05023 High Power Electrosurgery Review Update 2005

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Medicines and Healthcare products regulatory Agency logo

Evaluation report

Department of

Health logo

April 2005

MHRA 05023High power

electrosurgery review

update 2005

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

VA

LUATION
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About MHRA evaluation reports.

What you can expect.

The Device Evaluation Service (DES) aims to provide independent and objective

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mainly in NHS Trusts, do the evaluations under long term contract to, and in

accordance with protocols approved by, the Medicines and Healthcare products

Regulatory Agency (MHRA). The evaluations are usually of a unit supplied by the

manufacturer. We would expect this unit to be representative of the product on the

market but cannot guarantee this. Prospective purchasers should satisfy themselves

with respect to any modifications that might be made to the product type after

MHRAs evaluation. The reports are intended to supplement, not replace, information

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The MHRA DES does not have access to any information held by the Agency in its

capacity as the Competent Authority for the UK, apart from any information alreadyin the public domain. The reports will contain data given by the manufacturer on the

regulatory status of their devices but, apart from this, they are not an indicator of the

regulatory status of a product. Occasionally, DES refers products to the regulatory

arm of the MHRA for considerations of breaches of the legislation governing medical

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Steven Edwards, Norma Greene, Dr Diane Crawford.

CEDAR

Clinical Engineering Device Assessment and Reporting

Cardiff Medicentre

University Hospital of Wales

Heath Park

Cardiff

CF14 4UJ

Tel: 029 20682120

Fax: 029 20750239

E-mail: [email protected]

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

High power electrosurgery

review update 2005

Crown Copyright 2005

Apart from any fair dealing for the purposes of research or private study, or criticism, or review, as

permitted 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 the

Controller of Her Majestys 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]
http://www.cedar.wales.nhs.uk/http://www.cedar.wales.nhs.uk/


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

Table of principal applications . . . . . . . . . . . . . . . . . . . . 3Table of principal features . . . . . . . . . . . . . . . . . . . . . . . 4

Bovie IDS300 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Power curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Output voltage (Open circuit). . . . . . . . . . . . . . . . . 7

Leakage current. . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Main features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Manufacturers comments . . . . . . . . . . . . . . . . . . . 8

BOWA Arc350. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Power curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Output voltage (Open circuit) . . . . . . . . . . . . . . . . 11

Leakage current . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Main features . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Manufacturing standards . . . . . . . . . . . . . . . . . . . 12

Manufacturers comments . . . . . . . . . . . . . . . . . . 12

EMED ES350 SURGILOGIC . . . . . . . . . . . . . . . . . . . . 13

Power curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Output voltage (Open circuit). . . . . . . . . . . . . . . . 15

Leakage current. . . . . . . . . . . . . . . . . . . . . . . . . . 15

Safety features. . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Main features . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16


Contents

MHRA

05023Highpowerelectrosurgeryreview

update2005


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Martin Maxium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Power curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18


Leakage current. . . . . . . . . . . . . . . . . . . . . . . . . . 19

Safety features. . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Main features . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Manufacturing standards . . . . . . . . . . . . . . . . . . . 20


Olympus UES40 SurgMaster . . . . . . . . . . . . . . . . . . . . 21

Power curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Output voltage (Open circuit). . . . . . . . . . . . . . . . 23Leakage current. . . . . . . . . . . . . . . . . . . . . . . . . . 23

Safety features. . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Main features . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24


Valleylab Force EZ - 8C . . . . . . . . . . . . . . . . . . . . . . . . 25

Power curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26


Leakage current. . . . . . . . . . . . . . . . . . . . . . . . . . 27

Safety features. . . . . . . . . . . . . . . . . . . . . . . . . . . 27Main features . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28


Contents

MHRA


update2005


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Electrosurgery enables surgeons to simultaneously cut and seal tissue and

manufacturers are continually developing specialist features for minimal access

surgery. This technology facilitates new ways of working in surgery and can help

meet 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 in

conjunction with the previous issues on surgical diathermy: Bipolar electrosurgery

review 2001 (MHRA 01022); Low/medium electrosurgery review 2002 (MHRA

02037) and, in particular, the High powered electrosurgery review 2004 (MHRA

04080).

