Electrosurgical Unit KLS Martin ME MB1 with endo-mode

Transcription

Electrosurgical Unit KLS Martin ME MB1
with endo-mode
Instructions for Use
V 2.1-DE (02.10)
1
Summary Operating Instructions
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After checking compliance with mains voltage, connect to mains
Upon successful completion of the self-test, the unit is ready for operation
Bipolar operation
Monopolar operation
Connect neutral electrode to socket (19)
Connect bipolar instrument to socket (13)
Connect foot switch to socket (16)
Attach neutral electrode
HF current activation
with finger switch
Connect handle equipped with finger
switch to socket (17)
with foot switch
Switch coagulation foot switch pedal
to BIPOLAR mode
Connect handle without finger switch to
socket (17)
Adjust output power
Select appropriate type of current
Connect foot switch to socket (16)
with foot switch
Adjust output power
Set coagulation foot switch pedal
to MONOPOLAR mode
Activate / deactivate bipolar
coagulation current
Activate / deactivate cutting or
coagulation current
Select appropriate type of current
Bipolare Koagulation beenden
Bipolare
Koagulation
Auto-Coag. aktivieren
Adjust output power
Activate / deactivate cutting or
coagulation current
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Table of Contents
1
Summary Operating Instructions ................................................... 2
2
Functional Principles and Intended Use .......................................... 5
2.1
2.2
2.3
Monopolar Operation ............................................................................ 5
Bipolar Operation ................................................................................. 5
Intended Use ...................................................................................... 5
3
Putting the Unit into Service (Startup) ........................................... 6
3.1
3.2
3.3
3.4
3.5
Function of the Controls and Indicator Lights of the ME MB1 ...................... 6
Mains Connection ................................................................................. 8
ON ( Ι ) / OFF ( Ο ) .............................................................................. 8
Self-Test ............................................................................................ 8
Monopolar Operation ............................................................................ 8
3.5.1
Connecting the neutral electrode ...................................................................... 8
3.5.2
Connecting the handles ................................................................................... 9
3.5.3
Selecting the desired type of current ................................................................. 9
3.5.4
Setting the output power............................................................................... 10
3.5.5
Operation.................................................................................................... 11
3.5.6
Functional test ............................................................................................. 11
3.6
Bipolar Operation ............................................................................... 12
3.6.1
Neutral electrode function ............................................................................. 12
3.6.2
Foot switch operation.................................................................................... 12
3.6.3
Adjusting the output power ........................................................................... 13
3.6.4
Operation.................................................................................................... 13
3.6.5
Functional test ............................................................................................. 14
4
Safety Instructions .................................................................... 14
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8
4.9
4.10
General Information ........................................................................... 14
Placing the Patient Correctly ................................................................ 14
Attaching the Neutral Electrode............................................................ 15
Working with the Active Electrode ........................................................ 15
Further Safety Instructions.................................................................. 16
Cardiac Pacemakers, Implants ............................................................. 16
Guiding the Cables on the Patient ........................................................ 17
Depositing HF Instruments .................................................................. 17
Operation of Two Electrosurgical Units on One Patient ............................. 17
Accessories ....................................................................................... 17
5
Safety Checks .......................................................................... 18
6
Accessories .............................................................................. 19
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7
Care of the Unit ........................................................................ 19
7.1
7.2
7.3
Cleaning and Disinfecting .................................................................... 19
Sterilization of Reusable Accessories ..................................................... 20
Non-Sterilizable Accessories ................................................................ 20
8
Technical Description ................................................................. 20
8.1
Technical Specifications, Certificate ...................................................... 22
9
Diagrams ................................................................................. 24
9.1
9.2
9.3
Performance Diagrams ....................................................................... 24
Voltage Diagrams .............................................................................. 26
Guidelines and Manufacturer’s Declaration on Electromagnetic
Compatibility ..................................................................................... 27
10
Warranty ................................................................................. 31
11
Ecological Information ............................................................... 31
11.1
11.2
11.3
Disposal of Packing ............................................................................ 31
Ecological Aspects of Operation ............................................................ 31
Disposal of the Unit ............................................................................ 32
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Functional Principles and Intended Use
2.1
Monopolar Operation
The HF electrosurgical unit ME MB1 is a generator that converts the electric energy supplied by
the mains into a high-frequency current. Via a supply lead, this HF current is then led to a
handle before reaching the dot-shaped active electrode. Where the electrode is applied – in the
tissue surrounding the point of contact – a high field density is generated. It is this high energy
concentration which produces the desired electrosurgical effect in the area around the active
electrode. Subsequently, the current flows through the patient's body up to the large neutral
electrode. This is accompanied by a further reduction in current density. Thus, if used as intended, this method ensures that no thermal effect is produced in the region where the neutral
electrode is attached. The circuit is then closed via the neutral electrode’s connecting cable
(lead).
The HF generator can be activated by the user either with the foot switch or with the finger
switch provided on the surgeon's handle.
2.2
Bipolar Operation
Thanks to a special design (insulation), it is possible to build bipolar instruments in which the
active electrode and the neutral electrode are located directly opposite each other. This means
that the HF current travels only a very short path, just from one tip of the instrument to the
other. As a result, coagulation areas are highly limited while power requirements remain low.
2.3
Intended Use
The ME MB1 is an electrosurgical generator designed for the electrosurgical cutting or coagulating of living human or animal tissue.
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3
Putting the Unit into Service (Startup)
3.1
Function of the Controls and Indicator Lights of the ME MB1
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19
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Gebrüder Martin
KLS Martin Platz 1
D 78532 Tuttlingen
ME MB1
HF-Chirurgie
.....................................................………………....................………….................
100 – 127 / 220-240 V ~
50/60 Hz
800 VA
Type CF
Class I
.....................................................................................………………………........
