MANUFACTURER:

Fotona d.o.o.
Stegne 7
SI-1000 Ljubljana
Slovenia, EU
Phone: + 386 1 500 91 00
Fax: + 386 1 500 92 00
www.fotona.com

OPERATOR MANUAL
Er:YAG Optical Handpiece

Model: R11

64653 CE ENG 16
Please note that while every effort has been made to ensure that the data given in this manual is
accurate, the information, figures, illustrations, tables, specifications, and schematics contained herein
are subject to change without notice.

Copyright © Fotona d.o.o. All rights reserved.

The contents of this publication may not be reproduced in any form without
the explicit permission of Fotona d.o.o.

Page 2/33 64653 OM R11 CE ENG 16

Date of issue/Latest revision: 19. April 2016
Foreword

Dear customer,

Thank you for purchasing a Fotona laser system accessory and placing your trust in our brand. We are
certain that your Fotona accessory will be a perfect complement to your Fotona system and will provide
you with significant advantages and new treatment possibilities. With over 50 years of experience we
have a deep understanding of the modern physician’s needs and aim to provide laser-based solutions
and instruments that excel in quality and reliability.

Fotona medical laser systems and accessories have been developed and are manufactured according to
the most stringent international quality and safety requirements and standards. All Fotona products are
authorized to carry the CE mark.

The purpose of this Operator Manual is to provide general information and guidelines for your Fotona
accessory and instructions on how best to maintain the device. We strongly recommend carefully reading
and studying the entire content of this booklet and the respective system’s Operator Manual before
attempting to operate the device. Please take note of the various warnings and notes that are provided to
ensure a maximum lifespan of your device and to safeguard the safety of the patient, the medical
personnel and yourself.

Should you have any questions or comments regarding Fotona laser systems and accessories, we invite
you to contact us by email at info@fotona.com. Alternatively, we can be contacted through the contact
details provided on the cover page.

To ensure that we can be of optimal service, we kindly recommend registering your Fotona device online
at www.fotona.com.

We hope you will enjoy your Fotona laser system accessory and the added value and advantages it will
bring to your work.

The Fotona Team

64653 OM R11 CE ENG 16 Page 3/33

Page 4/33 64653 OM R11 CE ENG 16
Contents
1. INTRODUCTION ...................................................................................................................................... 7
2. INTENDED USE ....................................................................................................................................... 8
3. TECHNICAL CHARACTERISTICS ......................................................................................................... 8
4. HANDPIECE ASSEMBLY ....................................................................................................................... 8
4.1. General .............................................................................................................................................. 8
4.2. Installing the Handpiece..................................................................................................................... 9
4.3. Maintenance and Cleaning ................................................................................................................ 9
4.3.1. Cleaning the handpiece during treatment ....................................................................................... 9
4.3.2. Cleaning the handpiece after treatment........................................................................................ 10
4.4. Sterilization ...................................................................................................................................... 10
5. USING THE G-SET ADAPTERS WITH R11 HANDPIECE ................................................................... 11
6. TECHNICAL SPECIFICATIONS OF R11 HANPIECE WITH G-SET ADAPTERS ............................... 11
7. ASSEMBLING THE G-SET ADAPTERS WITH R11 HANDPIECE ...................................................... 12
7.1. Components ..................................................................................................................................... 12
7.2. Installing the R11 handpiece with G-SET adapters ......................................................................... 14
7.2.1. Installation Procedure ................................................................................................................... 15
8. REPROCESSING THE G-SET ADAPTERS AND SPECULUMS ......................................................... 17
8.1. Fundamental Points ......................................................................................................................... 17
8.2. Cleaning and Disinfection ................................................................................................................ 17
8.2.1. Detergent Selection Criteria .......................................................................................................... 17
8.2.2. Consumables used for Cleaning and Disinfection ........................................................................ 18
8.2.3. Post-Use Wipe Down .................................................................................................................... 18
8.2.4. Preparation for Cleaning ............................................................................................................... 19
8.2.5. Cleaning Procedure ...................................................................................................................... 19
8.2.6. Disinfection Procedure .................................................................................................................. 20
8.2.7. Drying Procedure .......................................................................................................................... 20
8.3. Post Cleaning Check ....................................................................................................................... 20
8.4. Packaging ........................................................................................................................................ 20
8.5. Sterilization ...................................................................................................................................... 20
8.6. Storage ............................................................................................................................................ 21
8.7. Materials Resistance........................................................................................................................ 21
8.8. Reusability ....................................................................................................................................... 22
9. MAINTENANCE OF G-SET ................................................................................................................... 23
9.1. Replacing the G-SET Parts ............................................................................................................. 23
10. USING THE LA ADAPTER WITH R11 HANDPIECE ......................................................................... 23
11. TECHNICAL SPECIFICATIONS OF R11 HANDPIECE WITH LA ADAPTER ................................... 24
12. ASSEMBLING THE LA ADAPTER WITH R11 HANDPIECE ............................................................. 24
13. REPROCESSING THE LA ADAPTER ................................................................................................ 25
13.1. Fundamental Points ....................................................................................................................... 25
13.2. Cleaning and Disinfection .............................................................................................................. 25
13.2.1. Detergent Selection Criteria ........................................................................................................ 25
13.2.2. Consumables used for Cleaning and Disinfection ...................................................................... 26
13.2.3. Post-Use Wipe Down .................................................................................................................. 26
13.2.4. Preparation for Cleaning ............................................................................................................. 26
13.2.5. Cleaning Procedure .................................................................................................................... 27
13.2.6. Disinfection Procedure ................................................................................................................ 27
13.2.7. Drying Procedure ........................................................................................................................ 27
13.3. Post Cleaning Check ..................................................................................................................... 27
13.4. Packaging ...................................................................................................................................... 27
13.5. Sterilization .................................................................................................................................... 28

