Caiman Lektrafuse User manual

Aesculap®
Aesculap Endoscopic Technology
Valid for units with software version 2.0 and higher
Instructions for use/Technical description
Lektrafuse HF generator GN200
Gebrauchsanweisung/Technische Beschreibung
Lektrafuse HF-Generator GN200
Mode d’emploi/Description technique
Générateur HF Lektrafuse GN200
Instrucciones de manejo/Descripción técnica
Generador AF Lektrafuse GN200
Istruzioni per l’uso/Descrizione tecnica
Generatore HF Lektrafuse GN200
Instruções de utilização/Descrição técnica
Gerador de AF Lektrafuse GN200
Gebruiksaanwijzing/Technische beschrijving
Lektrafuse HF-generator GN200
Bruksanvisning/Teknisk beskrivning
Lektrafuse HF-generator GN200
Инструкция по примению/Техническое описание
ВЧ-генератор Lektrafuse GN200
Návod k použití/Technický popis
VF generátor Lektrafuse GN200
Instrukcja użytkowania/Opis techniczny
Generator HF Lektrafuse GN200
Návod na použivanie/Technický opis
VF generátor Lektrafuse GN200
Kullanım Kılavuzu/Teknik açiklama
Lektrafuse HF jeneratörü GN200

2
3
1
9
4678 5
101112131415

2
Aesculap®
Lektrafuse HF generator GN200
Aesculap® Lektrafuse HF generator GN20 0
Legend
1Signal lamp HF-ON (surrounding ring)
2Operating mode selection button (MODE) (middle)
3Connection socket (foot switch)
4Signal lamp regrasp
5Display
6Signal lamp error
7Signal ring instrument
8Connection socket (instrument)
9Indicator lamp power ON
10 Equipotential connector
11 Fuse holder (with 2 fuses)
12 OFF/ON switch
13 Mains power input socket
14 Type plate
15 Ventilation slots
Symbols on product and packages
Caution
Observe important safety information such as warn-
ings and precautions in the instructions for use.
Follow the instructions for use
Marking of electric and electronic devices according
to directive 2002/96/EC (WEEE), see Disposal
Foot switch
Regrasp
Type CF applied part, defibrillation-protected
Equipotentialization
Fuse
Non-ionizing radiation
Alternating current
Batch designation
Serial number
Order number
Date of manufacture
LOT

3
Contents
1. Safe handling 3
1.1 Safe for use in conformance with IEC regulations 4
2. Product description 5
2.1 Scope of supply 5
2.2 Components required for operation 5
2.3 Intended use 5
2.4 Operating principle 5
2.5 Acoustic warning signal 6
2.6 Monitoring functions 6
2.7 Output power diagrams 7
2.8 Maximum peak output voltage (Up) 7
3. Preparation and setup 7
3.1 First use 7
4. Working with the Lektrafuse HF generator GN200 8
4.1 System set-up 8
4.2 Function checks 10
4.3 Safe operation 10
5. Validated reprocessing procedure 11
5.1 General safety instructions 11
5.2 General information 11
5.3 Preparations at the place of use 11
5.4 Preparation before cleaning 11
5.5 Cleaning/disinfection 12
5.6 Wipe disinfection for electrical devices without sterilization 13
5.7 Inspection, maintenance and checks 13
5.8 Storage and transport 13
6. Maintenance 13
6.1 Safety inspection 13
7. Troubleshooting list 15
7.1 Regrasp error 15
7.2 Warnings 16
7.3 Error reports 16
7.4 Failure messages 17
7.5 Problem solving 17
7.6 User maintenance 18
7.7 Fuse replacement 18
8. Technical Service 18
9. Accessories/Spare parts 18
10. Technical data 18
10.1 Ambient conditions 19
11. Disposal 19
12. Distributor in the US/Contact in Canada for product
information and complaints 19
1. Safe handling
CAUTION
Federal law restricts this device to sale by or on order of a physician!
Note
These instructions for use only describe the set-up, function and operation
of the Lektrafuse generator GN200 and is not suitable for initiating a
beginner in high-frequency surgery.
ŶGeneral risk factors associated with surgical procedures are not
described in this documentation.
ŶIt is the operating surgeon's responsibility to ensure that the surgical
procedure is performed correctly.
ŶThe operating surgeon must have a thorough understanding of both
the hands-on and conceptual aspects of the established operating
techniques.
ŹTransport the product only in its original box.
ŹPrior to use, check that the product is in good working order.
ŹObserve “Notes on Electromagnetic Compatibility (EMC)“, see
TA022130.
ŹThe Lektrafuse HF generator GN200 fulfills the requirements of
CISPR 11, Class A.
ŹTo prevent damage caused by improper setup or operation, and in order
not to compromise warranty and manufacturer liability:
– Use the product only according to these instructions for use.
– Follow the safety and maintenance instructions.
– Only combine Aesculap products with each other.
– Adhere to application instructions according to relevant norms, see
Safe for use in conformance with IEC regulations.
DANGER
Risk of injury to patients due to inappropriate
application!
ŹThe product and accessories should only be
operated by qualified or trained and experi-
enced personnel.
WARNING
Risk of injury and material damage due to inappro-
priate use of the product!
ŹUse the product only in accordance with the
intended use.
WARNING
Risk of injury and material damage due to improper
handling of the product!
The Lektrafuse HF generator together with the
accessories forms a system.
ŹFollow the instructions for use of the Lektrafuse
HF generator accessories.
ŹFollow the instructions for use of all products
used.

