an introduction to electrosurgery - frank's hospital...

Innovating Together

An introductionto Electrosurgery

This all in one device is packed with features whichreduce the complexity of ESU testing.

Maximum test current of 8A RMS for calibration of high current vessel sealing modes

Highly accurate load bank in 5Ω resolution to meet all manufacturer’s requirements

Tests all HF leakage tests as per IEC 60601-2-2 requirements

Cut testing times with easy, step-by-step, colour instructions on-screen

No need to connect to a laptop; tests run automatically to save more time

All-in-one test for contact quality monitoring (CQM) to within 1Ω resolution

Footprint is 50% smaller than competitors; easier to use, transport and store

You need to see it to believe itVisit www.rigelmedical.com/Uni-ThermOr call us on +44 (0) 191 587 8730

www.rigelmedical.com/Uni-Therm Innovating Together

The quickest and easiestway to test all leadingelectrosurgical devices

Introducing the new Rigel Uni-Therm electrosurgical analyser

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Contents

Foreword 2

1 Introduction 2

2 History 3

3 Electricity and Current 4

4 Electrosurgery 5

5 Techniques of Delivery 6

5.1 Monopolar 6

5.2 Bipolar 7

6 Electrosurgical Waveforms and their Tissue Effects 7

6.1 Cutting currents 8

6.2 Coagulation currents 8

6.3 Blended currents 9

7 Electrosurgical Units (ESUs) 9

7.1 Ground referenced generators 9

7.2 Isolated generators 9

7.3 Active electrode 10

7.4 Patient return electrode 10

8 ESU Hazards and Complications 11

9 Testing Electrosurgical Generators 11

9.1 Contact quality monitoring (CQM) verification 12

9.2 High frequency leakage test 14

9.3 Power management 15

9.4 Automating safety 16

10 Conclusion 17

References 18

Photo Credit 19

Appendix A 20

Appendix B 21

Innova t ing Togethe r

1 Introduction

Electrosurgery generator units (ESUs) are acrucial piece of equipment in the majority ofoperative settings and are the most usefuland common instruments used by surgeonstoday. Electrosurgery generators producehigh frequency alternating (AC) electriccurrent and differ from electrocautery unitsin that both cutting and coagulation effectscan be achieved through one piece ofequipment. Electrosurgery, also known assurgical diathermy, was first developed byWilliam Bovie in 1926, and is a treatmentmethod involving the production ofelectrical ly induced heat through thepassage of high frequency AC currentsthrough biological tissue. This techniqueallows the high frequency current to cut orcoagulate the tissue, minimising bloodloss and shortening operating times,

see Figure 1. The technique is determinedby the frequency and power of the ESUwhich causes burning and thermal damageto tissue cells [1, 2, 3].

Figure 1: Electrosurgical equipment

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Foreword

This booklet is written as a guideline for people involved in testing electrosurgical generators. All reasonablecare has been taken to ensure that the information, reference figures and data are accurate and have beentaken from the latest versions of various standards, guidance notes and recognised “best practises” toestablish the recommended testing requirements. Rigel Medical, their agents and distributors, accept noresponsibility for any error or omissions within this booklet or for any misinterpretations by the user. Forclarification on any part of this booklet please contact Rigel Medical before operating any test instrument.

No part of this publication shall be deemed to form, or be part of any contract for training or equipmentunless specifically referred to as an inclusion within such contract.

Rigel Medical assumes that the readers of this booklet are electronically and technically competent andtherefore does not accept any liability arising from accidents or fatalities caused directly or indirectly bythe tests described in this booklet.

Authors: Katherine Summers MEng and John Backes MA.

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www.rigelmedical.com

The principle of heat production via currentpassing into tissue can be adjusted toproduce a variety of tissue effects such ascoagulation, cutting, desiccation andfulguration. The crest factor (CF) is definedby the abil ity of an ESU to coagulatewithout cutting and centres on the idea ofshrinking the top layer of tissue which sealsand prevents blood loss from the capillarieswithout causing further thermal damage ortissue necrosis. The CF is measured by thepeak voltage divided by the RMS voltagewhich ranges from 1.4 for a pure sine waveto around a value of 10 for coagulation.There are two electrosurgical del iverytechniques; monopolar and bipolar. Themonopolar circuit requires electrical currentto flow through the human body, whilst inthe bipolar system the current flows fromone tine to the other through the tissue heldbetween forceps [2, 4].

Electrosurgery was introduced in the 1920s andcentred on rapid tissue heating. Temperaturesover 45°C can cause the normal cell function tobe inhibited and between 45°C and 60°Ccoagulation occurs causing the cell protein tosolidify. Increasing the temperature further to100°C produces desiccation and evaporation ofthe aqueous contents. Beyond 100°Ccarbonization occurs and the solid contents ofthe cells are reduced to carbon [1, 5].

2 History

The concept of using heat as a form oftherapy and treatment to stop bleeding has

been used for centuries. This was initiallyknown as thermal cautery where tissueswere burnt by thermal heat, includingsteam or hot metal with the intention ofdestroying damaged or diseased tissue toprevent infections and reduce bleeding.The earliest example of this can be found inancient Egyptian writing which described aprocess in which the tip of a probe washeated and applied to the tissue to producecoagulation, necrosis, or desiccation. In3000 BC, battle wounds were treated withheated stones or swords producinghemostasis and the Ancient Greekscauterised wounds to destroy abscessesand stop bleeding.

As technology evolved away from thermalcautery, a variety of devices which usedelectricity as a means to heat tissue andcontrol bleeding were created.Electrocautery developed in the 19thcentury as a means of destroying tissue byusing electrical currents to intensely heatan instrument; a clinical effect was realisedwhen the heated tool was applied to thetissues. However, electrocauteryencountered problems including not beingable to cut tissue or coagulate large vesselsefficiently.

Further advancement in electricaltechnology developed into modern-dayelectrosurgery beginning at the turn of thecentury when a French physicist, Alexd’Arsonval, demonstrated that radio-frequency currents could heat l ivingtissue without muscle or nerve stimulation.


In the 1920s, electrophysicist Wil l iamBovie, with the help of neurosurgeonHarvey Cushing, used electricity as anenergy source to facilitate the production ofan ESU which offered a means to cut andcoagulate human tissue efficiently using thesame device, as well as minimise bloodloss and reduce surgery times, see Figure2. The development of the Bovie ESUallowed Cushing to perform more complexneurosurgical procedures that he hadpreviously deemed inoperable before thedevelopment of electrosurgical technology,especially where vascular tumours werevery problematic to operate on due to therisk of blood loss.

