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Medicines and Healthcare products regulatory Agency logoEvaluation report

Department ofHealth logo

September 2004

MHRA 04080High powerelectrosurgery review 2004

best choice • best practice. www.mhra.gov.uk nww.medical-devices.nhs.uk

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Introduction

CONTENTS Page

Introduction 2

Summary of surgical modes 3Selecting of an ESU 4Table of principal features 7Table of principal applications 8

Product summaries:Aesculap GN640 9Conmed Excalibur Plus PC 11Conmed System 5000 13Erbe ICC350 15Erbe VIO 300D 17Eschmann TD830 19Eschmann TD850 21Martin ME MB2 23Valleylab Force 2 25Valleylab Force FX-8C 27

About MHRA evaluation reports 29Acknowledgments 29How to obtain MHRA reports 29

INTRODUCTION

electrosurgical terminology are included in theLow/ medium power electrosurgery review 2002[evaluation 02037] and Bipolar electrosurgeryreview 2001 [evaluation 01022]. Many technicalterms used in the product summary pages areexplained in evaluation 02037. This report shouldtherefore be read in conjunction with these earlierreports, which can be freely obtained from theMHRA office (details on page 29 of this document)or http://nww.cedar.wales.nhs.uk.

Manufacturers use various descriptions forsurgical modes and safety features but consistentterminology is used throughout this report andearlier evaluation reports 02037 & 01022. Tablessummarising each electrosurgical mode and theappropriate active electrodes for achieving thedesired surgical effect are listed on pages 3 and 4.These also list of the manufacturer’s specific termsto assist users and purchasers identify similarsurgical modes and features offered on modelsfrom different companies.

The section ‘Selecting an ESU’ provides advice onthe range of issues to consider when procurring anew or replacment electrosurgical generator.

Comparative tables of ESU features,electrosurgical modes and appropriate surgicalapplications on pages 7 and 8 will enable quickidentification of ESUs matching local procurementspecifications.

Product summary pages include power curves forthe maximum power setting and a typical surgicalsetting so users can more easily compareperformance. The ‘surgical setting’ in monopolarmodes was the power setting which produced 50Wpower in an equivalent patient circuit impedance of200Ω, in bipolar mode it was that at 20W when theimpedance was at 100Ω. The horizontal axis islabelled ‘test resistance’ as all measurements wereperformed using pure resistive loads from 50 to5000Ω for monopolar modes and 20 to 2000Ω forbipolar modes.

Product summary pages also display graphs ofpeak output voltage for a range of power settings.The active electrode was ‘open circuit’, simulatingthe initial situation for cutting and spraycoagulation. Power level settings in cutting/ blendmode, which produce peak voltages less than200V are unsuitable for cutting. In spraycoagulation mode the visible arc can disappear ifthe peak voltage/ gap is less than 1kV/mm.

MHRA evaluation 04080, September, 2004.

This issue of ‘Evaluation’ is a comparative reviewof High Power Electrosurgical Units [ESUs], alsoknown as surgical diathermy units. Samples ofmost manufacturers’ top of the range ESUgenerators are included in this issue. Where amanufacturer markets several ESUs usingdifferent design principles, one model from eachwas selected for evaluation, by mutual agreement.During the preparation of this report a number ofnew ESU models have been launched in the UKmarket. These will be evaluated in a reviewupdate, to be published in 2005.

All units included in this review are those capableof providing a maximum output power of between200W and 400W and tend to be high specificationtop of the range generators. These are commonlyused within general surgical theatres as they aresuitable for most surgical specialities, includingcardiology and urology.

Electrosurgery is used in 85% of all surgicalprocedures. It is capable of producing an incisionwith a simultaneous controlled level ofhaemostasis or to directly heat and seal tissuesurfaces and blood vessels, eg following surgicalincision. An overview of the electrosurgicaltechnique and glossary of technical and

2

MHRA evaluation 04080, September, 20043

Summary of surgical modes

SUMMARY OF SURGICAL MODESBy choosing the surgical mode, active electrodeand power level the surgeon can achieve a widerange of different surgical effects, from rapid andhighly localised heating to prolonged, moderateheating over a large area.

Mode: Pure CutElectrode Needle, Blade, Loop

Comments:

Pure Cut produces an incision withlittle or no haemostasis. Use thelowest power setting to achieve thedesired effect. The finer thedimension of the chosen electrodethe lower the required power level.Lower power levels also preventelectrode damage.

Crest Factor Typically 1.4 a sine wave

ManufacturerSpecific

Terminology

Aesculap: Power Cut 1.Conmed: Pure Cut.ERBE: Auto Cut and High CutEschmann: Normal Cut.Martin: Pure Cut.Valleylab: Pure Cut and Low Cut.

Mode: Blended CutElectrode Blade, Needle, Loop

Comments:

Blended Cut produces an incisionwith a controlled level ofhaemostasis, dependent uponcrest factor. Generally, highercrest factors produce deepercoagulation. Use the lowestpower setting to achieve thedesired effect. The finer thedimension of the chosen electrodethe lower the required power level.Reducing power also preventselectrode damage.

Crest Factor

Usually a pure sine wave pulsedon and off. CF commonly varyingbetween 2 and 6.

Manufacturerspecific

terminology

Aesculap: Power Cut 2, 3, 4.Conmed: Blend 1, 2, 3.ERBE: Dry Cut (VIO300D only).Eschmann: BlendMartin: Blend.Valleylab: Blend 1, 2, 3 (Force2)and Blend (Force FX).

Mode: Contact CoagulationElectrode Ball or Side of Blade

Comments:

Contact coagulation creates adesiccating effect within tissue.No cutting should be producedas the electrode is in contact withthe tissue to avoid arcing. Usethe lowest power setting toachieve the desired effect.Correct selection of power curveand setting will create controlleddesiccation without the electrodesticking to the tissue. Autostopcan ensure effective desiccation.



Terminology

Aesculap: Contact & Soft Coag.Conmed: Pinpoint Coag.ERBE: Soft Coag.Eschmann: Pinpoint Coag.Martin: Contact Coag.Valleylab: Coag and DessicateCoag.

Mode: Forced CoagElectrode Ball

Comments:

A contact coagulation modewhere the peak voltage isincreased so that the depth ofcoagulum is driven deeper intothe tissue. Many manufacturersdo not have a specific mode forthis procedure. However a lowpower setting spray coag modewill have a very similar effect.Fine electrodes will easilybecome damaged by the largepeak currents of this mode.

Crest FactorTypically variable however a CFof 6 to 9 is common. Dampedsine wave pulsed on and off.


Terminology

Conmed: Standard CoagERBE: Forced CoagValleylab: Fulgurate.

MHRA evaluation 04080, September, 2004 4

Summary of surgical modes

Mode: Spray CoagElectrode Ball

Comments:

A non-contact coagulation modewhere the peak voltage is high sothat the energy can arc across arelatively large air gap. Coagulationof a large area of profuse bleedingis created. The eschar formed ischarred and delicate. Fineelectrodes are easily damaged bythe large peak currents of thismode.

Crest FactorTypically variable, however a CF of7 to 14 is common. Damped sinewave pulsed on and off.


Terminology

Aesculap: Spray Coag.Conmed: Spray Coag.ERBE: Spray Coag.Eschmann: Spray Coag.Martin: Spray Coag.Valleylab: Spray Coag & Fulgurate.

Mode: Bipolar CoagulationElectrode Tweezers, Forceps

Comments:

A contact coagulation modeespecially useful for coagulation ofblood vessels. Generally lowerpower is required than monopolardue to the lower impedancebetween the tines.



