HF generator GN200 and foot switch GN201

1 2

9

3 8 7

6

5

4

GN200

15

GN201

14

13 12 11

10

en

Aesculap® Lektrafuse HF generator GN200 and foot switch GN201 Legend

Date of manufacture

1 Signal lamp HF-ON (surrounding ring) 2 Operating mode selection button (MODE) (middle) 3 Connection socket (foot switch) 4 Signal lamp regrasp 5 Display 6 Signal lamp error 7 Signal ring instrument 8 Connection socket (instrument) 9 Indicator lamp power ON 10 Connection (Equipotential connector) 11 Fuse holder (with 2 fuses) 12 OFF/ON switch 13 Mains power input socket 14 Type plate 15 Ventilation slots

Labeling of electrical and electronic devices according to directive 2012/19/EU (WEEE), see Chapter 12. Order number Batch designation Serial number Delivery quantity Temperature limits during transport and storage

Air humidity limits during transport and storage

Symbols on product and packages

Atmospheric pressure limits during transport and storage

Caution Observe important safety information such as warnings and precautions in the instructions for use. Follow the instructions for use

EAC symbol of the Eurasian Economic Union

Non-sterile medical product

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

“OFF” (power supply)

“ON” (power supply)

Foot switch

Regrasp Type CF applied part, defibrillation-protected Equipotentialization

Fuse Alternating current Non-ionizing radiation

Manufacturer

2

CE-approved in accordance with Directive (EU) 2017/745

Contents 1. 1.1 1.2 2. 2.1 3. 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 4. 4.1 5. 5.1 5.2 5.3

About this document... Scope... Warnings... Safe handling... Safe for use in conformance with IEC regulations... Product description... Scope of supply... Components required for operation... Areas of use and limitations of use... Operating principle... Acoustic warning signal... Monitoring functions... Output power diagrams... Maximum peak output voltage (Up)... Preparation and setup... First use... Working with the Lektrafuse HF generator GN200... System set-up... Function checks... Safe operation...

3 3 3 3 4 5 5 5 5 5 6 6 6 6 7 7 7 7 9 9

en 6. 6.1 6.2 6.3 6.4 6.5 6.6 6.7 7. 8. 8.1 8.2 8.3 8.4 8.5 8.6 8.7 9. 10. 11. 11.1 12.

1.

Reprocessing procedure... General safety information... Reusable products... Preparation before cleaning... Cleaning/disinfection... Wipe disinfection... Inspection, maintenance and checks... Storage and transport... Maintenance... Troubleshooting list... Regrasp error... Warnings... Error reports... Failure messages... Problem solving... User maintenance... Fuse replacement... Technical Service... Accessories/Spare parts... Technical data... Ambient conditions... Disposal...

9 9 9 9 9 10 10 10 11 12 12 12 13 13 14 14 14 14 14 15 15 15

About this document

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

1.1

Scope

This IFUs apply for the Lektrafuse HF generator GN200 and the foot switch GN201. ► For item-specific IFUs as well as material tolerability, 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 Danger. If not avoided, death or severe injuries may result. WARNING 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 set-up, function and operation of the Lektrafuse generator GN200 and is not suitable for initiating a beginner in high-frequency surgery. 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. WARNING Risk of injury and material damage if this product is not used as intended. ► Use the product only for its intended purpose. WARNING Risk of injury and material damage due to improper handling of the product! The Lektrafuse HF generator together with the accessories forms a system. ► Follow the instructions for use of the Lektrafuse HF generator accessories. ► Follow the instructions for use of all products used.

■ General risk factors associated with surgical procedures are not described in this documentation. ■ It is the operating surgeon's responsibility to ensure that the surgical procedure is performed correctly. ■ The operating surgeon must have a thorough understanding of both the hands-on and conceptual aspects of the established operating techniques. ► 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 TA022455. ► The Lektrafuse HF generator GN200 fulfills the requirements of CISPR 11, Class A. ► To prevent damage caused by improper setup or operation, and in order not to compromise warranty and manufacturer liability: – Use the product only according to these instructions for use. – Follow the safety and maintenance instructions. – Only combine Aesculap products with each other. – Adhere to application instructions according to relevant norms, see Chapter 2.1. ► 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. ► Only ever connect the product to power mains with equipment grounding conductor. WARNING Risk of injury from ignition or explosion of flammable gases! Sparks may occur when using the HF generator as directed. ► 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. ► Be sure that no inflammable liquids accumulate under the patient’s body or in body cavities (e.g. the vagina). Before using the HF generator, wipe up all fluids. ► 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. CAUTION Risk of interference with other devices! HF generators 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 generator. CAUTION Restriction to view and/or side-effects due to the development of steam/smoke during HF surgery! ► If necessary, use smoke suction. ► Ensure that the device does not come in direct contact with the patient

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

and HF generator at the same time. 2.1.2

Patient safety

DANGER Danger to life from inadequate preparation or operational errors in the HF generator! ► Be sure that the HF generator 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