64653 OM R11 CE ENG 16 Page 5/33

 13.6. Storage ........................................................................................................................................... 28
13.7. Materials Resistance ...................................................................................................................... 29
13.8. Reusability...................................................................................................................................... 29
14. MAINTENANCE LA ADAPTER ........................................................................................................... 30
14.1. Replacing the LA adapter .............................................................................................................. 30
15. WARRANTY ......................................................................................................................................... 30
16. DECONTAMINATION OF RETURNED EQUIPMENT ........................................................................ 30
LIST OF FIGURES ..................................................................................................................................... 31

Page 6/33 64653 OM R11 CE ENG 16

1. INTRODUCTION
Fotona produces and provides a variety of surgical beam delivery systems,
scanners and handpieces for use with the Fotona laser systems ranges.
All Fotona laser products undergo extensive testing, and if properly handled will
serve their purpose for many years.
To ensure a maximum life-span of the handpiece and to safeguard the safety of
the patient, operating staff and operator we strongly recommend that you carefully
study and fully comprehend the entire contents of this manual, as well as the
Operator Manual of the respective host laser system, before attempting to operate
the handpiece and the laser system.
Please note that the handpiece is delivered in non-sterile condition; follow the
instructions herein to sterilize handpiece before use.
Before attempting to handle or use the handpiece, please observe the following
warnings:

WARNING!
Inspect the handpiece upon arrival and before use for damage due to
transportation.
If any damage is noticed, the scanner should not be used.

WARNING!
To assure sterility, proper aseptic techniques and procedures must be
adhered to when handling the handpiece while removing it from the
sterilization pouch after sterilization.

WARNING!
Severe and/or permanent eye damage may occur.
Never look directly into the treatment or aiming beam or at laser light
scattered from reflective surfaces.
Never look directly into laser apertures, optical fiber tips, articulated arm
exit apertures or handpiece exits when power is applied to the laser, even
when laser safety eyewear is worn.

CAUTION
Although some components of different model handpieces are similar to
each other, they are not interchangeable.
Each handpiece model has unique properties and components; taking
away or adding components from other models will inevitably cause
irreparable damage.

NOTE
The model code and serial number are engraved on the handpiece.
When contacting a Fotona distributor or representative regarding servicing
and spare parts, please refer to the model code and serial number to avoid
any confusion.

64653 OM R11 CE ENG 16 Page 7/33

2. INTENDED USE
Please refer to the host laser system's Operator Manual and the accompanying
Application Notes for information on the intended use of the handpiece.

3. TECHNICAL CHARACTERISTICS
Operating wavelength: 2940 nm
Spot diameters: 2 – 7 mm
Applied part type: type B
Sterilization: Sterilizable in autoclave
NOTE: Valid for the handpiece tip only!

4. HANDPIECE ASSEMBLY

4.1. General
The model R11 optical handpiece (see Figure 1) is used to safely deliver Er:YAG
laser energy, transmitted through the laser system’s articulated arm, to the
treatment site.
It consists of a handpiece body (1) with lenses and protective window (2), a
handpiece tip (3) and a protective cover (4). The handpiece tip can be detached
from the handpiece body for cleaning and sterilization.
In operation the handpiece must be held perpendicularly to the treatment site with
the handpiece tip in contact with the target tissue.
The spot size is set, by turning the engraved ring (5) on the handpiece body. The
aiming beam shines coaxially with the treatment beam and always shows the
position where the treatment beam is being delivered. Please note that the spots
sizes of the aiming beam and treatment beam are not necessarily the same. Within
the treatment beam spot, the energy density is constant.

Figure 1: Er:YAG optical handpiece model R11

Page 8/33 64653 OM R11 CE ENG 16

4.2. Installing the Handpiece
• Remove the handpiece from the packaging.
• Remove the protective cover from the handpiece body, being careful not to
touch, wet or smear the lens at the handpiece input aperture.
• Place the handpiece on the articulated arm’s exit threaded adapter, making
sure that the handpiece is firmly fixed to the articulated arm.
• Select and confirm the handpiece type (R11) from the laser system’s display
as described in the system’s Operator Manual. If the laser system does not
provide the R11 option, choose R09.
•

WARNING!
Fingerprints, dust and especially moisture on optical components can
cause irreparable damage to the handpiece.

WARNING!
The operator is solely responsible for properly selecting the handpiece
according to the intended application and system settings.
The delivered energy or fluence per pulse can differ significantly from the
intended energy per pulse if an incorrect handpiece is selected on the
control panel.

NOTE
The selection of handpiece type limits the adjustable energy range for a
particular handpiece.

4.3. Maintenance and Cleaning

CAUTION
Do not let water enter the handpiece - this reduces the handpiece’s lifetime.
Before taking off the protective cover or removing the handpiece from the
articulated arm always dry the handpiece first with clean pressurized air or
by wiping it.

4.3.1. Cleaning the handpiece during treatment

Because of the ablative effect of the Er:YAG laser on tissue, debris accumulates
on the handpiece tip. Regularly check the condition of the handpiece tip during
treatment and wipe the nozzle if necessary. By doing so the laser energy will be
kept constant and the danger of damaging the handpiece will be minimized.

64653 OM R11 CE ENG 16 Page 9/33

 CAUTION
The laser plume and debris collected on the handpiece tip may contain
viable tissue particles.

