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9

DGM000551 Preface

DPSS Laser

CYBER
TM

Operator’s Manual

September 2008




DGM000
551

REVISION HISTORY


File name

Description

Prepared by:

Approved by:

Date

UM
CYBER
TM
August

01
-
08.doc

First version

R.Tondina

I. Carrer

August

01
, 2008

UM
CYBER
TM
September

03
-
08.doc

New software version and code plug
description and use



September 03,
2008


























































































































Latest update:
June 08
, 200
9

DGM000551 Preface

DPSS Laser

CYBER
TM

Operator’s Manual

September 2008



1

Latest update: September 3,
2008 DGM000551 Preface

DPSS Laser

CYBER
TM

Operator’s Manual

September 2008












Quanta
System SpA

Medical Division


Via IV Novembre,116

21058
-
Solbiate Olona VA
-
ITALIA

Tel.: ++39 0331 376797

Fax:

++39 0331 367815

www.quantasystem.com

quanta@quantasystem.com





CYBER TM

Operator’s Manual


0476



2

Latest update: September 3,
2008 DGM000551 Preface

DPSS Laser

CYBER
TM

Operator’s Manual

September 2008

Notice

No part of this manual may be reproduced or transmitted in any form or by
any
means without the written consent of
Quanta System SpA
.

The information in this manual is subject to change without notice.
Disclaimer

Quanta System

SpA

provides this document in its commitment to help facilitate
consistent, positive clinical outcomes, and to reduce patient risk and injury.
These
guidelines are

not, however, intended to in any way replace or substitute a
physician’s duty of care, professional responsibility, or
professional judgment, nor
are they intended to provide any warranty, promise, guarantee, assumption of risk
or duty, release, or indemn
ity.
Physicians shall at all times maintain responsibility for
patient treatment and
outcomes, and
Quanta System

SpA

further assumes no
liability for patient treatment
or outcome or for physician’s negligence, breach of
duty of care, or
malpractice.

In no way does this or any of
Quanta System

SpA
’s

policies, procedures, training
materials, guidelines, or instructions create an obligation for
Quanta System

SpA

to
perform any services.
Products and services may be purchased from
Quanta
System SpA
.

Quanta System SpA

Medical Division

Via IV Novembre,116

21058
-
Solbiate Olona VA
-
ITALIA

Tel.: ++39 0331 376797

Fax
: ++39 0331 367815

www.quantasystem.com

quanta@quantasystem.com




User Manual Code:
__DGM000551
______




Latest Update:
___
September

0
3
,2008______

Written

by: _______

I. Carrer
____


Verified

by: ______

_____

A
pprove
d by: ____
I. Carrer
__

_____


3

Latest update: September 3,
2008 DGM000551 Preface

DPSS Laser

CYBER
TM

Operator’s Manual

September 2008

TABLE OF CONTENTS

PREFACE

................................
................................
................................
................................
..................

5

About This Manual

................................
................................
................................
................................
.......

5

Who Should R
ead This Manual?

................................
................................
................................
.............

6

Obtaining Help

................................
................................
................................
................................
..................

6

SAFETY
................................
................................
................................
................................
......................

7

Introduction

................................
................................
................................
................................
.......................

7

Eye Injury

................................
................................
................................
................................
............................

7

Burns

................................
................................
................................
................................
................................
......

9

Reflection of the beam from instruments

................................
................................
...............

9

Ignition of flammable materials

................................
................................
................................
..........

10

Vapour/smoke plu
me

................................
................................
................................
................................
.

10

Electrical

................................
................................
................................
................................
............................

10

Operating room environment

................................
................................
................................
..........

10

SA
FETY FEATURES OF THE CYBER
TM

LASER SYSTEM

................................
................................
...

11

System Safety Features

................................
................................
................................
............................

12

Safety

classifications

................................
................................
................................
.............................

13

Labelling

................................
................................
................................
................................
.............................

14

SECTION 1

................................
................................
................................
................................
............

17

INTRODUCTION

................................
................................
................................
................................
.

17

1.1 System Overview

................................
................................
................................
............................

17

1.2 Cyber
TM

Fibre Optic

................................
................................
................................
..........................

17

1.3 General Instructions For Use

................................
................................
...............................

19

1.4 Sterilization

................................
................................
................................
................................
........

21

SECTION 2

................................
................................
................................
................................
............

22

SYSTEM INSTALLATION

................................
................................
................................
...............

22

2.1 Responsibility

................................
................................
................................
................................
.........

22

2.2 Enviro
nmental And Power Requirements

................................
................................
.

23

SECTION 3

................................
................................
................................
................................
............

24

OPERATING THE SYST
EM

................................
................................
................................
............

24


4

Latest update: September 3,
2008 DGM000551 Preface

DPSS Laser

CYBER
TM

Operator’s Manual

September 2008

3.1 Operating Instructions

................................
................................
................................
............................

24

3.2 Turning The System On

................................
................................
................................
..........................

24

3.
3 Optical Fibre Connection

................................
................................
................................
........................

25

3.4 The Touch Screen

................................
................................
................................
................................
.....

26

Menu Button

................................
................................
................................
................................
........................

29

Protections against non authorised use:

................................
................................
................................
..

29

SECTION 4

................................
................................
................................
................................
...........

30

PHYSICIAN INFORMATIO
N

................................
................................
................................
.......

30

4.1 Indications for use

................................
................................
................................
..............................

30

4.2 Training

................................
................................
................................
................................
......................

30

4.3 Warnings and

Risks
................................
................................
................................
.............................

31

4.4 Surgical Complications and Risks

................................
................................
...............................

34

4.5 Contraindications for Laser Surgery

................................
................................
.........................

35

4.6 Clinical Specialties

................................
................................
................................
...............................

35

General Surgery

................................
................................
................................
................................
.........

36

Gynaecology

................................
................................
................................
.

Error! Bookmark not defined.

Head and Neck/Otorhinolaryngology (ENT)

................................
................................
.............

40

Neurosurgery

................................
................................
................................
................................
..............

44

Urology

................................
................................
................................
................................
............................

46

SECTION 5

................................
................................
................................
................................
............

67

MAINTENANCE

................................
................................
................................
................................
...

67

5.1 Care of the Console

................................
................................
................................
................................
..

67

5.2 Preventative Maintenance Schedule

................................
................................
.............

69

SECTION 6

................................
................................
................................
................................
............

70

TROUBLESHOOTING

................................
................................
................................
.......................

70

6.1 System Prompts

................................
................................
................................
..............................

70

6.2 Troubleshooting Guide

................................
................................
................................
............................

72

SPECIFICATIONS

................................
................................
................................
............................

73

WARRANTY

................................
................................
................................
................................
..........

74

Warranty Policy

................................
................................
................................
................................
..........