DANGER Risk of burns suffered by the patient due to inadvertent activation of the HF generator! ► Switch off the HF generator immediately using the power OFF/ON switch in the event that it is activated accidentally. ► Always work with extreme care when operating the hand switch or the foot switch. DANGER Risk of injury to the patient due to an unintended rise of the HF output voltage due to a fault in the HF generator! ► Stop using the HF surgical device as soon as it shows even the slightest anomaly. WARNING Risk of injury to patients/users due to defective power cord or missing protective ground connections! ► Check the mains power cord/protective ground connections. WARNING Danger of injuries due to muscle contraction, caused by stimulation of the nerves and muscles! ► Work with particular care on sensitive structures. Always be sure to do the following: ► Position the patient in such a way that s/he is not in contact with any metal parts that are grounded or have a significant electric capacity against ground (e.g. operating table, fixtures). If necessary, interpose antistatic drape. ► Ensure that the patient will not be in contact with any damp cloths, drapes or bedding. ► Safeguard areas prone to strong perspiration against skin contact with the trunk of the patient’s body by inserting antistatic tissue between such areas and the trunk. ► Siphon off urine with a catheter. ► Ground the HF generator via the potential equalization connection. ► For patients with cardiac pacemaker or other active implants, consult with the relevant medical specialist prior to applying HF surgery, so that irreparable damage to the pacemaker or implant can be avoided. ► If possible, remove from the vicinity of HF electrodes any electrodes from physiological monitoring devices that are not equipped with protective resistors or HF dampers. ► Do not use needle electrodes for patient monitors. ► Arrange the wires and cables of monitoring devices in such a way that they do not come in contact with the patient’s skin. ► Keep the leads to the HF electrodes as short as possible, and arrange them in such a way that they do not touch the patient or any other wires or cables. ► Should the output power appear insufficient, check that: – the working electrodes are clean, – all plug connections are properly in place. ► Never place the Caiman instrument on or near the patient. ► Put down active electrodes that are not needed at any particular moment, in such a way that they will not touch the patient. ► For operations involving unavoidable, continuous contact between the electrodes and the patient (e.g. endoscopic procedures), press the power OFF/ON switch 12 to switch off the HF generator immediately after any inadvertent activation of the electrode. ► Do not remove hot electrodes from the patient’s body immediately after performing cutting or coagulation procedures.

en ► During operation of the generator, do not touch the electrodes on the

instrument (on the upper or lower side) as the electrodes can heat up and this may lead to burns or injuries. 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.

High frequency surgical device

GN200

Instructions for use

TA022414

Notes on Electromagnetic Compatibility

TA022455

3.2

Components required for operation

■ Power cord ■ Foot switch (optional) ■ Caiman instrument 3.3

Areas of use and limitations of use

3.3.1

Intended use

Lektrafuse HF generator GN200 Caiman Seal & Cut is a bipolar HF sealing system, which consists of the Lektrafuse HF generator and Caiman instruments. The Lektrafuse HF generator is used to convert mains power to HF power based on advanced bipolar technology. Caiman Seal & Cut instruments are only compatible with the Lektrafuse HF generator. The Caiman Seal & Cut system can be used for grasping, preparation, sealing and cutting of tissue, on vessels and vessel bundles with diameters up to and including 7 mm as well as soft tissue. The Caiman Seal & Cut system can be used during open and minimally invasive surgery in general surgical procedures including, but not limited to surgical specialties such as gynecology, urology, bariatric, colorectal and thoracic surgery. Refer to each Caiman Seal & Cut HF instrument’s IFU for additional indications, warnings and contraindications.

3.3.3 Absolute contraindications ■ Caiman Seal & Cut is not suitable for grasping, preparation, sealing and cutting of hard tissue such as bone or cartilage. ■ Caiman Seal & Cut is not approved for tubal sterilization, coagulation of the fallopian tubes, etc. ■ Caiman Seal & Cut is not approved for application on parenchyma tissue of organs. 3.3.4 Relative contraindications Particular caution must be exercised in case of pathological changes of vessels such as atherosclerosis. Since the safe and effective use of bipolar HF sealing systems strongly depends on factors such as tissue type, pathology and surgical procedure, the above information can only be used as a general guidance. The clinically successful application is dependent upon the knowledge and experience of the surgeon, who is responsible for deciding which structures can be reasonably treated and whether the patient’s condition, e.g. the coagulation status, allows a successful treatment while taking into account the safety and warning instructions given in these instructions for use.

3.4

Operating principle

The Lektrafuse HF generator GN200 works on a micro-processor controlled basis and converts the voltage of the mains supply into a high-frequency alternating current for bipolar vessel sealing. The sealing process is carried out via a closed control circuit. The sealing can be started and stopped via a button on the instrument or a foot switch. The Lektrafuse HF generator GN200 has two operating modes: ■ Standard mode: Pre-set operating mode ■ Plus mode: Operating mode with increased energy output

GN201 foot switch The foot switch is intended for use with the Lektrafuse HF generator to trigger the sealing cycle. If necessary, the sealing cycle can also be interrupted by the foot switch. The foot switch is only compatible with the Lektrafuse HF generator. Refer to the Lektrafuse HF generator’s additional indications, warnings and contraindications. 3.3.2 Indications Note The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications. For indications, see Chapter 3.3.1.

5

en 3.5

Acoustic warning signal

Status

Acoustic warning signal

Notes

System failure

3 repetitions of: 1 long beep, 3 KHz, 1 beep, 2 KHz Following each system failure, if identified (F001,...)

