Fona Aquamarine User manual

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Operating Instructions

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Table of contents
1General 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
2Safety information 9
2.1 Identification of danger levels....................................................................... 9
2.2 Standards and regulations ........................................................................... 9
2.3 Operating personnel..................................................................................... 10
2.4 Physical working principle ............................................................................ 10
2.5 Laser radiation hazards................................................................................ 10
2.6 Nominal ocular hazard distance................................................................... 11
2.7 Laser protective goggles .............................................................................. 12
2.8 UniTip, EndoTip and ActiveTip..................................................................... 13
2.9 Contamination .............................................................................................. 13
2.10 Installation .................................................................................................... 14
2.11 Modifications ................................................................................................ 15
2.12 Radiotelephones .......................................................................................... 15
2.13 Transfering data with usb stick..................................................................... 15
3System description 16
3.1 System overview .......................................................................................... 16
3.2 Laser operation modes................................................................................. 17
3.3 Handpiece with integrated laser source ....................................................... 18
3.4 Symbols and abbreviations .......................................................................... 18
3.4.1 Symbols........................................................................................... 18
3.4.2 Abbreviations................................................................................... 21
3.5 Technical Data ............................................................................................. 22
4Installation 26
4.1 Scope of supply............................................................................................ 26
4.2 Spare parts................................................................................................... 27
4.3 Labels........................................................................................................... 27
4.4 Initial start-up – procedure for proper assembly ........................................... 28

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4.4.1 Install power supply.......................................................................... 28
4.4.2 Handpiece and assembly of single-use fiber tips and light guide .... 30
4.4.2.1 Handpiece ......................................................................... 30
4.4.2.2 Connecting the handpiece to the operation unit................ 30
4.4.2.3 Assembly of sterile single-use optical fiber tips................. 31
4.4.2.4 Assembly of the ActiveTip light guide................................ 36
4.4.3 Install remote interlock – optional..................................................... 38
5Operation 40
5.1 Start the device for the first time ................................................................... 40
5.2 Switch on/off power....................................................................................... 42
5.3 Enter pin code ............................................................................................... 43
5.4 Home screen................................................................................................. 43
5.4.1 Self Test ........................................................................................... 44
5.4.2 Preset programs............................................................................... 45
5.5 Error messages, warnings and instructions .................................................. 49
5.6 Own programs............................................................................................... 51
5.7 Settings ......................................................................................................... 52
5.7.1 User management............................................................................ 52
5.7.2 Language ......................................................................................... 53
5.7.3 Audio & Video .................................................................................. 53
5.7.4 Service Menu ................................................................................... 53
6Indications, contraindications and medical precautions 54
6.1 Indications ..................................................................................................... 54
6.2 List of preset indications................................................................................ 55
6.3 Further non-preset indications ...................................................................... 55
6.4 Examples of treatment risk............................................................................ 56
6.5 Contraindications .......................................................................................... 56
7Cleaning, disinfection and sterilization 57
7.1 Cleaning ........................................................................................................ 57
7.2 Disinfection.................................................................................................... 58
7.3 Sterilization.................................................................................................... 58
7.4 Cleaning the control unit ............................................................................... 59
8Maintenance and service 60
8.1 Safety checks................................................................................................ 60
8.2 Cleaning the handpiece optics ...................................................................... 60
8.3 Maintenance.................................................................................................. 61
8.4 Software update ............................................................................................ 62

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8.5 Troubleshooting of simple defects................................................................ 63
8.6 Technical support, repair and testing ........................................................... 64
8.7 Replacing the rechargeable battery of the control unit................................. 64
8.8 Replacement of parts subject to wear and tear............................................ 66
9Electromagnetic compatibility 67
9.1 Electromagnetic emission ............................................................................ 68
9.2 Interference immunity................................................................................... 69
9.3 Working clearances...................................................................................... 71
10 Disposal 72
10.1 Batteries ....................................................................................................... 73
10.2 Accessories .................................................................................................. 73
11 Appendix 74
11.1 Appendix A – Certification ............................................................................ 74
11.2 Appendix B -Label positions......................................................................... 74
11.2.1 Control unit ...................................................................................... 74
11.3 Appendix C – Safety circuit (interlock).......................................................... 75

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1 General information
1.1 Dear Customer
We are pleased that you have equipped your practice with the
Aquamarine.
Aquamarine 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 Aquamarine.
Your Aquamarine Team
1.2 Contact data
Customer service In the event of technical queries, please use our online contact form at
www.fonadental.com. In the navigation bar, go to the menu commands
„CONTACTS“ / „Technical Support Request“ and then fill in the contact
form.
Manufacturer's address
Sirona Dental Systems GmbH
Fabrikstrasse 31
64625 Bensheim
Germany
Tel.: [phone]
Fax: [phone]
e-Mail: [email protected]
www.dentsplysirona.com

