GN160 bipolar high-frequency surgery device

en

Aesculap® GN160 bipolar high-frequency surgery device Legend 1 Power OFF switch 2 Power ON switch 3 Indicator lamp power ON 4 Operating mode display (STANDARD or FORCED) 5 Display field (STANDARD or MALIS value) 6 Unit display (STANDARD or MALIS) 7 Indicator lamp HF-ON 8 Output socket HF-bipolar 9 Indicator ring (green, white or red) 10 Control knob (with pushbutton function) 11 Connection socket (foot switch) 12 Equipotential connector 13 Mains power input socket 14 Fuse holder (with 2 fuses) 15 Nameplate

Labeling of electrical and electronic devices according to directive 2012/19/EU (WEEE), see Disposal

Manufacturer’s article number Manufacturer’s batch designation Manufacturer’s serial number Delivery quantity Temperature limits during transport and storage

Air humidity limits during transport and storage

Symbols on product and packages Caution Observe important safety information such as warnings and precautions in the instructions for use.

Atmospheric pressure limits during transport and storage

Follow the instructions for use CE-approved in accordance with Directive (EU) 2017/745 Non-sterile medical product

EAC symbol of the Eurasian Economic Union

“OFF” (power supply)

According to US federal law, this product may only be sold by a doctor or on the orders of a doctor

“ON” (power supply)

Foot switch

Type CF unit with defibrillation protection Equipotentialization connector

Fuse Alternating current Non-ionizing radiation

Manufacturer

Date of manufacture

2

en Contents 1. 1.1 1.2 2. 2.1

About this document... Scope... Warnings... Safe handling... Safe for use in conformance with IEC regulations... The operating environment Patient safety 3. Product description... 3.1 Scope of supply... 3.2 Components required for operation... 3.3 Intended use... Absolute contraindications Relative contraindications 3.4 Operating principle... 3.5 Monitoring functions... 3.6 Output graphs... 3.7 Adaptation curve... 3.8 Maximum peak output voltage (UP)... 3.9 Maximum output current... 4. Preparation and setup... 4.1 First use... 4.2 Stacking of units... 4.3 Moving stacks of units... 4.4 Dismantling stacks of devices... 5. Working with the HF device GN160... 5.1 System set-up... Connecting the accessories Connect power connection and switch on HF device GN160 Connecting a single-pedal foot switch (e.g. GN161) Connecting bipolar accessories 5.2 Function checks... 5.3 Safe operation... Switching the HF device on/off Setting a STANDARD or MALIS value Navigation in the submenu Activating the HF current 6. Reprocessing procedure... 6.1 General safety information... 6.2 Reusable products... 6.3 Preparation before cleaning... 6.4 Cleaning/disinfection... Product-specific safety instructions for the reprocessing procedure 6.5 Wipe disinfection for electrical devices... 6.6 Inspection, maintenance and checks... 6.7 Storage and transport... 7. Maintenance... 8. Troubleshooting list... 8.1 Fuse replacement... 9. Technical Service... 10. Accessories/Spare parts... 11. Technical data... 11.1 Ambient conditions... 12. Disposal...

1. 3 3 3 3 4 4 4 5 5 5 5 5 5 5 6 6 6 6 7 7 7 7 8 8 8 8 8 8 9 9 9 10 10 10 10 12 12 12 12 12 12 12 13 13 13 14 15 15 16 16 17 17 17

About this document

Note General risk factors associated with surgical procedures are not described in this documentation.

1.1

Scope

These instructions for use apply to the bipolar high-frequency surgical device GN160. ► For article specific instructions for use and material compatibility, see B. Braun eIFU at eifu.bbraun.com

1.2

Warnings

Warnings make clear the dangers to patient, user and/or product that could arise during the use of the product. Warnings are labeled as follows: DANGER Indicates a possible threat of danger. If not avoided, death or severe injuries may result. WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injuries may result. CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

2.

Safe handling

Note These instructions for use only describe the setup, function and operation of the GN160 high-frequency surgical device and is not suitable for initiating 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. ► See “Information on electromagnetic compatibility (EMC)," TA022455

at https://extranet.bbraun.com ► 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.