REGRASP error

3 repetitions of: 1 beep, 2 KHz, 1 beep, 3 KHz

Following each regrasp error, if identified

System error

3 beeps, 3 KHz

Following each failure report, if identified (E001,...)

System warning

3 beeps, 3 KHz

Following each warning, if identified

Start HF discharge

2 beeps, 480 Hz

When starting the HF discharge

HF discharge active

Beep, 480 Hz

Continually during HF discharge

■ In Standard mode: Repetition with 1.8 Hz ■ In Plus mode: Repetition with 2.8 Hz End of HF discharge

3 beeps, 530 Hz

When a sealing process has been successfully completed (no failure reports or errors)

Power up self-test

1 beep, 2 KHz

During the self-test, in order to check that the signal tone is functioning

3.6

Monitoring functions

3.6.1 Self-test As soon as it is switched on, the unit performs a self-test of the control elements, the acoustic warning signal, the microprocessor and the hardware function. During this phase, the message "Performing Self-Test" appears in the display 5.

Fig. 1 3.6.2 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 generator terminates the HF activation. In display 5, the error number of the corresponding error is displayed and an acoustic warning signal is emitted, see Chapter 8.

3.7

Fig. 3

Output power diagram Caiman 5 mm Seal & Cut instrument family

3.8

Maximum peak output voltage (Up) Note The following data allow the user to judge whether the HF generator GN200 is suitable for a given accessory (insulation rating).

Output power diagrams

Representation of the output power as a function of the load resistance.

WARNING Risk of injury to patient or user caused by inadequate accessories (insulation rating)! ► Make certain that the accessory voltage rating specified in the product documentation is higher than maximum peak output voltage. Maximum peak output voltage (Up) 200 V

Fig. 2

6

Output power diagram Caiman 12 mm Seal & Cut instrument family

en 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. 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 article no. GK535 (4 m length) or TA008205 (0.8 m length).

The voltage of the mains power supply must correspond to the voltage indicated on the type plate of the device. The device is fitted with a universal power supply unit, which means that it automatically adapts to mains voltages ranging from 100 V to 240 V without having to switch between voltage ranges. ► Ensure that the device is switched off. Also switch off with the power OFF/ON switch 12. ► Plug in the power cord in mains power input socket 13 in the rear panel of the HF surgical device. ► Plug in the mains plug at the building mains power socket. Switching on the device ► Switch on the device with the power OFF/ON switch 12. Indicator lamp power ON 9 is illuminated. The device performs a selftest, see Chapter 3.6.2: If no instrument is connected, the message "Attach Instrument" appears in the display 5 after the self-test. If the self-test fails, an error message is shown in the display 5.

► In order to ensure sufficient ventilation and cooling of the HF genera-

tor, leave at least 10 cm to 15 cm of space around the HF generator. The Lektrafuse HF generator is intended for operation and storage in closed spaces.

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.

5.

Working with the Lektrafuse HF generator GN200

5.1

System set-up

5.1.1

Connecting the accessories

Fig. 4 5.1.3 Connecting the foot switch Connecting the GN201 foot switch is optional. Both the foot switch plug and connection socket (foot switch) 3 carry a dot marking. To connect the plug to the connection socket correctly, these markings must be aligned.

DANGER Risk of injury due to unapproved configuration using additional components! ► For all applied components, ensure that their classification matches that of the application component (e.g. Type BF or Type CF) of the respective device. Combinations of accessories that are not mentioned in the present instructions for use may only be employed if they are specifically intended for the respective application, and if they do not compromise the performance and safety characteristics of the products. Only CAIMAN instruments can be used in connection with the Lektrafuse HF generator GN200, see Chapter 10. 5.1.2

Connecting the power supply

DANGER Risk of death from electric shock! ► Only ever connect the product to power mains with equipment grounding conductor. ► Set up the device in such a way that switching it off using the power OFF/ON switch is possible and straightforward. ► Set up the device in such a way that disconnecting the power cord is straightforwardly possible.

Fig. 5

7

en ► Adjust the foot switch plug and insert it into the foot switch connec-

tion socket 3 until it engages. When the device and the foot switch have been successfully connected, the message "Footswitch attached" appears for 3 seconds in the display 5.

► Connect the instrument with the connection socket 8.

The green signal ring 7 around the instrument connector lights up. The message "Ready to Seal" appears in the display 5.

Fig. 9 Fig. 6 Note Do not activate the foot switch continually during HF discharge. HF discharge is started and stopped by pressing once on the foot switch and then letting go. 5.1.4

Removing the foot switch

► Turn the locking ring counter-clockwise and withdraw the connecting

plug at the same time The message "Footswitch removed" appears in the display 5 for 3 seconds.

5.1.6 Selecting the operating mode The Lektrafuse HF generator has two operating modes for the sealing process. The selected operating mode will be retained until the HF generator is switched off. The operating mode can be changed during the procedure. ► Changing the operating mode: Press operating mode selection button (MODE) 2. ■ Standard mode: Pre-set operating mode ■ Plus mode: Operating mode with increased energy output The set operating mode is independent from the connected instrument. Changing or reconnecting the instrument does not change the set operating mode. The active operating mode is indicated in the display as follows: ■ Border ■ Bold font

Fig. 7 5.1.5 Connecting the instrument Only instruments of the CAIMAN Seal & Cut product family can be used in conjunction with the Lektrafuse HF generator GN200. The instrument connector has an arrow marking and the connection socket 8 has a dot marking. To connect the plug to the connection socket correctly, these markings must be aligned.