Figure 2: William T Bovie and the BovieESU

The original “Bovie” machine has served asthe model for the majority of subsequentlyproduced ESUs until the invention of theisolated generator in the 1970s. Theprincipal advantage of isolated ESUs is thatthey can produce lower voltages and moreconsistent waveforms, while isolatedcircuits al low for safety improvementsincluding impedance monitoring andreduced risk of skin burns [1, 3, 6, 7].

3 Electricity and Current

All matter is composed of atoms, whichconsist of negatively charged electrons,positively charged protons, and neutrons

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which have a neutral polarity. Atoms areneutrally charged when equal numbers ofelectrons and protons are present.

Electrons orbit atoms and with energymove out from one atom to another. Thenet charge of the atom changes due to thismovement; atoms with more protons thanelectrons become positively charged, andatoms with more electrons becomenegatively charged. Two properties ofelectricity that can influence patient careduring surgery are that electricitywill always follow the pathway of leastresistance; and that it will always seek toreturn to an electron reservoir like ground[1, 2, 8].

Electrical current is the movement ofelectrons due to a force which is driven bya difference in voltage. Electrical current isdirectly proportional to the voltage inrelation to the electrical resistance in thecircuit, as defined by the equation:

Current (I) = Voltage (V) / Resistance (R)

Two types of current exist; direct (DC) andalternating current (AC). Direct currentallows electrons to flow from the negativeterminal through the circuit to the positiveterminal in one direction (polarity) such as asimple battery. Alternating current, such asthe current from an electrical wall outlet,constantly changes polarity. Frequency isused to define the number of times an ACchanges polarity per second, measured incycles per second or hertz (Hz). AC current

is used to power most electrical deviceswithin operating rooms [1, 2].

In electrosurgery, the patient is afundamental part of the electrical circuit asthe current must flow through the body,which acts as a conductor. Early studiesinto electricity with the body by d’Arsonvaldiscovered that electricity can cause bodytemperature to increase. Current density isthe current applied per unit area. Heatproduction is a function of the currentdensity, resistance and time. The heatgenerated is inversely proportional to thesurface area of the electrode which meansthe smaller the electrode, the morelocalised and intense the heat energyproduced will be, and a higher currentdensity results in a higher concentration ofheat production [1, 2].

4 Electrosurgery

Electrosurgery is based on thetransformation of an energy current intoheat, with the resulting effect of cutting andcoagulating tissue at the point of currentapplication. Electrosurgery uses highvoltage and high frequency AC current andthe electrosurgical circuit is composed ofan electrical generator or ESU, an activeelectrode, the patient and a returnelectrode. Current enters the body becauseit is included in the circuit and biologicaltissue provides impedance which results inheat production as the electrons try toovercome this resistance [1].


Figure 3: AC current frequency

Standard mains operate at a frequency of50 or 60 Hz throughout most of the world.However; at this relatively low frequency,current can be felt by the body withpossible complications including acutepain, muscle spasms, cardiac arrests orheart arrhythmias that could result fromexcessive neuromuscular stimulation due tothe current and even a high risk ofelectrocution, see Figure 3. Therefore forpatient safety and because muscle andnerve stimulation cease above frequenciesof 100 KHz, radio frequencies are utilised,where radio refers to the region of the electromagnetic spectrum whereelectromagnetic waves can be generatedby AC currents, see Figure 3. The use ofhigh frequencies is crucial as frequenciesabove 200 KHz do not affect susceptibletissue therefore eliminating the possibility ofneuromuscular and cardiac interference

with the patient during surgery. The ESU’sgenerator is used to convert the mainselectricity supply at a frequency of 50 or 60Hz to high radio frequency waveforms andcreates a voltage for the flow of currentwhich allows the electrosurgical energy topass safely through the patient [1-3, 6, 8].

5 Techniques of Delivery

5.1 MonopolarMonopolar electrosurgery is the mostcommonly used mode in surgery and isusually represented by the Bovie pencil(small single probe), which is an activeelectrode located at the surgical site. Theelectrical current flows from the activeelectrode through the patient’s body, to thepatient return electrode and back to thegenerator, see Figure 4. The returnelectrode which is located on the patient'sbody away from the surgical site, has alarge surface area and low impedance usedto disperse the electrical current back tothe generator, which is necessary tocomplete the circuit and prevent alternateburn sites as the high frequency AC currentleaves the patient’s body. A high currentdensity is produced at the tip of the probewhich results in thermal heating andlocalised destruction. Monopolartechniques are used for cutting, fulgurationand dessication. Cutting and fulgurationrequire sparking and high voltages whereasdesiccation needs a large current flowthrough the patient [1, 3, 5, 9, 10].

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Figure 4: Monopolar and Bipolar delivery techniques for electrosurgery

5.2 BipolarIn bipolar electrosurgery the active andreturn electrodes are both located at thesi te of surgery, typical ly with in theinstrument tip which is usually forceps,see Figure 4. The current pathway isconfined to the tissue grasped betweenthe forcep tines with one tine connectedto one pole of the generator (act iveelectrode) and the other connected to theopposite (return electrode). Therefore nopatient return electrode is required tocomplete the circuit and the patient’s

body does not make up part of theelectrosurgical c i rcui t as only theintervening t issue between the t inescontains the high frequency electr icalcurrent. Due to the small amount of tissueheld in the instrument much lowervoltages are required and the thermalenergy produced is evenly dispersedbetween the two electrodes, coagulatingthe tissue with minimal thermal damage tosurrounding tissue. Bipolar techniques areused for dessicat ion without sparkingwhich avoids damage to adjacent tissuecaused by the arc and spraying of highfrequency current and are used in delicatehighly conductive tissue [1, 5, 9, 10].

6 Electrosurgical Waveforms andtheir Tissue Effects

ESUs can be programmed to function inseveral modes with dist inct t issuecharacteristics. The generator output canbe varied in two ways: the voltage can bealtered to dr ive more or less currentthrough the tissues, or the waveform canbe modified which influences the tissueeffect. The tissue effect associated withthe di fferent e lectrosurgical currentwaveforms is dependent on the size andshape of the electrode and the outputmode of the generator. There are threetypes of current waveforms: cutt ing,coagulation, and blended currents, seeFigure 5 [1, 6, 9, 10].