74

Annex A


RMA (Return Material Authorisation) Request

................................
................................
.

75

Annex B


LOGBOOK

................................
................................
................................
................................
.......

76


5

Latest update: September 3,
2008 DGM000551 Preface

DPSS Laser

CYBER
TM

Operator’s Manual

September 2008


Preface

About This Manual

This manual contains the safety, installation, operation, and maintenance
instructions for the
Cyber
TM

TM

laser system. It also provides information
on the use
and care of the system components,
recommended

eye protection,
troubleshooting, and warranty fo
r the
Cyber
TM

TM

laser system.



Safety
provides recommendations to avoid bodily injury, especially the
use of
protective eyewear. Read this section before attempting to operate
the
equipment when treating a patient.



Section 1: Introduction
describes the basic components of the system
and
describes the interface features.



Section 2: System Installation
provides the physical and
environmental requirements necessary to operate the
Cyber
TM

TM

laser system,
as well as information on how to move the instrument should you
need to.



Section 3: Operating the System
gives you step
-
by
-
step instructions on how
to
start up the system, select treatment parameters, operating procedures, and
how to
turn the

system off.



Section 4: Physician Information
contains information regarding
indications, contraindications, possible complications, precautions, and
post
-
treatment care.



Section 5: Maintenance
provides instructions on cleaning the system.



Section 6: Troub
leshooting
presents a list of error messages and
codes,
and gives suggestions on how to solve the problem.



Specifications
list

the product specifications. This section also includes
the
labels found on the
Cyber
TM

laser system console and
provides the
meaning
of each symbol found on the system and the labels.



Warranty
contains warranty information and specific instructions for
returning
the
Cyber
TM

laser system and
Cyber
TM

fibre

optic for repair.






6

Latest update: September 3,
2008 DGM000551 Preface

DPSS Laser

CYBER
TM

Operator’s Manual

September 2008

Who Should Read This Manual?

All users of the
Cyber
TM

TM

system should read this manual thoroughly
before
attempting any surgical procedure.
Pay particular attention to all
warnings,
contraindications, and precautions noted in
these manual and other related
materials
.
Failure to do so may result in h
arm to a patient or the user
of the
system.


Obtaining Help


1.

Read through the section of the guide specific to the operation you are
performing.
Refer to the table of contents to locate information.

2.

See
Section 6: Troubleshooting
for a list of problems and suggested
solutions.

3.

For additional information covering installation, medical applications, or
any
other questions, contact
Quanta System

SpA

Customer Response Cent
re

at:


Quanta System SpA

Medical Division


Via IV Novembre,116

21058
-
Solbiate Olona VA
-
ITALIA

Tel.: ++39 0331 376797

Fax:

++39 0331 367815

www.quantasystem.com

quanta@quantasystem.com







7

Section 1: Introduction

DPSS Laser

CYBER GREEN Operator’s Manual

September 2008

Safety

Introduction

This section describes specific laser hazards and appropriate precautionary
measures.

E
ye Injury

Recommended practice: all people in the nominal hazard
zone should
wear appropriate eyewear approved by the
laser safety advisor
.

Visible light and near
-
infrared laser energy passes through the transparent
components of the eye (cornea, lens, aqueous and vitreous humor), and is
focused on the retina. This light can cause an accidental retinal burn. The
degree
of injury to the eye wil
l depend upon the power of the beam, how

focused the beam is, and how long the eye is exposed to the beam.

Precautions against eye injury should include wave
-
length specific laser
protective eyewear for the operating room staff. Patient’s eyes and eyelids
should be protected from the laser beam in a method deemed appropriate by
the
laser protection advisor
.

See the Eye Protection Information Guide in this
section for more information regarding eye protection. Laser eyewear is not
interchangeable for a
variety of lasers.

Eye Protection Information Guide


It is the responsibility of the hospital or medical institution where the laser
surgery is performed to establish a written policy on eye protection.


The f
ollowing European standard EN 60825
-
1: 2003
-
02
applies to
each laser
source installed in the laser system, the value of:

MPE
-

Maximum permissible exposure

NOHD
-

Nominal Ocular Hazard Distance

The formulas and the numerical coefficients are specified in section 3, chapter 13,
table 6, figure 1,2,5,6,7 and 8 of the EN 60825
-
1: 2003
-
02 standard.

Nominal Ocular Hazard Distance (NOHD) and Maximum permissible exposure (MPE)







8

Section 1: Introduction

DPSS Laser

CYBER
TM

Operator’s Manual

September 2008


DPSS laser
2.01μm
:


1000

MPE

[
W
/m
2
]




For the NOHD:




a
MPE
P
NOHD


0
4

[m]

Where P
0

is the peak power of the laser output pulse,
a

is the diameter of the
output laser beam and


is the divergence of the output beam:


The calculated values are shown in

the following table:


120W
2.01μm


Beam

diameter

divergence

P0


MPE

NOHD

400

m

440 mrad

1
2
0W

1000

W
/m
2


2.6

m

600

m

440 mrad

1
2
0W

1000

W
/m
2

2.6

m

Laser Protective Eyewear

There are several products available for use with the
Cyber
TM

TM

laser system to
protect both eyes and video equipment.
This section describes the
laser
protective eyewear and the video camera filters that have been
designed to
meet
European standard EN 60825
-
1: 2003
-
02
for safe viewing in a medical
facility.
All the f
ilters have
L values
greater than
2

at
2.01μm
.
The OD of the
filters indicates how much the
light is attenuated and is defined as:

Optical Density = OD =

Log
10

(Filter Transmission)

A filter with an OD of 2 has a transmission of 1/100 or 10
-
2

while a filter with an
OD of 5 has a transmission of 1/100,000 or 10
-
5
.



The specification of the goggles to be used is:
D2010

L
2
.

NOTE
:
It is required
that
everyone in the
nominal ocular hazard zone

(NOHZ)
wear protective eyewear.


9

Section 1: Introduction

DPSS Laser

CYBER
TM

Operator’s Manual

September 2008


B
urns

Personnel using lasers should be
aware

of the fire hazards
associated
with laser use. Accidental irradiation of tissue other than the
target tissue
may result in a burn or vaporization, regardless of the
wavelength.
Surrounding the target area with moist d
rapes or saline
-
soaked
, sterile

s
wabs

will keep it moist and greatly reduce this hazard.

Flammable or combustible items in the laser environment may include:
flammable liquids or combustible ointments, gases, plastics, paper or gauze
materials, adhesive or

plastic tapes, and endotracheal tubes.

Laser appropriate fire extinguishers and water should be available where
lasers are u
sed
. Care and precision in aiming and applying laser energy is
of
paramount importance.

