VERSAPOINT II BIOMED Service Manual Feb 2011

BIOMED SERVICE MANUAL Electrosurgical Generator VERSAPOINT II Model 797000

1 2

CONTACT LIST ... 3 INTRODUCTION ... 4

2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 3

SYSTEM DESCRIPTIONS ... 8

3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 3.10 3.10.1 3.10.2 3.10.3 4

Principles of Operation and Generator outputs. ... 8 Generator Internal description ... 8 Functional Description ... 9 Power Supply Unit PSU... 10 Dual RF Board ... 10 Central Processing Unit CPU Board ... 11 ID/TC/Handswitch Board ... 11 Relay Board ... 12 External Connections ... 12 Generator General Description ... 13 Overview ... 13 PKRF Principles of Operation ... 14 VPRF Principles of Operation ... 15 SERVICE PROCEDURES ... 19

4.1 4.2 4.3 4.4 4.5 5

Intention ... 4 Purpose of document... 4 Electrosurgery ... 5 Legal notices and copyright ... 5 Use of this document ... 6 Equipment Safety ... 6 Diagnostic Test Equipment ... 7 Working Practises ... 7

Periodic Service ... 19 RF output & RF leakage checks general preamble ... 19 Fabrication of a versapoint II rf output testlead ... 21 VERSAPOINT II RF output check... 21 Mains electrical safety checks ... 24 FIRSTLINE GENERATOR FAULT DIAGNOSIS ... 26

5.1 Fault Type Interpretation ... 26 5.2 Fault Type ... 26 5.3 First Line Generator Fault Diagnosis Categories... 27 5.4 POST Faults With No Accessories Connected ... 27 5.5 Idle Condition Faults With No Accessories Connected ... 28 5.6 Faults Associated With Electrode Accessories ... 28 5.7 Faults Associated With Wired Footswitches ... 29 5.8 Faults Associated With Wireless Footswitches ... Error! Bookmark not defined. 5.9 Faults Occurring During Activation ... 29 5.10 Complaints Of Poor Tissue Effect ... 30 5.11 Error Code List ... 31 5.12 Generator Disassembly ... 37 6 7

DECONTAMINATION OF RETURNED PRODUCT ... 37 GENERATOR SERVICE REPORT ... 38

BIOMED SERVICE MANUAL 897105-AA

04 Feb 2011

Page 2 of 39

Gyrus ACMI Confidential

BIOMED SERVICE MANUAL Electrosurgical Generator VERSAPOINT II Model 797000

1 CONTACT LIST Customer Service USA

Customer Service Europe

Ethicon place contact details here

Ethicon place contact details here

Customer Service Eurasia Ethicon place contact details here

BIOMED SERVICE MANUAL 897105-AA

04 Feb 2011

Page 3 of 39

Gyrus ACMI Confidential

BIOMED SERVICE MANUAL Electrosurgical Generator VERSAPOINT II Model 797000

2 INTRODUCTION 2.1

INTENTION This document is provided to Ethicon as a template for a Biomedical Engineer Service manual for the Versapoint II generator. It is anticipated that Ethicon will copy much of its contents into their own format. This document will be provided to Ethicon under controlled distribution such that any changes made will be relayed to Ethicon automatically. Normally Biomed service manuals issued to Biomedical Engineers are not under change control so it is the responsibility of the reader to ensure they have the latest issue. Contacts should be provided for this purpose but are left blank in this document. This document must be used in conjunction with the VERSAPOINT II Operating Manual, which is shipped with all new VERSAPOINT II generators. It is assumed that all service personnel are familiar with and understand the contents of the operator manual.

2.2

PURPOSE OF DOCUMENT This service manual is intended expressly for use by qualified biomedical engineers to perform basic output checks and safety tests to establish product conformity for the purpose of commissioning, acceptance testing or annual maintenance. There are no user serviceable parts inside the generator. Ethicon recommends that VERSAPOINT II generators be inspected at least every 12 months to ensure continued safety of operation. The “case open” calibration and repair requirements will be met by utilising appointed service centres. Possession of this document does not constitute the right to perform any repair related work upon VERSAPOINT II electro-surgical generators. Any persons making use of this document to inspect or test the electro-surgical equipment so described will be expected to have attained an appropriate level of technical knowledge and skill such that all work is carried out in a fashion that neither constitutes a risk to the personal health of the service engineer nor compromises the electrical safety of the equipment. The use of this document for the test and safety check tasks must be carried out utilising appropriate items of test equipment. At all times, the persons carrying out these functions must be aware of the implications of end user and patient safety.

