lektrafuse_hf_generator_gn200_instructions_for_use.pdf
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Aesculap®
Aesculap Endoscopic Technology
Instructions for use/Technical description
Gebrauchsanweisung/Technische Beschreibung
Lektrafuse HF Generator GN200
Lektrafuse HF-Generator GN200
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Aesculap®
Lektrafuse HF Generator GN200
Legend
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Lektrafuse HF Generator
Aesculap
GN200®
Symbols on product and packages
Signal lamp HF-ON (surrounding ring)
HF activation button (RF on/off) (center)
Connection socket (foot switch)
Regrasp signal lamp
Display
Signal lamp error
Signal ring instrument
Connection socket (instrument)
Indicator lamp power ON
Equipotential connector
Fuse holder (with 2 fuses)
OFF/ON switch
Mains power input socket
Type plate
Ventilation slots
Caution, general warning symbol
Caution, see documentation supplied with the product
Error message
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
LOT
Batch designation
Serial number
Order number
Date of manufacture
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Contents
1.
1.1
2.
2.1
2.2
2.3
2.4
2.5
2.6
2.7
2.8
3.
3.1
4.
4.1
4.2
4.3
5.
5.1
5.2
5.3
5.4
6.
6.1
7.
7.1
7.2
7.3
7.4
7.5
7.6
7.7
8.
9.
10.
10.1
11.
12.
Safe handling
Safe for use in conformance with IEC regulations
Product description
Scope of supply
Components required for operation
Intended use
Operating principle
Acoustic warning signal
Monitoring functions
Adaptation curves
Maximum peak output voltage (Up)
Preparation and setup
First use
Working with the Lektrafuse HF Generator GN200
System set-up
Function checks
Safe operation
Validated reprocessing procedure
Preparation before cleaning
Cleaning/disinfection
Inspection, maintenance and checks
Storage and transport
Maintenance
Safety inspection
Troubleshooting list
Regrasp error
Warnings
Failure reports
Error messages
Problem solving
User maintenance
Fuse replacement
Technical Service
Accessories/Spare parts
Technical data
Ambient conditions
Disposal
Distributor in the US/Contact in Canada for product
information and complaints
1.
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Safe handling
Note
These instructions for use only describe the set-up, function and operation
of the Lektrafuse HF generator GN200 and is not suitable for initiating a
beginner in high-frequency surgery. A general description of the application of high-frequency electrosurgery can be found in the respective O.R.
manuals and other relevant literature.
These instructions and the device describe are intended exclusively for use
by qualified medical specialists who have been trained in the specific technique and the surgical procedures to be carried out.
DANGER
Risk of injury to patients due to inappropriate
application!
Ź The product and accessories should only be
operated by qualified or trained and experienced personnel.
Ź Transport the product only in its original box.
Ź Prior to use, check that the product is in good working order.
Ź Observe “Notes on Electromagnetic Compatibility (EMC)“, see
TA022130.
Ź The Lektrafuse HF generator GN200 fulfills the requirements of CISPR
11, Class A.
Ź To 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.
Ź Inspect the accessories regularly : Electrode cables and endoscopic
accessories, in particular, must be checked for possible damage to the
insulation.
Ź Keep the instructions for use accessible for the user.
Ź Always adhere to applicable standards.
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Aesculap®
Lektrafuse HF Generator GN200
1.1
Safe for use in conformance with IEC regulations
Patient safety
The operating environment
DANGER
WARNING
Risk of fatal injury from electric shock!
Ź Do not open the product.
Ź Connect the product only to a grounded power
supply.
Risk of injury from ignition or explosion of flammable gases! Sparks may occur when using the HF
device as directed.
Ź Do not use the device in an area where there is
a risk of explosion.
Ź When operating on the head and thorax region,
avoid using combustible anesthetics and combustion-supporting gases (e.g. laughing gas and
oxygen) or, when using such substances, aspirate them from the operation field.
Ź If possible, use incombustible cleaning and disinfecting agents.
Ź If flammable cleaning and disinfecting agents or
solvents are used: Verify that such agents have
evaporated prior to commencing HF surgery.
Ź Be sure that no inflammable liquids accumulate
under the patient’s body or in body cavities (e.g.,
the vagina). Before using the HF device, wipe up
all fluids.