NB:
Never use a clamp to secure the laser

f
ibre

optic to a
drape. The use of
a clamp to secure a

fibre

may cause the

fibre

to
bend at sharp angles and
damage the

fibre
. To do so can result in
an unsafe condition. The

fibre

can
break and release laser energy
causing a burn in the protective jacket. If
undetected, this
condition will result in a burn or ignition of flammable
materials.

When using the fibre with the laser, the fibre device connector
should never be
allowed to touch the floor or any wet surface.
If
the

fibre

connector does
contact a surface other than the laser
device port, dispose of the

fibre

in
accordance with hospital safety
regulations.

Reflection of the beam from instruments

Care should be taken when aiming the laser beam to prevent reflection of the
beam off metallic surgical instruments.
Mirror
-
finish instruments are
especially dangerous as they have highly reflective surfaces. The laser light
reflected from such instruments

is intense and potentially very harmful.

Matt
, dull, satin
-
finished, or
black
instruments have less glare and those
with
curved surfaces do not reflect light as intensely. While these
instruments usually produce a more diffused reflection that is less
harmful,

this
reflection can still be damaging.
Protective eyewear should be worn at
all
times to prevent eye damage.


NB:
When using anodized or black
instruments during a surgical procedure,
additional care
should be taken to prevent burns. These instrum
ents will
become
extremely hot when they come in contact with a laser beam and
are
not able to quickly dissipate heat.
When any tissue is touched
under these



10

Section 1: Introduction

DPSS Laser

CYBER
TM

Operator’s Manual

September 2008

Ignition of flammable materials

The laser can ignite many materials used during a surgical procedure.
Use of
non
-
flammable materials is strongly recommended.
See
Operating Room
Environment
in this section for more information regarding flammable
materials.


Vapour/smoke plume

There is
considerable concern about the biological plume created by

electrocautery

units, bone saws and lasers. Current medical literature
recommends that a smoke evacuator and in
-
line filter be used to capture this
plume.
The plume should be regarded as a source o
f active biological
material and a possible carcinogen.


Electrical

Electrical hazards with the laser are the same as with any electrical device.
Care should be taken when plugging the unit into the wall outlet.
The area
must be free of water and your hands must be dry. Always disconnect the
laser by grasping the plug and not the power cord. Examine the electrical

cord routinely; if signs of wear are noted, contact the
Quanta System SpA

or
you’re your local distributor
to
have it repaired or replaced.


Operating room environment


This section describes specific safety measures for the operating room to aid
safe operation of the laser system.


Laser Warning Signs

The area where the laser is operated should be clearly
labelled
. Warning
signs that specify the laser wavelength being used should be posted at all
operating room and access
-
door entrances.
Figure 1 is an example of a
sign
suitable for use with the
Cyber
TM

TM

laser system.


NB
:

Warning signs are not interchangeable. Select a
sign that is
appropriate for the wavelengths in use.












Figure 1



Cyber
Green laser
system W
arning
S
ign


VISIBLE AND INVISIBLE LASER
RADIATION

A
A
A
v
v
v
o
o
o
i
i
i
d
d
d



e
e
e
y
y
y
e
e
e



o
o
o
r
r
r



s
s
s
k
k
k
i
i
i
n
n
n



e
e
e
x
x
x
p
p
p
o
o
o
s
s
s
u
u
u
r
r
r
e
e
e



t
t
t
o
o
o



d
d
d
i
i
i
r
r
r
e
e
e
c
c
c
t
t
t



o
o
o
r
r
r



s
s
s
c
c
c
a
a
a
t
t
t
t
t
t
e
e
e
r
r
r
e
e
e
d
d
d



r
r
r
a
a
a
d
d
d
i
i
i
a
a
a
t
t
t
i
i
i
o
o
o
n
n
n
.
.
.



C
C
C
l
l
l
a
a
a
s
s
s
s
s
s



4
4
4



l
l
l
a
a
a
s
s
s
e
e
e
r
r
r



p
p
p
r
r
r
o
o
o
d
d
d
u
u
u
c
c
c
t
t
t
.
.
.



M
M
M
a
a
a
x
x
x
i
i
i
m
m
m
u
u
u
m
m
m



o
o
o
u
u
u
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t
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p
p
p
u
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t
t



l
l
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a
a
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s
s
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r
r



r
r
r
a
a
a
d
d
d
i
i
i
a
a
a
t
t
t
i
i
i
o
o
o
n
n
n
















































1
1
1
2
2
2
0
0
0
w
w
w
a
a
a
t
t
t
t
t
t
s
s
s



P
P
P
u
u
u
l
l
l
s
s
s
e
e
e



d
d
d
u
u
u
r
r
r
a
a
a
t
t
t
i
i
i
o
o
o
n
n
n
























C
C
C
W
W
W



W
W
W
a
a
a
v
v
v
e
e
e
l
l
l
e
e
e
n
n
n
g
g
g
t
t
t
h
h
h
s
s
s

































2
2
2
.
.
.
0
0
0
1
1
1
µ
µ
µ
m
m
m



A
A
A
i
i
i
m
m
m
i
i
i
n
n
n
g
g
g



b
b
b
e
e
e
a
a
a
m
m
m



C
C
C
l
l
l
a
a
a
s
s
s
s
s
s



3
3
3
R
R
R


















D
D
D
i
i
i
o
o
o
d
d
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e
e
e



l
l
l
a
a
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r
r



<
<
<
4
4
4
m
m
m
W
W
W
@
@
@
6
6
6
5
5
5
0
0
0
n
n
n
m
m
m



S
S
S
t
t
t
a
a
a
n
n
n
d
d
d
a
a
a
r
r
r
d
d
d



C
C
C
E
E
E
I
I
I



E
E
E
N
N
N



6
6
6
0
0
0
8
8
8
2
2
2
5
5
5
-
-
-
1
1
1
:
:
:



2
2
2
0
0
0
0
0
0
3
3
3
-
-
-
0
0
0
2
2
2




11

Section 1: Introduction

DPSS Laser

CYBER
TM

Operator’s Manual

September 2008



Remote Door Interlock


Always limit personnel in the operating room to those essential to the procedure.
To protect intruding personnel from exposure to the laser beam,
an optional
remote door interlock can be connected from the laser system to
the operating
room entrance door.

If the use of the remote door interlock is desired, the
medical engineering

personnel at
the user’s facility can connect it. Access to the laser
unit’s interlock
is made
via a socket located on the back panel of the laser (see
Section 1.1.
System Overview).


Safety Recommendations

The following are general safety recommendations for the operating room
and are
not specific to the
Cyber
TM

System:




Keep drapes and towels moist to prevent their ignition and burning.




Use non
-
flammable prepping solutions.




Prevent combustion of methane gas by packing the rectum during

perineal


procedures.


NB
:
All lasers operate with a

keyswitch
. Keep the laser key in a
designated place
and allow only trained personnel access to the key.


