A.R.C. Laser C-Pro User manual

User Manual
C-Pro Micromanipulator
Medical Device
A.R.C. LASER GmbH
Bessemerstr. 14
90411 Nürnberg
Germany
phone [phone]
fax [phone]
[email protected]

In case service is required please contact:
A.R.C. LASER GmbH
Bessemerstr. 14
D-90411 Nürnberg/Germany
TEL [phone]
FAX [phone]
Revision:
Date
Nov. 22 2017
File
Manual_C-PRO_10600nm_rev3.docx
Revisions-Date
12.10.2020
Author
Christin Bartlog, Markus Graf
Revised
Dr. R. Walker

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1INTRODUCTION ..........................................................................................................5
1.1 Copyright......................................................................................................................................5
1.2 Marking and Symbols..................................................................................................................5
1.3 Intended Use ................................................................................................................................6
2THEORY AND TECHNICAL BACKGROUND OF A MICROMANIPULATOR..............7
2.1 Functionality ................................................................................................................................7
2.2 Mirror and Lens-Based Systems................................................................................................7
3TRANSPORT AND STORAGE.....................................................................................9
3.1 Transport Case ............................................................................................................................9
3.2 Case Contents..............................................................................................................................9
3.3 Storage Conditions....................................................................................................................10
4INSTALLATION..........................................................................................................11
4.1 Installation Site ..........................................................................................................................11
4.2 Room Requirements..................................................................................................................11
4.2.1 Warning signs.........................................................................................................................11
4.2.2 Windows shielding..................................................................................................................11
4.2.3 Reflecting surfaces.................................................................................................................11
4.3 Inspection of C-Pro....................................................................................................................12
4.3.1 Inspection of deflection mirror ................................................................................................12
4.4 Connecting the C-Pro to the Surgical Microscope ................................................................12
4.4.1 Microscope compatibility ........................................................................................................12
4.4.2 Connecting the C-Pro.............................................................................................................13
4.5 Connecting the Micromanipulator to the Laser......................................................................14
4.5.1 Connecting the articulated arm...............................................................................................14
4.6 Orientation of the laser .............................................................................................................15
4.6.1 Operating area........................................................................................................................15
4.6.2 Angular position of the articulated arm...................................................................................15
5SAFETY INFORMATION AND TECHNICAL ACCEPTANCE ....................................17
5.1 General........................................................................................................................................17
5.2 Warnings and Regulations .......................................................................................................17
5.3 Eyewear Protection ...................................................................................................................19
5.4 Explosion and Fire Hazard........................................................................................................20
5.5 Protection against Undesired Radiation .................................................................................20
5.6 NOHD Safety Distance ..............................................................................................................20
5.7 CE Regulations ..........................................................................................................................21
5.8 RoHS2 Regulations ...................................................................................................................21
5.9 Stickers Labels and Markings..................................................................................................21
5.10 Operating Conditions:...............................................................................................................22
6USER INFORMATION AND SYSTEM INTRODUCTION............................................23

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6.1 Technical Introduction Training...............................................................................................23
6.2Medical Introduction Training ..................................................................................................23
6.3 Medical Device Parts and Accessories ...................................................................................24
6.3.1 C-Pro micromanipulator..........................................................................................................24
6.3.2 Accessories ............................................................................................................................25
6.4 Spot Diameters and Energy Densities.....................................................................................26
7OPERATION...............................................................................................................27
7.1 Working Distance ......................................................................................................................27
7.2 Defocusing of aiming / laser beam ..........................................................................................28
7.3 Controlling the laser beam .......................................................................................................29
7.4 Dismantling ................................................................................................................................29
7.5 Quick guide ................................................................................................................................30
7.6 C-Pro performance test after installation................................................................................30
8TECHNICAL DATA ....................................................................................................31
8.1 Dimensions.................................................................................................................................31
8.2 General........................................................................................................................................31
9SERVICE....................................................................................................................32
9.1 Introduction................................................................................................................................32
9.2 Care and Maintenance (by the user)........................................................................................32
9.2.1 Cleaning the exterior surfaces................................................................................................32
9.2.2 Cleaning the deflection mirror.................................................................................................32
9.3 Error Detection and Troubleshooting......................................................................................36
9.4 Proper Disposal .........................................................................................................................36
10 CUSTOMER SERVICE...............................................................................................37
10.1 Warranty Information ................................................................................................................37
10.2 Warranty Consignments, Packaging.......................................................................................37
10.3 Sales and Service Information .................................................................................................37