BIOMED SERVICE MANUAL 897105-AA

04 Feb 2011

Page 4 of 39

Gyrus ACMI Confidential

BIOMED SERVICE MANUAL Electrosurgical Generator VERSAPOINT II Model 797000

2.3

ELECTROSURGERY

The equipment described within this document is an electrosurgical generator. Electrosurgery functions by applying high frequency electrical power to the patient under surgeon command. In some instances, electrical powers of 200W or more can be applied to the patient to implement the requisite tissue effect. The user is referred to the instrument rear label and user manual for applicable specifications pertaining to this device. All applied parts, cables and handpieces used within the vicinity of the operating table will be sterilised. The electro-surgical generator and footswitch are considered non-sterile. Since electro-surgery involves the application of direct electrical energy to the patient, this will naturally constitute a potential hazard in the case of equipment malfunction. In common with all other approved systems, the design and construction of the VERSAPOINT II generators have been subjected to rigorous safety tests. Each generator has undergone a stringent test regime during its manufacture and ensures that any generator will possess a commensurate level of safety integrity. 2.4

LEGAL NOTICES AND COPYRIGHT Ethicon authorises the copying of the pro-forma sheets for the sole purpose of recording the servicing activity. The material presented within this document is provided for reference purposes only. All reasonable effort has been made to ensure that its content is accurate and factual. Ethicon does not warrant or make any representations or conditions regarding the use, validity, completeness, accuracy, or reliability of, or otherwise respecting, the information contained in this manual. Under no circumstances will Ethicon or any of their affiliated organisations be held liable for any personal injury, commercial loss or loss of profit, whether real, consequential or prospective, which is claimed to be due to be resulting from the use of this document. The information contained in this manual is subject to change at any time without notice. Later editions of this manual will contain revised and updated material. Any third party undertaking VERSAPOINT II generator testing must agree to comply with all pertinent regulatory issues in respect of the maintenance of the equipment. This may encompass mandatory compliance with those aspects of Ethicon ’s quality system dealing with generator service. Ethicon does not accept any responsibility for any VERSAPOINT II generator which has been subject to any unauthorised repair or modification by a third party or end user.

BIOMED SERVICE MANUAL 897105-AA

04 Feb 2011

Page 5 of 39

Gyrus ACMI Confidential

BIOMED SERVICE MANUAL Electrosurgical Generator VERSAPOINT II Model 797000

Generator warranty is void once the lid seal is broken unless permission is granted in advance to allow the breaking of the seal. All liability, howsoever arising, is transferred to the customer if a device is opened, repaired or modified in any way by non-authorised personnel and the end user or other third party by its conduct shall be deemed to have agreed to indemnify and hold harmless Ethicon for any liability, costs, expenses, or losses which may arise as a result of the end user’s or third party’s action. The exclusions, restrictions and limitations contained in this manual are intended to operate to the greatest extent permitted by any and all applicable laws

2.5

USE OF THIS DOCUMENT

An aid to performing basic output/safety tests & first line fault diagnosis. It is strongly recommended that any testing effort uses the tests outlined in the succeeding section. 2.6

EQUIPMENT SAFETY CAUTION:

Any attempt to first line diagnose a generator should only be carried out by a suitably qualified person who has adequate training, knowledge and practical experience.

WARNING:

Every precaution should be taken to avoid contact with the generator internal components whilst switched on, especially on the non-isolated side of the PSU board. Working on any live equipment is potentially dangerous.

