A.R.C. Laser Nuvolas User manual

User Manual
A.R.C. Laser GmbH
0123
Bessemerstr. 14
D-90411 Nürnberg
Tel.: [phone]
Fax: [phone]
[email protected]
www.arclaser.de

User Manual NUVOLAS
April 2023
File: User Manual_NUVOLAS_rev3.docx 2
Please contact for service:
A.R.C. Laser GmbH Headquarters:
A.R.C. Laser GmbH
Bessemerstr. 14
D-90411 Nürnberg
Tel.: [phone]
Fax: [phone]
[e-mail]
Copyright © A.R.C. Laser GmbH. All rights reserved.
This document contains confidential and copyrighted information and may only be used
with the devices described herein. Reproduction is prohibited without written permission
from A.R.C. Laser GmbH.
Local distributor

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1INTRODUCTION ..........................................................................................................5
1.1 Marking and Symbols...............................................................................................5
1.2 Intended Use............................................................................................................6
1.3 General Contraindications........................................................................................8
1.4 Theory and Technical Set-up....................................................................................8
2TRANSPORT AND STORAGE ....................................................................................9
2.1 Shipping and unpacking the device..........................................................................9
2.2 Return Shipment ....................................................................................................10
3SET-UP AND INSTALLATION...................................................................................11
3.1 Installation Site.......................................................................................................11
3.2 Room Requirements...............................................................................................11
3.2.1 Marking Access Points.................................................................................11
3.2.2 Window Shielding.........................................................................................11
3.2.3 Reflecting Surfaces......................................................................................12
3.3 Electrical Connection..............................................................................................12
4SAFETY INFORMATION............................................................................................13
4.1 General ..................................................................................................................13
4.2 Eye Safety..............................................................................................................14
4.3 Electrical Protection................................................................................................15
4.4 Explosion and Fire Hazard .....................................................................................15
4.5 Protection against Undesired Radiation..................................................................15
4.6 NOHD Safety Distance...........................................................................................16
4.7 CE Regulations ......................................................................................................16
4.8 RoHS3 regulations.................................................................................................16
4.9 Protective Housing.................................................................................................16
4.10 Connectors and Switches.....................................................................................17
4.11 External Interlock Switch......................................................................................18
4.12 Safety shutter / Aiming Beam...............................................................................19
4.13 Manual Reset.......................................................................................................19
4.14 Reset by Power Failure........................................................................................19
4.15 Labels and Markings............................................................................................20
4.16 Operating Conditions............................................................................................21
4.17 Electromagnetic Compatibility..............................................................................21
5ADVICE FOR USERS.................................................................................................22
5.1 Technical Introduction ............................................................................................22
5.2 Laser-Safety-Training.............................................................................................22
5.3 Medical Introduction ...............................................................................................22
5.4 Device Parts and Accessories................................................................................23
6OPERATION ..............................................................................................................25
6.1 Preparation.............................................................................................................27
6.2 Switch on the Laser................................................................................................28
6.2.1 Select / Add / Edit / Delete a user.................................................................29
6.2.2 Select / Add / Edit / Delete an application.....................................................29
6.3 Programs and Settings...........................................................................................30
6.3.1 Display / Main Menu.....................................................................................30
6.3.2 Settings........................................................................................................34
6.3.3 Service settings............................................................................................35
6.4 Inserting the applicator...........................................................................................36
6.5 READY- / Standby-Button ......................................................................................36
6.6 Release laser radiation...........................................................................................36
6.7 Treatment...............................................................................................................36
6.8 Laser-Stop..............................................................................................................37
6.9 Switch Off...............................................................................................................37
6.10 Symbols Description ............................................................................................38