S
AFETY FEATURES OF THE
CYBER
TM

LASER SYSTEM

Safety Regulations


The device is manufactured according to 93/42/CEE Annex II standard and the
system is
identified as follows:




Model

CYBER


Version

TM



Category of the
device

Laser for medical use


Classification

II b




Produced by

Quanta System SpA

Medical Division

Via IV Novembre 116

21058 Solbiate Olona VA

Italia



12

Section 1: Introduction

DPSS Laser

CYBER
TM

Operator’s Manual

September 2008



The safety features of
Quanta System SpA
’s
Cyber
TM

laser system are
described in the following sections. All required
labelling

information is also
provided in these sections.


System Safety Features


Quanta System

SpA
’s

Cyber
TM

laser system incorporates the following safety
features:



The laser will stop firing when the pressure is removed from
the
footswitch.



An automatic circuit breaker shuts the system completely off in the event
of
an electrical overload.



The laser provides an

operating room door interlock connection, which
must be s
et up by the hospital personnel if required.



The key can only be removed when the keyswitch is in the OFF position.



An on
-
board microprocessor continuously monitors the status of the
system, and
displays messages on the video screen along with
appropriate operator prompts.



Laser energy cannot be emitted from the system unless a
fibre

optic has
been connected.



Laser will go into ready when the READY button is touched
.



A

fibre

support pole elevates and positions the

fibre

in a safe and
unobtrusive position.



A continuous audible tone is heard when the surgical beam is activated
(i.e.
foot pedal is pressed).



A 2
-
second delay occurs before laser energy is emitted after the laser
is
placed in READY status.



An Emergency Laser Stop switch is available to disable the system
immediately, in the case of an emergency situation
.


NB
:
Do not attempt to remove any panel from the laser console. Any attempt to
remove the panels, unless
instructed by

authorised

Quanta System

SpA

personnel, can damage the laser and will void the manufacturer’s warranty.






13

Section 1: Introduction

DPSS Laser

CYBER
TM

Operator’s Manual

September 2008





Safety classifications


The product is classified as Class II b equipment at continuous operation with
intermittent loading, which is not protected against spillage of
liquids.
The

product is
not suitable for use in the presence of a flammable anesthetic mixture with air or
with oxygen or nitrous oxide.

In accordance with
CEI EN 60825
-
1: 2003
-
02

special attention must be paid to all
rules that will prevent accidents in the place of
installation, with specific attention to
the laser radiation.

This user manual should be available in the working area of the laser device.

All the warning labels have to be maintained in good condition.


Disposal of waste electrical and electronic equipme
nt

To comply with the European Commission Directive 2002/96/EC on Waste Electrical
and Electronic Equipment (WEEE) DO NOT dispose of this laser equipment in any
location other than designated locations.


Performance & Safety Standards:

The
Cyber
TM

TM

laser system and accessories comply with
EU

regulations for
medical
laser systems. In addition, the information below identifies
Standards
(European Norms and other Regulatory Guidelines) deemed as
relevant for addressing
particular aspects of the Quality

System, the requirements for Medical Lasers, the
Requirements for Medical Devices, and the Essential requirements of the EU Medical
Device Directive (Annex I).


ISO 13485:2003

MDD 93/42/EEC

EN6060 1
-
2
-
22: 1996

EN 60601
-
1
-
4:1997








This equipment has been tested and found to comply with the limits for medical
devices to the
93/42/CEE annex
II directive CE 0476
.
These limits are designed to
provide reasonable protection against harmful interference in a typical
medical
installation.
This equipment generates, uses, and can radiate radio
frequency energy
and, if not installed and used in accordance with the
instructions, may cause harmful
interference to other devices in the vicinity. However, there is no guarantee that
interference wil
l not occur in a particular
installation. If this equipment does cause
harmful interference to other
devices, which can be determined by turning the
equipment off and on, the
user is encouraged to try to correct the interference by one
or more of the
follo
wing measures:



14

Section 1: Introduction

DPSS Laser

CYBER
TM

Operator’s Manual

September 2008



Reorient or relocate the receiving device.



Increase the separation between the equipment.



Connect the equipment into an outlet on a circuit different from that to
which the
other device(s) are connected.



Consult the manufacturer or field
service technician for help.


Labelling

This figure shows the location of all labels on the laser unit.
The actual labels
used in these locations are also shown.



DANGER

VISIBLE AND INVISIBLE LASER RADIATION

AVOID EYE OR SKIN EXPOSURE

TO DIRECT
OR SCATTERED RADIATION

DPSS


LASER : 2010 nm

MAX OUTPUT: 120 W

DIODE LASER 635 nm MAX OUTPUT 4mW

CLASS IV LASER
PRODUCT


15

Section 1: Introduction

DPSS Laser

CYBER
TM

Operator’s Manual

September 2008



Key switch

VISIBLE AND INVISIBLE LASER RADIATION

Avoid eye or skin exposure to direct or scattered

Radiation. Class 4 laser product.

Maximum laser output


120 watts

Pulse duration

CW

Wave length


2.01µm

Aiming beam class 3R Diode laser
<4mW@650nm

Standard CEI EN 60825
-
1:2003
-
02

Laser Aperture

12”
touch screen

PC panel

Emergency off

Figure 2

-

Labeling
of Front Panel of Laser

Footswitch

Classification Label

LASER APERTURE


16

Section 1: Introduction

DPSS Laser

CYBER
TM

Operator’s Manual

September 2008









Interlock connector

Circuit breaker

Mains cable terminated
with 32A plug


Figure 3
-

Labeling of Rear Panel of Laser
Footswitch and connector socket


17

Section 1: Introduction

DPSS Laser

CYBER
TM

Operator’s Manual

September 2008

Section 1

Introduction

1.1
System Overview

The
Cyber
TM

laser system is a diode
-
pumped,
solid state
2010nm

laser.
The
laser system delivers visible
2010nm

laser
light with a power range of
1

to
120W
.

Different fibers are available for different applications:
a
side firing
fibre with 600
µm core diameter

and
and
bare optical fibres with 200, 400 and 600

µm core
diameter
.
Each fibre has an its own
code plug
that

manages the recognitio
n and
the expiration of the fibres

them
selves
.

The laser system also consists of an air
-
cooled internal mechanism, ensuring
safe
operating temperatures with no external wate
r connections.
Laser
energy
emission and system status selection is activated through

a

touch screen featu
re
located in the laser console.

1.2
Cyber
TM

Fibre Optic

Product Description


Side firing Fibre

The
Cyber
TM

Side

firing

fibre

features a “side firing”
mechanism delivering up
to 120W of
2010nm

power
to tissue.
The
fibre

is
guided to the treatment site
by the continuous flow cystoscope, consisting of
an inner and outer sheath set,
30° forward oblique telescope, and visual
obturator.

