High frequency surgical device GN060

Symbols on product and packaging Follow instructions for use (small white man on a blue background) Icon: Caution

Out put isolated from ground

Defibrillation-protected type CF applied part Foot switch

Potential equalization

Fuse Alternating current Marking of electric and electronic devices according to directive 2002/96/EC (WEEE). see Disposal

Non-ionizing radiation

LOT

Manufacturer’s batch designation

Manufacturer’s serial number

Manufacturer’s article number Date of manufacture

Contents 1. 1.1 2. 2.1 2.2 2.3 2.4 3. 3.1 3.2 3.3 3.4 3.5 4. 4.1 4.2 4.3 4.4 4.5 5. 5.1 5.2 5.3 5.4 5.5 5.6 5.7 6. 6.1 7. 7.1 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 Preparation and setup First use Stacking of units Moving stacks of units Dismantling stacks of devices Presetting the correct voltage Working with the HF surgical device GN060 System set-up Function checks Safe operation Protection against faulty operation Protection against incorrect dosage Validated reprocessing procedure General safety instructions General information Preparation before cleaning Cleaning/disinfection Wipe disinfection for electrical devices without sterilization Inspection, maintenance and checks Storage and transport Maintenance Safety inspection Troubleshooting list Fuse replacement Technical Service Accessories/Spare parts Technical data Ambient conditions Disposal Distributor in the US/Contact in Canada for product information and complaints

4 4 6 6 6 6 6 7 7 7 8 8 8 9 9 9 10 11 12 12 12 13 13 13 14 14 14 14 14 16 17 17 18 18 19 19 19

3

Aesculap® High frequency surgical device GN060

1.

Safe handling

CAUTION Federal law restricts this device to sale by, or on order of a physician!

WARNING

Note These instructions for use only describe the setup, function and operation of the high-frequency surgical device GN060 and is not suitable for introducing a beginner to 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.

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. ► To prevent damage caused by improper setup or operation, and in order

not to compromise warranty and manufacturers liability: – Use the product only in accordance with 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.

1.1

WARNING

Safe for use in conformance with IEC regulations WARNING

The operating environment

DANGER

4

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! ► Select the lowest possible power output. ► 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.

Patient safety

DANGER

DANGER

Always be sure to do the following: Danger to life 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 "Device on/off" switch and pull the mains plug. ► 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 neuromuscular stimulation through HF use, in particular for operation modes that create electric arcs between active electrodes and the tissue! ► Select the lowest possible power output.

► 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. ► 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 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. ► Do not remove hot electrodes from the patient’s body immediately after performing cutting or coagulation procedures. ► Never put down HF instruments or 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. ► Adjust the HF power output according to the intended surgical intervention. taking into account clinical experience and reference parameters. ► Always set the power output of HF devices to as low a level as possible. ► Should the output power appear insufficient with the usual settings, check that: – the working electrodes are clean, – all plug connections are properly in place. ► In operations where continuous contact between the electrodes and the patient cannot be avoided (e.g. endoscopic operations), switch off the HF device immediately on the "Device on/off" switch after an accidental activation. ► Adjust the acoustic warning, which signals the activation of the electrode, to such a level that it will always be heard without difficulty.

5

Aesculap® High frequency surgical device GN060

2.

Product description

2.1

Scope of supply

The device carries out a self-test every time it is switched on. Also during operation and when the HF output is activated, the most important functions are monitored. If disturbances or errors of any kind occur, the device immediately enters the safe operating mode, i.e. the HF generator is deactivated. The disturbances or errors recognized by the microprocessor are shown in the display as an error code, see Troubleshooting list.

Art. no.

High frequency surgical device

GN060

HF output performance charts

Notes on electromagnetic compatibility (EMC)

TA022130

High-frequency surgical device instructions for use GN060

TA021243

In the following two diagrams, see Fig. 1 and see Fig. 2, the power output of the HF device is represented dependent on the dose adjustment and the adjoining load resistance. Pout [W]

Designation

2.2

40

Components required for operation

■ Power cord ■ Foot switch (optional) ■ Bipolar connection cable ■ Bipolar forceps Intended use

The HF device GN060 is used for coagulation in neurosurgery, ENT surgery, urology, gynecology, hand surgery and in plastic reconstruction. The device is approved for use on open heart surgery (type CF).