Figure 5: a) Pure cutting current b) Blend 1-3c) Coagulation current

6.1 Cutting currentsCutting currents use an uninterruptedsinusoidal waveform with high average power,high current density and a CF of 1.4, seeFigure 5. The use of electric sparks allows forprecise cutting and focused heat whichminimises widespread thermal damage. Theelectrode should be held slightly away fromthe tissue to create a spark gap and dischargearc at specific locations which produces asudden and localised heating effect over a short period of time which causes extreme heating and vaporisation of intracellular fluid that bursts cells.A f ine, clean incision is created through the biological tissue with minimalcoagulation (hemostasis) or extensivethermal damage and the continuous currentdoes not allow for tissue cooling [1-3, 6, 9, 10].

6.2 Coagulation currentsCoagulation currents are characterisedby high voltage intermittent bursts ofdampened sine waves which drive thecurrent through the t issue and relat ivelylow current which reduces the duty cycleto 6%, Figure 5. Coagulat ion currentstyp ica l ly have a CF of around 10.Coagulat ion is electr ical sparking over awide area therefore less heat is producedresult ing in evaporat ion and relat ivelys low dehydrat ion which sea ls b loodvessels whi le keeping cel ls intact. “Thecoagulat ion current is operated with thepower sett ing between 30 to 50 W withvoltage spikes as high as 9000 V at 50W” [8]. In between bursts of current, theheat dissipates into the t issues reducingthe cutt ing effect whi lst enhancing thecoagulat ion during the 94% off cycle.

Desiccation is a direct contact form ofcoagulat ion where 100% of the electr icalenergy is converted into heat wi th inthe t issue, not seen with other currentwaveforms. It uses low current densityover a broad area which causesdehydration of cel ls without the need foran electr ical spark.

Fulgurat ion is a non-contact form ofcoagulat ion, producing a spark gap andelectr ic discharge arc to mediate thetissue as the air between the probe andtissue ionises. A spray effect at variousreg ions causes sha l low t issuedestruction [1-3, 6, 9, 10].

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High VoltageLow Voltage

COAGBLEND 3BLEND 2BLEND 1PURE CUT

Typical Example

94% off6% on

75% off25% on

60% off40% on

50% off50% on100% on

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6.3 Blended currentsA blended current is a modification of theduty cycle and operates at voltagesbetween those of cutting and coagulationwith a CF usually in the range of 3 to 10.Blended currents allow for tissue divisionwhilst maintaining a variable degree ofhemostasis which is defined by the offperiod. Although the total energy remainsthe same, the ratio of voltage and current isadjusted to increase hemostasis; byinterrupting the current and increasing thevoltage, to deliver a waveform inintermittent bursts. Three blends are shownin Figure 5. Modifications and reductions tothe duty cycle through progressive blendsproduce less heat and as the intervalbetween bursts progressively increases,greater coagulation is produced. However,as homeostasis increases, the cuttingability of the blended current decreases[1-3, 6, 9, 10].

The rate at which heat is produced is thedominant factor and only variable indetermining whether a waveform vaporisesor coagulates biological tissue. Surgeonshave the option to combine the cut andcoagulate currents to produce differenttissue effects. Coagulation can beperformed with the cutting current by usingthe electrode in direct contact with thetissue and this requires less voltage thanthe coagulation waveform. However powersettings may need to be adjusted andelectrode size varied to achieve the desiredsurgical effect [1].

7 Electrosurgical Units (ESUs)

7.1 Ground referenced generatorsOriginally, ESUs were ground referencedwhere the electrical current passed throughthe patient’s body and returned to ground.The grounding is intended to occur via thepatient return electrode which is usuallysituated on the thigh of the patient andaway from the surgical site. However,electrical currents seek to travel down thepathway of least resistance and thereforecurrent can travel through any conductivegrounding object which is in contact withthe patient as a method of ground return;such as ECG electrodes or tables andoperating staff. This increases thepossibility of creating alternate site burnson the patient at alternative grounding siteswhere the high frequency current has exitedthe patient. Many manufacturers no longerrely on ground referenced ESUs due to thehigh risk of skin burns associated withalternative grounding [1, 8, 9].

7.2 Isolated generatorsIsolated generator systems were developedin the early 1970's to overcome the risk ofalternative site burns due to groundedsystems. The current still passes throughthe patient and must return through thepatient return electrode which leads to thenegative side of an isolation transformerlocated within the generator. The returnelectrode is not connected or referencedto ground and therefore a l ternatepathways are avoided. The transformer


isolates the power with no voltage referenceto ground so that the current does not returnto ground or seek other grounded objects,therefore eliminating alternate skin burns. If the current does not find its way to thepatient return electrode then the ESU will stopdelivering energy current as there must be analternative grounding path of less resistancethan the return electrode [1, 8, 9].

7.3 Active electrodeThe active electrode delivers the highfrequency AC current from the ESU to thesurgical site. At the tip of the active electrode,electron flow and current density are high andspread across a relatively small area. Thecurrent density varies depending on the type,size and shape of the tip. There are a varietyof tips available including bipolar forceps fordesiccation, needle electrodes for precise cutand coagulation, blade electrodes for fastercut and coagulation and ball tips for broadcoagulation. The monopolar active electrodeis typically a small flat blade with the edgesshaped to easily initiate discharge arcs.Needle tip electrodes require a lower powersetting than blade or ball electrodes becausethe current is concentrated on a very smallarea at the tip of the electrode, see Figure 6.The active electrode should be used in aninsulated holster which will prevent accidentalburns to the patient and surgeon. To controlthe waveform, footswitches or switches onthe active electrode handle allow the surgeon to alternate between cutting and coagulationcurrents [5, 8].

Figure 6: a) Patient Return (Disruptive)and b) Active Electrodes

7.4 Patient return electrodeThe primary function of the patient returnelectrode is to collect the high frequency currentdelivered to the patient during electrosurgery andremove it from the patient safely back to theESU. The size of the return electrode should beproportional to the energy and the time that theESU is used. The large electrode area and smallcontact impedance reduces the current densityof the energy dispersing from the patient to levelswhere tissue heating is minimal thus preventingskin burns, see Figure 6 [1, 5, 8].

To combat failures in the return electrode andsubsequent patient injury, contact qualitymonitoring (CQM) systems were developed in1981 to monitor the quantity and quality ofcontact and impedance between the return

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Patient ReturnElectrode

Ball tipBlade tipNeedle tip

a)

b)

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electrode and the patient. The CQM system is aseparate monitoring current which is sent to thepatient return electrode and measures thepatient impedance. If the contact is interrupted,or there is a failure, an alarm sounds and the ESUis deactivated to prevent further damage; theCQM system only allows the ESU generator tofunction between a preselected safe range anddetects increases in impedance at the returnelectrode to prevent potential injury and skinburns at the return electrode [1, 3, 6-10].