Fig. 10

Fig. 11 Note In case of a regrasp error, the active operating mode is not displayed. The active operating mode can be displayed by pressing the operating mode selection button (MODE) 2. Note The Plus mode can be distinguished from Standard mode by the higher frequency of the beep during HF discharge. 5.1.7 Decommissioning ► Switch off the device with the power OFF/ON switch 12. All the poles of the device are disconnected from the power supply. ► Withdraw mains cable.

The device is completely disconnected from the power supply.

Fig. 8

8

en 5.2

Function checks

Prior to each use, carry out a functional test of the device: ► Check that the accessories have no visible damage. ► Prepare and set up the unit, see Chapter 4. ► Test the functionality of the following elements in the order shown: – Switch on the power OFF/ON switch 12; the power on signal lamp 9 lights up – Automatic self-test after switching on each time: brief acoustic signal, all display elements light up briefly. – Operating mode selection, see Chapter 5.1.6 – Foot switch, see Chapter 5.1.3 – Instrument, see Chapter 5.1.5 – Activation with instrument button and foot switch – Switch off the power OFF/ON 12 switch

5.3

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. ► Start the sealing process (HF discharge) by pressing the button on the

instrument or foot switch once. After completing the sealing process, the HF discharge is automatically stopped. During sealing process, the message "Sealing in Progress" is shown on the display 5.

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

► Disconnect the unit from mains power. ► Remove accessories.

6.4

Cleaning/disinfection

6.4.1

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.

Fig. 12 5.3.1 To activate/deactivate device ► Switch on/switch off the device with the power OFF/ON switch 12. 5.3.2 Operating mode The Lektrafuse HF generator GN200 automatically recognizes the connected instrument. The internal device settings are loaded. The user can choose between two operating modes. 5.3.3

6.

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

Activating the HF current

► Be sure that the patient is prepared in such a way that the HF generator

can be applied without any risk to the patient. ► Make sure that the required operating mode is selected. ► Ensure that the instrument and foot switch, if used, are correctly con-

nected. ► Activate the HF generator via the hand switch or the foot switch. ► Do not activate the hand switch or foot switch continually during HF

discharge. Note The vessel sealing process is started and ended by pressing the foot switch or hand switch on the instrument once. After completing the sealing process, the device stops the HF discharge automatically. The sealing process can be interrupted by repeatedly pressing the button. 9

en 6.5

Wipe disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Cleaning

RT

1

-

-

Alcohol(s), quaternary compound(s)*

II

Wipe disinfection

RT

≥1

-

-

Alcohol(s), quaternary compound(s)*

RT: *

Room temperature Recommended: 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. ► Set aside the product if it is damaged. ► Perform a safety inspection annually, see Chapter 7.

6.7

Storage and transport

CAUTION Damage to the product caused by switch-on too early after storage/transport at temperature below +10 °C (50 °F)! ► Allow the HF generator to acclimate at room temperature for about 1 hour. ► Transport the product only in its original box. ► For storage and transport conditions, see Chapter 11.1.

10

en 7.

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

No servicing is required for the Lektrafuse HF generator GN200.

possess the requisite training, knowledge and experience and who are authorized to do so. ► If there are significant deviations from the inspection protocol values, or if the prescribed maximum values are exceeded: Send in the device. For technical service, please contact your national B. Braun/Aesculap agency, see Chapter 9.

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.

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

1 Year Bipolar Electrosurgical Unit GN200 Aesculap AG, Am Aesculap-Platz 78532 Tuttlingen/Germany

RESPONSIBLE SN: ... INVENTORY NO.: ... ORGANIZATION: ... Measurement equipment: ... S C O P E O F I N S PE C T I O N

Verdict

1.) VISUAL INSPECTION 1.1 1.2 1.3 1.4 1.5

2.) ELECTRICAL INSPECTION 2.1 2.2 2.3 2.4 2.5 2.6

Protective earth resistance incl. mains cable

N.C. S.F.C. N.C. S.F.C. N.C. S.F.C.

according IEC60601-1*

Enclosure leakage current/touch current according IEC60601-1*

Patient leakage current according IEC60601-1*

Equipment leakage current - alternative method Applied part leakage current - alternative method

Verdict Pass / Fail

Insulation resistance

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 = 0,05 mA

according IEC62353:2007

2.8

Imax = 122 mA

according IEC60601-2-2:2009 according IEC62353:2007 (Preparation according Service Manual)

2.8.1 Mains against HF output 2.8.2 Mains against housing 2.8.3 HF-output against housing HF-output power measurement with induction-free resistor Instrument Channel RLoad C5 1 50 Ω C12 1 50 Ω 2 50 Ω DC resistance between the two HF output poles according IEC60601-2-2:2009 section 201.8.4.102

