Sirona sirolaser blue User manual

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No part of this publication may be reproduced, transmitted, stored or
translated into any language, in any form or through any electronic, magnetic,
optical, chemical, manual, physical device or other means, without the prior
written consent from Sirona Dental Systems GmbH, Fabrikstrasse 31,
64625 Bensheim, Germany.
Sirona Dental Systems GmbH reserves the right to correct or modify the
present document without prior notice.
SIROLaser is manufactured in compliance with the provisions of
Council Directive 93/42/EEC concerning medical devices (MDD).
Its compliance is based on the following standards: IEC 60601-1: 1998,
IEC 60601-1/A2: 1998 and IEC 60601-2-22: 1997.
0123

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Index
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Index
1Warning and safety information..................................... 6
1.1 Highlighting of warning and safety information ............................ 6
1.2 Intended use ................................................................................ 6
1.3 Instructions on use of the laser protective goggles...................... 7
1.4 Wireless phone interference ........................................................ 7
1.5 Disposal ....................................................................................... 8
2Glossary, symbols and abbreviations........................... 9
2.1 Symbols on the SIROLaser ......................................................... 9
2.2 Glossary....................................................................................... 10
2.3 Abbreviations............................................................................... 11
3Introduction...................................................................... 12
3.1 Classification................................................................................ 12
3.2 Safety precautions ....................................................................... 12
3.3 Transport and storage ................................................................. 14
3.3.1 Transport and storage ................................................................ 14
3.3.2 Operating conditions ................................................................... 14
3.4 Precautions.................................................................................. 15
4Installation........................................................................ 17
4.1 Packaging contents ..................................................................... 17
4.2 Spare parts .................................................................................. 18
4.2.1 Accessories ................................................................................ 18
4.3 Labels .......................................................................................... 18
4.4 Interlock ....................................................................................... 19
4.4.1 Explanation ................................................................................. 19
4.4.2 Installation of an interlock with door switch ................................. 19
4.4.3 Installation of an interlock jumper (without door switch) ............. 20
4.5 Connection of the foot switch....................................................... 20
4.6 Connection of the finger switch.................................................... 21
4.7 Connecting the optical fiber ......................................................... 22
4.7.1 Field of application ...................................................................... 22
4.7.2 Initial use of an optical fiber ........................................................ 22
4.7.3 Preparation for clinical use ......................................................... 24
4.7.4 Adjusting the sheath ................................................................... 27
4.8 Power supply connection............................................................. 27

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Index
5Operating Instructions.................................................... 28
5.1 Warning and error messages ...................................................... 28
5.2 Switching the laser unit on and off............................................... 30
5.3 Key panel..................................................................................... 30
5.4 Electronic access key .................................................................. 30
5.5 Setting up the software interface language ................................. 31
5.6 Main menu ................................................................................... 31
5.7 “SURGERY”,
“PERIODONTICS” and “ENDODONTICS” submenus ................ 32
5.8 “MANUAL SETTING AREA” submenu ........................................ 34
5.9 “SETUP AREA” submenu............................................................ 36
6Indications, contraindications and medical precautions38
6.1 Indications.................................................................................... 38
6.2 List of indications ......................................................................... 38
6.2.1 Examples of treatment risks ....................................................... 38
6.3 Contraindications ......................................................................... 39
6.4 Precautions.................................................................................. 39
7Cleaning and sterilization............................................... 40
7.1 Cleaning....................................................................................... 40
7.2 Disinfection .................................................................................. 41
7.3 Sterilization .................................................................................. 41
7.4 Cleaning of the laser unit and finger switch ................................. 42
8Maintenance and service................................................ 43
8.1 Calibration-Check ........................................................................ 43
8.1.1 Calibration-Check without use of an external power meter ........ 43
8.1.2 Calibration-Check with use of an external power meter ............. 44
8.1.3 Error message and incorrect parameter values .......................... 45
8.2 Safety checks .............................................................................. 46
8.3 Maintenance ................................................................................ 46
8.4 Basic troubleshooting .................................................................. 46
8.5 Technical support, repair and testing........................................... 47
9Technical data.................................................................. 48
10 Manufacturer’s declaration regarding electromagnetic
compatibility .................................................................... 49
10.1 Definitions .................................................................................... 49
10.1.1 Emission (electromagnetic) ........................................................ 49
10.1.2 Interference immunity ................................................................. 49
10.1.3 Immunity level ............................................................................. 49
11 Appendix .......................................................................... 53
11.1 Appendix A – Approvals .............................................................. 53
11.2 Appendix B – Label positions ...................................................... 53

