High Power Update 18 04 05 - Cedar · The Bovie IDS300 ESU is a straight-forward, general purpose electrosurgical generator. The unit comprises, 2 pure cut modes, called cut 1 and

Medicines and Healthcare products regulatory Agency logoEvaluation report

Department ofHealth logo

April 2005

MHRA 05023High power electrosurgery reviewupdate 2005

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

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About MHRA evaluation reports.

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The Device Evaluation Service (DES) aims to provide independent and objectiveevaluations of medical devices available on the UK market. Specialist centres,mainly in NHS Trusts, do the evaluations under long term contract to, and inaccordance with protocols approved by, the Medicines and Healthcare productsRegulatory Agency (MHRA). The evaluations are usually of a unit supplied by themanufacturer. We would expect this unit to be representative of the product on themarket but cannot guarantee this. Prospective purchasers should satisfy themselveswith respect to any modifications that might be made to the product type afterMHRA’s evaluation. The reports are intended to supplement, not replace, informationalready available to prospective purchasers.

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CEDAR

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Heath ParkCardiff

CF14 4UJ

Tel: 029 20682120Fax: 029 20750239

E-mail: [email protected]

For more information on CEDAR visit www.cedar.wales.nhs.uk

High power electrosurgeryreview update 2005

© Crown Copyright 2005

Apart from any fair dealing for the purposes of research or private study, or criticism, or review, aspermitted under the Copyright, Designs & Patents Act, 1998, this publication may only be reproduced,stored, or transmitted in any form or by any means with the prior permission, in writing, of theController of Her Majesty’s Stationery Office (HMSO).

Information on reproduction outside these terms can be found on the HMSO website(www.hmso.gov.uk) or e-mail: [email protected].

The MHRA is an executive agency of the Department of Health.

ISBN [1 84182 953 6]

www.cedar.wales.nhs.uk

Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Table of principal applications . . . . . . . . . . . . . . . . . . . . 3

Table of principal features . . . . . . . . . . . . . . . . . . . . . . . 4

Bovie IDS300 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Power curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6Output voltage (Open circuit). . . . . . . . . . . . . . . . . 7Leakage current. . . . . . . . . . . . . . . . . . . . . . . . . . . 7Main features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Manufacturers comments . . . . . . . . . . . . . . . . . . . 8

BOWA Arc350. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Power curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Output voltage (Open circuit) . . . . . . . . . . . . . . . . 11Leakage current . . . . . . . . . . . . . . . . . . . . . . . . . . 11Main features . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Manufacturing standards . . . . . . . . . . . . . . . . . . . 12Manufacturers comments . . . . . . . . . . . . . . . . . . 12

EMED ES350 SURGILOGIC . . . . . . . . . . . . . . . . . . . . 13Power curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Output voltage (Open circuit). . . . . . . . . . . . . . . . 15Leakage current. . . . . . . . . . . . . . . . . . . . . . . . . . 15Safety features. . . . . . . . . . . . . . . . . . . . . . . . . . . 15Main features . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Manufacturers comments . . . . . . . . . . . . . . . . . . 16

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Martin Maxium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17Power curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Output voltage (Open circuit). . . . . . . . . . . . . . . . 19Leakage current. . . . . . . . . . . . . . . . . . . . . . . . . . 19Safety features. . . . . . . . . . . . . . . . . . . . . . . . . . . 19Main features . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20Manufacturing standards . . . . . . . . . . . . . . . . . . . 20Manufacturers comments . . . . . . . . . . . . . . . . . . 20

Olympus UES40 SurgMaster . . . . . . . . . . . . . . . . . . . . 21Power curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Output voltage (Open circuit). . . . . . . . . . . . . . . . 23Leakage current. . . . . . . . . . . . . . . . . . . . . . . . . . 23Safety features. . . . . . . . . . . . . . . . . . . . . . . . . . . 23Main features . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24Manufacturers comments . . . . . . . . . . . . . . . . . . 24

Valleylab Force EZ - 8C . . . . . . . . . . . . . . . . . . . . . . . . 25Power curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26Output voltage (Open circuit). . . . . . . . . . . . . . . . 27Leakage current. . . . . . . . . . . . . . . . . . . . . . . . . . 27Safety features. . . . . . . . . . . . . . . . . . . . . . . . . . . 27Main features . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Manufacturers comments . . . . . . . . . . . . . . . . . . 28

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Electrosurgery enables surgeons to simultaneously cut and seal tissue andmanufacturers are continually developing specialist features for minimal accesssurgery. This technology facilitates new ways of working in surgery and can helpmeet government objectives of reduced length of stay for patients in hospital.