8 ESU Hazards and Complications

An electric current needs a closed circuit forelectricity to flow and therefore current has thepotential to travel along alternative pathways ofless resistance which can cause undesiredeffects. Improper electrosurgery can exposeboth the patient and staff to potential hazardssuch as electric shock and skin burns [6, 8, 9].

ESUs can cause burns at the intended surgicalsite, at alternate sites and at the return electrode.The patient return electrode is a common site ofinjury; which can be caused due to insufficientsize to safely disperse current, or interrupted andsignificantly reduced contact with the patient,which can result in the current exiting the bodyand producing unintended burns. Current candivert through an alternative earthing point andcause accidental burning elsewhere on the body.To avoid this, the patient should not touch anymetal object and is usually placed on aninsulated mattress to isolate the patient [9, 10].

Surgical smoke is produced as the tissue is

heated and vaporised and some of this smokecontains potentially harmful chemicals such ascarcinogens and cellular debris. To minimise theassociated health hazards, specially designedsmoke evacuation systems are used andfiltration masks worn during surgery [2, 8, 10].

ESUs are the most common source of ignition inoperating room fires and explosions. Alcohol-based skin preparation should be avoidedbecause liquids can pool under surgical towelsand be ignited by sparks from the activeelectrode. Electrosurgery sparks can also igniteflammable gases within body cavities [6, 10].

9 Testing Electrosurgical Generators

Electrosurgery is the principle of inducing heat byhigh frequency electrical current for coagulation,cutting, desiccation and fulguration of biologicaltissue developed by Bovie. The correct operationof electrosurgical generators is essential toensure patient safety and manage the risksassociated with the use of high and lowfrequency electrical current on the human body.

Manufacturers of electrosurgical generators mustfollow the strict design criteria of IEC 60601-2-2,which stipulates the specific requirements inorder to provide a controlled approach to patientsafety when using electrosurgical devices.

A thorough understanding of each energymodality, waveform and tissue effect is critical inreducing potential complications and hazardswhilst the performance and safety of these


electrosurgical devices must be regularly verified(every 3-6 months) for instance by using the RigelUni-Therm electrosurgical analyser, see Figure 7 [2, 9].

A typical test procedure to ensure the electricalsafety and performance is assessed can consistof the following test steps:

1) Visual inspection2) Low frequency electrical safety test

(leakage currents up to 1kHz), see Rigel Medical’s IEC 62353 guidance booklet

3) Verification of the contact quality monitoring (CQM) circuit, see 9.1

4) Testing for high frequency leakage, see 9.25) Check output power at certain loads

in relation to the function and waveform selection, see 9.3

Be aware; when testing electrosurgical generators,it is crucial to understand the operation of thedevice under test (DUT). The output energy ofelectrosurgical generators can lead to burn injuries.Always ensure that the tests are conducted by asuitably trained individual and limit the amount ofaccessible conductive parts that become live withhigh frequency electrical current.

To maximise safety, Rigel Medical has developed anumber of accessories to automate the testing andreduce the need for manual interaction duringtesting and whilst the output of electrical surgicalgenerators are active. See 9.4.

The new Uni-Therm electrosurgical analyser fromRigel Medical is the quickest and easiest way to testall leading electrosurgical generators, combining thetest functions to verify the CQM, the high frequency

leakage and the output power, all in a single testdevice. By providing built-in automation and datastorage, the Rigel Uni-Therm can be utilised both inthe field as well as at the end of demandingproduction lines or in test laboratories.

Figure 7: Rigel Medical’s Uni-Therm

9.1 Contact quality monitoring(CQM) verificationTo maximise the effectiveness of the surgicalprocedure and to reduce the risk of injury duringelectrosurgical procedures, the patient plate mustcover an optimum amount of skin surface area(quantity) and be high in conductivity (quality) wherethe energy exits the patient. This is monitored by theelectrosurgical device through impedance

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measurement (CQM) between the two (split) or moreconductive pads within the patient return plate, seeFigure 8. When extreme variations or very high/lowimpedance appears, the CQM will lead to an audibleand/or visual alarm and can lead to deactivation ofthe output energy to prevent potential patient injury.

Figure 8: Example of patient return plate

The Uni-Therm’s accurate CQM functionsimulator allows automatic and manual increaseor decrease of electrical resistance values in 1Ωresolution. This enables the testing of moderncontact quality monitoring systems that aretriggered by relative changes in resistance.

To carry out the CQM test using the Rigel Uni-Therm, connect a CQM test lead betweenthe patient plate connector and the front panel ofthe Rigel Uni-Therm, see Figure 9.

Figure 9: Connecting Rigel Uni-Therm to theCQM circuit

Unlike conventional analysers, the Rigel Uni-Therm utilises a motor driven potentiometerwhich can simulate resistance variations to within 1Ωresolution. This allows the user to trigger the CQMsystem by simulating fault conditions including veryhigh or very low impedance values or a large variationin impedance, for example a change of 10%.

The variable resistance (0–475Ω) is connected totwo black connectors on the CQM section at thefront of the Uni-Therm, and also connects to theneutral plate connector on the ESU. Impedance canbe controlled by utilising the rotary encoder on thefront panel to increase or decrease the impedance,see Figure 10 and 11.

Figure 10: Rotary encoder on the Rigel Uni-Therm

I nnova t ing Togethe r

Figure 11: CQM test screen on Rigel Uni-Therm

9.2 High frequency leakage testDesign criteria of electrosurgical generators (IEC60601-2-2), require the manufacture to limit theamount of capacitive leakage of the high frequencycurrent. At frequencies exceeding 400kHz, theelectrical current has a tendency to stray, leading todecrease in functionality and possible injury to thepatient.

Capacitive coupling might occur between the testleads during the setup. This is the reason why IEC60601-2-2 stipulates specific layout of test leadsand test loads to ensure the capacitive coupling islimited and controlled in a laboratory environment,these tests are referred to as the long lead tests. Amore practical approach is to ensure the test leadsare as short as possible and do not cross over, tolimit the influence of capacitive coupling.