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List of Figures
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List of Figures
Figure 1: “LASER STOP” button ................................................................ 13
Figure 2: Plugging the Y-connector into the laser unit ............................... 19
Figure 3: Plugging the interlock connector into the Y-connector ............... 19
Figure 4: Connection of the interlock jumper to the interlock socket ......... 20
Figure 5: Foot switch .................................................................................. 20
Figure 6: Connection of the foot switch ...................................................... 20
Figure 7: Distal part of the handpiece ........................................................ 21
Figure 8: Distal part with finger switch ....................................................... 21
Figure 9: Finger switch mounted on handpiece ......................................... 21
Figure 10: Optical fiber and guiding rings .................................................... 21
Figure 11: Connection of the finger switch ................................................... 22
Figure 12: Take-up device ........................................................................... 23
Figure 13: Connector ................................................................................... 23
Figure 14: Optical fiber with protection caps ................................................ 23
Figure 15: Optical fiber with magnet ............................................................ 23
Figure 16: Connecting the optical fiber ........................................................ 24
Figure 17: Protection cap on the laser unit. ................................................. 24
Figure 18: Inserting the optical fiber into the handpiece .............................. 26
Figure 19: Fitting the tip ............................................................................... 26
Figure 20: Adjusting the length of the optical fiber ....................................... 26
Figure 21: Sheath of the optical fiber is too long .......................................... 27
Figure 22: Power supply connection ............................................................ 27
Figure 23: Key panel .................................................................................... 30
Figure 24: Example of a treatment submenu ............................................... 33
Figure 25: “MANUAL SETTING AREA” submenu ....................................... 35
Figure 26: Label positions, top view ............................................................. 53
Figure 27: Label position, rear view ............................................................. 53
Figure 28: Label positions, bottom view ....................................................... 54

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1 Warning and safety information
1Warning and safety information
1.1 Highlighting of warning and safety
information
To prevent any personal injury or material damage, please observe the warn-
ing and safety information provided in the present operating instructions.
All such information is highlighted as follows:
For additional information.
If there is any risk of damage to the laser unit.
If there is any hazard to the life or health of persons.
¾This symbol indicates that you have to take action.
ªThis symbol indicates that a certain result will occur.
1.2 Intended use
NOTICE
i
The user should read and be thoroughly familiar with this manual before oper-
ating the laser. The equipment should be routinely inspected and maintained
in accordance with the instructions given in the maintenance section of this
manual. Accidental irradiation to other than the target tissue may result in laser
burn. Surrounding the target area with moist drapes or saline-soaked gauze
pads and keeping them moist will greatly reduce this hazards. Be sure the
draping is appropriate for laser surgery. It is recommended that a smoke evac-
uator or in-line filter be used to capture the plume whenever possible. The
plum should be regarded as a source of active biological material by the oper-
ating room personnel; it may contain viable tissue particulates.
NOTICE
i
Nominal Ocular Hazards Distance (NOHD) is 1.5 m from the distal end of the
fibre.
NOTICE
i
For the installation and use of the SIROLaser, Sirona Dental Systems GmbH
requires :
• compliance with IEC 60825-1 and its amendments
•compliance with any additional national laws and ordinances.
NOTICE
i
CAUTION
WARNING