This is an independent source of information on six different electrosurgical units(ESU) not included in the review published in September 2004. It should be read inconjunction with the previous issues on surgical diathermy: Bipolar electrosurgeryreview 2001 (MHRA 01022); Low/medium electrosurgery review 2002 (MHRA02037) and, in particular, the High powered electrosurgery review 2004 (MHRA04080).

The report is divided into two sections. The first section contains two comparativetables so the purchaser can quickly identify which ESU best suits their needs, bothin terms of clinical application and technical specification. The second sectioncomprises a product summary for each generator. Information supplied by themanufacturer and/or UK supplier has been used to compile the comparative tablesand 'Main features' part of each product summary. Power output, output voltage andleakage current data has been obtained from in-house testing, in accordance withBS EN 60601-2-2:2001 Medical electrical equipment Part 2-2: Particularrequirements for the safety of high frequency surgical equipment. All otherinformation has been obtained from the operator and service manuals.

The six devices we evaluated all offered a range of features covering the commonlyperformed general surgical procedures. Our observations below summarise some ofthe key differences between these products. Prospective purchasers areencouraged to read the detailed information in this report before selecting devicesfor local assessment.

The Bovie IDS300 offers a basic suite of output modes and is intuitive to use, as it issimilar in design to many other commonly found generators. Small lettering andbuttons on the front panel could lead to user errors, especially in poorly illuminatedareas.

The BOWA Arc350 has a good range of operating modes and a useful range of pre-programmed power settings, covering most of the commonly performed surgicalprocedures. However, it is not intuitive to use, requiring frequent reference to theoperator's manual.

The EMED ES350 Surgilogic is easy to use and has a good range of output modes.Currently high leakage currents exceed the limit set in the manufacturing standardand increase the risk, to staff and patients, of alternate site burns. The attachment ofmany laparoscopic accessories is prevented by the absence of an 8mm/4mm poweroutput socket.

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The Martin Maxium is the second ESU in the UK market to use LCD technology andit was found to be easy to use. It offers 37 different pre-programmed output settings,which may be confusing for some users.

The Olympus UES40 Surgmaster is specifically designed for resection under salinewith the TCRiS resectoscope accessory. It has a good range of operating modesand is easy to operate.

The Valleylab Force EZ-8C is simple to use for most surgical procedures. Specialistsettings may be obtained by the simultaneous use of several buttons on the frontpanel.

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Table of principal applications

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Surgical applications

Bov

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S300

Bow

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Emed

ES3

50

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ES40

Valle

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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 of principal features

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Modes, features & accessories

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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

Pedastal

Programmable

Other features not listed

DescriptionThe Bovie IDS300 ESU is a straight-forward, general purpose electrosurgicalgenerator. The unit comprises, 2 pure cut modes, called cut 1 and 2, 10 blendsettings, a pinpoint and spray coagulation mode as well as a single bipolarcoagulation mode. Cut 1 generates aconstant power over a wide range oftissue impedances, cut 2 generates aconstant power over a smaller impedancerange allowing the surgeon to experiencea suitable cutting experience in differenttypes of tissue. CEDAR Comments:Generally the diathermy unit is easy touse. However, the buttons on the frontpanel are very small and so is thelabelling, so it is possible to select theincorrect button under certain operatingconditions.