Monop.: 400 W / 300 Ohm
INT 10s/30s
Bip.:
100 W / 50 Ohm
450 kHz
.............................................………………………................................................
0297
Serial No.: ME MB1 0000 980001
Made in Germany
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V 2.1
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19
ON/OFF switch
Indicator light – monopolar cutting
Selector button – monopolar cutting Cut 1
Selector button – monopolar cutting Cut 2
Selector button – endo-mode
Power control switch - monopolar cutting
Indicator light - monopolar coagulation
Selector button – contact coagulation
Selector button – spray coagulation
Power control switch – monopolar coagulation
Indicator light – bipolar coagulation
Power control switch – bipolar coagulation
Socket for bipolar instruments
Switch-over button for blue foot switch pedal (bipolar)
Switch-over button for blue foot switch pedal (monopolar)
Socket for double-pedal foot switch for monopolar cutting as well as for monopolar
and bipolar coagulation (switchable)
Socket for monopolar handle
Indicator light for neutral electrode
Socket for neutral electrode
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24
Loudspeaker
Mains fuses
Power cable connector socket
Equipotential connector socket
Rating plate
Socket for neutral electrode
Neutral electrode insulated from ground at high frequency (floating)
Classification symbol (CF)
The unit is defibrillator-proof.
This symbol means ATTENTION!
REFER TO OPERATING INSTRUCTIONS
WARNING - HIGH FREQUENCY CURRENTS
HIGH VOLTAGE!
V 2.1
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3.2
Mains Connection
Before switching on the unit for the first time, please verify that the mains voltage corresponds
to the voltage indicated on the “power” label (next to the power cable connector socket). If the
voltage differs, please inform your KLS Martin contact partner directly.
If change-over to a different mains voltage should be necessary, this work must be performed
by a person specially authorized by Gebrüder Martin! The unit may never be opened by unauthorized persons!
The device is obtainable in 2 versions:
100–127 VAC, T 8 A (8 A slow-blow.)
220–240 VAC, T 4 A (4 A slow-blow.)
Connect the unit to the power supply system, then set the power switch located on the front
panel to “Ι”.
3.3
ON ( Ι ) / OFF ( Ο )
After switching on the unit with the power switch (1), the system is started and performs an
initial self-test.
3.4
Self-Test
When the unit is switched on, it executes a self-test: The keys for the five current modes light
up one after the other. The subsequent lighting up of all five current mode keys together, accompanied by an acoustic signal, indicates the successful end of the self-test.
The unit is operative.
Without these final signals, the unit is defective. The KLS Martin service technician has to be
informed.
3.5
Monopolar Operation
3.5.1
Connecting the neutral electrode
If the neutral electrode is missing (not connected), the red NE indicator light (18) starts flashing. In this condition, the HF current cannot be activated. Any attempt in this direction – by
pressing the finger button or foot switch – triggers an additional acoustic alarm signal.
If a multi-surface (two-part) electrode is connected, the indicator light (18) will go out only
after the electrode has been properly and securely applied. Since response times may differ,
this may take some time and should be taken into account when using such an electrode.
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3.5.2
Connecting the handles
For monopolar cutting and coagulation, either a handle with finger switches or a foot switch
plus a handle without finger switches can be connected. Handles with finger switches can be
connected to output (17).
Handles without finger switches as well as surgical instruments (such as resectoscopes) are
also connected to output (17). The corresponding foot switch must be connected to socket
(16).
Socket (17) allows the connection of handles with coaxial plugs as well as handles with 3-pin
plugs. For further details, please refer to the KLS Martin Accessories Catalog.
Surgical HF instruments without a switching function, such as resectoscopes, must be connected to the right-hand (coaxial) jack of output (17), as the foot switch only works on this
socket.
The selected active electrode must be inserted into the hexagonal socket of the surgical handle
until it engages. This prevents rotation of the electrode during use.
Warning
• Never activate the high-frequency current when inserting or exchanging electrodes!
3.5.3
Selecting the desired type of current
In the yellow “monopolar cutting” section of the control panel (front), three different types of
current are available:
Cutting 1
Smooth cut with no scab formation
Cutting 2
Cutting current with some/little scab formation
ENDO
Endo-mode
Time-controlled cutting mode enabling a fractionated and thus controlled cut for special applications, e.g. endoscopic papillotomy and endoscopic polypectomy.
This mode is characterized by a short but intensive pulse at the start of the cutting
process, combined with a coagulating effect that is strong enough to achieve hemostasis. As this pulse is repeated at regular intervals, it is ideal for removing pedicled
tumors (also called polyps) on an endoscopic basis – using the diathermy loop electrode for example.
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In the blue “monopolar coagulation” section of the control panel, two different types of current
are available:
Contact coagulation
For deep coagulation through direct contact between the electrode and the tissue
Spray coagulation / fulguration
High-voltage coagulation current for surface coagulation. Especially suitable for hemostasis in TUR, using small-surface instruments (e.g. loop electrodes)
3.5.4
Setting the output power
Setting the output power for cutting is done with the power control switch (6). For coagulation,
the control switch (10) must be used. Adjustment is possible between a preset minimum value
and a maximum value depending on the selected type of current (see Technical Specifications). The characteristic line allows fine adjustment in the lower range, while the upper power
range is characterized by a uniformly linear increase. This enables high-precision dosage in the
lower range without any need for special functions, which is particularly useful in difficult operations, while sufficient reserves are guaranteed in cases where a high power output is required.
Please note that this special feature means that the mid-position of the power control switch is
of course not equivalent to half the output available.
PLEASE NOTE: In the lower control range of the power control switch, the power output is not
precisely defined. Therefore, the unit should not be used in this output range.