Breakdown of insulation in the surgery leads as aresult of high voltages (peak to peak up to 10kV) isalso a consideration when testing the electrosurgicalgenerator. This can be verified by including thesurgical leads as part of the test setup. Beware that

this might lead to exposure to conductive parts andpossible injury.

The HF leakage test measures the HF leakagecurrent in various test configurations and comparesthe result to a user set pass/fail value using the rotaryencoder to navigate the screens.

The Uni-Therm simplifies the complex testconfigurations of high frequency leakage currentmeasurement, as required by IEC 60601-2-2, byproviding detailed instructional diagrams for eachhigh frequency leakage test set-up on its colourdisplay, see Figure 12.

Figure 12: Test screens for HF leakage on theRigel Uni-Therm

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Each high frequency leakage measurement canbe automatically initiated through the cut andcoag control on the Uni-Therm, improving safetyand speed of testing, see Figure 13.

Figure 13: Connection panel on the Rigel Uni-Therm

9.3 Power managementThe Uni-Therm provides a variety of optionsduring the power measurement and has theability to measure currents of up to 8 AmpereRMS. The unique internal load bank is designedto minimise the phase shift, which can lead toinaccurate measurements at high frequenciesand is typical of traditional electrosurgicalanalysers, see Figure 14.

Figure 14, Connecting the ESU power to theRigel Uni-Therm.

Current measurement in the Rigel Uni-Therm isdone through the use of a custom designedcurrent transformer, capable of accuratelymeasuring high currents when calibratingelectrosurgical generators with high currentvessel sealing treatment functions.

The power measurement options include:

Continuous: Measuring output power and current during a single load value

Graph: Measuring the output power and current under a changing load condition

External load: Measuring the output and current during short circuit testing or when using a specific external load resistor during development.

The large colour display provides a clear anddetailed interpretation of output power whilst cutand coag foot paddle control automates theprocess; making this a fast, effective and safetest procedure.


Graphical representations of power distribution curvescan be easily switched to numerical data at the touchof a button without the use of a PC, see Figure 15.

Figure 15: Power distribution in graph andnumerical detail

The Rigel Uni-Therm will control the device undertest (DUT) by using the internal footswitchcontroller with a footswitch adapter leading fromthe footswitch connector on the ESU to the cutand coag sockets on the front of the Uni-Therm.There are three test options: continuous, graph orexternal load.

9.4 Automating safetyThe whole test procedure for testing theelectrosurgical generator can be programmed intothe Rigel Uni-Therm. The cloning feature makessharing of test configurations between differentUni-Therms simple, so it is easier and faster toconfigure and update your test instrument.

Each test step can be set up with simple userinstructions for DUT settings such as mono or bi-polar, energy settings and waveform selection.

The CUT and COAG footswitch controls on theUni-Therm can be used to control theelectrosurgical generator. This can reduce the over-all test time and increase user safety, see Figure 16.

Figure 16: Connection panel for the cutand coag footswitch control on the RigelUni-Therm

A range of foot paddle switches is available for allleading brands of ESUs.

Please contact [email protected] your specific requirements.

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10 Conclusion

The use of electrosurgical generators hasled to more effective surgical treatmentsand improved pat ient safety throughgreater contro l and management ofcomplications during surgery.

Never the less, the use of electrosurgicalgenerators is not wi thout r isk andremains one of the more hazardouspractises in operating theatres.

Regular performance and safety tests ofthese high frequency generators can leadto further improvement of patient safetyby ensuring the safety features of eachgenerator is intact , and that theperformance accuracy is guaranteed.

When cons ider ing the purchase ofe lectrosurg ica l ana lysers, ensure thatyou understand the manufacturer ’srequirements and the technical capabi l i tyof your instal l base. For instance, whencal ibrat ing e lect rosurg ica l generatorswi th h igh current vesse l sea l ingtechnology, look for test equipment thatcan measure both short circuit currentsas wel l as currents over 5A RMS.

The Rigel Uni-Therm is versat i le andcompact yet offers safer, faster and moreaccurate test ing of e lect rosurg ica lgenerators enabl ing you to meetinternational and manufacturer specif ictest requirements simply and eff iciently.

We hope you have found the informationin this booklet useful and interesting,we welcome your feedback.

Please direct your feedback and questions to:

[email protected]

You can also fol low us on:


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References

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2. Gallagher, K., Dhinsa, B., Miles, J. (2010). Electrosurgery. Surgery. 29 (2) 70-72. (2007).

3. Electrosurgery Available: www.boss.net.au/clinical/studynotes/genper01.htm.Last accessed 18th Feb 2013.

4. Bussiere, R. L. (1997). Principles of Electrosurgery. Washington, U.S.A: Edmonds. 6.

5. Eggleston, J. L., Von Maltzahn, W.W. (2000). Electrosurgical Devices. In: Ed. Joseph D. Bronzino. The Biomedical Engineering Handbook. Boca Raton: CRC Press LLC.

6. Davison, J. M., Zamah, N. M. (2008). Electrosurgery: Principles, Biologic Effects and Results in Female Reproductive Surgery. Available: www.glowm.com/index.html?p=glowm.cml/section_view&articleid=21.Last accessed 18th Feb 2013.

7. Massarweh, N. N., Cosgriff, N., Slakey, D. P. (2006). Electrosurgery: History, Principles,and Current and Future Uses. Electrosurgery. 202 (3) 520-530.

8. Megadyne. The Electrical Authority (2005). Principles of Electrosurgery. Utah

9. K. Wang, A.P. Advincula. (2007). Current thoughts in Electrosurgery: Surgery and Technology. International Journal of Gynaecology and Obstetrics. 97, 245-250.

10.Hay, D.J. (2005). Electrosurgery. Surgery. 23 (29) 73-75.