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7TECHNICAL DATA ....................................................................................................39
7.1 General ..................................................................................................................39
7.2 Laser-Data .............................................................................................................39
7.3 Electrical Connection Data .....................................................................................39
7.4 Classification..........................................................................................................39
8MAINTENANCE .........................................................................................................40
8.1 Introduction ............................................................................................................40
8.2 Safety Check (STK)................................................................................................40
8.3 Care by the user.....................................................................................................41
8.4 Cleaning of accessories .........................................................................................42
8.4.1 Laser safety goggles ....................................................................................42
8.4.2 Applicators ...................................................................................................42
8.4.3 Foot switch...................................................................................................42
8.5 Error Detection.......................................................................................................42
8.5.1 System check...............................................................................................43
8.5.2 Troubleshooting............................................................................................43
8.5.3 Error Codes..................................................................................................44
8.5.4 Error Messages............................................................................................45
8.5.5 Status message............................................................................................45
8.6 Disposal .................................................................................................................45
9CUSTOMER SERVICE...............................................................................................46
9.1 Warranty Information..............................................................................................46
9.2 Warranty Shipment, Packaging..............................................................................46
9.3 Sales and Service Information................................................................................46
10 GUIDELINES AND MANUFCATURERS DECLARATION .........................................47
10.1 Electromagnetic Emission....................................................................................47
10.2 Electromagnetic Immunity (1)...............................................................................48
10.3 Electromagnetic Immunityy (2).............................................................................50
10.4 Recommended separation distances between portable and mobile RF
telecommunications equipment and the laser................................................51

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1 Introduction
We thank you for having chosen our NUVOLAS and wish you every success in using this
versatile laser system.
The NUVOLAS laser generates a laser beam of high intensity, which can cause injuries
if handled improperly. The user manual should therefore be read carefully before starting
up the device. If you have any further questions regarding the safety or the use of the
device or regarding the laser and laser radiation, please contact A.R.C. Laser GmbH.
1.1 Marking and Symbols
The symbol "Attention" is attached to all surfaces that mean danger to the
user. Before carrying out any further work on such marked parts, the
operating instructions should be consulted or the service of A.R.C. Laser
GmbH should be contacted.
The symbol "Attention laser radiation" is intended to warn the user
against directing laser beams to unwanted areas through improper
handling or improper operation of the device.

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1.2 Intended Use
The NUVOLAS is intended to be used for treatments requiring coagulation or
carbonization/vaporization of tissue, bony structures or blood. At high power outputs,
tissue can be carbonized and removed or separated by vaporization.
At low power output, heating of tissue or blood results in enzyme denaturation and
coagulation e.g. of blood vessels. For this effect, the laser is used together with
application fibers aiming the laser beam at the target tissue either directly in contact or
non-contact or via further optics e.g. through handpieces.
The laser effect allows focused treatment of the disease area with minimal impact on the
surrounding tissue.
The laser can be applied both in unsterile environment, for instance at a physician’s
examination room, and in a sterile environment e.g. operating theater.
It can be used in conjunction with e.g. handpieces or endoscopes where the fiber is fed
through the fiber/working channel to allow the physician to treat the desired area with the
laser.
The NUVOLAS is intended to be used for the following applications:
Laryngology
Otology
Rhinology
General Surgery
Medical
field
Indication
Risks
Contraindication
General contraindication:
radiation exposure to the
eye! (exception:
Ophthalmology)
Laryngology/
Oropharynx
Treatments requiring
coagulation or
carbonization/vaporization of
tissue, bony structures or
blood:
•Papillomatosis
•Papillomatosis Varices
•Reinke’s Edema
•Polyps
•Vascular lesions
•Ectasia Varices
•Contact Granuloma
•Leukoplakia
•Dysplasia
•Early Glottic Cancer
•Microvascular angiomata
•Cancer
•Nodule
•Stenosis
•Granulation Amyloid
•Hematomas
•Tonsillectomy
•edema
•bleeding/hemorrhage
•pain
•scar formation/web
formation
•tissue injury (e.g. burning)
•nerve injury
•crusting
•granulation
•swelling
•emphysema
•synechia/stenosis
•general or normal
conventional (non-laser)
operation collateral side
effects
Oxygen level can’t
be lowered below
30% due to previous
illness if used
nearby intubation
tube.