1
350
300
2
Ausgangsleistung
250
3
200
150
4
100
50
Output power in watts
400
100
1
80
60
40
20
0
1
2
3
4
5
6
7
Einstellung
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10
0
1
2
3
Setting
1
2
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4
10
=
=
=
=
Cutting 1
Cutting 2
Contact coagulation
Spray coagulation
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9
10
Setting
1 = Endo-mode
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3.5.5
Operation
To activate the HF current, either the yellow button of the handle or the yellow pedal of the
foot switch must be used if you have selected a cutting current. The blue button/pedal, in turn,
activates coagulation currents. In either case, the HF current output depends on the preset
types of current and the selected power settings. As soon as the handle button is pressed or
the appropriate foot switch pedal operated, the selected working channel is activated. At the
same time an acoustic signal is heard (different for cutting and coagulation) and the corresponding indicator lamp lights up. If HF current activation exceeds a period of 15 seconds, the
acoustic signal grows louder.
Please note!
If you want to use the foot switch in monopolar operation, the (monopolar) switch-over button
(15) for the blue foot switch pedal must first be activated.
If, in contrast, the (bipolar) switch-over button (14) is active, the bipolar HF output will be activated when the blue foot switch pedal is operated!
The yellow foot switch pedal always activates monopolar cutting current, irrespective of the
switch-over buttons.
The handle switches always activate monopolar currents, irrespective of the switch-over buttons.
Warning
• The safety guidelines for the patient and the operator of HF surgical devices as
listed in Section 4 (“Safety Instructions”) must always be duly observed. Special
attention must be given to a safe application of the neutral electrode and correct
placement of the patient.
• If two controls (e.g. the blue and yellow buttons of the handle) are pressed simultaneously, the generator will be blocked. No high-frequency power is available in
this case.
• The surface of the unit may heat up strongly if HF current is applied at a high
power setting for an extended period of time.
• The rated minimum voltage of accessories used must match the voltage values
indicated in Section 8.1.
• Only accessories that are in a perfect working condition may be used!
3.5.6
Functional test
Before using the unit, all of its functions must be checked. Please carry out the following tests:
1. Withdraw the plug of the neutral electrode's connecting cable from the socket (19). The red
alarm light (18) must start blinking. Try to activate the HF current. An acoustic alarm signal
must now be heard and HF current activation must be blocked.
2. Reinsert the plug of the NE connecting cable into the socket (19). The red warning light (18)
must stop flashing now.
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3. Connect the connecting cable of the electrode handle to socket (17). Activate the different
currents by operating either the finger switch on the electrode handle or the foot switch.
The indicator lights (2), (7) or (11) must now light up in accordance with the selected type
of current and the HF current activation signal must be audible.
Warning
• If you hear the HF current activation signal with no foot switch or electrode handle
connected to the unit, then the unit is defective and must not be used. A technical
inspection is required in this case.
• If you hear the HF current activation signal with the foot switch or electrode handle connected to the unit but not operated, then the foot switch or the handle is
defective and may not be used anymore. Replace immediately!
3.6
Bipolar Operation
3.6.1
Neutral electrode function
No neutral electrode is required for bipolar applications. In this operating mode, therefore, the
bipolar HF generator can be activated despite the flashing of the neutral electrode indicator
light (18).
However, since alternation between bipolar and monopolar application is usually required during the course of an operation, we recommend you to apply the neutral electrode nonetheless.
3.6.2
Foot switch operation
The features of the KLS Martin ME MB1 also include bipolar coagulation. The following accessories can be connected:
Bipolar coagulation
Any bipolar connecting cable featuring a small coaxial plug (e.g. different bipolar forceps) can
be connected to socket (13). The bipolar coagulation function is activated with the foot switch.
In order to be able to activate bipolar coagulation current, the blue pedal of the foot switch
must first be switched to the bipolar HF generator. For this, press the button (14) so that it will
light up. This setting will be retained also if the unit is switched off.
Please note that if the (monopolar) switch-over button (15) has been activated, the monopolar
HF output will be activated when operating the blue foot switch pedal!
The yellow foot switch pedal always activates monopolar cutting current, irrespective of the
switch-over buttons.
The handle switches always activate monopolar currents, irrespective of the switch-over buttons.
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3.6.3
Adjusting the output power
Setting the output power for bipolar coagulation is done with the power control switch (12).
Adjustment is possible between a preset minimum value and a maximum value (see Technical
Specifications). The characteristic line allows fine adjustment in the lower range, while the upper power range is characterized by a uniformly linear increase. This enables high-precision
dosage in the lower range without any need for special functions, which is particularly useful in
difficult operations, while sufficient reserves are guaranteed in cases where a high power output is required.
Please note that this special feature means that the mid-position of the power control switch is
of course not equivalent to half the output available.
PLEASE NOTE: In the lower control range of the power control switch, the power output is not
precisely defined. Therefore, the unit should not be used in this output range.
90
80
70
Ausgangsleistung
100
60
50
40
30
20
10
0
1
2
3
4
5
6
Einstellung
7
8
9
10
Setting
Bipolar coagulation
3.6.4
Operation
The blue pedal of the foot switch (14) must be switched to the “bipolar coagulation” type of
current!
Accordingly, the bipolar coagulation current is activated upon operating the blue foot switch
pedal.
The HF current output is determined by the selected power setting. Upon activating the current, an acoustic signal is heard and the corresponding indicator light (11) lights up. If HF current activation exceeds a period of 15 seconds, the acoustic signal grows louder.
Warning
• The surface of the unit may heat up strongly if HF current is applied at a high
power setting for an extended period of time.
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3.6.5
Functional test
Before using the unit, all of its functions must be checked. Please carry out the following tests:
1. As described in Section 3.6.1, we recommend connecting the neutral electrode also when
using the bipolar method, although this operating mode as such requires no dispersive electrode. So if you choose to connect the neutral electrode, please perform the following test:
Withdraw the plug of the neutral electrode's connecting cable from the socket (19). The red
alarm light (18) must start blinking. Try to activate the monopolar HF current. An acoustic
alarm signal must now be heard and the activation of the monopolar HF current must be
blocked.