Bovie IDS300

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Summary

• Max power: 300W cut• Max power: 80W spray coag• Max power: 80W bipolar• Fundamental freq: 490kHz• Modulation freq: 25 - 35 kHz• Class IIB• CF type• Output sockets: 1 monopolar, 1

bipolar and 1, 8mm pin socket• Power adjustment by push

button• Programmable with 10 separate memory locations• Dual monopolar activation is not provided• Dual bipolar and monopolar activation is not provided• Bipolar auto start and stop is not provided• Foot pedal selector switch on the footswitch to allow one pedal to control

either bipolar or monopolar output, or even a combination of both• A single bipolar coag mode• Ten different blended cut settings• Weight 8.75kg• Dimensions 311(W) 153(H) 413(L) mm

Price (ex VAT) £4850.00

Supplier: Avail MedicalAddress: 8 Ninian Park

Tame ValleyDosthillTamworthStaffordshireB77 5ES

Telephone: 01827 288883Fax: 01827 288334Website:Email: [email protected] BovieManufactured in: USA

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Technical assessment

Power curves

Bovie IDS300M

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IDS300 Cut Modes Power (RMS) Vs Load

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Test Resistance Ohms

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Pure Cut Power (max) Pure Cut Power (Surgical Setting) Blend Cut Power (max) Blend Cut Power (Surgical Setting)

IDS300 Coag Mode Power (RMS) Vs Load

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0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000Test Resistance Ohms

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Contact Coag Power (max) Spray Coag Power (max) Contact Coag Power (Surgical Setting) Spray Coag Power (Surgical Setting)

IDS300 Bipolar Power (RMS) Vs Load

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Coag Pow er (max) Coag Pow er (Surgical Setting)

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Output voltage (Open circuit)

Leakage current

Maximum level of high frequency leakage current was 115mA for pure cut mode and143mA for spray coagulation mode. Maximum permitted leakage current under thetest conditions specified in EN60601-2-2: 2001 is 150mA. Excessive leakage currentincreases the risk of alternate site burns.

Safety Features

• Return electrode monitoring.• Contact quality monitoring.

Bovie IDS300M

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IDS300 Spray Coag Voltage Vs PowerSetting

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IDS300 Pure Cut Mode Voltage Vs Power Setting

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Main features

Servicing

Comprehensive cover plan £585.00 per annum. Service includes unlimited use of aloan device / RTB Avail Medical.

Manufacturing standards

Manufacturer claims compliance with EN60601-1:c1990, EN60601-1-2: 2001 andEN60601-2-2:2000.

CE Mark: Yes Notified body: Semko AB Code: 0413

Manufacturers comments

The Bovie IDS 300 is a simple to use digitally controlled Electrosurgical Unit thatperforms well during all surgical procedures. The IDS 300 is a standard day to dayworkhorse for the busy Day Surgical Unit or main theatre complex.

Bovie IDS300M

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Facility Max power Rated load Peak voltage

Cut 1 300W 300Ω 2500V

Cut 2 300W 300Ω 1500V

Blend (max) 120W 300Ω 3300V

Pinpoint coag 120W 500Ω 3500V

Spray coag 120W 500Ω 7000V

Bipolar coag 150W 150Ω 1000V

DescriptionThe Bowa Arc 350 is a general purpose generator with a 300W maximum output.The unit has a good range of operating modes including a range of bipolar cuttingmodes. The unit also has a selection of pre-programmed user settings that aid theuse of electrosurgery for specific surgicalprocedures such as TURP. A dualfootswitch may be used to control eitherthe bipolar or monopolar output, or acombination of the two. The footswitchmust be connected to socket 3 on therear of the machine. Blend 0 is equivalentto a pure cut waveform. The powermanagment system is called ‘arc control’enabling a constant cutting speed to beachieved regardless of tissue impedance.CEDAR Comments: Generally thegenerator is not intuitive to use andconsultation with the user manual isrecommended.

