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

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101112131415

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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

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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

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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.

9
ŹAlign the foot switch plug and insert it into the foot switch connection
socket 3until it engages.
When the device and the foot switch have been successfully con-
nected, the message "Footswitch attached" appears for 3 seconds in
the display 5.
Fig.6
Note
Do not activate the foot switch continually during HF discharge. HF dis-
charge is started and stopped by pressing once on the foot switch and then
releasing.
Remove the foot switch
ŹTurn the locking ring counter-clockwise and withdraw the connecting
plug at the same time
The message "Footswitch removed" appears in the display 5for 3 sec-
onds.
Fig.7
Connecting the instrument
Only instruments of the CAIMAN Seal & Cut product family can be used
in conjunction with the Lektrafuse HF generator GN200.
The instrument connector has an arrow marking and the connection
socket 8has a dot marking. To connect the plug to the connection socket
correctly, these markings must be aligned.
Fig.8
ŹConnect the instrument with the connection socket 8.
The green signal ring 7around the instrument connector lights up. The
message "Ready to Seal" appears in the display 5.
Fig.9

10
Aesculap®
Lektrafuse HF generator GN200
Selecting the operating mode
The Lektrafuse HF generator has two operating modes for the sealing pro-
cess. The selected operating mode will be retained until the HF generator
is switched off. The operating mode can be changed during the procedure.
ŹChanging the operating mode: Press operating mode selection button
(MODE) 2.
ŶStandard mode: Pre-set operating mode
ŶPlus mode: Operating mode with increased energy output
The operating mode is independent from the connected instrument.
Changing or reconnecting the instrument does not change the operating
mode.
The active operating mode is indicated in the display as follows:
ŶBorder
ŶBold font
Fig.10
Fig.11
Note
In case of a regrasp error, the active operating mode is not displayed. The
active operating mode can be displayed by pressing the operating mode
selection button (MODE) 2.
Note
The Plus mode can be distinguished from Standard mode by the higher fre-
quency of the beep during HF discharge.
Shutting down
ŹSwitch off the device with the power OFF/ON switch 12.
All the poles of the device are disconnected from the power supply.
ŹWithdraw mains cable.
The device is completely disconnected from the power supply.
4.2 Function checks
Prior to each use, carry out a functional test of the device:
ŹCheck that the accessories have no visible damage.
ŹPrepare and set up the unit, see Preparation and setup.
ŹCheck the functionality of the following elements, one after the other,
in the following sequence:
– Switch on the power OFF/ON switch 12; the power on signal
lamp 9lights up
– Automatic self-test after each time the device is switched on: brief
acoustic signal, all display elements light up briefly
– Operating mode selection, see Selecting the operating mode
– foot switch, see Connecting the foot switch
– Instrument, see Connecting the instrument
– Activation with instrument button and foot switch
– Switch off the power OFF/ON switch 12
4.3 Safe operation
ŹStart the sealing process (HF discharge) by pressing the button on the
instrument or foot switch once.
After completing the sealing process, the HF discharge is automatically
stopped.
During sealing process, the message "Sealing in Progress" is shown on
the display 5.
Fig.12
To activate/deactivate device
ŹSwitch on/switch off the device with the power OFF/ON switch 12.
Operating mode
The Lektrafuse HF generator GN200 automatically recognizes the con-
nected instrument. The internal device settings are loaded. The user can
choose between two operating modes.
WARNING
Risk of injury and/or malfunction!
ŹAlways carry out a function check prior to using
the product.
WARNING
Risk of injury when using the product beyond the
field of view!
ŹApply the product only under visual control.