19

www.rigelmedical.comI nnova t ing Togethe r

Photo Credit

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20

Appendix A IEC 60601-1 Collateral Standards (© IEC Geneva, Switzerland)

IEC 60601-1-1

IEC 60601-1-2 (ACDV)

IEC 60601-1-3

IEC 60601-1-4

IEC 60601-1-6

IEC 60601-1-8 (CCDV)

IEC 60601-1-9

IEC 60601-1-10

IEC 60601-1-11

IEC 60601-1-12 (CDM)

MEDICAL ELECTRICAL EQUIPMENT – PART 1: GENERAL REQUIREMENTS FOR SAFETY 1: COLLATERALSTANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS

MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY ANDESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC PHENOMENA -REQUIREMENTS AND TESTS

MEDICAL ELECTRICAL EQUIPMENT – PART 1: GENERAL REQUIREMENTS FOR SAFETY – COLLATERALSTANDARD: GENERAL REQUIREMENTS FOR RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT

MEDICAL ELECTRICAL EQUIPMENT: PART 1-4: GENERAL REQUIREMENTS FOR COLLATERAL STANDARD:PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS

MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY ANDESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY

MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY ANDESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS ANDGUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICALSYSTEMS

MEDICAL ELECTRICAL EQUIPMENT - PART 1-9: GENERAL REQUIREMENTS FOR BASIC SAFETY ANDESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR ENVIRONMENTALLYCONSCIOUS DESIGN

MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY ANDESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OFPHYSIOLOGIC CLOSED-LOOP CONTROLLERS

MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY ANDESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICALEQUIPMENT AND MEDICAL ELECTRICAL SYSTEM USED IN HOME CARE APPLICATIONS

MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY ANDESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICALEQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE EMERGENCY MEDICAL SERVICESENVIRONMENT

21


Appendix B IEC 60601-2 Particular Standards (© IEC Geneva, Switzerland)

IEC 60601-2-1

IEC 60601-2-2

IEC 60601-2-3 (ADIS)

IEC 60601-2-4

IEC 60601-2-5

IEC 60601-2-6 (ADIS)

IEC 60601-2-7

IEC 60601-2-8

IEC 60601-2-10 (CCDV)

IEC 60601-2-11

IEC 60601-2-13

IEC 60601-2-16 (RDIS)

IEC 60601-2-17

IEC 60601-2-18

IEC 60601-2-19

IEC 60601-2-20

IEC 60601-2-21

IEC 60601-2-22

MEDICAL ELECTRICAL EQUIPMENT - PART 2-1: PARTICULAR REQUIREMENTS FOR THE SAFETY OFELECTRON ACCELERATORS IN THE RANGE 1 MEV TO 50 MEV

MEDICAL ELECTRICAL EQUIPMENT - PART 2-2: PARTICULAR REQUIREMENTS FOR THE SAFETY OFHIGH FREQUENCY SURGICAL EQUIPMENT

MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OFSHORT-WAVE THERAPY EQUIPMENT

MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OFCARDIAC DEFIBRILLATORS AND CARDIAC DEFIBRILLATORS MONITORS

MEDICAL ELECTRICAL EQUIPMENT - PART 2-5: PARTICULAR REQUIREMENTS FOR THE SAFETY OFULTRASONIC PHYSIOTHERAPY EQUIPMENT

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OFMICROWAVE THERAPY EQUIPMENT

MEDICAL ELECTRICAL EQUIPMENT - PART 2-7: PARTICULAR REQUIREMENTS FOR THE SAFETY OFHIGH-VOLTAGE GENERATORS OF DIAGNOSTIC X-RAY GENERATORS

MEDICAL ELECTRICAL EQUIPMENT - PART 2-8: PARTICULAR REQUIREMENTS FOR THE SAFETY OFTHERAPEUTIC X-RAY EQUIPMENT OPERATING IN THE RANGE 10 KV TO 1 MV

MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OFNERVE AND MUSCLE STIMULATORS

MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OFGAMMA BEAM THERAPY EQUIPMENT

MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR THE SAFETY OFANAESTHETIC WORKSTATIONS

MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETYAND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION ANDHAEMOFILTRATION EQUIPMENT

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OFREMOTE-CONTROLLED AUTOMATICALLY DRIVEN GAMMARAY AFTER-LOADING EQUIPMENT

MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OFENDOSCOPIC EQUIPMENT

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS OF SAFETY OF BABYINCUBATORS

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OFTRANSPORT INCUBATORS

MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OFINFANT RADIANT WARMERS

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OFDIAGNOSTIC AND THERAPEUTIC LASER EQUIPMENT

22

IEC 60601-2-23

IEC 60601-2-24 (ADIS)

IEC 60601-2-25

IEC 60601-2-26 (ADIS)

IEC 60601-2-27

IEC 60601-2-28

IEC 60601-2-29

IEC 60601-2-31

IEC 60601-2-32

IEC 60601-2-33

IEC 60601-2-34

IEC 60601-2-36 (1CD)

IEC 60601-2-37

IEC 60601-2-39

IEC 60601-2-40

IEC 60601-2-41 (CCDV)

IEC 60601-2-43

IEC 60601-2-44 (CCDV

MEDICAL ELECTRICAL EQUIPMENT - PART 2-23: PARTICULAR REQUIREMENTS FOR THE SAFETY,INCLUDING ESSENTIAL PERFORMANCE, OF TRANSCUTANEOUSPARTIAL PRESSURE MONITORINGEQUIPMENT

MEDICAL ELECTRICAL EQUIPMENT - PART 2-24: PARITCULAR REQUIREMENTS FOR THE SAFETY OFINFUSION PUMPS AND CONTROLLERS

MEDICAL ELECTRICAL EQUIPMENT - PART 2-25: PARTICULAR REQUIREMENTS FOR THE SAFETY OFELECTROCARDIOGRAPHS

MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OFELECTROENCEPHALOGRAPHS

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OFELECTROCARDIOGRAPHIC MONITORING EQUIPMENT

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF X-RAY SOURCE ASSEMBLIES AND X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS

MEDICAL ELECTRICAL EQUIPMENT - PART 2-29: PARTICULAR REQUIREMENTS FOR THE SAFETY OFRADIOTHERAPY SIMULATORS

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OFEXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE

MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OFASSOCIATED EQUIPMENT OF X-RAY EQUIPMENT

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OFMAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY,INCLUDING ESSENTIAL PERFORMANCE, OF INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT

MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OFEQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY

MEDICAL ELECTRICAL EQUIPMENT - PART 2-37: PARTICULAR REQUIREMENTS FOR THE BASICSAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC MEDICAL DIAGNOSTIC AND MONITORINGEQUIPMENT

MEDICAL ELECTRICAL EQUIPMENT - PART 2-39: PARTICULAR REQUIREMENTS FOR THE SAFETY OFPERITONEAL DIALYSIS EQUIPMENT

MEDICAL ELECTRICAL EQUIPMENT - PART 2-40: PARTICULAR REQUIREMENTS FOR THE SAFETY OFELETROMYOGRAPHS AND EVOKED RESPONSE EQUIPMENT

MEDICAL ELECTRICAL EQUIPMENT - PART 2-41: PARTICULAR REQUIREMENTS FOR THE SAFETY OFSURGICAL LUMINAIRES AND LUMINAIRES FOR DIAGNOSIS

MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR THE SAFETY OFX-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES

MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE SAFETY OFX-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY

23


IEC 60601-2-45

IEC 60601-2-46

IEC 60601-2-47 (RDIS)

IEC 60601-2-49

IEC 60601-2-50

IEC 60601-2-51

IEC 60601-2-52

IEC 60601-2-53

IEC 60601-2-54

IEC 60601-2-56

IEC 60601-2-57

IEC 60601-2-62 (ACDV)

IEC 60601-2-63 (CCDV)

IEC 60601-2-65 (CCDV)

MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR THE SAFETY OFMAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES

MEDICAL ELECTRICAL EQUIPMENT - PART 2-46: PARTICULAR REQUIREMENTS FOR THE SAFETY OFOPERATING TABLES

MEDICAL ELECTRICAL EQUIPMENT - PART 2-47: PARTICULAR REQUIREMENTS FOR THE SAFETY,INCLUDING ESSENTIAL PERFORMANCE, OF AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS

MEDICAL ELECTRICAL EQUIPMENT - PART 2-49: PARTICULAR REQUIREMENTS FOR THE SAFETY OFMULTIFUNCTION PATIENT MONITORING EQUIPMENT

MEDICAL ELECTRICAL EQUIPMENT - PART 2-5O: PARTICULAR REQUIREMENTS FOR THE SAFETY OFINFANT PHOTOTHERAPY EQUIPMENT

MEDICAL ELECTRICAL EQUIPMENT - PART 2-51: PARTICULAR REQUIREMENTS FOR SAFETY,INCLUDING ESSENTIAL PERFORMANCE, OF RECORDING AND ANALYSING SINGLE CHANNEL ANDMULTICHANNEL ELECTROCARDIOGRAPHS

MEDICAL ELECTRICAL EQUIPMENT - PART 2-52: PARTICULAR REQUIREMENTS FOR BASIC SAFETYAND ESSENTIAL PERFORMANCE OF MEDICAL BEDS

MEDICAL ELECTRICAL EQUIPMENT, PART 2-53: PARTICULAR REQUIREMENTS FOR THE SAFETY ANDESSENTIAL PERFORMANCE OF A STANDARD COMMUNICATIONS PROTOCOL FOR COMPUTERASSISTED ELECTROCARDIOGRAPHY

MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR BASIC SAFETYAND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY

MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETYAND ESSENTIAL PERFORMANCE OF SCREENING THERMOGRAPHS FOR HUMAN FEBRILETEMPERATURE SCREENING

PARTICULAR REQUIREMENTS FOR THE SAFETY AND ESSENTIAL PERFORMANCE OF INTENSE LIGHTSOURCES USED ON HUMANS AND ANIMALS FOR MEDICAL AND COSMETIC PURPOSES

MEDICAL ELECTRICAL EQUIPMENT - PART 2-62: PARTICULAR REQUIREMENTS FOR BASIC SAFETYAND ESSENTIAL PERFORMANCE OF HIGH INTENSITY THERAPEUTIC ULTRASOUND (HITU) SYSTEMS

MEDICAL ELECTRICAL EQUIPMENT - PART 2-63: PARTICULAR REQUIREMENTS FOR BASIC SAFETYAND ESSENTIAL PERFORMANCE OF DENTAL EXTRA-ORAL X-RAY EQUIPMENT

MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR BASIC SAFETYAND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT

24 Med-ekitcompatible

Med-eBasecompatible

Mainspowered

Barcodescanner

Batterypowered

Bluetoothcompatible

Performance Analysers

Rigel Uni-ThermElectrosurgical Analyser The new high power Rigel Uni-Therm accuratelymeasures the performance of electrosurgicalgenerators. Measurements include; highfrequency leakage, high power current andpower distribution and patient return platealarm testing.

The Rigel Uni-Therm offers the latest technologyin high frequency power measurement. It’s small,easy-to-use, has a large colour display andinnovative navigation making this a fast, efficienttest tool for testing the performance of alldiathermy machines.

Fully compliant with IEC 60601-2-2 One instrument for full compliance testing offering peace of mind

Accurate and safe Utilising full 10kV isolation on all measuring systems

High power load bankMeasure up to 6 A RMS with duty-cycle up to 100% for 60 seconds

High frequency leakage Easy to connect with onscreen help for each configuration

Power distribution curves Variable load with full 10kV isoltion from 0 to 5100Ω in 5Ω steps – Accurate, fast, and flexible

Remote electrode monitoring testingUsing electronic potentiometer range upto 500Ω in 1Ω steps with high and low alarms

Stand-aloneNot relying on PC or laptop, direct print facility via Bluetooth

Automatic and manual test sequencesFor fast and effective (repeat) testing

Stylish and rugged enclosureSmall footprint ideal for in-situ testing

Graphic colour user interface For fast and easy navigation and connection to DUT

Future upgrade ready Download future upgrades from the web into your tester

Prepared for PPM protocolsConfigured for automatic performance testing of a variety of parameters

Key Features

25


Please visit www.rigelmedical.com for more information

Rigel Multi-FloInfusion Pump Analyser

The market defining Rigel Multi-Flo infusionpump analyser is a portable instrument toaccurately and swiftly verify the performance ofall infusion devices. Offering instantaneous flowand available in 1, 2 and 4 individual channelconfiguration. The Multi-Flo boasts a large colourscreen, providing precise information on flowrate, occlusion and back pressure and trumpetcurves.

Features include:

IEC 60601-2-24 compliant

Instant flow and pressure

Compatible with all infusion devices

On-screen trumpet curve

Onboard data storage

Rigel Uni-PulseDefibrillator Analyser

The innovative Rigel Uni-Pulse defibrillatoranalyser is the most compact and versatileinstrument on the market, able to accuratelyverify all mono- and bi-phasic defibrillators andAED's. Features include: onscreen waveformcapture, built-in 12-lead ECG simulator,onboard memory and optional variable load boxensuring the Rigel Uni-Pulse meets all therequirements of IEC 60601-2-4.

Features include:

IEC 60601-2-4 Compliant

Mono and bi-phasic

Waveform capture, store & replay

Built-in 12 lead ECG simulator

Auto AED testing

26

Electrical Safety Analysers

Rigel 266 PlusElectrical SafetyAnalyser

The Rigel 266 Plus is ahighly compact, easy-to-use safetyanalyser designed to testin accordance withIEC/EN 60601-1, MDADB9801 and AS/NZ3200. This compact unitprovides a highly effectiveand portable test solution.