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1 Introduction
We are pleased to see that you have chosen our C-Pro and wish you every success in
your handling and application.
The mirror-based C-Pro micromanipulator made by A.R.C Laser GmbH is a high-precision
optical assembly, which perfectly meets the high requirements of microscopic laser
surgery.
This manual contains detailed information on the function, installation and handling of the
C-Pro micromanipulator.
The C-Pro allows precise control of CO2 laser beams, which may cause injuries if handled
improperly. The operating instructions should therefore be carefully read before the device
is put into operation. For further questions regarding the safety or application of the device
or the laser and the laser radiation, please contact A.R.C. Laser GmbH.
A T T E N T I O N !
We are obliged by local laws to sell this device only to licensed physicians, through our
local authorized dealer, which holds a valid MDEL (Medical Device Establishment
License).
1.1 Copyright
This user manual is protected under copyright. The copyright prohibit any duplication of
parts or of the entire user manual without an explicit written consent by A.R.C. Laser
GmbH.
Approved copy or parts extracted from this user manual, as licensed by A.R.C. Laser
GmbH, shall include references to the original document and author as stated in this
original document. Furthermore, this copyright applies to any translated copy of the user
manual to other languages.
We would like to point out, that this user manual was prepared based on A.R.C. Laser
proprietary data and to the best of our knowledge. A.R.C. Laser reserve the rights to
revise, renew or modify any of the included drawings, images or text without further notice.
In case of any content change, the revised document will be readily available for the
regulatory authorities.
1.2 Marking and Symbols
The international sign "Attention" is attached to all surfaces, which are
hazardous for the user. Before carrying out any further works at such marked
parts, please read the user manual or contact your local dealer or contact
directly to A.R.C. Laser GmbH service department.
The laser radiation sign is intended to warn the user against aiming laser
beams to undesired surfaces by improper handling. The laser beams of this
device are not visible. When using the protection goggles filtering such beams,
the user can neither identify nor see the beams.

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1.3 Intended Use
The micromanipulator allows to couple lasers (for example, CO2C-Las laser, A.R.C. Laser
GmbH) to common surgical microscopes. The C-Pro is used to precisely position and
focus the laser beam. The main fields of application are indications in the field of ENT and
gynecology.
CAUTION - The device may only be operated by specially trained personnel who have
knowledge of the medical effects and possible dangers of the device. You need the
necessary skills to use the micromanipulator in accordance with this manual.
The device, which is not in use, should be protected against unauthorized use.

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2 Theory and Technical Background of a
Micromanipulator
2.1 Functionality
By using a micromanipulator, microscopy-based indications can be performed with the
CO2laser. To this effect, it is necessary to have the laser beam path coincide with the
observation beam path. This can be effected by using mirrors or lenses (see figure 1). By
means of joystick control, it is possible to navigate the beam in the field of vision.
Fig. 1: Beam path at the micromanipulator
2.2 Mirror and Lens-Based Systems
Micromanipulators are divided into mirror-based and lens-based systems, depending on
their structures.
The benefit of mirror-based systems as compared to lens-based systems is the avoidance
of chromatic aberration and thus the avoidance of the chromatic enlargement difference. In
simple terms, this means that in the case of the C-Pro, the focus point of the target beam
and the effect beam lie in one plane. In the case of lens-based systems, the focus points
lie in different planes (see figure 2)

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Fig. 2: left - beam path of lens-based micromanipulator; right - beam path of mirror-based micromanipulator
Since the A.R.C. Laser GmbH attaches great importance to surgical precision, mirrors are
installed in the C-Pro instead of lenses - as is common with many other manufacturers.
If the operating field is very weakly illuminated, two target beams may be seen due to the
light refraction at the deflecting mirror. For the treatment, it is important to use the more
intense one of the two target beams for positioning. The weaker target beam is merely the
result of optical effects and is completely safe for the physician and patient.