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•Palatoplasty / LAUP
•Trismus
•Cordotomy
•Oral benign lesions
Rhinology
Treatments requiring
coagulation or
carbonization/vaporization of
tissue, bony structures or
blood.
•Epistaxis
•Turbinate surgery
•dryness
•edema
•bleeding
•pain
•granulation
•crust formation
•scar formation
•synechia
•general or normal
conventional (non-laser)
operation collateral side
effects
-
Otology
Treatments requiring
coagulation or
carbonization/vaporization of
tissue, bony structures or
blood.
•Tympanoplasty with and
without ossicular
reconstruction
•Tympanoplasty with
mastoidectomy
•Glomus Tympanicum
tumor
•acoustic trauma
•mechanical trauma (e.g.
floating footplate)
•vertigo
•tinnitus
•sensorineural hearing loss
•general or normal
conventional (non-laser)
operation collateral side
effects
-
General
Surgery
Treatments requiring
coagulation or
carbonization/vaporization of
tissue, bony structures or
blood.
•edema
•bleeding
•pain
•scar formation
•granulation
•swelling
•tissue injury
•general or normal
conventional (non-laser)
operation collateral side
effects.
Oxygen level can’t
be lowered below
30% due to previous
illness if used
nearby intubation
tube.

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1.3 General Contraindications
The NUVOLAS is not intended to be used for interventions of the central circulatory
system (arteriae pulmonales, aorta ascendens, arcus aortae, aorta descendens to the
bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa,
arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis,
venae pulmonales, vena cava superior and vena cava inferior). Furthermore, the
NUVOLAS is not intended to be used for treatments on the central nervous system (brain,
meninges and spinal cord).
1.4 Theory and Technical Set-up
The NUVOLAS is a diode laser with a wavelength of 514 nm. The laser radiation of the
diode is collimated by optics and coupled into the applicator.
The laser light is coupled into a quartz fiber via deflection mirrors and coupling parts. The
transmission ofthe different wavelength is independent for thefiber. Transmissions in the
range of 80% to 90% of the laser power are possible. The laser source is brought to and
maintained at the prescribed operating temperature via direct cooling. The passive
cooling circuit is controlled via fans.
The laser beam of the diode is polarized and therefore very easy to control.
A T T E N T I O N
The device may only be operated by specially trained personnel who are experts in the
medical effects and possible dangers of the device. You must have the necessary skills
use the laser in accordance with this instruction manual.
When not in use, the device should be protected against unauthorized use.

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2 Transport and Storage
We at A.R.C. Laser GmbH will make sure that the device is packed and transported with
the greatest possible care.
Before unpacking the laser, please check the packaging for damage and report any
damage immediately to the shipping agent and A.R.C. Laser GmbH. Only remove the
packaging in the presence of a representative of the carrier. Make a list of the damaged
parts and have this list signed by the courier.
The device must be transported at temperatures between -10° C and +60° C. The air
pressure during transport must be between 1080 hPa and 750 hPa. During storage, a
temperature range of -10° C to 60° C must be maintained. The environment/air must be
dry and clean. The relative humidity during transport and storage must be below 85 %.
2.1 Shipping and unpacking the device
Unpacking and installation of the device will be carried out by an authorized technician or
authorized representative of A.R.C. Laser GmbH. After the installation and the correct
connection of the device, the technician will put the device into operation and explain the
function of the device. All functions and safety procedures are discussed and
demonstrated here.
A T T E N T I O N
If the laser is transported or stored in temperatures below -10° C, it can be damaged
when starting. Unpack the laser and leave it at least eight hours at normal room
temperature so that the system reaches room temperature.

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2.2 Return Shipment
If you ship the device back to A.R.C. Laser GmbH, please use the carrying case for
transportation and shipping.
The transport packaging is designed so that
the unit fits exactly in the foam.
All accessories are stored in a suitable extra
packaging inside the transport box. A distance
holder is placed between the laser and the
display packaging.
If all the foam parts are in the right place and the
box is closed, the unit is ready for shipping.
Distance holder
(VP01093)

