KLS Martin ME102 User manual

Electro
surgical Unit ME 102
Instructions for Use
V. 3.1-EN (11.13)

2 V. 3.1
Quick Instructions for Use ME 102
For the assignment of the numbering, see section 4.2 “Functions of the Control Elements, Connections and Displays”, page 12.

V. 3.1 3
Symbol explanation
Safety alert symbol
CAUTION Indicates a situation which, if not avoided, could result
in minor or moderate injury.
WARNING Indicates a situation which, if not avoided, could result
in death or serious injury.
DANGER Indicates a situation which, if not avoided, will result
in death or serious injury.
Observe instructions for use
Item number (Item no.)
Manufacturer
NON WOOD The packaging is “non-wood”, i.e. wood packaging material that is not
subject to ISPM 15 and therefore suitable for international shipment.
Warning: Dangerous high voltage!
Class I equipment acc. to IEC 60601-1
CE mark of conformity
This product may not be disposed of as normal household garbage

Instructions for Use
Electrosurgical Unit ME 102
4 V. 3.1
Contents
1Product Liability and Warranty ...................................................... 6
1.1 General Information ..............................................................................6
1.2 Scope of Delivery..................................................................................6
1.3 Intended Use........................................................................................6
1.4 Warranty .............................................................................................7
1.5 User’s Inspection ..................................................................................7
1.6 Hotline.................................................................................................8
2Notices concerning this Document ................................................. 9
2.1 Symbols Used in this Document..............................................................9
2.2 Service Manual .....................................................................................9
3Functional Principle.....................................................................10
3.1 Monopolar Functional Principle.............................................................. 10
3.2 Bipolar Functional Principle................................................................... 10
4Commissioning ..........................................................................11
4.1 Technical Specification......................................................................... 11
4.2 Functions of the Control Elements, Connections and Displays ................... 12
4.3 Mains Connection................................................................................ 14
4.4 Equipotential Bonding Connection ......................................................... 14
4.5 Switching On / Off...............................................................................14
4.6 Monopolar Operation ........................................................................... 15
4.6.1 Connection of the Neutral Electrode ..................................................................15
4.6.2 Connection of Handles ....................................................................................16
4.6.3 Selecting the Monopolar Current Type...............................................................17
4.6.4Function of the Micro Button ............................................................................17
4.6.5 Setting the Monopolar Cutting Power ................................................................18
4.6.6 Setting the Monopolar Coagulation Power..........................................................18
4.6.7 Monopolar Operating Mode ..............................................................................19
4.6.8 Monopolar Functional Check ............................................................................19
4.7 Bipolar Operation ................................................................................20
4.7.1 Function of the Neutral Electrode......................................................................20
4.7.2 Connecting Bipolar Instruments .......................................................................20
4.7.3 Selecting the Bipolar Operating Mode................................................................21
4.7.4 Function of the Micro Button ............................................................................21
4.7.5 Bipolar Power Setting .....................................................................................22
4.7.6 Bipolar Operating Mode...................................................................................22
4.7.7 Bipolar Functional Check .................................................................................23

Instructions for Use
Electrosurgical Unit ME 102
V. 3.1 5
5Safety Measures.........................................................................24
5.1 General Information ............................................................................ 24
5.2 Patient Placement ............................................................................... 24
5.3 Application of the Neutral Electrode....................................................... 25
5.4 Working with the Active Electrode ......................................................... 27
5.5 Use of Two Electrosurgical Devices on One Patient .................................. 28
5.6 Work on Patients with Pacemakers or Other Implants .............................. 28
5.7 Cable Routing on the Patient ................................................................ 29
5.8 Putting Down RF Instruments ............................................................... 29
5.9 Interference with Other Devices............................................................ 29
5.10 Accessories ........................................................................................29
5.11 Additional Safety Notes........................................................................ 30
6Cleaning and Disinfection ............................................................31
7Safety Checks (SC) ....................................................................32
8Accessories................................................................................33
9Technical Data ...........................................................................34
10 Diagrams ..................................................................................35
10.1 Performance Diagrams Macro Mode....................................................... 35
10.2 Performance Diagrams Micro Mode........................................................ 36
10.3 Voltage Diagrams................................................................................ 37
11 Guidelines and Manufacturer’s Declaration Regarding
Electromagnetic Compatibility (EMC) ............................................38
12 Ecological Information ................................................................42
12.1 Disposal of Packing .............................................................................42
12.2 Ecological Aspects of Operation............................................................. 42
12.3 Disposal of the Unit .............................................................................42