The
Cyber
TM

fibre

is used to cut, coagulate and vaporize tissue in endoscopic
and open surgical procedures at
an

8
0° forward def
l
ection angle to the
fibre

axis.
It can rotate 360
-
degrees, allowing tissue access in multiple planes; and it is used
in surgical applications where lateral delivery of laser
energy is desired.
Cyber
TM

fibre
s

are sterile and designed for single
use only.

Cyber
TM

Fibre



Manipulator to rotate
the fibre


18

Section 1: Introduction

DPSS Laser

CYBER
TM

Operator’s Manual

September 2008

200, 400, 600

µm core

bare Fibre


The bare
fib
r
e
s

are available in 200, 400 and 600
µm core diameter
s
.
They are
supplied sterile and 5xtime reusable.

Code plug

All the fibre optics are supplied with a code plug to be connected on the right
side of fibre optic port.
The code plug is a
plastic connector includin
g a
microchip. Once the code plug is connected the type of fibre is displayed on the
screen.


T
he Cyber

TM

is allowed to work only with the inserted code plug.
It

allows the
Cyber
TM

to enter the READY mode.


If the connected fibre is a Side

Firing Fi
b
r
e, the code plug will authomatically
manage it as monouse. It means that this fibre can be used just for
one patient

and no longer of

a fixed amount of time
(2 hours)

or delivered energy

(500 KJ)
.
After these limits

the fibre expires. Once expired the fibre can no longer be used.

If the connected fibre is
a
bare fibre
, the code plug will
recognize the core


diameter (200, 400 and 600). If the
bare fibre
is a 200 µm core also a power
limit is set (40W). All the frontal fibres are managed as 6xtime re
-
usable fibres.
They are initially sterile with ETO method. After the first use they can be re
-
sterilized in a
utoclave for 5 times for a

6 times

overall use.


The code plug manages also a time
(6

hours)
or
an
energy limit

(800KJ) if the
number of re
-
uses is not reached.


The code plug will increment the number of

re
-
uses once both the code plug and
the optical fib
ers are connected for more than 3 minutes.

During the same operation it
is possible

to disconnect one fibre, to connect
another one and to return t
o the previous fibre without an increase of the
number of re
-
use
.
T
h
is is possible if the time between the last disconnection and
the
re
-
connection is shorter than 1 hour.


19

Section 1: Introduction

DPSS Laser

CYBER
TM

Operator’s Manual

September 2008


Fibre

Optic Handling Guidelines

If the tip of the

fibre

accumulates tissue debris during a procedure, turn the
laser to STANDBY, remove the

fibre

from the

cystoscope

and carefully wipe
the tip clean with moistened sterile gauze.

The correct method of removing debris from the
fibre

is to gently wipe from
the
tip of the
fibre

toward the control knob. When the procedure is
complete,
dispose of the
fib
re

using the standard hospital procedure for

bio
hazardous

material.
Always check if the fibre in use is monouse or re
-
usable

NB:

Improper
cleaning of the

fibre

tip may cause damage to
the

fibre
.

Calibration Information

Cyber
TM

fibres
do not have to be calibrated by hospital
personnel.


1.3
General Instructions For Use

1.

Remove the
Cyber
TM

fibre

optic from its sterile package using
aseptic
technique
.

2.

Before starting the surgical procedure, the
Cyber
TM

fibre

optic
should be
checked for
damage.

3.

Connect

fibre

hub into the

fibre

port on the laser system console.

Keep the
connecting end of the

fibre

clear of debris or liquids.

4.

Place the laser in READY mode to activate the aim beam.
CAUTION: Do
not
press the footswitch while checking the aim beam.
Place the
distal end
of the
fibre

on a non
-
reflective sterile surface and turn slightly
until the aim
beam can be visualized. If the aim beam is not seen, the
fibre

may be
defective and should not be used.



5.

Check for kinks or bright areas along the entire length of the
Cyber
TM

fibre
.

Do
not use the
fibre

if it has been damaged.

6.

Once the
Cyber
TM

fibre

has been checked, return the laser to the
STANDBY
mode.

7.

Position the
Cyber
TM

fibre

optic at the targeted treatment site.
The tip of
the
Cyber
TM

fibre

should be in clear view and extended
approximately 1 to 2
cm. beyond the distal end of the endoscope.

8.

Place the laser in READY mode to enable the footswitch
control.

9.

Laser software automatically corrects for

fibre

losses such that the power level
shown on the system video display indicates the actual amount of
power
delivered to tissue.


10.

Treatment

times vary based on distance to tissue, power settings, and other
factors.
The
fibre

should be maintained at a distance of 3 mm from the tissue

20

Section 1: Introduction

DPSS Laser

CYBER
TM

Operator’s Manual

September 2008

for maximum vaporization.
The efficiency of vaporization will decrease with
increasing distance from the tissue

and coagulation may
result.

Do not bend
the

fibre

at sharp angles.

11.

Avoid

contact of

fibre

tip with tissue.

If, during the procedure the tip
accumulates debris, turn the laser to the STANDBY mode, remove the
Cyber
TM

fibre

from the

cystoscope
, and carefully wipe the tip clean
with a sterile
gauze or towel. Begin at the end of the

fibre

and wipe along
the

fibre

tip.

12.

Never bury the cap of the

fibre

in tissue while firing the laser.

In the unlikely

event of a detached tip, it maybe
visually located through an appropriate scope
and removed using forceps. Irrigate the area thoroughly to remove any traces
of

fibre

or other material.


Warnings and Precautions for the Safe use of Bare

and Coaxial Optical

Fibre

Delivery Devices


The follo
wing warnings and precautions are applicable for each surgical
specialty
contained in this manual that requires the use of Disposable Optical

Fibre

Delivery
Devices
:










600micron bare optical fibr
e
400micron bare optical fibre




The recommended power settings are less important than the visual
tissue effect. Changes in the tissue texture and

colour

are the best


indicators of the laser’s effect.
Specific pulse duration depends on the tissue
and is left to the surgeon’s
preference and best medical

judge
ment
.



The lowest possible power settings required to achieve the desired
tissue effect should be used for treatment.



Higher wattages of power may be necessary to achieve the desired
tissue effects if fluid cooling is

utili
sed
. Excessive power settings may
cause damage to the
Disposable Optical

Fibre

Delivery Devices
.



The use of mechanical pressure on the
Disposable Optical

Fibre

Delivery
Devices

does not increase its cutting or

vaporisation

effects but may
induce bleeding, thermal damage and

fibre

destruction.



Due to the tip size of the Disposable Optical Fibre Delivery Devices, input
power from the laser source must be reduced to achieve equivalent power

21

Section 1: Introduction

DPSS Laser

CYBER
TM

Operator’s Manual

September 2008

densities obtained when using bare f
ibres of different diameters.