The report is divided into two sections. The first section contains two comparative

tables so the purchaser can quickly identify which ESU best suits their needs, bothin terms of clinical application and technical specification. The second section

comprises a product summary for each generator. Information supplied by the

manufacturer and/or UK supplier has been used to compile the comparative tables

and 'Main features' part of each product summary. Power output, output voltage and

leakage current data has been obtained from in-house testing, in accordance with

BS EN 60601-2-2:2001 Medical electrical equipment Part 2-2: Particular

requirements for the safety of high frequency surgical equipment. All other

information has been obtained from the operator and service manuals.

The six devices we evaluated all offered a range of features covering the commonly

performed general surgical procedures. Our observations below summarise some ofthe key differences between these products. Prospective purchasers are

encouraged to read the detailed information in this report before selecting devices

for local assessment.

The Bovie IDS300 offers a basic suite of output modes and is intuitive to use, as it is

similar in design to many other commonly found generators. Small lettering and

buttons on the front panel could lead to user errors, especially in poorly illuminated

areas.

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 surgical

procedures. However, it is not intuitive to use, requiring frequent reference to the

operator'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 standard

and increase the risk, to staff and patients, of alternate site burns. The attachment of

many laparoscopic accessories is prevented by the absence of an 8mm/4mm power

output socket.

Summary

1

MHRA


update2005


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The Martin Maxium is the second ESU in the UK market to use LCD technology and

it 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 saline

with the TCRiS resectoscope accessory. It has a good range of operating modes

and is easy to operate.

The Valleylab Force EZ-8C is simple to use for most surgical procedures. Specialist

settings may be obtained by the simultaneous use of several buttons on the front

panel.

Summary

2

MHRA


update2005


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Table of principal applications

3

MHRA


update2005

Surgical applications

BovieIDS300

BowaArc350

EmedES350

MartinMaxium

OlympusUES4

0

ValleylabForce

EZ-8C

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


9/33

Table of principal features

4

MHRA


update2005

Modes, features & accessories

BovieIDS300

BowaArc350

EmedES350

MartinMaxium

OlympusUES4

0

ValleylabForceEZ-8C

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 moni tor

Contact quality moni tor

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


10/33

Description

The Bovie IDS300 ESU is a straight-forward, general purpose electrosurgical

generator. The unit comprises, 2 pure cut modes, called cut 1 and 2, 10 blend

settings, a pinpoint and spray coagulation mode as well as a single bipolar

coagulation mode. Cut 1 generates a

constant power over a wide range of

tissue impedances, cut 2 generates a

constant power over a smaller impedancerange allowing the surgeon to experience

a suitable cutting experience in different

types of tissue. CEDAR Comments:

Generally the diathermy unit is easy to

use. However, the buttons on the front

panel are very small and so is the

labelling, so it is possible to select the

incorrect button under certain operating

conditions.

Bovie IDS300

5

MHRA


update2005

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 Medical

Address: 8 Ninian Park

Tame Valley

Dosthill

Tamworth

Staffordshire

B77 5ES

Telephone: 01827 288883

Fax: 01827 288334

Website:

Email: [email protected]

Manufacturer Bovie

Manufactured in: USA


11/33

6

Technical assessment

Power curves

Bovie IDS300

MHRA


update2005

IDS300 Cut Modes Power (RMS) Vs Load

0

50

100

150

200

250

300

350

0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

Test Resistance Ohms

PowerOutputWatts

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

0

20

40

60

80

100

120

140

0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000


PowerOutputWatts

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

IDS300 Bipolar Power (RMS) Vs Load

0

10

20

30

40

50

60

70

0 200 400 600 800 1000 1200 1400 1600 1800 2000Test Resistance Ohms

PowerOutputWatts

Coag Pow er ( max ) Coag Pow er ( Surgic al Setting)


12/33

7

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 the

test conditions specified in EN60601-2-2: 2001 is 150mA. Excessive leakage current

increases the risk of alternate site burns.

Safety Features

Return electrode monitoring.

Contact quality monitoring.