BIOMED SERVICE MANUAL 897105-AA

04 Feb 2011

Page 6 of 39

Gyrus ACMI Confidential

BIOMED SERVICE MANUAL Electrosurgical Generator VERSAPOINT II Model 797000

2.7

DIAGNOSTIC TEST EQUIPMENT

The list of recommended test equipment to perform the routine checks of the generator is as follows: 1. Approved Electro-surgical analyser* ++ 2. Approved instrument (IEC60601) to perform equipment safety tests 3. Biomed test cable VERSAPOINT II. Where applicable the equipment must have a recognised calibration certificate. *The VERSAPOINT II has RF output modalities that are very difficult for most electro-surgical analysers to measure. The technical authority has stated that testing the continuous wave output modalities of the generator are sufficient to confirm equipment functionality. ++ Ethicon recommends the use of a Fluke 8920A True RMS RF voltmeter or BC Biomedical ESU 2050, non-inductive load resistors and Pearson Current Transformer model 411 to measure the current output of the generator and calculate the delivered power. The 411 current transformer has a transfer function of 100mV per Amp. The calculated delivered power may be derived from:

Pm = (10*IV)2 * RL Where : Pm is the measured power in Watts IV is the voltage measurement on the Fluke 8920A representing true RMS current (volts) RL is the non-inductive load resistor in ohms Example

100W = (10 * 81.7x10-3V)2 * 150Ω 2.8

WORKING PRACTISES FUSES There are two mains fuses fitted to the generator; care must be taken to ensure any replacements fitted are approved types directly equivalent to the ones originally supplied by the manufacturer. The fuse details are on the rear panel label. ESD PRECAUTIONS The generator contains electrostatic discharge sensitive components. Care should be taken to minimise the risk of electrostatic discharge.

BIOMED SERVICE MANUAL 897105-AA

04 Feb 2011

Page 7 of 39

Gyrus ACMI Confidential

BIOMED SERVICE MANUAL Electrosurgical Generator VERSAPOINT II Model 797000

3 SYSTEM DESCRIPTIONS 3.1

PRINCIPLES OF OPERATION AND GENERATOR OUTPUTS. The reader is referred to the operator manual.

3.2

GENERATOR INTERNAL DESCRIPTION The VERSAPOINT II generator casework is comprised of the front fascia, rear panel, top and bottom panels, side extrusions and isolation board. The main generator Printed Circuit Boards (PCBs) comprise: Power Supply Unit (PSU), Dual RF. A Central Processing Unit (CPU) is a daughter board to the Dual RF. The Dual RF also carries the Relay and ID PCBs as daughter boards. The Relay PCB is the board closest to the Dual RF PCB. The ID board is mounted above the Relay PCB and itself caries the Wireless Footswitch receiver board. The front fascia caries the Vacuum Fluorescent Display (VFD), membrane keypad and the loudspeaker. There are two fans fitted that are activated by the electronics when required.

BIOMED SERVICE MANUAL 897105-AA

04 Feb 2011

Page 8 of 39

Gyrus ACMI Confidential

BIOMED SERVICE MANUAL Electrosurgical Generator VERSAPOINT II Model 797000

A diagram of the top view of the layout of the electronic sub-assemblies and key components is shown below. The front panel is located at the bottom edge of the drawing.

3.3

FUNCTIONAL DESCRIPTION

The VERSAPOINT II system consists of 5 main circuit boards: • Power Supply (PSU) • Dual RF – split into two sections: 1. PlasmaKinetic (PKRF) 2. VersaPulse (VPRF) • Micro-controller (CPU) • Relay (RLY) • Instrument Identification board (ID), including the Wireless Footswitch (WF) daughter board.

BIOMED SERVICE MANUAL 897105-AA

04 Feb 2011

Page 9 of 39

Gyrus ACMI Confidential

BIOMED SERVICE MANUAL Electrosurgical Generator VERSAPOINT II Model 797000

The functional elements of the boards and their interaction are illustrated in the block diagram below.

3.4

POWER SUPPLY UNIT PSU

The mains input is filtered with an on-board EMC filter before being rectified and if required (for 100 - 120Vac) automatically doubled to obtain a DC voltage. The board contains two switch mode power supplies, the supply that powers the DC bus for the RF board and the smaller supply that provides the necessary low-voltage rails for the operation of the system. An accurate 400W overdose limit (allowing potentially higher RF powers) is utilized. Two regulated 12V rails are provided to enable point of load +5V regulating on the PKRF and VPRF boards.