2.11

Measured value

Imax = 1,00 mA

according IEC62353:2007

HF-leakage current bipolar

2.10

FAIL

Rmax= 0,3 Ω (at ≥ 0,2 A)

according IEC62353:2007

Earth leakage current

2.7

2.9

PASS

Inspection of power cable for visually detectable damage Inspection of foot switch for visually detectable damage Type plate still present and readable Check fuse links for prescribed values Overall condition of device: dirt, damage

test voltage = 500 V DC

Rmin = 7 MΩ Rmin = 2 MΩ Rmin = 2 MΩ Rated value 145 Watt ± 20 % 150 Watt ± 20 % 150 Watt ± 20 % Rmin = 2 MΩ

Function test according to instructions for use

Performed:

T E S T R E S UL T No

Deficiencies were determined, by which patient, user or other individuals can be endangered

Repair Place/Date

…………………………………………………….. Inspector/Signature

Yes

Next date of inspection

Responsible Organization

* The listed allowable values comply with the requirements of the IEC60601-1:2005 + Cor.:2006 + Cor.:2007 + A1:2012 and IEC 62353:2014

Fig. 13 Servicing protocol

11

en 8.

Troubleshooting list

8.1

Regrasp error

A regrasp error, i.e. potentially insufficient sealing of the vessels, is displayed as follows: ■ Unambiguous sound sequence and interruption of the sound sequence of HF operation, also stops HF discharge ■ The yellow regrasp error light 4 on the front side of the HF generator lights up ■ Warning message in the display 5 on the front side of the HF generator Regrasp error message

Significance

Remedy

REGRASP INDICATOR – OPEN Visually check seal – Manually cut - Clean jaws OR Regrasp thicker tissue

Check the vessel sealing. Contact areas of the jaw part must be covered with dried vessel residue or bodily fluids. - or The gripped bundle of tissue is too thin

Clean contact areas with sterile water and a sponge Grip a thicker tissue bundle

REGRASP INDICATOR – SHORT Visually check seal – Manually cut Check for metal or occlusion in jaw Remove excess fluids

There is metal (e.g. staples) or other foreign material between the electrodes in the jaw part

Open and check jaw part Remove any foreign material Remove excess suction fluids in the operating area

REGRASP INDICATOR – TIME Visually check seal – Reseal as needed Seal cycle interrupted Seal endpoint not reached

HF generator has reached its maximum sealing time and has not ascertained any complete seal - or The user has ended HF discharge during sealing

Check the quality of the seal

► Check the sealed vessel.

Note In case of a regrasp error, the active operating mode is not displayed. The active operating mode can be displayed by pressing the operating mode selection button (MODE) 2.

Procedure if a regrasp error occurs: ► Do not cut the vessel. ► Open the instrument.

When correct hemostasis has occurred:

► Start the additional HF cycle.

► Cut the vessel manually with surgical scissors.

► If the additional HF cycle leads to a normal seal, the vessel can be cut,

When hemostasis has not occurred in the correct way: ► Lay the instrument on the vessel again, lock it in place and seal.

► If a regrasp error occurs again, do not cut the vessel, open the instru-

Note The regrasp error must not be confirmed. Activating the hand switch or foot switch will start the next sealing process immediately.

8.2

and the instrument can be opened and removed. ment and manually cut the sealed vessel with surgical scissors. When so doing, ensure that the hemostasis is correct.

Warnings

A warning is indicated as follows: ■ Individual tone (different from a failure, an error or normal HF operation) ■ Warning message in the display 5 on the front side of the HF generator Warning message

Significance

Remedy

Generator Cooling Please Wait

Excess generator temperature

Check the airflow around the generator

Generator Too Cold Please Wait

Generator must first warm up

Do not switch off the generator whilst it is warming up

12

en 8.3

Error reports

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

Error report

Significance

Remedy

E001

ERROR E001 Instrument HF activation button error Release Instrument RF-ON Button Remove and reattach instrument

Instrument "HF activation" button is pressed while the instrument is connected to the HF generator

Release the “HF activation" button Remove instrument and reconnect it

E002

ERROR E002 Instrument Error Remove and reattach OR Remove and replace instrument

HF generator cannot find instrument Remove instrument and reconnect it - or - or Instrument is defective and must be replaced Replace instrument

E003

ERROR E003 Footswitch Error Release footswitch Remove and reattach footswitch

Foot switch is pressed while the foot switch is connected to the HF generator

8.4

Release the foot switch Remove foot switch and reconnect it

Failure messages

A failure is indicated as follows: ■ Clear sound sequence (as necessary, may interrupt the sound of the HF discharge) ■ The red error light 6 on the front side of the HF generator lights up ■ Error message in the display 5 on the front side of the HF generator Note If the failure occurs during HF discharge, the vessel sealing may be incomplete or insufficient. In order to ensure that sufficient hemostasis has been achieved, follow the procedure for regrasp errors, see Chapter 8.1. Note If the error continues after turning the device off and on again twice, contact your B. Braun/Aesculap national representative. see Chapter 9. Failure code

Cause

Remedy

F001

Software error on the HF generator

Switch off HF generator, wait 5 s, switch HF generator on

F002

Dosage error of HF generator

Switch off HF generator, wait 5 s, switch HF generator on

F003

Hardware error

Switch off HF generator, wait 5 s, switch HF generator on

F004

Internal communication error of the HF generator

Switch off HF generator, wait 5 s, switch HF generator on

F005

Overheating of HF generator

Switch off HF generator and leave to cool Check the air stream around the generator