Bovie IDS300

MHRA


update2005

IDS300 Spray Coag Voltage Vs PowerSetting

0

500

1000

1500

2000

2500

3000

3500

4000

0 10 20 30 40 50 60 70 80

Power Setting Watts

PeakVoltage

IDS300 Pure Cut Mode Voltage Vs Power Setting

0

100

200

300

400

500

600

700

800

0 50 100 150 200 250 300

Power Setting Watts

PeakVo

ltage


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8

Main features

Servicing

Comprehensive cover plan 585.00 per annum. Service includes unlimited use of a

loan device / RTB Avail Medical.

Manufacturing standards

Manufacturer claims compliance with EN60601-1:c1990, EN60601-1-2: 2001 and

EN60601-2-2:2000.

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

Manufacturers comments

The Bovie IDS 300 is a simple to use digitally controlled Electrosurgical Unit that

performs 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 IDS300

MHRA


update2005

Facility Max power Rated load Peak voltage

Cut 1 300W 300 2500V

Cut 2 300W 300 1500V

Blend (max) 120W 300 3300V

Pinpoint coag 120W 500 3500V

Spray coag 120W 500 7000V

Bipolar coag 150W 150 1000V


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Description

The 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 cutting

modes. The unit also has a selection of pre-programmed user settings that aid the

use of electrosurgery for specific surgical

procedures such as TURP. A dual

footswitch may be used to control either

the bipolar or monopolar output, or acombination of the two. The footswitch

must be connected to socket 3 on the

rear of the machine. Blend 0 is equivalent

to a pure cut waveform. The power

managment system is called arc control

enabling a constant cutting speed to be

achieved regardless of tissue impedance.

CEDAR Comments: Generally the

generator is not intuitive to use and

consultation with the user manual isrecommended.

BOWA Arc350

9

MHRA


update2005

Summary




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



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



Supplier: Avail Medical

Address: 8 Ninian Park

Tame Valley

Dosthill

Tamworth

Staffordshire

B775ES

Telephone: 01827 288883

Fax: 01827 288334

Website:


Manufacturer BOWA

Manufactured in: Germany


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10


Power curves

BOWA Arc 350

MHRA


update2005

Arc 350 Cut Modes Power (RMS) Vs Load

0

50

100

150

200

250

300

350

0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000


PowerOutputWatts

Ble nd 0 Po wer (ma x) Ble nd 0 Po wer (Su rg ica l Set ting ) Ble nd Cu t 9 Po wer (ma x) Ble nd Cu t 9 Po wer (Su rg ica l Set ting )

Arc 350 Coag Mode Power (RMS) Vs Load

0

20

40

60

80

100

120

140

160

180

0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000


PowerOutputWatts

Contact Coag Power (max) Spray Coag Power (max) Contact Coag Power (Surgical Sett ing) Contact Coag Power (Surgical Sett ing)

Arc 350 Bipol ar Power (RMS) Vs Load

0

20

40

60

80

100

120

140

160

180

0 200 400 600 800 1000 1200 1400 1600 1800 2000


PowerOutputWatts

Cut Power (max) Coag Power (max) Cut Power (Surgical Sett ing) Coag Power (Surgical Sett ing)


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11


Leakage current




Safety features



BOWA Arc 350

MHRA


update2005

Arc 350 Pure Cut Mode Vol tage Vs Power Setti ng

0

50

100

150

200

250

300

350

400

450

500

550

600

650

0 50 100 150 200 250 300

Power Setting Watts

PeakVoltage

Arc 350 Spray Coag Volt age Vs PowerSett ing

0

500

1000

1500

2000

2500

3000

3500

4000

4500

5000

5500

6000

6500

0 20 40 60 80 100 120

Power Setting Watts

PeakVo

ltage


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12

Main features

Servicing

Comprehensive cover plan 1050.00 per annum. Service includes unlimited returns

to 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 superior

performance in all surgical specialities. The generator has been designed with

multiple output modes that provides the optimum tissue interaction from the various

pre-set programs. The unit can be programmed with individual user names. The

Arc350 will perform well in high impedance tissue from as little as 1 watt.

