Sirona sirolaser blue,SIROLaser Blue Operating Instruction
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Operating Instructions
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Sirona Dental Systems GmbH Table of contents
Operating Instructions SIROLaser Blue
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Table of contents
1
General information.................................................................................................. 6
1.1 Dear Customer.............................................................................................. 6
1.2 Contact data.................................................................................................. 6
1.3 General information on the Operating Instructions ....................................... 7
1.4 Intended use ................................................................................................. 7
1.5 Formats and symbols used ........................................................................... 8
2
Safety information .................................................................................................... 9
2.1 Identification of danger levels........................................................................ 9
2.2 Standards and regulations ............................................................................ 9
2.3 Operating personnel...................................................................................... 9
2.4 Physical working principle ............................................................................. 10
2.5 Laser radiation hazards................................................................................. 10
2.6 Nominal ocular hazard distance.................................................................... 11
2.7 Laser protective goggles ............................................................................... 11
2.8 EasyTips and MultiTips ................................................................................. 12
2.9 Contamination ............................................................................................... 12
2.10 Installation ..................................................................................................... 13
2.11 Modifications ................................................................................................. 14
2.12 Cellular phones ............................................................................................. 14
2.13 Transfering data with usb stick...................................................................... 14
3
System description ................................................................................................... 15
3.1 System overview ........................................................................................... 15
3.2 Laser operation modes ................................................................................. 17
3.3 Symbols and abbreviations ........................................................................... 18
3.3.1 Symbols ........................................................................................... 18
3.3.2 Abbreviations ................................................................................... 20
3.4 Technical Data .............................................................................................. 21
4
Installation ................................................................................................................ 25
4.1 Scope of supply............................................................................................. 25
4.2 Spare parts.................................................................................................... 26
4.3 Labels............................................................................................................ 26
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Table of contents Sirona Dental Systems GmbH
Operating Instructions SIROLaser Blue
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 guides....................................... 32
4.4.3 Install wireless foot control – optional............................................... 34
4.4.4 Install remote interlock – optional..................................................... 35
5
Operation.................................................................................................................. 36
5.1 Start the device for the first time ................................................................... 36
5.2 Switch on/off power....................................................................................... 38
5.3 Enter pin code ............................................................................................... 39
5.4 Sleep Mode ................................................................................................... 39
5.5 Main home screen......................................................................................... 39
5.5.1 Self Test ........................................................................................... 40
5.5.2 Favorites .......................................................................................... 42
5.5.3 Submenu: All applications................................................................ 42
5.5.3.1 My Applications ................................................................. 46
5.5.3.2 Settings ............................................................................. 46
5.5.4 Error messages, warnings and instructions ..................................... 53
5.5.4.1 Error messages and warnings........................................... 53
5.5.4.2 Instructions ........................................................................ 55
5.5.4.3 Information messages ....................................................... 56
6
Indications, contraindications and medical precautions ........................................... 57
6.1 Indications ..................................................................................................... 57
6.2 List of preset indications................................................................................ 57
6.3 Further non-preset indications ...................................................................... 59
6.4 Examples of treatment risk............................................................................ 60
6.5 Contraindications .......................................................................................... 60
7
Cleaning, disinfection and sterilization ..................................................................... 61
7.1 Cleaning ........................................................................................................ 61
7.2 Disinfection.................................................................................................... 62
7.3 Sterilization.................................................................................................... 62
7.4 Cleaning the control unit ............................................................................... 63
8
Maintenance and service ......................................................................................... 64
8.1 Safety checks................................................................................................ 64
8.2 Maintenance.................................................................................................. 64
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Operating Instructions SIROLaser Blue
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8.3 Troubleshooting of simple defects................................................................ 65
8.4 Technical support, repair and testing ........................................................... 66
8.5 Replacing the rechargeable battery of the control unit................................. 67
8.6 Replacing the batteries of the wireless foot control...................................... 68
8.7 Replacement of parts subject to wear and tear............................................ 69
9
Electromagnetic compatibility.................................................................................. 70
9.1 Electromagnetic emission ............................................................................ 70
9.2 Interference immunity................................................................................... 71
9.3 Working clearances...................................................................................... 73
10
Disposal................................................................................................................... 74
10.1 Batteries ....................................................................................................... 75
10.2 Accessories .................................................................................................. 75
11
Appendix.................................................................................................................. 76
11.1 Appendix A – Certification ............................................................................ 76
11.2 Appendix B -Label positions......................................................................... 76
11.2.1 Control unit ...................................................................................... 76
11.2.2 Wireless foot control – optional ....................................................... 77
11.3 Appendix C – Safety circuit (interlock).......................................................... 78
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1General information Sirona Dental Systems GmbH
1.1Dear Customer Operating Instructions SIROLaser Blue
1
General information
1.1
Dear Customer
We are pleased that you have equipped your practice with the SIROLaser
Blue.
