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vela ® XL
Instruction for Use
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Contents
1 Introduction ...........................................................................................................................................5
1.1 Proper use and indication ............................................................................................................5
1.2 Contra-indication and side effects................................................................................................5
2 Safety....................................................................................................................................................6
2.1 General instructions for use .........................................................................................................6
2.2 Warning and safety information ...................................................................................................7
2.3 Eye protection ..............................................................................................................................9
2.4 Restrictions in use......................................................................................................................10
2.5 Product labels ............................................................................................................................11
3 Technical requirements and start-up ..................................................................................................14
3.1 Technical and spatial requirements ...........................................................................................14
3.2 Start-up.......................................................................................................................................16
3.3 Marking the laser area ...............................................................................................................18
4 Description of the device ....................................................................................................................19
4.1 Basic device ...............................................................................................................................19
4.2 Switching elements and interfaces ............................................................................................20
Display (Fig.12) .......................................................................................................................................22
5 Operation and application...................................................................................................................23
5.1 Assembling the application fibres ..............................................................................................23
5.2 Dismantling the fibres.................................................................................................................24
5.3 Switching on the device .............................................................................................................24
5.4 Main menu..................................................................................................................................25
5.5 Application menu........................................................................................................................25
5.6 Triggering laser pulses...............................................................................................................27
5.7 Sub-menus .................................................................................................................................30
5.7.1 Pilot laser sub-menu ..............................................................................................................30
5.8 Configuration menu (set-up) ......................................................................................................31
5.8.1 Set language..........................................................................................................................33
5.8.2 Treatment log.........................................................................................................................33
5.8.3 Set date and time...................................................................................................................34
5.8.4 Adjust screen settings............................................................................................................34
5.8.5 Adjust the volume ..................................................................................................................35
5.8.6 Call up device information .....................................................................................................35
5.8.7 Reset factory setting ..............................................................................................................36
5.8.8 Open error history..................................................................................................................36
5.8.9 Access to service level (only possible for authorised service personnel)..............................37
5.9 Switch off....................................................................................................................................38
5.10 Cleaning .....................................................................................................................................38
5.11 Transport and storage................................................................................................................39
5.11.1 Transport and storage conditions......................................................................................39
6 Accessories.........................................................................................................................................39
6.1 Accessories ................................................................................................................................39
6.2 Cleaning .....................................................................................................................................41
7 Technical specifications......................................................................................................................42
7.1 Device specifications..................................................................................................................42
7.2 Laser parameters .......................................................................................................................43
7.3 Electromagnetic compatibility ....................................................................................................43
8 Rectifying faults and maintenance......................................................................................................48
8.1 Rectifying faults..........................................................................................................................48
8.2 Error messages..........................................................................................................................49

8.3 Technical customer service........................................................................................................53
8.4 Maintenance...............................................................................................................................54
8.5 Disposal......................................................................................................................................55
9 Warranty/Guarantee ...........................................................................................................................55

Copyright © StarMedTec GmbH, Deutschland
All rights reserved. Copies or photocopies of these operating instructions or parts thereof or conversion into
electronic media or machine-readable formats are not permitted without the prior written consent of the author.
Version: December 2009 – Version C

1 Introduction
1.1 Proper use and indication

The vela®XL is a surgical laser for use in many different disciplines, such as general surgery, dermatology,
endoscopy, gastroenterology, gynaecology, ENT, laparoscopy, orthopaedics, paediatrics, pulmonology,
urology, thoracic surgery and dentistry.
The vel®XL is used in combination with the approved application fibres which can be used directly or with
many different application instruments, such as endoscopes or hand pieces.
Indications are dissection, ablation and coagulation of soft and hard tissue.
The vela®XL emits laser beams with a wavelength of approx. 1.9 µm.
This special wavelength is transmitted by an optical fibre (application fibre) and, together with the
application-related parameters, enables efficient treatment with minimum stress to the surrounding tissue.
Various optical fibres and applicators are available for this laser system which allows it to be used for many
different applications. The accessories and the types of fibre are continuously extended and refined. If you
have any questions, contact StarMedTec GmbH or your local dealer.
1.2 Contra-indication and side effects

No laser-specific contra-indications or side effects are known at present.
If you have any questions, contact:
StarMedTec GmbH
Kreuzstraße 22
82319 Starnberg, Germany
Hotline
Phone: + 49 8151 / 26861 0

Fax: + 49 8151 26861 35
info@starmedtec.com

2 Safety
2.1 General instructions for use
The vela®XL is a medical-technical treatment device that may be used only for its intended use.
Mobile phones or similar devices must not be used when the laser is operating.
Because of potential risks from electromagnetic radiation, people with pacemakers must not be in
the vicinity of the laser.
We recommend that pregnant women should keep away from the laser area.
CAUTION
Like any highly effective medical device, handling and use of lasers requires specialist
knowledge and care. The laser may be used only by people who have been instructed in the
proper use of the device with consideration of the operating instructions and who are familiar
with its therapeutic effect and potential risks.
Maintenance and repair work may be carried out only by service technicians from StarMedTec GmbH or
specialists authorised by StarMedTec GmbH. Interference with the device by unauthorised persons voids the
warranty and excludes any claim for liability.
As regards disposal of the laser, StarMedTec GmbH will advise you about environmentally compatible
utilisation.