2.4

Operating principle

The HF device GN060 is a microprocessor-controlled device with corresponding convenience in operation and extensive monitoring functions. It is operated using a cleaning-friendly membrane keyboard. The device can be operated in the voltage ranges of 100 V to 120 V and 220 V to 240 V (+/- 10 %) with 50 Hz up to 60 Hz of mains frequency. For selecting the voltage, see Presetting the correct voltage. There are two operating modes available with an adjusted load characteristic in each case: ■ "Micro" operating mode: maximum 10 watts with approx. 50 ohms ■ "Macro" operating mode: maximum 50 watts with approx. 100 ohms The dose is adjusted with a counter with the buttons "+" and "-". The counting speed is two-level. Through this, the desired dose is adjustable quickly and precisely. The device also has the option of storing four device settings including dose values (empirical values) and of accessing them again at any time, see Store device settings. The stored settings are preserved even in the event of the device being switched off for a longer period of time (approx. 10 years). For activating the HF generator, a foot switch is needed as standard. If the optional automatic starting GN062 is built in, automatic operation can be used. This activates the HF output if, between the two arms of the coagulation forceps, the tissue resistance is below a particular value or if both forceps arms touch (note installation note TA021293 of the automatic starting) 6

Macro

30 20 Micro

10 0 Micro 0 Macro 0

Fig. 1 Pout[W]

2.3

50

2 10

4 20

6 30

8 40

10 50

Output SetƟŶŐ

Power output, dependent on the dose adjustment 50 45 40 35 30 25 20 15 10 5 0

Macro 50

Macro 25

Micro 9,9 Micro 5,0

10

100

1000 RL[ɰ]

Fig. 2

Power output, dependent on the load resistance

3.1

Maximum peak output voltage (up)

WARNING

Risk of injury to patients or users 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 for the intended setting.

Uout [V]

Note The following graph (see Fig. 3) allows the user to judge whether the HF device or its output setting is suitable for a given accessory (insulation rating). 350 Macro

300

First use

WARNING

3.2

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.

Stacking of units

The stacking provisions integrated in the device cover allows secure mounting of an accessory device (such as the JET irrigation unit GN090) on top of the HF device GN060. ► Make certain the system is set up on a sufficiently stable support (e.g. a table, ceiling support, equipment cart, etc.). Stacking products fitted with stacking devices:

250 200 150

Micro

100 50 0 0

10

20

30

40

A

50

C

B

Output SetƟŶŐ

Fig. 3

Maximum peak output voltage (up)

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

Fig. 4

Stacking of units

Legend A Accessory device, e.g. JET irrigation unit GN090 B Locking screw C Stacking cone ► Do not exceed a stack height of 475 mm. ► Remove the caps from stacking cones C. ► Unscrew the feet of the product that will be on top. ► Move stacking cones C to the correct mounting position by applying a screwdriver on locking screw B and turning it counterclockwise to the positive stop. ► Place the upper device on the one below it. ► Securing the device: Turn locking screw B clockwise to the positive stop. ► Slightly lift the units to check that they are safely connected to each other. ► Place the units in a stable position.

7

Aesculap® High frequency surgical device GN060

3.3

Moving stacks of units

► Always lift stacks from underneath the bottommost unit.

3.4

Dismantling stacks of devices

Voltage range

Imprint C

100 V to 120 V (+/- 10 %)

110

220 V to 240 V (+/- 10 %)

230

Dismounting a stack of products fitted with stacking devices:

B

23

A

24 Fig. 5

Dismantling stacks of devices

Legend B Locking screw ► Apply a screwdriver on locking screw B and turn it counterclockwise to the positive stop. ► Remove the topmost device. ► Screw back on the feet of the device, either by hand or using a screwdriver.

3.5

Presetting the correct voltage

The mains voltage must correspond to the voltage indicated on the type plate at the back of the unit. The correct voltage for the control unit is indicated in the window located at the back of the device. The standard voltage for the unit in Europe is: 230 V. Risk of fatal injury from electric shock! ► Unplug the device before replacing the fuse sets. DANGER ► If the indicated voltage does not correspond to the actual mains volt-

age, change the setting at the rear panel of the power unit: – Release clip B using a suitable screwdriver A and remove the fuse holder 25. – Pull out the voltage selection element 24 under the fuse holder. – Reinsert the voltage switching element so that the desired voltage C is legible. – Reinsert the fuse holder 25.