Performance, presets, foot control
You now possess a therapy device that features diode laser technology.
This device is characterized by a wide range of applications. It can be
used as rather pain-free therapy or as an extension to the conventional
treatment. A high number of therapies are already preset. According to
your approach you can change settings or put on also own treatment
programs. The laser can alternatively be activated by the finger switch at
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
Worldwide customer service
Customer service center In the event of technical queries, please use our online contact form at
www.sirona.com. In the navigation bar, go to the menu commands
"CONTACT"
/
"Customer Service Center"
and then click the
"CONTACT
FORM FOR TECHNICAL QUESTIONS"
button.
Manufacturer's address (w orl dw i de )
Manufacturer's address Sirona Dental Systems GmbH
Fabrikstrasse 31
64625 Bensheim
Germany
Trademark
Phone: +49 (0) 6251/16-0
Fax: +49 (0) 6251/16-2591
e-mail: contact@sirona.com
www.sirona.com
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Sirona Dental Systems GmbH 1General information
Operating Instructions SIROLaser Blue 1.3General information on the Operating Instructions
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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 different behaviour
Keep documents safe Always keep the Operating Instructions handy in case you or another
user require(s) information at a later point of time. To this product belong
even more documentations.
In case you sell the unit, make sure that the Operating Instructions and all
other technical documents are attached to it so that its new owner can
familiarize himself with its functioning and the specified warning and
safety information. 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 for:
● Soft-tissue surgery with simultaneous coagulation
● Germ reduction in endodontics
● Germ reduction in periodontology and implantology
● Low level laser therapy for the following: dentine-hypersensitivity and
wound healing
● Treatment of aphthous ulcers and herpes
● Desensitization
All patients coming to a dental office or clinic and needing a treatment that
can be done or supported by the use of a diode laser can be treated with
the SIROLaser Blue. For indications for use refer to chapter "Indications,
contraindications and medical precautions [ → 57]".
The use of the SIROLaser Blue is not appropriate in an operating theater.
WARNING
Do not use the device in the case when it shows a behaviour different to
the operating instructions.
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1.5Formats and symbols used Operating Instructions SIROLaser Blue
1.5
Formats and symbols used
The symbols and character formats used in the present manual have the
following meaning:
Instructions for action
References
Lists
Designations
✔ Prerequisite
1. First action step
2. Second action step
or
➢ Alternative action
Result, reaction of SIROLaser
Blue
Prompts you to do something.
See "General information [ → 6]" Identifies a reference to another
text passage.
[ → 8] Indicates the page being referred
to.
● List Designates a list.
'Designation' Denotes key and button
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Sirona Dental Systems GmbH 2Safety information
Operating Instructions SIROLaser Blue 2.1Identification of danger levels
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2
Safety information
2.1
Identification of danger levels
Lead text
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, Caution, Note
2.2
Standards and regulations
Requirements address, Si rona
For the installation and operation of the SIROLaser Blue, Sirona Dental
Systems GmbH requires:
Requirements SIROLaser Blue
● 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.