Terminology

Aesculap: Bipolar Coag.Conmed: Bipolar Coag.ERBE: Bipolar Coag.Eschmann: Micro & Macro Coag.Martin: Bipolar Coag.Valleylab: Precise, Macro andStandard bipolar coag.

Mode: Bipolar Cutting

Electrode Specialist Instrument

Comments:

Bipolar incisions are producedusually using specially designedimplements. Some bipolarcoagulation modes with a highpeak voltage used with very finetweezers can ablate small tissueregions, effectively cutting tissue.



Terminology

Aesculap: Bicut.Conmed: Bipolar Cut.ERBE: Bipolar Cut.Eschmann: Bipolar Cut.Valleylab: Macro Bipolar


Selecting an ESU

mode and power levels and can allow the surgeonto become familiar with the changed tissueresponse.

Arc initiation systems are useful for cutting‘under water’ where low impedance incisions areunavoidable e.g. Trans Urethral Resection of theProstate (TURP). The high conduction of electricityin saline makes the generation of an arc difficult.Some ESUs overcome this by automaticallygenerating a short cycle of higher peak voltage toinitiate a cutting arc and bubble of ionised vapourat the beginning of each manual activation. Thisfeature enables the reduction of peak voltagesduring the remainder of the activation period andmay be called Power Peak System (ERBE), FluidMode System (Conmed System 500), SpecialistCut (Eschmann), Dynamic Output Control (Martin).

Variable blend setting can permit the surgeon toadjust the degree of haemostasis to specificpatient factors, such as the presence of anti-coagulant drugs.

Bipolar vessel sealing using bipolar coagulationmodes with very broad peaked power curves maybe suitable for tubal sterilisation. Some are used inconjunction with impedance sensing auto stop.

Minimal invasive procedures where theinsulated active lead is within a metal cannula willresult in some current being transferred to thelaparoscopic equipment by capacitive coupling.The availability of surgical modes that have lowpeak voltage will reduce the risk of insulationbreakdown, alternate site burns and video monitorinterference.

Dual activation is available on a few ESUs whichcan enable two surgeons to activate twomonopolar cutting and coagulation modessimultaneously for TD850 (Eschmann), andmonopolar coagulation for VIO300D (ERBE).Some systems share the maximum power outputavailable to both surgeons.

Interconnecting support units such as argonand smoke evacuation units can be pluggeddirectly into some ESU generators, without theneed for cabling. Activation of the pencil switch onthe ESU can then simultaneously activate theappropriate accessory units.

Pedestals compatible with ESU generators canprovide convenient storage for manuals,consumables and accessories (suction/argon/smoke evacuator). When fitted with integral

SELECTING AN ESU

Careful study of the individual requirements ofeach speciality using the theatre is a useful startingpoint. The new or replacement ESU should aim toaccommodate all the specific requirements butwithout being over complex. It can be useful to tryto standardise on a limited range of ESU modelswithin a single hospital. Theatre staff and surgeonsworking in several theatres and medicalengineering staff then become more familiar withthese models. This approach is particularly usefulwhen the usual ESU is withdrawn for servicing orrepair, as the replacement device will perform in anidentical manner.

Bipolar mode should always be included in thespecification as this is a lower risk mode in somecircumstances. Many high power ESUs now offernew bipolar modes, which may be appropriatealternatives to current monopolar techniques.

Control layout and ease of use is an importantfactor. The optimum choice may differ dependingon the previous experience of staff. Local review ofthe different models being considered is important.Use a check list of routine procedures which eachmember of staff performs then scores. Checklistcould include some of the following: visibility oflettering and illuminated indicators (at specificdistances and under typical lighting conditions);number of actions required for common set-uptasks, etc.

Power level increments in 1W steps, or less,especially in bipolar mode, would be required foruse by neurosurgeons and others who use lowpower settings. By contrast, urologists may findchanging power levels using coarser increments athigh power levels more convenient.

Power curves for similarly named surgical modescan vary considerably between different models,even from the same manufacturer. Comparison ofthe power curves and the crest factor of ESUs withthose of devices under consideration may help toidentify the best match to ensure expectedperformance in the new model. This information isalways provided by the manufacturer in the usermanual. Discussion of these issues with staff inlocal medical engineering departments will behelpful. If selecting an ESU with different technicalcharacteristics surgeons are advised to explore theimpact on surgical performance with themanufacturers' clinical application specialist. Thiswill be useful for determining the optimum surgical

Selecting an ESU


hospital grade fused multiway connectors,mounted off the floor, they reduce trailing leadsand the risk of accidents (see Medical Device Alert2002 (26)).

Contact quality monitor [CQM] is essential forsafe use of high-powered ESUs. CQM alerts staffto partial peeling off of the return electrode, whichcan concentrate the current sufficient to cause askin burn. Using CQM with split return electrodesis strongly advised for all monopolar surgicalprocedures.

Software upgrades enable general purposeESUs to be kept up to date. It is important that themanufacturers are able to retain previousconfiguration options to minimise the need fortheatre staff retraining. Scientists/ engineersresponsible for medical equipment management inthe hospital can assist with procurement andinstallation of upgrades as well as new equipment.

Specialist accessories currently in use bysurgical teams may not be suitable for use with allnew ESU models. Written assurances aboutcompatibility and continued supply of accessoriesfrom the manufacturer and any third partysuppliers over an extended period of time shouldbe sought prior to purchase.

User training for theatre staff and surgeons mustbe compulsory and included as part of thepurchase arrangements. The clinical risk ofinstalling new quipment can be reduced by theatrestaff undertaking a competency based trainingprogramme and surgeons having access to expertusers for specialist advice on surgical techniqueand generator settings.

Maintenance costs are usually equal to thepurchase cost over the life of the equipmentSavings in the lifetime equipment cost can beachieved by involving the scientists/ engineersresponsible for medical equipment management inthe pre-purchase negotiations with themanufacturer. Consideration may be given to thefollowing issues:-

i) Spare parts agreement with themanufacturer. The usual expectation is that spareparts for the ESU generator are made available fora minimum of seven years following the finalproduction date.

ii) Training for medical engineering supportstaff can be negotiated advantageously at the timeof purchasing arrangements.

iii) User and service manuals must beincluded in the purchase price. Manuals may alsobe available on CD Rom, which may be useful ifcentralised information systems are beingconsidered in the future.

iv) Availability of loan units during repairmay be negotiable as part of the purchasearrangements.