4.3.2. Cleaning the handpiece after treatment

• Remove the tip from the handpiece body by gently pulling the tip.
• Wipe the handpiece tip with a cotton pad immersed in alcohol.
• Thoroughly clean the handpiece tip nozzle’s inner and outer surface, making
sure that no debris is left
The handpiece tip can also be cleaned in an ultrasound bath.
Check the protective window for scratches and/or dirt. If there are remains of
debris stuck on its surface, gently clean it with a cotton pad and alcohol\acetone.

4.4. Sterilization

WARNING!
It is paramount to sterilize the handpiece tip before each treatment to
minimize the risk of cross-contamination.

NOTE
The handpiece body together with the lens is not intended for sterilization.
If sterilized, irreparable damage will occur.

• Clean the handpiece as described in this manual.

• Put the handpiece tip in a sterilization pouch and place in an autoclave for 10
minutes, with recommended settings at 134°C and working pressure 2.1 – 2.2
Bar.
• Reassemble the handpiece and connect to the articulated arm.

Page 10/33 64653 OM R11 CE ENG 16

5. USING THE G-SET ADAPTERS WITH R11 HANDPIECE
The Model R11 handpiece can be used with G-SET adapters.

WARNING!
Inspect the G-SET adapter parts as well as corresponding handpieces upon
arrival and before each use for damage. If damaged either the parts of G-
SET or handpieces should not be used.

WARNING!
To assure sterility, proper aseptic techniques and procedures must be
adhered to when handling the parts of G-SET adapters while removing them
from the sterilization pouch after sterilization.

WARNING!
Severe and/or permanent eye damage may occur.
Never look directly into the treatment or aiming beams or scattered laser
light from reflective surfaces.
Never look directly into laser apertures, when power is applied to the
laser, even when laser safety eyewear is worn.

6. TECHNICAL SPECIFICATIONS OF R11 HANPIECE WITH G-

SET ADAPTERS
Operating wavelength of
adapters:
Spot sizes of GA adapter at
interaction site:
Width of cylindrical laser
ribbon at interaction site of
GC adapter:
Applied part type:
Sterilization:
2940 nm
2.6 mm (corresponds to setting 2 on R11)
3.8 mm (corresponds to setting 3 on R11)
5.1 mm (corresponds to setting 4 on R11)
6.4 mm (corresponds to setting 5 on R11)
7.7 mm (corresponds to setting 6 on R11)
9 mm (corresponds to setting 7 on R11)
4.5 mm (corresponds to setting 7 on R11
handpiece)
type B
sterilizable in autoclave
NOTE: Valid for GA and GC adapters only!

64653 OM R11 CE ENG 16 Page 11/33

7. ASSEMBLING THE G-SET ADAPTERS WITH R11
HANDPIECE

7.1. Components
The G-SET comprises:
• Model GA adapter with flat side-firing mirror and engraved scale for positioning
the interaction site,
• Model GC adapter with conical mirror with engraved scale for positioning a
circular shaped laser ribbon site, and
• Speculum for guiding the GA or GC adapter

The model GA adapter (see Figure 2) consist of:

• GA adapter tube with engraved scale,
• a gold coated flat mirror which generate a collimated side/fired laser spot of
selected size (see table in previous section: Technical specification of R11
handpiece with G-set adapters.)
• a mirror fixing nut.

The model GC adapter (see Figure 2) consists of:

• GC adapter tube with engraved scale,
• a gold coated conical mirror for generating a circular ribbon with a width of 4.5
mm uniformly illuminated with laser light.
• a mirror fixing nut.

Speculum (Figure 4) is used with model GA or GC adapter and facilitates the back
and forth movement and rotation of the inserted adapter. The engraving on the
inlet side allows for precise angular positioning of the side-fired beam with GA
adapter to achieve optimal overlap of laser spots on treatment area (see Figure 4).
Both adapters are designed to be attached and screwed to Fotona Model R11
handpiece (see Figure 3) and so assembled to be guided through the speculum
(see Figure 4).
The speculum allows for gliding the GA adapter back and forth and also rotating it.
When assembled with R11 handpiece the GA adapter serves as a side-firing
assembly which delivers laser spots with selected spot size and fluence on the
perimeter of the speculum. The position of the laser spot center related to the
speculum inlet surface can be easily determined with the engraved scale in
millimeters on the adapter. The angular position of laser spot can be also easily
determined in respect to engraved angular scale on speculum inlet surface (see
Figure 5).
When the GC adapter is assembled with R11 handpiece the speculum function is
to facilitate the positioning of the laser illuminated ribbon on the speculum
perimeter with the engraved scale in millimeters on the adapter.
The GA or GC adapters assembled with Fotona R11 handpiece and speculum are
intended to be used in various surgical procedures in gynecology with Fotona
Dynamis or Spectro family laser systems.

Page 12/33 64653 OM R11 CE ENG 16

 WARNING!
The GC adapter will operate properly only if it can be inserted in to the
Speculum smoothly. Handle the GC adapter with care. The conical mirror
holder should in no case be deformed. If a deformed GC adapter is inserted
in to the Speculum, the reflected beam from the conical mirror will not be of
regular shape and will have a non-uniform energy distribution on target
tissues.

NOTE
When used with Dynamis Spectro system with Graphical User Interface
(GUI) and Touchscreen the R11-GA and R11-GC (R11 with GA or GC adapter
for Gynecology) or R11-GAc and R11-GCc (in case of MClear and SClear
speculum) handpiece is to be selected in GUI.

GC mirror fixing nut Gold conical mirror GC adapter tube with

scale angled mirror

GA adapter tube with

GA mirror fixing nut Gold angled mirror scale angled mirror

Figure 2: The Fotona model GA and GC adapter breakdown.

Figure 3: The Fotona R11 handpiece with removed tip (spacer)

prepared to be attached to Fotona model GA adapter.