3

en 2.1

Safe for use in conformance with IEC regulations

2.1.1

The operating environment

DANGER Risk of death by electric shock! ► Do not open the product. ► Connect the product only to a grounded power supply. WARNING Risk of injury from ignition or explosion of flammable gases! Sparks may occur when using the HF device as directed. ► Do not use the device in an area where there is a risk of explosion. ► When operating on the head and thorax region, avoid using combustible anesthetics and combustion-supporting gases (e.g. laughing gas and oxygen) or, when using such substances, aspirate them from the operation field. ► If possible, use incombustible cleaning and disinfecting agents. ► If flammable cleaning and disinfecting agents or solvents are used: Verify that such agents have evaporated prior to commencing HF surgery. ► Be sure that no inflammable liquids accumulate under the patient’s body or in body cavities (e.g., the vagina). Before using the HF device, wipe up all fluids. ► Be sure there are no endogenous gases in the O.R. environment that could ignite. ► Be sure that any materials that were soaked in liquid oxygen (e.g., cotton wool, gauze) are kept far enough away from the HF environment that they cannot ignite. WARNING Risk of interference with other devices! HF devices create potentially harmful magnetic fields during normal use. ► Be sure that no electronic devices that could be damaged by an electromagnetic field are set up in the vicinity of the HF device. WARNING Obstructed view and/or side-effects due to steam/smoke emission during HF surgery! ► Always set the power output to as low a level as possible for the corresponding purpose. ► 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, simultaneous contact with the patient and the HF device. 2.1.2

Patient safety

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.

4

WARNING 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. WARNING 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! ► Always set the power output to as low a level as possible for the corresponding purpose. Always be sure to do the following: Note The interference generated during operation of the HF surgical device can influence the functionality of other electronic devices. In patients with cardiac pacemakers or other active implants, there is a possible risk that a fault can occur in the active implant or the implant could be damaged. In case of doubt, consult an expert. ► 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. ► Attach electrodes of physiological monitoring systems as far away as

possible from the HF surgical electrodes. ► Use monitoring systems fitted with devices to limit the HF current. ► 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.

en ► Should the output power appear insufficient with the usual settings,

check that: – the working electrodes are clean, – all plug connections are properly in place. ► For operations involving unavoidable, continuous contact between the electrodes and the patient (e.g. endoscopic procedures), press the power OFF switch at the HF device immediately after any inadvertent activation of the electrode. ► Adjust the acoustic warning, which signals the activation of the electrode, to such a level that it will always be heard without difficulty. Note The user is obligated to report all of the severe events in connection with the product to the manufacturer and the competent state authorities in which the user is located.

3.

Product description

3.1

Scope of supply

Designation

Art. no.

Bipolar HF surgical device

GN160

GN160 bipolar high-frequency surgery device instruc- TA022247 tions for use

3.2

Components required for operation

3.3

Intended use

■ Power cord ■ Foot switch (single pedal) ■ Bipolar connection cable ■ Bipolar instrument

The generator GN160 is a bipolar high frequency surgical device. It is used to convert electrical current into bipolar energy for coagulation with bipolar instruments in all fields of surgery. 3.3.1 Absolute contraindications Do not use bipolar instruments with the generator GN160 if the accessory voltage rating specified in the product documentation is lower than maximum peak output voltage for the intended setting. 3.3.2 Relative contraindications The following conditions, individual or combined, can lead to delayed healing or compromise the success of the operation: ■ Medical or surgical conditions (e.g. comorbidities, coagulation status) which could hinder the success of the operation. In the presence of relative contraindications, the user decides individually regarding the use of the product.

3.4

Operating principle

The HF device GN160 is fitted with a bipolar output socket that can provide HF currents for coagulation. The HF surgical device can be activated only through a single-pedal foot switch (e.g. footswitch for operation from any angle, GN161), which is connected via a socket in the rear panel of the HF surgical device. The output power is set directly by turning control knob 10, and is displayed in one of the two established units (STANDARD/MALIS; factory setting = STANDARD). All other device parameters (e.g. operating mode, volume, etc.) and system information (software version, serial no, …) are set and displayed via a submenu, which can be called up by pressing control knob 10. The operating mode display 4 and the display unit 6 for special functions are only visible when the corresponding special function is active. During normal operation, the display elements are hidden, contributing to the easy-to-use, uncluttered quality of the device controls. The HF device GN160 offers two operating modes, both with a setting range of 1–60 STANDARD (or 10–170 MALIS): ■ The STANDARD operating mode (factory default) allows rapid coagulation throughout the entire power range, with reduced tissue adhesion and carbonization of the tissue. ■ The FORCED mode allows rapid coagulation with increased sloughing of the surrounding tissue. The HF device GN160 can also be combined with accessory devices (e.g. JET irrigation unit GN090).

5

en 3.5

Monitoring functions

Self-test As soon as it is switched on, the HF unit performs a self-test of the control elements, the acoustic warning signal, the microprocessor and the hardware functions.