2.2 Warning and safety information
Only people who are trained in the use of the laser and who have adequate medical knowledge may use the
vela® XL.
National requirements for the setting up and operation of medical products and medical lasers must be
complied with. The operator must clarify whether the national authorities have to be notified about the
operation of laser equipment.
The vela® XL is an active medical product in Class IIb according to Medical Device Directive 93/42/EEC.
If used improperly, every laser can endanger health. The vela® XL is a Class 4 laser.
Do not direct the laser beam on to reflective surfaces (metal surfaces, mirrors, etc.).
Remember that reflective surfaces or instruments can divert the laser beam in an uncontrolled manner.
Particular care must be taken with glass surfaces, but highly polished metal surfaces a few metres away can,
under certain circumstances, also cause dangerous scattered laser radiation.
During laser emission the prescribed protective glasses must be worn in the laser area.
If you are using optical equipment for observation or adjustment, you may have to use suitable protective
filters with the correct safety level.
During operation the laser area must be isolated and marked according to Safety Standard EN/IEC 60825.
When handling all accessories, disposable items or materials that were in contact with the patient it is
important to take protective measures to prevent the transfer of germs. See Sections 5.10 “Cleaning”
(device) and 6.2 "cleaning” (accessories).
For the treatment use only undamaged application fibres that have been sterilised according to the
instructions. Observe the specified cleaning and sterilisation cycles. Do not use damaged or dirty application
fibres. The maximum usage time for the application fibres for each sterilisation cycle is limited to 150
minutes.
During the treatment make sure that neither the patient nor the person treating the patient touch the laser
device. The patient and the person treating the patient should only come into contact with the sterile
application fibres.
We have no knowledge of contra-indications in the treatment of pregnant women or children. There should
be a strict indication and the special circumstances should be considered carefully during the application.
Laser smoke and ablation products that are emitted into the surrounding air may contain viable tissue
particles. Use suitable extraction and filter systems and take suitable protective measures.
The operator must ensure that when laser beams are used for medical applications close to organs, body
cavities and tubes that could contain flammable gases or vapours protective measures are taken against the
risk of fire or explosion.
Protect surrounding organs or organ parts that are not to be treated with the laser against laser radiation with
(sterile) wet cloths.

If the laser is used in environments with enriched oxygen or with highly flammable gases or materials, there
is a risk of fire or explosion. Take the appropriate protective measures.
It is recommended that the laser is not used in environments with enriched oxygen.
Use only the "single use" or "reusable" application fibres approved by StarMedTec GmbH with the vela® XL.
In some cases, the application fibres are subject to country-specific restrictions and, because of this, are not
approved or available everywhere.
Check the laser device for damage before each use. If it is damaged, do not use the laser device.
If the display is faulty, do not use the laser device. The menu structure is interactive. Do not continue the
treatment if the display becomes dark or unclear. Set up the display/device so that you can read the display
clearly and legibly.
To prevent damage to health, move the device with at least two people; do not lift the device, not even with
the front handle.
Before transporting the vela® XL dismantle all accessories (application fibres, power cable, foot switch, ...).
The device should be transported with as little vibration as possible.
The life of the medical product is limited to 10 years. After this time, the adequacy of the technology must be
re-evaluated by StarMedTec GmbH.

2.3 Eye protection
Because of the high energy density of the emitted laser radiation, eyes are especially at risk and can be
damaged even by weak laser beams.
Therefore, the following conditions apply to laser radiation safety:
- Protect the patient by handling the laser proficiently.
- Protect everyone involved and the person carrying out the laser treatment against unintended exposure
to radiation.
- Protect objects in the operation area of the laser against damage, fire, explosion, etc.
CAUTION
Everyone must wear laser protection glasses or suitable eye protection in the laser area. If this
is not adhered to, irreversible eye damage may occur! Before using laser protection glasses
make sure that they are not damaged; in other words, the glasses must not have any
mechanical damage. The type described below must be used.
Laser protection glasses for the vela® XL must fulfil the following conditions:
D 1900 - 2000 nm L3 (according to DIN EN 207)

(L3 or higher protection class)
Laser operation types
D = Continuous wave
Wavelengths at which the

laser protection glasses offer protection
Protection level
To prevent mistakes, laser protection glasses must be marked appropriately.

Laser protection glasses with a higher level of protection (e.g. L3, L4,...) or glasses with a broadband filter with
protection level L3 or higher that includes wavelengths of 1900 - 2000 nm may also be used.
CAUTION
Never look directly into the laser beam.
If the patient cannot wear laser protection glasses during the treatment because the treatment is close to the
eyes, other adequate protective measures must be taken, such as using suitable eye cups.

2.4 Restrictions in use
Only accessories approved by StarMedTec GmbH may be used on the laser device vela® XL!
The vela® XL laser device must not be operated in rooms or areas where there is a risk of explosion!
The vela® XL laser device may be used only in rooms that are used for medical purposes. National
requirements must be complied with!
The laser device has been tested for electromagnetic susceptibility (EMS) and complies with all applicable
EMS requirements. However, interference cannot be fully excluded.
It is recommended that the vela® XL laser device is used only in rooms with a room temperature between
18°C - 30°C and relative humidity ≤ 75 %, non-condensing. The maximum permissible ambient temperature
of 30°C must not be exceeded.
The vela® XL laser device may not be operated at more than 2,000 m above sea level.
Note
The vela® XL laser device has been tested according to EN / IEC 60601-1-2 (EMV). For more
information, see Section 7.3 "Electromagnetic compatibility".

2.5 Product labels
Laser devices and products must be labelled.
NOTE
The following applies:

1. The labels must be easily legible.
2. The labels must remain visible during operation and service work.
3. Laser warning signs are to be black on a yellow background.
Device type label
The manufacturer's type label is located on the back side of the laser device. The warning symbol on the
type label points out that the instructions for use must be adhered to when the device is being used.
Fig. 1: Type label vela® XL

Laser warning sign on the back side of the laser device
The laser warning sign on the back side of the laser device provides information about the laser class,
wavelength, rating, pulse duration and frequency of the laser beam so that appropriate safety measures can
be taken.
VISIBLE AND INVISIBLE

LASER RADIATION
AVOID EYE OR SKIN EXPOSURE TO DIRECT
OR SCATTERED RADIATION
CLASS 4 LASER PRODUCT
50 mm
ACCORDING TO EN 60825-1:2007
LASER
LASER CLASS 4 Po ≤ 150 W
λ = 1,9 µm
PILOT
LASER CLASS 2 Po < 1 mW
λ = 0,5 µm
52 mm
108
Fig. 2: Warning and information signs on the laser device
Information sign on the back side of the laser device: foot switch & door interlock
The information sign marks the connections for the foot switch and the door interlock.
Information sign: connection foot switch & door interlock
Information sign: connection door interlock
Fig. 3: Information sign foot switch & door interlock