BOWA Arc 350

MHRA


update2005


Pure cut/blend 0 300W 500 560V

Blend 9 300W 500 850V

Moderate contact

coag120W 75 185V

Forced coag 120W 500 3500V


Bipolar cut 150W 500 560V

Bipolar contact coag 120W 75 182V

Bipolar ligation 200W 50 210V


18/33

Description

The ES350 Surgilogic is the first generator on the UK market from EMED. The unit

is designed for general surgery with a 350W maximum output power. It offers a good

range of operating modes including a range of bipolar cutting modes, (see page 15).

The unit has specialist settings that aid

the use of electrosurgery in difficult

surgical procedures, such as cutting

within a saline solution. CEDAR

Comments: The unit is easy to operate

with responsive operating buttons in a

logical design. It should be noted that

there is no 8mm pin socket so connection

for laparoscopic instruments may prove

difficult. The manufacturer claims

compliance with EN60601-1-2:2000, but

when tested against this standard it was

found that the high frequency leakage

current was in excess of the 150mA limit.

EMED ES350 SURGILOGIC

13

MHRA


update2005

Summary




Modulation freq: 100kHz

Class IIB

CF type

Output sockets: 1 monopolar

and 1 bipolar. 8mm pin socket is

not provided

Power adjustment by pushbutton

Programmable with 5 separate memory locations



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



Supplier: Medline

Address: Unit 33

Monument Business

Park

Warpsgrove Lane

Chalgrove

Oxfordshire

OX44 7RW

Telephone: 01865 400321

Fax: 01865 400736

Website: www.medlineuk.com


Manufacturer EMEDManufactured in: Poland


19/33

14


Power curves

EMED ES350 Surgilogic

MHRA


update2005

ES350 Cut Modes Power (RMS) Vs Load

0

50

100

150

200

250

300

350

0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000


P

owerOutputWatts


ES350 Coag Mode Power (RMS) Vs Load

0

20

40

60

80

100

120

140

0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000


PowerOutputWatts

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

20

40

60

80

100

120

0 250 500 750 1000 1250 1500 1750 2000


PowerOutputWatts

Cut Power (max) Coag Power (max) Cut Power (Surgical Sett ing) Coag Power (Surgical Sett ing)


20/33

15


Leakage current




Safety features




MHRA


update2005

ES350 Pure Cut Mode Voltage Vs Power Setting

0

100

200

300

400

500

600

700

800

0 50 100 150 200 250 300 350

Power Setting Watts

PeakVoltage

ES350 Spray Coag Voltage Vs PowerSetting

0

1000

2000

3000

4000

5000

6000

7000

0 10 20 30 40 50 60 70 80 90 100 110 120 130 140 150

Power Setting Watts

PeakVoltage


21/33

16

Main features

Servicing

Comprehensive cover plan 480.00 per annum. Emergency call out rate 60 per

hour. 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 designed

to 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 a

special 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 current

have been noted and modifications will be made to ensure compliance with

EN60601-1-2:2000.


MHRA


update2005


Pure cut 350W 300 350V

Blend 1 180W 300 1000V

Blend 2 1500W 100 500V

Soft coag 180W 150 400V




Bipolar coag 120W 40 230V


22/33

Description

The Maxium is the latest generator from Martin. The unit is a general purpose

generator with a 400W maximum output power. It offers an extensive range of

specialist bipolar and monopolar

operating modes, 37 modes in total.

These specialist settings aim to aid the

use of electrosurgery in difficult surgical

procedures such as coagulating blood

vessels and performing low hemorrhage

resection of pedunculated polyps. The

unit has an automatically controlled

vessel sealing system called Seal Safe

when used with the marClampTM series

bipolar clamp. CEDAR Comments: The

generator is easy to operate with

responsive operating buttons in a logical

LCD screen design. The large number of

operating modes may lead to someconfusion.