BOWA Arc350

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Summary

• Max power: 300W cut• Max power: 120W spray coag• Max power: 150W bipolar• Fundamental freq: 330kHz• Modulation freq: 12.5kHz• Class IIB• CF type• Output sockets: 2 monopolar, 2

bipolar and 2, 8mm pin sockets• Power adjustment by push

button• Programmable with 100 separate memory locations• Dual monopolar activation is not provided• Dual bipolar and monopolar activation is not provided• Bipolar auto start and stop• Foot pedal selector switch on the footswitch to allow one pedal to control

either bipolar or monopolar output, or a combination of both• Specialist pre-programmed user settings, specific for surgical procedures• A range of bipolar cut modes• Weight 14kg• Dimensions 430(W) 180(H) 400(L) mm


Supplier: Avail MedicalAddress: 8 Ninian Park

Tame ValleyDosthillTamworthStaffordshireB775ES

Telephone: 01827 288883Fax: 01827 288334Website:Email: [email protected] BOWAManufactured in: Germany

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Power curves

BOWA Arc 350M

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Arc 350 Cut Modes Power (RMS) Vs Load

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Blend 0 Pow er (max) Blend 0 Pow er (Surgical Setting) Blend Cut 9 Pow er (max) Blend Cut 9 Pow er (Surgical Setting)

Arc 350 Coag Mode Power (RMS) Vs Load

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160

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Contact Coag Pow er (max) Spray Coag Pow er (max) Contact Coag Pow er (Surgical Setting) Contact Coag Pow er (Surgical Setting)

Arc 350 Bipolar Power (RMS) Vs Load

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Cut Power (max) Coag Power (max) Cut Power (Surgical Setting) Coag Power (Surgical Setting)

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Leakage current


Safety features


BOWA Arc 350M

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Arc 350 Pure Cut Mode Voltage Vs Power Setting

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Arc 350 Spray Coag Voltage Vs PowerSetting

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Main features

Servicing

Comprehensive cover plan £1050.00 per annum. Service includes unlimited returnsto the service department and use of a loan unit during repair.


Manufacturer claims compliance with ISO 13485:2003.

CE Mark: Yes Notified body: TUV Code: 0123


The BOWA arc350 is a ‘future proof’ electrosurgical unit, that delivers a superiorperformance in all surgical specialities. The generator has been designed withmultiple output modes that provides the optimum tissue interaction from the variouspre-set programs. The unit can be programmed with individual user names. TheArc350 will perform well in high impedance tissue from as little as 1 watt.

BOWA Arc 350M

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Pure cut/blend 0 300W 500Ω 560V

Blend 9 300W 500Ω 850V

Moderate contactcoag 120W 75Ω 185V

Forced coag 120W 500Ω 3500V


Bipolar cut 150W 500Ω 560V

Bipolar contact coag 120W 75Ω 182V

Bipolar ligation 200W 50Ω 210V

DescriptionThe ES350 Surgilogic is the first generator on the UK market from EMED. The unitis designed for general surgery with a 350W maximum output power. It offers a goodrange of operating modes including a range of bipolar cutting modes, (see page 15).The unit has specialist settings that aidthe use of electrosurgery in difficultsurgical procedures, such as cuttingwithin a saline solution. CEDARComments: The unit is easy to operatewith responsive operating buttons in alogical design. It should be noted thatthere is no 8mm pin socket so connectionfor laparoscopic instruments may provedifficult. The manufacturer claimscompliance with EN60601-1-2:2000, butwhen tested against this standard it wasfound that the high frequency leakagecurrent was in excess of the 150mA limit.

EMED ES350 SURGILOGIC

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Summary

• Max power: 350W cut• Max power: 150W spray coag• Max power: 120W bipolar• Fundamental freq: 350kHz• Modulation freq: 100kHz• Class IIB• CF type• Output sockets: 1 monopolar

and 1 bipolar. 8mm pin socket isnot provided

• Power adjustment by pushbutton

• Programmable with 5 separate memory locations• Dual monopolar activation is not provided• Dual bipolar and monopolar activation is not provided• Bipolar auto start and stop• Foot pedal selector switch on front panel to allow one pedal to control either

bipolar or monopolar output• Specialist monopolar mode (K4) for urology and for procedures involving

cutting through saline• A range of bipolar cut modes• Weight 9.0kg• Dimensions 420(W) 160(H) 380(L) mm


Supplier: MedlineAddress: Unit 33

Monument Business ParkWarpsgrove LaneChalgroveOxfordshireOX44 7RW

Telephone: 01865 400321Fax: 01865 400736Website: www.medlineuk.comEmail: [email protected] EMEDManufactured in: Poland

