Lektrafuse HF Generator GN200 Instructions for Use

Aesculap® Lektrafuse HF Generator GN200

Legend

Lektrafuse HF Generator Aesculap GN200®

Symbols on product and packages

1 Signal lamp HF-ON (surrounding ring) 2 HF activation button (RF on/off) (center) 3 Connection socket (foot switch) 4 Regrasp signal lamp 5 Display 6 Signal lamp error 7 Signal ring instrument 8 Connection socket (instrument) 9 Indicator 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

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

2

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. 3 4 5 5 5 5 5 6 6 7 7 7 7 8 8 10 10 10 10 11 11 11 11 11 13 13 14 14 15 15 16 16 16 16 17 17 17

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.

17

3

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.

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

metal parts that are grounded or have a significant electric capacity against ground (e.g. operating table, fixtures). If necessary, interpose antistatic drape. Ź Ensure that the patient will not be in contact with any damp cloths, drapes or bedding. Ź 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. Ź Siphon off urine with a catheter. Ź For heart surgery, ground the HF device via the potential equalization connection. Ź 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. Ź 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. Ź Do not use needle electrodes for intraoperative monitoring. Ź Arrange the wires and cables of monitoring devices in such a way that they do not come in contact with the patient’s skin. Ź 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. Ź Should the output power appear insufficient with the usual settings, check that: – the working electrodes are clean, – all plug connections are properly in place. Ź Never lay active electrodes on or next to the patient. Ź Put down active electrodes that are not needed at any particular moment, in such a way that they will not touch the patient. Ź 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. Ź Do not remove hot electrodes from the patient’s body immediately after performing cutting or coagulation procedures. Ź 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

Components required for operation

Ŷ Power cord Ŷ Foot switch (optional) Ŷ 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.

5

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.

6

Notes

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

7

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.

8

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

9

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.

10

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.

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.

11

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

12

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.

13

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

14

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.

15

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: [email protected] 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

16

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