Martin Maxium

17

MHRA


update2005

Summary



Fundamental freq: 300 - 600kHz

Modulation freq: 18.5kHz

Class IIB

CF type


and 2 bipolar and 2, 8mm pin

socket

Power adjustment by rotatingdial


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


Over 35 specialist monopolar and bipolar modes for various different

procedures Weight 8.3kg



Supplier: Melyd Medical Ltd

Address: Unit 1

21 Kings Avenue

Prestatyn

Denbigshire

LL19 9AA

Telephone: 01745 853178

Fax: 01745 888826

Website: www.melydmedical

.com


Manufacturer Martin

Manufactured in: Germany


23/33

18


Power curves

Martin Maxium

MHRA


update2005

Maxium Cut Modes Power (RMS) Vs Load

0

50

100

150

200

250

300

350

400

450

0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000


Pow

erOutputWatts


Maxium Coag Mode Power (RMS) Vs Load

0

50

100

150

200

250

0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000


PowerOutputWatts

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

Contac t Coag Pow er (Sur gic al Setting) Mac ro Spr ay Coag Pow er ( Surgic al Setting)

Maxium Bipolar Power (RMS) Vs Load

0

20

40

60

80

100

120

140

160

0 200 400 600 800 1000 1200 1400 1600 1800 2000


PowerOutputWatts

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


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19


Leakage current

Maximum level of high frequency leakage current was 98mA for pure cut mode and

135mA for the macro spray coagulation mode. Maximum permitted leakage currentunder the test conditions specified in EN60601-2-2: 2001 is 150mA. Excessive

leakage current increases the risk of alternate site burns.

Safety features



Martin Maxium

MHRA


update2005

Maxium Spray Coag Voltage Vs PowerSetting

0

1000

2000

3000

4000

5000

6000

7000

8000

9000

10000

0 20 40 60 80 100 120 140

Power Setting Watts

PeakVoltage

Maxium Pure Cut Mode Voltage Vs Power Setting

0

200

400

600

800

1000

1200

1400

1600

0 50 100 150 200 250 300

Power Setting Watts

PeakVoltag

e


25/33

20

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 all

parts 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 of

parts 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 Maxium

MHRA


update2005


Pure cut 400W 400 2500V

Blend cut 320W 400 3100V

Super Blend 250W 400 3100V

Contact coag 250W 100 2800V


Macro spray coag 150W 1200

11000V

Bipolar pure cut 120W 300 1000V

Bipolar macro coag 120W 50 650V


26/33

Description

The UES40 SurgMaster is Olympuss latest electrosurgical unit and was launched in

2004. The unit comprises a novel TCRis resectoscope, a bipolar type device for

gynaecological applications which does not require a patient plate. The

resectoscope is used with physiological saline, which the manufacturer claims

greatly reduces the risk of TUR syndrome

and minimises the depth of tissuedenaturation. The URO cutting mode is for

producing incisions under a non-electrolyte

solution. The saline setting is for use when

operating through a physiological saline

solution usually in conjunction with the

TCRis resectoscope. CEDAR Comments:

The unit is intuitive to use and easy to set

up. TCRis stands for trans cervical

resection in saline and TURis stands for

trans urethral resection in saline.

Olympus UES40 SurgMaster

21

MHRA


update2005

Summary




Modulation freq: 100kHz

Class IIB

CF type


with 1, 8mm pin socket and 2

bipolar sockets

Power adjustment by pushbutton


Dual monopole activation is not provided


Foot pedal selector switch on front panel allows one pedal to control either


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 Ltd

Address: KeyMed House

Stock Road

Southend on Sea

Essex

SS2 5QH

Telephone: 01702 616333

Fax: 01702 465677

Website: www.keymed.co.uk

Email:

Manufacturer OlympusManufactured in: Japan


27/33

22


Power curves


MHRA


update2005

22

UES40 Cut Modes Power (RMS) Vs Load

0

50

100

150

200

250

300

350

0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000


Po

werOutputWatts

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

UES40 Bipolar Power (RMS) Vs Load

0

10

20

30

40

50

60

70

80

90

100

0 200 400 600 800 1000 1200 1400 1600 1800 2000


PowerOutputWatts

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

0

20

40

60

80

100

120

140

160

0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000


PowerOutputWatts

Coag 1 Power (max) Spray Coag Power (max) Coag 1 Power (Surgical Setting) Spray Coag Power (Surgical Setting)


28/33

23


Leakage current




Safety features




MHRA


update2005

UES40 Spray Coag Voltage Vs PowerSetting

0

500

1000

1500

2000

2500

3000

3500

4000

0 20 40 60 80 100 120

Power Setting Watts

PeakVoltage

UES40 Pure Cut Mode Voltage Vs Power Setting

0

50

100

150

200

250

300

350

400

450

500

550

0 50 100 150 200 250 300

Power Setting Watts

PeakVoltage


29/33

24

Main features

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'