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EMED ES350 SurgilogicM

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ES350 Cut Modes Power (RMS) Vs Load

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ES350 Coag Mode Power (RMS) Vs Load

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Contact Coag Power (max) Spray Coag Power (max) Contact Coag Power (Surgical Setting) Contact Coag Power (Surgical Setting)

ES350 Bipolar Power (RMS) Vs Load

0

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0 250 500 750 1000 1250 1500 1750 2000


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Cut Power (max) Coag Power (max) Cut Power (Surgical Setting) Coag Power (Surgical Setting)

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Leakage current


Safety features



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ES350 Pure Cut Mode Voltage Vs Power Setting

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Power Setting Watts

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ES350 Spray Coag Voltage Vs PowerSetting

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6000

7000

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Power Setting Watts

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Main features

Servicing

Comprehensive cover plan £480.00 per annum. Emergency call out rate £60 perhour. Non contract call out rate £85.00 per hour.


ISO9001:2000, EN60601-1:1990. Manufacturer claims compliance with EN60601-2-2:1998.

CE Mark: Yes Notified body: ORKI Code: A1947


New to the UK market, the EMED range of diathermy machines has been designedto provide fully featured machines at a competitive price level. The ES350 is a multi-purpose, fully equipped system for general theatre use. 5 memory settings plus aspecial programme for Polypectomy and Papillotomy is an additional feature.ES350 is also available with argon beam.

Comments made within this report with regard to high frequency leakage currenthave been noted and modifications will be made to ensure compliance withEN60601-1-2:2000.


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Pure cut 350W 300Ω 350V

Blend 1 180W 300Ω 1000V

Blend 2 1500W 100Ω 500V

Soft coag 180W 150Ω 400V




Bipolar coag 120W 40Ω 230V

DescriptionThe Maxium is the latest generator from Martin. The unit is a general purposegenerator with a 400W maximum output power. It offers an extensive range ofspecialist bipolar and monopolaroperating modes, 37 modes in total.These specialist settings aim to aid theuse of electrosurgery in difficult surgicalprocedures such as coagulating bloodvessels and performing low hemorrhageresection of pedunculated polyps. Theunit has an automatically controlledvessel sealing system called ‘Seal Safe’when used with the marClampTM seriesbipolar clamp. CEDAR Comments: Thegenerator is easy to operate withresponsive operating buttons in a logicalLCD screen design. The large number ofoperating modes may lead to someconfusion.

Martin Maxium

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Summary

• Max power: 400W cut• Max power: 150W spray coag• Max power: 120W bipolar• Fundamental freq: 300 - 600kHz• Modulation freq: 18.5kHz• Class IIB• CF type• Output sockets: 2 monopolar

and 2 bipolar and 2, 8mm pinsocket

• Power adjustment by rotatingdial

• Programmable with 5 separate memory locations• Dual monopole activation is provided• Dual bipolar and monopolar activation is provided• Bipolar auto start and stop, with ‘Seal Safe’ auto control vessel sealing

technology• Foot pedal selector switch on front screen to allow one pedal to control either

bipolar or monopolar output• Over 35 specialist monopolar and bipolar modes for various different

procedures• Weight 8.3kg• Dimensions 390(W) 182(H) 435(L) mm


Supplier: Melyd Medical LtdAddress: Unit 1

21 Kings AvenuePrestatynDenbigshireLL19 9AA

Telephone: 01745 853178Fax: 01745 888826Website: www.melydmedical

.comEmail: [email protected] MartinManufactured in: Germany

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Power curves

Martin MaxiumM

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Maxium Cut Modes Power (RMS) Vs Load

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Contact Coag Pow er (max) Macro Spray Coag Pow er (max)Contact Coag Pow er (Surgical Setting) Macro Spray Coag Pow er (Surgical Setting)

Maxium Bipolar Power (RMS) Vs Load

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Pure Cut Power (max) Macro Coag Power (max) Pure Cut Power (Surgical Setting) Macro Coag Power (Surgical Setting)

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Leakage current

Maximum level of high frequency leakage current was 98mA for pure cut mode and135mA for the macro spray coagulation mode. Maximum permitted leakage currentunder the test conditions specified in EN60601-2-2: 2001 is 150mA. Excessiveleakage current increases the risk of alternate site burns.