11
Activating the HF current
ŹBe sure that the patient is prepared in such a way that the HF genera-
tor can be applied without any risk to the patient.
ŹMake sure that the required operating mode is selected.
ŹEnsure that the instrument and foot switch, if used, are correctly con-
nected.
ŹActivate the HF generator via the hand switch or the foot switch.
ŹDo not activate the hand switch or foot switch continually during HF
discharge.
Note
The vessel sealing process is started and ended by pressing the foot switch
or hand switch on the instrument once. After completing the sealing pro-
cess, the device stops the HF discharge automatically. The sealing process
can be interrupted by pressing the button once more.
5. Validated reprocessing procedure
5.1 General safety instructions
Note
Adhere to national statutory regulations, national and international stan-
dards and directives, and local, clinical hygiene instructions for sterile pro-
cessing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possi-
ble variants of CJD, observe the relevant national regulations concerning
the reprocessing of products.
Note
Mechanical reprocessing should be favored over manual cleaning as it
gives better and more reliable results.
Note
Successful processing of this medical device can only be ensured if the pro-
cessing method is first validated. The operator/sterile processing techni-
cian is responsible for this.
The recommended chemistry was used for validation.
Note
If there is no final sterilization, then a virucidal disinfectant must be used.
Note
For up-to-date information about reprocessing and material compatibility,
see also the Aesculap Extranet at https://extranet.bbraun.com.
The validated steam sterilization procedure was carried out in the Aesculap
sterile container system.
5.2 General information
Dried or affixed surgical residues can make cleaning more difficult or inef-
fective and lead to corrosion. Therefore the time interval between appli-
cation and processing should not exceed 6 h; also, neither fixating pre-
cleaning temperatures >45 °C nor fixating disinfecting agents (active
ingredient: aldehydes/alcohols) should be used.
Excessive measures of neutralizing agents or basic cleaners may result in
a chemical attack and/or to fading and the laser marking becoming
unreadable visually or by machine for stainless steel.
Residues containing chlorine or chlorides e.g. in surgical residues, medi-
cines, saline solutions and in the service water used for cleaning, disinfec-
tion and sterilization will cause corrosion damage (pitting, stress corro-
sion) and result in the destruction of stainless steel products. These must
be removed by rinsing thoroughly with demineralized water and then dry-
ing.
Additional drying, if necessary.
Only process chemicals that have been tested and approved (e.g. VAH or
FDA approval or CE mark) and which are compatible with the product’s
materials according to the chemical manufacturers’ recommendations
may be used for processing the product. All the chemical manufacturer's
application specifications must be strictly observed. Failure to do so can
result in the following problems:
ŶOptical changes of materials, e.g. fading or discoloration of titanium or
aluminum. For aluminum, the application/process solution only needs
to be of pH >8 to cause visible surface changes.
ŶMaterial damage such as corrosion, cracks, fracturing, premature aging
or swelling.
ŹDo not use metal cleaning brushes or other abrasives that would dam-
age the product surfaces and could cause corrosion.
ŹFurther detailed advice on hygienically safe and material-/value-pre-
serving reprocessing can be found at www.a-k-i.org, link to Publica-
tions, Red Brochure – Proper maintenance of instruments.
5.3 Preparations at the place of use
ŹRemove any visible surgical residues to the extent possible with a
damp, lint-free cloth.
ŹTransport the dry product in a sealed waste container for cleaning and
disinfection within 6 hours.
5.4 Preparation before cleaning
ŹDisconnect the unit from mains power.
ŹRemove accessories.

12
Aesculap®
Lektrafuse HF generator GN200
5.5 Cleaning/disinfection
Product-specific safety instructions for the reprocessing procedure
Validated cleaning and disinfection procedure
DANGER
Risk of electric shock and fire hazard!
ŹUnplug the device before cleaning.
ŹDo not use flammable or explosive cleaning or
disinfecting solutions.
ŹEnsure that no fluids will penetrate the product.
CAUTION
Damage to, or destruction of the product caused by
mechanical cleaning/disinfection!
ŹOnly clean and disinfect the product manually.
ŹDo not sterilize the product under any circum-
stances.
CAUTION
Damage to the product due to inappropriate clean-
ing/disinfecting agents!
ŹOnly use cleaning/disinfecting agents approved
for surface cleaning. Follow the manufacturer’s
instructions for the respective cleaning/disin-
fecting agent.
CAUTION
Damage to the product due to inappropriate clean-
ing/disinfecting agents and/or excessive tempera-
tures!
ŹUse cleaning agents and disinfectants according
to the manufacturer's instructions.
ŹObserve specifications regarding concentration,
temperature and exposure time.
Validated procedure Special features Reference
Wipe disinfection for
electrical devices with-
out sterilization
– Chapter Wipe disinfec-
tion for electrical devices
without sterilization