Instructions for Use
Electrosurgical Unit ME 102
6 V. 3.1
1Product Liability and Warranty
1.1 General Information
We thank you for having decided to buy a KLS Martin product. This product carries the
CE mark, which means that it satisfies the essential requirements laid down in the EC Directive
concerning medical devices.
We are the manufacturer of this product:
Gebrüder Martin GmbH & Co. KG
A company of the KLS Martin Group
KLS Martin Platz 1 · D-78532 Tuttlingen · Germany
Postfach 60 · D-78501 Tuttlingen · Germany
Tel. [phone] · Fax [phone]
[e-mail] · www.klsmartin.com
1.2 Scope of Delivery
•Electrosurgical unit ME 102
—Item no. 80-010-02-04 (240 V)
—Item no. 80-010-02-12 (127 V)
•Mains cable
•Instructions for Use
1.3 Intended Use
The unit is used for electrosurgical cutting or coagulation of live human or animal tissue.
The operator may operate the device only if an on-site functional test has previously been
performed by Gebrüder Martin or a person authorized by Gebrüder Martin. In addition, a
responsible person designated by the operator must have been instructed in the proper
handling, application and operation of the unit, as well as in its permissible combination with
other medical devices, objects and accessories. This duly instructed officer shall subsequently
be responsible for familiarizing the operator’s staff with the unit as the need arises. We
recommend documenting all user instructions in a medical device logbook. A copy of the
logbook is available from Gebrüder Martin.
The operational safety of the unit must be verified at regular intervals, see section 7 “Safety
Checks (SC)”, page 32.
If the device is not functionally reliable and/or safe to operate, it must be marked as such and
withdrawn from service. A technical check is mandatory in any such case.

Instructions for Use
Electrosurgical Unit ME 102
V. 3.1 7
1.4 Warranty
Our Standard Terms and Conditions of Sale effective at the time shall apply. Agreements di-
verging from these Standard Terms and Conditions do not restrict the legal rights of the buyer.
Any warranty exceeding the above provisions shall require a contractual form and shall exclude
component-related vandalism, software updates and consumables.
Under this warranty, we will remedy free of charge any defects due to faulty workmanship or
the use of faulty materials, either through our Customer Service or directly at the factory. The
warranty for the unit is not extended by this.
Important Notices
The product may only be repaired by Gebrüder Martin or a qualified person or firm expressly
authorized by Gebrüder Martin to perform such work.
If the repair is carried out by a person or firm specially authorized by Gebrüder Martin, the
operator of the product is required to obtain from the repairer a certificate with details about
the nature and scope of the repair work done. This certificate must show the date of the repair
and the details of the person or firm carrying out the work and must be signed.
In all cases where a party other than the product manufacturer performed the work, repaired
products must be additionally marked with the repairer’s ID label.
Improper interventions or alterations performed by third parties during the period of limitation
shall void any and all warranty claims. Unauthorized actions performed on the product shall
invalidate any liability claims against Gebrüder Martin.
1.5 User’s Inspection
Immediately upon receipt, the goods must be checked for completeness and potential damage
in transit. Notice of any such damage must be given immediately.

Instructions for Use
Electrosurgical Unit ME 102
8 V. 3.1
1.6 Hotline
•Should you have any questions on how to handle the product or use it for clinical
applications, please do not hesitate to contact the Product Management:
Tel: [phone]
Fax: [phone]
•Should you have any technical questions, please do not hesitate to turn to our
Martin Service Center:
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]
•Should you have any questions concerning maintenance contracts or training courses,
please contact our Technical Service Manager:
Tel: [phone]
E-mail: [e-mail]
NOTICE
To answer your technical questions as efficiently as possible, our service technicians require
the serial number of the product. Therefore, pl
ease have this number at hand when
contacting our hotline. It is part of the information provided on the rating plate; see
section 4.2 “Functions of the Control Elements, Connections and Displays”, page 12.