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1 Warning and safety information
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NOTICE
i
SIROLaser is intended for surgery and coagulation of oral soft tissue as well.
This laser unit must only be used by trained personnel in compliance with the
applicable occupational safety regulations and accident prevention measures
as well as the present operating instructions.
NOTICE
i
The user is obliged to use only faultless materials, to observe the correct ap-
plication as well as to protect himself or herself, the patient and other persons
against hazards.
WARNING
This laser unit is not intended for operation in areas subject to explosion haz-
ards or in the vicinity of flammable materials or substances.
WARNING
Public legal provisions may include special safety regulations for the protec-
tion of persons against laser radiation. These regulations must be complied
with.
WARNING
Using controls or settings or performing procedures other than those specified
in this manual may result in hazardous radiation exposure.
1.3 Instructions on use of the laser protective
goggles
Before using the laser protective goggles, please read and observe the
instructions for use provided by the manufacturer and attached to the goggles
in the case.
Before using the laser protective goggles, please make sure:
zthat the laser protective goggles are not damaged,
zthat the laser protective goggles conform to standard EN 207 with pro-
tection level L5,
zand that the laser protective goggles are suitable for the correct wave-
length (labeled on the goggles).
These instructions apply particularly when using goggles supplied from an
outside source that are not included in the scope of delivery of the SIROLaser.
1.4 Wireless phone interference
CAUTION
To ensure the operational safety of medical electrical equipment, the use of
mobile wireless phones in practice or hospital environments must be prohibit-
ed.

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1 Warning and safety information
1.5 Disposal
If you plan to discontinue the use of your SIROLaser and intend to dispose of
the unit, make sure to observe the applicable legal provisions. Please contact
your local dental distributor or authorized service center for the disposal of the
SIROLaser.

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2 Glossary, symbols and abbreviations
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2Glossary, symbols and
abbreviations
2.1 Symbols on the SIROLaser
CE mark in accordance with Council Directive 93/42/EEC, stating the
manufacturer’s Notified Body
Date of manufacture (January 2005)
Best-before date: Do not use after January 2007
Batch number (consecutive number/month/year)
Type B applied part according to IEC 60601-1
Please refer to manual first
Refers to directive 2002/96/EC and EN 50419
Do not dispose with domestic waste
Socket for DC input from Sinpro MPU50–105 switching power supply
Socket for optical fiber
Socket for Y-connector
Laser radiation warning
Specification of laser output power and wavelength of IR and aiming beam
(see also chapter "Technical data")
States the compliance of the SIROLaser with IEC 60825-1, edition 1.2
Warns of potential laser radiation hazards when opening the laser unit
01-2005
01-200
7
0123 / 12 / 05
LOT
DC IN INTERLOCK/
SWITCH
Optical fiber

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2 Glossary, symbols and abbreviations
2.2 Glossary
Warns of class 4 laser radiation hazards when using the laser unit.
“LASER STOP” button: Press this button in case of an emergency.
CU
NU
SA
Operate the laser unit exclusively with the Sinpro MPU50-105 power sup-
ply.1
The disassembled handpiece and the tips must be sterilized only in auto-
claves with saturated water vapor at 135 °C (275 °F), 3 min. holding time
(2.13 bar; 30.89 psi overpressure)
1. Software extention (CU, NU, SA)
Laser
STOP
CONTINUOUS EMISSION Continuous laser emission
PULSED EMISSION Pulsed laser emission (chopped mode)
FREQUENCY Number of laser pulses per second
HERTZ Measuring unit for frequency
INTERLOCK Safety device that stops laser radiation when the door of the treatment room
is opened
JOULE Unit of measure for emitted energy
WATT Unit of measure for laser power
STOP End of treatment or treatment break
TIME Treatment time setting mode