Laser outlet opening sign
If a fibre is connected, the laser beam is emitted from the end of the fibre.
Fig. 4: Laser outlet opening sign
Laser emergency stop switch sign
When activated, the laser emergency stop switch immediately switches off the laser emission. Activate this
switch in an emergency.
Fig. 5: Laser emergency stop switch sign
The sign is positioned as follows:
Fig. 6: Signs on the back side of the vela® XL laser device
Type label
(Fig.1)
Foot switch & door interlock

(Fig.3)

Laser outlet opening
sign
(Fig. 4)
Laser emergency stop

switch sign
(Fig. 5)
Fig. 7: Signs on the front side of the vela® XL laser device
3 Technical requirements and start-up
3.1 Technical and spatial requirements

The electrical installation of the room in which the vela® XL is operated must fulfil national requirements and
specifications. The sockets must be installed with fixed wiring.
The fusing and the supply line for the vela® XL must be separate. Fusing with a circuit breaker Type C16 A
or higher.
Place the vela® XL only on a suitable nonslip base that can bear the weight of the device (see Section 7.1
"Device specifications").

It is recommended that the vela® XL is used only in rooms with an ambient temperature between 18°C –
30°C and relative humidity ≤ 75 %, non-condensing. The maximum permissible ambient temperature of
30°C must not be exceeded.
To ensure adequate cooling, the inflow and outflow of air at the sides should not be blocked. To ensure this,
if possible, install the vela® XL so that it is freestanding. On the side beside the air inlet and the air outlet
there must be a gap of at least 20 cm so that the air can flow in and out without restriction.
Ensure that the treatment room is adequately ventilated. Because the laser emits heat, ventilation of at least
200 m³/h is recommended.
CAUTION
Condensation on the laser device during operation may damage the device. It is important that
you allow the cool device to acclimatise at the prescribed ambient conditions in the treatment
room for several hours before you use it.

3.2 Start-up
CAUTION
If the laser device is used improperly, it can cause irreversible damage. Because of this, the
laser device may be operated only by appropriately trained and experienced staff.
Before using the laser device, operators must make sure that it functions and is in a proper condition.
The following points must be observed:

• Check the laser device, accessories and cables for obvious defects.
• The laser cannot be operated without the attached application fibre.
• Release the emergency stop switch if this has been activated.
• Observe the national safety regulations that apply in the country where the laser is used.
Attention
Insert the plug into a fixed socket with an earth wire contact (exclusive and with at least 16 A
fuse). Do not use a multiple socket.
For connection requirements, see Section 3.1 "Technical and spatial requirements".
Connect the foot switch to the socket on the bottom right side on the back of the device.
Connect the door contact plug to the socket on the bottom right side on the back of the device.
Install the required application fibre in the laser system. Observe the associated instructions for use and the
sterilisation conditions. See Section 5.1 "Assembling the application fibres" and the instructions for using the
application fibre.
ATTENTION
For the treatment use only undamaged application fibres that have been sterilised according to
the instructions. Observe the specified cleaning and sterilisation cycles. Do not use damaged
or dirty application fibres.

Place the power cable, the foot switch and the door interlock and the application fibres so that they are not in
the way of other people in the room and are not a hazard in any other way.

3.3 Marking the laser area
According to IEC EN 60825, the current warning signs must be attached at eye height on all access doors of
the laser treatment room. In addition to the warning signs, some national regulations require the installation
of warning lights.
Fig. 8: Marking the laser area
CAUTION
The above regulations are German regulations. If the laser device is to be operated outside
Germany, the applicable national or international regulations must be complied with.

4 Description of the device
4.1 Basic device
Display
Emergency stop
Key switch
Fig. 9: Basic laser device vela® XL

Power
switch
Foot switch
connection
Door
contact
connection
Power cable
Fig. 10: Back side of the vela® XL Fig. 11a and 11 b: Connection for application fibre
4.2 Switching elements and interfaces

Laser emergency stop (Fig. 9)
The laser emergency stop switch is used to switch off laser emission immediately, so that in case of faults
risks for people or the device can be prevented by the user's reaction. The switch is activated by pressing
the red button. When the switch has been activated, before the device can be switched on again it has to be
released by turning the red button in a clockwise direction. If the switch is not released, the device cannot be
switched on.
However, if the laser emergency switch is activated, this does not isolate the device from the power supply.
This is done only with the power switch on the back of the device.
Key switch (Fig. 9)

The key switch is used to switch the laser device on and off. The key switch has three positions: 1=OFF;
2=ON; 3=START. Remove the key to prevent unauthorised use of the device!
Foot switch connection (Fig. 10)

Socket for the foot switch.
Foot switch
The foot switch is used to trigger the laser emission.
Connection for application fibre (Figs. 11 a and 11 b)

The application fibre is connected via an SMA connector (DIN EN 186100). The socket is protected by a
screw cap that has to be removed before use.
The vela®XL may be operated only with application fibres that have been specified by StarMedTec GmbH in
Section 6 "Accessories".

The device must recognise the application fibres. An electronic test ensures that only parameters permitted
for the connected application fibres can be set and that the application fibres cannot be used in excess of
their specification. This also includes the fact that the application fibre must be replaced after 2.5 hours (150
minutes) to minimise recontamination of the fibres. Unauthorised application fibres will not be accepted.
Power switch (Fig. 10)

The power switch is used to switch on the laser device. When you have switched on the power switch, the
device is ready to operate and can be activated with the key switch.
The device is isolated from the power supply only by switching off the power switch (main switch).
Door contact connection (Fig. 10)

We recommend that you connect a door contact to the door contact connection. This interrupts the laser
emission as soon as the door is opened. If no contact is connected, connect the door contact plug.
NOTE
If neither a contact nor a door contact plug is connected, the laser device cannot be operated.
Power cable (Fig. 10)

Connect the supplied power cable to the power plug. Only the power cable specified in Section 6
"Accessories" may be used.

Display (Fig.12)
The display is a touchscreen unit that supplies information and allows you to enter data. The round
operating symbols (buttons) are used for entry. Press the button to open the associated function.
Fig. 12: Display
NOTE
Do not touch the surface of the touchscreen with sharp or unclean objects. This reduces the
picture quality and may damage the surface.