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3 Transport and Storage
3.1 Transport Case
The C-Pro micromanipulator is delivered in a special transport
case (see figure 3). The transport case is designed in such a
way that the C-Pro can be stowed and transported perfectly by
the user for any change of premises or applications.
This case can conveniently be placed on the drawer of the C-
Las trolley.
Fig. 3: C-Pro transport case
3.2 Case Contents
In the case there is a foam insert with recesses for any accessory required for the
connection and the application of the micromanipulator (see figure 4).
Note: The C-Pro and all accessories should always be stowed in the appropriate recesses
in the case after use.
The joystick and the dovetail of the C-Pro must always point towards the cover.
Fig. 4: Correct positioning of the C-Pro and equipment in the case;
* Additional accessories, not included in ZU12000
Cover compartment for operating manual
Handrest long
Cleaning Set
(1x pipette bottle, 1 x tweezer, 1 x cleaning
cloths
Dovetail ZEISS Microscope:
Sensera/Movena/Vario
C-Pro micromanipulator
Dovetail ZEISS Microscope:
Pentero *
Dovetail LEICA Microscope*
Threaded adapter for articulated arm
Adapter ring microscope cover*

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Checking the scope of delivery:
The delivery should be matched with the delivery note in order to verify the goods
received. Please inform A.R.C. Laser GmbH as soon as possible in case parts are missing
or damaged.
3.3 Storage Conditions
Transport and storage conditions
Temperature
-10°C to +60°C
Relative humidity
5%-85%
The C-Pro should be transported and stored only in its original carrying case to avoid
damage.
The C-Pro should be protected against water and moisture!

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4 Installation
4.1 Installation Site
Since the C-Pro is connected to an existing surgical microscope, the requirements
imposed by the microscope manufacturer apply to the installation site.
Please read the operating instructions to find out about the conditions required for the
installation of the laser.
4.2 Room Requirements
Legislation imposes the following requirements to any room in which a class 4 laser
(according to EN 60825-1) is operated.
4.2.1 Warning signs
All ingresses shall be clearly marked to prevent an outside person from entering, as this
might be hazardous.
Please attach the laser warning sign (triangle with laser symbol) as well as the
wavelength marking at each access door.
Please mount a warning lamp above each access door, which always has to light up,
when the laser is in operation.
This ensures warning to prevent accidental entry to the room without protective
goggles.
Please store the laser protective goggles at the entrance of the room and make sure
they are readily accessible.
4.2.2 Windows shielding
Windows need to be covered with suitable masking or shielding to prevent laser radiation
leakage. For any question or in case of any doubt, please contact your local A.R.C. Laser
authorized dealer, or contact directly to A.R.C. Laser GmbH at any time.
4.2.3 Reflecting surfaces
To avoid possible danger caused by reflected radiation direct or scattered, reflecting
surfaces must not be present in the room during operation. Such surfaces may include
mirrors
pictures with front glass
chrome surfaces
windows
These surfaces must be either removed or covered with suitable matt type material. Even
at the area around the laser fiber port, use only matted, non-reflecting as well as non-
combustible instruments and materials

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4.3 Inspection of C-Pro
Before connecting the micromanipulator, please check for possible damage and
contamination. Pay special attention to the inspection of deflection mirror.
4.3.1 Inspection of deflection mirror
It is very important that the surfaces of the deflecting mirror are free of impurities.
The following steps are recommended for the best possible inspection:
1. Place the micromanipulator on a lint-free cloth, which has previously been placed
on a table in a clean, lint-free environment. Adjust the micromanipulator with a light
of high illuminance (> 75W).
2. Turn the micromanipulator with clean, dry hands so that the entire surface of the
deflection mirror is visible.
3. Inspect the top and the underside of the deflection mirror for burn-in and
contamination. Hold the micromanipulator in a firm grip.
4. Note: Never touch the coated side of the deflection mirror.
5. If cleaning is necessary, please find the cleaning instructions in chapter 9.3.
4.4 Connecting the C-Pro to the Surgical Microscope
4.4.1 Microscope compatibility
The C-Pro can be adapted to the following microscopes. The following table contains the
adapters for the common microscope types, including the article number.
Microscope
Adapter
Article number
ZEISS OPMI
Sensera / Movena / Vario
dovetail ZEISS OPMI
Sensera / Movena / Vario
ZU02004
ZEISS OPMI Pentero
dovetail ZEISS OPMI Pentero
ZU02005
LEICA / wild (W/Cut-out)
dovetail LEICA M525
ZU02006
Haag Streit Hi-R 700
Dovetail Haag Streit Hi-R 700
ZU02007
Other dovetail adapters for microscopes only on request.
Adaption to ZEISS OPMI PICO and LEICA M300 is not possible.

