Lektrafuse HF GN200 Instructions for Use ver 2.0 and higher

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 5.5 5.6 5.7 5.8 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 Output power diagrams 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 General safety instructions General information Preparations at the place of use Preparation before cleaning Cleaning/disinfection Wipe disinfection for electrical devices without sterilization Inspection, maintenance and checks Storage and transport Maintenance Safety inspection Troubleshooting list Regrasp error Warnings Error reports Failure 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 12 12 12 12 12 14 14 15 15 16 16 17 17 17 18 18 19 19

Safe handling

CAUTION Federal law restricts this device to sale by or on order of a physician! Note The present instructions for use only describe the layout, function and operation of the Lektrafuse HF generator GN200 and are not suitable for instructing a beginner in high-frequency electrosurgery. 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 described 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! ► The product and accessories should only be operated by qualified or trained and experienced personnel.

► Transport the product only in its original box. ► Prior to use, check that the product is in good working order. ► Observe “Notes on Electromagnetic Compatibility (EMC)“, see

TA022130. ► The Lektrafuse HF generator GN200 fulfills the requirements of CISPR 11, Class A. ► 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. ► Inspect the accessories regularly: Electrode cables and endoscopic accessories, in particular, must be checked for possible damage to the insulation. ► Keep the instructions for use accessible for the user. ► Always adhere to applicable standards.

19

3

Aesculap® Lektrafuse HF Generator GN200

1.1

Safe for use in conformance with IEC regulations

Patient safety

The operating environment

DANGER

WARNING

CAUTION

CAUTION

Risk of death by electric shock! ► Do not open the product. ► Only ever connect the product to power mains with equipment grounding conductor. Danger of injury from burns and/or explosion from flammable gases! Sparks can occur even if the HF surgical device is used properly and according to its intended use. ► Do not use the device in explosion-hazard zones. ► When operating in the head or thoracic region, avoid using combustible anesthetics and accelerating gases (e.g. nitrous oxide or oxygen) or, when using such substances, ensure they are extracted from the region of operation. ► If possible, use incombustible cleaning and disinfecting agents. ► If combustible cleaning and disinfecting agents or solvents have to be used: Verify that such agents have evaporated prior to commencing HF surgery. ► Ensure that no combustible fluids accumulate under the patient or in body cavities (e.g. the vagina). Wipe off all fluids before using the HF surgical device. ► Ensure the absence of any endogenous, combustible gases. ► Check that oxygen-soaked materials (e.g. absorbent cotton or mull) are kept at a safe distance from the HF field, so that they cannot ignite. Risk of interference with other devices! Even during normal use, the HF surgical device creates electromagnetic fields that can interfere with other devices. ► Check that no electronic devices that could be subject to interference by electromagnetic fields are set up in the vicinity of the HF surgical device. Restriction to view and/or side-effects due to the development of steam/smoke during HF surgery! ► If necessary, use smoke suction.

► Ensure that the device does not come in direct contact with the patient

or in the sterile area respectively. ► Ensure that the user does not come into direct contact with the patient

and the HF device at the same time. 4

DANGER

DANGER

Danger due to inadequate preparation or faults in the HF surgical device! ► Check that the HF surgical device is in perfect working order. ► Ensure that neither the foot switch nor the hand switch has been penetrated by conductive fluids (e.g. blood, amniotic fluid). ► Ensure there is no short circuit in the foot or hand switch cables. Risk of burns suffered by the patient due to inadvertent activation of the HF surgical device! ► In case of any inadvertent activation of the HF surgical device, switch off the device immediately at the OFF/ON switch. ► Always exercise particular care when operating the foot switch.

DANGER

Risk of injury to the patient due to uncontrolled rise of the HF output voltage due to some fault in the HF surgical device! ► Stop 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 connections! ► Check the mains power cord/protective ground connections.

WARNING

Danger of injuries due to muscle contraction, caused by stimulation of the nerves and muscles! ► Work with particular care on sensitive structures.

Always be sure to do the following:

2.

Product description

2.1

Scope of supply

► 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. ► Ensure that the patient will not be in contact with any damp cloths, drapes or bedding. ► Safeguard 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. ► Siphon off urine with a catheter. ► For open heart surgery, ground the HF surgical device via potential equalization. ► 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 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. ► 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. ► For operations involving unavoidable, continuous contact between the electrodes and the patient (e.g. endoscopic procedures), press the OFF/ ON switch 12 at the HF surgical device immediately after any inadvertent activation of the electrode. ► 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 or 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

■ Power cord ■ Foot switch (optional) ■ Caiman 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 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 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 (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 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

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

Output power diagrams

Representation of the output power 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. ► 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. ► 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

Output power diagram Caiman 12 mm Seal & Cut instrument family

Note The potential equalization lead can be ordered from the manufacturer as article no. GK535 (4 m length) or TA008205 (0.8 m length). ► 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

Output power diagram 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! ► Adhere to the instructions for use of any medical device.