13
5.6 Wipe disinfection for electrical devices without sterilization
RT: Room temperature
Phase I
ŹRemove any visible residues with a disposable disinfectant wipe.
ŹWipe all surfaces of the optically clean product with a fresh, disposable
disinfectant wipe.
ŹObserve the specified application time (1 min minimum).
5.7 Inspection, maintenance and checks
ŹInspect the product after each cleaning and disinfecting cycle to be
sure it is: clean, functional, and undamaged.
ŹSet aside the product if it is damaged.
ŹPerform a safety inspection annually, see Maintenance.
5.8 Storage and transport
ŹTransport the product only in its original box.
ŹFor storage and transport conditions, see Ambient conditions.
6. Maintenance
No servicing is required for the Lektrafuse HF generator GN200.
Note
Maintenance must only be carried out by authorized personnel. If neces-
sary, the circuit diagrams and the service manual, which contains all the
necessary documents, are provided for this.
6.1 Safety inspection
A safety inspection must be carried out annually.
The person in charge of the inspection will document the inspection find-
ings and measurement values according to the printed inspection proto-
col.
ŹOnly have the product and its accessories inspected by persons who
possess the requisite training, knowledge and experience and who are
authorized to do so.
ŹIf there are significant deviations from the inspection protocol values,
or if the prescribed maximum values are exceeded: Send in the device.
For technical service, please contact your national B. Braun/Aesculap
agency, see Technical Service.
Phase Step T
[°C/°F] t [min] Conc. [%] Water quality Chemical
IWipedisinfectionRT 1 - - Meliseptol HBV wipes 50 % Propan-1-ol
CAUTION
Damage to the product caused by switch-on too
early after storage/transport at temperature below
+10 °C (50 °F)!
ŹAllow the HF generator to acclimate at room
temperature for about 1 hour.

14
Aesculap®
Lektrafuse HF generator GN200
Fig.13 Inspection protocol form Safety inspection
Inspection protocol – safety inspection
TEST INTERVAL: 1 Year
TYPE OF DEVICE:
MANUFACTURED BY:
Bipolar Electrosurgical Unit GN200
Aesculap AG, Am Aesculap-Platz 78532 Tuttlingen/Germany
SN: ............................... INVENTORY NO.: ...............................
RESPONSIBLE
ORGANIZATION: ..........................................................................
Measurement
equipment: ...........................................................................................................................................................................................
tcidreVNOITCEPSNIFOEPOCS
1.) VISUAL INSPECTION
PASS FAIL
1.1 Inspection of power cable for visually detectable damage
1.2 Inspection of foot switch for visually detectable damage
elbadaerdnatneserpllitsetalpepyT3.1
1.4 Check fuse links for prescribed values
1.5 Overall condition of device: dirt, damage
2.) ELECTRICAL INSPECTION
Measured value Verdict
Pass / Fail
2.1 Protective earth resistance incl. mains cable
according IEC62353:2007
R
max
=0,3 Ω(at ≥ 0,2 A)
2.2 Earth leakage current
according IEC60601-1*
N.C.
S.F.C.
I
max
= 0,50 m A
I
max
= 1,00 m A
2.3 Enclosure leakage current/touch current
according IEC60601-1*
N.C.
S.F.C.
I
max
= 0,10 m A
I
max
= 0,50 m A
2.4 Patient leakage current
according IEC60601-1*
N.C.
S.F.C.
I
max
= 0,01 m A
I
max
= 0,05 m A
2.5 Equipment leakage current - alternative method
according IEC62353:2007
I
max
= 1,00 m A
2.6 Applied part leakage current - alternative method
according IEC62353:2007
I
max
= 0,05 m A
2.7 HF-leakage current bipolar
according IEC60601-2-2:2009
I
max
= 122 m A
2.8 Insulation resistance
according IEC62353:2007 (Preparation according Service Manual) test voltage = 500 V DC
tuptuoFHtsniagasniaM1.8.2 R
min
= 7 MΩ
gnisuohtsniagasniaM2.8.2 R
min
= 2 MΩ
gnisuohtsniagatuptuo-FH3.8.2 R
min
= 2 MΩ
2.9 HF-output power measurement with induction-free resistor
Instrument Channel R
Load
Rated value
0515C Ω145 Watt
±
20 %
C24/44 1 50 Ω150 Watt
±
20 %
052 Ω150 Watt
±
20 %
2.10 DC resistance between the two HF output poles
according IEC60601-2-2:2009 section 201.8.4.102
R
min
= 2 MΩ
2.11 Function test according to instructions for use
Performed:
TLUSERTSET
Deficiencies were determined, by which patient, user or other individuals can be endangered
No Yes 
Repair …………………………………………………….. Next date of inspection
erutangiS/rotcepsnIetaD/ecalP Responsible Organization
* The listed allowable values comply with the requirements of the IEC60601-1:1988+A1:1991+A2:1995 and IEC60601-1:2005