1.4
Sterilization

Side Firing Fibre

The
Cyber
TM

Side Firing
fibre

is a sterile, single
-
use, disposable device
and should not be re
-
used or re
-
sterilized. After the
completion of the
procedure, dispose of the
Cyber
TM

fibre

following the standard hospital
protocol for bio
-
hazardous material.
The
Cyber
TM

fibre

is ethylene oxide
sterilized and is not designed or certified for
multiple use.


Do not re
-
sterilize. Do not reuse.

Bare

Fibre

The Cyber
TM

bare
fibre

is supplied sterile and 5xtime re
-
usable.

The method of sterilization is autoclave.The parameters of the autoclave are the
following:

Temperature =134°C

Time= 5 minutes

Pressure= 2 bar

After the
completion of the procedure, dispose of the Cyber
TM

fibre

f
ollowing the
standard hospital protocol for bio
-
hazardous material.


Storage

The
Cyber
TM

fibre

should be stored under ambient conditions.


Warranty

The warranty for the
Cyber
TM

fibre

optic covers only defects in the
material and workmanship.
Should you need to return this product, call the


Quanta System SpA

Customer Response
Centre

or your local distributor

for
“Return Authorization”.


22

Section 2: System Installation

DPSS Laser

CYBER
TM
Operator’s Manual

September 2008

Section 2

System Installation

2.1
Responsibility

This section provides general guidelines for the installation of the
Cyber
TM

laser system. This laser system has specific installation requirements.
It
is the customer’s responsibility to fulfill these requirements prior to the
installation of the system.

Failure to do so can result in intermittent
operation and even damage to the laser system. Please read the following
information
carefully.

NB
:
The crated system should be stored in a protected
area in
temperatures between 50°F (10°C) and 104°F (40°C).

Quanta System

SpA

/ Local Distributor
Responsibility

A
Quanta System

SpA

or Local Distributor
Service Representative will
install the laser system. Upon
arrival at the installation site, the
representative will perform the following:

1.

Verify appropriate
power.

2.

Uncrate the system and inspect for damage.

3.

Perform all optical, electronic, and system checks necessary to bring
the
laser into operation.

4.

Check

all shipped accessories.

Customer’s Responsibility

Provisions for proper power must be made prior to the

receipt and
installation of the system.
Return visits by service personnel for
installation
will not be covered under warranty. Upon completion of the
pre
-
installation
site preparation, call
Quanta System SpA

or Local
Distributor

to check shipment date and schedule

and arrange a date for

installation of the system.

Because the
Cyber
TM

system uses standard electrical service and has
built
-
in cooling systems, installation requires minimal site preparation.

NB
:
Do not attempt to turn on the system until it has
been installed and
tested by a Quanta System SpA
or Local Distributor
Service Engineer.
Severe damage to the system will result.




23

Section 2: System Installation


DPSS Laser

CYBER
TM

Operator’s Manual

September 2008


2.2 Environmental And Power Requirements


Environmental Requirements

The recommended temperature range for the room where the laser
will be operated is 10

to

25
°C
.

A dry low dust location with
adequate ventilation is required. Air conditioning is preferable but
not essential. The laser device has to operate in ambient
co
nditions specified in the following table.


Temperature

Max. Humidity

20 ° C

64 %

22 ° C

57 %

24 ° C

50 %

26 ° C

45 %

28 ° C

40 %

30 ° C

35 %



The devise at maximum power generates a waste heat output
corresponding to 4400watts.


Power Requirements


The device has to be connected with a power socket according to the
electrical safety standard.


Following the European safety standard the device is supplied wit
h a power
cable with a IEC309 16
A plug.


The laser can function when some voltage change is present in the service
line, however the voltage may not vary by more than ± 10%.




24

Section 5: Maintenance


DPSS Laser

CYBER
TM
Operator’s Manual

September 2008

On

Off

Section 3

Operating the System



3.1
Operating Instructions

This section contains a general operation description of the laser system.


Make sure that all the safety measures shown in the safety chapter
are observe
d before operating the device.


Caution, the operation of the laser system can

cause exposur
e to
dangerous laser radiation.


NB
:

To prevent damages caused by accidental eye exposure to the laser
radiation, all the personnel present in the laser working area must wear the
specific protective goggles.


Always check the goggle’s integr
ity and status
.

3.2

Turning The System On

It is assumed that the set up procedure has been completed (System
Installation chapter).


Switch on the circuit breaker





Insert the key switch and turn right, towards the
I
symbol

marked on the
key switch
.
If the laser fails to start

check the emergency push button is
not pressed. If the emergency push button is depressed twist to the right
to release. Turn the key to start the laser.









Key switch


25

Section 5: Maintenance


DPSS Laser

CYBER
TM

Operator’s Manual

September 2008

3.3
Optical Fibre Connection

The optical f
ibre must be connected through the
Fibre Port

on the front
panel of the LASER. If the optical Fibre is not connected to the
laser a

warning

is displayed

on screen
. This
prevents

laser
energy being released

if
the foots
witch is depressed when a f
ibre is not connected
.












N.B.
The expansion nut

of the optical fibre must be firmly tightened.

A loose connection could cause very low power to

exit from around the loose
connector and damage the fibre.


Once the fibre is connected also the code plug must be connected. If the code
plug is not connected to the laser a warning is displayed on the screen the
device will not enter the READY mode.

Af
ter some minutes in which both the fibre and the code plug are connected
the system will increment the number of fibre re
-
use.


















Optical Fibre Port

To connect the fibre first open the protection shutter. Then insert the
fibre taking care not to touch the end of the connector with your fingers
or
splash with water.

Now screw the fibre onto the internal connector by turning the fibre
connector to the right until finger tight.


Cod
e P
lug Connection


26

Section 5: Maintenance


DPSS Laser

CYBER
TM

Operator’s Manual

September 2008

3.4 The Touch Screen
PC panel

When the laser first starts the fibre selection screen appears,
and the
correct
size fibre

is displayed due to the recognition of code plug. The operator has to
decide if the
microscope filter is required
and

press OK.





.



When OK is pressed
the following mask will appear:






In this mask all the details related to the fibre are shown:

-

type of fibre
(side firing or bare) and core dimensions (200, 400 or 600 µm)
;

-

max power (120W for 600and 400 µm core fibres, 40W for 200 µm core
fibres);

-

max session lasing time (60 minutes for re
-
usable fibres, 120 minutes for
monouse fibres);

-

number of
re
-
use;

Fibre selected automatically
connecting the code plug

Press here
if using

the microscope eye
safety filter

Press here to confirm and continue

Press here to confirm and continue

CYBER
TM

CYBER
TM


27

Section 5: Maintenance


DPSS Laser

CYBER
TM

Operator’s Manual

September 2008

-

first use start time;

-

last use start time;

-

last use time;

-

current session lasing time;

-

total use time.