8

C B

25 Fig. 6

Device connection with fuse holder and voltage selection element

Legend 23 Device connector 24 Voltage selection element 25 Fuse holder A Screwdriver B Clip C Voltage switching element imprint

4.

Working with the HF surgical device GN060

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. All configurations must comply with basic standard IEC/DIN EN 60601-1. Any individual connecting devices with one another is responsible for such configuration and must ensure compliance with basic standard IEC/DIN EN 60601-1 or applicable national standards.

DANGER

Risk to life for patients and users due to inadvertent current supply to an instrument! ► Make certain that not more than one patient cable is connected to any output socket.

The insulation of the accessories (e.g. HF cables, instruments) must be adequately rated for the maximum peak output voltage (see IEC/DIN EN 60601-2-2). ► Please contact your B. Braun/Aesculap partner or Aesculap Technical Service (address: see Technical Service) with any inquiries in this respect. 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 disconnecting the power cord is straightforwardly possible.

Note Before operating the device, make certain that the supply voltage marked on the plug of the device matches that of the supply voltage being used. To change the setting, see Presetting the correct voltage.

The HF device GN060 must only be operated with an alternating current from 50 Hz to 60 Hz. The mains voltage must be between 100 V and 120 V or between 220 V and 240 V. The voltage is preselected on the mains voltage connector on the rear side of the device. Insert the power cord only in a properly mounted schuko power socket (for this see VDE 0107). To prepare the device for operation, proceed as follows: ► Connect the HF device to the mains voltage using a power cord (LED 1 illuminates). ► Connect the bipolar cable to the socket 14 or 15. ► Connect foot switch to the socket 16. ► Activate button 3 (LED 1 and LED 2 illuminate). The HF device is ready for operation. Note The isolation of the power cable from the device must also be treated as secure isolation from the mains in the sense of the IEC norm. When aligning the device, ensure that an isolation of the mains plug is possible without any problems.

4.2

Function checks

► Connect the HF device to the mains voltage.

Green LED 1 must illuminate. ► Activate "Device on/off" button 3. LED 2 must illuminate. All LEDs and segments of the display illuminate briefly. For HF devices with the "automatic starting" option: In the display, the "AU" display appears briefly. The HF device is operable based on the basic settings approximately 1 s after activation of the button. The LEDs 5 and 18 illuminate in the display field. In the display, "0.1" must be displayed as a dosage level. ► Press "+" key 10. The dosage level must be able to be increased to 9.9. ► Press "-" key 7. The dosage level must be able to be reduced to 0.1. ► Press key 4. For signaling the "Macro" mode, LED 6 in the display field must illuminate. "01" must be displayed as a dosage level. The dosage level can be set between the limit levels "01" and "50" with the "+" button 10 and the "-" button 7. ► If the "automatic starting" option is built in: Press key 19. The activation type must change. The activation type is displayed with LED 17 or LED 18. ► Check memory function see Store device settings and see Retrieve stored device settings. ► Connect foot switch to the socket 16 and activate. The acoustic and visual operating display 9 must correspond.

9

Aesculap® High frequency surgical device GN060

4.3

Safe operation

WARNING

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

WARNING

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

Switching on the device In order to be able to switch on the HF device it must be connected to the mains voltage. The green LED 1 lights up. ► Press the "Device on/off" button 3 in order to switch on the HF device. The green LED 2 lights up. Directly after switching on the HF device, all symbol LEDs and segments in the display light up for approx. 1 s. For HF devices with the "automatic switching" option, the display "AU" appears in the display briefly. About 1 s after switching on, the HF device has the following basic setting: ■ "Micro" operating mode ■ "Foot switch" activation type ■ Dosage "0.1"