64653 OM R11 CE ENG 16 Page 13/33

 Standard Slim Long Slim MClear SClear
Figure 4: Speculums used for axial and angular positioning of laser spots
(GA adapter) or axial position of laser illuminated ribbon (GC adapter).

Positions of GA adapter Range of GA adapter 6 marks for

where shadowing of the side rotation without treatment
fired beam is maximal (the shadowing the side positions
laser beam hits the speculum fired laser beam with
wire frame) – there are six speculum wire frame.
positions separated by 60º. There are six such
regions.

Speculum Speculum
wire frame glass

Figure 5: Engraving on Speculum inlet surface for angular positioning

of side-fired spots with GA adapter.

Figure 6: Fully assembled GA and GC adapters with R11 handpiece ready to be

inserted and guided through the Speculum.

7.2. Installing the R11 handpiece with G-SET adapters

WARNING!
The model GA and GC adapters and its parts are delivered in non-sterile
condition.
Before assembling the adapter together with Speculum all components of
the adapters and Speculum should be cleaned, disinfected, packed and
sterilized according to instructions herein.

Page 14/33 64653 OM R11 CE ENG 16

 WARNING!
The Fotona model R11 handpiece spacer should be removed and the
remaining body outer surface thoroughly cleaned and disinfected with
hospital grade disinfectant before attaching it to the sterilized adapter.
Aseptic technique should be used while removing the sterilized parts of the
adapter when removing it from sterilization pouch after sterilization and
assembling it together with R11 handpiece.

7.2.1. Installation Procedure

1. Carefully put together GA (or GC) adapter – insert the golden mirror in its
position on the adapter and fix it from the rear side with the mirror nut. (see
Figure 7)
2. Remove the the spacer of R11 handpiece and screw the handpiece in the GA
(or GC) adapter inlet part (see Fig 8 and Fig 9).
3. On R11 handpiece with GA adapter select the desired spot size on R11
handpiece. The selected spot size on handpiece must match the selection on
laser system Graphical user interface.
On R11 handpiece with GC adapter ALWAYS select the setting of 7 mm spot size.

Figure 7: Assembling the GA (or GC) adapter – fixing the gold mirror.

Figure 8: Attaching and fixing the R11 handpiece to the GA (or GC) adapter.

64653 OM R11 CE ENG 16 Page 15/33

 Figure 9: Fully assembled GA (or GC) adapter with R11 handpiece.

WARNING!
The operator is solely responsible for properly assembling the surgical set
according to the intended application and instructions described herein.

CAUTION
Assure yourself that the adapter is firmly and properly fixed to the R11
handpiece to prevent unscrewing of the adapter from the handpiece during
the treatment.
Do not allow the adapter not to be screwed to the end. This may lead
uncontrolled laser beam wandering at the interaction site.
Always select spot size of 7 mm on R11 handpiece when using R11
handpiece with GC adapter.

Page 16/33 64653 OM R11 CE ENG 16

8. REPROCESSING THE G-SET ADAPTERS AND
SPECULUMS

8.1. Fundamental Points

WARNING!
The wire speculums, MClear speculum and GA as well as GC adapters
require cleaning, disinfection and sterilization prior to each use. SClear
single use speculum requires disinfection before use as described in
section Disinfection Procedure in this Manual.

Cleaning and disinfection are required after removing the non-sterile adapters and
speculums from the protective packaging upon initial receipt. Reprocessing of
multiple use components such as GA and GC adapters, MClear and wire
speculums must be performed within 2 hours after application. Adequate cleaning
and disinfection are necessary to achieve effective sterilization.
The GA and GC adapters are used with model R11 handpiece and different
speculums.
The operator is responsible for ensuring the sterility or effective desinfection of
speculums, GA or GC adapter, and R11 handpiece. Only sufficiently validated
equipment should be used to accomplish sterilization. Product-specific procedures
and validated parameters for each cycle should be used for cleaning, disinfection
and sterilization. The disinfection and sterilization devices should be maintained
and checked regularly.
The legal provisions valid for your country as well as to the hygienic instructions of
the doctor’s practice or hospital in which you operate should be followed. This
applies particularly to the various guidelines regarding the inactivation of prions
(not relevant for USA).
Automated cleaning and disinfection procedures must not be used as this may
cause irreparable damage to adapter parts, especially gold coated mirrors.

8.2. Cleaning and Disinfection

8.2.1. Detergent Selection Criteria

Adhere to the following points when selecting cleaning and disinfection detergents
for your system:

64653 OM R11 CE ENG 16 Page 17/33

 • The detergents must be inherently suitable for cleaning and disinfecting steel
and plastic instruments.
• The used disinfectant must be approved for efficiency (for example
VAH/DGHM or FDA approval or CE marking) and compatible with the used
cleaning detergent. For USA a high level disinfectant is to be applied.
• The used detergents must be compatible with the adapter and speculum
materials (see section “Materials resistance” bellow).
• Avoid using combined cleaning/disinfection detergents.
• Follow the detergent manufacturer’s instructions with regards to concentration
and soaking time.
• Use only freshly prepared solutions and only sterile low contaminated (max. 10
germs/ml) and low endotoxin contaminated water (max. 0.25 endotoxin
units/ml); e.g. purified or highly purified water and filtered air for drying.
• Use only detergents that are compatible with the materials used in the the
adapters and speculum. Please see section “Materials resistance” for details
bellow.
• Pay attention to the instructions of detergent manufacturers regarding
concentration, temperature and soaking time as well post-rinising.
Do not use a metal brush or steel wool to clean the adapter parts especially
mirrors. They will get scratched.