When OK is pressed,
the
laser starts up and checks safety and calibration. As the laser
completes each check, information is displayed in the
status field and warnings, if any,
are displayed in the warnings field. See example below.




Once the start up is complete the
main control screen appears:








Ready and Standby

the emission mode

will
be
:



CW



Single Pulse



Burst with
number of pulses,
up to 10.



Repeat

In this area the status is
displayed:



STANDBY



READY



Power Check



EMITTING



ALARM

Press the


or + key to
change the
power.


Warning are displayed here

Press here to enter ready mode

Press here to select the
menu

There are three different
checks during Start Up:




STARTING1



STARTING2



Warm up…..


28

Section 5: Maintenance


DPSS Laser

CYBER
TM

Operator’s Manual

September 2008


After
choosing the power and emission setting that are
suitable for the
surgery
being undertaken and the settings have been agreed by the surgeon. The laser
operator can
star
t the laser emission as follows:


Press the
R
eady button to enter the READY MODE, the following
screen

will
appear
, asking you to confirm everyone is wear
ing suitable eyewear
:












To return to the STANDBY mode press the STAND
BY button.


Press here to
acknowledge and
continue

When the laser is in Standby Mode the Yellow light will
flash. When the laser is in Ready Mode the Yellow light is
on continuously.

When the footswitch is pressed and the l
aser is in Ready
Mode, in addition to the Yellow light remaining on, the
Green light is also on and the laser emits an audible
noise.


29

Section 5: Maintenance


DPSS Laser

CYBER
TM

Operator’s Manual

September 2008


When the system is in READY mode and the footswitch is
pressed the following screen
will appear:



M
enu

Button

When the
M
enu button is
pressed

the following
screen is displayed:







Protections against non

authorised use
:

When the laser system is not
in use and to
protected
against non authorised use. The
laser must be shutdown and the

laser key removed.




Press here to view
the alarms

Press here to restart the system

Press here to switch off the system

Press here to change the fibre

Press here to view the diagnostics
windows (advanced user)


30

Section 5: Maintenance


DPSS Laser

CYBER
TM

Operator’s Manual

September 2008

Section

4

Physician Information


4.1
Indications for use


Introduction


This section provides information on the use of the Cyber
TM

Laser System in
clinical applications. Information is provided by specialty and includes procedural
recommendations, along with specific indications and contraindications. The
information provided in this section is not intended to be all
-
inclusive and is

not
intended to replace surgeon training or experience.


Surgeons and staff who have been appropriately trained and who are thoroughly
familiar with the instructions and safety precautions provided in this manual
should only use the laser system. A review

of the published litera
ture is strongly
encouraged and recommended.


This manual is intended for operators of the Cyber
TM

Laser System. The Cyber
TM

Laser is available in several different configurations, therefore, not all
specialties or procedures pre
sented in this section may be applicable to your
particular configuration. Quanta System Cyber
TM

Laser System is designed

as a
multi
-
specialty system.


4.2
Training


Healthcare Professionals Education and Training


Standards of training for surgeons have been established by various Royal Colleges
and University Hospitals.
These standards
include the following;




Review of the following information.



Published literature.



General laser physics, biology and treatment tec
hniques for each specific
disease entity.



Treatment techniques for other surgical modalities in several specialties.



Familiarization with treatment parameters using all laser types, such as
Argon,

Ho:YAG
, Tunable Dye, CO2, KTP/
2010nm
, Nd:YAG, Diode and
Thulium.



Attendance at medical meetings dealing with the use of the laser.



Attendance at seminars and hands
-
on workshops on laser therapy in a
specific specialty. Quanta System maintains a listing of instructional
courses and mentorship sites in a broad ra
nge of medical specialties,
contact your local distributor for more details.



Mentorship’s should be made as frequently as possible with other surgeons
who are performing laser therapy. These usually allow in
-
depth discussions
of all aspects of laser treatm
ent, along with the possibility of observing or
participating in actual cases.



31

Section 5: Maintenance


DPSS Laser

CYBER
TM

Operator’s Manual

September 2008

Nursing Education and Training


Nursing education and training should include a review of the following infor
-
mation:




Published literature.



General laser physics, biology and
treatment techniques for each
specific disease entity.



Treatment techniques for other surgical modalities in several
specialties.



Familiarization with treatment parameters using other laser types,
such as Argon, Ho:YAG, Tunable Dye, CO2, KTP/
2010nm
, Nd:YAG
,
Diode and Thulium.



Attendance at medical meetings dealing with the use of the laser;
and



Attendance at seminars and hands
-
on workshops on laser therapy in
a specific specialty. Quanta System maintains a listing of instructional
courses in a broad range o
f medical specialties contact your local
distributor for more details.


4.3
Warnings and Risks


General Warnings and Precautions for the Cyber
TM

Laser System


The physician or surgeon should become fully acquainted with the unique
surgical and therapeutic effects produced with the
2010nm

wavelength
before using Quanta System Cyber
TM

Laser clinically. These effects in
clude
coagulation, depth of penetration and
cutting intensity.


Caution should be used with power (watts) and timing duration until the
surgeon is completely familiar with the biological interactions of the laser
energy on various types of tissue. Unless otherwise stated in the specific
application
section, the surgeon should begin at the lowest power and use
short duration exposures. The surgeon should note the surgical effect and
adjust the settings until the desired surgical effect is obtained.


The following warnings and precautions are
applicable for each surgical
specialty contained in this manual. For specific application warnings and
precautions, see the section specific to a given surgical specialty.




The Cyber
TM

Laser System is a surgical device that should be used
only by physicia
ns or surgeons who have been trained in laser
surgery through courses, mentorships, and under the guidance of
other physi
cians or surgeons knowledgeable in laser use. No claim is
made that the laser will cure any medical condition.


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BEFORE operating the la
ser system, surgeons and all staff operating
the laser should carefully read Section 1, General Warnings and
Caution, of this manual.



Surgeons using Quanta System Cyber
TM

Laser System must
understand the laser’s unique properties prior to using the device
.



Prior to turning the laser system on, operating room personnel and
the conscious / sedated patient should be wearing protective eyewear
suitable for
2010nm

laser energy.



Careful assessment of the target and surrounding tissue should be
made, and appropri
ate power and pulse duration should always be
used.



Tissue perforation can result if excessive laser energy is applied. This
can occur through the use of excessive laser power or the

application
of power for excessive periods of time, particularly in disea
sed tissue.



Aim and use the laser only on tissues that are in full view.


General Warnings and Precautions for the Cyber
TM

Laser System
continued




Extra caution should be used when lasing tissue close to known
arteries, nerves and veins.