The dosage can also be changed by retrieving a stored device adjustment, see Retrieve stored device settings. Store device settings For storing complete device settings including dosage values (empirical values), there are four memories available. Values that are already present are overwritten in the event of a storage process. ► Press button 20 in order to activate the storage process. LED 11 lights up. ► Press one of the four storage buttons 12 in order to store the current device settings. The LED 13 over the pressed storage button lights up when storage has been carried out successfully. Store operating example to the device settings As an example, in the operating mode "Macro", the dosage level "45" should be stored in the memory "3". ► Be sure that the HF device is in ready for operation. The green LED 1 and LED 2 light up. ► Press the buttons represented in the table consecutively: Button

Message displayed

Symbols lighting up

"01"

"Macro" 6

"01" to "45"

"Macro" 6

"45"

"Macro" 6 and LED 11

"45"

"Macro" 6 and LED 13

Selecting the operating mode ► "Micro-Macro" button 4 - press this button in order to select the oper-

ating mode. The corresponding LED "Micro" 5 or LED "Macro" 6 lights up. The operating mode changes every time the button is activated. For each change of operating mode, the lowest dose is set and shown in the display. Select activation type For HF devices with the "automatic starting" option, the activation type can be selected. ► Press button 19 in order to select the activation type. The corresponding LED 17 or LED 18 lights up. The activation type changes every time the button is activated. Adjust the dosage The dosage can be changed between the minimum and maximum values of the selected operating mode: ► Press "+" button 10 in order to increase the dosage or "-" button 7 in order to reduce the dosage. In the "Micro" operating mode, the value per counting step changes by 0.1, and in the "Macro" operating mode by 1. If the button is kept pressed, the counting frequency increases after the third counting step. The displayed dosage values correspond to the output in watts with nominal load, e.g. if the displayed dosage value "43" corresponds to an output of 32 watts with a load of 100 ohms, see HF output performance charts. 10

Retrieve stored device settings

4.4

Protection against faulty operation

► Press the desired storage button "1-4" 12.

The LED 13 over the pressed storage button lights up when the selection has been made successfully. The stored dosage level and the stored settings are displayed and taken over. The dosage level can be changed, see Adjust the dosage. LED 13 no longer lights up as there is no agreement with the stored value. Activate HF output ► Activate the HF output with the foot switch over the "automatic start-

ing" option with the coagulation forceps. Activation is signaled acoustically with a tone generator. The pitch is different for each operating mode. "Micro" corresponds to 725 Hz, "Macro" 850 Hz. The LED 9 "HF output active" lights up. When activating the HF output, the HF device does not react to operation with the membrane keyboard apart from the "Device on/off" button 3. The HF device can therefore be switched off at any time. Likewise, the activation of the HF output is not possible as long as a membrane key is pressed. Taking the HF device out of service ► Press the "Device on/off" button 3 in order to switch off the HF device.

"Device ready for operation" LED 2 goes out. LED 1 lights up, HF device is still ready for switching on. ► Withdraw mains cable. HF device is completely isolated from the power supply.

Continuous actuation of a key If a membrane key is pressed for longer than 15 s, this is interpreted as permanent contact and therefore as an error. The error code "F2" appears in the display. This prevents, for example, that an object the presses accidentally against an operating button remains unnoticed. The same error report appears if a membrane key is already pressed when the HF device is switched on. While an error code is being displayed, the activation of the HF output is not possible. If the cause of the error is remedied, normal work can then continue. Multiple keys pressed If two or more buttons are pressed at the same time, the error "F1" appears in the display. Locking mechanism In order to prevent unwanted manipulation, no change of the device adjustment is possible while the HF output is active. Conversely, an activation of the HF output is also not possible during the change of device settings. When switching from foot switch to automatic operation and the reverse, the foot switch must be deactivated and the two arms of the forceps must not touch. When switching on the HF device, all membrane keyboards and the foot switch must be disengaged. If these conditions are not observed, the error message "F2" is shown in the display. Normal working or operation of the HF device is only possible after the removal of the conditions causing the error. Permanent activation If the foot switch is activated for more than 30 s, or if a sticky contact or a short circuit in the foot switch or its cable occurs, this is interpreted as an error. Subsequently, the HF output is deactivated and the error message "F3" for permanent activation is shown in the display. When using the automatic starting: If the device is activated for longer than 30 s by the automatic starting, the error message for permanent activation "F3" is also displayed and the HF output is deactivated. The cause of the error message can hereby also be sticky forceps or a defective bipolar cable. If the cause of the error is removed (for example through the disengaging of the foot switch), normal work can continue. Activating the "Preparing for storage" button If the "Preparing for storage" button 20 is pressed accidentally, the HF output can not be activated. There are three ways of returning to the normal operating mode: ■ Storing device settings in a memory. ■ Pressing the "Preparing for storage" button again 20. ■ After approx. 10 s, the HF device automatically returns to the normal operating mode. 11

Aesculap® High frequency surgical device GN060

4.5

Protection against incorrect dosage

5.