Note The following data allow the user to determine 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)! ► 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! ► 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 ► 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, the 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 have a dot marking. To connect the plug to the connection socket correctly, these markings must be aligned.

Connecting the power supply

DANGER

Risk of death by electric shock! ► Only ever connect the product to power mains with equipment grounding conductor. ► Set up the device in such a way that switching it off using the power OFF/ON switch is possible and straightforward. ► Set up the device in such a way that disconnecting the power cord 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. ► Ensure that the device is switched off. Also switch off with the power OFF/ON switch 12. ► Plug in the power cord in mains power input socket 13 in the rear panel of the HF surgical device. ► Plug in the mains plug at the building mains power socket. Fig. 5 ► Align the foot switch plug and insert it into the foot switch connection

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 has an arrow marking and the connection socket 8 has 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 releasing. Remove the foot switch ► Turn the locking 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 ► 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

► Switch off the device with the power OFF/ON switch 12.

► 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. ► Disconnect power cord

The device is completely disconnected from the power supply.

4.2

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: ► Check that the accessories have no visible damage. ► Prepare and set up the unit, see Preparation and setup. ► 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

Activating the HF current ► Be sure that the patient is prepared in such a way that the HF unit can

be applied without any risk to the patient. ► Ensure that the instrument and foot switch, if used, are correctly con-

nected. ► 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

5.

Validated reprocessing procedure

WARNING

Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product.

5.1

General safety instructions

WARNING

Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control.

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing.

► 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.

Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible 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 processing method is first validated. The operator/sterile processing technician is responsible for this. The recommended chemistry was used for validation.

Fig. 10

10

Note If there is no final sterilization, then a virucidal disinfectant must be used.

5.4

Note For the latest information on reprocessing and material compatibility see also the Aesculap extranet at www.extranet.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

► Remove accessories.

5.2

► Disconnect the unit from mains power.

5.5

Cleaning/disinfection

Product-specific safety instructions for the reprocessing procedure

DANGER

Risk of electric shock and fire hazard! ► Unplug the device before cleaning. ► Do not use flammable or explosive cleaning or disinfecting solutions. ► Ensure that no fluids will penetrate the product.

CAUTION

Damage to, or destruction of the product caused by mechanical cleaning/disinfection! ► Only clean and disinfect the product manually. ► Do not sterilize the product under any circumstances.

CAUTION

Damage to the product due to inappropriate cleaning/disinfecting agents! ► Only use cleaning/disinfecting agents approved for surface cleaning. Follow the manufacturer’s instructions for the respective cleaning/disinfecting agent.

General information

Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the time interval between application and processing should not exceed 6 h; also, neither fixating precleaning 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, medicines, saline solutions and in the service water used for cleaning, disinfection and sterilization will cause corrosion damage (pitting, stress corrosion) and result in the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water and then drying. 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: ■ Optical 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. ■ Material damage such as corrosion, cracks, fracturing, premature aging or swelling. ► Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.

5.3

Preparation before cleaning

CAUTION

Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning agents and disinfectants according to the manufacturer's instructions. ► Observe specifications regarding concentration, temperature and exposure time.

Preparations at the place of use

► Remove any visible surgical residues to the extent possible with a

damp, lint-free cloth. ► Transport the dry product in a sealed waste container for cleaning and

disinfection within 6 hours.

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Aesculap® Lektrafuse HF Generator GN200

Validated cleaning and disinfection procedure Validated procedure

Special features

Reference

Wipe disinfection for electrical devices without sterilization

–

Chapter Wipe disinfection for electrical devices without sterilization

5.6

Wipe disinfection for electrical devices without sterilization

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Wipe disinfection

RT

≥1

-

-

Meliseptol HBV wipes 50 % Propan-1-ol

RT:

Room temperature

6.

Phase I ► Remove any visible residues with a disposable disinfectant wipe. ► Wipe all surfaces of the optically clean product with a fresh, disposable

disinfectant wipe. ► Observe the specified application time (1 min minimum).

5.7

Inspection, maintenance and checks

► Inspect the product after each cleaning and disinfecting cycle to be

sure it is: clean, functional, and undamaged. ► Set aside the product if it is damaged. ► Perform a safety inspection annually, see Maintenance.