F006

Error in the operating mode selection button (MODE) 2 (activated when switching on)

Switch off HF generator, wait 5 s, release operating mode selection button (MODE) 2, switch HF generator on

F007

Error with HF energy output

Switch off HF generator, wait 5 s, switch HF generator on

F008

Fault: HF outside the calibration

Switch off HF generator, wait 5 s, switch HF generator on

F009

Fault: Internal power supply

Switch off HF generator, wait 5 s, switch HF generator on

13

en 8.5

Problem solving

Finding

Remedy

HF generator does not switch on

Ensure that the power cord has been correctly plugged into the power supply 13 of the HF generator. Ensure that the power cord is connected to a functioning power source. Ensure that the power OFF/ON switch 12 of the HF generator is in the power ON position. Check the fuse in the fuse box and replace if necessary, see Chapter 8.7. If the error continues, replace power cord.

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

Switch off HF generator, wait 5 s, switch HF generator on again. If the error continues, contact your B. Braun/Aesculap national representative. see Chapter 9.

Self-test fails

Switch off HF generator, wait 5 s, switch HF generator on again. If the error continues, contact your B. Braun/Aesculap national representative. see Chapter 9.

HF generator is active (power ON signal lamp 9 lights up), and accessories are connected, but there is no HF discharge

Verify that the required foot switch (if used) is properly connected and plugged in. Ensure that the Caiman Seal & Cut Instrument is correctly connected and plugged in (green ring 1 is lit up). In order to start the HF discharge, activate the button on the instrument or the foot control. If the error continues, replace Caiman instrument.

8.6

User maintenance

9.

Technical Service

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

code. ► If the error continues after following the instructions in the display, contact your national B. Braun/Aesculap agency, see Chapter 9.

8.7

Fuse replacement

DANGER Risk of death by electric shock! ► Unplug the device before changing the fuses! Specified fuses: 2 units Aesculap art. no. TA021404: G fuse link, time lag (T) 8 A, breaking capacity H (1 500 A) ► Use a small screwdriver to release the clip on the fuse holder 11 and tilt up cover. ► Use a small screwdriver to release the fuse holder 11 and pull it out. ► Replace both fuses. ► Reinsert the fuse holder 11. ► Close the cover.

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. ► 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.

10. Accessories/Spare parts Art. no.

Designation

Fig. 14

TA021404

Fuse

Note If the fuses burn out frequently, the device is faulty and should be repaired. see Chapter 9.

–

Caiman 5 instrument family

–

Caiman 12 instrument family

GN201

Foot switch

Note Other accessories, applied parts and replacement parts are described in Aesculap brochure C-304-81 and C-902-02

14

en 11. Technical data Classification acc. to Directive (EU) 2017/745 Art. no.

Designation

Class

GN200

High frequency surgical device

IIb

GN201

Foot switch

IIb

Note After transporting or storing at temperature outside the operating temperature range, leave the HF generator for one hour before use so that it can reach room temperature.

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.

Performance data, information about standards Mains voltage ranges (Current intake)

100V~–240 V~ (6.7 A–2.8 A)

Frequency

50–60 Hz

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

I

Foot switch circuitry

ignition-safe acc. to IEC/DIN EN 60601, approved for use in “medical environment”

Output power

2 x 150 W on 50 Ohm

Device protection Time-Current characteristic Breaking capacity Construction

T8 AH/250 V T (Time lag) H (1 500 A) 5 mm x 20 mm

HF operating frequency

460 kHz ± 1 %, Quasi-Sinus

Operating mode

Int 10 s/30 s

Weight

8.1 kg

Dimensions (L x W x H)

400 mm x 355 mm x 100 mm

Application part type acc. to IEC/DIN 60601-1

CF

Recovery time of the defibrillation-protected output

0 seconds

CISPR11

Class A

EMC

IEC/DIN EN 60601-1-2

Conforming to standard

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

Note The user institution is obliged to process the product before its disposal, see Chapter 6. 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 Chapter 9.

11.1 Ambient conditions Operation

Storage and transport

Temperature

50 -10

Relative humidity

90 10

non-condensing

non-condensing

Atmospheric pressure

Note The atmospheric pressure of 700 hPa corresponds to a maximum operating altitude of 3 000 m. 15

fr 7.

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

Le générateur HF Lektrafuse GN200 ne demande aucun entretien quotidien.

sonnes disposant de la formation, des connaissances ou de l’expérience requises et qui peuvent effectuer le contrôle de manière indépendante. ► En cas d’écarts importants par rapport aux valeurs du procès-verbal de réception finale ci-joint ou lorsque les valeurs maximales sont dépassées: renvoyer l’appareil. Pour les prestations de service correspondantes, veuillez-vous adresser au représentant B. Braun/Aesculap national. voir Chapitre 9.

Remarque La révision d’entretien ne doit être confiée qu’à un personnel autorisé. Au besoin, les schémas électriques et le manuel d’entretien, dans lequel figurent tous les documents nécessaires, sont disponibles. 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.