4
Aesculap®
Lektrafuse HF generator GN200
ŹInspect the accessories regularly: Electrode cables and endoscopic
accessories, in particular, must be checked for possible damage to the
insulation.
ŹKeep the instructions for use accessible for the user.
ŹAlways adhere to applicable standards.
1.1 Safe for use in conformance with IEC regulations
The operating environment
ŹEnsure that the device does not come in direct contact with the patient
or in the sterile area respectively.
ŹEnsure that the user does not come into direct contact with the patient
and HF generator at the same time.
Patient safety
DANGER
Risk of death by electric shock!
ŹDo not open the product.
ŹOnly ever connect the product to power mains
with equipment grounding conductor.
WARNING
Risk of injury from ignition or explosion of flam-
mable gases! Sparks may occur when using the HF
generator as directed.
ŹDo not use the device in explosion-hazard zones.
ŹWhen operating in the head or thoracic region,
avoid using combustible anesthetics and accel-
erating gases (e.g. nitrous oxide or oxygen) or,
when using such substances, ensure they are
extracted from the region of operation.
ŹIf possible, use incombustible cleaning and dis-
infecting agents.
ŹIf combustible cleaning and disinfecting agents
or solvents have to be used: Verify that such
agents have evaporated prior to commencing HF
surgery.
ŹBe sure that no inflammable liquids accumulate
under the patient’s body or in body cavities (e.g.
the vagina). Before using the HF generator, wipe
up all fluids.
ŹEnsure the absence of any endogenous, combus-
tible gases.
ŹCheck that oxygen-soaked materials (e.g.
absorbent cotton or mull) are kept at a safe dis-
tance from the HF field, so that they cannot
ignite.
CAUTION
Risk of interference with other devices!
HF generators create potentially harmful magnetic
fields during normal use.
ŹBe sure that no electronic devices that could be
damaged by an electromagnetic field are set up
in the vicinity of the HF generator.
CAUTION
Restriction to view and/or side-effects due to the
development of steam/smoke during HF surgery!
ŹIf necessary, use smoke suction.
DANGER
Danger to life from inadequate preparation or
operational errors in the HF generator!
ŹBe sure that the HF generator is in perfect
working order.
ŹEnsure that neither the foot switch nor the hand
switch has been penetrated by conductive fluids
(e.g. blood, amniotic fluid).
ŹEnsure there is no short circuit in the foot or
hand switch cables.
DANGER
Risk of burns suffered by the patient due to inad-
vertent activation of the HF generator!
ŹSwitch off the HF generator immediately using
the power OFF/ON switch in the event that it is
activated accidentally.
ŹAlways exercise particular care when operating
the foot switch.
DANGER
Risk of injury to the patient due to an unintended
rise of the HF output voltage due to a fault in the
HF generator!
ŹStop using the HF surgical device as soon as it
shows even the slightest anomaly.
WARNING
Risk of injury to patients/users due to defective
power cord or missing protective ground connec-
tions!
ŹCheck the mains power cord/protective ground
connections.
WARNING
Danger of injuries due to muscle contraction,
caused by stimulation of the nerves and muscles!
ŹWork with particular care on sensitive struc-
tures.