8.2.2. Consumables used for Cleaning and Disinfection

The consumables used for cleaning and disinfection are:

• Single use 15 mm BRISTLE – STEM (Code: FLEX006, Clinipack) brushes, or
similar – position 1 on Figure 10
• Tooth-brush or suitable brush for surgical instruments cleaning – position 2 on
Figure 10

1 2

Figure 10: Consumables used for cleaning and disinfection.

8.2.3. Post-Use Wipe Down

Immediately after, or latest in two hours after use, remove the R11 handpiece from
the GA or GC adapter. Remove excess body fluids and tissue with a disposable
wipe gauze or damp cloth from the GA or GC adapter and speculum. Disassemble
the GA or GC adapter and do the same on all accessible surfaces of each part of
adapter. Flush and rinse using running water.

Page 18/33 64653 OM R11 CE ENG 16

 The mirrors of GA or GC adapters should be cleaned carefully with disposable
cotton wool pads as shown on Figure 11 bellow.

Figure 11: Cleaning the gold mirros with disposable cotton pads.

Under no circumstances should a metal brush or steel wool be used for cleaning.

8.2.4. Preparation for Cleaning

Place the speculum and all parts of GA (or GC) adapter in a disposable container
ready for immediate cleaning and disinfection.

8.2.5. Cleaning Procedure

1. Soak all parts in cleaning solution for the soaking time prescribed by the
detergent manufacturer. Make sure that all the parts are sufficiently covered by
the cleaning solution.
2. At the beginning of soaking time actively rinse the lumens of adapter and
speculum with cleaning solution.
3. Immediately after rinsing, brush all external surfaces of speculum and each
part of adapters in cleaning solution with a suitable surgical instrument
cleaning brush or a tooth brush. To correctly accomplish this step please
adhere to the following guidelines:
• For brushing the lumens of GA or GC adapters use a 15 mm BRISTLE –
STEM (Code: FLEX006, Clinipack) brush, or similar.
• Brush the lumen of MClear speculum and wire speculums with tooth brush
with longitudinal and rotational movements.
• The brushing of each lumen should be performed with three longitudinal
and three rotational movements.
• Brush all the external surfaces of GA and GC adapters as well as external
parts of speculums wit tooth brush.
• Gently clean the surface of GA and GC mirrors only with cotton pads in the
cleaning solution.
4. After brushing, leave all parts in the cleaning solution for the remaining of
soaking time prescribed by the manufacturer.
5. Remove all the parts from cleaning solution and rinse them for 5 minutes in
running water.

64653 OM R11 CE ENG 16 Page 19/33

8.2.6. Disinfection Procedure

If disinfecting several adapters and speculums at once, ensure that the parts of
each adapter and speculum do not come into contact with each other during the
disinfection procedure. SClear speculums should be disinfected separately.
1. Soak all of the adapter and laser speculum parts in disinfectant solution.
Ensure that all parts are submerged in the disinfectant solution and that they
are disassembled. Follow the instructions of the detergent and disinfectant
producer.
2. Remove all parts from the disinfectant solution and post-rinse them at least 5
times in water.
3. Rinse all parts of adapters and speculum in purified water for 1 minute.
4. Pay attention on complete removal of the water out of the glass speculums.
The suitability of the handpiece adapters and speculums for effective cleaning and
disinfection , as described in the procedure above, was demonstrated by an
independent accredited and recognized (§ 15 (5) MPG) test laboratory. The
cleaning detergent Cidezyme/Enzol and the disinfectant Cidex OPA (both Johnson
& Johnson, Norderstedt) were used*.

8.2.7. Drying Procedure

Dry all parts of the with oil-free and filtered compressed air.
*CIDEX®,CIDEZYME® and ENZOL are registered trademarks of Advanced Sterilization
Products a division of Ethicon Inc., a Johnson and Johnson company

8.3. Post Cleaning Check

Check all parts for any visible remains of any impurities, corrosion or damaged
surfaces. Replace damaged or corroded parts. Under no circumstances should you
continue to use a damaged adapter or speculum parts.
Parts that have remained unclean, despite the cleaning and disinfection
procedures, should be cleaned and disinfected again.

8.4. Packaging
Pack the dismantled, cleaned and disinfected parts into a single-use sterilization
package (single paper/foil) and/or into sterilization containers. The packaging
and/or containers must fulfill the following requirements:
• comply to EN ISO/ANSI AAMI ISO 11607
• be suitable for steam sterilization (temperature resistance up to at least 138°C
(280°F), sufficient steam permeability)
• be sufficiently resistant to mechanical damage and adequately protect the
handpieces and Threaded Cannulae
• be regularly maintained according to the manufacturer’s instructions
(sterilization container)

8.5. Sterilization
Use only sterilization procedures that conform to those listed below to sterilize the
adapter and laser speculum. Sterilization procedures that do not conform to the
criteria below must not be used.
Page 20/33 64653 OM R11 CE ENG 16
 The steam sterilizer must:
• use a gravity procedure (with sufficient product drying)
• conform to EN 13060 or EN 285
• be validated according to EN ISO 17665 --, valid IQ/OQ (commissioning) and
product specific performance qualification
• use a maximum sterilization temperature of 138°C (280°F); plus tolerance
according to EN ISO 17665 --. Sterilization temperatures less than 132°C
(270°F) are not appropriate and may not be used as they do not provide
sufficient sterilization.
The steam sterilization process must:
• not expose any part of adapters or speculum to temperatures higher than
138°C (280°F).
• use a sterilization time (exposure time at the sterilization temperature) at least
15 min at a minimum sterilization temperature of 132°C (270°F)/134°C (273°F).
National requirements may necessitate longer sterilization times (e.g. up to 18
minutes) to inactivate prions.
The suitability of the handpiece adapters and speculums for effective steam
sterilization, as described in the procedure above, was demonstrated by an
independent accredited and recognized (§ 15 (5) MPG) test laboratory. A steam
sterilizer HST 6x6x6 (Zirbus technology GmbH, Bad Grund) and the gravity
procedure were used. Typical medical practice and clinic conditions, as well as the
above-described procedure, were taken in consideration.