Table of principal features


Modes, features &accessories

Aes

cula

p G

N64

0

Con

med

Exc

alib

ur P

C

Con

med

Sys

tem

500

0

ERB

E IC

C35

0

ERB

E VI

O 3

00D

Esch

man

n TD

830

Esch

man

n TD

850

Mar

tin M

E M

B2

Valle

ylab

For

ce 2

Valle

ylab

For

ce F

X

Monopolar pure cut

Monopolar blend cut

Monopolar soft coag

Monopolar forced coag

Monopolar spray coag

Bipolar cut

Bipolar Coag

Bipolar auto stop

Bipolar auto start

Return electrode monitor

Contact quality monitor

LCD display

LED display

Argon unit

Smoke evacuation unit

Suction unit

Dual foot pedals

Single foot pedals

Software upgradable

Instrument auto - detection

Pedestal

Programmable

Other features not listed

Table 3 Table of principal features

7

Table of principal applications

Surgicalapplications

Aes

cula

p G

N64

0

Con

med

Exc

alib

ur P

C

Con

med

Sys

tem

500

0

ERB

E IC

C35

0

ERB

E VI

O 3

00D

Esch

man

n TD

830

Esch

man

n TD

850

Mar

tin M

E M

B2

Valle

ylab

For

ce 2

Valle

ylab

For

ce F

X

Cardiac

Chiropody

Colposcopy

Dental & oral

Dermatology

ENT

Endoscopy

Gasteroenterology

General surgery

Genitourinary

Gynaecology

Laproscopic

Maxillofacial

Microsurgery

Minor surgery

Opthalmology

Orthopaedics

Neurosurgery

Paediatric

Plastic & reconstructive

Thoracic

Urology (general)

Vascular

Vasectomy

Table 4 Table of principal applications

MHRA evaluation 04080, September, 2004. 8

9

Aesculap GN640 Product summary

Summary

300W Monopolar (Max). 100W Bipolar (Max).Weight 7.3 kg.Dimensions: 305(W) 175(H) 305(L)mm

SupplierB Braun Medical LtdThorncliffe ParkSheffieldS35 2PWTel: 0114 2259000Fax: 0114 2259111www.bbraun.com

Price £7087.00*

Report type Technical assessment

CE marking Yes, MD directive

Notified body TUV CE0123

Manufactured tostandard?

Certified to 93/42/EEC,ISO9001:2000, EN60601-1 1993,EN60601-2-2 2000.


Brief description

• Max power: 300W at 500Ω (rated load).• Fundamental frequency 447kHz.• Modulation frequency 20kHz.• Class IIB.• CF type.• Output sockets: 2 monopolar and 2 bipolar.• Monopolar cutting modes: 4 power cut modes and 2 micro cut. Power cut 1 is essentially a purecut mode. Power cut 2 - 4 are blended cutmodes. Both micro cut modes have outputvoltage regulation by the microprocessor forconsistent surgical effect in response to changingtissue impedances.• Monopolar coagulating modes: contact coag,soft coag and spray coag.• Bipolar modes: 2 cut modes and 2 coagulatingmodes. Cut modes may be used inconjunctionwith the BiTomTM instruments for effective cutting.Coagulation modes offer different power rangesfor general bipolar coagulating and microsurgicalapplications.

• Power adjustment via ‘up’ and ‘down’ pushbuttons on the front panel. Selectable on the LCDdisplay.• Single footswitch socket. Selectable on screento control bipolar or monopolar output.• Argon unit is an optional extra (Nelson Beamer).

Safety features• Return Electrode Monitoring.• Contact Quality Monitoring.Manufacturer’s term: PDM Permanent DynamicSystem (PDM).

Operating switches• Monopolar electrical dual pedals (blue/yellow) • Pencil switch• Bipolar - single electrical footswitch.

Main features

Servicing£250 per unit. Seviced in Germany. Price excludesVAT.* Price listed above comprises GN640 unit. Price

excludes VAT.

Facility MaxPower

RatedLoad

PeakVoltage

Power Cut 1 300W 500 Ω 1000V

Power Cut 2 250W 500 Ω 1000V

Power Cut 3 200W 500 Ω 1000V

Power Cut 4 150W 500 Ω 1000V

Micro Cut 1 300W 500 Ω N/A

Micro Cut 2 300W 500 Ω N/A

Contact Coag 120W 500 Ω 800V

Soft Coag 80W 800 Ω 1200V

Spray Coag 120W 1000 Ω 2300V

BiCut 1 100W 600 Ω 600V

BiCut 2 100W 100 Ω 470V

Bipolar Coag 1 100W 100 Ω 470V

Bipolar Coag 2 100W 100 Ω 470V

Technical assessment

Power curves

Leakage currentMaximum level of high frequency leakage currentmeasured was 104mA for monopolar pure cut andspray coagulation modes.

Maximum permissable limit 150mA.


Manufacturers comments

The Aesculap GN640 high frequency unit is amulti-purpose device suitable for virtually alltheatre based monopolar and bipolarrequirements. In cutting mode it offers Power Cut,Micro Cut and Bicut (for delicate bipolar cutting)and it can perform many types of coagulationincluding Contact, Spray and Bipolar Coagulation.

The Aesculap GN640 has 4 outputs, 2 x bipolarand 2 x monopolar which can be connectedsimultaneously utilising foot switches, fingercontrol and auto start/ cut off in Bipolar mode.

All this is supplied in an easy to maintain controlunit which has a self diagnosis error control givingimmediate identification of any part failure. Thistells the user which circuit board needs replacing(all circuit boards can be delivered within 24hours), a task which can easily be done by anyEBME department.

Product summary Aesculap GN640

GN640 Cut Modes Power (RMS) Vs Load

0

50

100

150

200

250

300

0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

Test Resistance (Ohms)

Po

we

r O

utp

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(Wa

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)

Max Pow er Cut 1 Typical Surgical Setting Cut 1Max Pow er Cut 3 Typical Surgical Setting Cut 3

GN640 Coag Modes Power (RMS) Vs Load

0

20

40

60

80

100

120

0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000


Po

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utp

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(Wa

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Max Pow er Soft Coag Typical surgical setting Soft CoagMax Pow er Spray Coag Typical Surgical Setting Spray Coag

GN640 Bipolar Power (RMS) Vs Load

0

20

4060

80

100

120

0 250 500 750 1000 1250 1500 1750 2000


Po

we

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utp

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(Wa

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)

Max Pow er Bipolar Cut 1 Typical Surgical Setting Bipolar Cut 1Max Pow er Bipolar Coag Typical Surgical Setting Bipolar Coag

GN 640 Cut 1 Voltage vs Power Setting

0100200300400500600700800

0 50 100 150 200 250 300

Power Setting (Watts)

Pe

ak

Vo

lta

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GN640 Spray Coag Voltage vs Power Setting

0

500

1000

1500

2000

2500

3000

0 20 40 60 80 100 120


Pe

ak

Vo

lta

ge

10

Output voltage (Open circuit)

11

Conmed Excalibur PC Product summary

Summary

300W Monopolar (Max). 50W Bipolar (Max).Weight 19.5 kg.Dimensions: 404(W) 159(H) 578(L)mm

SupplierConmed UK73/74 Shrivenham Hundred Business ParkSwindonWiltshireSN6 8TYTel: 01793 787910Fax: 01793 784568www.conmed.co.uk

Price £6500.00*





Certified to 93/42/EEC,EN60601-1988, EN60601-2-2 2000, ISO9001:1994.


Brief description

• Max power: 300W at 300Ω (rated load).• Fundamental frequency 416.7KHz.• Modulation frequency 20KHz.• Class IIB.• CF type.• Output sockets: 2 monopolar and 1 bipolar.• Monopolar cutting modes: 1 pure cut and 3blended cut.• Monopolar coagulating modes: standard (forcedcoag) and spray coagulation.• Bipolar modes: Cut and coagulation.• Power adjustment via ‘up’ and ‘down’ pushbuttons on the front panel.• Two rear footswitch sockets. One each for amonopolar pedal and a bipolar pedal.• Remote power changes using the active pencilare possible by selector switch on the front panel.• Footpedal control of the monopolar output is onlyavailable through the Bovie #12 socket on the frontpanel.

Safety features• Return Electrode Monitoring.• Contact Quality Monitoring.Manufacturer’s term: A.R.MTM - Automatic ReturnMonitoring.