5
Always be sure to do the following:
ŹPosition the patient in such a way that s/he is not in contact with any
metal parts that are grounded or have a significant electric capacity
against ground (e.g. operating table, fixtures). If necessary, interpose
antistatic drape.
ŹEnsure that the patient will not be in contact with any damp cloths,
drapes or bedding.
ŹSafeguard areas prone to strong perspiration against skin contact with
the trunk of the patient’s body by inserting antistatic tissue between
such areas and the trunk.
ŹSiphon off urine with a catheter.
ŹFor heart surgery, ground the HF generator via the potential equaliza-
tion connection.
ŹFor patients with cardiac pacemaker or other active implants, consult
with the relevant medical specialist prior to applying HF surgery, so
that irreparable damage to the pacemaker or implant can be avoided.
ŹIf possible, remove from the vicinity of HF electrodes any electrodes
from physiological monitoring devices that are not equipped with pro-
tective resistors or HF dampers.
ŹDo not use needle electrodes for intraoperative monitoring.
ŹArrange the wires and cables of monitoring devices in such a way that
they do not come in contact with the patient’s skin.
ŹKeep the leads to the HF electrodes as short as possible, and arrange
them in such a way that they do not touch the patient or any other
wires or cables.
ŹShould the output power appear insufficient with the usual settings,
check that:
– the working electrodes are clean,
– all plug connections are properly in place.
ŹNever lay active electrodes on or next to the patient.
ŹPut down active electrodes that are not needed at any particular
moment, in such a way that they will not touch the patient.
ŹFor operations involving unavoidable, continuous contact between the
electrodes and the patient (e.g. endoscopic procedures), press the
power OFF/ON switch 12 to switch off the HF generator immediately
after any inadvertent activation of the electrode.
ŹDo not remove hot electrodes from the patient’s body immediately
after performing cutting or coagulation procedures.
ŹDuring operation of the generator, do not touch the electrodes on the
instrument (on the upper or lower side) as the electrodes can heat up
and this may lead to burns or injuries.
2. Product description
2.1 Scope of supply
2.2 Components required for operation
ŶPower cord
ŶFoot switch (optional)
ŶCaiman Instrument
2.3 Intended use
The Lektrafuse HF generator GN200 is used for vessel sealing and vessel
division in open and minimally invasive surgery. The instruments can seal
vessels of up to and including 7 mm.
The Lektrafuse HF generator is not suitable for use in tube steriliza-
tion/tube coagulation for sterilization.
With respect to the electric shock hazard, the Lektrafuse HF generator
meets the classification and safety requirements of a type CF device.
The Lektrafuse HF generator is intended only for indoor operation and
storage.
2.4 Operating principle
The Lektrafuse HF generator GN200 works on a micro-processor con-
trolled basis and converts the voltage of the mains supply into a high-fre-
quency alternating current for bipolar vessel sealing.
The sealing process is carried out via a closed control circuit. The sealing
can be started and stopped via a button on the instrument or a foot
switch.
The Lektrafuse HF generator GN200 has two operating modes:
ŶStandard mode: Pre-set operating mode
ŶPlus mode: Operating mode with increased energy output
Designation Art. no.
High frequency surgical device GN200
Instructions for use TA022414
Notes on Electromagnetic Compatibility TA022130

6
Aesculap®
Lektrafuse HF generator GN200
2.5 Acoustic warning signal
2.6 Monitoring functions
Self-test
As soon as it is switched on, the unit performs a self-test of the control
elements, the acoustic warning signal, the microprocessor and the hard-
ware function. During this phase, the message "Performing Self-Test"
appears in the display 5.
Fig.1
Continuous test cycle during operation
During operation, safety-relevant functions and signals are monitored
through a continuous test cycle. As soon as a critical error is detected, the
HF generator terminates the HF activation. In display 5, the error number
of the corresponding error is displayed and an acoustic warning signal is
emitted, see Troubleshooting list.
Status Acoustic warning signal Notes
System failure 3 repetitions of: 1 long beep, 3 KHz, 1 beep, 2 KHz Following each system failure, if identified (F001,...)
REGRASP error 3 repetitions of: 1 beep, 2 KHz,
1 beep, 3 KHz
Following each regrasp error, if identified
System error 3 beeps, 3 KHz Following each failure report, if identified (E001,...)
System warning 3 beeps, 3 KHz Following each warning, if identified
Start HF discharge 2 beeps, 480 Hz When starting the HF discharge
HF discharge active 1 beep, 480 Hz
ŶIn Standard mode: Repetition with 1.8 Hz
ŶIn Plus mode: Repetition with 2.8 Hz
Continually during HF discharge
End of HF discharge 3 beeps, 530 Hz When a sealing process has been successfully completed (no
failure reports or errors)
Power up self-test 1 beep, 2 KHz During the self-test, in order to check that the signal tone is
functioning