Safety features


Martin MaxiumM

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Maxium Spray Coag Voltage Vs PowerSetting

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Main features

In total there are 26 monopolar modes and 11 bipolar modes provided in this unit.

Servicing

Option (a) Fully comprehensive cover plan £600.00 per annum. Service includes allparts and labour, all emergency callouts and 1 service visit per annum. Option (b)Service contract as above excluding emergency callout charges £350.00 Option (c)Service contract inclusive of labour costs and 1 service visit per annum, exclusive ofparts and emergency call outs £200.00.


Manufacturer claims compliance with EN60601-1 and EN60601-2-2.

CE Mark: Yes Notified body: DQS Code: CE 0297


'Manufacturer did not comment'

Martin MaxiumM

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Blend cut 320W 400Ω 3100V

Super Blend 250W 400Ω 3100V

Contact coag 250W 100Ω 2800V


Macro spray coag 150W 1200Ω 11000V

Bipolar pure cut 120W 300Ω 1000V

Bipolar macro coag 120W 50Ω 650V

DescriptionThe UES40 SurgMaster is Olympus’s latest electrosurgical unit and was launched in2004. The unit comprises a novel TCRis resectoscope, a bipolar type device forgynaecological applications which does not require a patient plate. Theresectoscope is used with physiological saline, which the manufacturer claimsgreatly reduces the risk of TUR syndromeand minimises the depth of tissuedenaturation. The URO cutting mode is forproducing incisions under a non-electrolytesolution. The saline setting is for use whenoperating through a physiological salinesolution usually in conjunction with theTCRis resectoscope. CEDAR Comments:The unit is intuitive to use and easy to setup. TCRis stands for trans cervicalresection in saline and TURis stands fortrans urethral resection in saline.

Olympus UES40 SurgMaster

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Summary

• Max power: 300W cut• Max power: 120W spray coag• Max power: 160W bipolar• Fundamental freq: 350kHz• Modulation freq: 100kHz• Class IIB• CF type• Output sockets: 2 monopolar

with 1, 8mm pin socket and 2bipolar sockets

• Power adjustment by pushbutton

• Programmable with 5 separate memory locations• Dual monopole activation is not provided• Dual bipolar and monopolar activation is not provided• Foot pedal selector switch on front panel allows one pedal to control either

bipolar or monopolar output• Specialist monopolar modes for urology and for procedures involving cutting

through saline• Specialist bipolar modes including cutting and heavy duty coagulation• Weight 12.0kg• Dimensions 350(W) 150(H) 400(L) mm


Supplier: KeyMed LtdAddress: KeyMed House

Stock RoadSouthend on SeaEssexSS2 5QH

Telephone: 01702 616333Fax: 01702 465677Website: www.keymed.co.ukEmail:Manufacturer OlympusManufactured in: Japan

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Power curves

Olympus UES40 SurgMasterM

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UES40 Cut Modes Power (RMS) Vs Load

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UES40 Bipolar Power (RMS) Vs Load

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Cut Power (max) Soft Coag 2 Power (max) Cut Power (Surgical Setting) Soft Coag 2 Power (Surgical Setting)

UES40 Coag Mode Power (RMS) Vs Load

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Coag 1 Pow er (max) Spray Coag Pow er (max) Coag 1 Pow er (Surgical Setting) Spray Coag Pow er (Surgical Setting)

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Leakage current


Safety features



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UES40 Spray Coag Voltage Vs PowerSetting

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Servicing

Comprehensive cover plan £784.00 per annum.


Manufacturer claims compliance with ISO9001:2000 and EN60601-2-2.