5 Operation and application
5.1 Assembling the application fibres

You will find the specified and approved application fibres in Section 6 "Accessories".
CAUTION
Do not bend or kink the application fibres too much as this can break the fibres.
Depending on the fibre, the minimum bending radius is 5 - 10 cm
(230 µm: 5 cm, 365 µm: 7.5 cm, 600 µm: 10 cm).
Remember that these bending radii should also not be exceeded during storage.
CAUTION
Do not operate the laser device with damaged application fibres.
Closely observe the installation and working instructions that are contained in the instructions for use for the
respective application fibres.
The general procedure is as follows:
1. Check that the sterile packaging is not damaged.

2. Remove the sterilised application fibre from the packaging just before you intend to use it and lay it on a
sterile surface.
3. Remove the protective cap from the application fibre and keep this in a safe place.
4. Before using the application fibre, make sure that it is not broken or damaged.
5. Move the application fibre from the sterile to the unsterile area, install it in the laser device and switch on
the device.
6. The fibre diameter is shown on the display by the automatic fibre identification. Check that the correct
fibre diameter is shown.
7. When the device is switched on, check the condition of the fibre with the help of the green pilot beam:
To do this, aim the tip of the fibre at a distance of approx. 5 cm vertically on to an even, light surface
(e.g. a sheet of white paper). The pilot beam should be easily visible, almost circular and homogeneous.
NOTE
Application fibres that have exceeded the maximum permitted number of cycles are
automatically blocked for use on the vela® XL.
To minimise the risk of recontamination, the maximum usage of an application fibre per
sterilisation cycle is restricted to 150 minutes.
The corresponding information is shown on the display.
.

5.2 Dismantling the fibres
1. Switch the laser device off.

2. Dismantle the application fibre from the laser device.
3. Place the protective cap on the fibre. Dispose of single-use fibres (in the packaging); clean reusable
fibres (not permitted or available everywhere) according to the instructions, disinfect them, package and
sterilise them.
4. Close the cover of the fibre connection on the device.
NOTE
Fibre management
The number of usage cycles of a fibre is reduced by 1 when the laser device is switched on,
the fibre is inserted and the laser is activated with the foot switch. If the fibre is removed –
even by mistake –, the laser device is switched off or the emergency stop button is pressed,
the number of uses with this fibre is reduced. Single-use fibres can then no longer be used.
5.3 Switching on the device

Switch the laser device on with the power switch.
Insert the key in the key switch and turn it clockwise as far as you can. Leave the key in this position until
you see on the screen: "device will be started" and the StarMedTec logo appears on the display.
While it is starting up, the laser device performs a system test. When the test routines have been completed,
the device automatically opens the main menu.
While the device is starting up and during the subsequent test no changes may be made to the system (do not
press the foot switch, touch the touchscreen, or activate any switches and do not insert or remove fibres).
NOTE
The laser emergency stop switch must not be depressed. Release the emergency stop switch
by turning the red button clockwise.
When you switch on the device for the first time (start-up) or if you restart it after the device has been reset to
"factory settings" you must choose the language. Choose the language in the configuration level (set-up).

5.4 Main menu
When you switch on the device, the StarMedTec GmbH logo is displayed during the system test.
Fig. 13: Company logo during self-test
After this, the main menu is displayed:
Fig. 14: Main menu
Touch the configuration symbol to open the configuration menu (set-up), where you can change the
basic settings for the device.
If an approved application fibre is connected, touch the application icon on the screen (Fig. 14) to
open the application menu. Here, you can adjust and activate the laser parameters. If you cannot open the
application menu, check the application fibre and replace it if necessary.
5.5 Application menu

In the application menu you can select all relevant parameters for the laser application and other sub-menus.
You can also switch the device from "STANDBY" to "READY".

Fig. 15: Application menu in STANDBY mode
Overview:
Left side of the application menu:
- On the left hand side are the navigation icons. With these you change to the other menu levels.
Middle and right hand side of the application menu:
- On the top right hand side the laser can be switched from STANDBY to READY and back again.
- Below that (blue scale) you can vary the heat input into the tissue in 10 steps (10 = standard, 9 to 1 =
reduction of the heat input).
- In the middle you see information about the size of the fibre being used and the remaining number of
cycles you can use the fibre.
- In the lowest line (green scale) you select the laser power (dependent on the selected step of heat
input)
- Change the laser settings with the right/left arrow icons. The chosen setting is displayed as a number
and as a graphic display between the arrow icons.
Operation icons:
= "Home": Return to the main menu
= "back": The previous menu level is opened
= "Pilot laser": Opens the sub-menu to adjust the pilot laser
Adjust the laser output with the "left" and "right" icons. Touch the corresponding icons to adjust the
laser output one level higher or lower. The current laser output is shown numerically and also graphically
between the arrow icons.
You can only change parameters and menus in STANDBY mode.
Touch the "Laser" icon to switch from STANDBY to READY mode or from READY to STANDBY mode.

You can activate the laser emission with the foot switch only in READY mode; as long as the foot switch is
depressed, the vela® XL emits laser radiation with the selected parameters.
In READY mode (the laser is not activated with the foot switch) any touch on the display puts the device
back to STANDBY mode. In LASER mode (as long as the laser emission is triggered by the foot switch) you
cannot make any entries via the screen.
Fig. 16: Application menu in READY mode
Note
The reduction of the heat input into the tissue is generated by reduction of the maximum
power permitted and a special modulation of the laser.
5.6 Triggering laser pulses
In READY mode the laser can be activated with the foot switch: laser beams are emitted with the set
parameters. On the screen you will see the laser warning information and "LASER". If the laser is active (foot
switch activated), you cannot make any changes on the screen.

Fig. 17: As soon as the device is activated with the foot switch and the laser beams are emitted, you will see the laser warning
information and "LASER" on the screen.

CAUTION
In READY mode the laser can be activated if you inadvertently press the foot switch. For
safety reasons, in breaks between the treatments you should switch the laser device from
READY to STANDBY mode.
If the laser is not activated for about 2 minutes in READY mode (e.g. with the foot switch), for the sake of
safety it automatically switches from READY to STANDBY mode. Touch the laser button again to put the
laser in READY mode again.