CAUTION
The flash sterilization procedure must not be used.
When sterilizing multiple surgical sets in one autoclave cycle ensure that
the sterilizer’s maximum load is not exceeded.
Please do not expose any handpieces to temperatures higher than 138°C
(280 °F).
Note that SClear speculum is intended for single use only and is not
suitable for steam sterilization.

8.6. Storage
Store sterilized adapters and speculums in their sterilization packages, in a dry
dust-free environment.

8.7. Materials Resistance

Please take care that the listed substances are not ingredients of cleaning or
disinfection detergent:
• organic, mineral or oxidizing acids (minimum admitted pH-value 5.5, neutral or
enzymatic cleaner recommended)
• strong lyes (maximum admitted pH-value 9.5)
• oxidizing agents (for example: peroxide)
• halogens (for example: clorine, iodine, bromine)
• aromated, halogenated hydrocarbons
Please do not expose any part of adapter and speculum to temperatures higher
than 138ºC (280 ºF).

64653 OM R11 CE ENG 16 Page 21/33

8.8. Reusability
Frequent reprocessing has marginal consequences on adapter parts such as the
adapter body and flat or conical mirror nut. End of life for these devices should be
determined based on wear and damage. The gold coated flat or conical mirror
surface must be free of blurs and scratches.
The speculum and the adapter parts can be reused 100 times in case of adequate
care and if they are undamaged and clean. The user is responsible for each further
use as well as for the use of damaged and dirty speculum or adapters. Fotona will
not be held liable for damages incurred due to the use of a dirty or damaged
speculum or adapter parts. The sterilization of speculum and all parts of adapters
is the sole responsibility of the operator.

Page 22/33 64653 OM R11 CE ENG 16

9. MAINTENANCE OF G-SET

9.1. Replacing the G-SET Parts

If damage, unacceptable wear or corrosion is observed on any part of the
speculum or adapter parts, it must be replaced with the same new part from
Fotona.
In case the flat or conical mirror or mirror nut is damaged or deformed in such a
manner that the adapter cannot be assembled properly do not attempt to repair it.
Replace it with a new one from the manufacturer.

10. USING THE LA ADAPTER WITH R11 HANDPIECE

The LA adapter assembled with Fotona R11 handpiece is intended to be used
orally in the first step of Fotona 4D* treatment.

* See the corresponding Application notes

WARNING!
Inspect the LA adapter as well as corresponding handpieces upon arrival
and before each use for damage. If damaged either the LA adapter or
handpieces should not be used.

WARNING!
To assure sterility, proper aseptic techniques and procedures must be
adhered to when handling the LA adapter while removing it from the
sterilization pouch after sterilization.

WARNING!
Severe and/or permanent eye damage may occur.
Never look directly into the treatment or aiming beams or scattered laser
light from reflective surfaces.
Never look directly into laser apertures, when power is applied to the
laser, even when laser safety eyewear is worn.

64653 OM R11 CE ENG 16 Page 23/33

11. TECHNICAL SPECIFICATIONS OF R11 HANDPIECE WITH
LA ADAPTER
Operating wavelength of adapters: 2940 nm

Spot sizes of LA adapter at 9 mm (corresponds to setting 7 on

interaction site: R11)

Applied part type: type B

Sterilization: sterilizable in autoclave

12. ASSEMBLING THE LA ADAPTER WITH R11 HANDPIECE

The LA adapter is designed to be attached and screwed to Fotona Model R11

handpiece (see Figure 12).
The angular position of laser spot can be easily determined in respect to engraved
circular mark at the base of the adapter (see Figure 13).

NOTE
When used with Dynamis Spectro system with Graphical User Interface
(GUI) and Touchscreen the R11-LA handpiece is to be selected in GUI.

CAUTION
Assure yourself that the LA adapter is firmly and properly fixed to the R11
handpiece to prevent unscrewing of the adapter from the handpiece during
the treatment.
Do not allow the adapter not to be screwed to the end. This may lead
uncontrolled laser beam wandering at the interaction site.
Always select spot size of 7 mm on R11 handpiece when using R11
handpiece with LA adapter.

Figure 12: The Fotona R11 handpiece with removed tip (spacer) prepared to be
attached to Fotona model LA adapter.

Figure 13: Engraved circular mark on Fotona LA adapter.

Page 24/33 64653 OM R11 CE ENG 16

13. REPROCESSING THE LA ADAPTER

13.1. Fundamental Points

WARNING
The LA adapter requires cleaning, disinfection and sterilization prior to
each use.

Cleaning and disinfection are required after removing the non-sterile adapter from
the protective packaging upon initial receipt. Reprocessing of multiple use
components such as LA adapter must be performed within 2 hours after
application. Adequate cleaning and disinfection are necessary to achieve effective
sterilization.
The LA adapter is used with model R11 handpiece.
The operator is responsible for ensuring the sterility or effective disinfection of LA
adapter and R11 handpiece. Only sufficiently validated equipment should be used
to accomplish sterilization. Product-specific procedures and validated parameters
for each cycle should be used for cleaning, disinfection and sterilization. The
disinfection and sterilization devices should be maintained and checked regularly.
The legal provisions valid for your country as well as to the hygienic instructions of
the doctor’s practice or hospital in which you operate should be followed. This
applies particularly to the various guidelines regarding the inactivation of prions
(not relevant for USA).
Automated cleaning and disinfection procedures must not be used as this may
cause irreparable damage to adapter parts, especially gold coated mirrors.