Ź Be sure there are no endogenous gases in the
O.R. environment that could ignite.
Ź Be sure that any materials that were soaked in
liquid oxygen (e.g., cotton wool, gauze) are kept
far enough away from the HF environment that
they cannot ignite.
DANGER
DANGER
CAUTION
CAUTION
Restriction to view and/or side-effects due to the
development of steam/smoke during HF surgery!
Ź If necessary, use smoke suction.
Ź Ensure that the device does not come in direct contact with the patient
or in the sterile area respectively.
Ź Ensure that the user does not come into direct contact with the patient
and the HF device at the same time.
4
Risk of burns suffered by the patient due to inadvertent activation of the HF device!
Ź Switch off the HF device immediately using the
power OFF/ON switch in the event that it is
activated accidentally.
Ź Always work with extreme care when operating
the hand switch or 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 device!
Ź Stop using the device immediately if even the
slightest functional anomaly is detected.
WARNING
Risk of injury to patients/users due to defective
power cord or missing protective ground connections!
Ź Check the mains power cord/protective ground
connections.
WARNING
Risk of damage to other devices!
HF devices create potentially harmful magnetic
fields during normal use.
Ź Be sure that no electronic devices that could be
damaged by an electromagnetic field are set up
in the vicinity of the HF device.
Danger to life from inadequate preparation or
operational errors in the HF device!
Ź Be sure that the HF device is in perfect working
order.
Ź Ensure that neither the foot switch nor the hand
switch has been penetrated by conductive fluids
(e.g. blood, amniotic fluid).
Ź Ensure there is no short circuit in the foot or
hand switch cables.
Danger of injuries due to muscle contraction,
caused by stimulation of the nerves and muscles!
Ź Work with particular care on sensitive structures.
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Always be sure to do the following:
2.
Product description
2.1
Scope of supply
Ź Position the patient in such a way that s/he is not in contact with any
Ź
Ź
Ź
Ź
Ź
Ź
Ź
Ź
Ź
Ź
Ź
Ź
Ź
Ź
Ź
metal parts that are grounded or have a significant electric capacity
against ground (e.g. operating table, fixtures). If necessary, interpose
antistatic drape.
Ensure that the patient will not be in contact with any damp cloths,
drapes or bedding.
Lay anti-static drape against parts of the body that tend to develop
large amounts of sweat in order to safeguard against skin-to-skin contact with the torso.
Siphon off urine with a catheter.
For heart surgery, ground the HF device via the potential equalization
connection.
For 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.
If possible, remove from the vicinity of HF electrodes any electrodes
from physiological monitoring devices that are not equipped with protective resistors or HF dampers.
Do not use needle electrodes for intraoperative monitoring.
Arrange the wires and cables of monitoring devices in such a way that
they do not come in contact with the patient’s skin.
Keep the pathways of the wires and cables of HF electrodes as short as
possible, and arrange them in such a way that they do not touch the
patient or each other.
Should the output power appear insufficient with the usual settings,
check that:
– the working electrodes are clean,
– all plug connections are properly in place.
Never lay active electrodes on or next to the patient.
Put down active electrodes that are not needed at any particular
moment, in such a way that they will not touch the patient.
When performing operations in which the patient must unavoidably be
brought into constant contact with electrodes (e.g., endoscopic surgery), immediately switch off the HF device at the power OFF/ON
switch 12 in the event that the electrode is activated accidentally.
Do not remove hot electrodes from the patient’s body immediately
after performing cutting or coagulation procedures.
During operation of the generator, do not touch the electrodes on the
instrument (on the upper and lower side) as the electrodes can heat up
and this may lead to burns or injuries.
Designation
Art. no.
High frequency surgical device
GN200
Instructions for use
TA022377
Notes on Electromagnetic Compatibility
TA022130
2.2
Ŷ
Ŷ
Ŷ
Components required for operation
Power cord
Foot switch (optional)
Lektrafuse Instrument
2.3
Intended use
The Lektrafuse HF generator GN200 is used for vessel sealing and vessel
separation 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 sterilization/
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 for operation and storage in
closed spaces.
2.4
Operating principle
The Lektrafuse HF generator GN200 works on a micro-processor controlled basis and converts the voltage of the mains supply into a high-frequency 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, the button on
the front of the device or a foot switch.