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1.3 General information on the Operating
Instructions
Observe the Operating Instructions Please familiarize yourself with the Aquamarine by reading through these
Operating Instructions before putting it into operation. It is essential that
you comply with the specified warning and safety information.
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 Aquamarine is developed as a table top laser device for:
● Soft-tissue surgery with simultaneous coagulation
● Germ reduction in endodontics
● Germ reduction in periodontology
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 Aquamarine. For indications for use refer to chapter "Indications,
contraindications and medical precautions".
The use of the Aquamarine 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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1.5 Formats and symbols used
The symbols and character formats used in the present manual have the
following definitions:
Instructions for action
References
Lists
Designations
✔Prerequisite
1. First action step
2. Second action step
or
➢Alternative action
Result, reaction of Aquamarine
Prompts you to do something.
See "General information" 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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Operating Instructions
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2 Safety 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:
2.2 Standards and regulations
For the installation and operation of the Aquamarine, the manufacturer
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 Aquamarine 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.
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.
NOTICE
Information to make work easier
For application information and other useful information.

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2.3 Operating personnel
Qualification/education The Aquamarine 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 The manufacturer recommends to gain practical experience in laser
dentistry before first use of the Aquamarine by attending an appropriate
training. Amongst others FONA Dental offers trainings. Please see the
FONA Dental homepage (www.fonadental.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 Aquamarine must not be
used by unauthorized persons. Therefore the Aquamarine equipment
must be protected against unauthorized access when not in use. This can
be achieved, for example, by switching the Aquamarine off after usage so
that the electronic access key (pin code) must be entered before using it
again.
2.4 Physical working principle
The 445 nm laser radiation of the Aquamarine is generated via a laser
diode inside the handpiece 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 and germ reduction.
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 Aquamarine.
Master switch of the practice Note that after switching off the master switch of the practice the
Aquamarine 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 to the right of the
touch screen on the front side of the Aquamarine control unit. The breaker
always cuts off the voltage from the device.
WARNING
The Aquamarine may only be used and maintained by thoroughly
trained personnel.

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Settings Failure to use the settings specified in this manual or perform the actions
described here may lead to a dangerous exposure to radiation.
The manufacturer 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
Aquamarine 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.
2.6 Nominal ocular hazard distance
The nominal ocular hazard distance (NOHD) from the distal end of the
optical fiber is 1.5 m.
CAUTION
Use of controls or adjustments or performance of procedures other than
those specified herein may result in hazardous radiation exposure.

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2.7 Laser protective goggles
All persons present in the room e.g. patient, dentist, assistant must
always wear the appropriate laser protective goggles which are delivered
along with the Aquamarine.
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:
– LB5 (435-465 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
Aquamarine.
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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2.8 UniTip, EndoTip and ActiveTip
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 disposable fiber tips (UniTip 320µm, EndoTip
200µm) or the glass rod (ActiveTip 8mm) from the Aquamarine, 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 disposable fiber tip or glass rod.
The optical fiber must not be twisted inside the tube of the single-use fiber
tip (UniTip 320µm and EndoTip 200µm). There is a risk of breakage.
Stop the laser activation of the Aquamarine immediately if the UniTip
320µm, EndoTip 200µm or ActiveTip is broken. Otherwise the tips may
become hot.
UniTip 320µm, EndoTip 200µm and ActiveTip 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
(ActiveTip) must be sterilized. The single-use fiber tips are delivered
sterile and must be used only once.
Tissue particles During cutting and coagulation of tissue, tissue particles could become
aerosolized. 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 environment. It
may contain particles of viable tissue.
WARNING
Single-use fiber tips (UniTip 320µm, EndoTip 200µm) must not be
sterilized again after usage. They are disposable products.
➢Never reuse the single-use fiber tips as they can also demage the
handpiece optics if used more than one time.

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2.10 Installation
Location The Aquamarine is to be protected against the intrusion of liquids.
The Aquamarine must not be used in areas in which the presence 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.
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 Aquamarine.
National directives regarding electrical installations must be observed.
Set up Set up the Aquamarine unit properly and completely before putting it into
operation, see chapter "Installation".
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.
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 Aquamarine if a visual inspection shows that it has been
damaged in any way.
WARNING
Locate the unit only in environments as described in chapter 9 (EMC,
electromagnetic compatibility). Not specified EMC disturbances may
result in degration of performance as described in chapter 3.5. In
addition, it may also result in hazardous laser radiation and interference
of other devices.