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2 Glossary, symbols and abbreviations
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2.3 Abbreviations
cm2Square centimeter
Hz Hertz
s Seconds
WWatt
mW Milliwatt (one thousandth of a Watt)
JJoule
nm Nanometer
VVolt
IR Infrared diode
NOHD Nominal Ocular Hazard Distance according to IEC 60825-1: 1993 +
A1:1997 + A2:2001

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3 Introduction
3Introduction
3.1 Classification
According to the applicable standards, the SIROLaser is classified as follows:
zClass I Type B according to EN IEC 60601-1:1990 + A1:1993 + A2:1 1995
zClass IIb according to Council Directive 93/42/EEC
zClass IV laser product according to IEC 60825-1: 1993 + A1:1997 +
A2:2001
zDegree of protection according to EN IEC 60601-1:1990 + A1:1993 +
A2:1 1995 medical unit: IP 20 (enclosure not water-proof); foot switch:
IPX5
CAUTION
The laser unit itself cannot be sterilized. However, some accessories must be
sterilized when used for contact applications.
WARNING
The laser unit is not suitable for use in the presence of anesthetics that are
flammable when in contact with air, oxygen or nitrogen monoxide.
3.2 Safety precautions
SIROLaser is manufactured in compliance with the provisions of Council
Directive 93/42/EEC concerning medical devices (MDD).
Always observe the following precautions:
WARNING
Always cover the optical fiber connection with the special protection caps pro-
vided, if the fiber is disconnected from the laser
CAUTION
Use of the operating controls or adjustment options in a way other than de-
scribed herein can lead to dangerous radiation.
CAUTION
Never insert your fingers or any objects into the exit ports. This is important in
order to avoid damage to the optical system.
CAUTION
In case of an emergency, switch the laser unit OFF immediately. To do this,
press the "LASER STOP" button on the control panel.

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3 Introduction
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Figure 1: “LASER STOP” button
Observe all labels on the laser unit.
WARNING
Operation of this laser unit by unauthorized persons must be prohibited in or-
der to prevent incorrect or improper use.
WARNING
Never direct the laser beam or the aiming beam toward the eyes or the thyroid
gland of a person. All persons present in the room (patient, dentist and assis-
tant) must always wear the laser protective goggles delivered along with the
laser unit.
WARNING
Never use optical instruments such as microscopes, eye loupes or magnifiers
together with the original protective goggles. Adequate eye protection is no
longer ensured in this case.
CAUTION
Always cover the optical fiber connection with the special protection caps pro-
vided.
WARNING
The unit is not suitable for use in the presence of anesthetics that are flamma-
ble when in contact with air, oxygen or protoxide.
WARNING
Oxygen-saturated materials such as cotton wool can catch fire due to the high
temperature that the unit reaches during operation. Label removers and flam-
mable solutions used for cleaning and disinfecting the laser unit should be al-
lowed to evaporate before using the device. Be aware of the fire risk caused by
flamable gases.

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3 Introduction
WARNING
Never direct the laser beam toward paper, plastics or dark surfaces. They may
catch fire or be damaged due to the high temperatures produced by the laser
beam.
WARNING
Laser plume must contain tissue particles. There is a risk of contamination! Al-
ways wear a face mask.
Observe the following in addition:
NOTICE
i
The unit must only be operated in rooms that comply with the requirements of
Council Directive 89/336/EEC. The applicable national or local legal regula-
tions must be complied with.
CAUTION
Avoid interference of the laser emission with optical sensors of devices oper-
ated in the vicinity of the SIROLaser.
3.3 Transport and storage
3.3.1 Transport and storage
The SIROLaser is supplied in a case that ensures proper and easy transport.
However, please observe the following:
CAUTION
Do not leave the laser unit in a car parked in the sun. The temperature inside
the car can reach levels that may damage its components.
To ensure appropriate storage, the laser unit must always be kept in the case
supplied.
When stored in the case provided by Sirona Dental Systems, the SIROLaser
withstands the following environmental conditions:
zTemperatures from -40° C (-40° F) to +70° C (+158° F)
zRelative humidity from 10 % to 90 %
zAtmospheric pressure from 800 hPa to 1060 hPa
When stored in its original transport packing, the SIROLaser withstands the
following environmental conditions:
zTemperatures from -40° C (-40° F) to +70 °C (+158° F)
zRelative humidity from 10 % to 95 %
zAtmospheric pressure from 800 hPa to 1060 hPa
3.3.2 Operating conditions
The SIROLaser may be operated in the following environmental conditions:
zTemperatures from +10° C (+50° F) to +33° C (+92° F)
zRelative humidity from 10 % to 95 %
zAtmospheric pressure from 800 hPa to 1060 hPa