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Aesculap®
Lektrafuse HF Generator GN200
2.5
Acoustic warning signal
Status
Acoustic warning signal
System error message
3 repetitions of: 1 long beep 3 KHz, 1 beep 2 KHz Following each system error, if identified (E001,...)
REGRASP error
3 repetitions of: 1 beep 2 KHz,
1 beep 3 KHz
Following each regrasp error, if identified
System failure report
3 beeps, 3 KHz
Following each failure report, if identified (E001,...)
System warning
3 beeps, 3 KHz
Following each warning, if identified (W001,...)
Start HF discharge
2 beeps, 480 Hz
When starting the HF discharge
HF discharge active
Repeating beep 480 Hz
Continually during HF discharge
HF discharge ended
3 beeps, 530 Hz
When a sealing process has been successfully complete (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
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 hardware 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 device 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.
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Notes
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2.7
Adaptation curves
Representation of the output voltage as a function of the load resistance.
3.
Preparation and setup
Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap.
Ź When 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 immediately.
Ź Connect 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.
Fig. 2
Adaptation curve Caiman 12 mm Seal & Cut instrument family
Note
The potential equalization lead can be ordered from the manufacturer as
art. no. GK535 (4 m length) or TA008205 (0.8 m length).
Ź In order to ensure sufficient ventilation and cooling of the HF device,
leave at least 10 cm to 15 cm of space around the HF device.
3.1
First use
WARNING
Fig. 3
Adaptation curve Caiman 5 mm Seal & Cut instrument family
2.8
Maximum peak output voltage (Up)
Risk of injury and/or product malfunction due to
incorrect operation of the electromedical system!
Ź Adhere to the instructions for use of any medical device.
Note
The following data allow the user to judge whether the HF device GN200 is
suitable for a given accessory (insulation rating).
WARNING
Risk of injury to patient or user caused by inadequate accessories (insulation rating)!
Ź Make certain that the accessory voltage rating
specified in the product documentation is
higher than maximum peak output voltage.
Maximum peak output voltage (Up) 200 V
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Aesculap®
Lektrafuse HF Generator GN200
4.
Working with the Lektrafuse HF Generator GN200
4.1
System set-up
Connecting the accessories
DANGER
Risk of injury due to unapproved configuration
using additional components!
Ź For all applied components, ensure that their
classification matches that of the application
component (e.g. Type BF or Type CF) of the
respective device.
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 performance and safety characteristics of the products.
Only CAIMAN instruments can be used in conjunction with the Lektrafuse
HF generator GN200, see Accessories/Spare parts.
Switching on the device
Ź Switch on the device with the power OFF/ON switch 12.
Indicator lamp power ON 9 is illuminated. The device performs a selftest, see Continuous test cycle during operation:
If no instruments are connected, there message "Attach Instrument"
appears in the display 5 after the self-test. If the self-test fails, an error
message is shown in the display 5.
Fig. 4
Connecting the foot control
Connecting the foot switch GN201 is optional.
Both the foot switch plug and connection socket (foot switch) 3 carry a
dot marking. To connect the plug to the connection socket correctly, these
markings must be aligned.
Connecting the power supply
DANGER
Risk of fatal injury from electric shock!
Ź Connect the product only to a grounded power
supply.
Ź Set up the device in such a way that switching
it off using the power OFF/ON switch is possible
and straightforward.
Ź Set up the device in such a way that a separation from the network cable is straightforwardly
possible.
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.
Ź Ensure that the device is switched off. Also switch off with the power
OFF/ON switch 12.
Ź Plug the power cord into the socket 13 at the back of the device.
Ź Plug in the mains plug at a socket of the building mains.
Fig. 5
Ź Adjust the foot switch plug and insert it into the foot switch connec-
tion socket 3 until it engages.
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When the device and the foot switch have been successfully connected, the message "Footswitch attached" appears for 3 seconds in
the display 5.
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 carries an arrow marking and the connection
socket 8 carries a dot marking. To connect the plug to the connection
socket correctly, these markings must be aligned.
Fig. 6
Note
Do not activate the foot switch continually during HF discharge. HF discharge is started and stopped by pressing once on the foot switch and then
letting go.
Remove the foot switch
Ź Turn the dwell ring counter-clockwise and withdraw the connecting
plug at the same time
The message "Footswitch removed" appears in the display 5 for 3 seconds.