2.3
Operating personnel
Qualification/education The SIROLaser Blue may only be operated by educated and qualified
personnel (dentist, assistent, dental hygienist). The applicable
occupational safety regulations and accident prevention measures, the
current operating instructions and national requirements concerning
education 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 country-specific requirements.
Experience, Sirona
Experience Sirona recommends to gain practical experience in laser dentistry before
first use of the SIROLaser Blue by attending an appropriate training.
WARNING
Warning of bodily injury
For an 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.
NOTICE
Information to make work easier
For application information and other useful information.
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2.4Physical working principle Operating Instructions SIROLaser Blue
Amongst others Sirona offers trainings. Please see the Sirona homepage
(www.sirona.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.
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 after usage so that the electronic access key (pin code) must be
entered before using it again.
2.4
Physical working principle
SIROLaser Blue
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
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.
With battery
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.
Improper use, Sirona
Sirona Dental Systems GmbH 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 owing to
the 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.
WARNING
The SIROLaser Blue may only be used and maintained by thoroughly
trained personnel.
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Sirona Dental Systems GmbH 2Safety information
Operating Instructions SIROLaser Blue 2.6Nominal ocular hazard distance
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Reducing the risk of burns If any tissue is unintentionally irradiate, this may lead to burns. This risk
can be reduced by surrounding the target area with moistened sterile
drapes or gauze doused in salt. These covering materials must meet the
requirements of laser surgery.
2.6
Nominal ocular hazard distance
The nominal ocular hazard distance (NOHD) from the distal end of the
optical fiber is 1.5 m.
2.7
Laser protective goggles
Laser protective goggle s SIROLaser Blue
All persons present in the room e.g. patient, dentist, assistent must
always wear the appropriate laser protective goggles delivered along with
the SIROLaser Blue.
Check before use 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. Make sure that the laser protective goggles:
● are not damaged
● conform to standard EN 207 with the following protection levels:
– user goggles: LB5 (445 ± 5 nm / 970 -10/+15 nm)
and LB1 (660 ± 5 nm)
– patient goggles: LB5 (445 ± 5 nm / 970 -10/+15 nm)
and LB3 (660 ± 5 nm)
● are suitable for the correct wavelengths (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 Blue.
Optical instruments Never use optical instruments such as microscopes, eye loupes or
magnifiers together with the original protective goggles. Otherwise
sufficient eye protection can no longer be ensured.
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2.8EasyTips and MultiTips Operating Instructions SIROLaser Blue
2.8
EasyTips and MultiTips
Optical fiber tips and connection socket Make sure that no dust, dirt and foreign particles can enter the optical
fiber socket or the optical system. Never place your finger or any other
objects in the optical connectors. Otherwise the unit may be permanently
damaged.
When disconnecting the EasyTip or MultiTip from the SIROLaser Blue,
always cover the connection socket at the handpiece with the special
protection cap supplied. Make sure that the optical system is clean before
connecting the EasyTip or MultiTip.
The optical fiber must not be twisted inside the tube of the single-use fiber
tip (EasyTip). There is a risk of breakage.
Stop the laser activation of the SIROLaser Blue immediately if the
EasyTip or MultiTip is broken. Otherwise the tips may become hot.
EasyTips and MultTips must be checked for sure seating prior to each
use.
2.9
Contamination
Accessories Danger of (cross) contamination. Pay attention not to hurt or stick yourself
or any other person with the laser fiber tip. This applies also, if the
handpiece is placed in the holder.
Prior to each use, the handpiece sleeve and the optical light guide
(MultiTip) must be sterilized. The single-use fiber tips are delivered sterile
and must be used only once.
Tissue particles By cutting and coagulation of tissue, tissue particles could get into the air.
Always wear a face mask, because a risk of infection exists.
A extractor or a filter should be used. The operating personnel should be
aware that biologically active material could get into the enviroment. It
may contain particles of viable tissue.
WARNING
Single-use fiber tips (EasyTip) must not be sterilized again after usage.
They are disposable products.
WARNING
Single-use fiber tips (EasyTip) must not be sterilized again after usage.