Instructions for Use
Electrosurgical Unit ME 102
V. 3.1 9
2Notices concerning this Document
Non
-observance of this document can lead to serious or even lethal patient injury!
Improper handling and care
as well as non-intended use can lead to premature wear and / or
pose a risk to patients and users!
Be sure to read, understand and follow the instructions given below!
•Every user is required to read this document completely and follow them carefully.
•In particular, be sure to heed all cautions, warnings and danger notices.
•Keep this document accessible to users at all times.
2.1 Symbols Used in this Document
Throughout this document, important information (such as general or safety-related notices) is
marked with the following symbols and signal words:
WARNING
Danger of death or serious injury!
Indicates a situation which, if not avoided, could result in death or serious injury!
CAUTION
Danger of minor injury!
Indicates a situation which, if not avoided, could result in minor or moderate injury!
NOTICE
Risk of material damage!
Indicates a situation which, if not avoided,
could lead to material damage (loss of time, data
loss, device/machine failure, etc.)!
2.2 Service Manual
Upon request, we will supply a service manual. It helps persons or companies authorized by us
to maintain / repair the unit. The service manual also contains order information for all
components that are available as spare parts.

Instructions for Use
Electrosurgical Unit ME 102
10 V. 3.1
3Functional Principle
3.1 Monopolar Functional Principle
The electrosurgical unit ME 102 is a generator that converts electrical energy from the grid into
a high-frequency current. This high-frequency current is fed to a point-shaped active electrode
via a supply line or a handle. This leads to high field line concentration in a small area at the
application site of the active electrode in the tissue surroundings of the point of contact. The
desired electrosurgical effect is achieved by this energy concentration in a small area in the
area of the active electrode. During further energy transport through the patient up to the
neutral electrode that is applied to a larger area, the concentration of the current is further
reduced. Therefore, there is, in accordance with its intended purpose, no thermal effect in the
area of the applied neutral electrode. The circuit is closed via the supply cable of the neutral
electrode.
The RF generator can be activated via either the foot switch or the finger switch on the surgical
handle.
3.2 Bipolar Functional Principle
Special constructional measures (insulation) permit design of bipolar instruments where the
active electrode and neutral electrode are positioned directly to each other. Here the path of
the high-frequency current only leads to one instrument tip to the other. Thus, there result
very short current paths and surrounding coagulation areas with low power requirements.

Instructions for Use
Electrosurgical Unit ME 102
V. 3.1 11
4Commissioning
4.1 Technical Specification
The electrosurgical unit can be used universally and has excellent performance data. The unit
meets the latest safety standards.
The unit is characterized by the following constructional characteristics:
•The characteristics of the RF generator result in automatic power adjustment for different
operation electrodes, tissue types and cutting speeds.
•Easy handling thanks to the clear arrangement of all control elements and their labeling
with easy-to-remember function symbols. The power is adjusted via a rotary knob. All
connections for active electrodes and neutral electrodes are located on the front side.
•Two current types for cutting: Smooth cutting and cutting with eschar formation.
•One monopolar current type for coagulation: Coagulation current with high power for
contact coagulation.
•One current type for bipolar coagulation.
•Optical and acoustic signals to indicate RF activation with activation LEDs in different colors
and different signal tones.
•MICRO function for microsurgery.
•Connection of one-piece as well as of two-piece neutral electrodes.
•Safety system according to IEC 601-2-2 for cases of a unit-related output error.
•No opening or cooling vents, no cooling fan. Low power loss thanks to high efficiency of the
generators.
•Hygiene-friendly foil front plate.
•Practice-oriented, high-quality accessory components.

Instructions for Use
Electrosurgical Unit ME 102
12 V. 3.1
4.2 Functions of the Control Elements, Connections and Displays
1
Mains switch
2
MICRO button
3
Connection for monopolar handle
4
Sockets for 3-pin handle
5
Connection for neutral electrode
6
Indicator LED for neutral electrode alarm

Instructions for Use
Electrosurgical Unit ME 102
V. 3.1 13
7
Switch button monopolar PURE CUT / BLEND CUT
8
Activation LED monopolar cutting
9
Power controller monopolar cutting
10
Activation LED monopolar coagulation
11
Power controller monopolar coagulation
12
Activation LED bipolar coagulation
13
Power controller bipolar coagulation
14
Connection for bipolar instruments
15
Switch button for foot switch activation (bipolar)
16
Switch button for bipolar automatic operation
17
Connection for mains cable / mains fuses
1 × T2.0 AH for mains voltage 100 – 127 VAC,
1 × T1.0 AH for mains voltage 220 – 240 VAC
G 5 × 20 mm
18
Connector for equipotential bonding
19
Connection for monopolar double-pedal foot switch
20
Connection for bipolar foot switch
21
Type plate
Connection for the neutral electrode.
Neutral electrode insulated against ground (floating).
Symbol for classification of the unit (CF). The unit is defibrillation-proof.
WARNING! PLEASE READ INSTRUCTIONS FOR USE!
WARNING! HIGH-FREQUENCY CURRENTS! CAUTION! HIGH VOLTAGE!