5.7 Sub-menus
5.7.1 Pilot laser sub-menu
Touch the "pilot laser" icon in the application menu.
Fig. 18: Pilot laser sub-menu
In the pilot laser sub-menu you can adjust the brightness of the pilot laser. Touch the "left" or "right" icon to
adjust the brightness of the pilot laser from 0 to 100%.
Touch the "Confirm" icon to accept the set value; use the "Back" icon to return to the application
menu without accepting the new value and the "Home" icon to open the main menu.

5.8 Configuration menu (set-up)
Touch the configuration icon in the main menu to open the configuration menu (set-up).
Fig. 18: Configuration menu
Here, you can open the following basic information and settings:
- Open treatment log
- Set language
- Set date and time
- Adjust screen settings
- Adjust the volume
- Call up device information

- Reset factory settings
- Open error history
- Access to service level (only possible for authorised service personnel).

5.8.1 Set language
Fig. 19: Set language
In this menu item you can choose the different languages. The languages are shown with a typical flag and
in the respective language.
Use the navigation icons to choose your required language.
Touch the "Confirm" icon to activate the language that is displayed.
5.8.2 Treatment log
Fig. 20: Treatment log
In this menu item you can open the last 10 treatment logs. The logs are generated automatically.
Displayed are:
- Date,
- Starting time (when the laser was first activated with the foot switch),
- Application fibre used,
- Duration of treatment (activation by foot switch until the fibre is replaced or the vela® XL is switched off),
- Laser on-time (length of time which the vela® XL was activated and emitted laser radiation),
- The entire laser output

5.8.3 Set date and time
Fig. 21: Set date and time
In this menu item you can adjust the date and time.
Touch the hour display to activate it and make it grey. The hour display can be changed with the arrow icons.
Adjust the minutes, years, month and day in the same manner.
Confirm and accept the new values with the icon.
5.8.4 Adjust screen settings
Fig. 22: Screen settings
With this menu item you can adjust the brightness of the screen.
Changes have to be confirmed with the icon.

5.8.5 Adjust the volume
Fig. 23: Volume adjustment
The volume can be adjusted from 0% to 100% within the permitted range.
5.8.6 Call up device information
Fig. 24: Device Info
On this page you can call up data and information: Serial number, software version, hardware version, total
output of the laser source, remaining life until the laser source has to be replaced

5.8.7 Reset factory setting
Fig. 25: Reset factory settings
In this menu item you can reset the factory settings of the device.
5.8.8 Open error history
Fig. 26: Error History
On this page you can read error codes and error-relevant data.

5.8.9 Access to service level (only possible for authorised service personnel)
Fig. 27: Service Access
Available only to authorised service personnel.

5.9 Switch off
Switch the laser device off by turning the key switch anti-clockwise, the display closes. We recommend that
you also isolate the device from the power supply with the power switch on the back.
CAUTION
Never leave the device switched on without supervision. Remove the key to prevent
unauthorised use of the device.
CAUTION
Laser emergency stop
The laser emergency stop is solely for emergencies during normal operation. When the laser
emergency stop switch is activated, the laser emission is switched off immediately. In addition,
the device's software control is interrupted incorrectly which means that some parameters may
not be saved. If the laser emergency stop switch has been activated, before starting the device
again make sure that you release the emergency stop by turning the red button clockwise.
5.10 Cleaning
CAUTION
The power cable must always be disconnected before you clean or disinfect.
Clean the surface of the device with a damp cloth and clear liquid skin disinfectant (e.g. Kodan® or
Sagrotan® ). Generally, if the device is only slightly dirty, it is enough to clean the surfaces with a damp cloth.
CAUTION
Aggressive cleaning agents, such as scouring powder, can damage the surfaces and display.

CAUTION
When you are cleaning the device, make sure that no liquid gets inside the device, as this
could cause faults.
5.11 Transport and storage

5.11.1 Transport and storage conditions
The vela® XL laser device can be stored and transported at temperatures of + 5°C to + 50°C, relative
humidity of 20% to 80% (non-condensing) and atmospheric pressure of 700 hPa to 1060 hPa.
CAUTION
Condensation on the laser device during operation may damage the device. It is important that
you allow a cold device to acclimatise at the prescribed ambient conditions in the treatment
room for several hours before you use it.
Before transporting the vela® XL dismantle all accessories (fibres, power cable, foot switch, etc).
6 Accessories
6.1 Accessories
Operators of the device are obliged to use only accessories that StarMedTec has approved for use with this
laser device.
StarMedTec accepts absolutely no liability for damage or subsequent damage resulting from using the
device with accessories that are not approved.
The supplied conformity declaration contains information about approved accessories (fibres).
See the instructions for use for information about operation, maintenance and disinfection.
You can obtain a current list of accessories from the vela® XL product range from StarMedTec GmbH at any
time. The product range is continuously updated and extended.

CAUTION
Never work with damaged accessories or damaged power cables.
CAUTION
When handling all accessories or materials that were in contact with the patient it is important
to take protective measures to prevent the transfer of germs.
List of accessories
Article number Description
6032 Laser protective glasses, normal
6033 Laser protective glasses for people who wear prescription glasses
6450 Application fibres single use, 230 µm core diameter
6451 Application fibres reusable, 230 µm core diameter
40001041 Power cable
40001101 Door interlock plug
40001102 Spanner set
41001021 Foot switch
Remember that the accessories may change due to experiences and technical developments. Ask your
dealer or StarMedTec Gmbh about the latest accessories.

6.2 Cleaning
Clean accessories with a disinfectant (e.g. Kodan) and a damp cloth. See the instructions for use regarding
cleaning instructions.
Clean, disinfect and sterilise application fibres according to the instructions for use.