Validated reprocessing procedure

5.1

General safety instructions

Self-test of the microprocessor As faultless function of the microprocessor is a requirement for flawless work with the HF device and all control and monitoring functions, a socalled self-test is carried out after every time the HF device is switched on. This test comprises a CPU, RAM, EPROM and watchdog test. Monitoring the program process In order to monitor the correct temporal program process, the HF device has a watchdog timer that must be triggered during the normal course of the program at regular intervals. If the trigger signal stays off for longer than 10 ms, the activation of the HF output is blocked via an independent piece of control hardware. Monitoring the dosage While the HF output is activated, the actual values of the parameters decisive for the applied power are (voltage and duty cycle) are recorded on an ongoing basis and compared with corresponding target values. If an error is recognized in the comparison of these values, the HF output is immediately blocked via several channels. Dependent on the respectively recognized error, the corresponding error code is shown in the display. Continued work is then possible only after the HF device has been switched off and back on again.

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing. 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. Note If there is no final sterilization, then a virucidal disinfectant must be used.

Monitoring the RAM values The target values entered via the membrane keyboard (dosage, operating and activation type) are stored in duplicate in the RAM memory and checked on an ongoing basis. Within this, the corresponding values must be the same and be in the approved value range. Monitoring the storage values The target values belonging to the stored dosage values (dosage and operating type) are stored in duplicate in a non-volatile memory (EEPROM) and checked upon memory retrieval. Within this, the corresponding values must be the same and be in the approved value range.

12

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.

5.2

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

5.4

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 and/or excessive temperatures! ► Only use cleaning/disinfecting agents approved for surface cleaning. Follow the manufacturer’s instructions for the respective cleaning/disinfecting agent. ► Observe specifications regarding concentration, temperature and exposure time.

Validated cleaning and disinfection procedure Validated procedure

Special features

Wipe disinfection for – electrical devices without sterilization

Reference Chapter Wipe disinfection for electrical devices without sterilization

Preparation before cleaning

► Keep the product separate from the power supply ► Remove accessories

13

Aesculap® High frequency surgical device GN060

5.5

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).

5.6

Inspection, maintenance and checks

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

sure it is: clean, functional, and undamaged. ► Inspect all cables, and in particular electrode cables, for any damage to their insulation. ► Set aside the product if it is damaged. ► Perform a safety inspection annually, see Maintenance.

5.7

Storage and transport

CAUTION

Damage to the product caused by switch-on to early after storage/transport at temperature below +10 °C (50° F)! ► Allow the HF device to acclimate at room temperature for about 3 hours.

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

14

Maintenance

The HF device GN060 does not require maintenance. 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 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 High frequency surgical device GN060, from serial number 4000 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 1.6

2.) ELECTRICAL INSPECTION 2.1 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

Measured value

Verdict PASS / FAIL

Applied part leakage current - alternative method

Imax = 0,05 mA

according IEC62353:2007

HF-leakage current bipolar

Imax =

Insulation resistance 2.8.1 Mains against bipolar HF-output 2.8.2 Mains against housing 2.8.3 Bipolar HF-output against housing HF-output power measurement with induction-free resistor Operational mode Dosage HF-output RLoad Bipolar MICRO 5.0 50 Ÿ MICRO 9.9 50 Ÿ MACRO 25 100 Ÿ MACRO 50 100 Ÿ 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

FAIL

Rmax= 0,3 Ÿ (at • 0,2 A)

according IEC62353:2007

according IEC60601-2-2:2009

2.8

PASS

Inspection of power cable for visually detectable damage Inspection of foot control for visually detectable damage Inspection of coagulation cable for visible signs of damage (record their number) and check the fitting of the plug connector Type plate still present and readable Check fuse links for prescribed values Overall condition of device: dirt, damage

50 mA

test voltage = 500 V DC

Rmin = 7 MŸ Rmin = 2 MŸ Rmin = 2 MŸ Rated value 5.0 Watt ± 20 % 9.9 Watt ± 20 % 25 Watt ± 20 % 50 Watt ± 20 % Rmin = 2 MŸ 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. 7

Checking protocol for safety inspection 15

Aesculap® High frequency surgical device GN060

7.