2. Reinsert the plug of the NE connecting cable into the socket (19). The red alarm light (18)
must stop flashing now.
3. Connect the connecting cable of a bipolar coagulation instrument to jack (13).
4. Press the button (14) to assign the “bipolar coagulation” current to the blue pedal of the
foot switch.
5. Operate the foot switch to activate the “bipolar coagulation” current. The indicator light (11)
must light up now and the HF activation signal must be sounded.
Warning
• If you hear the HF current activation signal while the foot switch is disconnected,
then the unit is defective and must not be used. Be sure to have the unit checked
and repaired in this case!
• If you hear the HF current activation signal with the foot switch connected but the
blue pedal has not been operated, this means that the foot switch is defective and
must be replaced!
4
Safety Instructions
4.1
General Information
Electrosurgical units are high-frequency generators that produce high voltages and high currents so they can carry out their intended purpose. To avoid any hazards to the patient, the
operating staff or other persons, the method described below should be carefully followed and
the operating and safety instructions be strictly observed.
4.2
Placing the Patient Correctly
The patient must be well insulated from grounded metal parts. It is particularly important to
ensure that the patient’s extremities cannot come in contact with metal parts.
If the patient is placed on an operating table, then he/she must be well insulated against high
frequencies by using enough intermediate layers (covering towels). As moisture, sweat or the
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V 2.1
like is likely to accumulate during the operation, a watertight sheet must be used to maintain
the insulating properties of the intermediate layers and prevent them from getting wet.
Under any circumstances, make sure that no liquids collect under the patient. If necessary, use
additional dry towels as intermediate layers.
All areas where sweat tends to accumulate – e.g. where the extremities touch the body or
there is skin-to-skin contact – should be kept dry by placing enough covering towels between
them (arm/trunk, legs, breasts).
These insulation requirements must be observed also when the patient needs to be repositioned during the operation!
4.3
Attaching the Neutral Electrode
Electrodes and cables must be attached carefully. To prevent any hazards, be sure you
•
attach the neutral electrode on the patient's body as close to the operating site as possible,
establishing full contact between the electrode surface and the patient’s skin;
•
see to it that the neutral electrode remains fully attached as long as the high-frequency
current is being used. When attaching the neutral electrode to extremities, don’t impede
the blood flow;
•
guide the connecting cables of the HF electrodes without loops and in such a way that they
neither touch the patient nor other cables. This applies especially to the neutral electrode.
Use only the cables provided by the manufacturer of the unit;
•
keep the current paths in the patient’s body as short as possible, making sure that the current flows through the body longitudinally or diagonally but not transversely, especially not
in the thorax. Metal parts that may be in or on the body are to be removed, insulated or
carefully watched for possible hazards.
Whenever the patient is repositioned, be sure to check the electrodes for proper application
and the electrode leads for correct routing.
Never attach the neutral electrode on implants, other metal parts, bony protrusions/outgrowths or scar tissue. Circumstances may require the cleaning or degreasing of the
attachment site; shave areas of abundant hair growth. Never employ agents that dry up the
skin (such as alcohol).
Don’t remove the neutral electrode by pulling the connecting cable or the connecting clip. Selfadhesive electrodes should be removed very carefully in order not to injure the skin.
4.4
Working with the Active Electrode
When using HF currents for surgical purposes, the following rules must be observed:
•
If a surgical unit and monitoring devices are simultaneously used on the same patient, then
only monitoring electrodes having protective resistors or HF chokes incorporated in their
connecting cables may be employed. Do not use needle electrodes for monitoring purposes! Moreover, the active surgical electrode should never be used near ECG electrodes (minimum distance: 15 cm).
V 2.1
15
•
The HF power should be kept as low as possible for the particular application.
Note:
An insufficient effect with the usual setting may be due to a poor attachment of the neutral
electrode, bad contact in plug-and-socket connections, broken cables (underneath the insulation) or encrusted electrodes. Be sure to check this; defective accessories must be replaced.
4.5
Further Safety Instructions
•
When working on body parts with low cross sections, the use of the bipolar technique may
be indicated in order to prevent an unintended coagulation in other sites.
•
Avoid using flammable anesthetics, nitrous oxide (N2O) and oxygen. The use of HF surgical
devices is always associated with spark formation at the active electrode. Inflammable materials used as cleaning or disinfecting agents or solvents must be allowed to evaporate before starting HF surgery. Note that there is a hazard of combustible liquids accumulating
under the patient or in body depressions like the navel or in body cavities like the vagina.
Liquid that has accumulated in such places must be removed before HF surgery takes
place. There is also a hazard of igniting flammable endogenous gases! Note that materials
saturated with oxygen, such as cotton and gauze, may also be ignited by the sparks produced in the normal use of the HF surgical unit!
•
Transurethral prostatic resections (TUR):
As is well-known, easily inflammable gases can be generated in the course of transurethral
prostatic resections (TUR), particularly during uninterrupted or extended HF application. In
such a case, the gases tend to accumulate in the upper region of the bladder. If ambient
air mixes with those gases, the hazard is still greater, as an accidental explosion might be
caused if the HF current comes in contact with the gas mixture. Therefore, see to it that
the gas-air bubble inside the bladder is kept as small as possible.
•
This device may not be used in combination with other systems unless permitted by the
manufacturer.
•
Other electromedical devices may be affected by operating this HF surgical unit.
4.6
Cardiac Pacemakers, Implants
As a rule, HF current should never be conducted across a patient’s implants. This must be taken into account when attaching the active and neutral electrodes. So never attach a neutral
electrode over endoprostheses!
In patients with active implants such as pacemakers or implanted electrodes, there is an additional risk when using HF electrosurgical techniques, as irreparable damage to the active implant or an impairment of its operation can occur. For this reason, the following guidelines
should be observed.
