow of air around the unit. The ELEKTROTOMB
should be protected from the danger of fluids entering the unit.
For
intracardiac
room or location where it is installed by means of the (yellow/green) power-stabilization cable supplied.
surgery this equipment must be connected to the main power stabilizer in the operating
2.2 Important notes for safe usage
Misuse of the generator and a disregard of these instruction can lead to serious injury!
Take care to study these instructions supplied with your ELEKTROTOMB
Warning!
The unit is not intendedfor me in explosion endangered areas
Caution must be exercised when anaesthetic gas mixtures such as Oxygen
are used during surgery in the thoracic or head regions. The use of anaesthetic gas, exhaust management
systems is to be recommended. Inflammable substances used for cleaning or disinfection or, particularly,
solvents used to remove adhesives, must be removed or fully evaporated before the using an
electrosurgical unit. The danger of pocketing or pooling of inflammable liquids or vapours in body
cavities such as the navel or vagina as well as in the depths of surgical wounds which must also be
considered and not underestimated. Liquids must not be allowed to gather or pool under the patient. The
presence of endogenic gases which may be ignited, must also be taken into account when using
electrosurgical equipment on the gut and a system of inert gas flushing is recommended. Material such as
cotton wool or gauze can, in certain circumstances, also be ignited via HF current induced sparking particularly in the presence of oxygen.
(02)
and nitrous Oxide
(~20)
The use of electrosurgery requires caution and the following rules should be considered
:LEKTROTOM@ 640
. The high frequency current output of the unit should be
task to be performed.
minimal and not more than is required for the
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Note:
A reduced or lack: offunction after setting the unit ou(but controls at ‘normal’power can be caused by a number
such as neutral electrode problems, bad connections, damaged cables or a crusted active electrode. Theses point should be
considered before selecting what rnz@!~ be a much bzjber unit ouput than necessav.
* Do not attempt to test the unit by directly discharging against a metal object or the negative electrode.
*The function of other electromedical equipment can be interfered with by the use of high frequency
current.
*The switching mechanisms of an electrode handle which is not completely water tight, may be
penetrated by blood, saline or other rinsing liquids or amniotic fluid producing an unpredictable
response from the generator.
* In order to prevent accidental HF current burns, the electrode handle should be placed on the
instrument trolley when not in use and not on the patient.
* Placing a finger switched, electrode handle onto very damp drapes or, into pooled liquid on the drapes,
may cause patient burns directly below the electrode handle.
2.3 First usage
offactors
Before the unit is first used surgically, the Manufacturer or their official agent shall:
a) have fully tested the unit in the position in which it is to be used;
b) have given full operational instructions for the unit to a responsible person.
2.4 Visual and functional checks before each use
Before each use the user must be sure that the unit and its accessories are in good working order.
The following visual checks should be made:
e check for external damage to the unit, insulation and plugs
0 check that the appropriate accessories a present and that they fit
* Very
Damaged or doubtful equipment must not be used.
Warning!
Sboukd the flow of HF current be indicated by tbe unit witbout the attachment of a foot-switch or electrode handle witb a
dozble, jhger switch then the unit is fazdty and must be examined before use. An indicated ma@nction following tbe
attachment of a foot-switch or electrode handle witb double, jnger switch sbows a defective accessory wbicb mm-t be checked
and eventuaLI replaced.
carefully check the insulation on endoscopic instruments
3LEKTROTOMO 640
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2.5 Cleaning, disinfecting and sterilisation
2.5.1 Cleaning and disinfecting of the unit
The entire exterior of the unit, including the foil covered operating panel, can be cleaned with normal, alcohol
free cleaning fluids. (Spray or wipe disinfecting)
Please take note of the manufacturers instructions for disinfectant solutions.
2.5.2 Cleaning, disinfecting and sterilisation of accessories
After use, accessories may be soaked in standard disinfecting solutions following the instructions of the
manufacturers, without exceeding soaking times. The life expectancy of some plastics may be shortened by
certain chemicals and a thorough rinsing of all accessories is important. Phenol and chlorine solutions are not
suitable. Alternatively, a mechanised washing and thermal disinfecting process is acceptable, provided
temperatures do not exceed 93” C.
Good operative results can only be expected when the active and negative electrode are perfectly clean and free
from any dried protein.
Connecting cables and the insulation of active electrodes must be constantly checked and maintained in perfect
condition. Articles with damaged insulation must not be used.