Features include: Small and compact Conform IEC 60601,

MDA DB 9801 1-25A earthbond

test current Up to 5 applied parts Direct print facility

Rigel 62353Electrical SafetyAnalyser

The Rigel 62353 is a costeffective automatic safetyanalyser dedicated to theIEC 62353 standard forroutine and testing afterrepair of medical devices.Offering automatic testsequences, data entryand storage as well as PCdownload capabilities.

Features include: Light, hand-held,

battery operation Conform IEC 62353 Fully customisable test

sequences Data entry and storage PC download Full, semi automatic

& manual tests

Rigel 288Electrical SafetyAnalyser

The 288 is the first trulyhand-held medicalelectrical safety tester tocombine the features of anautomatic/manual testerwith a data logging/assetmanagement facility.Control is through a menudriven GUI. A large datamemory and bluetoothfacility make this aneffective mobile unit.


battery operation Conform IEC 62353 /

60601/ VDE 0751 / NFPA-99 / AS-NZS 3551

Memory for up to 10,000 devices

Bluetooth communication

Full, semi automatic & manual tests

Rigel 277 PlusElectrical SafetyAnalyser

The Rigel 277 Plus is afully comprehensiveelectrical medical safetyanalyser used within thewidest possible range ofapplications. The ability tomanage results and printrecords means that theuser can manage the testand re-test proceduremore productively.

Features include: Conform IEC 60601 /

61010 / AAMI / NFPA-99 / S-NZS 3200

Onboard printer & QWERTY keyboard

100mA to 25A earthbond current

Full, semi automatic & manual tests


27

Vital Signs Simulators


Rigel UNI-SIMVital SignsSimulator

The world’s first combined,fully functional NIBP, SpO2and Patient Simulator in asingle hand-held unit.Extremely accurate andfeaturing full synchronisedfunctionality. A breakthroughin the way safety testing isimplemented, the UNI-SIMsaves time and money, aswell as simplifying thetesting process.


battery operation Combined NIBP, SpO2

and Patient Simulator in one unit

User configurable simulations

Full sychronised functionality


Rigel BP-SIMNIBP Simulator

The first hand-held NIBPsimulator to incorporatecustom settings, includingpaediatric and adult NIBPpressure simulations, pulsevolume adjustments, heartrate and manufacturer-specific envelopes. Largecapacity internal memoryfor data capture, storageand downloading of testresults via Bluetooth.


battery operation Adult & Paediatric

NIBP Simulations Manufacturer specific

O-curves Overpressure and leak

test Memory for up to

10,000 devices

Rigel SP-SIMSpO2 Simulator

The first hand-held SpO2simulator featuring pulsevolume adjustments,heart rate andmanufacturer-specific R-curves. The largecapacity internal memoryenables test results to be captured, storedand downloaded via Bluetooth.


battery operation Tests probe and

monitor both at the same time

User configurable simulations

Manufacturer R-curves Memory for up to

10,000 devices

Rigel 333PatientSimulator

The 333 is one of thesmallest, most powerfuland fully comprehensivepatient simulatorsavailable. Providing a true12 lead ECG signal with43 arrhythmias, dualinvasive blood pressure,respiration, temperatureand industry standardwaveforms.


battery operation Accurate 12-lead

simulation of 43 arrhythmias

Invasive blood pressure

Temperature & respiration

Performance wave forms

28

Med-eKit Elite

The Med-eKit Elite is ahandy and morespecialised carryingsolution. It has a hard-wearing pelican casewhich can be customisedto hold up to twoindividual testers (theRigel 288 and UNI-SIM,for instance). It can alsoinclude a label and resultsprinter, barcode scannerand PC software.

Features include: Configurable with up

to 4 tester functions Lightweight design Durable and robust

enclosure Water-proof design Secure locking

Med-eKit Lite

This new case is astandard accessory forthe Rigel 288,UNI-SIM and Uni-Pulsebiomedical testinginstruments. It can beconfigured to hold anumber of different itemsof test equipment andaccessories likea label results printer anda barcode scanner.

Features include: Carry securely on

back/ easy access from front

Configurable compartments fortesters and accessories

Extremely lightweight design

Suitable for up to 5 tester functions

Durable and water repellent design

Med-eKit Plus

The Med-eKit Plus is asolution package offeringa complete test set thatincludes electrical safety,vital signs simulator,ventilator tester and more.It can also feature a laptopof your specificationand our latest assetmanagement software.You could make life a lotmore efficient for yourselfif you included a range ofaccessories like thecompact barcode scannerand results/label printer.

Features include: Cost effective package

deal Configurable including

up to 5 tester functions Optional laptop

included Extremely lightweight

design Durable and water

repellent design

Med-eKit Pro

If you’re after a completebiomedical workshop onwheels, take a look at ourconfigurable Rigel Med-eKit Pro. Housed in adurable and handy trolleycase, it accommodates upto 10 different testers andsimulators, so you cancarry your analyser, vitalsigns simulator, defibanalyser, ventilator testerand more, safely andconveniently.

Features include: Integral wheels and

extendable handle for easy use

Configurable with up to 10 tester functions

Durable and robust enclosure

Water-proof design Secure locking

Med-eKit Solutions

29

You saw database management and work orderschedules as a major benefit, as they lead to fast,efficient test device configuration. You asked for timeand money-saving software to provide monthly scheduletests you could upload to your testers for easy re-test.

You also wanted preventative maintenance whichanalysed and compared results and which also sent youan alarm when devices could be deteriorating or neededto be replaced.

And you asked for test certificate software customisablefor details and logos in PDF format.

So we created Med-eBase software which can be used in a number of database environments, including: SQL and SQLite. This way your data’s secure and easilyaccessible. It can also be easily interrogated by thirdparty software which makes compatibility with othersoftware packages easy and straightforward.

Asset Management Software


Copyright © 2013 Rigel Medical

Part of

US OfficeRigel Medical, Seaward Group USA, 6304 Benjamin Road, Suite 506,Tampa, Florida, 33634, United States

Tel: +1 813-886-2775 Email: [email protected]

Rigel Medical, Bracken Hill, South West Industrial Estate,Peterlee, County Durham, SR8 2SW United Kingdom

Tel: +44 (0) 191 587 8730 Fax: +44 (0) 191 586 0227Email:[email protected] Web: www.rigelmedical.com

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