We recommend monitoring patients with cardiac pacemaker implants, using suitable equipment. A defibrillator and an external pacemaker should be kept ready for use. The output
power level of the electrosurgical unit should always be set as low as possible. The active elec16
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trode of the electrosurgical unit should be operated only at a minimum distance of 15 cm to
the implant or its electrodes. Wherever possible, the bipolar technique should be used. All instructions for use, particularly when attaching the neutral electrode, must be strictly observed.
4.7
Guiding the Cables on the Patient
If the monopolar and bipolar methods are used jointly, be sure to maintain a minimum distance of 10 cm between the two types of cable. Give the cables enough slack and avoid loops!
4.8
Depositing HF Instruments
HF instruments should never be placed on the patient while they are not being used!
4.9
Operation of Two Electrosurgical Units on One Patient
As a rule, the use of two electrosurgical units on one patient should be limited to cases where
this is necessary for medical reasons, as such simultaneous operation poses an increased risk
of unintended burns due to high-frequency leakage currents.
The following rules should be observed when working with two electrosurgical units simultaneously:
•
Be sure to use only type CF electrosurgical units from Gebrüder Martin.
•
Every HF unit operated in monopolar mode requires a neutral electrode attached separately
to the patient’s skin. Be sure to comply with the instructions for correct NE attachment!
•
No neutral electrode is needed for purely bipolar operation of electrosurgical units.
•
Regarding the flow of current from the active electrode to the neutral electrode, the expected current paths must not be allowed to cross or superimpose each other. Therefore,
the respective neutral electrodes must be attached as close to the surgical site as possible.
•
The sum total of the simultaneously applied power outputs must not exceed 400 watts.
4.10
Accessories
When using accessory equipment, please observe the following:
•
The accessories used must have sufficient electric strength. The rated minimum voltage of
any such product must match the voltage values indicated in Section 8.1.
•
Be sure to use only accessories that are in a perfect working condition (always check for
potential defects!).
V 2.1
17
5
Safety Checks
At least every 24 months, the following checks and tests must be performed on the unit by
qualified persons who have the necessary training, knowledge and practical experience to carry out such work responsibly and independently.
•
Visual inspection: check the unit and its accessories for mechanical and functional damage/defects.
•
Check all safety-related labels for legibility.
•
Check the fuses for compliance with rated current and prearcing time/current characteristic.
•
Perform functional test in accordance with Operating Instructions.
•
Check power control switch function: rotate switch in either direction and verify corresponding change in power output.
•
Check actual maximum output power against the specified maximum value at all outputs
for all available operating modes, taking account of the nominal load resistances indicated
in Section 8.1.
•
Check for correct acoustic and visual signals following HF current activation.
•
Carry out electrical checks in accordance with the test report sheet for periodic safety
checks.
Leakage currents may not exceed 1.5 times the value measured initially and at the same time
not exceed the specified limit value either.
The values measured first are available from the test report attached, which was established
when the unit was first installed.
We recommend the user to record all safety checks and related results in an equipment log.
If the unit is not fully reliable and/or safe to operate, it must either be repaired or the user
must be informed of the potential hazards involved in operating the system.
Important note!
The above checks may be carried out only by qualified Gebrüder Martin service personnel or by
a service representative that has been specially authorized to carry out such work.
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V 2.1
6
Accessories
The unit may only be used in combination with accessories, parts subject to wear and disposables that have been evidenced as safe for use by way of a Declaration of Conformity. The
use of untested accessories from other manufacturers may pose a hazard. In cases of doubt,
please contact the manufacturer.
For accessories specially certified for use with KLS Martin electrosurgical units, please refer to
the KLS Martin Accessories Catalog, which is available from Gebrüder Martin or can be directly
downloaded via www.klsmartin.com.
7
Care of the Unit
Be sure to observe all national hygiene and preparation-for-reuse regulations.
7.1
Cleaning and Disinfecting
Always disconnect the unit from the mains before cleaning and disinfecting it. When using
cleaning agents and disinfectants, no liquid must be allowed to enter the unit, particularly
when employing sprays.
Never use scouring agents, disinfectants or solvents that might scratch the housing or damage
the unit otherwise.
When cleaning or disinfecting the unit’s outer surfaces, adhere to recommended in-house procedures or use a nationally recognized and approved method.
Be sure that no liquids penetrate into the housing! Never sterilize the unit!
Note that the unit may only be used after all disinfectant residues have been carefully removed!
Manual disinfecting of accessories:
When disinfecting accessories (either by surface disinfection or immersion), the user is required to observe the respective manufacturer’s instructions as regards compatibility with the
material in question, dosage and exposure time.
Important note
• Accessories for electrosurgical equipment must always be kept in perfect working
order. Malfunctioning, damaged or defective accessories can pose a danger to patient and operator alike and impair the proper functioning of the electrosurgical
unit. Accessories unfit for use must be discarded.
V 2.1
19
7.2
Sterilization of Reusable Accessories
The following sterilizing temperatures are permitted:
Steam sterilization
at 134 °C
Electrode handle
yes
Active electrodes (monopolar and bipolar)
yes
Reusable neutral electrodes
yes
Note
• Parts marked as disposable accessories may neither be treated for reuse nor reused.
• Hot-air sterilization may not be used for electrodes, cables and other accessories. The high
temperatures associated with this type of sterilization could damage insulation, soldered
connections, etc.
• All other procedures need to be validated by the user/owner.
7.3
Non-Sterilizable Accessories
Non-sterilizable accessories like the foot switch require regular cleaning using a disinfectant.
8
Technical Description
The KLS Martin ME MB1 is a microprocessor controlled, universally applicable electrosurgical
unit with outstanding performance characteristics. It also incorporates the latest safety technology.
The unit has the following design features:
•
Self-adaptation: the HF generator largely adapts output power automatically to the type of
electrode used as well as to different kinds of tissue and cutting speeds.
