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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
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About MHRA evaluation reports.
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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]
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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
Manufacturers comments . . . . . . . . . . . . . . . . . . 16
Contents
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Martin Maxium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Power curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Output voltage (Open circuit). . . . . . . . . . . . . . . . 19
Leakage current. . . . . . . . . . . . . . . . . . . . . . . . . . 19
Safety features. . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Main features . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Manufacturing standards . . . . . . . . . . . . . . . . . . . 20
Manufacturers comments . . . . . . . . . . . . . . . . . . 20
Olympus UES40 SurgMaster . . . . . . . . . . . . . . . . . . . . 21
Power curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Output voltage (Open circuit). . . . . . . . . . . . . . . . 23Leakage current. . . . . . . . . . . . . . . . . . . . . . . . . . 23
Safety features. . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Main features . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Manufacturers comments . . . . . . . . . . . . . . . . . . 24
Valleylab Force EZ - 8C . . . . . . . . . . . . . . . . . . . . . . . . 25
Power curves . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Output voltage (Open circuit). . . . . . . . . . . . . . . . 27
Leakage current. . . . . . . . . . . . . . . . . . . . . . . . . . 27
Safety features. . . . . . . . . . . . . . . . . . . . . . . . . . . 27Main features . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Manufacturers comments . . . . . . . . . . . . . . . . . . 28
Contents
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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
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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
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Table of principal applications
3
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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
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Table of principal features
4
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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
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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
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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 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
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6
Technical assessment
Power curves
Bovie IDS300
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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
Test Resistance Ohms
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)
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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
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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
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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
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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
Price (ex VAT) 9500.00
Supplier: Avail Medical
Address: 8 Ninian Park
Tame Valley
Dosthill
Tamworth
Staffordshire
B775ES
Telephone: 01827 288883
Fax: 01827 288334
Website:
Email: [email protected]
Manufacturer BOWA
Manufactured in: Germany
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10
Technical assessment
Power curves
BOWA Arc 350
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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
Test Resistance Ohms
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
Test Resistance Ohms
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
Test Resistance Ohms
PowerOutputWatts
Cut Power (max) Coag Power (max) Cut Power (Surgical Sett ing) Coag Power (Surgical Sett ing)
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11
Output voltage (Open circuit)
Leakage current
Maximum level of high frequency leakage current was 113mA for pure cut mode and119mA 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.
BOWA Arc 350
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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.
Manufacturing standards
Manufacturer claims compliance with ISO 13485:2003.
CE Mark: Yes Notified body: TUV Code: 0123
Manufacturers comments
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
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Facility Max power Rated load Peak voltage
Pure cut/blend 0 300W 500 560V
Blend 9 300W 500 850V
Moderate contact
coag120W 75 185V
Forced coag 120W 500 3500V
Spray coag 120W 500 6000V
Bipolar cut 150W 500 560V
Bipolar contact coag 120W 75 182V
Bipolar ligation 200W 50 210V
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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
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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 is
not 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
Price (ex VAT) 2660.00
Supplier: Medline
Address: Unit 33
Monument Business
Park
Warpsgrove Lane
Chalgrove
Oxfordshire
OX44 7RW
Telephone: 01865 400321
Fax: 01865 400736
Website: www.medlineuk.com
Email: [email protected]
Manufacturer EMEDManufactured in: Poland
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14
Technical assessment
Power curves
EMED ES350 Surgilogic
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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
Test Resistance Ohms
P
owerOutputWatts
Pure Cut Power (max) Pure Cut Power (Surgical Setting) Blend Cut Power (max) Blend Cut Power (Surgical Setting)
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
Test Resistance Ohms
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
Test Resistance Ohms
PowerOutputWatts
Cut Power (max) Coag Power (max) Cut Power (Surgical Sett ing) Coag Power (Surgical Sett ing)
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15
Output voltage (Open circuit)
Leakage current
Maximum level of high frequency leakage current was 78mA for pure cut mode and164mA 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.
EMED ES350 Surgilogic
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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
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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.
Manufacturing standards
ISO9001:2000, EN60601-1:1990. Manufacturer claims compliance with EN60601-2-
2:1998.
CE Mark: Yes Notified body: ORKI Code: A1947
Manufacturers comments
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.