Troubleshooting list

Error codes In the event of an error. one of the error codes detailed in the following table appears in the display 8. Error code

Detection

Cause

Remedy

F1

Multiple keys pressed

Several buttons activated at the same time or object that presses on several buttons

Only press one button or, if necessary, remove object from the keyboard. If an error is still displayed, there is probably a defect present in the keyboard. Contact Aesculap Technical Service.

F2

Membrane key held for longer than 15 s

A key has been activated for more than 15 s or an object is pressing on the keyboard

Activate the keys for a shorter period of time or, if necessary, remove the object from the keyboard. If an error is still displayed, there is probably a defect present in the keyboard. Contact Aesculap Technical Service.

F3

Foot switch activated for longer than 30 s

–

Release foot switch and activate it again. If the error message continues to be displayed even if the foot switch is not activated, it is possible that this or the lead cable of the foot switch defective. Contact Aesculap Technical Service.

F4

EEPROM writing error

It was not possible to write EEPROM

Switch off the HF device and switch it on again If the error message continues to be displayed, there is an error in the EEPROM. Contact Aesculap Technical Service.

F5

EEPROM reading error

It was not possible to read EEPROM see F4

E1-E6

Error in electronics

–

EF

Microprocessor error

–

16

Switch off the HF device and switch it on again If the error message continues to be displayed, there is a device error. Contact Aesculap Technical Service.

7.1

Fuse replacement

8.

Technical Service

Risk of fatal injury from electric shock! ► Unplug the device before changing the fuses! DANGER

WARNING

Specified fuses: TA021539 (T 3.15 AH/250 V) ► Unlatch clip B with a suitable screw driver A. ► Remove fuse holder 25. ► Replace both fuse sets 26. ► Reinsert fuse holder 25 so that it audibly snaps into place.

23

A

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

26

B

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

agency. Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +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.

25 Fig. 8

Device connector with fuse holder and voltage switching element

Legend 23 Device connector 25 Fuse holder 26 Fuse sets A Screwdriver B Clip Note If the fuses burn out frequently, the HF device is faulty and should be repaired, see Technical Service.

17

Aesculap® High frequency surgical device GN060

9.

Accessories/Spare parts

Power cord

10. Technical data Classification acc. to Directive 93/42/EEC

Art. no.

Approvals

Length [m]

TE730

Europe

5.0

TE734

United Kingdom and Ireland

5.0

TE735

USA, Canada, Japan

3.5

Art. no.

Designation

Class

GN060

Bipolar HF surgical device

IIb

Mains voltage ranges

100-120 V +/- 10 % 220-240 V +/- 10 %

Frequency

50-60 Hz

Current consumption (for 50 W HF release)

1.1 - 1.0 A (for 100 - 120 V) 0.6 - 0.6 A (for 220 - 240 V)

Current consumption (Readiness for operation)

approx. 0.1 A (for 100 - 120 V) approx. 0.05 A (for 220 - 240 V)

Potential-compensation line Art. no.

Designation

Length [m]

GK535

Potential-compensation line

4.0

TA008205

Potential-compensation line

0.8

Foot switch/automatic starting

Protection class (acc. to IEC/ I DIN EN 60601-1) Output frequency

450 kHz

Output power

"Micro": 10 W at 50 Ohms "Macro": 50 W at 100 Ohms

Device protection Time-Current characteristic Breaking capacity Construction

T 3.15 AH / 250 V T (time lag) H (1 500 A) 5 mm x 20 mm

Bipolar instruments and connection cable

Weight

4.7 kg

Note Information concerning instruments and connection cables is available on request and can be found in Aesculap brochure C-304-81.