3.7

Adaptation curve

Operating modes STANDARD and FORCED: (Pout) = f (RL) (measured with original cable: CL = 175 pF)

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. The code number of the error is displayed in display field 5 and an acoustic warning signal may be issued, see Troubleshooting list.

3.6

Output graphs

Output power (Pout) as function of setting (STANDARD/MALIS):

Fig. 1

Fig. 3

Operating mode: STANDARD

Fig. 4

Operating mode: FORCED

STANDARD

3.8

Maximum peak output voltage (UP) Note The following graphs allow the user to judge whether the HF device or its output setting is suitable for a given accessory (insulation rating).

Fig. 2

6

MALIS

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.

en Maximum peak output voltage (UP) as function of setting (STANDARD/MALIS):

4.1

First use

WARNING 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.

4.2

Stacking of units

The stacking provisions integrated in the device cover allows secure mounting of an accessory device (e.g. JET Irrigation unit GN090) on top of the HF device GN160. ► Make certain the system is set up on a sufficiently stable support (e.g. a table, ceiling support, equipment cart, etc.).

Fig. 5

STANDARD

Fig. 6

MALIS

3.9

Maximum output current

Stacking products fitted with stacking devices: ► 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 onto the 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.

A

C

B

The maximum output current for both operating modes, standard and forced, equals 1.15 A (RMS).

4.

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. ► Make certain that the control elements, mains power switch and power socket 13 are freely accessible for the user. 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.

Fig. 7

Stacking of units

Legend A Accessory device, e.g. JET irrigation device GN090 B Locking screw C Stacking cone

► 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). The device is authorized for operation in the operating room.

7

en 4.3

Moving stacks of units

► Always lift stacks from underneath the bottommost unit.

4.4

Dismantling stacks of devices

Dismounting a stack of products fitted with stacking devices: ► 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.

B

Fig. 8

Dismantling stacks of devices

Legend B Locking screw

5.

Working with the HF device GN160

5.1

System set-up

5.1.1

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. Also note that any equipment connected at the interfaces must demonstrably meet the respective IEC standards (e.g. IEC 60950 for data processing equipment, IEC/DIN EN 60601-1 for electromedical devices). 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. 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 address your B. Braun/Aesculap partner or Aesculap Technical Service with any inquiries in this respect; for a contact address, see Technical Service. 5.1.2

Connect power connection and switch on HF device GN160

DANGER Risk of death by electric shock! ► Only ever connect the product to power mains with equipment grounding conductor. The mains voltage must correspond to the voltage indicated on the type plate at the back of the unit. The HF device is fitted with a universal power adapter for mains voltages 100–120 V and 220–240 V. ► Plug in the power cord in mains power input socket 13 in the rear panel of the HF device. ► Connect power supply by inserting into a wall socket. ► Switch on the HF device with the "Power ON" switch 2. Indicator lamp power ON 3 is illuminated. The HF device performs a self-test. On switching on the device for the first time, the basic factory default settings will be shown on the display at the end of the self-test, see Fig. 9.

Fig. 9

Factory default setting

On every further switch-on, the device settings last used prior to the most recent switch-off will be applied and displayed.

8

en 5.1.3 Connecting a single-pedal foot switch (e.g. GN161) Both the foot switch plug and connection socket (foot switch) 11 carry an arrow marking. To connect the plug to the connection socket correctly, the two arrows must be aligned.

Note IEC/DIN EN 60601-2-2:2007 requires active plugs with more than one contact pin to be specified with fixed pin spacing. Loose (flying) leads are not allowed! ► Plug in the bipolar connection cable in output socket HF 8.

5.2

Function checks

Factory settings display:

Operating mode: Standard Unit: STANDARD

Fig. 10

Connecting a single-pedal foot switch (e.g. GN161)

► Plug in the foot switch plug in connection socket foot switch 11.

5.1.4

Connecting bipolar accessories

WARNING Risk for patients and users due to inadvertent current supply to an instrument! ► Make certain that a maximum of one bipolar connection cable is connected to the output socket. Note Connect the bipolar cable only after switching on the GN160!

Note Every subsequent switch-on of the HF device is followed by the display of the last device settings applied prior to the most recent switch-off. Any changed settings applied during the function test are saved immediately. Any device settings other than the factory settings must be noted down before the function test is continued! If in doubt, we recommend restoring the factory settings. ► Always carry out function checks before using the product. ► Check that the accessories do not show any visible damage. ► Prepare and set up the HF unit, see Preparation and setup. ► Connect the unit to power supply, see Connect power connection and

switch on HF device GN160. ► Check the functionality of the following elements, one after the other,

in the following sequence: User action

Device reaction

1. Press power ON switch 2.

Indicator lamp power ON 3 is illuminated. The HF device performs a self-test, accompanied by an acoustic signal. All display elements are activated in rapid sequence.