They are disposable products.
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Sirona Dental Systems GmbH 2Safety information
Operating Instructions SIROLaser Blue 2.10Installation
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2.10
Installation
Location The SIROLaser Blue is to be protected against the intrusion of liquids.
The SIROLaser Blue must not be used in areas, in which the appearance
of liquids is probable.
Verify that the line voltage corresponds to the voltage indicated on the
rating plate of the power supply or in the technical specifications.
Do not place the unit near heat sources. Do not cover the convection
openings for air cooling on the sides of the unit.
Make sure that the electrical system is equipped with the required devices
for protection against direct and indirect contact (thermomagnetic
switches, residual current circuit breakers) and has been set up by a
qualified electrician in compliance with the applicable standards.
Avoid interference between the laser emission and any optical sensors of
devices operated in the vicinity of the SIROLaser Blue.
National directives regarding electrical installations must be observed.
Set up Set up the SIROLaser Blue unit properly and completely before putting it
into operation, see chapter "Installation [ → 25]".
Functional Check The system owner is obliged to use only technically faultless products.
Please check the unit for proper functioning before putting it into
operation. In case of unusual noises, check both the unit and the
handpiece. If the unit has fallen down, have it checked by qualified
technical personnel.
To prevent the unit being accidently pulled from the table, the handpiece
hose should never be under tension. Please always ensure that ca.
40 cm of the handpiece hose hangs.
With battery
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.
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2.11Modifications Operating Instructions SIROLaser Blue
2.11
Modifications
Product safety, Sirona
General product safety As manufacturers of dental medical equipment and in the interest of the
operational safety of your system, we stress the importance of having
maintenance and repair of this product performed only by Sirona Dental
Systems GmbH or by agencies expressly authorized by us. Furthermore
components must always be replaced with original Sirona spare parts
upon failure. When having such work done, we suggest that you request
a certificate stating the type and extent of work performed, including
information about any modifications of the rated parameters or of the
operating ranges (if applicable), as well as the date, name of organization
and signature. Please use a fault circuit interrupter to connect this system
to the electrical line power supply. Modifications to this system which
might affect the safety of the system owner, patients or other persons are
prohibited by law! For reasons of product safety, this product may be
operated only with original Sirona accessories or third-party accessories
expressly approved by Sirona. The user is responsible for any damage
resulting from the use of non-approved accessories.
It is not permitted to modify the design or construction of the unit.
Maintenance The unit must be checked and maintained at regular intervals, as
described in chapter "Maintenance and service [ → 64]".
Damages If you accidentally spill any liquid on the unit, immediately stop treatment,
disconnect the power cable and contact your local dental dealer or your
authorized service center for assistance.
Never under any circumstances try to disassemble the SIROLaser Blue.
This is limited exclusively to trained and authorized personnel.
2.12
Cellular phones
Portable and mobile RF communications equipment may interfere with
medical electrical equipment. Therefore, the use of mobile wireless
phones in medical office or hospital environments must be prohibited.
2.13
Transfering data with usb stick
To guarantee the correct datatransfer for software update or storage of
the history file use always an USB-Stick with the following specification:
● USB class 2.0 or above
● Minimum capacity of 512 MB
● Filesystem FAT32 or NTFS
Always perform the datatransfer according to the instructions of the
manual. Never disconnect the USB-stick during data transfer while you
perform a software update or the storage of the history file.
The connection of the SIROLaser to other USB-devices could result in
previously unidentified risks for your patients, yourself or others.