3.5

DUAL RF BOARD

This board has the dual functionality of the PKRF circuitry and VPRF circuitry. BIOMED SERVICE MANUAL 897105-AA

04 Feb 2011

Page 10 of 39

Gyrus ACMI Confidential

BIOMED SERVICE MANUAL Electrosurgical Generator VERSAPOINT II Model 797000

The PKRF stage is a resonant bipolar RF circuit with voltage and current feedback that directly regulates the power produced by the PSU board. The VPRF stage is a fixed frequency bipolar RF circuit with voltage and current monitoring feedback and impedance measurement circuitry. The board also includes three local ‘point of load’ 12V to 5V regulators (VP circuitry, PK/CPU/ID circuitry and the VFD) with the purpose of improving reliability by reducing voltage drops and common circulating currents in the looms supplying the 5V lines.

3.6

CENTRAL PROCESSING UNIT CPU BOARD

The CPU board incorporates a high specification 32-bit Fujitsu micro-controller. High memory capacity RAM / ROM to aid supporting potential future functionality as new electrodes become available. The board interface is a rugged 64 pin type connector. There is a USB interface, added as a daughterboard.

3.7

ID/TC/HANDSWITCH BOARD

The ID/TC/Handswitch board has two capacitor ID channels to identify the two potential capacitors that would be connected to the RF output socket. It uses ID circuitry with proven good noise rejection and robustness. The architecture of the design incorporates a means of processing the ID counts in hardware (FPGA), removing load from the CPU providing a good response to ID change. Also on the board is support for 3 handswitching channels, the circuit employs a low impedance ac drive signal with synchronous detection for good noise rejection. Hand switching may be disabled in absence of accessories which require this function. The board also accepts the inputs from the wired footswitch and interfaces to the wireless footswitch daughterboard. Wireless footswitch functionality may be disabled in absence of accessories which require this function. The three input sources are put through a switching matrix where each input type can be masked individually and all lines are monitored for status. The ID board mounts in a stacked board arrangement with the relay board, it being plugged into the relay board and the relay board plugged into the RF board. The wireless footswitch daughterboard is a custom version of an OEM board manufactured by Linemaster Corp. The customisation includes an optimised PCB design and custom software. The wireless system uses a modified version of the Zigbee protocol, supporting 3 input channels (CUT, COAG & MODE). BIOMED SERVICE MANUAL 897105-AA

04 Feb 2011

Page 11 of 39

Gyrus ACMI Confidential

BIOMED SERVICE MANUAL Electrosurgical Generator VERSAPOINT II Model 797000

3.8

RELAY BOARD

The VERSAPOINT II system is designed to be compatible with both the existing range of Versapoint instruments and newly designed instruments that exploit the additional performance and features on the VERSAPOINT II platform. The existing instruments are supported using the single capacitor ID scheme whilst the new instruments rely on having two capacitors fitted to different respective connector pins. However, due to limitations with the new ID circuit with respect to operating with some of the resistor/capacitor combinations, the full ID table from VERSAPOINT II will be limited (all current Versapoint instruments are supported).

3.9

EXTERNAL CONNECTIONS

The following interconnections are available on the VERSAPOINT II system: IEC Mains Input (Back Panel) A standard IEC 60320 input connector, with integrated twin fuse drawer is fitted. Adjacent label to define the operational voltage, fuse rating and type. RS232 Interface (Back Panel) A standard 9-way female D-type connector interconnects internally to the processor card allowing serial communication for service use only. USB Media connector (Back Panel) A type A USB socket for the purpose of connecting to USB memory devices. The connector permits in field programming of the system software via a USB memory stick. Footswitch (fascia) A fisher type connector for use with a 3 function (2-pedal + 1-button) footswitch. Utilises 4-pins and has a polarity mark to align with the footswitch plug.

BIOMED SERVICE MANUAL 897105-AA

04 Feb 2011

Page 12 of 39

Gyrus ACMI Confidential

BIOMED SERVICE MANUAL Electrosurgical Generator VERSAPOINT II Model 797000

Instrument Output connectors (RF output socket fascia) A custom 8-pin design, based upon the existing Versapoint connector but incorporates an additional 3-pins (over the 5-pin Versapoint socket) to support additional features. The view on the socket is on the mating face.