The following plug types can be connected at output socket HF 8.

Fig. 11

Fig. 12

Sequence: 1. Display operating mode (FORCED) 4 2. All segments of display field 5 (as running light) 3. Display Unit (MALIS) 6 4. Indicator lamp HF-ON 7 5. Indicator ring (green) 9 6. Indicator ring (white) 9 7. Indicator ring (red) 9 Acoustic signal stops when the selftest is completed and the unit is ready for operation. Indicator ring 9 is illuminated green after completion of the self-test. The most recent device settings applied prior to the last switch-off are displayed.

Coax plug

2-pin plug

2. Rotate the adjustment knob 10 in a clockwise direction.

The parameter value displayed in display field 5 is increased.

3. Rotate the adjustment knob 10 in a counterclockwise direction.

The parameter value displayed in display field 5 is decreased.

9

en User action

Device reaction

4. Press control knob 10 (>2 s).

Indicator ring 9 is illuminated white. Display of selected operating mode in display field 5 Operating mode STANDARD

5.3.2 Setting a STANDARD or MALIS value The STANDARD or MALIS value is set via control knob 10 and displayed in display field 5. Slow rotation of control knob 10 allows selecting any possible setting; quick rotation allows going through the entire setting range by only a few turns. For both operating types (STANDARD/FORCED), STANDARD values of 1-60 and MALIS values or 10-170 respectively are available. The possible setting range and graduation depend on the unit selected (STANDARD or MALIS):

Operating mode FORCED

5. Press control knob 10 again (>2 s).

6. Plug in the single-pedal foot switch plug in connection socket (foot switch) 11.

No device reaction If the HF device is activated at this stage, the foot switch is defective!

7. Press the single-pedal foot switch.

The HF device is activated. Indicator ring 9 turns off. Indicator lamp HF-ON 7 illuminated If there is no device reaction at this stage, there can be a fault either in the HF device or in the foot switch. Repeat the test with another foot switch, see Troubleshooting list. Indicator lamp power ON 3 turns off.

► In case of device reactions other than those intended: Do not use the

HF device and contact Technical Service, see Technical Service.

5.3

Setting range

Graduation

STANDARD

1,0–10,0

0,1

10,0–30,0

0,5

30–60

1

10–170

1

The submenu is quitted. Indicator ring 9 is illuminated green. Display of most recent setting in display field 5

8. Press power OFF switch 1.

Display unit

Safe operation

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

MALIS

Note The precision of the setting meets the requirements of IEC/DIN EN 606012-2! ► Turn control knob 10 clockwise or counterclockwise to set the intended

STANDARD or MALIS value. 5.3.3 Navigation in the submenu The submenu allows the following settings and display of system information: ■ Settings – Operating mode (STANDARD/FORCED) – Noise – Unit (STANDARD/MALIS) ■ System information – Last error event – Software version – Serial number Note The HF device can not be activated while the submenu is active! ► To call up the submenu: Press and hold control knob 10 (>2 s).

WARNING Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control. 5.3.1

Switching the HF device on/off

► Switching on the HF device: Press power ON switch 2. ► Switching off the HF device: Press power OFF switch 1.

Note The safe and all-pole disconnection of the product from the main power supply is only guaranteed when the power cord is unplugged.

10

The first submenu item (Operating mode) is displayed. ► To call up the next submenu item: Briefly press control knob 10 (<2 s).

The next submenu item is called up. ► To quit the submenu: Press and hold control knob 10 (>2 s). The setting for the displayed submenu item is applied. If no input via the control knob is applied through a period of 30 s, the setting of the displayed submenu item is applied and the submenu is quitted automatically.

en Setting the operating mode ► To select an operating mode: Press and hold control knob 10 (>2 s). The following display appears in display field 5: – In operating mode STANDARD

Selecting the unit (STANDARD/MALIS) ► To select the unit: Press and hold control knob 10 (>2 s).

The submenu item (Operating mode) is displayed. ► Repeatedly, briefly (<2 s) press control knob 10 until submenu item

Unit (Unt) (Unt = Unit) is displayed. – In operating mode FORCED

► To set an operating mode: Turn control knob 10.