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2.11 Modifications
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 the
manufacturer or by agencies expressly authorized by us. Furthermore
components must always be replaced with original 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 accessories or third-party accessories
expressly approved by the manufacturer. 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".
Damages If you accidentally spill any liquid on the unit, immediately stop treatment,
disconnect the power cable and contact your local dental depot or your
authorized service center for assistance.
Never under any circumstances try to disassemble the Aquamarine. This
is limited exclusively to trained and authorized personnel.
2.12 Radiotelephones
Mobile RF communications equipment can affect electro-medical
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 data transfer for software update, storage of the
history file or user profiles use always an USB-Stick with the following
specification:
● USB class 2.0 or above
● Minimum capacity of 512 MB and maximum 2 GB
● Filesystem FAT32 or NTFS
Always perform the data transfer according to the instructions of the
manual. Never disconnect the USB-stick during data transfer while you
perform a software update.
The connection of the Aquamarine to other USB devices could result in
previously unidentified risks for your patients, yourself or others.

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3 System description
3.1 System overview
Aquamarine (Control unit & handpiece with laser source)
A LED lights
B Touch screen
C Laser Stop key
D Carry handle
E Handpiece including laser diode
F Single-use fiber tips (UniTip 320µm, EndoTip 200µm)
G Finger switch with exchangeable keypad
H Removable handpiece sleeve
I Magnetic handpiece holder and cooling element for the laser
source
J Cable for wires
K Guideway for cable winding

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The sockets and plugs are color-coded.
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 mode presents a stable
output power control since the maximum power equals the average
power.
In adjacent example the laser is in CW mode with a power of 1 W.
Chopped mode
In literature sometimes referred to as "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 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 1 W
and a duty cycle of 20%. The average power is 0.2 W.
A ON/OFF switch
B Power supply socket (grey)
C Interlock connector including interlock connector bridge (red)
D Socket for handpiece cable (black)
E USB port
CAUTION
The metal part on the back side of the handpiece can get warm. It serves
as a passive cooling element for the laser source. However, an
automatic control interrupts the laser emission when the temperature
limit is reached.

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3.3 Handpiece with integrated laser source
The laser source (diode) of the Aquamarine is integrated into the
handpiece of the unit, which makes optical lines inside the handpiece
cable obsolete.
The handpiece is magnetically held inside the handpiece holding. Without
fixed handpiece a weak magnetic field is measurable inside the
handpiece holding (well). Do not place a magnetic data medium in or
above the holding well. It could lead to data loss.
The handpiece has a passive cooling system to guarantee the cooling of
the laser source. The metal end of the handpiece serves as cooling
element. Therefore, it is normal that the metal part on the back of the
handpiece can get warm.
To guarantee that this part does not get too warm an automatic control is
integrated.
If the handpiece back is getting closer to the temperature limit, the unit
indicates that.
If the handpiece reaches the limit the unit will automatically interrupt the
laser emission. The handpiece than has to cool down.
Firing the laser with max. power is possible for 4 minutes continuously
until the laser emission will be interrupted.
3.4 Symbols and abbreviations
3.4.1 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 Aquamarine
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
0123
XXXX/XX/XX
LOT
STERILE EO
NON
STERILE
SN

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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
Fragile, Handle with care
This packaging has to be stored and transported this way up
It is only allowed to stack up to 4 packages maximum
Please refer to manual first (IEC 60601-1 3rd ed.)
Power flip switch indicator on the control unit's backside: "I" indicates on,
"O" indicates off position of the flip switch.
Class II unit according to EN 60601-1:2006
Connection socket for DC input from FRIWO FW8030M/18 power supply
Connection socket for interlock
Connection socket for USB
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.

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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
Intermittent operation. The laser can be operated with max. power for 4
minutes. Afterwards, the cooling element will get too warm. The cooling
time is 25 minutes.
Laser radiation warning
Warning of hot surfaces. The back part of the handpiece can get warmer
during operation as is serves as a cooling element for the laser source.
Warning of a magnetic field in the holder of the handpiece.
Specification of laser output power and wavelength of blue and aiming
beam, see also chapter "Technical Data [ → 22]".
Warns of Class 4 laser radiation hazards when using the unit.
Warns of laser radiation emission at the distal tip of the handpiece. It also
indicates the socket for the handpiece cable.
"Laser Stop" key: press this button in case of an emergency