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4.4.2 Connecting the C-Pro
The following steps are necessary to adapt the micromanipulator to the microscope
1. Please screw the adapter plate to the microscope. (if not pre-mounted)
2. Screw the adapter for the articulated arm completely to the thread on the
micromanipulator (see figure 5).
3. Push The dovetail adapter attached to the micromanipulator into the adapter plate
so that the lens of the microscope is located centrally above the housing of the
micromanipulator. As a rule, lens and housing diameters are the same.
4. Tighten the thumbscrew of the adapter plate.
The C-Pro is now fixed (see figure 6).
Fig. 5: Screwing the articulated arm adapter
Fig. 6: C-Pro fixed to the surgical microscope; lense of the microscope has to be centered with the
housing of the mirror

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4.5 Connecting the Micromanipulator to the Laser
4.5.1 Connecting the articulated arm
1. Make sure the laser is off.
2. Unscrew the black dust cap from the articulated arm.
3. Inspect the thread of the articulated arm. It must be clean and undamaged.
4. Screw the articulated arm to the C-Pro with the thread adapter. Make sure the
articulated arm is in the correct position. (see figure 7-8). The articulated arm is taken
out of the holder by means of slight pressure of the two fingers, so that the
connecting joint between the two legs assumes the position as shown here.
When the arm is correctly aligned, the
green symbol is visible.
In case the articulated arm is in the wrong
position, a red warning symbol shows up.
Fig. 9: Wrong position of the
articulated arm
Fig. 7-8: The correct way to open the articulated arm

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4.6 Orientation of the laser
4.6.1 Operating area
Fig. 10: The laser must be placed in the operating theater in such a way that the articulated arm moves in the illustrated operating area.
The laser must be positioned in such a way that the articulated arm is within the operating
range shown in figure 10.
4.6.2 Angular position of the articulated arm
The two arms of the articulated arm must have an angle of between 90° and 120°.
Fig. 11: Correct angular range of the articulated arm legs; the minimum and maximum working angles are shown on the right.

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The correct angular position can be checked by means of the marking on the connecting
joint of both legs. The angle mark (green arrow on the second leg) must be in line with the
angular range mark (red-green-red label on the first leg) (see figure 11 - right).
After the laser has been placed in the positions described in 4.5.1 and 4.5.2, the laser and
the operating microscope can be switched on.
Both the micromanipulator and the laser may only be operated by trained personnel.
Fig. 12: Complete installation of C-Pro on micromanipulator and C-Las

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5 Safety Information and Technical Acceptance
5.1 General
The C-Pro Micromanipulator is a precision instrument for medical applications. A.R.C.
Laser has devoted the utmost care for safety aspects during its design and manufacturing
as well as implementing intensive testing procedures prior to shipment, to ensure the
device you are receiving is safe to use.
The C-Pro is an accessory for the CO2laser. This laser is classified according to EN
60601-2-22 or EN 60825-1 in the laser class 4.
Class 4 of the standard describes high-energy laser and therefore special actions must be
taken before using the device to ensure safe and proper use. In particular, it is important to
protect the eyes and the skin of the operator, the patient and accompanying persons.
Laser safety goggles must be used, and to carry out appropriate actions to clothing. In
particular, you have to protect yourself from reflected laser light. Additionally in the room -
in which the laser is operated - no flammable materials are to be stored.
Even though the safety information included in this manual is detailed, it is not intend to
replace industry standards and guidelines for laser safety.
We would recommend keeping the document “Operation of Laser Facilities and Accident
Prevention Regulations for Laser Radiation” which may be obtained through your local
authorized dealer.
In addition, you can refer to the regulations of the American National Standard Agency
ANSI Z136.3-1996 "American National Standard for the Safe Use of Lasers in Health Care
Facilities" and ANSI Z136.1-1995 "American National Standard for the Use of Lasers“.
Our local dealer's technical support department will gladly answer any questions you may
have and provide you with appropriate training as well as assist with obtaining additional
industry standards and guidelines for laser safety.
5.2 Warnings and Regulations
1. All A.R.C. Laser GmbH lasers are class 4 lasers. Therefore, precautions must be
taken to prevent the spread of direct and indirect laser radiation outside the operating
field. Reflections or scattering of the laser beam may cause serious damage to eyes
and skin.
2. During installation and maintenance, avoid exposure to laser radiation.
3. The use of the C-Pro requires that the operating instructions of the microscope and
the laser have been carefully read and that the users are familiar with the safe and
intended use of these devices.
4. The C-Pro is to be used only by persons who have been trained in the use of laser
systems.
5. The wavelength of a CO2laser (10,600nm) is located in the electromagnetic
spectrum in the middle range of the infrared radiation. This wavelength is invisible to
the human eye, but it is not harmless. It is therefore important to wear protective
goggles during the entire treatment.
6. The laser must not be placed in the vicinity of easily flammable or explosive
substances, e.g. anesthetics, alcohol or disinfectants.