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3 Set-up and Installation
3.1 Installation Site
Before the device is delivered, it must be ensured that the laser can be set up in a suitable
location.
The NUVOLAS should be operated in an easily accessible place. The laser should not
be operated near a heater, since air cooling works best when the ambient temperature is
not higher than 28° C. Higher temperatures can cause the device to switch off due to
overheating. A place of installation in direct sunlight can cause an early shutdown and
must be avoided in any case.
If the temperature is too low (below 18° C), the device cannot be started to prevent
condensation on the internal optics; this could result in permanent damage to the laser.
•The device should be set up so that the laser beam is not aimed directly at a door,
window or reflective material.
•The device should be operated in a dust-free room. There should be no carpets on
the floor or the walls.
When the device is not in use, it should be stored in the acrrying case. The wiring must
be installed so that there are no tripping hazards or other hazards
All control elements must also be free and easily accessible. The air humidity is monitored
internally and must be below 75 %.
3.2 Room Requirements
The legislation imposes the following requirements to any room in which a class 4 laser
according to IEC 60825-1 is operated.
3.2.1 Marking Access Points
All entrances must be clearly marked so that unintentional or unauthorized entry, which
can lead to a hazard, is avoided.
•Laser warning signs (triangle with laser symbol) and the wavelength labeling
must be attached to each access door.
•A warning lamp must be attached above each access door. This must always
light up when the laser is in operation.
•Unintentional entry into the room without safety glasses is avoided.
•The laser safety goggles must be easily accessible at the entrance.
3.2.2 Window Shielding
It must be ensured that no laser radiation can escape the room. Inparticular,the windows
must be secured with suitable materials. If you have any questions, your contact person
at A.R.C. Laser GmbH is available to assist you.

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3.2.3 Reflecting Surfaces
To avoid danger from reflected direct and scattered radiation, there must be no reflective
surfaces in the room.
These can be:
•Mirrors
•Pictures behind glass
•Chrome surfaces
•Windows
These surfaces must be removed or suspended or matted. In the area of laser use, only
matted, non-reflective and non-flammable instruments and materials should be used.
3.3 Electrical Connection
The laser is operated with 230 V AC by an integrated power supply. The power supply is
approved by A.R.C. Laser GmbH especially for the NUVOLAS; only this power supply is
approved to be used.
The power supply unit can be connected to 100 V to 240 V AC voltage (50 Hz / 60 Hz).
A T T E N T I O N
To protect against electric shock, the unit must be connected to a power supply with a
protective earth conductor.
A T T E N T I O N
Different input voltages require different fuse values!
230 V 2xT 3.15A
110 V 2xT 6.3A
Do not use excessive fuses when operating the laser.

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4 Safety Information
4.1 General
The NUVOLAS laser is a precision instrument for medical applications. The system has
been carefully developed and tested through intensive testing before shipping. In order
to offer you and the operating personnel all possible protection, we recommend that you
read this section of the operating instructions carefully.
The NUVOLAS falls under laser class 4 according to EN 60601-2-22, EN 60825-1
respectively.
Class 4 in the standard describes high-energy lasers and therefore special measures
must be taken before commissioning in orderto ensure safe andtrouble-free working with
the device. It is particularly important to protect the eyes and skin of the operator, the
patient and third parties. Laser safety glasses must be used for eye protection.
The following explanations are not exhaustive. All users of laser devices should enclose
applicable legal regulations and provisions with the device and inform the staff
accordingly.
If the device is operated outside Germany, provisions of the American National Standard
Office ANSI Z136.3-2018 "American National Standard for the Safe Use of Lasers in
Health Care Facilities" and ANSI Z136.1-2014 "American National Standard for the Use
of Lasers” must be respected.
This manual is limited to the operation, maintenance and control of the device. The
manual is not a guide for the treatment of diseases that can be remedied by laser.
With regard to the devices supplied, such as fibers or probes, the safety, operating and
maintenance instructions in the corresponding manuals must be observed.
A.R.C. Laser GmbH cannot be held responsible for damage or damage resulting from
improper use.
The warranty for the device expires if the laser has been opened (even partially), modified
or repaired by unqualified personnel.