13.2. Cleaning and Disinfection

13.2.1. Detergent Selection Criteria

Adhere to the following points when selecting cleaning and disinfection detergents
for your system:

64653 OM R11 CE ENG 16 Page 25/33

 • The detergents must be inherently suitable for cleaning and disinfecting steel
and plastic instruments.
• The used disinfectant must be approved for efficiency (for example
VAH/DGHM or FDA approval or CE marking) and compatible with the used
cleaning detergent. For USA a high level disinfectant is to be applied.
• The used detergents must be compatible with the adapter and speculum
materials (see section “Materials resistance” bellow).
• Avoid using combined cleaning/disinfection detergents.
• Follow the detergent manufacturer’s instructions with regards to concentration
and soaking time.
• Use only freshly prepared solutions and only sterile low contaminated (max. 10
germs/ml) and low endotoxin contaminated water (max. 0.25 endotoxin
units/ml); e.g. purified or highly purified water and filtered air for drying.
• Use only detergents that are compatible with the materials used in the the
adapters and speculum. Please see section “Materials resistance” for details
bellow.
• Pay attention to the instructions of detergent manufacturers regarding
concentration, temperature and soaking time as well as post-rinising.
Do not use a metal brush or steel wool to clean the adapter parts especially
mirrors. They will get scratched.

13.2.2. Consumables used for Cleaning and Disinfection

The consumables used for cleaning and disinfection are:

• Regular tooth-brush or suitable brush for surgical instruments cleaning.

13.2.3. Post-Use Wipe Down

Immediately after, or latest in two hours after use, remove the R11 handpiece from
the LA adapter and close it with special protective cover (see Figure 14). Remove
excess body fluids and tissue with a disposable wipe gauze or damp cloth from the
adapter. Flush and rinse using running water.

Figure 14: Attachment of protective cover to the LA adapter.

13.2.4. Preparation for Cleaning

Place the LA adapter with attached protective cover in a disposable container

ready for immediate cleaning and disinfection.

Page 26/33 64653 OM R11 CE ENG 16

13.2.5. Cleaning Procedure

1. Soak the adapter in cleaning solution for the soaking time prescribed by the
detergent manufacturer. Make sure that complete adapter is sufficiently
covered by the cleaning solution.
2. At the beginning of soaking time actively rinse the lumens of adapter and
speculum with cleaning solution.
3. During soaking, brush all external surfaces of the adapter in cleaning solution
with a tooth brush. To correctly accomplish this step please adhere to the
following guidelines:
4. After brushing, leave all parts in the cleaning solution for the remaining of
soaking time prescribed by the manufacturer.
5. Remove all the adapter from cleaning solution and rinse them for 5 minutes in
running water.

13.2.6. Disinfection Procedure

If disinfecting several adapters at once, ensure that they do not come into contact
with each other during the disinfection procedure.
1. Soak the adapter in disinfectant solution. Ensure that all the surfaces are
submerged in the disinfectant solution. Follow the instructions of the detergent
and disinfectant producer.
2. Remove the adapter from the disinfectant solution and post-rinse them at least
5 minutes in running water.
3. Rinse the adapter in purified water for 1 minute.
The suitability of the handpiece adapter for effective cleaning and disinfection , as
described in the procedure above, was demonstrated for a similar applicator by an
independent accredited and recognized (§ 15 (5) MPG) test laboratory. The
cleaning detergent Cidezyme/Enzol and the disinfectant Cidex OPA (both Johnson
& Johnson, Norderstedt) were used*.
*CIDEX®,CIDEZYME® and ENZOL are registered trademarks of Advanced Sterilization Products a
division of Ethicon Inc., a Johnson and Johnson company

13.2.7. Drying Procedure

Dry the adapter’s external surfaces with the oil-free and filtered compressed air.

13.3. Post Cleaning Check

Check the adapter for any visible remains of any impurities, corrosion or damaged
surfaces. Under no circumstances should you continue to use a damaged adapter.
If the adapter remained unclean, despite the cleaning and disinfection procedures,
should be cleaned and disinfected again.

13.4. Packaging
Protective cover should be removed from LA adapter prior to packing.
Pack the cleaned and disinfected adapter into a single-use sterilization package
(single paper/foil) and/or into sterilization containers. The packaging and/or
containers must fulfill the following requirements:

64653 OM R11 CE ENG 16 Page 27/33

 • comply to EN ISO/ANSI AAMI ISO 11607
• be suitable for steam sterilization (temperature resistance up to at least 138°C
(280°F), sufficient steam permeability)
• be sufficiently resistant to mechanical damage and adequately protect the
handpieces and Threaded Cannulae
• be regularly maintained according to the manufacturer’s instructions
(sterilization container)

13.5. Sterilization
Use only sterilization procedures that conform to those listed below to sterilize the
adapter and laser speculum. Sterilization procedures that do not conform to the
criteria below must not be used.
The steam sterilizer must:
• use a gravity procedure (with sufficient product drying)
• conform to EN 13060 or EN 285
• be validated according to EN ISO 17665 --, valid IQ/OQ (commissioning) and
product specific performance qualification
• use a maximum sterilization temperature of 138°C (280°F); plus tolerance
according to EN ISO 17665 --. Sterilization temperatures less than 132°C
(270°F) are not appropriate and may not be used as they do not provide
sufficient sterilization.
The steam sterilization process must:
• not expose any part of adapters or speculum to temperatures higher than
138°C (280°F).
• use a sterilization time (exposure time at the sterilization temperature) at least
15 min at a minimum sterilization temperature of 132°C (270°F)/134°C (273°F).
National requirements may necessitate longer sterilization times (e.g. up to 18
minutes) to inactivate prions.
The suitability of the handpiece adapters and speculums for effective steam
sterilization, as described in the procedure above, was demonstrated for a similar
applicator by an independent accredited and recognized (§ 15 (5) MPG) test
laboratory. A steam sterilizer HST 6x6x6 (Zirbus technology GmbH, Bad Grund)
and the gravity procedure were used. Typical medical practice and clinic
conditions, as well as the above-described procedure, were taken in consideration.