The twin ID capacitors and hand switches are configured as shown in the figure above (RF wires not shown). The pin-out details of the connector is shown above.

3.10 GENERATOR GENERAL DESCRIPTION

3.10.1 Overview The intended purpose of the generator is to provide RF energy to a range of bipolar electrodes for use in electrosurgical procedures. The generator is to be used as part of a system, the other main components being a footswitch, handpiece connector cable and electrodes. Connection for the handpiece is located on the front panel of the generator, the wired footswitch connector is located on the front. The footswitch has two activation pedals: a yellow pedal to activate the CUT / ABLATE / blend output modalities and a blue pedal to activate the COAG / desiccate output plus a third Mode button. The generator will work from 100 – 120V a.c or 230V a.c. supply at 50/60Hz. It is an electrical class I device, as defined by IEC 60601-1, with protectively earthed metallic chassis. Double fusing is provided via the drawer on the universal mains power input socket on the back panel. The fuses are rated time lag as indicated on the back panel label. The mains supply is applied to the generator via a double pole illuminated switch that is fitted to the front panel. The mains inlet accepts an IEC60320 style cable socket. A suitable mains cable, or power cord as referred to in the U.S., is supplied with the equipment BIOMED SERVICE MANUAL 897105-AA

04 Feb 2011

Page 13 of 39

Gyrus ACMI Confidential

BIOMED SERVICE MANUAL Electrosurgical Generator VERSAPOINT II Model 797000

at delivery. Within North America, this power cord will be a UL recognised hospital grade type. Operator switches are provided on the front panel membrane. Two pairs of buttons control the respective set power adjust (up and down) for the two output modalities available from the footswitch as required. The yellow and blue sections on the membrane artwork indicate the power settings corresponding to each pedal of the footswitch. The centre or MODE button, invokes the user configuration menu. This permits selection of the vaporise or blend waveform. A separate pair of volume buttons is provided for up and down. There are three activation select buttons; wired footswitch, wireless footswitch and hand switching. Note that hand and wireless foot switching will be disabled until there are accessories on the market which require this functionality. In essence the generator has two RF output stages. The PKRF output stage is a bipolar output stage which operates in resonance mode and a fixed frequency VersaPulse mode. Both outputs are available on the RF socket but not simultaneously. The RF socket can accept legacy Versapoint connectors. 3.10.2 PKRF Principles of Operation For the purposes of bipolar explanation, the outer electrode will be referred to as the return and the central electrode as the active even though the relative potentials on each electrode will alternate. The return electrode is not intended for tissue contact although no hazard would exist if this did happen. To function, both electrode surfaces must be completely immersed in isotonic saline, which forms the prime electrical conduction path for the generator. When the RF output voltage is applied between the active tip and return of the electrode there is a migration of Na+ and Cl- ions to complete the electric circuit. Since the saline comprises a part of the electrical circuit, the electrodes may be placed further apart than with conventional bipolar instruments. In fact, this separation is a key parameter in deriving tissue effect since the electromagnetic field pattern created dictates the depth of diathermy (electrosurgical) action. For a given electrode immersed in irrigant, the output impedance seen by the generator will depend upon the exposed conductor dimensions, the saline concentration and saline temperature. As electrosurgical energy is issued to the electrode, the saline will dissipate heat due to the passage of RF current and its conductivity will increase as it becomes warmer. Hence, equilibrium impedance would exist for any constant power level and impedance has a negative slope for increasing power up to the indicated threshold power. At this power the temperature of the saline in the vicinity of the active electrode has elevated such that it is almost at boiling point and minute vapour pockets start to form. The vapour pockets will tend to envelop the active tip such that the output impedance, dictated by the conductive path to the return, will suddenly begin to increase. An important feature to note is that the actual output power delivered has gone down as the electrode moves between the saline and vapour pocket environment. As the load impedance increases, output voltage will continue to increase such that vaporisation becomes progressively more likely with tissue contact, i.e. less conductance. In fact, a clamping mechanism is required for a Vaporise waveform to prevent premature destruction of an electrode were the BIOMED SERVICE MANUAL 897105-AA