The following display appears in display field 5: – In operating mode STANDARD

As long as the unit STANDARD is selected, the Unit display 6 is hidden. If the unit MALIS is selected, display Unit 6 is illuminated. ► To select the unit: Turn control knob 10. ► To adopt the setting: Briefly press control knob 10 (<2 s). The next submenu item is called up. ► To quit the submenu: Press control knob 10 briefly (<2 s) or wait for

Display Operating mode 4 is not visible. The following display appears in display field 5: – In operating mode FORCED

30 s. The setting for the displayed submenu item is applied. Displaying the last error event Note For more detailed fault descriptions, see Troubleshooting list. ► To call up the submenu: Press and hold control knob 10 (>2 s).

Display Operating mode 4 is illuminated. ► To apply the setting: Briefly press control knob 10 (<2 s). The next submenu item is called up. ► To quit the submenu: Press and hold control knob 10 (>2 s). The setting for the displayed submenu item is applied. Adjusting the volume The signal volume of the HF device can be adjusted to any of 9 volume levels. ► To select an operating mode: Press and hold control knob 10 (>2 s). The first submenu item (Operating mode) is displayed. ► Repeatedly, briefly (<2 s) press control knob 10 until submenu item

(Volume) is displayed. The following display appears in display field 5 (SP (for speaker) and the actual volume level setting (1–9)):

An acoustic signal is issued at the currently set volume. ► To adjust the volume: Turn control knob 10.

The actual volume level is displayed and an acoustic signal is issued at the actual volume.

The first submenu item (Operating mode) is displayed. ► Repeatedly, briefly (<2 s) press control knob 10 until submenu item

(Last error event) is displayed. The following display appears in display field 5 (E (for error) and the respective error code):

► To switch to another submenu item: Briefly press control knob 10

(<2 s). The next submenu item is called up. ► To quit the submenu: Press control knob 10 briefly (<2 s) or wait for

30 s. Displaying the software version ► Press and hold control knob 10 (>2 s). The submenu item (Operating mode) is displayed. ► Repeatedly, briefly (<2 s) press control knob 10 until submenu item

(Software version) is displayed. The following marquee display appears in display field 5 (SoF (for software), followed by an underscore and the three-digit version number):

► To adopt the setting: Briefly press control knob 10 (<2 s).

The next submenu item is called up. ► To quit the submenu: Briefly press control knob 10 (<2 s).

The setting for the displayed submenu item is applied. - or ► To quit the submenu without adopting the setting: Press control

knob 10 for some time (>2 s) or wait for 30 s.

► To switch to another submenu item: Briefly press control knob 10

(<2 s). The next submenu item is called up. ► To quit the submenu: Press control knob 10 briefly (<2 s) or wait for

30 s.

11

en Displaying the serial number ► Press and hold control knob 10 (>2 s). The submenu item (Operating mode) is displayed.

6.4

Cleaning/disinfection

6.4.1

Product-specific safety instructions for the reprocessing procedure

► Repeatedly, briefly (<2 s) press control knob 10 until submenu item

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.

(Serial number) is displayed. The following marquee display appears in display field 5 (Sn for serial number, followed by an underscore and the four-digit device serial number):

► To quit the submenu: Briefly press control knob 10 (<2 s).

- or ► Press control knob 10 for some time (>2 s) or wait for 30 s.

5.3.4

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. ► Verify that the required accessories are properly connected and plugged in. ► Be sure that all settings on the HF device are appropriate for the intended application. ► Press the foot switch. Indicator lamp HF-ON 7 will be illuminated for the duration of the activation. Note The activation period is limited to a maximum of 120 s, meaning: after 120 s of continuous activation, the HF current is deactivated automatically. To alert the user to the automatic deactivation, the activation signal volume will rise, during the last 60 s, from the selected volume setting to maximum volume.

6.

Reprocessing procedure

6.1

General safety information

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for reprocessing. Note It should be noted that successful reprocessing of this medical device can only be guaranteed following prior validation of the reprocessing method. The operator/reprocessor is responsible for this.

6.2

Reusable products

Influences from processing that result in damage to the product are unknown. A careful visual and functional inspection before the next use is the best opportunity to recognize a product that is no longer functional.

6.3

Preparation before cleaning

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

12

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.

en 6.5

Wipe disinfection for electrical devices

Phase

Step

D [°C/°F]

t [min]

Conc. [%]

Water quality

Chemistry

I

Cleaning

RT

1

-

-

17 % propane-1-ol, 0.23 % Didecyldimethylammonium chloride*

II

Wipe disinfection

RT

≥1

-

-

17 % propane-1-ol, 0.23 % Didecyldimethylammonium chloride*

RT: *

Room temperature Validation was performed with Meliseptol® wipes sensitive (B. Braun)

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

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

6.6

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.

6.7

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.

13

en 7.