•
Output control for especially fine adjustment in the lower power range and high power reserves in the upper range.
•
An advanced safety concept including two microprocessors.
•
Easy handling thanks to the straightforward arrangement of all controls and easy-toremember functional symbols. The power is set with user-friendly rotary switches. All connectors for the active and neutral electrodes and the foot switch are arranged on the front
panel.
20
V 2.1
•
Two types of cutting current: choice between smooth cutting and cutting with scab formation.
•
One pulsed current for cutting (useful for polypectomy for example).
•
Two types of coagulation current: choice between a high-power coagulation current for
contact coagulation and a coagulation current with a high crest factor for spray coagulation.
•
The electrosurgical unit ME MB1 includes an additional HF generator for bipolar coagulation.
•
Automatic self-test carried out each time the unit is switched on.
•
Visual and acoustic indication of HF current activation through indicator lights of different
color and different acoustic signals for cutting and coagulation.
•
Combination connector sockets for KLS Martin coaxial cables and for disposable accessories.
•
The integrated KLS Martin Patient Control System (PCS) ensures constant NE application
monitoring using a two-part neutral electrode.
•
Safety device (in accordance with IEC 601-2-2) as a protection in the event of a faulty
overdose caused by the unit.
•
Acoustic warning signal if the HF current is activated for more than 15 seconds (switch-on
time).
•
No openings or cooling slots, no cooling fan. Low power loss thanks to highly efficient generators.
•
Easy to clean membrane front panel.
•
Practical, high-quality accessory components.
V 2.1
21
8.1
Technical Specifications, Certificate
Supply voltage
100–127 V / 220–240 V; 50–60 Hz
adjustable by dummy plug inside the unit
Power input
without HF output
approx. 16 VA
at max. power output
approx. 800 VA
Class of protection
I
Classified acc. to MDD
II b
Leakage currents
(LF and HF)
in compliance with IEC 601, Part 2-2
Type of equipment
CF; defibrillator-proof
Nominal frequency
450 kHz
Modulation frequency
30 kHz
Beamer operation
via foot switch socket
HF Output Parameters
Crest Factor
Voltage
Current Type
HF Power
Cutting 1
max. 400 W at
300 Ω
1.6 at
300 Ω
max. 2300 V ss
Cutting 2
max. 300 W at
300 Ω
2.1 at
300 Ω
max. 2500 V ss
Endo-mode
max. 100 W at
200 Ω
1.6 at
200 Ω
max. 2800 V ss
Contact coagulation
max. 250 W at
200 Ω
3.4 at
200 Ω
max. 3200 V ss
Spray coagulation
max. 120 W at
300 Ω
5.6 at
300 Ω
max. 9000 V ss
Bipolar coagulation
max. 100 W at
100 Ω
2.1 at
100 Ω
max. 600 V ss
22
V 2.1
Duty type
intermittent 10 s / 30 s = duty factor of 25%
Mains fuses
100-127 V: 8 A, slow-blow.
220-240 V: 4 A, slow-blow.
Sound level
HF current activation: 55 dB(A) (adjustable 50-60 dB by Technical
Service)
Alarm: 65 dB(A)
Weight
8.1 kg
Interference suppression
Limits in conformity with EN 55011 and IEC 601-2-2;
interference immunity in conformity with IEC 801
Dimensions
Width
405 mm
Height
135 mm
Depth
380 mm
Conditions of transport Ambient temperature
and storage
Relative air humidity
Atmospheric pressure
-25 °C to +70 °C
10% to 100%
500 hPa to 1060 hPa
Operating conditions
+10 °C to +40 °C
30% to 75%
700 hPa to 1060 hPa
Ambient temperature
Relative air humidity
Atmospheric pressure
in conformity with 93 / 42 / EEC
V 2.1
23
9
Diagrams
9.1
Performance Diagrams
ME MB1 monopolar cutting 1
ME MB1 monopolar cutting 2
350
HF-Leistung in Watt
300
250
1
150
100
50
250
HF-Leistung in Watt
400
200
ME M1 / MB1 monopolares
Schneiden 2
300
HF output in watts
HF output in watts
ME M1 / MB1 monopolares
Schneiden 1
200
150
2
0
0
200
400
1
100
50
2
0
0
600 800 1000 1200 1400 1600 1800 2000
Anschlußwiderstand in Ohm
200
Connection resistance in ohms
400
600 800 1000 1200 1400 1600 1800 2000
ME MB1 endo-mode
ME MB1 contact coagulation
100
250
80
60
1
40
20
HF output in watts
HF output in watts
1 = Power control switch set to position 10
200
150
1
100
2
50
2
0
0
0
200
400
600
800
1000
1200 1400
1600 1800
2000
0
200
400
600
800
1000
1200
1400
1600
1800
2000
ME MB1 bipolar coagulation
120
100
1
80
60
40
2
20
HF output in watts
100
ME M1 / MB1 Spraykoagulation
HF-Leistung in Watt
HF output in watts
ME MB1 spray coagulation
90
80
70
1
60
50
40
30
20
0
0
200
400
600 800 1000 1200 1400 1600 1800 2000
1
2
10
2
0
0
200
400
600
800
1000 1200 1400
1600 1800 2000
24
V 2.1
ME M1 / MB1 Einstellung
monopolares Schneiden
400
1
HF-Leistung in Watt
300
2
200
100
0
1
2
3
4
5
6
Einstellung
7
8
9
ME MB1 setting, endo-mode
HF output in watts
HF output in watts
ME MB1 setting, monopolar cutting
10
100
1
80
60
40
20
0
1
2
3
4
5
Setting
6
7
8
9
10
Setting
1 = Cutting 1
2 = Cutting 2
1
150
2
100
50
0
1
2
3
4
5
6
Einstellung
Setting
7
8
9
10
ME MB1 Einstellung bipolares
Koagulieren
100
HF-Leistung in Watt
250
200
ME MB1 setting, bipolar coagulation
HF output in watts
ME M1 / MB1 Einstellung
monopolares Koagulieren
HF-Leistung in Watt