Fig. 7
Fig. 8
Ź Connect the instrument with the connection socket 8.
The green signal ring 7 around the instrument connector lights up. The
message "Ready to Seal" appears in the display 5.
Fig. 9
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Aesculap®
Lektrafuse HF Generator GN200
Decommissioning
To activate/deactivate device
Ź Switch off the device with the power OFF/ON switch 12.
Ź Switch on/switch off the device with the power OFF/ON switch 12.
All the poles of the device are disconnected from the power supply.
Ź Withdraw power cord
The device is completely disconnected from the power supply.
4.2
WARNING
Risk of injury and/or malfunction!
Ź Always carry out a function check prior to using
the product.
Risk of injury when using the product beyond the
field of view!
Ź Apply the product only under visual control.
Ź Start the sealing process (HF discharge) by pressing the button on the
instrument, the foot switch or the HF activation button (RF on/off) 2
on the front of the device once.
After completing the sealing process, the HF discharge is automatically
stopped.
During HF sealing, the message "Sealing in Progress" is shown on the
display 5.
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Activating the HF current
Ź Be sure that the patient is prepared in such a way that the HF unit can
be applied without any risk to the patient.
Ź Ensure that the instrument and foot switch, if used, are correctly con-
nected.
Ź Activate the HF device via the hand switch, foot switch or HF activa-
tion button (RF on/off) 2 on the front of the device.
Note
Do not activate the foot switch or button continually during HF discharge.
The vessel sealing process is started and ended by pressing the foot switch
or the HF activation button (RF on/off) 2 on the front of the device or button on the instrument once. After completing the sealing process, the
device stops the HF discharge automatically. The sealing process can be
interrupted by repeatedly pressing the button.
Safe operation
WARNING
Fig. 10
The Lektrafuse HF generator GN200 automatically recognizes the connected instrument. The internal device settings are loaded. It is not necessary/possible for the user to set the operating mode or the parameters.
Function checks
Prior to each use, carry out a functional test of the device:
Ź Check that the accessories have no visible damage.
Ź Prepare and set up the unit, see Preparation and setup.
Ź Check 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
9 lights up
– Automatic self-test after each time the device is switched on: brief
acoustic signal, all display elements light up briefly
– Foot control, see Connecting the foot control
– Instrument, see Connecting the instrument
– Activation with RF on/off 2 on the front of the device, button on
the instrument and foot switch
– Switch off the the power OFF/ON switch 12
4.3
Operating mode
5.
Validated reprocessing procedure
5.1
Preparation before cleaning
Ź Keep the product separate from the power supply.
Ź Remove accessories.
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5.2
Cleaning/disinfection
Product-specific safety instructions for the reprocessing procedure
DANGER
CAUTION
Risk of electric shock and fire hazard!
Ź Unplug the device before cleaning.
Ź Do not use flammable or explosive cleaning or
disinfecting solutions.
Ź Ensure that no fluids will penetrate the product.
CAUTION
CAUTION
Damage to, or destruction of the product caused by
mechanical cleaning/disinfection!
Ź Only clean and disinfect the product manually.
Ź Do not sterilize the product under any circumstances.
Damage to the product due to inappropriate cleaning/disinfecting agents!
Ź Only use cleaning/disinfecting agents approved
for surface cleaning. Follow the manufacturer’s
instructions for the respective cleaning/disinfecting agent.
Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures!
Ź Use cleaning agents and disinfectants according
to the manufacturer's instructions.
Ź Observe specifications regarding concentration,
temperature and exposure time.
Validated cleaning and disinfection procedure
Note
Reprocessing may only take place in accordance with the following listed
procedures in version V6. These are documented in the Validated Reprocessing Procedures brochure (AVA-V6). You can also find this brochure in
the Aesculap extranet at www.extranet.bbraun.com
Validated procedure
Special features
Reference
Wipe disinfection for electrical
devices without sterilization
–
Chapter Wipe disinfection for electrical devices
without sterilization
5.3
Inspection, maintenance and checks
Ź Inspect the product after each cleaning and disinfecting cycle to be
sure it is: clean, functional, and undamaged.
Ź Set aside the product if it is damaged.
Ź Perform a safety inspection annually, see Maintenance.
5.4
6.
Maintenance
No servicing is required for the Lektrafuse HF generator GN200.
