K-LASER Blue Derma User manual

Operating instructions K-Laser Blue Derma Rev. ZE Page 1 of 70
Blue Derma
Operating instruction
English

Operating instructions K-Laser Blue Derma Rev. ZE Page 2 of 70
No part of this publication may be reproduced, transmitted, stored or translated into any
language, in any form or through any electronic, magnetic, optical, chemical, manual,
physical device or other means, without written consent from Eltech K-Laser s.r.l. Via
Castagnole 20/H, Treviso.
Title –Operating Instruction K-Laser Blue Derma (English language)
Date –24/10/2019
Rev. ZE
Manufacturer:
Via Castagnole, 20/H
31100 Treviso
Italy.
Tel. [phone]
Fax [phone]
e-mail [e-mail]
web site: www.klaser.eu
The device is manufactured in compliance with the provisions of
Council Directive 93/42/EEC and 2007/47/CE concerning medical devices.
0476
ISO 13485:2016

Operating instructions K-Laser Blue Derma Rev. ZE Page 3 of 70
1Warning and safety information................................................................................5
1.1 Highlighting of warning and safety information......................................................5
1.2 Intended use .........................................................................................................5
1.3 Instructions on use of the laser protective goggles................................................6
1.4 Interferences caused by mobile wireless phones..................................................6
1.5 Disposal of main unit and parts.............................................................................6
1.6 Safety precautions.................................................................................................7
2Symbols and abbreviations.....................................................................................10
2.1 Symbols on the device........................................................................................10
2.2 Glossary..............................................................................................................11
2.3 Abbreviations ......................................................................................................11
3Technical Data..........................................................................................................12
3.1 Specification........................................................................................................12
3.2 Device specification.............................................................................................12
3.3 Wireless footswitch specification.........................................................................13
3.4 Transport and storage.........................................................................................13
3.5 Operating conditions ...........................................................................................13
4Installation ................................................................................................................14
4.1 Standard equipment............................................................................................14
4.2 Spare parts and optional.....................................................................................15
4.3 Power supply.......................................................................................................16
4.3.1 Replacing the rechargeable battery .............................................................17
4.4 Optic fiber with connector....................................................................................18
4.4.1 Handpiece for therapy..................................................................................19
4.4.2 Contact surgical handpiece..........................................................................20
4.4.3 No contact surgical handpiece.....................................................................23
4.4.4 ENT handpiece ............................................................................................25
4.5 Care of handpiece’s fiber ....................................................................................26
4.6 Interlock...............................................................................................................27
4.7 Wireless footswitch..............................................................................................27
5Operation ..................................................................................................................28
5.1 Start the device for the first time..........................................................................28
5.2 Switch on/off power.............................................................................................29
5.3 Enter pin code.....................................................................................................30
5.4 Main menu screen...............................................................................................30
5.5 Programs.............................................................................................................31
5.6 Therapy...............................................................................................................44
5.7 Set-up..................................................................................................................48
5.7.1 Date&Time...................................................................................................49
5.7.2 Change P.I.N................................................................................................49
5.7.3 Set touch......................................................................................................50
5.7.4 History..........................................................................................................51
5.8 Error messages and warnings.............................................................................53
6Indications, contraindications and medical precautions......................................54
6.1 Indications...........................................................................................................54
6.2 Contraindications.................................................................................................54
6.3 Precautions .........................................................................................................54

Operating instructions K-Laser Blue Derma Rev. ZE Page 4 of 70
7Post treatment cleaning...........................................................................................55
7.1 Cleaning of the unit .............................................................................................55
7.2 Cleaning of the handpiece for therapy.................................................................56
7.3 Cleaning of the contact surgical handpiece.........................................................57
7.4 Cleaning of no contact surgical handpiece..........................................................59
7.5 Cleaning of the ENT handpiece ..........................................................................60
8Maintenance and service.........................................................................................61
8.1 Maintenance........................................................................................................61
8.2 Troubleshooting of simple defects.......................................................................61
8.3 Safety check........................................................................................................62
8.4 Technical support, repair and testing ..................................................................62
9Manufacturer’s declaration on electromagnetic compatibility.............................63
9.1 Definitions ...........................................................................................................63
9.1.1 Emission (electromagnetic)..........................................................................63
9.1.2 Interference immunity...................................................................................63
9.1.3 Immunity level..............................................................................................63
10 Appendix...................................................................................................................67
10.1 Appendix A –Label positions..............................................................................67