Operating switches• Monopolar electrical single and dual pedals(blue/yellow) available.• Pencil switch.• Bipolar single electrical.• Remote control via ordinary pencil switch.

Main features

ServicingUp to 3 Units £295 plus VAT/visit. 2 visits/year.Emergency call out £65/ hour plus VAT. Plus£0.40/mile.Non contract call out rate £85/hour plus VAT. Plus£0.40/mile.Prices exclude VAT.

Facility MaxPower

RatedLoad

PeakVoltage

Pure Cut 300W 300 Ω 825VBlend 1 180W 300 Ω 900VBlend 2 120W 300 Ω 950VBlend 3 80W 300 Ω 1000V

StandardCoag 120W 300 Ω 3250V

Spray-Coag 80W 500 Ω 5000V

Bipolar Cut 50W 50 Ω 175VBipolar Coag 50W 50 Ω 175V

* Price comprises Sys5000 unit, monopolar andbipolar foot switches, mounting carts and user andservice manuals. Price excludes VAT


Power curves

Leakage currentMaximum level of high frequency leakage currentmeasured was 139mA for monopolar spraycoagulation mode.


Product summary Conmed Excalibur PC




The Excalibur continues to be an extremelypopular full feature generator and is equally athome in a small day surgery unit or a morespecialised theatre environment. The Excalibur issupplied with a robust steel mounting cart and bothmonopolar and bipolar pedals. It also boasts 9 userprogrammable memories, 4 cut, 3 coagulation and2 bipolar modes. It also features ‘Remote powercontrol’ and patient plate monitoring.

Manufacturers two year warranty.

Excalibur PC Cut Modes Power (RMS) vs Load

050

100150200250300350

0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000


Po

we

r O

utp

ut

(Wa

tts

)

Pure Cut Max Pow er Pure Cut Typical Surgical SettingBlend 1 Max Pow er Blend 1 Typical Surgical Setting

Excalibur PC Coag Modes Power (RMS) vs Load

0255075

100125150

0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000


Po

we

r O

utp

ut

(Wa

tts

)

Spray Coag Max Pow er Spray Coag Typical Surgical SettingStandard Coag Max Pow er Standard Coag Typical Surgical Setting

Excalibur PC Bipolar Modes Power (RMS) vs Load

0

10

20

30

40

50

60

0 250 500 750 1000 1250 1500 1750 2000


Po

wer

Ou

tpu

t (W

atts

)

Bipolar Cut Max Pow er Bipolar Cut Typical Surgical SettingBipolar Coag Max Pow er Bipolar Cut Typical Surgical Setting

Excalibur PC Pure Cut Mode Voltage vs Power Setting

050

100150200250300350400

0 50 100 150 200 250 300


Pe

ak

Vo

lta

ge

Excalibur PC Spray Coag Mode Voltage vs Power Setting

0250500750

10001250150017502000

0 10 20 30 40 50 60 70 80


Pe

ak

Vo

lta

ge

12

13

Conmed System 5000 Product summary

Summary

300W Monopolar (Max). 90 W Bipolar (Max).Weight 9.75kgDimensions: 350 (W) 140 (H) 480 (L)mm

SupplierConMed UK.73/74 Shrivenham Hundred Business Park.Swindon, Wiltshire.SN6 8TYTel: 01793 787910Fax: 01793 784568www.conmed.co.uk

Price £9600.00*





Certified to 93/42/EEC,ISO9001:2000, EN60601-1:1996,EN60601-2-2:2000.


Brief description

• Max power: 300W at 500Ω (rated load).• Fundamental frequency 391KHz.• Modulation frequency 20KHz.• Class IIB.• CF type.• Output sockets: 2 monopolar and 1 bipolar.• Monopolar cutting modes: 1 pure cut and 3blended cut.• Monopolar coagulating modes: Pinpoint which isessentially a contact coagulation mode, standard(forced coag) and spray coagulation.• Bipolar modes: micro and macro coagulation.Macro coagulation may be used for bipolar cuttingwith the correct bipolar implement.• Speciality surgical modes, general, laparoscopicand fluid. Laparoscopic mode limits the maximumoutput voltage for safety reasons. Fluid modeincreases the peak voltage at the begining ofactivation to initiate a cut under water.•Pulse cut and pulse coag. Output power is

fractionated to provide constant cutting speed andtherefore surgical effect.• Power adjustment via ‘up’ and ‘down’ pushbuttons on the front panel.• Two rear footswitch sockets. One for monopolarpedal and one for a bipolar pedal.• Remote power changes using the active pencilare possible.

Safety features• Return Electrode Monitoring.• Contact Quality Monitoring.Manufacturer’s term: A.R.MTM - Automatic ReturnMonitoring.

Operating switches• Monopolar electrical single and dual pedals(bue/yellow) available.• Pencil switch.• Bipolar single electrical footswitch.

Main features

ServicingUp to 3 units £295 plus VAT/visit. 2 visits/year.Emergency call out £65/ hour plus VAT. Plus£0.40/mile.Non contract call out rate £85/hour plus VAT. Plus£0.40/mile.Prices exclude VAT.* Price comprises Sys5000 unit, monopolar and

bipolar foot switches, mounting carts and user andservice manuals. Price excludes VAT.

Facility MaxPower

RatedLoad

PeakVoltage

Pure Cut 300W 500 Ω 760VBlend 1 200W 500 Ω 790VBlend 2 200W 500 Ω 1010VBlend 3 200W 500 Ω 1160VPinpoint

Coag 120W 500 Ω 1600V

StandardCoag 120W 500 Ω 3000V

Spray Coag 80W 500 Ω 5600VBipolar Micro

Coag 50W 50 Ω 160V

BipolarMacro Coag 90W 500 Ω 550V


Power curves

Leakage currentMaximum level of high frequency leakage currentmeasured was 100mA for monopolar pure cut andspray coagulation modes.



The System 5000, the latest ConMedelectrosurgical generator offers a ‘fluids mode’ foruse in urology and gynaecology, laparoscopic and‘general modes’ for open surgery. Pulsed outputsare available in cut and coagulation modes.

Designed for ease of use, easy to clean and move,the pedestal has baskets for foot switches,accessories and cable storage. The instrumentportals are illuminated and their shape makes theinsertion of accessories trouble-free. The ‘readyplug’ eliminates adaptor use. There is a bipolaroutput meter for macro and standard bipolar odes,9 programmable memories, complete with cart andfootswitches.

Manufacturers two year waranty.

Product summary Conmed System 5000


System 5000 Cut Modes Power (RMS) vs Load

050

100150200250300

0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

Test Impedance (Ohms)

Po

we

r O

utp

ut

(Wa

tts

)


System 5000 Coag Modes Power (RMS) vs Load

0

2040

6080

100120

140

0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000


Po

wer

Ou

tpu

t (W

att

s)

Spray Coag Max Pow er Spray Coag Typical Surgical SettingPin Point Max Pow er Pin Point Typical Surgical Setting

System 5000 Bipolar Power (RMS) vs Load

0

20

40

60

80

100

0 250 500 750 1000 1250 1500 1750 2000


Ou

tpu

t P

ow

er

(Wa

tts

)

Macro Bipolar Max Pow er Macro Bipolar Typical Surgical SettingMicro Bipolar Max Pow er Micro Bipolar Typical Surgical Setting

Sys5000 Pure Cut Voltage vs Power Setting

0100200300400500600700

0 50 100 150 200 250 300


Pe

ak

Vo

lta

ge

Sys5000 Spray Coag Voltage vs Power Setting

0

1000

2000

3000

4000

0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80


Pe

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14


15

ERBE ICC350 Product summary

Summary

300W Monopolar (Max). 120W Bipolar (Max).Weight 10 kg.Dimensions: 410(W) 152(H) 368(L)mm