5.8

Storage and transport

CAUTION

Damage to the product caused by switch-on too early after storage/transport at temperature below +10 °C (50 °F)! ► Allow the HF device to acclimate at room temperature for about 1 hour.

► Transport the product only in its original box. ► For storage and transport conditions, see Ambient conditions.

12

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.

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. ► 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. ► 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.

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.

Earth leakage current 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

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.) ELECTRICAL INSPECTION 2.1

PASS

test voltage = 500 V DC

Rmin = 7 M: Rmin = 2 M: Rmin = 2 M: Rated value 145 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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Aesculap® Lektrafuse HF Generator GN200

7.

Troubleshooting list

7.1

Regrasp error

A regrasp error, i.e. potentially insufficient sealing of the vessels, is displayed as follows: ■ Clear sound sequence and interruption of the sound sequence of HF operation, also halts the HF discharge ■ The yellow regrasp error light 4 on the front side of the HF device flashes ■ 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 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 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: ► Do not cut the vessel. ► Open the instrument. ► Check the sealed vessel. When correct hemostasis has occurred: ► Cut the vessel manually with surgical scissors. When hemostasis has not occurred in the correct way: ► Place 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. ► Start the additional HF cycle. ► If the additional HF cycle leads to a normal seal, the vessel can be cut,

and the instrument can be opened and removed. ► If a regrasp error occurs again, do not cut the vessel, open the instrument and manually cut the sealed vessel with surgical scissors. When so doing, ensure that the hemostasis is correct.

14

7.2

Warnings

A warning is indicated as follows: ■ Individual tone (different from a failure, an error or normal HF operation) ■ 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

Error reports

An error is indicated as follows: ■ Clear tone sequence (different from a failure or normal HF operation) ■ Error message in the display 5 on the front side of the HF device Error code

Error 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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Aesculap® Lektrafuse HF Generator GN200

7.4

Failure messages

A failure is indicated as follows: ■ Clear sound sequence (as necessary, may interrupt the sound of the HF discharge) ■ The red error light 6 on the front side of the HF device flashes ■ Failure report in the display 5 on the front side of the HF device

Note If the failure 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 failure continues after turning the device off and on again twice, contact your national B. Braun/Aesculap agency, see Technical Service.

Failure 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 device is switched on, but no displays are illuminated and the self-test is not being carried out

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.

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.

16

7.6

User maintenance

8.

Technical Service

► In case of error, follow the instructions in the display and note the error

code.

Risk of injury and/or malfunction! ► Do not modify the product.

► If the error continues after following the instructions in the display,

contact your national B. Braun/Aesculap agency, see Technical Service.

WARNING ► For service and repairs, please contact your national B. Braun/Aesculap

7.7

Fuse replacement Risk of fatal injury from electric shock! ► 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) ► Use a small screwdriver to release the clip on the fuse holder 11 and tilt up cover. ► Use a small screwdriver to release the fuse holder 11 and pull it out. ► Replace both fuses. ► Reinsert the fuse holder 11. ► Close the cover.

Fig. 12

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: +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.

Note If the fuses burn out frequently, the device is faulty and should be repaired, see Technical Service.

17

Aesculap® Lektrafuse HF Generator GN200

9.

Accessories/Spare parts

10. Technical data

Art. no.

Designation

Classification acc. to Directive 93/42/EEC

TA021404

Fuse

Designation

Class

PL720SU

Instrument Caiman 5

Art. no.

PL730SU

Instrument Caiman 12

GN200

High frequency surgical device

IIb

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

18

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

10.1 Ambient conditions Operation

Storage and transport

Temperature

50 -10

Relative humidity

12. Distributor in the US/Contact in Canada for product information and complaints 3773 Corporate Parkway Center Valley, PA, 18034, USA

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. ► Detailed information concerning the disposal of the product is avail-

able through your national B. Braun/Aesculap agency, see Technical Service.

19

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.

Earth leakage current 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

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.) ELECTRICAL INSPECTION 2.1

PASS

test voltage = 500 V DC

Rmin = 7 M: Rmin = 2 M: Rmin = 2 M: Rated value 145 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 Procès-verbal de contrôle technique de sécurité

49

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.

Earth leakage current 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

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.) ELECTRICAL INSPECTION 2.1

PASS

test voltage = 500 V DC

Rmin = 7 M: Rmin = 2 M: Rmin = 2 M: Rated value 145 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 Certificado de revisión Control técnico de seguridad

67