CAUTION
The flash sterilization procedure must not be used.
When sterilizing the LA adapter with other multiple surgical sets in one
autoclave cycle, ensure that the sterilizer’s maximum load is not exceeded.
Please do not expose the adapter to temperatures higher than 138°C
(280°F).
Be sure to remove the protective cover from the LA adapter before starting
the sterilization process.

13.6. Storage
Store sterilized LA adapter and speculums in their sterilization packages, in a dry
dust-free environment.

Page 28/33 64653 OM R11 CE ENG 16

13.7. Materials Resistance
Please take care that the listed substances are not ingredients of cleaning or
disinfection detergent:
• organic, mineral or oxidizing acids (minimum admitted pH-value 5.5, neutral or
enzymatic cleaner recommended)
• strong lyes (maximum admitted pH-value 9.5)
• oxidizing agents (for example: peroxide)
• halogens (for example: clorine, iodine, bromine)
• aromated, halogenated hydrocarbons
Please do not expose the LA adapter to temperatures higher than 138ºC (280ºF).

13.8. Reusability
Frequent reprocessing has marginal consequences on LA adapter parts. End of life
for these devices should be determined based on wear and damage. The gold
coated mirror surface must be free of blurs.
The LA adapter can be reused in case of adequate care and if they are
undamaged and clean. The user is responsible for each further use. Fotona will not
be held liable for damages incurred due to the use of a dirty or damaged LA
adapter. The sterilization of LA adapters is the sole responsibility of the operator.

64653 OM R11 CE ENG 16 Page 29/33

14. MAINTENANCE LA ADAPTER

14.1. Replacing the LA adapter

If damage, unacceptable wear or corrosion is observed on any part of the adapter,
it must be replaced with the new LA adapter from Fotona.

15. WARRANTY
Certain limitations apply to Fotona's warranty. Optical parts, components and
handpieces are warranted for 90 days from the date of shipment from the
manufacturer’s site.
Optical parts (such as, but not limited to, lenses, sapphire windows, fiber tips) and
components that come in contact with the operator or patient while operating the
laser system, and consumables are not under warranty.
The warranty expires if personnel, not authorized by Fotona, take part in any
attempted repairs to the system. The warranty does not apply in the event of
misuse, negligence or accidental damage.

16. DECONTAMINATION OF RETURNED EQUIPMENT

Equipment sent back to Fotona or authorized service facilities for repair, must be
properly decontaminated in order to comply with transportation laws.
The decontamination must be performed with a chemical germicide approved for
use as a "Hospital Disinfectant".
A Decontamination Certificate (provided in this Manual) must be enclosed with the
shipment.
If equipment is received without a Decontamination Certificate, Fotona will assume
that the equipment is contaminated and will charge the customer with the cleaning

Page 30/33 64653 OM R11 CE ENG 16

LIST OF FIGURES
Figure 1: Er:YAG optical handpiece model R11........................................................................................... 8
Figure 2: The Fotona model GA and GC adapter breakdown. .................................................................. 13
Figure 3: The Fotona R11 handpiece with removed tip (spacer) ............................................................... 13
Figure 4: Speculums used for axial and angular positioning of laser spots ............................................... 14
Figure 5: Engraving on Speculum inlet surface for angular positioning ..................................................... 14
Figure 6: Fully assembled GA and GC adapters with R11 handpiece ready to be inserted and guided
through the Speculum. ............................................................................................................................... 14
Figure 7: Assembling the GA (or GC) adapter – fixing the gold mirror. ..................................................... 15
Figure 8: Attaching and fixing the R11 handpiece to the GA (or GC) adapter. .......................................... 15
Figure 9: Fully assembled GA (or GC) adapter with R11 handpiece. ........................................................ 16
Figure 10: Consumables used for cleaning and disinfection...................................................................... 18
Figure 11: Cleaning the gold mirros with disposable cotton pads. ............................................................. 19
Figure 12: The Fotona R11 handpiece with removed tip (spacer) prepared to be attached to Fotona
model LA adapter. ...................................................................................................................................... 24
Figure 13: Engraved circular mark on Fotona LA adapter. ........................................................................ 24
Figure 14: Attachment of protective cover to the LA adapter. .................................................................... 26

64653 OM R11 CE ENG 16 Page 31/33

Page 32/33 64653 OM R11 CE ENG 16
 Decontamination Certificate

The undersigned certifies that the Fotona device being returned herein by

___________________________ _____________________________
Individual/Institution City, State, Country

has been cleaned and is free from biohazards, including - but not limited to -
human or animal blood, tissue or fluids or components thereof.

The undersigned also agrees to reimburse Fotona for any costs incurred in
cleaning the enclosed equipment, in the event said item(s) are received by
Fotona in a contaminated condition.

____________________________________________________________
Model

____________________________________________________________
Serial Number

____________________________________________________________
Typed/Printed Name

____________________________________________________________
Position/Title

____________________________________________________________
Signature and Date

64653 OM R11 CE ENG 16 Page 33/33