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3 Introduction
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CAUTION
Following transport and storage, allow the laser unit to acclimate for about
1 hour in order to reduce the risk of malfunction due to condensation.
3.4 Precautions
Using controls or settings or performing functional tests other than those
specified in this manual may result in hazardous radiation exposure.
Sirona Dental Systems GmbH cannot be held liable for any damage caused
by improper use or non-compliance with the instructions and information pro-
vided in this manual.
Please remember the following:
CAUTION
SIROLaser may only be operated by trained and qualified personnel.
CAUTION
Laser equipment not in use must be protected against unauthorized access.
This can be achieved for example by switching off the laser unit after use,
so that the electronic access key must be entered prior to further operation.
Set up the SIROLaser laser unit properly and completely before putting it into
operation (see chapter 4).
Make sure that the electrical system is equipped with the required devices for
protection against direct and indirect contact (thermomagnetic switches,
residual current circuit-breaker) and has been set up by a qualified electrician
in compliance with the applicable standards.
National regulations concerning electrical installations shall be obeyed.
Verify that the line voltage corresponds to the voltage indicated on the rating
plate of the switching power supply or in the technical specifications.
WARNING
Do not use the laser unit if a visual inspection reveals damage.
WARNING
Do not use the laser unit in the presence of flammable materials.
If you accidentally spill liquid on the unit, immediately stop treatment, discon-
nect the power supply cable and contact your local dental distributor or autho-
rized service center for assistance.
CAUTION
Do not attempt to disassemble the laser unit in any case. This is limited exclu-
sively to trained and authorized personnel.
Do not place the laser unit near heat sources.
Do not cover the convection openings for air cooling on the sides of the unit.

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3 Introduction
CAUTION
Never allow dust or dirt to enter the optical fiber socket and the optical system.
Otherwise, the unit may be permanently damaged
CAUTION
Always protect the optical fiber socket as well as the optical fiber itself with the
special protection caps. Do not allow dust, dirt or other foreign bodies to enter
the optical fiber socket. Always make sure that the optical system is clean be-
fore connecting the optical fiber.
WARNING
Prior to each treatment, the handpieces must be sterilized and the optical fi-
bers must be wipe disinfected.
CAUTION
Switch the laser off immediately if the optical fiber is broken. Otherwise the tips
may become hot.
NOTICE
i
The tips must be checked for sure seating prior to each use.

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4 Installation
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4Installation
If national or local legal regulations require that the installation of the
SIROLaser be performed by specialized personnel, these regulations must
be complied with.
WARNING
The handpieces and the tips are supplied non-sterile, you must clean, disin-
fect and sterilize these products prior to first use and prior to each subsequent
use.
4.1 Packaging contents
The following components are included in the scope of supply of the
SIROLaser:
Qty Designation
1SIROLaser unit
1Transport case
Power cord 1
1. Dependent on the SIROLaser version
1Switching power supply
1Interlock connector
1Y-connector
1Interlock jumper
2Laser protective goggles (for operator and assistant)
1Laser protective goggles (for patients)
1Take-up reel incl. 200µm optic fiber L, 3 m long ( 9' 10")
1Take-up reel incl. 320µm optic fiber L, 3 m long ( 9' 10")
2Handpieces
1Finger switch
1Foot switch
1Ceramic-coated scissors for optical fiber trimming
1Set of tips (30°, 45°, 60°, sterilizable)
1User Manual
1Set of warning labels (country-specific)
2Optical fiber connectors with magnet