HF output in watts
ME MB1 setting, monopolar coagulation
80
60
40
20
0
1
2
3
4
5
6
Einstellung
7
8
9
10
Setting
1 = Contact coagulation
2 = Spray coagulation
V 2.1
25
9.2
Voltage Diagrams
ME MB1 cutting 1 + 2
peak
ME M1 / MB1 Schneiden 1 + 2
HF voltage in volts
1500
HF-Spannung in Volt peak
1250
1000
750
500
250
0
1
2
3
4
5
6
7
Einstellung
8
9
10
Setting
ME MB1 endo-mode
ME MB1 contact coagulation
peak
1500
HF voltage in volts
1250
1000
750
500
250
ME M1 / MB1 Kontakt Koagulation
3000
2500
peak
1750
HF voltage in volts
2000
2000
1500
1000
500
0
1
2
3
4
0
1
2
3
4
5
6
7
Setting
8
9
10
peak
HF voltage in volts
4500
HF voltage in volts
3750
3000
2250
1500
750
0
26
4
5
6
7
Setting
10
8
9
10
ME MB1 Bipolare Koagulation
500
400
peak
5250
3
9
ME MB1 bipolar coagulation
6000
2
8
Setting
ME MB1 spray coagulation
1
5
6
7
Einstellung
300
200
100
0
1
2
3
4
5
6
7
Einstellung
8
9
10
Setting
V 2.1
9.3
Guidelines and Manufacturer’s Declaration on Electromagnetic
Compatibility
Guidance and manufacturer’s declaration according to DIN EN 60601-1-2,
clause 6.8.3.201 a) 3)
Table 201: Electromagnetic emission
The KLS Martin ME MB1 ENDO is intended for use in an electromagnetic environment as specified below. The customer or the user of the ME MB1 ENDO should assure that it is used in
such an environment.
Emission tests
Compliance
Electromagnetic environment – Guidance
HF emissions according to
DIN EN 55011
Group 2
The ME MB1 ENDO must emit electromagnetic
energy in order to perform its intended function.
Nearby electronic equipment may be affected.
HF emissions according to
DIN EN 55011
Class B
The limits of this class are kept only in standby
mode (without HF current activation)!
Harmonic emissions according to
DIN EN 61000-3-2
Class A
Voltage fluctuations/flicker
emissions according to
DIN EN 61000-3-3
V 2.1
Complies
The ME MB1 ENDO is suitable for use in all establishments, including domestic establishments
and those directly connected to the public lowvoltage power supply network that supplies
buildings used for domestic purposes.
27
clause 6.8.3.201 a) 3)
Table 201: Electromagnetic emissions
The KLS Martin ME MB1 ENDO is intended for use in the electromagnetic environment specified below. The customer or the user of the ME MB1 ENDO should assure that it is used in
Immunity test
DIN EN 60601
test level
Compliance level
Electromagnetic
environment –Guidance
Electrostatic discharge (ESD) according to DIN EN
61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the relative humidity should be at
least 30%.
Fast electrical transients / bursts according to DIN EN
61000-4-4
±2 kV for power
supply lines
±1 kV for input/output lines
±2 kV for power
supply lines
±1 kV for input/output lines
Mains power quality should
be that of a typical industrial or hospital environment.
Surge according to
DIN EN 61000-4-5
±1 kV differential
mode
±2 kV common
mode
±1 kV differential
mode
±2 kV common
mode
be that of a typical industrial or hospital environment.
0% U T
(100% dip in U T ) for
0.5 cycle
40% U T
5 cycles
70% U T
25 cycles
0% U T
5 seconds
be that of a typical industrial or hospital environment. If the user of the ME
MB1 ENDO requires continued operation during mains
power interruptions, it is
recommended to power the
ME MB1 ENDO from an uninterruptible power supply.
3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical industrial or hospital environment.
<5% U T
(>95% dip in U T ) for
0.5 cycle
Voltage dips, short 40% U T
power interruptions (60% dip in U T ) for
and supply voltage 5 cycles
fluctuations ac70% U T
cording to DIN EN
61000-4-11
25 cycles
<5% U T
(>95% dip in U T ) for
5 seconds
Power frequency
(50/60 Hz) magnetic field according to
DIN EN 61000-4-8
3 A/m
NOTE: U T is the a. c. mains voltage prior to application of the test level.
28
V 2.1
clause 6.8.3.201 b) Table 204: Electromagnetic immunity
The KLS Martin ME MB1 ENDO is intended for use in the electromagnetic environment specified below. The customer or the user of the ME MB1 ENDO should assure that it is used in
Immunity
test
DIN EN 60601
test level
Compliance
level
Electromagnetic environment – Guidance
Portable and mobile HF communications
equipment should be used no closer to any
part of the ME MB1 ENDO (including
cables) than the recommended separation
distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance:
d = 1.17 P
Conducted HF
according to
DIN EN
61000-4-6
Radiated HF
according to
DIN EN
61000-4-3
NOTE 1:
NOTE 2:
3 V eff
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
3 V eff
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
d = 1.17 P 80 MHz to 800 MHz
d = 2.33 P 800 MHz to 2.5 GHz
where p is the maximum output power
rating of the transmitter in watts (W) according to the transmitter manufacturer
and d is the recommended separation distance in meters (m).
Field strengths from fixed HF transmitters,
as determined by an electromagnetic site
surveya, should be less than the compliance level in each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following symbol.