SupplierERBE Medical UK LtdThe Antler Complex2 Bruntcliffe WayMorleyLeedsLS27 0JGTel: 0113 2530333Fax: 0113 2532733www.erbeuk.com

Price £8750.00*

MHRA evaluation 04080,September, 2004

Brief description

• Max power: 300W at 500Ω (rated load).• Fundamental frequency 330KHz.• Class IIB.• CF type.• Output sockets: 2 monopolar and 1 bipolar.• Monopolar cutting modes: Auto, high and endocut. Endo cut is selected by using programme ‘E’.• Power Peak SystemTM automatically makesextra power available to instigate a cut underwater.• Monopolar coagulating modes: soft, forced andspray coag. Soft coag has auto stop capability.Twin output coagulation is permittable, allowing 2surgeons to operate simultaneously.• Bipolar modes: Cut and coagulation. Bipolarcutting is accessed via programme ‘B’.Coagulation has auto start (usually disabled) andauto stop capability. • Power adjustment via ‘up’ and ‘down’ pushbuttons on the front panel.

• Two rear footswitch sockets. 1 bipolar and 1monopolar. A switch on the front allows bipolarcontrol via monopolar foot pedal.• Argon unit is an optional extra [APC300].

Safety features• Return Electrode Monitoring.• Contact Quality Monitoring.Manufacturer’s term: NESSY - Neutral ElectrodeSafety System.

Operating switches• Monopolar electrical single and dual pedals(blue/yellow).• Pencil switch• Bipolar single electrical footswitch.

Main features

Servicing

Non contract price:Rate/hour service (on site) £68.25Rate/hour travel £66.15Contract price:Standard annual service £593.25**Total care annual service £889.35All prices exclude VAT.** Service includes loan unit.


CE marking Yes, MD directive.

Notified body DEKRA CE0124


Certified to 93/42/EEC,EN60601-1:1990,EN60601-2-2:1990.ISO 9001 1994.

* Price listed above comprises ICC350 unit, usermanual, two pedal monopolar foot switch, returnlead, box of 50 return plates. Price excludes VAT.

Facility MaxPower

RatedLoad

PeakVoltage

Auto Cut 300W 500 Ω 650VHigh Cut 300W 500 Ω 570V

Soft Coag 120W 125 Ω 1900V

ForcedCoag 120W 350 Ω 2300V


BipolarCoag 120W 125 Ω 190V

Product summary Erbe ICC350



Power curves

Leakage currentMaximum level of high frequency leakage currentmeasured was 47mA for monopolar pure cutmode.




Comments have been received from themanufacturer and, where appropriate, theirsuggested changes have been incorporated intothis report.

ICC350 Cut Modes Power (RMS) Vs Load

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Auto Cut Effect 1 Auto Cut Effect 3Typical Surgical Setting Cut Effect 1 Typical Surgical Setting Cut Effect 3

ICC350 Coag Mode Power (RMS) Vs Load

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Soft Pow er Spray Pow erTypical Surgical Setting Soft Coag Typical Surgical Setting Spray Coag

ICC350 Bipolar Mode Power (RMS) vs Load

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Full Pow er Typical Surgical Setting

ICC350 Voltage Auto Cut Mode vs Power Setting

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ICC350 Spray Coag Voltage vs Power Setting

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17

ERBE VIO 300D Product summary

Summary

300W Monopolar (Max), 120W Bipolar (Max).Weight 9.5 kg.Dimensions: 410(W) 165(H) 380(L)mm

SupplierERBE Medical Uk LtdThe Antler Complex2 Bruntcliffe WayMorleyLeedsLS27 0JGTel: 0113 2530333Fax: 0113 2532733www.erbeuk.com

Price £9501.00*



Notified body DEKRA CE0124


Certified to 93/42/EEC,ISO9001:2000, EN60601-1:1996,EN60601-2-2:2000.


Brief description

• Max power: 300W at 500Ω (rated load).• Fundamental frequency 350KHz.• Class IIB.• CF type.• Output sockets: sockets are removable so anycombination of monopolar and bipolar output canbe configured.• Monopolar cutting modes: auto, high, dry andprecise cut.• Monopolar coagulating modes: soft, swift, forcedand spray coag. As well as a twin output coag,allowing 2 surgeons to operate simultaneously.• Bipolar modes: cut, soft and forced coagulation.• Liquid crystal display that depicts surgical effectas the settings are changed.• Power adjustment via ‘up’ and ‘down’ pushbuttons on the front panel.• Auto detect instruments multi-functionalreceptacle.

• Two rear footswitch sockets. Configurable forbipolar or monopolar.• Argon unit is an optional extra. Automaticconnection between units by stacking them on topof each other. [APC 2].

Safety features• Return Electrode Monitoring.• Contact Quality Monitoring.• Return Electrode Orientation Monitor.• Return Electrode Low skin Resistance Monitor.Termed: NESSY neutral electrode safety system.

Operating switches• Monopolar electrical single and dual pedals(blue/yellow).• Pencil switch.• Bipolar single electrical.

Main features

ServicingNon contract price:Rate/hour service (on site) £68.25Rate/hour travel £66.15Contract price:Standard annual service £790.00**Total care annual service £1185.00All prices exclude VAT.** Service includes loan unit.

, Price listed above comprises VIO unit, usermanual, dual monopolar foot switch (with remode),return lead, box of 50 return electrodes. Priceexcludes VAT.

Facility MaxPower

RatedLoad

PeakVoltage

Auto Cut 300W 500 Ω 740VHigh Cut 300W 500 Ω 950VDry Cut 200W 500 Ω 1450V

Soft Coag 200W 500 Ω 190VSwift Coag 200W 500 Ω 2500V

Forced Coag 120W 500 Ω 1800VSpray Coag 120W 500 Ω 4300VBipolar Cut 100W 500 Ω 740V

Bipolar Soft Coag 120W 75 Ω 190VBipolar Forced Coag 90W 200 Ω 560V

Precise Cut 50W 500 Ω 390VPrecise Coag 50W 75 Ω 110V

Twin Coag 200W 500 Ω 2000VBiClamp 300W 25 Ω 220V


Power curves



Product summary ERBE VIO 300D


Output voltage(Open circuit)



VIO Coag Modes Power (RMS) vs Load

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Typical Surgical Setting Soft Coag E4 Max Pow er Soft Coag E4Max Pow er Spray Coag E1 Typical Surgical Setting Spray Coag E1

VIO Cut Modes Power (RMS) Vs Load

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Max Pow er Auto Cut E8 Typical Surgical Setting Auto Cut E8Max Pow er Dry Cut E8 Typical Surgical Setting Dry Cut E8

VIO Bipolar Modes Power (RMS) Vs Load

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Max Pow er Bipolar Cut E4 Typical Surgical Setting Bipolar Cut E4Max Pow er Soft Coag E4 Typical Surgical Setting Soft Coag E4

VIO Auto Cut Effect 4 Voltage vs Power Setting

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VIO Spray Coag Effect 1 Voltage vs Power Setting

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Eschmann TD830 Product summary

Summary

345W Monopolar (Max), 50W Bipolar (Max).Weight 14 kg.Dimensions: 390(W) 190(H) 425(L)mm

SupplierEschmann Bros & Walsh LtdPeter RoadLancingWest SussexBN15 8TJTel: 01827 288 883Fax: 01827 288 334www.eschmann.co.uk

Price £6499.00*


Brief description

• Max power: 345W at 150Ω (rated load, normalcut mode).• Fundamental frequency 475kHz.• Class IIB.• CF type.• Output sockets: 2 monopolar and 1 bipolar.• Monopolar cutting modes: Normal cut, blendand specialist cut. Normal cut is essentially apure cut waveform. Specialist cut has higher peakvoltages for initiating cuts under water i.e. TURP.• Monopolar coagulating modes: Pinpoint andspray coagulation. Pinpoint coagulation isessentially a contact coagulation mode.• Bipolar modes: Macro and micro coagulation.• Power adjustment via a rotating switch.• Power indicator either in Watts or a scale 1 to 10.• Three rear sockets for foot pedal connection.