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Sirona Dental Systems GmbH 3System description
Operating Instructions SIROLaser Blue 3.1System overview
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System description
3.1
System overview
SIROLaser Blue (Control unit)
A LED lights
B Touch screen
C Laser Stop key
D Carry handle
E Single-use fiber tips (EasyTip)
F Finger switch with exchangeable keypad
G Metal handpiece sleeve
H Snap tab
I Cable for optical fiber and wires
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3.1System overview Operating Instructions SIROLaser Blue
Wireless foot control
Wireless foot control – optional
A ON/OFF switch
B Power supply socket
C Interlock connector including interlock connector bridge
DUSB port
A Foot switch
B Registration key
C Safety and positioning bar
C
B
A
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Sirona Dental Systems GmbH 3System description
Operating Instructions SIROLaser Blue 3.2Laser operation modes
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3.2
Laser operation modes
Continuous wave mode (CW)
CW implies a continuous, uninterrupted laser beam as long as the laser
is activated (and determined by a time set). This means a very good
power control since the maximum power equals the average power.
In adjacent example the laser is in CW mode with a power of 3 W.
Chopped mode
in literature sometimes also called "pulse mode"
The laser beam is interrupted at regular intervals (e.g. 50% ON and 50%
OFF) which can be adjusted via the duty cycle. The average power is the
product of power and duty cycle.
The result is a better thermal control due to the fact that the OFF periods
are used for thermal relaxation of the tissue.
In adjacent example the laser is in chopped mode with a power of 3 W
and a duty cycle of 20%. The average power is 0.6 W.
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3.3Symbols and abbreviations Operating Instructions SIROLaser Blue
3.3
Symbols and abbreviations
3.3.1 Symbols
Type B applied part according to IEC 60601-1
CE mark in accordance with Council Directive 93/42/EEC, stating the
manufacturer's Notified Body. Verifies the compliance of the SIROLaser
Blue
FDA label nanoLOC
This label stands for device compliance of the wireless foot pedal
Date of manufacture: yyyy-mm-dd
Best before date – Do not use after: year-month
Batch number
Single-use fiber tip is sterile, sterilized with gas (ethylene oxide)
Single-use fiber tip is not sterile
Steripoint
®
as evidence of sterilization process
Filled with green dot: EO processed
Serial Number
Reference number
Please refer to manual first (IEC 60601-1 3rd ed.)
Please observe the user manual of the laser unit
Do not use when packaging is damaged
Temperature limitations, transport and storage
Protect against moisture, keep dry
0123
XXXX/XX/XX
LOT
STERILE EO
NON
STERILE
SN
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Sirona Dental Systems GmbH 3System description
Operating Instructions SIROLaser Blue 3.3Symbols and abbreviations
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Fragile, Handle with care
refer to manuals 3rd edit ion SIROLaser Blue
Please refer to manual first (IEC 60601-1 3rd ed.)
Power switch (on the backside of the control unit)
Power supply MPU100-106
Connection socket for DC input from Sinpro MPU101-106 power supply
Connection socket for interlock
Connection socket for USB
Interference is possible in the vicinity of the device
The disassembled handpiece sleeves may be sterilized only in
autoclaves with saturated water vapor at minimum sterilization values of
135°C (275°F), 3 min. holding time and 2.04 bar (29,59 psi) overpressure.
Single-use only for sterile delivered fiber tips, no reuse
Refers to directive 2002/96/EC and EN 50419
Do not dispose with domestic waste
Laser radiation warning
Label Laser specification 3W SIROLaser Blue
Specification of laser output power and wavelength of blue, IR and red/
aiming beam, see also chapter "Technical Data [ → 21]".
Warns of potential laser radiation hazards when opening the laser unit.
Warns of Class 4 laser radiation hazards when using the unit.
Warns of laser radiation emission at the distal tip of the handpiece.
CAUTION
CLASS 4 VISIBLE AND INVISIBLE LASER
RADIATION WHEN OPEN. AVOID EYE
OR SKIN EXPOSURE TO DIRECT
OR SCATTERED RADIATION
CAUTION
VISIBLE AND INVISIBLE LASER RADIATION.
AVOID EYE OR SKIN EXPOSURE TO
DIRECT OR SCATTERED RADIATION
CLASS 4 LASER PRODUCT
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3.3Symbols and abbreviations Operating Instructions SIROLaser Blue
Warns of laser radiation hazards when the fiber connector is unscrewed.