Begin laser treat
ment at the lowest power, with short duration
exposures until fully familiar with the tissue effects of the applicable
wavelength.



Flash fires can occur. Refer to Section 1,
General Warnings and
Caution,
for more information. A bowl of water should be
available in
case a fire occurs.



Quanta System has no clinical information or experience concerning
the use of the Cyber
TM

Laser System on pregnant women or nursing
mothers.



Patients who experience discomfort during laser treatment may
require analgesics.



As with conventional non
-
laser surgical procedures, there is no
guarantee that treatment with the Cyber
TM

Laser System will
entirely eliminate the disease. Repeated treatment or alternative
therapies may subse
quently be required.



The laser may not be
effective for coagulation in massive
haemorrhage situations. The surgeon must be prepared to control
haemorrhages with strident alternative non
-
laser techniques, such as
ligature or cautery.



Alterations in surgical approach or technique may be required to
accom
modate laser use.



The surgeon should schedule follow
-
up visits in the same manner as

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Section 5: Maintenance


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TM

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September 2008

for any patient undergoing such surgery with other modalities.



Surgeons should be thoroughly trained and proficient in all aspects of
endoscopic surgery prior to usi
ng the laser through an endoscope.
Depth perception through an endoscope is distorted. The surgeon
must rely on both the visual and tactile feedback of the delivery
system.



Care must be taken to protect endotracheal tubes from laser
radiation. Ignition or
perforation of endotracheal tubes by the laser
beam could result in serious or fatal patient complications.



A smoke evacuator and in
-
line filter should be used to capture the
smoke plume that results from laser procedures. The plume should
be regarded as
a source of active biological material and a possible
car
cinogen.

Warnings and Precautions for the Safe use of Bare, Side Fire and
Coaxial Optical Fibre Delivery Devices


The following warnings and precautions are applicable for each surgical
specialty co
ntained in this manual that requires the use of Disposable Optical
Fibre Delivery Devices:




The recommended power settings are less important than the visual
tissue effect. Changes in the tissue texture and colour are the best
indicators of the laser’s eff
ect. Specific pulse duration depends on
the tissue and is left to the surgeon’s preference and best medical

judge
ment
.



The lowest possible power settings required to achieve the
desired tissue effect should be used for treatment.



Higher wattages of power
may be necessary to achieve the desired
tissue effects if fluid cooling is

utilised
. Excessive power settings
may cause damage to the Disposable Optical Fibre Delivery
Devices.



The use of mechanical pressure on the Disposable Optical Fibre
Delivery Devices

does not increase its cutting or

vaporisation

effects
but may induce bleeding, thermal damage and fibre destruction.



Due to the tip size of the Disposable Optical Fibre Delivery Devices,
input power from the laser source must be reduced to achieve
equival
ent power densities obtained when using bare fibres of
different diameters.






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Section 5: Maintenance


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September 2008



4.4
Surgical Complications and Risks


The same complications and risks that exist for conventional or traditional
surgery exist for laser surgery. These include, but are not
limited to, the
following.


Non
-
Thermal Complications and Risks:



Perforation



Aspiration



Induced haemorrhage



Allergic reaction to medication



Hypertension



Arrhythmia



Pain



Gas over
-
distension



Pneumothorax and



Infection


Thermal (Acute) Complications and
Risks:



Induced haemorrhage



Ulceration



Perforation



oedema



Pain



Fever



Leukocytosis and



Chills


Thermal (Chronic) Complications and Risks:



Delay in healing



Perforation



Stricture



Delayed haemorrhage



Sepsis and



Embolism




NOTE Refer to individual specialty
sections for application
-
specific
compli
cations and risks. Also see Section 1,
General Warnings and
Caution.




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Section 5: Maintenance


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4.5
Contraindications for Laser Surgery


The Cyber
TM

Laser System should only be used in conditions where its use is
appro
priate and of
proven efficacy. Clinical applications should be performed
by a qualified surgeon.


The use of the laser is contraindicated for patients:




Whose general medical condition contraindicates surgical
intervention;



Where appropriate anaesthesia is contraindicat
ed by patient history;



Where tissue (especially tumours) is calcified;



For haemostasis of vessels over approximately two millimetres in
diam
eter; and



Where laser therapy is not considered the treatment of choice.


4.6
Clinical Specialties


This section pr
ovides information on the use of Quanta System Cyber
TM

Laser System in clinical specialties. Information is provided by specialty and
in
cludes procedural recommendations along with specific indications and
contraindications. The information provided in t
his section is not intended to
be all
-
inclusive and is not intended to replace surgeon training or experience.
Regulations may differ country by country and this information is provided for
example only.


Applications:


General Surgery


Gynaecology


Head &

Neck / Otorhinolaryngology (ENT)


Neurosurgery / Neuroendoscopy


Urology







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Section 5: Maintenance


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September 2008

General Surgery


Indications:


For Endoscopic/Laparoscopic procedures




When performing laparoscopic general surgery, it is vital for the
surgeon to appreciate that the view
provided to the surgeon is
monocular (not binocular) and that depth perception is decreased.
Practice on the part of the surgeon to get the feel of operating through
a monocular scope is strongly recommended prior to clinical use.




When the body cavity is
insufflated during laser surgery, the surgeon
and the anaesthesiologist must appreciate the risk of air embolism,
should a blood vessel be opened. Most surgeons prefer CO2 as the
distending gas of choice, as it is readily absorbed and does not lead to
embo
lism. The anaesthesiologist should monitor the patient for any
unusually high CO2 absorption and adjust procedures as necessary.




It will be necessary to change surgical approach or technique to
accommodate delivery of laser energy through an endoscope or
laparoscope.




All recommended practices for safe laparoscopy should be followed per
the manufacturer of the laparoscopic equipment.



Specific Complications and Risks:




Refer to Surgical Complications and Risks for general information.




Thermal damage at s
ite of incision.



For Endoscopic/Laparoscopic procedures




None known specific to General Surgery other than those associated
with laparoscopy procedures in general (e.g., over
-
distension,
subcutane
ous emphysema).




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Section 5: Maintenance


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September 2008


Applications General Surgery


Vaporizing, coagulating, incising, excising, debulking, and ablating of soft
tissue in endoscopic (i.e., laparoscopic) or open procedures.


Suggested Power Parameters:


Intra Abdominal Tumour Surgery.




Power 5 to 10 watts



Mode Continuous (CW)



Technique Ne
ar Contact
-

Contact



Delivery Device 0.4mm or 0.6mm bare fibre


Cancer Nodule Removal.




Power 5 to 10 watts



Mode Continuous (CW) or Pulsed



Technique Near Contact
-

Contact



Delivery Device 0.4mm or 0.6mm bare fibre


Anal Surgery.





Power 5 to 10 watts



Mode Continuous (CW)



Technique Near Contact
-