Maintenance ► Only have the product and its accessories inspected by persons who

No servicing is required for the HF device GN160. 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. Servicing must be performed once annually. The person in charge of the inspection will document the inspection findings and measurement values according to the printed inspection protocol.

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.

Maintenance protocol TEST INTERVAL: TYPE OF DEVICE: MANUFACTURED BY:

1 Year Bipolar Electrosurgical Unit GN160 Aesculap AG, Am Aesculap-Platz 78532 Tuttlingen/Germany

RESPONSIBLE SN: ... INVENTORY NO.: ... ORGANIZATION: ... SCOPE OF INSPECTION

Finding

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

OK Yes / No

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

Imax = 0,05 mA

according IEC62353:2007

HF-leakage current bipolar

Imax =

Insulation resistance power according IEC62353:2007 (Preparation according Service Manual)

2.9

FAIL

Rmax= 0,3 Ω (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

55 mA

test voltage = 500 V DC

2.8.1 Mains against HF output Rmin = 7 MΩ 2.8.2 Mains against housing Rmin = 2 MΩ 2.8.3 Bipolar HF-output against housing Rmin = 2 MΩ HF-output power measurement with induction-free resistance Operational mode Dosage HF-output RLoad Rated value Bipolar STANDART 60 75 Ω 60 Watt ± 20 % FORCED 60 100 Ω 60 Watt ± 20 % DC resistance between the two HF output poles Rmin = 2 M Ω according IEC60601-2-2:2009 section 201.8.4.102

2.11 Function test according to instructions for use Place/Date Inspector/Signatur

Performed:

Responsible Organization

* The listed allowable values comply with the requirements of the IEC 60601-1:2005 + Cor.:2006 + Cor.:2007 + A1:2012 as well as IEC 62353:2014

Fig. 13 Servicing protocol

14

en 8.

Troubleshooting list

If an error occurs, the following display appears in display field 5, which is made up of the letters E (for error) and the error code:

At the same time, the indicator ring 9 lights up red.

Malfunction

Detection

Cause

Remedy

1

Switch-on self-test activated for foot switch

Foot switch pressed during switch-on, or foot switch defective

Release or unplug the foot switch Contact Aesculap Technical Service, see Technical Service

2

Switch-on self-test control knob

Control knob pressed during switch-on, or control knob defective

Release the control knob Contact Aesculap Technical Service, see Technical Service

3

Control knob pushbutton function

Control knob kept pressed for too long; control knob defective

Release the control knob Contact Aesculap Technical Service, see Technical Service

4

Time limit exceeded

HF activation time limit exceeded

Release the foot switch

10-89

Internal error

Internal device fault/error

Switch off the HF unit and switch it on again Contact Aesculap Technical Service, see Technical Service

90-99

Calibration

Lack of balancing

Contact Aesculap Technical Service, see Technical Service

8.1

Fuse replacement

DANGER Risk of death by electric shock! ► Unplug the device before changing the fuses! Specified fuse sets

TA020005 (2 pcs.)

Designation

T 2.5 AH / 250 V

Time-Current characteristic

T (idle)

Breaking capacity

H (1 500 A)

Construction

5 mm x 20 mm

A B

► Push down latch nose A at fuse holder C and unlock the fuse holder.

B

C

► Remove fuse holder C. ► Replace both fuse sets B. ► Insert fuse holder C so that it clicks into its proper position.

Fig. 14 Fuse replacement Legend A Latch nose B Fuse sets C Fuse holder Note If the fuses burn out frequently, the device is faulty and should be repaired, see Technical Service.

15

en 9.

Technical Service

DANGER Danger to life of patients and users if the product malfunctions and/or protective measures fail or are not used! ► Do not perform any servicing or maintenance work under any circumstances while the product is being used on a patient. ► Do not modify the product.

10. Accessories/Spare parts Power cord Art. no.

Approvals

Length [m]

TE730

Europe

5.0

TE734

United Kingdom and Ireland

5.0

TE735

USA, Canada, Japan

3.5

► 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] Other service addresses can be obtained from the address indicated above.

Potential-compensation line Art. no.

Designation

Length [m]

GK535

Potential-compensation line

4.0

TA008205

Potential-compensation line

0.8

Foot switch Art. no.

Designation

GN161

Single-pedal foot switch (round)

GK226

Single foot switch

Bipolar instruments and connection cable Note Information concerning the instruments and connection cable is available on request and can be found in the Aesculap brochure C-304-81. Spare parts Art. no.

Designation

TA020005

Fuses that can be used with this unit

TA022455

Notes on electromagnetic compatibility (EMC) for RF device GN160

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

16

en 11. Technical data

11.1 Ambient conditions

Classification acc. to Directive (EU) 2017/745

Operation

Art. no.