"Laser Stop" key: press this button in case of an emergency
Operate the unit exclusively with the Sinpro MPU101-106 power supply
3.3.2 Abbreviations
FINGER SWITCH
NOHD Nominal ocular
hazard distance
VA Volt-ampere
CW Continuous Wave V
eff
Effective voltage
PF Pulsed Frequency or
Chopped Mode
V
th
Threshold voltage
cont. continuous V/m Volt per meter
approx. approximately mA Milliampere
IR Infrared diode A/m Ampere per meter
g Gram mW Milliwatt
kg Kilogram W Watt
µs Microseconds P Power
ms Milliseconds P
max
Maximum power
s Seconds J Joule
µm Micrometer RF Radiofrequency
nm Nanometer Hz Hertz
mm Millimeter kHz Kilohertz
cm Centimeter MHz Megahertz
m Meter GHz Gigahertz
WxLxH Width x length x
height
kPa Kilopascal
DC Direct current voltage kpsi Kilo-pound-force per
square inch
AC Alternating current
voltage
db/km Decibels per kilometer
mV Millivolt °C Degree Celsius
V Volt °F Degree Fahrenheit
kV Kilovolt
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Sirona Dental Systems GmbH 3System description
Operating Instructions SIROLaser Blue 3.4Technical Data
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3.4
Technical Data
Technical Data SIROLaser Advance Blue
General
SIROLaser Blue specification
Beam guide: Flexible quartz glass fiber
Display: Full color, graphical LCD touch screen
Cooling: Internal air cooling controlled by output
Temperature switch: Software temperature switch at 48° C
Door contact connection: Potential-free contact 5 VDC/20 mA (TTL)
Dimensions (W x L x H): ~ 182 x 197 x 189 mm
Weight: ~ 1300 g (incl. handpiece and rechargeable
battery)
Laser type: Diode laser
Wavelengths & optical
power:
445 ± 5 nm / approx. 0.2 - 3.0 W (CW)
970 -10/+15 nm / approx. 0.2 - 2.0 W (CW)
660 ± 5 nm / approx. 0.5 - 100 mW (CW)
Laser system: 445 & 970 nm: Class IV
660 nm: Class I
(according to IEC 60825-1)
Device classification: Class IIb (according to Council Directive 93/
42/EEC)
Emission modes: CW (continuous wave),
chopped 1 Hz to 10 kHz
Pulse: Repeated pulse
Pulse duration: Chopped mode: 10 µs - 0.99 sec.
IP degree of protection: Laser unit: IP20; wireless foot control: IPX5
(according to EN IEC 60601-1)
Aiming beam: 660 ± 5 nm, max. 1 mW
NOHD: From the distal end of the optical fiber: 1.5 m
Optical fiber thickness: 200 and 320 µm (single-use fiber tips)
4 and 8 mm (glas rods)
Operation: Electrical wireless foot control or finger
switch, with electronic access key
Nominal power input: 15 V DC 6.66 A max. 100 VA MPU101-106
Insulation class: Class I, type B (according to IEC 60601-1)
Warning: To avoid the risk of electric shock,
this equipment must only be connected to a
supply mains with protective earth.
Type of protection against
electric shock:
SIROLaser handpiece applied part type B
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3System description Sirona Dental Systems GmbH
3.4Technical Data Operating Instructions SIROLaser Blue
Technical Data optical fiber, standard
Optical fibers specification
Technical Data wireless foot control
Wireless foot control
Power supply: The SIROLaser Blue may only be operated
with the Sinpro MPU101-106 power supply.
Input voltage: 100 - 240 VAC
Input current: 1.25 - 0.5 A
Input frequence: 47 - 63 Hz
Separation of mains: The seperation of the mains of SIROLaser
Blue is conducted by unplugging the plug of
the power supply on the backside of the
unit's housing.