7
2.7 Output power diagrams
Representation of the output power as a function of the load resistance.
Fig.2 Output power diagram Caiman 12 mm Seal & Cut instrument
family
Fig.3 Output power diagram Caiman 5 mm Seal & Cut instrument
family
2.8 Maximum peak output voltage (Up)
Note
The following data allow the user to judge whether the HF generator
GN200 is suitable for a given accessory (insulation rating).
Maximum peak output voltage (Up): 200 V
3. Preparation and setup
Non-compliance with the following instructions will preclude all respon-
sibility and liability in this respect on the part of Aesculap.
ŹWhen setting up and operating the product, adhere to
– national regulations for installation and operation,
– national regulations on fire and explosion protection.
Note
For the safety of patients and users it is essential that the mains power cord
and, especially, the protective earth connection are intact. In many cases
defective or missing protective earth connections are not registered imme-
diately.
ŹConnect the device via the potential equalization terminal at the rear
panel of the device to the potential equalization system of the room
used for medical purposes.
Note
The potential equalization lead can be ordered from the manufacturer as
article no. GK535 (4 m length) or TA008205 (0.8 m length).
ŹIn order to ensure sufficient ventilation and cooling of the HF genera-
tor, leave at least 10 cm to 15 cm of space around the HF generator.
3.1 First use
WARNING
Risk of injury to patient or user caused by inade-
quate accessories (insulation rating)!
ŹMake certain that the accessory voltage rating
specified in the product documentation is
higher than maximum peak output voltage.
WARNING
Risk of injury and/or product malfunction due to
incorrect operation of the electromedical system!
ŹAdhere to the instructions for use of any medi-
cal device.

8
Aesculap®
Lektrafuse HF generator GN200
4. Working with the Lektrafuse HF gener-
ator GN200
4.1 System set-up
Connecting the accessories
Combinations of accessories that are not mentioned in the present
instructions for use may only be employed if they are specifically intended
for the respective application, and if they do not compromise the perfor-
mance and safety characteristics of the products.
Only CAIMAN instruments can be used in conjunction with the Lektrafuse
HF generator GN200, see Accessories/Spare parts.
Connecting the power supply
The voltage of the mains power supply must correspond to the voltage
indicated on the type plate of the device.
The device is fitted with a universal power supply unit, which means that
it automatically adapts to mains voltages ranging from 100 V to 240 V
without having to switch between voltage ranges.
ŹEnsure that the device is switched off. If necessary, switch off with the
power OFF/ON switch 12.
ŹPlug in the power cord in mains power input socket 13 in the rear
panel of the HF surgical device.
ŹPlug in the mains plug at the building mains power socket.
Switching on the device
ŹSwitch on the device with the power OFF/ON switch 12.
Indicator lamp power ON 9is illuminated. The device performs a self-
test, see Continuous test cycle during operation:
If no instrument is connected, the message "Attach Instrument"
appears in the display 5after the self-test. If the self-test fails, an error
message is shown in the display 5.
Fig.4
Connecting the foot switch
Connecting the foot switch GN201 is optional.
Both the foot switch plug and connection socket (foot switch) 3have a
dot marking. To connect the plug to the connection socket correctly, these
markings must be aligned.
Fig.5
DANGER
Risk of injury due to unapproved configuration
using additional components!
ŹFor all applied components, ensure that their
classification matches that of the application
component (e.g. Type BF or Type CF) of the
respective device.
DANGER
Risk of death from electric shock!
ŹOnly connect the product to power mains with
equipment grounding conductor.
ŹSet up the device in a way that switching it off
using the power OFF/ON switch is possible and
straightforward.
ŹSet up the device in a way that disconnecting
the power cord is straightforwardly possible.