Designation

Class

GN160

Bipolar HF surgical device

IIb

Storage and transport

Temperature

Relative humidity Mains voltage ranges

100-120 V ± 10 % 220-240 V ± 10 %

Frequency

50-60 Hz

Power consumption (with a 60-Watt HF delivery)

1.00-0.81 A (for 100-120 V) 0.44-0.41 A (for 220-240 V)

Power consumption (serviceability)

ca. 0,12 A (for 100-120 V) ca. 0.14 A (for 220-240 V)

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

I

Protection type acc. to IEC 60529

IP31

Foot switch circuit

fused in conformance with IEC 60601, certified for use in a “medical environment”

Output power

STANDARD: 60 W at 75 Ohms FORCED: 60 W at 100 Ohms

Output frequency

346 kHz

Operating mode

Int 10 s/30 s

Device protection Time-Current characteristic Breaking capacity Construction

T 2.5 AH / 250 V T (idle) H (1 500 A) 5 mm x 20 mm

Weight

6 kg

Dimensions (L x W x H)

325 mm x 305 mm x 135 mm

Max. cable length, HF accessory

5m

Applied part

Type CF Defibrillation-protected output Recovery time 0 s

EMC

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

Conforming to standard

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

Atmospheric pressure

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

12. Disposal WARNING Risk of infection due to contaminated products! ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging. Note The user institution is obliged to process the product before its disposal, see Reprocessing procedure. 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.

17

fr 7.

Maintenance ► Faire contrôler le produit et les accessoires uniquement par des per-

L'appareil HF GN160 ne demande aucune maintenance. Remarque Seul du personnel spécialisé est autorisé à procéder à la mise en service. En cas de besoin, veuillez consulter les schémas de connexion et le manuel d'entretien, dans lesquels toutes les données nécessaires sont présentées. Une maintenance doit être effectuée une fois par an. Le contrôleur consigne les résultats du contrôle et les valeurs de mesure conformément au procès-verbal de contrôle ci-joint.

sonnes disposant de la formation, des connaissances ou de l'expérience requises et qui ne sont pas soumises à un pouvoir de directive lors du contrôle. ► En cas d’écarts importants par rapport aux valeurs du procès-verbal de réception finale ci-joint ou lorsque les valeurs maximales sont dépassées: Envoyer l'appareil. Pour les prestations de service correspondantes, adressez-vous à votre représentation nationale B. Braun/Aesculap, voir Service Technique.

Maintenance protocol TEST INTERVAL: TYPE OF DEVICE: MANUFACTURED BY:

1 Year Bipolar Electrosurgical Unit GN160 Aesculap AG, Am Aesculap-Platz 78532 Tuttlingen/Germany

RESPONSIBLE SN: ... INVENTORY NO.: ... ORGANIZATION: ... SCOPE OF INSPECTION

Finding

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

OK Yes / No

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

Imax = 0,05 mA

according IEC62353:2007

HF-leakage current bipolar

Imax =

Insulation resistance power according IEC62353:2007 (Preparation according Service Manual)

2.9

FAIL

Rmax= 0,3 Ω (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

55 mA

test voltage = 500 V DC

2.8.1 Mains against HF output Rmin = 7 MΩ 2.8.2 Mains against housing Rmin = 2 MΩ 2.8.3 Bipolar HF-output against housing Rmin = 2 MΩ HF-output power measurement with induction-free resistance Operational mode Dosage HF-output RLoad Rated value Bipolar STANDART 60 75 Ω 60 Watt ± 20 % FORCED 60 100 Ω 60 Watt ± 20 % DC resistance between the two HF output poles Rmin = 2 M Ω according IEC60601-2-2:2009 section 201.8.4.102

2.11 Function test according to instructions for use Place/Date Inspector/Signatur

Performed:

Responsible Organization

* The listed allowable values comply with the requirements of the IEC 60601-1:2005 + Cor.:2006 + Cor.:2007 + A1:2012 as well as IEC 62353:2014

Fig. 13 Protocole de maintenance

46

es 7.

Conservación ► La supervisión del producto y de los accesorios debe confiarse exclusi-

El parato AF GN160 no necesita mantenimiento. Nota El mantenimiento debe realizarse exclusivamente por personal autorizado. En caso necesario, se facilitarán los esquemas eléctricos y el manual de servicio técnico, en el que se encuentran todos los documentos necesarios. Se debe realizar una puesta a punto una vez al año. El inspector documentará los resultados de la supervisión y los valores medidos presentados en el certificado de revisión.

vamente a profesionales independientes con la formación requerida para ello o que dispongan de los conocimientos o experiencia necesarios. ► En caso de que existan importantes desviaciones con respecto a los valores del certificado de revisión de puesta en servicio, o en caso de que los valores máximos se sobrepasen, se deberá proceder del siguiente modo: Enviar el aparato. Si el producto necesita alguna reparación debe dirigirse al representante de B. Braun/Aesculap, ver Servicio de Asistencia Técnica de su país.