CE Mark: Yes Notified body: TUV Code: 0197


'Manufacturer did not comment'


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Blend 250W 200Ω 1200V

URO 300W 200Ω 1200V

Coag 1 120W 200Ω 2200V

Coag 2 120W 200Ω 3200V

Spray 120W 200Ω 3300V


Bipolar soft ooag 1 90W 100Ω 220V

Bipolar soft coag 2 90W 100Ω 220V

Bipolar coag hard 160W 100Ω 240V

Saline pure cut 320W 100Ω 500V

Saline blend cut 320W 100Ω 900V

Saline coag 1 200W 100Ω 250V

Saline coag 2 80W 100Ω 880V

DescriptionThe Force EZ incorporates the Valleylab ‘Instant Response Technology’ powermanagment system. When using the bipolar mode, the cut modes, desiccate 2 and3 coagulation modes, the output voltage is automatically controlled by amicroprocessor within the generator to compensate for the changing impedance atthe site of operation. This leads to the flatter shaped power curves visible in thetechnical assessment (see page 25). The ‘Instant Response Technology’ is notapplied to the desiccate 1 and fulgurate 1 and 2 coagulation modes. Dessicaterefers to a contact coagulation mode andfulgurate to a spray type coagulation. Itshould also be noted that dessicatemodes 1,2,3 and fulgurate modes 1 and 2are special modes and are notautomatically set from the front panel. Toadjust between dessicate 1,2 and 3 andfulgurate 1 and 2 the footswitch buttonand either the fulgurate or dessicate bluebutton must be pushed simultaneously.This is described within the operatingmanual. CEDAR comments: The unit isintuitive to use and easy to set up, butdoes have hidden surgical mode settings.

Valleylab Force EZ - 8C

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Summary

• Max power: 300W cut• Max power: 120W spray coag• Max power: 70W bipolar• Fundamental freq: 393 - 470kHz• Modulation freq: 30 - 57kHz• Class IIB• CF type• Output sockets: 1 monopolar with

1, 8mm pin socket and 1 bipolar• Power adjustment by rotating

knob• Non programmable• Dual monopolar activation not provided• Dual bipolar and monopolar activation not provided• Foot pedal selector switch on front panel allows the same pedal to control

either bipolar or monopolar output• Specialist monopolar modes for fulguration and desiccation


Supplier: ValleylabAddress: 154 Fareham Road

Gosport HampshireChalgrovePO13 0AS

Telephone: 01329 224115Fax: 01329 224260Website: www.valleylab.comEmail:Manufacturer Tyco HealthcareManufactured in: USA

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Power curves

Valleylab Force EZ-8CM

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Force EZ Cut Modes Power (RMS) Vs Load

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Pure Cut Power (max) Blend Cut Power (max) Pure Cut Power (Surgical Setting) Blend Cut Power (Surgical Setting)

Force EZ Bipolar Power (RMS) Vs Load

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Coag Power (max) Coag Power (Surgical Setting)

Force EZ Coag Mode Power (RMS) Vs Load

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Contact Coag Power (max) Spray Coag Power (max) Contact Coag Power (Surgical Setting) Contact Coag Power (Surgical Setting)

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Leakage current


Safety features



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Force EZ Pure Cut Mode Voltage Vs Power Setting

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Servicing

PPM contract £350.00 per annum for 1-3 units. Extra units charged at £100 per unitto a maximum of 3 units.


ISO9001:1994, EN60601-1:1995. Manufacturer claims compliance with EN60601-2-2:2000.

CE Mark: Yes Notified body: BSi Code: 0086


The 'hidden' modalities should be viewed as an opportunity for a customer, whosesurgical needs are different to the factory default settings, to be able to customise theiroutput if necessary. The factory default settings were chosen as these will meet thesurgical needs of the surgeon in almost every surgical procedure performed. Veryoccasionally a surgeon will have an unique requirement. The ability to change thefactory default settings is therefore an option that is available, but rarely used,particularly in the UK. In effect the Force EZ has more versatility than the standardoutputs offered on the front panel if required. The reason that these are 'hidden' is tomake the unit as simple and easy to use as possible and not to complicate the frontpanel.


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Blend 200W 300Ω 1700V

Bipolar 70W 100Ω 150V

Dessicate 1 120W 500Ω 1750V



Fulgurate 1 120W 500Ω 3000V

Fulgurate 2 120W 500Ω 4250V

Documents

High Power Update 18 04 05 - Cedar · The Bovie IDS300 ESU is a straight-forward, general purpose electrosurgical generator. The unit comprises, 2 pure cut modes, called cut 1 and