Dentsply Sirona SiroLaser Blue User manual

New as of: 10.2018
SiroLaser Blue
Operating Instructions (valid for USA)
English
Rx only. Federal law restricts this device to sale by or
under the order of a dentist, physician, or licensed
healthcare practitioner.

Table of contents Dentsply Sirona
Operating Instructions SiroLaser Blue
266 56 842 D3648
D3648.201.03.02.0210.2018
Table of contents
1General information ................................................................................................ 5
1.1 Dear Customer............................................................................................. 5
1.2 Contact data................................................................................................. 5
1.3 General information on the Operating Instructions ...................................... 6
1.4 Intended use ................................................................................................ 6
1.5 Formats and symbols used.......................................................................... 7
2Safety information................................................................................................... 8
2.1 Identification of danger levels ...................................................................... 8
2.2 Standards and regulations ........................................................................... 8
2.3 Operating personnel .................................................................................... 9
2.4 Physical working principle............................................................................ 9
2.5 Functional check .......................................................................................... 9
2.6 Laser radiation hazards ............................................................................... 10
2.7 Nominal ocular hazard distance................................................................... 10
2.8 Laser protective goggles.............................................................................. 11
2.9 EasyTips and MultiTips................................................................................ 11
2.10 Contamination.............................................................................................. 12
2.11 Installation.................................................................................................... 12
2.12 Modifications ................................................................................................ 13
2.13 Radiotelephones .......................................................................................... 13
2.14 Transferring data with USB stick.................................................................. 13
3System description ................................................................................................. 14
3.1 System overview.......................................................................................... 14
3.2 Laser operation modes ................................................................................ 16
3.3 Symbols and abbreviations.......................................................................... 17
3.3.1 Symbols ......................................................................................... 17
3.3.2 Abbreviations ................................................................................. 20
3.4 Technical Data ............................................................................................. 21
4Installation............................................................................................................... 25
4.1 Scope of supply ........................................................................................... 25
4.2 Spare parts .................................................................................................. 26
4.3 Labels .......................................................................................................... 26

Dentsply Sirona
Operating Instructions SiroLaser Blue
Table of contents
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4.4 Initial start-up – procedure for proper assembly........................................... 27
4.4.1 Install power supply ....................................................................... 27
4.4.2 Handpiece and assembly of single-use fiber tips and therapy
rods................................................................................................ 28
4.4.2.1 Handpiece .................................................................... 28
4.4.2.2 Assembly of sterile single-use optical fiber tips............ 28
4.4.2.3 Assembly of therapy light guide.................................... 33
4.4.3 Install wireless foot control – optional ............................................ 34
4.4.4 Install remote interlock – optional................................................... 35
5Operation ................................................................................................................ 36
5.1 Start the device for the first time .................................................................. 36
5.2 Switch on/off power...................................................................................... 38
5.3 Enter pin code.............................................................................................. 40
5.4 Sleep Mode.................................................................................................. 40
5.5 Main home screen ....................................................................................... 40
5.5.1 Self Test......................................................................................... 41
5.5.2 Favorites ........................................................................................ 43
5.5.2.1 Change a favorite ......................................................... 43
5.5.3 Submenu: All applications.............................................................. 44
5.5.3.1 My Applications ............................................................ 48
5.5.3.2 Settings......................................................................... 48
5.5.4 Error messages, warnings and instructions................................... 55
5.5.4.1 Error messages and warnings...................................... 55
5.5.4.2 Instructions ................................................................... 57
5.5.4.3 Information messages .................................................. 58
6Indications, contraindications and medical precautions.......................................... 59
6.1 Indications.................................................................................................... 59
6.2 List of preset indications .............................................................................. 60
6.3 Additional indications ................................................................................... 61
6.4 Creating a further 445nm and a 660 nm program........................................ 61
6.5 Examples of treatment risk .......................................................................... 61
6.6 Contraindications ......................................................................................... 62
7Cleaning, disinfection and sterilization.................................................................... 63
7.1 Cleaning....................................................................................................... 63
7.2 Disinfection .................................................................................................. 64
7.3 Sterilization .................................................................................................. 64
7.4 Cleaning the control unit .............................................................................. 65

Table of contents Dentsply Sirona
Operating Instructions SiroLaser Blue
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8Maintenance and service........................................................................................ 66
8.1 Safety checks............................................................................................... 66
8.2 Cleaning the handpiece optics..................................................................... 66
8.3 Maintenance ................................................................................................ 67
8.4 Troubleshooting of simple defects ............................................................... 68
8.5 Technical support, repair and testing........................................................... 69
8.6 Replacing the rechargeable battery of the control unit ................................ 70
8.7 Replacing the batteries of the wireless foot control ..................................... 71
8.8 Replacement of parts subject to wear and tear ........................................... 72
9Electromagnetic compatibility ................................................................................. 73
9.1 Electromagnetic emission ............................................................................ 73
9.2 Interference immunity .................................................................................. 74
9.3 Working clearances ..................................................................................... 76
10 Disposal .................................................................................................................. 77
10.1 Batteries....................................................................................................... 78
10.2 Accessories.................................................................................................. 78
11 Appendix................................................................................................................. 79
11.1 Appendix A – Certification............................................................................ 79
11.2 Appendix B -Label positions ........................................................................ 79
11.2.1 Control unit..................................................................................... 79
11.2.2 Wireless foot control – optional...................................................... 80
11.3 Appendix C – Safety circuit (interlock) ......................................................... 81