MHRA


update2005


Pure cut 300W 200 1200V

Blend 250W 200 1200V

URO 300W 200 1200V

Coag 1 120W 200 2200V

Coag 2 120W 200 3200V

Spray 120W 200 3300V


Bipolar soft ooag 1 90W 100 220V

Bipolar soft coag 2 90W 100 220V

Bipolar coag hard 160W 100 240V

Saline pure cut 320W 100 500V

Saline blend cut 320W 100 900V

Saline coag 1 200W 100 250V

Saline coag 2 80W 100 880V


30/33

Description

The Force EZ incorporates the Valleylab Instant Response Technology power

managment system. When using the bipolar mode, the cut modes, desiccate 2 and

3 coagulation modes, the output voltage is automatically controlled by a

microprocessor within the generator to compensate for the changing impedance at

the site of operation. This leads to the flatter shaped power curves visible in the

technical assessment (see page 25). The Instant Response Technology is not

applied to the desiccate 1 and fulgurate 1 and 2 coagulation modes. Dessicate

refers to a contact coagulation mode and

fulgurate to a spray type coagulation. Itshould also be noted that dessicate

modes 1,2,3 and fulgurate modes 1 and 2

are special modes and are not

automatically set from the front panel. To

adjust between dessicate 1,2 and 3 and

fulgurate 1 and 2 the footswitch button

and either the fulgurate or dessicate blue

button must be pushed simultaneously.

This is described within the operating

manual. CEDAR comments: The unit is

intuitive to use and easy to set up, butdoes have hidden surgical mode settings.

Valleylab Force EZ - 8C

25

MHRA


update2005

Summary



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: Valleylab

Address: 154 Fareham Road

Gosport

Hampshire

Chalgrove

PO13 0AS

Telephone: 01329 224115

Fax: 01329 224260

Website: www.valleylab.com

Email:

Manufacturer Tyco HealthcareManufactured in: USA


31/33

26


Power curves

Valleylab Force EZ-8C

MHRA


update2005

Force EZ Cut Modes Power (RMS) Vs Load

0

50

100

150

200

250

300

350

0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000


PowerOutputWatts

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

0

10

20

30

40

50

60

70

80

0 200 400 600 800 1000 1200 1400 1600 1800 2000


PowerOutputWatts

Coag Power (max) Coag Power (Surgical Setting)

Force EZ Coag Mode Power (RMS) Vs Load

0

20

40

60

80

100

120

140

0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

Test Resistance Ohm)

PowerOutputWatts

Contact Coag Power (max) Spray Coag Power (max) Contact Coag Power (Surgical Set ting) Contact Coag Power (Surgical Sett ing)


32/33

27


Leakage current




Safety features




MHRA


update2005

Force EZ Pure Cut Mode Voltage Vs Power Setting

0

100

200

300

400

500

600

700

800

900

1000

1100

0 50 100 150 200 250 300

Power Setting Watts

PeakVoltage

Force EZ Spray Coag Voltage Vs PowerSetting

0

500

1000

1500

2000

2500

3000

3500

4000

4500

0 20 40 60 80 100 120

Power Setting Watts

PeakVoltage


33/33

Main features

Servicing

PPM contract 350.00 per annum for 1-3 units. Extra units charged at 100 per unit

to 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, whose

surgical needs are different to the factory default settings, to be able to customise their

output if necessary. The factory default settings were chosen as these will meet the

surgical needs of the surgeon in almost every surgical procedure performed. Very

occasionally a surgeon will have an unique requirement. The ability to change the

factory 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 standard

outputs offered on the front panel if required. The reason that these are 'hidden' is to

make the unit as simple and easy to use as possible and not to complicate the front

panel.


HRA


update2005


Pure cut 300W 300 1000V

Blend 200W 300 1700V

Bipolar 70W 100 150V

Dessicate 1 120W 500 1750V



Fulgurate 1 120W 500 3000V

Fulgurate 2 120W 500 4250V

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05023 High Power Electrosurgery Review Update 2005

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