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4.2 Eye Safety
As a safety measure against direct or indirect laserradiation, it is necessarythat everyone
in the room wear laser safety glasses.
When using the laser, only those laser safety glasses may be used which are designed
for the respective wavelength, with the appropriate protection level and a CE mark.
The following laser safety glasses from A.R.C. Laser GmbH are suitable for the
NUVOLAS:
•AS01003: Protection level D LB6 + I LB6 + RM LB 8 / Optical density OD8+
There are different types of laser safety glasses that also allow spectacle wearers to wear
a tight goggle on top of their own which are protective to all sides. In particular, the
scattered radiation that does not directly come from the front of the eye may present risks
resulting from internal reflections on the glasses. Therefore, we encourage you to wear
laser safety glasses which also guarantee a full protection to the side parts.
When using a microscope, either laser safety glasses can be worn or it is possible to
install an eye safety filter firmly into the beam path of the microscope. Please note that
when using a beam splitter in the microscope, the eye safety filter is installed below the
beam splitter to protect all outgoing beams above at the same time. Optionally, it is also
possible to equip each individual beam path with an eye safety filter.
The following eye safety filters from A.R.C. Laser GmbH are suitable for the NUVOLAS
and can be seen as external accessories of the laser system:
•BG06076/ BG06077: Optical density OD5+
The eye safety filters must be firmly installed in the respective microscope and checked
by an employee of A.R.C. Laser GmbH or an authorized representative during delivery.
A T T E N T I O N
Never look directly at the laser beam or in the light reflected by the laser beam. This
will cause damage to your retina.
A T T E N T I O N
Third persons in the operating room, still have to wear laser safety goggles even if an
eye safety filter is used.

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4.3 Electrical Protection
Never remove the housing parts of the laser. Work on the device may only be carried out
by authorized A.R.C. Laser GmbH service personnel.
The room in which the laser is operated should be kept dry. In the event that cleaning is
necessary, make sure that the floor is dry before starting up the device.
4.4 Explosion and Fire Hazard
Never work with the laser near flammable anesthetics, flammable solutions or other
flammable materials. Flammable plastic parts or paper parts in particular should also be
removed from the working area of the laser. There is a fire or explosion hazard if the laser
is used in the presence of flammable materials, solutions, or gases or an oxygen-enriched
environment
4.5 Protection against Undesired Radiation
By using a foot switch the NUVOLAS emits laser radiation. The foot switch should never
be outside the area of the attending doctor. It is not allowed for anyone other than the
attending doctor to trigger the foot switch.
Especially in operating theaters where there are multiple foot switches, it is important to
ensure that the laser foot switch is close to the laser device.
A T T E N T I O N
Never use the laser if you notice any visible defect on the device.
Never use the device if you notice any visible defect on the power plug, wires or supply
lines are exposed.
A T T E N T I O N
Laser radiation must not be applied if the oxygen concentration of the treatment
environment is greater than 30% (e.g. during ventilation). There is a risk of fire!
If an intubationtube is used for treatments in the pharynx/larynx and oralcavity, a laser-
safe intubation tube is required.
There is danger to life here!

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4.6 NOHD Safety Distance
The NOHD (Nominal Ocular Hazard Distance) is the distance at which the irradiance is
equal to the exposure limit value of the cornea of the eye. The NOHD identifies the danger
area within which there is a risk of damage to the health of the eye if you look directly into
the laser beam without protection.
The NOHD is calculated according to EN 60825-1 and taking into account the permitted
power fluctuations (+/- 20%) according to EN 60601-2-22 using the following equation:
𝑁𝑂𝐻𝐷 = √4∗𝑃
𝑀𝑍𝐵∗𝜋− 𝐷𝑖𝑎𝑚𝑒𝑡𝑒𝑟 𝐿𝑎𝑠𝑒𝑟 𝑏𝑒𝑎𝑚
𝐵𝑒𝑎𝑚𝑠 𝑑𝑖𝑣𝑒𝑟𝑔𝑒𝑛𝑐𝑒
4.7 CE Regulations
The laser system NUVOLAS has been approved by the notified body in accordance with
the European Directive 93/42/EEC for medical devices. Accordingly, the device bears the
CE mark CE 0123.
The device has been checked for electrical and mechanical safety. All parts we use
comply with the CE regulations or have been tested for approval or suitability by the
notified body.
Additional devices that you attach to the device require approval from an official test
center. Changes to the device or interventions on your part will void the approval and
warranty.
The test approval number is included with the device.
4.8 RoHS3 regulations
Our company operates worldwide and regards the protection of the environment and
natural resources as an entrepreneurial obligation. Based on individual tests, A.R.C.
Laser GmbH confirms that, to the best of our knowledge, our products do not contain any
substances in concentrations whose placing on the market is prohibited according to the
applicable requirements of Directive 2015/863/EU (RoHS 3).
4.9 Protective Housing
The NUVOLAS laser system has a protective housing. It prevents radiationfrom the laser
from escaping and protects users from touching live parts. This housing must not be
removed.
Wavelength λ: 514 nm
NOHD: 1.8 m
Beam divergence α(full angle): 25.4°
Permitted Maximum Radiation: 1.9x10³ Jm-2