7 Technical specifications
7.1 Device specifications

Laser type Laser class 4 (EN / IEC 60825-1)
Wavelength approx. 1.9 µm
Maximum output 120 W
Minimum output 1W
Beam transmission Fibre system
Aiming beam 532 nm

Output < 1 mW
Operation Touchscreen
Cooling Compressor cooling system
Power connection 200 V – 240V 50 – 60 Hz

16 A (max. 3 kW)
Dimensions approx. 295 × 950 × 1035 mm (W/D/H)
Weight Basic device: approx. 150 kg
Electrical protection class Protection class 1 (EN / IEC 60601-1)

Protection type IP 20 (EN / IEC 60529)
Application part Type BF (EN / IEC 60601-1)
Operation/transport and Operation Transport / Storage

storage conditions
Temperature 18 – 30°C 5 – 50°C
Atmospheric 700 – 1060 hPa 700 – 1060 hPa

pressure
Relative humidity 30 – 75% non- 20 – 80% non-
condensing condensing
Switching cycle cw
Standards and guidelines EN / IEC 60601-1

CE 1275 labelling
Medical product Class IIb (Rule 9) according to MDD 93/42/EEC
Manufacturer StarMedTec GmbH
Kreuzstraße 22 - 24, 82319 Starnberg, Germany

7.2 Laser parameters
600 µm application fibre: max 120 W
7.3 Electromagnetic compatibility
NOTE
Portable and mobile HF communication equipment may affect electrical medical equipment.
NOTE
Electrical medical equipment is subject to special precautionary measures regarding EMC and
must be installed and operated according to these guidelines.
The following cables must be used to comply with interference emission and interference immunity.
Tab. 1: Cable overview

Cable Length
Power cable 16 A 5m
Foot switch with cable 3m
CAUTION
Use of different cables and accessories may cause higher interference emission or reduced
interference immunity.

Tab. 2: Electromagnetic emissions
Guidelines and manufacturer's declaration – electromagnetic emissions
The vela® XL is designed for operation in an environment as described below. Users of the vela® XL
must ensure that it is operated in such an environment.
Interference emission Compliance Electromagnetic environment - guide
measurements
HF emissions Class A The vela® XL uses HF energy only for its
according to CISPR 11 internal function. Therefore, its HF emission is
very low and it is unlikely that neighbouring
electronic devices will be affected.
HF emissions Class A The vela® XL is not subject to any special
according to CISPR 22 connection conditions.
Harmonics Not applicable The quality of the power supply should
according to IEC 61000-3-2 correspond to a typical commercial or hospital
Voltage fluctuations according Complies environment.
to IEC 61000-3-3
Flicker according to IEC 61000- Complies
3-11
CAUTION
The vela® XL must not be operated directly beside other devices. If it has to be operated
close to other devices, the vela® XL must be observed to check that it operates as intended in
this arrangement.

Tab. 3: Electromagnetic immunity
Guidelines and manufacturer's declaration – electromagnetic immunity
The vela® XL is designed for operation in the electromagnetic environment described below.
Customers or users of the vela® XL must ensure that it is operated in such an environment.
Immunity tests IEC 60601 test Compliance level Electromagnetic environment -
level guides
Electrostatic discharge ± 6 kV). ± 6 kV). Floors should be wood, concrete or
(ESD) according to Contact discharge Contact discharge ceramic tile. If floors are covered
IEC 61000-4-2 with synthetic material, the relative
humidity should be at least 30%.
± 8 kV). ± 8 kV).
Air discharge Air discharge
Electrical fast transient ± 2 kV for power ± 2 kV for power The quality of the power supply
interference/bursts. supply lines supply lines should correspond to that of a
according to typical business or hospital
IEC 61000-4-4 environment.
± 1 kV ± 1 kV
for ingoing and for ingoing and
outgoing cables outgoing cables
Surges ± 1 kV differential ± 1 kV differential The quality of the power supply
according to mode mode should correspond to that of a
IEC 61000-4-5 typical business or hospital
environment.
± 2 kV common ± 2 kV common
mode mode
Voltage dips, short < 5% UT < 5% UT The quality of the power supply
interruptions and (> 95% dip in UT) (> 95% dip in UT) for should correspond to that of a
voltage variations in for ½ cycle ½ cycle typical business or hospital
power supply input environment.
lines according to 40% UT If users of the vela® XL require
IEC 61000-4-11 (60% dip in UT) 40% UT continued function even in case of
for 5 cycles (60% dip in UT) for 5 interruptions in the power supply, we
cycles recommend that the vela® XL is
70% UT connected to an uninterruptible
(30% dip in UT) power supply or a battery.
for 25 cycles 70% U T
(30% dip in UT) for
< 5% UT 25 cycles
(> 95% dip in UT)
for 5 s
< 5% UT
(> 95% dip in UT) for
5s
Power frequency 3 A/m 3 A/m The vela®XL contains no
magnetic field components that can be affected by
(50/60 Hz) according magnetic fields.
to IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.

Tab. 4: Electromagnetic immunity
Guidelines and manufacturer's declaration – electromagnetic immunity
The vela® XL is designed for operation in the electromagnetic environment described below.
Customers or users of the vela® XL must ensure that it is operated in such an environment.
Immunity tests IEC 60601 test Compliance level Electromagnetic
level environment - guidelines
Portable and mobile radio devices should
not be used closer to the vela® XL and
cables than the recommended separation
distance, which is calculated according to
the equation suitable for the transmission
frequency.
Recommended separation distance:

Conducted HF 3 Veff 3 Veff d = 1.17/V*√P
disturbances 150 kHz to
according to 80 MHz
IEC 61000-4-6
Radiated HF 3 V/m 3 V/m

d = 1.17 m/V*√P 80 MHz to 800 MHz
disturbances 80 MHz to
according to 2.5 GHz
IEC 61000-4-3
d = 2.33 m/V*√P 800 MHz to 2.5 GHz
Where P is the maximum output power

rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
According to an inspection on locationa the

field strength of stationary radio transmitters
should be less than the conformity level b
Interference may occur in the vicinity of

equipment marked with the following
symbol.
1. At 80 MHz and 800MHz the higher frequency range applies.
2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

a)
The field strength of stationary transmitters such as base stations of mobile telephones and mobile
radio devices, amateur radios, AM and FM radio and TV transmitters can theoretically not be
determined in advance. To determine the electromagnetic environment with respect to the stationary HF
transmitters, a study of the location should be undertaken. If the measured field strength in the location
in which the vela® XL is used exceeds the conformity level specified above, the vela® XL should be
observed in order to ensure that it operates properly. If unusual features are observed, additional
measures may be required, such as a different set-up or another location for the vela® XL.
b)
Across the frequency range of 150 kHz to 80 MHz the field strength should be less than 3 V/m.
Tab. 5: Recommended separation distances