15
7. Troubleshooting list
7.1 Regrasp error
A regrasp error, i.e. potentially insufficient sealing of the vessels, is dis-
played as follows:
ŶUnambiguous sound sequence and interruption of the sound sequence
of HF operation, also stops HF discharge
ŶThe yellow regrasp error light 4on the front side of the HF generator
lights up
ŶWarning message in the display 5on the front side of the HF generator
Procedure if a regrasp error occurs:
ŹDo not cut the vessel.
ŹOpen the instrument.
ŹCheck the sealed vessel.
When correct hemostasis has occurred:
ŹCut the vessel manually with surgical scissors.
When hemostasis has not occurred in the correct way:
ŹPlace the instrument on the vessel again and lock it in place.
Note
The regrasp error must not be confirmed. Activating the hand switch or foot
switch will start the next sealing process immediately.
Note
In case of a regrasp error, the active operating mode is not displayed. The
active operating mode can be displayed by pressing the operating mode
selection button (MODE) 2.
ŹStart additional HF cycle.
ŹIf the additional HF cycle leads to a normal seal, the vessel can be cut,
and the instrument can be opened and removed.
ŹIf a regrasp error occurs again, do not cut the vessel, open the instru-
ment and manually cut the sealed vessel with surgical scissors. When
so doing, ensure that the hemostasis is correct.
Regrasp error message Significance Remedy
REGRASP INDICATOR – OPEN
Visually check seal – Manually cut
- Clean jaws
OR
Regrasp thicker tissue
Check the vessel sealing. Contact areas of the jaw part
must be covered with dried vessel residue or bodily fluids.
- or -
The gripped bundle of tissue is too thin
Clean contact areas with sterile water and
a sponge
Grip a thicker tissue bundle
REGRASP INDICATOR – SHORT
Visually check seal – Manually cut
Check for metal or occlusion in jaw
Remove excess fluids
There is metal (e.g. staples) or other foreign material
between the electrodes in the jaw part
Open and check jaw part
Remove any foreign material
Remove excess suction fluids in the operat-
ing area
REGRASP INDICATOR – TIME
Visually check seal – Reseal as needed
Seal cycle interrupted
Seal endpoint not reached
HF generator has reached its maximum sealing time and
has not ascertained any complete seal
- or -
The user has ended HF discharge during sealing
Check the quality of the seal

16
Aesculap®
Lektrafuse HF generator GN200
7.2 Warnings
A warning is indicated as follows:
ŶIndividual tone (different from a failure, an error or normal HF opera-
tion)
ŶWarning message in the display 5on the front side of the HF generator
7.3 Error reports
An error is indicated as follows:
ŶUnambiguous tone sequence (different from a failure or normal HF
operation)
ŶFailure message in the display 5on the front side of the HF generator
Warning message Significance Remedy
Generator Cooling
Please Wait
generator temperature too high Check the airflow around the generator
Generator Too Cold
Please Wait
Generator must first warm up Do not switch off the generator whilst it is warming up
Error code Error report Significance Remedy
E001 ERROR E001
Instrument HF activation button error
Release Instrument RF-ON Button
Remove and reattach instrument
Instrument "HF activation" button is
pressed while the instrument is con-
nected to the HF generator
Release the “HF activation" button
Remove instrument and reconnect it
E002 ERROR E002
Instrument Error
Remove and reattach OR
Remove and replace instrument
HF generator cannot find instrument
- or -
Instrument is defective and must be
replaced
Remove instrument and reconnect it
- or -
Replace instrument
E003 ERROR E003
Footswitch Error
Release footswitch
Remove and reattach footswitch
Foot switch is pressed while the foot
switch is connected to the HF generator
Release foot switch
Remove foot switch and reconnect it