The following
sterilisation temperatures are acceptable:
Gas sterilisation Gas sterilisation
up to 70 OC up to 70 OC
Connecting cables for
electrode handle
Electrode handle
Active electrodes
Bipolar coagulation
forceps
Neutral electrode of
conductive silicon rubber
Yes Yes
Yes Yes
Yes Yes
Yes
Yes
3. Operating the ELEKTROTOMB 530
3.1 Pushbuttons and signal lights
3.1.1 The front of the ELEKTROTOM@ 530
Yes
Yes
Hot air sterilisation
at200OC
no
no
Yes
no
no
ZLEKTROTOM@ 640
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
Unit STANDBY OFF-switch
Unit STANDBY ON-switch
Indicator lamp for incorrect output
Indicator lamp HF leakage current monitoring and for
Version
11.20
and
11.24 also a indication
for overheating of the generator
Indicator lamp neutral electrode monitoring
Light bar indicator for the CUT power
Output control - CUT
Indicator lamp CUT
Selection switch TUR
Selection switch Cut II
Selection switch Cut I
Light bar indicator for the COAGULATION power
Output control COAGULATION
Indicator lamp COAGULATION
Selection switch CONTACT COAGULATION
Selection switch SPRAY COAGULATION
Light bar indicator for BI-COAGULATION power
Output control BI-COAGULATIN
Indicator lamp BI-COAGULATION
Selection switch for foot switch start BI-COAGULATION
(with our without Auto- Stop-Mode)
Selection switch for automatic start BI-COAGULATION
(with our without Auto- Stop-Mode)
Socket for active electrode with 8 mm banana plug
Socket for double pedal foot switch to control active electrode 1
Socket for active electrode 1
Socket for neutral electrode (single or split neutral electrode)
Additional sockets for disposable hand pieces
Socket for active electrode 2
Selection switch Contact Coagulation with Auto-Stop
Socket for bipolar coagulation instruments
Socket for single foot switch (Bi-coagulation)
Selection switch bipolar coagulation with Auto-Stop-Mode
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3.1.2 Rear panel of ELEKTROTOMB 530
ZLEKTROTOM@ 640 http://www.berchtold.de/ET530me.htrr
,,,-”
Symbol for acoustic signal (volume not adjustable)
32
Rating plate with serial no. and indication of voltage
33
Equipotential cable connector
34
Mains switch
35
Mains fuses in fuse holder
36
37
Connection socket for mains cable
3.1.3 Description of the pictograms
Socket for hand piece with double finger switch for activating cut or
coagulation
Socket for foot switch, for both double pedal foot switch (monopolar)
and single foot switch (bipolar)
_ __ _-
-,,__^, “- ,,-..- ..- ^_.~
,,,- ,“-~ -..~ “-,- ..,.. ,,,.,,, - ,-
Socket for neutral electrode cable, single or split neutral electrode
Selection
switch for Bipolar coagulation ,automatic start with or
_- _ ~-. ^
,~ .._ -,. --II_..-,.,, ~.“. --
without Auto-Stop. When the switch is illuminated current will
automatically be switched on for Bi-coagulation 2 seconds after the
forceps grasp the tissue and when Auto-Stop is selected, automatically
switched off after coagulation. The Auto-Stop-Mode can be switched
on and off by means of the “Auto” switch.
Selection switch for Bipolar coagulation using a foot switch. Foot switch
start with or without Auto-Stop. The Auto-Stop-Mode can be switched
on and off by means of the “Auto” switch.
..- _ ,,_..,- __ _.
Selection switch for Auto-Stop-Mode of the coagulation method selected
or Stan-switch with no. 1 or 2. When the switch is illuminated current
will automatically be switched off after coagulation
<LEKTROTOMO 640 http://www.berchtold.de/ET530Fe.htn
Socket for Bipolar coagulation instruments.
Floating output - the neutral electrode is isolated from earth at both
high and low frequencies
“,, ,,“-.,,-.” ,.,,,,.,. “,
~““.__ .,.,,. _- -.,, “,~ .,~,,, ,-.,, _“- -.. ..-. __. , ,.,-_ ,,“, ^FI_
Type CF equipment. This unit provides a high degree of protection
against electric shock, especially with reference to permitted low
frequency leakage current. Therefore this unit is suitable for direct
cardiac application.
Notice: ATTENTION! Please refer to the operator’s manual
ATTENTION! High voltage, voltages of > 1000 V may be present at this
socket.
_.,._ ,, -” . ...,.. - ,,,,,,, _ _.,,^ _i , ,,
1___1,, ,,,.,.-.
” _.. “” ...,.- II____ ,,,_. ^-““.,,
,,_X11.. ___--~,, ,, ._-
.- ...“~--. _
3.1.4 Types of output
The unit produces unmodulated or selectively modulated High Frequency current. The selection
switches permit a choice of the following current types:
CUT I
Unmodulated RF current.
This current type gives sharp cutting with little arc formation and without
coagulation
of the cut surfaces.
ZLEKTROTOMO 640
http://www.berchtold.de/ET530-e.htn
CUT II
Lightly modulated RF current. This current type gives a clean cut with
some coagulation of the cut surfaces
_x .,., , ..--~- cI_ _I_
_ ,,,,,__ ,-
TUR
-... ~.” ...,__ ..,. -“...x”““” ..,,.., -. ..I x _-,,. - --
(Transurethral resection)
Unmodulated RF current.
This
current type
the areas of Urology (TUR), Ar&roscopy or using rinsing fluids.
offers optimum parameters for endoscopic resections in
,, __ .,“,I_.,_,IX _ ~ ,,____^ - _” .,,, _I
SPRAY COAGULATION
Highly modulated RF current with high initial voltage peak for spray
coagulation or fulguration
CONTACT COAGULATION
with or without Auto-Stop
Lightly modulated RF current for contact coagulation using ball or plate
electrodes, or
switch is illuminated and when Auto-Stop is selected, current is
automatically switched off after coagulation.
artery clamps.
The Auto-Stop Mode is engaged when its
-, x__I .” ,,_.,- _ ,,-..._
Technical description
4.
4.1 Technical description to Version 11.23
4.1.1 Technical data
4.1.1.1 Mains connection
Mains voltage
Nominal frequency
Power consumption
Loading relationship
Mains fuses
1 lo-120 / 220-240 V alternate current f 10 9’0
(See marking at the rear of the unit)
50/60
750
int. lOs/3Os (Time relation: active / pause)
2 each 2,5 A (inert) according to rating plate
Hz
VA
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