Operating instructions K-Laser Blue Derma Rev. ZE Page 5 of 70
1 Warning and safety information
1.1 Highlighting of warning and safety information
To prevent personal injury and/or material damage, you must observe the warning and safety
information provided in the present operating instructions.
All such information is highlighted by signal words as follows:
Notice
for additional information;
Caution
if there is any risk of damage to the device;
Warning
if there is any hazard to the life or health of persons.
This symbol indicates that you have to take action.
This symbol indicates that a certain result will occur.
1.2 Intended use
K-Laser Blue is developed as portable laser device in the following version
Derma: 445 nm with 8 W in CW, 10 W in pulsed mode, 970 nm with 3 W in CW,
total power 445 nm + 970 nm of 13 W and 660 nm with 100 mW.
The following table summarizes in detail the intended use based on the device model:
The operator can set up the parameters manually in order to be able to use the equipment with his
specific requirements.
The device can be used in medical practice, in physical therapy centers and in sport facilities. The
device can be used in an ambulatory for surgical and medical practice.
Notice
The device may be operated only by medical qualified personnel. The applicable occupational
safety regulations and accident prevention measures and the current operating instructions
must be complied with.
Notice
Users are obliged to use only faultless materials, to ensure correct application and to protect
themselves, the patient and other persons against hazards.
Warning
The device must not be used in areas where an explosion hazard exists or in the vicinity of
highly flammable materials.
Warning
Public legal requirements may include special safety regulations concerning protection against
laser radiation. These requirements must be fulfilled.
Warning
Failure to use the settings specified in this manual or perform the actions described here may
lead to a dangerous exposure to radiation.
Surgery:
- incision and coagulation of soft tissue.
Dermatological surgery:
- benign skin disease (nevus, keratosis, fibromas…);
- pigmented and vascular lesions;
- mild to moderate acne vulgaris.
Therapy:
- muscular & skeletal pathologies;
- osteoarticular diseases;
- edemas;
- soft tissue injuries;
- wound healing;
- laser acupuncture.

Operating instructions K-Laser Blue Derma Rev. ZE Page 6 of 70
1.3 Instructions on use of the laser protective goggles
Before using the laser protective goggles, please read and observe the instructions for use
provided by the manufacturer and attached to the goggles in the case.
Before using the laser protective goggles, please make sure:
the laser protective goggles are not damaged;
the laser protective goggles conform to standard EN 207 and EN 208;
the laser protective goggles are equivalent to the technical features listed in paragraph 4.1.
These instructions apply particularly when using goggles supplied from an outside source that are
not included in the scope of delivery of the device.
Warning
Check the laser protective goggles before each use. In case of damage, do not use the
goggles and replace them (see chapter Spare parts and optional).
1.4 Interferences caused by mobile wireless phones
Caution
To ensure safe operation of medical electrical equipment, the use of mobile wireless phones in
practice or hospital environments may be avoided.
Mobile devices, or radio frequencies (including cables for antenna and external antenna) must
not be closer than 30 cm (12 inches) respect every part of the device, included the power
cable provided by the manufacturer. Otherwise performance degradation of the device could
happen.
Caution
Not use the laser unit with surgical high frequency devices.
1.5 Disposal of main unit and parts
Notice
TO ALL OPERATORS pursuant to the Legislative Decree of the 14th of June 2014, n. 49,
actuation of directive 2012/19/EU on the waste of the electrical and electronic equipment.
The sign of the barred trash bin displayed on equipment or packaging thereof indicates that
upon completion of its life cycle, it should be disposed of separately from other waste.
The separate disposal of dead equipment is the producer’s responsibility. Therefore, the user
must contact the producer and follow their established procedure for its disposal.
The proper disposal of this equipment will automatically provide for the recycling and proper
processing and disposal of the same which helps to prevent possible negative effects on our
environment and health, and encourages the recycling of its parts. The improper or illegal disposal
by the user will entail the application of administrative sanctions according to the laws and
regulations in force.
Notice
Contact the distributor of your Country for the correct disposal of the main unit.
Notice
Handpieces, optic fibers, tools for cutting and disposable tips may be disposed in the domestic
refuse. Please disinfect or sterilize the parts prior to disposal.

Operating instructions K-Laser Blue Derma Rev. ZE Page 7 of 70
1.6 Safety precautions
Each device is manufactured in compliance with the provisions of Council Directive 93/42/EEC
(MDD) and 2007/47/CE concerning medical devices. Always observe the following precautions:
Warning
When disconnecting the optic fiber from the device, always cover the connector with the
special protection cap. Otherwise the unit may be permanently damaged. Make sure that no
dust or dirt can enter the connections of the optic system.
Caution
Any use of the controls or setting options in a manner other than the one described here may
lead to a dangerous exposure to radiation. Manufacturer is not responsible for damages
caused to the non-correct use of the device or to the disrespect of the instructions and caution
indicated in the present manual.
Caution
Never place your finger or any other objects in the optical connectors. This could cause
damage to the optical instrument.
Caution
Switch the device OFF immediately in case of an emergency. To do this, press the “LASER
STOP” button below the touch screen on the front side of the control unit.
Warning
Observe all labels on the device.
Warning
Operation of this laser unit by unauthorized persons must be prohibited in order to prevent
incorrect or improper use. Laser equipment not in use must be protected against unauthorized
access. This can be achieved for example by switching off the laser unit after use, so that the
electronic access key must be entered prior to further operation.
Warning
Never direct the laser beam toward a person’s eye or thyroid gland. All persons present in the
room (patient, operator and assistant) must always wear the laser protective goggles delivered
along with the device.
Warning
Never use optical instruments such as microscopes, eye loupes or magnifiers together with the
original protective goggles. Otherwise sufficient eye protection can no longer be ensured.
Warning
Oxygen-saturated materials such as cotton wool can catch fire owing to the high temperature
that the unit reaches during operation. Label removers and flammable solutions used for
cleaning and disinfecting the device should be allowed to evaporate before using the device.
Observe fire hazards caused by flammable gases.
Warning
The unit is not suitable for use in the presence of anesthetics that are flammable when in
contact with air, oxygen or nitrogen monoxide.