17
7.4 Failure messages
A failure is indicated as follows:
ŶClear sound sequence (as necessary, may interrupt the sound of the HF
discharge)
ŶThe red error light 6on the front side of the HF generator lights up
ŶError message in the display 5on the front side of the HF generator
Note
If the failure occurs during HF discharge, the vessel sealing may be incom-
plete or insufficient.
In order to ensure that sufficient hemostasis has been achieved, follow the
procedure for regrasp errors, see Regrasp error.
Note
If the failure continues after turning the device off and on againtwice, con-
tact your national B. Braun/Aesculap agency, see Technical Service.
7.5 Problem solving
Failure code Cause Remedy
F001 Software error on the HF generator Switch off HF generator, wait 5 s, switch HF generator on
F002 Dosage error of HF generator Switch off HF generator, wait 5 s, switch HF generator on
F003 Hardware error Switch off HF generator, wait 5 s, switch HF generator on
F004 Internal communication error of the HF generator Switch off HF generator, wait 5 s, switch HF generator on
F005 Overheating of HF generator Switch off HF generator and leave to cool down
Check the air stream around the generator
F006 Error in the operating mode selection button (MODE) 2(activated
when switching on)
Switch off HF generator, wait 5 s, release operating mode
selection button (MODE) 2, switch HF generator on
F007 Error with HF energy output Switch off HF generator, wait 5 s, switch HF generator on
F008 Fault: HF outside the calibration Switch off HF generator, wait 5 s, switch HF generator on
F009 Fault: Internal power supply Switch off HF generator, wait 5 s, switch HF generator on
Finding Remedy
HF generator does not switch on Ensure that the power cord has been correctly plugged into the power supply 13 of the HF
generator.
Ensure that the power cord is connected to a functioning power source.
Ensure that the power OFF/ON switch 12 of the HF generator is in the power ON position.
Check the fuse in the fuse box and replace if necessary, see Fuse replacement.
If the error continues, replace power cord.
The device is switched on, but no displays are illumi-
nated and the self-test is not being carried out
Switch off HF generator, wait 5 s, switch HF generator on again.
If the error continues, contact your national B. Braun/Aesculap agency, see Technical Ser-
vice.
Self-test fails Switch off HF generator, wait 5 s, switch HF generator on again.
If the error continues, contact your national B. Braun/Aesculap agency, see Technical Ser-
vice.
HF generator is active (power ON signal lamp 9lights
up), and accessories are connected, but there is no HF
discharge
Verify that the required foot switch (if used ) is properly connected and plugged in.
Ensure that the Caiman Seal & Cut Instrument is correctly connected and plugged in (green
ring 1is lit up).
In order to start the HF discharge, activate the button on the instrument or the foot switch.
If the error continues, replace Caiman instrument.

18
Aesculap®
Lektrafuse HF generator GN200
7.6 User maintenance
ŹIn case of error, follow the instructions in the display and note the error
code.
ŹIf the error continues after following the instructions in the display,
contact your national B. Braun/Aesculap agency, see Technical Service.
7.7 Fuse replacement
Specified fuses: 2 units Aesculap art. no. TA021404:
G fuse link, time lag (T) 8 A, breaking capacity H (1 500 A)
ŹUse a small screwdriver to release the clip on the fuse holder 11 and
tilt up cover.
ŹUse a small screwdriver to release the fuse holder 11 and pull it out.
ŹReplace both fuses.
ŹReinsert the fuse holder 11.
ŹClose the cover.
Fig.14
Note
If the fuses burn out frequently, the device is faulty and should be
repaired, see Technical Service.
8. Technical Service
ŹFor service and repairs, please contact your national B. Braun/Aesculap
agency.
Modifications carried out on medical technical equipment may result in
loss of guarantee/warranty rights and forfeiture of applicable licenses.
Service addresses
Aesculap Technischer Service
Am Aesculap-Platz
78532 Tuttlingen / Germany
Phone: [phone]
Fax: [phone]
E-Mail: [email protected]
Or in the US:
Aesculap Inc.
Attn. Aesculap Technical Services
615 Lambert Pointe Drive
Hazelwood
MO, 63042 USA
Aesculap Repair Hotline
Phone: [phone]
Fax: [phone]
Other service addresses can be obtained from the address indicated above.
9. Accessories/Spare parts
Note
Other accessories, applied parts and replacement parts are described in
Aesculap brochure C-304-81 and C-902-02
10. Technical data
Classification acc. to Directive 93/42/EEC
DANGER
Risk of death by electric shock!
ŹUnplug the device before changing the fuses!
DANGER
Danger to life of patients and users if the product
malfunctions and/or protective measures fail or are
not used!
ŹDo not perform any servicing or maintenance
work under any circumstances while the product
is being used on a patient.
ŹDo not modify the product.
Art. no. Designation
TA021404 Fuse
– Caiman 5 instrument family
– Caiman 12 instrument family
GN201 Foot switch
Art. no. Designation Class
GN200 High frequency surgical device IIb