Maintenance protocol TEST INTERVAL: TYPE OF DEVICE: MANUFACTURED BY:

1 Year Bipolar Electrosurgical Unit GN160 Aesculap AG, Am Aesculap-Platz 78532 Tuttlingen/Germany

RESPONSIBLE SN: ... INVENTORY NO.: ... ORGANIZATION: ... SCOPE OF INSPECTION

Finding

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

OK Yes / No

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

Imax = 0,05 mA

according IEC62353:2007

HF-leakage current bipolar

Imax =

Insulation resistance power according IEC62353:2007 (Preparation according Service Manual)

2.9

FAIL

Rmax= 0,3 Ω (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

55 mA

test voltage = 500 V DC

2.8.1 Mains against HF output Rmin = 7 MΩ 2.8.2 Mains against housing Rmin = 2 MΩ 2.8.3 Bipolar HF-output against housing Rmin = 2 MΩ HF-output power measurement with induction-free resistance Operational mode Dosage HF-output RLoad Rated value Bipolar STANDART 60 75 Ω 60 Watt ± 20 % FORCED 60 100 Ω 60 Watt ± 20 % DC resistance between the two HF output poles Rmin = 2 M Ω according IEC60601-2-2:2009 section 201.8.4.102

2.11 Function test according to instructions for use Place/Date Inspector/Signatur

Performed:

Responsible Organization

* The listed allowable values comply with the requirements of the IEC 60601-1:2005 + Cor.:2006 + Cor.:2007 + A1:2012 as well as IEC 62353:2014

Fig. 13 Protocolo de puesta a punto

62

it 7.

Manutenzione ordinaria ► Far controllare il prodotto e gli accessori soltanto da personale che

L'apparecchio HF GN160 non richiede alcuna manutenzione. Nota La manutenzione ordinaria deve essere eseguita solo da personale autorizzato. In caso di necessità sono a disposizione gli schemi elettrici e il manuale di servizio in cui si trovano tutte le documentazioni necessarie. Deve essere eseguita una manutenzione ordinaria all’anno. Il controllore documenta i risultati del controllo ed i valori misurati in base al protocollo di prova prestampato.

disponga della necessaria formazione, conoscenze ed esperienza e che ai fini del controllo sia assolutamente indipendente. ► Se si rilevano massicci scostamenti dai valori del protocollo del collaudo finale allegato o se sono superati i valori massimi indicati: Accendere l'apparecchio Per i corrispondenti interventi di assistenza rivolgersi alla rappresentanza nazionale B. Braun/Aesculap, vedere Assistenza tecnica.

Maintenance protocol TEST INTERVAL: TYPE OF DEVICE: MANUFACTURED BY:

1 Year Bipolar Electrosurgical Unit GN160 Aesculap AG, Am Aesculap-Platz 78532 Tuttlingen/Germany

RESPONSIBLE SN: ... INVENTORY NO.: ... ORGANIZATION: ... SCOPE OF INSPECTION

Finding

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

OK Yes / No

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

Imax = 0,05 mA

according IEC62353:2007

HF-leakage current bipolar

Imax =

Insulation resistance power according IEC62353:2007 (Preparation according Service Manual)

2.9

FAIL

Rmax= 0,3 Ω (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

55 mA

test voltage = 500 V DC

2.8.1 Mains against HF output Rmin = 7 MΩ 2.8.2 Mains against housing Rmin = 2 MΩ 2.8.3 Bipolar HF-output against housing Rmin = 2 MΩ HF-output power measurement with induction-free resistance Operational mode Dosage HF-output RLoad Rated value Bipolar STANDART 60 75 Ω 60 Watt ± 20 % FORCED 60 100 Ω 60 Watt ± 20 % DC resistance between the two HF output poles Rmin = 2 M Ω according IEC60601-2-2:2009 section 201.8.4.102

2.11 Function test according to instructions for use Place/Date Inspector/Signatur

Performed:

Responsible Organization

* The listed allowable values comply with the requirements of the IEC 60601-1:2005 + Cor.:2006 + Cor.:2007 + A1:2012 as well as IEC 62353:2014

Fig. 13 Protocollo di manutenzione ordinaria

78