EMED ES350 Surgilogic
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Facility Max power Rated load Peak voltage
Pure cut 350W 300 350V
Blend 1 180W 300 1000V
Blend 2 1500W 100 500V
Soft coag 180W 150 400V
Forced coag 180W 300 1000V
Spray coag 150W 1500 3800V
Bipolar cut 100W 300 320V
Bipolar coag 120W 40 230V
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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
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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 pin
socket
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
Price (ex VAT) 10500.00
Supplier: Melyd Medical Ltd
Address: Unit 1
21 Kings Avenue
Prestatyn
Denbigshire
LL19 9AA
Telephone: 01745 853178
Fax: 01745 888826
Website: www.melydmedical
.com
Email: [email protected]
Manufacturer Martin
Manufactured in: Germany
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18
Technical assessment
Power curves
Martin Maxium
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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
Test Resistance Ohms
Pow
erOutputWatts
Pure Cut Power (max) Pure Cut Power (Surgical Setting) Blend Cut Power (max) Blend Cut Power (Surgical Setting)
Maxium Coag Mode Power (RMS) Vs Load
0
50
100
150
200
250
0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000
Test Resistance Ohms
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
Test Resistance Ohms
PowerOutputWatts
Pure Cut Power (max) Macro Coag Power (max) Pure Cut Power (Surgical Setting) Macro Coag Power (Surgical Setting)
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19
Output voltage (Open circuit)
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
Return electrode monitoring.
Contact quality monitoring.
Martin Maxium
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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
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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.
Manufacturing standards
Manufacturer claims compliance with EN60601-1 and EN60601-2-2.
CE Mark: Yes Notified body: DQS Code: CE 0297
Manufacturers comments
'Manufacturer did not comment'
Martin Maxium
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Facility Max power Rated load Peak voltage
Pure cut 400W 400 2500V
Blend cut 320W 400 3100V
Super Blend 250W 400 3100V
Contact coag 250W 100 2800V
Forced coag 150W 300 5500V
Macro spray coag 150W 1200
11000V
Bipolar pure cut 120W 300 1000V
Bipolar macro coag 120W 50 650V
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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
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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 2
bipolar 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
Price (ex VAT) 10495.00
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
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Technical assessment
Power curves
Olympus UES40 SurgMaster
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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
Test Resistance Ohms
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
Test Resistance Ohms
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
Test Resistance Ohms
PowerOutputWatts
Coag 1 Power (max) Spray Coag Power (max) Coag 1 Power (Surgical Setting) Spray Coag Power (Surgical Setting)
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Output voltage (Open circuit)
Leakage current
Maximum level of high frequency leakage current was 74mA for pure cut mode and82mA 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.
Olympus UES40 SurgMaster
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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
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24
Main features
Servicing
Comprehensive cover plan 784.00 per annum.
Manufacturing standards
Manufacturer claims compliance with ISO9001:2000 and EN60601-2-2.
CE Mark: Yes Notified body: TUV Code: 0197
Manufacturers comments
'Manufacturer did not comment'
Olympus UES40 SurgMaster
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Facility Max power Rated load Peak voltage
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 cut 90W 100 450V
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
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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
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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
Price (ex VAT) 7564.00
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
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Technical assessment
Power curves
Valleylab Force EZ-8C
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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
Test Resistance Ohms
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
Test Resistance Ohms
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)
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Output voltage (Open circuit)
Leakage current
Maximum level of high frequency leakage current was 108mA for pure cut mode and100mA 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.
Valleylab Force EZ-8C
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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
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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.
Manufacturing standards
ISO9001:1994, EN60601-1:1995. Manufacturer claims compliance with EN60601-2-
2:2000.
CE Mark: Yes Notified body: BSi Code: 0086
Manufacturers comments
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.
Valleylab Force EZ-8C
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Facility Max power Rated load Peak voltage
Pure cut 300W 300 1000V
Blend 200W 300 1700V
Bipolar 70W 100 150V
Dessicate 1 120W 500 1750V
Dessicate 2 120W 300 330V
Dessicate 3 120W 300 550V
Fulgurate 1 120W 500 3000V
Fulgurate 2 120W 500 4250V