Note
Maintenance must only be carried out by authorized personnel. If necessary, the circuit diagrams and the service manual, which contains all the
necessary documents, are provided for this.
Storage and transport
CAUTION
Damage to the product caused by switch-on to
early after storage/transport at temperature below
+10 °C (50° F)!
Ź Allow the HF device to acclimate at room temperature for about 1 hour.
Ź Transport the product only in its original box.
Ź For storage and transport conditions, see Ambient conditions.
6.1
Safety inspection
A safety inspection must be carried out annually.
The person in charge of the inspection will document the inspection findings and measurement values according to the printed inspection protocol.
Ź Only have the product and its accessories inspected by persons who
possess the requisite training, knowledge and experience and who are
authorized to do so.
Ź If 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.
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Aesculap®
Lektrafuse HF Generator GN200
Inspection protocol – safety inspection
TEST INTERVAL:
TYPE OF DEVICE:
MANUFACTURED BY:
1 Year
Bipolar Electrosurgical Unit GN200
Aesculap AG, Am Aesculap-Platz 78532 Tuttlingen/Germany
RESPONSIBLE
SN: ............................... INVENTORY NO.: ............................... ORGANIZATION: ..........................................................................
SCOPE OF INSPECTION
Verdict
1.) VISUAL INSPECTION
1.1
1.2
1.3
1.4
1.5
2.2
2.3
2.4
2.5
2.6
2.7
Protective earth resistance incl. mains cable
N.C.
S.F.C.
N.C.
S.F.C.
N.C.
S.F.C.
according IEC60601-1*
Enclosure leakage current/touch current
according IEC60601-1*
Patient leakage current
according IEC60601-1*
Equipment leakage current - alternative method
2.10
Verdict
Pass / Fail
Applied part leakage current - alternative method
Imax = 0,05 mA
according IEC62353:2007
HF-leakage current bipolar
Imax = 122 mA
Insulation resistance
2.8.1 Mains against HF output
2.8.2 Mains against housing
2.8.3 HF-output against housing
HF-output power measurement with induction-free resistor
Instrument
Channel
RLoad
C5
1
50 :
C24/44
1
50 :
2
50 :
DC resistance between the two HF output poles
according IEC60601-2-2:2009 section 201.8.4.102
2.11 Function test according to instructions for use
Place/Date
Inspector/Signature
Imax = 0,50 mA
Imax = 1,00 mA
Imax = 0,10 mA
Imax = 0,50 mA
Imax = 0,01 mA
Imax = 0,05 mA
Imax = 1,00 mA
according IEC62353:2007
according IEC62353:2007 (Preparation according Service Manual)
2.9
Measured value
Rmax= 0,3 : (at t 0,2 A)
according IEC62353:2007
Earth leakage current
according IEC60601-2-2:2009
2.8
FAIL
Inspection of power cable for visually detectable damage
Inspection of foot switch for visually detectable damage
Type plate still present and readable
Check fuse links for prescribed values
Overall condition of device: dirt, damage
2.) ELEKTRICAL INSPECTION
2.1
PASS
test voltage = 500 V DC
Rmin = 7 M:
Rmin = 2 M:
Rmin = 2 M:
Rated value
150 Watt r 20 %
150 Watt r 20 %
150 Watt r 20 %
Rmin = 2 M:
Performed:
Responsible Organization
* The listed allowable values comply with the requirements of the IEC60601-1:1988+A1:1991+A2:1995 and IEC60601-1:2005
Fig. 11 Inspection protocol form Safety inspection
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7.
Troubleshooting list
7.1
Regrasp error
A regrasp error, i.e. potentially insufficient sealing of the vessels, is displayed as follows:
Ŷ clear sound sequence and interruption of the sound sequence of HF
operation
Ŷ The yellow regrasp error light 4 on the front side of the HF device lights
up
Ŷ Warning message in the display 5 on the front side of the HF device
Regrasp error message
significance
Remedy
REGRASP INDICATOR – OPEN
Visually check seal – Manually cut
- Clean jaws
OR
Regrasp thicker tissue
The vessel seal must be checked. 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 the 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 operating area
REGRASP INDICATOR – TIME
Visually check seal – Reseal as needed
Seal cycle interrupted
Seal endpoint not reached
HF device 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
Procedure if a regrasp error occurs:
Ź Do not detach the vessel.