Recommended separation distances between portable and mobile HF communications
equipment and the VELA XL
The vela® XL is intended for use in the electromagnetic environment in which radiated HF
disturbances are controlled. The customer or the user of the vela® XL can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile HF
communications equipment (transmitters) and the vela® XL as recommended below, according to
the maximum output power of the communications equipment.
Separation distance according to transmission frequency
Rated maximum output power [m]
of transmitter 150 kHz to 80 MHz to 800 MHz to 2.5 GHz
80 MHz 800 MHz
[W]
d = 1.17/V*√P d = 1.17/V*√P d = 2.33 m/V* √P
0,01 0.12 0.12 0.23
0,1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.7 3.7 7.37
100 11.7 11.7 23.3
For transmitters rated at a maximum output power not listed above, the separation distance can be
estimated using the equation applicable to the respective column, where P is the maximum output
power rating of the transmitter in watts (W) according to the transmitter manufacturer.
1. At 80 MHz and 800MHz the higher frequency range applies.
2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

8 Rectifying faults and maintenance
8.1 Rectifying faults

Faults are either displayed on the device display or the display turns blank when the device switches off
automatically.
If no message is displayed, the problem could be due to one of the causes listed below:
No. Fault Cause Action
- No function Device not plugged in Plug device into the socket
- No function Power supply switch (back Change power supply switch

of device) is at "0" (back of device) to position "1"
- No function Laser emergency stop Turn laser emergency stop switch

switch has been activated in clockwise direction
→ unlock
- No function Main fuse in building Check fuse and replace if

electrical system defective necessary
- Device cannot be operated Foot switch depressed Release foot switch

8.2 Error messages
If a message is displayed, follow the suggestions in the message. If a fault cannot be rectified, switch the
device off and start it again after about 20 seconds. If the same error message is displayed, contact your
dealer or StarMedTec GmbH.
No. Description Action
Maximum life of the laser source will be

Acknowledge message; ask service department to
1001 reached in xx hours. Inform service
replace the laser source as soon as possible
department: replace laser source
Allow laser to cool: Check ambient temperature, if
available, switch on air conditioning; check that the air
Cooling water temperature too high:
1002 flow around the laser is not hindered; acknowledge
Allow the device to cool.
message; continue treatment only when the laser has
cooled somewhat.
Allow laser to cool: Check ambient temperature, if
Device temperature too high: Allow the available, switch on air conditioning; check that the air
1003
device to cool. flow around the laser is not hindered; acknowledge
message
Maintenance interval expires soon: Carry
1004 Acknowledge message; arrange service date
out maintenance by xx.
Maintenance overdue! Have Acknowledge message; arrange service date
1005
maintenance carried out without delay! immediately
Acknowledge message; prepare application fibre after
1006 The applicator can be used xx times still
treatment and send for sterilisation
1007 Dispose of the applicator after use Acknowledge message; dispose of applicator after use
Water level low: Inform service
1008 Acknowledge message and request service
department.
Fibre may not be used again: Use new Dispose of application fibre and replace with a new
1101
fibre. application fibre
Unscrew application fibre from device, check application
Fibre identification not possible: Replace
1103 fibre and connect again or replace and use a new
fibre!
application fibre
Foot switch activated too soon: Release
1104 Release foot switch
foot switch!
Door contact faulty or door not closed: Check door contact (door interlock); close door if door
1105
Check door contact or close door. contact is combined with room lock (optional)
Unscrew application fibre from laser, check application
Fibre identification not possible: Check
fibre or use new fibre
application fibre
Unscrew application fibre from laser, check application
Fibre identification not possible: Check
fibre or use new fibre
application fibre
Active usage time within the current sterilisation cycle
1110 Sterilisation complete: Change fibre. has expired. Remove application fibre from device and
replace with new application fibre

Device temperature too low: Wait until Wait until the laser has warmed up, acknowledge
1203
device has reached working temperature. message
Allow laser to cool: Check ambient temperature: if
available, switch on air conditioning; check that the air
Cooling water temperature too high: Wait
1204 flow around the laser is not hindered; acknowledge
until the device has cooled.
message; continue treatment only when the laser has
cooled.
Cooling water temperature too low: Wait Wait until the laser has reached its operating
1205
until the device has warmed up. temperature.
Cooling water temperature too low:
1206 Restart the laser device.
Restart device
Laser output too low: Restart device or If the message is displayed again after the restart: write
1301
contact service down the error message and inform technical service
Laser output too high: Restart device or If the message is displayed again after the restart: write
1302
Average laser output too low: Restart If the message is displayed again after the restart: write
1303
device or contact service down the error message and inform technical service
Average laser output too high: Restart If the message is displayed again after the restart: write
1304
Shutter fault: Restart device or contact If the message is displayed again after the restart: write
1305
service down the error message and inform technical service
1306
1307
Output measurement fault: Restart If the message is displayed again after the restart: write
1308
Output measurement fault: Restart If the message is displayed again after the restart: write
1309
Water temperature sensor fault: Restart If the message is displayed again after the restart: write
1310
Cooling water temperature much too low: Wait until the device has warmed up.
1311
Wait until the device has warmed up.
Installation not performed: notify service Ask service to perform installation
1312
and have installation performed.
Life of laser source exceeded: Inform Ask service to replace the laser source
1313 service department: replace radiation
source.
Fibre identification fault: Restart device or If the message is displayed again after the restart: write
1314
Touchpanel fault: Switch off device and Write down the error message and inform technical
1315
notify service department. service
Excess temperature! The device will Write down the error message and inform technical
1316 switch off automatically in a few seconds: service
Inform service department.
Air temperature sensor fault: The device Write down the error message and inform technical
1317 will switch off automatically in a few service
seconds: Inform service department.