04 Feb 2011

Page 14 of 39

Gyrus ACMI Confidential

BIOMED SERVICE MANUAL Electrosurgical Generator VERSAPOINT II Model 797000

generator to follow the inherent Vaporise curve. It is the level of the vaporisation waveform clamp voltage that defines the electrode performance with tissue impedance. The output waveforms associated with PKRF outputs are VC1, VC2, VC3, BV1, BV2 & DES. VC1 is the most aggressive CUT followed by VC2 then VC3. The aggressiveness of these CUT waveforms is a function of their respective voltage limits. The BV1 and BV2 are blend waveforms. The DES output has the most voltage limiting since it is used for coagulating / desiccating processes. 3.10.3 VPRF Principles of Operation The VersaPulse output of the generator comes from the other output stage on the dual RF board. This output stage has a fixed 360kHz frequency of operation that operates in both pulsed and continuous mode. The VersaPulse output utilises a method of improving (compared to standard continuous PKRF) instrument ‘fire up’ under difficult conditions. The difficult conditions that can see benefits include large electrodes, high suction and cold saline. The system exploits the hysteresis effect of instrument fire-up, whereby the power required to create a vapour pocket around the tip is greater than that to maintain it. To achieve Vapour pocket formation for a given electrode an energy threshold has to be reached. This threshold is dependent upon the impedance of the electrode in saline, the flow rate of the saline past the electrode tip and the temperature of the saline. This impedance is mainly determined by electrode geometry, larger = lower. Under difficult conditions the larger electrode forms can require over 200W to reach this threshold (at the limit for the current Versapoint system capabilities). Once established the energy needed to maintain the pocket is much lower than the threshold level. The VersaPulse approach aims to provide high pulses of energy into low impedances to break through the threshold, at which point the system reverts to a lower continuous power level to maintain the vapour pocket. VersaPulse mode (VP) delivers power initially by using high energy pulses. The high energy is achieved with a high current pulse. Between pulses no power is applied. Consequently the average power over time is equivalent to Versapoint power levels. The current pulses allow the plasma vapour pocket to envelop the complete loop, increasing impedance and allowing the generator to operate more efficiently. Once a stable vapour pocket has been established the system runs in a continuous non-pulsing manner, equivalent to Versapoint. In very high flow conditions continuous operation shall only occur when the tip is in contact with tissue. Little engagement force is necessary.

BIOMED SERVICE MANUAL 897105-AA

04 Feb 2011

Page 15 of 39

Gyrus ACMI Confidential

BIOMED SERVICE MANUAL Electrosurgical Generator VERSAPOINT II Model 797000

The DC from the PSU charges the capacitors (using the set power) until the ‘High dc’ threshold is reached at which point the RF is switched ON. If the pulse of RF is not sufficient to maintain the Vapour pocket around the instrument tip then the impedance remains low, the delivered power from the PSU < the dissipated power at the tip and the capacitors discharge to the ‘Low dc’ threshold and the RF is switched off and the cycle repeated. If the electrode tip ‘Fires Up’ then a high impedance state is maintained and the delivered power (from the PSU) => the dissipated power at the tip and the pulsing stops.

BIOMED SERVICE MANUAL 897105-AA

04 Feb 2011

Page 16 of 39

Gyrus ACMI Confidential

BIOMED SERVICE MANUAL Electrosurgical Generator VERSAPOINT II Model 797000

For VP waveforms increasing the power increases the pulse repetition rate and likelihood of continuous operation. Conversely reducing power reduces the repetition rate and likelihood of continuous operation. Note: the VP2 output is a slightly lower voltage that VC1, hence slightly less aggressive. But it will fire up more readily due to the VP pulsing action. BIOMED SERVICE MANUAL 897105-AA