Ź Open the instrument.
Ź Check the sealed vessel.
When correct hemostasis has occurred:
Ź Detach the vessel manually with surgical scissors.
When hemostasis has not occurred in the correct way:
Ź Lay the instrument on the vessel again and lock it in place.
Note
The regrasp error must not be confirmed. The activation of the hand switch,
foot switch or HF activation button (RF on/off) button 2 directly starts the
next sealing process.
Ź Start the additional HF cycle.
Ź If the additional HF cycle leads to a normal seal, the vessel can be
detached, and the instrument can be opened and removed.
Ź If a regrasp error occurs again, do not detach the vessel, open the
instrument and manually detach the sealed vessel with surgical scissors. When so doing, ensure that the hemostasis is correct.
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Aesculap®
Lektrafuse HF Generator GN200
7.2
Warnings
A warning is indicated as follows:
Ŷ Individual tone (different from a failure, an error or normal HF operation)
Ŷ Warning message in the display 5 on the front side of the HF device
Warning message
significance
Remedy
Generator Cooling
Please Wait
Excess generator temperature
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
7.3
Failure reports
A failure is indicated as follows:
Ŷ clear tone sequence (different from n error or normal HF operation)
Ŷ Failure message in the display 5 on the front side of the HF device
Failure code
Failure report
significance
Remedy
E001
ERROR E001
Instrument RF-ON Button Error
Release Instrument RF-ON Button
Remove and reattach instrument
"HF activation (RF-on/off) 2" instrument
switch pressed while the instrument is
connected to the HF device
Release the "HF activation (RF on/off) instrument switch 2".
Remove instrument and reconnect it
E002
ERROR E002
Instrument Error
Remove and reattach instrument
- or Remove and replace instrument
HF device 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 device
Release foot switch
Remove foot switch and reconnect it
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7.4
Error messages
An error is indicated as follows:
Ŷ clear sound sequence (as necessary, may interrupt the sound of the HF
discharge)
Ŷ The red error light 6 on the front side of the HF device lights up
Ŷ Error report in the display 5 on the front side of the HF device
Note
If the error occurs during HF discharge, the vessel sealing may be incomplete or insufficient.
In order to ensure that sufficient hemostasis has been achieved, follow the
procedure for regrasp errors, see Regrasp error.
Note
If the error continues after turning the device off and on again twice, contact your national B. Braun/Aesculap agency, see Technical Service.
Error code
Cause
Remedy
F001
Software error on the HF device
Switch off HF device, wait 5 s, switch HF device on
F002
Dosage error of HF device
Switch off HF device, wait 5 s, switch HF device on
F003
Hardware error
Switch off HF device, wait 5 s, switch HF device on
F004
Internal communication error of the HF device
Switch off HF device, wait 5 s, switch HF device on
F005
Overheating of HF device
Switch off HF device and leave to cool
Check the air stream around the generator
F006
Error on the RF on/off button 2 (activated when switching on)
Switch off HF device, wait 5 s, release RF on/off button 2,
switch on HF device
F007
Error with HF energy output
Switch off HF device, wait 5 s, switch HF device on
F008
Fault: HF outside the calibration
Switch off HF device, wait 5 s, switch HF device on
F009
Fault: Internal power supply
Switch off HF device, wait 5 s, switch HF device on
7.5
Problem solving
Finding
Remedy
HF device does not switch on
Ensure that the power cord has been correctly plugged into the power supply 13 of the HF
device.
Ensure that the power cord is connected to a functioning power source.
Ensure that the power OFF/ONN switch 12 of the HF device 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 current is switched on, but no displays are illumi- Switch off HF device, wait 5 s, and switch HF device on again.
nated and the self-test is not being carried out
If the error continues, contact your national B. Braun/Aesculap agency, see Technical Service.
Self-test fails
Switch off HF device, wait 5 s, and switch HF device on again.
If the error continues, contact your national B. Braun/Aesculap agency, see Technical Service.
HF device is active ("power ON signal lamp 9" light
up), and accessories are connected, but there is not 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 1 is lit up).
In order to start the HF discharge, activate the "RF on/off" button 2.
If the error continues, replace Lektrafuse instrument.
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Page 18
Aesculap®
Lektrafuse HF Generator GN200
7.6
User maintenance
8.