Water cooling flow fault: Restart device If the message is displayed again after the restart: write
1318
or contact service down the error message and inform technical service
Water cooling fault: Restart device or If the message is displayed again after the restart: write
1319
Laser source fault: Restart device or If the message is displayed again after the restart: write
1401
Laser source fault: Restart device or If the message is displayed again after the restart: write
1402
Laser source fault! The device will switch Write down the error message and inform technical
1403 off automatically in a few seconds: Inform service
service department.
Laser source fault! Power Supply fault: If the message is displayed again after the restart: write
1404
Restart device or contact service down the error message and inform technical service
Laser source fault! Emission fault: If the message is displayed again after the restart: write
1405
Restart device or contact service down the error message and inform technical service
Software fault: Restart device or contact If the message is displayed again after the restart: write
1501
1502
1503
1504
1505
1506
1507
1508
1509
1510
1511
1512
1513
1514
Undervoltage 24V: Restart device or If the message is displayed again after the restart: write
1515
Fault in saved application data: Restart If the message is displayed again after the restart: write
1516
Hardware fault AD converter: Restart If the message is displayed again after the restart: write
1517

Hardware fault AD converter: Restart If the message is displayed again after the restart: write
1518
No application data available: Restart If the message is displayed again after the restart: write
1519
Voltage deviation 12V: Restart device or If the message is displayed again after the restart: write
1520
Synchronisation fault: Restart device or If the message is displayed again after the restart: write
1521
Fault in USB connection: Restart device If the message is displayed again after the restart: write
1522
or contact service down the error message and inform technical service
Incompatible firmware or data: Inform Write down the error message and inform technical
1525
service department. service
Invalid application data: Inform service Write down the error message and inform technical
1526
department. service

8.3 Technical customer service
StarMedTec GmbH offers an extensive warranty and support programme to ensure that your laser device
continues to perform reliably for many years. This programme includes our service hotline. Highly qualified
staff in the service team will quickly help you resolve any problems you may encounter. If necessary, you can
obtain information how you can make use of our repair service.
Our foreign customers should first contact the service hotline of their local dealer.
If you have any questions, contact:
StarMedTec GmbH
Kreuzstraße 22
82319 Starnberg, Germany
Hotline
Phone: + 49 8151 / 26861 0

Fax: + 49 8151 26861 35
info@starmedtec.com

8.4 Maintenance
Maintenance and repair work may only be carried out by StarMedTec GmbH service technicians or by
technicians who have been approved by StarMedTec GmbH.
Repairs or maintenance work carried out by unauthorised personnel make our guarantee void and exclude
any future warranty and liability claims. If maintenance work is not performed properly, this may also cause
the device to malfunction, which puts users and patients at risk.
CAUTION
If the vela® XL does not operate properly, do not try and interfere with the device yourself.
Please contact StarMedTec GmbH or your authorised StarMedTec GmbH service partner.
Please note that the manufacturer is responsible for the functioning, reliability and safety of the device only if:
• transport, installation, start-up, modifications, maintenance and repairs have been carried out by
authorised personnel,
• the electrical installation in the room in which the laser is operated complies with statutory requirements
and our installation requirements,
• the device and accessories are used in accordance with this user manual, and
• users are trained and instructed.
Maintenance intervals
An inspection of the complete laser system should be carried out by an authorised service technician at least
once within each 12-month period or if a message is displayed on the device (whichever comes first).
Technical checks
Technical safety checks may only be carried out by authorised service technicians and must be documented
in the medical product book (equipment book).
The check must include the accessories, wearing parts, disposable items and connected interfaces which
the operator uses with the device if the use of the device could be affected in terms of safety by this ancillary
equipment.
NOTE
Technical checks must be carried out at intervals of maximum 12 months and must be
documented in the medical product book.

The following technical safety checks must be performed, taking account of the national safety
regulations in the country in which the device is used:
• Visual inspection of the device and accessories

• Function check
• Output check
• Earth conductor check (pursuant to IEC 60601-1)
• Check of the earth leakage current under normal conditions (pursuant to IEC 60601-1)
• Check of the radiation source and optical components, maintain or replace
• Update internal log function
• Document in writing and send a copy to the service department at StarMedTec GmbH
CAUTION
If faults are discovered during the technical safety check which could put patients, users or
third parties at risk, the device may not be operated until these faults have been rectified by an
authorised service technician.
8.5 Disposal
StarMedTec GmbH will take your used device back and undertakes to dispose of it in accordance with
national regulations. Please contact your dealer or StarMedTec GmbH regarding the return of your laser
device.
9 Warranty/Guarantee
See your order confirmation for warranty arrangements.

Please contact StarMedTec GmbH to discuss a maintenance agreement.

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vela ® XL

Instruction for Use

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Version: December 2009 – Version C

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1.1 Proper use and indication

1.2 Contra-indication and side effects

If you have any questions, contact:

Phone: + 49 8151 / 26861 0

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2.1 General instructions for use

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The device should be transported with as little vibration as possible.

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Therefore, the following conditions apply to laser radiation safety:

- Protect the patient by handling the laser proficiently.

D 1900 - 2000 nm L3 (according to DIN EN 207)

Wavelengths at which the

To prevent mistakes, laser protection glasses must be marked appropriately.

Never look directly into the laser beam.

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Laser devices and products must be labelled.

The following applies:

Device type label

Fig. 1: Type label vela® XL

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VISIBLE AND INVISIBLE

Information sign: connection foot switch & door interlock

Information sign: connection door interlock

Fig. 3: Information sign foot switch & door interlock

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Fig. 4: Laser outlet opening sign

Laser emergency stop switch sign

Fig. 5: Laser emergency stop switch sign

The sign is positioned as follows:

Fig. 6: Signs on the back side of the vela® XL laser device

Foot switch & door interlock

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Laser emergency stop

Fig. 7: Signs on the front side of the vela® XL laser device

3 Technical requirements and start-up

3.1 Technical and spatial requirements

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The following points must be observed:

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Fig. 8: Marking the laser area

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4.1 Basic device

Fig. 9: Basic laser device vela® XL

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4.2 Switching elements and interfaces

Key switch (Fig. 9)

Foot switch connection (Fig. 10)

Connection for application fibre (Figs. 11 a and 11 b)

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Power switch (Fig. 10)

Door contact connection (Fig. 10)