Safety features• Patient Voltage Monitor • Patient Earth Monitor • Return Electrode Monitoring.• Contact Quality Monitoring.• Excess Power Monitor.

Operating switches• Monopolar electrical single and dual pedals(blue/yellow).• Pencil switch.• Bipolar single electrical (white) and singlepneumatic (white).

Main features

Servicing

Contract price:Preventative maintenance contract: £77.00/ visit(2 visits/ year) Price excludes parts andemergency breakdowns.

Comprehensive maintenance contract £374.00 (2visits/ year)Prices exclude VAT.


CE marking Yes, MD directive. Annex II.

Notified body AMTAC MEDIQA CE0473

Manufacturedto standard?

Certified to Annex II 93/42/EEC,EN60601-1:1990, EN60601-2-2:1998, ISO9001:1994,EN46001:1996.

Facility Max Power RatedLoad

PeakVoltage

Normal Cut 345W 150 Ω 1150V

Blend 300W 200 Ω 2200V

SpecialistCut 345W 200 Ω 1500V

PinpointCoag 170W 150 Ω 2150V


Bipolar MicroCoag 17W 50 Ω 150V

BipolarMacro Coag 50W 100 Ω 230V

* Price listed above comprises TD830 unit. Priceexcludes VAT.


Power curves

Leakage currentManufacturer states: ‘Leakage current is alwaysless than 100µA to earth from all patient circuits atnominal mains voltage’.

High frequency leakage current could not beverified for this unit as the test procedure trippedthe plate voltage monitor alarm, disabling theoutput.

Output voltage(Open circuit)

Product summary Eschmann TD830



The TD830 is designed for speed, accuracy andease of use, ensureing training requirements arekept to a minimum. With one bipolar and onemonopolar outputs the specialist surgeon can useseven separate research based cutting andcoagulation output modes. The bipolar andmonopolar generators can be used simultaneouslyenabling 2 surgeons to operate on one patient atthe same time. Safety circuits such as the leakagelimiting circuit, patient earch and plate voltagemonitors work together to help in the detection ofpotential risks, thus safeguarding the patient,surgeon and theatre staff.

The power curves shown interpolate between thepower output values for the load resistancesspecified in the CEDAR protocol. However, thesemeasurements yield an apparent maximum powerconsiderably below that which would have beenobtained if the rated load had been applied (150Ωfor pure cut and pinpoint coag and 200Ω for blend,specialist cut and spray coag). Power outputcurves incorporating the rated load and maximumpower values can be seen in the Eschmann TD830user manual.

TD830 Cut Modes Power (RMS) vs Load

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Pure Cut Typical Surgical Setting Pure Cut Max Pow erBlend Typical Surgical Setting Blend Max Pow er

TD830 Coag Modes Power (RMS) vs Load

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Spray Coag Typical Surgical Setting Spray Coag Max Pow erPin Point Coag Typical Surgical Setting Pin Point Coag Max Pow er

TD830 Bipolar Modes Power (RMS) vs Load

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Micro Bipolar Max Pow er Micro Bipolar Typical Surgical SettingMacro Bipolar Max Pow er Macro Bipolar Typical Surgical Setting

TD830 Pure Cut Voltage vs Power Setting

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TB830 Spray Coag Voltage vs Power Setting

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20

21

Eschmann TD850 Product summary

Summary

210W Monopolar (Max), 50W Bipolar (Max).Weight 18.1kg.Dimensions: 435(W) 200(H) 474(L)mm

SupplierEschmann Bros & Walsh LtdPeter RoadLancingWest SussexBN15 8TJTel: 01827 288 883Fax: 01827 288 334www.eschmann.co.uk

Price £7999.00*


CE marking Yes, MD directive. Annex II.

Notified body AMTAC MEDIQA CE0473Manufacturedto standard?

Certified to Annex II 93/42/EEC,EN60601-1:1990, EN60601-2-2:1991, ISO9001:1994,EN46001:1996.


Brief description

• Max power: 210W at 750Ω (rated load, specialistcut mode).• Fundamental frequency 475kHz.• Class IIB.• CF type.• Output sockets: 2 monopolar and 1 bipolar.• Monopolar cutting modes: normal cut, blendedcut and specialist cut. Normal cut is essentially apure cut waveform. Specialist cut has higher peakvoltages for initiating cuts under water i.e. TURP.• Monopolar coagulating modes: Pinpoint andspray coagulation. Pinpoint coagulation isessentially a contact coagulation mode.• Bipolar modes: cut mode, macro and microcoagulation.• 6 Parameter change modes: Reduces the outputpower and peak voltage of the diathermy modesenabling laparoscopic, endoscopic andarthroscopic procedures. • Remote control pad.• Video synchronisation facility.

• The unit comprises two separate monopolargenerators. Allowing 2 surgeons to worksimultaneously from the same ESU. (see graph,page 22).• Power adjustment via a rotating switch.• Seven rear sockets for foot pedal connection.

Safety features• Patient Voltage Monitor.• Patient Earth Monitor.• Return Electrode Monitoring.• Contact Quality Monitoring.• Excess Power Monitor.

Operating switches• Monopolar electrical single and dual pedals(blue/yellow).• Pencil switch.• Bipolar single electrical (white) and singlepneumatic.• Remote control. Alters monopolar power settingonly.

Main features

ServicingContract price:Preventative maintenance contract: £77.00/ visit(2 visits/ year) Price excludes parts andemergency breakdowns.Comprehensive maintenance contract £843.00 (2visits/ annum). Prices exclude VAT.

Facility MaxPower

RatedLoad

PeakVoltage

Normal Cut 160W 700 Ω 850VBlend 130W 750 Ω 1100V

Specialist Cut 210W 750 Ω 1100V

Pinpoint Coag 90W 550 Ω 1250VSpray Coag 80W 300 Ω 2200VBipolar Cut 40W 400 Ω 400V

Bipolar MicroCoag 8W 80 Ω 160V

Bipolar MacroCoag 50W 80 Ω 300V

ParameterChange Modes Various Various Various

* Price listed above comprises TD850 unit. Priceexcludes VAT.

Product Summary Eschmann TD850


Leakage currentManufacturer states: ‘Leakage current is alwaysless than 10µA to earth from all patient circuits atnominal mains voltage’.

High frequency leakage current could not beverified for this unit as the test procedure trippedthe plate voltage monitor alarm, disabling theoutput.

•Output voltage (Open circuit)


The TD850 includes one bipolar and twomonopolar generators. It is designed for speed,accuracy and simplicity of use. All 3 generatorscan be used simultaneously in either cut orcoagulation modes, enabling 3 surgeons tooperate on one patient at the same time. TheTD850 offers over 14 separate research basedcutting and coagulation output modes. Safetycircuits such as leakage limiting circuit, patientearth and plate voltage monitors work together tohelp in the detection of potential risks, thussafeguarding the patient, surgeon and theatrestaff.