Technical Service
Ź For errors and failures, following the instructions in the display and
note the error code.
Risk of injury and/or malfunction!
Ź Do not modify the product.
Ź If the error continues after following the instructions in the display,
contact your national B. Braun/Aesculap agency, see Technical Service.
WARNING
Ź For service and repairs, please contact your national B. Braun/
7.7
Fuse replacement
Risk of fatal injury from electric shock!
Ź Unplug the device before changing the fuses!
DANGER
Specified fuses: 2 units Aesculap art. no. TA021404:
G fuse link, time lag (T) 8 A, breaking capacity H (1 500 A)
Ź Use a small screwdriver to release the clip on the fuse holder 11 and
tilt up cover.
Ź Use a small screwdriver to release the fuse holder 11 and pull it out.
Ź Replace both fuses.
Ź Reinsert the fuse holder 11.
Ź Close the cover.
Fig. 12
Note
If the fuses burn out frequently, the device is faulty and should be
repaired, see Technical Service.
Aesculapagency.
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:
+49 (7461) 95 -1601
Fax:
+49 (7461) 14 -939
E-Mail:
ats@aesculap.de
Or in the US:
Aesculap Inc.
Attn. Aesculap Technical Services
615 Lambert Pointe Drive
Hazelwood
MO, 63042 USA
Aesculap Repair Hotline
Phone:
+1 (800) 214 -3392
Fax:
+1 (314) 895 -4420
Other service addresses can be obtained from the address indicated above.
9.
Accessories/Spare parts
Art. no.
Designation
TA021404
Fuse
PL720SU
Instrument Caiman 5
PL730SU
Instrument Caiman 12
PL731SU
Instrument Caiman 12 plus
GN201
Foot switch
Note
Other accessories, applied parts and replacement parts are described in
Aesculap brochure C-304-81 and C-902-02
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Page 19
10. Technical data
10.1 Ambient conditions
Operation
Classification acc. to Directive 93/42/EEC
Art.
no.
Designation
Class
GN200
High frequency surgical device
IIb
Storage and transport
Temperature
50
-10
Relative
humidity
Mains voltage ranges
(Current intake)
100V~–240 V~ (6.7 A–2.8 A)
Frequency
50–60 Hz
Protection class (acc. to
IEC / DIN EN 60601-1)
I
Foot switch circuit
ignition-safe acc. to IEC/DIN EN 60601,
approved for use in “medical environment”
Output power
2 x 150 W on 50 Ohm
Device protection
Time-Current characteristic
Breaking capacity
Construction
T8 AH/250 V
T (Time lag)
H (1 500 A)
5 mm x 20 mm
HF operating frequency
460 kHz ± 1 %, Quasi-Sinus
Operating mode
Int 10 s/30 s
Weight
8.1 kg
Dimensions (L x W x H)
400 mm x 355 mm x 100 mm
Application part type acc.
to IEC/DIN 60601-1
CF
Recovery time of the defibrillation-protected output
0 seconds
CISPR11
Class A
EMC
IEC/DIN EN 60601-1-2
Conforming to standard
IEC/DIN EN 60601-1
IEC/DIN EN 60601-2-2
90
10
non-condensing
non-condensing
Atmospheric
pressure
Note
The atmospheric pressure of 700 hPa corresponds to a maximum operating
altitude of 3,000 m.
Note
After transporting or storing at temperature outside the operating temperature range, leave the HF device for one hour before use so that it can reach
room temperature.
11. Disposal
Note
The user institution is obliged to process the product before its disposal, see
Validated reprocessing procedure.
Adhere to national regulations when disposing of or recycling the product, its components and its packaging!
The recycling pass can be downloaded from the Extranet
as a PDF document under the respective article number.
(The recycling pass includes disassembling instructions for
the product, as well as information for proper disposal of
components harmful to the environment.)
Products carrying this symbol are subject to separate collection of electrical and electronic devices. Within the
European Union, disposal is taken care of by the manufacturer as a free-of-charge service.
Ź Detailed information concerning the disposal of the product is avail-
able through your national B. Braun/Aesculap agency, see Technical
Service.
12. Distributor in the US/Contact in Canada
for product information and complaints
3773 Corporate Parkway
Center Valley, PA, 18034,
USA
17