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4.10 Connectors and Switches
On the back of the device the following connect
On/Off
switch
Foot
switch ●
AUXII
●
Power
connection
Door
interlock●
Ventilation
Do not block
Touch
screen
●
Grounding
AUXI ●
Service
connector
●
AUX III ●

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It is prohibited to use the device's sockets for other usages than those detailed here.
Port
Description
Note
Color
Touch
screen
Connector for the A.R.C. Laser
touch screen
To control the NUVOLAS
Green
AUX 1
Currently without use
Black
Foot
switch
Connector for the A.R.C. Laser
foot switch
Only use accessories approved and
tested by A.R.C. Laser.
Blue
Door
interlock
Connector for the door interlock
switch
The door interlock switch must be
designed for at least 12V and 20mA.
Light red
AUX 2
Warning light / smoke evacuation
Optional
Orange
AUX 3
Currently without use
Dark red
Service
port
Connector for service cable
The service port may only be used by
A.R.C. Laser service personnel.
Yellow
Power
Supply
Connection for medical approved
power supply, A.R.C. Laser
Use A.R.C. supplied and approved
accessories only
-
4.11 External Interlock Switch
A door interlock switch is required by the accident prevention regulations. The device is
equipped with an interlock connector as standard, which can be replaced by a door
interlock switch. The laser switches off when the door is opened. In addition, the laser
cannot be switched to the READY mode when the door is open. An error message
appears on the control panel. When the door is closed, the error message disappears
and the laser can be switched READY again.
When installing a door interlock switch, note the following:
The switch and wiring must be provided for at least 12 V and 20 mA. The wires should
end with a standard male connector. The choice of polarity is expedient in both variants.
The socket for connecting the door switch can be found underneath the table. Insert the
door switch connector there.
Make sure the socket is stucks firmly to prevent unexpected system interlock problems.
ACHTUNG
To avoid the risk ofelectric shock, this devicemust only beconnectedto asupply network
with a protective earth conductor.

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4.12 Safety shutter / Aiming Beam
The NUVOLAS has an internal safety shutter. This shutter is opened mechanically by
inserting the fiber. Only if a fiber is properly plugged in, the laser can be switched into
READY mode by pressing the READY button.
The aiming beam is only visible when a fiber is plugged in and the laser is in the READY
mode. This aiming beam is a laser beam with very low power.
4.13 Manual Reset
If an error occurs, the system switches into STANDBY mode and an error message is
shown. A restart should fix the error due to the automatic recalibration. Please refer to
chapter 8.5.3 to identify the error messages.
If the error still occurs, this can only be remedied by trained personnel. Please contact
the service of A.R.C. Laser GmbH in this case.
4.14 Reset by Power Failure
If the device is disconnected from the power grid accidentally - e.g. due to a power failure
- it usually restarts automatically. The system recalibrates and deletes all unsaved
settings. If there is still an error, it can only be corrected by trained personnel. Please
contact A.R.C. Laser GmbH service department should this occur.

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4.15 Labels and Markings
The NUVOLAS is provided with various warnings in accordance with European and
worldwide guidelines. This is to prevent the laser user from being exposed to laser
radiation due to carelessness.
TYPE PLATE
(on the backside of the device)
1. Manufacturer
2. Laser name
3. Wavelength, Power
4. Power consumption
5. Serial number (SN)
6. Manufacturing date
7. Medical device (MD)
8. No disposal in domestic waste
9. Unique Device Identification
(UDI = SN + GTIN + manufacturing date)
10. Global Trade Item Number (GTIN)
11. CE mark
12. Applied part type BF
13. See instructions for use
WARNING LABELS
Marks the laser exit and the used
wavelength.
The NUVOLAS may only be used
with Fibers and Probes which
consists of an U.C. connector.