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7. Plastic objects, such as specula and goggles, might melt under the influence of the
laser beam, which could lead to fire-causing chemical reactions.
8. When the laser is used in laryngologic indications, please take care that materials
used in the operation, e.g. laser tubes, endotracheal tubes, adhesive tapes,
ointments and medical solutions are protected from catching fire. This can be
achieved by the use of fire-resistant instruments, venturi ventilation, humidification
and non-burning gas mixtures. The anesthesia staff should use fire-resistant, laser-
resistant tubing. In addition, the oxygen concentration must be reduced.
9. The smoke produced during the treatment may affect the physician's field of vision,
be toxic, and contain tissue particles. In order not to endanger the health of the
persons in the room, the smoke must be dissipated through a smoke extractor
designed for use with medical lasers.

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5.3 Eyewear Protection
A T T E N T I O N !
Never look directly into the laser beam or to the light reflected by the laser beam. Never
look directly into the exit of the fiber optics or into the exit of a laser optics (e.g. hand piece)
as this will cause serious eye injury.
Protective eyewear for both the operator and the patient needs to be able to stop laser
radiation coming from all directions from striking the eye. This is clearly defined by
accident prevention regulations.
When using the C-Pro with the CO2laser (invisible and visible light), only those laser
safety glasses designed for the wavelength and bearing the CE mark and the protection
class OD 8+ for 10600 nm may be used. Protective goggles - according to approval - are
available from A.R.C. Laser GmbH.
Please address reorders to A.R.C. Laser GmbH, indicating the wavelength or the item
number of the goggle.
Should you require any additional information on protective goggles, please contact your
local A.R.C. Laser authorized dealer.
There are different types of goggles that allow spectacle wearers to wear tight goggles on
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 the goggles, which also guarantee a full protection to the side
parts.
The treatment space should not to be opened during the treatment from outside. In
addition, a warning light should be attached on the outside. When operating with the laser
this warning light must be turned on. In addition, sufficient goggles should be present in the
room to be provided to any accompanying persons with glasses. For the patient, a patient-
compliant eye protection has to be ensured.

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5.4 Explosion and Fire Hazard
A T T E N T I O N !
Never work with the laser in the vicinity of easily flammable anesthetics such as oxygen
and oxygen-enriched atmosphere (special mechanical ventilation!) easily flammable
solutions or material. In particular, please remove combustible plastic or paper elements
from and around the operating area of the laser. Focusing the green or IR laser beam on
flammable materials may ignite these and cause a fire or explosion!
When working with the laser, make sure the laser is switched from READY mode to
STAND-BY mode, in case the treatment has to be interrupted. This will assure that no
laser radiation will be emitted due to unintentional stepping on the pedal switch.
5.5 Protection against Undesired Radiation
Never grip the hand piece or fiber tip with their exit pointing or touching your exposed skin
as this may cause burns to the skin. Do not focus the laser beam on easily flammable
materials as this may cause a fire.
The pedal switch controlling the laser Pulse should never be outside the range of the
operator holding the laser hand piece/fiber. It is prohibited that any person other than the
operator controls the pedal switch.
In operating rooms in which several pedal switches are available, it is particularly important
to make sure that the laser pedal switch is in within the operator vicinity.
A T T E N T I O N !
During a laser treatment, the system is in "Ready" mode. Should the operator need to
pause the treatment for any reason; the laser must be switched back to "Stand-by" mode.
In case of pauses exceeding 1 minute, please press the "Ready" key.
The device must be turned off when left without supervision, to prevent usage by
unauthorized individuals.
5.6 NOHD Safety Distance
The values listed below are based on:
BGI 832 - Operation on Laser Devices
Application of safety regulations
„Laser Radiation“ BGV B2 on new laser classes and MZB-values according to DIN EN 60
825-1 (VDE 0837-1): 2001-11
Trade association of Precision Engineering and Electrical Engineering BGFE dated April
2003(ZH1/405)
 
Wavelength λ: 10600 nm
NOHD: 1.4 m