Optical fiber diameters: 200 µm fiber 320 µm fiber
Core diameter: 200 µm 320 µm
Cladding diameter: 240 µm 385 µm
Coating diameter: 270 µm 408 µm
All diameters ± 20%
Optical fiber length: 200 μm fiber: 13 ± 1 mm (end of tube to end
of fiber)
200 μm fiber Endo: 27 ± 1 mm (end of tube
to end of fiber)
320 μm fiber: 13 ± 1 mm (end of tube to end
of fiber)
Tube length: 200 μm fiber: ~ 25 mm
200 μm fiber Endo: ~ 25 mm
320 μm fiber: ~ 25 mm
Minimum transmission
efficiency at related
wavelength:
The optical fiber material has an attenuation
of around 1 dB/km @970 nm
Maximum transmission
power:
100 kW/mm² (Nd:YAG, cw at 1060 nm)
Numerical aperture: ≥ 0.22
Tensile strength: 70 kpsi
Frequency: 2.4 GHz - 2.4835 GHz (ISM band)
Transmitting power: < 2 mW (short-range device)
Modulation type: Multi-dimensional Multi Access (MDMA)
Battery: Type AAA, 1.5 V
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23
Sirona Dental Systems GmbH 3System description
Operating Instructions SIROLaser Blue 3.4Technical Data
bеЦдблЬ
Transport and storage
The SIROLaser Blue comes in a cardboard box that ensures proper and
easy transport.
Appropriate storage, Sirona
To ensure appropriate storage, the device must always be kept in the box
supplied by Sirona Dental Systems.
Thus stored, the SIROLaser Blue can withstand the following ambient
conditions:
● Temperatures from -40° C to +70° C
● Relative humidity from 10 % to 95 %
● Atmospheric pressure from 50 kPa to 106 kPa
Battery must be charg ed
In its original transport packaging, the SIROLaser Blue can withstand the
following ambient transport conditions:
● Temperatures from -40° C to +70° C
● Relative humidity from 10 % to 95 %
● Atmospheric pressure from 50 kPa to 106 kPa
Operating conditions
The SIROLaser Blue may be operated in the following environmental
conditions:
● Temperatures from +10° C to +33° C
● Relative humidity from 10 % to 95 %
● Atmospheric pressure from 80 kPa to 106 kPa
CAUTION
Do not leave the SIROLaser Blue in a vehicle parked in the sun. The
inside temperature of the car could thus heat up to a point where
individual components may be damaged.
NOTICE
The rechargeable battery must be fully charged regularly. After six
months of no charging (storage) the rechargeable battery might lose its
loading capacity and might not be rechargeable anymore.
CAUTION
Following transport and storage, let the SIROLaser Blue adapt to room
temperature for about one hour prior to operation to reduce the risk of
malfunctions caused by condensation.
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3System description Sirona Dental Systems GmbH
3.4Technical Data Operating Instructions SIROLaser Blue
Sterile delivered single-use fiber tips
Labeling Each tip is sterilized with gas (ethylene oxide). A label on the outer
packing of each set of 25 single-use fiber tips indicates the sterilization
procedure (see 3.3.1 symbols).
A green dot on the label of the outer packing serves as a process indicator
for a correct sterilization process (see 3.3.1 symbols).
Storage To ensure the proper storage and therefore the sterility of the tips, the
following environmental factors have to be considered in terms of
storage:
● Protection from moisture
● Pollution
● Mechanical stress
● Direct solar or UV radiation
● Influence of temperature
● In a closed storage system (e.g. cupboard, drawer), or
● in shelves or rooms of the room class II according to DIN 1946-4:
2008 -12
● From 15°C to 25°C (room temperature)
● Under relative humidity from 40% to 60% (dry conditions)
Only store the single-use fiber tips in the outer packaging, which serves
as the safety packaging (carton).
Use firstly the oldest tips according to their best-before month. It is
labeled on each packaging tube of the tips and on the outer packaging of
the tip set. The remaining quantity remains in the closed outer packaging
(carton).
Do not refill an outer packaging (carton) of the single-use fiber tip sets
with new tips.
WARNING
Do not use the single-use fiber tips if there is no green dot on the label
of the outer packaging.
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