Dentsply Sirona
Operating Instructions SiroLaser Blue
1 General information
1.1 Dear Customer
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1General information
1.1 Dear Customer
We are pleased that you have equipped your practice with the
SiroLaser Advance Plus.
The SiroLaser Blue features diode laser technology. This device is
characterized by a wide range of applications. A number of output
settings are preset in the unit. Manual setting changes can be made
and custom presets may also be introduced. The laser can alternatively
be activated by the finger switch on the handpiece or by the optional
wireless foot switch.
These Operating Instructions are designed to assist you prior to initial
use and whenever you require information later on. It is important to
observe all safety information to prevent personal injury and material
damage. Please perform maintenance and cleaning based on the
corresponding instructions.
We wish you much success and pleasure with the SiroLaser Blue.
Your SiroLaser Blue Team
1.2 Contact data
Customer service center For technical questions, use the contact form on the internet at the
following address:
http://srvcontact.sirona.com
Contact in the USA Dentsply Sirona USA
500 W College Avenue
York, PA 17401
USA
[email protected]
Manufacturer's address Sirona Dental Systems GmbH
Fabrikstrasse 31
64625 Bensheim
Germany
Tel.: +49(0) 6251/16-0
Fax: +49(0) 6251/16-2591
e-Mail: [email protected]
www.dentsplysirona.com

1 General information
1.3 General information on the Operating Instructions
Dentsply Sirona
Operating Instructions SiroLaser Blue
666 56 842 D3648
D3648.201.03.02.0210.2018
1.3 General information on the Operating
Instructions
Observe the Operating Instructions Please familiarize yourself with the SiroLaser Blue by reading through
these Operating Instructions before putting it into operation. It is
essential that you comply with the specified warning and safety
information.
WARNING
Do not use the device in the case when it shows a behaviour different
to the operating instructions.
Keep documents safe Retain these Operating Instructions in case you or another user
require(s) information at a later point in time.
Make sure that the Operating Instructions and all other technical
documents remain with the unit. The technical documents are a
component of the product.
Help If you reach an impasse despite having thoroughly studied the
Operating Instructions, please contact your dental dealer.
1.4 Intended use
The SiroLaser Blue is developed as a table top laser device intended for:
● (970nm and 445nm): intra- and extra-oral surgery including incision,
excision, hemostasis, coagulation and vaporization of soft tissue
including marginal and inter-dental and epithelial lining of free gingiva
and is indicated for: frenectomy; frenotomy; biopsy; operculectomy;
implant recovery; gingivectomy; gingivoplasty; gingival troughing; crown
lengthening; hemostasis of donor site; removal of granulation tissue;
laser assisted flap surgery; debridement of diseased epithelial lining;
incisions and draining of abscesses; tissue retraction for impressions;
papillectomy; vestibuloplasty; excision of lesions; exposure of
unerupted/partially erupted teeth; removal of hyperplastic tissues;
treatment of aphthous ulcers; leukoplakia; laser removal of diseased,
infected, inflamed and necrosed soft tissue within the periodontal
pocket; sulcular debridement (removal of diseased, infected, inflamed
and necrosed soft tissue in the periodontal pocket to improve clinical
indices including gingival index, gingival bleeding index, probe depth,
attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to
root canal therapy; fibroma removal; gingival incision and excision;
treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft
tissue curettage; reduction of gingival hypertrophy.
● Whitening (970nm and 445nm): For light activation for bleaching
materials for teeth whitening and for laser-assisted whitening/
bleaching of teeth.
● Low Level Laser Therapy (660nm and 970nm): To emit energy in
the red and infrared spectrum to provide topical heating for the
purpose of elevating tissue temperature for the temporary relief of
minor muscle and joint pain and stiffness, minor arthritis pain, or
muscle spasm, and for the temporary increase in local blood
circulation and/or temporary relaxation of muscles.
The use of the SiroLaser Blue is not appropriate in an operating theater.

Dentsply Sirona
Operating Instructions SiroLaser Blue
1 General information
1.5 Formats and symbols used
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1.5 Formats and symbols used
The symbols and character formats used in the present manual have
the following definitions:
Instructions for action üPrerequisite
1. First action step
2. Second action step
or
➢ Alternative action
Result, reaction of SiroLaser
Blue
Prompts you to do something.
References See "General information [→5]" Identifies a reference to another
text passage.
[→7] Indicates the page being referred
to.
Lists ● List Designates a list.
Designations 'Designation' Denotes key and button