Instructions for Use
Electrosurgical Unit ME 102
14 V. 3.1
4.3 Mains Connection
For the assignment of the numbering, see section 4.2 “Functions of the Control Elements,
Connections and Displays”, page 12.
Before initial switching on of the unit, ensure that your grid complies with
the voltage setting of the unit indicated on the label (next to the power
input). If the voltages should not match, please contact our
Martin Service Center (see section 1.6 “Hotline”, page 8).
Potential adjustment to another supply voltage on site may only be carried
out by a person authorized to do so by Gebrüder Martin. Unauthorized
persons may not open the unit!
The unit is available in two versions:
•100 – 127 VAC, T 2.0 AH
•220 – 240 VAC, T 1.0 AH
The fuses can be found in the insert (17) on the mains connection socket.
Connect the unit to the power outlet using the mains cable. Set mains switch (1) on the front
side of the unit to position “ON”.
In order to be able to completely separate the unit from the grid in the event of danger, either
the power socket of the unit or the outlet into which the mains cable is plugged in should
remain accessible.
For the decommissioning of the unit, no special measures are necessary.
4.4 Equipotential Bonding Connection
For the assignment of the numbering, see section 4.2 “Functions of the Control Elements,
Connections and Displays”, page 12.
Equipotential bonding, aka potential equalization, is the conductive electrical
connection of the casings of units. It ensures that the units will always, even in
case of an electric defect, have the same potential. Equipotential bonding is
required for certain operating theaters, e. g. for intercardial operations, and can
be realized via the equipotential bonding connection (18). The necessary
connection cable is not included in the scope of delivery and can be purchased if
required.
4.5 Switching On / Off
For the assignment of the numbering, see section 4.2 “Functions of the Control Elements,
Connections and Displays”, page 12.
O
I
After switching on at the mains switch
(1), the unit is operational. The surface of
the rocker switch must light up in green.

Instructions for Use
Electrosurgical Unit ME 102
V. 3.1 15
4.6 Monopolar Operation
For the assignment of the numbering, see section 4.2 “Functions of the Control Elements,
Connections and Displays”, page 12.
4.6.1 Connection of the Neutral Electrode
Connect the neutral electrode to connection (5). You can connect either one-piece neutral
electrodes or two-surface electrodes that allow the monitoring of the contact to the patient.
If the neutral electrode is not connected, the red neutral electrode indicator LED (6) flashes. If
you try to activate the unit in a monopolar operating mode in this state via the finger or foot
switch, there will be an additional acoustic warning signal. The RF current cannot be activated.
This does not affect the bipolar coagulation current.
The indicator LED (6) goes dark after connecting a one-surface neutral electrode. Therefore
ensure that the neutral electrode is safely and fully attached to the patient. The indicator
LED (6) goes dark after reaching a safe application state when a multi-surface electrode (e. g.
KLS Martin TWIN-PAD) is correctly connected. As in this case individual run-in times are to be
expected, a lead time for the application must be considered.
WARNING
Risk of
burns from improper handling of the neutral electrode!
A one
-part neutral electrode cannot be monitored. In case of insufficient contact, there will be
no warning signal!

Instructions for Use
Electrosurgical Unit ME 102
16 V. 3.1
4.6.2 Connection of Handles
For monopolar cutting and coagulation, a handle with finger switch or a handle without a finger
switch can be connected together with a foot switch.
The handle with finger switch is connected to socket (3).
Handles with coax plug as well as handles with 3-pin plug can be
connected to socket (3).
•Pay attention to the information in the accessories catalog of
KLS Martin.
Handles without finger switch or surgical RF instruments without
switch function (e. g. resectoscopes) are also connected to
socket (3). The corresponding double-pedal foot switch is
connected to socket (19) on the rear of the unit.
•The desired active electrode must be inserted into the hexagonal guide of the handle.
—The hexagon of the electrode snaps into place.
—Rotation of the electrode during the application is prevented.
WARNING
Risk of electric shock!
When inserting the electrode and while replacing an electrode, the high
-frequency current
must not be activated.