Operating instructions K-Laser Blue Derma Rev. ZE Page 8 of 70
Warning
Never direct the laser beam toward paper, plastics or objects with dark surfaces. They could
catch fire due to the high temperatures produced by the laser beam.
Caution
Avoid interference between the laser emission and any optical sensors of devices operated in
the vicinity of the device.
Caution
Do not place the unit near heat sources. Do not cover the convection openings for air cooling
on the sides of the unit.
Caution
The device may be operated only by authorized personnel. In order to prevent false or
improper use, the device must not be used by unauthorized persons. Do not write down the
electronic access key somewhere else in order to reduce risk of misuse of the laser by
unqualified persons. Please turn off the unit after the use.
Warning
Set up the laser unit properly and completely before putting it into operation.
Warning
Make sure that the electrical system is equipped with the required devices for protection
against direct and indirect contact (thermomagnetic switches, residual current circuit breakers)
and has been set up by a qualified electrician in compliance with the applicable standards.
National directives regarding electrical installations must be observed.
Warning
Verify that the line voltage corresponds to the voltage indicated on the rating plate of the
adapter or in the technical specifications.
Warning
Do not use the device if a visual inspection shows that it has been damaged.
Warning
If you accidentally spill any liquid on the unit, immediately stop treatment, disconnect the power
cable and contact your local depot or your authorized service center for assistance.
Caution
Never under any circumstances try to disassemble the device. This is limited exclusively to
trained and authorized personnel.
Caution
Switch the device OFF immediately in case of fiber breakage.
Caution
The use of this device close to or over (above or under) other devices must be forbidden
because an improper functionality could happen. If needed to do this, the unit and the other
ones must be maintained under control to verify the correct functionality.
Caution
The device may only be operated with the Sinpro MPU101-106 power supply and the power
cable provided.
Operation with other power supplies may result in failure or destruction of the laser unit and the
use of power cables not provided by Eltech K-Laser can compromise the conformity of the
device regarding emissive requirement and immunity. If any power supply, power cable or
accessory other than the one recommended is used, the approval of the entire unit
automatically becomes void and the warranty expires.
Caution
The use of accessories, transductors or power cables not provided by the manufacturer of the
device, could increase the electromagnetic emission and decrease the electromagnetic
immunity of the device.

Operating instructions K-Laser Blue Derma Rev. ZE Page 9 of 70
Warning
It is recommended not to use the handpiece for therapy in direct contact to skin of the patient,
but to keep distance from the skin and always move it!
Warning
Before therapeutical treatment with the handpiece for therapy, please treat fix points, keeping a
distance of at least two centimetres from the skin of the patient, in particular if you are using
CW (continuous emissions), in order to check the sensibility of the patient and the energy
density, especially if the patient’s skin is particularly brown.
Warning
In case of the use of the handpiece for therapy it is recommended to verify that the part to
treatment not present neo of great dimension or dark zones that could absorb excessive
amounts of energy. In this case protect with dioxide of titanium or zinc the treatment part.
Caution
Laser fume and/or plume may contain viable tissue particulates.
Notice
For the use of handpieces, please read carefully specific instructions and warnings.

Operating instructions K-Laser Blue Derma Rev. ZE Page 10 of 70
2 Symbols and abbreviations
2.1 Symbols on the device
Symbol
Description
Type B applied part according to IEC 60601-1.
0476
CE mark in accordance with Council Directive 93/42/EEC and
2007/47/CE, stating the manufacturer’s Notified Body.
20XX
Date of manufacture (year).
Please refer to manual first.
Do not dispose with domestic waste.
Connection socket for DC input from the power supply.
Connection socket for scanner handpiece (not implemented).
Connection socket for interlock.
Connection socket for USB.
Laser radiation warning.
Specification of laser output power and wavelength of IR and
aiming beam (see also Chapter “Technical data”).
Verifies the compliance of the device with IEC 60825-1.
Warns of potential laser radiation hazards when opening the laser
unit.
Warns of Class 4 laser radiation hazards when using the unit.