04 Feb 2011

Page 17 of 39

Gyrus ACMI Confidential

BIOMED SERVICE MANUAL Electrosurgical Generator VERSAPOINT II Model 797000

BIOMED SERVICE MANUAL 897105-AA

04 Feb 2011

Page 18 of 39

Gyrus ACMI Confidential

BIOMED SERVICE MANUAL Electrosurgical Generator VERSAPOINT II Model 797000

4 SERVICE PROCEDURES 4.1

PERIODIC SERVICE Inspect the Generator and Footswitch for obvious signs of mechanical damage or wear. Ensure that the generator case shows no sign of tampering. Evidence of damaged casework needs to be investigated to ensure that the internals of the generator are safe. Ethicon recommends the return of damaged generators to an approved service centre. The sales representative handling the generator account will be able to advise. Check the generator back panel label is present and decipherable and that the front panel markings and symbols are still legible. Retract the fuse drawer of the mains inlet connector and verify that both fuses are intact and match the rated current and breaking characteristics as per the back panel label. Switch on the Generator, ensuring that the internal Power On Self Test (POST) is completed normally, as reported on the front panel display. Check that the audio alarm, front panel warning indicator and vacuum fluorescent display are functioning normally via the user verification sequence, which follows initialisation. The generator should be tested for electrical safety on an annual basis. Whilst there is no requirement to do so, end users may elect to perform basic RF output and RF leakage checks on an annual basis. All servicing activity should be documented in accordance with local documented procedures. A typical format for service activity recording is included in the Generator Service Report in this manual.

4.2

RF OUTPUT & RF LEAKAGE CHECKS GENERAL PREAMBLE Whilst in standby mode, the generator constantly monitors the RF socket to detect valid electrodes. The VERSAPOINT II generator has a number of operating modes that have defaults depending on the value of capacitors embedded in the applied electrodes. The generator has the capability to remember adjustments from the defaults. The connection of a valid electrode will cause the generator to select the appropriate default power settings or customized power setting for that particular electrode. Alternative power settings and modalities within a certain range may be selected by the user and can be stored. The VERSAPOINT II generator identifies electrodes with an internal oscillator that changes frequency depending on the value of capacitance in the applied electrodes. To be able to measure the RF output of the generator, it is desirable to invoke the band associated with the capacitor in the test cable.

The use of the test cable is not to be used for clinical use. Any doubt about the performance of the generator must be referred to the nearest service centre. BIOMED SERVICE MANUAL 897105-AA

04 Feb 2011

Page 19 of 39

Gyrus ACMI Confidential

BIOMED SERVICE MANUAL Electrosurgical Generator VERSAPOINT II Model 797000

WarningThere is a risk of electric shock, RF burns, personnel injury and equipment damage if safe working practises are not adhered to. Deployment of a test regime for the purpose of testing the RF output power of VERSAPOINT II generators shall not cause Ethicon or any approved supplier, to be liable for direct, indirect consequential and/or injury and/or damages, even if Ethicon or such approved supplier have advised the possibility of such damages arising from any cause whatsoever, including negligence. Applying a Test Cable to the RF output socket will enable a suitable band to test the generator output. To date, Ethicon has not received any data concerning unsuitability of third party electrosurgical analysers to perform basic RF output and RF leakage tests. As a guide, the analyser must have selectable non-reactive loads and have means to perform the RF leakage tests in accordance with IEC 60601-2-2 2007. It is very unlikely that third party electrosurgical-analysers will be able to measure the pulsing or balanced outputs to a true RMS value. The VC1 mode may be checked with relative ease, as this is a nominally sinusoidal continuous waveform. The VC1 is the most aggressive cut waveform as this has the highest voltage limit, followed by VC2 then VC3. Output checks should be prompted by the settings in the enclosed Generator Service Report in this manual. In short the test involves selecting the VC1 modality and nominal output power via the keyboard and display. The power output checks limits in the Generator Service report represent part of the published load curves for the VERSAPOINT II generator. It is assumed that the user is familiar with their electrosurgical analyser to select the appropriate non-reactive load impedance and measurement methodology. An appropriate footswitch is required to instigate RF outputs.

Any doubt about the performance of the RF output of the generator must be referred to the nearest service centre.

BIOMED SERVICE MANUAL 897105-AA

04 Feb 2011

Page 20 of 39

Gyrus ACMI Confidential