Instructions for Use
Electrosurgical Unit ME 102
V. 3.1 17
4.6.3 Selecting the Monopolar Current Type
The unit has three monopolar operating modes:
•Monopolar cutting 1
•Monopolar cutting 2
•Monopolar contact coagulation
The front is divided into two control fields for distinction of the monopolar operating modes:
In the control field on the monopolar unit side that is marked yellow, an indicator LED (8)
indicates activation of the monopolar cutting current, and there are two different current types
available for cutting:
Button (7) not pressed
Cutting 1
Clean cut without eschar formation
Button (7) pressed and flashing
Cutting 2
Cutting current with low eschar formation
In the control field that is marked blue on the front plate of the unit, an indicator LED (10)
indicates the activation of monopolar coagulation current, and there is one current type for
coagulation:
Without button! Contact coagulation
Coagulation with high depth upon direct contact between electrode
and tissue
4.6.4 Function of the Micro Button
The micro button affects all monopolar and bipolar operating modes:
•If the Micro button is activated (button flashes), the maximum
output of the unit is reduced by about 2/3 to approx. 1/3 and can
then be precisely adjusted with the power controllers (9), (11)
or (13).

Instructions for Use
Electrosurgical Unit ME 102
18 V. 3.1
4.6.5 Setting the Monopolar Cutting Power
Use the power controller (9) for setting the cutting power. The power
setting is adjusted from a preset minimum value to a maximum value
depending on the selected cutting current type and the MICRO function.
The output power increases in roughly linear relation to the rotation
angle; the correlation can be seen in the diagrams for the monopolar
current types.
Setting Cutting 1
Setting Cutting 2
Power output in watts
Power output in watts
Setting
Setting
4.6.6 Setting the Monopolar Coagulation Power
Use the power controller (11) for setting the coagulation power. The
power setting is adjusted from a preset minimum value to a maximum
value for the coagulation current depending on the MICRO function. The
output power increases in roughly linear relation to the rotation angle;
the correlation can be seen in the diagram for the monopolar coagulation
current type.
Setting Coagulation
Power output in watts
Setting

Instructions for Use
Electrosurgical Unit ME 102
V. 3.1 19
4.6.7 Monopolar Operating Mode
Failure to comply with the patient and user r
ules for the application of
electrosurgery explained in section
5 “Safety Measures”, page 24, may result in
severe and even lethal injury!
•
Ensure safe application of the neutral electrode and correct positioning of the patient.
•
After prolonged application of RF current at high power, the surface of the unit can heat
up significantly.
•Only accessories in flawless working condition may be used.
Upon activation the RF current is switched on according to the previously selected operating
mode by triggering the handle or foot switch. The RF current is provided in accordance with
the preset current types and the set power. After activation, a continuous tone is emitted and
the activation LED for the operating mode lights up.
4.6.8 Monopolar Functional Check
All functions of the unit must be checked before using the unit. The following functional checks
must be performed:
•Remove plug of the connection cable for the neutral electrode from the connection
socket (5). The red indicator LED (6) flashes. When an attempt is made to activate a
monopolar RF current, an intermittent acoustic warning signal is sounded instead of the
continuous activation tone. The activation of RF current is blocked. When selected, bipolar
currents can, however, be activated.
•Re-insert the plug of the connection cable for the one-surface neutral electrode into the
connection socket (5). The red indicator LED (6) must not flash any longer. When using a
split neutral electrode ensure that it is correctly applied to the patient so that the alarm
disappears.
•Connect connection cable with electrode handle to socket (3). Activate the selected current
type by actuating the finger switch on the electrode handle or the foot switch. The
activation LEDs (8) or (10) assigned to the individual current types must light up
depending on the selected current type, and the RF activation signal must sound.

Instructions for Use
Electrosurgical Unit ME 102
20 V. 3.1
CAUTION
Risk of malfunction, risk of injury!
If the
RF activation signal can be heard when no double foot switch or electrode handle is
connected, the unit is defective.
•
The unit must not be operated.
•A technical inspection must be performed.
CAUTION
Risk of malfunction, risk of injury!
If the
RF activation signal can be heard while the double switch or electrode handle is
connected but none of the control elements is trig
gered, one of these accessory parts is
defective.
•
This accessory must not be used.
•It must be replaced.
4.7 Bipolar Operation
For the assignment of the numbering, see section 4.2 “Functions of the Control Elements,
Connections and Displays”, page 12.
4.7.1 Function of the Neutral Electrode
For bipolar application no neutral electrode is required. When selecting bipolar coagulation, the
monitoring of the neutral electrode is deactivated.
NOTICE
As a changeover from bipolar to monopolar application during the course of an operation is to
be expected, we recommend application of a neutral electrode under all circumstances.
4.7.2 Connecting Bipolar Instruments
All bipolar connection cables with small coax plug (e. g. for bipolar forceps, bipolar RF pliers)
can be connected to socket (14).