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

1 Year Bipolar Electrosurgical Unit GN200 Aesculap AG, Am Aesculap-Platz 78532 Tuttlingen/Germany

RESPONSIBLE SN: ... INVENTORY NO.: ... ORGANIZATION: ... Measurement equipment: ... S C O P E O F I N S PE C T I O N

Verdict

1.) VISUAL INSPECTION 1.1 1.2 1.3 1.4 1.5

2.2 2.3 2.4 2.5 2.6

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 Applied part leakage current - alternative method

Insulation resistance

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 = 0,05 mA

according IEC62353:2007

2.8

Imax = 122 mA

according IEC60601-2-2:2009 according IEC62353:2007 (Preparation according Service Manual)

2.8.1 Mains against HF output 2.8.2 Mains against housing 2.8.3 HF-output against housing HF-output power measurement with induction-free resistor Instrument Channel RLoad C5 1 50 Ω C12 1 50 Ω 2 50 Ω DC resistance between the two HF output poles according IEC60601-2-2:2009 section 201.8.4.102

2.11

Verdict Pass / Fail

Imax = 1,00 mA

according IEC62353:2007

HF-leakage current bipolar

2.10

Measured value

Rmax= 0,3 Ω (at ≥ 0,2 A)

according IEC62353:2007

2.7

2.9

FAIL

Inspection of power cable for visually detectable damage Inspection of foot switch for visually detectable damage Type plate still present and readable Check fuse links for prescribed values Overall condition of device: dirt, damage

2.) ELECTRICAL INSPECTION 2.1

PASS

test voltage = 500 V DC

Rmin = 7 MΩ Rmin = 2 MΩ Rmin = 2 MΩ Rated value 145 Watt ± 20 % 150 Watt ± 20 % 150 Watt ± 20 % Rmin = 2 MΩ

Function test according to instructions for use

Performed:

T E S T R E S UL T No

Deficiencies were determined, by which patient, user or other individuals can be endangered

Repair Place/Date

…………………………………………………….. Inspector/Signature

Yes

Next date of inspection

Responsible Organization

* The listed allowable values comply with the requirements of the IEC60601-1:2005 + Cor.:2006 + Cor.:2007 + A1:2012 and IEC 62353:2014

Fig. 13 Protocole de maintenance

39

es 7.

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

El generador AF Lektrafuse GN200 no necesita mantenimiento.

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 al fabricante. Si el producto necesita alguna reparación diríjase al representante de B. Braun/Aesculap de su país, ver Capítulo 9.

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.

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

1 Year Bipolar Electrosurgical Unit GN200 Aesculap AG, Am Aesculap-Platz 78532 Tuttlingen/Germany

RESPONSIBLE SN: ... INVENTORY NO.: ... ORGANIZATION: ... Measurement equipment: ... S C O P E O F I N S PE C T I O N

Verdict

1.) VISUAL INSPECTION 1.1 1.2 1.3 1.4 1.5

2.2 2.3 2.4 2.5 2.6

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 Applied part leakage current - alternative method

Insulation resistance

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 = 0,05 mA

according IEC62353:2007

2.8

Imax = 122 mA

according IEC60601-2-2:2009 according IEC62353:2007 (Preparation according Service Manual)

2.8.1 Mains against HF output 2.8.2 Mains against housing 2.8.3 HF-output against housing HF-output power measurement with induction-free resistor Instrument Channel RLoad C5 1 50 Ω C12 1 50 Ω 2 50 Ω DC resistance between the two HF output poles according IEC60601-2-2:2009 section 201.8.4.102

2.11

Verdict Pass / Fail

Imax = 1,00 mA

according IEC62353:2007

HF-leakage current bipolar

2.10

Measured value

Rmax= 0,3 Ω (at ≥ 0,2 A)

according IEC62353:2007

2.7

2.9

FAIL

Inspection of power cable for visually detectable damage Inspection of foot switch for visually detectable damage Type plate still present and readable Check fuse links for prescribed values Overall condition of device: dirt, damage

2.) ELECTRICAL INSPECTION 2.1

PASS

test voltage = 500 V DC

Rmin = 7 MΩ Rmin = 2 MΩ Rmin = 2 MΩ Rated value 145 Watt ± 20 % 150 Watt ± 20 % 150 Watt ± 20 % Rmin = 2 MΩ

Function test according to instructions for use

Performed:

T E S T R E S UL T No

Deficiencies were determined, by which patient, user or other individuals can be endangered

Repair Place/Date

…………………………………………………….. Inspector/Signature

Yes

Next date of inspection

Responsible Organization

* The listed allowable values comply with the requirements of the IEC60601-1:2005 + Cor.:2006 + Cor.:2007 + A1:2012 and IEC 62353:2014

Fig. 13 Protocolo de puesta a punto

53

it 7.

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

Il generatore HF Lektrafuse GN200 non richiede interventi di manutenzione.

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 relativi servizi di assistenza rivolgersi al rappresentante B. Braun/Aesculap nazionale, vedere Capitolo 9.

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.