2 Safety information
2.1 Identification of danger levels
Dentsply Sirona
Operating Instructions SiroLaser Blue
866 56 842 D3648
D3648.201.03.02.0210.2018
2Safety information
2.1 Identification of danger levels
To prevent personal injury and material damage, please observe the
warning and safety information provided in this document. Such
information is highlighted as follows:
WARNING
Warning of bodily injury
For a possible danger that could result in light to serious bodily injury
or death.
CAUTION
Caution against damage
For a possibly harmful situation which could lead to damage of the
product or an object in its environment.
NOTE
Information to make work easier
For application information and other useful information.
2.2 Standards and regulations
For the installation and operation of the SiroLaser Blue, Dentsply Sirona
requires:
● compliance with IEC60825-1 and its amendments,
● observance of any supplemental national laws and regulations.
Public legal requirements may include special safety regulations
concerning protection against laser radiation. These requirements must
be fulfilled.
The SiroLaser Blue is manufactured in compliance with the provisions
of Council Directive 93/42/EEC (MDD) concerning medical devices.
National directives regarding electrical installations must be observed.

Dentsply Sirona
Operating Instructions SiroLaser Blue
2 Safety information
2.3 Operating personnel
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2.3 Operating personnel
Qualification The SiroLaser Blue may be operated only by trained and qualified
personnel (dentists, dental surgeons). The applicable occupational
safety regulations and accident prevention measures and the current
operating instructions must be complied with.
Know-how Know-how and expertise about laser therapy as well as the skilled use
of the laser and the applied indications are required. Please refer to
applicable US-specific requirements.
Experience Dentsply Sirona recommends to gain practical experience in laser
dentistry before first use of the SiroLaser Blue by attending an
appropriate training. Amongst others Dentsply Sirona offers trainings.
Please see the Dentsply Sirona homepage (www.dentsplysirona.com).
Obligation of the user Users are obliged to use only faultless materials, to ensure correct
application and to protect themselves, the patient and other persons
against hazards.
All persons present during use of the SiroLaser Blue must wear
protective eyewear. To protect users, the patient, and other persons
against hazards, ensure correct application of protective eyewear.
Unauthorized access In order to prevent false or improper use, the SiroLaser Blue must not
be used by unauthorized persons. Therefore the SiroLaser Blue
equipment must be protected against unauthorized access when not in
use. This can be achieved, for example, by switching the SiroLaser Blue
off following use so that the electronic access key (pin code) must be
entered before using it again.
WARNING
The SiroLaser Blue may only be used and maintained by thoroughly
trained personnel.
2.4 Physical working principle
The 445nm, 970nm and 660nm laser radiation of the SiroLaser Blue
is generated via different laser diodes inside the control unit and guided
to the treatment region via quartz fibers. The laser radiation is absorbed
by the tissue and converted to heat used for cutting, coagulation, germ
reduction and desensitization.
2.5 Functional check
Please check the unit for proper functioning every time before putting it
into operation. In case of unusual noises, check both the unit and the
handpiece. If the unit dropped or has fallen to the floor, have it checked
by qualified technical personnel.
To prevent the unit being accidentally pulled from the table, the
handpiece hose should never be under tension. Please always ensure
that approximately 40 cm of the handpiece hose hangs and is not under
tension.

2 Safety information
2.6 Laser radiation hazards
Dentsply Sirona
Operating Instructions SiroLaser Blue
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If there is any doubt about the correct function of the switching power
supply or the correct electric power supply (wall outlet) the unit may only
be used with internal electric power supply (battery).
Do not use the SiroLaser Blue if a visual inspection shows that it has
been damaged in any way.
2.6 Laser radiation hazards
Never direct the laser or aiming beam toward a person's eye! All
persons present in the room e.g. patient, dentist and assistant must
always wear the laser protective goggles.
Observe all labels on the SiroLaser Blue.
Master switch of the practice Note that after switching off the master switch of the practice the
SiroLaser Blue will still remain switched on. It is then energized by the
rechargeable battery.
Emergency stop In case of an emergency press the "Laser Stop" button below the touch
screen on the front side of the SiroLaser Blue control unit.
Settings Failure to use the settings specified in this manual or perform the
actions described here may lead to a dangerous exposure to radiation.
CAUTION
Use of controls or adjustments or performance of procedures other
than those specified herein may result in hazardous radiation
exposure.
Dentsply Sirona cannot be held liable for any damage caused by
improper use or non-compliance with the instructions and information
provided in this manual.
Flammable materials Never direct the laser beam towards any flammable material, e.g. paper
or plastics. They could catch fire due to the high temperatures produced
by the laser beam.
The unit is not suitable for use in the presence of anesthetics that are
flammable when in contact with air, oxygen or nitrogen monoxide.
Oxygen-saturated materials such as cotton wool can catch fire due to
high temperature that the unit reaches during operation. Label removers
and flammable solutions used for cleaning and disinfecting the
SiroLaser Blue should be allowed to evaporate before using the device.
Observe fire hazards caused by flammable gases.
Reducing the risk of burns Unintentional exposure to the laser radiation may lead to burns. This
risk can be reduced by surrounding the target area with moistened
sterile drapes or moistened gauze. These materials must meet the
requirements of laser surgery.
2.7 Nominal ocular hazard distance
The nominal ocular hazard distance (NOHD) from the distal end of the
optical fiber is 1.5 m.