Dimensions (L x W x H)

305 mm x 305 mm x 82 mm

Applied part

Type CF Defibrillation-protected output Recovery time: 0 seconds

EMC

IEC/DIN EN 60601-1-2 CISPR11 Class A

Conforming to standard

IEC/DIN EN 60601-1 IEC/DIN EN 60601-2-2

Conformity mark

CSA-CUS

Art. no.

Designation

GN161

Single-pedal foot switch (round)

GK226

Single foot switch

GN062

Automatic starting

Spare parts Art. no.

Designation

TA021539

Fuses that can be used with this unit

TA022130

Notes on electromagnetic compatibility (EMC)

Note Information on other accessories and replacement parts is available on request and can be found in Aesculap brochure C-304-81. LR 50 151

18

10.1 Ambient conditions Operation

Storage and transport

Temperature

Relative humidity

Atmospheric pressure

Note The atmospheric pressure of 700 hPa corresponds to a maximum operating altitude of 3 000 m.

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.

12. Distributor in the US/Contact in Canada for product information and complaints Aesculap Inc. 3773 Corporate Parkway Center Valley, PA, 18034, USA 19

Inspection protocol – safety inspection TEST INTERVAL: TYPE OF DEVICE: MANUFACTURED BY:

1 Year High frequency surgical device GN060, from serial number 4000 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 1.6

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

Imax = 0,05 mA

according IEC62353:2007

HF-leakage current bipolar

Imax =

Insulation resistance 2.8.1 Mains against bipolar HF-output 2.8.2 Mains against housing 2.8.3 Bipolar HF-output against housing HF-output power measurement with induction-free resistor Operational mode Dosage HF-output RLoad Bipolar MICRO 5.0 50 Ÿ MICRO 9.9 50 Ÿ MACRO 25 100 Ÿ MACRO 50 100 Ÿ 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

Applied part leakage current - alternative method

according IEC62353:2007 (Preparation according Service Manual)

2.9

Measured value

Rmax= 0,3 Ÿ (at • 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 control for visually detectable damage Inspection of coagulation cable for visible signs of damage (record their number) and check the fitting of the plug connector Type plate still present and readable Check fuse links for prescribed values Overall condition of device: dirt, damage

2.) ELECTRICAL INSPECTION 2.1

PASS

50 mA

test voltage = 500 V DC

Rmin = 7 MŸ Rmin = 2 MŸ Rmin = 2 MŸ Rated value 5.0 Watt ± 20 % 9.9 Watt ± 20 % 25 Watt ± 20 % 50 Watt ± 20 % Rmin = 2 MŸ 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. 7

Protocole de vérification pour le contrôle technique de sécurité 51

Inspection protocol – safety inspection TEST INTERVAL: TYPE OF DEVICE: MANUFACTURED BY:

1 Year High frequency surgical device GN060, from serial number 4000 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 1.6

2.) ELECTRICAL INSPECTION 2.1 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

Measured value

Verdict PASS / FAIL

Applied part leakage current - alternative method

Imax = 0,05 mA

according IEC62353:2007

HF-leakage current bipolar

Imax =

Insulation resistance 2.8.1 Mains against bipolar HF-output 2.8.2 Mains against housing 2.8.3 Bipolar HF-output against housing HF-output power measurement with induction-free resistor Operational mode Dosage HF-output RLoad Bipolar MICRO 5.0 50 Ÿ MICRO 9.9 50 Ÿ MACRO 25 100 Ÿ MACRO 50 100 Ÿ 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

FAIL

Rmax= 0,3 Ÿ (at • 0,2 A)

according IEC62353:2007

according IEC60601-2-2:2009

2.8

PASS

Inspection of power cable for visually detectable damage Inspection of foot control for visually detectable damage Inspection of coagulation cable for visible signs of damage (record their number) and check the fitting of the plug connector Type plate still present and readable Check fuse links for prescribed values Overall condition of device: dirt, damage

50 mA

test voltage = 500 V DC

Rmin = 7 MŸ Rmin = 2 MŸ Rmin = 2 MŸ Rated value 5.0 Watt ± 20 % 9.9 Watt ± 20 % 25 Watt ± 20 % 50 Watt ± 20 % Rmin = 2 MŸ 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. 7

Certificado de revisión de la supervisión técnica de seguridad 69