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

1 Year Bipolar Electrosurgical Unit GN200 Aesculap AG, Am Aesculap-Platz 78532 Tuttlingen/Germany

RESPONSIBLE SN: ... INVENTORY NO.: ... ORGANIZATION: ... Measurement equipment: ... S C O P E O F I N S PE C T I O N

Verdict

1.) VISUAL INSPECTION 1.1 1.2 1.3 1.4 1.5

2.2 2.3 2.4 2.5 2.6

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 Applied part leakage current - alternative method

Insulation resistance

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 = 0,05 mA

according IEC62353:2007

2.8

Imax = 122 mA

according IEC60601-2-2:2009 according IEC62353:2007 (Preparation according Service Manual)

2.8.1 Mains against HF output 2.8.2 Mains against housing 2.8.3 HF-output against housing HF-output power measurement with induction-free resistor Instrument Channel RLoad C5 1 50 Ω C12 1 50 Ω 2 50 Ω DC resistance between the two HF output poles according IEC60601-2-2:2009 section 201.8.4.102

2.11

Verdict Pass / Fail

Imax = 1,00 mA

according IEC62353:2007

HF-leakage current bipolar

2.10

Measured value

Rmax= 0,3 Ω (at ≥ 0,2 A)

according IEC62353:2007

2.7

2.9

FAIL

Inspection of power cable for visually detectable damage Inspection of foot switch for visually detectable damage Type plate still present and readable Check fuse links for prescribed values Overall condition of device: dirt, damage

2.) ELECTRICAL INSPECTION 2.1

PASS

test voltage = 500 V DC

Rmin = 7 MΩ Rmin = 2 MΩ Rmin = 2 MΩ Rated value 145 Watt ± 20 % 150 Watt ± 20 % 150 Watt ± 20 % Rmin = 2 MΩ

Function test according to instructions for use

Performed:

T E S T R E S UL T No

Deficiencies were determined, by which patient, user or other individuals can be endangered

Repair Place/Date

…………………………………………………….. Inspector/Signature

Yes

Next date of inspection

Responsible Organization

* The listed allowable values comply with the requirements of the IEC60601-1:2005 + Cor.:2006 + Cor.:2007 + A1:2012 and IEC 62353:2014

Fig. 13 Protocollo di manutenzione ordinaria

67

pt 7.

Manutenção ► Os produtos e os acessórios só podem ser verificados por pessoas que

O gerador de AF Lektrafuse GN200 não necessita de manutenção.

disponham da necessária formação, conhecimentos ou experiência e que possam executar a verificação independentemente de ordens de terceiros. ► No caso de grandes desvios aos valores constantes no protocolo de aceitação final, em anexo, ou quando os valores máximos indicados forem ultrapassados: enviar o aparelho. Para os respetivos serviços de manutenção entre em contacto com o seu representante local nacional da B. Braun//Aesculap, ver Capítulo 9.

Nota A conservação apenas pode ser efectuada por profissionais autorizados. Se necessário, são disponibilizados esquemas de circuitos e o manual de assistência, onde se encontram todos os documentos necessários. A manutenção deve ser realizada uma vez por ano. O inspector documentará os resultados do controlo e os valores medidos, de acordo com o protocolo de verificação.

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

1 Year Bipolar Electrosurgical Unit GN200 Aesculap AG, Am Aesculap-Platz 78532 Tuttlingen/Germany

RESPONSIBLE SN: ... INVENTORY NO.: ... ORGANIZATION: ... Measurement equipment: ... S C O P E O F I N S PE C T I O N

Verdict

1.) VISUAL INSPECTION 1.1 1.2 1.3 1.4 1.5

2.) ELECTRICAL INSPECTION 2.1 2.2 2.3 2.4 2.5 2.6

Protective earth resistance incl. mains cable

N.C. S.F.C. N.C. S.F.C. N.C. S.F.C.

according IEC60601-1*

Enclosure leakage current/touch current according IEC60601-1*

Patient leakage current according IEC60601-1*

Equipment leakage current - alternative method Applied part leakage current - alternative method

Verdict Pass / Fail

Insulation resistance

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 = 0,05 mA

according IEC62353:2007

2.8

Imax = 122 mA

according IEC60601-2-2:2009 according IEC62353:2007 (Preparation according Service Manual)

2.8.1 Mains against HF output 2.8.2 Mains against housing 2.8.3 HF-output against housing HF-output power measurement with induction-free resistor Instrument Channel RLoad C5 1 50 Ω C12 1 50 Ω 2 50 Ω DC resistance between the two HF output poles according IEC60601-2-2:2009 section 201.8.4.102

2.11

Measured value

Imax = 1,00 mA

according IEC62353:2007

HF-leakage current bipolar

2.10

FAIL

Rmax= 0,3 Ω (at ≥ 0,2 A)

according IEC62353:2007

Earth leakage current

2.7

2.9

PASS

Inspection of power cable for visually detectable damage Inspection of foot switch for visually detectable damage Type plate still present and readable Check fuse links for prescribed values Overall condition of device: dirt, damage

test voltage = 500 V DC

Rmin = 7 MΩ Rmin = 2 MΩ Rmin = 2 MΩ Rated value 145 Watt ± 20 % 150 Watt ± 20 % 150 Watt ± 20 % Rmin = 2 MΩ

Function test according to instructions for use

Performed:

T E S T R E S UL T No

Deficiencies were determined, by which patient, user or other individuals can be endangered

Repair Place/Date

…………………………………………………….. Inspector/Signature

Yes

Next date of inspection

Responsible Organization

* The listed allowable values comply with the requirements of the IEC60601-1:2005 + Cor.:2006 + Cor.:2007 + A1:2012 and IEC 62353:2014

Fig. 13 Protocolo de conservação

81