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4 Installation
4.2 Spare parts
4.2.1 Accessories
Upon request, the SIROLaser can be delivered with the following accesso-
ries:
4.3 Labels
Attach the appropriate country-specific labels to your laser unit. For more
information regarding the labels and label positions, see Appendix B – Label
positions.
¾Attach country-specific label 1 on the opposite side of English label 1.
¾Attach country-specific label 2 below English label 2.
Qty Designation Order Number
1Laser protective goggles (for operator and
assistant)
60 47 737
1Laser protective goggles (for patient) 60 47 745
1Switching power supply 60 47 778
1Power cord EU 60 56 613
1Power cord AUS 61 29 741
1Power cord DK 61 30 012
1Interlock connector 60 56 472
1Y-connector 60 56 506
1Interlock jumper 61 47 024
1Take-up reel incl. 200µm optic fiber, 3 m long
( 9' 10")
60 47 786
1Take-up reel incl. 320µm optic fiber, 3 m long
( 9' 10")
60 53 578
1Handpiece 60 47 695
1Finger switch 60 47 760
1foot switch 60 47 752
1Ceramic-coated scissors for optical fiber
trimming
60 56 480
1Set of tips (30°, 45°, 60°, sterilizable) 60 47 794
1User Manual 60 50 092
1Set of warning labels (country-specific) 60 56 498
1Optical fiber connector with magnet 60 56 647
50 SIROLaser patient information brochures
German
English
French
Spanish
Italian
60 85 695
60 85 711
60 85 737
60 85 703
60 85 729
Laser protective goggles for wearers of
glasses (nontransparent)
60 56 514
Take-up reel incl. 400 µm optic fiber
3 m long
60 53 586

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4 Installation
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4.4 Interlock
4.4.1 Explanation
The interlock is a safety device that stops laser radiation whenever the door
of the treatment room is opened. It is essential to connect the interlock device
to a switch that is located near the door of the treatment room in order to
ensure automatic interruption of the laser radiation.
NOTICE
i
The installation must be performed by a qualified electrician who is also re-
sponsible for the installation and maintenance of the electrical system to which
the SIROLaser is connected.
Please request the technical data sheet with wiring diagram for installation of
the interlock device.
NOTICE
i
If national or local legal regulations require additional or different measures to
be taken for the safety of dentist, assistant or patient, these regulations must
be complied with.
4.4.2 Installation of an interlock with door switch
¾Plug the Y-connector into the „INTERLOCK/SWITCH“ socket.
¾As soon as a cable is connected to the interlock connector, connect the
interlock connector to the Y connector.
Figure 2: Plugging the Y-connector
into the laser unit
Figure 3: Plugging the
interlock connector into
the Y-connector

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4 Installation
4.4.3 Installation of an interlock jumper (without door
switch)
If you have protected the treatment room via suitable measures, however,
have not installed the interlock with the door switch, you can replace the Y-
connector with the space-saving interlock jumper.
¾Plug the interlock jumper into the interlock socket.
4.5 Connection of the foot switch
¾Plug the foot switch cable into the socket of the Y connector or into the
interlock jumper.
NOTICE
i
The degree of protection of the foot switch is IPX5. Therefore, this foot switch
may not be used in hospital operating rooms. Please contact Sirona Dental
Systems LLC or your local dental distributor if you want to use the laser unit to-
gether with the foot switch in a hospital OR operation theatre.
Figure 4: Connection of the interlock
jumper to the interlock
socket
Figure 5: Foot switch
Figure 6: Connection of the foot switch