At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio stations and AM and FM radio and TV stations, cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed HF transmitters,
an electromagnetic site survey should be considered. If the measured field strength in the location in
which the ME MB1 ENDO is used exceeds the applicable HF compliance level specified above, the ME
MB1 ENDO should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the ME MB1 ENDO.
b
Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
V 2.1
29
Recommended separation distances between portable and mobile HF
telecommunications equipment and the ME MB1 ENDO according to DIN EN 606011-2,
clause 6.8.3.201 b), Table 206
The ME MB1 ENDO is intended for use in an electromagnetic environment in which radiated
HF disturbances are controlled. The customer or the user of the ME MB1 ENDO can help prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile HF telecommunications equipment (transmitters) and the ME MB1 ENDO as recommended below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
(in m)
Rated maximum
output of transmitter
W
150 kHz to 80 MHz
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1
1.17
1.17
2.33
10
3.7
3.7
7.4
100
11.7
11.7
23.3
d =[
3.5
] P
V1
80 MHz to 800 MHz
d =[
3.5
] P
E1
800 MHz to 2.5 GHz
d =[
7
] P
E1
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
NOTE 1:
NOTE 2:
30
At 80 MHz and 800 MHz, the separation distance for the higher frequency
range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and
people.
V 2.1
10
Warranty
Our General Conditions of Sales effective at the time shall apply.
Within this period of guarantee all defects proven to be manufacturing or material defects are
repaired free of charge by out appointed service agent or directly in our factory.
Please keep the guarantee card and note its wording.
Important Note
Any repairs to be performed on the unit may be carried out only by the manufacturer´s own
personnel or by a qualified person or firm that has been expressly authorized by us to perform
such work.
If repair work has been carried out by an authorized person or company, the serviceman is
required to issue to the user/owner a certificate detailing about the nature and scope of the
maintenance or repair work done. Such certificate must show the date when the work has
been carried out and must be signed, giving full particulars as to the person/company performing the work. If repair work has been carried out by a party other than the manufacturer, the
equipment or parts repaired must be labeled, in addition, with the repairer´s identification
mark.
11
Ecological Information
11.1
Disposal of Packing
Gebrüder Martin will, as a matter of course, take back the full packaging of the ME MB1 if so
desired, to recycle as many parts of the packaging as possible.
If you do not wish to make use of this offer, you can dispose of the packaging with the normal
paper or domestic garbage.
11.2
Ecological Aspects of Operation
When vaporizing tissue, you should take care not to inhale the resulting vapors in concentration over an extended period of time. Apart from the products of tissue combustion, however,
no other noxious substances are generated as long as the ME MB1 is used as intended.
If the treatment is interrupted and the unit is not being used for an extended period, we recommend you to switch it off for safety as well as economic reasons (energy saving).
If disposable products are used in a treatment, please note that such articles may be disposed
of with the domestic or hazardous garbage only after they have been carefully cleaned, disinfected and if need be, sterilized. Infected, sharp parts of single-use instruments must be handled like any other “sharps” (cannulas, needles and scalpels) in accordance with valid regulations (disposal via germ-proof and puncture-proof containers).
V 2.1
31
11.3
Disposal of the Unit
In designing the unit, we tried to avoid using composite materials wherever possible. This concept ensures that a significant part of the unit can be recycled once it has reached the end of
its useful life. This also explains why we offer to take back the unit so it can be appropriately
recycled.
We would also like to point out that the provisions of the electronic-waste regulation must be
duly observed at the time of disposal.
Marking of electric and electronic equipment in accordance with Directive 2002/96/EC (WEEE Directive) and the German Electrical and
Electronic Equipment Act (ElektroG)
This symbol on the product or its packaging indicates that the product may not
be disposed of as normal household garbage.
32
V 2.1
V 2.1
33
34
V 2.1
V 2.1
35
KLS Martin Group
Karl Leibinger GmbH & Co. KG
KLS Martin France SARL
KLS Martin L.P.
78570 Mühlheim · Germany
Tel. +49 74 63 838-0
[email protected]
68000 Colmar · France
Tel. +33 3 89 21 66 01
[email protected]
Jacksonville, Fl 32246 · USA
Office phone +1 904 641 77 46
[email protected]
KLS Martin GmbH + Co. KG
Martin Italia S.r.l.
Gebrüder Martin GmbH & Co. KG
79224 Umkirch · Germany
Tel. +49 76 65 98 02-0
[email protected]
20059 Vimercate (MB) · Italy
Tel. +39 039 605 67 31
[email protected]
Representative Office · Russia
121471 Moscow
Tel. +7 (499) 792-76-19
[email protected]
Stuckenbrock Medizintechnik GmbH
Nippon Martin K.K.
78532 Tuttlingen · Germany
Tel. +49 74 61 16 58 80
[email protected]
Osaka 541-0046 · Japan
Tel. +81 6 62 28 90 75
[email protected]
Representative Office · China
201203 Shanghai
Tel. +86 21 2898 6611
[email protected]
Rudolf Buck GmbH
Martin Nederland/Marned B.V.
78570 Mühlheim · Germany
Tel. +49 74 63 99 516-30
[email protected]
1270 AG Huizen · The Netherlands
Tel. +31 35 523 45 38
[email protected]
A company of the KLS Martin Group
KLS Martin Platz 1 · 78532 Tuttlingen · Germany
Postfach 60 · 78501 Tuttlingen · Germany
Tel. +49 7461 706-0 · Fax 706-193
[email protected] · www.klsmartin.com
Date of Release: 02.10 ·
90-157-52-31 · Printed in Germany · Copyright by Gebrüder Martin GmbH & Co. KG · Alle Rechte vorbehalten ·
Technische Änderungen vorbehalten · We reserve the right to make alterations · Cambios técnicos reservados · Sous réserve de modifications techniques
Ci riserviamo il diritto di modifiche tecniche · Revision Number: V 2.1

Electrosurgical Unit KLS Martin ME MB1 with endo-mode

Transcription

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