Power curves

TD850 Cut Modes Power (RMS) vs Load

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Pure Cut Max Pow er Pure Cut Typical Surgical SettingBlend Max Pow er Blend Typical Surgical Setting

TD850 Coag Modes Power (RMS) vs Load

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Pin Point Coag Max Pow er Pin Point Coag Typical Surgical SettingSpray Coag Max Pow er Spray Coag Typical Surgical Setting

TD850 Bipolar Modes Power (RMS) vs Load

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High Coag Max Pow er High Coag Typical Surgical SettingLow Coag Max Pow er Low Coag Typical Surgical Setting

Dual Monopole Activation Pure Cut Mode Power (RMS) Vs Load

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User 1 Pow er User 2 Pow er Single Use Pow er

TD850 Pure Cut Voltage vs Power Setting

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0 10 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160Power Setting (Watts)

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TD850 Spray Coag Voltage vs Power Setting

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22


Martin ME MB2 Product summary

Summary

400W Monopolar (Max), 100W Bipolar (Max).Weight 8.6KgDimensions: 405(W) 135(H) 380(L)mm

SupplierMelyd Medical LtdUnit 1, 21 Kings Avenue,PrestatynDenbighshireLL19 9AATel: 01745 853178Fax: 01745 888826www.melydmedical.com

Price £4999*


CE marking Yes, MD directive Annex II.

Notified body DQS CE 0297


Certified to Annex II93/42/EEC, EN60601-1:1995, EN60601-2-2:2001,ISO9001:1994,EN46001:1996.

Brief description

• Max power: 400W at 300Ω (rated load).• Fundamental frequency 450kHz.• Modulation frequency 30kHz.• Class IIB.• CF type.• Output sockets: 1 monopolar and 1 bipolar.• Monopolar cutting modes: pure cut, blended cutand endo cut.• Monopolar coagulating modes: contact andspray coagulation.• Bipolar mode: coagulation.• Automatic start for bipolar coagulation(selectable).• Auto switch off for bipolar coagulation(selectable). However, the output power does notfully switch off until the forceps are completelyremoved from the tissue. Instead the output ispulsed ‘on’ then ‘off’ for a greater coagulatingeffect. It is still for the surgeon to determine whento end the coagulating process by removal of theforceps from the tissue.

• Power adjustment via a rotating switch.• One footswitch socket that may control eithermonopolar output or bipolar output, selectable bya switch on the front panel.• Argon unit is an optional extra. (Martin ArgonBeamer System MABS).

Safety features• Return Electrode Monitoring.• Contact Quality Monitoring.Manufacturer’s term: Patient Control System(PCS).

Operating switches• Monopolar electrical dual pedals (blue/yellow) • Pencil switch• Bipolar-No special pedal (use monopolar pedalabove).

Main features

Servicing

Contract price:Standard annual service: £200.00 per visit.Price excludes VAT.

* Price listed above comprises ME MB2 unit. Priceexcludes VAT.


PeakVoltage

Pure Cut 400W 300 Ω 2300V

Blend 300W 300 Ω 2500V

Endo Cut 100W 200 Ω 2800V

ContactCoag 250W 200 Ω 3200V

SprayCoag 120W 300 Ω 9000V



Power curves



Product summary Martin ME MB2





ME MB2 Cut Power (RMS) vs Load

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Max Pow er Cut Typical Surgical Setting Pure Cut Max Pow er Blend Typical Surgical Setting Blend

ME MB2 Coag Power (RMS) vs Load

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Max Pow er Contact Coag Typical Surgical Setting Contact CoagMax Pow er Spray Coag Typical Surgical Setting Contact Coag

ME MB2 Bipolar Power (RMS) vs Load

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Max Pow er Typical Surgical Setting

ME MB2 Pure Cut Voltage vs Power Setting

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ME MB2 Spray Coag Voltage vs Power Setting

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24

Valleylab Force 2 Product summary

Summary

300W Monopolar (Max), 70 W Bipolar (Max).Weight 10kgDimensions: 200 (W) 330 (H) 530 (L)mm

SupplierTyco Healthcare Valleylab154 Fareham RoadGosportHampshirePO13 0ASTel: 01329 224115Fax: 01329 224260www.valleylab.com

Price £5000.00*

Report type Technical assessmentCE marking Yes, MD directive Annex II

Notified body BSI CE0086.Manufactured tostandard?

Certified to 93/42/EEC,EN60601-1:1995,EN60601-2-2:2000,ISO9001:1994,EN46001:1996.

Brief description

• Max power: 300W at 300Ω (rated load).• Fundamental frequency 510kHz.• Modulation frequency 31kHz.• Class IIB.• CF type.• Output sockets: 2 monopolar and 1 bipolar.• Monopolar cutting modes: 1 pure cut and 3blend modes.• Monopolar coagulating modes: coag, which isessentially a spray coagulation mode and lowvoltage coag [LVC]. It should be noted that LVC isvery similar to a blend waveform. LVC isaccessed by pressing the ‘Ready’ button and the‘Coag power down’ button simultaneously. Itshould be noted that this mode is not labelled onthe front of the unit.• Bipolar mode: coagulation.• Power adjustment via ‘up’ and ‘down’ pushbuttons on the front panel.

• Two rear footswitch sockets. One for monopolarpedal and one for a bipolar pedal at the rear ofthe unit.• Argon unit is an optional extra. (Force Argon IITM)•Remote power changes using the active pencil arepossible by using the Valleylab power controlpencil with this unit.

Safety features• Return Electrode Monitoring.• Contact Quality Monitoring.Manufacturer’s term: Return Electrode Monitoring(REM).

Operating switches• Monopolar electrical dual pedals (blue/yellow).• Pencil switch.• Bipolar single electrical.

Main feature

Servicing

Up to 3 units £700 / year. 2 visits / year.Emergency call out £60 / hour.Non contract call out rate £85 / hour.Prices exclude VAT.* Price listed above comprises Force 2 unit. Price

excludes VAT but includes the cost of delivery.


PeakVoltage

Pure Cut 300W 300 Ω 1750V

Blend 1 250W 300 Ω 1900V

Blend 2 200W 300 Ω 2000V

Blend 3 150W 300 Ω 2000V

Coag 120W 300 Ω 3500V

Low V-Coag 99W 300 Ω 2000V


MHRA evaluation 04080, September, 2004.25


Power curves

Leakage CurrentMaximum level of high frequency leakage currentmeasured was 103mA for monopolar spraycoagulation mode.


Product summary Valleylab Force 2




These comments focus on the mechanism ofpower sharing during dual activation on the Force2 (see page 5). Although surgeons share thepower on the Force 2, how much power theyreceive is dependent on the relative impedance atthe electrode and so the power may notnecessarily be halved. In addition, as this appliesto non-contact modalities (fulgurate and spray)which are high voltage applications, the surgicaleffect is not degraded as long as one surgeondoes not touch down on the tissue. It is a systemthat works well in cardiothoracic and plasticsurgery.

Please note that later this year, Valleylab will ceasemarketing of the Force 2 within the UK.

Force 2 Cut Modes Power (RMS) Vs Load

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Force 2 Coag Mode Power (RMS) Vs Load

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Coag Max Pow er Coag Typical Surgical Setting

Force 2 Bipolar Modes Power (RMS) vs Load

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Typical Surgical Setting Max Pow er

Force 2 Pure Cut Voltage vs Power Setting

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Force 2 Coag Output Voltage vs Power Setting

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Valleylab Force FX Product summary

Summary

300W Monopolar (Max), 70 W Bipolar (Max).Weight 8.2kgDimensions: 356 (W) 111 (H) 457 (L)mm

SupplierTyco Healthcare Valleylab154 Fareham RoadGosportHampshirePO13 0ASTel: 01329 224115Fax: 01329 224260www.valleylab.com

Price £10,132.00*


CE marking Yes, MD directive Annex IINotified body BSI CE0086


Certified to 93/42/EEC,EN60601-1:1995,EN60601-2-2:2000,ISO9001:1994,EN46001:1996.


Brief description• Max power: 300W at 300Ω (rated load).• Fundamental frequency 390kHz (pure cut),470kHz (bipolar) and 393kHz to 470kHz (coag).• Modulation frequency 28±7KHz (spray coagonly).• Class IIB.• CF type.• Output sockets: 2 monopolar and 1 bipolar.• Monopolar cutting modes: Pure cut, low cut andblended cut.• Monopolar coagulating modes: desiccate coagmodes 1 through to 3. These modes areessentially contact coagulation waveforms.Desiccate 1 has a blend type waveform whereasdesiccate 2 and 3 have pure sinusoidalwaveforms with different shaped power curvesand output voltage ranges. Two fulgurate modes‘Fulgurate’ and ‘Low Crest Factor Fulgurate’,which are essentially forced coagulation modes.The LCF mode has a lower output voltage range.The unit also has a spray coag mode with shiftingmodulating frequency centred on 29KHz ± 7KHz.

•Dual coagulation is permitted with this unit bypower sharing the output.• Bipolar mode: precise, standard and macrocoagulation. Macro may also be used for cutting.• Power adjustment via ‘up’ and ‘down’ pushbuttons on the front panel.• Three rear footswitch sockets. Two formonopolar pedals and one for a bipolar pedal.

Safety features• Return Electrode Monitoring.• Contact Quality Monitoring.Manufacturer’s term: Return Electrode Monitoring(REM).

Operating switches• Monopolar electrical dual pedals (blue/yellow). • Pencil switch.• Bipolar single electrical.

Main features

ServicingUp to 3 units £700 / year. 2 visits / year.Emergency call out £60 / hour.Non contract call out rate £85 / hour, excluding VAT* Price listed above comprises Force FX unit. Price

excludes VAT but includes the cost of delivery.

Facility MaxPower

RatedLoad

PeakVoltage

Low Cut 300W 300 Ω 230VPure Cut 300W 300 Ω 170VBlend Cut 200W 300 Ω 430VDesiccate

Coag 120W 500 Ω 2500V

FulgurateCoag 120W 500 Ω 5000V

LCFFulgurate 120 500 Ω 3660V

Spray Coag 120W 500 Ω 5550VPreciseBipolar 70W 100 Ω 230V

StandardBipolar 70W 100 Ω 170V

MacroBipolar 70W 100 Ω 430V


Power curves

Leakage currentMaximum level of high frequency leakage currentmeasured was 110mA for monopolar pure cutmode.


Product summary Valleylab Force FX




These comments focus on the mechanism ofpower sharing during dual activation on the ForceFX (see page 5). Although surgeons share thepower on the FX, how much power they receive isdependent on the relative impedance at theelectrode and so the power may not necessarily behalved. In addition, as this applies to non-contactmodalities (fulgurate and spray) which are highvoltage applications, the surgical effect is notdegraded as long as one surgeon does not touchdown on the tissue. It is a system that works wellin cardiothoracic and plastic surgery.

Force FX Cut Modes Power (RMS) vs Load

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Pure Cut Max Pow er Blend Max Pow erPure Cut Typical Surgical Setting Blend Typical Surgical Setting

Force FX Coag Modes Power (RMS) vs Load

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Dessicate Max Pow er DessicateTypical Surgical SettingSpray Coag Max Pow er Spray Coag Typical Surgical Setting

Force FX Bipolar Modes Power (RMS) vs Load

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Force FX Pure Cut Voltage vs Power Setting

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Force FX Spray Coag Voltage vs Power Setting

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28

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA)

The Medical Devices Agency has merged with the Medicines Control Agency to form the Medicines andHealthcare products Regulatory Agency. www.mhra.gov.uk

ACKNOWLEDGMENTSThis report was prepared by Steven Edwards, Dr Stephanie Wentworth and Dr Diane Crawford of CEDAR,Medical Physics and Clinical Engineering Directorate, Cardiff and Vale NHS Trust, under contract to theMHRA.

Enquiries to Steven Edwards at CEDAR, Cardiff Medicentre, Heath Park, Cardiff, CF14 4UJTel: 02920 682120, Fax: 02920 750239. e-mail: [email protected]: www.cedar.wales.nhs.uk

Mr Martin Glasspool, Programme Manager, MHRA, Hannibal House, Elephant and Castle, London,SE1 6TQ. e-mail: [email protected] Tel: 020 7972 8156INTERNET: www.mhra.gov.uk

We would like to thank Mr Justin McCarthy and Mr Peter Willson for their helpful comments. Finally we wouldlike to thank all of the manufacturers and their distributors for loaning the devices free of charge.

HOW TO OBTAIN MHRA evaluation REPORTSMHRA evaluation reports are free of charge to NHS Trusts and Clinics

In England In Scotland In Wales In Northern IrelandMHRABusiness ServicesHannibal HouseElephant & CastleLondonSE1 6TQTel: 020 7972 8181

Mr H WaughHealth Planning & Quality DivisionScottish ExecutiveHealth DepartmentSt.Andrew’s HouseEdinburgh, EH1 3DGTel: 0131 244 6913

Ms L Welsby National Assembly for WalesHIMTE 3Cathays ParkCardiffCF10 3NQTel: 029 2082 3373

Mr Brian GodfreyHealth EstatesStoney RoadDundonaldBelfastBT16 1USTel: 028 9052 3714

WHAT YOU CAN EXPECT FROM MHRA evaluation REPORTS - DISCLAIMERThe Device Evaluation Service (DES) aims to provide independent and objective evaluations of medicaldevices available on the UK market. Specialist centres, mainly in the NHS, do evaluations under long termcontract to, and in accordance with, protocols approved by the MHRA. The evaluations are usually of a unitsupplied by a manufacturer. We would expect this unit to be representative of the product on the market, butcannot guarantee this. Prospective purchasers should satisfy themselves with respect to any modificationsthat might be made to the product type after MHRA’s evaluation. The reports are intended to supplement,not replace, information already available to prospective purchasers.

© CROWN COPYRIGHT 2004Apart from any fair dealing for the purpose of research or private study, or criticism or review, as permitted under theCopyright, Designs & Patents Act, 1988, this publication may only be reproduced, stored or transmitted in any form orby any means with the prior permission, in writing, of the Controller of Her Majesty’s Stationery Office (HMSO). Enquiriesabout reproduction should be made to the MHRA at the above address.


About MHRA evaluation reports

29

OTHER RECENT MHRA REPORTS ON ESU DEVICESEvaluation reports are available from the above addresses, and 2002 reports onwards are available in fulltext on the MHRA NHSnet website, http://nww.medical-devices.nhs.uk02037 Low Medium Power Electrsurgery Review 2002 March, 200201022 Bipolar Electrosurgery Review 2001 March, 2001

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